CELL-DYN Ruby System Service Manual Version 201958-114 Document Control Number 201959-114 (Front Matter) ©2006, 2015 by Abbott Laboratories. All rights reserved. Revision Log Click to view Chapter 4 Removal and Replacement and Chapter 5 Verification Procedure Revision History. All other Revision History is located in the table below: VERSION DATE SECTIONS REVISED/ADDED TSBs INCORPORATED ISAs INCORPORATED Revision 201958-114 Change Listing N/A N/A 201958-113 November 2013 Revision 201958-113 Change Listing N/A N/A 201958-112 August 2013 Revision 201958-112 Change Listing N/A N/A 201958-111 July 2012 Revision 201958-111 Change Listing N/A N/A 201958-110 March 2011 Revision 201958-110 Change Listing N/A N/A 201958-109 November 2010 Revision 201958-109 Change Listing N/A N/A 201958-114 March 2015 201958-108 July 2010 Revision 201958-108 Change Listing N/A N/A 201958-107 October 2009 Revision 201958-107 Change Listing N/A N/A 201958-106 June 2009 Revision 201958-106 Change Listing N/A N/A 201958-105 November 2008 Revision 201958-105 Change Listing N/A N/A 201958-104 July 2008 Revision 201958-104 Change Listing N/A N/A 201958-103 March 2008 Revision 201958-103 Change Listing N/A N/A 201958-102 February 2007 Revision 201958-102 Change Listing N/A 170-004 201958-101 April 2006 New Document N/A N/A CELL-DYN RUBY System Service and Support Manual (Version 201958-114) • © 2006, 2015 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. Proprietary Information (Document Control Number 204679-103) The information, documents and related graphics published herein (the "Information") are the sole property of Abbott Laboratories. Permission to use the Information is granted, provided that: The copyright notice appears on all copies; Use of the Information is for operation of ABBOTT products by Abbott trained personnel or informational use only; The Information is not modified in any way; and No graphics are used separate from accompanying text. Each person assumes full responsibility and all risks arising from use of the Information. The Information is presented "AS IS" and may include technical inaccuracies or typographical errors. Abbott Laboratories reserves the right to make additions, deletions, or modifications to the Information at any time without any prior notification. Qualifications: All samples (printouts, graphics, displays, screens, etc.) are for information and illustration purposes only and shall not be used for clinical or maintenance evaluations. Data shown in sample printouts and screens do not reflect actual patient names or test results. The information was developed to be used by Abbott Laboratories-trained personnel, by other persons knowledgeable or experienced with the operation and service of the product identified, under the supervision and with cooperation from Abbott Laboratories technical support or service representatives. In no event shall Abbott Laboratories or its affiliates be liable for any damages or losses incurred in connection with or arising from the use of the information by persons not fully trained by Abbott Laboratories. This limitation shall not apply to those persons knowledgeable or experienced with the operation and service of the product identified, under the supervision and with cooperation from Abbott Laboratories technical sales or service representatives. No part of this media may be reproduced, stored, retrieved, or transmitted in any form or by any means without the prior written permission of Abbott Laboratories. No confidential relationship shall be established in the event that any user of the Information should make any oral, written or electronic response to Abbott Laboratories (such as feedback, questions, comments, suggestions, ideas, etc.). Such response and any information submitted therewith shall be considered non-confidential, and Abbott shall be free to reproduce, publish or otherwise use such information for any purposes whatsoever including, without limitation, the research, development, manufacture, service, use, or sale of products incorporating such information. The sender of any information to Abbott is fully responsible for its content, including its truthfulness and accuracy and its non-infringement of any other person's proprietary rights. Abbott Laboratories is not engaged in rendering medical advice or services. Updates to the Information may be provided in either paper or electronic format. Always refer to the latest documents for the most current information. All Abbott Laboratories product names and trademarks are owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, trade dress, or product name may be made without the prior written authorization of Abbott Laboratories, except to identify the product or services of Abbott Laboratories. All other trademarks, brands, product names, and trade names are the property of their respective companies. All rights reserved. Except as permitted above, no license or right, express or implied, is granted to any person under any patent, trademark, or other proprietary right of Abbott Laboratories. ABBOTT LABORATORIES MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND OR NATURE WITH RESPECT TO THE INFORMATION. ABBOTT LABORATORIES HEREBY DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS OR IMPLIED, CREATED BY LAW, CONTRACT OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE OR NON-INFRINGEMENT. IN NO EVENT SHALL ABBOTT LABORATORIES BE LIABLE FOR ANY DAMAGES OF ANY KIND OR NATURE, INCLUDING, WITHOUT LIMITATION, DIRECT, INDIRECT, SPECIAL (INCLUDING LOSS OF PROFIT) CONSEQUENTIAL OR INCIDENTAL DAMAGES ARISING FROM OR IN CONNECTION WITH THE EXISTENCE OR USE OF THE INFORMATION, REGARDLESS OF WHETHER ABBOTT LABORATORIES HAS BEEN ADVISED AS TO THE POSSIBILITY OF SUCH DAMAGES. This CELL- DYN Ruby System Service Manual is published by Abbott Diagnostics, a division of Abbott Laboratories, Abbott Park, IL 60064, U.S.A. Please direct all inquiries concerning information in this manual to the foregoing address. CELL-DYN and CELL-DYN Ruby are trademarks of Abbott Laboratories in various jurisdictions. CELL-DYN Ruby System Service and Support Manual (Version 201958-111) • © 2006, 2012 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. Revision 201958-102 Change Listing This page lists the changes from Version 201958-101 to Version 201958-102 of this manual. Section Numbers Sections Revised/Added Revision Title Change to "Front Matter Content Control Number 201958-102" Title Change to "Document Control Number 201959-102" Front 1 1.2 Proprietary Information Change Copyright date General Data Change to "Document Control Number - 201960-102" Theory of Operation HGB Measurement changed 540 nm wavelength to 555 nm wavelength in two places 1.2 Changed graphic 9H_6016a to 9H_6016b 2 Troubleshooting Change to "Document Control Number - 201961-102" 2.1 Block Diagrams Changed 9H_9048.PDF 2.4 Deleted section and made a PLACEHOLDER 4 Removal & Replacement Change to "Document Control Number - 201962-102" 4 B1.02 Added new Part Numbers and Names 4 B1.02 Added new Note and updated graphic 9H_8038a to 9H_8038b 4 B1.03 Added new Part Number 4 B1.03 Added new Note to Replacement action 4 E1.01 Changed steps and added new Note to Replacement action 4 F1.04 Deleted Part Name 5 Verification Procedures Change to "Document Control Number - 201963-102" 5.1 Verification Procedures Updated Verification Procedure and Verification Matrix tables 5 VP-16 Updated Note and graphic 9H_6010a to 9H_6010b 5 VP-17 Deleted procedure and made a PLACEHOLDER 5 VP-18 Updated text in procedure 5 VP-19 Added text in step in Verify PMT Dynode Voltage 5 VP-31 Changed psi valves in text of procedure 5 VP-36 Changed Purpose and added Materials to procedure 5 VP-38 Added new VP "Un-installing Installed Version of the Operator's Manual" 5 VP-41 Updated steps in New Application Software Installation area and changed time in Note in Reload Application Software area 5 VP-45 Added new VP "System Language Change Procedure" 5 VP-46 Added new VP "Installation of Operator's Manual from Media (English and Multilingual Version)" 5 VP-52 Added new VP "Operating System - User Account Log On Procedure" 5 VP-54 Updated text in Verify Performance Specification action area 5 VP-55 Added new VP "Creating a Windows XP Firewall Exception for the File Transfer Program" CELL-DYN RUBY System Service and Support Manual (Version 201958-102) • Copyright 2006, 2007 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. Revision 201958-103 Change Listing This page lists the changes from Version 201958-102 to Version 201958-103 of this manual. Section Sections Numbers Revised/Added Revision Front Title Change to "Front Matter Content Control Number 201958-103" Front Title Change to "Document Control Number 201959-103" Front Proprietary Information Change Control Number 204679-101 Chap 4 Title Document Control Number, change to "201962-103" Chap 4 Locator table Parts and RR names will be pulled directly from approved records in FRU. Chap 4 All RR procedures Parts and verification information will be pulled directly from approved records in FRU. A note dynamically sourced from FRU, "Inspect tools for damage, ensure calibration is not expired and replace if necessary.", has been added at the beginning of the RR. An additional verification procedure, G110, has been added as the final verification of each RR. Chap 5 Verification Procedures Change to "Document Control Number - 201963-103" Chap 5 All VPs Two notes dynamically sourced from FRU, "Inspect tools for damage, ensure calibration is not expired and replace if necessary." and "At the completion of this VP: After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary.", have been added at the beginning of the procedure. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. Revision 201958-104 Change Listing This page lists the changes from Version 201958-103 to Version 201958-104 of this manual. Section Numbers Sections Revised/Added Revision Front Title Change to "Front Matter Content Control Number 201958-104" Front Title Change to "Document Control Number 201959-104" Chap 2 Troubleshooting Change to "Document Control Number 201961-103" Chap 2 Troubleshooting Edited Analyzer Setpoints Reference Chart information. Chap 5 VP-18 Updated graphic 9h_6012b. Chap 5 VP-19 Updated graphic 9h_6012b. Chap 5 VP-20 Updated graphic 9h_6012b. Chap 5 VP-21 Updated graphic 9h_6012b. CELL-DYN RUBY System Service and Support Manual (Version 201958-104) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. Revision 201958-105 Change Listing This page lists the changes from Version 201958-104 to Version 201958-105 of this manual. Section Numbers Sections Revised/Added Revision Front Title Change to "Front Matter Content Control Number 201958-105" Front Title Change to "Document Control Number 201959-105" Troubleshooting Change to "Document Control Number 201961-104" Chap 2 Chap 2 Updated graphic 9H_9048d Cable Connection Diagram. Chap 2 Updated graphic 9H_9048d_A. Chap 2 Updated graphic 9H_9048d_B. Chap 2 Updated graphic 9H_9054b, Integrated Sample Loader, Sample Processor Flow Diagram. Chap 2 Updated graphic 9H_9057b_A. Chap 2 Updated graphic 9H_9057b_B. Chap 5 Verification Matrix Updated text in Hard Disk Drive. CELL-DYN RUBY System Service and Support Manual (Version 201958-105) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. Revision 201958-106 Change Listing This page lists the changes from Version 201958-105 to Version 201958-106 of this manual. Section Numbers Sections Revised/Added Revision Front Title Change to "Front Matter Content Control Number 201958-106" Front Title Change to "Document Control Number 201959-106" Troubleshooting Change to "Document Control Number 201961-105" Chap 2 Chap 2 Updated graphic 9H_9048e Cable Connection Diagram. Chap 2 Updated graphic 9H_9048e_B. CELL-DYN RUBY System Service and Support Manual (Version 201958-106) • © 2006, 2009 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. Revision 201958-107 Change Listing This page lists the changes from Version 201958-106 to Version 201958-107 of this manual. Section Numbers Sections Revised/Added Revision Front Title Change to "Front Matter Content Control Number 201958-107" Front Title Change to "Document Control Number 201959-107" Troubleshooting Change to "Document Control Number 201961-106" Chap 2 Chap 2 Updated graphic 9H_9056b Diagnostic Flow System Diagram. CELL-DYN RUBY System Service and Support Manual (Version 201958-107) • © 2006, 2009 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. Revision 201958-108 Change Listing This page lists the changes from Version 201958-107 to Version 201958-108 of this manual. Section Numbers Sections Revised/Added Revision Front Title Change to "Front Matter Content Control Number 201958-108" Front Title Change to "Document Control Number 201959-108" Front Proprietary Information Change Manual Revision Number to 204679-102 Proprietary Information Updated the Trademark information Troubleshooting Change to "Document Control Number 201961-107" Analyzer Setpoints Reference Chart Deleted Pressure/Vacuum Pump Recover Time Test (at sea level) table. Optics Bench Offset Specification Updated text in Individual Gain Setting, Mean Channel Range and CV Specification table. Application Software Corrected day typo in the Day column of table. Chap 2 CELL-DYN Ruby System Service and Support Manual (Version 201958-108) • © 2006, 2010 • CELL-DYN and CELL-DYN Ruby are registered trademarks of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. Revision 201958-109 Change Listing This page lists the changes from Version 201958-108 to Version 201958-109 of this manual. Section Numbers Sections Revised/Added Revision Front Title Change to "Document Control Number 201959-109" Front Title Change to "Front Matter Content Control Number 201958-109" General Data Change to "Document Control Number 201960-103" Chap 1 Updated two graphics, Sample Staging Flow Diagram 9H_9039b and Sample Delivery Flow Diagram 9H_9040b. CELL-DYN Ruby System Service and Support Manual (Version 201958-109) • © 2006, 2010 • CELL-DYN and CELL-DYN Ruby are registered trademarks of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. Revision 201958-110 Change Listing This page lists the changes from Version 201958-109 to Version 201958-110 of this manual. Section Numbers Sections Revised/Added Revision Front Title Change to "Document Control Number 201959-110" Front Title Change to "Front Matter Content Control Number 201958-110" General Data Change to "Document Control Number 201960-104" Chap 1 Update text in Motor Control Subsystem, under Introduction to change ‘AC’ to ‘DC’ and add ‘and by the PRM’. Chap 2 Troubleshooting Change to "Document Control Number 201961-108" Updated graphic 9H_9055b Vac/Press Supply Flow Diagram. CELL-DYN Ruby System Service and Support Manual (Version 201958-110) • © 2006, 2011 • CELL-DYN and CELL-DYN Ruby are registered trademarks of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. Revision 201958-111 Change Listing This page lists the changes from Version 201958-110 to Version 201958-111 of this manual. Section Numbers Sections Revised/Added Revision Front Title Change to Manual Revision Number "201959-111" Front Title Change to "Front Matter Content Control Number 201958-111" Front Proprietary Information Change Document Control Number to 204679-103 Proprietary Information Updated the Trademark information Troubleshooting Changed document control number from "201961-109" to "201961-110". Troubleshooting Changes to diagrams 9H_9054c, 9H-9056c, 9H_9057c, 9H_9057c_a, 9H-9058b RR - B1.02 Updated graphic 9h_8038b. RR - D1.01 Updated graphic 9h_8061b. RR - F1.01 Update to Sample Loader Cover removal procedure. Chap 2 Chap 4 CELL-DYN Ruby System Service and Support Manual (Version 201958-111) • © 2006, 2012 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. Revision 201958-112 Change Listing This page lists the changes from Version 201958-111 to Version 201958-112 of this manual. Section Numbers Sections Revised/Added Revision Front Title Change to Manual Revision Number "201958-112" Front Title Change to "Front Matter Content Control Number 201959-112" Troubleshooting Changed document control number from "201961-109" to "201961-110" Troubleshooting Changes to diagrams Chap 2 CELL-DYN Ruby System Service and Support Manual (Version 201958-112) • © 2006, 2013 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. Revision 201958-113 Change Listing This page lists the changes from Version 201958-112 to Version 201958-113 of this manual. Section Numbers Sections Revised/Added Revision Front Title Change to Manual Revision Number "201958-113" Front Title Change to "Front Matter Content Control Number 201959-113" Troubleshooting Changed document control number from "201961-110" to "201961-111" Troubleshooting Changes to diagram 9h_9054d Chap 2 CELL-DYN Ruby System Service and Support Manual (Version 201958-113) • © 2006, 2013 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. Revision 201958-114 Change Listing This page lists the changes from Version 201958-113 to Version 201958-114 of this manual. Section Numbers Sections Revised/Added Revision Front Title Change to Manual Revision Number "201958-114" Front Title Change to "Front Matter Content Control Number 201959-114" General Data Change document control number from "201960-104" to "201960-105." Chap 1 Change title and content for Warning icons and Descriptions to Safety Symbols and Classifications. CELL-DYN RUBY System Service and Support Manual (Version 201958-114) • © 2006, 2015 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. General Data Document Control Number 201960-105 CELL-DYN RUBY System Service and Support Manual (Version 201958-114) • © 2006, 2015 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. Safety Links Biohazards Biological Hazards Chemical Hazards Electrical Safety Electrostatic Discharge (ESD) Hazard Signal Words Laser Safety Mechanical Hazards Physical Hazards Safety Symbols & Classification Static Hazard Hazard Signal Words Introduction Operation, maintenance and servicing of CELL-DYN Ruby system may expose individuals to potential safety and health hazards. All work must be performed in accordance with procedures described in the Abbott Operator's or Service Manuals. This section describes the types and locations of potential hazards that could cause physical harm to service personnel. Warnings are inserted throughout this manual to alert service personnel to potential hazards. Standard warning conventions including hazard signal words (example, Danger) and symbols are described below. These words and symbols are used to indicate physical, mechanical, or procedural conditions that could result. Definitions Hazard signal word definitions are described below. Signal Word DANGER Definition Denotes an immediate hazard which, if not avoided, could result in serious injury or death. This signal word represents the highest level of any hazardous situation. WARNING Denotes a hazard which could result in moderate to serious personal injury. Caution Denotes potential hazards that could result in minor injury. Also used for conditions or activities that could interfere with proper functioning or performance of the instrument. Note Denotes operator or service information. Safety Symbols & Classification Safety hazard symbols are used in this manual and on instrument labels to identify potentially dangerous conditions or situations. In this manual and on some instrument labels, text accompanies the safety symbol to describe the hazard, or symbols may be used in lieu of text. For other instrument labels, the operator is to refer to the manual for specific information, or you must recognize the symbols and understand the type and degree of potential hazard. Symbol Classification Symbol Description Safety Recommendation DANGER Class 3B Laser Identifies an activity or area where operators are exposed to an eye hazard if procedural or engineering control is not observed Denotes lasers or laser systems that can produce an eye hazard if viewed directly. This includes intrabeam viewing of specular reflections. DANGER High Voltage Identifies high voltage areas over 600 volts and the possibility of electrical shock in noted activity or at posted locations in the power supply. Prior to servicing power supply assemblies, verify that the system is powered off and the power cord to the analyzer is disconnected. WARNING Chemical Hazard Identifies an activity or an area where hazardous chemicals are present. Wear safety glasses, chemical resistant gloves, and a lab coat when handling the following solutions (Abbott cleaning solutions and various reagents). These solutions may be potentially harmful. Refer to the Material Safety Data Sheet (MSDS) or package insert for specific safety information. In case of contact with the skin or eyes, flush with water at least 15 minutes. If irritation persists or signs of toxicity occur from exposure, seek medical attention immediately. WARNING Splash/ Spray Hazard Identifies an activity where fluids may be under pressure. Fluids may be under pressure. Follow procedures and wear appropriate personal protective equipment. WARNING Potential Biohazard Identifies an activity or area where operators may be exposed to potentially infectious substances Consider all clinical specimens, reagent controls, surfaces, or components that contain or have contacted human blood or serum as potentially infectious. Wear gloves, lab coats, and safety glasses, and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule (29 CFR Part 1910.1030) or other equivalent biosafety procedures. WARNING Electrical Identifies the possibility of When the instrument is powered and protective covers are removed, there are exposed electrical systems that could startle or seriously Shock Hazard electrical shock if procedural or engineering controls are not observed injure personnel upon contact. Use appropriate safety precautions to prevent body and/or tool contact with live electrical components, especially power supplies. Turn off the power to the instrument and disconnect the power cord before replacing fuses, printed circuit boards, (etc.). Replace only the fuses that are externally accessible and labeled. Only use replacement fuses of the specified type and electrical rating. Caution Lifting Hazard Identifies an activity where it may be required to lift or move a heavy object. The system weighs approximately 230 pounds. Obtain assistance when moving and/or use appropriate lifting devices. Caution Moving Parts Identifies an activity or an area where moving parts are present. Possible injury may result from allowing part of your body to enter a range of mechanical movement during instrument operation. Keep all protective covers in place when instrument is running. Caution Identifies an Consult caution/warning instructions. activity that may present a safetyrelated hazard. Caution Identifies an Electrostatic area where Discharge electrostatic discharge may be present. A ground strap must be worn while servicing the system. Indicates that the material has Harmful (Xn) or Irritant (Xi) properties. The operator must wear a ground strap while servicing the system. The labeling of CELL-DYN Ruby System reagents/calibrators/controls or liquid consumables may include this hazard symbol. The symbols are used to convey particular properties of the chemical or chemical mixture, and to notify you that precautions should be taken when working with the material. Always consult the specific package insert or Material Safety Data Sheet for further information. Biohazards WARNING Potential Biohazard Biological Hazards The following activities may involve the presence of biological materials: Handling samples, reagents, calibrators, and controls Cleaning spills Handling and disposing of waste Moving the System Performing maintenance procedures Performing decontamination procedures Performing component replacement procedures Precautions Consider all clinical specimens, reagents, controls, and calibrators that contain human sourced material and instrument surfaces or components that have come in contact with human sourced material as potentially infectious. No known test method can offer complete assurance that products derived from human sourced material or instrument components exposed to human sourced material will not transmit infection. Therefore, all products derived from human sourced materials and instrument components exposed to human sourced material should be considered potentially infectious. It is recommended that all potentially infectious materials be handled in accordance with the OSHA Bloodborne Pathogens Rule (29 CFR Part 1910.1030) or other equivalent biosafety procedures. Precautions include, but are not limited to the following: Wear gloves, lab coats, and protective eyewear when handling human sourced material or contaminated instrument components. Do not pipet by mouth. Do not eat, drink, smoke, apply cosmetics, or handle contact lenses when handling human sourced material or contaminated instrument components. Clean spills of potentially infectious materials and contaminated instrument components with an appropriate tuberculocidal disinfectant, such as 0.5% sodium hypochlorite or other suitable disinfectant. Decontaminate and dispose of all specimens, reagents, and other potentially contaminated materials in accordance with local, state, and federal regulations. If you are exposed to biohazardous or potentially infectious materials you should immediately take the following steps to cleanse the affected area, and seek medical attention as soon as possible: Eyes-rinse with water for 15 minutes. Mouth-rinse with water. Skin-wash the affected area with soap and water. Puncture wound-allow to bleed freely. Wash the affected area with soap and water. Sharps Probes, needles, aspiration probes are sharp and potentially contaminated with infectious materials. Avoid contact with the tips of these parts. Handling Spills Clean spills in accordance with established biosafety practices. In general, safe work practices for cleaning spills include: 1. 2. 3. 4. 5. Wear appropriate personal protective equipment, such as gloves, labcoat, and protective eyewear. Absorb the spill with absorbent material. Wipe the spill area with detergent solution. Wipe the area with an appropriate tuberculocidal disinfectant such as a 0.5% sodium hypochlorite solution. Dispose of spilled and contaminated material in accordance with local, state, and federal regulations. Instrument or Part Decontamination Always wear appropriate personal protective equipment (protective eyewear, gloves, lab coat) while performing decontamination activities. Prior to service or maintenance, the instrument should be decontaminated in accordance with the following: 1. Remove and dispose of contaminated disposables in a regulated medical waste container. 2. Clean and decontaminate the exterior of the instrument using a detergent solution followed by a 0.5% sodium hypochlorite solution or other tuberculocidal disinfectant. Flush the fluid pathway as specified in the CELL-DYN Ruby System Operator's Manual. For information on preparing the proper concentration of sodium hypochlorite solution, refer to VP-14 Decontamination. Caution Under normal circumstances, printed circuit boards do not require decontamination. Field Replaceable Units (FRUs) enclosed inside the skins of computer and peripheral equipment are not considered to be contaminated. Decontamination may affect the performance of a printed circuit board or internal computer component. Handling Waste Dispose of all potentially infectious materials (clinical specimens reagents, controls, calibrators, standards, cuvettes, liquid consumables, and contaminated gloves, wipes, swabs, and other disposables that may be contaminated) in accordance with local, state, and federal regulations. Sharps, such as probes, needles, broken glass, slides and other sharps that are contaminated with potentially infectious substances, should be placed in an appropriately labeled, puncture resistant and leak proof container before treatment and disposal. Electrical Safety The CELL-DYN Ruby System does not pose uncommon electrical hazards to Operators if it is installed and operated without alteration, and is connected to a power source that meets required specifications. Refer to Pre-Site Specification & Checklist for details. Basic electrical hazard awareness is essential to the safe operation of any system. Only qualified field service personnel should perform electrical servicing. Elements of electrical safety include, but are not limited to the following: Periodically inspect electrical cabling into and on the system for signs of wear and damage. Turn the instrument OFF before disconnecting the power cord and before cleaning, servicing, or performing maintenance on any electrical or internal component. In the event of a blown fuse or thrown circuit breaker, determine the cause and correct the problem before attempting to resume operation of the equipment. Replace only the fuses that are externally accessible and labeled. Only use replacement fuses of the specified type and electrical rating. Assure the power to the instrument is turned OFF. A high voltage charge may remain on the power supply with the power OFF. Use an electrically insulated tool to disconnect the power supply and short (both male pins) to the instrument chassis. Keep liquids away from all connectors of electrical or communication components. Unplug the instrument before clean-up of major liquid spills. Clean spilled fluids immediately. Do not touch any switches or outlets with wet hands. Keep the floor dry and clean under and around the system. Use only approved power cords and electrical accessories, such as those supplied with the instrument, to protect against electric shock. Connect power cords only to properly grounded outlets. It is recommended that a ground fault circuit interrupter be used when working in a wet environment. Laser Safety DANGER AVOID DIRECT EXPOSURE TO BEAM The CELL-DYN Ruby is a Class 1 laser product. Do not look directly into the laser beam, aperture, or any reflection of the beam from a mirror-like surface. Do not place any optics into the beam, or remove the protective covers, or bypass the interlocks. Do not use controls or adjustments, or perform procedures other than those specified. Do not remove, damage, or obliterate the laser warning labels. If any label becomes illegible, replace it. When the access door, or inner protective cover are removed, helium-neon laser power up to 10 mW continuous wave at 632.8 nm in a beam with a 1 mR divergence could be accessible in the interior of the optics bench. This amount of energy, with insignificant attenuation with distance, is sufficient to cause eye damage. Caution Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous laser light exposure. If the instrument is used or modified in a manner not specified by the manufacturer, the protection provided by the instrument may be impaired. Laser Caution Labels The Class 1 Laser Product Label (Abbott PN 9230702) placement is shown below. The label consists of black lettering against a yellow background. The label is located on the backside of the instrument and positioned at a clearly visible location. The inner protective cover laser warning labels must not be removed and are to remain legible. The protective housing label (Abbott PN 9230701) is shown below. The label consists of black lettering against a yellow background. This label appears on the protective cover (under the top cover) that covers the laser mirrors and on the upper left side of the flow panel. For beam alignment and other open beam configurations, follow instructions provided by the Service Manual, Advisories, and Bulletins regarding the requirement for using laser safety eyewear. If required, assure laser eyewear is not damaged and has an optical density of 1-2 at a wavelength of 632.8 nm. During open beam configurations, assure that the beam is confined to the laser bench area and only personnel with proper eye protection are present. Class 1 Laser Product Label (PN 9230702) Laser Protective Housing Warning Label (PN 9230701) Under Top Cover Laser Warning Label Location Flow Panel Laser Warning Label Location Rear Panel Class 1 Laser Product Label Mechanical Hazards The CELL-DYN Ruby System is an automated system that operates under computer control. As with most automated equipment, there is potential for injury and bodily harm from moving mechanical components whenever the instrument is in operation. The system minimizes mechanical hazards by providing guards to protect against accidental contact with moving components, and encoding the software with safety features. Operators of the CELL-DYN Ruby System are potentially exposed to moving mechanical components such as the syringe panel. Use caution when performing any maintenance procedure on the syringe panel as moving parts can pinch. Basic elements of mechanical equipment safety include but are not limited to: Never bypass or override a safety device. Keep all protective covers and barriers in place. Never perform manual tasks on the work surface of the System. Never allow any part of your body to enter a range of mechanical movement during System operation. Do not wear articles of clothing or accessories that could catch on the System. Keep pockets free of items that could fall into the System. Be especially cautious when performing adjustment, maintenance, cleaning, or repair procedures. Use caution when loading reagents. In the event of an instrument malfunction or an unexpected sequence of movements, be aware that unexpected field service personnel reflex actions could occur, causing injury. Chemical Hazards You may be exposed to hazardous chemicals when handling reagents, calibrators, controls, or liquid consumables. Exposure to hazardous chemicals is minimized by following instructions provided in the assay-specific Package Inserts and Material Safety Data Sheets (MSDS). Exposure levels are further reduced by the design features of the instrument when it is used properly. Precautions In general, observe the following precautions when handling chemicals: Consult Material Safety Data Sheets for safe use instructions and precautions. Avoid contact with skin and eyes. If contact with material is anticipated, wear impervious gloves and protective eye wear and clothing. Always maintain good housekeeping. Do not eat, drink, or store food and beverages in areas where chemicals are used. If irritation or signs of toxicity occur after exposure, seek medical attention. Hazard symbols that may appear on CELL-DYN Ruby System product labeling may be accompanied by Risk (R) and Safety (S) numbers and represent specific risk and safety phrases as defined by European Community Directives. The risk and safety phrases describe precautions to be used when working with a particular chemical or chemical mixture. For all (R) and (S) numbers that appear on product labeling, refer to the corresponding phrases indicated in the Package Insert or similar document. Physical Hazards Sharps and Probes The probe, vent needle, and aspiration probe are sharp and potentially contaminated with infectious materials. Avoid contact and handle cautiously to prevent injury. Never reach into the instrument while it is in operation. In general, use of sharps and glassware should be minimized. Use mechanical means to remove contaminated broken glassware. Dispose of sharps in an appropriately marked, puncture-resistant, and leakproof container before treatment and disposal. Heavy objects The waste container is heavy when full. Use care when handling the container to reduce the risk of injury. The system is heavy and has unsupported sections of the shell. Ensure that you have adequate help before attempting to move the system. Push only on solid sections of the housing; do not exert pressure on unsupported sections of the shell. Use proper lifting techniques when moving the System. Trip hazard The System is equipped with a power cord and various computer connectors. To avoid a tripping hazard, ensure cords in high traffic areas are properly stowed. Electrostatic Discharge (ESD) Many of the electronic components on the System circuit boards are susceptible to electrostatic discharge (ESD). Static discharge of as little as 100 - 200 volts can damage or destroy a component. To put that in perspective, depending on the floor covering, relative humidity and other factors, walking across a floor generates between 250 - 35,000 electrostatic volts. Attempts to ground oneself and remove the static charge by grasping the instrument chassis provides only momentary resolution. Static Hazard Static protective procedures are used during the manufacture of PC boards. Replacement PC board assemblies are also protected by use of static protective packaging as well as boxed to prevent physical damage. Assemblies that have failed and are returned for repair are also handled at the repair shop under static protection procedures. Handling Guidelines - PC Subassemblies These guidelines assure protection against failures created by static. Retain spare PC board subassemblies in the static-protective bags. Use an approved static-protective field service kit, or the ground strap shipped with the board, whenever a board is removed from an instrument or protective bag. Replace the defective PC board in the same protective bag to return for repair. Continued use of the protective shipping boxes, both during shipping and storage, eliminates most failures caused by physical damage. Static Protective Service Kit The static protective service kit (14207-035) is designed to keep the FSE/FSR, replacement part, work surface, and instrument at the same ground level. Generally, an instruction set accompanies the kit, however, in the absence of specific instructions, follow ESD Procedure. Kit Parts Static protective work surface Wrist strap and attaching cable Grounding clip or cable ESD Procedure Note Use where ESD symbol is present and static protective equipment is not shipped with replacement part. 1. Place the work mat on a solid surface close to the instrument, allow the ground strap to reach the instrument. 2. Attach the ground clip to the instrument chassis. 3. Attach the other end of the ground clip cable and the connector from the wrist strap to the work mat. (Exception: Some wrist strap cables provide a clip to connect to the same ground source as the mat cable). 4. Attach wrist strap to your wrist, make sure the metallic button on the inside of the wrist strap is in direct contact with your 5. 6. 7. skin. Place PC boards, removed from the instrument, on the work mat. Replacement PC boards should be placed on the work mat before removing from the protective bag and remain on the mat until installation. Defective PC boards should be replaced in the static-protective bag before removal from the work mat area. CELL-DYN RUBY System Service and Support Manual (Version 201958-114) • © 2006, 2015 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. System Description Introduction This section contains information on assembly locations, mechanical hardware descriptions and functions, fluidic hardware descriptions and functions, and electronic hardware descriptions and functions. Descriptions of the CELL-DYN Ruby parameters, reagents, and operation is contained in the Operator's Manual. System Configuration Introduction Refer to CELL-DYN Ruby System. The CELL-DYN Ruby does have an industrial type single board computer build in the analyzer. The CELL-DYN Ruby personal computer section is divided into three parts: PC Module, Video Display, and Keyboard. The PC Module resides in the Analyzer as a module, and the Video Display and Keyboard are external to the Analyzer. The sample processing section of the Analyzer performs the functions of reagent and sample handling and gathers raw cell data from the HGB Flow Cell and Optics Bench described in Section 1. The PC Module, in conjunction with the Video Display and Keyboard, perform the final processing of the raw cell data and all the user interface functions, such as display, printing, RS-232 communications, etc. Analyzer Configuration Analyzer Front View is a front view of the Analyzer showing the major assemblies. These assemblies perform the functions of sample, reagent, and waste processing, and is explained in detail later in this section. The optics bench (flow cytometer) is located on top of the instrument, just behind the flow panel. Analyzer Left Side View is a left side view showing the air supply. Analyzer Right Side View is a right side view of the Analyzer, showing the PC module and computer door. CELL-DYN Ruby System Analyzer Front View Designator Description Designator Description 3.1 Analyzer Main 5.1 Right Front Flow Panel 3.1.10 Optical Sensor, Center Cover 5.1.1 Shear Valve 4.1 Left Front Flow Panel 5.1.2 HGB Heater 4.1.1 Diluent/Sheath 5.1.3 (quiet) Reservoir 1 WBC Lyse Reservoir 4.1.2 Diluent/Sheath 5.1.4 (noisy) Reservoir 2 WC-2 4.1.3 Vent Acc 5.1.5 WC-4 4.1.4 WC-1 5.1.6 Overpressure Sensor 4.1.5 WC-3 5.1.7 Dual Syringe Drive (C,D) 4.1.6 Diluent/Sheath 5.1.8 Filter (small) Dual Syringe Drive (A,B) 4.1.7 Sample Staging Peristaltic Pump 5.1.9 Drip Tray 4.1.8 RBC/PLT Mixing Chamber 5.1.10 RBC/HGB Diluent Syringe 4.1.9 WBC (WOC) Chamber 5.1.11 WBC Lyse Syringe 4.1.10 HGB Flow Cell 5.1.12 HGB Lyse Syringe 4.1.11 WOC Heater 5.1.13 Sample Injection Syringe 4.1.12 Bubble Trap 5.1.14 Ultrasonic Short Sample Sensor (S1) Sol. 2-1, 2-2, 4-1, 5-1, 5-2, 5-4, 5-5, 5-6, 5-7, 6-1, 6-2, 6-3, 6-4, 6-7, 6-8, 9-1, 9-2, 9-3, 9-4, 9-5, 9-6, 9-7, 9-8 Solenoid Valve 3.9 kg White (NO) 5.1.15 Short Sample Sensor (S2) Sol. 6-5, 6-6 Solenoid Valve Black (NC) 5.1.16 Cover Blood Sample Detector Sol. 1-1, 1-2, 1-3, 1-4, 1-7, 1-8, 2-4, 2-5, 2-6, 2-7, 3-1, 3-2, 3-3, 3-6, 3-7, 3-8, 4-2, 4-3, 4-4, 4-5, 4-6 Solenoid Valve 3.9 kg White (NO) Sol. 1-5, 2-3, 2-8, 3-4 Solenoid Valve Black (NC) Analyzer Left Side View Designator Description Designator Description 3.1 Analyzer Main 7.1.7 ACC 3 3.1.9 APS 7.1.8 ACC 4 6.1 Optics Bench Assy 7.1.9 ACC 5 7.1 VAC/PRESS Supply/Electronics Assy 7.1.10 SHM 1 7.1.1 PRESS Pump 7.1.11 SHM 2 7.1.2 VAC Pump 7.1.12 Chopper Drive PCB, OTS 7.1.3 VPM 7.1.13 Fan 2 7.1.4 PRM V1 (7-1), V4 (7-2) Solenoid Valve 5kg Large Black (NO) 7.1.5 ACC 1 V2, V3, V5 7.1.6 ACC 2 Analyzer Right Side View Solenoid Valve 3.9kg White (NO) Designator Description Designator Description 8.1 Computer/Electronics Assy 8.1.7 Industrial SBC 8.1.1 ATX CPS 8.1.8 PDM 8.1.2 CD-RW 8.1.9 TCM 8.1.3 FDD 8.1.10 CPU/DCM 8.1.4 HDD 8.1.11 MAM 8.1.5 Backplane PCI/ISA ATX 8.1.12 SPM 8.1.6 HSSL Keyboard Adapter 8.1.13 Fan 3 Analyzer Rear View Designator Description Designator Description 3.1 Analyzer Main 3.1.6 Diluent/Sheath Inlet 3.1.1 AC IN + Filter 3.1.7 WBC Lyse Inlet 3.1.2 Analyzer Main Switch 3.1.8 Fan Filter 3.1.3 External Waste Full Sensor Connector 3.1.11 Fan 1 3.1.4 External Waste Outlet Computer/Electronics Assy 3.1.5 HGB Lyse Inlet 8.1 Analyzer Top View Flow System Functional Description Introduction The flow system differs substantially from our other instruments in three ways. The first is that there is no impedance transducer on the CELL-DYN Ruby, and RBCs and PLTs are both counted and sized by the optical flow cell. The second is that the HGB mixing chamber is a light-tight enclosure that is also the HGB flow cell. The third is that the initial whole blood sample is aspirated by a vacuum source and not a sample syringe or pump. The other principles of the flow system are very similar to the CELL-DYN 3700 and CELL-DYN Sapphire. For the sake of explanation, the flow system is divided into the following distinctly different functions needed to perform the various flow sequences used on the CELL-DYN Ruby. Vacuum Flow Pressure Flow Reagent Flow Sample Aspiration Flow Dilution & Mixing Flow Sample Staging Flow Sample Delivery & Measurement Flow Cleaning & Waste Flow The following paragraphs describe each of these functions. Vacuum Flow Description Associated Pinch Valves Valve Number 5 Valve Function ACC5, VAC 2 (variable) Supply 17 WC-2, VAC 2 Supply 31 WC-4, VAC 1 Supply 45 WBC Lyse Reservoir, VAC 1 61 Diluent/Sheath (noisy) Reservoir 2, VAC 1 62 Diluent/Sheath (quiet) Reservoir 1, VAC 1 97 WC-3, VAC 1 Functional Description Refer to Vacuum Flow Diagram. There are two vacuum accumulators employed on the CELL-DYN Ruby: ACC 4 holds VAC 1 that is used to pull fluids into the reagent reservoirs and waste chambers. ACC 5 holds VAC (variable) and supplies WC-2. The primary purpose of this vacuum is to aspirate the whole blood sample through the shear valve. It has three (3) levels depending on being in the open (Hematology or Retic) or closed (Hematology) sample mode. Due to the plumbing configuration, the vacuum level is higher when in the closed mode. Vacuum Flow Diagram Pressure Flow Description Associated Pinch Valves Valve Number Valve Function 2 ACC 2, PRESS 2 Supply 3 ACC 3, PRESS 3 Supply 18 WC-2, PRESS 1 Supply 32 WC-4, PRESS 1 46 WBC Lyse Reservoir, PRESS 3 63 Diluent/Sheath (quiet) Reservoir 1, PRESS 3 64 Diluent/Sheath (noisy) Reservoir 2, PRESS 2 Functional Description Refer to Pressure Flow Diagram. PRESS 1, generated directly by the pump, performs the functions of supplying pressure to ACC 2 and ACC 3, and also supplies pressure to WC-1 through WC-4 used for emptying the chambers. PRESS 2 is used to supply Diluent/Sheath (noisy) Reservoir 2 used for hydrodynamic focusing in the optical flow cell, and also flushing the optical flow cell. PRESS 3 is used to supply pressure to the Diluent/Sheath (quiet) Reservoir 1 and WBC Lyse Reservoir. This low pressure is used for various flushing functions throughout the flow system. A low pressure is needed to prevent leaking when the wash blocks are used to clean the open and closed probes. Pressure Flow Diagram Reagent Flow Description Associated Pinch Valves Valve Number Valve Function 11 Shear Valve Diluent/Sheath (quiet) Flush 15 Open Sample Probe Diluent/Sheath (quiet) Flush 22 Sample Injection Syringe Diluent/Sheath (noisy) 23 WBC Lyse Reservoir Output 28 Main HGB Lyse Supply 33 RBC/HGB Diluent Syringe Diluent/Sheath (quiet) 34 Closed Probe Diluent/Sheath (quiet) Flush 65 Diluent/Sheath (noisy) Reservoir 2 Output 66 Diluent/Sheath (quiet) Reservoir 1 Output 91 Optical Flow Cell Diluent/Sheath (noisy) Flow 94 HGB Flow Cell Diluent/Sheath (quiet) Flush 95 RBC/PLT Mixing Chamber Diluent/Sheath (quiet) Flush 96 WBC (WOC) chamber/WOC Heater WBC Lyse Flush Functional Description Refer to Reagent Flow Diagram. The Diluent/Sheath entering the flow system supplies two reservoirs: the Diluent/Sheath (quiet) Reservoir 1 and the Diluent/Sheath (noisy) Reservoir 2. The Diluent/Sheath (quiet) exiting the Reservoir 1 through 66 performs the following functions. Flushes the shear valve through 11 Flushes the open sample probe through 15 Fills the RBC/HGB diluent syringe through 33 Flushes the closed sample probe through 34 Flushes the HGB flow cell through 94 Flushes the RBC/PLT cup through 95 Flushes the WBC (WOC) chamber/WOC Heater through 96 Dilutes the RBC/PLT sample Partially dilutes the HGB sample The Diluent/Sheath (noisy) exiting the Reservoir 2 through 65 is used for hydrodynamic focusing of the sample streams, filling the sample injection and WBC Lyse syringe, and flushing the optical flow cell. Reagent Flow Diagram Sample Aspiration Flow Description Associated Pinch Valves Valve Number Valve Function 12 Sample Aspiration Vacuum 17 WC-2, VAC 2 Supply Functional Description Sample Aspiration Flow Diagram. During sample aspiration, the whole blood sample is pulled from the open or closed probe through the shear valve by the vacuum in WC-2 (variable). Due to the differences in plumbing (open vs. closed), the VAC 2 is a variable vacuum set to three different levels (open mode Hematology, Retic, and closed mode Hematology). To detect a short sample condition during sample aspiration and transfer two ultrasonic sensors (S1, S3) and one blood sample detector (S2, green 555 nm LED) are employed in the sample aspiration flow system. S1 controls the leading edge (open&closed mode) during aspiration. S3 controls the leading edge (open mode) during transfer. These sensors detect the presence or absence of liquid in the aspiration line, and they are not adversely affected by the density or viscosity of the sample. Blood sample detector (S2) controls the leading edge (closed mode) during transfer. Sample Aspiration Flow Diagram Dilution & Mixing Flow Description Associated Pinch Valves Valve Number Valve Function 24 HGB Lyse Syringe Output 25 WBC Lyse Syringe Output 26 RBC/HGB Diluent Syringe HGB/NOC Dilution 27 RBC/HGB Diluent Syringe RBC/PLT Dilution 51 HGB Flow Cell Vent Functional Description Refer to Dilution & Mixing Flow Diagram. The CELL-DYN Ruby employs hydrodynamic transfer to transport the RBC/PLT, WBC (WOC), and HGB/NOC dilutions to its respective cup where we apply PRESS 3 for bubble mixing. The input ports in the cups are oriented so that the whole blood and reagent swirl when injected by the syringes. To make the HGB/NOC dilution the RBC/HGB Diluent syringe pushes the 12 µL of whole blood and approximately 1.7 mL of diluent/sheath into the HGB cup; simultaneously the HGB lyse syringe injects approximately 0.9 mL of HGB lyse, resulting in a 1:217 dilution ratio (nominal). As stated previously, the HGB cup is also the HGB flow cell, and the HGB sample remains in the cup until sample measurement. To make the RBC/PLT dilution the RBC/HGB Diluent syringe pushes the 1.67 µL of whole blood and approximately 2.8 mL of diluent/sheath into the RBC/PLT cup, resulting in a 1:1677 dilution ratio (nominal). To make the WBC (WOC) dilution the WBC lyse syringe pushes the 20 µL of whole blood and approximately 1.0 mL of WBC lyse into the WBC cup, resulting in a 1:50 dilution ratio (nominal). Dilution & Mixing Flow Diagram Sample Staging Flow Description Associated Pinch Valves Valve Number Valve Function 41 NOC Sample Staging 52 Staging Pump Input 54 RBC/PLT Sample Staging 55 WBC (WOC) Sample Staging Functional Description Refer to Sample Staging Flow Diagram. After dilution and mixing the RBC/PLT, WBC (WOC), and NOC samples must be staged before processing through the optical flow cell. The staging is performed by a peristaltic pump and valve 52. The RBC/PLT is staged first through 54, the NOC is staged second through 41, and, if applicable, the WBC (WOC) is staged third through 55. Sample Staging Flow Diagram Sample Delivery Flow Description Associated Pinch Valves Valve Number Valve Function 22 Sample Injection Syringe Diluent/Sheath (noisy) 64 Diluent/Sheath (noisy) Reservoir 2, PRESS 2 65 Diluent/Sheath (noisy) Reservoir 2, Output 91 Optical Flow Cell Diluent/Sheath (noisy) Flow Functional Description Refer to Sample Delivery Flow Diagram. After the sample is staged at the flow cell, it is injected into the flow cell by the Sample Injection syringe for sample processing. The syringe first moves up at a fast speed, and then slows down. During the slow speed movement, the count window opens for a precise period of time for sample measurement. During the delivery period Diluent/Sheath is forced in by PRESS 2 to hydrodynamically focus the sample stream. After the delivery period the Sample Injection syringe is re-filled with Diluent/Sheath through 22. Sample Delivery Flow Diagram Cleaning & Waste Flow Description Associated Pinch Valves Valve Number Valve Function 11 Shear Valve Diluent/Sheath (quiet) Flush 12 Sample Injection Vacuum 13 Shear Valve Drain, WC-4 14 Open Sample Probe Drain, WC-4 15 Open Sample Probe Diluent/Sheath (quiet) Flush 21 RBC/PLT Mixing Chamber Drain 24 HGB Lyse Syringe Output 25 WBC Lyse Syringe Output 27 RBC/HGB Diluent Syringe RBC/PLT Dilution 34 CS Probe Diluent/Sheath (quiet) Flush 36 CS Vent Trap Drain, WC-4 37 CS Probe Drain, WC-4 38 CS Vent Trap Vent 52 Staging Pump Input 56 Optical Flow Cell Output 57 Optical Flow Cell Drain 91 Optical Flow Cell Diluent/Sheath (noisy) Flow 92 WBC (WOC) Chamber/WOC Heater Drain, WC-3 93 HGB Flow Cell Drain, WC-3 94 HGB Flow Cell Diluent/Sheath (quiet) Flush 96 WBC (WOC) Chamber/WOC Heater WBC Lyse Flush Functional Description Refer to Cleaning & Waste Flow Diagram. There are two basic functions performed by the cleaning and waste plumbing: flushing components and draining components. The WBC (WOC) Chamber/WOC Heater is flushed with WBC Lyse through 96. The HGB flow cell and RBC/PLT mixing chamber are flushed with Diluent/Sheath (quiet) through 94 and 95. The optical flow cell is flushed with Diluent/Sheath (noisy) through 91. The shear valve and ID of the open/closed probe are flushed with Diluent/Sheath (quiet) through 11. The outside of the open and closed probes are flushed with Diluent/Sheath (quiet) through 15 and 34. During cleaning, the reagent syringes flush the lines from the syringes to the mixing chambers to prevent carryover. The waste chambers perform the draining and collection of waste from the various components. WC-1 collects waste from the following components: Optical flow cell output and drain through 56 and 57 Sample staging pump WC-2 collects waste from the sample aspiration plumbing through 12. WC-3 collects waste from the following components: RBC/PLT mixing chamber through 21 HGB flow cell through 93 WBC (WOC) Chamber/WOC Heater through 92 WC-4 collects waste from the following components: Shear valve and ID of the open/closed probe through 13 Open probe through 14 Closed probe through 37 CS vent trap through 36 Cleaning & Waste Flow Diagram Optics Bench Description The CELL-DYN Ruby optics bench is functionally the same as the other CELL-DYN 3000 Series Analyzers. The CELL-DYN Ruby optics bench baseplate has a cutout that accommodates the location of the shear valve. A detailed description of the functions of the optics bench components is contained in Optics Bench Theory. CELL-DYN Ruby Optics Bench shows the physical layout of the components on the optics bench. CELL-DYN Ruby Optics Bench Aspiration Tower Description Aspiration Tower Functions Refer to Aspiration Tower. The aspiration tower, located in the center of the flow panel performs the following functions. Pierces and vents the sample tube Works in conjunction with the sample aspiration plumbing, aspirates the blood sample Spins the sample tube for barcode reading Senses the height of the sample tube being processed Works in conjunction with the cleaning and waste plumbing, rinses the vent/aspirate probe Aspiration Tower Functional Description Guide System Assemblies The functions of piercing, tube spinning, and cleaning are performed by two guide systems: GS1 and GS2. The vent/aspirate needle is attached to GS1, and the barcode spinner, wash block, and tube height flag are attached to GS2. Both move vertically along two shafts, and are connected together by a sliding shaft. GS1 is directly driven up and down by the stepper motor. GS2 is pulled up by the shaft linking it to GS1 and moves down by gravity. An optical sensor senses the home (up) position of GS1 and the position of GS2 is sensed by the tube height sensors. A solenoid driven stop holds GS2 in the up position when the vent/aspirate needle is being washed. Barcode Spin Assembly Refer to Aspiration Tower and Tube Spinning. The barcode spin assembly consists of a DC motor, two gears, a belt, and a spin cone. The spin cone is designed to accommodate both standard and Sarstedt tubes. The cone has slots that grip the tube cap when spinning the tube. The top of the cap of a standard tube is larger than that of a Sarstedt tube and does not completely enter the recess of the cone (Tube Spinning (D)). The edges of the slots dig into the tube cap spinning the tube. The top of the cap of a Sarstedt has a smaller diameter than a standard tube, and this smaller area does not create enough friction to spin the tube. To overcome this problem, the Sarstedt tube has a three (3) pin locking mechanism used as spin tabs. When the tube first starts spinning, it slips in the cone until the spin tabs enter a slot. The tabs then ride on the edge of the slot, spinning the tube (Tube Spinning (F)). Aspiration Tower Tube Spinning Tube Height Sensing Refer to Tube Height Sensors. The computer uses the tube height sensors to sense and identify the type of tube at the aspirate position and to sense the vertical position of GS2. Tube Height Sensors The basic reason for distinguishing between a standard and a Sarstedt tube is that the Sarstedt tube has a plunger remaining in the bottom of the tube. This dictates that the vent/aspirate needle is driven into the tube 1/2 inch less when a Sarstedt tube is sensed than when a standard tube is sensed. In Tube Height Sensors (A) GS1 is at the home position and both S1 and S2 are open. When GS2 is lowered onto a standard tube (Tube Height Sensors (B)), S1 is closed and S2 is open. When GS2 Is lowered onto a Sarstedt tube (Tube Height Sensors (C)), both S1 and S2 are closed. When there is no tube at the aspirate position (Tube Height Sensors (D)), GS2 moves to the bottom position and S1 is open and S2 is closed. Aspiration Tower Functional Sequence The aspiration tower performs the following steps during an Sample Loader count cycle. 1. The GS2 stop is disengaged, the spin cone starts spinning, and GS1 and GS2 move down for a pre-determined period of time. 2. GS1 and GS2 stop moving, the tube is spun for barcode reading, and the tube height sensors are checked to determine the 3. 4. 5. type of tube being processed. The spin cone stops spinning and GS1 moves the vent/aspirate needle into the tube to a distance dictated by the type of tube being processed. This pierces the cap and vents the tube of pressure or vacuum and allows sample aspiration. Vacuum #2 is applied to aspirate the blood sample. Refer to Probe Cleaning & Air Gap. GS1 moves the vent/aspirate needle up and the outside of the needle is washed (Probe Cleaning & Air Gap (A)). GS1 continues to home position and the GS2 stop engages the bottom of GS2 preventing it from moving down. Note For demonstration purposes the vent/aspirate probe in Probe Cleaning & Air Gap is rotated 90° from its actual orientation. 6. The spin cone spins to dislodge the sample tube and, if stuck in the cone, the tube drops. 7. GS1 moves the vent/aspirate needle into the wash block and the vent needle is rinsed (Probe Cleaning & Air Gap (B)). 8. After the shear valve returns to the aspirate position the vent/aspirate needle tip moves into the wash block and the inside of 9. 10. the aspirate needle is rinsed (Probe Cleaning & Air Gap (C)). The aspirate needle tip moves out the bottom of the wash block and the air gap is aspirated (Probe Cleaning & Air Gap (D)). The vent/aspirate needle moves up to the home position and stops. The tower is now ready to process the next sample tube. Probe Cleaning & Air Gap Aspiration Tower Electronics Refer to Aspiration Tower Electronics Diagram. There are three sensors, two motors, and one solenoid on the aspiration tower. They are all controlled by sample handler module #1 (SHM1). SHM1 communicates with the CPU/DCM via the RS-485 bus. Aspiration Tower Electronics Diagram Sample Handler Module Description There are two SHMs in the CELL-DYN Ruby system. SHM1 controls the aspiration tower, and SHM2 controls the Sample Loader. Refer to SHM Block Diagram. The SHM performs the following functions. Provides serial communications with the CPU/DCM Provides serial communications with the barcode reader Drives and reads up to eight optical sensors Drives and reads up to two reflective tube sensors Drives up to eight solenoids Drives one DC motor Drives one stepper motor SHM Block Diagram Electronic Subsystems Introduction CELL-DYN Ruby Electronic Assemblies The CELL-DYN Ruby electronics consists of a variety of individual printed circuit boards and electronic assemblies. The following is a list of these with their acronyms: Miscellaneous Boards Vacuum/Pressure Module (VPM) Cable Distribution Module (CDM) Sample Handler Module (SHM) Status Alert Board (SAB) Measurement & Motion Control Boards & Assemblies Photo-Diode Preamplifier (PD PAM) Photo-Multiplier Tube (PMT) PMT Supply/Preamplifier (PMT PAM) HGB Flow Cell/Mixing Chamber Main Amplifier Module (MAM) Signal Processing Module (SPM) Central Processing Module/Device Control Module (CPM/DCM) Motor Processor Module (MPM) Stepper Driver Board (SDB) Shear Valve Driver Module (SVD) Motor Drive Module (MDM) Pump Relay Module (PRM) Solenoid Driver Module (SDM) Sample Handler Module (SHM) Sensor Interface Boards & Assemblies Flow Control Module (FCM) Reagent Sensor Board (RSB) Ultrasonic Short Sample Sensor Sample Detector Board (SDB) Shear Valve Sensor Board (SVSB) Temperature Control Module (TCM) System Power Boards & Assemblies Analyzer Power Supply (APS) ATX Computer Power Supply (CPS) Power Distribution Module (PDM) Laser Power Supply (LPS) Data Station Boards & Assemblies Industrial Single Board Computer (SBC) Type ROBO-8713VGA Backplane, 6-slot PCI/ISA 3 1/2" Floppy Disk Drive HDD IDE 5.1 GB or larger CD-RW Drive ATAPI 52x Multimedia Kit to work with ROBO-8713VGA VGA Video Display Serial Link/Membrane Keyboard Controller Card CELL-DYN Ruby Electronic Subsystems To aid in understanding the overall system, these electronic modules are divided into the following functional subsystems: Data Interface Subsystem A/D Converter Subsystem D/A Converter Subsystem Measurement Subsystem Solenoid Control Subsystem Motor Control Subsystem Status Sensor Subsystem Reagent Heater Subsystem Vacuum & Pressure Subsystem Power Distribution Subsystem Personal Computer Subsystem The following paragraphs describe each of these individual functional subsystems. Data Interface Subsystem Refer to Data Interface Subsystem. The function of this subsystem is to provide data interface and control throughout the system. The data interface subsystem includes: system motion control, vacuum and pressure control, data acquisition control, raw measurement data, and system status. System Bus Descriptions Serial Bus Communications The high speed serial link provides serial communications between the CPU/DCM and the PC module. The initial program is downloaded to the CPU/DCM over this bus at start-up. The CPU/DCM also sends raw measurement data (listmode) to the PC module for final processing by the algorithms that reside in the PC module. The MPM serial bus provides communications with the MPM for control of the stepper motors. It also provides readback of the output of the A/D converter on the MPM for diagnostic purposes. The RS-485 bus provides serial communications with the aspiration control and tube control boards which provides control of the aspiration tower and Sample Loader. The debug terminal bus provides serial communications with an external terminal or computer for diagnostic purposes. Data Interface Subsystem Parallel Bus Communications The high speed external CPU bus provides high speed communications with the SPM and MAM for control of measurement and data acquisition. The peripheral bus provides communications with the FCM and VPM for the following: Readback of system sensors Control of pinch valves Control of the shear valve Control of status indicators Control of vacuum and pressure Readback of vacuum and pressure The tag bus provides the CPU/DCM with a code, generated on the SPM, that identifies the particular analog voltage being sent to the A/D for processing. This allows the computer to properly process and store the A/D output. The MUX DAC control bus provides address data for steering the output of the D/A converter on the CPU/DCM to the appropriate sample-and-hold circuits on the MAM, SPM, FCM, and VPM. There is only one D/A for generating control voltages, and it must be shared by the boards. CPU/DCM Description Refer to CPM/DCM Block Diagram. The CPU/DCM board combines the functions of the CELL-DYN 3500 68KCPU and DCM boards. Most of the interface and control functions were described in the previous paragraph. Another interface function of the CPU/DCM is the 7-segment display, which displays the results of the internal start-up diagnostics. The CPU/DCM generates the reference voltages used for diagnostic purposes, and divides the +/-15V by two for display. The output of the selftest MUX is made available to the A/D for readback. The A/D and D/A is explained in detail later in this section. CPM/DCM Block Diagram A/D Converter Subsystem Refer to A/D Converter Subsystem. The primary function of the A/D Converter Subsystem is to convert the amplitude of an analog voltage or captured pulse peak to a digital value. In the case of pulses, each pulse is generated by a particle passing through the optical flow cell. In the optical flow cell, one cell generates several pulses simultaneously, because there are several optical detectors excited as the cell passes through the sensing zone. These pulses are captured and measured one at a time by the A/D. The CPU/DCM contains the only analog-to-digital converter in the Analyzer, and it is multiplexed to measure analog voltages from other boards and auxiliary voltages within the board itself. Each pulse measurement has an identifying tag associated with it, generated by the SPM. In a long byte stream of data, the tag indicates the source of the measured value following it. A tag sequencer performs time-division multiplexing of all the pulse measurements. The tag sequencer is programmed to loop on a series of measurements. The results of these measurement conversions are transferred to the main memory on the CPU/DCM via direct memory access (DMA). The DMA transfers data at high rates without CPU intervention. Measurements made in this way are referred to as automatic measurements. The CPU uses the A/D to perform a secondary function of measuring analog voltages at different points of the system, such as Hemoglobin, diagnostics, calibration voltages, etc. These measurements are initiated asynchronously by the CPU, and they are referred to as manual measurements, as opposed to automatic measurements for pulses. These measurements do not use DMA transfer. After the requested manual measurement has been made, a flag is set and the tag sequencer continues as before with the next iteration of automatic measurements. A/D Converter Subsystem There are four A/D busses used in the system. The voltages to be processed by the A/D are individually placed on the busses under control of the MUX DAC control bus. D/A Converter Subsystem Refer to D/A Converter Subsystem and Sample & Hold Circuits. The purpose of the D/A subsystem is to generate all the DC reference and control voltages used throughout the Analyzer. The heart of the subsystem is the CPU/DCM board employing a 12bit digital-to-analog converter (DAC). D/A Converter Subsystem The DAC output voltages are programmed under control of the CPU. The analog voltage is then placed on three DAC busses simultaneously, and then steered into the appropriate sample and hold circuit on one of the boards by the MUX DAC control bus. By continuously sending the different analog voltages from the DAC and refreshing the S/H on each board, all the DC voltages remain stable during system operation. Diagnostic readback of all locally generated voltages is also available. Sample & Hold Circuits Measurement Subsystem Introduction Refer to Measurement Subsystem. The measurement subsystem performs the following major functions: Initial detection and amplification of signals from the optical flow cell and HGB flow cell. Individual pulse processing and rejection of invalid cells. Hardware counting of valid cells. A/D conversion of pulse peak and HGB voltages. Transfer of raw data to the PC module for processing by final software algorithms. Measurement Subsystem The measurement subsystem provides detection, amplification, and processing of signals from the optical flow cell and HGB flow cell. The output signals from the four optical channels are amplified by programmable gain amplifiers on the MAM and sent to the SPM. If the amplitude of the pulse is above the selected trigger threshold, the signals are processed by the peak hold circuitry. The peak hold voltages are then individually sent to the CPU/DCM via the analog ADC bus. The tag bus also sends a code with each pulse peak, identifying the channel. An A/D converter on the CPU/DCM converts these voltages to a 12-bit digital code which is placed in memory, and then sent on to the PC module for final processing and display. The output of the HGB flow cell is amplified by the FCM and placed on the ADC bus. It is then processed by the A/D in much the same manner as the optical signals. Photo-Diode Preamplifier Description Refer to Photo-Diode Preamplifier. A photo-diode in each of the preamplifiers provide initial detection and amplification of the forward scatter channels. Each board consists of a photo-diode and a two-stage current to voltage amplifier. Photo-Diode Preamplifier The photo-diode produces an electrical current that is directly proportional to the light intensity falling on its sensing element. When a cell passes through the sensing zone of the optical flow cell, it produces an instantaneous burst of scattered light. This produces a current pulse at the output of the photo-diode. The amplifier converts this to an amplified voltage pulse, which is routed to the MAM for further amplification and processing. PMT Preamplifier Description Refer to PMT Preamplifier. The PMT preamplifier provides the initial amplification of the PMT signal, and supplies the high voltage (VDYN) to the PMT. A variable resistor provides adjustment of the high voltage for calibration purposes. An inverting amplifier in the feedback loop divides the high voltage by 100, and the output is supplied to the A/D for display. To prevent damage to the PMT, the output of the amplifier chain is monitored by the over current comparator. If the signal exceeds a preset level, the output of the comparator shuts down the high voltage supply. PMT Preamplifier Main Amplifier Module (MAM) Description Refer to Main Amplifier Block Diagram. The MAM performs the processing of the optical channels between the preamplifiers and the SPM. Main Amplifier Block Diagram The MAM performs the following Functions: Linear amplification for the optical channels Log amplification for the 0° and 10° channels Programmable gain for the optical channels Baseline restoration for the optical channels Calibration of the log amplifiers Offset adjustment for the log amplifiers Test pulse generation for the optical channels Readback of baseline restorer offsets Readback of PMT VDYN voltages When processing WBCs the signals from the preamplifiers are amplified by the linear amplifiers, baseline restored, and sent directly to the SPM for further processing. The log amplifiers are not used in the WBC mode. In the RBC/PLT mode, the linear amplifiers perform the same functions described above, the linear outputs 0°/10°/90° are processed by the SPM for RBC histogram construction and MCV. Due to the larger size differential between RBCs and PLTs, amplifiers with more dynamic range are needed for the optical flow cell to adequately process both cells simultaneously. The linear outputs for the 0° and 10° channels are amplified again by the three-decade log amplifiers, and then routed to the SPM for processing. Log amplified signals are also used for PLT histogram construction and MPV. The log amplifier calibration circuitry calibrates the log amplifiers during system start-up, ensuring proper operation. The offset adjustment circuitry provides offset compensation for each of the log amplifiers. The test pulse generator supplies fixed-height pulses to the optical channels for diagnostic purposes. A reference circuit supplies +/-10VDC used in calibrating the log amplifiers. An analog multiplexer provides readback of the baseline restorer outputs and PMT VDYNs via the A/D on the CPU/DCM for diagnostic purposes. Signal Processor Module (SPM) Description Refer to Signal Processor Module Block Diagram. The SPM performs the final pulse processing before the signals are sent to the A/D on the CPU/DCM. The SPM performs the following functions. Sets the threshold voltages under computer control Selects the trigger threshold under computer control Using thresholds, detects valid cell pulses Captures WBC, RBC, and PLT cell peak voltages Generates WBC, RBC, and PLT hardware counts Generates tag sequencer identifier codes Generates variable height test pulses for testing linear and log channels Generates reference voltages for internal use Provides readback of the cell peak voltages, threshold voltages, -10V, and +5V The basic functions of the SPM detecting valid cell pulses, counting valid cell pulses, and capturing the peak voltages of valid cell pulses. There are six peak hold circuits that capture the peak voltages of the linear and log channels. Those circuits are controlled by the bank 1 and bank 2 pulse detection and peak capture logic circuits. Note Presently bank 1 is used to process WBC, NOC, RBC, and PLT, and bank 2 is not used. The logic circuits contain the threshold comparators and hardware counters used to detect and count valid cell pulses. In bank 1 the trigger channel can be 0° or 10° (linear or log), and in bank 2 the trigger channel is always the 10° log channel. If the threshold criteria is met, a count is generated and the peak is held and passed on the A/D for conversion. If the threshold criteria is not met, the pulse is not counted or converted. Signal Processor Module Block Diagram The reference voltage and test pulse generator provides the threshold voltages for bank 1 and bank 2, reference voltages for internal use, and variable height test pulses for diagnostic purposes. The A/D MUX and control circuitry multiplexes the analog voltages onto ADC3, and generates the tag identifiers used to properly process and store the digital results. Solenoid Control Subsystem Introduction Refer to Solenoid Control Diagram #1 and Solenoid Control Diagram #2. Solenoid control data resides in software on the CPU/DCM, and sent to the FCM. The FCM then places the data on the SDM data bus and it is clocked into the appropriate SDM by the clock signals. The SDM then provides the current drive to open and close individual solenoids. Each SDM can drive a maximum of eight solenoids. There are five solenoids (1 thru 5) that are not driven by the SDMs, and are driven directly by the VPM. The function of these solenoids is explained later in this section. There are two (2) driver outputs of SDM5 used to enable/disable the circuitry on the TCM PCB for HTR-1 (HGB/NOC) and HTR-2 (WBC/WOC). Solenoid Control Module Description Refer to Solenoid Driver Module Block Diagram. The SDM consists of eight solenoid drivers, an on/off latch, and a hi/lo power latch. Each solenoid operates in three power modes: off, low power, and high power. The solenoid is initially pulled in with high power applied to ensure maximum pinching torque. After 0.5 seconds low power is applied to hold the solenoid which requires less torque. This technique reduces overall power consumption and heat generation. The eight bits of on/off and power data is supplied to the latches via the solenoid data bus. The data is then clocked to the drivers by hi clock and on clock signals to control the individual solenoids. Each solenoid has a LED that indicates the status of the driver output. It is important to note that when the solenoid is activated, the LED should be brighter for 0.5 seconds and dimmer when in the hold mode. Solenoid Driver Module Block Diagram Solenoid Control Diagram #1 Solenoid Control Diagram #2 Motor Control Subsystem Introduction Refer to Motor Control Subsystem. There are seven stepper motors in the CELL-DYN Ruby Analyzer. Six are controlled by the MPM, which is a microprocessor based DMA controller, and one is controlled by SHM1. The MPM sends power, speed, and direction data to the stepper drivers which provide the actual drive current to the stepper motors. The MPM receives commands from the CPU via the MPM serial bus. The stepper motor control circuitry on SHM1 performs the same functions as the MPM and stepper drivers for the aspiration probe up/down motor. The FCM sends start commands and direction control to the shear valve driver which then drives the shear valve motor. Since it is an DC motor, limit switches are used to control the travel of the shear valve in both directions. The vacuum and pressure pumps are DC motors, and are controlled by the CPU, VPM, PRM. The SHM1 drives the aspiration probe up/down stepper motor and the DC barcode spin motor. It receives commands from the CPU via the RS-485 serial bus. The DC Y-Valve is driven by the motor drive module which receives on/off and direction control from SDM4. Motor Processor Module Description Refer to Motor Processor Module Block Diagram. The MPM is an intelligent (microprocessor-based) controller, operating under CPU control it can control up to twelve stepper motors (M0 to M11). It communicates with the CPU via the MPM Serial Link. It provides motor current information with data bits I0 and I1, and motor speed and direction with data bits PH0 and PH1. For diagnostic purposes, the MPM measures motor winding current using an integrating A/D converter, which monitors the voltage drop across resistors on the stepper driver board. It also routes +5VDC, +28VDC, and ground to the stepper driver boards. Motor Control Subsystem Motor Processor Module Block Diagram Stepper Driver Board Description Refer to Stepper Driver Board Block Diagram. The stepper driver board operates under the control of the motor processor module. It contains the circuitry required to control and drive a two-phase stepper motor. The stepper driver circuitry consists of two motor driver ICs, one for each winding of the two-phase stepper motor. These ICs contain the input control logic, current sense comparators, single pulse generator, and output circuitry. External components configure the single pulse generator, current sense low-pass filtering, and maximum winding current. The stepper driver board provides sensing of the voltage across the two stepper motor windings by the MPM for diagnostic purposes. The voltage across each stepper motor winding is sensed through one megohm resistors on each end of the winding. These resistors form a part of the integrating A/D converter circuitry on the MPM that is a part of the overall diagnostics for the stepper motor circuitry. Stepper Driver Board Block Diagram Status Sensor Subsystem Introduction Refer to Status Sensor Subsystem. The status sensor subsystem provides the main computer with the status of system mechanical, electronic, and fluidic functions. It employs optical sensors, ultrasonic sensors, thermal sensors, and fluid sensors to detect various system conditions. The optical sensors are primarily used to detect mechanical position: such as, shear valve position, y-valve position, etc. The ultrasonic sensors (S1 and S3) are used to detect the leading edge of fluid or bubbles in the sample aspiration tubing. It is used during sample aspiration to detect a short sample condition. The blood sample detector (S2), green 555 nm LED, is used during sample aspiration in the closed mode to detect a short sample condition. Thermal sensors are used to trigger the reagent heater element condition. There are two types of fluid sensors used: in-line and level. The in-line sensor consists of two electrodes placed in fluidic tubing to detect bubbles in the tubing indicating an empty condition. The level sensor is two electrodes placed at the top of a reagent reservoir or waste container to detect a full condition. Additionally, there is another type of level sensor used in the two VAC ACC 1 and ACC 2 to prevent them from overflow of foam or liquid introduced by system malfunction through WC-2, WC-3, WC-4. Flow Control Module Description Refer to Flow Control Module Block Diagram. The flow control module is a multi-purpose board the performs a number of interface and control functions. They are: Provides detection and interface of the fluid sensors Controls the shear valve Provides interface of the shear valve limit switches Controls the status alert board Sends clock and reset signals to the SDMs Supplies LED current to the HGB flow cell Provides initial amplification of the HGB voltage Multiplexes the HGB voltage to the A/D Multiplexes the VPM voltages to the A/D Provides interface of the heater elements HTR-1 and HTR-2 Status Sensor Subsystem Fluid Sensor Description Refer to AC Voltage Divider. The fluid sensor circuitry is based on an AC voltage divider. A one-shot applies a 5 volt, 10 microsecond pulse to one end of a reference resistor for each fluid sensor. The other end of the resistor is connected to a filter capacitor in parallel with the AC coupled fluid sensor. A comparator compares the voltage across the AC coupled fluid sensor with a fixed reference voltage. The CPM captures the output of the comparator at the end of the 10 microsecond period. Flow Control Module Block Diagram The reference resistor is selected so that, if there is liquid between the sensor electrodes, the voltage at the comparator remains below the reference voltage for longer than 10 microseconds, indicating a full condition. If there is no fluid between the fluid sensor electrodes, the voltage rises above the comparator reference voltage within the 10 microseconds, indicating an empty condition. The filter capacitor time constant is short compared to 10 microseconds, and the AC coupling capacitor time constant is long compared to 10 microseconds. AC Voltage Divider For troubleshooting purposes, it is important to note that at no time is a constant +5VDC seen on the plus (+) sensor electrode. However, pulses can be viewed with an oscilloscope at the plus (+) electrode. Reagent Heater Subsystem The flow panel is equipped with two Reagent Pre-Heater Elements. The heater elements have an adjustable operational temperature range between 15°C ±0.5°C (59°F ±1.8°F) and 45°C ±0.5°C (113°F ±1.8°F). The Temperature Control Module (TCM) is enabled during instrument prime to control the reagent heater temperature. It takes approximately 6 minutes to stabilize. During instrument standby, both heater elements are disabled. HGB Pre-Heater (HTR-1) The temperature is set to 45°C ±0.5°C (113°F ±1.8°F). Diluent/Sheath for HGB dilution and HGB Lyse is pre-heated and transferred to the HGB flow cell. The nominal temperature of the dilution in the HGB flow cell is 32°C (89.6°F). WBC (WOC) Pre-Heater (HTR-2) The WBC (WOC) Chamber is surrounded by the heater. The temperature is set to 25°C ±0.5°C (77°F ±1.8°F). Vacuum and Pressure Subsystem Introduction There are two regulated vacuum and three regulated pressure levels employed in the CELL-DYN Ruby Analyzer. Since there is only one vacuum pump and one pressure pump, both systems are set up in a primary and secondary configuration. Since the systems are very similar, we will use the pressure system as an example in explaining the functions of both systems. Refer to Vacuum & Pressure Subsystem. Pressure regulator 1 monitors the pressure level in the primary ACC 1, PRESS 1. If the pressure level falls below a certain threshold, the pump is turned on until the desired level is reached. If pressure regulator 2 senses a drop in the ACC 2, PRESS 2, solenoid 2 is opened which bleeds pressure from the ACC 1 to ACC 2 until the desired level is reached. The ACC 3, PRESS 3 is replenished through solenoid 3 from the ACC 1, under control of pressure regulator 3. The two levels of vacuum operate in exactly the same manner. Both systems have vent solenoids which are opened at selected times to allow the primary pressure and vacuum accumulators to return to atmosphere. The vacuum and pressure levels are set by the computer via DAC4. A reference voltage (setpoint) is multiplexed to an individual sample and hold circuit for each vacuum or pressure level. This voltage is then used to set the lower threshold for that particular regulator. The actual vacuum and pressure levels are monitored by the computer via the analog multiplexer and ADC4. If there is a condition, both PRESS and VAC levels fall below a set threshold at the same time, PRESS PUMP ON and VAC PUMP ON are staggered 100 ms, controlled by a microprocessor. Pump Relay Module Vacuum & Pressure Subsystem Vacuum/Pressure Module Description Refer to Vacuum/Pressure Module Block Diagram. The vacuum/pressure module is the main control board for the vacuum and pressure subsystem. It performs the following functions: Provides logic for control of the pumps and solenoids Provides drive for the pumps and solenoids Senses the vacuum and pressure levels Controls the vacuum and pressure levels Provides interface for the vacuum wet sensors Provides interface for the vacuum and pressure setpoints Provides interface for the vacuum and pressure levels and reference voltages for monitoring and readback The vacuum/pressure module can operate in two modes: closed-loop and open-loop. In the closed-loop mode the vacuum/pressure module controls the vacuum and pressure, and the computer only monitors the levels. In the open-loop mode the computer takes direct control of the pumps and solenoids, allowing it to control levels, open and close solenoids, etc. This mode is used mainly during diagnostics, and special conditions such as inhibiting the vacuum pump in a vacuum accumulator wet condition, or inhibiting both pumps during optical sample delivery. The vacuum and pressure levels are controlled by setpoints that set the lower threshold for the vacuum and pressure. These voltages are sent from the D/A via DAC4, and stored by the by the sample-and-hold circuits. The vacuum and pressure voltages and reference voltages are sent to the A/D via the analog MUX and ADC4. The reference voltage supply generates the reference voltages used as bias for the pressure and vacuum sensors. Vacuum/Pressure Module Block Diagram Power Distribution Subsystem The power distribution subsystem supplies the Analyzer voltages used for measurement, fluidic control, mechanical motion control, and the PC module. It consists of three (3) power supply modules: the APS, ATX CPS, and the Laser PS. Refer to Power Distribution Subsystem. Line AC is routed through an RF filter and Terminal Block PCB where it splits to the APS and ATX CPS. Both power supplies are AC-line switching power supplies with active PFC (Power Factor Correction) circuit, and with full range input features. The circuitry on the APS generates two outputs consisting of two regulated DC voltages, +15.5VDC and +28VDC to GND. The total output power is 1,000 W: +15.5VDC: CDM1&CDM2, PDM, FCM +28VDC: MDM, MPM, SHM1&SHM2, CDM1&CDM2, TCM, FAN1-3, PRM, SVD, Laser PS, PDM, FCM The following voltages are generated by the PDM using a DC to DC converter: +5VDC: MAM, SPM, CPU/DCM, MDM, MPM, VPM, FCM, SHM1 and SHM2 ±15VRAW: voltage switcher on PDM The following voltage switcher output voltages are used: ±15VDC: MAM, SPM, CPU/DCM, VPM, FCM, SHM1 and SHM2, linear voltage regulator input voltage The following linear regulator output voltages are used: ±12VDC: MPM The circuitry on the ATX CPS generates five regulated DC voltages, +3.3VDC, ±5VDC, ±12VDC to GND_ATX. The total output power is 300W: +3.3VDC: BACKPLANE +5VDC: BACKPLANE, HDD, FDD, CD-RW -5VDC: BACKPLANE +12VDC: BACKPLANE, HDD, FDD, CD-RW -12VDC: BACKPLANE Power Distribution Subsystem Personal Computer Subsystem Refer to Personal Computer Subsystem. The personal computer subsystem is the main intelligence of the CELL-DYN Ruby system. It consists of an industrial design single board computer (SBC) module (internal to the Analyzer), an external video display, and an external keyboard, mouse and hand held barcode reader. It performs the following functions: Stores main control program for the Analyzer Applies software algorithms to the raw cell data Stores and applies troubleshooting information Stores and applies dilution and calibration factors Stores patient history and QC data Provides floppy and hard disk storage Provides CD-RW capability Provides Audio connectivity Provides GbE LAN port Provides operator keyboard and hand held barcode reader entry Provides one parallel port, two serial ports and three USB ports Provides VGA port Communicates with Analyzer via the HSSL Controller Interfaces with external peripheral devices, such as the Printer, Laboratory Information System, etc. Personal Computer Subsystem CELL-DYN Ruby System Service and Support Manual (Version 201958-110) • © 2006, 2011 • CELL-DYN and CELL-DYN Ruby are registered trademarks of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. Theory of Operation Introduction The CELL-DYN Ruby is a fully automated in vitro hematology analyzer that uses electronic and optical principles to perform measurements on blood cells contained in precisely diluted blood samples. The CELL-DYN Ruby uses a colorimeter to measure Hemoglobin (HGB) concentration. A laser based flow cytometer performs the following functions: Using light scatter, it counts, sizes, and classifies white blood cells (WBCs). Using light scatter, it counts and sizes platelets (PLTs). Using light scatter, it counts and sizes red blood cells (RBCs). Hemoglobin Theory Dilution Ratio and Sample Transport The shear valve sections off 12 µL of whole blood. This section is then transported, along with approximately 1.7 mL of pre-heated (45°C ± 0.5°C) Diluent/Sheath to the HGB/NOC mixing chamber where it is mixed with approximately 0.9 mL of HGB lyse, resulting in a 1:217 (nominal) dilution ratio. The final dilution in the HGB/NOC mixing chamber measures a temperature of approximately 32°C. The dilution is ready for measurement after bubble mixing. Note The HGB/NOC heater is adjusted for laboratory air temperature below or equal to 20°C (68°F). HGB Measurement Hemoglobin Measurement Block Diagram is a block diagram of a simplified hemoglobin (HGB) measurement system. The concentration of hemoglobin contained in the prepared sample is measured and displayed in grams per deciliter (g/dL), US default units. This concentration is proportional to the absorbance of the light by the sample in the green 555 nanometer (nm) wavelength region. The light path consists of a current-controlled LED emitting a 555 nm wavelength, the HGB cup\flow cell, and a photodiode. The output current from the photodiode, proportional to the light energy received, is amplified by the current-to-voltage amplifier providing the output signal. The ratio of voltages when measuring a clear reference solution in the HGB cup/flow cell, and then measuring the prepared hemoglobin sample, represents the hemoglobin concentration. Hemoglobin Measurement Block Diagram Flow Cytometer Theory Introduction The optics bench contains the CELL-DYN Ruby Flow Cytometer. The basic purpose of the optics bench is to detect light scattered from cells as they pass through a flow cell illuminated by a HeNe Laser. This light can be scattered from the surface and internal structure of the cell. The optical and electronic components of the optics bench convert the light to an equivalent electronic signal for processing by the electronic hardware and software. The optics bench generates the following measured parameters: White Blood Cell Count WBC 5-Part Differential Platelet Count and MPV RBC Count and MCV Before beginning an in-depth description of the optics bench, we must examine a number of basic flow cytometry principles in greater detail. Light Scatter Theory As stated previously, the CELL-DYN Ruby optics bench uses the principle of light scatter to count, size, and classify cells. The following are descriptions of the basics of light scatter as it applies to the CELL-DYN Ruby. Forward Scatter The first scatter group is forward scatter, collected in the forward direction. Forward scatter is further divided into 0° scatter, collected at 1° to 3° from the axial plane, and 10° scatter, collected at 3° to 10° from the axial plane. 0° scatter is mainly representative of particle size and is not very sensitive to cell structure. 10° scatter is still mainly representative of cell size, but it is more sensitive to cell structure than 0° scatter. Side Scatter The second scatter group is orthogonal (side) scatter, collected between approximately 60° and 120° from the axial plane. This side scatter consists of two types: polarized side scatter (90°) and depolarized side scatter (90°D). Polarized side scatter is light remaining vertically polarized after scattering, and depolarized side scatter is light that is rotated to horizontal polarization during scattering. Cell Scatter Cell Scatter depicts the way particles or cells scatter light. We can see in the three cases depicted that all cells or particles scatter light at all angles and polarization. The particle or cell depicted in Cell Scatter (A) has surface characteristics and structure that do not scatter much light at wide angles. The particle or cell depicted in Cell Scatter (B) has surface characteristics and structure that scatter much more light at wide angles. The cell depicted in Cell Scatter (C) has internal granules, and these granules generate much more side scatter than a cell with no granules. Some granulated cells generate side scatter consisting primarily of polarized side scatter, with very little being depolarized. Others, because of the structure of the granules, generate more depolarized side scatter. This phenomenon is examined in more detail later in this section. Cell Scatter Optical Flow Cell Theory In order to detect and process cell scatter, it is essential cells pass through the focused laser beam one at a time. The flow cell is the assembly on the optics bench that makes this single-file flow possible. The flow cell is the optical sensing zone of a flow cytometer. Optical Flow Cell is a front and top view of the CELL-DYN Ruby flow cell and the associated lenses. The actual flow cell is a clear quartz block with a square 250 micron channel in the center. This channel flares out into a cone at the bottom of the flow cell. Hydrodynamic Focusing A delivery syringe injects the diluted sample through an injection tube; simultaneously, 9 psi of pressure forces Diluent/Sheath fluid into the assembly. The sheath converges on the sample in the cone, and forces it into a small stream approximately 30 microns in diameter. Due to the characteristics of the fluid flow, the sample and sheath streams are laminar, meaning they do not mix with one another. This overall principle is known as hydrodynamic focusing. Because the sample stream is now very small, cells pass through the laser beam in single file, allowing them to be processed one at a time. Optics Bench Theory CELL-DYN Ruby Optics Bench is a block diagram of the CELL-DYN Ruby optics bench. For explanation, we will follow the light along the various paths, and examine in detail the functions of the optical and electronic components. Illumination Optics The vertically polarized output of the laser is reflected at a 90° angle by the Rear Mirror and passes through the Cylindrical Lens (CELL-DYN Ruby Optics Bench). This lens changes the shape of the beam from a circle to an ellipse, which concentrates the power along the horizontal axis of the ellipse (Beam Shape and Power Distribution). It is again reflected at another 90° angle by the Front Mirror. The beam then passes through a 125 µm slit, which blocks all but the center portion of the elliptical beam. We can see in Beam Shape and Power Distribution that the power distribution of the beam, after the slit, is flat. This flat power distribution allows the cell stream to wander slightly in the Flow Cell and still be exposed to the same light intensity. The imaging lens focuses the beam on the Cell Stream where light is scattered in the forward and 90° directions. Optical Flow Cell Beam Shape and Power Distribution Forward Scatter Components In the forward direction, the forward focusing lens focuses the scatter on the 0° detector and the 10° detector. Since the 0° scatter is at a low angle, it passes through a hole in the perforated mirror and directly onto a photocell in the 0° detector. The 10° scatter is reflected by the surface of the perforated mirror onto a photocell in the 10° detector. The laser beam diameter is much larger than the average cell, and much of the light passes by the cell. If this axial light were allowed to reach the 0° detector, it would result in saturation of the detector circuitry. To solve this problem, an obscuration bar is placed in the beam path to block the axial light. This bar allows only 0° scatter to reach the detector. CELL-DYN Ruby Optics Bench Side Scatter Components In the 90° direction, the objective lens focuses the scatter to the center of the 1,000 µm Slit. This slit blocks the scatter from the walls of the flow cell channel, which would interfere with scatter from the cell stream. The field focusing lens focuses the 90° polarized and depolarized scatter onto the polarized and depolarized detectors. A beam splitter reflects 10% of the scatter to detector #3 and allows 90% to pass through to the horizontal polarizer. This polarizer allows only horizontally polarized scatter to pass on to detector #4, which is the scatter that was depolarized by the cell. Because the side scatter is at a very low level, photomultiplier tubes are used as detectors in both channels. Optical Measurement Electronics Theory Introduction Optical Measurement Electronics is a basic block diagram of the CELL-DYN Ruby optical measurement electronics. In this measurement circuitry, up to four channels can be used to count, size, and classify cells. Each channel provides its own distinct information relating to cell size or morphology (structure). Particle Processing Optical Measurement Electronics shows the complete set of possible signal paths of the optical measurement electronics. The electrical cell signals originate at the four optical detectors located on the optics bench assembly. The detectors and their associated pre-amplifiers provide electrical pulses. These pulses represent the light scattered when a cell passes through the laser beam. Signals from each of these detectors flow through separate linear amplifiers. Following the linear amplifiers, the first two signals (0°, 10°) flow through logarithmic amplifiers. Following these logarithmic amplifiers, the signals are routed to the signal comparators and the peak hold circuits. The peak hold circuits capture the amplitude of the signal pulses. The analog outputs of the peak capture circuits are passed on to the A/D system where they are digitized for storage in computer memory. The comparators compare the incoming cell signals (pulses) to DC threshold voltages. The comparator outputs are digital signals which indicate when a pulse equals or exceeds the threshold value. The logic following the comparators is used to control the peak capture circuits and the hardware counters that generate the hardware count. Optical Measurement Electronics Note Presently bank 1 is used to process WBC, NOC, RBC, and PLT, and bank 2 is not used. The peak hold circuits are grouped into two banks, bank 1 and bank 2. Bank 1 is the more general and configurable of the two banks. This bank is used for both WBC measurement and RBC measurement. The 0°, 10°, 90°, and 90°D signals flow to peak hold circuits 1, 2, 3, and 4. Either the linear or logarithmic signals can be supplied to the first two peak hold circuits. This linear or logarithmic selection also determines which signal is passed to the bank 1 comparator. In addition, a separate control signal is used to switch between linear and logarithmic signals being sent to the peak hold circuit. The bank 1 peak hold circuits are controlled by the bank 1 comparator. This comparator compares the selected signal (0° or 10°) to the bank 1 lower threshold. The comparator also triggers the bank 1 counter. This counter accumulates the total number of pulses which exceed the bank 1 lower threshold. Optical Hematology Parameters Introduction Unlike our other instruments, the CELL-DYN Ruby does not employ an impedance transducer to count and size RBCs and PLTs. RBC and PLT data is derived from the optical flow cell, and HGB is the only measured parameter that is not derived from the optical flow cell. The following paragraphs describe the basic theory of the optical hematology parameters. WBC Theory Dilution Ratio and Sample Transport The shear valve sections off 20 µL of whole blood. This section is then transported, along with approximately 1.0 mL of WBC Lyse to the WBC (WOC) mixing chamber/WOC Heater where it is mixed, resulting in a 1:50 (nominal) dilution ratio. The final dilution in the WBC (WOC) mixing chamber measures a temperature of 25°C ± 0.5°C. The dilution is ready for measurement after bubble mixing. Note The WOC heater is adjusted for laboratory air temperatures below or equal to 20°C (68°F). WBC Scatter The CELL-DYN Ruby performs a WBC count and a five-part differential. Generating a five-part differential consists of separating the WBCs into five distinct subpopulations. The five subpopulations are: Lymphocytes, Monocytes, Basophils, Neutrophils, and Eosinophils. To understand how this is accomplished, we must first examine WBC scatter in more detail. WBC Scatter shows the way WBCs scatter light. For the sake of explanation, we can divide the WBCs into two major groups: nongranular cells (mononuclear) and granular cells (polynuclear). The nongranular cells are composed of Lymphocytes and Monocytes; and the granular cells are composed of Basophils, Neutrophils, and Eosinophils. WBC Scatter The internal structure of the nongranular cells (Lymphocytes, Monocytes) has almost no scatter effect on the axial light, and most of the scatter is from the surface of the cell. This scatter falls mainly in the 0° and 10° channels, with very little falling in the 90° and 90°D channels. Note Basophiles tend to generate less side scatter than other granular cells in this application. Therefore, this cell type displays on the 90° versus the 10° scatter that is determined to be the mononuclear cell region. The magnitude of the scatter in the 0° channel is mainly proportional to cell size and is not, to any great extent, affected by cell structure. The 10° channel is mainly proportional to size, but is more sensitive to cell complexity (structure). On the other hand, the internal granules of the granular cells cause the granular cells to scatter much more light at side scatter angles. In the case of Basophils and Neutrophils, most of the side scatter is vertically polarized and falls in the 90° channel, with very little falling in the 90°D channel. The Eosinophil has a unique quality in that the granules have the property of depolarizing more of the light before scattering. So, much more of the side scatter from an Eosinophil falls in the 90°D channel than that of a Basophil or Neutrophil. WBC Scatterplots The CELL-DYN Ruby graphically displays data in the form of histograms and scatterplots. A shortcoming of histograms is that information is gathered from only one channel at a time, and only relates to pulse amplitudes and number of pulses for that particular channel. This technique is fine for displaying RBC or PLT distributions, but it is a limiting factor when trying to classify and display the five distinctly different types of WBCs. When generating scatterplots, data are gathered from two channels simultaneously. This allows the CELL-DYN Ruby to mix and match size and morphology to count, size, and classify WBCs. WBC Scatterplots WBC Scatterplots depicts three of the scatterplots used on the CELL-DYN Ruby. Each valid cell is represented by a dot on the scatterplot. The dots are positioned at a point determined by the combination of the output levels of the two channels. If we apply arbitrary numbers to these outputs, as in WBC Scatterplots (A), we can better understand the placement of the dots. The output of the 0° channel has an output level of 11 (Y-Axis), and the output of the 10° channel is 8 (X-Axis). Thus, the corresponding dot is placed at the intersection of the two levels: 0°-11 and 10°-8. An increase in the 0° output level moves the dot up (+Y) on the Yaxis, and an increase in the 10° output level moves the dot to the right (+X) on the X-axis. The same concept is used for generating all other scatterplots. Once the data (list mode data) is gathered, the software can apply mathematical equations to separate the various cell populations and generate a 5-Part Differential and various morphological flags. The first of these is shown in WBC Scatterplots (B); in this step the 10° and 90° channels are used to separate the mononuclear cells from the polynuclear cells. The second is shown in WBC Scatterplots (C); in this step the 90° and 90° depolarized channels are used to separate the Eosinophils from the Neutrophils. Once these two determinations have been made, the software can use equations to make the other cell classifications as shown in WBC Scatterplots (D). WBC Measurement Electronics Configuration The WBC configuration is the simplest configuration. The circuitry not used for this configuration is shown in dashed lines. For this configuration, all four signals pass through the linear amplifiers to the bank 1 peak hold circuits (peak holds 1 through 4). The output of the linear 0° amplifier is also connected to the bank 1 comparator, and is the trigger for this configuration. This comparator allows capturing of pulse heights and counting of pulses when the linear 0° signal exceeds the bank 1 lower threshold. For this configuration, the logarithmic amplifiers and the bank 2 circuitry are not used. WBC Measurement Electronics Configuration RBC/PLT Theory Dilution Ratio and Sample Transport The shear valve sections off 1.67 µL of whole blood. This section is then transported, along with approximately 2.8 mL Diluent/Sheath, to the RBC/PLT mixing chamber where it is mixed, resulting in a 1:1677 (nominal) dilution ratio. RBC/PLT Histogram Generation There are 256 channels (bins) available for each optical channel, and each channel equates directly to a pulse amplitude within a certain range. In the case of RBCs and PLTs, each channel can be equated to an individual cell within a certain size range. For RBCs and PLTs these channels can be referred to as size channels. We can use these size channels to generate RBC and PLT histograms that graphically represent the overall size distribution of a particular sample. RBC Histogram Generation is a drawing of a smoothed RBC histogram and an exploded view of the raw counts per channel of the peak portion of the histogram (A). RBC Histogram Generation If we compare RBC Histogram Generation (B) with RBC Histogram Generation (A), we can see the relationship of channel data to the actual histogram shape. The raw counts increase with volume on the leading edge, and decrease on the trailing edge. In our other instruments, the size width of each channel in cubic microns, from channel 0 to channel 255, is the same. This is because our other instruments use linear amplifiers to amplify the RBC and PLT pulses. In the CELL-DYN Ruby logarithmic amplifiers are used to amplify the RBC and PLT pulses, and the channel width is not the same over the entire range. RBC/PLT Measurement Electronics Configuration Refer to RBC/PLT Measurement Electronics Configuration. Configuration bank 1 is used to measure RBC and PLT. The logarithmic 0° and 10° signals are passed to peak holds 1 and 2 of bank 1. The output of the 10° log amp is used as the trigger for both RBC and PLT. There is no upper hardware threshold for RBC, and the upper threshold for PLT is set by software. Nuclear Optical Count (NOC) Theory Fragile White Blood Cells A common problem when optically counting WBCs is a condition known as fragile (nonviable) white cells. Fragile white cells are WBCs where the cell membrane is abnormally fragile, and it is destroyed by the WBC lyse, leaving only the nucleus intact. This condition results in an erroneous low count because most of the pulses from the nuclei fall below the lower hardware threshold and are not counted even though they are valid cells present in the patient sample before lysing. RBC/PLT Measurement Electronics Configuration Fragile white cells are common in patients with leukemias and certain viral infections, and it is extremely important that an accurate WBC count be reported under these clinical conditions. Count Rate Analysis In order to count samples with fragile white blood cells, the abnormal sample must be flagged and an accurate count be obtained by an alternative counting method. The CELL-DYN Ruby uses the WBC count rate to determine if the sample contains an excessive amount of fragile cells. Refer to WBC Count Rate. The first step in generating the count rate is to divide the 7.5 second WBC count time into fifteen time slots of 500 microseconds each. WBC Count Rate The WBC count is then accumulated and stored for each of these 500 microsecond time slots, allowing the rate of decline to be determined. If we compare A with B, we can see that the rate of decline is much higher for B than for A. The cause for the increased rate of decline in B is that fragile cells are being destroyed by the WBC lyse during the count time. If this rate of decline exceeds a pre-determined level, a flag is set indicating the presence of an excessive amount of fragile cells in the sample. This flag indicates that an alternative method of counting is needed to obtain an accurate count for that particular sample. Nuclear Optical Counting The CELL-DYN Ruby uses the Nuclear Optical Count (NOC) to perform an accurate count on samples containing excessive fragile WBCs. In the NOC mode the HGB sample is saved in the HGB/NOC mixing chamber, and processed through the optical flow cell to count the nuclei. This is possible because the HGB lyse destroys the cell membranes and leaves the nuclei intact. Because the nuclei and cells have a 1:1 ratio, we can count the total number of WBCs using this technique. Nuclear Optical Count Scatterplot Nuclear Optical Count Scatterplot is a drawing of a NOC scatterplot. The WBC nuclei display as a distinct population in the lower left quadrant. A threshold is used to separate the WBC nuclei from stroma and other debris. Thresholds, Triggers, and Gain Theory Introduction In order to effectively calibrate, troubleshoot, and repair the CELL-DYN Ruby, it is essential one gains a working understanding of the functions of thresholds, triggers, and gain settings, and the effects they have on counts, histograms, and scatterplots. Thresholds A lower threshold is a voltage generated under computer control that sets the lower threshold voltage for a given pulse. If the pulse does not equal or exceed the threshold, the pulse represents a cell, particle, or electronic noise that is below the range of the particular parameter being measured, and the pulse is not processed by the measurement circuitry. Lower and Upper Thresholds An upper threshold is a voltage much the same as a lower threshold, but it is the upper threshold voltage for a particular pulse. Any given pulse exceeding the upper threshold is also rejected and not processed by the measurement circuitry. Upper thresholds reject pulses representing cells, particles, or noise that are above the range of the parameter being measured. Trigger Threshold A trigger threshold is a lower threshold that acts as the main enable for all the optical channels. In the optical measurement electronics we can trigger off the 0° or 10° channels. If the amplitude of a particular pulse does not equal or exceed the selected trigger threshold, that pulse is not counted or processed by the A/D. Gains If we refer back to Optical Measurement Electronics, we can see that each channel has an independent gain control. In the case of the photodiode channels (0° and 10°), the overall gain can be changed on the Main Amplifier Module. In the case of the photomultiplier tube channels (90° or 90°D), the gain of the channel can be changed by varying the dynode voltage (supply voltage to the PMT) on the preamplifier module, or by changing the gain on the Main Amplifier Module. The principle that increasing the gain increases pulse amplitude, and decreasing gain decreases pulse amplitude is quite simple. However, the effect gain has on counts, histograms, and scatterplots is not as straightforward, and must be examined in greater detail. Thresholds, and Gain Effects On Histograms Thresholds, Gain and Histograms depicts the basics of how thresholds and gain can affect histograms. Thresholds, Gain and Histograms (A) depicts a normal histogram of a particular cell population. The population is not named because the effects are the same for all cell types. In this case, the lower threshold is placed at a point to reject any noise, and only the valid cells are counted and displayed. Noise to the left of the lower threshold can be in any combination of the following: other cells, cellular debris (stroma), particulate reagent contamination, stray light (optical counting only), or electronic background noise. In Thresholds, Gain and Histograms (B), the lower threshold is lowered to a point where some of the noise is above the threshold and is displayed. This condition results in an increased count because noise is now counted along with the valid cell population. In Thresholds, Gain and Histograms (C), the lower threshold is increased to a point where some of the valid cell population is rejected, resulting in a decreased count. In Thresholds, Gain and Histograms (D) the upper threshold is lowered to a point where some of the valid cell population are rejected, resulting in a decreased count. In Thresholds, Gain and Histograms (E) the gain is lowered, moving both noise and valid cells to the left, with the same overall effect on counts as in (C). In Thresholds, Gain and Histograms (F) the gain is increased, moving both noise and valid cells to the right, with the same overall effect on counts as in (B). Thresholds, Gain and Histograms In Thresholds, Gain and Histograms (F), the gain is increased, moving both noise and valid cells to the right, with the same overall effect on counts as in Thresholds, Gain and Histograms (B). If the gain were increased even more, the upper threshold would begin to reject some of the larger cells in the valid cell population. In this case, an increase or decrease in counts is unpredictable, because the noise raised above the lower threshold is unpredictable. Thresholds, and Gain Effects On Scatterplots Thresholds, Gain and Scatterplots depicts the basics of how thresholds and gain can affect scatterplots. Scatterplots are affected in much the same way as histograms, the major difference being that there is an X and a Y axis representing the two channels. Under certain configurations, thresholds and gain can have an effect on two channels simultaneously. Thresholds, Gain and Scatterplots shows only changes in the channel (Y-axis). In Thresholds, Gain and Scatterplots (A), noise is located in the lower left corner below the lower threshold, and the lower threshold is positioned to exclude the noise and include all the valid cells. In Thresholds, Gain and Scatterplots (B) the 0° lower threshold is lowered, and we can see the dots representing noise above the threshold, resulting in increased counts. In Thresholds, Gain and Scatterplots (C), the lower threshold is raised to a point where some of the Lymphocytes are being rejected, resulting in a decreased count. In Thresholds, Gain and Scatterplots (D) the gain is lowered, with the same overall effect on counts as in (C). In Thresholds, Gain and Scatterplots (E), the gain is raised, with the same overall effect on counts as in (B). Thresholds, Gain and Scatterplots CELL-DYN RUBY System Service and Support Manual (Version 201958-102) • Copyright 2006, 2007 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. Sample Loader Description Introduction The Sample Loader enables the CELL-DYN Ruby to process up to 50 closed sample tubes in an automatic and walk-away mode, with a throughput of approximately 73 samples per hour in Test Selection: CBC. The Sample Loader mounts on the front of the Analyzer (Analyzer & Sample Loader), and is controlled by the CPU/DCM via SHM2. The Sample Loader performs the following automated functions: Positions blood sample tubes at the vent/aspirate station for venting and sample aspiration Moves the racks from the load side to the unload side Mixes blood sample tubes Reads rack and sample tube barcodes Analyzer & Sample Loader Sample Loader Mechanical Description Rack Description Rack Barcode Labels Refer to Sample Loader Rack. Each rack has an identifying barcode, and one barcode label at each tube position (except tube position # 1). Barcodes are read when the tube is in the vent/aspirate position. The racks also have slots through which the barcodes of the sample tubes are read. In addition, the 10 sample tube positions are numerically identified 1 through 10. Sample Loader Rack Rack Orientation and Locking The racks have an orientation groove to prevent them from being incorrectly placed in the Sample Loader. If the rack is reversed, tabs normally riding in the groove prevent it from indexing through the processing station. The rack at the processing station is mechanically locked in position after each index step by a spring loaded ball on the rear wall that engages a detent in each tube position in the rack. This assures correct positioning and avoids the possibility of accidental movement. Functional Descriptions Barcode Reader The Sample Loader employs a diode-array, auto-discriminating barcode reader capable of reading Code 39, Interleaved-2-of-5, Codabar, and Code 128 formats with checksum capability. To reduce the possibility of error, bar code reading takes place at the vent/aspiration position. Sample Loader Top View Designator Description Designator Description 9.1 Sample Loader 9.1.10 Sample Processor Assy 9.1.3 Barcode Reader 9.1.11 Rotary Valve Assy 9.1.8 Optical Sensor, Load Side Empty 9.1.18 Mixer Assy 9.1.9 Open Probe Assy Mixer Assembly Refer to Mixer Bladder Operation and Inversion Mixing. The mixer assembly consists of a bank of two vertically-oriented pneumatic grippers (bladders) mounted on a horizontal shaft and driven by a stepper motor. The gripping mechanism consists of two closed-end bores in a block. Inside each bore is a metal sleeve and a rubber bladder that inflates from the outside, reducing the inside diameter and gripping the sample tube. When vacuum is applied (Mixer Bladder Operation (A)), the bladder opens, releasing the sample tube. When pressure is applied (Mixer Bladder Operation (B)), the bladder expands, firmly gripping the tube and the cap. Mixer Bladder Operation During a normal mixing cycle the following occurs: Vacuum (VAC 1) is applied to the mixer bladder, lift air cylinder control valve opens to atmospheric air pressure and the mixer assembly is lowered over the sample tubes. Mixer assembly captures the sample tube(s). Refer to Mixer Bladder Operation. Pressure (PRESS 1) is applied and the mixer and tubes are raised to clear the rack. The motor rotates the mixer through at least 15 inversions, as shown in Inversion Mixing. The motor returns the mixer assembly to the vertical position. flag trips an optical sensor, verifying the vertical position. Lift air cylinder control valve opens to atmospheric air pressure, gravity moves the mixer and the tubes down into the rack. Mixer assembly releases the sample tube(s). Vacuum is applied and the mixer moves up, clearing the tubes. Inversion Mixing When the mixing sequence is completed, the rack indexes one step and the process repeats. Assuming the sequence starts with the first tube in the rack, each tube receives at least 30 inversions (15 inversions times two mixing positions). Index Assemblies Refer to Sample loader View. Longitudinal (X-axis) indexing of the racks is made in one-inch increments along the rear wall of the baseplate. An air cylinder provides the movement. Sample loader View Designator Description Designator Description 9.1 Sample Loader 9.1.5 Optical Sensor, Mixer Head Home 9.1.1 Air Cylinder, Rack Advance 9.1.6 Optical Sensor, Lifter Home 9.1.2 Optical Sensor, Unload Side Fourth & Fifth Rack 9.1.7 Tube Mixer Head 9.1.3 Barcode Reader Manifold Assy 9.1.4 Third & Fourth Tube Sensor 9.1.14 Refer to Index Pawl. The cylinder drives a rod with spring-loaded pawls (fingers) mounted along the length. These fingers engage grooves in the side of the rack through a slots in the rear wall. Index Pawl Cross Transfer Assemblies Refer to Rack Movement, and Sample Loader Bottom View. The cross transfer assemblies provide lateral (Y-axis) movement of the racks. Rack Movement The cross transfer assembly is a pair of sweep arms that move in a horizontal plane through slots in the front and rear walls. The ends of the arms are fitted to vertical shafts that are geared together, and the opposite tips of the arms move in equal arcs simultaneously. The tips of the arms contact the side of the rack, pushing it laterally across the baseplate. The cross transfer air cylinders activate after each longitudinal index, but the two racks at the front and back of the processing station prevent any lateral movement (Rack Movement (A)). When the racks reach the position shown in Rack Movement (B), they index laterally. Sample Loader Bottom View Designator Description Designator Description 9.1 Sample Loader 9.1.14 Manifold Assy 9.1.1 Air Cylinder, Rack Advance 9.1.15 Air Cylinder, Load Side Cross Transfer 9.1.12 Load Side Cross Transfer Arms 9.1.16 Air Cylinder, Mixer Lift 9.1.13 Unload Side Cross Transfer Arms 9.1.17 Rack Position Sensing Air Cylinder, Unload Side Cross Transfer Refer to Sample Loader Bottom View. A single optical sensor senses when the load side is empty. When the last rack is completely in the processing station a flag mounted on the sweep arm gear assembly blocks the sensor when the arms activate. There are two sensors on the unload side that sense when the fourth and fifth racks enter the unload side. When the fifth (last) rack is finished processing the Sample Loader halts and an alarm alerts the operator. Sample Loader Electronics Description The Sample Loader electronics provide communications with, and control of, the various electronic and mechanical components in the Sample Loader. The electronics consist of the following assemblies: Sample Handler Module #2 (SHM2) Air Cylinder & Mixer Bladder Solenoid Valves (V1-V5) Mixer Motor Lifter Home Up Sensor Mixer Head Home Sensor Load Side Empty Sensor Unload Side Fourth Rack Sensor Unload Side Fifth Rack Sensor Third and Fourth Tube Sensors Barcode Reader As with the overall system, the Sample Loader electronics consist of functional subsystems. They are: Pneumatics Control Subsystem Motor Control Subsystem Sensor Interface Subsystem Pneumatics Control Subsystem Refer to Sample Loader Pneumatic Diagram and Pneumatic Control Electronics Diagram. The pneumatics control subsystem provides electronic control of the valves supplying pressure/vacuum to the air cylinders and vacuum/pressure to the mixer bladders. The Sample Loader employs five 3-way valves to drive the air cylinders and mixer bladders. In the case of V1, V2, and V5 a pushpull configuration is used to drive the air cylinders, with pressure extending and vacuum retracting. V3 pressure lifts the mixer head and gravity lowers it. In the case of the mixer bladders, a variable regulator (0-10 PSI) reduces the incoming PRESS 1 to 6.0 PSI to inflate the bladders. The valves are controlled by the driver outputs on SHM2, and SHM2 is controlled by the CPU/DCM via the RS-485 serial bus. Sample Loader Pneumatic Diagram Pneumatic Control Electronics Diagram Motor Control Subsystem Refer to Motor Control Subsystem. The mixer stepper motor provides the inversion mixing of the sample tubes. It is driven by a stepper driver circuit on SHM2. Motor Control Subsystem Sensor Interface Subsystem Refer to Sensor Interface Subsystem. The sensor interface subsystem allows the CPU/DCM to read the status of the sensors in the Sample Loader, and read tube barcodes. SHM2 provides the LED drive and reads the outputs of the photo-detectors of the optical sensors. There are two reflective tube sensors that sense the third and fourth tube positions in the processing station. They are mainly used to ensure that an expected tube is in the correct position, and to ensure that the tubes are both lifted and dropped by the mixer head. Processing Station Tube Positions shows how the tube positions are numbered in reference to the processing station. Processing Station Tube Positions The LEDs of the two reflective tube sensor are driven by 25 kHz pulse train to prevent ambient light interference. A filter on SHM2 responds only to a 25 kHz output of the detector. The barcode reader is controlled and read via a 4-wire serial bus. Sensor Interface Subsystem CELL-DYN RUBY System Service and Support Manual (Version 201958-101) • Copyright 2006 • CELL-DYN is a registered trademark of Abbott Laboratories. CELLDYN RUBY is a trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. Troubleshooting Document Control Number 201961-111 CELL-DYN Ruby System Service and Support Manual (Version 201958-113) • © 2006, 2013 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. Analyzer Setpoints Reference Chart Voltage Specification PDM Test Point Value E8 GND Range E1 + 15.00 VDC ± 0.4 VDC E2 - 15.00 VDC ± 0.4 VDC E3 - 12.00 VDC ± 0.5 VDC E4 + 12.00 VDC ± 0.5 VDC E5 + 28.00 VDC ± 0.5 VDC E6 + 15.50 VDC ± 0.5 VDC E7 + 5.00 VDC ± 0.2 VDC CPU/DCM Test Point TPAGND Value Range Comments GND TP4 (VREF-) - 10.00 VDC ± 0.1 VDC adjust POT-R4 MAM Test Point TP1 Value Range Comments GND TP2 (VREF+) + 10.00 VDC ± 0.01 VDC adjust POT-R84 VPM Test Point TP3 Value GND Range Comments TP2 (VREF+) + 10.00 VDC ± 0.01 VDC adjust POT-R16 TP1 (VREF-) - 10.00 VDC ± 0.01 VDC verify TCM Test Point Value TP0 GND Range Comments TP1 + 2.39 VDC ± 0.01 VDC adjust POT-R7 TP2 + 1.94 VDC ± 0.01 VDC adjust POT-R14 TP5 + 5.00 VDC ± 0.01 VDC adjust POT-R4 Stepper Motor Winding Current Specification Phase 0 Phase 0 Phase 0 Phase 3 Motor Low Medium High High A 1.0 - 1.6 2.4 - 3.2 3.5 - 4.5 3.5 - 4.5 B 1.4 - 2.0 3.4 - 4.0 5.0 - 5.6 5.0 - 5.6 C 1.4 - 2.0 3.4 - 4.0 5.0 - 5.6 5.0 - 5.6 D 1.4 - 2.0 3.4 - 4.0 5.0 - 5.6 5.0 - 5.6 E 1.5 - 2.1 3.4 - 4.2 4.9 - 5.9 4.9 - 5.9 G 1.5 - 2.1 3.4 - 4.2 4.9 - 5.9 4.9 - 5.9 Pressure/Vacuum Accumulator Level Specification Pressure Accumulator Value Range PRESS 1 13.00 PSI ± 0.50 PSI PRESS 2 9.00 PSI ± 0.50 PSI PRESS 3 4.25 PSI ± 0.25 PSI Vacuum Accumulator Value Range VAC 1 13.00 inHg ± 0.50 inHg VAC 2 (Open) 2.80 inHg ± 0.20 inHg VAC 2 (Closed) 3.30 inHg ± 0.20 inHg VAC 2 (Retic) 2.10 in Hg ± 0.20 inHg Setpoints (Setpoint Entry - Default Settings) Gain Settings Parameter Nominal Gain Setting WOC 0° Gain 1500 WOC 10° Gain 1000 WOC 90° Gain 1400 WOC 90°D Gain 1400 NOC 0° Gain 1500 NOC 10° Gain 1000 RBC/PLT 0° Gain 1650 RBC/PLT 10° Gain 1200 RBC/PLT 90° Gain 1000 LinRBC 0° Gain 1500 LinRBC 10° Gain 1200 LinRBC 90° Gain 2000 Retic 0° Gain 1500 Retic 10° Gain 1000 Retic 90° Gain 1400 Note Gains need to be adjusted, see Individual Gain Setting, Mean Channel Range and CV Specification Threshold Level Parameter Nominal Gain Setting RBC Lo 550 WOC Lo 360 NOC Lo 400 Retic Lo 100 LinRBC Lo 300 Miscellaneous Parameter Nominal Gain Setting Speaker Level 4095 SPM Reference Voltage 4095 PRESS 1 3550 PRESS 2 2500 PRESS 3 1150 VAC 1 1580 VAC 2 (Open) 400 VAC 2 (Closed) 460 VAC 2 (Retic) 300 Vacutainer Tube -1525 Sarstedt Tube -1350 HGB Current 1000 Note Gains need to be adjusted, see Pressure/Vacuum Accumulator Level Specification. Note Gains need to be adjusted, see Raw Data Summary - HGB Reading Specification Raw Data Summary - HGB Reading Specification Parameter HGB Reference Target 2050 Range ± 200 HGB Sample* *HGB Sample must be within 20 units from HGB Reference after background count Optics Bench Offset Specification Baseline Verification on Pre-amplifier PCB Channel Test Point Channel 1 (0°) Channel 2 (0°) TP2 GND TP1 < 0.05 VDC TP2 GND TP1 < 0.05 VDC Individual Gain Setting, Mean Channel Range and CV Specification Note Verify NOC Gain Settings are equal to the WOC Gain Settings for channels 0° and 10°. Note Verify Retic Mode Gain Settings are equal to the WOC Gain Settings for channels 0°, 10° and 90°. Parameter Channel 1 (0°) Channel 2 (10°) Channel 3 (90°) Channel 4 (90°D) 35 ±3 65 ±5 Mean from Bead Blood Worksheet ±6 Mean from Bead - Blood Worksheet ±10 <6 <5 < 18 < 18 Nominal Gain Setting < 2300 < 2300 1200 - 1700 1200 - 1700 RBC/PLT 0° (7.0 µm SRP) Mean Channel 180 ±1 RBC/PLT 10° (3.3 µm SRP) Mean Channel RBC/PLT 0° (5.0 µm SRP) Mean Channel RBC/PLT 10° (7.0 µm SRP) Mean Channel Mean Channel WOC 0°, 10°, 90°, 90°D (7.0 µm SRP) CV% Mean Channel LinRBC 0°, 10°, 90° (HCM) Nominal Gain Setting 121 ±1 129 ±1 202 ±5 Mean from HCM Assay Sheet Mean from HCM Assay Sheet Mean from HCM Assay Sheet < 3800 < 2000 < 3000 QC Moving Average X-B Parameter Lower Limit Upper Limit Target Value Units Action Limit (%) MCV 55.0 125.0 89.3 fL 30.0 MCH 20.0 40.0 30.5 pg 30.0 MCHC 24.0 44.0 34.1 g/dL 30.0 WBC Parameter Lower Limit Upper Limit Target Value Units Action Limit (%) Lym 0° Mn 40.0 70.0 55.0 channel 30.0 Lym 10° Mn 45.0 80.0 63.0 channel 30.0 Neu 0° Mn 120.0 200.0 163.0 channel 30.0 Neu 10° Mn 110.0 185.0 145.0 channel 30.0 Neu 90° Mn 87.0 163.0 119.0 channel 30.0 Neu 90° D Mn 11.0 31.0 21.0 channel 30.0 NE Angle 12.0 32.0 22.0 degree 40.0 RBC Parameter Lower Limit Upper Limit Target Value Units Action Limit (%) RL 0° Mn 0.00 255.0 117.0 channel 30.0 RL10° Mn 0.00 255.0 115.0 channel 30.0 RL 90° Mn 0.00 255.0 120.0 channel 30.0 Rbc 0° Mn 0.00 255.0 175.0 channel 30.0 Rbc 10° Mn 0.00 255.0 225.0 channel 30.0 Plt 0° Mn 0.00 255.0 45.0 channel 30.0 Plt 10° Mn 0.00 255.0 80.0 channel 30.0 HbS Mn 0.00 4095 1125 D/A reading 100.0 HbR Mn 0.00 4095 2000 D/A reading 100.0 RETC Parameter Lower Limit Upper Limit Target Value Units Action Limit (%) Rtc 0° Mn 0.00 255.0 47.5 channel 40.0 Rtc 10° Mn 0.00 255.0 63.0 channel 20.0 Rtc 90° Mn 0.00 255.0 21.5 channel 20.0 SRP/Blood Comparison Cell Regions Parameter Lower Channel Upper Channel LYM 0° 20 100 LYM 10° 20 100 GRAN 0° 100 240 GRAN 10° 120 240 NEU 90° D 10 110 Login Passwords Operating System Software Login Password afse IbFSE! admin Syssetup cd no password required Application Software Operator ID Password CSC today's day date + 5 FSE Day Password Day Password 1 0507 21 0729 2 0128 22 0321 3 0908 23 1128 4 0816 24 0701 5 1006 25 0603 6 0222 26 0808 7 0524 27 0418 8 1026 28 0922 9 0130 29 1102 10 0817 30 0221 11 1107 31 0702 12 0513 32 0220 13 0616 33 1207 14 0202 34 0315 15 1016 35 0405 16 0728 36 1216 17 0614 37 0810 18 0416 38 1126 19 1119 39 0717 20 0924 40 0521 Note The four character passwords noted above are valid only when entered in reverse order. For example the valid password for Day 1 is 7050. CELL-DYN Ruby System Service and Support Manual (Version 201958-108) • © 2006, 2010 • CELL-DYN and CELL-DYN Ruby are registered trademarks of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. Block Diagrams Links Cable Connection Diagram 9H_9048.PDF Measurement Block Diagram 9H_9051.PDF Motor Control Block Diagram 9H_9053.PDF Power Distribution Block Diagram 9H_9049.PDF Sensor Block Diagram 9H_9050.PDF Solenoid Control Block Diagram 9H_9052.PDF CELL-DYN RUBY System Service and Support Manual (Version 201958-106) • © 2006, 2009 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. CABLE CONNECTION DIAGRAM 2 3 4 5 J2 J7 J3 J8 J4 J9 J5 J10 7 NC 9520532 J1 SDM2 J6 9600930 2 3 4 J2 J7 J3 J8 J4 CDM1 J9 9601080 J6 6 9520532 J1 J10 9601920 Speaker & Status BD. NC J7 J2 NC J8 J4 J10 NC J5 J1 SDM3 J6 9600930 2 3 4 NC J2 J7 J3 J8 J4 J9 J5 J10 6 7 8 S2 3 4 J2 9520532 4 J2 2 J3 3 J4 J17 5 J5 J12 J15 J8 J4 J9 J5 5 6 J10 2 J2 J7 J3 J8 6 4 J4 J9 J5 J10 7 9522020 3 5 J2 J7 J3 4 5 J4 J5 J8 (SOL 61-68) J18 952077 8 Over P Pressure Sensor J16 J4 J1 J2 J3 J4 9520874 DC Motor J5 Diluent/Sheath (quiet) Reservoir 1 Level 9520835 9212130 Exhaust Fan 9212130 Exhaust Fan 9212130 LH Intake Fan J3 9522009 J11 ATX PC Power J11 9522306 9522038 9522012 J13 TCM 9522094 9522011 J15 J20 J14 J17 9522005 9522008 6 9522009 9522017 J7 J3 J8 8 J4 J9 9522053 7 TCM 9602980 J1 J2 J3 J4 J5 J6 J10 9520861 J5 J2 J6 9522095 J3 J5 NC 9522079 CCW 9212944 J4 MDM 9601940 9522061 CW 1 NC J5 9522046 J10 9520853 J12 9520854 J7 J13 NC J11 J14 9520855 9520856 J18 9522055 Input Power B J1 J1 9522037 SDM5 / J8 J16 9522083 VAL-2 9522083 VAL-3 9522083 VAL-4 J3 J4 J1 J3 PMT PREAMP 9601010 J2 J5 9522018 (CH3) PMT PMT (CH4) 9522055 9520255 Manifold VAL-5 UPPOS Mixer Home Sensor J10 9522084 J12 J13 9522032 J15 9522045 J9 9522086 Rack Sensors 9522088 Tube Sensor Assy J11 J16 9212940 M Mixer Motor 2104220 Bar Code Reader Note: for Refurb Instruments with PCB 9600920, make the connections as follows: 9250847 to J1 9600920 9522016 to J2 9600920 COM 1 COM 2 Data Station Power Switch 9522024 J18 Video Display J27 ATX P/S Laser 9522083 9340117 Sample Loader Controller Status 0-3 9212928 Computer J10 Data Station 9341079 9312025 9212909 Laser P/S Tube M Spinner Ext. VAL-1 9601000 PREAMP 0 DEG (CH1) 9601000 PREAMP 10 DEG (CH2) PMT PREAMP 9601010 J1 J2 J3 J6 J19 9522036 SDM5 / J3 Rotary Valve Assy Bottom View J7 NC 9212943 9522049 CTR COV DPT Sensor SHM (2) 9602290 9522083 J1 EXT. CPU BUS +5V ± 15V 9522042 HTR-1 (HGB Right PL) HTR-2 (WOC Left PL) Motor 2 NC SPRCSR M Motor Ext. Aspiration Tower Controller J2 9522094 J1 9522078 J1 9212942 NC J15 J3 9522018 NC 9522075 NC NC J2 J4 9522072 9600420 Sensor & Chopper Driver NC NC J16 9522039 J12 J26 RH Intake Fan 9211956 9522035 FCM J15, J16 J2 8 9520860 9522013 J5 J6 J7 J8 J9 J10 9522054 G Peristaltic Pump Motor MAM 9601951 9522082 NC NC 9522016 J12 J9 9522080 PDM 9601981 9522017 9520563 9522016 GS2 SOL 9522087 SPRCSR Sensor J14 E OTS Motor 9522056 J10 J13 9212941 9522047 J1 J2 J1 J2 9522018 9522848 MUX DAC Control 9522020 J10 Diluent/Sheath (noisy) Reservoir 2 Level 9520836 J2 ADC2 9520505 CDM2 External Waste Full J4 9601080 J7 9520857 9522051 7 J6 9522011 WBC LYSE Reservoir Level J9 9522031 J3 J4 J5 J6 J7 J8 J9 J15 J10 J11 J12 J13 J14 J7 CPU / DCM 9601820 J3 J4 J5 J9 9522095 J8 DAC3 J4 HGB 9212922 J2 J1 ADC3 Shear Valve Dr. 9602220 J1 9520785 6 J9 J10 9520839 J10 J1 J2 C WBC Lyse Syr. Motor RBC/HGB 9520154 J1 J2 D Diluent Syr. Motor 9600422 Chopper Driver 9601601 J3 SHM (1) 9602290 J1 9522085 9520155 MPM SPM 9601830 9522082 J14 9520500 J3 9522046 J11 J10 9520505 9520850 J12 9522054 J1 NC J2 9522055 J17 NC J13 9520849 Peripheral BUS 9520834 9522050 3 S1 J1 J2 B HGB Lyse Syr. Motor 9522081 Data Station * Serial Link 9520862 (SOL 51-58) 2 J3 FCM 9601320 9520849 J1 SDM9 J6 9600930 1 9520859 J1 SDM6 J6 9600930 J11 J20 9600420 Chopper Driver Motor 9520844 9520847 MPM Serial Link J6 J5 DAC1 ADC1 J7 3701818 Ultrasonic J8 Short Sample Sensor (SOL 91-98) 4 1 9520851 9520852 J22 J25 J18 9520860 J2 2 5 J26 9600422 Chopper Driver J1 J2 A Sample Injection Syr. Start SW 3701818 Ultrasonic Short Sample Sensor 9600910 Reagent Empty In-Line Sensor J2 A NC J1 SDM5 J6 9600930 S3 9212939 9520862 9520859 J1 NC 1 9522080 J14 9520832 9520826 J6 (SOL 41-48) J3 Pres. Pump 9522093 9520532 J21 J23 J24 J4 J5 J8 J13 9520831 J1 J2 J4 Pump Relay 9601201 Vac. Pump J3 J7 J3 9522035 J15 9522035 J16 J14 9522080 9520750 J1 J9 J12 J19 J1 VAC Press 9601220 9522093 J6 J1 SDM4 J6 9600930 2 J2 9601169 Short Sample Sensor 1 VAC 1 OVFL 9520528 J10 VAC 2 OVFL 9520875 J11 Test Conn . J16 (SOL 31-38) 1 J7 Solenoid 9520858 J1 9522090 9520870 SP 7 8 J6 9520826 (SOL 21-28) 1 9520838 J11 NC J9 J5 5 9520858 NC 9520825 J3 9522092 9522092 J3 9522008 8 (SOL 11-18) 1 9520845 SDM Data, +5V 9522053 934107 1 SBC J1 SDM1 J6 NC SOL 9600930 1 SOL J26 J11 LPT1 Keyboard / Mouse / Hand Held Barcode Reader HSSL BLK WHT GRN 9210462 AC In 9522091 5107518 9522043 Power Signal to PDM / J11 3X USB APS Ethernet LAN +28V P/S BLK 1 WHT GRN Audio Door HOT NEU GND J8 J12 CD-RW, HDD FDD 3 2107612 9522096 9341047 9522089 9522040 9H_9048f CABLE CONNECTION DIAGRAM J1 SDM1 J6 NC SOL 9600930 1 SOL 2 3 4 5 J2 J7 J3 J8 J4 J9 J5 J10 7 J1 SDM2 J6 9600930 2 3 4 J2 J7 J3 J8 J4 9520858 J1 J2 9520532 J4 9520532 J5 J10 NC J7 NC J8 J10 NC J1 SDM3 J6 9600930 2 3 4 NC J2 J7 J3 J8 J4 J9 J5 J10 6 7 8 S2 3 4 5 J2 J7 J3 J8 J4 J9 J5 J10 9522035 J15 9522035 J16 J14 9522080 9520750 J1 9520532 4 J2 2 J3 3 J4 J17 5 J5 J12 J15 9522080 S3 9520851 9520852 J22 J25 J11 J20 J3 9520849 9522020 9520839 J18 9520778 NC J3 J4 9522017 9520874 DC Motor 9522017 9522095 9522020 Diluent/Sheath (quiet) Reservoir 1 Level 9520835 9522013 9522094 9522011 9522005 J3 9522009 9522008 J1 SDM5 J6 9600930 1 2 J2 J7 J3 J8 J4 J9 J5 J10 6 J1 SDM9 J6 9600930 1 2 4 5 9522009 (SOL 91-98) 7 9520859 3 4 6 J1 SDM6 J6 9600930 1 2 J2 J7 9522017 J2 J7 J3 J8 8 J4 J9 9522053 J5 J10 9520861 7 TCM 9602980 J1 J2 J3 J4 J5 J6 6 9522051 7 J2 9522050 3 4 5 J3 J8 J4 J9 J5 J10 (SOL 61-68) J6 9522095 9520860 J3 J5 NC 9522078 9522079 CCW 9212944 HTR-1 (HGB Right PL) HTR-2 (WOC Left PL) 9522061 CW 9522005 9522036 SDM5 / J3 Motor Rotary Valve Assy Bottom View 2 J7 J4 H J K L M N O P Q 9522094 J1 8 G 9522035 FCM J15, J16 (SOL 51-58) 5 F 9522011 J10 Diluent/Sheath (noisy) Reservoir 2 Level 9520836 J11 E J2 WBC LYSE Reservoir Level J9 9522031 J5 HGB 9212922 9520862 A NC Over P Pressure Sensor Shear Valve Dr. 9602220 J1 9520785 CDM2 External Waste Full J4 9601080 J7 9520857 9520860 J2 D 9520862 Pres. Pump J8 B C 9522080 9520849 Peripheral BUS J10 DAC 1 ADC1 3701818 Ultrasonic Short Sample Sensor S1 J18 9520859 J1 A 3701818 Ultrasonic Short Sample Sensor 9600910 Reagent Empty In -Line Sensor J26 FCM 9601320 J14 9520832 9520826 J6 (SOL 41-48) J3 9520834 9522093 9520532 J21 J23 J24 J4 J5 J8 J13 9520831 J1 J2 J4 Pump Relay 9601201 Vac. Pump J3 6 J12 J19 J1 VAC Press 9601221 9522093 J6 J1 SDM4 J6 9600930 2 J2 9601169 Short Sample Sensor 1 VAC 1 OVFL 9520528 J10 VAC 2 OVFL 9520875 J11 Test Conn . J16 (SOL 31-38) 1 J7 Solenoid 9520858 J1 9212939 9522090 J9 9520870 SP 7 8 J6 9520826 (SOL 21-28) 1 9520838 J11 NC J9 J5 5 6 9601920 Speaker & Status BD. J3 9522092 NC 9520825 CDM1 J9 9601080 J6 8 9522092 J3 9522008 NC (SOL 11-18) 1 SDM Data, +5V 9522053 9522037 SDM5 / J8 1 MDM 9601940 9H_9048e_A R CABLE CONNECTION DIAGRAM 9212939 A Start SW 9520845 9600422 Chopper Driver J1 J2 A Sample Injection Syr. 9600420 Chopper Driver Motor 9520847 MPM Serial Link J6 J5 DAC1 9520851 B 9520852 C J8 9522080 D 9522081 Data Station * Serial Link 9522082 J14 9520500 J3 9522046 J11 J10 9520505 9520850 J12 9522054 J1 NC J2 9522055 J17 J13 NC J7 SPM 9601830 MPM 9601601 J3 J2 J1 DAC3 J5 ADC3 J7 9520849 Peripheral BUS J16 J6 J9 ADC2 9520505 F G 9522013 J5 J6 J7 J8 J9 J10 ATX PC Power J11 H 9522095 J 9522020 K 9212130 Exhaust Fan 9522306 LH Intake Fan TCM L M 9522038 J13 9522012 J19 9522094 9522011 9522005 J15 J20 J14 9522008 J17 9522009 J18 9522017 J16 J12 J26 9522039 RH Intake Fan 9211956 N J1 J2 C WBC Lyse Syr. Motor J1 D Motor J1 J2 J10 9522018 RBC/HGB Diluent Syr. 9212941 9522047 J1 J2 E OTS Motor 9522056 J1 J2 9520563 9522016 NC NC 9522054 G Peristaltic Pump Motor NC NC 9522016 9522018 NC J15 J3 J1 9601000 PREAMP 0 DEG (CH1) 9601000 PREAMP 10 DEG (CH2) J6 NC J7 9522055 J1 9520853 J12 9520854 J14 J9 9522049 CTR COV DPT Sensor J16 9520855 9520856 9212943 M Tube Spinner Ext Aspiration Tower Controller SHM (2) 9602290 9522083 J1 VAL-1 9522083 VAL-2 9522083 VAL-3 9522083 VAL-4 9522083 VAL-5 J3 B 9522046 J10 J13 NC J11 9522075 J2 J4 NC J14 SPRCSR Motor Ext M NC EXT. CPU BUS +5V ± 15V J5 9212942 NC NC J2 NC 9522072 9600420 Sensor & Chopper Driver MAM 9601951 9522082 J12 9522085 GS2 SOL 9522087 SPRCSR Sensor J13 9522080 PDM 9603100 J1 J2 J3 J4 SHM (1) 9602290 9522848 MUX DAC Control 9522017 J1 J2 B HGB Lyse Syr. Motor 9600422 Chopper Driver J10 J11 J12 J13 J14 J2 CPU / DCM 9601820 9520155 9520154 J3 J4 J5 J6 J7 J8 J9 J15 J4 J4 E 9520844 J1 PMT PREAMP 9601010 J1 J2 J3 J1 J3 PMT PREAMP 9601010 J2 J4 J5 9522018 (CH3) 9522084 J12 J13 9522032 9212940 9522045 2104220 Rack Sensors 9522088 9522055 J11 Tube Sensor J16 Assy Sample Loader Controller J9 (CH4) Manifold UPPOS Mixer Home Sensor J10 PMT PMT 9340117 9522086 Mixer Motor Bar Code Reader M Note: for Refurb Instruments with PCB 9600920, make the connections as follows: 9250847 to J1 9600920 9522016 to J2 9600920 Input Power Status 0-3 O 9212928 Computer Data Station 9341079 P Q 9212909 Laser P/S ATX P/S 9312025 Laser 934107 1 SBC R COM 1 COM 2 Data Station Power Switch 9522024 - J18 Video Display J27 9522042 9522005 9520255 J10 J26 J11 LPT1 Keyboard / Mouse / Hand Held Barcode Reader HSSL Power Signal to PDM / J11 BLK WHT GRN 9210462 AC In 9522091 5107518 9522043 3X USB Ethernet LAN APS Audio Door +28V P/S BLK 1 WHT GRN J8 HOT NEU GND 3 J12 9522089 2107612 9522096 CD-RW, HDD FDD 9522040 9341047 9H_9048f_B T o V P M T o F C M J 9 1 2 3 4 5 6 J 1 0 1 2 3 4 5 6 J 1 1 1 * A n a ly z e r 2 P o w e r 3 O ff 4 T o F A N 3 J 1 2 1 2 J 1 3 1 T o F A N 1 2 T o L a s e r P S J 1 4 1 2 T o T C M J 1 5 1 2 T o S V S B J 1 6 1 2 T o C D M 1 J 1 7 1 2 3 4 5 6 J 1 8 1 T o C D M 2 , F C M 3 2 4 5 6 J 1 9 1 T o F A N 2 T o P R M 2 J 2 0 1 2 P o w e r D is tr ib u tio n M o d u le P o w e r C o n n e c to r s + 5 V + 1 5 V G N D -1 5 V + 5 V G N D + 1 5 V E 7 + 5 V D C E 1 + 1 5 V D C G N D -1 5 V E 2 + 5 V _ A T X + 2 8 V 3 2 **T o D a ta S ta tio n 5 4 7 8 6 9 1 0 D V D V + 5 V + 5 V -1 + 1 + 2 G G G + 2 8 V G N D + 5 V + 2 8 V G N D + 2 8 V + 5 V + 1 5 V -1 5 V G N D G N + 1 + 2 + 2 G N D D 5 .5 V 8 V 8 V G N D + 2 8 V G N D G N + 1 + 2 + 2 D E 6 5 .5 V 8 V 8 V + 1 5 .5 V D C + + 1 -1 G 5 V 5 V 5 V N D G N D + 2 8 V E 5 G N D + 2 8 V D C + 2 8 V E 8 G N D + 2 8 V + 5 V G N D + 1 5 .5 V G N D + 5 V S T A S T A S T A _ A T U T U T U T X S 0 S 1 S 2 S T A T U S 3 N C N C N C + 5 V _ A T X + 1 5 .5 V G N + 2 8 G N G N + 2 8 D V D D G N D G N D V + 1 2 V _ A T X 1 2 3 F ro m P D M -J 1 8 3 5 J 1 + 2 8 V + 1 5 .5 V G N D 4 1 2 J 2 8 J 3 1 2 3 3 N C 7 6 1 6 4 N C N C S S R N C 2 N C 2 3 4 J 2 1 1 1 5 S 1 N O 1 3 2 IN H IB IT 5 J 5 1 2 3 4 5 6 7 8 J 6 1 2 3 4 5 6 7 8 J 7 1 2 3 J 8 1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 T o S D M B N C J 4 1 2 3 8 J 4 1 2 3 4 5 6 7 8 T o S D M A + 5 V _ A T X 4 7 2 3 1 R 1 V 2 V 2 V 8 V N D N D N D * A n a ly z e r P o w e r O F F J 1 1 1 & 2 P o w e r C o n n e c to rs J 3 N C 5 4 V C D M T o M A M S P M C P U /D C M 2 D D B L O C K D IA G R A M P o w e r D is tr ib u tio n M o d u le P o w e r C o n n e c to r s 1 4 D D IS T R IB U T IO N J 2 6 G N D -1 5 V G N G N + 1 5 G N -1 5 J 1 1 2 3 4 5 6 7 8 3 + 5 V + 5 V E 4 + 1 2 V D C E 3 -1 2 V D C G N D D -1 5 V D C G N D _ A T X + 2 8 V G N D + 2 8 V G N D G N G N + 1 5 G N -1 5 G N D G N D + 1 5 V + 1 2 V _ A T X J 2 6 1 P O W E R + 5 V + 5 V G N D T o S D M C J 5 T o M P M 1 * * T o D a ta S ta tio n T o S H M 1 S H M 2 J 2 6 1 2 3 4 5 6 7 8 9 1 0 + 5 S T S T S T V _ A T A T A T A T U S U S U S 2 3 R 2 X 0 1 2 1 S T A T U S 3 N C N C N C + 5 V _ A T X 2 3 4 5 N C S S R F C M 6 J 3 T o S D M s -J 9 1 0 N O J 4 N C M o to r C o n tro l O u tp u t C o n n e c to r J 3 -J 1 4 1 + 2 8 V T o M D M 2 + 5 V 3 M 0 I0 M 0 I1 M 0 P h 0 In p P o w F ro A P u t e r m S M 0 P H 1 T O C D B 5 6 7 F B + F B - 8 9 3 J 8 T o S h e a r V a lv e D r iv e r - J 2 3 J 1 1 J 5 1 6 3 5 4 F ro m P D M -J 1 8 + 5 V G N D J 1 4 + 5 V G N D 1 3 J 1 2 T o U tr a s o n ic S h o r t S a m p le S e n s o r (S 3 ) - J 3 T o O v e rp re s s u re S e n s o r 1 3 G N D G N D + 1 5 .5 V + 2 8 V + 2 8 V + 5 V G N D 1 T o U tr a s o n ic S h o r t S a m p le S e n s o r (S 1 ) - J 3 T o S h o r t S a m p le S e n s o r (S 2 ) - J 1 4 + 2 8 V + 1 5 .5 V G N D 1 2 P o w e r C o n n e c to rs + 5 V G N D 9 T o S D M 9 -J 1 0 T y p ic a l M P M T o S D M D 3 1 + 5 V G N D J 1 0 3 2 + 5 V G N D 1 0 N o te : P in c o n fig u r a tio n s o n t h e a s s e m b lie s th a t a r e n o t s h o w n a re th e s a m e a s th o s e s h o w n . 9 H _ 9 0 4 9 a S E N S O R B L O C K D IA G R A M T y p ic a l F C M E le c tr o d e & V P M R e a g e n t E m p ty IF D ilu e n t E 1 E m F lu id S e n s o r In p u t + F L U ID L IN E E le c tr o d e E 2 - E 4 W B C In - L in e S e n s o r s S B J 1 / S h e a th E 5 1 p ty L y s e E m p ty E 6 4 6 E x te r n a l W a s te F u ll 1 J 7 D ilu e n t / S h e a th ( Q u ie t) R e s e r v o ir 1 L e v e l 1 J 8 J 6 D ilu e n t / S h e a th ( N o is y ) R e s e r v o ir 2 L e v e l 1 L y s e R e s e r v o ir L e v e l 1 0 1 1 1 1 1 3 J 1 0 1 1 0 1 3 G N D 1 5 J 9 A la r m 1 J 4 S h o r t S a m p le S e n s o r B o a r d ( S 2 ) T P 4 8 6 9 1 0 1 1 1 2 F C M 1 J 1 5 T y p ic a l S H M + 5 V 1 2 1 A G N D J 1 3 3 J 9 3 M ix e r L ifte r U p S e n s o r 6 F o u rth T u b e S e n s o r J 3 2 1 2 J 1 2 A G N D 3 2 2 J 1 1 3 + 5 V 2 2 J 1 3 V a lv e C C W 6 4 V a lv e C W 3 D G N D J 1 6 4 + 5 V D G N D 1 T P 1 J 2 3 1 V a lv e C C W 7 D r iv e In A G N D 1 1 J 1 0 V P M J 1 1 R o ta r y V a lv e S e n s o r s C lo s e d M o d e S e n s o r 2 J 4 O p e n M o d e S e n s o r 2 J 5 M D M O p tic a l S e n s o r In p u t + 5 V J 4 -J 5 2 In 3 A G N D 3 V a lv e C W 6 D r iv e 2 5 k H z L E D 7 1 S h e a r V a lv e D r iv e r M o d u le L im it S e n s o r B o a r d # 2 W e t 5 9 1 0 1 1 1 2 T y p ic a l M D M 1 A G N D 3 V a c u u m A c c u m u la to r O v e r flo w S e n s o r s V a c u u m # 1 W e t 4 8 J 1 1 2 5 k H z L E D In 3 6 8 + 5 V 3 + 5 V 1 In 1 2 J 1 0 4 T h ir d T u b e S e n s o r J 1 1 S H M 2 M ix e r H e a d H o m e S e n s o r V a c u u m + 5 V 1 U ltr a s o n ic S h o r t S a m p le S e n s o r B o a rd (S 3 ) J 3 J 1 4 2 In T u b e S e n s o r In p u t 9 U . S . F o u rth R a c k S e n s o r 3 2 In 7 D G N D U . S . F ifth R a c k S e n s o r J 1 6 H T R 2 5 6 J 9 3 A G N D U ltr a s o n ic S h o r t S a m p le S e n s o r B o a rd (S 1 ) A la r m 2 T P 2 R e f H T R 1 In 4 3 L o a d S id e E m p ty S e n s o r J 2 1 2 3 S a m p le L o a d e r S e n s o r s 1 5 T C M + 5 V 3 C o v e r S e n s o r 6 1 2 S H M 1 9 T u b e H e ig h t S e n s o r ( S 1 ) + 5 V J 9 -J 1 0 J 1 0 C D M 2 R e a g e n t & W a s te L e v e l S e n s o rs W B C J 2 6 4 G N D 6 T u b e H e ig h t S e n s o r ( S 2 ) 2 O p tic a l S e n s o r In p u t 3 G S 1 H o m e S e n s o r 1 2 E 8 H G B L y s e E m p ty T y p ic a l S H M A s p ir a tio n T o w e r S e n s o r s J 8 6 7 O v e rp re s s u re S e n s o r N O + 5 V G N D 2 3 J 1 0 9 H _ 9 0 5 0 a M E A S U R E M E N T B L O C K D IA G R A M T P 1 J 1 A m p lifie r s 6 J 1 0 4 L in A m p lifie r s T P 3 T P 2 A G N D 0 º P h o to d io d e P re a m p L o g A m p lifie r s 2 C H C H C H C H C H C H T P 8 A m p lifie r s J 1 6 1 0 º P h o to d io d e P re a m p J 1 2 4 L in A m p lifie r s 1 1 7 5 3 7 3 9 1 1 5 9 1 1 C H C H C H C H C H C H 1 L in 1 L o g 2 L in 2 L o g 3 L in 4 L in P e a k H o ld C ir c u its J 7 A m p lifie r M U X 3 1 A D C 3 2 T o C P U /D C M T P 4 L o g A m p lifie r s T P 7 T P 1 2 F C M T P 9 H G B F lo w C e ll A G N D A G N D T P 2 J 2 A m p lifie r s A G N D in o g in o g in in J 6 A G N D T P 2 P M T 1 L 1 L 2 L 2 L 3 L 4 L J 1 5 A G N D T P 1 A G N D S P M M A M 4 J 1 3 4 L in A m p lifie r s T P 5 H G B V o lta g e J 1 8 3 2 L E D C u rre n t A m p lifie r 1 M U X 4 A G N D A m p lifie r 8 8 1 A D C 1 2 T o C P U /D C M 3 5 A G N D T P 3 V D Y N /-1 0 0 J 2 5 A m p lifie r J 2 4 1 A D C 4 2 F ro m V P M T P 1 9 0 º P M T P re a m p 2 A G N D T P 2 J 2 A m p lifie r s P M T 4 J 1 4 4 L in A m p lifie r s T P 6 T P 3 V D Y N /-1 0 0 8 8 T P 2 T P 1 AG N D 9 0 º D P M T P re a m p 2 + 1 0 V R e fe re n c e A G N D 9 H _ 9 0 5 1 a SOLENOID CONTROL BLOCK DIAGRAM SDM3 J1 J2 J3 Solenoid Data / +5V/5V Ret. J9 J4 J3 J6 J7 J8 CLK J1 FCM 3-5 3-6 3-7 3-8 Spare CS Vent Trap Drain (WC-4) CS Probe Drain (WC-4) CS Vent Trap Vent CLK J4 J1 J9 J2 J3 J4 J5 J6 J10 J7 J8 Peripheral Bus J16 CPU/DCM J17 J1 ON/OFF J7 J8 CW/CCW From PDM J6 MDM DC Rotary Valve Motor J5 SDM5 J1 J9 J2 J3 Shear Valve Diluent/Sheath (quiet) Flush J6 Sample Aspiration Vacuum Shear Valve Drain (WC-4) Open Sample Probe Drain (WC-4) Open Sample Probe Diluent/Sheath (quiet) Flush (NC) Spare WC-2 VAC 2 Supply WC-2 PRESS 1 Supply J4 J5 J10 J6 J7 J8 From FCM J3 J4 5-1 HGB Flow Cell Vent 5-2 Staging Pump Input 5-3 Enable/Disable Control HTR-1 (HGB/NOC) 5-4 RBC/PLT Sample Staging 5-5 WBC (WOC) Sample Staging 5-6 Optical Flow Cell Output 5-7 Optical Flow Cell Drain 5-8 Enable/Disable Control HTR-2 WBC (WOC) +28V 5 +15.5V 4 GND 3 1 1 2 To 3 5 SDMA 6 7 J6 J2 HTR-1 HTR-2 J6 CDM2 1-1 1-2 1-3 1-4 1-5 1-6 1-7 1-8 J2 J1 J1 J3 4-1 NOC Sample Staging 4-2 WBC (WOC) Bubble Mixing 4-3 RBC/PLT Bubble Mixing 4-4 HGB/NOC Bubble Mixing 4-5 WBC Lyse Reservoir VAC 1 4-6 WBC Lyse Reservoir PRESS 3 J1 J2 SDM1 J19 CDM Connectors J1 J2 J3 J9 J4 J5 J6 TCM CLK J2 CDM1 J1 J2 J4 J5 J6 J10 J10 J15 J16 SDM4 3-1 WC-4 VAC 1 Supply 3-2 WC-4 PRESS 1 3-3 RBC/HGB Diluent/Sheath Diluent/Sheath (quiet) Fill 3-4 Closed Probe Diluent/Sheath (quiet) Flush (NC) 1 2 3 4 5 6 7 8 9 On CLK A Hi CLK A On CLK B Hi CLK B On CLK C Hi CLK C On CLK D Hi CLK D Reset J2 1 2 3 To 5 SDMB 6 7 J4 1 2 To 3 5 SDMC 6 7 SDM6 J1 J9 J2 J3 J4 J5 J6 J10 J7 J8 2-1 2-2 2-3 2-4 2-5 2-6 2-7 2-8 6-1 Diluent/Sheath (noisy) Reservoir 2 VAC 1 6-2 Diluent/Sheath (quiet) Reservoir 1 VAC 1 6-3 Diluent/Sheath (quiet) Reservoir 1 PRESS 3 6-4 Diluent/Sheath (noisy) Reservoir 2 PRESS 2 6-5 Diluent/Sheath (noisy) Reservoir 2 Output (NC) 6-6 Diluent/Sheath (quiet) Reservoir 1 Output (NC) 6-7 WC-1 PRESS 1 6-8 WC-1 Vent J1 J9 J2 J3 J4 J5 J6 J10 J7 J8 SDM2 RBC/PLT Mixing Chamber Drain Sample Injection Syringe Diluent/Sheath(noisy) WBC Lyse Reservoir Output (NC) HGB Lyse Syringe Output WBC Lyse Syringe Output RBC/HGB Diluent Syringe HGB/NOC Dilution RBC/HGB Diluent Syringe RBC/PLT Dilution Main HGB Lyse Supply (NC) J5 1 2 To 3 5 SDMD 6 7 SDM9 9-1 Optical Flow Cell Diluent/Sheath (noisy) Flow 9-2 WBC (WOC) Chamber/WOC Heater Drain (WC-3) 9-3 HGB Flow Cell Drain (WC-3) 9-4 HGB Flow Cell Diluent/Sheath (quiet) Flush 9-5 RBC/PLT Mixing Chamber Diluent/Sheath (quiet) Flush 9-6 WBC (WOC) Chamber/WOC Heater WBC Lyse Flush 9-7 WC-3 VAC 1 9-8 WC-3 PRESS 1 J1 J9 J2 J3 J4 J5 J6 J10 J7 J8 VPM J17 J1 J2 J3 J4 J5 SHM1 Aspiration Tower RS-485 Bus RS-485 Bus J16 J1 J2 J3 J4 J5 J6 J7 J8 FCM Connectors V1 (7-1) ACC 1, PRESS 1 Vent V4 (7-2) ACC 4, VAC 1 Vent V2 ACC 2, PRESS 2 Supply V3 ACC 3, PRESS 3 Supply V5 ACC 5, VAC 2 (Variable) Supply GS2 Stop Solenoid Spare Spare Spare Spare Spare Spare Spare On/Off SHM2 Sample Loader V1 Rack Advance J1 J16 V2 Load Side Cross Transfer J2 V3 Mixer Lift J3 V4 Mixer Bladders J4 V5 Unload Side Cross Transfer J5 Spare J6 Spare J7 Spare J8 J1 SHM Solenoid Connector +28V J1-J8 R1-R7 DS1-DS7 Driver On CLK 1 Hi CLK 1 On CLK 2 Hi CLK 2 On CLK 3 Hi CLK 3 On CLK 4 Hi CLK 4 Reset 1 1 2 3 4 To 5 6 CDM1 7 8 9 15 J3 PD0 PD1 PD2 PD3 PD4 PD5 PD6 PD7 +5V 1 2 3 4 To 5 6 SDMs 7 8 9 10 SDM Connectors & Driver Outputs J9 PD0 PD1 PD2 PD3 PD4 PD5 PD6 PD7 +5V 1 2 3 4 5 6 7 8 9 10 +28V Q1-Q8 TP1 Hi/Lo CR1-CR8 Driver 2 AGND J2 On CLK 5 Hi CLK 5 On CLK 6 Hi CLK 6 Reset AGND 1 2 3 To 4 CDM2 9 15 J4 +28V +15.5V UR RET On CLK 9 Hi CLK 9 Reset R1-R8 DGND DGND 1 2 3 To 5 SDM9 6 7 +15.5V J10 1 2 3 5 6 7 +28V TP2 +15.5V UR RET On CLK Hi CLK Reset DS1-DS8 On/Off Driver J1-J8 Solenoid Drive 1 2 9H_9052b MOTOR CONTROL BLOCK DIAGRAM MPM Stepper Motor Control Aspiration Tower Motor Control MPM Serial Link J6 CPU/DCM J2 MPM J1 CDB J2 A Sample Injection Syringe J4 J1 CDB J2 B HGB Lyse Syringe PH0 1 PH0 2 J5 J1 CDB J2 C WBC Lyse Syringe J6 J1 CDB J2 D RBC/HGB Diluent Syringe J13 J1 CDB J2 E Open Probe J8 J1 CDB J2 G Microprocessor & Digital Control Discharge Discharge Complete Ramping A/D Converter J3 FB+ 8 FB- 9 TO CDB Digital Control Bus J2 MPM Serial Link M0 Phase Control Latch J3 6 M0 TO Current CDB Control M0 PH1 7 Latch M0 PH0 M0 I0 M0 I1 J3 4 M1-M11 TO Control CDB Latches 5 J4-J14 PH1 4 5 PH1 6 J8 Sample Staging Pump Barcode Spin Motor +28V 1 Typical MPM Motor Control Output Connector J3-J14 1 +28V 2 +5V 3 M0 I0 4 M0 I1 5 TO M0 PH0 6 CDB M0 PH1 7 FB+ 8 FB9 DC Shear Valve Motor Control J8 FCM J2 +5V 1 3 1 3 DGND 4 5 CW/CCW On/Off 4 5 Shear Valve Driver Module TO MPM 7 2 3 1 8 9 Stepper Motor Phase 0 Driver Stepper Motor Phase 1 Driver J7 2 On/Off 2 J2 +28V +5V TP1 GND FB+ FB- FB+ FB- Winding Voltage Feedback (Diagnostics) DC CW/CCW Rotary Valve Motor 2 J1 DC 2 J2 MA MB PH0 MB - Drive 1 MDM J8 2 PH0 1 MA 3 + Drive J14 10 Vacuum & Pressure Pump Control Motor 2 PRM F1 PH1 1 Rotary Valve Motor Control SDM Chopper Driver Board J4 Shear Valve Motor CDB Block Diagram J1 PH0 6 I0 4 I1 5 Motor PH0 2 Driver 2 MPM Motor Control Block Diagram (Motor 0) Mixer Stepper Motor PH0 1 Motor PH1 4 PH1 J9 J13 SHM2 SHM1 J7 Sample Loader Motor Control GS1 Stepper Motor J3 PH1 PH1 +5VDC 4 5 R2 J18 1 VPM 4 3 +5VDC R10 J1 Pressure Pump On 1 Pressure Pump On 4 3 J4 1 +28VDC 2 GND Pressure Pump J2 DC 1 2 3 Vacuum Pump J3 ISO2 MP R3 ISO1 R9 1 2 DC 3 9H_9053b System Flow Diagrams Links Diagnostic Flow System Diagram 9H_9056.PDF Diagnostic Flow System Diagram (Color) 9H_9058.PDF Flow Panel Diagram 9h_9057.PDF Integrated Auto Loader, Sample Processor Flow Diagram 9H_9054.PDF Vac/Press Supply Flow Diagram 9H_9055.PDF CELL-DYN Ruby System Service and Support Manual (Version 201958-111) • © 2006, 2012 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. INTEGRATED SAMPLE LOADER, SAMPLE PROCESSOR FLOW DIAGRAM S2 1.0" / 2.54 cm To Ultrasonic Short Sample Sensor (S1) C1 R4 3x 9340955 Modified Lengths Torque to 32 ozf in / 0.226 Nm 2.50" / 6.35 cm Rotary Valve Block Y543 4.0" / 10.16 cm Front 9400226 Vent / Liquid Isolator AIR WC-4 WC-4 Back 1 VAC 1 5.70" / 14.98 cm L DI 2.7" / 6.86 cm S2 1.0" / 2.54 cm N1 29.0" / 73.66 cm W N1 24.0" / 60.96 cm C1 NOTE: Tubing Should be Against Port. PR ES S 4 C- 1 DI L S2 1.0" / 2.54 cm 9341074 Multi-Port Coupler-2 Sample Loader N1 30.5" / 77.47 cm Y532 1.0" / 2.54 cm N1 26.0" / 66.04 cm Y633 12.0" / 30.48 cm PRESS 1 Closed Tube Probe / Wash Block Open Tube Probe / Wash Block R2 S2 0.8" / 2.03 cm N2 9.0" / 22.86 cm VAC 1 R2 N1 2.0" / 5.08 cm N2 11.0" / 27.94 cm N2 6.0" / 15.24 cm Rack Advance Load Side Cross Transfer Unload Side Cross Transfer N2 14.0" / 35.56 cm N2 2.0" / 5.08 cm Mixer Lift Tube Gripper F3 N1 10.0" / 25.40 cm C1 V1 2 FO V2 V5 V3 V4 3 1 1 FO " / FO / FO 0 0" m . 6. c m 4 c N 2 5. 24 N 2 0. 16 1 "/ 1 CV3 25 cm . 7 2 CVO 1 N 2 8. 4 1 FO 3 REG FO 1 N2 1.0" / 2.54 cm N2 5.0" / 12.7 cm T9 R1 N1 12.0" / 30.48 cm Y535 15.0" / 38.10 cm Sample Loader Manifold Y535 26.0" / 66.04 cm 9H_9054d VAC / PRESS SUPPLY FLOW DIAGRAM Y634 11.0" / 27.94 cm Y6.0" / 15.24 cm Y635 7.0" / 17.78 cm CV CLP2 Y638 1.5" / 3.81 cm CLP2 Y638 9.5" / 24.13 cm Y635 2.0" / 5.06 cm Y638 4.5" / 11.43 cm T3 PS5 B A VAC 2 Vacuum Y638 1.5" / 3.81 cm PS4 VAC 1 Vacuum D B Y635 4.5" / 11.43 cm Y635 4.0" / 10.16 cm Y631 14.5" / 36.83 cm A B C B A Y13.0" / 33.02 cm C 9211734 ACC 5 VAC 2 B A PS1 IN C5 C5 IN C5 Y635 17.0" / 43.18 cm C5 F1 V2 Y631 7.0" / 17.78 cm Pump 1 (Vacuum) S2 4.0" / 10.16 cm Y633 1.0" / 2.54 cm Y5 1.8" / 4.57 cm Y634 2.5" / 6.35 cm CV R2 CLP2 T4 Y633 1.0" / 2.54 cm Y638 15.0 / 38.10 cm Y635 6.0" / 15.24 cm Y635 5.0" / 12.70 cm CLP2 Y5 24.0" / 60.96 cm S2 4.0" / 10.16 cm T3 CV T3 CLP2 Y634 12.0" / 30.48 cm V5 T4 (7-2) Yellow D IN OUT REG C ACC 2 PRESS 2 Y634 1.5" / 3.81 cm P1 9211732 A P1 Y635 9.0" / 22.86 cm SY 3.0" / 7.62 cm SY 8.0" / 20.32 cm T7 A C D ACC 1 PRESS 1 Y634 1.5" / 3.81 cm P1 Y633 15.0" / 38.10 cm Y633 17.5" / 44.45 cm B 9211732 Y634 1.5" / 3.81 cm B OUT OUT Y634 4.0" / 10.16 cm IN REG CLP2 Y633 5.0" / 12.70 cm Y633 6.0" / 15.24 cm CV CLP2 Orange Y634 3.5" / 8.89 cm CLP2 T3 Y633 3.0" 7.62 cm V1 V4 Y633 7.5" / 19.05 cm CLP2 (7-1) Y631 21.0" / 53.34 cm CLP2 3 S1 10.0" / 25.40 cm Vent VAC 2 S P1 CV Y5 24.0" / 60.96 cm R2 R4 CLP2 T5 Y633 7.0" / 17.78 cm ES 9601220 VPM PCB OUT OUT Pump 2 (Pressure) Y638 7.0" / 17.78 cm Y638 1.5" / 3.81 cm V3 CLP2 PR PRESS 1 (Pressure) S2 1.5" / 3.81 cm CLP2 E E E REG OUT IN Brown OUT REG IN ACC 4 VAC 1 9211734 PRESS 2 (Pressure) Green IN ACC 3 PRESS 3 R4 Y5 3.0" / 7.62 cm CV C OUT REG Gray PS2 Vent Vent A PS3 B A PRESS 3 (Pressure) B A R2 P1 9211732 B A Y635 4.5" / 11.43 cm CLP2 CV CLP2 T3 VAC 1 CV 1 CLP2 PRESS 1 VAC 1 Y635 19.5" / 49.53 cm PRESS 1 Drain ACC-5 Y631 28.0" / 71.12 cm Y635 25.0" / 63.50 cm Drain ACC-4 Y634 16.0" / 40.64 cm SS 2 PRE Waste 3109000 MULT-PORT Coupler-1 VAC/PRESS Supply 9H_9055b .007 orifice 9H_9056c Y1 CLP 2 CV2 WC3 97 Y630 8.0 (20.32) S2 0.75 (1.90) Y630 10.0 (25.40) Y633 7.5 (19.05) R2 96 Y630 1.5 (3.81) P3 V1 P2 DI L WAST E Y630 6.0 (15.24) P1 L4 Y630 6.0 (15.24) Y1 Y633 12.0 (30.48) S2 1.3 (3.30) S2 1.3 (3.30) Y638 27.0 (68.58) Y632 37.0 (93.98) Y630 1.0 (2.54) S2 1.3 (3.30) S2 1.3 (3.30) T2 T1 T1 N1 2.3 (5.84) Y630 21.0 (53.34) Y630 27.0 (68.58) Y1 Y1 Y630 1.0 (2.54) T1 CLP 2 CV2 CLP 2 Y63 CLP 2 N1 5.0 (12.70) N1 6.0 Y63(15.24) 7 R2 R2 R2 A Y532 1.0 (2.54) P2 WBC LYSE A R2 WC-4 B 45 T1 P1 S2 Y637 1.0 2.0 (2.54) (5.08 ) 6 PRESS 3 46 S2 1.3 (3.30) Y622 5.2 (13.21) WBC LYSE RESERVOIR C N1 10.0 (25.40) D R2 C B PRESS 1 WC-2 D VAC 1 R2 VAC 2 CLP 2 T5 Y633 22.0 (55.88) Y638 36.0 (91.44) Y634 41.0 (104.14) Y630 9.5 Y630 9.5 (24.13) (24.13) Y633 48.0 (121.92) Y630 16.0 (40.64) CLP CV2 2 N1 10.0 (25.4) T1 S2 1.3 (3.30) 34 L1 T1 N1 0.6 (0.15) C1 S2 1.5 (3.81) HGB LYSE CLP 2 CV2 S2 1.3 (3.30) N1 6.5 (16.51) S2 1.3 (3.30) C2 L2 Y535 18.0 (45.72) N1 10.5 (26.67) Y535 17.8 (45.21) N1 2.2 (5.59) S2 1.3 Y622 T1 (3.30) 0.5 (1.27) C1 Y637 33 5.0 (12.7) R2 CV2 18 C2 N1 9.5 (34.13) N1 3.8 (9.65) LL 1 27 37 Y622 7.0 (17.78) N1 2.0 (5.08) N1 1.0 (2.54) 14 S2 1.3 (3.30) S2 1.3 (3.30) T1 Y522 1.0 (2.54) N1 6.3 (16.00) T1 CV1 CLP 2 17 S2 1.3 (3.30) N1 11.5 (29.21) S2 3.0 (7.62) S2 1.3 (3.30) S2 1.3 (3.30) S2 1.3 (3.30) S2 1.3 (3.30) 36 S2 1.3 (3.30) N1 8.3 (21.08) S2 1.3 (3.30) 38 P1 Y630 30.0 (76.20) CV2 L1 N1 23.0 (58.42) Y630 13.0 (15.24) Y630 4.0 (10.16) Y630 5.5 (13.97) Y632 59.0 (149.86) Y633 R2 Y63 5 Y63 1 WASTE Y635 23.0 (58.42) Y633 21.0 (53.34) T5 Y632 11.5 (29.21) 3109001 MULTI-PORT COUPLER-2 VAC/PRESS SUPPLY Y630 6.0 (15.24) Y632 59.0 (149.86) WASTE T5 Y631 42.0 Y635 23.0 (106.68) (58.42) Y635 48.0 (121.9) HGB LYSE Y635 19.0 (48.26) Y637 12.5 (31.75) Y635 19.0 (48.26) WBC LYSE DILUENT/ SHEATH Y630 21.0 (53.34) WASTE DRAIN ACC-4 DRAIN ACC-5 N1 1.5 (3.81) DILUEN T CLP 2 T1 AIR T2 Y535 1.4 (3.56) Y535 9.0 (22.86) L1 L1 WASTE Y638 7.0 (17.78) T5 1 T1 CLP 2 Y635 2.5 (6.35) T5 N1 1.4 (3.55) L1 N1 20.3 (51.56) L2 LL 1 32 R1 S2 1.5 (3.81) LL 1 15 L1 Y535 9.0 (22.86) S2 1.0 (2.54) CV2 Y630 0.75 (1.90) VAC 2 VAC 1 VAC 1 R1 N1 1.0 (2.54) N1 20.2 (51.31) N1 21.7 (55.12) Y63 2 R2 Y630 13.0 (15.24) PRESS 3 PRESS 2 PRESS 1 PRESS 1 S2 1.5 (3.81) L1 31 T1 C1 CV2 S2 1.5 (3.81) N1 5.0 (12.7) N1 9.0 (22.86) C1 R1 N1 8.3 (21.08) C D A B S2 3.5 (8.89) T1 S2 0.75 (1.90) S2 1.3 (3.30) Y543 7.13 (18.11) 22 N1 2.0 (5.08) 23 L2 LL 1 T1 B WC1 Y543 12.5 (31.75) L1 98 T6 N1 0.5 (1.27) 28 TO ROTARY VALVE BLOCK ULTRASONI C SHORT SAMPLE SENSOR (S1) Y543 7.75 (19.69) Y543 1.5 (3.81) L1 26 RBC/ HGB DILUENT C1 L1 L1 T6 N1 2.0 (5.08) S2 1.5 (3.81) 42 25 Y627 12.0 (30.48) Y626 2.0 (5.08) S2 1.3 (3.30) 24 WBC LYSE 56 N1 1.3 (3.30) Y626 6.0 (15.24) Y626 9.25 (23.49) S1 5.0 (12.7) WBC/ (WOC) WOC HEATER N1 7.5 (19.05 ) L2 HGB HEATER Y532 1.0 (2.54) S2 1.0 (2.54) A R1 L1 N1 8.5 (21.59) S2 1.0 (2.54) N1 1.0 (2.54) S2 1.3 (3.30) C D 92 S2 1.0 (2.54) N1 2.0 (5.08) R1 N1 10.5 T1 (26.67) FRON T VALVE T1 S2 1.5 (3.81) L1 N1 3.7 (9.39) L1 S2 1.0 (2.54) N1 5.0 (12.7) S2 1.0 (2.54) N1 3.8 (9.65) HGB LYSE L1 N1 1.4 (3.55) S2 N1 4.0 2.0 (10.16 ) T1 (5.08) T1 43 SAMPLE INJECTIO N L1 57 44 N1 1.8 (4.57) S2 1.3 (3.30) S2 0.6 (1.52) S2 0.6 (1.52) L1 Y532 1.0 (2.54) N1 0.8 (0.20) T1 S2 1.3 (3.30) N1 9.0 (22.86) 94 L1 N1 13.0 (33.02) S2 1.3 (3.30) N1 6.0 (15.24) 0.7 (1.78) S1 5.0 (12.70) S2 0.6 (1.52) S2 1.3 (3.30) N1 5.0 (12.7) 21 Y532 12.3 (31.24) L1 S2 1.0 (2.54) L1 Y543 2.3 (5.84) N1 8.2 (20.82) R1 CLP2 L2 Y622 3.5 (8.89) L1 CV 2 T1 CV1 N1 15.0 (38.1) 11 C1 L1 C1 L1 C1 REAR VALVE C1 12 Y631 42.0 (106.68) Y630 0.75 (1.90) T1 N1 11.0 (27.94) 13 L1 R2 L1 S3 2.0 (5.08) P2 Y635 11.0 (27.9) CLP 2 N1 4.7 (11.94 ) S2 1.3 (3.84) T1 N1 0.8 (0.02) 55 L1 68 C3 CLP CV2 2 C1 41 S2 1.3 (3.30) S2 1.5 (3.81) ACC-5 ACC-4 S2 1.0 (2.54) S2 1.0 (2.54) C3 Y630 1.0 (2.54) CLP 2 Y532 P2 1.0 (2.54) T3 Y631 38.0 (96.52) P2 T1 T3 N1 1.3 (3.30) 54 L1 CV1 L1 T1 N1 1.3 (3.30) N1 8.2 (20.82) N1 6.0 (15.24) C1 S1 5.0 (12.70 ) N1 2.30 (5.84) 93 T1 N1 1.3 (3.30) SHORT SAMPLE SENSOR (S2) N1 9.5 (24.13) N1 1.0 T1 (2.54) N1 2.0 (5.08) B CA S2 1.3 (3.30) T3 F2 CV2 N1 0.8 (0.20) N2 1.0 (2.54) L1 67 S2 0.75 (1.90) T1 Y543 4.10 (10.41) ULTRASONI C SHORT SAMPLE SENSOR (S3) HGB S2 1.3 (3.30) 5 S2 0.75 (1.90) N1 30.0 (76.20) S2 N1 2.0 (5.08) N1 5.3 (13.46 ) R1 R 1 4 T1 N1 3.5 (8.89) Vent ACC T1 95 R 1 3 N1 2.3 (5.84) T1 N1 0.6 (1.52) S2 1.3 T1 (3.30) S2 1.0 (2.54) N1 1.5 (3.81) L1 R2 N1 1.5 (3.81) LL 2 Y633 7.5 (19.05) Y632 37.0 (93.98) C A BDE R1 S2 0.6 (1.52) N1 13.3 (33.78) N1 13.5 (34.29) N1 10.5 (26.67) N1 1.7 (4.32) S2 1.3 (3.30) C1 S2 1.0 (2.54) C1 S2 1.0 (2.54) C1 L1 N1 1.0 (2.54) 64 N1 7.0 (17.78) C1 Y635 39.0 (99.06) S2 3.5 (8.89 ) S2 1.3 (3.30) 2 L1 CV1 T3 C1 S2 1.0 (2.54) R2 65 R 1 N1 4.5 (11.43) Y634 11.0 (27.94) Y635 3.3 (8.38) 66 C1 RBC/ PLT C1 R 1 1 N1 1.0 (2.54) N1 1.6 (4.06) 63 L1 N1 4.0 (10.16) T3 S2 1.3 C1 (3.30) S2 1.3 (3.30) S2 1.3 (3.30) 91 L1 L1 R 1 52 C1 S2 1.3 (3.30) R2 T4 L1 51 62 S2 5.5 (13.97 ) S2 1.3 (3.30) T4 61 N1 12.5 (31.75) S2 1.3 (3.30) L1 N1 3.0 (7.62) Y632 59.0 (149.86) S2 1.3 (3.30) N1 7.5 (19.05 ) S2 0.6 (1.52) N1 20.0 (50.8) N1 5.2 (13.21) S2 1.3 (3.30) T5 B 4 R4 Y543 1.5 (3.81) Y543 7.75 (19.69) R6 S2 CLP 2 Y632 2.5 (6.35) Y54 7.5 (19.05) B 4 S2 0.6 (1.52) S2 1.3 (3.30) CLP 2 Y632 1.0 (2.54) CLP 2 CV2 Y54 7.5 (19.05) Y54 8.75 (22.23) Y54 7.5 (19.05) B 4 L1 .082 DIA TUBE B RINS VEN C E T A SAMPL .050 DIA B E TUBE WBC WOC MIXING 4 CHAMBER Y54 11.5 (29.51) B 4 Y633 3.5 (8.89) CLP 2 CV2 Y638 8.0 (20.32) DILUENT/SHEATH (QUIET) RESERVOIR 1 Y632 3.0 (7.62) DILUENT/SHEATH (NOISY) RESERVOIR 2 Y632 5.0 (12.7) Y632 2.0 (5.08) L4 FLOW PANEL DIAGRAM OPTICA L FLOW CELL S2 0.6 (1.52) S2 0.75 (1.90) Y636 12.0 (30.48) N1 21.7 (55.12) N1 20.3 (51.56) REAGENT EMTPY IN-LINE SENSORS Y636 49.0 (124.46) Y637 54.0 (137.16) Y535 17.8 (45.21) Y535 18.0 (45.72) Y635 48.0 (121.92) Y633 48.0 (121.92) WC-4 WC-4 VAC 1 PRESS 1 N1 12.8 (32.51) N1 20.2 (51.31) 1 AIR DIL WC-4 DIL 9341075 MULTI-PORT COUPLER-1 SAMPLE LOADER 9H_9057c R2 FLOW PANEL DIAGRAM L1 N1 1.0 (2.54) 64 N1 0.8 T1 (0.20) C1 Vent ACC F2 T1 S2 1.3 (3.30) 67 T3 ACC-5 ACC-4 S2 1.0 (2.54) S2 1.0 (2.54) C3 68 C3 L1 S3 2.0 (5.08) CV3 P2 C D A 98 B 97 R2 P2 Y635 11.0 (27.9) S2 0.6 (1.52) S2 0.6 (1.52) S2 0.6 (1.52) 57 L1 94 C1 N1 4.0 (10.16) T1 Y532 1.0 (2.54) N1 3.7 (9.39) WOC HEATER S1 5.0 (12.7)* N1 2.0 (5.08) N1 11.0 (27.94) Y543 7.13 (18.11) A17 S2 1.0 (2.54) 92 S2 1.0 N1 2.0 (2.54) (5.08) N1 1.0 (2.54) R1 S2 2.0 (5.08) N1 7.5 (19.05) L1 56 N1 8.5 (21.59) S2 1.3 (3.30) C1 Y543 12.5 (31.75) L1 T1 S2 0.75 (1.90) C D A B 96 CV2 WC-3 Y630 8.0 (20.32) Y630 10.0 (25.40) A18 22 C1 Y633 7.5 (19.05) A16 C1 T1 S2 1.0 (2.54) L1 A15 L1 93 T1 CV1 N1 0.8 (0.20) T1 L1 S2 1.3 (3.30) L1 N1 1.4 (3.55) S2 1.5 (3.81) L1 N1 5.0 (12.70) N1 9.0 (22.86) L1 N1 23.0 (58.42) A19 A20 S2 0.75 (1.90) CV2 R2 CLP2 T5 N2 1.0 (2.54) N1 1.0 (2.54) T1 S2 1.3 (3.30) C1 L1 S2 1.3 N1 4.5 (3.30) (11.43) L1 L1 N1 0.8 (0.02) S2 1.3 (3.84) 21 S2 3.5 (8.89) WC-1 B CA N1 4.7 (11.94) 55 S2 1.3 (3.30) T1 R1 5 T1 L1 Y532 1.0 P2 (2.54) A14 N1 2.0 (5.08) N1 5.3 (13.46) R1 4 T1 T3 Y631 38.0 (96.52) Y635 39.0 (99.06) N1 1.3 (3.30) S2 1.0 (2.54) CA BDE N1 1.5 (3.81) LL2 T3 L1 N1 1.5 (3.81) R2 Y633 3.5 (8.89) S2 1.0 (2.54) R1 S2 1.5 (3.81) Y632 37.0 (93.98) C1 Y633 7.5 (19.05) S2 1.0 (2.54) N1 3.5 (8.89) C1 S2 1.0 (2.54) R1 3 54 S2 1.3 (3.30) T1 T1 2 R1 N1 1.7 (4.32) S2 1.3 (3.30) N1 2.3 (5.84) T1 N1 0.6 41 (1.52) L1 CV1 95 A13 S2 0.75 (1.90) N1 10.5 (26.67) N1 13.0 (33.02) T4 N1 13.3 (33.78) N1 13.5 (34.29) N1 9.0 (22.86) C1 Y543 1.5 (3.81) HGB S2 1.3 (3.30) C1 R1 1 N1 1.0 (2.54) N1 1.6 (4.06) R2 S2 1.3 (3.30) S2 1.3 T3 (3.30) N1 7.0 (17.78) C1 RBC/ PLT S2 1.3 (3.30) S2 3.5 (8.89) S2 5.5 (13.97) S2 1.3 (3.30) L1 S2 1.3 (3.30) 65 R1 C1 S2 0.6 (1.52) C1 N1 5.0 (12.7) 66 L1 63 N1 3.0 (7.62) Y634 11.0 (27.94) Y635 3.3 (8.38) R2 Y632 59.0 (149.86) S2 1.3 (3.30) T3 52 N1 4.0 (10.16) C1 61 S2 1.3 (3.30) 91 A12 R6 L1 51 N1 7.5 (19.05) T4 L1 S2 S2 1.3 (3.30) S2 1.3 (3.30) 62 B4 B4 N1 20.0 (50.8) N1 5.2 (13.21) N1 12.5 (31.75) L1 S2 1.3 (3.30) B4 WBC/(WOC) Y632 2.5 (6.35) Y543 7.75 (19.69) RINSE SAMPLE .050 DIA TUBE WBC WOC MIXING CHAMBER N1 6.0 (15.24) T5 CLP2 S2 0.6 (1.52) S2 0.6 (1.52) A S2 0.6 (1.52) Y632 1.0 (2.54) CV2 B4 0.7 (1.78) S1 5.0 (12.70) CLP2 CLP2 S2 1.3 (3.30) CV2 B C VENT B4 Y54 7.5 (19.05) L1 .082 DIA TUBE S2 11.0 (27.94) Y54 7.5 (19.05) Y54 8.75 (22.23) Y54 7.5 (19.05) S2 1.5 (3.81) CLP2 DILUENT/SHEATH (NOISY) RESERVOIR 2 DILUENT/SHEATH (QUIET) RESERVOIR 1 Y632 3.0 (7.62) Y632 5.0 (12.7) Y632 2.0 (5.08) L4 Y638 8.0 (20.32) OPTICAL FLOW CELL Y635 2.5 (6.35) *Critical Length x.xx±.05" Y630 6.0 (15.24) A4 A2 A1 A3 Y630 1.0 (2.54) A5 Y638 7.0 (17.78) A6 Y635 19.0 (48.26) A7 Y630 1.5 (3.81) A8 Y634 41.0 (104.14) A9 A10 A11 9H_9057c_A FLOW PANEL DIAGRAM 12 N1 15.0 (38.1) L1 Y622 3.5 (8.89) L1 L1 R1 S2 1.0 (2.54) HGB HEATER = Critical Length x.xx ±.05" B1 B5 B4 B3 B2 Y535 9.0 (22.86) B6 B7 B8 Y627 12.0 (30.48) B9 N1 6.5 (16.51) S2 1.3 (3.30) N1 2.3 (5.84) S2 1.3 (3.30) N1 9.5 (34.13) Y622 5.2 (13.21) CLP2 CV2 45 T1 N1 10.0 (25.4) N1 6.0 (15.24) R2 P1 B10 46 T1 WBC LYSE RESERVOIR C1 R2 L1 N1 0.6 (0.15) S2 1.3 (3.30) 34 18 T1 N1 10.0 (25.4) Y622 7.0 (17.78) C1 S2 1.5 (3.81) 17 T1 T1 C2 Y622 0.5 (1.27) T1 Y637 5.0 (12.7) Y522 1.0 (2.54) 33 N1 11.5 (29.21) S2 1.3 (3.30) N1 8.3 (21.08) S2 1.3 (3.30) S2 1.3 (3.30) S2 1.3 (3.30) S2 1.3 (3.30) S2 1.3 (3.30) C1 Y636 49.0 (124.46) 37 C2 R2 N1 23.0 (58.42) T2 14 N1 2.2 (5.59) S2 1.3 (3.30) T1 LL1 LL1 27 Y535 1.4 (3.56) L2 Y535 18.0 (45.72) N1 10.5 (26.67) Y535 17.8 (45.21) N1 3.8 (9.65) LL1 AIR 36 L1 R2 Y637 2.0 (5.08 ) B11 R2 P1 S2 1.0 (2.54) B12 P2 Y532 1.0 (2.54) Y637 54.0 (137.15) B13 B14 B15 N1 11.5 (29.21) A20 T1 N1 2.0 (5.08) N1 1.0 (2.54) Y632 37.0 (93.98) A19 L2 CV1 LL1 N1 5.0 (12.7) T1 L1 L1 38 T2 Y535 9.0 (22.86) N1 12.8 (32.51) * N1 1.0 (2.54) N1 1.5 (3.81) T1 N1 1.4 (3.55) 32 T1 15 L1 N1 20.3 (51.56) R1 Y535 18.0 (45.72) Y543 1.5 (3.81) N1 21.7 (55.12) N1 20.2 (51.31) Y543 7.75 (19.69) TO ROTARY VALVE BLOCK ULTRASONIC SHORT SAMPLE SENSOR (S1) S2 1.5 (3.81) L1 N1 20.2 (51.31) R1 S2 1.5 (3.81) L2 31 T1 Y535 17.8 (45.21) FRONT VALVE A18 42 N1 10.5 T1 (26.67) N1 8.2 (20.82) Y543 12.5 (31.75) L1 L1 N1 2.0 (5.08) N1 2.0 T6 (5.08) S2 1.5 (3.81) N1 0.5 (1.27) T1 S2 1.0 (2.54) 23 28 L1 T6 S2 1.0 (2.54) 26 N1 20.3 (51.56) Y543 2.3 (5.84) S2 1.3 (3.30) * 7.13 A17 Y543 (18.11) N1 1.8 (4.57) L1 N1 1.3 (3.30) 25 R1 N1 21.7 (55.12) T1 L2 Y627 12.0 (30.48) Y626 2.0 (5.08) REAR VALVE N1 6.3 (16.00) A16 44 24 WBC LYSE N1 11.0 (27.94) 43 N1 3.8 (9.65) R1 L2 Y626 9.25 (23.49) * Y626 6.0 (15.24) N1 2.30 (5.84) C1 S2 1.3 (3.30) C1 HGB LYSE CV1 C1 S2 1.3 (3.30) S1 5.0 (12.70) SAMPLE INJECTION N1 1.0 (2.54) S2 1.3 (3.30) A15 N1 6.0 (15.24) RBC/ HGB DILUENT A14 N1 9.5 (24.13) N1 5.0 (12.70) N1 8.2 (20.82) N1 10.5 (26.67) L1 S2 1.3 (3.30) Y532 12.3 (31.24) N1 5.0 (12.7) S2 1.3 (3.30) CLP2 S2 1.3 (3.30) CV2 N1 8.3 (21.08) SHORT SAMPLE SENSOR (S2) 11 S2 1.3 (3.30) 13 L1 Y532 1.0 (2.54) S2 * Y543 4.10 (10.41) ULTRASONIC SHORT SAMPLE SENSOR (S3) A13 S2 3.0 (7.62) A12 T1 N1 1.3 (3.30) N1 1.3 (3.30) S2 1.0 (2.54) T1 Y543 7.75 (19.69) S2 1.3 (3.30) S2 0.75 (1.90) N1 30.0 (76.20) S2 1.3 (3.30) R4 Y543 1.5 (3.81) B16 B17 9H_9057b_B FLOW PANEL DIAGRAM A11 A4 A6 A5 A3 Y635 19.0 (48.26) Y630 1.5 (3.81) Y630 1.0 (2.54) CLP2 CV2 CLP2 CLP2 Y630 0.75 (1.90) Y1 A9 V1 P3 Y632 37.0 (93.98) Y634 41.0 (104.14) CLP2 CV2 Y633 7.5 (19.05) P2 Y630 6.0 (15.24) DIL WASTE P1 Y630 0.75 (1.90) C1 Y630 30.0 (76.20) CLP2 CV2 Y630 6.0 (15.24) L4 Y630 21.0 (53.34) Y630 27.0 (68.58) Y1 Y630 1.0 (2.54) CLP2 Y1 Y630 1.0 (2.54) Y1 CV2 C2 CLP2 CV2 CLP2 C3 CLP2 Y630 13.0 (15.24) Y638 27.0 (68.58) C4 Y633 12.0 (30.48) T5 Y630 13.0 (15.24) T5 Y632 59.0 (149.86) Y635 48.0 (121.92) C5 Y633 48.0 (121.92) C6 Y635 23.0 (58.42) C7 Y633 21.0 (53.34) C8 Y631 42.0 (106.68) C9 Y630 16.0 (40.64) Y630 4.0 (10.16) Y630 5.5 (13.97) CLP2 CV2 CLP2 Y633 22.0 (55.88) T5 Y638 36.0 (91.44) Y634 41.0 (104.14) Y637 12.5 (31.75) Y630 21.0 (53.34) Y632 11.5 (29.21) WASTE DRAIN ACC-4 DRAIN ACC-5 1 VAC 2 VAC 1 VAC 1 Y635 19.0 (48.26) Y635 19.0 (48.26) T5 3109001 MULTI-PORT COUPLER-2 VAC/PRESS SUPPLY Y631 42.0 (106.68) Y635 23.0 (58.42) Y635 48.0 (121.9) Y630 6.0 (15.24) WASTE PRESS 3 PRESS 2 PRESS 1 PRESS 1 HGB LYSE Y636 12.0 (30.48) DILUENT/SHEATH Y632 37.0 (93.98) Y632 59.0 (149.86) Y635 39.0 (99.06) Y631 38.0 (96.52) A1 Y638 7.0 (17.78) A10 WBC LYSE A2 A8 A7 REAGENT EMTPY IN-LINE SENSORS Y636 49.0 (124.46) Y632 59.0 (149.86) Y637 54.0 (137.16) C10 C11 9H_9057a_C FLOW PANEL DIAGRAM Y636 49.0 (124.46) B2 N1 21.7 (55.12) B3 N1 20.3 (51.56) B4 Y535 17.8 (45.21) B5 N1 20.2 (51.31) B6 Y535 18.0 (45.72) B7 B8 B9 Y627 12.0 (30.48) B1 N1 12.8 (32.51) B11 A C Y632 B13 Y637 2.0 (5.08) B10 R2 WC-4 N1 10.0 (25.40) B12 D A B14 C B Y637 54.0 (137.15) WC-2 DILUENT C1 C2 B Y632 37.0 (93.98) Y630 9.5 (24.13) B15 D N1 6.0 (15.24) WBC LYSE HGB LYSE B16 R2 N1 5.0 (12.70) B17 Y636 C3 Y630 9.5 (24.13) C4 Y638 27.0 (68.58) PRESS 1 R2 PRESS 3 C7 Y635 23.0 (58.42) Y633 48.0 (121.92) C8 Y633 21.0 (53.34) C9 Y631 42.0 (106.68) C10 Y636 49.0 (124.46) C11 Y637 54.0 (137.16) Y630 9.5 (24.13) VAC 2 WASTE Y630 9.5 (24.13) Y635 R2 Y631 Y631 42.0 (106.68) C5 C6 Y635 48.0 (121.92) R2 Y633 VAC 1 N1 11.5 (29.21) WASTE N1 12.8 (32.51) N1 21.7 (55.12) N1 20.2 (51.31) N1 20.3 (51.56) Y535 17.8 (45.21) Y535 18.0 (45.72) Y635 48.0 (121.92) Y633 48.0 (121.92) WC-4 WC-4 VAC 1 PRESS 1 1 AIR DIL WC-4 DIL 9341075 MULTI-PORT COUPLER-1 SAMPLE LOADER 9H_9057a_D .007 orifice 9H_9058b A1.01 Left Access (Front) Cover Version - 201962-103_2783_1 List/Part Numbers List/Part Number Description 8921291201 DOOR ASSY, LF ACCESS, CDRUBY Inspect tools for damage, ensure calibration is not expired and replace if necessary. A1.01 Left Access (Front) Cover Time Required Tools/Materials 00:05 min Flat Blade Screwdriver Removal Action Steps Preparation 1. Place the instrument in STANDBY and power OFF. Remove Left Front Cover 1. Open the Left Front Cover. 2. Disconnect the ground wire from the instrument chassis. 3. Use a flat blade (small) screwdriver to remove the C-Clip [2] from the lower hinge. Note Retain the clip for reassembly. Be careful when removing the C-Clip. The hinge contains hardware, which can be lost. 4. Lift and remove the cover. Reference Replacement Action Steps Reference Install Left Front Cover 1. Install in reverse order. Verification Procedures Order VP Description VP Detail / Note 1 G10 - Covers / Doors / Panels Verify cover/door/panel(s) are correctly installed and securely fastened and/or open/close freely. N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. Expected Results CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. A1.02 Right Access (Front) Cover Version - 201962-103_2780_1 List/Part Numbers List/Part Number Description 8921291101 DOOR ASSY, RF ACCESS, CDRUBY Inspect tools for damage, ensure calibration is not expired and replace if necessary. A1.02 Right Access (Front) Cover Time Required Tools/Materials 00:05 min Flat Blade Screwdriver Removal Action Steps Preparation 1. Place the instrument in STANDBY and power OFF. Open Right Front Cover Remove Right Front Cover 1. Open Right Front Cover. 1. Locate the status alert PCB [1] (mounted on the cover) and disconnect cable connector J1. 2. Use a Phillips screwdriver to remove the screw securing the clamp [3] and cable to the cover. 3. Use a flat blade (small) screwdriver to remove the C-Clip [2] from the lower hinge. Retain the clip for reassembly. Note Reference Be careful when removing the C-Clip. The hinge contains hardware, which can be lost. 4. Lift and remove the cover. Replacement Action Steps Reference Install Right Front Cover 1. Install in reverse order. Verification Procedures Order VP Description VP Detail / Note 3 G9 - System Power Verify system powers ON and starts up/ initializes successfully. 2 G10 - Covers / Doors / Panels Verify cover/door/panel(s) are correctly installed and securely fastened and/or open/close freely. 4 G19 - Prime Verify reagents prime. Check to ensure no leaks and/or bubbles are prevalent in the line. 5 G21 - Status Alert Indicator Verify status alert indicator lights are on. 1 G121 - J1 Cable Connector Verify cable connector J1 is secure. N/A Expected Results G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. A1.03 Tower (NoIse) Cover Version - 201962-103_2784_1 List/Part Numbers List/Part Number Description 8921291801 NOSE SECTION COVER ASSEMBLY, CDRUBY 8921291802 NOSE SECTION COVER ASSEMBLY, CDRUBY Inspect tools for damage, ensure calibration is not expired and replace if necessary. A1.03 Tower (NoIse) Cover Time Required Tools/Materials 00:01 min None Removal Action Steps Reference Preparation 1. Be sure instrument is in the Open Mode. Note Error message displays if cover is removed while in the Closed Mode. Remove Tower Cover 1. Open both left and right access (front) covers. 2. Grasp both sides of the tower cover, and lift cover off of the locating pins. Replacement Action Steps Reference Install Tower Cover 1. Install in reverse order. Verification Procedures Order VP Description VP Detail / Note 1 G10 - Covers / Doors / Panels Verify cover/door/panel(s) are correctly installed and securely fastened and/or open/close freely. N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. Expected Results CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. A1.04 Top Cover Version - 201962-103_2785_1 List/Part Numbers List/Part Number Description 8931393101 COVER, TOP, CDRUBY Inspect tools for damage, ensure calibration is not expired and replace if necessary. A1.04 Top Cover Time Required Tools/Materials 00:05 min Phillips Screwdriver Removal Action Remove Top Cover Steps Reference 1. Use a Phillips screwdriver to remove the four (4) screws securing the top cover. [1] 2. Carefully lift and remove the cover from the top of the instrument. Replacement Action Steps Reference Install Top Cover 1. Install in reverse order. Verification Procedures Order VP Description VP Detail / Note 1 G10 - Covers / Doors / Panels Verify cover/door/panel(s) are correctly installed and securely fastened and/or open/close freely. N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. Expected Results CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. A1.05 Right Side Cover Version - 201962-103_2786_1 List/Part Numbers List/Part Number Description 8931393201 COVER, SIDE, RIGHT, CDRUBY 8931397501 COVER, SIDE, RIGHT, CDRUBY Inspect tools for damage, ensure calibration is not expired and replace if necessary. A1.05 Right Side Cover Time Required 00:05 min Tools/Materials Removal Action Remove Right Side Cover Steps Reference 1. Use a Phillips screwdriver to remove the four (4) screws securing the right side cover [1] to the instrument. 2. Carefully lift and remove the cover from the right side of the instrument. Replacement Action Install Right Side Cover Steps Reference 1. Install in reverse order. Verification Procedures Order VP Description VP Detail / Note 1 G10 - Covers / Doors / Panels Verify cover/door/panel(s) are correctly installed and securely fastened and/or open/close freely. N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. Expected Results CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. A1.06 Left Side Cover Version - 201962-103_2787_1 List/Part Numbers List/Part Number Description 8931393301 COVER, SIDE, LEFT, CDRUBY 8931397401 COVER, SIDE, LEFT, CDRUBY Inspect tools for damage, ensure calibration is not expired and replace if necessary. A1.06 Left Side Cover Time Required Tools/Materials 00:05 min Phillips Screwdriver Removal Action Remove Left Side Cover Steps Reference 1. Use a Phillips screwdriver to remove the four (4) screws securing the left side cover [1] to the instrument. 2. Carefully lift and remove the cover from the left side of the instrument. Replacement Action Steps Install Left Side Cover 1. Install in reverse order. Reference Verification Procedures Order VP Description VP Detail / Note 1 G10 - Covers / Doors / Panels Verify cover/door/panel(s) are correctly installed and securely fastened and/or open/close freely. N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. Expected Results CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. B1.01 Shear Valve Driver Version - 201962-103_2788_3 List/Part Numbers List/Part Number Description 8921204901 SHEAR VALVE DRIVER ASSEMBLY 8921204902 SHEAR VALVE DRIVER ASSEMBLY Inspect tools for damage, ensure calibration is not expired and replace if necessary. B1.01 Shear Valve Driver Note These videos represent simulated scenarios of instrument access and repair, and some may not accurately depict actual PPE guidelines. Trained personnel should follow procedures as outlined in Biological Hazards and safety procedures. Time Required 40 min Tools/Materials Phillips Screwdriver WARNING Potential Biohazard WARNING Splash/Spray Hazard Removal Action Steps Preparation 1. Place the instrument in STANDBY and power OFF. 2. Open the left [1] and right [2] access covers and remove the tower cover. [3] 3. Remove the top cover to the instrument. [4] Reference VIDEO Note Remove Shear Video contains no audio sound. Valve Ceramics and the Shear Valve Driver Assembly (If the video does not display, or to view the video full size: Click Here) Remove Shear Valve Ceramics 1. Remove the shear valve retaining screw [1] from the center of the shear valve. 2. Carefully remove the three (3) ceramic pieces from the shear valve. [2] Note Do not disconnect the tubing from the front and back ceramic pieces. 3. Set the center ceramic piece aside. Note Be careful when handling the center ceramic piece. The part is fragile and can break. Remove Shear Valve Driver Assembly 1. Remove the four (4) screws [1] that secure the shear valve driver assembly in place.> 2. Disconnect cable connectors J2 and J3 from the driver PCB [2] (mounted on the shear valve driver assembly). 3. Angle the assembly and remove it from the back. [3] Note The preamplifier cables may need to be moved out of the way prior to removing the assembly. Replacement Action VIDEO Install Shear Valve Driver Steps Reference Note Video contains no audio sound. (If the video does not display, or to view the video full size: Click Here) Install Shear Valve and Shear Valve Driver 1. Angle the Shear Valve Driver Assembly and place it in from the back. [3] 2. Connect cable connectors J2 and J3 from the driver board [2] mounted on the shear valve driver assembly. Note Reconnect preamplifier cables if disconnected for removal. 3. Install the four (4) screws [1] that secure the shear valve driver assembly in place. Install Shear Valve Ceramics 1. Replace the three (3) ceramic pieces from the shear valve. [2] Note Shear Valve ceramic pieces should be put back together wet. 2. Install the shear valve retaining screw [1] from the center of the shear valve. Prepare for Operation 1. Install the top cover and four (4) cover screws. [4] 2. Install the Tower cover [3] and close the left [1] and right [2] access covers. Verification Procedures Order VP Description 1 VP-01 System Voltage Verification VP Detail / Note Expected Results Verify and document the following Power Distribution Module Voltages: E1=+15V±0.4 E2=-15.0V±0.4 E3=-12.0V±0.5 E4=+12.0V±0. E5=+28V±0.5 E6=+15.5V±0.5 E7=+5.1V±0.2 E8= GND 2 VP-07 Motor Operation Verification N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. CELL-DYN Ruby System Service and Support Manual (Version 201958-103) • © 2006, 2015 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. B1.02 Y-Valve Version - 201962-103_2789_3 List/Part Numbers List/Part Number Description 8921294501 Y VALVE ASSY, PRE-ALIGNED WITH FLAG AND WHEEL 8921294601 Y-VALVE MOTOR ASSY W-COUPLER Inspect tools for damage, ensure calibration is not expired and replace if necessary. B1.02 Y-Valve Note These videos represent simulated scenarios of instrument access and repair, and some may not accurately depict actual PPE guidelines. Trained personnel should follow procedures as outlined in Biological Hazards and safety procedures. Time Required 30 min Tools/Materials Phillips Screwdriver 1/2" Wrench or Adjustable Wrench or Needle-nose Pliers WARNING Potential Biohazard WARNING Splash/Spray Hazard Removal Action Steps Preparation 1. Place the instrument in STANDBY and power OFF. 2. Open the left [1] and right [2] access covers and remove the tower cover. [3] VIDEO Remove YValve cover and Remove Note Video contains no audio sound. Reference Y-Valve and Encoder Assembly (If the video does not display, or to view the video full size: Click Here) Remove YValve Cover Remove the two (2) screws securing the Y-Valve cover to the assembly. [1] Note The Encoder tabs [2] must be in the vertical position to remove the assembly. Remove YValve and Encoder Assembly 1. Locate the Y-Valve assembly. [1] 2. Disconnect the tubing from the top of the Open Mode Probe and unscrew the fittings from the three (3) valve ports. [2] 3. Use needle-nose pliers, a 1/2" wrench, or adjustable wrench to loosen the nut [3] securing the YValve assembly to the bracket. 4. Lift assembly up and out. Caution Do not loosen the set screw [4] securing the Encoder wheel to the YValve. This is set at the factory, and loosening the screw results in misalignment of the two parts. Remove YValve Motor 1. Disconnect the motor in-line cable connector. 2. Using a thin-shaft Phillips screwdriver, locate and remove the three (3) screws [1] securing the motor to the bracket. Note Remove the screws by inserting the screwdriver through the holes in the bracket. 3. Lift motor up and out. Replacement Action Install Y-Valve Motor Steps 1. Mount the Y-valve Motor to the bracket with the 3 screws. [1] 2. Connect the Motor Inline cable. Reference VIDEO Note Install YVideo contains no audio sound. Valve, Encoder Assembly and Install Y-Valve Cover (If the video does not display, or to view the video full size: Click Here) Install Y-Valve Note and Encoder Tubing lengths leading to and Assembly from the y-valve assembly are critical to system performance. 1. Install the Y-Valve and Encoder Assembly by seating the assembly back into the bracket. 2. Tighten the nut [3] with needle nose pliers to secure the Y-Valve assembly to the bracket. 3. Screw the fittings from the three (3) valve ports [2] into place and reseat tubing to Open Mode Probe. Install Y-Valve Secure the Y-Valve cover with 2 screws. Cover [1] Completion 1. Replace the tower cover. [3] 2. Close the left [1] and right [2] access doors. Verification Procedures Order VP Description VP Detail / Note Expected Results 2 G5 - Precision Verify precision is within instrument specifications. Precision within specifications = Pass 1 VP-07 Motor Operation Verification N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. CELL-DYN Ruby System Service and Support Manual (Version 201958-103) • © 2006, 2015 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. B1.03 Ultrasonic Sensor Version - 201962-103_2790_2 List/Part Numbers List/Part Number Description 8370181802 SENSOR, AIR BUBBLE (BLOOD), CD3200 Inspect tools for damage, ensure calibration is not expired and replace if necessary. B1.03 Ultrasonic Sensor Time Required 00:40 min Phillips Screwdriver Tools/Materials Wire Cutters Tie Wraps Removal Action Steps Preparation 1. Power down instrument and remove power cord. Remove Ultrasonic Note The Ultrasonic Sensor 1 PCB, used for sample detection Sensor 1 prior to the shear valve, is mounted on the front flow PCB Cover panel. Ultrasonic Sensor 2 PCB, used for open mode sample detection after the shear valve, is mounted behind the flow panel. For Ultrasonic Sensor 2 removal, go to Remove Ultrasonic Sensor 2. 1. Remove the tower cover, and open the right front access door. 2. Locate the ultrasonic sensor 1 PCB Cover [1] mounted on the PCB. 3. Squeeze the left side of the sensor cover at the top and bottom, and pull outward to disengage the left locking tab. 4. Squeeze the left top and the right sides of the cover and pull outward to disengage the upper tab. 5. Gently pull the upper portion of the cover away from the panel, and disengage the lower tab by gently pulling the cover downward. Remove Ultrasonic Sensor 1 1. Disconnect the sensor cable from J1 on the ultrasonic sensor 1 PCB. [1] 2. Remove tie wraps securing sensor cable to wire harness. 3. Disconnect the tubing to both inlet and outlet ports [2] on the sensor port head. Reference Note Be sure not to break the sensor head port(s) when disconnecting tubing. 4. Remove and discard the ultrasonic sensor. Remove Ultrasonic Sensor 2 1. Remove the top cover from the instrument (4 screws), to allow access to the ultrasonic sensor 2 PCB [1] mounted behind the flow panel. 2. Disconnect the sensor cable to J1 on the ultrasonic sensor 2 PCB. [1] 3. Remove the tie wraps securing the sensor cable to the wire harness. 4. Route and remove the sensor cable through the grommet in the front flow panel. [2] Note Utrasonic Sensor 1 PCB may need to be removed to allow enough room to route cables past the grommet. 5. Disconnect the tubing to both inlet and outlet ports [3] on the sensor head. Note Be sure not to break sensor head port(s) when disconnecting tubing. 6. Remove and discard the ultrasonic sensor. Replacement Action Steps Reference Replace Ultrasonic Sensor 1. Install the new ultrasonic (sensor 1 and/or 2) in reverse order. Verification Procedures Order VP Description VP Detail / Note Expected Results 1 G7 - Background Counts Verify background counts are within specifications. Background counts within specifications = Pass 2 G4 - Control Run Verify controls are within specifications for assay(s)/ parameter(s). Controls within specifications = Pass 3 G24 - Normal Operation Run three cycles/samples in open and/or closed mode and verify normal operation, e.g. binding, liquid leaks, etc. N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. B1.04 Open Probe Drive Assembly Version - 201962-103_2771_1 List/Part Numbers List/Part Number Description 8921291401 OTS ASSEMBLY, CDRUBY Inspect tools for damage, ensure calibration is not expired and replace if necessary. B1.04 Open Probe Drive Assembly Time Required 00:40 min Phillips Screwdriver Tools/Materials 7/64" Hex Wrench WARNING Potential Biohazard Removal Action Steps Preparation 1. Place the instrument in STANDBY and power OFF. 2. Open the left [1] and right [2] access covers and remove the tower cover [3]. Remove Open Probe Drive Assembly 1. Disconnect the aspiration tubing from the top of the open probe. 2. Disconnect the wash block tubing. Reference 3. Mark the tubing. 4. Locate the sample loader right access panel [1] and remove the two (2) screws. Note The access panel is located underneath the sample loader. 5. Locate and disconnect the OTS motor in-line cable connector (located underneath the sample loader). 6. Remove the four (4) screws [2] securing the assembly to the sample loader platen. Replacement Action Replace Open Probe Drive Assembly Steps Reference 1. Replace the Open Probe Drive Assembly by following the steps above in reverse order. Verification Procedures Order VP Description VP Detail / Note Expected Results 2 G4 - Control Run Verify controls are within specifications for assay(s)/ parameter(s). Controls within specifications = Pass 1 VP-07 Motor Operation Verification N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. B1.05 Open Probe Wash Block Version - 201962-103_6123_1 A Part Number is currently not assigned to this RR. Go to GPPM UserInterface Inspect tools for damage, ensure calibration is not expired and replace if necessary. B1.05 Open Probe Wash Block Note These videos represent simulated scenarios of instrument access and repair, and some may not accurately depict actual PPE guidelines. Trained personnel should follow procedures as outlined in Biological Hazards and safety procedures. Time Required 30 min Tools/Materials Pliers 3/32" Hex Wrench WARNING Potential Biohazard WARNING Splash/Spray Hazard Removal Action Steps Preparation 1. Select the following in the Ruby Software: Maintenance As-Needed Clean or Replace Open Mode Probe Disable Analyzer for the Pop-up window 2. Open the front left (1) and right (2) access covers. Remove the Tower cover (3) on the Ruby to expose the Aspiration tower. VIDEO Remove Open Note Video contains no audio sound. Mode Probe Wash Block Reference (If the video does not display, or to view the video full size: Click Here) Remove the Open Mode Probe Wash Block 1. Remove the tubing carefully from the top of the Open Mode Probe. [1] 2. Use a 3/32" Hex Wrench to remove the two (2) screws from the top of the assembly and remove the Open Mode Probe. [2] 3. Remove the small metal bar that holds the screws in place. [3] 4. Lift the Open Mode Probe upwards to remove it from the assembly. [4] 5. Place the bar and the Probe to the side. 6. Use a 3/32” Hex Wrench, remove the two (2) screws [5] from the bottom side of the plate and remove the Wash Block. 7. Pull the Open Mode Wash Block downward carefully to remove it from the housing. 8. Use Pliers to remove the Wash Block from the two (2) tubing connections. [6] Note Mark tubing to note which tubing goes on top and which one goes on the bottom of the wash block. Discard the old Wash Block in the Biohazard waste. Replacement Action Steps Reference VIDEO Install the Open Mode Probe Wash Block Note Video contains no audio sound. (If the video does not display, or to view the video full size: Click Here) Install the Open Mode Probe Wash Block 1. Connect the new Open Mode Probe Wash Block to the two (2) tubing connections while verifying the correct location of each tubing. [6] 2. Push the Wash Block up to the metal plate to secure it. 3. Screw in the two (2) screws from below using the 3/32" Hex Wrench. [5] 4. Lower the Open Mode Probe from above through the Wash Block. [4] 5. Line up the small metal bar to the screw holes and place on top of the Probe to secure it. 6. Use a 3/32" Hex Wrench, screw in the two (2) screws from the top of the assembly to secure the Open Mode Probe. [2] 7. Plug the tubing carefully from the Y-Valve to the top of the Open Mode Probe. [1] Completion 1. Put the front tower cover on the Ruby (3) and close the left (1) and right (2) front access doors. 2. Select the following from the Ruby Software screen: Enable Analyzer from the visible pop-up window Log Task Complete Verification Procedures Order VP Description VP Detail / Note Expected Results 1 G7 - Background Counts Verify background counts are within specifications. Background counts within specifications = Pass 2 G24 - Normal Operation Run three cycles/samples in open and/or closed mode and verify normal operation, e.g. binding, liquid leaks, etc. N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. CELL-DYN Ruby System Service and Support Manual (Version 201958-114) • © 2015 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. B1.06 Closed Mode Needle Wash Block Version - 201962-103_6118_1 A Part Number is currently not assigned to this RR. Go to GPPM UserInterface Inspect tools for damage, ensure calibration is not expired and replace if necessary. B1.06 Closed Mode Needle Wash Block Note These videos represent simulated scenarios of instrument access and repair, and some may not accurately depict actual PPE guidelines. Trained personnel should follow procedures as outlined in Biological Hazards and safety procedures. Time Required 30 minutes Tools/Materials Phillips Screwdriver Pliers WARNING Potential Biohazard WARNING Splash/Spray Hazard Removal Action Steps Preparation 1. Select the following from the Ruby Software screen:: Maintenance As-Needed Clean or Replace Closed Mode Needle Disable Analyzer for the Pop-up window 2. Open the left [1] and right [2] (front) access covers and remove the tower cover. [3] VIDEO Note Remove Closed Video contains no audio sound. Mode Needle and Closed Mode Needle Wash Block Reference (If the video does not display, or to view the video full size: Click Here) Remove Closed Mode Needle Note Prior to disconnecting the tubing, you may want to label the tubing to ensure it is properly reconnected to the correct position. 1. Slide the two (2) tubings from the top of the closed mode needle carefully. [1] 2. Loosen the thumbscrew [2] on the closed mode needle bracket. 3. Remove the bracket and needle and set both aside. Remove Closed Mode Needle Wash Block 1. Remove the two (2) screws securing the Wash block to the Spin Cone bracket. [1] 2. Disconnect the two (2) tubings from the connectors on the side of the Closed Mode Wash Block. [2] 3. Unscrew the two (2) connectors from the Closed Mode Needle Wash Block. [3] Replacement Action Steps Reference VIDEO Install Closed Mode Needle Wash Block and Install Closed Mode Needle Note Video contains no audio sound. (If the video does not display, or to view the video full size: Click Here) Install Closed Mode Needle Wash Block 1. Screw the two (2) connectors into the side of the Closed Mode Needle Wash Block. [3] 2. Connect the two (2) tubings to the connectors on the side of the Closed Mode Wash Block. [2] 3. Mount the Wash Block to the Spin Cone bracket and secure the two (2) screws. [1] Install Closed Mode Needle 1. Insert the Closed Mode Needle. [3] 2. Verify the needle goes through the Wash Block. 3. Verify angled port on top of Close Mode Needle is facing the instrument. 4. Mount the Closed Mode Needle bracket and tighten the thumbscrew. [2] 5. Connect the two tubings to the top of the Closed Mode Needle. [1] 6. Verify the vent tubing is connected to the angled port of the Closed Mode Needle. Completion 1. Install the tower cover. [3] 2. Close the left [1] and right [2] front access covers. 3. Select the following from the software screen: Enable Log Task Complete Verification Procedures Order VP Description VP Detail / Note Expected Results 1 G7 - Background Counts Verify background counts are within specifications. Background counts within specifications = Pass 2 G24 - Normal Operation Run three cycles/samples in open and/or closed mode and verify normal operation, e.g. binding, liquid leaks, etc. N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. CELL-DYN RUBY System Service and Support Manual (Version 201958-114) • © 2015 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. B1.07 Overpressure Sensor Version - 201962-103_6122_1 A Part Number is currently not assigned to this RR. Go to GPPM UserInterface Inspect tools for damage, ensure calibration is not expired and replace if necessary. B1.07 Overpressure Sensor Note These videos represent simulated scenarios of instrument access and repair, and some may not accurately depict actual PPE guidelines. Trained personnel should follow procedures as outlined in Biological Hazards and safety procedures. Time Required 30 min Tools/Materials Needle Nose Pliers Phillips Screwdriver WARNING Potential Biohazard WARNING Electrical Shock Hazard WARNING Splash/Spray Hazard Removal Action Steps Preparation 1. Power down instrument and remove power cord. 2. Open the left [1] and right [2] front access covers and remove the Tower cover. [3] Reference VIDEO Remove Overpressure Sensor Note Video contains no audio sound. (If the video does not display, or to view the video full size: Click Here) Remove Overpressure Sensor 1. Locate the overpressure sensor on right side of panel. [1] 2. Remove silicon tubing attached at port. [2] 3. Use a Phillips screwdriver to unscrew the two (2) screws that hold the overpressure sensor. [3] 4. Use the needle nose pliers to remove the red and orange connectors attached to the side of the overpressure sensor. [4] Note Label the wires to identify for correct reconnection. Replacement Action VIDEO Install Overpressure Sensor Steps Reference Note Video contains no audio sound. (If the video does not display, or to view the video full size: Click Here) Install Overpressure Sensor 1. Using the needle nose pliers, connect the orange and red wires to the overpressure sensor. [4] 2. Seat the new overpressure sensor and install with the two (2) saved Philips screws. [3] 3. Connect the silicon tubing to the port on the front of the overpressure sensor. [2] Completion 1. Install the Tower cover of the Ruby. [3] 2. Close the right [2] and left [1] side covers. 3. Power on the instrument. Verification Procedures Order VP Description VP Detail / Note Expected Results 1 G7 - Background Counts Verify background counts are within specifications. 2 G24 - Normal Operation Run three cycles/samples in open and/or closed mode and verify normal operation, e.g. binding, liquid leaks, etc. 3 G138 - Run Control - Verify controls are within specifications for assayparameter(s). N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. Background counts within specifications = Pass CELL-DYN Ruby System Service and Support Manual (Version 201958-114) • © 2015 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. B1.08 Tube Sensor PCB Version - 201962-103_6120_1 A Part Number is currently not assigned to this RR. Go to GPPM UserInterface Inspect tools for damage, ensure calibration is not expired and replace if necessary. B1.08 Tube Sensor PCB Note These videos represent simulated scenarios of instrument access and repair, and some may not accurately depict actual PPE guidelines. Trained personnel should follow procedures as outlined in Biological Hazards and safety procedures. Time Required 30 min Tools/Materials Phillips Screwdriver Side Cutters or Scissors TIE WRAP NYL .09"W 4.00"L (6005321) Qty: 1 WARNING Potential Biohazard WARNING Splash/Spray Hazard Removal Action Steps Preparation 1. Place the instrument in STANDBY and power OFF. 2. Open the left [1] and right [2] access covers and remove the tower cover. [3] 3. Remove the front Drip Plate. [4] Reference VIDEO Remove Tube Note Video contains no audio Sensor PCB sound. (If the video does not display, or to view the video full size: Click Here) Remove Tube Sensor PCB 1. Locate the Tube Sensor PCB assembly. [1] 2. Cut the tie wrap holding the Tube Sensor PCB Cover in place. 3. Remove the Tube Sensor PCB Cover and unplug the Tube Sensor PCB Cable. [2] 4. Unscrew the two (2) screws holding the Tube Sensor PCB in place and remove the Tube Sensor PCB. [3] Replacement Action VIDEO Install Tube Sensor PCB Steps Reference Note Video contains no audio sound. (If the video does not display, or to view the video full size: Click Here) Install Tube Sensor PCB 1. Mount New Tube Sensor PCB to the Loader and secure it with two (2) screws. [3] 2. Connect cable to the tube sensor PCB. [2] 3. Loop a new tie wrap around the cable through two (2) holes on back side of cover with the tie wrap lock on the outside. DO NOT TIGHTEN. [3] 4. Lift mixer assembly and slide cover over tube sensor PCB. 5. Ensure cover is sitting flush on top of the tube sensor PCB, and the two (2) sensors are protruding through the sensor cover. [4] 6. Secure the tie wrap once the sensor cover is in place. [5] Completion 1. Install the Front Drip plate. [4] 2. Reseat Tower Cover [3], and close left [1] and right [2] access covers. Verification Procedures Order VP Description 1 VP-58 Tube Sensor Adjustment N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP Detail / Note Expected Results CELL-DYN Ruby System Service and Support Manual (Version 201958-114) • © 2015 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. C1.01 Optics Bench Version - 201962-103_2770_1 List/Part Numbers List/Part Number Description 8921206404 OPTICAL BENCH ASSEMBLY, CD3200 8921206406 ASSY, OPTIC BENCH, CDRUBY Inspect tools for damage, ensure calibration is not expired and replace if necessary. C1.01 Optics Bench Time Required 02:00 hr Phillips Screwdriver Tools/Materials 11/32" Nut Driver Flat Blade Screwdriver WARNING Electrical Shock Hazard Removal Action Steps Preparation 1. Place the instrument in STANDBY and power OFF. 2. Remove the top cover (4 screws) [1]. 3. Locate the dust cover assembly [2] for the optical flow cell. 4. Lift the square plug from the top of the cover (plug seals flow cell tubing at the top of the assembly) and carefully compress the springloaded end caps. 5. Lift the dust cover assembly up and forward to remove it from the instrument. 6. Locate the black L-shaped cover on the left side of the optics bench. 7. Using a Phillips screwdriver, remove the two (2) screws and remove the cover. Reference Remove Optics Bench Base Plate Mounting Screws Remove Optics Bench Connectors 1. Using an 11/32" nut driver, locate and remove the four (4) optics mounting screws [1] from the base plate. 1. Locate and disconnect cable connector J1 from each of the 0 and 10 degree photo detector PCBs. [1] 2. Locate and disconnect cable connector J2 from each of the PMT pre-amplifier PCBs. [2] 3. Locate the large, white laser tube connector [3] at the right rear of the optics bench. 4. Use a flat blade screwdriver to dislodge the connector at the joints. WARNING Do not touch the connector contacts until the Ground Laser Tube Connector Action is performed. Ground Laser Tube Connector 1. Take the laser tube side of the connector (with exposed contacts) and ground it to the instrument chassis (this discharges the laser tube). Disconnect Flow Cell Tubing 1. Remove the two (2) screws [1] on the flow cell cover. 2. Lift and remove flow cell cover. 3. Disconnect the flow cell tubing (1 - 5) from the manifold. Note Use a paper towel to absorb any residual liquid from the tubing. Remove Optics Bench 1. Lift the optics bench out and place it on top of the back left corner of the chassis. 2. Find a suitable location to set the optics bench down. Note Be sure not to set the optics bench down on the PMT tubes and the flow cell. Place supports under the bench to protect these areas. Replacement Action Steps Reference Replace Optics Bench 1. Replace the Optics Bench by following the steps above in reverse order. Verification Procedures Order VP Description 3 VP-18 Optics Bench Alignment Procedure VP Detail / Note Expected Results Verify and document the following: EOS =³ 98%. CV% = < 3.0 for 0D/10D and < 12.5 for 90D/90DP. 2 VP-19 PMT Dynode Voltage Verification/Adjustment Verify and document the following: WBC Specs: Ch 0 Mean 35, Range 32-38, Expected CV 5.0%, Final CV <6.0% CH 10 Mean 65, Range 60-70, Expected CV 4%, Final CV < 5% Ch 90 Mean from Opt-Cal, Range ± 6 Channels, Expected CV 13%, Final CV <18% Ch 90 Dep Mean from Opt-Cal, Range ± 10 Channels, Expected CV15%, Final CV <18% Dynode Voltage: Ch 3-Vdyn/100 and Ch 4-Vdyn/100 <9.00 (900 volts). 4 VP-20 System Gains Verification/Adjustment Verify and document the following: WBC Specs: Ch 0 Mean 35, Range 32-38, Expected CV 5.0%, Final CV <6.0% CH 10 Mean 65, Range 60-70, Expected CV 4%, Final CV < 5% Ch 90 Mean from Opt-Cal, Range ± 6 Channels, Expected CV 13%, Final CV <18% Ch 90 Dep Mean from Opt-Cal, Range ± 10 Channels, Expected CV15%, Final CV <18% RBC/PLT Specs Target Ch. Target Ch. Target Ch. ±1 Target Ch. 5 for RBC/PLT 0° (7 µm) = 180 ±1 for RBC/PLT 0° (5 µm) = 129 ± 1 for RBC/PLT 10° (3.3 µm) = 121 for RBC/PLT 10° (7 µm) = 202 ± Retic gains equal WBC gains NOC 0° /10° Gains = WOC 0° /10° Gains 5 VP-21 WBC OPTI-CAL Verification/Adjustment Verify and documente the following: 0° channel mean = 35 ± 3 10° channel mean = 65 ±5. 1 VP-35 Optical Flow Cell Wetting Procedure N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. Verify and document that the backgrounds results are within specificaion: WOC £ 0.10 NOC £0.10 RBC £0.02 HGB £0.10 PLT£5.0 CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. D1.01 Power Supply Version - 201962-103_2772_2 List/Part Numbers List/Part Number Description 8934104701 POWER SUPPLY, SPEC, LAMBDA, CUSTOM, CDRUBY Inspect tools for damage, ensure calibration is not expired and replace if necessary. D1.01 Power Supply Time Required Tools/Materials 00:45 min Phillips Screwdriver Removal Action Steps Preparation 1. 2. 3. 4. 5. Place the instrument in STANDBY and power OFF. Disconnect the power cord from the outlet. Remove the optics bench. (C1.01 Optics Bench) Disconnect laser power supply connector. Remove Optics Bench baseplate (four screws). Reference Remove Power Supply 1. Loosen the four (4) screws at the base of the power supply assembly [1]. 2. Slide the power supply assembly toward the front of the instrument, until the mounting cutouts clear the screws and lift up. 3. Tilt the front end of the assembly upward to remove the cable connectors. Disconnect Connectors 1. Disconnect the following cable connectors on the power supply. AC Inputs (Front of assembly - as seen from the front - left to right) [1] Black (ACIn1) White (ACIn2) Green (gnd) Power Distribution Module (PDM) J8 Replacement Action Steps Reference Replace Power Supply 1. Replace the power supply by following the steps above in reverse order. Verification Procedures Order VP Description 1 VP-01 System Voltage Verification VP Detail / Note Expected Results Verify and document the following Power Distribution Module Voltages: E1=+15V±0.4 E2=-15.0V±0.4 E3=-12.0V±0.5 E4=+12.0V±0. E5=+28V±0.5 E6=+15.5V±0.5 E7=+5.1V±0.2 E8= GND N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. CELL-DYN Ruby System Service and Support Manual (Version 201958-103) • © 2006, 2012 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. E1.01 Vacuum/Pressure Assembly Version - 201962-103_2773_1 A Part Number is currently not assigned to this RR. Go to GPPM UserInterface Inspect tools for damage, ensure calibration is not expired and replace if necessary. E1.01 Vacuum/Pressure Assembly Time Required Tools/Materials 00:45 min Phillips Screwdriver Removal Action Steps Preparation 1. Place the instrument in STANDBY and power OFF. 2. Remove the left side cover (4 screws). Remove Vacuum/Pressure Assembly Note The Vacuum/Pressure Assembly is mounted on slide rails for ease of access and serviceability. 1. Loosen the two (2) knurl capture screws from the inner (SHM) panel and open the panel toward the front of the instrument. 2. Remove the locking screw [1]. 3. Press the rail latch while sliding the assembly out toward the left of the instrument. Note The rail latch is located under the right rail. [4] Reference 4. Disconnect cable connector J4 on the pump relay PCB. [2] 5. Disconnect cable connectors J6, J12 thru J15, and J17 on the VPM PCB. [3] 6. Locate the air supply line coupler. 7. Move the red switch [5] to the OPEN position and disconnect the coupler. Replacement Action Replace Vacuum/Pressure Assembly Steps Reference 1. Install all cable connectors, air supply line coupler, and components by following the steps above in reverse order. 2. To return the assembly to the normal position, push up on the rail latch and push the assembly back in place. Note Avoid potential harm from splashing biohazard by positioning the vacuum pump coiled vent line away from critical components. Verification Procedures Order VP Description 2 VP-16 Vacuum & Pressure Level Verification/Adjustment VP Detail / Note Expected Results Verify and document the following: Pressure 1 = 12.5-13.5psi Pressure 2 = 8.5-9.5psi Pressure 3 = 4-4.5psi Vac 1 = 12.5-13.5 Hg Vac 2(open) = 2.6-3 Hg Vac 2 (closed) = 3.1-3.5Hg Note: Monitor while instrument is in Closed Mode. Vac 2(retic) = 300Hg Note: This is a set point values found on Setpoint screen. 1 VP-04 VPM Reference Voltage Verification/Adjustment N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. Verify and document that the VPM voltage = 10.0 V (± 0.01 V). CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. F1.01 Sample Loader Version - 201962-103_2774_2 A Part Number is currently not assigned to this RR. Go to GPPM UserInterface Inspect tools for damage, ensure calibration is not expired and replace if necessary. F1.01 Sample Loader Time Required 00:90 min Phillips Screwdriver Tools/Materials 7/64" Hex Wrench Removal Action Preparation Steps Note The removal of this assembly allows access to all major sample loader components, thus making it easier to service. 1. Place the instrument in STANDBY and power OFF. 2. Open the left [1] and right [2] (front) access covers and remove the tower cover [3]. Remove Sample Loader Covers and Tower Securing Screw 1. Remove the left [1] and right [2] panels from the rear rail of the sample loader. 2. Remove the screw [3] at the top of the tower assembly. 3. Unscrew aspiration fitting from top Y-Valve port [4]. Reference Separate Sample Loader from Analyzer 1. Lift the sample loader center/drip tray cover [1] and remove it from the instrument. 2. Remove the four (4) screws from the sample loader skirt cover [2]. 3. Slide the cover toward the front of the instrument and remove the cover. 4. Locate the sample loader slide bracket [3] (on both sides of the unit) and remove the front screw [4] and loosen rear screw [5]. 5. Grasp the sample loader and carefully pull it toward the front of the instrument. Note Be sure not to catch or disconnect any tubing in the process. Note The Sample Loader should pull away from the instrument approximately three to four inches. Disconnect Tubing Coupler and SHM PCB Cable Connections 1. Locate and disconnect the vacuum and pressure tubing coupler [1]. 2. Remove the left side cover. (A1.06 Left Side Cover) 3. Locate the SHM 1 [2], SHM 2 [3] and OTS Chopper Driver [4] PCBs. 4. Disconnect the following cable connectors: SHM 1 J1, J9, J10, J12, J13, J14, and J16. SHM 2 J1, J2, J3, J4, J5, J9, J10, J11, J12, J13, J15, and J16. OTS Chopper Driver J2 Remove Sample Loader 1. Guide all required cables between the SHM PCBs and sample loader through the opening in the lower left side of the flow panel [1]. 2. Remove the rear screw on both the left and the right side sample loader slide brackets. 3. Grasp the sample loader by the ends and carefully slide it out of the brackets and place it on a flat surface. Replacement Action Steps Reference Replace Sample Loader 1. Replace the Sample Loader by following the steps above in reverse order. Verification Procedures Order VP Description 1 VP-26 Mixer Up/Down Verification 2 VP-27 Mixer Head Rotation Verification 3 VP-28 Mixer Bladders Verification 4 VP-29 Rack Advance & Tube Sensors Verification 6 VP-31 Mixer Bladders Pressure Verification/Adjustment 5 VP-30 Cross Transfer Arms & Rack Sensors Verification N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP Detail / Note Expected Results Verify and document that the pressure 1 psi = 12.5-13.5 psi. CELL-DYN Ruby System Service and Support Manual (Version 201958-103) • © 2006, 2012 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. F1.02 Bladder Grippers Version - 201962-103_2775_1 List/Part Numbers List/Part Number Description 8930114401 SLEEVE, .875"OD 9130647 MIX HEAD REPAIR SERVICE KIT Inspect tools for damage, ensure calibration is not expired and replace if necessary. F1.02 Bladder Grippers Time Required 00:50 min Feeler Gauge Tools/Materials 9/64" Hex Wrench 3/32" Hex Wrench 1/4" Socket or Wrench Phillips Screwdriver Vacuum/Pressure Gauge or Meter DI Water Q-TIPS Soap Solution (for leak test) Removal Action Steps Preparation 1. Place the instrument in STANDBY and power OFF. 2. Open the left [1] and right [2] (front) access covers and remove the tower cover [3]. Remove Mixer Head 1. Remove the closed mode needle from the mounting arm by loosening the thumbscrew. Reference 2. Loosen the thumbscrew [1] to release the mixer head and allow to pivot forward. 3. Remove vacuum/pressure tubing from the elbow fitting on the mixer head body. 4. Remove the screw [1] holding the tubing clamp. 5. Disconnect the cable connector from the mixer head home sensor. 6. Loosen the set screws [2] on the mixer cap holding the mixer head to the motor shaft by using a 3/32" hex wrench and remove the mixer head. Note Remove the mixer head by rotating it forward until it is horizontal with the platen. 7. Remove the four (4) Phillips screws [3] from the mixer cap. Remove ORings and Bladder Grippers 1. Loosen the two (2) hex screws [3] by using a 9/64" hex wrench until the mixer cap separates from the mixer body. Note Do not remove the two (2) hex screws from the mixer cap just loosen the hex screw until the cap and body separates. 2. Remove and discard the two (2) O-rings. [1] 3. Remove the two (2) sleeves from the body of the mixer head. 4. Remove the bladder grippers [2] from the two (2) sleeves and discard. Replacement Action Replace ORings and Bladder Grippers Steps 1. Insert the O-rings into the two (2) recesses in the mixer cap. 2. Insert the bladder grippers [2] through the sleeve and fold each end evenly over the sleeve. Note The fold should be between 0.30" - 0.40" over the outer sleeve. 3. Repeat above step for the remaining sleeve. 4. Insert the sleeves into the mixer body using DI water, twisting gently if necessary. Do not force. 5. Mount the mixer cap to the mixer body. 6. Tighten the four (4) Phillips screws in an "X" pattern to uniformly mount the mixer cap to the body. Reference 7. Tighten the two (2) hex screws snugly, but do not over tighten. 8. Re-tighten the four (4) Phillips screws, and make sure that there is no gap between the mixer cap and the mixer body. Install Mixer Head 1. Slide the mixer head back onto the motor shaft, and make sure a gap of about 0.020" ± 0.005" exists [1] between the tip of the screw head and the mixer body. 2. Tighten the setscrew on the mixer assembly to the motor shaft. 3. Install the close mode sample needle. Verification Procedures Order VP Description 2 VP-27 Mixer Head Rotation Verification 1 VP-31 Mixer Bladders Pressure Verification/Adjustment 3 G22 - Sample Loader / Autoloader N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP Detail / Note Expected Results Verify and document that the pressure 1 psi = 12.5-13.5 psi. Place ten (10) test tubes in a rack and run samples in closed mode. Verify no errors occur. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. F1.03 Spinner Motor Assembly Version - 201962-103_2776_2 List/Part Numbers List/Part Number Description 8921294701 TUBE SPINNER MOTOR ASSY W-PULLEY Inspect tools for damage, ensure calibration is not expired and replace if necessary. F1.03 Spinner Motor Assembly Note These videos represent simulated scenarios of instrument access and repair, and some may not accurately depict actual PPE guidelines. Trained personnel should follow procedures as outlined in Biological Hazards and safety procedures. Time Required 17 min Tools/Materials Allen Wrench Phillips Screwdriver Cutters WARNING Potential Biohazard WARNING Splash/Spray Hazard Removal Action Steps Preparation 1. Place the instrument in STANDBY and power OFF. 2. Open the left [1] and right [2] (front) access covers and remove the tower cover [3]. VIDEO Reference Disconnect Note Video Spin Motor contains no In-Line audio Cable and sound. Remove Spin Motor Assembly (If the video does not display, or to view the video full size: Click Here) Disconnect Spin Motor In-Line Cable 1. Remove the left side metal panel under the autoloader. [1] 2. Disconnect the motor in-line cable connector under the autoloader. [2] Remove Spinner Motor 1. Remove Assembly the screw securing the cable and tubings. [1] 2. Clip the tie wrap holding the cable in place. [2] 3. Remove the two (2) set screws securing the Spinner Motor Assembly to the bracket. [3] Replacement Action VIDEO Install Spinner Motor Assembly, Secure Spin Motor Cable and Connect Spin Motor In-Line Cable Steps Reference Note Video contains no audio sound. (If the video does not display, or to view the video full size: Click Here) Install Spinner Motor Assembly 1. Install the motor on the bracket. [1] 2. Install the belt around the cone and motor. [2] 3. Replace the two set screws to hold the motor in place. [3] 4. Verify the tension of the belt. Secure Spin Motor Cable 1. Reroute the cable to under the autoloader. 2. Replace the tie wrap to hold the cable in place. [2] 3. Secure the cable and tubings with holder and screw. [1] Connect the Spin Motor InLine Cable 1. Connect the cable under the autoloader. [2] 2. Install the cover under the autoloader. [1] Completion Install the Tower cover [3] and close the left [1] and right [2] access covers. Verification Procedures Order VP Description 1 VP-24 Bar Code Spin Assembly Verification N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP Detail / Note Expected Results CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2015 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. F1.04 Mix Head & Mixer Lifter Assembly Version - 201962-103_2777_1 List/Part Numbers List/Part Number Description 8921292101 MIXER ASSY, CDRUBY Inspect tools for damage, ensure calibration is not expired and replace if necessary. F1.04 Mix Head & Mixer Lifter Assembly Time Required Tools/Materials Not Assessed None Note The mixer lifter FRU comes with the slider bearing taped, or rubber banded, to fasten it in position on the track (Mixer Lifter Assembly). Do Not allow the slider bearing to slide off of the track. If this happens, the tiny ball bearings can escape, and the FRU cannot be restored to operational state. The air cylinder w/piston rod can be ordered separately, but does not include the air fitting. The mix head sensor (magnetic, reed), and the 'Z' up sensor (photo-interrupter), and the stepper motor, can also be ordered separately. Refer to the following illustrations. Mixer Lifter Assembly Sample Loader Mixer Note When the FRU is ordered, the adjustments shown in Verify Clearances [5] are already done. Note The head stop adjustment is verified with the mixer and lifter assemblies mounted on the platen. Refer to FRU instructions. Note The proper bladder pressure is 6.5 PSI ± 0.2PSI. Removal Action Steps Reference Preparation 1. Remove the sample loader from the system. (F1.01 Sample Loader) 2. Clean the platen and racks with water. Note To work with the sample loader on a flat surface, two small part boxes placed underneath at the ends can be used to rest the assembly on. This helps prevent inadvertent damage to loader components. Remove Mixer and Lifter 1. Remove the plastic cable clamps secured to the front of the 2. 3. 4. 5. 6. 7. lifter support, and remove the coiled wrap on the cables and tubing at the top of the assembly. Disconnect the cable from the upper position (Z) sensor, and disconnect the air line from the fitting on the mix head. From the underside of the sample loader baseplate [1], disconnect the tubing from the air cylinder. Locate the quick connections on the motor cable and the mix head sensor cable and disconnect them. Feed the two (2) cables through the hole in the baseplate to the top. From the underside, remove the three (3) screws securing the lifter assembly to the sample loader baseplate. Remove the mixer and lifter assemblies together as a unit. [1] [2] To separate the two (2) assemblies, remove the nyloc nut at the very top of the piston rod. Be sure to save the nut. [2] Remove the four (4) screws holding the mixer assembly to the slider bearing on the lifter. Be sure to save the screws. [2] Note When the mixer assembly is removed, the slider bearing is free. Be sure to keep the slider bearing from sliding off the end of the track. Use tape or a rubber band to hold the slider in place. If the slider is allowed to slide off the track, the tiny ball bearings can escape, and the slide cannot be restored to operational condition. Also take care with the new assembly when it is unpacked and prepared for use. Replacement Action Install Mixer and Lifter Steps 1. To assemble the mixer assembly, use the same four (4) screws to attach the mixer assembly to the slider bearing on Reference the lifter. Note Be sure to align the mixer bracket to the slider bracket so they are square to each other before tightening the screws. [2] 2. Re-attach the piston rod using the nyloc nut. Using a feeler gauge, adjust the nut for 0.020" play under the nut. [2] 3. Verify smooth operation by manually moving the mix head up and down. There should be no mechanical resistance. If necessary, loosen the two (2) screws securing the cylinder bracket [3], to adjust its position for minimum friction on the piston rod, then re-tighten them. Note Do not lubricate the air cylinder. 4. Check the 'Z' upper sensor bracket and flag for proper alignment. [3] 5. Install the assembled mixer and lifter to the sample loader baseplate using same three (3) screws. 6. Route the tubing and cables through the hole in the baseplate. Re-connect all of the cables and tubing in reverse order. Verify Clearances 1. Re-check the play under the nyloc nut on the piston rod. It should be 0.020". 2. Check the mix head (rotate) stop adjustment in parallel with the bottom clearance adjustment (Step3). Ensure the mix head rotation stops exactly at vertical, with an even gap between the bottom edges and the two (2) rack guide walls. [4] [5]. 3. With the mix head resting at the bottom of it's vertical travel, check the clearance between the bottom of the mix head and the top of the rack guide walls. [4] It should be at 0.020" �0.005". To adjust the clearance, loosen the 2 screws securing the bottom stop/flag to the mix head bracket. [4] Secure Cables/Tubing 1. Secure the cables and mix head tubing, and re-attach the plastic cable clamps to the front of the slider. 2. Install the coiled wrap to neatly secure the cables. Verification Procedures Order VP Description 1 VP-26 Mixer Up/Down Verification 2 VP-27 Mixer Head Rotation Verification 3 VP-28 Mixer Bladders Verification 4 VP-31 Mixer Bladders Pressure Verification/Adjustment N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP Detail / Note Expected Results Verify and document that the pressure 1 psi = 12.5-13.5 psi. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. F1.05 Detent Pin and Index Bar (X-Axis) Assemblies Version - 201962-103_2778_1 A Part Number is currently not assigned to this RR. Go to GPPM UserInterface Inspect tools for damage, ensure calibration is not expired and replace if necessary. F1.05 Detent Pin and Index Bar (X-Axis) Assemblies Time Required Tools/Materials Not Assessed Phillips Screwdriver Removal Action Steps Prerequisite 1. Place the instrument in STANDBY and power OFF. Preparation 1. Open the left [1] and right [2] (front) access covers and remove the tower cover [3]. 2. Perform Remove Sample Loader Covers and Tower Securing Screw (F1.01 Sample Loader). 3. Perform Separate Sample Loader from Analyzer (F1.01 Sample Loader). Clean/Adjust Detent Pin Retainer 1. Remove the two (2) screws from the bar code reader bracket [1]. 2. Remove two (2) screws from the detent pin assembly. [2] 3. Remove the e-rings retaining the springs and the pins. 4. Clean the pins and pin bores in the retainer and platen with alcohol and Q- Reference TIPS. 5. Clean the mounting surface and the platen. 6. Assemble and install. 7. Place a rack in position with the bar code window aligned with the window in the inner wall. [3] 8. Adjust the tension for no gap between erings and retainer with the rack in position and the detents engaged. [4] Note Be sure that both detent pins are in contact with the rack. [5] 9. Re-attach the bar code reader (loose). Note Adjustment of the bar code reader is necessary at this time. Remove Rear Platen Wall Assembly 1. Locate and remove the two (2) screws 2. 3. 4. 5. 6. securing each of the sample loader access panels from under the unit. Open the access panels. Remove the unload side sweep arm assembly. (F1.06 Sweep Arm (Y-Axis)) Disconnect both unload sensor cable connectors. Locate the four (4) screws [1] securing the rear platen wall (contains the indexer and pawl assembly). Slide out the rear platen wall assembly from the sample loader. Remove Indexer Air Cylinder and Pawl Assembly 1. Remove the two screws (2) securing the air cylinder (with bracket) to the rear platen wall assembly [1]. 2. Remove the screw securing each of the two indexer bar retaining blocks [2]. 3. Lift the assembly from the rear platen wall. 4. Loosen the two (2) setscrews [3] and separate the indexer bar from the air cylinder. Replacement Action Steps Reference Replace Sample Loader 1. Replace the Indexer Bar by following the steps above in reverse order. Verification Procedures Order VP Description 1 VP-29 Rack Advance & Tube Sensors Verification N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP Detail / Note Expected Results CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. F1.06 Sweep Arm (Y-Axis) Version - 201962-103_2779_1 List/Part Numbers List/Part Number Description 8930270601 SWEEP ARM, CDRUBY 8930270701 SWEEP ARM, LOAD SIDE, CDRUBY 8930270801 SWEEP ARM, UNLOAD SIDE, CDRUBY 8930270901 SHAFT, SWEEP ARM, CDRUBY 8930271001 SHAFT-ARM, SWEEP ARM, CDRUBY 8930271101 BEARING BLOCK, SWEEP ARM, RUBY Inspect tools for damage, ensure calibration is not expired and replace if necessary. F1.06 Sweep Arm (Y-Axis) Time Required Tools/Materials Not Assessed Phillips Screwdriver Flat blade screwdriver Removal Action Steps Prerequisite 1. Place the instrument in STANDBY and power OFF. Preparation 1. Open the left [1] and right [2] (front) access covers and remove the tower cover [3]. 2. Perform Remove Sample Loader Covers and Tower Securing Screw (F1.01 Sample Loader). 3. Perform Separate Sample Loader from Analyzer (F1.01 Sample Loader). Remove Sweep Arm Reference Air Cylinders 1. Remove the two (2) screws [1] from the 2. 3. 4. 5. 6. sample loader left access panel (located under the unit). Open the access panel and locate the sweep arm air cylinder. Disconnect the pneumatic line to the cylinder [2]. Locate and remove the pin [3] securing the pin between the sweep arm assembly and the air cylinder. Use a flat blade screwdriver and remove the c-clip [4] securing the air cylinder to the bottom of the sample loader platen. Slide the air cylinder off of the mounting pin. Note Both load and unload air cylinders are removed in the same manner. Remove Unload and Load Side Sweep Arm Assemblies 1. Locate and remove two (2) screws [1] securing the Sweep Arm Assembly to the sample loader platen. 2. Compress the arms together and slide the assembly out from the cutout. Note Both load and unload side sweep arms are removed in the same manner. Replacement Action Steps Install Sweep Arm Assemblies Reference 1. When replacing the sweep arms, be sure that both the left and right arms are aligned as described. Verification Procedures Order VP Description 1 VP-29 Rack Advance & Tube Sensors Verification 2 VP-30 Cross Transfer Arms & Rack Sensors Verification N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP Detail / Note Expected Results CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. F1.07 Autoloader Sweep Arm Spring Replacement Procedure Version - 201962-103_4701_1 A Part Number is currently not assigned to this RR. Go to GPPM UserInterface Inspect tools for damage, ensure calibration is not expired and replace if necessary. F1.07 Autoloader Sweep Arm Spring Replacement Procedure Time Required Tools/Materials Not Assessed Phillips Screwdriver Flat blade screwdriver Removal Action Steps Prerequisite 1. Place the instrument in STANDBY and power OFF. Preparation 1. Open the left [1] and right [2] (front) access covers and remove the tower cover [3]. 2. Perform Remove Sample Loader Covers and Tower Securing Screw (F1.01 Sample Loader). 3. Perform Separate Sample Loader from Analyzer (F1.01 Sample Loader). Remove Sweep Arm Air Cylinders 1. Remove the two (2) screws [1] from the sample loader left access panel (located under the unit). 2. Open the access panel and locate the sweep arm air cylinder. 3. Disconnect the pneumatic line to Reference the cylinder [2]. 4. Locate and remove the pin [3] securing the pin between the sweep arm assembly and the air cylinder. 5. Use a flat blade screwdriver and remove the c-clip [4] securing the air cylinder to the bottom of the sample loader platen. 6. Slide the air cylinder off of the mounting pin. Note Both load and unload air cylinders are removed in the same manner. Remove Unload and Load Side Sweep Arm Assemblies 1. Locate and remove two (2) screws [1] securing the Sweep Arm Assembly to the sample loader platen. 2. Compress the arms together and slide the assembly out from the cutout. Note Both load and unload side sweep arms are removed in the same manner. Remove Springs 1. Remove the old spring [1] on both sweep arm assemblies. Replacement Action Steps Install Springs 1. Replace with new spring [1] on both sweep arm asseblies. Re-Install Sweep Arm Reference Assemblies 1. When reinstalling the sweep arms, be sure that both the left and right arms are aligned as shown. 2. Re-assemble Ruby in reverse order of dis-assembly. Verification Procedures Order VP Description 1 VP-29 Rack Advance & Tube Sensors Verification 2 VP-30 Cross Transfer Arms & Rack Sensors Verification N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP Detail / Note Expected Results CELL-DYN RUBY System Service and Support Manual (Version 201958-105) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. F1.08 Aspiration Tower Stop Solenoid Version - 201962-103_5008_1 A Part Number is currently not assigned to this RR. Go to GPPM UserInterface Inspect tools for damage, ensure calibration is not expired and replace if necessary. F1.08 Aspiration Tower Stop Solenoid Time Required Tools/Materials 01:45 hrs Phillips Screwdriver 7/64" Hex Wrench Caution Possible Electrostatic Discharge Shock Removal Action Steps Preparation 1. Place the instrument in STANDBY and power OFF. 2. Open the left [1] and right [2] (front) access covers and remove the tower cover. [3]. Remove Sample Loader Covers and Tower Securing Screw 1. Remove the left [1] and right [2] panels from the rear rail of the sample loader. 2. Remove the screw [3] at the top of the tower assembly. 3. Remove aspiration tubing from top Y- Reference Valve port. [4] Separate Sample Loader from Analyzer 1. Lift the sample loader center/drip tray cover [1] and remove it from the instrument. 2. Remove the four (4) screws from the sample loader skirt cover [2]. 3. Slide the cover toward the front of the instrument and remove the cover. 4. Locate the sample loader slide bracket [3] (on both sides of the unit) and remove the front screw [4] and loosen rear screw [5]. 5. Grasp the sample loader and carefully pull it toward the front of the instrument. Note Be sure not to catch or disconnect any tubing in the process. Note The Sample Loader should pull away from the instrument approximately three to four inches. Disconnect Tubing Coupler and SHM PCB Cable Connections 1. Locate and disconnect the vacuum and pressure tubing coupler [1]. 2. Remove the left side cover. (A1.06 Left Side Cover) 3. Locate the SHM 1 [2], SHM 2 [3] and OTS Chopper Driver [4] PCBs. 4. Disconnect the following cable connectors: SHM 1 J1, J9, J10, J12, J13, J14, and J16. SHM 2 J1, J2, J3, J4, J5, J9, J10, J11, J12, J13, J15, and J16. OTS Chopper Driver J2 Remove Sample Loader 1. Guide all required cables between the SHM PCBs and sample loader through the opening in the lower left side of the flow panel.[1] 2. Remove the rear screw on both the left and the right side sample loader slide brackets. 3. Grasp the sample loader by the ends and carefully slide it out of the brackets and place it on a flat surface. Remove Stop Solenoid 1. Disconnect the cable connection under the platen. [1] 2. Remove the two (2) screws from the solenoid mounting bracket [2] and remove solenoid from aspiration tower. Replacement Action Steps Replace Stop Solenoid 1. Replace the Stop Solenoid by following the steps above in reverse order. Note Before tightening the solenoid mounting screws, lift the solenoid to the highest point, then tighten screws to hold solenoid in place. Failure to do so can result in tube height sensor errors. Reference Replace Sample Loader 1. Replace the Sample Loader by following the steps above in reverse order. Verification Procedures Order VP Description 5 VP-26 Mixer Up/Down Verification 1 VP-22 Aspiration/Vent Needle Verification 2 VP-23 Tower Unit Stop Solenoid Verification 6 VP-27 Mixer Head Rotation Verification 4 VP-25 Tube Height Sensors (S1/S2) Verification 3 VP-24 Bar Code Spin Assembly Verification 7 VP-28 Mixer Bladders Verification 8 VP-29 Rack Advance & Tube Sensors Verification 10 VP-31 Mixer Bladders Pressure Verification/Adjustment 9 VP-30 Cross Transfer Arms & Rack Sensors Verification N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP Detail / Note Expected Results Verify and document that the pressure 1 psi = 12.5-13.5 psi. CELL-DYN RUBY System Service and Support Manual (Version 201958-107) • © 2006, 2009 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. F1.09 Tube Spinner Bracket with Cone Version - 201962-103_6119_1 A Part Number is currently not assigned to this RR. Go to GPPM UserInterface Inspect tools for damage, ensure calibration is not expired and replace if necessary. F1.09 Tube Spinner Bracket with Cone Note These videos represent simulated scenarios of instrument access and repair, and some may not accurately depict actual PPE guidelines. Trained personnel should follow procedures as outlined in Biological Hazards and safety procedures. Time Required 20 min Tools/Materials Phillips Screwdriver Allen Wrench WARNING Potential Biohazard WARNING Splash/Spray Hazard Removal Action Steps Preparation 1. Select the following from the Ruby Software display: Maintenance Tab As-Needed Clean or Replace Closed Mode Needle to the pop-up window Disable Analyzer 2. Open the left [1] and right [2] (front) access covers and remove the tower cover. [3] VIDEO Note Remove Closed Video contains no audio Mode Needle and sound. Spin Cone and Bracket Reference Assembly (If the video does not display, or to view the video full size: Click Here) Remove Closed Mode Needle Note Prior to disconnecting the tubing, you may want to label the tubing to ensure it is properly reconnected to the correct position. 1. Remove the two tubings from the top of the closed mode needle. [1] 2. Loosen the thumbscrew [2] on the closed mode needle bracket and remove the bracket and needle and set both aside. Remove Spin Cone and Bracket Assembly 1. Remove the two (2) screws holding the Spin Cone bracket in place. [1] 2. Remove the two (2) screws securing the Wash block to the Spin Cone bracket. [2] 3. Remove the two (2) Allen screws mounting the Spin Motor to the Spin Cone bracket. [3] 4. Remove the Spin Motor [4] and belt [5] from the Spin Cone bracket. [6] Replacement Action VIDEO Install Spin Cone and Bracket and Closed Mode Needle Steps Reference Note Video contains no audio sound. (If the video does not display, or to view the video full size: Click Here) Install Spin Cone and Bracket 1. Mount the Spin Motor with belt to the Spin Cone bracket with the two Allen screws. [3] Note Verify belt tension. 2. Mount the Wash Block to the Spin Cone bracket with two screws. [2] 3. Mount the Spin Cone bracket to the instrument with two screws. [1] Install Closed Mode Needle 1. Insert the Closed Mode Needle removed from above and verify it goes through the Wash Block. [3] Note Verify angled port on top of Close Mode Needle is facing the instrument. 2. Mount the Closed Mode Needle bracket and tighten the thumbscrew. [2] 3. Connect the two tubings to the top of the Closed Mode Needle. [1] Note Verify the vent tubing is connected to the angled port of the Closed Mode Needle. Completion 1. Install the tower cover [3] and close the left [1] and right [2] front access covers. 2. Select the following from the Ruby Software display: Enable Analyzer Log Task Complete Verification Procedures Order VP Description 1 VP-24 Bar Code Spin Assembly Verification N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP Detail / Note Expected Results CELL-DYN RUBY System Service and Support Manual (Version 201958-114) • © 2015 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. F1.10 Detent Pin Assembly Version - 201962-103_6128_1 A Part Number is currently not assigned to this RR. Go to GPPM UserInterface Inspect tools for damage, ensure calibration is not expired and replace if necessary. F1.10 Detent Pin Assembly Note These videos represent simulated scenarios of instrument access and repair, and some may not accurately depict actual PPE guidelines. Trained personnel should follow procedures as outlined in Biological Hazards and safety procedures. Time Required 30 min Tools/Materials Phillips Screwdriver Pliers WARNING Potential Biohazard WARNING Splash/Spray Hazard Removal Action Prerequisite Preparation Steps Place the instrument in STANDBY and power OFF. Open the left [1] and right [2] (front) access covers and remove the tower cover. [3] VIDEO Note Remove Barcode Video contains no audio Reader and Detent sound. Pin/Bar Reference (If the video does not display, or to view the video full size: Click Here) Remove Barcode Reader and Detent Pin/Bar 1. Use a marker and outline or mark the position of the Barcode Reader and Detent Pin Bar. 2. Remove two screws from the barcode reader assembly. [1] 3. Remove two screws from the detent pin assembly [2] and lift assembly out of loader. [3] Clean the mounting surface and the platen. Clean/Adjust Detent Pin Retainer 1. Remove the e-rings retaining the springs and the pins. 2. Clean the pins and pin bores in the retainer and platen with alcohol and cotton swab. 3. Clean the mounting surface and the platen. Replacement Action VIDEO Steps Note Reference Install Detent Pin/Bar and Barcode Reader Video contains no audio sound. (If the video does not display, or to view the video full size: Click Here) Install Detent Pin/Bar and Barcode Reader 1. Install the e-rings retaining the springs and the pins. 2. Install two screws from the detent pin assembly. [2] 3. Install two screws from the barcode reader assembly. [1] 4. Place a rack in position with the barcode window aligned with the window in the inner wall. [3] 5. Adjust the tension so no gap is between e-rings and retainer with the rack in position and the detents engaged. [4 and 5] Note Be sure that both detent pins are in contact with the rack. 6. Reattach the barcode reader (loose). Note Adjustment of the barcode reader is necessary at this time. Completion Install Tower Cover [3] and close left [1] and right [2] front access covers. Verification Procedures Order VP Description 1 VP-29 Rack Advance & Tube Sensors Verification N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP Detail / Note Expected Results CELL-DYN RUBY System Service and Support Manual (Version 201958-114) • © 2015 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. G1.01 HGB Flow Cell Version - 201962-103_2781_1 List/Part Numbers List/Part Number Description 8921292201 HGB FLOW CELL ASSY, CDRUBY Inspect tools for damage, ensure calibration is not expired and replace if necessary. G1.01 HGB Flow Cell Time Required Tools/Materials 00:45 min Phillips Screwdriver Removal Action Steps Preparation 1. Place the instrument in STANDBY and power OFF. 2. Open the left [1] and right [2] (front) access covers and remove the tower cover [3]. Remove Tubing and Connector Note Prior to removing the HGB Flow Cell tubing, be sure to mark the lines for proper assembly. 1. Remove the tubing [1] from the flow cell (two (2) in front, two (2) on top and one at the base). 2. Disconnect the in-line cable connector. [2] Reference Remove HGB Flow Cell 1. Remove the two (2) screws [1] on top of the HGB flow cell to remove the flow cell cover. 2. Remove the two (2) screws [2] at back of the flow cell to remove it. Replacement Action Replace HGB Flow Cell Steps Reference 1. Replace the HGB Flow Cell by following the steps above in reverse order. Verification Procedures Order VP Description 1 VP-05 HGB Current Verification/Adjustment VP Detail / Note Expected Results Verify and document the following: HGB output voltage = 5.10v ± 0.10v. HGB Sample and HGB Ref=2050± 200 N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. H1.01 Syringe Driver Assembly A-B Version - 201962-103_2782_2 List/Part Numbers List/Part Number Description 8921217302 SYRINGE DRIVER, DUAL A-B 8921217402 SYRINGE DRIVER ASSEMBLY, C-D Inspect tools for damage, ensure calibration is not expired and replace if necessary. H1.01 Syringe Driver Assembly A-B Note These videos represent simulated scenarios of instrument access and repair, and some may not accurately depict actual PPE guidelines. Trained personnel should follow procedures as outlined in Biological Hazards and safety procedures. Time Required 45 min Tools/Materials Phillips Screwdriver WARNING Potential Biohazard WARNING Electrical Shock Hazard WARNING Splash/Spray Hazard Removal Action Steps Preparation 1. Place the instrument in STANDBY and power OFF. 2. Open the left [1] and right [2] access covers and remove the tower cover. [3] Reference VIDEO Note Remove Video contains no audio sound. Autoloader Skirt, Separate Note Autoloader From Video shows the removal of the Analyzer and Syringe Drive Assembly A-B only. Remove Syringe Drive Assembly A-B (If the video does not display, or to view the video full size: Click Here) Remove Autoloader Skirt 1. Remove Drip Plate. [1] 2. Remove the right and left panels [2] from the rear rail of the sample loader. 3. Remove the four (4) screws from the sample loader skirt cover. [3] 4. Slide the cover toward the front of the instrument and remove the cover. Separate Autoloader from Analyzer 1. Locate the sample loader slide bracket [1] on both sides of the unit and remove the front screw [2] and loosen rear screw. [3] 2. Remove the screw [4] at the top of the tower assembly. 3. Disconnect the tubing [5] from the top port of the Y-Valve. 4. Grasp the sample loader and carefully pull it out from the front of the instrument. Note Be sure tubing remains connected and protected from any damage. Note The Sample Loader should pull away from the instrument approximately three to four (4) inches. Remove Syringe Driver Assembly A-B 1. Unseat each syringe from its bracket. 2. Unscrew the luer fittings [1] from the top of each syringe and set the syringes aside. Note Use gauze to pat the ends of the disconnected tubing to prevent leaks on the instrument.. 3. Remove the two (2) screws and spacer bar that separate the two (2) syringe drives. [2] 4. Remove the four (4) mounting screws [3] from the A-B syringe driver assembly. 5. Pull out the drive assembly and disconnect the ribbon cables on each side. Note Carefully remove assembly to prevent damage to tubing or other components. a Replacement Action Steps Reference VIDEO Note Install Syringe Video contains no audio sound. Driver Assembly A-B and Secure Note the Autoloader Video shows the replacement of to the Analyzer the Syringe Driver Assembly A-B only. (If the video does not display, or to view the video full size: Click Here) Install Syringe Driver Assembly 1. Connect the two (2) ribbon cables A-B on each side of the syringe drive assembly. 2. Seat the syringe drive assembly back into the instrument. 3. Secure the A-B syringe drive assembly using the four (4) screws. [3] 4. Secure the spacer bar between the two syringe drives with two (2) screws. [2] 5. Reconnect all four syringes to the tubings with the luer lock fittings [1] and reseat all syringes in their brackets in their brackets. Secure the Autoloader to the Analyzer 1. Push Autoloader back into position against instrument. 2. Secure four (4) screws in brackets on sides of autoloader. [1 and 2] 3. Reconnect tubing to Y-valve.[3] 4. Replace Tower screw to secure Tower to instrument. [4] Note Verify tubings are undamaged or pinched between autoloader and instrument. Completion 1. Secure the autoloader skirt with four (4) screws. [4] 2. Replace Drip Tray [2] and the right and left panels [3] from the rear rail of the sample loader. 3. Replace the Tower Cover [3]. Close left [1] and right [2] front access covers. Verification Procedures Order VP Description 1 VP-07 Motor Operation Verification N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP Detail / Note Expected Results CELL-DYN Ruby System Service and Support Manual (Version 201958-103) • © 2006, 2015 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. H1.02 Syringe Driver Assembly C-D Version - 201962-103_6121_2 A Part Number is currently not assigned to this RR. Go to GPPM UserInterface Inspect tools for damage, ensure calibration is not expired and replace if necessary. H1.02 Syringe Driver Assembly C-D Note These videos represent simulated scenarios of instrument access and repair, and some may not accurately depict actual PPE guidelines. Trained personnel should follow procedures as outlined in Biological Hazards and safety procedures. Time Required 45 min Tools/Materials Phillips Screwdriver WARNING Potential Biohazard WARNING Electrical Shock Hazard WARNING Splash/Spray Hazard Removal Action Steps Preparation 1. Place the instrument in STANDBY and power OFF. 2. Open the left [1] and right [2] access covers and remove the tower cover. [3] VIDEO Remove Note Reference Video contains no audio sound. Autoloader Skirt, Note Separate Video shows the removal of the Autoloader Syringe Driver Assembly C-D only. From Analyzer and Remove Syringe Driver Assembly CD (If the video does not display, or to view the video full size: Click Here) Remove Autoloader Skirt 1. Remove Drip Plate. [1] 2. Remove the right and left panels [2] from the rear rail of the sample loader. 3. Remove the four (4) screws from the sample loader skirt cover. [3] 4. Slide the cover toward the front of the instrument and remove the cover. Separate Autoloader From Analyzer 1. Locate the sample loader slide bracket [1] on both sides of the unit and remove the front screw [2] and loosen rear screw. [3] 2. Remove the screw [4] at the top of the tower assembly. 3. Disconnect the tubing [5] from the top port of the Y-Valve. 4. Grasp the sample loader and carefully pull it out from the front of the instrument. Note Be sure tubing remains connected and protected from any damage. Note The Sample Loader should pull away from the instrument approximately three to four inches. Remove Syringe Driver Assembly CD 1. Unseat each syringe from its bracket. 2. Unscrew the luer fittings [1] from the top of each syringe and set the syringes aside. Note Use gauze to pat the ends of the disconnected tubing to prevent leaks on the instrument. 3. Remove the two (2) screws and spacer bar that separate the two (2) syringe drivers. [2] 4. Remove the four (4) mounting screws [3] from the C-D syringe driver assembly. 5. Pull out the driver assembly and disconnect the ribbon cables on each side. Note Be careful to prevent damage to the tubing or other components when removing the assembly. Replacement Action Steps Reference VIDEO Install Syringe Note Video contains no audio sound. Driver Assembly C- Note D and Secure Video shows the replacement of the the Syringe Driver Assembly C-D. Autoloader to the Analyzer (If the video does not display, or to view the video full size: Click Here) Install Syringe Driver Assembly CD 1. Connect the two (2) ribbon cables on each side of the syringe drive assembly. 2. Seat the syringe driver assembly back into the instrument. 3. Secure the C-D syringe driver assembly using the four (4) screws. [1] 4. Secure the spacer bar between the two syringe drivers with two (2) screws. [2] 5. Reconnect all four syringes to the tubings with the luer lock fittings [3] and reseat all syringes in their brackets. Secure the Autoloader to the Analyzer 1. Push Autoloader back into position against instrument. 2. Secure four (4) screws in brackets on sides of autoloader. [1 and 2] 3. Reconnect tubing to Y-valve. [3] 4. Replace Tower screw to secure Tower to instrument. [4] Note Verify tubings are undamaged or pinched between autoloader and instrument. 5. Secure the autoloader skirt with four (4) screws. [4] 6. Replace Drip Tray. [5] Completion 1. Install the right [5] and left panels [4] from the rear rail of the sample loader. 2. Install the Tower Cover. [3] 3. Close left [1] and right [2] front access covers Verification Procedures Order VP Description 1 VP-07 Motor Operation Verification N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP Detail / Note Expected Results CELL-DYN Ruby System Service and Support Manual (Version 201958-114) • © 2015 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. J1.01 Hard Disk Drive Version - 201962-103_4869_1 List/Part Numbers List/Part Number Description 8200570701 DISK DRIVE, IDE 4.3GB OR LARGER Inspect tools for damage, ensure calibration is not expired and replace if necessary. J1.01 Hard Disk Drive Time Required 00:40 min Tools/Materials Phillips Screwdriver WARNING Potential Biohazard Removal Action Steps Preparation 1. Perform a back-up of System Set-Up Files and SQL Database. VP-48 Backup Procedure 2. Perform a system Shutdown, power off the instrument and remove the power cord. 3. Use a Phillips screwdriver to remove the four (4) screws securing the top cover. [1] 4. Carefully lift and remove the cover from the top of the instrument. Preparation (Continued) 1. Use a Phillips screwdriver to remove the four (4) screws securing the right side cover [1] to the Reference instrument. 2. Carefully lift and remove the cover from the right side of the instrument. 3. Loosen the upper and lower thumbscrews and open the CPU door assembly to gain access to the Hard Disk (HD), Floppy Disk (FD), and DVD Drive Area. Removing Drive Note Any of the three (3) drives may be removed as follows: 1. Remove the four (4) screws securing the faceplate onto the drive housing. Removing Drive (Continued) 1. Remove the flat ribbon cables for all three (3) drives. Note Remove these cables from the drives only. Removing Drive (Continued) 1. Remove the power cables from all three (3) drives. 2. Remove the four (4) drive housing mounting screws and carefully remove the housing from the CPU door. Removing Drive (Continued) 1. Remove and replace the hard disk drive. Note Write down the manufacturer of the new drive before starting the installation. Note The hard disk drive is on the bottom. Follow the directions in the picture to replace the appropriate drive. Replacement Action Installing Drive Steps 1. Set and check the jumper(s) for the new drive. Note The hard disk drive jumper(s) is set in the �Master� position. Note Identify the manufacturer of the new drive and set the jumper(s) using the following pictures. Installing Drive (Continued) 1. Perform Action: Removing Drive, in reverse order. Reference 2. Perform Action: Preparation, in reverse order. Verification Procedures Order VP Description VP Detail / Note 6 G5 - Precision Verify precision is within instrument specifications. Precision within specifications = Pass Expected Results 5 G7 - Background Counts Verify background counts are within specifications. 3 VP-49 Restore Setup 1 VP-47 Operating System Installation and Hard Disk Drive Format 4 VP-46 Installation of Operator's Manual from Media (English and Multilingual Version) 2 VP-41 Application Software Installation Procedure 7 G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. Background counts within specifications = Pass CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2009 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. J1.02 Floppy Disk Drive Version - 201962-103_4870_2 List/Part Numbers List/Part Number Description 8200570201 Disk Drive, 3.5 inch, 1.44 MB 8200571301 Dk Drive, 3.5" 1.44MB WHT Inspect tools for damage, ensure calibration is not expired and replace if necessary. J1.02 Floppy Disk Drive Note These videos represent simulated scenarios of instrument access and repair, and some may not accurately depict actual PPE guidelines. Trained personnel should follow procedures as outlined in Biological Hazards and safety procedures. Time Required 40 min Tools/Materials Phillips Screwdriver Needle Nose Pliers WARNING Potential Biohazard Removal Action Steps Preparation 1. Perform a back-up of System Set-Up Files and SQL Database. VP-48 Backup Procedure. 2. Perform a system Shutdown, power off the instrument and remove the power cord. Remove Right Cover 1. Use a Phillips screwdriver to remove the four (4) screws securing the right side cover [1] to the instrument. 2. Lift and remove the cover carefully from the right side of the instrument. Reference VIDEO Note Remove Video contains no audio Floppy Drive, sound. Remove Drive Cable, and Remove Drive Housing (If the video does not display, or to view the video full size: Click Here) Remove Floppy Drive Note Any of the three (3) drives may be removed as follows: 1. Remove the four (4) screws securing the faceplate onto the drive housing. [1] 2. Remove the face plate and disconnect the two cables. [2] 3. Loosen the upper and lower thumbscrews to pull the CPU housing out. [3] 4. Loosen thumbscrews to CPU door. [4] 5. Open the CPU door assembly to gain access to the Hard Disk (HD), Floppy Disk (FD), and DVD Drive Area. Note Any of the three (3) drives may be removed as follows below. Remove Drive Remove the flat ribbon cables for Cable all three (3) drives. [5] Note Remove these cables from the drives only. Remove Drive Housing 1. Remove the power cables from all three (3) drives. [1] 2. Remove the four (4) drive housing mounting screws [2] and carefully remove the housing from the CPU door. 3. Remove the four (4) screws that hold the Floppy Drive in the housing. [3] Replacement Action VIDEO Install the Floppy Drive and Install The Face Plate Steps Reference Note Video contains no audio sound. Note Video shows the replacement of the Floppy Drive. (If the video does not display, or to view the video full size: Click Here) Install Floppy Drive 1. Cut out the tab from the PCB of the Floppy Drive (Figure 1). 2. Position the Floppy Drive into the drive housing and replace the four (4) screws to secure the drive. [3] 3. Reseat drive housing into CPU door and securely mount with four screws. [2] Note Make sure cables to face plate are accessible. 4. Open the CPU housing and open the internal door to the housing. 5. Connect the power cables [1] and ribbon cables to the appropriate drives. [5] 6. Close the CPU housing door and tighten the thumbscrews.. 7. Push the CPU housing back into the instrument and tighten the two (2) thumbscrews. Install the Face Plate 1. Connect the two (2) cables to the face plate. [2] 2. Mount the face plate to the side of the instrument with the four screws. [1] Completion 1. Install the right side cover [1] to the instrument. 2. Secure with the four (4) screws. Verification Procedures Order VP Description VP Detail / Note Expected Results 3 G5 - Precision Verify precision is within instrument specifications. Precision within specifications = Pass 2 G7 - Background Counts Verify background counts are within specifications. Background counts within specifications = Pass 1 G28 - Floppy Disk Verify that the LED on the floppy disk drive turns on. N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. CELL-DYN Ruby System Service and Support Manual (Version 201958-103) • © 2006, 2015 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. J1.03 DVD Drive Version - 201962-103_4871_3 A Part Number is currently not assigned to this RR. Go to GPPM UserInterface Inspect tools for damage, ensure calibration is not expired and replace if necessary. J1.03 DVD Drive Note These videos represent simulated scenarios of instrument access and repair, and some may not accurately depict actual PPE guidelines. Trained personnel should follow procedures as outlined in Biological Hazards and safety procedures. Time Required 40 min Tools/Materials Phillips Screwdriver Needle Nose Pliers WARNING Potential Biohazard Removal Action Steps Preparation 1. Perform a back-up of System Set-Up Files and SQL Database. VP-48 Backup Procedure. 2. Perform a system Shutdown, power off the instrument and remove the power cord. Remove Right Cover 1. Use a Phillips screwdriver to remove the four (4) screws securing the right side cover [1] to the instrument. 2. Carefully lift and remove the cover from the right side of the instrument. Reference VIDEO Remove DVD Drive Note Video contains no audio sound. (If the video does not display, or to view the video full size: Click Here) Remove Face Plate Note Any of the three (3) drives may be removed as follows: 1. Remove the four (4) screws securing the faceplate onto the drive housing. [1] 2. Remove the face plate and disconnect the two cables. [2] 3. Loosen the upper and lower thumbscrews to pull the CPU housing out. [3] 4. Loosen thumbscrews to CPU door. [4] 5. Open the CPU door assembly to gain access to the Hard Disk (HD), Floppy Disk (FD), and DVD Drive Area. Remove Drive Housing and DVD Drive 1. Remove the flat ribbon cables for all three (3) drives. [5] Note Remove these cables from the drives only. 2. Remove the power cables from all three (3) drives. [1] 3. Remove the four (4) drive housing mounting screws [2] and carefully remove the housing from the CPU door. 4. Remove the four (4) screws that hold the DVD drive in the housing. [3] Replacement Action Install Drive Steps Reference Set and check the jumper for the new drive. Note The DVD drive jumper(s) is set in the "Slave" position. Note Identify the manufacturer of the new drive. VIDEO Install DVD Drive, Drive Housing and Face Plate Note Video contains no audio sound. (If the video does not display, or to view the video full size: Click Here) Install DVD Drive and Drive Housing 1. Position the DVD drive into the drive housing and replace the four (4) screws to secure the drive. [3] 2. Reseat drive housing into CPU door and securely mount with four (4) screws. [2] Note Make sure cables to face plate are accessible. 3. Open the CPU housing and open the internal door to the housing. 4. Connect the power cables [1] and ribbon cables to the appropriate drives. [5] 5. Close the CPU housing door and tighten the thumbscrews. 6. Push the CPU housing back into the instrument and tighten the two (2) thumbscrews. Install Face Plate Completion 1. Connect the two (2) cables to the face plate. {2] 2. Mount the face plate to the side of the instrument with the four (4) screws. [1] Replace the right side cover [1] to the instrument, securing it with the four (4) screws. Verification Procedures Order VP Description VP Detail / Note Expected Results 3 G5 - Precision Verify precision is within instrument specifications. Precision within specifications = Pass 2 G7 - Background Counts Verify background counts are within specifications. Background counts within specifications = Pass 1 VP-49 Restore Setup N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. CELL-DYN Ruby System Service and Support Manual (Version 201958-103) • © 2006, 2015 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. J1.04 SATA Hard Disk Drive Version - 201962-103_5892_2 List/Part Numbers List/Part Number Description 8200572801 DK DRIVE SATA DESKTOP 8200572901 ADAPTER SATA IDE 9130744 KIT DK DRIVE SATA WITH ADAPTER Inspect tools for damage, ensure calibration is not expired and replace if necessary. J1.04 SATA Hard Disk Drive Time Required 00:40 minutes Tools/Materials Philips Screwdriver WARNING Potential Biohazard Removal Action Steps Preparation 1. Perform a back-up of System SetUp Files and SQL Database. VP48 Backup Procedure 2. Perform a system Shutdown, power off the instrument and remove the power cord. 3. Use a Phillips screwdriver to remove the four (4) screws securing the top cover. [1] 4. Carefully lift and remove the cover from the top of the instrument. Preparation (Continued) 1. Use a Phillips screwdriver to remove the four (4) screws securing the right side cover [1] to Reference the instrument. 2. Carefully lift and remove the cover from the right side of the instrument. 3. Loosen the upper and lower thumbscrews and open the CPU door assembly to gain access to the Hard Disk (HD), Floppy Disk (FD), and DVD Drive Area. Removing Drive Note Any of the three (3) drives may be removed as follows: 1. Remove the four (4) screws securing the faceplate onto the drive housing. Removing Drive (Continued) 1. Remove the flat ribbon cables for all three (3) drives. Note Remove these cables from the drives only. Removing Drive (Continued) 1. Remove the power cables from all three (3) drives. 2. Remove the four (4) drive housing mounting screws and carefully remove the housing from the CPU door. Removing Drive (Continued) 1. Remove and replace the Hard Disk drive. Note The Hard Disk drive is on the bottom. Follow the directions in the picture to replace the appropriate drive. Replacement Action Steps Installing Drive 1. Set and check the jumper(s) for the new drive. Note The Hard Disk drive jumper(s) is set in the Reference Master position. Note Set the jumper(s) using the following pictures. Installing Drive (Continued) 1. Perform Action: Removing Drive, in reverse order. 2. Perform Action: Preparation, in reverse order. Verification Procedures Order VP Description VP Detail / Note Expected Results 6 G5 - Precision Verify precision is within instrument specifications. Precision within specifications = Pass Verfiy percision is within instrument specifications. 5 G7 - Background Counts Verify background counts are within specifications. Verify background counts are within specifications. 3 VP-49 Restore Setup 1 VP-47 Operating System Installation and Hard Disk Drive Format 4 VP-46 Installation of Operator's Manual from Media (English and Multilingual Version) 2 VP-41 Application Software Installation Procedure N/A G110 - After repair is complete, verify per Background counts within specifications = Pass released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. CELL-DYN RUBY System Service and Support Manual (Version 201958-113) • © 2006, 2014 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. J1.05 SATA DVD Drive Version - 201962-103_5893_1 List/Part Numbers List/Part Number Description 8200572901 ADAPTER SATA IDE 8200573901 DVD/CD RW COMBO SATA BEIGE 9130745 KIT, DVD/CD RW SATA WITH ADAPTER Inspect tools for damage, ensure calibration is not expired and replace if necessary. J1.05 SATA DVD Drive Time Required 00:40 minutes Tools/Materials Philips Screwdriver WARNING Potential Biohazard Removal Action Steps Preparation 1. Perform a back-up of System Set-Up Files and SQL Database. VP-48 Backup Procedure 2. Perform a system Shutdown, power off the instrument and remove the power cord. 3. Use a Phillips screwdriver to remove the four (4) screws securing the top cover. [1] 4. Carefully lift and remove the cover Reference from the top of the instrument. Preparation (Continued) 1. Use a Phillips screwdriver to remove the four (4) screws securing the right side cover [1] to the instrument. 2. Carefully lift and remove the cover from the right side of the instrument. 3. Loosen the upper and lower thumbscrews and open the CPU door assembly to gain access to the Hard Disk (HD), Floppy Disk (FD), and DVD Drive Area. Removing Drive Note Any of the three (3) drives may be removed as follows: 1. Remove the four (4) screws securing the faceplate onto the drive housing. Removing Drive (Continued) 1. Remove the flat ribbon cables for all three (3) drives. Note Remove these cables from the drives only. Removing Drive (Continued) 1. Remove the power cables from all three (3) drives. 2. Remove the four (4) drive housing mounting screws and carefully remove the housing from the CPU door. Removing Drive (Continued) 1. Remove and replace the DVD drive. Note The DVD drive is on the top. Follow the directions in the picture to replace the appropriate drive. Replacement Action Steps Installing Drive 1. Set and check the jumper(s) for the new drive. Note The DVD drive jumper(s) is set in the Slave position. Note Set the jumper(s) using the following pictures. Reference Installing Drive (Continued) 1. Perform Action: Removing Drive, in reverse order. 2. Perform Action: Preparation, in reverse order. Verification Procedures Order VP Description VP Detail / Note Expected Results 4 G5 - Precision Verify precision is within instrument specifications. Precision within specifications = Pass 3 G7 - Background Counts Verify background counts are within specifications. Background counts within specifications = Pass 2 VP-53 BIOS Setup and Configuration Procedure 1 VP-49 Restore Setup 5 G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. CELL-DYN RUBY System Service and Support Manual (Version 201958-113) • © 2006, 2014 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. K1.01 Back Panel Fan Replacement Version - 201962-103_5606_1 A Part Number is currently not assigned to this RR. Go to GPPM UserInterface Inspect tools for damage, ensure calibration is not expired and replace if necessary. K1.01 Back Panel Fan Replacement Time Required 01:00 hr Phillips Screwdriver 11/32" Nut Driver Tools/Materials Adjustable Wrench WARNING Electrical Shock Hazard Removal Action Steps Preparation 1. Place the instrument in STANDBY and power OFF. 2. Disconnect power from the power source. 3. Remove the back panel outer screws (14 screws) [1]. 4. Remove the 2 screws on the top left of the back fans. These attach to the laser bench on the inside. [2] Reference 5. Carefully pull away on the back to allow access to the 2 fans. It is not necessary to remove any reagent tubing. Be careful to not disconnect any electrical wires. Remove the 2 back panel fans 1. Carefully unplug the 2 fan cables by pushing on the black latch in the connectors [1] 2. Using an 11/32" nut driver or an adjustable wrench, and a screwdriver, locate and remove the four (4) screws [2] from the back of the top fan first. Take off the fan including the metal guards and place to the side. 3. Remove the bottom fan using an 11/32" nut driver or an adjustable wrench, and a screwdriver as before. Place the metal guards and bottom fan off to the side. Replacing the fans Replace the back cover 1. Replace the bottom fan with a new one using an 11/32" nut driver or an adjustable wrench, and a screwdriver as before, putting the metal guards on in the correct orientation [1]. Connect the new fan into the cable and verify the latch is secure. 2. Verify that the metal guards are facing outwards from the instrument. 3. Also verify that the white side of the fan is visible from the back. This ensures air is blowing out (Towards you). 4. Replace the top fan as before, ensuring proper orientation and verifying that it is plugged into the fan cable. 1. Align the back panel to the back of the instrument. Screw in the 2 screws that attach to the laser bench on the inside. [1] 2. Reinstall the back cover outer screws (14 screws) [2]. Power On 1. Reconnect power to the power source. 2. Turn the instrument back ON. Verify that both of the fans are blowing out (Towards you) when the instrument comes back on. Verification Procedures Order VP Description VP Detail / Note 1 G14 - Fan Verify that the fan is rotating and that the air flows in the correct direction. N/A G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. Expected Results CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2012 • CELL-DYN RUBY is a registered trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. VP-01 System Voltage Verification Version - 201963-103_1170_3 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-01 System Voltage Verification Purpose To verify the instrument power supply voltages on the Power Distribution Module. # 2 Phillips Screwdriver Materials Required Digital Multimeter Clip Leads Action Steps Type Time Not Assessed 00:15 min Reference Preparation 1. Place the system into STANDBY and power OFF the analyzer. 2. Remove the right side cover and open the computer door to gain access to the power supply module. 3. Locate the PDM PCB mounted on top of the computer door. Note The PDM PCB can also be accessed by removing the top cover (four screws) and locating the PCB on the right side of the analyzer. Measure and Verify System Voltage Power Distribution Module Test Points (Old Style Board) 1. Connect the negative clip lead on E8 (GND). 2. Connect the positive clip lead to the desired test point according to Power Distribution Module Voltages. 3. Power ON the analyzer. 4. Measure and verify the voltages according to Power Distribution Module Voltages. Note Be sure to power OFF the analyzer before connecting or removing the clip leads on the test points. Failure to do so may result in component damage. Power Distribution Module Test Points (New Style Board) Power Distribution Module Voltages Note Measure to E8 (GND) CELL-DYN Ruby System Service and Support Manual (Version 201958-103) • © 2006, 2010 • CELL-DYN and CELL-DYN Ruby are registered trademarks of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. VP-02 A/D Verification/10 Volt Reference Adjustment Version - 201963-103_1169_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-02 A/D Verification/10 Volt Reference Adjustment Verifies the accuracy of the A/D Converter by using the A/D to read the 9.901 volt reference Purpose generated on the CPU/DCM PCB and to set the level of the 10 volt reference. Not Type Assessed Note The CELL-DYN Ruby utilizes an A/D converter to convert all critical voltages levels to a 12-bit digital code. This code is read by the computer and these voltages are then displayed on the Digital/Voltage Readings screen in the Diagnostics menu. # 2 Phillips Screwdriver Materials Digital Multimeter Required Clip Leads Potentiometer Adjustment Tool Action Steps Preparation 1. Remove the right side cover (four screws). 2. Loosen the top and bottom knurl capture screws [1] on the right side of the door assembly to gain access to the CPU/DCM PCB. 00:05 Time min Reference Open CPU Access Door 1. Turn the knurl locking pins [1] on the door assembly counter clockwise and open the CPU access door. Adjust A/D Converter 1. Locate the CPU/DCM PCB on the inside of the right side door assembly and connect the positive lead of the DMM to TP4 [4] and the negative lead to TPAGND [5]. 2. Adjust R4 [1] for a reading of -10.0 V (± 0.1v). 3. Move the positive lead to TP3 [3] (9.901 V reference) and verify that the meter reading is 9.90 V (± 0.03 V). 4. Move the positive lead to TP2 [2] (99mV reference) and verify that the meter reading is 0.099 V (± 0.003 V). Verify A/D Converter Adjustment 1. From the Diagnostics menu, select Digital / Voltage Readings 9.901v ref (click on box to left) Stream Note The Password for Operator ID: FSE is required to gain access to the Digital / Voltage Readings screen. 2. Observe the 9.901v ref on the DCM section of the Digital / Voltage Readings screen. 3. Verify that the voltage displayed is 9.90 V (± 0.05V). 4. Press Stop, followed by Clear All when verification is complete. 5. Press Close to exit the Digital / Voltage Readings screen. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-03 MAM Reference Voltage Verification/Adjustment Version - 201963-103_1168_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-03 MAM Reference Voltage Verification/Adjustment Purpose To verify and/or adjust the MAM reference voltage. Type Not Assessed # 2 Phillips Screwdriver 00:10 min Materials Required Digital Multimeter Time Clip Leads Potentiometer Adjustment Tool or Small Slotted Screwdriver Action Steps Preparation 1. Remove the right side cover (four screws). 2. Loosen the top and bottom knurl capture screws [1] on the right side of the door assembly to gain access to the CPU/DCM PCB. Reference Identify MAM PCB 1. Identify the MAM PCB on the door assembly (top PCB). Verify MAM Reference Voltage 1. Connect the positive lead of the DMM to TP2 [1] and the negative lead to TP7 [2]. 2. Verify the reading is 10.0 V (± 0.01 V). If the reading meets the specification, the procedure is complete. If the reading does not meet the specification, go to Adjust MAM Reference Voltage. Adjust MAM Reference Voltage 1. Adjust R84 [3] for a reading of 10.0 V (± 0.01 V). CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-04 VPM Reference Voltage Verification/Adjustment Version - 201963-103_1167_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-04 VPM Reference Voltage Verification/Adjustment To verify and/or adjust the VPM reference voltage. Purpose # 2 Phillips Screwdriver Materials Required Digital Multimeter Clip Leads Potentiometer Adjustment Tool Action Steps Preparation 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Verify VPM Reference Voltage Place the instrument in Shutdown. Turn the instrument power OFF. Remove the left side cover (four screws). Loosen the two (2) knurl capture screws from the inner (SHM) panel and open the panel toward the front of the instrument. Locate the air supply line coupler. [1] Move red switch to left (OPEN) and disconnect the coupler. Remove the screw [2] at the base of the Air Power Supply assembly, which is used to secure and prevent it from sliding. Slide the Air Power Supply assembly out toward the left of the instrument until it locks into place. Reconnect the air supply line coupler and slide the red switch to the right (LOCK). Turn the instrument power ON. 1. Connect the positive lead of the DMM to TP2 (VREF+) [2] and the negative lead to TP1 (VREF) [1]. 2. Verify the reading is 10.0 V (± 0.01 V). If the reading meets the specification, the procedure is complete. If the reading does not meet the specification, go to Adjust VPM Reference Voltage. Adjust VPM Reference 1. Locate and adjust R16 [3] for a reading of Type Time Not Assessed 00:15 min Reference Voltage Assemble Instrument 10.0 V (± 0.01 V). 1. Assemble the instrument in reverse order. Note Be sure to press the locking latch (located under the assembly front rail) before sliding the Air Power Supply assembly back into the instrument. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-05 HGB Current Verification/Adjustment Version - 201963-103_1157_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-05 HGB Current Verification/Adjustment Purpose Verifies the accuracy of the HGB LED current to ensure a HGB output voltage of 5.00 volts. Note Not Type Assessed The HGB flow cell must be filled with reference solution to perform this verification/adjustment procedure. Materials Required None Time Action Steps Preparation 1. Run one background count to insure that the HGB mixing chamber is full of liquid. HGB Current Verification 1. From the Diagnostics menu, select: Digital / Voltage Readings HGB output (click on box to left) Stream Note The Password for Operator ID: FSE is required to gain access to the Digital / Voltage Readings screen. 2. Verify that the HGB output voltage on the Digital / Voltage Readings screen is 5.10 v ± 0.10v. If the voltage is within range, the procedure is complete. If the voltage is not within range, go to HGB Current Adjustment. HGB Current Adjustment 1. From the Diagnostics menu, select Setpoints Miscellaneous (in the Setpoint Entry screen). 2. Move the cursor to HGB Current: (on the screen). 3. Increase or decrease the setpoint value in order to set the HGB output voltage to specification. Note 00:10 min Reference A change of 50 yields a voltage change of approximately 0.3 V. 4. Press Set Analyzer Close 5. Repeat HGB Current Verification until HGB output voltage is set to specification. Raw Data Summary Verification 1. Run a background count. 2. From the Diagnostics menu, select Diagnostic Views Run View Raw Data Summary Note A check mark displays next to Diagnostic Views, which indicates that screen is active in the Run View screen. 3. Review both the HGB Sample and HGB Reference readings. Verify that the readings are within 2050 ± 200. 4. Verify that the HGB Sample reading is within 20 points of the HGB Reference reading. 5. From the Diagnostics menu, click on Diagnostic Views to deactivate (remove check mark) and return the Run View screen to display results. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-06 Touch Screen Calibration Procedure Version - 201963-103_1165_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-06 Touch Screen Calibration Procedure To calibrate the touch screen feature on the screen. Purpose Materials Required None Time Action Steps Prerequisite 1. Instrument must be in the Window XP screen. (Exit the CD-Ruby application program.) Touch Screen Calibration Type 1. From the Windows application screen, locate the Elo icon in the lower right corner. [1] 2. Click on the Elo icon to display the menu. [2] 3. Select Align [3] from the menu to begin calibration. Note The message, Touch the targets from a position of normal use. [4] displays. 4. Use your fingertip to momentarily touch each target that displays on the screen. 5. When the message, Touch the screen. Does the cursor follow your finger? [5] displays, contact and move your fingertip around the screen surface. Be sure that the cursor follows the movement of your finger. 6. When the verification of cursor movement is complete, touch or click on the green check mark [6] to exit the program. Note If the cursor does not follow your finger, click on the blue re-do arrow [7] to repeat the calibration procedure. Not Assessed Not Assessed Reference Check Elo Touchscreen Properties 1. Right-Click on the Elo ico in the lower right corner. 2. Select Elo Touchscreen Properties. [1] 3. In the Elo Touchscreen Properties screen select the Properties 1 [2] tab and select Advanced [3]. 4. In the Advanced screen ensure that Disable touch [4] is UNCHECKED. If it is checked uncheck it and click Apply. 5. Click Ok in the Advanced Window to close. 6. Click OK to close the Elo Touchscreen Properties screen. CELL-DYN Ruby System Service and Support Manual (Version 201958-103) • © 2006, 2011 • CELL-DYN and CELL-DYN Ruby are registered trademarks of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. VP-07 Motor Operation Verification Version - 201963-103_1171_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-07 Motor Operation Verification Purpose Materials Required Allows visual verification of system motor operation by running an exercise routine. None Action Verify Motor Operation Time Steps 1. From the Diagnostics menu, select Mechanical Operations Motor Operations 2. Locate the Exercise Motors drop down window [1] and select the desired motor to operate. 3. Press the Start button [2] (next to the Exercise Motors drop down window) to begin operation. 4. Verify that the assembly moves smoothly without stopping or jerking. 5. When the action is complete, select Exit Diagnostics, followed by Init (F12) to initialize the system. Shear Valve and Y Valve Operation Type 1. From the Diagnostics menu, select: Mechanical Operations Motor Operations 2. Locate Shear Valve Position and select Aspirate [1] to exercise the motor. (The Message from Analyzer field indicates the action.) Note The Aspirate button toggles between Aspirate and Dispense. Reference Not Assessed 00:05 min 3. Exercise the Y Valve Position by selecting Open Mode [2]. (The Message from Analyzer field indicates the action.) Note The Open Mode button toggles between Open Mode and Close Mode. 4. When the action is complete, select Exit Diagnostics [3], followed by Init (F12) to initialize the system. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-08 Motor Initialization Verification Version - 201963-103_1163_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-08 Motor Initialization Verification Purpose Materials Required Allows visual verification of the homing operation of the system motors initializing when a home motor routine is executed. Not Type Assessed None 00:05 Time min Action Verify Motor Homing Steps Reference 1. From the Diagnostics menu, select Mechanical Operations Motor Operations 2. Locate the Home Motors drop down window [1] and select the desired motor to operate. 3. Press the Start button [2] (next to the Home Motors drop down window) to begin operation. 4. Verify that the assembly moves smoothly without stopping or jerking. 5. When the action is complete, select Exit Diagnostics [3], followed by Init (F12) to initialize the system. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-09 Solenoid Operation Verification Version - 201963-103_1175_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-09 Solenoid Operation Verification Purpose Materials Required Allows the operator to exercise a bank of eight (8) solenoids or individual solenoids to verify their operation. None Time Action Cycle Bank Not Type Assessed Steps 00:10 min Reference 1. From the Diagnostics menu, select Mechanical Operations Solenoid Operations 2. Follow the on-screen instructions [1] to cycle the desired bank. 3. Verify that the solenoids are opened in ascending order. 4. When the action is complete, select Exit Diagnostics [3], followed by Init (F12) to initialize the system. Step Solenoids 1. From the Diagnostics menu, select Mechanical Operations Solenoid Operations 2. Follow the on-screen instructions [2] to operate individual solenoids. 3. When the action is complete, select Exit Diagnostics [3], followed by Init (F12) to initialize the system. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-11 Bar Code Reader Verification/Alignment Version - 201963-103_1162_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-11 Bar Code Reader Verification/Alignment Purpose To provide instructions for using the bar code diagnostics and for performing alignment of the bar code reader. Not Type Assessed Materials Required Specimen Tube With Bar Code Label Needle Alignment Tool (942008) Needle Alignment Tool (9420081) Not Time Assessed Links Access Bar Code Diagnostics Tube Bar Code Detection/Alignment Rack Bar Code Alignment Bar Code Read Rate Access Bar Code Diagnostics Action Access Bar Code Diagnostics Steps Reference Bar Code Diagnostic Screen Display 1. From the Diagnostics menu, select Bar Code Alignment Note The Password for Operator ID: FSE is required to gain access to the Bar Code Diagnostics screen. Note The following Diagnostic Selections are available: Tube bar code alignment Rack bar code alignment Bar code read rate Tube Bar Code Detection/Alignment This test is useful for testing the customer's bar codes and test tubes under the same conditions as running samples. When using the Tube bar code alignment diagnostic, you need a tube with a bar code attached. The tube should be of the type specified in the CELL-DYN Ruby System Operator's Manual (13 mm diameter x 17mm height), but need not have sample collected. The bar code should be the same as those used by the customer. It needs to meet all of the bar code specifications, and be attached in the manner specified in the CELL-DYN Ruby Operator's Manual, Section 4: Bar Code Specifications. The bar code reader should be cleaned with lint free gauze and DI water. Action Perform Tube Bar Code Detection Steps Reference TUBE BARCODE Results 1. Before beginning, place a bar coded tube in a sample rack. 2. Manually move the sample rack into position so that the slot containing the tube is under the spinner. Note You can feel the spring loaded detent engage the slot locating hole in the rack. The window in the rack should line up with the window in the inner rack guide wall. 3. Be sure that the Diagnostic Selection is set to Tube bar code alignment. 4. When ready to begin press Start. Note The spinner descends and captures the tube. As the tube rotates, the bar code reader continuously reads the bar code on the tube, and displays the Bar Code result and Read No. on the screen. The results are displayed in the form Read No. : X : X (successful reads : attempts). Audible beeps are heard when successful reads occurs. The test should read any valid symbology consistently. 5. To stop the test press Stop. If this test consistently misreads, check label and replace if necessary. If labels are still not reading correctly, check them against the bar code specifications in the Bar Code Setup Menu CELL-DYN Ruby Operator's Manual, Section 4: Bar Code Specifications. Also verify whether labels contain a Check Digit and refer to Bar Code Setup Menu (located under the Setup menu, Administrative Setup), for correct configuration. If system is configured correctly, then ensure the Bar Code Reader has been cleaned and Perform Tube Bar Code Alignment. Perform Tube Bar Code Alignment 1. Use the CD3000 Series Needle Alignment Tool (9420081) for making the tube bar code alignment. Note Remove the dowel pin with a pair of pliers. The dowel pin can be reinserted after the alignment is complete. 2. Insert the alignment tool into a rack. Be sure to rotate the tool so the test bar code is exactly in the center of the bar code window. [1] Note Use CD-3200 rack with the Needle Alignment Tool (9420081). If a CD-3200 rack is not available, stand the tool on the platen with the bar code in the center of the window in order to align. [2] 3. Manually move the sample rack into position on the platen so that the slot containing the Needle Alignment Tool is at the bar code reading window. Note You can feel the spring loaded detent engage the slot locating hole in the rack. The window in the rack should line up with the window in the guide wall. 4. Be sure that the Diagnostic Selection is set to Tube bar code alignment. 5. When ready to begin press Start. Note The bar code reader begins continuous reading. The Needle Alignment Tool should be read as TEST on the display. Audible beeps are heard when successful reads occur. If the Needle Alignment Tool is not reading correctly, loosen the two (2) screws securing the bar code reader assembly to the base, and carefully move the reader left and right until proper reading occurs. 6. When the reader is aligned, carefully tighten the mounting screws and ensure the Needle Alignment Tool still reads. 7. To stop the test press Stop. Rack Bar Code Alignment This test is used for verifying Rack ID and individual Rack Slot ID Bar Code detection. Note All maintenance items in the Maintenance view, Clean Loader Components should be performed before beginning this procedure. Action Perform Rack Bar Code Detection Steps Reference 1. Before beginning, manually move an empty sample rack into position so that the Rack ID bar code is directly in front of the read window. 2. Be sure that the Diagnostic Selection is set to Rack bar code alignment. 3. When ready to begin press Start. Note The bar code reader continuously reads the bar code on the rack, and displays the bar code result and Read No. on the screen. The results are displayed in the form Read No. : X : X (successful reads: attempts). Audible beeps are heard when successful reads occur. 4. To stop the test press Start. Bar Code Read Rate This diagnostic is used to further test the bar code reader to ensure consistent reading without errors. When using the Bar Code Read Rate diagnostic, you need a tube with a bar code attached. The tube should be of the type specified in the CELL-DYN Ruby System Operator's Manual (13mm diameter x 17mm height), but need not have sample collected. The bar code should be the same as those used by the customer. It must meet all of the bar code specifications, and be attached in the manner specified in the CELL-DYN Ruby Operator's Manual, Section 4: Bar Code Specifications. The bar code reader should be cleaned with lint free gauze and DI water. Action Perform Bar Code Read Rate Steps Reference Good Reads Display 1. Before beginning, place a tube in a sample rack. Manually move the sample rack into position so that the slot containing the tube is under the spinner. Note You can feel the spring loaded detent engage the slot locating hole in the rack. The window in the rack should line up with the window in the guide wall. 2. Be sure that the Diagnostic Selection is set to Bar code read rate. 3. When ready to begin press Lower Needle. Note The spinner descends and captures the tube. 4. Rotate the captured tube by hand until the bar code faces the reader window. 5. When ready to begin press Start. Note The scanner reads the bar code 100 times, and displays the percentage of good reads. The same test is repeated 11 more times, and displays the percentage of good reads. 6. The read rate percentage should be 98% for all 12 results. If the test meets specification, go to Step7. If the test is failing, repeat cleaning and Perform Tube Bar Code Alignment. Then repeat the test. 7. When the test is complete press Finish. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-12 Optical Specimen Sensor 2 Verification/Adjustment Version - 201963-103_1166_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-12 Optical Specimen Sensor 2 Verification/Adjustment To verify and/or adjust the Optical Specimen Sensor. Purpose Type Not Assessed Dilution of Low control (diluted with diluent reagent to an RBC count of 0.8 ± 0.08 M/uL) 00:20 min Materials Required DMM with leads Time Small non-conductive screwdriver (tweaker) Jumper leads to clip meter leads onto test points (Optional) The optical specimen sensor is used only during Closed Mode aspiration to sense the leading edge of the specimen and to assure that a column of blood has traveled through the shear valve assembly. The optical specimen sensor is not used during Open Mode aspiration. Action Steps Preparation 1. Be sure that the instrument is in the READY state and in Open Mode. 2. Open the Right Access (Front) Cover and remove the Tower (Nose) Cover. 3. Run a background count. Adjust/Verify Specimen Sensor #2 1. Ensure that the aspiration line is properly primed with diluent. 2. Remove the plastic cover over the two (2) sensor 3. 4. 5. 6. 7. PCBs (located in the upper right side of the flow panel). The optical specimen sensor PCB is located on the right. Using a Digital Multi-Meter, attach the positive meter lead to TP1 and the negative lead to TP3. Switch the meter to DC volts and adjust R1 to a reading of 2.0 V ± 0.2 V. The red indicator LED should be OFF. Move the positive meter lead to TP4 and verify a 0.5 V. reading of Run a background and verify that the voltage reading is never at a constant > 0.5 V during the cycle. Create a low control dilution with an RBC count of 0.8 ± 0.08 M/uL and present the dilution to the open probe, and open V12 [3] to aspirate. Aspirate the dilution through the shear valve and all the way through the optical specimen sensor [1] by Reference about 1 inch. 8. With the dilution present in the sensor, the red indicator LED turns ON and the voltage reading is > 3.0 V. 9. Open V13 [4] to clear the lines of blood. Run a background to rinse and replenish the line with diluent reagent. Ensure that the LED returns to the OFF state as when diluent reagent is present in the optical specimen sensor line. 10. Install the plastic cover over the PCBs, Tower (Nose) Cover and close the Right Access (Front) Cover. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-13 LIS Communication Verification Version - 201963-103_1161_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-13 LIS Communication Verification Verifies transmission of data to/from instrument. Purpose Materials Required Action Loopback Connector (92532-01) Type Time Steps Preparation 1. Install the loopback connector to COM1 (rear of analyzer) on the PC module. 2. Turn the instrument power ON. Verify LIS Loopback 1. From the Setup menu, select Administrative Setup LIS Setup LIS Configuration 2. Disable (un-check box) Enable "Query All" [1] and Automatic Link Test [2]. 3. Select the LIS Tests and press Loopback Test. [3] 4. Verify successful test: If the message at the bottom of the LIS Setup window reads Test was successful [4], select OK [5] to exit the LIS Setup window and go to Remove Loopback Connector. If after 15 seconds the message Test failed displays at the bottom of the LIS Setup window, go to Step5. 5. Select LIS Configuration and verify that Comm Port is set to COM1. 6. Verify that the loopback connector is connected to the correct COM port. 7. Press Clear Test Result [6] and repeat Step3. Not Assessed 00:05 min Reference Remove Loopback Connector Check LIS Link Status 1. Remove the loopback connector from the COM1 port. Note Prior to beginning this procedure, be sure that instrument is connected to an LIS computer. 1. From the Setup menu, select Administrative Setup LIS Setup LIS Tests 2. Press Test LIS Link. [1] 3. Verify successful test: If the message at the bottom of the LIS Setup window reads Test was successful [2], select OK [3] to exit the LIS Setup window. If after 15 seconds the message Test failed displays at the bottom of the LIS Setup window, go to Step4. Note During this procedure, the CD-Ruby is sending an ENQ (inquiry) to the LIS computer and waits 15 seconds to receive an ACK (acknowledge) in response. An ACK in response indicates a successful test. 4. Verify hardware and software connectivity between the CD-Ruby and LIS computer. 5. Press Clear Test Result [4] and repeat Step2. Enable LIS Logging and Note In order to turn on this feature, the Operator Sign Capture On must be set or logged in as CSC (upper right Program corner of window). The password is the current date plus 5. For example, if the date is the 1st, then the password would be 6 (1+5). 1. From the Diagnostics menu, select: Debugging Functions General Settings 2. Enter the CSC password to access the General Settings window. 3. Locate the LIS Logging box [1] (in the center of the window) and click on the box to check it. Note Leave the Debug Info box [2] disabled (unchecked). 4. Initiate LIS communication by either transmitting results to the LIS computer or sending a request to the Orders window. Note LIS logging can be kept on to capture transmission to/from CD-Ruby. However, keeping it activated for an extended period of time occupies disk space and creates a large capture file. Retrieve LIS Note Capture In order to retrieve LIS capture data, the LIS Data logging feature must be enabled, see Enable LIS Logging and Capture Program. 1. Exit the CD-Ruby Application program by selecting File, Exit. 2. Select Start, My Computer. 3. Select Syspart (C:). 4. Locate and double-click on CDRuby, LIS. Note A list of all captured files displays. Filenames are created by the date and time when the capture was initiated. For example, LIS.060203.1705.txt was created on February 3, 2006 at 17:05. 5. View the files by double-clicking on the desired file (opens the NOTEPAD application under WINDOWS XP and displays the file content), or copy the files to removable media (floppy disk, CD-ROM, or USB drive). 6. Return to the CD-Ruby application by closing all opened windows, selecting Start, All Programs, and CD-Ruby (executes the CD-Ruby application). CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2009 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-14 Decontamination Procedures Version - 201963-103_1160_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-14 Decontamination Procedures Purpose Materials Required To decontaminate all surfaces before servicing. Not Assessed Type Time Not Assessed Not Assessed Note For Decontamination Procedures refer to CELL-DYN Ruby System Operator's Manual, Section 9: Service and Maintenance, Nonscheduled Maintenance Procedures. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-15 Vacuum & Pressure Retention Verification Version - 201963-103_1159_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-15 Vacuum & Pressure Retention Verification Purpose To verify the system's ability to retain the appropriate vacuum and pressure levels. Type Not Assessed Note A failure indicates a leak in the system. Materials Required None Time Action Steps 00:15 min Reference Preparation 1. Ensure that the instrument is in the READY mode. 2. Locate the sample loader coupler [1] (on the right side of the unit between the flow panel and sample loader). 3. Locate the orange and green striped tubing going to the coupler and use hemostats to clamp the lines together. Note Be sure to remove hemostats when verification is complete. Vacuum and Pressure Pumps Off-time Verification 1. Verify the off-time for both the vacuum and pressure pumps is two (2) minutes or greater between automatic recovery cycles. Note If either pump activates sooner than two (2) minutes from the last activation, troubleshoot accordingly. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-16 Vacuum & Pressure Level Verification/Adjustment Version - 201963-103_1156_3 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-16 Vacuum & Pressure Level Verification/Adjustment To verify that the system vacuum and pressure levels are within specification. Purpose Materials Required None Type Time Action Steps Not Assessed 00:15 min Reference Preparation 1. Ensure that the instrument is in the Open mode. Vacuum and Pressure Level Verification Vacuum & Pressure Specification 1. From the Diagnostics menu, select: Digital / Voltage Readings Check All Voltages (below Check All) Stream Note The Password for Operator ID: FSE is required to gain access to the Digital / Voltage Readings screen. 2. Refer to Vacuum & Pressure Specification, and verify that the vacuum and pressure levels are within specifications. If all the vacuum and pressure levels are within specification, proceed to Fine Tune Vacuum 2 Open. If there are any vacuum or pressure levels out of specification, continue with Step3. 3. While in the Digital / Voltage Readings screen, press Stop, followed by Close. 4. From the Diagnostics menu, select Setpoints Miscellaneous 5. Use New Set Points Formula to calculate the new setting(s). 6. Move the cursor to the appropriate vacuum(s) or pressure(s), and enter new set points. new setting(s) and press [ENTER] key on the keyboard. New Set Points Formula Note Vacuum 2 Open set point must remain between 350 and 450, while meeting the specification. Vacuum 2 Closed set point must remain between 420 and 500, while meeting the specification. Vacuum 2 Retic set point needs to remain at software default 300 and should not be changed. 7. Press Set Analyzer, followed by Close. Note If the level is reduced, the vacuum or pressure must be bled off to the new level before performing verification steps. A background count may be used for bleeding off vacuum and/or pressure. 8. Repeat Step1 through Step7 until all vacuum and pressure levels are within specification. Fine Tune Vacuum 2 Open 1. Run Low Control twice in Patient specimen type and verify each time that the leading edge of sample reaches the ultrasonic sensor (located between the Y-Valve and the input to the Shear Valve). Note If the leading edge is not reaching the ultrasonic sensor, the Vacuum 2 Open setting is too low. Refer to Vacuum and Pressure Level Verification. 2. Verify no Sampling Error messages display. 3. Run High Control twice in Patient specimen type and verify each time that the leading edge of sample reaches the ultrasonic sensor. 4. Verify no Sampling Error messages display. 5. Adjust Vacuum 2 Open set point as necessary and repeat Step1 and Step4. Verification 1. From the Diagnostics menu, select: Digital / Voltage Readings Check All Voltages (below Check All) Stream Note The Password for Operator ID: FSE is required to gain access to the Digital / Voltage Readings screen. 2. Verify proper vacuum and pressure levels. Refer to Vacuum & Pressure Specification for specification. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2009 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-18 Optics Bench Alignment Procedure Version - 201963-103_1148_4 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-18 Optics Bench Alignment Procedure To verify/align the optics bench. Purpose Type Not Assessed # 2 Phillips Screwdriver 01:00 hr Materials Required .050 Hex Wrench Time Optics Alignment Kit Cat. (8921183801) DMM with Clip Leads Laser Power Meter 7.0 µm Polymer Microspheres (8160600401) Laser Safety Glasses (with OD1 for HeNe laser) Syringe Caution Class 3B laser light when open. Avoid exposure to beam. WARNING Electrical Shock Hazard Action Steps Prerequisite 1. Check the background results by running a blank cycle in patient mode. Any issues with backgrounds or hotspots should be addressed first. 2. Verify with the customer whether the recommended autoclean(s) are being performed. The operator's manual recommends that autoclean should be run daily, and before maintenance. Extended autoclean should be performed monthly. 3. Verify with the customer whether they are changing the millipore filter (LN 06H92-01) (ACS PN 6H9201), on a monthly basis as recommended. 4. Verify that all vacuum and pressure readings are within specifications. Reference 5. Verify that the shear valve has been cleaned 6. 7. 8. 9. 10. 11. 12. 13. and moistened (Refer to the CELL-DYN Ruby Operator's Manual, Section 9.). Verify that the injection syringe, syringe drive, and the peri-pump tubing are in good condition. Ensure that all of the optics related pinch valves, pinch tubings, all associated fittings are in good condition, and free from crimps or other restrictions. (V-65, V-91, V-57, V-56, V54, V-55). Check all the tubing connections on WC-1 for crimps or damage. Loose dust should be cleaned out of the laser bench by using a vacuum. Perform optical flow cell cleaning and debubble procedure (VP-34 Optical Flow Cell Cleaning Procedure). Clean the quartz lens on the flow cell using lens paper and lens cleaner. Perform Optics bench cleaning procedure VP33 Optics Bench Cleaning Procedure). Verify that the offsets are all < 1.0. Preparation 1. Ensure instrument power is OFF. 2. Remove top cover, both optics covers, and open flow cell access door. Replace Laser Tube 1. Disconnect the laser connector and short both male pins to instrument chassis. 2. Remove Laser Clamps and replace Laser. 3. Install the clamps and tighten them until they are snug, but the Laser can still be moved. 4. Move the laser body until 3/4 inch extends 5. 6. 7. 8. 9. beyond the front laser clamp and rotate the laser body until the front label is on top. Connect the laser connector and ensure the laser shutter is closed. Turn the instrument power ON. Prime the instrument. Allow a 15-minute laser warm-up period. Open the laser shutter. Verify Laser Power 1. Place the laser power meter detector head into the upright mount. 2. Place the mount into the tooling holes between the front and back mirrors. 3. Set the laser power meter to 20mW scale, and switch it on. 4. Verify laser power reading is above 5.0 mw. Note New laser tube power is typically above 5.0 mw. Verify/Align Laser for True Vertical Polarization 1. Place the polarizer lens in the beam path along with the laser power meter and observe the meter. 2. Switch to the 20 µW scale. 3. Rotate the laser tube until the power reading is minimum through the polarizer lens. The final reading should be < 3 µW. 4. Tighten both straps on the laser tube. Note Be sure not to move the laser tube while securing the screws. 5. Check the laser power after securing the screws. Repeat Step3 and Step4, if misadjusted. 6. Remove polarizer assembly, detector mount, and laser power meter from the beam path. Perform Rear Mirror Coarse Verification/Alignment 1. Place the alignment post in the front tooling hole (located next to the front mirror, between the front and rear mirrors). 2. Verify that the laser beam is centered and passes through the hole in the alignment post. If the beam is centered and passes through the post, remove the post and go to Perform Front and Rear Mirror Alignment (X-axis). If the beam is not centered, go to Step3. 3. Using a 0.050" hex wrench, adjust the X and Y alignment screws at the back of the rear mirror. Be sure that the beam is centered through the alignment post. 4. Remove alignment post. Perform Front and Rear Mirror Alignment (X-axis) Note Hanging Mount This adjustment achieves maximum power through the forward slit. 1. Mount the laser power meter head into the 2. 3. 4. 5. 6. 7. Perform Front and Rear Mirror Alignment (Y-axis) hanging (detector) mount and place it on the forward slit assembly. Refer to Hanging Mount. Monitor the power reading from behind the forward slit (Hanging Mount). Using a 0.050" hex wrench, adjust the rear mirror X screw (Mirror - Rear View) for maximum power through the slit. Typically this value is be 1.4 - 1.7 mW (approximately 1/5 of the power reading from part A). Remove the hanging mount and carefully slide the flow cell out of the beam path. Use the X screw on the front mirror to align the beam to the center of the alignment hole on Mirror - Rear View the obscuration bar (Obscuration Bar and Mirror - Rear View). This is easier to see with the use of a neutral density filter, or the polarizer lens to attenuate the beam. Re-check the rear X adjustment (power through the slit). Repeat X rear and X front adjustments as necessary to achieve maximum power through the slit with the beam centered on the obscuration bar. When finished, slide the flow cell back into Obscuration Bar place. 90D Slit Note This adjustment achieves minimum offset for 0D and 10D. 1. From Maintenance view, select Special Protocols Empty/Fill Optical Flow Cell Empty Flow Cell 2. Remove the cover over the PMTs. 3. Remove the pinch tubing from under V-56 and connect a syringe to the T fitting at V-54. The 4. 5. 6. 7. 8. 9. 10. 11. syringe is used to induce a bubble into the flow cell. With the flow cell empty, note that the image of the flow cell walls are projected onto the 90D slit (90D Slit). They display as two small red marks on the edges of the slit. If the red marks become hard to see, induce more air into the flow cell using the syringe. Adjust the rear mirror Y screw to vertically center the red marks on the slit (90D Slit and Mirror - Rear View Mirror - Rear View). Using a DMM, connect the positive lead to TP1 on the 0D photodiode PCB. Connect the negative lead to TP2. Set the DMM to the 300 mV scale. Pull the flow cell out of the beam path. Adjust the front mirror Y screw for minimum reading on the DMM. The end result should be a reading of < 50 mV. Slide the flow cell back in and repeat the rear Y adjustment. Slide the flow cell back out and repeat the front Y adjustment. Repeat both rear and front Y adjustments as necessary until the red marks are centered, and the DMM is reading minimum. The end result should be a reading of < 50 mV. Disconnect the meter leads from the 0D photodiode PCB and connect them to the 10D photodiode PCB. Positive lead to TP1, negative lead to TP2. Note This adjustment is easier by using 2 DMMs. 12. Perform front mirror Y and rear mirror Y adjustments for the 10D photodiode PCB in the same manner as for the 0D. Refer to Step6 through Step10. Ensure the final reading on DMM is < 50 mV. Perform Front and Rear Mirror Alignment (Y-axis) (continued) 1. Slide the flow cell back into the beam path and verify that the red marks are centered on the 90D slit. 2. Install the pinch tubing under V-56 and remove the syringe. 3. Slide the flow cell back in and select Fill Flow Cell on the Empty/Fill Optical Flow Cell screen and run one blank cycle to prime. 4. Verify that the DMM reading for each PCB is < 100 mV. If this specification is not met, repeat flow cell internal and external cleaning. If this specification is still not met, replace the flow cell. Prepare Polymer Microspheres Solution 1. Place 2 mL of diluent in a clean container. 2. Add 15 drops of 7.0 µm polymer microspheres and mix well. Remove Covers 1. Remove top cover and flow cell access cover. Perform Optical Flow Cell Alignment (Coarse) Beam Images 1. Loosen the locking screw on the lower (y-axis) micrometer, and back off (CW viewed from top) on the micrometer (Beam Images) until the beam is striking the flow cell at a point to the rear of the flow cell channel. Note The scatter pattern on the obscuration bar should resemble A (Beam Images). Placing a piece of white paper in front of the obscuration bar aids in viewing the scatter pattern. 2. While observing the scatter pattern, rotate the micrometer CCW until the pattern of the rear wall of the flow cell channel is observed, and record the micrometer setting (B - Beam Images). 3. Continue rotating CCW until the pattern of the front wall is observed, and record the micrometer setting (C - Beam Images). 4. Rotate the micrometer CW to a setting halfway between those recorded in Step1 and Step2. This should coarsely center the flow cell channel on the beam. Note The pattern resembles that of D (Beam Images) and is at the brightest level. 5. Cover the opening with a black cloth to block ambient light. 6. From the Diagnostics menu, select Diagnostic Views Note A check mark displays next to Diagnostic Views, which indicates that the screen is active. Run View 7. Expand the WBC Data folder, by selecting the plus (+) symbol. 8. Select the CALC CV folder. Note The histograms for each of the four channels displays on the screen. 9. From the Specimen Type drop down window, select SRP. Enter the following into the Specimen ID or QCID Field: 7_um_SRP (entry is case sensitive). 10. Place polymer microspheres solution under probe and press [START SWITCH] to aspirate polymer microspheres and run a count cycle. If there is data in all four displays, go to Perform Flow Cell Alignment. If there is no data, repeat Step3 through Step10. 1. Prepare a microsphere dilution using 15 drops of 7.0 µm polymer microspheres (concentrated) into 2 mL of diluent. The count should be between 1.5-3.5. 2. Place a black drop cloth over the bench. 3. From the Diagnostics menu, select Extended WBC Diag Note Extended WBC screen is displayed. 4. Follow the on-screen instructions and place 5. 6. Perform Flow Cell Alignment 7. 8. the 7.0 µm polymer microspheres dilution under the probe and select Start or F8. When the count begins, observe the display and adjust the lower (Y) micrometer for the tightest possible population, and the lowest possible CVs in the 0D/10D window. The goal here is to get the CVs as small as possible. Observe the 90D/90DP window and adjust the right (X) micrometer to get the highest channel results, and to move the butterfly pattern high and away toward the upper right of the display. Repeat the Extended WBC as necessary until optimal 0D/10D and 90D/90DP results are achieved. Perform VP-20 System Gains Verification/Adjustment. WBC Mean Channel and CV Specification Replace Optics Covers 1. Replace both optics covers. Perform Verification 90D/90DP Scattergram 1. Go to the Run View screen and select Patient 2. 3. 4. 5. 6. (under Specimen Type). Verify that CBC is selected under Test Selection. Place the 7.0 µm polymer microspheres dilution under the probe and press the Start Switch. If the alignment is good and the gains are 98% EOS. The correct there should be butterfly should display in green and above the discriminator line on the 90D/90DP scattergram. The example shown in 90D/90DP Scattergram has typical shape. From the Specimen Type drop down window, CALC CV screen select SRP. Enter the following into the Specimen ID or QCID Field: 7_um_SRP (entry is case sensitive). Place the 7.0 polymer microspheres dilution under the probe and press the Start Switch. From the Diagnostics menu, select Diagnostic Views Note A check mark displays next to Diagnostic Views, which indicates that the screen is active. 7. Expand the WBC Data folder, by selecting the plus (+) symbol. 8. Select the CALC CV folder. Note The histograms for each of the four channels displays on the screen. 9. On a healthy bench it should be possible to achieve CVs of < 3.0 for 0D/10D and < 12.5 for 90D/90DP. Refer to WBC Mean Channel and CV Specification. 10. Run some fresh normal whole bloods and verify the appearance of the scattergrams. The populations should be tight with good Normal Whole Blood Scattergrams separation. Neotrophil and Lymphocyte clusters should fall in the correct locations with no flags (Normal Whole Blood Scattergrams). Replace Covers 1. Install all covers. Perform Backup Procedure 1. Perform VP-48 Backup Procedure to save new gains. CELL-DYN Ruby System Service and Support Manual (Version 201958-103) • © 2006, 2010 • CELL-DYN and CELL-DYN Ruby are registered trademarks of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. VP-19 PMT Dynode Voltage Verification/Adjustment Version - 201963-103_1149_3 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-19 PMT Dynode Voltage Verification/Adjustment To verify and/or adjust the PMT dynode voltages for 90° and 90° depolarized channels. Purpose # 2 Phillips Screwdriver Materials Required 3/16" Hex Wrench 7.0 µm Polymer Microspheres (8160600401) CELL-DYN Ruby Diluent/Sheath Clean Container Black Cloth Type Time Caution Class 3B laser light when open. Avoid exposure to beam. Action Prepare Polymer Microspheres Solution Steps 1. Place 2 mL of diluent in a clean container. 2. Add 15 drops of 7.0 µm polymer microspheres and mix well. Determine 90° and 90° Depolarized Mean Channels and Gain Settings 1. From the Diagnostics menu, select Auto-Gain Wizard View Setpoints Gain Settings 2. Record and save the gain setting values for WOC 90° Gain and WOC 90° D Gain. 3. Select Close to exit out of the Setpoint Entry screen. 4. From the Auto-Gain procedure selection screen, select Verify/Set WOC 0°, 10°, 90°, 90°D & RBC/PLT 0° Gain (7 um SRP) Next > 5. Record and save the Target Channels for WOC 90° and WOC 90° D. 6. Select Cancel, followed by Yes in the Cancel Auto- Reference Not Assessed 00:30 min Gain Wizard? window. 1. From the Diagnostics menu, select Diagnostic Views Note A check mark displays next to Diagnostic Views, which indicates that the screen is active. Run View 2. Expand the WBC Data folder, by selecting the plus (+) symbol. 3. Select the CALC CV folder. Note The histograms for each of the four channels displays on the screen. 4. From the Specimen Type drop down window, Verify PMT Dynode Voltage select SRP. Enter the following into the Specimen ID or QCID Field: 7_um_SRP (entry case sensitive). 5. Place the 7.0 µm polymer microspheres solution under the probe and press [START SWITCH] to aspirate the polymer microspheres and run a count cycle. 6. Observe the mean channel values for the 90° and 90° depolarized channels on the CALC CV screen, and compare them to the mean channel numbers recorded in Determine 90° and 90° Depolarized Mean Channels and Gain Settings. Determine the following: If the mean channel values (taken from the CALC CV screen) meet the recorded Target Channels, (± 6 channels for 90° and ± 10 channels for 90° Dep.) (refer to table) and the gain setting values (Setpoint Entry screen) are less than 2500, the procedure is complete. If the mean channel values taken from the CALC CV screen do not meet specification, go to Prepare for PMT Dynode Voltage Adjustment. WBC Mean Channel and CV Specification Prepare for PMT Dynode Voltage Adjustment 1. Remove the top cover from the analyzer, and locate the PMT preamplifiers [1] [2] on the right side of the optical bench. Note The board on the left is for the 90° channel [1] and the board on the right is for the 90° depolarized channel [2]. Note R11 adjusts the dynode voltage on both boards. Dynode Voltage Adjustment 1. From the Diagnostics menu, select Setpoints Gain Settings 2. Move cursor to WOC 90° Gain and enter 2000. 3. Move cursor to WOC 90° D Gain and enter 2000. 4. Select Set Analyzer Close 5. Cover the optical bench with a black cloth to block ambient light. 6. From the Diagnostics menu, select Extended WBC Diag 7. Follow the on-screen instructions and place the 7.0 µm polymer microspheres solution under the probe, and select Start or F8 to aspirate the polymer microspheres and start the Extended WBC cycle. Note Both 90° channels are extremely sensitive to ambient light. The black cloth must remain in place when adjusting the dynode voltages. 8. Locate and observe the 90° MEAN channel on the Extended WBC screen and adjust R11 on the 90° Preamplifier PCB (left PCB) until the 90° MEAN channel being displayed is in close proximity to the value recorded in Determine 90° and 90° Depolarized Mean Channels and Gain Settings. Note This is a coarse preliminary manual adjustment that is more finely tuned with the auto gain circuitry. 9. Repeat Step7 and Step8 for the 90° depolarized preamplifier (right PCB). Verify Dynode Voltage Adjustment 1. From the Diagnostics menu, select Digital / Voltage Readings Check All Stream 2. Verify that Ch 3-Vdyn/100 and Ch 4-Vdyn/100 are less than 9.00 (900 volts). Note Dynode voltages greater than 9.00 (900 volts) indicate a problem or indicate that the Photo Multiplier Tubes (PMT(s)) needs replacement. Troubleshoot as necessary. 3. Select Stop followed by Close to exit the screen. Perform Auto Gain Adjustment 1. Perform VP-20 System Gains Verification/Adjustment and verify/set WOC 0°, 10°, 90°, 90°D & RBC/PLT 0° Gain (7 um SRP). WARNING Failure to perform the WOC auto gain adjustment results in erroneous patient results. A WBC auto gain adjustment is needed to reestablish the correct gain settings. CELL-DYN RUBY System Service and Support Manual (Version 201958-104) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-20 System Gains Verification/Adjustment Version - 201963-103_1150_4 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-20 System Gains Verification/Adjustment Purpose This procedure is used to set and/or verify the gain settings using the Auto-Gain Wizard for the following:· Not Type Assessed WOC 0°, 10°, 90°, 90°D (7 µm SRP)· RBC/PLT 0° (7 µm SRP)· RBC/PLT 0° (5 µm SRP)· RBC/PLT 10° (3.3 µm SRP)· RBC/PLT 10° (7 µm SRP)· Linear RBC 0°/10°/90° (HCM) Materials Required 7.0 µm Polymer Microspheres (8160600401) 5.0 µm Polymer Microspheres (8160600301) 3.30 µm Polymer Microspheres (8160600501) HCM (CD 26 08H59-01 or 08H59-02 High Control, or CD29 08H58-01 or 08H58-02 High Control) Action Steps Prerequisite 1. Go to VP-18 Optics Bench Alignment Procedure and perform Perform Verification. 2. Verify that the CV's meet the specification. 3. Be sure that all Scheduled items under Maintenance view are performed and are up to date. Preparation 1. Instrument must be in Ready state and in Open Mode. 2. From the Diagnostics menu, select Auto-Gain Wizard Note Reference Time 00:45 min The Password for Operator ID: FSE is required to gain access to the Digital / Voltage Readings screen. 3. From the Auto-Gain procedure selection screen, select Enter SRP/FL-CAL Demographics Next > Note CELL-DYN Ruby application software screens (e.g., Auto-Gain Wizard) will continue referring to FL Cal. 4. Enter the lot numbers and expiration dates for SRP 7.0, SRP 5.0, SRP 3.3, and HCM. 5. Select Next >. Note The Auto-Gain procedure selection screen displays and Verify/Set WOC 0°, 10°, 90°, 90°D & RBC/PLT 0° Gain (7 µm SRP) is automatically selected. 1. From the Auto-Gain procedure selection screen, select Verify/Set WOC 0°, 10°, 90°, 90°D & RBC/PLT 0° Gain (7 µm SRP) Next > 2. From WOC 0°/10°/90°/90°D & RBC/PLT 0°-Verify Gain (using 7 µm SRP) screen, enter the Target Channel values. Refer to Figure. 3. Follow the on-screen instructions and run the 7 µm SRP in the Open Mode. 4. The results of the 7 µm SRP run occupy the Actual Channel row of the table. Based on these results, new gains are calculated and placed in the New Gain row of the table. 5. Select Next > to apply new gain and proceed to gain verification. WOC & RBC/PLT 0° (7 µm SRP) Auto Gain Verification/Adjustment 6. Re-run the 7 µm SRP in the Open Mode to verify the new gain settings. Note If any result discrepancies are observed, select Cancel and troubleshoot as necessary. 7. Select Next >, followed by Yes to accept (save) the new gain settings and begin the next procedure. WBC Mean Channel and CV Specification RBC/PLT 0° (5 µm SRP) Auto Gain Verification 1. From the Auto-Gain procedure selection screen, select Verify RBC/PLT 0° Gain (5 µm SRP) Next > 2. In the RBC/PLT 0°-Verify Gain (using 5 µm SRP) screen, follow the onscreen instructions and run 5.0 µm SRP in Open Mode to verify the new gains settings. Note Target Channel for RBC/PLT 0° (5 µm SRP) is 129 ± 1. 3. The results of the 5.0 µm SRP run occupy the Actual Channel row of the table. The Actual Channel results are based on the Current Gain setting. 4. Select Next > to begin the next procedure. RBC/PLT 10° (3.3 µm SRP) Auto Gain Verification/Adjustment 1. From the Auto-Gain procedure selection screen, select Verify/Set RBC/PLT 10° Gain (3.3 µm SRP) Next > 2. From RBC/PLT 10°-Verify Gain (using 3.3 µm SRP) screen, follow the onscreen instructions and run 3.3 µm SRP in Open Mode. Note Target Channel for RBC/PLT 10° (3.3 µm SRP) is 121 ± 1. 3. The results of the 3.3 µm SRP run occupy the Actual Channel row of the table. Based on these results, new gains are calculated and placed in the New Gain row of the table. 4. Select Next > to apply new gain and proceed to gain verification. 5. Re-run the 3.3 µm SRP in the Open Mode to verify the new gain settings. Note If any result discrepancies are observed, select Cancel and troubleshoot as necessary. 6. Select Next >, followed by Yes to accept (save) the new gain settings and begin the next procedure. RBC/PLT 10° (7 µm SRP) Auto Gain Verification 1. From the Auto-Gain procedure selection screen, select Verify RBC/PLT 10° Gain (7 µm SRP) Next > 2. From RBC/PLT 10°-Verify Gain (using 7 µm SRP) screen, follow the onscreen instructions and run 7.0 µm SRP in Open Mode. Note Target Channel for RBC/PLT 10° (7 µm SRP) is 202 ± 5. 3. The results of the 7.0 µm SRP run occupy the Actual Channel row of the table. The Actual Channel results are based on the Current Gain setting. 4. Select Next > to begin the next procedure. Linear RBC 0°/10°/90° (HCM) Auto Gain Verification/Adjustment 1. From the Auto-Gain procedure selection screen, select Verify/Set Lin RBC 0°/10°/90° Gain (FL-CAL) Next > 2. From the Lin RBC - Verify Gain (using HCM) [1] screen, enter the LinRBC 0°/10°/90° Target Channels [2] using the published HCM OPTICAL ASSAY VALUES from the GSS Website. 3. Follow the on-screen instructions and run the HCM in the Open Mode. 4. The results of the HCM run occupy the Actual Channel [3] row of the table. Based on these results, new gains are calculated and placed in the New Gain row of the table. 5. Select Next > to apply new gain and proceed to gain verification. 6. Re-run the HCM in the Open Mode to verify the new gain settings. [4] Note If any result discrepancies are observed [5], select Cancel and troubleshoot as necessary. 7. Select Next >, followed by Yes to accept (save) the new gain settings and begin the next procedure. Gain Settings Summary 1. From the Auto-Gain procedure selection screen, select Gain Settings Summary Next > 2. Select Print to print out a summary of the gain settings, which includes Original Gain and Current Gain. 3. Select Finish to exit the Auto-Gain Wizard application. NOC and RETC Gain Settings Verification 1. From the Diagnostics menu, select Setpoints 2. Select Gain Settings view and locate the RETC 0° Gain, RETC10° Gain and RETC 90° Gain settings. Note The password for Operator ID: FSE is required to gain access to Setpoint Entry screen. 3. Verify that gain values are the same as those for WOC 0° Gain, WOC 10° Gain and WOC 90° Gain settings. If required, make necessary changes to insure that RETC values are equal to WOC values. 4. Locate the NOC 0° Gain and NOC 10° Gain settings. 5. Verify that gain values are the same as those for WOC 0° Gain and WOC 10° Gain settings. If required, make necessary changes to insure that NOC values are equal to WOC values. 6. Select Set Analyzer if changes were made to gain settings. 7. Select Close to exit the Setpoint Entry screen. CELL-DYN RUBY System Service and Support Manual (Version 201958-104) • © 2006, 2012 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. null VP-21 WBC OPTI-CAL Verification/Adjustment Version - 201963-103_1151_3 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-21 WBC OPTI-CAL Verification/Adjustment Verify/adjust the gain for the WOC 90° and 90°D channels using OPTI-CAL as a reference material. CELLPurpose Determine and store the polymer microspheres reference channels used for reference after an OPTI- Type DYN Ruby CAL gain adjustment. 7.0 µm Polymer Microspheres (8160600401) Materials OPTI-CAL product (9900005) Required 1 red top test tube Calculator (recommended) CELL-DYN Ruby Diluent/Sheath Reagent Action Steps Time Reference 1. Ensure the instrument and laser bench are performing within the recommended specifications (WBC Mean Channel and CV Specification). 2. Ensure that the dynode voltages are < 900 volts. Refer to VP-19 PMT Dynode Voltage Verification/Adjustment. Note For any other optical bench verifications/adjustments, refer to VP-18 Optics Bench Alignment Procedure. Prerequisite WBC Mean Channel and CV Specification Preparation OPTI-CAL Assay Values 1. With the instrument in OPEN mode, verify/perform VP-20 System Gains Verification/Adjustment, and verify/set WOC 0°, 10°, 90°, 90°D & RBC/PLT 0° Gain (7 um SRP) using the current Target 00:40 min Channels. 2. From the Auto-Gain Wizard screen, View Setpoints Gain Settings 3. Record or print the gain setting values for WOC 90° Gain and WOC 90° D Gain. 4. Select Cancel, followed by Yes in the Cancel Auto-Gain Wizard? window. 5. From the Diagnostics menu, select SRP/Blood Comparison. 6. Select Cell Regions and use the keyboard to 7. 8. 9. 10. 11. 12. configure the screen to match the corresponding OPTI-CAL assay sheet. Also verify the software version, expiration date, and lot number printed on the assay sheet. Select OK to exit the SRP/Blood-Cell Region Entry screen. Select Patient from Specimen Type drop-down menu in the lower left corner of the screen. Prepare the OPTI-CAL product accordingly, allow the vial to come to room temperature and mix thoroughly before running. Place the vial under the Open Probe and press the Start Switch to aspirate. When the cycle is complete, record the 90° and 90°DEP channel values for Gran Mean. Run the OPTI-CAL product two (2) more times and record the 90° and 90°DEP channel values for Gran Mean. Calculate the average of the three (3) OPTI-CAL runs for Gran Mean: 90° and 90°DEP. Compare the results to the assay values given on the corresponding OPTI-CAL Assay Values sheet. The values should match within the following specification, 90 deg ± 3.5, 90 depol ±2.0. If the values are within specification, then go to Enter New Gain Setpoints. If the values are not within specification to go to Step13 to compute new gain setpoints. 13. Compute the new gain setpoint for the 90° and 90°DEP as follows: New setpoint = X(Y/Z) where: X = current gain setpoint (from printout) Y = Gran channel value from assay sheet (OPTI-CAL Assay Values sheet.) Z = Average channel value from Step12. Enter New Gain Setpoints 1. From the Diagnostics menu, select Auto-Gain Wizard View Setpoints Gran Mean: 90° and 90°DEP Gain Settings 2. Enter the new calculated gain setpoint values for WOC 90° Gain and WOC 90°D Gain. Select Set Analyzer to save the new values. Note Be sure to press [SET ANALYZER] before leaving the setpoint screen. 3. Select Close to exit the Setpoint Entry screen. 4. Select Cancel, followed by Yes in the Cancel Auto-Gain Wizard? window. 5. From the Diagnostics menu, select SRP/Blood Comparison 6. Repeat Step9 through Step12 (Preparation) and ensure recovery of Gran Mean: 90° and 90°DEP to OPTI-CAL Assay Values. Prepare Microspheres Dilution 1. Mix the 7.0 µm polymer microspheres bottle to resuspend the particles. 2. Add 15 drops of 7.0 µm polymer microspheres to a red top test tube. 3. Add 2 mL of CELL-DYN Ruby Diluent/Sheath Reagent. Enter New Target Channels 1. Select SRP from Specimen Type drop-down menu in the lower left corner of the screen. 2. Run the 7.0 µm polymer microspheres dilution three (3) times and record the SRP Mean channel for 90° and 90°DEP. 3. Verify on each run that the SRP CVs are in specification. Also verify the 0 deg mean channel is 35 ± 3 and 10 deg mean channel is 65 ±5. 4. Compute the average mean channel for 90° and 90°DEP for the three (3) runs. 5. From the Diagnostics menu, select Auto-Gain Wizard Verify/Set WOC 0°, 10°, 90°, 90°D & RBC/PLT 0° Gain (7 um SRP) Next > 6. Enter the calculated Target Channels for WOC 90° and WOC 90°D. Press Enter after each input. 7. Follow the on-screen instructions and run the 7.0 µm polymer microspheres dilution to establish the new gain setting values. Re-run the polymer microspheres to verify the new settings. 8. Select Next > to accept new gain settings. 9. Select Yes to accept new settings. 10. Select Cancel, followed by Yes in the Cancel Auto-Gain Wizard? window. Save Values 1. Perform VP-48 Backup Procedure to save new target channels and gains. CELL-DYN RUBY System Service and Support Manual (Version 201958-104) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-22 Aspiration/Vent Needle Verification Version - 201963-103_1152_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-22 Aspiration/Vent Needle Verification Purpose Materials Required To verify proper Aspiration//vent needle movement and GS1 sensor operation. BD Specimen Tube Action Time Steps 1. Be sure that the instrument is in the Initialized state and in Open Mode. GS1 Sensor Status Display 1. From the Diagnostics menu, select Mechanical Operations Tower Tests Needle (Place tube under needle) 2. Place empty sample tube in a rack and 3. 4. 5. 6. 7. 8. manually move the sample rack into position on the platen so that the slot containing the tube is directly under the Aspiration/Needle Assembly. Select Down. [1] Verify that the spin cone captures the tube and the needle moves down smoothly without any stopping or jerking. Check the GS1/GS2 - Needle Home status [2] and verify that status changes from 1 to 0 when the needle moves down. Select Up. [3] Verify that the needle moves up smoothly without any stopping or jerking and that GS1/GS2 - Needle Home status changes from 0 to 1. Select Close Window [4] to exit the Diagnostics menu. Note Selecting Exit Diagnostics changes the instrument state from Diagnostics to Uninitialized. The instrument must be Initialized before continuing. Not Assessed 00:05 min Reference Preparation Verify Aspiration/Vent Needle Type CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-23 Tower Unit Stop Solenoid Verification Version - 201963-103_1153_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-23 Tower Unit Stop Solenoid Verification Purpose Materials Required To verify tower unit stop solenoid operation. #2 Phillips Screwdriver Action Type Time Steps Preparation 1. Be sure that the instrument is in the Initialized state and in Open Mode. 2. Remove the left side cover (four screws). Verify Tower Unit Stop Solenoid Operation 1. From the Diagnostics menu, select Mechanical Operations Tower Tests Solenoid 2. Alternately select Retract and Extend. 3. Verify that the tower unit stop solenoid retracts and extends smoothly and fully with each command. 4. Verify that LED DS1 on SHM1 is ON with the Retract command and OFF with the Extend command. Note The SHM PCBs are located on left side of the instrument. 5. Select Close Window to exit the Diagnostics menu. Note Selecting Exit Diagnostics changes the instrument state from Diagnostics to Uninitialized. The instrument must be Initialized before continuing. Install Cover Not Assessed 00:05 min Reference 1. Install left side cover. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-24 Bar Code Spin Assembly Verification Version - 201963-103_1158_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-24 Bar Code Spin Assembly Verification Purpose Materials Required To verify bar code spin assembly operation. BD Specimen Tube Action Type Time Steps Preparation 1. Be sure that the instrument is in the Initialized state and in Open Mode. Verify Bar Code Spin Assembly Operation 1. From the Diagnostics menu, select Mechanical Operations Tower Tests Motor 2. Place an empty sample tube in a rack and manually move the sample rack into position on the platen so that the slot containing the tube is directly under the Spin Cone Assembly. 3. Select Spin [1] to drop the spin cone over the tube and begin the spin motor operation. Note The button toggles to Stop. 4. Verify that the tube is spun smoothly without any stopping or jerking. 5. Select Stop [2] to halt spin motor operation and raise the spin assembly off of the tube. 6. Select Close Window [3] to exit the Diagnostics menu. Note Selecting Exit Diagnostics changes the instrument state from Diagnostics to Uninitialized. The instrument must be Initialized before continuing. Not Assessed 00:05 min Reference CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-25 Tube Height Sensors (S1/S2) Verification Version - 201963-103_1155_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-25 Tube Height Sensors (S1/S2) Verification Verify the operation of the Tower Unit's GS1 and GS2 mechanism as it drops down to capture a Purpose specimen tube. The status of S1 and S2 sensors is used to detect specimen tube types (BD, Sarstedt or No Tube) in the aspirate position. Not Type Assessed BD Specimen Tube Materials Sarstedt Specimen Tube Required 00:05 Time min Action Steps Reference Preparation 1. Be sure that the instrument is in the Initialized state and in Open Mode. Verify operation of Tube Height Sensors (S1/S2) Home Position Example 1. From the Diagnostics menu, select Mechanical Operations Tower Tests GS1/GS2 2. Place empty BD sample tube in a rack and manually move the sample rack into position on the platen so that the slot containing the tube is directly under the Spin Cone Assembly. 3. Select Down/Up to lower the spin assembly BD Tube Example and detect tube type. Note Spin assembly automatically raises to home position. 4. Verify the sensor status and for a BD sample tube (see BD Tube Example). 5. Place empty sarstedt sample tube in a rack and manually move the sample rack into position on the platen so that the slot containing the tube is Sarstedt Tube Example directly under the Spin Cone Assembly. 6. Select Down/Up to lower the spin assembly and detect tube type. 7. Verify the sensor status for a sarstedt sample tube (see Sarstedt Tube Example). 8. Manually move an empty sample rack (no tubes) into position on the platen directly under the Spin Cone Assembly. 9. Select Down/Up to lower the spin assembly. 10. Verify the sensor status for No Tube (see No No Tube Example Tube Example). 11. Select Close Window to exit the Diagnostics menu. Note Selecting Exit Diagnostics changes the instrument state from Diagnostics to Uninitialized. The instrument must be Initialized before continuing. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-26 Mixer Up/Down Verification Version - 201963-103_1147_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-26 Mixer Up/Down Verification To verify mixer assembly up/down operation. Purpose Materials Required None Action Type Time Steps Preparation 1. Be sure that the instrument is in the Initialized state and in Open Mode. Verify Mixer Up/Down Operation Note In software version 2.0ML, the Load Empty and Unload Nearly Full Flag Sensors status boxes do not appear. 1. From the Diagnostics menu, select Mechanical Operations Loader Tests Move Mixer 2. Alternately select Down and Up. 3. Verify that the assembly moves up and down smoothly without any stopping or jerking. 4. Verify that the Lift Up sensor is 1 when mixer assembly is up and 0 when down. 5. Select Close Window to exit the Diagnostics menu. Note Selecting Exit Diagnostics changes the instrument state from Diagnostics to Uninitialized. The instrument must be Initialized before continuing. Not Assessed 00:05 min Reference CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2009 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-27 Mixer Head Rotation Verification Version - 201963-103_1154_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-27 Mixer Head Rotation Verification To verify mixer head rotation. Purpose Materials Required None Action Type Time Not Assessed 00:05 min Steps Preparation 1. Be sure that the instrument is in the Initialized state and in Open Mode. Verify Mixer Head Rotation Note In software version 2.0ML, the Load Empty and Unload Nearly Full Flag Sensors status boxes do not appear. 1. From the Diagnostics menu, select Mechanical Operations Loader Tests Rotate Mixer 2. Alternately select Down and Up. 3. Verify that the assembly moves up and down smoothly without any stopping or jerking. 4. Verify that the Rotate Sensor is 1 when the header is up (135° angle) and 0 when the header is down (home). 5. Select Close Window to exit the Diagnostics menu. Note Selecting Exit Diagnostics changes the instrument state from Diagnostics to Uninitialized. The instrument must be Initialized before continuing. Reference CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2009 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-28 Mixer Bladders Verification Version - 201963-103_1164_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-28 Mixer Bladders Verification To verify operation of mixer bladder inflation. Purpose Materials Required None Action Type Time Steps Preparation 1. Be sure that the instrument is in the Initialized state and in Open Mode. Verify Mixer Bladder Operation 1. From the Diagnostics menu, select Mechanical Operations Loader Tests Grip/Release Tube 2. Locate and release the mixer stop by rotating the knurl capture screw 1 counterclockwise. 3. Rotate the mixer assembly toward the front of the instrument until the bladders can be seen. 4. Alternately select Grip and Release. 5. Verify that the mixer bladders inflate [3] and deflate [2] completely. Note Be sure to press Release (deflate bladders) when check is complete. 6. Move the mixer assembly back to the home position and re-attach the mixer stop by securing it with the knurl capture screw. 7. Select Rotate Mixer and cycle between Up and Down. Be sure mixer assembly operates correctly. 8. Select Close Window to exit the Diagnostics menu. Note Selecting Exit Diagnostics changes the instrument state from Diagnostics to Not Assessed 00:05 min Reference Uninitialized. The instrument must be Initialized before continuing. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2009 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-29 Rack Advance & Tube Sensors Verification Version - 201963-103_1176_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-29 Rack Advance & Tube Sensors Verification Purpose To verify rack advance and tube detection operation. Specimen Tubes (2) Materials Required Rack Action Type Time Steps Preparation 1. Be sure that the instrument is in the Initialized state and in Open Mode. Verify Rack Advance & Tube Sensor Operation 1. From the Diagnostics menu, select Mechanical Operations Loader Tests Rack Advance 2. Place a rack with tubes in slots 1 and 2 at the load side rear wall (right/rear side of the Sample Loader). Note Selecting Tube Sensors, followed by Start in the Sample Loader Diagnostics screen activates the sensors for individual sensor troubleshooting without rack advance. Select Stop when diagnostics are complete. 3. Select Start. 4. Verify that the rack indexes smoothly through the processing station without any stopping or jerking during index movements. 5. Verify that when the tube in slot 1 is advanced to Tube Sensor, Position 3, a 1 is indicated on the screen. Similarly, when a tube is presented to Tube Sensor, Position 4, a 1 should be indicated on the screen. Note Be sure that Position 3 and Position 4 sensors return back to 0 when no tubes are present. Not Assessed 00:05 min Reference 6. Select Stop to halt rack advance. 7. Select Close Window to exit the Diagnostics menu. Note Selecting Exit Diagnostics changes the instrument state from Diagnostics to Uninitialized. The instrument must be Initialized before continuing. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2009 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-30 Cross Transfer Arms & Rack Sensors Verification Version - 201963-103_1190_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-30 Cross Transfer Arms & Rack Sensors Verification Purpose Materials Required Action To verify cross transfer arm and rack sensor operation. Five (5) Racks Type Time Steps Not Assessed 00:15 min Reference Preparation 1. Be sure that the instrument is in the Initialized state and in Open Mode. Verify Cross Transfer Arms & Rack Sensor Operation 1. From the Diagnostics menu, select Mechanical Operations In software version 1.0ML the Load Empty and Unload Nearly Full Flag Sensors status boxes were also included in the Sample Loader Diagnostics screen. Load Empty The Load Empty sensor is never used. CELL-DYN Ruby software (both V1.0ML and V2.0ML) raises the Load Zone Empty condition Arms (SIM 1111) when the barcode reader detects no rack after a given number of index cycles. 2. Leave the load side and unload side empty (no racks), and alternately select Unload Nearly Full The Unload Nearly Full sensor is only used in CELL-DYN Ruby Extend and Retract. software V1.0ML. The Unload Area Nearly Full condition (SIM 3. Verify that the arms extend and retract 1110) has been removed from software V2.0ML. (fully) smoothly without any stopping or Example of software version 2.0ML Sample Loader Diagnostics jerking. window: 4. Verify the following sensor status when the arms are fully retracted. [1] Loader Tests Unload Full = 1 Unload Nearly Full = 1 (v1.0ML only) 5. Leave the load and unload sides empty, and press Extend. 6. Verify the following sensor status when arms are fully extended with no racks. [2] Unload Full = 0 Unload Nearly Full = 0 (v1.0ML only) 7. Select Retract. 8. Place five (5) racks in the unload side (left side), and select Extend. 9. Verify the following sensor status. [3] Unload Full = 1 Unload Nearly Full = 1 (v1.0ML only) 10. Select Retract. 11. Place four racks in the unload side (left side) and select Extend. 12. Verify the following sensor status. [4] Unload Full = 0 Unload Nearly Full = 1 (v1.0ML only) 13. Select Retract. 14. Select Close Window to exit the Diagnostics menu. Note Selecting Exit Diagnostics changes the instrument state from Diagnostics to Uninitialized. The instrument must be Initialized before continuing. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2009 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-31 Mixer Bladders Pressure Verification/Adjustment Version - 201963-103_1187_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-31 Mixer Bladders Pressure Verification/Adjustment To verify/adjust proper pressure setting for inflatable mixer bladder. Purpose Pressure Gauge Materials Required Slotted Screwdriver #2 Phillips Screwdriver Type Time Action Not Assessed 00:15 min Steps Preparation 1. Be sure that the instrument is in the Initialized state. 2. Remove the front skirt cover from the sample loader (four (4) screws). 3. Slide the Sample Loader out on its rails toward the front. Verify/Adjust the Mixer Bladder Inflate Pressure 1. From the Diagnostics menu, select Digital / Voltage Readings Pressure 1 psi (check box to left) Stream 2. Verify Press 1 psi is 12.5-13.5 psi. If within range, go to Step5. If not within range, perform VP-16 Vacuum & Pressure Level Verification/Adjustment. 3. Locate the autoloader slide bracket on both sides of the unit, remove the front screw, and loosen the rear screw. 4. Select Stop, followed by Close to exit the Digital/Voltage Readings screen. 5. From the Diagnostics menu, select Mechanical Operations Loader Tests Grip/Release Tube 6. Remove tubing from vacuum/pressure port on the side of the mixer, and connect tubing to pressure gauge. 7. Select Grip (applies pressure). 8. Locate the pressure regulator (on the right side of the Sample Loader, between the instrument flow panel and Sample Loader). 9. Using a stubby slotted screwdriver, adjust the regulator for 6.0 psi ± 0.5 psi. 10. Remove pressure gauge and reconnect tubing to vacuum/pressure port. 11. Select Release to relieve the pressure being applied to the mixer bladders. Reference 12. Select Exit Diagnostics. Install Sample Loader and Front Skirt Cover 1. Slide the sample loader back into place and secure it with screws. 2. Install the Front skirt cover to the sample loader. Prepare for Operation 1. 2. 3. 4. 5. Remove pressure gauge and reconnect tubing to vacuum/pressure port. Select Release to relieve the pressure being applied to the mixer bladders. Select Exit Diagnostics. Re-attach the Sample Loader to the instrument. Install the Front Skirt Cover to the Sample Loader. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-32 Shear Valve Driver Lubrication Procedure Version - 201963-103_1191_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-32 Shear Valve Driver Lubrication Procedure Purpose To lubricate the shear valve. Type Not Assessed Oil (14237-015, Dallas/Europe; 1605806, Santa Clara) 00:45 min Materials Required #2 Phillips Screwdriver Time Three (3) levels of controls Action Steps Reference Preparation 1. Power OFF instrument using the proper shutdown procedure. Lubricate Shear Valve Driver Shear Valve Driver Lubrication Points 1. Remove the shear valve driver from the Analyzer (B1.01 Shear Valve Driver). 2. Lubricate the assembly (see Shear Valve Driver Lubrication Points). 3. Install the shear valve driver. Verification 1. Run background count and verify results are within specifications. 2. Run an n = 10 precision study and verify that CV's are within specifications. 3. Run three (3) levels of controls and verify that results are with assay specifications. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-33 Optics Bench Cleaning Procedure Version - 201963-103_1186_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-33 Optics Bench Cleaning Procedure To clean optics bench. Purpose Not Type Assessed Cotton Swabs High Grade Lens Paper (Kodak recommended - DO NOT USE Baxter S/P, as it may scratch the lens.) Canned Air - Optics Grade Flashlight Materials Required Caution Class 3B laser light when open. Avoid exposure to beam. Action Steps Clean Fan Filters 1. Clean the left side and right side fan filters. Clean Optics Bench and Lens/Mirrors 1. Remove the analyzer top cover. 2. Using pressurized air, remove dust and dirt from the optics bench and surrounding area. 3. Remove all covers from the optics bench. 4. Close the laser shutter. 5. Using lens cleaning paper on the end of a cotton swab, clean the rear mirror, cylindrical lens, front mirror, imaging lens, and flow cell. Caution Do not use lens cleaning solution on mirrors. If cleaning fluid is needed, use reagent grade methanol only. 6. Repeat the cleaning process to ensure that all residual particles are removed. Reference Time 00:30 min Note Use a flashlight to shine on the mirrors and lens in order to help identify if dust and other contaminants remain on the components. Inspect Laser Beam Laser Output Halo 1. Open the laser shutter. 2. With laser on, check for a red glow or halo around the opening where the laser beam exits the laser tube (Laser Output Halo). 3. Check for a red glow or halo around the forward slit. If the laser output lens is dirty, a halo displays on the forward slit in the form of a football shaped laser beam (Forward Slit Halo). 4. If a halo exists in either location, clean the laser with a dry cotton swab, or use lens paper (Laser Tube Cleaning). A burst of canned air may be used to remove any remaining particles. Be sure to keep can upright. Note Caution should be used when cleaning the laser output lens. Use only a cotton swab. Do not use any metal objects when cleaning. Lens paper may be placed at the end of the swab to help reduce cotton fibers from adhering to the lens. Forward Slit Halo 5. Close the laser shutter. Laser Tube Cleaning Clean 10° Mirror Mark Mirror Positions 1. Mark the position of the mirror and housing with a pencil (Mark Mirror Positions). 2. Remove screws and mirror (Mirror Removal). 3. Clean the mirror using reagent grade methanol or microscope lens cleaning solution (green) and high grade lens paper. (Kodak recommended - DO NOT USE Baxter S/P). Ensure surface is clean; use compressed air to remove any remaining lint. 4. Replace mirror and align marks. Note DO NOT tighten screws. Mirror Removal 5. Open the laser shutter. Prepare WBC Polymer Microspheres Solution 1. Place 2 mL of diluent in a clean container. 2. Add 15 drops of 7.0 µm polymer microspheres and mix well. Adjust 10° Mirror for Maximum Mean 1. From MAIN MENU, press [DIAGNOSTICS] [MORE] (three times) [WBC DATA] 2. Place the 7.0 µm polymer microspheres solution under the probe. 3. Press [EXTENDED WBC COUNT], [START] (aspirates the polymer microspheres and starts the cycle). 4. Observe the 10° mean, and rotate the mirror for the highest 10° mean reading. 5. Tighten mirror screws ensuring maximum reading is maintained, and erase pencil marks. Perform Adjustment/Verification 1. Perform VP-20 System Gains Verification/Adjustment. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2009 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-34 Optical Flow Cell Cleaning Procedure Version - 201963-103_1192_3 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-34 Optical Flow Cell Cleaning Procedure To clean the optical flow cell internally. Purpose CELLType DYN Ruby 10 cc syringe Enzymatic Cleaner (99644-01) 1% sodium hypochlorite solution or ISE cleaning solution (1360-02) CELL-DYN 22 (93111-01) or CELL-DYN 29 PLUS w/Retic (08H58-01) tri-level controls Materials Required Time 01:10 hr Caution Class 3B laser light when open. Avoid exposure to beam. Action Steps Prerequisite 1. Verify Instrument is in Ready state. Preparation 1. Perform an Auto-Clean procedure with enzymatic cleaner. 2. From the Maintenance view, select Special Protocols Empty/Fill Optical Flow Cell Empty Flow Cell 3. Fill the 10 cc syringe with the ISE Cleaning Solution. 4. Loosen the two (2) screws to the flow cell front access cover and lift up and out to remove cover. Fill Optical Flow Cell with Cleaning Solution 1. Remove the pinch tubing from under solenoid valve 56. Note Do not disconnect the tubing. Leave the tubing out of solenoid valve 56. 2. Disconnect the tubing from fitting #1 on the optical flow cell manifold and attach a 10 mL syringe with cleaning solution. 3. Gently inject solution into the optical flow cell using short forward Reference and reverse strokes to create turbulent motion. Note Inject at least 8 mL of the cleaning solution to completely fill the flow cell. 4. Disconnect the syringe and reconnect the tubing to fitting #1 on the optical flow cell manifold. 5. Place the pinch tubing back in solenoid valve 56. 6. Let the solution remain in the optical flow cell for up to three (3) to five (5) minutes. Note Do not allow the ISE cleaning solution to remain in the optical flow cell for over 5 minutes. 7. Install the flow cell front access cover (two screws). Refill Optical Flow Cell with Reagent 1. Select Fill Flow Cell on the Empty/Fill Optical Flow Cell screen. 2. Repeat the Empty/Fill Optical Flow Cell procedure to fully flush the flow cell of the cleaning solution. Verification 1. Run three (3) background counts. 2. Ensure the backgrounds are within specification (see Background Background Results Specification Results Specification). 3. Run three levels of controls and ensure results are within assay ranges. CELL-DYN Ruby System Service and Support Manual (Version 201958-108) • © 2006, 2010 • CELL-DYN and CELL-DYN Ruby are registered trademarks of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. VP-35 Optical Flow Cell Wetting Procedure Version - 201963-103_1185_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-35 Optical Flow Cell Wetting Procedure To wet the optical flow cell. Purpose CELLType DYN Ruby CN Free HGB/NOC Lyse (03H80-02) 10 cc Syringe CELL-DYN 22 (93111-01) or CELL-DYN 29 PLUS w/Retic (08H58-01) tri-level controls Materials Required Time 01:10 hr Caution Class 3B laser light when open. Avoid exposure to beam. Action Steps Prerequisite 1. Verify Instrument is in Ready state. Preparation 1. From the Maintenance view, select Special Protocols Empty/Fill Optical Flow Cell Empty Flow Cell 2. Fill the 10 cc syringe with the CN Free HGB/NOC Lyse. 3. Remove the two (2) screws to the flow cell front access cover and remove cover. Fill Optical Flow Cell with Lyse Reagent 1. Remove the pinch tubing from under solenoid valve 56. Note Do not disconnect the tubing. Leave the tubing out of solenoid valve 56. 2. Detach the tubing from fitting #3 on the optical flow cell manifold and attach the 10 mL syringe with CN Free HGB/NOC Lyse. 3. Gently inject lyse reagent into the optical flow cell using short forward and reverse strokes to create turbulent motion. Reference Note Inject at least 8 mL of the lyse reagent to completely fill the flow cell. 4. Disconnect the syringe and reconnect the tubing to fitting #3 on the optical flow cell manifold. 5. Place the pinch tubing back in solenoid valve 56. 6. Let the solution remain in the optical flow cell for up to three (3) to five (5) minutes. 7. Install the flow cell front access cover (two screws). Refill Optical Flow Cell with Reagent 1. Select Fill Flow Cell on the Empty/Fill Optical Flow Cell screen. 2. Repeat the Empty/Fill Optical Flow Cell procedure to fully flush the flow cell of the lyse reagent. Verification 1. Run three (3) background counts. 2. Ensure the backgrounds are within specification (see Background Background Results Specification Results Specification). 3. Run three levels of controls and ensure results are within assay ranges. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-36 Temperature Control Module (TCM) Adjustment Procedure Version - 201963-103_1193_3 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-36 Temperature Control Module (TCM) Adjustment Procedure Purpose To verify and adjust temperature control module (TCM). Digital Multimeter Materials Required Clip Leads Potentiometer Adjustment Tool Action Steps Prerequisite 1. Be sure that the instrument is in the Initialized state. LED DS5 Verification 1. Verify that red LED DS5 is ON. Note DS1: Heater-1 (HGB heater) is energized when DS1 is ON. DS2: Heater-2 (WOC heater) is energized when DS2 is ON. DS3: Temperature at Heater-1 is out of range (high or low) when DS3 is ON. DS4: Temperature at Heater-2 is out of range (high or low) when DS4 is ON. DS5: Power (regulated +28 V) is present when DS5 is ON. TCM PCB Voltage Adjustments 1. Using a DMM, connect the positive lead to TP5 2. 3. 4. 5. 6. and negative lead to TP0. Locate and adjust R4 to +5.00 ± 0.01volts. Move the positive lead to TP1. Locate and adjust R7 to 2.39 ± 0.01volts. Move the positive lead to TP2. Locate and adjust R14 to 1.94 ± 0.01volts Note HGB heater is set at 45 �C and monitor is set at 40 and 51 �C. WOC heater is set at 25 �C and monitor is set at 20 and 40 �C. All temperatures are measured at the Type Time Not Assessed 00:20 min Reference heater block not at mixing chamber. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2009 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-37 Optical Channel Baseline Voltage Verification Version - 201963-103_1194_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-37 Optical Channel Baseline Voltage Verification Purpose Materials Required To verify optical channel offset voltages. Black cloth (if necessary) Action Type Time Steps Not Assessed 00:20 min Reference Preparation 1. Be sure that the instrument is in the Ready state and in Open Mode. Verify Optical Channel Baseline Voltages Note 1. From the Diagnostics menu, select Digital / Voltage Readings Check All Stream For an alternate method of optical offset verifications, refer to VP-18 Optics Bench Alignment Procedure, Perform Front and Rear Mirror Alignment (Y-axis). 2. Ensure top cover is in place, or cover optics bench with black cloth. 3. Verify that Baseline 1 through Baseline 4 are less than 1.0 V. If any are greater than 1.0 V, perform VP-33 Optics Bench Cleaning Procedure. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-38 Uninstalling Installed Version of Operator Version - 201963-103_1195_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-38 Uninstalling Installed Version of Operator's Manual The procedure to uninstall an old version of the CELL DYN Ruby Operator's manual. Purpose None Materials Required Action Uninstalling Operator's Manual Time Steps 1. Ensure that Analyzer is 2. 3. 4. 5. CELL-DYN Ruby Type (170) in Ready, Initialized, or Uninitialized status as indicated in the Analyzer Status region. From the CELL-DYN Ruby Application menu bar select Admin level Operator ID (upper right hand corner). From the CELL-DYN Ruby Application menu bar, select File, Exit. Select Start (lower left corner), Log Off. At the Log Off Windows prompt, select Log Off. Note When entering information, remember to enter it exactly as shown, as it is case sensitive. 6. Select admin from the user name display and type Syssetup followed by Enter. 7. Insert the new version of the CD ROM Reference 15 mins containing the Online Operator�s Manual (CELL-DYN Ruby�) into the DVD drive. 8. Select Start, My Computer. 9. Double click on CDROM icon (D:) and double click on the Ruby Setup.Exe icon (as shown) to execute the program. Note If the icon does not display as shown, click View on the D: window Toolbar and select Icons from the drop down menu. 10. Select the radio button to Remove CELL-DYN Ruby Online Operator�s Manual and click Finish. 11. Wait until the process is completed, then click Close. [3} 12. Select Start, Turn off Computer, and Restart. Verification 1. From the CELL-DYN Ruby Application menu bar, select Help, then Operator's Manual. Verify that the manual has been removed. CELL-DYN Ruby System Service and Support Manual (Version 201958-103) • © 2006, 2010 • CELL-DYN and CELL-DYN Ruby are registered trademarks of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. VP-39 HGB Flow Cell Cleaning Procedure Version - 201963-103_1196_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-39 HGB Flow Cell Cleaning Procedure Purpose This procedure first uses the Auto Clean routine to clean the flow cell, and if that is unsuccessful Not Type Assessed a manual procedure is used. Materials Required CELL-DYN Enzymatic Cleaner 20% Bleach Solution 20 mL Syringe Action 00:20 Time min Steps Reference Preparation 1. Be sure that the instrument is in the Ready state and in Open Mode. Perform Flow Cell Auto Clean 1. From the Maintenance view, select Scheduled Auto-Clean 2. Follow the on-screen instructions to perform the procedure, then select Auto-Clean. 3. Run three background counts to purge enzyme cleaner. 4. From the Diagnostics menu, select Digital / Voltage Readings HGB output (check box on left) Stream 5. Verify that the HGB OUTPUT voltage is 5.10 ± 0.10 volts. If the voltage is within range, procedure is complete. If the voltage is not within range, select Stop, followed by Close to exit the Digital/Voltage Readings screen. Go to Manually Clean Flow Cell. Manually Clean Flow Cell HGB Flow Cell Plumbing 1. Manually open solenoid valve 93 to drain liquid from the HGB flow cell. 2. Prepare and aspirate 20% bleach solution into syringe. 3. Remove tubing from port [1] and connect syringe to port (HGB Flow Cell 4. 5. 6. 7. Plumbing). Inject bleach solution until it can be seen exiting top port. [2] Leave solution in flow cell for five to ten minutes. Manually open solenoid valve 93 to drain bleach from the HGB flow cell. Repeat Step3 through Step6 with DI Water to flush bleach from flow cell. 8. Remove syringe, and connect tubing to port. [1] 9. Run three background counts to purge bleach. 10. From the Diagnostics menu, select Digital / Voltage Readings HGB output (check box on left) Stream 11. Verify that the HGB output voltage is 5.10 ± 0.10 volts. Note If voltage is slightly out-of-range, perform VP-05 HGB Current Verification/Adjustment. 12. Select Stop, followed by Close to exit the Digital/Voltage Readings screen. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-40 Power-Up CPU/DCM 7-Segment LED Verification Version - 201963-103_1197_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-40 Power-Up CPU/DCM 7-Segment LED Verification To verify CPU/DCM 7-segment LED display. Purpose Materials Required None Action Verify Power-Up CPU/DCM 7Segment LED Type Time Not Assessed 00:05 min Steps 1. Power-up the system and observe the 7-segment LED on the Reference CPU/DCM 7-Segment LED Status Conditions CPU/DCM (CPU/DCM 7-Segment LED Status Conditions). Note When all tests have passed, the initialization continues, during which the CPU/DCM loads it's program into memory from the hard drive. When the CPU/DCM begins running it's program, the 7- segment display changes to an alternating display of E then 1. The normal operational state of the CPU/DCM is indicated by the continuous alternating display of E..1..E..1 .....etc. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-41 Application Software Installation Procedure Version - 201963-103_1198_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-41 Application Software Installation Procedure To install system software. Purpose Materials Required CELL-DYN Ruby System Installation Disks 1 & 2 Action Type Time Steps Prerequisite 1. Be sure to perform VP-48 Backup Procedure when installing the application software. 2. Perform this procedure following an operating system installation or when corruption of the application program is suspected. New Application Software Installation Note Perform this Action only when the hard disk drive has been replaced or the operating system has been reloaded/installed. 1. Select Start (lower left corner), Log Off. 2. At the Log Off Windows prompt, select Log Off. Note When entering information, remember to enter it exactly as shown, as it is case sensitive. 3. Select Admin from the user name display and type Syssetup followed by Enter. Note Entering the Admin user mode allows full access and user rights. 4. Insert the CELL-DYN Ruby Application Installation Disk (CD) into the CD-ROM drive. 5. Select Start (lower left corner), My Computer. 6. Double click on CD-RW Drive (D:) and double click on Setup to execute the program. 7. When the CD Ruby Software Setup window displays, select from Step 1 CD Ruby Software Prerequisites. Not Assessed 00:15 min Reference Note The CD Ruby Software Prerequisites installation process takes approximately one (1) minute to complete. 8. Once the program is loaded, the message, MSDE is installed. You can uninstall it now. displays. Go to Reload Application Software. Uninstall Application Software Note When reloading the application software, the program must first be uninstalled before it can be reloaded. 1. From the CELL-DYN Ruby application program, select File, then Exit. 2. Select Start (lower left corner), Log Off. 3. At the Log Off Windows prompt, select Log Off. Note When entering information, remember to enter it exactly as shown, as it is case sensitive. 4. Select Admin from the user name display and type Syssetup followed by Enter. Note Entering the Admin user mode allows full access and user rights. 5. From the CELL-DYN Ruby application program, select File, Exit. 6. Insert the CELL-DYN Ruby Application Installation Disk (CD) into the CD-ROM drive. 7. Select Start (lower left corner), My Computer. 8. Double click on DVD-R Drive (D:) and double click on Setup to execute the program. 9. When the CD Ruby Software Setup window displays, select from Step 2 CD Ruby Software. 10. When the CD Ruby Software wizard displays, select Remove CD Ruby Software followed by Finish. 11. Once the uninstall procedure is complete the message, CD Ruby Software has been successfully removed. Click "Close" to exit. displays. Follow the instructions and select Close to exit. Note The uninstall process takes approximately ten (10) seconds to complete. 12. Select OK when the message, CD Ruby Software was uninstalled successfully! displays. 13. Go to Reload Application Software. Reload Application Software 1. At the CD Ruby Software Setup window, select from Step 2 CD Ruby Software. 2. When the CD Ruby Software wizard displays, follow the onscreen instructions to load the application software. Note The installation process takes approximately three (3) minutes to complete. 3. Once the installation procedure is complete the 4. 5. 6. 7. 8. message, CD Ruby Software has been successfully installed. Click "Close" to exit. displays. Follow the instructions and select Close to exit. Select OK when the message, CD Ruby Software was installed successfully. displays. Close the CD Ruby Software Setup window. Remove the CELL-DYN Ruby Application Installation Disk (CD) from the CD-ROM drive. Select Start, Turn Off Computer, Turn Off to shutdown the system. Press the computer ON/OFF switch (located next to the floppy drive) to boot the software. Note The system automatically executes the CDRuby Application software. 9. Go to VP-49 Restore Setup. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2010 • CELL-DYN and CELL-DYN RUBY are registered trademarks of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. VP-42 Hard Drive Utilities Version - 201963-103_1189_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-42 Hard Drive Utilities Purpose Materials Required Provides hard disk utilities to scan the disk for possible corruption or bad sectors. Also, provides the defragmentation procedure. Not Type Assessed None 00:20 Time min Action Steps Prerequisite 1. Perform this procedure whenever bad sectors or corruption of the hard disk drive is suspected. Preparation 1. From the CELL-DYN Ruby application program, select File, Exit. 2. Select Start (lower left corner), Log Off. 3. At the Log Off Windows prompt, select Log Off. 4. Select afse from the user name display and type IbFSE! (case sensitive) followed by Enter. Note Entering the afse user mode allows full access and user rights. 5. From the CELL-DYN Ruby application program, select File, Exit. Check Disk Utility 1. Select Start (lower left corner), My Computer. 2. Right (mouse) click on Syspart (C:). 3. Select Properties, Tools (located along the top of the menu screen). 4. Locate the Error-checking portion of the screen and select Check Now. 5. From the Check Disk Syspart (C:) window, select Automatically fix file system errors, followed by Start. 6. A message displays asking you if you would like to schedule the disk check next time you Reference restart the computer. Select Yes. 7. Close the Syspart (C:) Properties, followed by My Computer screens. 8. Select Start, Turn Off Computer, Restart to reboot the system. Note The Check Disk utility is automatically performed. This process takes approximately ten seconds to complete, after which the system reboots and executes the CD-Ruby application program. Do not touch the computer during this process. 9. Go to Defragmentation Utility. Defragmentation Utility 1. 2. 3. 4. Perform Preparation. Select Start (lower left corner), My Computer. Right (mouse) click on Syspart (C:). Select Properties, Tools (located along the top of the menu screen). 5. Locate the Defragmentation portion of the screen and select Defragment Now. 6. When the Disk Defragmenter window displays, select Defragment. Note The Disk Defragmenter program begins its defragmentation process. The duration of this process depends on the severity of the fragmentation, as well as the number of files. Do not touch the screen during this process. 7. When the message, Defragmentation is complete for: Syspart (C:) displays, select either View Report or Close. 8. Close the Disk Defragmenter, followed by Syspart (C:) Properties, then My Computer screens. 9. Select Start, Turn Off Computer, Restart to reboot the system. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-44 Vacuum Accumulator 1 and 2 Rinsing Procedure Version - 201963-103_1184_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-44 Vacuum Accumulator 1 and 2 Rinsing Procedure Purpose To rinse Vacuum Accumulators 1 and 2 with DI Water. Clean 500 mL Beaker or Container Materials Required DI Water 12 inches of S3 Silicon Tubing. Action Steps Prerequisite 1. Be sure that instrument is in the Initialized or Ready state. Preparation 1. Open Left Access (Front) Cover. 2. Remove the Left Panel from the rear rail of the Sample Loader. Induce DI Water into Vacuum Accumulators 1 and 2 1. Locate VAC 1 and VAC 2 accumulator drain lines. [1] 2. Measure and add 250 mL of DI Water into a clean 500 mL beaker or container. Caution Do not place more than stated amount of DI water in container. 3. Remove silicon portion of the VAC 1 drain line (along with plug) and attach the 12 inch portion of S3 silicon tubing. [2] 4. Insert the end of the S3 silicon tubing into the DI Water container and allow the vacuum to aspirate all of the liquid. 5. Remove the 12 inch piece of silicon tubing and install the original tubing along with the plug. 6. Repeat Step1 through Step5 for the VAC 2 drain line. Type Time Not Assessed 00:15 min Reference Drain Rinse Liquid with Drain Accumulator Protocol 1. From the Maintenance view, Select Special Protocols Drain Accumulator Drain Accumulator (from pop up window). Note The Drain Accumulator procedure takes approximately 2 - 3 minutes to complete. 2. Select Init (F12) to initialize the system. (Not required for Version 2.0ML) CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2009 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-45 System Language Change Procedure Version - 201963-103_1183_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-45 System Language Change Procedure Purpose Materials Required The procedure to change the system language to English, Spanish, French, Italian, German, Portuguese and Japanese. Correct keyboard for the language: Time German: 7D11-30 French: 7D11-20 Spanish: 7D11-50 Italian: 7D11-40 Note Portuguese and Japanese will use the U.S. English Keyboard Note The parts listed in this section cannot be obtained from Santa Clara. They must be obtained through the system in Delkenheim, Germany. Action Steps Change System Note Language for This Section Applies to Instruments Manufactured Instruments with with the Language Pack installed Santa Clara SN the Language 36850BG – 35915BG, and Flextronics SN 54276BG Pack Installed and above. And Refurbished CELL-DYN Ruby Only Serial Numbers, and Instruments that have had the Language Pack installed as part of TSB 170026. Configure to Windows Language: Note Each time the language is changed, both the Windows Language and Application Language Procedures must be followed. 1. With the CD Ruby powered ON, place the UI into Admin mode (available under the drop down menu in the right hand corner, see Fig. 1). 2. Exit the CD Ruby Software (File → Exit). 3. Click on Start and then Log Off. 4. Login under Admin (ID pass= Syssetup). CELLType DYN Ruby Reference 15 mins 5. On the Windows XP screen, under Admin Login, navigate to My Computer and then (Start → My Computer). 6. Double click on the red icon, drive D:\. Run MUISETUP.EXE. 7. Select the desired language under Default user settings, and check box BOTH "Match the language for non-Unicode programs with the default user language." and "Match the default shell UI font with the default user language." Click OK. (Fig. 16 example for English). Note If both check boxes are not checked in Step 4, a Windows file will get corrupted and the Operating System will need to be re-installed. CD ROM OS RECOVERY CDRUBY (8938163501) should be on-hand in the event this occurs. 8. You will be prompted to restart the computer. Click Yes. Configure to desired application language: 9. With the CD Ruby powered ON, place the UI into Admin mode (available under the drop down menu in the upper right corner). 10. From the menu bar, select File, then Exit to exit the application. 11. Navigate as follows: Start > My Computer > C: > CDRuby > config (directory should read C:\CDRuby\config) and delete the contents of the config folder. 12. Procede to Change System Language. Change System Language 1. In the CD-Ruby Application program, switch the OPID to a user with Administrator access. 2. From the menu bar, select File, then Exit to exit the application. 3. From the Start menu, select Control Panel. 4. Select Regional and Language Options. Note Do not make any changes to the Regional Options tab. The CD-Ruby program allows setup of date and time, including format. 5. Select Languages tab. 6. Locate the language used in menus and dialogs drop down menu. Select the language you would like to use for CD-Ruby and the operating system. Selecting Keyboard Language Note Only the Spanish, German, French, and Italian keyboards listed under "Materials" at the beginning of this document and English keyboards are supported by the CDRuby application. 1. Locate the Text Services and Input Languages tab and select Details. 2. Locate the Default input language drop down menu and select the desired language. Note If the language-keyboard option is not present, locate the correct combination from the Installed services drop down menu and use the Add button to select the desired combination. 3. Select OK to activate the selections and exit the Control Panel. 4. Reboot the system by selecting Start, followed by Turn Off Computer, then Restart. Note Once the computer has restarted, the Windows XP account is automatically logged in as cd and the CD-Ruby program will automatically begin. 5. Reboot the system by selecting Start, followed by Turn Off Computer, then Restart. Cleaning Database Note In order to get the correctly translated set of Operator IDs and reagent names, a Clean Database procedure will have to be performed. 1. From the application, switch the OPID to user FSE . Type in the FSE password (see the CD Ruby System Service Manual, Troubleshooting section, Analyzer Setpoints Reference Chart). 2. From the menu bar, select Diagnostics, followed by Manufacturing Functions , then Clean Database. Type in the FSE password again. 3. Select Yes from the dialog box to start cleaning up the database. This will remove everything except the SetPoint Log and the Calibration Log. 4. Once the procedure is complete, a dialog box appears alerting you that the database cleanup was done successfully. Select OK to exit the application program. 5. Select Start, followed by Turn Off Computer, then Restart. Set Date and Time Format 1. Select CSC from the Operator ID menu. Password for CSC is the current date (day) plus 5. For example, if the date (day) is the 1st, then the password will be 6. 2. From the menu bar, select Setup, Administrative Setup. 3. Select User Interface Preferences. Set the correct date format. 4. Select Set Date/Time and enter the local date and time. 5. Select OK to save and exit. Setting Local Unit Sets 1. From the menu bar, select Setup, Unit Sets Selection to select the local Unit Sets format. 2. Select OK to save and exit. Verification 1. Verify that all application screen text appears in the chosen language. 2. Verify that date and time, along with selected format appears in the upper right corner of the screen (title bar). 3. Initialize system and prime. 4. Locate Specimen Typeand select Patient. 5. Press open mode touch plate and run a cycle. When complete, verify that unit sets are correct. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2013 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. VP-46 Installation of Operator's Manual from Media (English and Multilingual Version) Version - 201963-103_1182_3 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-46 Installation of Operator's Manual from Media (English and Multilingual Version) Purpose Materials Required Action The procedure to load the Operators' Manual into the CELL-DYN Ruby Application program. CELL-DYN System Operator's Manual (CELL-DYN Ruby) CD-ROM, current revision. Steps Prerequisite 1. Obtain the current version of the English or Multilingual Online Operator's Manual (CELL-DYN Ruby) disk. 2. From the CELL-DYN Ruby Application menu bar, select Help, then About CELL-DYN Ruby. 3. Take note of the instrument software version in the dialog box. 4. Select OK to close the dialog box. Installation of Operator's Manual Instructions 1. Ensure that Analyzer is in Ready, Initialized, or Uninitialized status as indicated in the Analyzer Status region. 2. From the CELL-DYN Ruby Application menu bar select Admin level Operator ID (upper right hand corner). 3. From the CELL-DYN Ruby Application menu bar, select File, Exit. Reference CELL-DYN Type Ruby Time 15 mins 4. Select Start (lower left corner), Log Off. 5. At the Log Off Windows prompt, select Log Off. Note When entering something, remember to enter it exactly as shown, as it is case sensitive. 6. Select admin from the 7. 8. 9. 10. user name display and type Syssetup followed by Enter. Insert the current English or Multilingual version of the disk containing the Online Operator's Manual (CEL-DYN Ruby) into the DVD drive. Select Start, My Computer. Double click on CDROM icon (D:) and double click on the Setup.exe icon as appears in this picture to execute the program. Once the program installation wizard appears, select Next. Note If installing the Multilingual version go to step 13, if installing the English version, skip to step 14. 11. Select the language of choice using the radio buttons, then select Next. 12. Verify that the setup program is appropriate for the version of application software on the Instrument. Note Refer to Action: Prerequisite Step 2. 13. If the version is correct, select Next. Note If the version is not correct, select Cancel to exit. Obtain the correct version and repeat this procedure. 14. Select Next again to confirm installation. Installation of Operator's Manual Instructions (continued) 1. Once installation is complete, select Close to exit setup. Close the D: window. 2. Remove the disk from the DVD drive. 3. Select Start, Turn Off Computer, and then Restart to return to the CELL-DYN Ruby application program. Verification 1. From the CELL-DYN Ruby Application menu bar, select Help, then Operator's Manual. Verify that the manual has been installed by navigating through the various sections. 2. Click the "X" in the upper right corner to close the manual and return to the Ruby application. CELL-DYN Ruby System Service and Support Manual (Version 201958-103) • © 2006, 2010 • CELL-DYN and CELL-DYN Ruby are registered trademarks of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. VP-47 Operating System Installation and Hard Disk Drive Format Version - 201963-103_1181_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-47 Operating System Installation and Hard Disk Drive Format Purpose Materials Required Installation of the Windows operating system for CELL-DYN Ruby CELL-DYN Ruby System Service Disk Action Type Time Not Assessed 00:05 min Steps Prerequisite 1. Be sure to perform VP-48 Backup Procedure before installing the operating system. Failure to do so results in loss of data. Note This procedure is performed when installing a new hard disk drive or corruption of the current drive's data files is suspected. Preparation 1. Be sure that there are no external USB drives connected to the USB port at rear of instrument. Remove all USB drives if connected. Note A drive connected to the USB port affects the boot sequence and not allow the operating system to install correctly. New Installation of Operating System Software 1. Turn ON the computer (the switch is located next to the floppy drive). 2. While the computer is booting up, insert the CELL-DYN Ruby Operating System Disk (CD) into the CD-ROM drive. 3. Press Control+Alt+Delete (simultaneously) to reboot the computer. 4. As the computer is rebooting, watch for the onscreen message, Boot from CD. Press any key to BOOT from the CD. Follow instructions and select any key to begin the installation process. Note The onscreen prompt displays very quickly and a key must be pressed at that moment or else the program continues to execute. If this happens, repeat Step3 and Step4. 5. Go to Reload Operating System Software, Step5. Reload Operating System Software 1. From the CELL-DYN Ruby application program, select File, then Exit. Reference 2. Insert CELL-DYN Ruby Operating System Disk (CD) into the CD-ROM drive. 3. Select Start (lower left corner), Turn Off Computer, then Restart 4. As the computer is rebooting, watch for the onscreen message, Boot from CD. Press any key to BOOT from the CD. Follow instructions and select any key to begin the installation process. Note The onscreen prompt displays very quickly and a key must be pressed at that moment or else the Windows and CD-Ruby programs are executed. If this happens, repeat Step1 through Step4. 5. When the onscreen message, Start Ruby OS Installation. Press any key to continue displays, follow the instructions and select any key. Note The installation program reformats the drive and installs the operating system. This process takes approximately 20 minutes. 6. When the installation is complete the message, Ruby OS Installed. Press any key to continue displays, follow the instructions and select any key. 7. While the system is rebooting, remove the operating system disk from the CD-ROM drive. 8. Once the system is rebooted, the System Settings Change window displays and displays the message, Do you want to restart your computer now?. Select Yes to restart the system. 9. Perform VP-41 Application Software Installation Procedure. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-48 Backup Procedure Version - 201963-103_1180_3 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-48 Backup Procedure To backup system setup files and SQL Database. Purpose Materials Required Two (2) new CD-R or CD-RW Disks. Action Type Time Not Assessed Depends on number of files Steps Reference Prerequisite 1. Be sure that CD-Ruby application program is running. 2. Log into CD Ruby application as Admin in upper right corner. Perform Backup of Setup Files and SQL Database 1. Select File, Backup. 2. When the Backup window displays, select Setup, Config, and Log Files. 3. Insert new or empty CD-R or CD-RW disk into CD-ROM drive. Note Using a CD-RW disk allows reuse of the media for another backup. 4. Select Start Backup to begin the Backup process. Note When the process is complete, the CD-ROM drive automatically ejects the disk. 5. Repeat Step1 through Step4 for backing up the Database Files. Note Use a separate (new or empty) CD-R or CD-RW disk to backup the SQL Database. Also, only 5,000 files can be stored on a single CD disk. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2010 • CELL-DYN and CELL-DYN RUBY are registered trademarks of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. VP-49 Restore Setup Version - 201963-103_1179_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-49 Restore Setup Purpose Materials Required To Restore saved setup and log files, along with SQL Database files to hard drive. Type One (1) disk with backed up setup and log files One (1) disk with backed up SQL Database files. Depends on number of Time files Action Not Assessed Steps Prerequisite 1. Be sure that CD-Ruby application program is running. Restore Database Files 1. Select File, Restore. 2. When the Restore window displays, select Database Files. 3. Select OK to begin the Restore process. Note The duration of this process depends on the size of the SQL Database. Do not touch the computer during this time. Restore Setup and Log Files 1. Select File, Restore. 2. Select applicable files to be restored or select all files for a full restore. 3. Select Start Restore to begin the Restore process. Note A message displays if a particular file is selected, but not found on the Restore disk. Select OK to continue. 4. Once the files have been restored, select File, Exit. 5. Select Start, All Programs, CDRuby (executes the CD-Ruby Application program). The RestorFiles window displays and provides three (3) options for Restore: Restore Now Restore Later Remove Backup Files. 6. Select the Restore Now option to perform an immediate Restore function. Note The Restore Later option allows the program to execute without restoring the files, but Reference prompts you when the CD-Ruby Applications program is restarted. The Remove Backup Files completely deletes all restore files placed in the queue. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-50 List Mode Data (raw file) Collection Version - 201963-103_1172_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-50 List Mode Data (raw file) Collection To collect List Mode (rawfile) data. Purpose Materials Required None Type Time Not Assessed Not Assessed Raw file storage is a means of creating raw (unprocessed) data files to be used in engineering or scientific studies, or for troubleshooting purposes. The raw file storage program is always enabled on the CD-Ruby and records all 10,000 cycle runs. Once the same sequence number is executed in a cycle run, the contents of the raw data file is overwritten with the new data. Action Copy Raw Files from Raw Directory Steps 1. Exit the CD-Ruby Application program by selecting File, Exit. 2. Select Start, My Computer. 3. Select Syspart (C:). 4. Locate and double-click on cdlogs, followed by raw. Note A list of all raw data files recorded thus far displays. The filename is established by the sequence number, followed by the raw file extension (.raw). The raw files can only be viewed with a special application, which does not reside on the CD-Ruby. 5. Select the raw files that you would like to copy to a removable storage device. 6. Insert an empty disk into the floppy disk drive, or CD into the CD-RW drive or connect a USB drive to the USB port at rear of instrument. 7. Select File, Send to, and the location of the desired removable storage media. Note If the raw files are being copied onto a CD, refer to Copy Raw Files onto CD Disk. 8. Remove the removable storage media device and Reference close all open windows. 9. Select Start, All Programs, followed by DSPlusU.exe to execute the CD-Ruby application. Prepare for Operation 1. Remove the removable storage media device and close all open windows. 2. Select Start, All Programs, followed by DSPlusU.exe to execute the CD-Ruby application. Action Copy Raw Files onto CD Disk Steps Note This action is a continuation from Copy Raw Files from Raw Directory. Perform this action only if you plan on using a CD disk as your removable storage media 1. Select CD-RW Drive (D:) from the Address drop- down menu. Note The message, Files Ready to Be Written to the CD, displays at the top of the list of files that you wish to copy. 2. Select File, Write these files to CD. Note The CD Writing Wizard displays. 3. Follow the on-screen instructions to copy the selected raw files to a CD disk. Reference Execute Application Program 1. Remove the CD disk and close all open windows. 2. Select Start, All Programs, followed by DSPlusU.exe to execute the CD-Ruby application. 3. Remove any diskettes and power off the system and reboot. CELL-DYN Ruby System Service and Support Manual (Version 201958-108) • © 2006, 2010 • CELL-DYN and CELL-DYN Ruby are registered trademarks of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. VP-51 Analyzer Serial Number Loading and HSSL Com Procedure Version - 201963-103_1178_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-51 Analyzer Serial Number Loading and HSSL Com Procedure To enter the instrument's serial number and execute the HSSL Communications protocol. Purpose Materials Required None CELLType DYN Ruby Time 00:05 min Note This procedure must be performed when a new CPU/DCM PCB is installed or corruption to the HSSL Com protocol is suspected. Action Steps Prerequisite 1. Be sure that instrument is in the Initialized state. Enter Analyzer Serial Number and Execute HSSL Communications Protocol 1. From the Diagnostics menu, select HSSL Log. The HSSL Log window displays. 2. From the Diagnostics menu, select Manufacturing Functions Analyzer Config 3. When the Analyzer Configuration 4. 5. 6. 7. window displays, type the instrument's serial number in the Analyzer Serial Number box. [1] Select Apply to execute the HSSL Communications protocol. Verify that HSSL Com transmission and receive messages display on the HSSL Log. [2] If no transmission and receive messages display on the HSSL Log, troubleshoot as necessary. [3] Close all windows. Reference CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-52 Operating System - User Account Log On Procedure Version - 201963-103_1188_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-52 Operating System - User Account Log On Procedure The procedure to log on to afse or admin User accounts in the Operating System. Purpose Materials Required None Type Time Action CELL-DYN Ruby 5 mins Steps Prerequisite 1. From the CELL-DYN Ruby Application program, switch the OPID to a user with administrator access. 2. From the menu bar, select File, then Exit to exit the application. Note Operator IDs Admin, FSE or CSC will allow the user to exit the application program. Operating System Log On for afse User Account Note The afse user account mode has full access rights. 1. Select Start, Log Off. 2. At the Log Off Windows prompt, select Log Off. Note When entering information, remember to enter it exactly as shown, as it is case sensitive. 3. Select afse from the user name display and type IbFSE! followed by Enter. Note Restarting or turning off/on the Data Module will automatically default and reboot the cd User account. Operating System Log On for admin User Account Note Entering the admin user account mode allows full access and user rights. 1. Select Start, Log Off. 2. At the Log Off Windows prompt, select Log Off. Note When entering information, remember to enter it exactly as shown, as it is case sensitive. Reference 3. Select admin from the user name display and type Syssetup followed by Enter. Note Restarting or turning off/on the Data Module will automatically default and reboot the cd User account. Verification Note There is no verification procedure needed. The operating system will only allow access into the different User accounts if the password is correct. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-53 BIOS Setup and Configuration Procedure Version - 201963-103_1177_3 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-53 BIOS Setup and Configuration Procedure To configure the system CMOS. Purpose Materials Required None Type Time Action CELL-DYN Ruby Not Assessed Steps Preparation 1. From the CD-Ruby Application Software, select File, Shutdown. 2. At the prompt, select OK. 3. When the computer shuts down, press the computer ON/OFF switch (located next to the floppy drive) to boot the system. 4. During the initial stage of the boot process, select Delete on the keyboard to enter the Setup (BIOS) program. Load Optimized Defaults 1. From the main Setup menu, use the arrow keys to move the cursor to Load Optimized Defaults (located on the right column). 2. Select Enter to execute the change. 3. Type Y, followed by selecting Enter. Standard CMOS Features 1. From the main Setup menu, use the arrow keys to move the cursor to Standard CMOS Features. 2. Select Enter to open the screen. Note To change setting, select the menu item by pressing Enter. Use the arrow keys to move to desired selection and select Enter to accept. Move the cursor if necessary to set the date and time. 3. Verify that IDE Channel 0 Master recognizes a hard disk drive. 4. Verify that IDE Channel 0 Slave recognizes a CD-ROM (e.g. PLEXTOR) drive. 5. Verify that Drive A: indicates 1.44M, 3.5 in. (floppy drive). Reference 6. Verify that Video indicates Video EGA/VGA. 7. Select ESC to return to the main Setup menu. Advanced BIOS Features 1. From the main Setup menu, use the arrow keys to move the cursor to Advanced BIOS Features. 2. Select Enter to open the screen. Note To change setting, select the menu item by pressing Enter. Use the arrow keys to move to desired selection and select Enter to accept. 3. Verify that First Boot Device is set to Floppy. 4. Verify that Second Boot Device is set to CDROM. 5. Very that Third Boot Device is set to Hard Disk. 6. Set the Quick Power on Self-Test to Disable. 7. Select ESC to return to the main Setup menu. Integrated Peripherals 1. From the main Setup menu, use the arrow keys to move the cursor to Integrated Peripherals. 2. Select Enter to open the screen. Note To change setting, select the menu item by pressing Enter. Use the arrow keys to move to desired selection and select Enter to accept. 3. Using the arrow keys, move the cursor to Super I/O Devices. 4. Select Enter to open the screen. 5. Verify that Onboard Serial Port 1 is set to 3F8/IRQ4. 6. Verify that Onboard Serial Port 2 is set to Disabled. ATTENTION: If new SATA DVD DRIVE and Adapter installed in CD Ruby Computer Assembly, perform the additional steps 7 to 10 (otherwise continue to step 11): 7. Hit Esc to return to "Integrated Peripheral." 8. Select "On Chip IDE Device." 9. Set "IDE Primary Slave UDMA" to [Disabled]. 10. Select F10 to Save. 11. Select Esc twice to return to first menu. PnP/PCI Configurations 1. From the main Setup menu, use the arrow keys to move the cursor to PnP/PCI Configurations. 2. Select Enter to open the screen. Note To change setting, select the menu item by pressing Enter. Use the arrow keys to move to desired selection and select Enter to accept. 3. Verify that PNP OS Installed is set to Yes. 4. Select ESC to return to the main Setup menu. Save and Exit. 1. Select F10 to Save & Exit Setup. 2. Follow the on screen instructions to complete. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2014 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-54 WBC Gain Optimization Version - 201963-103_1174_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-54 WBC Gain Optimization Purpose Materials Required To provide an alternative procedure for optimization of WBC gains. None Type Time Not Assessed Not Assessed This procedure provides an alternative procedure for optimization of WBC gains. Its purpose is to standardize the performance of the laser bench using whole blood as a reference rather than inert material such as polymer spheres. This procedure should be used in instances of customer complaints of false or erratic flagging, especially VARLYM and BAND flags, when the laser bench performance has been verified to be within specification otherwise. Upon successful completion of this procedure, new target channels for autogain are established. The optimal gain settings can then be reestablished later using 7.0 µm polymer microspheres as usual. It is recommended that this procedure be performed by experienced field service personnel only. Action Steps Reference Prerequisite 1. Obtain 20 fresh whole blood samples for use. Note It is very important that the samples used in this procedure are normal healthy samples. The samples must be fresh, within 8 hours of draw. All parameters must be of normal range values. The samples need to have good tight populations with good separation and no flags. Verify Performance Specifications Laser Bench Specification 1. Verify whole blood CVs, and carryover are within specification. 2. Verify that the Laser Bench Specification are met. If bench performance is not within specification, perform VP-18 Optics Bench Alignment Procedure. Setup Cell Regions Cell Region Channels 1. Install all the laser bench covers, or cover them with a black drop cloth. 2. From the Diagnostics menu, select Setpoints and print the gain settings from the setpoint window (for reference). 3. Press Close to exit the Setpoints window. 4. From the Diagnostics menu, select SRP/Blood Comparison, Cell Regions. 5. Enter the channels from Cell Region Channels in the Cell Regions screen. Close Cell Regions Window Verify Initial Gain Settings 1. Press OK to close the Cell Regions window. Optical Channels Gran Results Specification 1. Select Patient from the Specimen Type drop down menu. 2. With the SRP/Blood Comparison window open, mix and run one of the blood samples using the Open mode. 3. When the sample is complete, record the Gran results for all four optical channels that display. 4. Compare the results to the targets in Optical Channels Gran Results Specification: If results are within tolerance, go to Verify Lym Results. If the results are not within the indicated tolerance, go to Calculate/Enter Gain Settings. Calculate/Enter Gain Settings Gain Settings Calculation 1. Use the Gran results and the gain settings from the Setpoints window to calculate the new gain settings using the formula Gain Settings Calculation. If results are within tolerance, go on to Verify Lym Results. 2. From the Diagnostics menu, select Setpoints and enter the new gain settings. Press Set Analyzer to save the new settings. Print or record the new gain settings. Press Close to exit the Setpoints window. From the Diagnostics menu, select SRP/Blood Comparison. 7. From the Specimen Type drop down menu, select Patient. 8. Re-run the same sample and compare the Gran results with the targets. 3. 4. 5. 6. If not within range, reject the sample and try again. Verify Lym Results Lym Settings Calculation 1. Record the Lym results for 0 and 10 degrees (only) and compare them to the following. Gran Settings Calculation Note In this procedure, values called lym gains and gran gains are used along with weighting factors for proper lym and gran separation. The weighting factors are used to calculate the new final gain settings for 0D and 10D channels only. 0D and 10D Gain Settings Calculation If not within the indicated tolerance, use the Lym results for 0D and 10D channels and the gain settings to calculate Lym gains for 0D and 10D channels using the Lym Settings Optical Channels Gran Results Specification Calculation formula. If within tolerance, go to Calculate/Enter Final Gain Settings. 2. Calculate gran gains using Gran Settings Calculation: 3. Calculate the new 0D and 10D gain settings using 4. 5. 6. 7. 8. 9. the 0D and 10D Gain Settings Calculation weighting formula. From the Diagnostics menu, select Setpoints and enter the new 0D and 10D gain settings. Press Set Analyzer to save the new settings. Press Close to exit the Setpoints window. From the Diagnostics menu, select SRP/Blood Comparison. From the Specimen Type drop down menu, select Patient. Re-run the same sample and compare the Gran and Lym results with the target channels from Optical Channels Gran Results Specification and Step1. If within tolerance, go to Calculate/Enter Final Gain Settings. If not within tolerance, reject the sample and try again. Calculate/Enter Final Gain Settings Gran Gains Calculation 1. Using the CELL-DYN Ruby Gain Optimization Worksheet (9H_6100.PDF), run all 20 of the blood samples in the SRP/Blood Comparison window. Note Be sure to select Patient from the Specimen Lym Gains Calculation Type drop down menu. 2. Record the lym and gran results 3. Calculate the sum of the results for each column and record them in the Sum of results row on the worksheet. 4. Calculate the average result for each column on the 0D and 10D Gain Settings Calculation worksheet as follows: 5. Enter in the appropriate cell in the Average row of the worksheet. 6. Note the current gain settings from the setpoint entry 7. 8. 9. 10. 11. 12. 13. Calculate/Enter Autogain Target Channels Results screen. Record them on the worksheet in the Gran columns. Calculate Gran gains using the targets given on the worksheet, and the average results obtained from Step4 (see Gran Gains Calculation), and record on the worksheet: For 90D and 90DP, enter the Gran gain as the final gain (at the bottom of worksheet). For 0D and 10D, calculate lym gains using the targets and average results in the Lym columns on the worksheet. Calculate (see Lym Gains Calculation) and record on the worksheet. Calculate the final gains for 0D and 10D using the 0D and 10D Gain Settings Calculation weighting formula. Record at the bottom of worksheet. From the Diagnostics menu, select Setpoints and enter the final gain settings from the worksheet. Press Set Analyzer to save the new settings. Press Close to exit the Setpoints window. Average Microsphere Results Calculation 1. From the Diagnostics menu, select SRP/Blood Comparison. 2. From the Specimen Type drop down window, select SRP. 3. Prepare a dilution of 15 drops of 7.0 µm polymer microspheres to 2 mL of diluent in a clean container. 4. Run the polymer microspheres three (3) times and record the latex results from the screen for all four channels on the Microsphere Worksheet (9H_6101.PDF). 5. Calculate the sum of the microsphere results for each channel (result 1 + result 2 + result 3). 6. Average the microsphere results for all four channels (use Average Microsphere Results Calculation). Record them on the worksheet. Note The averages are the new target channels for performing subsequent autogain adjustments using 7.0 µm polymer microspheres. 7. Verify that the new target channels values are within the specified range (see Average Microsphere Results Specification). If the target(s) are out of range, use the upper or lower range limit as the target value. 8. From the Diagnostics menu, select Auto-Gain Wizard. 9. Select Verify/Set WOC 0°, 10°, 90°, 90°D & Average Microsphere Results Specification RBC/PLT 0° Gain (7 µm SRP). 10. Press Next to enter the window. 11. Enter the average channel results obtained from Step6 as the target channel for all four channels. 12. Follow the on-screen instructions and run 7.0 polymer microspheres to perform the WOC 0°, 10°, 90°, 90°D & RBC/PLT 0° gain adjustment. Checkout Lym and Gran Populations 1. From the Specimen Type drop down menu, select Patient and perform another run of the samples in the SRP/Blood Comparison window. 2. Verify the Lym and Gran populations display as expected (see example in Lym and Gran Populations). The Lym and Gran populations should be close to the center of the boxes. Whole blood results from the Run screen look generally like example in Whole Blood Results. The populations should be tight clusters with good separation and proper location. Whole Blood Results 3. Verify control results. 4. When finished, perform VP-48 Backup Procedure to save new gain settings to a disk. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2008 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. CELL-DYN Ruby Gain Optimization Worksheet CELL-DYN Ruby Gain Optimization Worksheet Lym 0D Gran 0D Lym 10D Gran 10D Gran 90D Gran 90DP Target 59 160 59 149 125 21 Gain Settings(after part C) N/A N/A Gran gains N/A N/A N/A N/A N/A 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Sum of results Average Lym gains Final gains N/A N/A N/A System S/N # _____________________________________________ FSR _____________________________________________________ 9H_6100a Date __________________________ CELL-DYN Ruby Microsphere Worksheet 0D 1 2 3 Sum of Results Average 9H_6101a 10D 90D 90DEP VP-55 Create Windows XP Firewall Exception for File Transfer Program Version - 201963-103_1173_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-55 Create Windows XP Firewall Exception for File Transfer Program Purpose Materials Required To create a Windows XP Firewall Exception for the File Transfer Program to allow for retrieval CELL-DYN Type Ruby of files/logs by AbbottLink. None Action Prerequisite Time Steps Note This procedure should only be performed at the time the CELL-DYN Ruby is connected to AbbottLink using an AbbottLink PC. This will result in a Windows XP firewall exception being created, which will prevent alerts for the file transfer program from being generated when files or logs are retrieved from the Ruby. Note The system may be in the Uninitialized, Initialized, or Ready state. Exit Ruby Application 1. If the Operator ID is not Admin, then select Admin from the Operator ID drop down list. 2. If the password is configured for the Admin login then enter the appropriate password. 3. On the Ruby Menu Bar select File, then Exit, to exit the Ruby application. Reference 15 mins Log Off Windows XP Log into Windows XP Admin Account 1. On the Windows XP task bar select Start, then Log Off. 1. Select admin from the user name display. Note When entering information, remember to enter it exactly as shown, as it is case sensitive. 2. Enter Syssetup for the password. Restart CD Ruby Software 1. Select Start, All Programs, CDRuby to restart the CDRuby Software. Contact Instrument to AbbottLink PC Request Log Retrieval Unblock FTP Application Exit Ruby Software Application 1. Contact the AbbottLink GSS group or your local AbbottLink administrator to have the CELL-DYN Ruby deployed to the AbbottLink PC. 1. Request the AbbottLink Administrator retrieve a log from the Ruby. 1. When Windows Security Alert notification is displayed, select Unblock. 1. If the Operator ID is not Admin, then select Admin from the Operator ID drop down list. 2. If a password is configured for the Admin login then enter the appropriate password. 3. On the Ruby Menu Bar select File, then Exit, to exit the Ruby Application. Open Windows XP Firewall Program 1. On Windows Task bar click on Start, then Control Panel. 2. Double click the Windows Firewall icon to open the Windows XP Firewall program. Verify Windows XP Firewall FTP Exception 1. Click on the Exceptions tab. 2. Verify there is a File Transfer Program exception listed and checked. 3. Click OK to close the Windows Firewall dialog box. 4. Close the Control Panel by clicking on the X at the upper right corner of the Control Panel. Log Off Windows XP 1. On the Windows XP task bar select Start, then Log Off. Log On Windows cd Account 1. Select the cd user name from the display to log in as the normal Ruby user. 2. The Ruby application will start. CELL-DYN Ruby System Service and Support Manual (Version 201958-103) • © 2006, 2010 • CELL-DYN and CELL-DYN Ruby are registered trademarks of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. VP-56 Mix Head Adjustment Procedure Version - 201963-103_4217_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-56 Mix Head Adjustment Procedure Purpose The purpose of this procedure is to adjust/verify Mix Head Adjustment. 3/32" Allen Wrench Materials Required Phillips Screw Driver Feeler Gauge Set Action Preparation Type Time Steps Note Be sure that instrument is Initialized. 1. Remove the Nose Cover and open the Right and Left Front Doors. 2. Loosen the two (2) screws on the Mixer Assembly Top Flag. 3. Insert an empty loader rack at the mixing zone to allow the Mix-Head to rest flush against the rack or back rail. 4. Place instrument in the Admin mode. 5. Select Diagnostics menu, followed by Mechanical Operations, then Loader Tests. 6. Select Move Mixer, from the Sample Loader Diagnostics screen. 7. Click on Down to lower the Mixer Assembly. CELL-DYN Ruby 90 mins Reference Adjust the MixHead to the Vertical Position 1. Loosen the two (2) retaining set-screws that lock the Mix-Head to the motor shaft at the front and the top, using a 3/32� Allen wrench. 2. Loosen the Keeper- Nut and adjust the screw, if the Stop-Screw prevents the Mix-Head from being vertically positioned. 3. Check that the Mixer-Stop is fully seated against the Mixer Motor Mount and that the motor mount thumbscrew is fully tightened. 4. Set an initial clearance of .003� between the right side of the Mix-Head body and the Motor Boss. 5. Tighten the front and top Retaining Set-Screws that secure the Mix-Head to the motor shaft, without disturbing the position of the Mix-Head. 6. Rotate the Mix-Head and insure that it does not bind. Note If binding occurs, increase gap between the right side of the Mix-Head body and the Motor Boss in .001 � increments up to a maximum of .007 � if necessary to eliminate binding. 7. Tighten the Retaining Set-Screws to 10 inch-lbs force. Adjust the MixHead to the Vertical Position (continued) 1. Check that Mix-Head body can be placed into a vertical (home) position with power applied. Note The Mix-Head body should be perpendicular to the top surfaces of the Rear Rail and Center Frame. Adjust the Tube Sensor Bracket, Stop-Screw and Keeper-Nut 1. Loosen Tube Sensor Bracket mounting screws and position bracket fully towards the Front Rail. 2. Tighten the mounting screws. Note Make sure that the bracket mounting screws are not contacting components or traces on Tube Sensor PCB Assembly. 3. With the Mix-Head still in the down position, move the Mix-Head body towards the Front Rail until it touches the Tube Sensor Bracket. 4. Adjust the Stop-Screw until it makes contact with the Mix-Head. 5. Turn the Stop-Screw clockwise an additional amount so that the Mix-Head body cannot be positioned any closer than about � the distance between the vertical (home) position and the closest part of the Tube Sensor Bracket 6. Tighten the Keeper-Nut. 7. Slightly raise the Mixer Assembly. Rotate the MixHead all the way towards the Tube Sensor and confirm that the Mix-Head does not touch the sensor. 8. Manually set the Mix-Head at the vertical position. Visually confirm that there is a gap/space between the Mix-Head and the Stop-Screw. Adjust the gap between the MixHead and the Rear/Center Rails 1. Lower the Mix-Head and ensure that the MixHead is still at a vertical position. 2. Use a feeler gauge to set the space/gap between the bottom of the Mix-Head and the top of the Rear/Center Rails at 0.020�. 3. Tighten the two (2) screws on the Mixer Assembly Top Flag. Verification 1. From the Sample Loader Diagnostics screen, select Move Mixer. 2. Click on Up to raise the Mixer Assembly. 3. Perform VP-57, Mix Sensor Adjustment Procedure. 4. Perform VP-58, Tube Sensor Adjustment Procedure. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2009 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-57 Mix Sensor Adjustment Procedure Version - 201963-103_4218_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-57 Mix Sensor Adjustment Procedure The purpose of this procedure is to adjust/verify Mix Sensor position. Purpose Driver, Allen, 3/32" Materials Required Driver, Allen, 7/64" Action Preparation Type Time Steps Note Be sure that instrument is Initialized. 1. Remove the Nose Cover and open the Right and Left Front Doors. 2. Place instrument in the Admin mode. 3. Select Diagnostics menu, followed by Mechanical Operations, then Loader Tests. 4. Select Sample Loader Diagnostics screen, then Move Mixer. 5. Click on Down to lower the Mixer Assembly. Note Manually set the bottom of the Mix-Head body perpendicular to the top surfaces of the Rear Rail and Center Frame. Note If this condition cannot be met, perform VP-56 Mix-Head Adjustment. CELL-DYN Ruby 45 mins Reference Adjust Mix Sensor 1. Loosen the two (2) Sensor Locking Screws on the Mix Sensor Assembly. 2. If the sensing light is off, back out the Sensor Adjusting Screw until the light turns on. 3. Slowly adjust the Sensor Adjusting Screw clockwise until sensor light turns off. 4. Turn screw about � turn or less clockwise for additional margin after Mix Sensor light turns off. 5. Lock down the two (2) Sensor Locking Screws. Verification 1. Select the Sample Loader Diagnostics screen, then Move Mixer. 2. Click on Up to raise the Mixer Assembly. 3. Select Rotate Mixer and observe status of Rotate Sensor: Click on Up: Mix-Head moves up towards the back. Rotate Sensor=1 Click on Down: Mix-Head moves down towards the front. Rotate Sensor=0 4. Select the Sample Loader Diagnostics screen, then Move Mixer. 5. Click on Down to lower the Mixer Assembly. 6. Verify that the Mix-Head is vertical. 7. Click on Close Window. 8. Replace the Nose Cover and close the Right and Left Front Doors. 9. Re-initialize the instrument. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2009 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-58 Tube Sensor Adjustment Version - 201963-103_4219_2 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-58 Tube Sensor Adjustment Purpose The purpose of this procedure is to adjust/verify Tube Sensor Adjustment. Materials: Materials Required Empty Vacutainer Tube Five (5) Specimen Tubes Type Time CELL-DYN Ruby 60 mins Tools: Thin Flat Blade Screwdriver Action Preparation Steps Note Be sure that instrument is Initialized. 1. Remove the Nose Cover and open the Right and Left Front Doors. 2. Place instrument in the Admin mode. 3. Select Diagnostics menu, followed by Mechanical Operations, then Loader Tests. 4. Select the Sample Loader Diagnostics screen, then Tube Sensors. S2 Tube Sensor Adjustment/ Verification 1. Using a thin blade screwdriver, turn the Tube Sensor Potentiometer located behind S2 Sensor clockwise twenty (20) turns, or until a click is felt. Reference Note This click indicates the minimum sensitivity range of the twenty (20)-turn potentiometer. 2. Insert an empty Vacutainer Tube (no labels) into a tube rack. 3. Insert the rack in the Autoloader, so the tube is positioned in front of the S2 Sensor on Tube Sensor Board. 4. Click on Start next to Tube Sensors in the Sample Loader Diagnostics screen. Note The status of Position 3 sensor on the screen which corresponds to the S2 Sensor: 0 (zero) tube not present 1 (one) tube present 5. Position the tube inside the rack slot to the furthest point away from the Tube Sensor. 6. If Position 3 tube present indication is 1 on the screen, then turn potentiometer counterclockwise five (5) turns, for added tube position sensing margin and proceed to Step 9. Otherwise, if Position 3 indicates 0, proceed to Step 7. 7. If Position 3 tube present indication is 0, maintain the far back position of the tube in the rack and turn potentiometer counterclockwise until Position 3 tube present indication is 1. 8. Turn potentiometer counterclockwise five (5) additional turns, for added tube position sensing margin. 9. Move the tube away from Position 3 and verify a Position 3 tube present indication of 0. S1 Tube Sensor Adjustment/Verification 1. Position the tube in front of the S1 Sensor on the Tube Sensor Board. 2. Turn the Tube Sensor Potentiometer located behind the S1 Sensor clockwise twenty (20) turns, or until a click is felt. Note This click indicates the minimum sensitivity range of the twenty (20)-turn potentiometer. 3. Position the tube inside the rack slot to the furthest point away from the Tube Sensor. 4. If Position 4 tube present indication is 1 on the Sample Loader Diagnostics screen, 5. 6. 7. 8. 9. 10. 11. then turn potentiometer counterclockwise five (5) turns, for added tube position sensing margin and proceed to Step 7. Otherwise, if Position 4 indicates 0, proceed to Step 5. If Position 4 tube present indication is 0, maintain the far back position of the tube in the rack and turn potentiometer counterclockwise until Position 4 tube present indication is 1. Turn potentiometer counterclockwise five (5) additional turns, for added tube position sensing margin. Move the tube away from Position 4 and verify a Position 4 tube present indication of 0. In the Sample Loader Diagnostics screen, click on Stop next to Tube Sensors and remove the rack. Click on Close Window. Replace the Nose Cover and close the Right and Left Front Doors. Re-initialize and prime the instrument. Verification 1. Place five (5) specimen tubes into a rack. 2. Place the instrument in the Closed Mode and run the rack. Note Be sure that all tubes are processed without any Autoloader error messages. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2009 • CELL-DYN is a registered trademark of Abbott Laboratories. CELL-DYN RUBY is a registered trademark of Abbott Laboratories. • Abbott Park, IL 60064 • All rights reserved. VP-59 SQL Database Recovery Procedure Version - 201963-103_4420_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-59 SQL Database Recovery Procedure To provide instructions to restore the SQL database from autobackup (software version 2.0ML). Purpose None Materials Required Action Prerequisite Steps 1. This procedure is to be done if the message shown in Figure 1 is displayed. Run the Restore Utility Time Reference Note The CD Ruby auto backup creates two backup copies of the SQL database. The Restore utility attempts to restore the most recent backup first. If the restore fails, the utility then attempts to restore the second backup. 1. Exit the CD Ruby application and login to Windows as �admin� with the password �Syssetup�. 2. Open My Computer. Locate C:\CDRuby\ RestoreUtilU.exe Double click to run. 3. You will be prompted with the CELL-DYN Type Ruby Figure 1 40 mins dialog box shown in Figure 2. Figure 2 4. Click Yes. The restore process starts. The Restore dialog box (Figure 3) appears while restoring from the full database backup, which may take several minutes. Note If a message displays stating that the database cannot be restored from the most recent backup, skip to Action: �Failed Restore �. Figure 3 5. The next step in the process will automatically restore from the transaction logs (Figure 4). Note Depending on the number of transaction logs (n) the message shows x/n where x is the current transaction log being restored. 6. When the Restore Utility has completed, the dialog box in Figure 5 displays. Note If the dialog box in Figure 5 displays, skip to Action: Verification. If the dialog box does not display, continue with the next step (Failed Restore). Failed Restore Figure 4 Figure 5 1. On failed restore, a second dialog box prompting you to restore from the earlier back up appears (Figure 6). Figure 6 2. Click Yes. The restore proceeds as described in Step 4 above. 3. On a successful restore, a message box is displayed (Figure 7). 4. If the restore from the second backup fails, the message in Figure 8 displays. Figure 7 Figure 8 5. If a restore fails from both backups, the database will need to be restored through the CD Ruby application from the last CD backup. (Refer to VP-49). Note If unable to restore from both auto backups, copy the files listed at the right to a USB drive and forward them to GSS to be submitted for software investigation. Verification 1. Log out of the Windows admin account and log in to the cd account. 2. Verify that the Ruby application starts without errors. 3. Bring the system to the Ready state and verify background counts are within specification. 4. Verify calibration C:\Program Files\Microsoft SQL Server\MSSQL$RUBYMSDEINSTANCE C:\CDRuby\SqlMsg.log C:\AutoBackup\RubyBak0 C:\AutoBackup\RubyBak1 and control recovery. CELL-DYN RUBY System Service and Support Manual (Version 201958-103) • © 2006, 2010 • CELL-DYN and CELL-DYN RUBY are registered trademarks of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. VP-60 Russian and Chinese (Simplified) Language Pack Installation Version - 201963-103_5304_1 Inspect tools for damage, ensure calibration is not expired and replace if necessary. At the completion of this VP: G110 - After repair is complete, verify per released Operation and Service Procedures. If the system/instrument produces results, ENSURE appropriate Quality Control is in specification and calibrate as necessary. VP-60 Russian and Chinese (Simplified) Language Pack Installation To install Russian and Chinese (Simplified) language packs onto the CD Ruby Purpose Windows XP language pack CD Materials Required CD Ruby with OS Installed and Application (2.1ML or Higher) Installed Action Prerequisite Steps Reference Note This procedure is only for installation of Russian or Chinese (Simplified) languages. Do not perform this procedure if Japanese is the intended language. Instrument must be in the Windows XP screen under Admin. 1. With the CD Ruby powered ON, place the UI into Admin mode (available under the drop down menu in the right hand corner, see Fig. 1). 2. Exit the CD Ruby Software (File → Exit). 3. Click Start then Log Off (Fig 2). 4. Login under Admin (ID pass= Syssetup) (Fig 3). Fig. 1 Fig. 2 Type Time CELL-DYN Ruby 30 mins Fig. 3 Installation Installing Chinese (Simplified) of MUI Language Pack: Packs from CD 1. Insert CD Ruby Language Pack CD into the Ruby disc drive. 2. While in the Windows XP screen under admin login, navigate to My Computer (Start → My Computer, Fig. 4). 3. Double click on the red icon, drive D:\ (Fig. 5). 4. Run SetupCDRubyLangApp.exe. This will open the CDRuby Language Installer window (Fig. 6). Fig. 4 5. Under Language available on CD, select Chinese (Simplified) (Fig. 6). 6. Click Install (Fig. 6). 7. Allow 5 minutes for the language pack to install. The first phase of the installation will bring up the Windows XP Multilingual User Interface Pack stating "Multilingual File was successfully uninstalled (Fig. 7) Click OK to proceed. 8. Allow 5 minutes for the installation to copy the required files (Fig. 8). 9. A prompt will come up stating, "Multilingual File Installation was completed successfully." Click OK (Fig. Fig. 5 9). 10. A prompt will come up asking to restart the computer. Click Yes (Fig. 10). 11. The CD Ruby will now restart, and upon restart, will open the CD Ruby application. 12. Perform Action: Prerequisite. Fig. 6 13. Proceed to step Installing Russian Language Pack. Fig. 7 Fig. 8 Fig. 9 Fig. 10 Installing Russian Language Pack 1. While in the Windows XP screen under admin login, navigate to My Computer (Start → My Computer, Fig. 11). 2. Double click on the red icon, drive D:\ (Fig. 12). 3. Run SetupCDRubyLangApp.exe. This will open the CDRuby Language Installer window (Fig. 13). Fig. 11 4. Under Language available on CD, select Russian (Fig. 13). 5. Click Install (Fig. 13). 6. Allow 5 minutes for the language pack to install. 7. A prompt will come up stating, "Multilingual File Installation was completed successfully." Click OK (Fig. 14). Fig. 12 8. A prompt will come asking to restart the computer. Click Yes. (Fig. 15). 9. The CD Ruby will now restart, and upon restart, will open the CD Ruby application. 10. Both supported Language Packs are now installed to the CD Ruby and can now be found in the Regional and Language Options under the Control Panel. Fig. 13 Fig. 14 Fig. 15 Configure to Windows Language 1. Exit the Ruby Application (refer to Action: Prerequisite, Steps 1-2). 2. Click Start and then Log Off. 3. Login under Admin (ID pass = Syssetup). 4. While in the Windows XP screen under admin login, navigate to My Computer (Start → My Computer). 5. Double click on the red icon, drive D:\. Run MUISETUP.EXE. 6. Select the desired language under Default user settings, and check box BOTH "Match the language for nonUnicode programs with the default user language." and "Match the default shell UI Fig. 16 font with the default user Note language." Click OK. (Fig. Each time the language is changed, both the Windows Language and 16 example for English) Application Language Procedures must be followed. Note If both check boxes are not checked in Step 4, a Windows file will get corrupted and the Operating System will need to be reinstalled. CD ROM OS RECOVERY CDRUBY (8938163501) should be onhand in the event this occurs. 7. A prompt will come up asking to restart the computer. Click Yes. Configure to Windows Language 1. With the CD Ruby powered ON, place the UI into Admin mode (available under the drop down menu in the upper right corner). 2. From the menu bar, select File, then Exit to exit the application. 3. Navigate as follows: Start > My Computer > C: > CDRuby > config (directory should read C:\CDRuby\config) and delete the contents of the config folder. 4. Follow VP-45 System Language Change Procedure to set CD Ruby Application to desired language. CELL-DYN RUBY System Service and Support Manual (Version 201958-113) • © 2006, 2014 • CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. • Abbott Park, IL 60064 • All rights reserved. Maintenance (PMI) Process Preventive Maintenance ISA Link Refer to ISA 170-003 (current version). Pre-Site Specification & Checklist Refer to ISA 170-003 (current version). Installation Refer to ISA 170-003 (current version). ABBOTT ADD INSTRUMENT SERVICE ADVISORY ISA 170-003T 192015-17422-JS Active Subject: CELL-DYN Ruby Pre-Installation, Installation and Integration Checklists, and PM Procedure Document #: ISA 170-003T Originator: Chad Koehn/SANTACLARA/ADD/ABBOTT Product: CELL-DYN Ruby (170) Approved For Release: Patricia A Yanuzzi/ADD_LAKE_HUB/ADD_HUB/ADD/US Site of Document Control: Santa Clara Published Date: 01/09/2015 Effective Date:08/09/2013 Part / Kit #: 9130732; 9130733; 8921173202 Classification: Part Availability: 02/29/2012 Preventive Maintenance (PM) @ This ISA obsoletes ISA 170-003S. I. Distribution: Worldwide II. Purpose: The purpose of this ISA is to notify the Area Service and Support Organizations of the CELL-DYN Ruby System Pre-Installation, Installation and Integration Checklists, and PM Procedure. III. Administrative Notes: @ - CD-Ruby PM #1 is recommended to be completed once every year. - A few key maintenance steps within the CD-Ruby PM #1 procedure will be completed once every two (2) years as designated . - The Ruby PM Procedure, Total Call, Parts List, and Checklist Documents are being updated to reflect the current ISA revision in the documents headers or footers, no content changes have been made. - The frequency has been changed from required to recommended to align with the factory and field maintenance strategy. ISA 170-003S has been upgraded to ISA 170-003T as follows: - A new version of the CELL-DYN Ruby Installation Checklist 9157085G was released by Santa Clara and is replacing 9157085F. The PM and Total call documents are being revised for ISA revision version only, no technical content is being changed. IV. Parts: - All recommended PM parts are highlighted in the Attachments section below. - The Total Call procedure does not specify any part requirements. New Inventory Number Description Affected Inventory Numbers Inventory Disposition Notes 9130732 KIT, PINCH TUBING, PM, None CDRUBY 9130733 KIT, PM, CDRUBY V. Attached Files: @ Title CELL-DYN Ruby System PreInstallation Checklist CELL-DYN Ruby Installation Checklist Attachment None N/A N/A N/A N/A Intended Use Filename Filesize, Date, Time & Zone CDRuby Preinstall Checklist v1.2.pdf 38 KBytes, For Pre-Installation of 09/13/2011, the CELL-DYN Ruby 7:03 AM by Abbott Personnel GMT-8 9157085G.pdf 157 KBytes, For Installation of the CELL-DYN Ruby by 01/08/2015, Abbott Personnel 01:45 PM, GMT-8 CELL-DYN Ruby Integration Checklist 9157087B.pdf 84 KBytes, For Integration of the 1/9/2015, CELL-DYN Ruby by 5:08 pm, Abbott Personnel GMT-6 CELL-DYN Ruby Preventative Maintenance Procedure PPM-170- 215 KBytes, 003R CELLDYN Ruby 01/09/2015 05:10 PM, PM1.pdf GMT-6 Recommended Preventative Maintenance of the CELL-DYN Ruby by Abbott Personnel CELL-DYN Ruby Total Call Procedure PPM-170- 145 KBytes, 003R CELLDYN Ruby 01/09/2015, Total Call.pdf 05:11 PM, GMT-6 Recommended Total Call on the CELL-DYN Ruby by Abbott Personnel CELL-DYN PM/Total Call Checklist ISA 170-003R 322 KBytes, CD Ruby PMTC Check List 01/08/2015, .xls 01:50 PM, GMT-8 Checklist for recommended PM and Total Call procedures CELL-DYN Ruby PM Parts List CD-Ruby PM 30 KBytes, Parts List.pdf 01/09/2015, 05:11 PM GMT-6 List of PM parts for Abbott field personnel while conducting the recommended preventative maintenance checklist. Trademark: CELL-DYN and CELL-DYN Ruby are trademarks of Abbott Laboratories in various jurisdictions. All other trademarks, brands, product names and trade names are the property of their respective companies. All rights reserved. This document is Confidential for use by Abbott trained personnel only. Admin Maintenance & Document # History: END OF DOCUMENT CELL-DYN RUBY SYSTEM PRE-INSTALLATION CHECKLIST (SITE READINESS VERIFICATION FORM) ACCOUNT INFORMATION Account Name ________________________________________________________________________ Delivery Address________________________________________ Bldg. & Floor _________________ City_________________________________ State ____________ Zip Code ____________________ Primary Contact _________________________________________ Phone _______________________ Secondary Contact _______________________________________ Phone _______________________ Customer Number _______________________________________ Email______________________________________ POWER REQUIREMENTS A constant, non-fluctuating power source. Note: Use of an AC line with dimmer switches can cause electrical current fluctuations that could affect proper functioning of the system, and therefore is not recommended. Three outlets grounded to the same grounding wire. Separated grounding can result in voltage differences that can create internal interference in the system. Note: if a UPS is used, fewer outlets will be needed. (CHECK ONE) YES_____ NO ______ modifications. If NO, have the customer notify their electrician to add additional outlets and/or make any necessary Are multiple instruments being installed? (CHECK ONE) YES_____ NO ______ If YES, each instrument must be on a separate circuit. POWER SPECIFICATIONS Module Analyzer Display Printer Voltage Frequency Max Current BTU/Hr 100 – 240 VAC 47 – 63 Hz 5.0 – 2.2 amps 550 watts 100 – 240 VAC 50/60 Hz 1.5 amps 50 watts For power specifications, refer to the printer operator’s manual or other documentation received with your printer. SITE SPECIFICATIONS ANALYZER space meets criteria according to specifications. Record Space Measurements: Width: _____________ Height: _____________ Depth: _____________ Physical Specifications: 34.0” 19.25” 30.25” (86.4 cm) Analyzer Width (49.9 cm) Analyzer Height (76.8 cm) Analyzer Depth Weight: 232.0 Ibs. (105.2 kg) Analyzer (“ indicates inches) (‘ indicates feet) If reagents or waste will be located below the counter, verify a 4” (10.2 cm) opening is available for routing of reagent / waste lines © 2006, 2011 Abbott Laboratories, Abbott Park IL 60064, USA. CELL-DYN Ruby Pre-Installation Checklist v 1.2 Page 1 of 2 ISA 170-003 Clearance Requirements for Service Access Unit Analyzer Above * 12” inches (30.5 cm) Behind 6” inches (15.2 cm) Left Side 16” inches (40.6 cm) Right Side 16” inches (40.6 cm) * FOR OPTIMUM SERVICEABILITY, A MINIMUM OF 16” (40.6 CM) ABOVE THE ANALYZER IS HIGHLY RECOMMENDED DELIVERY ROUTE Measure door width openings from entryway to lab Record all door width measurements ______________________________________________________ (check one) _______ Door and entryway openings are 36" or wider _______ Door and entryway openings are less than 36" but equal to or greater than 32" Note: Removal of instrument from shipping container may be required – Contact the Logistics Product Manager _______ Door and entryway openings are less than 32” Note: Removal of door and hinges by customer may be required, or some disassembly of the system by qualified Abbott field personnel may be required Is there a loading dock Does the loading dock have a raised delivery platform Yes_____ No_____ If No, Contact the Logistics Product Manager Yes_____ No_____ If No, Contact the Logistics Product Manager If any of the following are answered Yes – Contact the Logistics Product Manager Does the instrument have to be transported up or down stairs Yes_____ # of floors/steps_____ Does the instrument have to be transported in a freight elevator Yes_____ Record elevator door width_______ Will the instrument have to be lifted over any barriers Yes_____ Height of barrier______ Will the instrument need to be transported over a grass crossing Yes_____ No_____ No_____ No_____ No_____ MISCELLANEOUS Liquid waste disposal options (select one) ______ External waste container used for liquid waste recovery ______ Floor drain at floor level and located within 10 feet of the liquid waste exit at the side of the instrument Check the type of bar code label the customer is using or will use _____ _____ Codabar Interleaved 2 of 5 _____ _____ Code 39 Code 128 HOST INTERFACE (LIS) LIS COMPANY NAME_________________________________________ PRIMARY LIS CONTACT ______________________________________ TELEPHONE _______________________ SECONDARY LIS CONTACT_____________________________________ TELEPHONE _______________________ FAX______________________ FAX______________________ Has a CELL-DYN Ruby LIS Interface Specification been supplied to the LIS vendor YES____ NO_____ Customer Signature/Title and Date _______________________________________________ Abbott Representative Signature and Date _________________________________________ Fax completed report to Logistics Product Manager CELL-DYN and CELL-DYN Ruby are trademarks of Abbott Laboratories in various jurisdictions © 2006, 2011 Abbott Laboratories, Abbott Park IL 60064, USA. CELL-DYN Ruby Pre-Installation Checklist v 1.2 Page 2 of 2 ISA 170-003 CELL-DYN Ruby System Field Installation Checklist Print and complete this checklist during CELL-DYN Ruby System installation. Installation is complete after verifying that the device performs as intended. Verification will be successful after completion of this installation checklist. The completed checklist and associated printouts will be left for the customer to retain with a copy of the service order invoice. This Installation Checklist contains verification steps that must be entered on the install ticket to complete the installation test and inspection summary. To do this, add Product List # NNNN-Install as a part used. Select the Install part where NNNN = 0+the 3 digit product code of the instrument, e.g. 0170-INSTALL for C-D Ruby. Use Action Taken: N360 “Installed Instrument” with Reason for Action: FA68 “Install VP Documentation”. Click on Get Verification Procedure. This will force the required verification onto the ticket. This part usage can be added when the ticket is created. This will flag users to document the required VPs prior to closing the ticket. Verify that any Active Field Action Mandatory TSB that applies to this instrument has been installed prior to closing the Installation ticket. Note: Installation does not include assay correlation or performance testing that would be included in integration and startup activities. Note: A translated, locally approved, copy of this checklist may be provided by the local service area/country organization. Note: This information was developed for use by Abbott Laboratories trained personnel, by other persons knowledgeable or experienced with the operation and service of the product identified, or under the direct supervision and with co-operation from Abbott Laboratories technical sales or service representatives. In no event shall Abbott Laboratories or its affiliates be liable for any damages or losses incurred in connection with or arising from the use of the information by persons not fully trained by Abbott Laboratories. This limitation shall not apply to those persons knowledgeable or experienced with the operation and service of the product identified, or under the direct supervision and with cooperation from Abbott Laboratories technical sales or service representatives. Note: Refer to the current revision of the CELL-DYN Ruby System Operator’s Manual for detailed procedures and activities. Action 1. Verify Site Requirements Steps Reference 1. Verify service access space on all sides of the instrument: A minimum of six (6) linear feet (1.83 meters) of counter space is needed. For service access, allow six (6) inches (15.2 cm) of clearance behind the instrument, 12 inches (30.5 cm) above and 16 inches (40.6 cm) on the left and right sides of the instrument. 2. Verify sufficient space is available for reagents. Reagents must be placed either at or below instrument level, never above. 3. Instrument waste: Allow waste to drain into a suitable waste container such as an empty, properly labeled cubitainer or an appropriate drain. Direct disposal to drains must be in accordance with federal, state and local requirements. The drain must be suitable for waste that could present a biological or chemical hazard. 4. Environmental considerations: Avoid placement of the instrument in direct sunlight, in the path of cooled or heated air, near centrifuges, X-ray equipment, Magnetic Resonance Imaging (MRI) equipment, Cathode Ray Tubes (CRT's), video terminals, computers, or copiers. 5. Verify that a minimum of three (3) grounded power outlets is available (one each for the Analyzer, Monitor, and printer). Page 1 of 12 Check if Performed 9157085 G October 2014 CELL-DYN Ruby System Field Installation Checklist Action 2. Prepare for Installation Steps Reference 1. Verify that all necessary items are available: analyzer, monitor, printer, keyboard, accessory kit, Sample Loader Rack Kit, reagents, calibrator, controls, Enzymatic Cleaner and HCM. 2. Unpack the accessory kit, printer, and Monitor. Note: 3. Check if Performed Refer to Appendix B of the CELL-DYN Ruby System Operator's Manual for a list of accessory kit items. Inspect items for any obvious signs of damage and/or discrepancy. Document any damaged, deficient, and/or missing items in the space provided below. Be sure to document corrective action taken for these items (i.e., replaced, ordered). __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ __________________________________________________ Note: 3. Prepare Optics Bench Assembly If any items are damaged or missing, contact your local Hematology Customer Service Representative. 1. Open left and right side flow panel door(s), remove center nose cover and WOC flow cell (access) cover (located on the flow panel). Block center nose cover sensor. 2. Remove the instrument’s top, left and right side covers. 3. Loosen all four of the laser bench tie-down screws and remove flow cell lock-down screw, located on the flow cell base plate. Note: Do not re-install covers at this time. 4. Removal of packing material and open probe installation 5. Re-seat cables on printed circuit boards (PCB’s) 1. Locate and remove the bubble wrap material from the Mixer Assembly. 2. Open the inner panel to access the pump assemblies. Locate and remove the bubble wrap material between the Vacuum and Pressure Pump Assemblies. 3. Locate the clear plastic bag (secured to Sample Loader Platen) containing the open probe. 4. Remove the probe retainer plate (two screws) on the Open Tube Sampler Assembly. 5. Remove open probe from plastic bag and secure with retainer plate and screws. 6. Connect the aspiration tubing (from Y-Valve) to top of probe. 1. Open the computer enclosure on the right side by loosening the holding screws. 2. Locate and verify that all cable connections on all PCBs are properly secured and connected. If necessary, reseat cable connections. 3. Close the left inner (access) panel and computer enclosure and secure with corresponding screws. Page 2 of 12 9157085 G October 2014 CELL-DYN Ruby System Field Installation Checklist Action 6. Install Shear Valve Ceramic Center Section Steps 1. Remove right side skirt cover on Sample Loader to fully access the syringes. 2. Remove the protective caps from the syringe Luer-Lok fittings, then manually fill the sample injection syringe with diluent/sheath reagent and attach each of the four syringes to its respective fitting. Ensure the tubing is not twisted when attaching Luer-Lok fittings to syringes. 3. Install each syringe into its respective driver, assuring that the syringe is seated properly in the syringe driver bracket. 1. Install the pinch tubing for the six (6) N/C valves on the front panel: V15, V23, V28, V34, V65, & V66. Note: 9. Connect Reagent and Waste Lines Be sure the notch on the ceramic center section is facing down. 1. Note: 8. Install Tubing Be careful to prevent the polished surfaces from being scratched. Reassemble the shear valve ceramic sections to their operational state and reinstall the shear valve knob, making sure to tighten completely. Note: 7. Install Syringes Ensure that tubing moves easily from side to side and is seated properly. 2. Locate the peristaltic pump (left side of flow panel) and install the pump tubing under the rollers. 1. Connect the reagent lines to the color-coded barbs located at the rear of analyzer. Place the lines in their respective reagent containers. 2. Disposal of waste: • If using an external container, install the waste line assembly. Be sure to plug in and ground the sensor cable. • If not using an external waste container, arrange to run tubing directly into a sink or drain that is suitable for the disposal of waste with possible biological and chemical hazard. Use the waste dummy plug from the CELL-DYN Ruby Accessory Kit to disable “external waste full” sensor. Warning: 10. Inspect Flow Panel Components 1. Check if Performed Remove the shear valve knob and the plastic dummy center section in the shear valve assembly. Locate and unpack the center section of the shear valve, located with the factory setup information packet. Save the plastic dummy center section for future instrument transport. Follow the maintenance procedures from the Operator’s Manual for cleaning and wetting the shear valve sections. Note: 2. Reference The waste is under pressure. Be sure that the Waste Outlet Tube is securely placed in the drain hole or waste box, the flow of waste is unobstructed, and that all System components are located away from any potential waste overflow. Perform a thorough visual inspection of all flow panel components and tubing for any signs of damage, restrictions, kinks, crimps, loose connections, improper seating, etc. Reseat or replace as necessary. Page 3 of 12 9157085 G October 2014 CELL-DYN Ruby System Field Installation Checklist Action 11. Connect Cables 12. Install Printer Steps 1. Install the AC power cords on the Monitor and Analyzer. 2. Connect the VGA and touch-screen USB cable from the Monitor to the Data Module (rear of instrument). 3. Connect the hand held barcode reader, optical mouse, and external keyboard to the Data Module (rear of instrument). 4. Connect the HSSL interface cable between the two designated connection points on the rear panel of the Data Module. 1. Install the printer and power cord. Use the instructions provided in the OEM carton to install the print head and ink cartridges. Install one end of the printer data cable to rear of the Data Module and the other end to printer. Note: 13. Power ON System Reference Check if Performed Note: Refer to the CELL-DYN Ruby System Operator's Manual, Section 1, for assistance on connecting cables to Data Module. It is not necessary to connect the audio speakers. Note: The touch-screen USB cable must be connected to one of the available USB ports. Note: Review the ISA database for specific printer driver installation instructions, if necessary. If connecting to a UPS or line conditioner, use an appropriately rated unit by taking into account power consumption for the analyzer, printer and monitor. This will alleviate an over current condition. 1. Power on the following units: 2. Monitor Analyzer main switch (rear upper right corner) Printer When the instrument indicates “Initialized”, move the cursor to the upper right corner of the screen and click on the Operator ID drop-down arrow to change from Guest to Admin. 3. From the menu bar, click on File, followed by Exit. 14. Touch Screen Calibration 1. Refer to the CELL-DYN Ruby Service Manual, Section 5 Verification Procedures. Perform VP-06 Touch Screen Calibration Procedure. 15. Initialize, Prime and Administrative Setup 1. Click on Start, followed by All Programs, then CDRuby. Wait until the system analyzer status indicates “Initialized”. 2. Move the cursor to the upper right corner of the screen and click on the Operator ID drop-down arrow to change from Guest to Admin. 3. From the menu bar, select Setup, followed by Administrative Setup and click on User Interface Preferences. Select Set Date/Time. Set the current date and time. Select the local time zone, then click Apply and OK. 4. From the toolbar, click on Reagents, followed by New Entry (F6) to set up reagent usage log(s). Complete New Entry (F6) for Dil/Sheath, WBC Lyse and HGB Lyse Reagents. 5. Click on Run View and select Prime (F12) to prime the instrument. Observe the reagent reservoirs for proper filling and reagent sensing. 6. Once the instrument is in the “Ready” state, click on Maintenance, followed by Scheduled, then Auto-Clean and perform an Auto-Clean procedure using Enzymatic Cleaner. Page 4 of 12 Note: If the customer wishes to have the time automatically update for Daylight Savings Time, check the box “Automatically adjust clock for daylight savings changes”. 9157085 G October 2014 CELL-DYN Ruby System Field Installation Checklist Action 16. Voltage Reading Verification/ Adjustments Steps 1. While in the “Ready” state (Open), from the menu bar, select Diagnostics, Digital/Voltage Readings. Click on Check All, Stream. Verify proper pressure levels (Pressure 1 – 3), vacuum levels (Vacuum 1 - Open 2) and HGB Output. 2. Print and retain a copy of the Digital/Voltage Readings screen. Press Stop in the dialog box. 3. Press Select Closed (F11) mode, then press Stream in the Digital/Voltage Readings dialog box and verify vacuum level Closed 2 falls in specification. Note: 17. HGB Reference and Sample Reading Verifications Refer to Table A, Voltage Reading Specifications. If out of specification, troubleshoot as necessary. 4. Print and retain a copy of the Digital/Voltage Readings screen. Select Stop and close dialog box. 1. From the menu bar, select Diagnostics, Diagnostic Views, click on Raw Data Summary. Verify that HGB reference and sample readings are within 2050 ±200. The difference between the HGB sample and reference readings must be ≤ 20 counts after a background cycle. Note: 18. Perform Sample Loader Cycle Test Reference Print and retain a copy of the RAW DATA SUMMARY screen. 1. Unpack the Sample Loader Rack Kit and install the Rack ID labels. 2. Place five (5) racks into the platen on the load side. 3. Place ten (10) normal whole blood sample tubes with bar code labels into random tube slots in the five (5) racks. 4. Press Select Closed (F11). Press the Start Loader (F12) key and observe the following: 5. Table A (Voltage Reading Specifications) Specification Pressure 1 13.0 ± 0.5 PSI Pressure 2 9.0 ± 0.5 PSI Pressure 3 4.25 ± 0.25 PSI Vacuum 1 13.0 ± 0.5" Hg Open 2 2.8 ± 0.2" Hg Closed 2 3.3 ± 0.2” Hg Retic 2 * HGB Output 5.10V ± 0.10Vdc * Vacuum 2 Retic mode is set to 300 (default) in the Setpoints screen. If the readings are out of specifications, refer to VP-5 in the CELL-DYN Ruby System Service Manual and/or troubleshoot as necessary. 2. • Proper rack movement • Proper tube sensing • Proper tube capture and mixing • Proper spinner and needle movement • Proper bar code read • Proper sample aspiration and detection • Verify the following messages appear: Unload area nearly full and Unload area full. Note: Check if Performed If malfunction is observed, refer to VPs 23 through 31 in the CELL-DYN Ruby System Service Manual and/or troubleshoot as necessary. Press Select Open (F11) to continue analyzer operation in open mode. Page 5 of 12 9157085 G October 2014 CELL-DYN Ruby System Field Installation Checklist Action 19. Verify PreAmplifier (0° and 10°) Output 20. Cover Installation 21. Optics Bench Gain Verification/ Adjustments Steps Reference 1. Use a DVM, connect the positive lead to TP1 (signal), the negative lead to TP2 (GND) on the 0° Photodiode PCB, read on the DVM <100mV. 2. If increased voltage reading is observed, remove WOC Flow Cell Dust Cover and pull the WOC Flow Cell out of the beam path, read on the DVM <50mV. 3. If voltage reading is out of specification, refer to Reference section for appropriate Verification Procedure(s) to reference during troubleshooting. 4. Slide the WOC Flow Cell back in, read on the DVM <100mV. 5. Continue with Steps 1 through 3 on the 10° Photodiode PCB. 6. Install WOC Flow Cell Dust Cover. 1. Install WOC flow cell (access) cover (located on the flow panel). 2. Re-install instrument’s top, left and right side covers. 3. Re-install right side skirt cover on Sample Loader. 4. Remove material used to block the center nose cover sensor. 5. Re-install center nose cover. 6. Close left and right side flow panel door(s). 1. Initial Gain Setting: From the menu bar, select Diagnostics, Setpoints 2. Click on the Threshold Level tab and verify the default thresholds, refer to Table B. 3. Click Close to exit window. 4. Prepare a dilution of 7.0 µm Polymer Microspheres to yield a WBC count between 3.0 and 4.0 K/µL. 5. In the Run View, select Diagnostics from the menu bar, then select Auto-Gain Wizard, Enter SRP/FL-CAL Demographics, click Next and follow directions on screen. 6. Verify/Set WOC 0°, 10°, 90°, 90° D & RBC/PLT 0° Gain, running the dilution of 7µm SRP, minimize Auto-Gain Wizard, print and retain a copy of the scatter plots, Mean Channel Numbers and CV’s. 7. Refer to Table C and verify that the WOC Mean Channel Numbers, CVs and Gains are within limits. If not within limits, troubleshoot as necessary. Refer to Table D and verify that RBC/PLT 0° Peak Channel Number is within limits. Check if Performed Refer to VP-33 Optics Bench Cleaning Procedure and VP-18 Optics Bench Alignment Procedure Refer to VP-20 System Gains Verification/Adjustment Note: Refer to factory setup information packet and compare mean channel numbers, CVs and gains to those in Step 7. 8. Continue with Verify/Set RBC/PLT 10° Gain, running 3.3µm SRP. Refer to Table D and verify that RBC/PLT 10° Peak Channel Number is within limits. 9. Verify RBC/PLT 0° Gain, running 5µm SRP. Refer to Table D and verify Peak Channel Number is within limits. 10. Verify RBC/PLT 10° Gain, running 7µm SRP. Refer to Table D and verify Peak Channel Number is within limits. 11. Proceed to Action: 22 Lin RBC 0°/10°/90° Gain Verification/Adjustments Page 6 of 12 9157085 G October 2014 CELL-DYN Ruby System Field Installation Checklist Action Steps Reference Check if Performed Table B (Threshold Level Settings) RBC WOC NOC Lo Retic LIN RBC 550 360 400 100 300 Table C (WOC Channel Specifications) CV Target Peak Gain Channel Limits Channel Settings Ch 1 (0°) ≤ 5% 35 ± 1.5 ≤ 2300 Ch 2 (10°) ≤ 4% Ch 3 (90°) ≤ 13% *Sheet ± 6.0 1200-1700 ≤ 2300 Ch 4 (90° D) ≤ 15% *Sheet ± 10 1200-1700 65 ± 1.5 *Values obtained from Bead – Blood Worksheet Table D (Target Peak Channel Specifications) Channel Target SRP Peak Channel RBC 0° 180 ± 1 7.0 µm RBC 10° 121 ± 1 3.3 µm RBC 0° 129 ± 1 5.0 µm RBC 10° 202 ± 5 7.0 µm 22. Lin RBC 0°/10°/90° Gain Verification/ Adjustments 1. Obtain a refrigerated bottle of HCM. Allow it to warm to room temperature. Note: 2. Verify/Set Lin RBC 0°/10°/90° Gain. 3. Enter the Target Channel Numbers for Lin RBC 0°/10°/90° obtained from the HCM Optical Assay Values. Note: 23. Perform Auto Clean Cycle Mix and handle the HCM the same way as any other CELL-DYN control products. Table E (Gain Specifications) Channel Gain Setting 0° ≤ 3800 10 ° ≤ 2000 90 ° ≤ 3000 Refer to current HCM Optical Assay Values on the GSS Website. 4. Mix the HCM and run the material. 5. Verify Peak Channel Numbers, refer to the HCM Optical Assay Values. Also, verify that gain settings don’t exceed the specifications listed in Table E. 6. Print Auto-Gain Summary. 7. Select Finish to close the Auto-Gain Wizard. 1. From the Maintenance view, Scheduled tab click on Auto-Clean and follow directions on screen. Page 7 of 12 9157085 G October 2014 CELL-DYN Ruby System Field Installation Checklist Action 24. Background Count Verification Steps Reference 1. While in the Open Mode, locate the Specimen ID or QCID box. Select Background from the drop-down menu. 2. Press the touch plate to initiate a background cycle. 3. When cycle is complete, verify background counts are within specifications. Refer to Table F Background Specifications. 4. Repeat Steps 1-3, until results are within specification. If the results continue out of specification after several attempts, troubleshoot as necessary. Table F (Background Specifications) Parameter Specification WOC ≤ 0.10 K/µL NOC ≤ 0.10 K/µL RBC ≤ 0.02 M/µL HGB ≤ 0.10 g/dL PLT ≤ 5.0 K/µL RETC ≤100 counts Note: Be sure to re-select Background from the Specimen ID or QCID box prior to each run. 5. Print and retain a copy of the Background count results. 25. Open Mode Carryover Test (CBC+NOC ) 1. Obtain a normal whole-blood specimen and run the specimen three (3) times in the Open Mode with Patient in Specimen Type and CBC+NOC in Test Selection. (Document "Passed" in Verification on Install Ticket) Note: Be sure to re-select Patient in Specimen Type and CBC+NOC in Test Selection prior to each run. 2. Select Background from the Specimen ID or QCID drop-down menu. 3. Run three (3) background cycles in succession. Note: Be sure to re-select Background from the Specimen ID or QCID box prior to each run. 4. Calculate % carryover as follows for WOC, NOC, RBC, HGB, and PLT. Refer to the Carryover Formula in the Reference section. 5. Refer to Table G for Carryover Specifications. If the results are out of specifications, troubleshoot as necessary. 6. Print and retain the results data, along with the backgrounds that were used to calculate the carryover %. 7. Press the Select Closed (F11) box to place the instrument into the Closed Mode. Page 8 of 12 Check if Performed Note: If customer will run Retic samples, confirm RETC background counts. Table G (Carryover Specifications) Parameter Carryover WOC ≤ 1.0 % NOC ≤ 1.0 % RBC ≤ 1.2 % HGB ≤ 1.0 % PLT ≤ 1.7 % Carryover Formula: % Carryover = (Bkgd #1 - Bkgd #3) ) X 100 ((Sample #3 - Bkgd #3) 9157085 G October 2014 CELL-DYN Ruby System Field Installation Checklist Action 26. Closed Mode Carryover Test (CBC+NOC ) (Document "Passed" in Verification on Install Ticket) Steps Reference 1. Set Default Patient Test Selection to CBC+NOC. To do this go to Setup, Patient Sample Setup, Demographics tab. Refer to Figure 1. 2. Thoroughly mix and place the sample tube from Action 25 step 1 into a rack and place into the load side of the Sample Loader. 3. Press Start Loader and run the same specimen three (3) times through the Closed Mode. Press Stop Loader when complete. 4. Locate Background bar code labels in accessory kit. Attach the labels to three (3) empty tubes and place the tubes into a rack, then place into the load side of the Sample Loader. 5. Press Start Loader and run the tubes through the Closed Mode. Press Stop Loader when complete. 6. Calculate % carryover for Closed Mode as follows for WOC, NOC, RBC, HGB, and PLT. Refer to the Carryover Formula in the Reference section. 7. Refer to Table H for Carryover Specifications. If the results are out of specifications, troubleshoot as necessary. 8. Print and retain the results data, along with the backgrounds that were used to calculate the carryover %. 9. Press the Select Open (F11) box to place the instrument into the Open Mode. 10. Set Default Patient Test Selection back to CBC. To do this go to Setup, Patient Sample Setup, Demographics tab. Refer to Figure 1. 27. Open Mode Carryover Test (CBC) (Document "Passed" in Verification on Install Ticket) 1. Obtain a normal whole-blood specimen and run the specimen three (3) times in the Open Mode with Patient in Specimen Type and CBC in Test Selection. Note: 2. Be sure to re-select Patient in Specimen Type and CBC in Test Selection prior to each run. Check if Performed Figure 1. Table H (Carryover Specifications) Parameter Carryover WOC ≤ 1.0 % NOC ≤ 1.0 % RBC ≤ 1.2 % HGB ≤ 1.0 % PLT ≤ 1.7 % Carryover Formula: % Carryover = (Bkgd #1 - Bkgd #3) ) X 100 ((Sample #3 - Bkgd #3) Carryover Formula: % Carryover = (Bkgd #1 - Bkgd #3) ((Sample ) X 100 #3 - Bkgd #3) Run three (3) air cycles (blank aspirations) in succession with Patient in Specimen Type and CBC in Test Selection.. Note: Be sure to re-select Patient in Specimen Type and CBC in Test Selection prior to each run. 3. Calculate % carryover as follows for WOC, NOC, RBC, HGB, and PLT. Refer to the Carryover Formula in the Reference section. 4. Refer to Table G for Carryover Specifications. If the results are out of specifications, troubleshoot as necessary. 5. Print and retain the results data, along with the backgrounds that were used to calculate the carryover %. 6. Press the Select Closed (F11) box to place the instrument into the Closed Mode. Page 9 of 12 9157085 G October 2014 CELL-DYN Ruby System Field Installation Checklist Action 28. Closed Mode Carryover Test (CBC) (Document "Passed" in Verification on Install Ticket) Steps 1. Thoroughly mix and place the sample tube from action 27 step 1 into a rack and place into the load side of the Sample Loader. 2. Press Start Loader and run the same specimen three (3) times through the Closed Mode. Press Stop Loader when complete. 3. (Document "Passed" in Verification on Install Ticket) Check if Performed Carryover Formula: % Carryover = (Bkgd #1 - Bkgd #3) ((Sample ) X 100 #3 - Bkgd #3) Place three (3) empty tubes into the load side of the Sample Loader. Note: 29. Open Mode Precision Reference Do NOT label tubes with Background bar code labels. 4. Press Start Loader and run the tubes through the Closed Mode. Loader will stop after third tube with “3 Consecutive Short Samples”. 5. Calculate % carryover for Closed Mode as follows for WOC, NOC, RBC, HGB, and PLT. Refer to the Carryover Formula in the Reference section. 6. Refer to Table H for Carryover Specifications. If the results are out of specifications, troubleshoot as necessary. 7. Print and retain the results data, along with the backgrounds that were used to calculate the carryover %. 8. Press the Select Open (F11) box to place the instrument into the Open Mode 1. From the menu bar, select Calibration, Quick Precision Check…. In the Quick Precision Check dialog box, verify Open Mode is displayed. Select New Precision Check. 2. Obtain a normal whole-blood specimen. 3. Thoroughly mix and run the specimen in the Open mode. 4. Complete ten (10) consecutive cycles. 5. Verify that results (except MPV and RDW) display “PASS”. If results are not within specification, troubleshoot as necessary. 6. Print and retain a copy of the Open Mode Precision check. 7. Press the Select Closed (F11) box to place the instrument into the Closed Mode. Note: Refer to the CELL-DYN Ruby Operator’s Manual, Section 4, for the whole blood ranges used for imprecision testing. Table I (Open/Closed Precision Specifications) Parameter CV% WOC ≤ 2.4 NOC ≤ 2.8 RBC ≤ 1.8 HGB ≤ 1.4 MCV ≤ 0.8 PLT ≤ 3.8 Note: Evaluation of CV% for MPV and RDW is not required. 30. Closed Mode Precision (Document "Passed" in Verification on Install Ticket) 1. Obtain sufficient volume of normal whole blood from a single donor within four (4) hours of draw to complete ten (10) runs. 2. Pool, mix, and aliquot into unused, red top (nonanticoagulant) tubes. WOC ≤ 2.4 3. Open the Quick Precision Check… dialog box. Verify Closed Mode is displayed. Select New Precision Check. NOC ≤ 2.8 4. Thoroughly mix and run the specimen tubes in the Closed mode. RBC ≤ 1.8 HGB ≤ 1.4 MCV ≤ 0.8 PLT ≤ 3.8 5. Keep running the rack in Closed mode for a total of ten (10) runs. 6. Verify that results (except MPV and RDW) display “PASS”. If results are not within specification, troubleshoot as necessary. 7. Print and retain a copy of the Closed Mode Precision check. Page 10 of 12 Table J (Open/Closed Precision Specifications) Parameter CV% Note: Evaluation of CV% for MPV and RDW is not required. 9157085 G October 2014 CELL-DYN Ruby System Field Installation Checklist Action Steps Reference 31. Run Quality Control Material 1. Run controls. Print and retain a copy of the Low, Normal and High Control files. 32. Backup Setpoints 1. From the menu bar, select File, Backup…. The Backup dialog box opens. 2. Place a labeled floppy disk in the disk drive. 3. In the Backup to floppy field, select the Start Backup button. The dialog box will indicate the status. 4. When backup is complete, the message: “Backup Completed successfully” displays. 5. Remove the floppy disk from the disk drive and store it in a safe location. 33. LIS Checkout Note: If applicable, follow VP-13, LIS Communication Verification, in the CELL-DYN RUBY System Service Manual to verify the analyzer data transmission. 34. Operator’s Manual Installation Note: Refer to the CELL-DYN RUBY System Service Manual and/or applicable ISA for instructions on installing/loading the operator’s manual. 35. Local Language Setup Note: Refer to the CELL-DYN RUBY System Service Manual and/or applicable ISA for instructions on setting the system to the local language. Check if Performed Note: Calibration will be performed and control recovery verified during system integration. Be sure to install the correct language keyboard in addition to setting up the system. If Russian or Chinese (Simplified) is the desired language, then CDROM (C) LANG RUS CHS CDRUBY (8938167801) must be ordered and installed per VP-60 Russian and Chinese (Simplified) Language Pack Installation. DO NOT install if Russian or Chinese (Simplified) are NOT the desired language. 36. Assemble Documentation 1. Assemble the following printouts for future use. Sign and date all documents. • Digital/Voltage Readings screen (closed and open) • Raw Data Summary screen • Auto Gain Summary • Background counts • Open and Closed Mode Carryover (COtest QCID) • Open and Closed mode precision checks • Low, Normal and High Control QCID files Page 11 of 12 9157085 G October 2014 CELL-DYN Ruby System Field Installation Checklist Action 37. Document the Install Steps 1. 2. 3. Reference Check if Performed Document successful completion of the installation in your local call management system. If TSBs have been installed, you must close those tickets to report TSB completion. Ensure that P/N “0170-Install” is documented in Usage. a. Use Action Taken: N360 Installed Instrument and Reason for Action: FA68 Install VP Documentation b. Click on Get Verification Procedure c. Enter Verification test summary, e.g. mark “Passed” or enter results if required by verification procedure. Assemble factory setup information packet (envelope with multiple pages), installation print-outs and a copy of this installation checklist. Provide a copy of these documents to the customer for their records. Note: Refer to Local Area Service and Support Organization procedures and make additional copies as necessary. Instrument Serial Number_____________________________ Software Version_____________________________ FSR Print Name______________________________ FSR Signature ______________________ FSR ID# _____________ Date ___________________ Primary Operator Signature ___________________________ Date ___________________ Comments ________________________________________ _________________________________________________ _________________________________________________ _________________________________________________ _________________________________________________ _________________________________________________ _________________________________________________ CELL-DYN Ruby Service and Support Information Copyright ©2008, 2014 CELL-DYN is a trademark of Abbott Laboratories in various jurisdictions. Abbott Park, Illinois 60064. All rights reserved. Luer-Lok is property of its respective owner. Page 12 of 12 9157085 G October 2014 ® CELL-DYN Ruby System Field Integration Checklist Action Steps Verify Maintenance 1. Ensure that all required maintenance has been performed. Refer to the CELL-DYN Ruby System Operator’s Manual, Section 9: Service and Maintenance. Verify Background Counts 1. Run a Background count in Open Mode. Verify that results are within specifications. Note: Refer to Table A for Background Specifications. If the values are out of specifications, troubleshoot as necessary. 2. Verify Open Mode Precision Print and retain a copy of the Background count. 1. Obtain a normal whole blood specimen within four (4) hours of draw. 2. From the menu bar, select Calibration, Quick Precision Check…. In the Quick Precision Check dialog box, verify Open Mode is displayed. Select New Precision Check. 3. Thoroughly mix and run the specimen in the Open mode. 4. Complete ten (10) consecutive cycles. 5. Verify that results (except MPV and RDW) display “PASS”. If results are not within specification, troubleshoot as necessary. 6. 7. Check if Performed Reference Print and retain a copy of the Open Mode Precision check. Press the Select Closed (F11) box to place the instrument into the Closed Mode. Table A (Background Specifications) Parameter WOC Specification < 0.10 x 103/μl NOC < 0.10 x 103/μl RBC < 0.02 x 106/μl HGB < 0.10 x 103/μl PLT < 5.00 x 103/μl Note: Refer to the CELL-DYN Ruby Operator’s Manual, Section 4, for the whole blood ranges used for imprecision testing. Table B (Open/Closed Precision Specifications) Parameter CV% WOC < 2.4 NOC < 2.8 RBC < 1.8 HGB < 1.4 MCV < 0.8 PLT < 3.8 Note: Evaluation of CV% for MPV and RDW is not required. Verify Closed Mode Precision 1. Obtain sufficient volume of normal whole blood from a single donor within four (4) hours of draw to complete ten (10) runs. 2. Pool, mix, and aliquot into five (5) unused, red top (nonanticoagulant) tubes. 3. Open the Quick Precision Check… dialog box. Verify Closed Mode is displayed. Select New Precision Check. 4. Thoroughly mix and run the specimen tubes in the Closed mode. 5. Keep running the rack in Closed Mode for a total of ten (10) runs. 6. Verify that results (except MPV and RDW) display “PASS”. If results are not within specification, troubleshoot as necessary. 7. Print and retain a copy of the Closed Mode Precision check. Page 1 of 5 9157087 B DEC 2008 ® CELL-DYN Ruby System Field Integration Checklist Action Verify Pre-Calibration Perform Auto Calibration Steps Reference 1. Verify that all reagents are at least 1/3 full and if a waste container is used, that it is half empty. 2. Verify the correct List Numbers and expiration dates. 3. From the menu bar, select Calibration, Manual Calibration. In the Manual Calibration dialog box, select the Calibration Factors tab, then print and retain a copy of the current Open and Closed Mode Calibration Factors. Label the sheets as “current”. 4. Select the Dilution Factors tab to display the current Open and Closed Mode Dilution Factors. 5. Print and retain a copy of the Open and Closed Mode Dilution Factors and label as “Current”. 1. Refer to the CELL-DYN Ruby System Operator’s Manual, Section 6: Calibration Procedures and perform an Auto Calibration in the Open Mode using calibrator. Check if Performed Note: Before beginning, obtain six (6) normal whole blood specimens within four (4) hours of draw for the Open/Closed Mode Bias Check 2. From the menu bar, select Calibration, Auto-Calibration Wizard. In the Auto-Calibration Wizard dialog box, confirm that Open is selected in the Sample Mode field. Select Next >. 3. Proceed through subsequent dialog boxes to verify PreCalibration steps. When the Auto Background cycle is complete, select Next >. 4. In the Calibrator Setup dialog box, enter the calibrator information and assay values. Enter “6” for the number of runs for calibration. Select Next >. 5. Run the calibrator 6 times. Select Next >. 6. Follow the instructions in the Auto-Calibration Wizard to apply new factors and continue with the Open/Closed Mode Bias Check. Note: when new open mode factors are applied, the factors are copied to the closed mode. Perform Open/Closed Mode Bias Check 1. Follow the instructions in the Auto-Calibration Wizard to perform the Open/Closed Mode Bias Check. 2. Apply new factors (if necessary) to adjust open/closed mode bias. Print AutoCalibration Summary 1. When the “Auto-Calibration Completed Successfully!” screen appears, select Print to print the Auto-Calibration Summary. Page 2 of 5 9157087 B DEC 2008 ® CELL-DYN Ruby System Field Integration Checklist Action Customize Software QCID File Setup Steps 1. Coordinate with the customer and set up the following: • • • • • • • • • • • • • • • • • • • • • • • • • • 1. Reference Check if Performed Customize Run View: - Chartable Page (Parameter Sets) - Lab Page - Graphs Page Units Selection Data Log View QC View Customize Printed Report - Header - Printed Report options Patient Sample Setup - Limits - Default Patient Test Selection Orders Setup (Automatic Orders Cleanup) QC Download ID File Setup Moving Averages - Moving Average View - Moving Average Acceptance Setup - Monitor Off/On User Interface Preferences (QCID Daily Cleanup) LIS setup (Auto and Manual Transmission) Operators Setup - Operator Account setup - Laboratory I/Laboratory II customization Set up QCID files for each level (Low, Normal and High) of commercial control. Note: Refer to the CELL-DYN Ruby System Operator's Manual for instructions on the automated upload of assay values from a QC Disk. 2. Run all three levels of commercial controls per the customer's laboratory practice and verify that the results are within assay range. If results are not within assay ranges, troubleshoot as necessary. Page 3 of 5 9157087 B DEC 2008 ® CELL-DYN Ruby System Field Integration Checklist Action Retic QCID File Setup Steps The following steps should be performed if customer will be running the Reticulocyte Assay. 1. Set up Retic QCID files for each level (Level I and II) of reticulocyte control. Note: Refer to the CELL-DYN Ruby System Operator's Manual for instructions on running the Reticulocyte Assay. Backup Setup 2. Run a reticulocyte background count. Verify that results are within specification. 3. Run both levels (I and II) of reticulocyte control per the customer's laboratory practice and verify that the results are within assay range. If results are not within assay ranges, troubleshoot as necessary. 1. Perform a backup of the Calibration Factors, QC Limits, Patient Limits and Analyzer Setpoints. Reference Table C (Background Specifications) Parameter RETIC Check if Performed Specification < 100 counts Note: Refer to the CELL-DYN Ruby System Operator's Manual, Section 6: Calibration Procedures, Subsection: Post-Calibration Procedure. Verify Completion 1. While on site, run each level of control daily for a minimum of five (5) to ten (10) runs each, and verify that each level's mean falls within expected assay ranges. If results are not within expected ranges, troubleshoot as necessary. 2. Ensure correlations have begun and results are acceptable. 3. Assure performance of instrument meets customer's expectations after the installation is complete. Note: Refer to Local Area Service and Support Organization procedures to discuss follow-up schedule with customer as needed. Assemble Final Documentation 1. • • • • • • • • Train Additional Operators Assemble the following documents for future use. Sign and date all documents. Background counts Open and Closed mode precision results Current Open and Closed mode Calibration Factors Current Open and Closed mode Dilution Factors Auto-Calibration Summary printout Calibrator assay sheet All three levels of controls QCID files Include reticulocyte documentation if run, background count, and controls Additional Operators Trained Date Trained Page 4 of 5 9157087 B DEC 2008 ® CELL-DYN Ruby System Field Integration Checklist Action Document the Installation Steps Reference 1. Document successful completion of the installation in your local call management system. 2. Assemble all documents and ensure copies are issued to the customer. Check if Performed Note: Refer to Local Area Service and Support Organization procedures and make additional copies as necessary. Sign Document Anticipated “On-Line” Date:__________________ Additional comments or any problems requiring follow-up: ________________________________________ ________________________________________ ________________________________________ ________________________________________ ________________________________________ People informed at the completion of the install: Field Service____________________________________ HPS____________________________________ SR_____________________________________ Optional: DSM____________________________________ HDM____________________________________ TS Signature: _____________________ Date: __________ Customer Signature: _________________ Date: __________ CELL-DYN Ruby Service and Support Information ©2008 CELL-DYN is a registered trademark of Abbott Laboratories, Abbott Park, Illinois 60064. All rights reserved. Luer-Lok is a registered trademark of Becton Dickinson Company. Page 5 of 5 9157087 B DEC 2008 CELL-DYN Ruby PM #1 Sub-Process Bar 1 2 3 ShortNote Reminders General Attention Activator SafetyWarning Overview Instructions & Explanations 4 5 Picture/info on right 6 7 CD Ruby Service Manual CD Ruby Operator’s Manual Target 4 hours 1 1.4 & 17.1 Background Specifications 1 Review Initial Condition 1.1 Wear all PPE 1.2 Review Event Log & Data Log 1.2a Interview customer about performance & issues 1.2b Correct outstanding issues 1.3 Review QC, X-B 1.3a Correct outstanding issues 1.4 Verify: ISA/TSB status, background, control recovery 1 1.5 Run 1 patient minimum five times in open Note: Reference Customer Control File (the customer might have set mode precision to verify instrument their own means) and or Assay sheet. operation 2 1.6 Observe instrument operation during step 2 1.5 & 20.7 Precision Specifications 1.5 which will help identify potential issues 1.7 Run 5 samples into WB QCID file. Retain for use at completion of PM 1.8 Inspect closed aspiration vent needle for damage. Verify vent is clear of blockage. Replace as needed Note: Vent needle can be verified by observing the Vent Trap during a close mode cycle and look for fluid entering the vent trap. 1.9 Review and Print: Cal Factors, Dil Factors, Setpoint screen 1.10 Run 7μm SRP, verify data of Optical WBC CV's before PM is started for reference later. 2 Decontaminate Instrument 2.1 Flush flow cell and waste lines to WC-1 through V56 using 10% bleach. Let sit minimum 5 minutes. Replace WC and tubing from flow cell to WC-1 if damaged 3 2.2 Run 3 tubes 10% bleach through SL to clean closed aspiration pathway and decontaminate the blood pathways. 3 2.1 Flushing Optical Flow Cell CD Ruby Flushing the Optic Flow Cell and WC1.wmv 3 Fans 3.1 Inspect 4 external fans for proper operation. Replace if non-functional & date 3.1a Replace fans every 2 years & date 3.2 Perform Page 469 - Clean Fan Filter p 9-49 ISA 170-003T January, 2015 ©2012, 2015 Abbott Laboratories, Abbott Park, IL 60064 For Internal Use Only CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. Page 1 of 5 CELL-DYN Ruby PM #1 4 8.2 Bleaching Waste Chambers CD ruby cleaning WC3.wmv 4 Solenoids 6 4.1 In Diagnostic, close all Solenoids, VP-09 Solenoid Operation Verifications 4.2 Press on individual solenoids check that they are fully closed. (Solenoids no addition movement) 4.3 Note any solenoids that do click closed for further action later NOTE: Do this before replacing tubing 4.4 Inspect each solenoid for salt buildup, corrosion or rust 4.5 Note any solenoids that show size of rust or salt build up. 5 Front Panel 5.1 Turn instrument off 5.2 Inspect open & closed mode wash blocks for damage. Replace as needed. 5.3 Inspect open probe for damage. Replace as needed 6 Mixing Chambers 6.1 Inspect RBC & WBC mixing chambers for corrosion, leaks or excessive buildup 5 9.1 Waste Line Check 6.2 Confirm metal inlet ports are not loose 7 Reservoir 7.1 Inspect for leaks 7.2 Confirm metal posts are intact & no salt buildup 7.3 Confirm inlet tubing for diluent is not crimped or restricted 7.4 Correct as needed 8 Waste Chambers 8.1 Inspect all WC for cracks, leaks, plumbed correctly 8.2 If WC-3 has a lot of buildup, remove & clean with bleach 4 NOTE: This may take 30 minutes or more 8.3 Replace WC as needed 9 Waste Line 9.1 Check date on tag for waste line to cube 5 9.2 Replace if > 6 months or close to that time NOTE: Do not replace if system is connected to a permanent drain 10 Syringe Drives 10.1 Inspect and Clean Syringe Drives as needed ISA 170-003T January, 2015 ©2012, 2015 Abbott Laboratories, Abbott Park, IL 60064 For Internal Use Only CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. Page 2 of 5 CELL-DYN Ruby PM #1 10.2 Check all syringes, brackets & luer fittings. Replace as needed 11 Peristaltic Pump 11.1 Inspect peri-pump for damage 11.1a Replace if needed 11.2 Clean shoe and rollers 11.3 Replace peri-pump tubing with customer stock based on customer replacement schedule. 6 4, 12, & 13 Solenoids , Tubing & Check Valves CD Ruby Tubing Map Kit Bag PN Tubing PN Length (Inch) Quantity Valve # 12 Solenoids 6 12.1 Blow out each solenoid with canned air 12.2 Clean or Replace damaged solenoids identified in section 4 1-1 1-2 1-4 1-7 1-8 2-1 2-2 2-4 2-5 2-6 9360024 93476-01 1.3 50 2-7 4-4 3-1 4-5 3-2 4-6 3-3 5-1 3-6 5-2 3-7 5-4 3-8 5-5 4-1 5-7 4-2 6-1 4-3 6-2 6-3 6-4 6-7 9-1 9-3 9-4 9-5 9-6 9-8 9360025 93476-01 1.5 15 1-5 2-3 2-8 3-4 6-8 9-2 9-7 V3 13 Tubing & Check Valves 6 13.1 Replace all Silicone tubing in all pinch valves 13.1a Remember solenoids on VPM 13.2 Inspect all Tygon tubing for damage & replace as needed 13.3 Replace check valve on vent assembly 14 HGB Flow Cell 7 14.1 Inspect tubing for kinks or damage 14.2 Inspect connections including metal fittings 14.3 Replace any damaged component 15 Pressure Sensor Kit Bag PN Tubing PN Length (Inch) Quantity Valve # 9360239 93476-01 2.0 1 5-6 9360240 93476-01 3.0 1 1-3 9360241 93476-01 3.5 1 6-5 Kit Bag PN Tubing PN Length (Inch) Quantity Valve # 9360243 93476-01 5.5 1 6-6 9360244 93177-01 3.0 1 V1 9360245 93177-01 8.0 1 V4 9360242 93476-01 4.0 2 V2 V5 7 14 HGB Flow Cell Ruby VP 39 Flushing HGB Flow Cell.wmv 15.1 Replace pressure sensor. 15.2 Turn instrument on and prime. 16 Vacuum /Pressure Subassembly 16.1 Inspect Vacuum & Pressure accumulators for cracks, excessive salt buildup 16.1a Replace pressure accumulator 1 every two (2) years. 16.2 If needed, vacuum accumulators can be checked by confirming the resistance between the 2 leads is more then 20 MegaOhms. 16.3 Perform VP-44 Vacuum Accumulator 1 and 2 Rinsing Procedure if needed 16.4 Perform VP-16 Vacuum & Pressure Level Verification/Adjustment 17 Laser Bench 17.1 Confirm background within spec 1 17.2 Run at least 1 sample to confirm proper scatter before performing optical checks/alignment ISA 170-003T January, 2015 ©2012, 2015 Abbott Laboratories, Abbott Park, IL 60064 For Internal Use Only CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. Page 3 of 5 CELL-DYN Ruby PM #1 17.3 Verify Optical WBC CVs referencing VP-18 Optics Bench Alignment Procedure 8 17.3 WBC Mean Channel & CV Specifications beginning at step “Perform Verification” using diluted 7.0 SRP 8 17.4 If CVs are out of spec: 17.4a Perform complete VP-18 Optics Bench Alignment Procedure NOTE: : If CVs are within specs& no Diff issue reported by customer, there is no need to clean or align bench 18 Autoloader 18.1 Perform Page 437 – Clean Loader Components p 9-16 NOTE: Do not use bleach or alcohol on grippers 18.2 If excessive diluent on platen, verify operation of detent pins 18.3 Clean detent pins 9 18.4 Replace tube grippers every 24 months 18.5 Inspect cable and Tube Sensor board for corrosion replace if needed 10 18.5a Clean or adjust Tube Sensor as needed VP-58 Tube Sensor Adjustment 18.6 Clean Forward Indexer & Pawls. Confirm spring action 11 18.7 Clean Sweep Arm Bushings. Do not oil or lube 12 18.8 Inspect Spring on Sweep Arms. Replace every 2 years or as needed F1.07 Autoloader Sweep Arm Spring Replacement Procedure 18.9 Clean Bar Code Reader. Adjust position as needed VP-11 Bar Code Reader Verification/Alignment 18.10 Perform the following VPs: 18.10a VP-23 Tower Unit Stop Solenoid Verification 18.10b VP-24 Bar Code Spin Assembly Verification Offset Specifications Pull the flow cell out of the beam path. Adjust the front mirror Y screw for minimum reading on the DMM. The end result should be a reading of < 50 mV for the OFFSETS for both the 0 and 10 degree photodiodes. With Diluent in the flow cell the reading should be <100 mV. 9 18.3 Clean Detent Pins 10 18.5 Inspect Tube Sensor 18.10c VP-25 Tube Height Sensors (S1/S2) Verification 18.10d VP-26 Mixer Up/Down Verification 18.10e VP-27 Mixer Head Rotation Verification 18.10f VP-28 Mixer Bladders Verification 18.10g VP-29 Rack Advance & Tube Sensors Verification 18.10h VP-30 Cross Transfer Arms & Rack Sensors Verification 18.10i VP-31 Mixer Bladders Pressure ISA 170-003T January, 2015 ©2012, 2015 Abbott Laboratories, Abbott Park, IL 60064 For Internal Use Only CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. Page 4 of 5 CELL-DYN Ruby PM #1 Verification/Adjustment 11 18.6 Clean Forward Indexer & Pawls 19 Data Station 19.1 19.2 19.3 19.4 19.5 Clean inside data station Clean keyboard Clean external barcode reader Clean monitor Clean mouse 20 Final Verification Procedures 20.1 After every Verification procedure print out results and save when possible. 20.2 Perform VP-15 Vacuum & Pressure Retention Verification 12 18.7 Clean Sweep Arm Bushing 20.3 Perform VP-05 HGB Current Verification/Adjustment 20.4 Set optical Gains and linear Gains Referencing VP-20, System Gains Verification /Adjustment.. 20.5 Run 5 samples in CBC NOC mode (saved from beginning of PM) on sample loader. Compare to results pre & post PM 20.6 Verify Carryover by running 3 backgrounds following step 20.5. 13 20.7 Verify Open and Closed precision & confirm within specs 2 20.8 Verify Mode to Mode Bias check. 13 20.6 Carryover Calculation & Specifications 20.9 Run a minimum of one batch in Moving Average, if customer is monitor X-B 20.10 Review X-B 20.11 \ Verify all controls are within specs 20.12 Perform Calibration, Section 6 as needed 20.13 Verify LIS operation VP-13 LIS Communication Verification 20.14 Perform Backup VP-48 Backup Procedure 20.15 Close PM Activity on Call Management System. Talsico® Process Picture Maps™ & all associated intellectual property are owned by Talsico International, ABN 20 419 167 619, & subject to licensing Agreement End of document ISA 170-003T January, 2015 ©2012, 2015 Abbott Laboratories, Abbott Park, IL 60064 For Internal Use Only CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. Page 5 of 5 CELL-DYN Ruby Total Call Sub-Process Bar 1 2 ShortNote Reminders 4 5 Picture/info on right General Attention Activator SafetyWarning Overview 3 6 7 CD Ruby Service Manual CD Ruby Operator’s Manual Target 45 minutes Instructions & Explanations 1 Review Initial Condition 1.1 Wear all PPE 1.2 IF ANY OF THE FOLLOWING ITEMS WERE DONE DURING THE INSTRUMENT SERVICING YOU DO NOT HAVE TO REPEAT. 1.3 Review Event Log & Data Log 1.4 Verify: ISA/TSB status, background, control recovery 1 1.5 Print: Cal Factors, Dil Factors, Setpoint screen if you have made changes during the service call. 1 1.4 & 15.6 Background Specifications 2 Fans 2.1 Inspect 4 external fans for proper operation. Replace if non-functional & date 2.2 Verify Fan Filters are clean referencing Page 469 - Clean Fan Filter p 9-49 Note: Reference Customer Control File (the customer might have set their own means) and or Assay sheet 3 Front Panel 3.1 Inspect open & closed mode wash blocks for damage. Replace as needed 3.2 Inspect open probe for damage. Replace as needed 3.3 Inspect closed aspiration vent needle for damage. Verify vent is clear of blockage. Replace as needed Note: Vent needle can be verified by observing the Vent Trap during a close mode cycle and look for fluid entering the vent trap. 2 7.1 Waste Line Check 4 Mixing Chambers 4.1 Inspect RBC & WBC mixing chambers for corrosion, leaks or excessive buildup 4.2 Confirm metal inlet ports are not loose 4.3 Inspect for leaks 4.4 Confirm metal posts are intact & no salt buildup 4.5 Correct as needed 5 Reservoir 5.1 Inspect for leaks 5.2 Confirm metal posts are intact & no salt buildup ISA 170-003T Januray, 2015 3 10 & 11 Solenoids , Tubing & Check Valves CD Ruby Tubing Map ©2012, 2015 Abbott Laboratories, Abbott Park, IL 60064 For Internal Use Only CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. Page 1 of 3 CELL-DYN Ruby Total Call 5.3 Correct as needed 4 12 HGB Flow Cell Ruby VP 39 Flushing HGB Flow Cell.wmv 6 Waste Chambers 6.1 Inspect all WC for cracks, leaks, plumbed correctly 6.2 Replace WC as needed 7 Waste Line 7.1 Check date on tag for waste line to cube 2 7.2 Replace if > 6 months or close to that time NOTE: Do not replace if system is connected to a permanent drain 8 Syringe Drives 8.1 Inspect each syringe drive if they appear to be damaged, dirty referencing H1.01 Syringe Driver Assembly 8.2 Check all syringes, brackets & luer fittings. Replace as needed 5 15.3 WBC Mean Channel & CV Specifications 9 Peristaltic Pump 9.1 Inspect peri-pump tubing 9.2 Replace with customer stock as needed based customer schedule 10 Solenoids 3 10.1 Visually inspect each solenoid for salt buildup, corrosion or rust 10.2 Replace damaged solenoids 11 Tubing 3 11.1 Inspect all Silicone tubing in all pinch valves 11.1a Remember solenoids on VPM 11.2 Replace as needed 11.3 Inspect all Tygon tubing for damage & replace as needed 6 14.1 Inspect Tube Sensor 12 HGB Flow Cell 4 12.1 Inspect tubing for kinks or damage 12.2 Inspect connections including metal fitting 12.3 Replace any damaged component 13 Other 13.1 Inspect Vacuum & Pressure accumulators for cracks, excessive salt build up 14 Autoloader 14.1 Inspect tube sensor & for corrosion in connector 6 14.1a clean or adjust as needed VP-58 Tube Sensor Adjustment ISA 170-003T Januray, 2015 ©2012, 2015 Abbott Laboratories, Abbott Park, IL 60064 For Internal Use Only CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. Page 2 of 3 CELL-DYN Ruby Total Call 14.2 Clean Forward Indexer and Pawls as 7 14.2 Clean Forward Indexer & Pawls needed. Confirm spring action 7 14.3 Clean detent pins as needed 8 14.4 Clean Sweep Arm Bushings as needed. Do not oil or lube 9 14.5 Clean Bar Code Reader. Adjust position as needed VP-11 Bar Code Reader Verification/Alignment 14.6 Clean racks, platen, & rack barcode labels as needed Page 437 – Clean Loader Components p 9-16 15 Final Verification Procedures 8 14.3 Clean Detent Pins 15.1 Perform VP-15 Vacuum & Pressure Retention Verification 15.2 Perform VP-16 Vacuum & Pressure Level Verification/Adjustment 15.3 Verify optical CV within specification using 7 um beads. If not in specifications, do alignment per VP-18 Optics Bench Alignment Procedure 5 9 14.4 Clean Sweep Arm Bushing 15.4 Verify HGB voltage is 5.1 VP-05 HGB Current Verification/Adjustment 15.5 Verify each SL rack movement 15.5a run a minimum of 2 racks with 5 sample tubes spread out 15.6 Run background & verify within specs 1 15.7 Verify Open and Closed precision & confirm within specs Calibration, Section 6 page 6-18 10 15.8 Review X-B 15.9 Verify all controls within specs 15.10 Verify no aspiration errors when running 10 15.7 Precision Specifications the High control in Step 15.7. 15.11 Perform Calibration, Section 6 as needed 15.12 Verify LIS operation VP-13 LIS Communication Verification 15.13 Perform Backup if and Calibration or Gains were changed VP-48 Backup Procedure Talsico® Process Picture Maps™ & all associated intellectual property are owned by Talsico International, ABN 20 419 167 619, & subject to licensing Agreement End of document ISA 170-003T Januray, 2015 ©2012, 2015 Abbott Laboratories, Abbott Park, IL 60064 For Internal Use Only CELL-DYN Ruby is a trademark of Abbott Laboratories in various jurisdictions. Page 3 of 3 Cell Dyn Ruby PM Checklist Text PM Initial Condition Front Panel Laser Bench Auto Loader Data Station Verification Total Call Initial Condition Front Panel Auto Loader Verification ISA 170-003T Percent Complete 0% 0% 0% 0% 0% 0% Percent Complete 0% 0% 0% 0% Page 1 of 1 Cell Dyn Ruby PM Check List Analyzer S/N : FSR ID : Date : Customer Name: City: Phone Number: 1 CHECK INITIAL CONDITION 0 13 12/10/2015 0% REVIEW AND VERIFY FALSE Review SYS LOG and DATA LOG. Interview customer about performance, issues, etc FALSE Review QC, X-B, CAL History, Dilution factors FALSE Verify ISA and TSB Status FALSE Verify background counts are within range FALSE Verify control counts are with in range FALSE Run open mode quick precision FALSE Observe instrument operation during precision to help identify potential issues FALSE Run 5 samples in control file and retain samples for use at the completion of PM FALSE Inspect closed aspiration vent needle for damage or blockage, replace as needed FALSE Run 7μm SRP, verify data of Optical WBC CV's before PM 0 10 FALSE Print the following data screens: CAL Dil 90 90D Set Point DECONTAMINATE INSTRUMENT FALSE Flush flow cell and waste lines to Waste Chamber 1 through V56 using 10% bleach FALSE FALSE Run 3 tubes of 10% Bleach on Sample loader Do a Prepare for Shipping with 10% bleach FANS FALSE Inspect all four external fans for proper operation, replace if non-functional or every 2 years, and date FALSE Clean all fan filters 2 FRONT PANEL 0 24 0% FLOW PANEL FALSE Inspect both Open and Closed Wash Blocks and Sample Probes, Inspect Vent to Close Mode Probe MIXING CHAMBERS FALSE Inspect RBC and WBC Mixing Chambers for corrosion, leaks, or excessive buildup FALSE Confirm metal inlet ports are not loose RESERVOIR FALSE Inspect reservoirs for leaks FALSE Confirm metal posts are intact and there is no salt buildup FALSE Confirm inlet tubing for diluent is not crimped or restricetd, correct as needed WASTE CHAMBERS FALSE Inspect all waste chambers for cracks or leaks FALSE Check date on Waste line to cube, replace if greater then six months or nearing that time FALSE If WC-3 has a lot of buildup, remove and clean with bleach (this may take 30 minutes or more) SYRINGE DRIVES FALSE Inspect and clean each of the Syringe Drives FALSE Check all syringes, brackets and luer fittings, replace as needed FALSE HGB Syringe 2.5 ml FALSE Diluent Syringe 10.0 ml FALSE WBC Lyse Syringe 2.5ml FALSE Injection Syringe ISA 170-003T Page2 of 10 Cell Dyn Ruby PM Check List Analyzer S/N : FSR ID : Date : Customer Name: City: Phone Number: 12/10/2015 PERISTALTIC PUMP FALSE Inspect the peripump for damage, replace if needed FALSE Clean shoes and rollers FALSE Replace Peri-Pump tubing with customer stockbased on customer replacement schedule SOLENOIDS AND TUBING FALSE Inspect each of the Solenoids for salt buildup, corrosion, or rust. Replace as needed FALSE Blow out each solenoid with canned air FALSE Replace all Silicone tubing in all valves, including solenoids on VPM FALSE Inspect all Tygon Tubing for damage, replace as needed FALSE Replace all check valves on Flow Panel HGB FLOW CELL Clean HGB Flow Cell with 10% Bleach FALSE FALSE FALSE Inspect tubing for kinks or damage Inspect all fittings, Y tubing connections including the metal fittings, and reagent inlet lines PRESSURE SENSOR FALSE Replace Pressure Sensor SHEAR VALVE Lube the Shear Valve driver FALSE FALSE Clean Shear Valve Ceramics FALSE Replace all Check valves in the Pneumatics area OTHER FALSE Inspect Vacuum and Pressure Accumulators for cracks or excessive salt build up Replace Pressure Accumulator 1 every two (2) years and date. 3 LASER BENCH FALSE 0 2 0% Confirm the Initialization and the prime of the system LASER BENCH FALSE Run at least 1 sample to confirme proper scatter before performing optical checks/alignment FALSE Confirm Optical CV's, do not clean or align bench if CVs are within specs and no issues reported by customer 4 AUTOLOADER 0 10 0% GENERAL FALSE FALSE FALSE Clean tube Sensor Inspect cable to Tube Sensor board for corrosion, replace if needed Clean tube grippers with DI water, do not use bleach or alcohol FALSE Replace Tube Grippers every two years INDEXERS FALSE Clean Forward Indexer and pawls, including spring action DETENT PINS FALSE Clean detent pins FALSE If excessive diluent on platen, verify operation of detent pins SWEEP ARMS FALSE Clean sweep arm bushings. Do not oil or lube FALSE Inspect Spring on Sweep arms. Replace every 2 years or as needed ISA 170-003T Page3 of 10 Cell Dyn Ruby PM Check List Analyzer S/N : FSR ID : Date : Customer Name: City: Phone Number: 12/10/2015 B/C READER FALSE Clean barcode reader. Adjust postion as needed FALSE Clean racks, platen, and rack barcode labels 5 DATA STATION 0 5 0% 0 16 0% DATA STATION FALSE Clean inside FALSE Clean keyboard FALSE Clean External barcode reader FALSE Clean monitor FALSE Clean mouse 6 VERIFICATION PNEUMATICS FALSE Verify Vac/Pressure Retention FALSE Verify and set vacuum and pressure level FALSE Verify System Voltages FALSE Confirm HGB Voltage HGB V LASER BENCH Verify optical CV's within specification 0 FALSE FALSE 10 90 90D Confirm Gains for WBC, RBC, PLT and Linear gains SAMPLE LOADER Verify each rack movement correctly, by running a minimum of 2 racks with 10 bloods spread out FALSE FALSE Verify Sample Aspiration Sensors DATA Run 5 same samples from before in CBC NOC mode and compare results pre & post PM FALSE FALSE FALSE Verify background counts Verify Precision in Open and Closed mode and confirm within specs Open Mode: WBC NOC RBC HGB MCV PLT Closed Mode: WBC NOC RBC HGB MCV PLT FALSE Verify Carryover FALSE Verify Moded to Mode Bias check FALSE Verify X-B data (run a minimum of one batch in Moving Average if customer is monitoring X-B data) ISA 170-003T Page4 of 10 Cell Dyn Ruby PM Check List Analyzer S/N : FSR ID : Date : Customer Name: City: Phone Number: CONTROL RUN FALSE Verify all Controls are within specification. CALIBRATION RUN Calibrate if necessary. FALSE DATA STATION Back Up the System Configuration Files. FALSE FALSE Verify LIS operation CLOSE THE ACTIVITY Close PM Activity on Call Management System FALSE PM Completed on: Thursday, December 10, 2015 Field Engineer Signature: Customer Signature: ISA 170-003T Page5 of 10 12/10/2015 Cell Dyn Ruby PM Check List ISA 170-003T Page6 of 10 Press to Copy Text Press to Reset 7 Ruby PM 0 0 0 0 0 0 0 0 0 0 0 12 Verification 0 0 0 0 0 0 0 0 0 0 19 Total Characters First prepare the ticket in CMSNext, Display "Ticket details and Troubleshooting Text" screen, Click on Grey Button titled "Press to Copy Text", Go to CMSNext and Paste into the report!! ( CTRL + V ) Cell Dyn Ruby Total Call Analyzer S/N : FSR ID : Date : Customer Name: City: Phone Number: 1 CHECK INITIAL CONDITION 0 9 12/10/2015 0% REVIEW AND VERIFY FALSE Review SYS LOG and DATA LOG. Interview customer FALSE Review QC, X-B, CAL History, Dilution factors. Correct any issues found FALSE Verify ISA and TSB Status FALSE Verify background counts are within range FALSE Verify control counts are with in range FALSE Print the following data screens: CAL Dil Set Point DECONTAMINATE INSTRUMENT Flush flow cell and waste lines to Waste Chamber FALSE FALSE Run 3 tubes of 10% Bleach on Sample loader FANS Inspect all four external fans for proper operation. Replace if nojnfunctional and date FALSE FALSE Verify fan filters are clean 2 FRONT PANEL 0 17 0% FLOW PANEL FALSE Inspect both Open and Closed Wash Blocks, and Sample Probes and Closed Mode vent MIXING CHAMBERS Inspect RBC and WBC Mixing Chambers for corrosion, leaks, or excessive buildup FALSE FALSE Confirm metal inlet ports are not loose and do not have salt buildup. Correct as needed. RESERVOIR Inspect Reagent reservoirs for leaks FALSE FALSE Confirm metal inlet ports are not loose and do not have salt buildup. Correct as needed. WASTE CHAMBERS Inspect waste chambers for cracks or cracks. Replace if needed. FALSE FALSE Inspect Waste line to cube. Replace if older than 6 months or close to that time. SYRINGE DRIVES FALSE Inspect each of the Syringe Drives FALSE Check all syringes, brackets and luer fittings. Replace as needed. FALSE HGB Syringe 2.5 ml FALSE Diluent Syringe 10.0 ml FALSE WBC Lyse Syringe 2.5ml Injection Syringe FALSE FALSE Inspect Peri-Pump tubing. Replace with customer stock as needed based on customer schedule SOLENOIDS AND TUBING Inspect all valves for salt build up, corrosion, or rust. Replace as needed. FALSE FALSE Inspect all Silicone tubing, replace as needed. Include valves on VPM FALSE Inspect all Tygon Tubing, replace as needed HGB FLOW CELL Inspect all fittings, Y tubing connections, metal fittings. Replace if damaged FALSE OTHER Inspect Vacuum and Pressure Accumulators for cracks or excessive salt buil up. Replace if needed FALSE ISA 170-003T 8 of 10 Cell Dyn Ruby Total Call Analyzer S/N : FSR ID : Date : Customer Name: City: Phone Number: FALSE 3 AUTOLOADER 0 9 12/10/2015 0% GENERAL FALSE Clean tube Sensor FALSE Inspect Tube Sensor board FALSE Clean tube grippers INDEXERS FALSE Clean Forward Indexer and pawls and pawls as needed. Confirm spring action DETENT PINS FALSE Clean detent pins as needed SWEEP ARMS FALSE Clean sweep arm bushings as needed. Do not oil or lube FALSE Inspect Spring on Sweep arms B/C READER FALSE Clean barcode reader. Adjust position as needed FALSE Clean racks, platen, and rack barcode labels 4 VERIFICATION 0 15 0% PNEUMATICS FALSE Verify Vac/Pressure Retention FALSE Verify vacuum and pressure level FALSE Verify System Voltages FALSE Verify HGB Voltage HGB V LASER BENCH FALSE Verify optical CV Gains are within specifications using 7 um beads 0 10 90 FALSE Verify Gains for WBC, RBC, PLT and Linear gains SAMPLE LOADER FALSE Verify each rack movement FALSE Verify Sample Aspiration Sensors DATA FALSE Verify background counts Analyzer S/N : FSR ID : Customer Name: City: ISA 170-003T 9 of 10 90D Cell Dyn Ruby Total Call Date : Phone Number: FALSE Verify Precision in Open and Closed mode and confirm within specs Open Mode: WBC FALSE NOC RBC HGB MCV PLT Closed Mode: WBC NOC RBC HGB MCV PLT Review X-B data CONTROL RUN Verify Controls recovery FALSE CALIBRATION RUN FALSE Calibrate as necessary DATA STATION Back Up the System Configuration Files FALSE FALSE Verify LIS operation Completed on: Thursday, December 10, 2015 Field Engineer Signature: Customer Signature: ISA 170-003T 10 of 10 12/10/2015 ISA 170-003T CELL-DYN Ruby Pre-Installation, Installation and Integration Checklists, and PM Procedure Recommended Preventive Maintenance Parts List Note: Not all parts will be needed, or used. Some individual parts are included in the Kits at bottom of Table. Part numbers subject to change without immediate PM document revisions. Part Number 06H92-01 08H38-01 8510615001 91485-01 8310815101 03H86-01 09H06-01 04H34-01 04H40-01 28561-01 28560-01 02H82-02 9130542 9130543 8310651701 8310654301 8310653101 92161-02 09H38-02 08H43-01 08H44-01 09H32-01 8932078301 8921016301 8921122101 8921174902 9130732 9130733 8921173202 Description CD32 IN-LINE MILLPORE FLTRS-6 FILTER AIR INLINE SW PRESSURE 20 PSI MINI ADJA PERIST PMP TBG-MD FTG TBG VLV CHECK .125"ID KYNA DB CHECK VLV .125 " CDRUBY ASPIRATION NEEDLE SRNG 10 ML KIT 35 SRNG 2.5ML KIT 30/35 SRNG 2.5ML SRNG 500UL CD4K DIL/SHTH SYR TBG SILI (S1) .032"ID .156"OD TBG SILI (S2) .062"ID .187"OD TBG VINYL 1/16"ID 1/8"OD CLR TBG TYG 1/32"ID 3/32"OD FLEXIB TBG TYG 1/8"ID 3/16"OD WASTE OUTLET TUBE RGT LN W/CAP, CDRUBY TBG DIL/STH RGT32 TBG HB/NOC RGT32 OPEN MODE PROBE, CDRUBY WASH BLOCK, OTS, CD3200 ASSY,SOLV,N/C W/.125"WSHR ASSY, SOLV, 3.9KG WHT (NO WSHR) ASSY, REAGENT RESERVOIR 125MM KIT, PINCH TUBING, PM, CDRUBY Recommended Two (2) Year Parts Replacement KIT, PM, CDRUBY WASTE BOTTLE, 1K - PRESSURE ACCUM, 3K, 5" TALL This document is intended for internal use only. Page 1 of 1 ACTIVE PRINTER COMPATIBILITY & VALIDATED (updated Feb. 2015). (Default printer in green, Optional printer in yellow) Item Printer model / Type 1 OKI Microline 320 B&W 110V / Dot matrix Abbott List Number for Abbott List 220 V (only if Number for printer is 110 V printer in the US orderable from US) Replacement Cartridge CD1800 CD3700 CD3200 Yes Yes Yes 20821-01 20822-01 13401-01 2 HP OfficeJet 8100 100V-240V (Color Ink jet) 08H62-05 08H62-05 See Note 1, 2 08H62-07(YLW) 08H62-06(BLK) 08H62-09(CYN) 08H62-08(MGTA) 3 OKI B4600 B&W 110V / Laser 08H60-04 08H60-05 08H61-02 4 HP CP2025n Color 120V/Laser (Superceded by HP M451dn) 08H07-08 Buy 220 V printer locally See Note 2 09H00-30(BLK) 09H00-34(MA) 09H00-32(CYN) 09H00-36(YEL) 5 HP M451dn Color 120V/Laser 08H07-09 Buy 220 V printer locally See Note 2 08H07-10(BLK) 08H07-12(MA) 08H07-11(CYN) 08H07-13(YEL) 6 Konica 1650EN Color 120V/Laser 09H80-01 Buy 220 V printer locally See Note 2 09H80-04(MA) 09H80-05(YEL) 09H80-06(CYN) 09H80-07(BLK) 7 HP H470 Color Ink jet 120V-240V 09H76-01 09H76-01 See Note 1, 2 09H77-01(BLK) 09H77-02(CLR) 8 Epson LX 300+II (120V) 08H89-20 Buy 220 V printer locally 08H89-28 Yes CDSapphire CD Ruby CD Emerald 18 Est.Cost ( $ US) Ink Life (pages) Paper hold (sheet) Printer Language/OS 325.00 Info not avail. 1 Bin Epson FX, DOS Yes Yes see see Note Note 3 3 Yes See Note 4 150.00 2300 (Blk) 1500 (Clr) 250 PCL3 / Windows XP Yes Yes Yes 240.00 2500 (Blk) 250 PCL5 / Windows 95 Yes 505.00 2,500(Blk) 2,000(Clr) 250 PCL6, Postcript Yes 499.00 4,000(Blk) 2,600(Clr) 250 PCL6, Postcript 320.00 2,500(Blk) 2,500(Clr) 250 PCL6, Postcript Yes 315.00 480 (Blk) 320 (Clr) 150 PCL3 Yes 200.00 3 millions characters Yes Note: 1/ Item 2, 7: Recommend to use local cartridges with local printer (For ex. Europe cartridges are not compatible with US printers and vice versa) 2/ Recommend to buy printer locally. Download instruction from ISA to install printer. 3/ Item 2: Requires adapter 08H77-05 for CD3200 and CD3700 (not compatible with adapter 08H77-04 or older). 4/ Item 2: Printer HP Officejet 8100 replaced HP 6940 for CD3200, CD3700 and Ruby only, not used for CD Emerald. Epson ESC P/2