ACL Elite ACL Elite Pro Service Manual P/N 181121-14 (CD version) Revision 00 January 2006 Manufacturer Instrumentation Laboratory Company 113 Hartwell Avenue - P.O. Box 9113 Lexington, MA 02421-3125 U.S.A. Telephone: (781) 861-0710 EU Authorized Representative Instrumentation Laboratory SpA Viale Monza 338 - 20128 Milan, Italy Telephone: 39-2-25221 ACL Elite / ElitePro Service Manual ACL Elite / ElitePro Service Manual P/N 00018112113 Elite / ElitePro Service Manual (paper version) Revision 00 January 2006 P/N 00018112114 Elite / ElitePro Service Manual (CD version) Revision 00 January 2006 Foreword This Service Manual contains information necessary to install, service, maintain and troubleshoot the Instrumentation Laboratory ACL Elite / ElitePro system. This Service Manual is intended for IL field engineers, or service engineers from organizations duly recognized and authorized by Instrumentation Laboratory, who have been previously trained on how to use, maintain and troubleshoot the IL ACL Elite / ElitePro model. For detailed information on Operator’s interface and other user related topics, reference the ACL Elite / ElitePro Operator’s Manual. The ACL Elite / ElitePro system is compatible with the diverse requirements for supply voltage and frequency encountered throughout the world. The ACL Elite / ElitePro system conforms to the directives and standards of the Community European 89/336/EEC + 92/31EEC + 93/68EEC and certified by CE marking. This system is approved to CE standards EN55011:1991 (CISPR 11), Group 1, Class A; EN50082-1:1997 and EN61010-1993 + A2:1995 (IEC 1010-1). The ACL Elite / ElitePro system also conforms to the directives and standards of the CSA and certified by CSA marking. This system is approved to CSA standards with licence number LR24215 and produced under CSA certification number 161648/1121145. All instruments bear the CE and CSA monograms. This publication and any and all materials (including software) concerning the products of IL ACL Elite / Elite Pro Systems are of proprietary nature and are communicated on a strictly confidential basis; they may not be reproduced, recorded, stored in a retrieval system, transmitted or disclosed in any way and by any means whatsoever, whether electronic, mechanical through photocopying or otherwise, without IL’s prior written consent. Information contained herein is believed by IL to be accurate: in any event, no responsibility, whether express or implied, is assumed hereby by IL for or in connection with the use thereof, or for infringement of any third party rights which might arise therefrom, or from any representation or omissions contained therein. Information is subject to change and/or updating without notice. Manufacturer Instrumentation Laboratory Company 113 Hartwell Avenue - P.O. Box 9113 Lexington, MA 02421-3125 U.S.A. Telephone: (781) 861-0710 EU Authorized Representative Instrumentation Laboratory SpA Viale Monza 338 - 20128 Milan, Italy Telephone: 39-2-25221 Instrumentation Laboratory Co. 113 Hartwell Avenue, Lexington Ma. 02421 ACL Elite / ElitePro Service Manual ACL Elite / ElitePro Service Manual Index Foreword ACL Elite / ElitePro Service Manual Index Chapter 1 General Information 1.1 1.2 1.3 1.4 1.4.1 1.4.2 1.4.3 1.4.4 1.4.5 1.4.6 1.4.7 1.4.8 1.4.9 1.4.10 1.4.11 1.4.12 1.4.13 1.5 1.5.1 1.5.2 1.5.3 1.5.4 1.5.5 1.6 Product Use Measured Parameters Presentation of Results Instrument Description and Operation Main hardware components Sample Tray Reagent Area Rinse/Waste Area Rotor loading and Analysis Area Liquid Crystal Display (LCD) Keyboard Interface Connectors Internal Cooling System On-board Barcode Reader External Barcode Scanner External printer Floppy disk drive Additional Features Standby Status End of the Cycle Power loss Setup and Utility Programs Fault Detection Procedural Limitations Chapter 2 Operator Interface Description 2.1 2.2 2.3 2.4 2.5 Screen areas and main commands description Available input devices Instrument status Password Analysis and Service programs menu description Index Page 1 of 5 ACL Elite / ElitePro Service Manual Chapter 3 General Description 3.1 3.2 3.2.1 3.2.2 3.3 3.3.1 3.3.2 3.3.3 3.3.4 3.3.5 3.3.6 3.3.7 3.3.8 3.3.9 3.3.10 3.3.11 3.4 3.5 Main Fluidic System Description Main Optic System Description Coagulimetric Optic Channel Chromogenic Optic Channel Electronic Description Interconnection schematic Quick reference board function table Quick reference board function diagram CPU Master Board #1 & PC104 Board Slave Board #2 Acquisition & Sensors Board #3 Rotor Exchange Module Board #4 Motors Board #5 Photometric & Temperatures Control Board #6 Switching Power Supply Board Instrument Ground Circuit Main Hardware Components Description Software Description Chapter 4 Parts Replacement 4.1 Parts Replacement 4.1.1 Autosampler Assy Replacement 4.1.2 Peltier 1 Assy, Peltier 2 Assy Replacement 4.1.3 Sample Arm Assy Replacement 4.1.4 Rotor Holder Assy Replacement 4.1.5 Rotor Exchange Module Replacement (excluded on ACL Elite) 4.1.6 Rotor Holder Cover Assy Replacement 4.1.7 Halogen Lamp Assy Replacement 4.1.8 Dilutors Replacement 4.1.9 Display Replacement 4.1.10 Hard Disk Drive Replacement 4.1.11 Rotor Preheater Replacement (ACL Elite only) 4.2 Instrument Covers Removing 4.3 Instrument Boards Replacement Page 2 of 5 Index ACL Elite / ElitePro Service Manual Chapter 5 Installation & Maintenance 5.1 Installation 5.1.1 Site requirements 5.1.2 Unpacking and inspection 5.1.3 Mounting Instrument parts 5.1.4 First turn on cycle 5.1.5 Instrument set-up 5.1.6 Performance tests 5.1.7 Installation Procedure & Checklist 5.2 Maintenance 5.2.1 Daily Maintenance 5.2.2 Weekly Maintenance 5.2.3 Bi-Weekly Maintenance 5.2.4 Monthly Maintenance 5.2.5 Yearly Maintenance 5.2.6 As needed Maintenance 5.2.7 Maintenance schedule 5.3 Shut down & Shipment precautions 5.3.1 Long term shut down 5.3.2 Shipment Chapter 6 Troubleshooting 6.1 Error Messages & Troubleshooting 6.1.1 System errors 6.1.2 Temperature errors 6.1.3 Mechanical errors 6.1.4 R.E.M. errors 6.1.5 Optic errors 6.1.6 Acquisition errors 6.1.7 Liquid sensors errors 6.1.8 Operative errors 6.1.9 Database errors 6.1.10 Sample identification errors 6.1.11 DMS errors 6.1.12 Analytical errors 6.2 Service Tools 6.3 Standard Tools Index Page 3 of 5 ACL Elite / ElitePro Service Manual Chapter 7 Check Out & Adjustment 7.1 7.2 7.3 7.4 7.4.1 7.4.2 7.5 7.5.1 7.5.2 7.5.3 7.6 7.6.1 7.6.2 7.6.3 7.6.4 7.6.5 7.6.6 7.6.7 7.6.8 7.6.9 7.7 7.7.1 7.7.2 7.7.3 7.7.4 7.7.5 7.7.6 7.7.7 7.7.8 7.7.9 7.8 7.8.1 7.8.2 7.9 7.9.1 7.9.2 7.10 7.11 7.12 7.13 7.14 7.15 Quick Reference Guide to Electronic Adjustment Coagulimetric Channel Chromogenic Channel Liquid Sensor Wash-Reference Emulsion Volume test Needles Sensor test Optic Sensor Rotor Stack. Rotor Waste container. Autosampler housing. Motors Adjust Rotor motor Rotor Holder Cover motor Sample Arm Horizontal motor Sample Arm Vertical motor Autosampler motor Sample / Reagent Dilutor motors Transport motor Rotor Arm Horizontal motor Rotor Arm Vertical motor Modules Positioning Sample Arm Assy. Autosampler Assy. Rotor Holder Assy. Needles Block Assy Rotor Stack Assy. Rotor Arm Assy. R.E.M. Centering Rotor Arm Tilt Adjustment R.E.M. selftest Dilutors Module Dilutors Test Volume Test Magnetic Sensor Rotor Cover Sensor Rotor Stack Cover Sensor Rotor Waste Presence Switch Switching Power Supply check out & Adjustment Touch Screen Calibration Interface Test Temperature Control Floppy Disk Drive Test Page 4 of 5 Index ACL Elite / ElitePro Service Manual 7.16 Software checking & loading 7.16.1 Software Identification 7.16.2 Software Upload & Upgrade 7.16.3 Databases Check 7.16.4 Backup / Restore of the system configuration 7.16.5 Upgrade IL Library 7.16.6 Complete Software Re-Install 7.16.7 Hard Disk Drive Formatting 7.16.8 Main CPU Board BIOS Setup 7.16.9 PC 104 Board Expansion Module Settings Chapter 8 System Interfacing 8.1 8.2 8.3 8.4 8.5 8.6 8.7 Keyboard External Parallel Printer Network Modem Mouse Host Computer External Bar Code Reader Chapter Parts List 9.1 9.2 9.3 9 Start Up Kit Expendable Service Parts list Chapter Drawings 10 Chapter 11 Service Notes Chapter Appendix A B 12 Host Communication Protocol Barcodes Label specifications Index Page 5 of 5 ACL Elite/ElitePro Service Manual Chapter 1 General Information This chapter of the manual contains general information about the ACL Elite/ElitePro system(s), including its use, measured parameters, presentation of results, hardware description and operation, additional features and procedural limitations. Description and use of the ACL Elite/ElitePro Operator’s Interface is addressed in a separate chapter of this manual. Following are the specific sections. 1.1 1.2 1.3 1.4 1.5 1.6 1.7 Product Use Measured Parameters Presentation of Results Instrument Description and Operation Additional Features Procedural Limitations Symbols Chart Chapter 1 – General Information Page 1 of 22 ACL Elite/ElitePro Service Manual 1.1 Product Use The IL ACL Elite/ElitePro systems are fully automated, high productivity analyzers designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. The systems provide results for both direct hemostasis measurements and calculated parameters. 1.2 Measured Parameters The ACL Elite/ElitePro systems are used to perform the following tests: Coagulometric Tests • • • • PT-FIB (Prothrombin Time and PT-Based Fibrinogen concentration) APTT (Activated Partial Thromboplastin Time) TT (Thrombin Time) Single Factors (VII, X, V, II, XII, XI, IX, VIII) Absorbance Tests • • • • • • Antithrombin Heparin Xa Protein C Plasmin Inhibitor (alpha-2-antiplasmin) Plasminogen Fibrinogen-C (Clauss method) Immunological Tests • • D-Dimer von Willebrand Factor Special Tests • • • • • ProClot (clotting Protein C) Protein S APCR-V Pro-IL-Complex * Hepatocomplex * Note: An (*) indicates that the test is not available in the United States. Profiles Page 2 of 22 Chapter 1 – General Information ACL Elite/ElitePro Service Manual The user may program Profiles on patient samples to be performed on a random access basis. Refer to the Operator’s Manual for additional information on this subject. Tests Groups Some tests can be run together as a group, thus saving time when the number of samples to be analyzed is relatively small. Following are some examples: PT-FIB/APTT PT-FIB/APTT/TT Double Tests The ACL Elite/ElitePro offers the user the capability to set up double tests. Refer to the Operator’s Manual for additional information on this subject. 1.3 Presentation of Results The ACL Elite/ElitePro offers the following choices to display and print results of testing: • • • • • • • • • • • • • s (seconds) R (Ratio) NR (Normalized Ratio) INR (International Normalized Ratio) % (Percent activity) U/mL (units/mL) mg/dL (for example for Fibrinogen) g/L (for example for Fibrinogen) ng/mL (for example for D-Dimer) microg/L (for example for D-Dimer) micromol/L IU/mL (International Unit) User configurable unit Chapter 1 – General Information Page 3 of 22 ACL Elite/ElitePro Service Manual 1.4 Instrument Description and Operation The ACL is a family of fully automated computer-controlled, microcentrifugal analyzers. The ACL Elite/ElitePro systems incorporate a Liquid Crystal Display (LCD) unit that displays the status of the instrument, permits the user to select desired procedures and, through the use of menus and options, guides the operator through these procedures. Information and instructions are entered into the system either via a Touch Screen device, through a standard PC keyboard or through a serial or USB mouse. When sample testing is initiated, the samples and reagents are sequentially pipetted into a 20-cuvette polystyrene rotor (loading process). Sample and reagents are then mixed by centrifugation process. The mixing is carried out by a combination of rapid acceleration and braking actions that are effective in thoroughly mixing the liquids. Reaction measurements (data acquisition) via the photometer are made while the rotor is spinning. The ACL measures the parameters at 37 oC ± 1 oC (98.6 oF ± 1.8 oF), at an ambient temperature from 15 oC to 32 oC (59 oF to 89 oF). However, if the ACL is in a temperature controlled environment where the ambient temperature is held constant, the measurements are made within a narrower temperature range: 37 oC ± 0.25 oC. The results are displayed on the LCD and printed by the (optional) external printer, and/or sent to a host computer. The ACL performs automatic calibration, offers a series of utility programs for the operator and manages a complete quality control program. Page 4 of 22 Chapter 1 – General Information ACL Elite/ElitePro Service Manual 1.4.1 Main hardware components The ACL Elite/ElitePro analyzers include several hardware components and modules, which interact with each other to carry out the analytical process. This section contains descriptions of those components and their functions as well as the operations that take place during the analytical process. The figure below highlights some of the main components of the ACL Elite/ElitePro, as viewed from the front of the system. 7 6 2 8 1 9 3 10 11 5 14 12 13 4 1 2 3 4 5 6 7 Wash-R Emulsion Dilutors Sample Tray Reagent Area Sampling Arm Floppy Disk Drive LCD 8 9 10 11 12 13 14 Rotor Stack Area Rotor Holder Cover Rotor Transport & Rotor Arm (excluded on ACL Elite) Rotor Waste Area Keyboard Adaptors (shown in storage area) Liquid Waste Outlet Chapter 1 – General Information Page 5 of 22 ACL Elite/ElitePro Service Manual More information about the other components on the instrument is given in Chapter 3 “General Description”. Following are the specific sub-sections with the item descriptions. 1.4.2 1.4.3 1.4.4 1.4.5 1.4.6 1.4.7 1.4.8 1.4.9 1.4.10 1.4.11 1.4.12 1.4.13 Sample Tray Reagent Area Rinse/Waste Area Rotor loading and Analysis Area Liquid Crystal Display (LCD) Keyboard Interface Connectors Internal Cooling System On-board Barcode Reader External Barcode Scanner External printer Floppy disk drive 1.4.2 Sample Tray The ACL Autosampler system includes a rotating sample tray that contains: 40 x 14.2 mm diameter positions for cups and primary tubes and 10 x 23 mm diameter positions to hold accessory materials such as calibrators, diluents, reagent vials, etc. Page 6 of 22 Chapter 1 – General Information ACL Elite/ElitePro Service Manual Optical sensors located around the tray verify that the tray is correctly positioned, and also detect the presence of cups, tubes and vials. Three different sample trays can be used with the ACL system, each one appropriate for different size primary tubes: 3 mL, 5 mL and S11.5; all of them can be used for 0.5, 2 or 4 mL cups. 3 mL 5 mL S 11. Primary tube, 3 or 3.5 mL total volume (13x75 mm) 181108-99 Primary tube, 5 mL total volume (13x75 mm and/or 13x100 mL) 181108-98 Sarstedt type primary tube, 3 mL volume (11.5x66 mm) and/or 5 mL volume (11.5x92 mm) 181812-85 Note: The dimensions and volumes mentioned above are all nominal values. Warning: Do not access sample or reagent area while probe arm is operating. Chapter 1 – General Information Page 7 of 22 ACL Elite/ElitePro Service Manual Additional Reagents positions The ten internal positions of the sample tray - A1 to A10 - are used for placing materials such as calibrators, diluents or reagents in a choice of containers such as 23 mm vials (10 mL filling volume), 18 mm vials (4 mL filling volume) or cups. Adapters are needed for the 4 mL vials and cups as seen in the picture below. Normally, position A1 is usually reserved for a cup containing calibration plasma (normal pool) and position A10 is reserved for a cup containing IL Factor Diluent, for use in the calibration procedure. 1.4.3 Reagent Area The ACL Elite reagent area consists of 8 reservoirs labelled R1 to R8, and the ACL ElitePro reagent area consists of 12 reservoirs labelled R1 to R12, designed to hold reagent containers. An area alongside the vial holes is designed to hold the vial caps while the vials are in use. Positions R1 to R4 are cooled by a Peltier-effect temperature regulator and are equipped with a stirring mechanism, (magnetic stirbar). Positions R5 to R8 are used for reagents at room temperature; these positions do not have a stirring mechanism. Positions R9 to R12 (ACL ElitePro), are cooled by a Peltier-effect temperature regulator however are not equipped with a stirring mechanism, (magnetic stirbar). The reagents in positions R1 to R6, and R9 to R12 (ACL ElitePro) are aspirated with the internal needle (reagent needle) while the reagents placed in positions R7 and R8 are aspirated with the external needle (sample needle). Page 8 of 22 Chapter 1 – General Information ACL Elite/ElitePro Service Manual Warning: Do not access sample or reagent area while probe arm is operating. All twelve reagent positions can hold 28 mm vials (16 mL filling volume). Smaller diameter vials require the use of color coded adapters. Grey: for 10 mL vials requiring magnetic stirrer Purple: for 8 mL vials not requiring magnetic stirrer Green: for 4 mL vials not requiring magnetic stirrer Dark Blue: for sample tray 4ml Vials and cups Chapter 1 – General Information Page 9 of 22 ACL Elite/ElitePro Service Manual 1.4.4 Rinse/Waste Area The rinse / waste system of the ACL Elite/ElitePro consists of a removable Rinse / Waste Reservoir positioned between reagent positions R4 and R5. A plastic tube is connected to the reservoir that drains the waste from the reservoir to a waste container outside the analyzer (left hand side) where the waste is collected. The Rinse / Waste Reservoir which is always filled with Wash-R emulsion, is used as a washing basin for the dispensing needles in-between cycles; the liquid waste is then drained and collected in the waste container on the outside of the analyzer for proper disposal. WARNING ! BIOLOGICAL HAZARDS EXIST. Avoid touching, with bare hands, any parts of the system which may have come in contact with potentially infectious fluids. ALWAYS wear gloves when performing any type of Maintenance/Service action on this area. 1.4.5 Rotor Loading and Analysis Area The area of the analyzer where the reaction cuvettes are loaded and the analysis takes place is located under the rotor holder cover in the center of the instrument, on the right side of the reagent area. This area includes: • • • • The reaction cuvettes (rotors) storage system and mechanisms involved in the transport of the rotors, (excluded on ACL Elite). The plate where the rotor is placed during loading and analysis (Rotor Holder). The hardware components responsible for ensuring proper mixing of reagents and samples in the cuvettes. The optical system used to make the analytical measurements. Page 10 of 22 Chapter 1 – General Information ACL Elite/ElitePro Service Manual Rotor (reaction cuvettes) The disposable precision reaction cuvettes, made of UV-transparent acrylic, are radially arranged in groups of 20. The 20-cuvette unit is called a rotor. Each wedge-shaped cuvette contains two compartments, a small one near the center to hold the sample and/or reagent and a larger one that holds reagents only. A partial dam between both compartments maintains their contents separate during the loading process; as centrifugal action starts, the sample/reagent in the inside compartment flows over the dam to mix with the contents in the large compartment. The reaction and analysis take place within the large, outside compartment, while the rotor is spinning. Chapter 1 – General Information Page 11 of 22 ACL Elite/ElitePro Service Manual Rotor Exchange Module (R.E.M.) The Rotor Stack, the Rotor Transport and the Rotor Arm compose this assembly. (excluded on ACL Elite) • Rotor stack Before their use, rotors are stored in the rotor stack that holds up to 12 rotors (240 cuvettes). The rotor stack compartment, which may be accessed from the top of the analyser on the right side, can be filled at any time (continuous rotor loading) either manually (one rotor at a time) or using a special rotor refill tool (up to 10 rotors at a time). The rotor stack area is thermostatically controlled in order to keep the rotors in a temperature range between 36°C and 39oC and the rotor stack is insulated to help thermal-regulation. The ACL Elite has a smaller rotor storage area thermostatically controlled between 36°C and 39oC. Rotors are manually placed into the storage area. Page 12 of 22 Chapter 1 – General Information ACL Elite/ElitePro Service Manual • Rotor Transport (excluded on ACL Elite) Below the rotor stack, a rotor transport mechanism moves the bottom rotor out to make it available to the rotor arm mechanism. • Rotor Arm (excluded on ACL Elite) The robotic arm takes the rotor and inserts it into the rotor holder. This is the area where the rotor will remain during the loading and analysis process. Once analysis is completed, if the rotor is fully utilized (or if requested by the user), the rotor arm takes the rotor and discards it into the rotor waste container. The ACL Elite does not contain the robotic mechanism to place rotors onto the Rotor Holder. With the ACL Elite rotors are manually placed onto the Rotor Holder prior to sample loading and analysis, and manually removed when the analysis cycle is completed. Rotor Holder and Rotor Loading The Rotor Holder is an aluminium disk that holds the rotor in place during loading and analysis. The rotor holder is thermostatically controlled to a temperature of 38.5 ± 0.5o C to insure 37 oC inside the cuvette. Chapter 1 – General Information Page 13 of 22 ACL Elite/ElitePro Service Manual The loading of samples and reagents into the reaction cuvettes involves the action of the sampling / dispensing arm and needles. When starting with a new rotor, cuvette 20 is generally filled with a normal pool of calibration plasma. Cuvette 19 is usually filled with the Wash-Reference Emulsion aspirated from the one-litre bottle housed against the back wall of the analyzer. The remaining 18 rotor cuvettes (1-18) are filled with samples and reagents as required by the programmed request. Rotor Waste Area The used rotors are dropped inside the Rotor Waste Container. This container is accessed from a door in the right front area of the analyzer for removal and disposal of the used rotors, as seen in the figure below. With the ACL Elite rotors are manually removed from the rotor holder after analysis is complete and may be disposed of in the Rotor Waste container or other suitable method. Page 14 of 22 Chapter 1 – General Information ACL Elite/ElitePro Service Manual WARNING ! BIOLOGICAL HAZARDS EXIST. Avoid touching, with bare hands, any parts of the system which may have come in contact with potentially infectious fluids. ALWAYS wear gloves when performing any type of Maintenance/Service action on this area. Chapter 1 – General Information Page 15 of 22 ACL Elite/ElitePro Service Manual 1.4.6 Liquid Crystal Display (LCD) This module consists of a Liquid Crystal Display, 12-inch active matrix (LCD), which has Touch Screen capability, allowing all operations to be carried out using the LCD. The LCD guides the operator during the analytical process and displays calibrator data and patient results. It is also used to display calibration curves, and to perform several utility programs that are easily accessible through this input device. The LCD screen system reproduces 256 colors, and shows numeric and alphanumeric characters. The interaction with the operator is also made user friendly by the availability of graphics and icons. The screen is divided into three areas: • • • The upper section displays “Status area and main menu’”. The central section displays “Working area”. The lower section displays “Toolbar area”. Page 16 of 22 Chapter 1 – General Information ACL Elite/ElitePro Service Manual 1.4.7 Keyboard The ACL Elite/ElitePro has a standard computer keyboard with mechanical keys that allow the user to access the various operating modes of the instrument. Although the instrument is equipped with and supports the USA keyboard layout, the ACL software itself also supports the layout for the following languages: German, French, Spanish, Italian and English (UK). 1.4.8 • Interface Connectors USB connectors (4) to interface USB mouse, USB External Barcode Scanner, and/or USB Printer. The ACL Elite/ElitePro includes an interface for a USB external barcode scanner that allows reading reagent barcodes. The external barcode scanner is a standard accessory for the ACL ElitePro system and an optional feature for the ACL Elite system. • RS-232 C Interface for Host The ACL Elite/ElitePro contains an RS-232C interface (DTE Standard) for the output of data to a central computer (Host) or a personal computer. Communication to a host computer is via ASTM protocol. • RS-232 C Interface for an optional serial mouse (mouse must be serial mouse, PS-2 mouse with adaptor is not supported) • Ethernet not supported in this software release • External Printer Output (parallel port) The ACL Elite/ElitePro has an output for an optional external printer. Two emulation protocols are available for printers: ESC/P2 (Epson like printers) and HP-PCL 5 (for HP like Laser Printers). • Standard PC keyboard Chapter 1 – General Information Page 17 of 22 ACL Elite/ElitePro Service Manual Host 1.4.9 USB Ports (4) Serial Mouse Ethernet Parallel Printer Keyboard Internal Cooling System The cooling of the system is insured by the presence of fans mounted on the internal right and left sides of the analyzer. An air filter prevents dust from entering the system. A two-level alarm warns the user when the internal temperature of the instrument rises above damaging levels. The first level alerts the operator of the temperature rise and displays a warning. The second level switches off the instrument. 1.4.10 On-board Barcode Reader The on-board barcode reader, a standard feature of the ACL Elite/ElitePro, is located in the sampling area as indicated in the figure below. A small window indicates its position. Following are the numerical and alphanumerical readable codes. • • • • Codabar Code 39 Code 128 Interleave 2 of 5 When using barcoded sample tubes, it is important to position them in the sample tray such that the labels are facing towards the outside of the sample tray. This will allow a correct reading of the labels by the on-board barcode reader. Page 18 of 22 Chapter 1 – General Information ACL Elite/ElitePro Service Manual 1.4.11 External Barcode Scanner The external barcode scanner for the ACL Elite/ElitePro is able to read numerical and alphanumerical IL Reagent bottle labels. The maximum barcode label length readable is 6 cm with a resolution of 0.2 mm. Following are the numerical and alphanumerical readable codes. • Code 128 1.4.12 External Printer (optional) An external 80-column printer can be interfaced to the ACL Elite/ElitePro. Two emulation protocols can be used: ESC P2 or HP-PCL 5. The ESC P2 is a typical Epson like protocol while the HP-PCL 5 is a typical Hewlett Packard like protocol for Laser and /or Inkjet printers. 1.4.13 Floppy Disk Drive A floppy disk drive is mounted in the upper right part of the ACL Elite/ElitePro. This device is used for some of the utility programs. Chapter 1 – General Information Page 19 of 22 ACL Elite/ElitePro Service Manual The floppy disk drive is accessible by pushing both sides of the small door to open it. 1.5 Additional Features This section provides information on any additional features improved in the ACL Elite/ElitePro. 1.5.1 Standby Status If the ACL Elite/ElitePro is left ON for a period longer than 30 minutes without any operator action, the system moves into the Standby status. The LCD screen goes blank. Pressing the Touch Screen reactivates the display and allows the system to resume normal operation. When the system enters the Standby status, all motors are deactivated to reduce power consumption and the LED source is switched off. While the instrument is in the Standby status, an automatic priming cycle of Wash Reference Emulsion solution is performed every 30 minutes. The Database is saved when the instrument goes into the Standby status. 1.5.2 End of the Cycle At the end of each analytical cycle, an audible signal notifies the operator that the cycle has been completed. 1.5.3 Power loss The ACL contains a Hard Disk Drive to store the database in the event of a power interruption. The instrument performs an automatic save of the database to retain the Page 20 of 22 Chapter 1 – General Information ACL Elite/ElitePro Service Manual data every entry into standby or when exiting from the main program to power the system off. The instrument has an internal clock that keeps track of the date and time. 1.5.4 Setup and Utility Programs The instrument incorporates several utility programs that allow certain functions to be changed or set according to the user’s needs. These programs also help in troubleshooting. For additional information, refer to Chapter 2 “Operator Interface Description” in this manual. 1.5.5 Fault Detection The system automatically monitors faults to ensure accuracy of sample data and proper system performance. Fault monitoring includes display of alarms and warnings. For additional information, refer to Chapter 6 “Troubleshooting” in this manual. 1.6 Procedural Limitations The operating range of the ACL Elite/ElitePro is 15 to 32 oC ( 59 to 89 oF) and at up to 85% Relative Humidity (not condensing). The ACL Elite/ElitePro has been tested per EN61010-1 to insure there are no safety hazards within the temperature range 5 to 40ºC (41 to 104 oF) and functional performance characteristics are resumed when the instrument re-enters the range of 15 to 32 oC ( 59 to 89 oF). 1.7 Symbols Chart The following chart displays the various symbols that may be associated with the ACL Elite/Elite Pro system. Chapter 1 – General Information Page 21 of 22 ACL Elite/ElitePro Service Manual CE Mark Temperature Limitation Use By Manufacturer Batch Code Biological Risk ATTENTION: See Instructions For use CAUTION: Risk of electric Shock NOTE: Important user Information ATTENTION: Consult Documents Serial Number In Vitro Diagnostic Device Authorized Representative Contains sufficient for <n> tests Earth Off (supply) On (supply) End of Life Disposal (WEEE) Catalog Number Protective Conductor terminal -Earth Do Not Actuate Page 22 of 22 Chapter 1 – General Information ACL Elite/ElitePro Service Manual Chapter 2 Operator Interface Description This chapter is designed to familiarize the service engineer with the Operator Interface (OI) items used during the process of requesting and performing analytical and service operations, such as the data input devices, elements within menus, buttons and icons. Following are the specific sections. 2.1 2.2 2.3 2.4 2.5 Screen areas and main commands description. Available input devices. Instrument status. Passwords. Analysis and Service program menu description. 2.1 Screen areas and main commands description. This section provides information about the Operator Interface displayed on screen. The basic interaction with the ACL Elite/ElitePro is done through menus which allow access to sets of related functions (analysis, calibration, QC, set-up, diagnostics, etc.) and through the use of windows, dialogue or message boxes to input or retrieve information. The screen is divided in the following 3 main areas. 2.1.1 2.1.2 2.1.3 Status area and main menu. Working area. Toolbar area. Note: On the screen, any disabled object (menu, check-box, and button) is displayed dimmed and it cannot be selected. 2.1.1 Status area and main menu This is the upper part of the screen that contains the following items. • • • • IL Logo Indication of current instrument status (see section 2.3) Date and Time Windows like Menu bar (see section 2.5) Chapter 2 - Operator Interface Description Page 1 of 13 ACL Elite/ElitePro Service Manual 2.1.2 Working area This is the central area of the screen, which display windows containing data, commands or messages. Within the ACL Elite/ElitePro screens these items are grouped or contained in three different types of defined windows that are following. • Standard window In the analysis menu, this is a larger area that contains sets of related data, which can be edited by the user by means of command buttons. In the service menu, or in any common menu, this is an area that contains configuration and setting options with command buttons. • Dialogue box This is a small area used to prompt the user to choose one of several options (OK, Abort, Retry, Ignore, Cancel, Yes, No). • Message box This is an area used only to provide information. Command buttons allow the user to select options, cause actions and get from one part of the software to another. The buttons are positioned in different areas depending on the screen. Some are identified with text that is self-explanatory of the action. Some are shown with an icon inside that illustrates an action as defined in the following table. Page 2 of 13 Chapter 2 - Operator Interface Description ACL Elite/ElitePro Service Manual Command Buttons Icons Command / Action Confirm Cancel (Dimmed if Edit action not allowed) Print Host Delete Add Add an item to the list. Remove Remove an item from the list. Transfer Transfer an item from one list to another. Details Chapter 2 - Operator Interface Description Page 3 of 13 ACL Elite/ElitePro Service Manual Information Provide information in different languages. New Sample Extract Sample Data Note Patient Name Patient Details Save Save information to floppy disk. Inside the standard windows, “Check boxes” may be present which allow the user to “mark” an item. If a check box or button is in mutual exclusion with another check box or button, there is a frame wrapping the two, along with “graphic” information. Page 4 of 13 Chapter 2 - Operator Interface Description ACL Elite/ElitePro Service Manual In the dialogue and in the message boxes icons may be present. Following is the table with all possible icons and their corresponding meanings. Icon Meaning ERROR To call attention to high priority failures and fault messages. WARNING ! To deliver different kinds of messages. For example to warn the user of a “not allowed/wrong” operation, or of “problems/errors” detected by the instrument during or after an operation. QUESTION To request confirmation by the user before starting an operation or before cancelling an action. INFORMATION To offer general information. In some boxes, but not always, the message is followed by a request for confirmation. 2.1.3 Toolbar area This is the bottom part of the screen, which contains a series of command buttons for immediate and easy access to particular functions. The status of the buttons (Active or Dimmed) is dependent on the instrument status, but independent from the type of information displayed in the working area. The buttons are shown with an icon inside that illustrates an action as defined in the following table. Toolbar Command Buttons Icons Command / Action Short Turn Around Time (STAT) Urgent sample. Pressing this button opens a window that guides the operator. Confirmation is required. Instrument Status Informs the operator about the status of the operation in progress. Chapter 2 - Operator Interface Description Page 5 of 13 ACL Elite/ElitePro Service Manual Close/Open Cover This operation is disabled if there is a possible interference with the instrument operation. STOP Confirmation is required. Resume Starts the operations paused due to a STAT request. Data Base View The system goes back to the database view or “Main” screen. Host Status This icon appears only during communication with the Host to inform the operator about the status of this action. Printer Status This icon appears only during printing to inform the operator about the status of this action. Warning ! This icon appears when there is at least one warning. Press to open “Warning List”. Exit Allows the operator to exit the Service menu. Log Out Allows the operator to exit the Analysis menu. Confirmation is required. It is mandatory to follow the proper Log Out sequence (pressing the Log Out Icon), before powering off the instrument. Page 6 of 13 Chapter 2 - Operator Interface Description ACL Elite/ElitePro Service Manual Reagent Status Indicates status of reagents by color change QC Status By pressing icon, a screen is displayed indicating the last 100 QC results. A red ! in the icon indicates a QC error. 2.2 Available input devices This section provides information about the available input devices and their use in different screens. Following are the specific sub-sections for each device. 2.2.1 Touch Screen 2.2.2 Standard PC Keyboard 2.2.3 Mouse 2.2.4 External Bar Code Reader 2.2.1 Touch Screen The main information input device for the user is the touch screen. To start an “enter command” or “edit value” action the operator touches the area to be edited, which results in the immediate display of the numerical keypad (if enabled). If the information to be entered is strictly numerical, the editing is done directly on the keypad. If the information requires alphanumeric characters, the input is done through the external keyboard. The editing action may be closed by pressing the "Confirm" or the "Cancel" buttons or in some cases by touching a different area of the screen (implicit confirmation). Once the confirmation is done, the system performs an automatic check on the entered value. If an error situation is detected the user is notified by means of dialogue boxes and the editing action is reactivated. The touch screen supports auto-repeat functions in order to make lists easier to scroll. Chapter 2 - Operator Interface Description Page 7 of 13 ACL Elite/ElitePro Service Manual 2.2.2 Standard PC Keyboard The main function of the PC keyboard is to enter and edit data in the alphanumeric fields. To start the editing action, select the field to be edited. Move the cursor from the current object (it may be the default object if the window was just opened) to the desired object by pressing [TAB] or [Shift] [TAB]. To close the editing action press [Enter] or select another active object or move the cursor by pressing the [TAB] or [Shift] [TAB] keys. In all cases, closing the editing action causes the system to activate checks on the entered data and the user is notified of any error conditions by means of a dialogue box. If the editing action has been implicitly closed (touching a different area of the screen) the fault condition of the entered value will be changed to the pre-existing one. Pressing the [ESC] key without activating any control may also close the editing action; in this case the value returns to the pre-existing one. Main and secondary menus may be selected using the keyboard. Pressing [ALT] +Character opens the menus; selections within the secondary menus are done using the Character key. The keyboard may also be used to activate the Toolbar functions ( [F 1] to [F 10] ). Pressing [ALT]-[TAB] allows shifting from an activated window to another visible window. Pressing [CTRL + F4] will activate the Log Out function. 2.2.3 Mouse The serial mouse or USB mouse is a device that may be used as a selecting device in place of touching the screen. If at the instrument turn on the mouse is connected to the proper port of the Interface Board then the Mouse arrow pointer is displayed. 2.2.4 External Barcode Reader The external barcode reader is a device used to “read” the information encoded in IL reagent barcode labels. 2.3 Instrument Status Located in the upper part of the screen, within the “Status Area”, this item identifies the current state of the instrument as one of the following. • SYSTEM INIT (BOOT/START-UP) This indicates that the instrument, after the turn on, is performing start-up operations (Initializing). Page 8 of 13 Chapter 2 - Operator Interface Description ACL Elite/ElitePro Service Manual • LOG-IN This indicates that the instrument is inoperative and is waiting for the inputting of the User Identification and the Password of the operator (see section 2.4). • READY This indicates that there have been no blocking errors detected, there are no analytical operations in progress and the instrument is ready to start. • OPERATING This indicates that either an analytical function is in progress (Calibration or Sample Analysis) or a diagnostic function is being performed. • HOLD This identifies a system "pause" reached during an analytical session (STAT request, no rotors, etc.). In order to continue the current session, select “Resume” (green flag icon in the Toolbar). • FAILURE This indicates that the system has detected a blocking malfunction for a software problem or mechanical assembly (devices, temperature control, etc.). • STAND-BY This is the status into which the instrument moves automatically after 30 minutes of inactivity. The LCD lamp in the video module is turned off and its status led becomes green. Both the coagulimetric LED and Halogen Lamp are off and the system performs a Database check then becomes inoperative. To exit from the stand by status enter any command (Touch the screen, press any key etc.). • SERVICE This is the status assumed when the instrument is in the Service program or in its menus. To gain access to the Service program it is necessary to insert the proper identification password at the LOG-IN prompt, (User: Service, Password: System Fix) and then select on the windows like menu bar “Diagnostic” and then “Service”. The Service program contains all the software tools and utilities to allow the Service Engineer to perform a complete check out and adjustment of the whole instrument. In the Service program the coagulimetric LED and Halogen Lamp are turned on for default. To exit from the Service program select the “Exit” button on the Toolbar. Note: When the “Exit” button is touched, the system performs an initialization of the instrument. Chapter 2 - Operator Interface Description Page 9 of 13 ACL Elite/ElitePro Service Manual During this initialization all the motors are moved to the home position and the instrument attempts to recover from any errors before access to the Analysis program is allowed. 2.4 Passwords This section contains the available passwords implemented in the instrument software together with the description of the allowable functions. Following are the Log-In passwords: User Password Gained functions description Lab Manager level 3 Gain access only to the Analysis program. Service System Fix Gain access to all Service and Analysis programs Note: User name and password are case sensitive. In the User as in the Password fields pay attention to type correctly the “Upper/Lower Case letters” and the “spaces”. Otherwise the system shows an “Error” message box. Following is a Service program password: Password Function description ACL8 Allows the service engineer to Reset the Test Counter. Note: The password is required only if in the Test Counter Menu, the Reset button is touched. 2.5 Analysis and Service program menu description This section contains an overview of the configuration of the Windows like Menu bars contained in the two main programs. Each of the two programs is basically composed by specific menus (in the Analysis program: Analysis, QC and Calibration, while for the Service program: Service) and by common menus (Diagnostic, Setup and Utility). Specific information about the Analysis menus is provided in the Operator Manual. A quick description of the menus that are common in the two programs is also provided. Following are the specific sub-sections. 2.5.1 Analysis program Windows like Menu bar. 2.5.2 Service program Windows like Menu bar. 2.5.3 Common Menu description. Page 10 of 13 Chapter 2 - Operator Interface Description ACL Elite/ElitePro Service Manual 2.5.1 Analysis program Windows like Menu bar This sub-section is designed to provide information about the location of the menu in the Analysis program. A menu may be opened by selecting the appropriate area of the screen (touch or click with the mouse) or using the keyboard: [ALT] + Character. The selection of menus to be opened may be done in all directions: up and down or right and left. The displayed items, which have a secondary menu, are identified with a marker (¾). Selecting a menu item, touching an external area, or pressing [ESC] from the standard keyboard closes a menu. The “Analysis Windows Like Menu Expanded Diagrams” is available in the figure 2.5.1 Drawing 1 of the Chapter 10 “Drawings”. 2.5.2 Service program Windows like Menu bar This sub-section is designed to provide information about the location of the menu in the Service program. A menu may be opened by selecting the appropriate area of the screen (touch or click with the mouse) or using the keyboard: [ALT] + Character. The selection of menus to be opened may be done in all directions: up and down or right and left. The displayed items, which have a secondary menu, are identified with a marker (¾). Selecting a menu item, touching an external area, or pressing [ESC] from the standard keyboard closes a menu. The “Service Windows Like Menu Expanded Diagrams” is available in the figure 2.5.2 Drawing 1 of the chapter 10 “Drawings”. 2.5.3 Common Menu description This sub-section is designed to provide information on the menus that are common and present in both the Analysis and the Service program. More information about these 3 menus is provided in the Operator’s Manual. Following are the specific sub-section for these 3 menus. 2.5.3.a Diagnostic 2.5.3.b Setup 2.5.5.c Utility Chapter 2 - Operator Interface Description Page 11 of 13 ACL Elite/ElitePro Service Manual 2.5.3.a Diagnostic Following is the table with the description of the functionality of each option in the “Diagnostic” menu. Option Description Priming This performs a priming cycle of the fluidic system with Wash-Reference Emulsion by means of the Dilutors. This performs a configurable cleaning cycle of the Needles Block with Cleaning Solution by means of the Dilutors. This is a schedule that reminds the operator of dates and/or notes about the instrument maintenance actions. This screen allows monitoring of the temperatures of the heating and cooling systems. This is a test that allows the operator to verify/adjust the Needles Block position. It’s a table where are traced by the system the errors that occurred during the last session. It’s a table where the system saves a trace of the last 100 actions of the operations on the system configuration. This option allows the Service Engineer to access the Service program (proper password required to activate). Cleaning Maintenance Temperature Control Needles Position Session Error History Logbook Service 2.5.3.b Setup Following is the table with the description of the functionality of each option in the “Setup” menu. Option Description Tests This is a second level menu with options that allow the operator to configure the analytical tests. This is a second level menu with options that allow the operator to configure the analytical profile tests. This is an option that allows the operator to configure the liquids used by the instrument. This is a second level menu, with options that allow the operator to configure the interface with the internal / external device. This is an option that allows to the operator to configure the system. This is an option that allows the operator to set the date and the internal clock time. This is an option that allows at the operator to select the measuring units for the data. Profiles Liquids Interfaces System Configuration Date / Time Units Page 12 of 13 Chapter 2 - Operator Interface Description ACL Elite/ElitePro Service Manual 2.5.3.c Utility Following is the table with the description of the functionality of each option in the “Utility” menu. Option Description Upgrade IL Library This option allows the operator to upgrade the IL library present in the system with new liquids, tests and profiles. This option allows the operator to backup or restore the current system configuration (for Hardware, QC, AR, and Patients). This option allows the operator to store the data (QC, AR, Patients database and Calibration) on floppy disks using the “.TXT” format. If required these floppy disks are then readable from a PC. This option allows the operator to check the software ID, and/or upload and upgrade the instrument software. This option allows the operator to save on floppy disk the raw data of all the rotors analyzed in the last session using the “.TXT” or “.DAT” formats. If required these raw data disks can be viewed on a PC. This option allows the operator to save on floppy disk the file where the instrument stores any operation performed and any command received. If required, this file may be delivered to IL for troubleshooting purposes. This option is dimmed (the Decapper unit is a feature not available at this time). This option is always dimmed (only for R&D purposes). This option is always dimmed (only for R&D purposes). Backup / Restore Archive Software Save Last Rotor Map Save Trace Decapper Debug Testing Chapter 2 - Operator Interface Description Page 13 of 13 ACL Elite/ElitePro Service Manual Chapter 3 General Description This chapter of the manual contains general descriptions about the ACL Elite/ElitePro system, including the use and functionality. Following are the specific sections. 3.1 3.2 3.3 3.4 3.5 Main Fluidic System Description Main Optic System Description Electronic Description Main Hardware Components Description Software Description Note: Refer to section 7.0 of this manual for specific adjustment procedures and locations. 3.1 Main Fluidic System Description This section provides information about the fluidic system functionality during the analysis and on its components. The fluidic functions are sampling, dispensing and flushing the system. The ACL Elite/ElitePro fluidic system includes the components described in the following sub-sections. 3.1.1 3.1.2 3.1.3 Wash-Reference Emulsion bottle. Dilutors Chamber and Electro-Valves. Sample Arm Assembly. 3.1.1 Wash-Reference Emulsion bottle This is a plastic bottle containing 1 L of silicon emulsion that is used as a wash solution for the Needles Block and for the optical reference of the Coagulimetric Channel. A capacitive sensor located inside the bottle detects the Wash-Reference Emulsion level. Chapter 3 General Description Page 1 of 40 ACL Elite/ElitePro Service Manual 3.1.2 Dilutors Chamber and Electro-Valves The Dilutor Chamber is an acrylic block with two cylinders which contain a stainless steel piston and an O ring / Teflon seal. A stepping motor and lead screw on which the fork actuator for the piston is mounted drives each piston. Volumes up to 140 µl can be aspirated or dispensed. Since the pistons do not touch the walls of the chambers in which they move, the volume of the liquid dispensed depends entirely upon the accuracy of the piston and the travel. The travel is determined by the stepping motor and driving lead screw. Note: Due to the critical adjustment and burn-in procedure required after the O ring replacement, no service action must be attempted at sub assy level in the field. In order to keep different liquids separate in the same fluidic line (ex: The in line Wash-Reference Emulsion and sample or reagent) the instrument loads a small air bubble between the two liquids. The two Electro-Valves are mounted within the Dilutors Chamber, each one connected to one of the pistons. Two Electro-Valves are electronically controlled and connect the pistons to the Wash-Reference Emulsion bottle as well as to the two needles of the Needles Block mounted on the Sample Arm. The “Instrument Fluidic System Diagram” is provided in figure 3.1.2 Drawing 1 of the Chapter 10 “Drawings”. Page 2 of 40 Chapter 3 General Description ACL Elite/ElitePro Service Manual 3.1.3 Sample Arm Assembly Two stainless steel needles (External for Sample, Auxiliary Material and Reagent and the Internal for Reagent only) are mounted on the end of the Sample Arm that is moved by the Sample Arm Movement Assy. The Sample Arm allows the Needles Block to move in the proper positions and to perform with the dilutors the following operations. - Aspiration of sample, reagent and auxiliary material from their respective locations. Dispensing into the internal and external compartments of the reaction cuvettes within the rotor. Washing of the needles with Wash-Reference Emulsion in the Rinse/Waste Reservoir. Two specific capacitive sensors connected to the Needle Block are used to detect the level of the liquid around the sample (External) and reagent (Internal) needle. These liquid sensors are integrated into the ACL analytical cycles in such a way that their operation does not affect the throughput of the system. For all analytical cycles the verification by the sensors is done “in-line” during the loading phase. The sampling arm stops when the needle is just below the liquid surface to allow proper aspiration of the programmed amount of liquid. Following is the sequence of the sensor operations during a cycle. - self-check liquid test washing final sensor self-check Operators are warned of sensor failures. Results for a sample for which the system detected insufficient volume will appear with a warning. In the case that all sample containers in the sample tray are empty the cycle will be aborted after the final selfcheck. No other warnings appear on the video or on the printer. Chapter 3 General Description Page 3 of 40 ACL Elite/ElitePro Service Manual 3.2 Main Optic System Description This section provides information about the optic system onboard used by the instrument to perform the analysis on the samples / reagent reaction during the acquisition cycle as well as on its main components. The ACL uses two different optic principles to measure the hemostasis parameters: - The light scattering (nephelometry) used for the Coagulimetric Channel. The light absorption used for the Chromogenic Channel. Emerging Light Rotor Cuvette Chromogenic Channel Sample Scattered Light Coagulimetric Channel Incident Light The rotor cuvette loading and analysis area also houses two optical systems for analysis: Coagulimetric (nephelometric method) and Chromogenic (absorbance method). Following are the specific sub-section. 3.2.1 Coagulimetric Channel 3.2.2 Chromogenic Channel Page 4 of 40 Chapter 3 General Description ACL Elite/ElitePro Service Manual 3.2.1 Coagulimetric channel The ACL coagulimetric channel uses the light scattering method. The system measures the rise in turbidity caused by the formation of the clot, within the rotor cuvettes. When a ray of light passes through a medium containing finely dispersed matter in suspension, the ray is diffused by the particles (light scattering) due to the reflection and refraction phenomena. The diffused light is measured at 90° with respect to the incident light (see next figure). This system is known as nephelometric measurement. Nephelometric analysis is particularly suited for the determination of the very finely dispersed matter. Figure below shows the ACL optic system. The coagulimetric channel uses a high efficiency light emitter diode (LED) as light source (wavelength is 660 nm approx.). The light radiation coming from the LED is transferred to the Rotor Holder using an optic fibre system. Due to the narrow bending radius required connecting the LED output to the rotor mounting assy, the use of a very flexible optic fibre is required. For this reason a multiple fibres system, composed by a large number of single fibres (about 1000), is used. The optic fibre is locked to both the emitter side and the rotor side, using 2 set screws. Note: When the optic fibre is locked on the diode side, the applied torque cannot exceed 90° degrees CW or CCW at the rotor holder side. A specific circuit, powered by the Switching Mode Power Supply Board with the +12 Vdc, provides a constant current to the diode. Chapter 3 General Description Page 5 of 40 ACL Elite/ElitePro Service Manual The light emitter is also equipped with a “LED OFF” line, coming from the Motor Board (Board #5), which de-activates the LED when the instrument enters the Standby status. The light generated by the light emitter diode is transmitted through the optic fibre and is scattered by the reaction mixture present in the rotor cuvette. This scattered light is read by using a solid state optical detector, which is installed below the Rotor Holder and is directly connected to the Acquisition & Sensors Board (Board #3) through a coaxial cable. 3.2.2 Chromogenic channel The Chromogenic Channel is based on the light absorption principle. A polychromatic source of light hits the cuvette content. The radiation passes through the solution contained in the cuvette and the unabsorbed portion of light reaches the photocell that transforms the light energy of the ray striking it into an electrical signal. Figure below shows the ACL optic system. The Chromogenic Channel uses a Halogen lamp with an effective life of 1000 hours. The main characteristics of the lamp are the following: • • Voltage: 6 V Wattage: 10 W The lamp is installed into an appropriate socket that allows an easy installation into the Source Lamp assy. The Halogen Lamp Socket can be replaced by accessing the area through a removable cover inside the rotor waste area, in the center of the Page 6 of 40 Chapter 3 General Description ACL Elite/ElitePro Service Manual instrument. In case of replacement of the halogen lamp, attention must be paid to avoid that fingerprints are left on the lamp bulb. The Chromogenic Lamp is powered at a regulated voltage, generated by a particular electronic circuit located onto the Switch Mode Power Supply. The circuit is provided with protections against open circuit and short circuit. The lamp is activated only during the chromogenic cycles, and when the instrument is in the Service programs. The lamp beam passes through an optical filter that “removes” the infrared radiation (named antiheat filter) in order to avoid damage to the fibre, caused by the high temperature present near the lamp. The filter is mounted in the Halogen Lamp Assembly. The beam passes through a quartz optic fibre, and then is fed to the rotor through a focusing system, composed by an optic condenser (the two lenses). The assembly composed by the focusing system plus the optic fibre is called Optical Collimator Assembly. One end of the optic fibre is secured to the source lamp assembly by means of a setscrew, while the other end, is secured below the rotor mounting assembly. The quantity of radiation unabsorbed by the cuvette contents, passes through a 405 nm interference filter and than is detected by an optical sensor (solid state photodiode). Both the optical detector and the filter are mounted in the Rotor Holder Cover. The photodetector is directly connected to the Acquisition & Sensor Board #3 through a coaxial cable. Note: The optical path width for the Chromogenic Channel is 0.5 cm (cuvette height). The absorbance values provided by the analyzer are normalized to 1 cm. These values are generally double the ones obtained on other ACL models, for which the absorbance values are strictly the ones obtained for the 0.5 cm cuvette path. 3.3 Electronic Description This section describes the electronic system of the instrument. Electronic drawings and explanation of the logical functionality are also included. Following are the specific sub-sections. 3.3.1 3.3.2 3.3.3 3.3.4 3.3.5 3.3.6 3.3.7 3.3.8 3.3.9 3.3.10 Interconnection schematic Quick reference board function table Quick reference board function diagram CPU Master Board #1 Slave Board #2 Acquisition & Sensors Board #3 Rotor Exchange Module Board #4 (Excluded in ACL Elite) Motors Board #5 Photometric & Temperatures Control Board #6 Switching Power Supply Board Chapter 3 General Description Page 7 of 40 ACL Elite/ElitePro Service Manual 3.3.11 3.3.12 3.3.1 Instrument Ground Circuit Interface Board Interconnection Schematic The purpose of this drawing is to clarify the starting point and the route of each major signal present in the Instrument. The major modules are logically grouped. An exception is made for the big Module Interconnection Board which is split for better identification of each single module driven. The “Mother Board and Interconnections General Block Diagrams” is available in figure 3.3.1 Drawing 1 of the Chapter 10 “drawings”. Page 8 of 40 Chapter 3 General Description ACL Elite/ElitePro Service Manual 3.3.2 Quick Reference Board Functions Table This sub-section is designed to describe the circuits on the main boards and the main modules and parts driven. Following is the board function table. BOARDS CPU Master Board # 1 MAIN COMPONENTS / CIRCUITS • • • • • • • Main Microprocessor IDE Hard Disk, Floppy Disk controller Serial/Parallel/USB Port controller Ethernet controller • • Arcnet controller Serial Port controller • Communication with Slave Board # 2 • Interface Board (Host port) • Touch Screen Board (Touch Screen) • • • Slave Microprocessor Arcnet controller Serial controller • Communication with PC104 Board • Control of Boards #3, #4, #5 and #6 • Internal Bar Code Reader • PC104 Board Slave Board # 2 Acquisition & Sensors Board # 3 MODULES / PARTS CONTROLLED / DRIVEN • A/D Converter • Coagulimetric & Chromogenic optic channels amplification circuit • Samples Tray detectors circuit • Needles Sensors drive circuit • Reference Emulsion presence circuit • Analysis Compartment Cover Hall Sensor circuit Hard Disk and Floppy Disk LCD Board (LCD) Speaker Interface Board (Mouse, Printer, Keyboard, Ethernet and USB ports) • Coagulimetric & Chromogenic Optical channels • Sample Tray Optical Sensors • Liquid Level Detection Board (Needles Block) • Reference Emulsion Sensor • Analysis Compartment Cover Hall sensor Chapter 3 General Description Page 9 of 40 ACL Elite/ElitePro Service Manual Rotor Exchange Module Board # 4 (excluded in ACL Elite) Motors Board # 5 Page 10 of 40 • REM Slave Microprocessor • Power switching step-up 12v-24v • Rotor Arm Horizontal Motor drive circuit • Rotor Arm Vertical Motor drive circuit • Transport Motor drive circuit • REM Motors Dual Channel Optical Switch reading circuit • Infra Red sensors drive circuit • Electromagnets drive circuit • Rotors Feed Stack Cover Hall sensor circuit • Rotors Waste presence detector circuit • Rotor Arm Horizontal Motor 24Vdc • Rotor Arm Vertical Motor 24Vdc • Transport Motor 24Vdc • REM Motors Dual Channel Optical Switch • Rotor Stack & Rotors Waste Full Infra Red Sensors • Rotor Arm & Rotor Stack Electromagnets • Rotor Stack Cover Sensor • Rotors Waste Presence Detector • Power switching step-up 12v-26v • Autosampler drive circuit • Sample Arm Horizontal Motor drive circuit • Sample Arm Vertical Motor drive circuit • Reagent Dilutor Motor drive circuit • Sample Dilutor Motor drive circuit • Magnetic Stirrer Motors drive circuit • Dilutor Electro-valves drive circuit • Coagulimetric Channel LED drive circuit • Motors Dual Channel Optical Switch reading circuit (W/O REM Motors) • Autosampler Motor 12Vdc • Sample Arm Horizontal Motor 12Vdc • Sample Arm Vertical Motor 26Vdc • Reagent Dilutor Motor 12Vdc • Sample Dilutor Motor 12Vdc • Magnetic Stirrer Motors 26Vac • Dilutor Electro-valves 12Vdc • Coagulimetric Channel LED 12Vdc • Motors Dual Channel Optical Switch (W/O REM Motors) Chapter 3 General Description ACL Elite/ElitePro Service Manual Photometric & Temperature s Control Board # 6 • +5VREF generator circuit • Rotor Motor drive circuit • Rotor Cover Motor drive circuit • Rotor Holder Thermoregulation • Peltiers Thermoregulation • Rotor Transport Thermoregulation • Rotors Stack Thermoregulation • Rotor Motor 70Vdc • Analysis Compartment Cover Motor 12Vdc • Thermoregulation Rotor Holder • Thermoregulation Peltier 1 • Thermoregulation Peltier 2 (ACL ElitePro) • Thermoregulation Transport Plate • Thermoregulation Rotors Feed Stack • • • Power line filter Voltages generators Main current protection circuit Voltages protection circuit Chromogenic Lamp Protection circuit • All modules • USB 1.1 Hub takes single USB port and generates 4 USB ports Overcurrent protection for each individual USB port (USB port will be disabled if overcurrent detected) • USB ports on Interface Board • If USB port is shut down the unit must be rebooted to reenable the USB port to active state Switching Power Supply Board • • Interface Board • 3.3.3 Quick Reference Board Functions Diagram This sub-section provides a graphical representation of the hardware components correlation. The “Quick Reference Board Function Diagram” is available in figure 3.3.3 Drawing 1 of the Chapter 10 “Drawings”. 3.3.4 CPU Master Board (Board # 1) & PC104 Board The CPU Master Board and the PC104 Board, located between the system Card Housing and the Dilutor Assembly, are powered through the Switching Power Supply, which provides a +5Vdc (DGT) and +12Vdc (DGT). The CPU Master Board (Board #1) has a Personal Computer architecture design. Chapter 3 General Description Page 11 of 40 ACL Elite/ElitePro Service Manual The “CPU Master Board General Block Diagram” is available in figure 3.3.4 Drawing 1, while the “PC104 Board General Block Diagram” is available in figure 3.3.4 Drawing 2 of the chapter 10 “Drawings”. The main functions reported in the following outline are further expanded and presented on specific paragraphs. CPU Master Board General Block Diagram (see paragraph 3.3.4.a) • • • • Software runtime. Internal devices control. External devices control. Communication with PC104 Board. PC104 Board General Block Diagram (see paragraph 3.3.4.b) • Communication with the Slave Board (Board # 2). • External devices control. • Touch Screen control. 3.3.4.a CPU Master Board General Block Diagram (See figure 3.3.4 Drawing 1) • Software runtime. At the instrument power on the CPU Master downloads from the Hard Disk Drive both the Operating System and the Application software. A local MEMORY BANK is used during the software runtime. After downloading, the Board #1 starts system initialization testing the instrument hardware through the Slave Board (Board # 2). The control of the MEMORY BANK is achieved through the SYSTEM & DRAM CONTROLLER and the MEMORY CONTROLLER. The Hard Disk Drive control is performed through the SYSTEM & DRAM CONTROLLER and the PERIPHERALS STANDARD CONTROLLER. In addition to the Operating System and Application software the Hard Disk Drive also allows Patient and Analytical Database storage. The CPU Master Board reads the internal device configuration, through the SYSTEM & DRAM CONTROLLER from the BIOS MEMORY. • Internal device control. The internal devices of the instrument controlled from the Board # 1 are: The active matrix LCD (Liquid Crystal Display) controlled by the VGA CONTROLLER and the VIDEO MEMORY (through the LCD ACTIVE MATRIX CONNECTOR CN6). The VGA CONTROLLER can also support Page 12 of 40 Chapter 3 General Description ACL Elite/ElitePro Service Manual standard PC monitor (through PC MONITOR CONNECTOR P1), and/or passive matrix LCD (through the LCD PASSIVE MATRIX CONNECTOR CN11). The Floppy Disk Drive controlled by the PERIPHERAL STANDARD CONTROLLER (through the FLOPPY DISK DRIVE CONNECTOR CN22). The Hard Disk Drive (located under the CPU Master Board) controlled by the PERIPHERAL STANDARD CONTROLLER (through the HARD DISK DRIVE CONNECTOR CN23). The SPEAKER (located on the rear of the system Card Housing) controlled by the SYSTEM & DRAM CONTROLLER (through the UTILITY CONNECTOR CN21). • External devices control. The external devices controlled by Board # 1 (through the Interface Board) are: The standard PC Keyboard controlled from the SYSTEM & DRAM CONTROLLER (through the UTILITY CONNECTOR CN21). An external Ethernet interface controlled from the ETHERNET CONTROLLER (through the ETHERNET CONNECTOR CN4). An external Parallel Printer controlled from the PERIPHERAL STANDARD CONTROLLER (through the PARALLEL PORT CONNECTOR CN26). A PC serial Mouse controlled from the PERIPHERAL STANDARD CONTROLLER (through the MOUSE SERIAL PORT CONNECTOR CN30). Four USB ports (version 1.1) are connected to a integrated USB standard controller thru connector CN24. • Communication with PC104 Board. The CPU Master Board communicates with the PC104 Board through the SYSTEM & DRAM CONTROLLER and the PC104 CONNECTOR CN13 – CN14 – CN29. The CPU Master Board receives the signal RESET from the Mother Board through the UTILITY CONNECTOR CN21. This signal is generated from the Slave Board (Board # 2) and is sent also to the PC104 Board. The Board # 1 provides to the PC104 Board a +5Vdc (DGT). Chapter 3 General Description Page 13 of 40 ACL Elite/ElitePro Service Manual 3.3.4.b PC104 Board General Block Diagram (See figure 3.3.4 Drawing 2) • Communication with the Slave Board (Board # 2). The CPU Master Board communicates to the PC104 Board through the connector CN13 – CN14. The PC104 Board interfaces with the Slave Board (Board # 2) through the ARCNET CONTROLLER, which is connected with the ARCNET CONNECTOR CN5 (CN4 could also be used as it replicates CN5 pinout, being parallel connected). The controller is electrically de-coupled by means of the ISOLATION & TRANSCEIVER CIRCUIT. • External device control. The CPU Master Board communicates to the PC104 Board through the connector CN13 – CN14. The PC104 Board, through the SERIAL CONTROLLER, controls the MODEM – HOST – BAR CODE SERIAL PORT CONNECTOR CN7 – CN8 – CN9. These serial ports though the Interface Board allow the instrument to communicate with the external devices. • Touch Screen control. The CPU Master Board communicates to the PC104 Board through the connector CN13 – CN14. The PC104 Board through the TOUCH SCREEN CONTROL BOARD SERIAL LINE CN6 and the TOUCH SCREEN CONTROL BOARD POWER CN3, controls the Touch Screen Board located inside the Display assembly. 3.3.5 Slave Board (Board # 2) The Slave board (Board #2) is located on the system card housing and powered through the Switching Power Supply, which provides a +5Vdc (DGT). The Slave Board is equipped with a microprocessor (MCU U1), a resident memory bank and a circuitry handling various interrupt signals that are sent to the board. Multiple data and address busses are employed: (D0 - D15 and A0 - A23) are used to connect the MCU U1 to the internal bus (DB0 - DB15 and AB0 - AB23). The internal busses are then buffered to external data and address bus (SLD0 - SLD15 and SLA0 SLA23) through which the Slave board communicates with the Boards # 3, # 5 and # 6. The “Slave Board General Block Diagram” is available in figure 3.3.5 Drawing 1 of the Chapter 10 “Drawings”. The main functions reported in the following outline are further expanded and presented on specific paragraphs. Page 14 of 40 Chapter 3 General Description ACL Elite/ElitePro Service Manual Slave Board General Block Diagram (see paragraph 3.3.5.a) • • • • • Main Reset circuits. Power supply presence circuit. Communication Section (see paragraph 3.3.5.b). Memory Section (see paragraph 3.3.5.c). Glue Logic Section (see paragraph 3.3.5.d). Communication Section (see paragraph 3.3.5.b) • Receives commands forwarded from the CPU Master Board (Board # 1). • Controls the REM Board (Board #4) and the internal Bar Code Reader. Memory Section (see paragraph 3.3.5.c) • Programs run time and data storage. Main Logic Section (see paragraph 3.3.5.d) • Interfaces the Slave board with the external data and address bus. • Interrupt controller. 3.3.5.a Slave Board General Block Diagram (See figure 3.3.5 Drawing 1) • Main reset circuit The RESET CIRCUIT U3 generates the signal RESET used to initialize the whole system. The RESET CIRCUIT can be triggered by any of the following devices/signals: - The MAIN LOGIC EPLD U12 (Main Logic Section). The signal INIT generated on the Switching Power Supply. The local microswitch RESET SWITCH SW1 (used only for manufacturing testing purposes). The LED LD1 is illuminated only when the signal RESET is present. • Power supply presence circuit Chapter 3 General Description Page 15 of 40 ACL Elite/ElitePro Service Manual The LED LD4 is illuminated always while the Board # 2 is powered with +5Vdc (DGT). 3.3.5.b Communication Section (See figure 3.3.5 Drawing 2) • Receives commands forwarded from the CPU Master Board (Board # 1). The Slave board communicates with the CPU Master Board by means of an Arcnet connection, using a dedicated cable and connector P6 (P7 could also be used as it replicates P6 pinout, being parallel connected). The data transmission is handled by the ARCNET CONTROLLER CIRCUIT U27. The controller is electrically de-coupled by means of the ISOLATION CIRCUIT ISO1 – ISO2. A DC/DC CONVERTER REG1, connected to the LED LD2, provides a dedicated power supply to the TRANCEIVER CIRCUIT U29. A further circuit controlled by the CANBUS CONTROLLER U28 is present but not used on the Slave board. • Controls the REM Board (Board #4) and the internal Bar Code Reader. A serial communication is achieved by the SERIAL CONTROLLER CIRCUIT U31 – U32. The serial controller is electrically de-coupled by means of the ISOLATION CIRCUIT ISO3 – ISO10. A DC/DC CONVERTER REG2, connected to the LED LD3, provides a dedicated power supply to the DRIVER CIRCUIT U33 – U34 – U35. The serial communication line TX0 – RX0 coming from MCU U1, is also linked to the DRIVER CIRCUIT U33 – U34 – U35, which handles the serial communication line TXD4 – RXD4 to the REM board (board # 4). Signals TRIGBARC, TX1 – RX1 are respectively utilized for both enabling (TRIGBARC) and communicate (TX1 - RX1) with the internal Bar Code reader. The serial ports P8 - P9 - P10 are not used during the normal operations. Use of these ports is limited to the manufacturing process when the board is connected to external devices, which program the resident logic. 3.3.5.c Memory Section (See figure 3.3.5 Drawing 3) • Programs run time and data storage. A few memory devices are employed to support the MCU U1 on the Slave Board, these are: The SERIAL EPROM U2 is directly linked to a serial port of the MCU U1. The RAM STATIC MEMORY BANK U22-25 linked to MCU U1 through the data bus DB0 - DB15 and the address bus AB0 - AB19. The FLASH EPROM MEMORY U14 - U21 linked to MCU U1 through the data bus DB0 - DB15 and the address bus AB0 - AB19. Page 16 of 40 Chapter 3 General Description ACL Elite/ElitePro Service Manual The MCU U1 is also connected to the BOOT LOADER EPROM U26 from, which downloads the boot program by sending the command CSBOOT while initializing. 3.3.5.d Main Logic Section (See figure 3.3.5 Drawing 4) • Interfaces the Slave board with the external data and address bus. The MCU U1 is connected through the data bus D0 - D15 to the INTERNAL DATA BUS TRANSCEIVER U4, which outputs DB0 - DB15 as local data bus connecting to other devices resident on the Slave board. The local data bus BD0 - DB15, is then linked to the EXTERNAL DATA BUS TRANSCEIVER U7 – U36. These devices output SLD0 - SLD15 (slave data bus), which allows MCU U1 to communicate with the Board # 3, # 5 and # 6, located on the system card housing. The address bus A0 - A23 links MCU U1 to the INTERNAL ADDRESS BUS BUFFER U5 – U6 which outputs AB0 - AB23 as local address bus connecting to other devices resident on the Slave board. The local address bus AD0 - AD23, is then linked to the EXTERNAL ADDRESS BUS BUFFER U8 – U9. These devices output SLA0 - SLA23 (slave address bus), which allows MCU U1 to communicate with the Board # 3, # 5 and # 6, located on the system card housing. The control signal R/W is fed to the INTERNAL ADDRESS BUS BUFFER U5 –U6 which outputs a signal BR/W connected to the MAIN LOGIC EPLD U12. The EPLD generates the individual control signals RD and WR which are routed to the INTERNAL ADDRESS BUS BUFFER U5 –U6 where they get converted into BRD and BWR. The EXTERNAL INTERRUPT BUS BUFFER U10 – U11 buffer the commands and output the commands SLRD and SLWR which become control signals of the external data and address bus. The MAIN LOGIC EPLD U12 also handles the chip select signals for the local devices as well as the board select commands. The board select commands (BS0 BS3) are fed to the EXTERNAL INTERRUPT BUS BUFFER U10 – U11 which provide outputs SLBS0 - SLBS3 to the Board # 3, # 5 & # 6 located on the system Card Housing. • Interrupt controller. Possible interrupts generated outside the Slave board are input via the EXTERNAL INTERRUPT BUS BUFFER U10 – U11 and then routed to the INTERRUPT Chapter 3 General Description Page 17 of 40 ACL Elite/ElitePro Service Manual CONTROLLER EPLD U13. The EPDL U13 handles the interrupts following a scheme of priority and sends signals IRQ1 - IRQ7 to the MCU U1. The interrupts, which can be generated and logged into the Slave board are as follows: INIT (Initial Reset) This signal is raised from the Switching Power Supply and has the purpose of keeping the system reset for a pre-defined period of time thus allowing the power supply voltages to reach stability. POWERFAIL This signal is raised from the Switching Power Supply, which can detect a lack of supply voltage, and may lead to a decrease of the dc voltages thus impairing proper functioning of the logic. STS This can be raised by the Acquisition & Sensor Board (Board # 3) when the A/D conversion has been accomplished and the data is available on the bus. ELETFAIL This can be raised by the Rotor Exchange Module Board (Board # 4) in case of malfunction of an electromagnet thus impairing proper rotor displacement. ROTCUV and ROTCUVZ These can be raised by the Motor Board (Board # 5) and are utilized to highlight a possible malfunction of either the rotor motor or associated device, such as the Dual Channel Optical Switch. ROTFAIL This can be raised by the Photometric & Temperature Control Board (Board # 6) in case of a malfunction of the Rotor Motor. 3.3.6 Acquisition & Sensors Board (Board # 3) The Acquisition & Sensor Board, is located in the system Card Housing, and powered through the Switching Power Supply, which provides the +5Vdc (DGT), +15Vdc (ANA), -15Vdc (ANA) and +12Vdc (PW). The Acquisition & Sensors Board communicates with the Slave Board (Board # 2) through the signals SLD0 - SLD15 “slave data bus”, and the signals SLA0 - SLA7 “slave address bus”. This communication is supported by the control signals SLRD, SLWR, RESET as well as the Board enabling signal SLBS0. The “Acquisition & Sensors Board General Block Diagram” is available in figure 3.3.6 Drawing 1 of the Chapter 10 “Drawings”. The main functions reported in the following outline are further expanded and presented on specific paragraphs. Acquisition & Sensors Board General Block Diagram (see paragraph 3.3.6.a) Page 18 of 40 Chapter 3 General Description ACL Elite/ElitePro Service Manual • • • • • • • • Reading Warning signals from Switching Power Supply. Control signals for Switching Power Supply. Multiplexer & Acquisition Section (see paragraph 3.3.6.b). Channel Amplifier Section (see paragraph 3.3.6.c). Sample Tray Detectors Emitter & Receiver Sections (see paragraph 3.3.6.d). Needles Sensor Section (see paragraph 3.3.6.e). Reference Emulsion Presence Section (see paragraph 3.3.6.f). Analysis Compartment Cover Sensor Section (see paragraph 3.3.6.g). Multiplexer & Acquisition Section (see paragraph 3.3.6.b) • A/D Conversion for most important signals. • Sends the interrupt signal STS to the Slave Board (Board # 2). • Frequency generation for Magnetic Stirrer Motors. Channel Amplifier Section (see paragraph 3.3.6.c) • Optical channel amplification. Sample Tray Detectors Emitter & Receiver Sections (see paragraph 3.3.6.d) • Container on Sample Tray detection. Needles Sensor Section (see paragraph 3.3.6.e) • Liquid presence detection during the analysis loading cycle. Reference Emulsion Presence Section (see paragraph 3.3.6.f) • Reference Emulsion presence level in the bottle. Analysis Compartment Cover Hall Sensor Section (see paragraph 3.3.6.g) • Analysis Compartment Cover position detection. 3.3.6.a Acquisition & Sensors Board General Block Diagram (See figure 3.3.6 Drawing 1) Chapter 3 General Description Page 19 of 40 ACL Elite/ElitePro Service Manual • Reading Warning signals from Switching Power Supply. The Switching Power Supply, in case of malfunction, sends two warning signals to the Acquisition & Sensor Board (Board # 3). The signal THERFAIL is raised by the Switching Power Supply in case the temperature of the environment reaches a level (about 60 C°), which is dangerous for the Switching Power Supply. If overheating is detected (about 75 C°) the Switching Power Supply enters the Protection Mode shutting down the power to the instrument. The second signal MISSLAMP is raised by the Switching Power Supply when the current for the Halogen Lamp gets too low. Both signals enter in the PARALLEL I/O U5 and are read by the Slave Board. • Control signals for Switching Power Supply. The Slave Board (Board # 2) sends to the PARALLEL I/O U5 two control signals for the Switching Power Supply. The first is the signal LAMPWR that controls the Halogen Lamp status. The second is the signal PWROFF that controls the +9Vdc, +12Vdc and +70Vdc power voltage status. 3.3.6.b Multiplexer & Acquisition Section (See figure 3.3.6 Drawing 2) • A/D Conversion for most important signals. Following are the most important signals converted: COAG – CHROM for the Analysis Compartment Optical Channels reading. TPELT1 for the Peltier temperature detection. TPELT2 for the second Peltier temperature detection (ACL ElitePro). TROT for the Rotor Holder temperature detection. TFSLITTA for the Transport Plate temperature detection. TFSILOS for the Rotors Feed Stack temperature detection. +5VREF for the 5V Reference voltage detection. SCUVINT for the Sample Tray internal ring container detection. SCUVEXT for the Sample Tray middle and external rings container detection. SLIQ for the liquid presence detection. SFLUSH for the Reference Emulsion level detection. SHALL for the Analysis Compartment Cover closed detection. The Board # 3 uses the multiplexer MPLX CIRCUIT U1 to select that signal will convert the A/D CONVERTER CIRCUIT U11. This selection is driven by the PARALLEL I/O U5 that sends the control signals MUX0 - MUX3 to the multiplexer. The EPLD U6 controls with the start signal ADRC and the end signal ADSTAT the conversion process of the A/D CONVERTER CIRCUIT U11. The EPLD U6 controls the timer programmable TIMER PROG. U9 that allows the EPLD of work with the Rotor Motor’s speed during acquisition at 600 or 1200 Rpm, and introduces a delay in the acquisition time pre-selected in the Curve Adjustment Service menu (see section Page 20 of 40 Chapter 3 General Description ACL Elite/ElitePro Service Manual 7.2 for Coag. and section 7.3 for Chrom.). The EPLD U6 receives from the PARALLEL I/O U5 the control signals AACQ to select the static or the dynamic acquisition and the signals SCALF to select the delay for Coag. Ch. or Chrom. Ch. The EPLD U6 receives the signals ROTCUV – ROTCUVZ from the Motors Board (Board # 5) and they are very important signals to synchronise the data acquisition. • Sends the interrupt signal STS to the Slave Board (Board # 2). When the new data is ready the EPLD U6 receives the signal ADSTAT from the A/D CONVERTER CIRCUIT U11, then enables the BUFFER 3-STATE U12 – U13 with the signal RDADC and sends the interrupt signal STS to the Slave Board (Board # 2). • Frequency generation for Magnetic Stirrer Motors. The timer programmable TIMER PROG. U10 is used to produce the frequency FREQST for the work of the Magnetic Stirrer Motors drivers on the Motors Board (Board # 5). 3.3.6.c Channels Amplifier Section (See figure 3.3.6 Drawing 3) • Optical channel amplification. The Optical sensor of the Coagulimetric Channel is located under the Rotor Holder. This sensor is connected to the Acquisition & Sensors Board through a coaxial cable that enters in the specific amplifier’s box. The sensor’s signal enters in the AMPLIFIER CIRCUIT U17 – U21, and the output COAG is one of the most important signals converted in the Multiplexer & Acquisition Section. This circuit is composed also by the trimmers RV1 used to adjust the Offset and RV2 used to adjust the Gain during the instrument testing (see section 7.2). The Optical sensor of the Chromogenic Channel is located under the Analysis Compartment Cover. This sensor is connected to the Acquisition & Sensors Board through a coaxial cable that enters in the specific amplifier’s box. The sensor’s signal enters in the AMPLIFIER CIRCUIT U20 – U22, and the output CHROM is one of the most important signals converted in the Multiplexer & Acquisition Section. This circuit is composed also by the trimmers RV4 used to adjust the Offset and RV3 used to adjust the Gain during the instrument testing (see section 7.3). 3.3.6.d Samples Tray Detectors Emitter & Receiver Sections (See figures 3.6.6 Drawing 4 and Drawing 5) • Container on Sample Tray detection. The Autosampler is designed to accept patient samples, as well as calibrants on the same tray (Sample Tray). Chapter 3 General Description Page 21 of 40 ACL Elite/ElitePro Service Manual Forty positions are available to load patient samples. Two rings (outermost and middle ring) can accept twenty cup/tubes each. A third ring (innermost) is available on the Sample Tray and up to ten positions can be loaded with calibrants, controls and/or reagents. Two optical sensors are located in the Autosampler housing with the purpose of detecting the presence of the containers in the Sample Tray. The internal sensor is placed in the internal wall while the external sensor is placed in the external wall of the Autosampler housing. Both the sensors detect the presence of the containers using the refraction principle. The power section for the infra red light emitter of the sensors is controlled by the PARALLEL I/O U5 that sends the enabling signals ESCUV – ESCUVINT – ESCUVEXT to the EPLD U6. The Sample cup/tubes can be placed in the Sample Tray on two different rings. As the sample cup/tubes can be placed on both the outermost and the middle ring, two different levels of current are needed to drive the external sensor which shall detect the presence of sample containers located either close (outermost ring) or far (middle ring). To select the most appropriate current level, the EPLD U6 sends the AUTOC signal to the SWITCH CIRCUIT U26 which through the signals SCUVL1 – SCUVL2 set the current level output at the CURRENT GENERATOR U43A – U46A. The trimmer RV6 allows the adjustment of the current in the emitter during the instrument testing (see sub-section 7.5.3). The outputs of the power circuit for the external sensor are ANLED1 – KD1. The auxiliary materials containers are placed in the innermost ring of the Sample Tray and are detected by the internal sensor. The trimmer RV7 allows the adjustment of the current in the emitter during the instrument testing (see sub-section 7.5.3). The outputs of the power circuit for the internal sensor are ANLED2 – KD2. The external sensor receives the refracted light and sends to the receiver circuit the signal ET1 which is filtered and amplifier to produce the signal SCUVEXT. This signal is then converted in the Multiplexer & Acquisition Section. To select the right work’s level, the EPLD U6 sends the controls signal AUTOC to the SWITCH CIRCUIT U26 that can link the trimmer RV10 to control the gain of the AMPLIFIER CIRCUIT U27A. The trimmer RV10 allows, for the outermost ring, the adjustment of the amplifier gain for the receiver signal during the instrument testing (see sub-section 7.5.3). Another control signal is BLIVSCUV which is sent to the COMPARATOR CIRCUIT U48A to select the right work level and produce the logical signal PCUVEXT, then this signal is read from the PARALLEL I/O U5. The DRIVER CIRCUIT U28 controls the LED DL1 that is lighted when the sample containers are detected during the Autosampler / BCR Test (see sub-section 7.5.3). The internal sensor receives the refracted light and sends to the receiver circuit the signal ET2 witch is filtered and amplified to produce the signal SCUVINT, one of the most important signals converted in the Multiplexer & Acquisition Section. The circuit produces also the logical signal PCUVINT which is read from the PARALLEL I/O U5. The DRIVER CIRCUIT U28 controls the LED DL2 that is Page 22 of 40 Chapter 3 General Description ACL Elite/ElitePro Service Manual lighted when the auxiliary materials containers are detected during the Autosampler Test (see sub-section 7.5.3). 3.3.6.e Needles Sensor Section (See figure 3.3.6 Drawing 6) • Liquid presence detection during the analysis loading cycle. The Liquid Level Detector Board, connected to the needles block assembly, sends the signals AGOSS for the sample needle and AGOSR for the reagent needle to the Acquisition & Sensors Board. The EPLD U36 selects with the enabling signals EAGOS - EAGOR the sample/reagent needle sensor signal. The EPLD U36 also controls with the signals EAUTOZEROS – RAUTOZEROS the reading or the reset of the auto-zero circuit. The selected signals enter in the specific circuit and produce the output signal SLIQ, which is then converted in the Multiplexer & Acquisition Section. The EPLD U36 sends the control signals GXL1 – GXL2 to the SWITCH CIRCUIT U51 which, according with the cycle in progress, sets the gain of the AMPLIFIER CIRCUIT U39B by connecting either the trimmer RV11 (for the Reagent) or RV12 (for the Sample) as appropriate. The trimmer RV11 and RV12 allow the adjustments of the amplifier gain for the output SLIQ during the instrument testing (see section 6.3.1). The signal SLIQ is also compared with one of the three threshold signals SG1 – SG2 – SG3, this selection is controlled by EPLD U36 to produce the logical signal PSAGO, then this signal is read from the PARALLEL I/O U5. The DRIVER CIRCUIT U28 controls the LED DL4 that is lit when the liquids are detected during the Needles Sensor Test (see subsection 7.4.1). The PARALLEL I/O U5 sends to the EPLD U36 the signal EAGHITIP aimed at enabling the entire liquid detectors circuit and the signal LGT2 to enables the timer programmable TIMER PROG. U9. 3.3.6.f Reference Emulsion Presence Section (See figure 3.3.6 Drawing 7) • Reference Emulsion presence level in the bottle. The sensor located inside the cap of the Reference Emulsion bottle detects the volume of the liquid in the bottle. The PARALLEL I/O U5 enables with the signal ECLKLIQ the timer programmable TIMER PROG. U10, which outputs the clock signal CLKSENSE, amplified and used with the name of CLKSINE as a reference. This signal CLKSINE is sent to the sensor and returns to the board attenuated with the name of BFLUSH. The signal attenuation is proportional to the missing volume of Reference Emulsion, so the signal MFLUSH is the amplified reading of the sensor. The EPLD U6 – U36 controls through the signal SFLH the SWITCH CIRCUIT U26. This circuit then selects between the inputs MFLUSH and CLKSINE the output signal MSENSE. The signal MSENSE is then amplified and output as SFLUSH from the AMPLIFIER CIRCUIT U24. The signal SFLUSH is then converted in the Multiplexer & Acquisition Section. Chapter 3 General Description Page 23 of 40 ACL Elite/ElitePro Service Manual The trimmer RV9 allows the adjustments of the amplifier gain for the output signal SFLUSH during the instrument testing (see sub-section 7.4.1). The trimmer RV8 allows the factory adjustment of the amplifier gain for the reference signal CLKSINE. 3.3.6.g Analysis Compartment Cover Sensor Section (See figure 3.3.6 Drawing 8) • Analysis Compartment Cover position detection. The magnetic sensor, located under the Fluidic Plate on the left side of the Analysis Compartment, detects the presence of the magnet placed in the Analysis Compartment Cover and outputs the signals COVDET1 – COVDET2 for the Acquisition & Sensor Board. The circuit output, signal SHALL, is one of the most important signals converted in the Multiplexer & Acquisition Section. The trimmer RV5 allows the adjustments of the amplifier for the output signal SHALL during the instrument testing (see sub-section 7.9.1). The signal SHALL is also used to generate the signal PHALL which enters in the DRIVER CIRCUIT U28 to control the LED DL3 which is illuminated when the cover is closed. 3.3.7 Rotor Exchange Module Board (Board # 4) (excluded from ACL Elite) The Rotor Exchange Module Board, is located in the system Card Housing, and powered through the Switching Power Supply, which provides the +5Vdc (DGT), +15Vdc (ANA), -15Vdc (ANA) and +12Vdc (PW). The R.E.M. Board is equipped with a microprocessor (CPU U1) and a resident memory bank. The R.E.M. Board communicates with the Slave Board (Board # 2) through the serial communications line TXD4 – RXD4. The “Rotor Exchange Module Board General Block Diagram” is available in figure 3.3.7 Drawing 1 of the chapter 10 “Drawings”. The main functions reported in the following summary are further expanded and presented on specific paragraphs. Rotor Exchange Module General Block Diagram (see paragraph 3.3.7.a) • • • • • • • • • Reading of the Motor Dual Channel Optical Switch. Rotors Waste container presence detection. Rotors Feed Stack cover position detection. CPU ready condition circuit. Transport Motors Section (see paragraph 3.3.7.b). Rotor Arm Motors Section (see paragraph 3.3.7.c). Memory & Communication Section (see paragraph 3.3.7.d). Infra Red Sensors Section (see paragraph 3.3.7.e). Electro Magnets Control Section (see paragraph 3.3.7.f). Page 24 of 40 Chapter 3 General Description ACL Elite/ElitePro Service Manual Transport Motor Section (see paragraph 3.3.7.b) • Transport Motor drives circuit. Rotor Arm Motors Section (see paragraph 3.3.7.c) • Rotor Arm Horizontal Motor drives circuit. • Rotor Arm Vertical Motor drives circuit. Memory & Communication Section (see paragraph 3.3.7.d) • Resident Memory Bank and communication with the Slave Board (Board # 2). Infra Red Sensors Section (see paragraph 3.3.7.e) • New and used Rotors presence detection. Electro Magnets Control Section (see paragraph 3.3.7.f) • Rotors loading from Caliper and Rotors Feed Stack. • Sends the interrupt signal ELETFAIL to the Slave Board (Board # 2). 3.3.7.a Rotor Exchange Module General Block Diagram (See figure 3.3.7 Drawing 1) • Reading of the Motor Dual Channel Optical Switch. Three Dual Channel Optical Switches are mounted on the Transport and on the Rotor Arm assembly to detect the positions of the motors. The motor position is coded by an Encoder disk or flag located on the movement assy. The Dual Channel Optical Switch sends to the Board # 4 the signals read on the Encoders. These signals enter in the BUFFER CIRCUIT U27 – U28 – U29, which output the signals: SLOT_CAS – EDGE_CAS for the Transport Motor, SLOT_ROT – EDGE_ROT for the Rotor Arm Horizontal Motor and SLOT_HIG – EDGE_HIG for the Rotor Arm Vertical Motor. These signals are routed directly or through the multiplexer MPLX CIRCUIT U6 into the CPU U1. The motor rotation, sensed by the Dual Channel Optical Switch, allows the CPU U1 to detect possible “motor failures”. • Rotors Waste container presence detection. Chapter 3 General Description Page 25 of 40 ACL Elite/ElitePro Service Manual The status of the mechanical switch, located inside the Rotors Waste container compartment, is read through the BUFFER CIRCUIT U27, which outputs the signal DOOR_WST to the CPU U1. • Rotors Feed Stack cover position detection. The magnetic sensor, located over the Rotors Feed Stack, is activated by a magnet embedded inside the Feed Stack cover. The magnet sensor status is read through the BUFFER CIRCUIT U30, which outputs the signal COP_SILOS to the CPU U1. • CPU ready condition circuit. The CPU U1 through the EPLD U2 controls the LED DL1, which is lit when the CPU U1 is ready. 3.3.7.b Transport Motor Section (See figure 3.3.7 Drawing 2) • Transport Motor drive circuit. The Slave Board sends to the CPU U1 the command relative to the Transport Motor movement. The CPU U1 controls the TRANSPORT MOTOR DRIVER U14 – DX1, whose output signals are the motor phases M1A – M1BB. The CPU U1 uses the demultiplexer DEMPL U29 to send the enable signal M1_PWR_ENA to the driver circuit, and the multiplexer MPLX U6 to check the presence of the signal MO_CAS generated by the driver only if there is a malfunction. The TRANSPORT MOTOR DRIVER U14 – DX1 is powered by the LOCAL GENERATOR +24VPW U10. The jumpers in M1 are factory pre-set to obtain full or half steps as required. 3.3.7.c Rotor Arm Motors Section (See figure 3.3.7 Drawing 3) • Rotor Arm Horizontal Motor drives circuit. The Slave Board sends to the CPU U1 the command relative to the Rotor Arm Horizontal Motor movement. The CPU U1 controls the ROTOR ARM HORIZONTAL MOTOR DRIVER U16 – DX2, whose output signals are the motor phases M2A – M2BB. The CPU U1 uses the demultiplexer DEMPL U29 to send the enable signal M2_PWR_ENA to the driver circuit, and the multiplexer MPLX U6 to check the presence of the signal MO_ROT generated by the driver only if there is a malfunction. The ROTOR ARM HORIZONTAL MOTOR DRIVER U16 – DX2 is powered by the LOCAL GENERATOR +24VPW U10. The jumpers in M2 are factory pre-set to obtain full or half steps as required. • Rotor Arm Vertical Motor drives circuit. Page 26 of 40 Chapter 3 General Description ACL Elite/ElitePro Service Manual The Slave Board sends to the CPU U1 the command relative to the Rotor Arm Vertical Motor movement. The CPU U1 controls the ROTOR ARM VERTICAL MOTOR DRIVER U18 – DX3, whose output signals are the motor phases M3A – M3BB. The CPU U1 uses the demultiplexer DEMPL U29 to send the enable signal M3_PWR_ENA to the driver circuit, and the multiplexer MPLX U6 to check the presence of the signal MO_HIG generated by the driver only if there is a malfunction. The ROTOR ARM VERTICAL MOTOR DRIVER U18 – DX3 is powered by the LOCAL GENERATOR +24VPW U10. The jumpers in M3 are factory pre-set to obtain the full or half steps as required. 3.3.7.d Memory & Communication Section (See figure 3.3.7 Drawing 4) • Resident Memory Bank and communication with the Slave Board (Board # 2). The CPU U1 controls through the data bus D0 – D7, the address bus A8 – A15, and the BUFFER 3-STATE CIRCUIT U3, the RAM MEMORY U4 and the ROM FLASH MEMORY U5, used for the program’s run-time and data storage. The CPU U1 through the EPLD U2 sends the enable signals to the memories. The serial communication line of the CPU U1 is linked with the SERIAL I/O CIRCUIT U8, which handles the serial communication line TXD4 – RXD4 to the Slave Board (Board # 2). 3.3.7.e Infra Red Sensors Section (See figure 3.3.7 Drawing 5) • New and Waste Rotors presence detection. Three optical sensors are located on the Rotor Exchange Module assy, with the purpose of detecting the presence of the rotors along the route. This route begins in the Rotors Feed Stack and ends in the Rotors Waste container. Two optical sensors are located in the Rotors Feed Stack and one above the Rotors Waste container. These three sensors detect the presence of the rotors using the refraction principle. The upper sensor located inside the Rotors Feed Stack allows the system to detect for presence of new rotors in the storage area of the Rotor Stack (over the mechanical movements). This sensor is powered by the POWER CIRCUIT Q7, which provides the signals AFCS and CFC. The sensor receives the refracted light and sends to the receiver circuit the signals FCS, which is handled by the circuit to produce the signal FC_STR. This signal is read by the CPU U1 through the multiplexer MPLX CIRCUIT U7. This circuit is composed also by the trimmer PT1 used to adjust the signal during the instrument testing (see sub-section 7.5.1). The lower sensor located inside the Rotors Feed Stack allows the system to detect for presence of a new rotor on the Rotor Transport plate. Chapter 3 General Description Page 27 of 40 ACL Elite/ElitePro Service Manual This sensor is powered by the POWER CIRCUIT Q7, which provides the signals AFCC and CFC. The sensor receives the refracted light and sends to the receiver circuit the signals FCC, which is handled by the circuit to produce the signal FC_CAS. This signal is read by the CPU U1 through the multiplexer MPLX CIRCUIT U7. This circuit is composed also by the trimmer PT2 used to adjust the signal during the instrument testing (see sub-section 7.5.1). The sensor located above the Rotors Waste container allows the system to detect the conditions of “Waste container full”. This sensor is powered by the POWER CIRCUIT Q7, which provides the signals AFCW and CFC. The sensor receives the refracted light and sends to the receiver circuit the signals FCW, which is handled by the circuit to produce the signal FC_WST. This signal is read by the CPU U1 through the multiplexer MPLX CIRCUIT U7. This circuit is composed also by the trimmers PT3 used to adjust the reading of the signal during the instrument testing (see sub-section 7.5.2). The CPU U1 through the EPLD U2 sends the signal CK_LED, which is used to enable the circuit. 3.3.7.f Electro Magnets Control Section (See figure 3.3.7 Drawing 6) • Rotor loading from Caliper and Rotors Feed Stack. Three similar mechanisms achieve the rotors loading on the Rotor Exchange Module assembly. One of them is the Caliper, located over the Rotor Arm, used to load and unload the Analysis Compartment and to move the used rotors to waste. Two of them are located inside the Rotors Feed Stack to allow the correct rotors loading. These mechanisms use three identical electromagnets. The CPU U1 through the EPLD U2 controls the POWER CIRCUIT Q1 – Q2 – Q3 – D7 – D8, which outputs the signals used to power the electromagnets. These signals are EMCL for the Caliper, EMS1 for the upper movement inside the Rotors Feed Stack and EMS2 for the lower one. The signal EM_SUPPLY is used as common to recover the high current produced during the electromagnet opening. • Sends the interrupt signal ELETFAIL to the Slave Board (Board # 2). The RESISTIVE CIRCUIT controls the signals for the electromagnets and sends the warning TEM_CLM for the Caliper, TEM_ST1 for the upper movement, TEM_ST2 for the lower movement, and the signal 24V_MOT for the LOCAL GENERATOR +24VPW. These signals are read by the CPU U1 through the multiplexer MPLX CIRCUIT U7. If a warning signal is active the CPU U1 commands the EPLD U2 to disable the electromagnet with the failure and sends the interrupt signal ELETFAIL to the Slave Board (Board # 2). Page 28 of 40 Chapter 3 General Description ACL Elite/ElitePro Service Manual 3.3.8 Motors Board (Board # 5) The Motors Board, is located in the system Card Housing, and powered through the Switching Power Supply, which provides the +5Vdc (DGT), and +12Vdc (PW). The Motors Board communicates with the Slave Board (Board # 2) through the signals SLD0 - SLD7 “slave data bus”, and the signals SLA0 - SLA7 “slave address bus”. This communication is supported by the control signals SLRD, SLWR, RESET as well as the Board enabling signal SLBS2. The “Motors Board General Block Diagram” is available in figure 3.3.8 Drawing 1 of the chapter 10 “Drawings”. The main functions reported in the following summary are further expanded and presented on specific paragraphs. Motors Board General Block Diagram (see paragraph 3.3.8.a) • Reading of the signals originated by the Dual Channel Optical Switch mounted on • • • • • • • the Autosampler Motor, the Sample Arm Motors, the Dilutors Motors, the Rotor Motor and the Analysis Compartment Cover Motor. Sends the interrupt signals ROTCUV – ROTCUVZ to the Slave Board (Board # 2) and to the Acquisition & Sensor Board (Board #3). Dilutor Electro Valves control. Coagulimetric Channel LED status control. Autosampler Motor Section (see paragraph 3.3.8.b). Sample Arm Motors Section (see paragraph 3.3.8.c). Dilutors Motors Section (see paragraph 3.3.8.d). Magnetic Stirrer Motors Section (see paragraph 3.3.8.e). Autosampler Motor Section (see paragraph 3.3.8.b) • Autosampler Motor drives circuit. Sample Arm Motors Section (see paragraph 3.3.8.c) • Sample Arm Horizontal Motor drives circuit. • Sample Arm Vertical Motor drives circuit. Dilutors Motors Section (see paragraph 3.3.8.d) • Reagent Dilutor Motor drives circuit. • Sample Dilutor Motor drives circuit. Chapter 3 General Description Page 29 of 40 ACL Elite/ElitePro Service Manual Magnetic Stirrer Motors Section (see paragraph 3.3.8.e) • Magnetic Stirrer Motors drives circuit. 3.3.8.a Motors Board General Block Diagram (See figure 3.3.8 Drawing 1) • Reading of the signals originated by the Dual Channel Optical Switch mounted on the Autosampler Motor, the Sample Arm Motors, the Dilutors Motors, the Rotor Motor and the Analysis Compartment Cover Motor. The positions of the motors are coded by Encoder disks or flags located on the movement assy. The Dual Channel Optical Switch sends to the Board # 5 the signals read on the Encoders associated. These signals are: SMALOW – SMAHIGH for the Autosampler Motor SMOLOW – SMOHIGH for the Sample Arm Horizontal Motor SMVLOW – SMVHIGH for the Sample Arm Vertical Motor SMDREAG for the Reagent Dilutor Motor (uses a Single Channel Optical Switch) SMDSAMP for the Sample Dilutor Motor (uses a Single Channel Optical Switch) SMRTLOW – SMRTHIG for the Analysis Compartment Cover Motor SMRLOW – SMRHIGH for the Rotor Motor. These signals enter in the BUFFER CIRCUIT U7 – U8 then in the PARALLEL I/O U1, which is controlled through the “slave data and address bus” from the Slave Board (board # 2). The motor rotation, sensed by the Dual Channel Optical Switch, allows the Slave Board to detect possible “motor failures”. • Sends the interrupt signals ROTCUV – ROTCUVZ to the Slave Board (Board # 2) and to the Acquisition & Sensor Board (Board #3). The Dual Channel Optical Switch mounted on the Rotor Motor is very important to achieve a proper reading during the Analysis Acquisition. Its signals SMRLOW – SMRHIGH through the BUFFER CIRCUIT U7 – U8 enter the EPLD U41, which sends the signals ROTCUV – ROTCUVZ to the Acquisition & Sensor Board (Board # 3) and to the Slave Board (Board # 2). • Dilutor Electro Valves control. The Slave Board controls through the “slave data and address bus” the PARALLEL I/O U1, which communicates the request status for the Electro Valves to the DRIVER CIRCUIT U5. This driver energize/de-energize the Electro Valves through the power signals EV1 – EV2. Page 30 of 40 Chapter 3 General Description ACL Elite/ElitePro Service Manual • Coagulimetric Channel LED status control. The Slave Board controls through the “slave data and address bus” the PARALLEL I/O U1, which output enables the power circuit Q1 to send the signal LEDOFF to the Coagulimetric Channel LED. 3.3.8.b Autosampler Motor Section (See figure 3.3.8 Drawing 2) • Autosampler Motor drives circuit. The Slave Board sends to the EPLD U43 the command relative to the Autosampler Motor movement. The EPLD U43 through the demultiplexer DEMPLX CIRCUIT U24 controls the AUTOSAMPLER MOTOR DRIVER U21 – U22, which output signals are the motor phases MFA1 – MFA4. The Autosampler Motor drives circuit is powered from the LOCAL GENERATOR +5VPW U40, factory adjusted by means of the trimmer RV6. The trimmer RV3 is factory adjusted to set the reference voltage to the demultiplexer DEMPLX CIRCUIT U24. 3.3.8.c Sample Arm Motors Section (See figure 3.3.8 Drawing 3) • Sample Arm Horizontal Motor drives circuit. The Slave Board sends to the EPLD U42 the command relative to the Sample Arm Horizontal Motor movement. The EPLD U42 through the demultiplexer DEMPLX CIRCUIT U34 controls the SAMPLE ARM HORIZONTAL MOTOR DRIVER U31 – U32, which output signals are the motor phases MFO1 – MFO4. The Sample Arm Horizontal Motor drive circuit is powered from the LOCAL GENERATOR +5VPW U40. The trimmer RV4 is factory adjusted to set the reference voltage to the demultiplexer DEMPLX CIRCUIT U34. • Sample Arm Vertical Motor drives circuit. The Slave Board sends to the EPLD U43 the command relative to the Sample Arm Vertical Motor movement. The EPLD U43 through the demultiplexer DEMPLX CIRCUIT U38 controls the SAMPLE ARM VERTICAL MOTOR DRIVER U35 – U36, which output signals are the motor phases MFV1 – MFV4. The Sample Arm Vertical Motor drive circuit is powered from the LOCAL SWITCHING POWER SUPPLY +26VPW U7. This circuit is also powered from the LOCAL GENERATOR +5VPW U40. The trimmer RV5 is factory adjusted to set the reference voltage to the demultiplexer DEMPLX CIRCUIT U38. 3.3.8.d Dilutors Motors Section (See figure 3.3.8 Drawing 4) Chapter 3 General Description Page 31 of 40 ACL Elite/ElitePro Service Manual • Reagent Dilutor Motor drives circuit. The Slave Board sends to the EPLD U42 the command relative to the Reagent Dilutor Motor movement. The EPLD U42 through the demultiplexer DEMPLX CIRCUIT U16 controls the REAGENT DILUTOR MOTOR DRIVER U13 – U14, which output signals are the motor phases MFR1 – MFR4. The Reagent Dilutor Motor drives circuit is powered from the LOCAL GENERATOR +5VPW U40. The trimmer RV1 is factory adjusted to sets the reference voltage to the demultiplexer DEMPLX CIRCUIT U16. • Sample Dilutor Motor drives circuit. The Slave Board sends to the EPLD U42 the command relative to the Sample Dilutor Motor movement. The EPLD U42 through the demultiplexer DEMPLX CIRCUIT U20 controls the SAMPLE DILUTOR MOTOR DRIVER U17 – U18, which output signals are the motor phases MFS1 – MFS4. The Sample Dilutor Motor drives circuit is powered from the LOCAL GENERATOR +5VPW U40. The trimmer RV2 is factory adjusted to set the reference voltage to the demultiplexer DEMPLX CIRCUIT U20. 3.3.8.e Magnetic Stirrer Motors Section (See figure 3.3.8 Drawing 5) • Magnetic Stirrer Motors drives stage. The Slave Board sends to the EPLD U43 the command relative to the Magnetic Stirrer Motors movement. The EPLD U43 controls the MAGNETIC STIRRER MOTOR DRIVER U25 – U26 – U27 – U28, which outputs signals are the motor phases AGTR1A – AGTR4B. The driver circuit is powered from the LOCAL SWITCHING POWER SUPPLY +26VPW U7. These driver circuits work with AC motors, so they need the frequency signal STFREQ (50 Hz) from the Acquisition & Sensors Board. The REFERENCE VOLTAGE GENERATOR U39 and the THRESHOLD CIRCUIT U11 allow to the COMPARATOR CIRCUIT U6 – U12 to detect a possible malfunction of the magnetic stirrers. In case a malfunction is detected the COMPARATOR CIRCUIT U6 – U12 outputs the warning signals ALAGTR1 ALAGTR4. These warning signals are read through the PARALLEL I/O U1 by the Slave Board, and by the EPLD U43 that turns off the magnetic stirrer motor raising a fail warning. 3.3.9 Photometric & Temperatures Control (Board # 6) The Photometric & Temperatures Control Board, is located in the system Card Housing, and powered through the Switching Power Supply, which provides the +5Vdc (DGT), +15Vdc (ANA), -15Vdc (ANA), +9Vdc (PW), +12Vdc (PW) and +70Vdc (PW). Page 32 of 40 Chapter 3 General Description ACL Elite/ElitePro Service Manual The Motors Board communicates with the Slave Board (Board # 2) through the signals SLD0 - SLD7 “slave data bus”, and the signals SLA0 - SLA7 “slave address bus”. This communication is supported by the control signals SLRD, SLWR, RESET as well as the Board enabling signal SLBS3. The “Photometric & Temperatures Control Board General Block Diagram” is available in figure 3.3.9 Drawing 1 of the chapter 10 “Drawings”. The main functions reported in the following outline are further expanded and presented on specific paragraphs. Photometric & Temperatures Control General Block Diagram • • • • • Rotor Motor Section (see paragraph 3.3.9.a). Analysis Compartment Cover Motor Section (see paragraph 3.3.9.b). Rotor Thermoregulation Section (see paragraph 3.3.9.c). Peltiers Thermoregulation Section (see paragraph 3.3.9.d). Transport & Rotors Feed Stack Section (see paragraph 3.3.9.e). Rotor Motor Section (see paragraph 3.3.9.a) • Rotor Motor drives circuit. • Sends the interrupt signal ROTFAIL to the Slave Board (Board # 2). Analysis Compartment Cover Motor Section (see paragraph 3.3.9.b) • Analysis Compartment Cover Motor drives circuit. Rotor Thermoregulation Section (see paragraph 3.3.9.c) • Rotor Holder temperature detection and control. Peltier Thermoregulation Section (see paragraph 3.3.9.d) • Peltier temperature detection and control. • +5VREF generator circuit. Transport & Rotors Feed Stack Section (see paragraph 3.3.9.e) • Transport plate temperature detection and control. • Rotors Feed Stack temperature detection and control. Chapter 3 General Description Page 33 of 40 ACL Elite/ElitePro Service Manual 3.3.9.a Rotor Motor Section (See figure 3.3.9 Drawing 2) • Rotor Motor drives circuit. The Slave Board through the PARALLEL I/O U4 sends to the EPLD U5 the command relative to the Rotor Motor movement. The EPLD U5 controls the ROTOR MOTOR DRIVER U7 – U8 – U10 – U14, which output signals are the motor phases RF1 – RF4. The Rotor Motor drive circuits are powered from the LOCAL GENERATOR +5VPW U13. • Sends the interrupt signal ROTFAIL to the Slave Board (Board # 2). The circuits ROTOR MOTOR DRIVER U7 – U8 – U10 – U14 send the signals VSENSE1 – VSENSE2 to the COMPARATOR CIRCUIT U12, which is aimed to detect possible motor failure. If a failure is present this circuit outputs the signal IRFAIL, which enters the BUFFER CIRCUIT U2. The buffer sends the interrupt signal ROTFAIL to the Slave Board (Board # 2). The Slave Board disables the interrupt ROTFAIL through the PARALLEL I/O U4, which sends the signal ROTCLR to the EPLD U5. The EPLD U5 controls with the signal NROTCLR the SWITCH CIRCUIT U18, which sends the signal CLFAIL to reset the COMPARATOR CIRCUIT U12. If there is a warning for high current, the driver circuits output the signals AACHOP – BBCHOP, which are used to disable the EPLD U5 3.3.9.b Analysis Compartment Cover Motor Section (See figure 3.3.9 Drawing 3) • Analysis Compartment Cover Motor drives circuit. The Slave Board through the PARALLEL I/O U4 sends to the EPLD U5 the command relative to the Analysis Compartment Cover Motor movement. The EPLD U5 through the demultiplexer DEMPLX CIRCUIT U37 controls the COVER MOTOR DRIVER U15 – U16, which outputs signals are the motor phases MFT1 – MFT4. The Analysis Compartment Cover Motor drives circuit is powered from the LOCAL GENERATOR +5VPW U13. The trimmer RV6 is factory adjusted to set the reference voltage to the demultiplexer DEMPLX CIRCUIT U37. 3.3.9.c Rotor Thermoregulation Section (See figure 3.3.9 Drawing 4) • Rotor Holder temperature detection and control. Page 34 of 40 Chapter 3 General Description ACL Elite/ElitePro Service Manual The thermistor located inside the Rotor Holder sends the signal SROT1 – SROT2 to the Photometric & Temperatures Control Board. This signal is connected to the jumper JR1, the reference resistance R59 and to the trimmer RV1. When the jumper JR1 is on the check position the trimmer RV1 allows the factory adjustment of the circuit. When the jumper JR1 is in the reading position the signal SROT1 – SROT2 is amplified and outputs as TROT, which is sent to the Acquisition & Sensor Board (Board # 3). The Slave Board through the Acquisition & Sensors Board acquires the temperature of the Rotor Holder, and controls the PARALLEL I/O U4 that sends the enable signal INCOIL to the EPLD U6. The EPLD U6 controls the thermoregulation circuit, which provides the signal Z1 – FOTGND to the heating coil of the Rotor Holder. The circuit that provides the power is also composed of: The PACKET DELAY CIRCUIT U26A – U21 output signal TASTD, which controls the timing of the sinusoidal wave signals packet. The PHASE DISPLACEMENT CIRCUIT U22 output the signal COMROT that, with the SWITCH CIRCUIT U19, controls the phase of the sinusoidal wave signal generated by the OSCILLATOR CIRCUIT U23. The IMPULSE GENERATOR U24 generate the signal that triggers the POWER CIRCUIT Q11 that activates the LC oscillator circuit providing heating to the rotor holder. The trimmer RV2 is factory set to obtain the most suitable time shift to the power signal and avoid overcurrent which may damage the POWER CIRCUIT Q11. 3.3.9.d Peltiers Thermoregulation Section (See figure 3.3.9 Drawing 5) • Peltier temperature detection and control. The thermistor located inside the Peltier sends the signal SPELT1 to the Photometric & Temperatures Control Board. This signal is connected to the jumper JR2, with the reference resistance R86 and to the trimmer RV3. When the jumper JR2 is on the check position the trimmer RV3 allows the factory adjustment of the circuit. When the jumper JR2 is in the reading position the signals SPELT1 is amplified and outputs as TPELT1, which is sent to the Acquisition & Sensor Board (Board # 3). The Slave Board through the Acquisition & Sensors Board acquires the temperature of the Peltier, and controls the PARALLEL I/O U4 that sends the enable signal INPELT1 to the SWITCH CIRCUIT U19. This circuit outputs the signal ONPELT1 to active the CURRENT GENERATOR CIUCUIT U32A, which provide the current signal +VP1 to the Peltier cell used to cool the Peltier assembly. Another identical circuit, as reported in fig. 3.3.9 Drawing 5, is present on the Board # 6 for the ACL 1000, but not used in the ACL Elite. • +5VREF generator circuit. The Board # 6 has a dedicated voltage generator circuit, called REFERENCE VOLTAGE GENERATOR +5VREF U29, which provides the signal +5VREF. This reference signal is used in the temperature control sections and is also sent for the conversion to the Acquisition & Sensor Board (Board # 3). Chapter 3 General Description Page 35 of 40 ACL Elite/ElitePro Service Manual The reference value is factory pre-set through the trimmer RV4. 3.3.9.e Transport & Rotors Feed Stack Section (See figure 3.3.9 Drawing 6) • Transport Plate temperature detection and control. The thermistor located inside the Transport Plate sends the signal SSLITTA to the Photometric & Temperatures Control Board. This signal is amplified and outputs as TFSLITTA to the Acquisition & Sensor Board (Board # 3). The Slave Board through the Acquisition & Sensors Board acquires the temperature of the Transport Plate, and controls the PARALLEL I/O U4 that sends the enable signal INPREH to the SWITCH CIRCUIT U18. This circuit outputs the signal ONSLITTA to activate the POWER CIRCUIT Q10, which provides the current signal PSLITTA to the heating pad used to heat the transport plate. The Transport Plate temperature detection and control is not used on the ACL Elite. On the ACL Elite a jumper resistor pack is installed to simulate Transport Plate temperature. • Rotors Feed Stack temperature detection and control. The thermistor located inside the Rotors Feed Stack sends the signal SSILOS to the Photometric & Temperatures Control Board. This signal is amplified and outputs as TFSILOS to the Acquisition & Sensor Board (Board # 3). The Slave Board through the Acquisition & Sensors Board acquires the temperature of the Feed Stack, and controls the PARALLEL I/O U4 that sends the enable signal INPREH to the SWITCH CIRCUIT U19. This circuit outputs the signal ONSILOS to active the POWER CIRCUIT Q14, which provide the current signal PSILOS to the heating pad used to heat the Rotors Feed Stack. For the ACL Elite this circuit controls the rotor storage area pre heating. Page 36 of 40 Chapter 3 General Description ACL Elite/ElitePro Service Manual 3.3.10 Switching Power Supply Board The Switching Power Supply Board, located under the dilutor assembly, provides to the instrument +5VDGT, +12VDGT, +15VANA, -15VANA, +9VPW, +12VPW, +70VPW and +6VLAMP. The Power Entry provides the signal LINE-IN that allows the operation of the Switching Power Supply. This signal must be in the range from 100-120Vac to 220240Vac (50-60 Hz). The “Switching Power Supply Board General Block Diagram” is available in figure 3.3.10 Drawing 1 of the chapter 10 “Drawings”. The main functions reported in the following outline are further expanded and presented on specific paragraphs. Switching Power Supply Board General Block Diagram (see paragraph 3.3.10.a) • • • • • • • Line filter. Automatic identification of the line voltage. Control & Protection stage for all the generators. Sends the ready signal to the system. Control the turn off of the power voltages. Chromogenic Lamp drives circuit. Communicate warning status to the system. 3.3.10.a Switching Power Supply Board General Block Diagram (See figure 3.3.10 Drawing 1) • Line filter. The Switching Power Supply Board has a LINE FILTER integrated on board. • Automatic identification of the line voltage. The Board through the POWER FACTOR CORRECTION BOARD PCB1 identifies the line voltage connected to the instrument, and sets the Switching Power Supply Board as appropriate. The line voltage acceptable for the Switching Power Supply Board are100-120Vac to 220-240Vac (50-60 Hz). Chapter 3 General Description Page 37 of 40 ACL Elite/ElitePro Service Manual • Control & Protection stage for all the generators. The POWER CONTROL BOARD PCB2 controls all the voltage generators, and protects them from short circuit or high voltage. If one of these problems is present on the voltage GENERATOR +5VDGT, +15VANA and -15VANA, the POWER CONTROL BOARD PCB2 sets to “Protection Mode”, turns off all the dc voltage and lights the LED DL1. To recover proper working conditions it is necessary to switch the system OFF for at least 20 seconds prior switching it back ON. The TRIMMER RV2 – RV3 – RV4 – RV5 – RV6 are used to adjust the digital and analog voltage outputs. The Test Points TP1 – TP9 are used for factory testing of the Switching Power Supply Board. • Sends the ready signal to the system. At the instrument turn on, the POWER CONTROL BOARD PCB2 controls all the dc voltage outputs, when all of them are stabilized, sends the signal INIT to the Slave Board (Board # 2). • Control the turn off of the power voltages. When the POWER CONTROL BOARD PCB2 receives the signal POWEROFF from the Acquisition & Sensors Board (Board # 3), it disables the power voltages GENERATOR +9VPW, +12VPW and +70VPW. • Chromogenic Lamp drives circuit. When the POWER CONTROL BOARD PCB2 receive the signal LAMPWR from the Acquisition & Sensors Board (Board # 3), enables the GENERATOR +6VLAMP that turns on the Chromogenic Lamp. • Communicate warning status to the system. The POWER CONTROL BOARD PCB2 sends three warning signals to the system in case of malfunction, which are detected as follows: The signal POWERFAIL is sent to the Slave Board (Board # 2) if the output voltages are lower than the 80% of the normal value, or in any case before that the Switching Power Supply is turned off. The signal THERFAIL is sent to the Acquisition & Sensors Board (Board # 3) if the environment temperature is over 60 C°. If this temperature rises up to read 75 C°, the Board sets to “Protection Mode” and turns off the instrument. The signal MISSLAMP is sent to the Acquisition & Sensors Board (Board # 3) if a Short Circuit or a no load is detected on the GENERATOR +6VLAMP. Page 38 of 40 Chapter 3 General Description ACL Elite/ElitePro Service Manual 3.3.11 Instrument Ground Circuit This sub-section provides information about the Instrument Ground System, in order to help the service engineer in the assembling of the circuit placed in whole the Instrument. The diagram of the “Instrument Ground Circuit” is available in figure 3.3.11 Drawing 1 of the chapter 10 “Drawings”. 3.3.12 Interface Board The interface board provides serial and USB connections to peripheral devices such as printer, mouse, keyboard and barcode scanner as well as communication to a host system. A parallel printer port is also supported. The Interface Board connects to the Pentium CPU. NOTE: If the USB ports detect an overload the USB Hub disables that port or. To reenable the USB ports the instrument must be re-booted. The interface board is also protected by 2 onboard fuses. 3.4 Main Hardware Components Description This section contains a list of the main hardware components and modules, which interact with each other to carry out the analytical process. The figure below highlights some of the main hardware components of the ACL Elite/Elitepro as viewed from the front of the instrument, while the main electronic boards and system interconnection ports are located on the rear of the system. Chapter 3 General Description Page 39 of 40 ACL Elite/ElitePro Service Manual 1. Wash-Reference Emulsion Bottle with liquid level sensor. 2. Dilutors Assy. 3. Autosampler Housing with internal BCR and presence sensors for cups/tubes on Sample Tray. 4. Reagent Tray Area with Peltier Assy for Reagents cooling & stirring. (positions R9-R12 ACL ElitePro only). 5. Sample Arm with liquid level sensors in the Rinse / Waste position. 6. Floppy Disk Drive (covered). 7. LCD display with Touch Screen. 8. Rotor Stack Assy. (rotor pre-heating area for ACL Elite). 9. Rotor Holder automatic Cover. 10. Rotor Transport and Rotor Arm Assy. (excluded on ACL Elite). 11. Rotor Waste Container compartment with presence and status sensors. 12. Alphanumeric Keyboard. 13. Adapters Area. 14. Liquid Waste Outlet. 3.5 Software Description This section contains a general description of the main software and its physical location in the system. At the turn on the instrument shows the CPU Master Board (Board #1) BIOS boot screen with the CPU Master initialization. Then the system loads the operating system and the application program from the Hard Disk Drive and performs the initialization of both the electronic boards and the modules. The Hard Disk Drive stores all the software of the instrument, both the application program (Analytical and Service programs) and backup files of the software working on the Slave Board (Board #2) and R.E.M. Board (Board #4). These two specific softwares are stored in the memories located onboard the Slave Board and the R.E.M. Board where are located two slave microprocessors. The two microprocessors load the software directly from the memories (Flash Eprom) at the instrument turn on. In order to load a new software revison in the instrument or download the software from the Hard Disk Drive to the boards memories, the software upgrade procedure has to be performed as described in the sub-section 7.16. Page 40 of 40 Chapter 3 General Description ACL Elite/ElitePro Service Manual Chapter 4 Parts Replacement This chapter of the manual contains general descriptions about the operations required to replace the main assemblies as well as the electronic boards and the covers present on the ACL Elite/ElitePro system. Following are the specific sections. 4.1 4.2 4.3 Parts Replacement. Instrument Covers Removal. Instrument Boards Replacement. Caution: Prior to any part replacement insure that the unit is turned off and power cord disconnected. 4.1 Parts Replacement This section is designed to guide the Service Engineer through the replacement of the major assemblies contained in the Instrument. Following are the specific sub-sections for each module. 4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 4.1.6 4.1.7 4.1.8 4.1.9 4.1.10 4.1.11 Autosampler Assy Replacement. Peltier 1 Assy, Peltier 2 Assy Replacement. Sample Arm Assy Replacement. Rotor Holder Assy Replacement. Rotor Exchange Module Replacement. (excluded on ACL Elite) Rotor Holder Cover Assy Replacement Halogen Lamp Assy Replacement Dilutors Replacement. Display Replacement. Hard Disk Drive Replacement. Rotor Preheater Assy replacement (ACL Elite only) 4.1.1 Autosampler Assembly Replacement The Autosampler Assembly is composed of a grey upper support called Flange Adjustable that is moved by the mechanical assembly, located under the Fluidic Plate, called Autosampler Movement Assy. The whole assembly is connected to the system through the Module Interconnection Board. Chapter 4 – Parts Replacement Page 1 of 28 ACL Elite/ElitePro Service Manual • Procedure to Remove the Autosampler Assy Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 4 5 6 Remove the 2 screws that secure the Flange Adjustable. Remove the Flange Adjustable. Remove the 2 screws that secure the Internal Ring Sensor to the Fluidic Plate. Remove from the Module Interconnection Board the connectors P72, P73, P74 and the 2 ground cables (see “Instrument Ground Circuit” figure 3.3.11 Drawing 1 of the chapter 10 “Drawings”). Remove the 4 column screws that mount the Autosampler Movement Assy to the Fluidic Plate. Remove the Autosampler Movement Assy. The Autosampler Movement Assy P/N 181108-30 includes the following spare parts: - • 1 Dual Channel Optical Switch flat (fixed with 2 screws) P/N 182356-80 1 Autosampler Internal Ring Sensor (fixed with 1 strap) P/N 84869-38 Procedure to Replace the Autosampler Assy Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. Page 2 of 28 Chapter 4 – Parts Replacement ACL Elite/ElitePro Service Manual 1 2 3 4 5 - Follow in the opposite direction the “Procedure to Remove the Autosampler Assy” paying attention to the position of the Internal Ring Sensor cable with respect to the encoder disk. Perform the Motor Adjustment test for the Autosampler Motor as described in the sub-section 7.6.5. Follow the procedure for the Autosampler Assy module centering as described in the sub-section 7.7.2. Perform the check out & adjustment for the Internal/External Rings Sensors as described in the sub-section 7.5.3. Perform the verification/adjustment of the Needles Sensors as described in the sub-section 7.4. Peltier 1 Assy, Peltier 2 Assy Replacement The Peltier 1 Assembly is located under the Fluidic Plate and is connected to the system through the Module Interconnection Board. • Procedure to Remove the Peltier 1 Assy Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 Remove the connectors P121, P122, P123, P124, P126 and the 2 ground cables (see “Instrument Ground Circuit” figure 3.3.11 Drawing 1 of the chapter 10 “Drawings”). Remove the 3 screws that secure the Peltier 1 Assembly. Remove the Peltier 1 Assembly. The Peltier 1 Assy P/N 181108-34 includes the following spare parts: - • 1 Peltier Temperature Sensor (fixed with 2 screws and 1 strap) P/N 181021-28 4 Stirrer Motors (removable after removed the black dissipater, which is fixed with 3 screws located under the black dissipater) P/N 82433-10 Procedure to Replace the Peltier 1 Assy Chapter 4 – Parts Replacement Page 3 of 28 ACL Elite/ElitePro Service Manual Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 Follow in the opposite direction the “Procedure to Remove the Peltier 1 Assy” paying attention to the location of the cables on the rear of the assembly. Verify with a Magnetic Stirrer Bar the functionality of the 4 Stirrer Motors. Verify that the Peltier 1 thermoregulation system works correctly as described in the sub-section 7.14. 2 3 • Procedure to Remove Peltier 2 Assembly (ACL ElitePro) Materials / tools necessary: - Standard tools. Peltier 2 Assembly part number 181106-34 Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. NOTE: It is necessary to remove the Sample Arm Movement Assembly to gain access to the Peltier 2 Assembly for removal. To remove the Sample Arm Movement Assembly refer to Section 4.1.3. 1. Remove the sample Arm Movement Assembly (refer to section 4.1.3.) 2. Remove the connectors P131 and P132 and the 2 ground cables (see “Instrument Ground Circuit” figure 3.3.11 Drawing 1 of the chapter 10 “Drawings”). 3. Remove the 3 screws that secure the Peltier 2 Assembly. 4. Remove the Peltier 2 Assembly. • Procedure to Replace the Peltier 2 Assy (ACL ElitePro) Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1. Follow in the opposite direction the “Procedure to Remove the Peltier 2 Assy” paying attention to the location of the cables on the rear of the assembly. 2. Replace the Sample Arm Movement Assembly. (Refer to section 4.1.3). 3. Perform all Sample Arm Movement and Sample Arm Assembly alignments as described in sections 7.6.3, 7.6.4, 7.7.1, and 7.7.4. 4. Verify that the Peltier 1 thermoregulation system works correctly as described in the sub-section 7.14. Page 4 of 28 Chapter 4 – Parts Replacement ACL Elite/ElitePro Service Manual 4.1.3 Sample Arm Assembly Replacement The Sample Arm Assembly is composed of an upper support called Sample Arm and a lower assembly, located under the Fluidic Plate, called the Sample Arm Movement Assy. The whole assembly is connected to the system through the Module Interconnection Board. • Procedure to Remove the Sample Arm Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 Loosen the knob, located on the rear of the Sample Arm, which fixes the Needles Block. Remove the Needles Block and then remove its connector for the liquid sensor. Remove the upper cover of the Sample Arm fixed with a screw. Remove the Liquid Level Detection Cable from the Needles & Wash-R Interconnection Board. Loosen the 3 setscrews located at 120° on the aluminium support. Remove the Sample Arm. 2 3 4 5 6 The Sample Arm P/N 181108-95 includes the following spare parts: • 1 Needles Block P/N 181108-43 1 Liquid Level Detection Board P/N 182356-40 1 Liquid Level Detection Cable P/N 190675-75 Procedure to Remove the Sample Arm Movement Assy Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 4 Remove the Sample Arm as described in the above procedure. Remove the connectors P91, P92, P93, P94 and the 2 ground cables (see “Instrument Ground Circuit” figure 3.3.11 Drawing 1 of the chapter 10 “Drawings”). Remove the 3 black columns that fix the Sample Arm Movement Assy. Remove the Sample Arm Movement Assy. Chapter 4 – Parts Replacement Page 5 of 28 ACL Elite/ElitePro Service Manual The Sample Arm Movement Assy P/N 190856-06 includes the following spare parts: - • 2 Dual Channel Optical Switch flat (fixed with 2 screws) P/N 182356-80 Procedure to Replace the Sample Arm Movement Assy Materials / tools necessary: - Standard tools. - Sample Arm Centring Tool P/N 190513-00 Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 Page 6 of 28 Follow in the opposite direction the “Procedure to Remove the Sample Arm Movement Assy”. Center the shaft of the assembly in the hole of the Fluidic Plate using the Sample Arm Centering Tool P/N 190513-00. Perform the Motor Adjustment tests for the Sample Arm Horizontal and Vertical Motor as described in the sub-section 7.6.3 and 7.6.4. Chapter 4 – Parts Replacement ACL Elite/ElitePro Service Manual • Procedure to Replace the Sample Arm Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 Follow in the opposite direction the “Procedure to Remove the Sample Arm”. Follow the procedure for the module centering of this assembly as described in the sub-section 7.7.1. and also the procedure to fine adjust the Needles Block Assy position as described in the sub-section 7.7.4. Perform the Liquid Level Sensor test as described in the sub-section 7.4. 4.1.4 Rotor Holder Movement Assy Replacement The Rotor Holder Movement Assy is located under the Fluidic Plate. The Rotor Holder Movement Assy is connected to the system through the Photometer Interface Board. • Procedure to Remove the Rotor Holder Movement Assy Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 4 Remove the Halogen Lamp Assy as described in the sub-section 4.1.7. Remove the connectors P140, P141, P143, P144, P145, the Coag. Coaxial Cable from the Board #3 and the 3 ground cables (see “Instrument Ground Circuit” figure 3.3.11 Drawing 1 of the chapter 10 “Drawings”). Remove the 3 black columns that fix the Rotor Holder Movement Assy. Remove the Rotor Holder Movement Assy. Chapter 4 – Parts Replacement Page 7 of 28 ACL Elite/ElitePro Service Manual The Rotor Holder Movement Assy P/N 181108-50 includes the following spare parts: - 1 Dual Channel Optical Switch (fixed with 2 screws) P/N 70908-00 1 Rotor Holder Snap (fixed with 1 side screw) P/N 181108-51 1 Coagulimetric Sensor w/cable (fixed with 1 setscrew and 1 screw for the ground cable) P/N 84869-46 1 Optical Collimator Assy (fixed with 2 screws) P/N 181021-95 1 Brushes Assembly (fixed with 2 screws and soldered at 2 wires) P/N 181024-43 1 Photometer Interface Board (fixed with 3 screws) P/N 182356-30 1 Coagulimetric Channel LED (fixed with 2 screws and 1 set screw) P/N 181025-15 1 Optic Fiber Assy for Coagulimetric LED P/N 067218-05 Following are notices about particular Spare Parts replacements. - - Coagulimetric Sensor w/cable must be located in the bottom of the sensor housing and insure the Black Spacer is located between the Coagulimetric Sensor and its glass windows under the Rotor Holder. Optical Collimator Assy must be placed in the bottom of its housing and the 2 screws must be properly tightened. The other side of the Optical Collimator must be placed in the bottom of its Halogen Lamp Assy housing paying attention not to damage the fibre when tightening the setscrew. Brushes Assembly must be aligned so that the four brushes completely touch the two rings under the Rotor Holder. Coagulimetric Channel LED and Fibre must be located with the Optic fibre in the bottom of the Rotor Holder housing (see Coagulimetric Channel in section 7.2). Procedure to Replace the Rotor Holder Movement Assy Page 8 of 28 Chapter 4 – Parts Replacement ACL Elite/ElitePro Service Manual Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 4 5 4.1.5 Follow in the opposite direction the “Procedure to Remove the Rotor Holder Movement Assy”. Perform the Motor Adjustment test for the Rotor Motor as described in the sub-section 7.6.1. Follow the procedure for the module centering of the Rotor Holder as described in the sub-section 7.7.3. Verify that the thermoregulation system for the Rotor Holder works correctly as described in the sub-section 7.14. Perform the tests for both the Coagulimetric and the Chromogenic Channels as described in sections 7.2 and 7.3. Rotor Exchange Module Assembly Replacement (excluded on ACL Elite) Note: Section 4.1.5 is not applicable to the ACL Elite. The Rotor Exchange Module (REM) Assembly is composed of several mechanical assemblies assembled on a common support, located under the Fluidic Plate, called Rotor Exchange Module Assy (Basic). The R.E.M. Assembly is located to the right of the Rotor Holder Cover and is covered by the R.E.M. Cover. This includes the Rotor Stack module cover that allows the insertion of new rotors in the Rotor Stack. On the Rotor Exchange Module Assy (Basic) are located: the Rotor Arm, the Rotor Transport and the Rotor Stack. Under the Rotor Exchange Module Assy (Basic) is located the Rotor Arm Movement Assy. The Rotor Transport mechanical movement is not removable as it is incorporated in the Rotor Exchange Module Assy (Basic). The whole R.E.M. is connected to the system through the Upper and the Lower R.E.M. Interconnection Boards. Following are the specific paragraph for the R.E.M. sub-modules replacement. 4.1.5.a Rotor Arm Assembly Replacement 4.1.5.b Rotor Transport Assembly Replacement 4.1.5.c Rotor Stack Assembly Replacement 4.1.5.d Rotor Exchange Module (Basic) Replacement 4.1.5.a Rotor Arm Assembly Replacement The Rotor Arm Assembly is composed of an upper support called Rotor Arm and by a lower assembly, located under the R.E.M. and a common support under the Fluidic Plate, called Rotor Arm Movement Assy. The whole assembly is connected to the system through the R.E.M. Upper and Lower Interconnection Board. Chapter 4 – Parts Replacement Page 9 of 28 ACL Elite/ElitePro Service Manual • Procedure to Remove the Rotor Arm Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 Remove the connector P112 of the Electro-Magnet. Loosen the 3 setscrews located at 120° on the aluminium support securing the arm to the shaft. Remove the Rotor Arm. The Rotor Arm P/N 181108-55 includes the following spare parts: - • 1 Spring for Rotor Arm P/N 181103-06 1 Electro-Magnet (fixed with 2 screws) P/N 181108-60 Procedure to Remove the Rotor Arm Movement Assy Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 4 Remove the connectors P104, P105, P107, P108 and the ground cable (see “Instrument Ground Circuit” figure 3.3.11 Drawing 1 of the chapter 10 “Drawings”). Remove the Rotor Exchange Module Assy (Basic) as described in this subsection at the paragraph 4.1.5.d. Remove the 3 nuts that fix the Rotor Arm Movement Assy. Remove the Rotor Arm Movement Assy. Page 10 of 28 Chapter 4 – Parts Replacement ACL Elite/ElitePro Service Manual The Rotor Arm Movement Assy P/N 181108-54 includes the following spare parts: - • 2 Dual Channel Optical Switch flat (fixed with 2 screws) P/N 182356-80 Procedure to Replace the Rotor Arm Movement Assy Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 • Follow in the opposite direction the “Procedure to remove the Rotor Arm Movement Assy”. Perform the Motor Adjustment tests for the Rotor Arm Horizontal and Vertical Motor as described in the sub-sections 7.6.8 and 7.6.9. Procedure to Replace the Rotor Arm Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 Follow in the opposite direction the “Procedure to Remove the Rotor Arm”. Follow the module centering procedure to align the Rotor Arm at the Rotor Transport as described in the sub-section 7.7.6. Follow the module centering procedure to align the R.E.M. at the Rotor Holder as described in the sub-section 7.7.7. Chapter 4 – Parts Replacement Page 11 of 28 ACL Elite/ElitePro Service Manual 4.1.5.b Rotor Transport Assembly Replacement The Rotor Transport Assembly is composed of a black upper support (like a Rotor Holder) called Rotor Transport and by a mechanical movement (moved by the Transport Motor) incorporated in the R.E.M. Assy (Basic) located under the Fluidic Plate. The whole assembly is connected to the system through the R.E.M. Lower Interconnection Board. • Procedure to Remove the Rotor Transport Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 Remove the connector P111 of the thermoregulation. Loose the 3 screws that fix the Rotor Transport. Remove the Rotor Transport. The Rotor Transport P/N 181108-57 doesn’t include spare part. Page 12 of 28 Chapter 4 – Parts Replacement ACL Elite/ElitePro Service Manual • Procedure to Replace the Rotor Transport Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 Follow in the opposite direction the “Procedure to Remove the Rotor Transport”. Verify that the thermoregulation system for the Rotor Transport works correctly as described in the section 7.14. 4.1.5.c Rotor Stack Assy Replacement The Rotor Stack Assy is located on the right side of the R.E.M. The whole assembly is connected to the system through the R.E.M. Upper Interconnection Board. • Procedure to Remove the Rotor Stack Assy Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 Remove the connectors P113, P114, P116, P117, P118, P119 and the ground cable (see “Instrument Ground Circuit” figure 3.3.11 Drawing 1 of the chapter 10 “Drawings”). Remove the 3 screws, located under the common support, which fix the Rotor Stack Assembly (see “Rotor Exchange Module Replacement” figure 4.1.5 Drawing 1 of the chapter 10 “Drawings”). Remove the Rotor Stack Assy. The Rotor Stack Assy P/N 181108-94 includes the following spare parts: - 2 Electro-Magnet (fixed with 2 screws) P/N 181108-60 2 Spring for Rotor Stack P/N 181103-22 1 Rotor Stack Cover Sensor (fixed with a screw) P/N 182356-70 1 Optical Sensor Rotor Stack Upper P/N 84869-36 1 Optical Sensor Rotor Stack Lower P/N 84869-37 Chapter 4 – Parts Replacement Page 13 of 28 ACL Elite/ElitePro Service Manual • Procedure to Replace the Rotor Stack Assy Materials / tools necessary: - Standard tools. - Silos Alignment tool Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 4 5 6 Follow in the opposite direction the “Procedure to Remove the Rotor Stack Assy”. Verify that the thermoregulation system for the Rotor Stack works correctly as described in the section 7.14. Follow the module centering procedure to align the Rotor Stack and the Rotor Transport as described in the sub-section 7.7.5. Perform the Optic Sensor test for the Rotor Stack as described in the subsection 7.5.1. Verify that the Rotor Stack Cover Sensor works correctly as described in the sub-section 7.9.2. Perform the RA – SL – RH test as described in the sub-section 7.7.9 to verify the proper rotors movements inside the Rotor Stack. 4.1.5.d Rotor Exchange Module Assy (Basic) Replacement The Rotor Exchange Module Assy (Basic) is an assembly that incorporates the black R.E.M. Common Support plate, the Rotor Transport mechanical movement and the Transport Motor. • Procedure to Remove the R.E.M. Assy (Basic) Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 4 5 6 7 8 Remove the Halogen Lamp as described in the sub-section 4.1.7. Remove the 2 screws, which fix the Coag. Channel LED without removing the Optic Fiber. Remove the Rotor Arm as described in the paragraph 4.1.5.a. Remove the Rotor Transport as described in the paragraph 4.1.5.b. Remove the Rotor Stack as described in the paragraph 4.1.5.c. Remove the connectors P103, P104, P105, P106, P107, P108, P109, P110 and the 2 ground (see “Instrument Ground Circuit” figure 3.3.11 Drawing 1 of the chapter 10 “Drawings”). Raise the Instrument on the 2 Main Support legs. Remove the 5 fixing screws, located on the Fluidic Plate, which fix the whole assembly (See the “REM Common Support Position 3” in the drawing Page 14 of 28 Chapter 4 – Parts Replacement ACL Elite/ElitePro Service Manual 9 10 11 12 “R.E.M. Replacement” available in the figure 4.1.5 drawing 1 of the chapter 10 “Drawings”). Hold with one hand the right side, then slowly push down the left side of the REM Common Support (See the “REM Common Support Position 2” in the drawing “R.E.M. Replacement” available in the figure 4.1.5 drawing 1 of the chapter 10 “Drawings”). Remove the whole REM Common Support following the arrows (See the “REM Common Support Position 1” in the drawing “R.E.M. Replacement” available in the figure 4.1.5 drawing 1 of the chapter 10 “Drawings”). Remove the Rotor Arm Movement Assy fixed with 3 nuts. The assembly that includes the black R.E.M. Common support plate, the Rotor Transport mechanical movement and the Transport Motor is called Rotor Exchange Module Assy (Basic). The Rotor Exchange Module Assy (Basic) P/N 181108-53 includes the following spare parts: - • 1 Dual Channel Optical Switch flat (fixed with 2 screws) P/N 182356-80 1 Rotor Transport Motor (fixed with 4 screws) P/N 82433-00 1 Optical Sensor Rotor Waste Full (fixed with 4 screws) P/N 84869-47 Procedure to Replace the R.E.M. Assy (Basic) Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 Secure with the 3 nuts the Rotor Arm Movement Assy in place. Put the whole REM Common Support under the tilted Instrument (See the “REM Common Support Position 1” in the drawing “R.E.M. Replacement” available in the figure 4.1.5 drawing 1 of the chapter 10 “Drawings”). Following the arrows lift the right side of the REM Common Support, paying attention to center the 3 Rotor Stack fixing point holes in the Fluidic Plate (See the “REM Common Support Position 2” in the drawing “R.E.M. Chapter 4 – Parts Replacement Page 15 of 28 ACL Elite/ElitePro Service Manual 4 5 6 7 Replacement” available in the figure 4.1.5 drawing 1 of the chapter 10 “Drawings”). Hold with one hand the right side, then slowly lift the left side of the REM Common Support (See the “REM Common Support Position 3” in the drawing “R.E.M. Replacement” available in the figure 4.1.5 drawing 1 of the chapter 10 “Drawings”). Secure the 5 screws, located on the Fluidic Plate, which fix the whole assembly (See the “5 REM fixing points”). Now follow in the opposite direction from the point 7 to the point 1 the procedure for removing the R.E.M. Assy (Basic). Perform the Motor Adjustment tests for the Transport Motor as described in the sub-section 7.6.7. Note: It’s required to perform the relevant check out procedures for all the other assemblies that had been removed. Page 16 of 28 Chapter 4 – Parts Replacement ACL Elite/ElitePro Service Manual 4.1.6 Rotor Cover Assembly Replacement The Rotor Cover Assembly is composed of an upper cover called Rotor Cover, by a mechanical support called Arm with Pulley and by an assembly, located under the Fluidic Plate, called Rotor Cover Movement Assy. The whole assembly is connected to the system through the Photometer Interface Board. Rotor Cover Assy Arm with Pulley Rotor Cover Belt Rotor Cover Movement Assy • Procedure to Remove the Rotor Cover Assy Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 Remove the 3 screws, located on the lower black side, which fix the upper white support. Chapter 4 – Parts Replacement Page 17 of 28 ACL Elite/ElitePro Service Manual 2 3 Remove the 2 screws, located on the metallic mechanical arm, which fix the black lower support. Remove the Chromogenic Coaxial Cable. The Rotor Cover P/N 181108-46 includes the following spare parts: - • 1 Chromogenic Coaxial Cable (connected to the Board #3) P/N 84869-44. 1 Filter Optical 405 nm (located in the black “Filter & Sensor Housing”, fixed with 5 screws, and held in the bottom with a white spacer) P/N 89721-00. 1 Chromogenic Sensor Board (located in the Filter & Sensor Housing color black and fixed with 6 screws) P/N 82627-00. Procedure to Replace the Rotor Cover Assy Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 • Follow in the opposite direction the “Procedure to Remove the Rotor Cover” paying attention to the clearance of the optic parts. Perform the tests for the Chromogenic Channel as described in the sub section 7.3. Procedure to Remove the Arm with Pulley Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 4 Remove the Rotor Holder as described in the sub-sections 4.1.4. Remove the Rotor Cover and the Rotor Cover Movement Assy as described in this sub-section 4.1.6. Remove the Chromogenic Coaxial Cable. Remove the Arm with Pulley (fixed with 4 screws). The Arm with Pulley includes the following spare part. • 1 Rotor Cover Belt P/N 66675-60 Procedure to Replace the Arm with Pulley Materials / tools necessary: Page 18 of 28 - Standard tools. Chapter 4 – Parts Replacement ACL Elite/ElitePro Service Manual Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 • Follow in the opposite direction the “Procedure to Remove the Arm with Pulley”, paying attention to secure the Chromogenic Coaxial Cable in a proper position to prevent damage during the Arm with Pulley movement. Procedure to Remove the Rotor Cover Movement Assy Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 4 5 6 7 8 Remove the Halogen Lamp as described in the sub-section 4.1.7. Remove the connectors P143, P144 and the ground cable (see “Instrument Ground Circuit” figure 3.3.11 Drawing 1 of the chapter 10 “Drawings”). Remove Rotor Holder Movement Assy as described in the sub-section 4.1.4. Remove all the 5 Boards in the Card Housing. Remove the bulkhead and the 2 fixing knobs located inside the Card Housing. Loosen the 3 screws that fix the Cover Movement Assy. Loosen the tension of the Rotor Cover Belt lifting the Cover Movement Assy and free the belt from the pulley holding the motor encoder at the top. Remove the 3 loosen screws and the Cover Movement Assy. The Rotor Cover Movement Assy P/N 181108-47 (Elite) and P/N 181106-48 (ElitePro)-includes the following spare part: - 1 Dual Channel Optical Switch (fixed with 2 screws) P/N 70908-00 Chapter 4 – Parts Replacement Page 19 of 28 ACL Elite/ElitePro Service Manual • Procedure to Replace the Rotor Cover Movement Assy - Rotor Cover Motor Centring Tool P/N 190510-00 - Rotor Cover Encoder Centring Tool P/N 190575-00 Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 4 5 Assemble the Rotor Cover Movement Assy (without tightening the 3 screws). Lift the Rotor Cover Movement Assy and, with the Encoder at the top, insert the Rotor Cover Belt on the Rotor Cover Motor pulley. Using the Rotor Cover Centering Tool in the niche between the support and the assembly, push down the Rotor Cover Movement Assy until the Rotor Cover Belt reaches the proper tension (take as example the tension of the other belts on the assemblies in the instrument). In this condition tighten the 3 screws paying attention to the horizontal positioning of the assembly. Loosen the 2 setscrews that fix the Encoder to the motor shaft, rotate the Encoder until it is in the middle of the Dual Channel Optical Switch sensor. Lower the Encoder until its upper side is horizontal and about 1 mm above the upper side of the Dual Channel Optical Switch sensor then tighten the 2 setscrews. Dual Channel Optical Switch Note: If available use the Rotor Cover Encoder Centering Tool P/N 190575-00. 6 7 8 9 10 11 Assemble and fix with 2 knobs the bulkhead located inside the rear of the Card Housing. Insert and connect the 5 Boards in the Card Housing. Assemble the Rotor Holder Movement Assy as described in the sub-section 4.1.4. Connect P143, P144 and the ground (see “Instrument Ground Circuit” figure 3.3.11 Drawing 1 of the chapter 10 “Drawings”). Assemble the Halogen Lamp Assy as described in the sub-section 4.1.7. Perform the Motor Adjustment test for the Rotor Cover Motor as described in the sub-section 7.6.2. Page 20 of 28 Chapter 4 – Parts Replacement ACL Elite/ElitePro Service Manual 4.1.7 Halogen Lamp Assy Replacement The Halogen Lamp Assy is located under the Fluidic Plate. The Halogen Lamp Socket is powered directly through the Switching Power Supply Board. It is possible, without removing the Front Cover, to change the Halogen Lamp Socket Assy through the Rotor Waste compartment. • Procedure to Remove the Halogen Lamp Assy Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 4 5 6 Remove the connector of the Halogen Lamp Socket Assy. Remove the power connector from the Switching Power Supply Board (fixed with 2 screws) and the 2 ground cables (see “Instrument Ground Circuit” figure 3.3.11 Drawing 1 of the chapter 10 “Drawings”). Remove the R.E.M. Cover. Remove the 2 screws, located on the Fluidic Plate that fixes the Halogen Lamp Assy. Remove the Halogen Lamp Assy paying attention not to damage the Optical Collimator Assy. Remove the Optical Collimator Assy loosening the setscrew. The Halogen Lamp Assy includes the following spare part: - 1 Halogen Lamp Socket (fixed with 1 knob and 1 screw) P/N 181021-81 Chapter 4 – Parts Replacement Page 21 of 28 ACL Elite/ElitePro Service Manual • Procedure to Replace the Halogen Lamp Assy Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 Follow in the opposite direction the “Procedure to Remove the Halogen Lamp Assy” paying attention not to damage the Optical Collimator Assy when tightening the setscrew. Perform the “Chromogenic Channel check out & adjustment” test as described in the sub-section 7.3.1. 2 4.1.8 Dilutor Assy Replacement The Dilutor Assy is located under the rectangular Transparent Cover behind the Sample Tray. The Dilutor Assy is connected to the system through the Module Interconnection Board. • Procedure to Remove the Dilutor Assy Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 4 5 Remove the connectors P81, P82, P83, P84, P85, P86 and the ground cable (see “Instrument Ground Circuit” figure 3.3.11 Drawing 1 of the chapter 10 “Drawings”). Remove the fluidic tube that connects the Wash-R Emulsion Bottle to the T Connector. Remove the 2 fluidic tubes that connect the 2 Dilutor Electro-Valves to the Needles Block. Remove the 3 screws that fix the Dilutor Assy. Remove the Dilutor Assy. The Dilutor Assy P/N 181108-58 includes the following spare part: - 2 Single Channel Optical Switch (fixed with 2 screw) P/N 70907-00 1 Dilutor Chamber (fixed with 2 screw) P/N 181108-56 2 Dilutor Electro-Valve 3 Way (fixed with 2 screw) P/N 181108-38 1 T Connector P/N 74068-00 Page 22 of 28 Chapter 4 – Parts Replacement ACL Elite/ElitePro Service Manual • Procedure to Replace the Dilutor Assy Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 Follow in the opposite direction the “Procedure to Remove the Dilutor Assy”. Perform the Motor Adjustment tests for the Sample/Reagent Motors as described in the sub-section 7.6.6. Perform the Volume Check and the Dilutor Test as described in “Dilutor Module” test in the section 7.8. 3 4.1.9 Display Assembly Replacement The Display Assembly is located on a tower support on the right side of the Instrument. The Display Assembly is connected to the CPU Master Board and to the PC104 Board through the Display Cable. • Procedure to Remove the Display Assembly Materials / tools necessary: - Standard tools Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1. Disconnect the VGA, Power and Serial Cables from the rear of the monitor. 2. While holding the monitor loosen and remove the black knob. Remove the white and grey washers. 3. Remove the monitor from the support pole. Remove the metallic washer that sits between the monitor bracket and the support pole. Chapter 4 – Parts Replacement Page 23 of 28 ACL Elite/ElitePro Service Manual clamp Bracket attached to monitor Serial cable Knob with washers underneath Power cable VGA cable • Procedure to Replace the Display Assembly Materials / tools necessary: - Standard tools Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1. Mount flat metallic washer onto support pole. 2. Mount bracket attached with monitor onto support pole. 3. Mount gray washer so that the outer diameter is touching the surface of the bracket and the inner diameter raised, then the white washer. 4. Mount black clamping knob onto support pole. Tighten securely. 5. Insert power connector into receptacle at the base of the monitor. Make sure the orientation of the power cable is similar to what is shown in the picture above. 6. Connect the serial and VGA cables to the monitor. 7. Perform the Touch Screen Calibration procedure as described in section 7.12. 4.1.10 Hard Disk Drive Replacement The Hard Disk Drive is located under the CPU Master Board #1 and PC104 Board support in the middle of the rear side of the Instrument. The Hard Disk Drive is connected to the CPU Master Board through the HDD data flat cable. • Procedure to Remove the Hard Disk Drive Materials / tools necessary: Page 24 of 28 - Standard tools. Chapter 4 – Parts Replacement ACL Elite/ElitePro Service Manual Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 4 5 • Remove all the cables connected to the CPU Master Board #1 and PC104 Board. Remove the Needles & Wash-R Sensor Interconnection Board support that is fixed with 2 screws, and remove Video Cable connector bracket. Remove the HDD with the CPU Master Board and the PC104 Board removing the 2 external screws and loosening the 1 internal screw. Remove the HDD power and data cables connectors. Remove the HDD that is fixed with 4 screws. Procedure to Replace the Hard Disk Drive Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 Follow in the opposite direction the “Procedure to Remove the Hard Disk Drive”. Perform the procedures described in the section 7.16 “Software Checking and Loading”. Note: In order to completely restore the system status on the new Hard Disk Drive as before the replacement of the damaged one, it is necessary to perform the following operations. - Format and partition the new hard disk drive as described in sub-section 7.16.6. Perform Software Installation procedure as described in section 7.16.5 Perform the Upgrade procedure for the IL Library described in the sub-section 7.16.4. Perform the Restore procedure of the last Backup of the system configuration available described in the sub-section 7.16.3. Chapter 4 – Parts Replacement Page 25 of 28 ACL Elite/ElitePro Service Manual 4.1.11 Rotor Preheater Assembly (ACL Elite only) The ACL Elite Rotor Preheater Assy is located on the right side of the instrument. The assembly is connected to the system through the R.E.M. Upper Interconnection Board by connector P117 and the REM Lower Interconnection Board by connector P111. Three screws mount the Rotor Preheater assembly to the instrument. • Procedure to Remove the Rotor Preheater Assy Materials / tools necessary: - Standard tools. Precaution Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 3 Remove the connectors P111 (Lower Interconnection board) and P117 (Upper Interconnection Board) Remove the 3 screws, located under the common support, which fix the Rotor Preheater Assembly. Remove the Rotor Preheater Assy. Page 26 of 28 Chapter 4 – Parts Replacement ACL Elite/ElitePro Service Manual • Procedure to Replace the Rotor Preheater Assy Materials / tools necessary: - Standard tools. Make sure that the Instrument has been switched OFF prior to going through the following procedure. 1 2 Follow in the opposite direction the “Procedure to Remove the Rotor PreheaterAssy”. Verify that the thermoregulation system for the Rotor Preheater works correctly as described in the section 7.14. 4.2 Instrument Covers Removal This section is designed to clarify the Instrument Covers names and positions as well as the removing / assembling sequence and fixing points. Following is the Covers lists with the relevant fixing points. Cover Name 1 Left Side Cover 2 Right Side Cover 3 Upper Cover 6 Front Lower Plate Fixing point 3 Screws 3 Screws 4 Screws (2 for each side) 2 Screws (1 for each side + 2 hook shape on the bottom) 6 Screws (2 for each side + 2 under the Front Lower Plate) 2 Knob 7 R.E.M. Cover No screws. 8 Reagent Transparent Cover 9 Dilutors Transparent Cover 10 Keyboard Support 3 screws. 4 Rear Cover 5 Front Cover No screws. Note Must remove the Left & Right Side Covers first. Must remove the Left & the Right Side Covers first. Must remove the Left & Right Side Covers first. Must remove the Left & Right Side Covers and the Front Cover first. Remove with caution the 3 fixing points at pressure. Press with cautions the 2 fixing points at pressure. 4 Screws (2 for each slider) The table is according with the drawing “Instrument Covers” reported in the figure 4.2 Drawing 1 of the chapter 10 “Drawings”. Chapter 4 – Parts Replacement Page 27 of 28 ACL Elite/ElitePro Service Manual 4.3 Instrument Boards Replacement This section provides information on the electronic boards located in several places inside the instrument that compose the electronic system. Following is a board list with the proper Check Out & Adjustment required after board replacement for troubleshooting purposes. Board Name P/N CPU Master Board #1 181120-23 PC104 Board 182355-20 Slave Board #2 182355-30 Acquisition & Sensors Board #3 182355-40 Rotor Exchange Module Board #4 (excluded in ACL Elite) 182356-00 Check Out & Adjustment Section Check Software revision Test for functionality. Verify BIOS settings. No Adjustment Required. Verify Expansion Module settings. No Adjustment Required. Check Software revision. Upgrade SW if required Test for functionality. No Adjustment Required. Test for functionality. Coagulimetric Channel Check Out Chromogenic Channel Check Out Liquid Sensors Check Out Autosampler Optic Sensors Check Out Rotor Cover Sensor Check Out Check Software revision. Upgrade SW if required (REM upgrade) Test for functionality. REM Optic Sensors Check Out 7.16.1 3.3.4 7.16.7 Test for functionality. No Adjustment Required. Test for functionality. Temperatures Check Out. No Adjustment Required. Test for functionality. No Adjustment Required. Test for functionality. No Adjustment Required. Test for functionality. No Adjustment Required. Test for functionality. No Adjustment Required. 3.3.8 Motors Board #5 182355-50 Photometric & Temperature Control Board #6 Switching Power Supply Board Interface Board 182355-61 Fan control Board 182356-90 Liquid Level Detection Board 182356-40 Page 28 of 28 Chapter 4 – Parts Replacement 182356-60 181120-70 7.16.8 7.16.1 7.16.5 3.3.5 3.3.6 7.2 7.3 7.4.2 7.5.3 7.9.1 7.16.1 7.16.5 7.5 3.3.9 7.14 3.3.10 7.13 7.14 7.4.2 ACL Elite/ElitePro Service Manual Chapter 5 Installation & Maintenance This section provides information related to the instrument installation, as recommendation for the unpacking and the various set-up procedures necessary to put the system in working condition, as well as operator maintenance procedures. Sub-sections detailing instrument cleaning and decontamination procedures, plus shut down and shipment precautions complete this section. Following are the specific sub-sections with the relevant procedures. 5.1 5.2 5.3 Installation Maintenance Shut down & Shipment precautions WARNING ! BIOLOGICAL HAZARDS EXIST. Avoid touching, with bare hands, any parts of the system which may have come in contact with potentially infectious fluids. ALWAYS wear gloves when performing any type of Maintenance/Service action on this area. Warning: Do not access the sample or reagent area while the probe arm is operating. As a reminder for the technical personnel, the above warning is also directly shown in those sub-sections describing the maintenance / cleaning actions on the fluidic lines of the instrument. Chapter 5 – Installation & Maintenance Page 1 of 36 ACL Elite/ElitePro Service Manual 5.1 Installation This sub-section contains all the information necessary to install, set-up and place in working condition the ACL Elite/ElitePro system. Before attempting the installation of the ACL Elite/ElitePro system in the laboratory, inspect the site with laboratory personnel to identify the desired location for the system and to insure that the environment meets all the requirements for its successful installation. In addition ensure that the Coagulimetric Optic Test Kit P/N 97580-50 and the Chromogenic Optic Test Kit P/N 97579-50 together with the Temperature Probe P/N 70954-00 are available. Following are the specific sub-sections. 5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.1.6 5.1.7 Site requirements Unpacking and inspection Mounting Instrument parts First turn on cycle Instrument set-up Performance tests Installation Procedure and Checklist Note: The ACL Elite/ElitePro system must only be installed either by IL personnel or IL authorized personnel. 5.1.1 Site requirement Following are the specific paragraphs with the required condition to install the ACL Elite/ElitePro system. • • • Ambient condition Space requirements Electrical requirements • Ambient Condition The instrument will function correctly in an ambient temperature of 15-32 °C (59 °F to 89 °F) with a relative humidity of up to 85% (non-condensing). In accordance with the IEC regulations no instrument failures will occur in presence of short-term ambient temperature as low as 5 °C or as high as 40 °C. The instrument should be positioned in an area free from dust, fumes, vibrations and excessive variations of temperature. Page 2 of 36 Chapter 5 – Installation & Maintenance ACL Elite/ElitePro Service Manual • Space requirements Following are the external dimensions and the weight of the ACL Elite/ElitePro analyzer. Height at display level Height of analysis surface Width (including LCD) Depth Weight 60 cm 27 cm 100 cm 60 cm 63 Kg 23.6inches 10.6 inches 39.4 inches 23.6 inches 139 lbs. The heat generated by the instrument during normal operation is exhausted from the bottom, in the front-right and left side of the unit. Sufficient space must be allowed around the instrument to permit circulation of air for cooling. The instrument must be positioned so that a waste tube can be easily connected on its left side. If the operator wishes to work from a sitting position in front of the system, leg-space should be provided under the front of the instrument. • Electrical requirements Voltage The instrument has been designed to operate correctly with variations of ± 10% on the nominal line voltage and with line frequencies between 50-60 Hz. The instrument has a power supply that can operate from 100 to 240 VAC and it automatically switches to the line voltage required. Warning: Check that the nominal line voltage in the laboratory is compatible with the label on the rear of the instrument as shown in the table below. Value as shown on the label 100 – 240 VAC Values of line voltage for Normal function 100, 110, 115, 120, 125 Vac ±10% 220, 230, 240 Vac ±10% Power Consumption Check that the line is capable of supplying 350 VA. Note: The average power consumption is about 350 VA, but peak loads or current surges may exceed this value when turning the instrument on and during the temperature warm-up. Chapter 5 – Installation & Maintenance Page 3 of 36 ACL Elite/ElitePro Service Manual Line Frequency The instrument will function at any frequency between 50-60 Hz. The power cord provided with the system is specifically designed for it and should not be substituted. The cord plugs into the Power Entry socket as shown in the figure below. The Power Entry module includes the ON/OFF switch. Fuse The fuses are enclosed in the compartment to the right of the Power Entry socket. Fuses have to meet the specification 6.3 A – 250 V. Instruments at 100 – 240vac utilize 2 fuses rated at 6.3 amps. Caution: Prior to accessing the fuse holder to install / replace fuses insure the unit is powered off and the power cord disconnected. Only use fuses rated for the specified current and voltage. Page 4 of 36 Chapter 5 – Installation & Maintenance ACL Elite/ElitePro Service Manual Interface ports The instrument is provided with several connectors, located on the rear, which are associated with relevant devices. NOTE: If the USB ports detect an overload situation the USB ports are disabled. To re-enable the USB ports the Elite/ElitePro instrument must be powered off and rebooted. Following are the connectors and the relevant devices. Serial Mouse Host USB Ports (4) Ethernet Parallel Printer Connectors names Devices Host Serial Mouse USB Ethernet Parallel Printer Keyboard Host Computer Standard PC Serial Mouse External BCR, USB Mouse, USB Printer Ethernet (Future) Parallel Printer Standard PC Keyboard 5.1.2 Keyboard Unpacking and inspection Before unpacking the boxes containing the ACL Elite/ElitePro and accessories, visually inspect them to verify that there has been no damage done during shipping and handling. In case of damage notify the carrier and your IL Representative immediately. Remove the box containing the rotors and the Start-up kit. Using the Start-up kit list included in the box, confirm that all the components are present. Remove the instrument and place it on the working surface. Remove the adhesive tape used for transport from the various parts. Note: Two people should lift the instrument using the space below the unit at the front and at the back as shown on the figure below. Chapter 5 – Installation & Maintenance Page 5 of 36 ACL Elite/ElitePro Service Manual In the figure below are highlighted the instrument carrying points 5.1.3 Mounting Instrument parts This sub-section provides information about the parts that have to be mounted on the Instrument before switching it on. BARCODE READER BRACKET (ACL ElitePro) Mount the Barcode Reader bracket onto the rear of the LCD Monitor as follows: 1. Remove the monitor mounting bracket (may be white or black) from the rear of the monitor (4 screws). 2. Place the barcode reader bracket p/n 282104-00 onto the back of the monitor followed by the original monitor mounting bracket. Secure both brackets to the monitor using the 4 screws previously removed. Bracket mounting screws 4 places Monitor bracket (may be black or white) Barcode reader bracket p/n 282104-00 mounted under monitor mounting bracket Page 6 of 36 Chapter 5 – Installation & Maintenance Bracket mounting screws 4 places ACL Elite/ElitePro Service Manual LCD Monitor The ACL Elite/ElitePro LCD Monitor must be installed on the instrument during the installation process. Mount the LCD Monitor as follows. clamp Bracket attached to monitor Serial cable Knob with washers underneath Power cable VGA cable 1. Remove cables from plastic bag on support pole and monitor from packaging. 2. Remove clamping knob, white washer, gray washer, and metallic washer from the monitor support pole. 3. Mount flat metallic washer onto support pole. 4. Mount bracket attached with monitor onto support pole. 5. Mount gray washer so that the outer diameter is touching the surface of the bracket and the inner diameter raised, then the white washer. 6. Mount clamping knob onto support pole. Tighten securely. 7. Remove clamp from the back of the monitor by loosening screw. 8. Insert the power cable into the clamp. The distance between the clamp and the end of the power cable connector should be 6 inches. Insert power connector into receptacle at the base of the monitor. Make sure the orientation of the power cable is similar to what is shown in the picture above. 9. Mount the clamp to the back of the monitor using screw, split washer, and flat washer provided. See picture above for location. 10. Connect the serial and VGA cables to the monitor. Waste tube Connect the waste tube to the fitting on the bottom left hand side of the Instrument. Cut the tube to suitable length to fit into the waste container which must be situated below the instrument waste outlet port, as shown in the figures below. Note: The horizontal section of the tube should be kept as short as possible and the free end should not be immersed in the liquid waste container. Chapter 5 – Installation & Maintenance Page 7 of 36 ACL Elite/ElitePro Service Manual CAUTION ! The liquid waste from the instrument is to be considered contaminated and should be disposed of according to the waste management procedures of the laboratory and in compliance with local regulations (see also NCCLS GP25-A, Vol. 13 No. 22: Clinical Laboratory Waste Management, Dec. 1993). In the figure below are reported the Waste tube connection and waste container proper position. Rinse, Sample and Reagent Accessories Verify that the Needles Waste-Rinse reservoir is placed in its appropriate position. Fit the appropriate Sample Tray on its corresponding support. Fit the reagent adapters in their appropriate positions, as shown in the figure below. Following are the 3 color coded reagent adaptors available for the reagent positions R1 to R12. Adaptor Color Grey Reagent Vials 10 mL vials requiring magnetic stirrer Purple 10 mL vials not requiring magnetic stirrer Green 4 mL vials not requiring magnetic stirrer Page 8 of 36 Chapter 5 – Installation & Maintenance ACL Elite/ElitePro Service Manual Place 4 magnetic stirrers inside the reagent vials in reagent positions R1 to R4. Reagent Adaptors for the R1-R12 positions Different vial adaptors are used for the additional positions on the Sample Tray. In the figure below are reported the Reagent Adaptors for the Sample Tray A1-A10 positions. Wash-Reference Emulsion Bottle Place a capped 1 litre bottle of Wash-Reference Emulsion in the appropriate position at the back of the dilutors. Remove the bottle cap and insert the sensor and siphon cap into the bottle. Insure the sensor and siphon cap is fully seated into the bottle. Make sure that the connectors of the Reference Emulsion Sensor and for the Liquid Level Detection Cable are properly connected on the Needles & Wash-R Sensor Interconnection Board. Chapter 5 – Installation & Maintenance Page 9 of 36 ACL Elite/ElitePro Service Manual Positioning of the Wash-Reference Emulsion Bottle Electro-Valve / Needle Block connection Verify that the two fluidic tubes from the Electro-Valve in the Dilutor Assy to the Needles Block are tightly connected. Note: The tube from the left hand Electro-Valve fits into the lower position on the Needles Block (internal Needle, Reagent). The tube from the right hand Electro-Valve fits into the upper position on the Needles Block (external needle, Sample). Mouse Connect the Serial Mouse or USB Mouse to the appropriate port on the rear panel. External Bar-Code Reader Connect the External Bar-Code Reader to the USB port in the rear panel. (ElitePro only) External Printer (Optional Feature) Connect the External Printer to its port (Parallel Printer port) in the rear panel. 5.1.4 First turn on cycle Before turning the Instrument on, check that the line voltage setting of the laboratory is in accordance with the Instrument label. Switch the instrument on using the Power Switch on the Power Entry. The system initializes the instrument with a series of electronics and mechanics selfchecks. During this initialization check that the Sample Arm, the Rotor Arm and the Rotor Cover may be free to move without obstruction. Following are some of the messages displayed during the System Init phase. Page 10 of 36 Chapter 5 – Installation & Maintenance ACL Elite/ElitePro Service Manual ACL Starting. Please wait… Checking Database……Check Ok. Continuing Init. The Init System phase continues with a progress bar in a window where the following is displayed. Init System in Progress. Please Wait. When the progress bar is full and all the sequence of self-checks is ended, then the Login window appears. - Touching the USER window it goes in reverse mode. Press “Del” (Delete Key) on the main Keyboard, the window becomes empty. Type the word “Service”. Touching the PASSWORD window it goes in reverse mode. Type the word “System Fix” then confirm touching “√”. The system shows the main Analytical Menu. Touch Utility on the Main Menu Bar then the Software and the Software Identification option. Check that in the SW Identification screen all the software is at the lastest revision. The last software revision is also present in the Instrument Start Up Kit. Check for Magnetic Stirrer bar rotation in the R1 – R4 reagents positions. Note: Any temperature and liquid level sensors warning may be present. In this case the yellow Warning button on the Tool Bar is active. Touch Setup on the Main Menu Bar then the Date/Time option. Choose the date format and set the current date and time. Press “√” to accept. Mounting (if needed) the Needles Block and then perform/verify the Needle Position procedure as described in the sub-section 7.7.4. Select Diagnostic from the Main Menu Bar and click the Priming option. The following Priming screen is displayed during the priming cycle: Chapter 5 – Installation & Maintenance Page 11 of 36 ACL Elite/ElitePro Service Manual During the Priming cycle insure that the air bubbles in the dilutor chambers are removed. If necessary, pinch the chamber outlet tubes while the piston is descending and release them before the piston reaches bottom dead point. Repeat the Priming cycle several times if necessary. If in the end of the Priming the message “SENSOR FAIL” in the Warning area is displayed, the priming cycle must be repeated. Check that there are no blockages or leaks in the fluid path and that the liquid is flowing smoothly from the bottle to the dilutors and from the dilutors to the needles. Check that the discharge of liquid from the Wash/Rinse Reservoir to the instrument outlet and then to the liquid waste container is not impaired. Check the Air Cooling System. Verify that the 2 Instrument Fans in the right hand side of the instrument are operating properly as also the 2 Secondary Fans on the left hand side. Locate the ventilation filter slider on the right side of the instrument and verify also that the filter is clean. Before checking the Temperatures wait until all the start up temperature warnings have disappeared, then enter Diagnostic on the Main Menu Bar and select the Temperature Control option, which will open the Temperature Control screen. Page 12 of 36 Chapter 5 – Installation & Maintenance ACL Elite/ElitePro Service Manual As the temperature is continuously checked the screen is constantly refreshed showing a blink effect. The temperature should be within the following ranges for each area (as described in the section 7.14). Rotor Holder Peltier Rotor Transport (ACL ElitePro) Rotor Stack (ACL ElitePro) Rotor Preheater (ACL Elite) 5.1.5 38 to 39 °C 10 to 16 °C 34 to 40 °C 34 to 40 °C 34 to 40 °C Instrument Setup The purpose of this sub-section is to verify that all the main Setup options have been already set or otherwise to help the customer to make setup selections. Select Setup from the Main Menu Bar then set the following options. System Configuration Patient Database listing QC Database listing Reflex Status Current Language Sample Tray type Sensor Enable HW Enable Date / Time Unit Chapter 5 – Installation & Maintenance Page 13 of 36 ACL Elite/ElitePro Service Manual 5.1.6 Performance tests The following test, which we recommend be carried out at the installation, check the precision and the linearity of the two Optic Channels as well as the precision and the accuracy of the dilutors. Perform a Priming cycle then check the Optic Channel precision and accuracy as described in the sub-sections 7.2.2 (for Coagulimetric) and 7.3.2 (for Chromogenic). Perform a Priming cycle then check the Dilutors precision as described in the subsection 7.8.1 (for Coagulimetric and Chromogenic Channel). Perform a Priming cycle then carry out the PT-FIB calibration cycle as described in the Operator’s Manual. 5.1.7 Installation Procedure & Checklist The following Installation Checklist should be used as a guide when installing the ACL Elite/ElitePro instrument. A reference to detailed procedures contained in the ACL Elite/ElitePro Service Manual are indicated on the Installation Checklist. 5.1.7.1 Initialization Plug instrument into suitable power source, 100 - 115V or 220V. Turn power on and wait for instrument to initialize. With login displayed, touch USER on the LCD and type Service. Touch PASSWORD on LCD display and type (including 1 space between words): System Fix. NOTE: This procedure is designed to check that adjustments have been performed. If any step fails the check criteria adjustment is required. 5.1.7.2 1. Procedure ROTOR HOLDER COVER FUNCTION Touch SERVICE→MOTOR ADJUST→ROTOR HOLDER COVER. The rotor holder cover sets to its intermediate position (automatic loading position). Touch the HOME POSITION icon and the rotor cover will position itself and open. Touch icon that shows ROTOR COVER OPEN with arrow upward repeatedly and observe the rotor cover moves upward until it reaches the full Page 14 of 36 Chapter 5 – Installation & Maintenance ACL Elite/ElitePro Service Manual open position. Verify on the LCD display that there is a minimum of two (2) and a maximum of five (5) minus signs to the right of the home sensor arrow. Touch HOME POSITION. Touch NEXT CW POSITION two (2) times and observe that the rotor cover closes properly. Touch the check (√) to exit. â–¼ Home Sensor 2. + + + + + + -- -- -- MAGNETIC STIRRER BARS ROTATION CHECK Materials / tools necessary Magnetic Stirrer Bars P/N 97466-06 (4) 8.0 mL Bottles (4) Place a magnetic stirrer bar in bottle and place the bottle into each reagent position R1, R2, R3 and R4. Check that the bar rotates in each position. Remove bottles from reagent positions. 3. SYSTEM CONFIGURATION CHECK Touch SETUP→SYSTEM CONFIGURATION. Sensor Liquid, Wash R Emulsion and HW Enable – “REM” and “Additional Reagents” should be enabled for ACL ElitePro, and disabled for ACL Elite. Visually check that there is an “X” to the left of these parameters to “Enable” and no “X” to disable. Touch check (√) to exit. 4. SOFTWARE REVISION CHECK Touch UTILITY→SOFTWARE→SOFTWARE IDENTIFICATION. Check that the software identifications are at the latest versions. Master SW Identification Slave SW Identification REM SW Identification IL Test Library Touch check (√) to exit. X.X X.X XX.XX X Chapter 5 – Installation & Maintenance Page 15 of 36 ACL Elite/ElitePro Service Manual 5. FLOPPY DISK CHECK Material / tools necessary for this check: 1.44 MB Floppy Disk (formatted) Touch SERVICE→FLOPPY DISK DRIVE TEST. Remove disk from drive if present. Touch CONTINUE. If a message DISK PRESENT IN DRIVE appears, the drive has failed this check. Insert a write-protected floppy disk in the floppy disk drive. Touch CONTINUE. A message should appear INSERT DISK… Remove disk from drive and change the switch on the disk to enable it to read and write, reinsert disk. Touch CONTINUE. Check that a message OPERATION IN PROGRESS and a test progress bar is displayed. It is not necessary to wait for the disk drive to complete this task. Touch ABORT to exit. Touch YES. Touch CANCEL. 6. INTERFACE CHECK Materials / tools necessary: RS 232 Test Connector P/N 199992-01 Touch SERVICE→INTERFACE TEST. Touch the down arrow on the side of the test name. Touch the bottom down arrow to select RS 232 #2 HW loop. Touch CONTINUE and install RS 232 connector into the mouse serial port. Touch START. The next window must state TEST PASSED. Touch OK. Touch “X” to exit. Touch SERVICE→INTERFACE TEST. Touch the down arrow on the side of the test name. Touch the bottom down arrow to select RS 232 #3 HW loop. Touch CONTINUE and install RS 232 connector into the host serial port. Touch START. The next window must state TEST PASSED. Touch OK. Touch “X” to exit. Verify USB ports functionality by connecting a USB device (ie. mouse, scanner, etc) to the USB port. Reboot system to allow ACL Elite/ElitePro to recognize USB device connection and verify USB device functions properly. Page 16 of 36 Chapter 5 – Installation & Maintenance ACL Elite/ElitePro Service Manual 7. AUTOSAMPLER MOTOR STEP LOSS CHECK Touch SERVICE→MOTOR ADJUST→AUTOSAMPLER. Touch HOME POSITION. The system moves the autosampler motor until the home position is achieved. Check that the HOME SENSOR and the POSITION SENSOR are both in the ON condition. With the step increment set to one (1), repeatedly touch curved CW arrow (or the curved CCW arrow) until the status changes from plus to minus in the window to the right of the “Home Sensor” icon. Then reverse the motion by touching the opposite key until the status changes from plus to minus again. Check that there are a maximum of three (3) missed steps by counting the minus signs to the left (or to the right) of the reference arrow. 8. SAMPLE ARM MODULE CHECK Material / tools necessary: Sample Tray Needle Adjustment Tool P/N 181039-41 0.5 mL Sample Cups P/N 067992-00 Cup Adapters 2.0 mm Allen Wrench Lift clear reagent cover. Check the centering of the sample arm base to the cavity in the system cover. Gently lift sample arm up to its upper limit and rotate it to check that the three (3) set screws are tightened properly. Touch SERVICE→MOTOR ADJ→SAMPLE ARM MOTOR→HORIZONTAL ARM MOTOR. Touch HOME POSITION. The sample arm should position itself over the sample tray position for Elite or reagent position R12 for ElitePro. Touch NEXT COUNTERCLOCKWISE POSITION seven (7) times for Elite or eleven (11) times for ElitePro. The sample arm should position itself over the wash station. Gently push sample arm down into the wash station and check that the needles enter straight into the center of the wash station bath. Gently lift sampler arm up to its upper limit. Touch check (√) to exit. Touch NO. Make sure the rotor cover is open (touch ROTOR COVER OPEN icon). Install the needle adjustment tool into the rotor position. Touch SERVICE→MOTOR ADJUST→SAMPLE ARM MOTOR→HORIZONTAL ARM MOTOR. Touch NEXT COUNTERCLOCKWISE POSITION several times to move the sample arm over the rotor position. Touch check (√) to exit. Touch NO. Chapter 5 – Installation & Maintenance Page 17 of 36 ACL Elite/ElitePro Service Manual Touch SERVICE→MOTOR ADJUST→ROTOR MOTOR. Touch HOME POSITION to set rotor. Touch check (√) to exit. Touch NO. Touch SERVICE→MOTOR ADJUST→SAMPLE ARM MOTORS→VERTICAL ARM MOTOR. Touch HOME POSITION. Touch NEXT DOWN POSITION. The sample arm should go down. Check that the needles align over the reference dots. The needles should be set so they brush the surface of the reference dots. Touch NEXT UP POSITION. Touch check (√) to exit. Touch YES. Place cup adaptor and 0.5 mL cup in the A1 position of the sample tray. Place 0.5mL cups in position 1 and 2 of the sample tray. Place sample tray in instrument. Touch SERVICE→MOTOR ADJUST→AUTOSAMPLER. Touch HOME POSITION. Touch check (√) to exit. Touch NO. Touch SERVICE→MOTOR ADJUST→SAMPLER ARM MOTORS→HORIZONTAL ARM MOTOR. Touch HOME POSITION and the sample arm will move to the sample tray position. Remove the alignment tool from the rotor position and touch ROTOR COVER (Icon) to close the rotor cover. Gently push the sample arm down into the A1 position. Check that the needle aligns in the center of the 0.5 mL cup without touching the inside diameter of the cup. Gently lift sample arm to the upper limit. Touch NEXT COUNTERCLOCKWISE POSITION. The sample arm will go to position 2 on the sample tray. Gently push the sample arm down into the position 2. Check that the needle aligns in the center of the 0.5 mL cup without touching the inside diameter of the cup. Gently lift sample arm to the upper limit. Touch NEXT COUNTERCLOCKWISE POSITION. The sample arm will go to position 1 on the sample tray. Gently push the sample arm down into the position 1. Check that the needle aligns in the center of the 0.5 mL cup without touching the inside diameter of the cup. Gently lift sample arm to the upper limit. 9. ROTOR EXCHANGE MODULE CHECK (exclude for ACL Elite) Material / tools necessary: Disposable Rotors P/N 068000-00 Magnetic Disk 2.0 mm Allen Wrench Touch ROTOR COVER and remove the stack cover to gain access. Check that the three (3) set screws on the Rotor Arm are tightened properly. Page 18 of 36 Chapter 5 – Installation & Maintenance ACL Elite/ElitePro Service Manual Place the magnet disk over the sensor board on the stack and secure with a piece of tape. Load a stack of fifteen (15) rotors in the rotor stack. Align the notches in the top five (5) rotors that are above the stack. Empty the rotor waste container and place it back in the housing. Touch SERVICE→MODULE POSITIONING→RA-SL-RH TEST. The instrument initializes the motors of the R.E.M., the rotor holder and the rotor cover. Once initialization is completed, the system starts loading / unloading until the stack of rotors is exhausted. Check visually that all the rotors in the stack are loaded and removed from the rotor position. The pliers should secure the rotor around the top of the rotor when the rotors are being transferred. A message should appear that the waste container is full. Open the door and remove rotors from container. Reinstall the waste container and the system should start to load and unload rotors. Touch check (√) to exit. 10. AUTOSAMPLER / BCR CHECK Material / tools necessary: Sample Tray 0.5 mL Sample Cups (new, unused) 2.0 mL Sample Cups (new, unused) 4.0 mL Bottle 10.0 mL Glass Vials Bar Code Labels Take a sample tray and prepare an assortment of cups, sample tubes (including some with bar code labels) and some empty positions. NOTE: Make sure the cups are indeed clean and free from any scratches. Touch SERVICE→AUTOSAMPLER→BCR TEST. Touch START WITH BCR. Check for presence: when a cup is present there should be a one (1) in that position. A zero (0) is reported when there is no cup present. Check the bar codes by moving the horizontal scroll bar to the right. Check that each bar code reported is the same as the bar code in that sample tray position. Touch check (√) to exit. 11. LIQUID LEVEL SENSORS CHECK Materials / tools necessary: 1000 Microliter Pipette w/tips 0.50 mL Sample Cup 4.0 mL Sample Cup Reference Bottle w/500 mL Ref. Sol. Chapter 5 – Installation & Maintenance Page 19 of 36 ACL Elite/ElitePro Service Manual Sample Tray Remove reference bottle from instrument and place the bottle with 500 mL of reference solution in its place. Touch SERVICE→SENSOR TEST→WASH-R EMULSION VOL. Check that the R-Emulsion value is 500 mL +/- 150 mL. ( adjust RV9, Acquisition & Sensors Board if necessary) Dispense 150 microliters of reference solution in a 0.5 mL sample cup and place the cup in position 1 of the Sample Tray. Dispense 1500 microliters of reference solution in a 4.0 mL bottle and place the bottle in the R1 position. Touch SERVICE→SENSOR→NEEDLES SENSOR TEST. Touch START. Check expected values: Position 1 liquid value must be ≥ 3.9 volts. ( adj RV12, Acq & Sen Bd if necessary). Position R1 liquid value must be ≥ 3.5 volts. ( adj RV11, Acq & Sen Bd if necessary) Touch (X) to exit. 12. TEMPERATURE CHECK: PERFORM D-DIMER CYCLE USING DEIONIZED WATER Materials / tools necessary for this check: Green Bottle Adapter 4.0 mL bottle (1) 8.0 mL Bottles (5) Deionized Water Place 4 mL bottle with deionized water in reagent position R4. Place 8 mL bottles with deionized water in sample tray positions A1, A2, A3, A4 & A5. Touch SETUP→TEST→VIEW / DEFINE. Enable D-Dimer only, disable everything else. Touch check (√). Touch DOOR EXIT (located in lower right corner, shown with door open and arrow going out). Touch CALIBRATION→CALIBRATE. Touch START. Wait for cycle to complete (arm will stop). Touch DIAGNOSTIC→TEMPERATURE CONTROL. Check that the four (4) temperature values are within specification shown on the LCD Display. Remove bottles from reagent position and sample tray. Page 20 of 36 Chapter 5 – Installation & Maintenance ACL Elite/ElitePro Service Manual 13. ROTOR HOLDER COVER SENSOR CHECK Touch SERVICE→A / D CONVERTER TEST. Check Cover Sensor (Hall) voltage value. The value must be ≥ 2.7 volts. (adjust RV5, Acquisition & Sensors Board if necessary) Touch ROTOR COVER (icon) to open rotor cover. Check Cover Sensor (Hall) voltage value. The value must be between 1.4 to 1.9 volts. Touch ROTOR COVER (icon) to close rotor cover. Touch check (√) to exit. 14. OPTIC CHANNELS CHECK Materials / tools necessary: Rotors 1000 Microliter Pipette w/tips Deionized Water Reference Solution NOTE: Instrument must be on for a minimum of thirty (30) minutes. Offset Check Touch ROTOR COVER (icon that shows cover open) to open the chamber. Rotate the rotor holder in the analysis compartment to block the LED light’s optic pathway. Touch ROTOR COVER (icon that shows cover open) to close rotor cover. Touch SERVICE→A / D CONVERTER TESTS. Check that the coagulimetric and the chromogenic channels’ average voltages are within the specification range of 0.002 to 0.015 volts. (NOTE: Occasional spikes above this value are allowed.) Coagulimetric channel: ( Adjust RV 1 Acquisition & Sensors Board if necessary). Chromogenic channel: ( Adjust RV 4 Acquisition & Sensors Board if necessary) NOTE: It is important to watch the voltage reading for one (1) minute and observe that the voltage occasionally fluctuates slightly above 0.000. Touch check (√) to exit. Gains Check Touch SERVICE→OPTICAL MODULE TEST→ACQUISITION ADJUSTMENT. Touch ROTOR COVER (icon) to open cover. Insure no rotor is in the chamber. Touch ROTOR COVER (icon) to close cover. Touch START. Check that the chromogenic (V) value is within the specification: 8.700 +/0.050 volts. (Adjust RV3 Acquisition & Sensors Board if necessary) Touch ROTOR COVER (icon that shows cover open) to open the chamber. Chapter 5 – Installation & Maintenance Page 21 of 36 ACL Elite/ElitePro Service Manual Place 200 microliters of the instrument’s reference solution in position 20 of a new rotor. Insert rotor into chamber. Touch ROTOR COVER (icon that shows cover open) to close rotor cover. Wait three (3) minutes for temperature to stabilize. Touch START. Check that the coagulimetric (V) value is within the specification: 2.6 +/- 0.3 volts. (Adjust RV2 Acquisition & Sensors Board if necessary) Touch STOP. Touch OK. Touch check (√) to exit. Curves Check NOTE: Dispensed volume, temperature, and time are critical to the results of this test. Touch SERVICE→OPTICAL MODULE TEST→CURVE ADJUST (coagulimetric rotation speed set @ 1200 rpm). Check that the SELECT DELAY (μs) is the same as the value on the instrument label next to Coag. “1200 DELAY.” (The label is located on the drawer under the top right hand corner of the keyboard.) Note: If this delay value is incorrect, it will be necessary to change the label when all of the related tests are completed. Keep records of new values on Checklist. Touch START. Check the delay to the left of the 1000 value. Check that the delay to left of the 1000 value is the same as the SELECT DELAY value on the LCD display (and the label). Touch the arrow below SELECT CHANNEL. Touch CHROMOGENIC. Touch the arrow below SELECT CHANNEL again. Touch START. Check the delay to the left of the 1000 value. Check that the delay to the left of the 1000 value is the same as the SELECT DELAY value on the instrument label next to Chrom. “1200 DELAY.” Check that the maximum delay delta (i.e., absolute value of the difference) between coagulimetric and chromogenic values (@ 1200 rpm) on the Checklist is ≤ 90. Touch the arrow below select channel. Touch COAGULIMETRIC. Touch the arrow below SELECT CHANNEL again. Touch the arrow below ROTATION SPEED. Touch 600 (rpm)-. Page 22 of 36 Chapter 5 – Installation & Maintenance ACL Elite/ElitePro Service Manual Touch the arrow below ROTATION SPEED again. Touch START. Check and record on the Checklist the delay to the left of the 1000 value. Touch the arrow below SELECT CHANNEL. Touch CHROMOGENIC. Touch the arrow below SELECT CHANNEL again. Touch START. Record on the Checklist the delay to the left of the 1000 value. Check that the maximum delay delta between coagulimetric and chromogenic values (@ 600 rpm) on the Checklist is ≤ 120. Touch rotor cover icon to open motor cover. Remove rotor. Touch rotor cover icon to close rotor cover. Touch “X” to exit. Fiber Adjustment Check Remove rotor – this check is performed without a rotor. Touch SERVICE→OPTICAL MODULE TEST→FIBER ADJUSTMENT TEST. Touch START. Check that all the cuvette values are < 0.070. Touch SET TO ENVELOPE MODE. Check that all the max. / min. values are < 0.050. Touch STOP. Touch OK. Place clean rotor in chamber. Touch START. Check that the cuvette values are > 0.140. Touch SET TO ENVELOPE MODE. Check that all the max. / min. values are < 0.050. Remove rotor. 15. DILUTOR CHECK Materials / tools necessary: Graduated Capillary P/N 00082589-00 Blue Dye Tubing Removal Tool Green Bottle Adapters (3) 4.0 mL Bottles (3) 8.0 mL Bottle Deionized Water Instrument’s Reference Solution Volume Check Note: Use caution in removing the tubes not to disturb the needles adjustment Touch SERVICE→DILUTOR TESTS→VOLUME CHECKS. Chapter 5 – Installation & Maintenance Page 23 of 36 ACL Elite/ElitePro Service Manual Touch SAMPLE DILUTOR. Remove top tube from sample arm and connect capillary to the tube. Hold tube over 8.0 mL empty bottle. Touch START. The instrument will prime and then prompt you to place the capillary in the blue dye. Touch OK. Check that the dye is aspirated into the capillary and stops in between the top two (2) lines on the capillary. After ten (10) seconds the dye will be dispensed and should stop in between the bottom two (2) lines on the capillary. Perform this check several times to ensure that the results are repeatable and that the system has been primed properly. If the liquid consistently sets above or below the two lines, a correction is required. The correction can be entered in the window SELECT CORRECTION VALUE. First attempt decrementing (or incrementing) the correction value by 1 unit. The allowable range is –8 to +8. Repeat the test to ensure that the entered value achieves proper volume dispensing. NOTE: If a value has changed with respect to the original setting, it is necessary to change the label when all related tests are completed. Touch check (√) to replace value and exit. Disconnect the capillary from the sample tube and reinstall the tube on the top of the sample arm. Remove the bottom tube from the sample arm and connect the capillary to the tube. Hold the tube over the empty 8.0 mL bottle. Touch SERVICE→DILUTOR TESTS→VOLUME CHECKS. Touch REAGENT. Touch START. The instrument will prime and then prompt you to place the capillary in the blue dye. Touch OK. Check that the dye is aspirated into the capillary and stops in between the top two (2) lines on the capillary. After ten (10) seconds the dye will be dispensed and should stop in between the bottom two (2) lines on the capillary. Perform this check several times to ensure that the results are repeatable and that the system has been primed properly. If the liquid consistently sets above or below the two lines, a correction is required. The correction can be entered in the window SELECT CORRECTION VALUE. First attempt decrementing (or incrementing) the correction value by 1 unit. The allowable range is –8 to +8. Repeat the test to ensure that the entered value achieves proper volume dispensing. NOTE: If a value has changed with respect to the original setting, it is necessary to change the label when all related tests are completed. Touch check (√) to replace value and exit. Disconnect the capillary from the reagent tube and reinstall the tube on the bottom of the sample arm. Touch check (√) to exit. Page 24 of 36 Chapter 5 – Installation & Maintenance ACL Elite/ElitePro Service Manual Coagulimetric Check Note: Use caution in removing the tubes not to disturb the needles adjustment. Use tubing removal tool to invert the sample and reference tubes on the sample arm. (Sample tube onto reference and reference tube onto sample.) Place deionized water in 4.0 mL bottle and place bottle in position R4. Place the instrument’s reference solution in a 4.0 mL bottle and place in position R1. Touch ROTOR COVER icon to open rotor cover. Install a new rotor in chamber. Touch ROTOR COVER icon to close rotor cover. Touch SERVICE→DILUTOR TESTS→DILUTOR TEST. Touch START MANUAL ROTOR LOADING. Wait for instrument to complete test. Check that when the test is completed there are no red values displayed. Coagulimetric specifications: CV% (cuvette 1 to 6) :<=4 CV% (cuvette 7 to 12) :<=5 CV% (cuvette 13 to 18) :<=5 CV% (Reference) :<=2.5 Mean Reference : 2.0V to 3.0 V R2 : >=0.997 If there are red values, repeat the test with a new rotor. If instrument fails again (red values at the end of the test), corrective action is required. Prime the dilutors (insure air bubbles are removed from pistons and tubing), check needle block alignment, repeat dilutor tests volume checks. Repeat the dilutor test. Chromogenic Check Use tubing tool to reinvert sample and reagent tubes on the sample arm. (Reagent tube on the bottom and sample tube on the top). Remove bottle with reference solution from position R1 and replace it with PNA 160µmol/l in a new bottle. Touch rotor cover icon to open rotor cover. Replace rotor with a new rotor. Touch rotor cover icon to close rotor cover. Touch arrow next to CHANNEL TYPE. Touch the down arrow to choose CHROMOGENIC. Touch arrow next to CHANNEL TYPE. Touch arrow next to LOADING TYPE. Touch the down arrow to choose REAGENT DILUTOR. Touch arrow next to LOADING TYPE. Touch “START IN MANUAL LOADING” Check that when the test is completed there are no red values displayed, except for the MEAN value which can be red with the specification of 7.2 to 8.8. Chapter 5 – Installation & Maintenance Page 25 of 36 ACL Elite/ElitePro Service Manual Chromogenic specifications: CV% (cuvette 1 to 6) :<=1.5 CV% (cuvette 7 to 12) :<=3 CV% (cuvette 13 to 18) :<=5 CV% (Refeence) :<=0.4 Mean Reference : 7.2V to 8.8 V R2 : >=0.997 If there are red values (except for the mean), repeat the test with a new rotor. If instrument fails again (red values at the end of the test), corrective action is required. Prime the dilutors (insure air bubbles are removed from pistons and tubing), check needle block alignment, repeat dilutor tests volume checks. Repeat the dilutor test. Touch check (√) to exit. 16. TOUCH SCREEN CHECK Exit the Service menu by touching the CLOSE DOOR icon, which should bring you to the “Ready” screen. Using a fingertip, touch the (vertical) down scroll arrow. The highlighted bar should move down. Using a fingertip, touch the (vertical) up scroll arrow. The highlighted bar should move up. Page 26 of 36 Chapter 5 – Installation & Maintenance ACL Elite/ElitePro Service Manual ACL Elite/ElitePro Installation Checklist Service Rep:_____________________ Date:________________ Serial Number:___________________ Account:___________________________ Perform adjustments as necessary. Set configurations as necessary. Refer to ACL Elite/ElitePro Service Manual. Check overall instrument appearance. Insure accessory kit is complete. Test Number 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 Action to Check / Perform Check Air Filter Check Display Locking Mechanism Check Software Revision Check System Configuration Check System Interfaces Configuration (keyboard, barcodes, printer, host) Check Magnetic Stirrer Bar Rotation Check Floppy Disk Check Mouse / Host / Parallel Printer Ports Check Waste Line Efficiency Verify Sample Arm Module Positioning / Alignment Verify Needles Block Alignment Check Temperatures (Verify good rotor brush contact) Insure Sample Arm and Rotor Caliper Arm mounting set screws are tight Verify Rotor Motor Cover Stored Step setting Verify Rotor Exchange Module Functionality R.E.M. -- SA-SL-RH Test Rotor Waste Container Sensor Rotor Stack Sensor Verify Autosampler / BCR Test Container Presence and Offset Bar Code Labels Identification and Offset Verify Liquid Level Detection Sensors Wash-Reference Emulsion Sensor Needles Block Sensors Verify Optic Channels (Coag & Chrom) Offsets Gains Curves 405 Filter Test Fiber Adjustment Test Light Source Verification Perform Dilutor Test Coagulimetric Chromogenic Volume Check Coagulation Performance Tests Coagulimetric Precision Test Coagulimetric Linearity Test Chromogenic Performance Tests Chromogenic Precision Test Chromogenic Linearity Test (level 80) Chromogenic Linearity Test (level 160) Chapter 5 – Installation & Maintenance Reference Paragraph 5.2.4 5.1.3 7.16.1 5.1.5 8.0 5.1.4 7.15 7.13 5.2.1 7.7.1 7.7.4 7.14 N/A 7.6.2 Pass/Adjust/ Check 7.7.9 7.5.1 7.5.2 7.5.3 7.5.3 7.4.1 7.4.2 7.2.1 / 7.3.1 7.2.1 / 7.3.1 7.2.1 / 7.3.1 7.3.1 7.2.4 7.2.3 / 7.3.3 7.8.1 7.8.1 7.8.2 7.2.2 7.2.2 7.3.2 7.3.2 7.3.2 Page 27 of 36 ACL Elite/ElitePro Service Manual 5.2 Maintenance In order to keep the ACL Elite/ElitePro analyzer in optimal operating condition it is recommend that the following procedures be carried out by a trained operator at the frequency specified. The Maintenance subsection of the Diagnostic menu allows the user to access and record dates and notes related to the performance of specific maintenance operations. If any maintenance action is not performed within the recommended period then the relevant line will appear in red. Following are the specific sub-sections. 5.2.1 5.2.2 5.2.3 5.2.4 5.2.5 5.2.6 5.2.7 Daily Maintenance Weekly Maintenance Bi-Weekly Maintenance Monthly Maintenance Yearly Maintenance As needed Maintenance Maintenance schedule WARNING ! BIOLOGICAL HAZARDS EXIST. Avoid touching, with bare hands, any parts of the system which may have come in contact with potentially infectious fluids. ALWAYS wear gloves when performing any type of Maintenance/Service action on this area. Page 28 of 36 Chapter 5 – Installation & Maintenance ACL Elite/ElitePro Service Manual 5.2.1 Daily Maintenance At the beginning and at the end of each working day perform a Priming cycle to ensure the complete removal of all sample or reagent residual along the fluidic paths. While the priming cycle is in progress, the operator should visually inspect three items: • That number of bubbles in the Dilutor Chamber reduces to minimum. If bubbles are still present, pinch the chamber outlet tubes while the piston is descending and releases them before the piston reaches the bottom dead center. Repeat the priming cycle as needed until all bubbles are gone. • That there are no blockages or leaks in the liquid flow path and the liquid is flowing smoothly from reservoir to dilutors and from dilutors to needles. • That there is free flow of the liquid waste from the washing chamber to the instrument outlet tube and then to the waste container (check the liquid level in the waste container). Note: The instrument has sensors to detect the availability of Wash Reference Emulsion as well as new and waste rotors. In order to start the working day with the maximum instrument autonomy it’s advisable to empty the Rotor Waste Container from used rotors, fill the Rotor Stack with brand new rotors and check the level of the Wash Reference Emulsion in the bottle. 5.2.2 Weekly Maintenance The weekly preventive maintenance for the ACL Elite/ElitePro consists in cleaning all the key instrument areas which normally come in contact with sample and reagents and therefore accumulate residues that will, if allowed to build up, impair the instrument functionality and affect the tests results. The parts / areas to be cleaned are: • Instrument exposed surfaces. • The Needle Block. • The Rinse / Waste reservoir. WARNING ! BIOLOGICAL HAZARDS EXIST. Avoid touching, with bare hands, any parts of the system which may have come in contact with potentially infectious fluids. ALWAYS wear gloves when performing any type of Maintenance/Service action on this area. • Instrument exposed surfaces Wipe down all exposed surfaces of the analyzer body, the inside of the Autosampler compartment and the Rotor compartment (excluding the rotor holder) using a cloth Chapter 5 – Installation & Maintenance Page 29 of 36 ACL Elite/ElitePro Service Manual soaked in a 0.1 N Hydrochloric Acid (HCl) solution (IL Cleaning Solution P/N 98317-00). Rinse using a cloth soaked in distilled water. Wipe dry. • The Needle Block Place 2 glass vials with 4 mL of 0.1 N HCl solution in reagent positions R6 and R7 Click the Diagnostic button on the Main menu bar and select the Cleaning option of the Diagnostic submenu to display the Cleaning screen. In this screen the operator defines the configuration of the cleaning operation, according to the needs of the instrument. Clicking the Start button starts the cleaning cycle and opens a window displaying a bar that moves to show the elapsed time of the procedure. • The Rinse / Waste reservoir Remove the Rinse / Waste reservoir, wash it thoroughly with 0.1N HCl solution (IL Cleaning Solution P/N 98317-00) and rinse it with distilled water. 5.2.3 Bi-Weekly Maintenance The rotor holder and the optical path components located in the analysis area must be cleaned every two weeks under normal instrument use. WARNING ! BIOLOGICAL HAZARDS EXIST. Avoid touching, with bare hands, any parts of the system which may have come in contact with potentially infectious fluids. ALWAYS wear gloves when performing any type of Maintenance/Service action on this area. Press the “Open/Close Cover” icon to open the Rotor Holder Cover. Proceed as follows using the following figure as a reference: Page 30 of 36 Chapter 5 – Installation & Maintenance ACL Elite/ElitePro Service Manual Using a cotton tip applicator moistened with distilled water, clean all 20 holes in the Rotor Holder and the surfaces of the Channels sensors and fibers. Use a clean, dry cotton tip applicator to remove all moisture from these areas. 5.2.4 Monthly Maintenance • Check and clean the Air Filter In order to check and clean the analyzer air filter, it must first be removed from its location on the right side of the instrument. The filter slides out when pulled after inserting a finger in the holder slot (see figure below). Chapter 5 – Installation & Maintenance Page 31 of 36 ACL Elite/ElitePro Service Manual Check the filter: if it is dirty or blocked, clean it with compressed air or by washing it in water and blowing it dry. Do not place a wet filter into its position. If the filter appears damaged, it should be replaced. Insert the clean or new Air Filter back in its holder. 5.2.5 Yearly Maintenance The yearly preventive maintenance for the ACL consists of replacing the following expandable parts. • • • • • Replace the Air Filter Replace the sample and reagent tubes Replace the Needle Block (see sub-section 5.2.6) Replace the waste tube Replace the waste reservoir WARNING ! BIOLOGICAL HAZARDS EXIST. Avoid touching, with bare hands, any parts of the system which may have come in contact with potentially infectious fluids. ALWAYS wear gloves when performing any type of Maintenance/Service action on this area. 5.2.6 As needed Maintenance WARNING ! BIOLOGICAL HAZARDS EXIST. Avoid touching, with bare hands, any parts of the system which may have come in contact with potentially infectious fluids. ALWAYS wear gloves when performing any type of Maintenance/Service action on this area. • Waste Line Cleaning Procedure The waste line cleaning procedure is performed to prevent formation of clots or to clean any possible blockages (due to clotting) in the waste line. The frequency with which this procedure should be done depends on the daily workload. Materials / Tools needed: Page 32 of 36 - 20 mL plastic syringe - 20 cm of PVC tube, 4 mm ID, 6 mm OD. - 20 mL of distilled water or 10% bleach. Chapter 5 – Installation & Maintenance ACL Elite/ElitePro Service Manual 1 2 3 4 5 • Remove the needle from the plastic syringe (if necessary), and fit the PVC tube on the end on the syringe (the tube’s dimensions must be such that it will fit onto the syringe on one end and into the waste line at the other end). Fill the syringe with distilled water or 10% bleach. Remove the Rinse / Waste Reservoir and clean it if necessary (refer to Section 5.2.2). Insert the free end of the PVC tube into the waste line, carefully inject the distilled water or 10% bleach into the waste line and check that the liquid flows out from the external waste line of the instrument to the waste container. Repeat the procedure several times to ensure removal of any potential blockage then replace the Rinse / Waste reservoir. Cleaning of Sample Spillage In case of sample / reagent spillage wipe using a clean cloth or cotton tip applicator soaked in a 0.1N HCl solution (IL Cleaning Solution P/N 98317-00). Follow with distilled water and dry with a clean cloth or cotton tip applicator. In case of sample / reagent spillage in the Autosampler or in the Rotor Holder compartment, it may be required to clean also the 2 sensors in the Autosampler and the two optical paths in the analysis area (see sub-section 5.2.3). • Needles Block replacing Press the “Open/Close Cover” icon to open the Rotor Cover. Click “Diagnostic” on the Main menu bar and select “Needles Position”. The Sample Arm moves over the Rotor Holder. Loosen the white knob on the back of the Sample Arm, disconnect the tubing (label tubings for proper reconnection) and the Liquid Sensor Cable and remove the Needle Block. Insert the new Needle Block, connect the sensor cable and the two tubings (connect tubing to proper needle) and position the block higher than the arm’s top surface. Follow the needle positioning procedure as described in the sub-section 7.7.4. • Needle Positioning procedure The procedure to reposition or adjust the Needles Block is necessary after having dismantled for cleaning, decontamination or changes of the Needles Block. The procedure is described in sub-section 7.7.4. • Needles Block decontamination procedure This sub-section describes the procedure to decontaminate the ACL Needles Block. It’s recommended after using the system to test a highly infectious sample and as a general precaution to prevent and eliminate potential bacterial contamination. Chapter 5 – Installation & Maintenance Page 33 of 36 ACL Elite/ElitePro Service Manual The use of the ACL system for the analysis of known or suspected highly infectious samples, should be followed by careful disinfecting of the instrument surfaces and parts which have been in contact with the samples. The disinfecting agent used to perform the procedure indicated below is a 1:8 dilution of IL Cleaning Agent P/N 98327-00, which is a solution of sodium hypochlorite with a concentration of less than 0.625% of available chlorine. The 1:8 diluted solution is prepared by mixing 1 part Cleaning Agent with 7 parts of distilled water. Note! Use only IL Cleaning Agent (P/N 98327-00) diluted 1:8 with distilled water. The use of undiluted IL Cleaning Agent may cause corrosion of metal parts. Materials / Tools needed: - 2 glass 10 mL vials - IL Cleaning Agent P/N 98327-00 - Distilled water Prepare approximately 16 mL of diluted Cleaning Agent solution (mix 2 part of IL Cleaning Agent and 14 parts distilled water). Load the ACL reagent position R6 and R7 with the 2 glass vials filled with 8 mL of the prepared diluted Cleaning Agent solution Press “Diagnostic” on the Main menu bar, select “Cleaning” and then press “Start”. At the end of the cleaning cycle remove the vials in position R6 and R7 and perform a Priming cycle. Replace the external waste tube and the waste container. CAUTION ! The discarded items must be placed in an appropriate container for further incineration, according to proper local regulations. In the case of suspected severe contamination, replace the tubing and discard the old one in an appropriate container for further incineration, according to proper local regulations • Hard Drive Maintenaance Using the Hard Drive Maintenance Diskette part number 000190357-70, perform the hard drive maintenance as needed. Refer to procedure 000190357-70 included with the Hard Drive Maintenance Diskette. Page 34 of 36 Chapter 5 – Installation & Maintenance ACL Elite/ElitePro Service Manual 5.2.7 Maintenance schedule Frequency Maintenance procedure Daily At the beginning and at the end of each working day or once per shift, carry out a priming cycle. Empty the liquid waste container when needed. Empty the rotors waste container when needed. Fill the Rotor Stack with new rotors when needed. Load a new bottle of Wash – Reference Emulsion when needed. Clean the exposed instrument surfaces, inside the Autosampler and the analysis compartments (with the exception of the Rotor Holder). Clean the Needles Block carrying out the dedicated cleaning cycle Clean the Rinse / Waste reservoir Clean the analysis compartment optical parts with a cotton tip applicator moistened with distilled water: Clean the LED sensor surface Clean the LED optic fibre surface Clean the Halogen Lamp sensor surface Clean the Halogen Lamp fibre optic surface Clean the 20 holes of the Rotor Holder Check the Air Filter Replace the Air Filter Replace the sample and reagent tubes Replace the Needles Block Replace the waste tube Replace the waste reservoir Clean the Waste line Clean the sample spillage Replace the Needles Block Position the Needles Block Decontaminate the Needles Block Hard Drive Maintenance Weekly Bi-Weekly Monthly Yearly As needed Chapter 5 – Installation & Maintenance Page 35 of 36 ACL Elite/ElitePro Service Manual 5.3 Shut down & Shipment precautions This section gives some suggestions in case of long term shut down or shipment of the instrument. The following procedures describe how to prepare the ACL before a shut down or a shipment. 5.3.1 5.3.2 Long term shut down Shipment 5.3.1 Long term shut down For long period of inactivity, more than one week, the following actions should be carried out. 1 2 3 4 5 6 7 8 9 10 Perform a Priming cycle by selecting “Priming” in the “Diagnostic” menu. Remove any container on board the instrument. Empty the Rotor Waste Container. Remove and close the Wash – Reference Emulsion bottle. Empty the fluidic tubes by performing another Priming cycle. Close the Wash – Reference Emulsion aspiration tube with adhesive tape. Log-out and switch the instrument Off. Empty and remove the waste tube and the waste container. Disconnect the ACL system electrically from the main power, removing the Power Cord from the rear of the instrument and from the main line. Cover the instrument with a dust cover. 5.3.2 Shipment In case of shipment, carry out the following actions. 1 2 3 4 5 6 Perform the actions suggested in the sub-section 5.3.1. Remove the Needles Block, wash it with IL Cleaning Solution P/N 98317-00 and rinse with distilled water. Pack it separately. Wipe instrument external surfaces with 10% bleach and rinse surfaces with a cloth, paper towels, etc. dampened with DH2O. Remove and pack separately also all the other accessories (Sample Tray, Adapters, Keyboard etc…). Fix with adhesive tape all the parts that could be moving during the transport (Sample Arm, Rotor Cover, Rotor Stack Cover, Rotor Waste Compartment Panel etc…). Close with adhesive tape the waste outlet tube on the left side of the instrument. If the original packing is not available is recommended that a suitable box to isolate the instrument from any external impact to be used (paying particular attention to the Display Assembly). In this case pack all the accessories in another box, separately. Page 36 of 36 Chapter 5 – Installation & Maintenance ACL Elite/ElitePro Service Manual Chapter 6 Troubleshooting This Chapter is designed to provide the Service Engineer information about the error messages displayed by the instrument as well as suggestions and tools to fix the problem during the Instrument Troubleshooting. Following are the specific sections. 6.1 6.2 6.3 Error Messages & Troubleshooting Service Tools Standard Tools 6.1 Error Messages and Troubleshooting This section provides information about instrument error conditions and specific errors displayed by the instrument. Following are the specific sub-section for each category of problem. 6.1.1 6.1.2 6.1.3 6.1.4 6.1.5 6.1.6 6.1.7 6.1.8 6.1.9 6.1.10 6.1.11 6.1.12 System errors Temperature errors Mechanical errors R.E.M. error Optic errors Acquisition errors Liquid sensors errors Operative error Database errors Sample identification errors DMS errors Analytical errors Chapter 6 – Troubleshooting Page 1 of 37 ACL Elite/ElitePro Service Manual 6.1.1 System Errors The following paragraphs provide information about problems related to the PC like system present inside the instrument. • • • Unexpected Shut Down and Turn On problems. Problems detected by the CPU Master Board’s BIOS. Problems detected by the Main Program • Unexpected Shut Down and Turn On problems. ERROR MESSAGES MEANING AND POSSIBLE CAUSES, PARTS TO BE EFFECTS CHECKED OR REPLACED Instrument Turn On with Black Screen At Turn On the Instrument LCD (video display) is Black. Instrument Turn On with Touch Screen problem The Instrument performs the Turn On cycle but the Touch Screen is inoperative. Instrument Shut Down for Voltage problem Unexpected Shut Down for a Short Circuit or for a lowering of the voltages on the Switching Power Supply. The SPS is in Protection Mode (DL1 On). Page 2 of 37 Check that the SPS is not in Protection Mode (DL1 On). Check the presence of all the output voltages on the SPS’s Test Point TP1 – TP9 (w/o TP6 for voltage +6VLAMP). If the SPS is in protection Mode or output voltages are less go to the error message “Instrument Shut Down for Voltage” problem. Replace the Display Cable. Replace the CPU Master Board (Board #1). Replace the Video Display Assembly. Turn Off the Instrument and verify the proper Display Cable connection on CN3 and CN6 in the PC104 Board. Replace the Display Cable. Replace the PC104 Board. Replace the Display Assembly. Turn Off the Instrument for at least 20 seconds. Check the Main fuses into the Power Entry. Unplug the 5 Boards located in the Card Housing, CN12 on the CPU Master Board and then Turn On: Check for the presence of the output voltages on the SPS’s Test Point TP1 – TP9 (w/o TP6 for the voltage +6VLAMP). If now the voltages are present then investigate for which load or Board in Card Housing is the problem. Turn Off the Instrument, unplug the 3 connectors on the Power (K1, K2 & K3) and Turn On. Now Check for the presence of the output voltages on the SPS’s Test Point TP1 – TP9 (w/o TP6 for the voltage +6VLAMP). If the voltages are present, then investigate for which load or Interconnection Board is present the Short Circuit. Replace the SPS Board. Chapter 6 – Troubleshooting ACL Elite/ElitePro Service Manual Instrument Shut Down for Temperature problem • Unexpected Shut Down for high temperature on the Switching Power Supply’s thermistor (over 75 °C). The SPS is in Protection Mode (DL1 On). Verify that the environment temperature doesn’t exceed 40°C. Verify that there is enough space around the Instrument for the fan’s cooling. Turn OFF the Main Switch and allow the Instrument to cool (about 15 minutes). In the meanwhile check the Air Filter, clean or replace if necessary. Now Turn On the Instrument and check that the Fans work correctly. Check the presence of all the output voltages on the SPS’s Test Point TP1 – TP9 (w/o TP6 for voltage +6VLAMP); pay attention to the +12VPW for the Fans. Replace the SPS Board. Replace the Acquisition & Sensors Board (Board #3) Problems detected by the CPU Master Board’s BIOS. ERROR MESSAGES MEANING AND POSSIBLE CAUSES, PARTS TO BE EFFECTS CHECKED OR REPLACED Hard Disk Drive Failure During the Boot phase the CPU Master Board’s BIOS detects a problem on the HDD. During the Boot phase the CPU Master Board’s BIOS detects a problem on the FDD. During the Boot phase the CPU Master Board’s BIOS detects a problem on the RAM Memory. During the Boot phase the CPU Master Board’s BIOS detects a problem on the Keyboard. Floppy Disk Drive Failure RAM Memory Failure Keyboard Failure Verify that the HDD parameters are present in the BIOS configuration (No changes are required, only to check for possible parameters lost). Replace the CPU Master Board (Board #1). Replace the Hard Disk Drive. Verify that the FDD parameters are present in the BIOS configuration (No changes are required, only to check for possible parameters lost). Replace the Floppy Disk Drive. Replace the CPU Master Board (Board #1). Replace the CPU Master Board (Board #1). Replace the Keyboard. Replace the Interface Board. Replace the CPU Master Board (Board #1). Replace the Mother Board. Chapter 6 – Troubleshooting Page 3 of 37 ACL Elite/ElitePro Service Manual • Problems detected by the Main Program ERROR MESSAGES MEANING AND POSSIBLE CAUSES, PARTS TO BE EFFECTS CHECKED OR REPLACED Warning: Error opening file The Main Program detects a problem during opening file. Warning: Error reading file The Main Program detects a problem during reading file. Warning: Error writing to file The Main Program detects a problem during writing to file. The Main Program detects a problem during the loading of the current session. During the communications from the CPU Master to the Slave, the timeout is expired. Warning: Session loading Error Warning: Master – Slave communicatio n timeout Error Warning: Timeout Expired Warning: Error parsing loading parameters Warning: Invalid parameters Warning: Zip / Unzip Error Warning: REM download Error Page 4 of 37 Following the procedure in the sub-section 7.16.2, make the Upload and then the Upgrade of the Master Software. Replace the CPU Master Board (Board #1). Following the procedure in the sub-section 7.16.2, make the Upload and then the Upgrade of the Master Software. Replace the CPU Master Board (Board #1). Following the procedure in the sub-section 7.16.2, make the Upload and then the Upgrade of the Master Software. Replace the CPU Master Board (Board #1). Following the procedure in the sub-section 7.16.2, make the Upload and then the Upgrade of the Master and of the Slave Software. Replace the CPU Master Board (Board #1). Following the procedure in the sub-section 7.16.2, make the Upload and then the Upgrade of the Master and of the Slave Software. Replace the CPU Master Board (Board #1). Replace the Slave Board (Board #2). Invalid parameters are detected during the sending from the CPU Master to the Slave. Following the procedure in the sub-section 7.16.2, make the Upload and then the Upgrade of the Master and of the Slave Software. Replace the CPU Master Board (Board #1). Replace the Slave Board (Board #2). The Main program detects a problem during the Download of the R.E.M Software. Following the procedure in the sub-section 7.16.2, make the Upload and then the Upgrade of the REM Software. Replace the R.E.M. Board (Board #4). Replace the Slave Board (Board #2). Chapter 6 – Troubleshooting ACL Elite/ElitePro Service Manual Alarm: Slave Absent Alarm: Slave program not loaded Alarm: Flash Memory Error Alarm: Arcnet Connection Error Alarm: A/D Converter Error Alarm: OI Error Alarm: Error Creating Window Alarm: Timeout Expired Alarm: Unknown message Alarm: Error sending message Alarm: Error creating timer Alarm: Master – Slave message has incorrect length Alarm: Master The CPU Master doesn’t find the Slave. The CPU Master doesn’t find the software onboard of the Slave Bd The CPU Master detects a problem on the Flash Memory on the Slave Board. The Main program detects a problem in the communications with the Slave through Arcnet. Following the procedure in the sub-section 7.16.2, make the Upload and then the Upgrade of the Slave Software. Replace the Slave Board (Board #2). Following the procedure in the sub-section 7.16.2, make the Upload and then the Upgrade of the Slave Software. Replace the Slave Board (Board #2). The Main Program detects a problem during the creating of a window for the Operator Interface graphic program. Following the procedure in the sub-section 7.16.2, make the Upload and then the Upgrade of the Master Software. Replace the CPU Master Board (Board #1). The Main Program detects a problem during the creating of a timer. The Main Program detects a problem in the length of a message sent from the CPU Master to the Slave. The Main Program Following the procedure in the sub-section 7.16.2, make the Upload and then the Upgrade of the Master Software. Replace the CPU Master Board (Board #1). Following the procedure in the sub-section 7.16.2, make the Upload and then the Upgrade of the Slave Software. Replace the Slave Board (Board #2). Verify the Arcnet interconnection cable. Try also to use the connector CN4 (on the PC104 Board) and P7 (on the Slave Board). Replace the Slave Board (Board #2). Replace the PC104 Board. Following the procedure in the sub-section 7.16.2, make the Upload and then the Upgrade of the Master Software. Replace the CPU Master Board (Board #1). Following the procedure in the sub-section 7.16.2, make Chapter 6 – Troubleshooting Page 5 of 37 ACL Elite/ElitePro Service Manual – Slave message has incorrect code 6.1.2 detects a problem in the code of a message sent from the CPU Master to the Slave. the Upload and then the Upgrade of the Master Software. Replace the CPU Master Board (Board #1). Temperatures Errors ERROR MESSAGES MEANING AND POSSIBLE CAUSES, PARTS TO BE EFFECTS CHECKED OR REPLACED Warning: Incubation temperature out of range in startup The Instrument is powered On less then 30 minutes and the Rotor Holder is warming up. The Instrument is powered On more then 30 minutes and the Rotor Holder temperature is out of range 3839 C°. Warning: Incubation temperature out of range Warning: Peltier 1 temperature out of range in startup Warning: Peltier 1 temperature out of range Warning: Peltier 2 temperature out of range in startup Page 6 of 37 The Instrument is powered On less then 30 minutes and the Peltier 1 is cooling. Wait for the the Rotor Holder warm up. If after 30 minutes the Rotor Holder hasn’t achieved the right temperature (38-39 °C) the error message becomes: “Warning: Incubation temperature out of range”. Verify the Rotor Holder movement assy: Verify, with a DVM that on the connector P148 is present the resistance of the thermistor (If it’s a Short Circuit or an Open Circuit verify the Brushes assy. If the Brushes Assy is correct then read the thermistor’s resistance directly on the 2 rings. If the thermistor is defective replace the whole Rotor Holder movement Assy). Verify on the connector P148 that the Heater Coil isn’t interrupted or the capacitor unsoldered. Verify the Photometric and Temperature Control Board (Board #6) functionality as described in the sub-section 3.3.9. Verify the Photometer Interface Board. Waiting for the Peltier 1 to cool. If after 30 minutes the Peltier 1 hasn’t achieves the right temperature (10-16 °C) the error message becomes: “Warning: Peltier 1 temperature out of range”. The Instrument is powered On more then 30 minutes and the Peltier 1 temperature is out of range 10-16 C°. The Instrument is powered On less then 30 minutes and the Peltier 2 is cooling. Chapter 6 – Troubleshooting ACL Elite/ElitePro Service Manual Warning: Peltier 2 temperature out of range The Instrument is powered On more then 30 minutes and the Peltier 2 temperature is out of range 10-16 C°. Warning: Rotor Transport temperature out of range in startup Warning: Rotor Transport temperature out of range The Instrument is powered On less then 30 minutes and the Rotor Transport is warming up. The Instrument is powered On more then 30 minutes and the Rotor Transport temperature is out of range 34-40 C°. Warning: Rotor Stack temperature out of range in startup Warning: Rotor Stack temperature out of range The Instrument is powered On less then 30 minutes and the Rotor Stack is warming up. The Instrument is powered On more then 30 minutes and the Rotor Stack temperature is out of range 34-40 C°. Verify the Peltier 2 assy: Verify, with a DVM, which on the connector P131 is present the resistance of the thermistor (If it’s a Short Circuit or an Open Circuit replaces the thermistor). Verify, with a DVM, which on the connector P131 is present also the resistance of the Peltier Cell (If it’s a Short Circuit or an Open Circuit replaces the whole Peltier 2 Assy). Verify the Photometric and Temperature Control Board (Board #6) functionality as described in the sub-section 3.3.9. Verify the Modules Interconnection Board. Wait for the Rotor Transport warm up. If after 30 minutes the Rotor Transport hasn’t achieves the right temperature (34-40 °C) the error message becomes: “Warning: Rotor Transport temperature out of range”. Verify the Rotor Transport assy: Verify, with a DVM, which on the connector P111 is present the resistance of the thermistor (If it’s a Short Circuit or an Open Circuit replaces the Rotor Transport). Verify, with a DVM, which on the connector P111 is present also the resistance of the Heating Pad (If it’s a Short Circuit or an Open Circuit replaces the Rotor Transport). Verify the Photometric and Temperature Control Board (Board #6) functionality as described in the sub-section 3.3.9. Verify the REM Lower Interconnection Board. Wait for the Rotor Stack warm up. If after 30 minutes the Rotor Stack has not achieved the right temperature (34-40 °C) the error message becomes: “Warning: Rotor Stack temperature out of range”. Verify the Rotor Stack assy: Verify, with a DVM, which on the connector P117 is present the resistance of the thermistor (If it’s a Short Circuit or an Open Circuit replaces the Rotor Stack). Verify, with a DVM, which on the connector P117 is present also the resistance of the Heating Pad (If it’s a Short Circuit or an Open Circuit replaces the Rotor Stack). Verify the Photometric and Temperature Control Board (Board #6) functionality as described in the sub-section 3.3.9. Verify the REM Lower Interconnection Board. Chapter 6 – Troubleshooting Page 7 of 37 ACL Elite/ElitePro Service Manual Warning: Instrument Temperature Error Alarm: Temperature Power off Page 8 of 37 The internal temperature of the Instrument, detected by the Switching Power Supply’s thermistor, reaches the critical temperature of 60 C°. If it reaches 75 C° then the SPS Board will enter in Protection Mode and the whole Instrument Shut Down (see Instrument Shut Down for temperature). One of the Assembly’s temperatures reached a critical value or is OUT OF RANGE since more then 15 minutes. The Instrument for protection purposes Turns Off the thermoregulation system for the Rotor Holder, Peltier and/or REM’s Modules. Verify that the environment temperature doesn’t exceed 40°C. Verify that there is enough space around the Instrument for the fan’s cooling. Turn OFF the Main Switch and wait for Instrument cooling (about 15 minutes). In the meanwhile check the Air Filter for cleaning or replacement. Now Turn On the Instrument and check that the Fans work correctly. Check the presence of all the output voltages on the SPS’s Test Point TP1 – TP9 (w/o TP6 for voltage +6VLAMP); pay attention to the +12VPW for the Fans. Replace the SPS Board. Replace the Acquisition & Sensors Board (Board #3). Is possible remove the Alarm’s message and restore the normal situation only with a Log-Out, a Turn Off and after few seconds a Turn On. Now is possible investigate about the assembly with the problem and perform the troubleshooting with the help of the Temperature Warning’s message associated in this section. If the problem is extended at all the temperatures then go in the A/D Converter test, check if all the values on the screen are ***** or -----, in this case replace the Acquisition & Sensors Board (Board #3). Chapter 6 – Troubleshooting ACL Elite/ElitePro Service Manual 6.1.3 Mechanical Errors ERROR MESSAGES MEANING AND POSSIBLE CAUSES, PARTS TO BE EFFECTS CHECKED OR REPLACED Warning: Autosampler Motor Error The Instrument detects a problem during the Autosampler Motor movement. Warning: Stirrer R1 Error The Instrument detects a problem on the Magnetic Stirrer Motor 1 (Reagent Position R1). The Instrument detects a problem on the Magnetic Stirrer Motor 2 (Reagent Position R2). The Instrument detects a problem on the Magnetic Stirrer Motor 3 (Reagent Position R3). The Instrument detects a problem on the Magnetic Stirrer Motor 4 (Reagent Position R4). The Instrument detects a problem during the Sample Dilutor Motor movement. Warning: Stirrer R2 Error Warning: Stirrer R3 Error Warning: Stirrer R4 Error Warning: Sample line Dilutor Motor Error Warning: Reagent line Dilutor Motor Error The Instrument detects a problem during the Reagent Dilutor Motor movement. Check for mechanical obstruction during the movement. Check Motor Phase setting. Check for the plug in of the connectors P74 (for the motor) and P73 (for DCOS). Check for the functionality of the Motor and of the DCOS as described in the sub-section 7.6.5. Replace the Motors Board (Board #5). Replace the Modules Interconnection Board. Replace the Magnetic Stirrer Motor 1. Replace the Motors Board (Board #5). Replace the Modules Interconnection Board. Replace the Magnetic Stirrer Motor 2. Replace the Motors Board (Board #5). Replace the Modules Interconnection Board. Replace the Magnetic Stirrer Motor 3. Replace the Motors Board (Board #5). Replace the Modules Interconnection Board. Replace the Magnetic Stirrer Motor 4. Replace the Motors Board (Board #5). Replace the Modules Interconnection Board. Check for the plug in of the connectors P83 (for the motor) and P81 (for SCOS). Check for the functionality of the Motor and of the SCOS as described in the sub-section 7.6.6. Replace the Motors Board (Board #5). Replace the Modules Interconnection Board. Check for the plug in of the connectors P84 (for the motor) and P82 (for SCOS). Check for the functionality of the Motor and of the SCOS as described in the sub-section 7.6.6. Replace the Motors Board (Board #5). Replace the Modules Interconnection Board. Chapter 6 – Troubleshooting Page 9 of 37 ACL Elite/ElitePro Service Manual Warning: Sample Arm Horizontal Motor Error The Instrument detects a problem during the Sample Arm Horizontal Motor movement. Warning: Sample Arm Vertical Motor Error The Instrument detects a problem during the Sample Arm Vertical Motor movement. Warning: Rotor Holder Motor Error The Instrument detects a problem during the Rotor Holder Motor movement. Warning: Rotor Cover Motor Error The Instrument detects a problem during the Rotor Cover Motor movement. Check for mechanical obstruction during the movement. Check Motor Phase setting. Check for the plug in of the connectors P93 (for the motor) and P92 (for DCOS). Check for the functionality of the Motor and of the DCOS as described in the sub-section 7.6.3. Replace the Motors Board (Board #5). Replace the Modules Interconnection Board. Check for mechanical obstruction during the movement. Check for the plug in of the connectors P94 (for the motor) and P91 (for DCOS). Check for the functionality of the Motor and of the DCOS as described in the sub-section 7.6.4. Replace the Motors Board (Board #5). Replace the Modules Interconnection Board. Check for mechanical obstruction during the movement. Check Motor Phase setting. Check for the plug in of the connectors P147 (for the motor) and P142 (for DCOS). Check for the functionality of the Motor and of the DCOS as described in the sub-section 7.6.1. Replace the Photometric and Temperatures Control Board (Board #6). Replace the Motors Board (Board #5). Replace the Photometer Interface Board. Check for mechanical obstruction during the movement. Check for the plug in of the connectors P144 (for the motor) and P143 (for DCOS). Check for the functionality of the Motor and of the DCOS as described in the sub-section 7.6.2; pay attention to tension of the Cover movement Belt. Replace the Photometric and Temperatures Control Board (Board #6). Replace the Motors Board (Board #5). Replace the Photometer Interface Board. Warning: Home Position not found Alarm: Motor Phase and Delay Error Page 10 of 37 Chapter 6 – Troubleshooting ACL Elite/ElitePro Service Manual Alarm: Autosampler Motor Error The Instrument detects a problem during the Autosampler Motor movement. Alarm: Sample line Dilutor Motor Error The Instrument detects a problem during the Sample Dilutor Motor movement. Alarm: Reagent line Dilutor Motor Error The Instrument detects a problem during the Reagent Dilutor Motor movement. Alarm: Sample Arm Horizontal Motor Error The Instrument detects a problem during the Sample Arm Horizontal Motor movement. Alarm: Sample Arm Vertical Motor Error The Instrument detects a problem during the Sample Arm Vertical Motor movement. Alarm: Rotor Holder Motor Error The Instrument detects a problem during the Rotor Holder Motor movement. Check for mechanical obstruction during the movement. Check Motor Phase setting. Check for the plug in of the connectors P74 (for the motor) and P73 (for DCOS). Check for the functionality of the Motor and of the DCOS as described in the sub-section 7.6.5. Replace the Motors Board (Board #5). Replace the Modules Interconnection Board. Check for the plug in of the connectors P83 (for the motor) and P81 (for SCOS). Check for the functionality of the Motor and of the SCOS as described in the sub-section 7.6.6. Replace the Motors Board (Board #5). Replace the Modules Interconnection Board. Check for the plug in of the connectors P84 (for the motor) and P82 (for SCOS). Check for the functionality of the Motor and of the SCOS as described in the sub-section 7.6.6. Replace the Motors Board (Board #5). Replace the Modules Interconnection Board. Check for mechanical obstruction during the movement. Check Motor Phase setting. Check for the plug in of the connectors P93 (for the motor) and P92 (for DCOS). Check for the functionality of the Motor and of the DCOS as described in the sub-section 7.6.3. Replace the Motors Board (Board #5). Replace the Modules Interconnection Board. Check for mechanical obstruction during the movement. Check for the plug in of the connectors P94 (for the motor) and P91 (for DCOS). Check for the functionality of the Motor and of the DCOS as described in the sub-section 7.6.4. Replace the Motors Board (Board #5). Replace the Modules Interconnection Board. Check for mechanical obstruction during the movement. Check Motor Phase setting. Check for the plug in of the connectors P147 (for the motor) and P142 (for DCOS). Check for the functionality of the Motor and of the DCOS as described in the sub-section 7.6.1. Replace the Photometric and Temperatures Control Board (Board #6). Replace the Motors Board (Board #5). Replace the Photometer Interface Board. Chapter 6 – Troubleshooting Page 11 of 37 ACL Elite/ElitePro Service Manual Alarm: Rotor Cover Motor Error 6.1.4 The Instrument detects a problem during the Rotor Cover Motor movement. Check for mechanical obstruction during the movement. Check for the plug in of the connectors P144 (for the motor) and P143 (for DCOS). Check for the functionality of the Motor and of the DCOS as described in the sub-section 7.6.2; pay attention to tension of the Cover movement’ Belt. Replace the Photometric and Temperatures Control Board (Board #6). Replace the Motors Board (Board #5). Replace the Photometer Interface Board. R.E.M. (Rotor Exchange Module) Errors ERROR MESSAGES MEANING AND POSSIBLE CAUSES, PARTS TO BE EFFECTS CHECKED OR REPLACED Warning: Rotor Arm Horizontal Motor Error The Instrument detects a problem during the Rotor Arm Horizontal Motor movement. Warning: Rotor Arm Vertical Motor Error The Instrument detects a problem during the Rotor Arm Vertical Motor movement. Warning: Rotor Transport Motor Error The Instrument detects a problem during the Rotor Transport Motor movement. Warning: Rotor Arm Electromagnet Error The Instrument detects a problem in the ElectroMagnet located on the Rotor Arm. Page 12 of 37 Check for mechanical obstruction during the movement. Check Motor Phase setting. Check for the plug in of the connectors P104 (for the motor) and P107 (for DCOS). Check for the functionality of the Motor and of the DCOS as described in the sub-section 7.6.8. Replace the R.E.M. Board (Board #4). Replace the R.E.M. Lower Interconnection Board. Check for mechanical obstruction during the movement. Check for the plug in of the connectors P105 (for the motor) and P108 (for DCOS). Check for the functionality of the Motor and of the DCOS as described in the sub-section 7.6.9. Replace the R.E.M. Board (Board #4). Replace the R.E.M. Lower Interconnection Board. Check for mechanical obstruction during the movement. Check for the plug in of the connectors P103 (for the motor) and P106 (for DCOS). Check for the functionality of the Motor and of the DCOS as described in the sub-section 7.6.7. Replace the R.E.M. Board (Board #4). Replace the R.E.M. Lower Interconnection Board. Check the Electro-Magnet on the Rotor Arm. Replace the R.E.M. Board (Board #4). Replace the R.E.M. Upper Interconnection Board. Chapter 6 – Troubleshooting ACL Elite/ElitePro Service Manual Warning: Rotor Arm Electromagnet Circuit Error Warning: Rotor Stack Upper Electromagnet Error Warning: Rotor Stack Upper Electromagnet Circuit Error Warning: Rotor Stack Lower Electromagnet Error Warning: Rotor Stack Lower Electromagnet Circuit Error Warning: REM CPU Error Warning: REM communication Error The Instrument detects a problem in the driver circuit for the ElectroMagnet located on the Rotor Arm. The Instrument detects a problem in the Upper Electro-Magnet of the Rotor Stack. The Instrument detects a problem in the driver circuit for the Upper Electro-Magnet of the Rotor Stack. The Instrument detects a problem in the Lower Electro-Magnet of the Rotor Stack. The Instrument detects a problem in the driver circuit for the Lower Electro-Magnet of the Rotor Stack. The Instrument detects a problem in the CPU on the R.E.M. Board. The Instrument detects a problem during the communications from the CPU on the R.E.M. Board to the CPU on the Slave Board. Replace the R.E.M. Board (Board #4). Replace the R.E.M. Upper Interconnection Board. Check the Electro-Magnet on the Rotor Arm. Check the Upper Electro-Magnet of the Rotor Stack. Replace the R.E.M. Board (Board #4). Replace the R.E.M. Upper Interconnection Board. Replace the R.E.M. Board (Board #4). Replace the R.E.M. Upper Interconnection Board. Check the Upper Electro-Magnet of the Rotor Stack. Check the Lower Electro-Magnet of the Rotor Stack. Replace the R.E.M. Board (Board #4). Replace the R.E.M. Upper Interconnection Board. Replace the R.E.M. Board (Board #4). Replace the R.E.M. Upper Interconnection Board. Check the Lower Electro-Magnet of the Rotor Stack. Following the procedure in the sub-section 7.16.2, make the Upload and then the Upgrade of the REM Software. Replace the R.E.M. Board (Board #4). Replace the Slave Board (Board #2). Following the procedure in the sub-section 7.16.2, make the Upload and then the Upgrade of the REM Software. Replace the R.E.M. Board (Board #4). Replace the Slave Board (Board #2). Chapter 6 – Troubleshooting Page 13 of 37 ACL Elite/ElitePro Service Manual Warning: REM execution Error The Instrument detects a generic problem during the movements of the REM’s assembles and/or ElectroMagnet. Alarm: REM electric Error The REM’s CPU detects a Short Circuit on one, or more then one, driver circuit on Board. So, for protection purposes, the REM’s CPU Turns Off the +12VPW, which power the Board. The REM’s CPU detects a problem on the +24VPW generated on the REM Board. Alarm: REM voltage out of range Page 14 of 37 It’s a generic message, typically it’s associated to another error (see the Warning List and the File Error History); after the resolution of other problems if this error message doesn’t disappear then Log-Out, Turn Off and On the Instrument. Following the procedure in the sub-section 7.16.2, make the Upload and then the Upgrade of the REM Software. Replace the R.E.M. Board (Board #4). Replace the Slave Board (Board #2). Replace the R.E.M. Upper or Lower Interconnection Board. Following the procedure in the sub-section 7.16.2, make the Upload and then the Upgrade of the REM Software. Replace the R.E.M. Board (Board #4). Check in the File Error History for the presence of other alarm message associated. Replace the R.E.M. Upper or Lower Interconnection Board. Check the presence of the +12VPWR on the TP2 of the Switching Power Supply Board. Replace the R.E.M. Board (Board #4). Chapter 6 – Troubleshooting ACL Elite/ElitePro Service Manual 6.1.5 Optic Errors ERROR MESSAGES MEANING AND POSSIBLE CAUSES, PARTS TO BE EFFECTS CHECKED OR REPLACED Warning: Halogen Lamp Error Analysis aborted for an unexpected Halogen Lamp Turn Off or a lowering of the +6VLAMP voltage on the Switching Power Supply. The Instrument detects a problem on the Optical Reference or the Optical Channels during the Analysis. Following are the checks performed: Warning: No Wash-R Emulsion / Optical Channel Error 1) During the rotor verification: - OFFSET Coagulimetric Ch <70mV. (without rotor) - OFFSET Chromogenic Ch <70 mV. (without rotor) 2) During the Acquisition: - Coagulimetric Channel’s values, read on the Wash-R Emulsion, within range 1.5 – 4.0 V. - Chromogenic Channel’s values, read on the distilled water, within range 5.0 - 9.5 V. - Chromogenic Channel’s values, read on the Wash-R Emulsion <3.5V. Check the Halogen Lamp. Assess Service Program and check the +6VLAMP voltage on the TP6 of the SPS; if required adjust this voltage through RV2. Replace the Acquisition & Sensors Board (Board #3). Check the presence of Wash-R Emulsion or Distilled Water in the Rotor’s cuvettes. Cleans the Rotor Holder holes and all the optic parts in the analysis compartment (for both Optic Channels), using cotton tips with Distilled Water. Check Out and Adjust the Optic Channels value: Coagulimetric Channel OFFSET: 0 – 15 mV. GAIN: with Wash-R Emulsion in cuv. #20 2.6 V. Chromogenic Channel OFFSET: 0 – 15 mV. GAIN: with no cuvette in rotor holder 8.7 V. Check also that the Chromogenic Channel value reading with the Wash-R Emulsion in the cuv. #6 is <3.5 V. If failed, replace the Optical Filter at 405 nm, located over the Chromogenic Sensor inside the Rotor Cover. Check the light sources efficiency. Chapter 6 – Troubleshooting Page 15 of 37 ACL Elite/ElitePro Service Manual 6.1.6 Acquisition Errors ERROR MESSAGES MEANING AND POSSIBLE CAUSES, PARTS TO BE EFFECTS CHECKED OR REPLACED Warning: Rotor Holder Motor blocked during acquisition Analysis aborted for an unexpected failure of the Rotor Holder Motor during the acquisition. Warning: Home Position not found during acquisition Analysis aborted for an unexpected failure during the acquisition, of the DCOS associated to the Rotor Holder. Warning: Unexpected cuvette interruption Analysis aborted for an unexpected failure during the acquisition, of the DCOS associated to the Rotor Holder. Warning: Unexpected ADC interrupt Analysis aborted for an unexpected A/D Converter Interrupt, during the acquisition. Acquisition signal goes to zero during analysis cycle Warning: Null optical reference ADC error in acquisition Warning: Data transmission error during acquisition Page 16 of 37 Analysis aborted for an unexpected error of the data transmission, during the acquisition. Check for the plug in of the connectors P147 (for the motor) and P142 (for DCOS). Check for the functionality of the Motor and of the DCOS as described in the sub-section 7.6.1. Replace the Photometric and Temperatures Control Board (Board #6). Replace the Motors Board (Board #5). Replace the Photometer Interface Board. Check for the plug in of the connectors P147 (for the motor) and P142 (for DCOS). Check Motor Phase setting. Check for the functionality of the Motor and of the DCOS as described in the sub-section 7.6.1. Replace the Motors Board (Board #5). Replace the Photometric and Temperatures Control Board (Board #6). Replace the Photometer Interface Board. Replace the Slave Board (Board #2). Replace the Acquisition & Sensors Board (Board #3). Check for the plug in of the connectors P147 (for the motor) and P142 (for DCOS). Check for the functionality of the Motor and of the DCOS as described in the sub-section 7.6.1. Replace the Motors Board (Board #5). Replace the Photometric and Temperatures Control Board (Board #6). Replace the Photometer Interface Board. Replace the Slave Board (Board #2). Replace the Acquisition & Sensors Board (Board #3). Check Coag and Chrom Acquisition Voltage. Replace the Acquisition & Sensors Board (Board #3). Replace the Slave Board (Board #2). Check Coag and Chrom Acquisition Voltage and “Offset” Voltage. Check “Curve Adjustment” setting. Check LED, optical fibre, coaxial cable connection. Replace Acquisition & Sensors Board (Board #3) Replace the Acquisition & Sensors Board (Board #3). Replace the Slave Board (Board #2). Chapter 6 – Troubleshooting ACL Elite/ElitePro Service Manual Warning: Rotor Holder Motor error during acquisition Warning: Acquisition stopped Warning: Rotor Cover opened during acquisition 6.1.7 Analysis aborted for an unexpected failure of the Rotor Holder Motor during the acquisition. Check Motor Phase setting. Check for the plug in of the connectors P147 (for the motor) and P142 (for DCOS). Check for the functionality of the Motor and of the DCOS as described in the sub-section 7.6.1. Replace the Photometric and Temperatures Control Board (Board #6). Replace the Motors Board (Board #5). Replace the Photometer Interface Board. Analysis aborted for an unexpected opening of the Rotor Cover during the acquisition. Check for the functionality of the Rotor Cover Sensor as described in the sub-section 7.9.1; pay attention to the correct positioning of the sensor. Replace the Rotor Cover Sensor. Replace the Acquisition & Sensors Board (Board #3). Replace the Photometric Interface Board. Liquid Sensors Error ERROR MESSAGES MEANING AND POSSIBLE CAUSES, PARTS TO BE EFFECTS CHECKED OR REPLACED Warning: Sample Low Level in Position xxx The Instrument detects, during the loading, a Low Level on the Sample located in the position xxx. Warning: Liquid “Id” Low Level in Position xxx for test yyy The Instrument detects, during the loading, a Low Level on the Liquid “Id” located in the position xxx and used for the test yyy. Check the presence and the level of the Liquid in the Position xxx. Perform any Priming cycles and then check for air bubbles along the fluidic path. Following the procedure in the sub-section 7.4.2, checks for the functionality of the Needles Sensor; pay attention to the correct positioning of the Needles Block. Replace the Needles Block. Replace the LLD Board. Replace the LLD Cable. Check the presence and the level of the Liquid “Id” in the Position xxx. Perform any Priming cycles and then check for air bubbles along the fluidic path. Following the procedure in the sub-section 7.4.2, checks for the functionality of the Needles Sensor; pays attention to the correct positioning of the Needles Block. Replace the Needles Block. Replace the LLD Board. Replace the LLD Cable. Chapter 6 – Troubleshooting Page 17 of 37 ACL Elite/ElitePro Service Manual Warning: Mandatory Liquid “Id” Low Level in Position xxx for test yyy Warning: Wash-R Emulsion Low Level Warning: Wash-R Emulsion absent Warning: Sample sensor Error Warning: Reagent sensor Error Page 18 of 37 The Instrument detects, during the loading, a Low Level on the Mandatory Liquid “Id” located in the position xxx and used for the test yyy. Check the presence and the level of the Mandatory Liquid “Id” in the Position xxx. Perform any Priming cycles and then check for air bubbles along the fluidic path. Following the procedure in the sub-section 7.4, checks for the functionality of the Needles Sensor; pays attention to the correct positioning of the Needles Block. Replace the Needles Block. Replace the LLD Board. Replace the LLD Cable. The Instrument Check the presence and the level of the Wash-R detects a Low Emulsion (at least over 100 mL). Level on the Wash- Check also the horizontally of the Wash-R Emulsion’s bottle and for the correct insertion of the R Emulsion. cap sensor. Following the procedure in the sub-section 7.4.1, checks for the functionality of the Wash-R Emulsion Sensor. The Instrument Check the presence and the level of the Wash-R detects, during a Emulsion (at least over 100 mL). not analytical cycle, Following the procedure in the sub-section 7.4.1, checks for the functionality of the Wash-R Emulsion that the Wash-R Emulsion is absent. Sensor. Replace the Reference Emulsion Sensor. Replace the Needles & Wash-R Sensor Interconnection Board. Replace the Acquisition & Sensors Board (board #3). Replace the Mother Board The Instrument Following the procedure in the sub-section 7.4.2, detects a problem checks for the functionality of the Needles Sensor. Replace the Needles Block. on the Sample Replace the LLD Board. line’s Liquid Replace the LLD Cable. Sensor. Replace the Needles & Wash-R Sensor Interconnection Board. Replace the Acquisition & Sensors Board (board #3). Replace the Mother Board The Instrument Following the procedure in the sub-section 7.4.2, detects a problem checks for the functionality of the Needles Sensor. Replace the Needles Block. on the Reagent Replace the LLD Board. line’s Liquid Replace the LLD Cable. Sensor. Replace the Needles & Wash-R Sensor Interconnection Board. Replace the Acquisition & Sensors Board (board #3). Replace the Mother Board Chapter 6 – Troubleshooting ACL Elite/ElitePro Service Manual Warning: Wash-R sensor Off Warning: Sample sensor Off Warning: Reagent sensor Off Alarm: WashR Emulsion absent 6.1.8 The Wash-R Emulsion Sensor is disabled in the System Configuration menu’. The Sample line’s Sensor is disabled in the System Configuration menu’. The Reagent line’s Sensor is disabled in the System Configuration menu’. The Instrument detects, during an analysis, that the Wash-R Emulsion is absent. The analysis aborts. Solves the problem associated to the Wash-R Sensor, then enable the sensor in the System Configuration menu to restore the normal condition. Solves the problem associated to the Sample Sensor, then enable the sensor in the System Configuration menu to restore the normal condition. Solves the problem associated to the Reagent Sensor, then enable the sensor in the System Configuration menu to restore the normal condition. Check the presence and the level of the Wash-R Emulsion (at least over 100 mL). Following the procedure in the sub-section 7.4.1, checks for the functionality of the Wash-R Emulsion Sensor. Replace the Reference Emulsion Sensor. Replace the Needles & Wash-R Sensor Interconnection Board. Replace the Acquisition & Sensors Board (board #3). Replace the Mother Board Operative Errors ERROR MESSAGES MEANING AND POSSIBLE CAUSES, PARTS TO BE EFFECTS CHECKED OR REPLACED Warning: Rotor Waste Door open and/or Rotor Waste Container absent Warning: Rotor Waste Full The Instrument detects, before the Rotor unloading, that the Rotor Waste door is open and/or the Rotor Waste is missing. The Instrument detects, before the Rotor unloading, that the Rotor Waste is full. Check in the Optic Sensor test the functionality and the mechanical assemble of the Rotor Waste Presence Switch. Replace the REM Lower Interconnection. Replace the REM Board (Board #4). Following the procedure in the sub-section 7.5.2, checks for the functionality of the Waste Full Sensor. Replace the REM Lower Interconnection. Replace the REM Board (Board #4). Chapter 6 – Troubleshooting Page 19 of 37 ACL Elite/ElitePro Service Manual Warning: Printer failure The Instrument detects, before the document printing, that the External Printer fails or is not ready to print. Warning: Cleaning not performed The Instrument detects, during the cleaning cycle, that the cleaning’s liquid is missing in the positions R6 and/or R7. Warning: Forced open Rotor Cover The Instrument detects, during loading or incubation, that the Rotor Cover is open. The Instrument detects that the Rotor Stack Cover is open. Warning: Rotor Stack Cover open Warning: Floppy Not Present The Instrument detects that the Floppy Disk is missing. Warning: Floppy disk write protected The Instrument detects, during a writing operation, that the Floppy Disk is write protected. The Instrument detects, during a writing operation, that the Floppy Disk is full. Warning: Floppy disk full Page 20 of 37 Check that the External Printer is connected and OnLine. Check in the Interface Setup that the transmission protocol selected is consistent (ex. ESC/P2). Following the procedure in the section 7.13.5, checks for the functionality of the External Printer. Replace the Interface Board. Replace the CPU Master Board. Check for the presence of the liquids required in the positions R6 and R7. Following the procedure in the sub-section 7.4,checks for the functionality of the Needles Sensor. Replace the Needles Block. Replace the LLD Board. Replace the LLD Cable. Replace the Needles & Wash-R Sensor Interconnection Board. Replace the Acquisition & Sensors Board (board #3). Replace the Mother Board. Check for the functionality of the Rotor Cover Sensor as described in the sub-section 7.9.1; pay attention to the correct positioning of the sensor. Replace the Rotor Cover Sensor. Replace the Acquisition & Sensors Board (Board #3). Replace the Photometric Interface Board. Check for the functionality of the Rotor Stack Cover Sensor in the Optic Sensor test. Check for the presence of the Magnet. Replace the Rotor Stack Cover Sensor. Replace the REM Upper Interface Board. Replace the REM Board (Board #4). Check for the presence of the Floppy Disk in the Floppy Disk Drive. Replace the Floppy Disk Drive. Replace the Cable of the Floppy Disk Drive. Replace the CPU Master Board. Check that the Floppy Disk in the Floppy Disk Drive is not write protect. Replace the Floppy Disk. Replace the Floppy Disk Drive. Replace the Cable of the Floppy Disk Drive. Replace the CPU Master Board. Check that the Floppy Disk in the Floppy Disk Drive is not full. Replace the Floppy Disk. Replace the Floppy Disk Drive. Replace the Cable of the Floppy Disk Drive. Replace the CPU Master Board. Chapter 6 – Troubleshooting ACL Elite/ElitePro Service Manual Warning: Timeout expired during loading 6.1.9 During the loading of the analytical cycle the timeout is expired. Following the procedure in the sub-section 7.16.2, make the Upload and then the Upgrade of the Master and of the Slave Software. Replace the Slave Board (Board #2). Database Errors ERROR MESSAGES MEANING AND POSSIBLE CAUSES, PARTS TO BE EFFECTS CHECKED OR REPLACED Warning: Database full The Instrument detects that the Database is full. Restore normal conditions performing a Backup (Recommended) and a Delete of the Patient data. Warning: Error restoring Database Warning: Error backing up Database Alarm: Error opening Database Alarm: Check Database error Alarm: Database Error 6.1.10 Samples Identification Errors ERROR MESSAGES Warning: No Test to Perform MEANING AND POSSIBLE CAUSES, PARTS TO BE EFFECTS CHECKED OR REPLACED Warning: Error in Samples Identification There is not consistency between Samples ID and programmed Loadlists. The Barcode Reader can’t recognize one or more Sample ID Labels. Warning: Internal Bar Code Reader Error The Instrument detects the Internal Bar Code Reader fail. Check for the consistency between Samples ID on the Sample Tray and the programmed Loadlists. Check for the presence of a good label on the Samples and the correct position. Check that the Labels are as specification required (see Appendix B). Check for the correct assemble and alignment of the Internal Barcode Reader. Check for the cleaning and the transparency of the plastic slide in front to the BCR. Replace the Internal Barcode Reader. Replace the Slave Board (Board #2). Replace the Module Interconnection Board. Chapter 6 – Troubleshooting Page 21 of 37 ACL Elite/ElitePro Service Manual 6.1.11 DMS Errors ERROR MESSAGES MEANING AND POSSIBLE CAUSES, PARTS TO BE EFFECTS CHECKED OR REPLACED Warning: Host Com.: ASTM Error Informative Message. Warning: Host Com.: Bad Test Code Informative Message. Warning: Host Com.: Too Many Test Informative Message. Warning: Host Com.: Unknown Test Code Warning: Host Com.: Host Not Responding Warning: Host Com.: Host Required Stop Informative Message. Warning: Host Com.: Format Error Informative Message. Warning: Host Com.: Test Order without Sample ID Warning: Host Com.: Sample ID without Test Order Warning: Host Com.: Invalid Sample ID Informative Message. Warning: Host Com.: Used Sample ID Informative Message. Page 22 of 37 Informative Message. Informative Message. Informative Message. Informative Message. Verify the functionality of the Host communication serial line as described in the section 7.13. If the HW passes the test then consult the Appendix A “Host Communication Protocol”. Verify the functionality of the Host communication serial line as described in the section 7.13. If the HW passes the test then consult the Appendix A “Host Communication Protocol”. Verify the functionality of the Host communication serial line as described in the section 7.13. If the HW passes the test then consult the Appendix A “Host Communication Protocol”. Verify the functionality of the Host communication serial line as described in the section 7.13. If the HW passes the test then consult the Appendix A “Host Communication Protocol”. Verify the functionality of the Host communication serial line as described in the section 7.13. If the HW passes the test then consult the Appendix A “Host Communication Protocol”. Verify the functionality of the Host communication serial line as described in the section 7.13. If the HW passes the test then consult the Appendix A “Host Communication Protocol”. Verify the functionality of the Host communication serial line as described in the section 7.13. If the HW passes the test then consult the Appendix A “Host Communication Protocol”. Verify the functionality of the Host communication serial line as described in the section 7.13. If the HW passes the test then consult the Appendix A “Host Communication Protocol”. Verify the functionality of the Host communication serial line as described in the section 7.13. If the HW passes the test then consult the Appendix A “Host Communication Protocol”. Verify the functionality of the Host communication serial line as described in the section 7.13. If the HW passes the test then consult the Appendix A “Host Communication Protocol”. Verify the functionality of the Host communication serial line as described in the section 7.13. If the HW passes the test then consult the Appendix A “Host Communication Protocol”. Chapter 6 – Troubleshooting ACL Elite/ElitePro Service Manual Warning: Host Com.: Database Full Informative Message. Warning: Host Com.: Sent Different Sample ID Warning: Host Com.: Invalid Instrument ID Informative Message. Informative Message. Verify the functionality of the Host communication serial line as described in the section 7.13. If the HW passes the test then consult the Appendix A “Host Communication Protocol”. Verify the functionality of the Host communication serial line as described in the section 7.13. If the HW passes the test then consult the Appendix A “Host Communication Protocol”. Verify the functionality of the Host communication serial line as described in the section 7.13. If the HW passes the test then consult the Appendix A “Host Communication Protocol”. 6.1.12 Analytical Errors ERROR MESSAGES MEANING AND POSSIBLE CAUSES, PARTS TO BE EFFECTS CHECKED OR REPLACED This sub-section is not available in this Service Manual release 2. For reference on the analytical errors consult the proper section of the Operator’s Manual. Chapter 6 – Troubleshooting Page 23 of 37 ACL Elite/ElitePro Service Manual 6.2 Service Tools In this section are described the Service Tools that have been designed to aid in servicing of the ACL Elite/ElitePro. All tools listed below are applicable to the ACL 8/9/10K and Elite/ElitePro. A kit containing most of the service tools is available under P/N 190653-00, and except for the Coagulimetric Optic Test kit p/n 00097580-50 and the Chromogenic Optic Test kit p/n 00097579-50. Tools not included in the kit must be ordered separately. Following is the table with the main information about the Service Tools. Name Temperature Probe Coagulimetric Optic Test Kit Chromogenic Optic Test Kit Graduated Capillary Kit RS 232 C Interface Check Connector RS 232 C Interface Check Connector Adapter Needles Position Tool Sample Arm Centering Tool Rotor Arm Centering Tool Needles Waste Centering Tool Peltier Centering Tool Touch Screen Calibration Tool Rotor Cover Motor Centering Tool Rotor Cover Encoder Centering Tool Rotor Stack Centering Tool Rotor Snap Alignment tool Rotor Temperature Simulation tool Part Number 70954-00 97580-50 Used for Rotor Holder temperature test Coagulimetric Channel performance checks Chromogenic Channel performance checks Sample / Reagent Dilutor line dispensation test Serial lines test (Require the Adapter below to work) Serial lines test YES YES YES NO 190503-00 Needles Position test Sample Arm Movement Assy positioning Rotor Arm positioning 190515-00 Sample Arm positioning NO 190507-00 190574-00 Peltier positioning Touch Screen Calibration test NO NO 190510-00 Rotor Cover Movement Assy positioning Rotor Cover Movement Assy Encoder positioning Rotor Stack positioning NO 97579-50 82589-00 99211-01 71467-70 181039-41 190513-00 190575-00 190833-38 190800-00 190675-48 Alignment of rotor snap mounting pins Simulates resistance value of rotor holder thermistor Following is a detailed description of each Service Tool above listed. Page 24 of 37 Already used in ACL family Chapter 6 – Troubleshooting YES YES YES NO NO NO NO NO NO ACL Elite/ElitePro Service Manual • Temperature Probe (P/N 70954-00) Purpose: This Tool allows the checking of the actual temperature within the rotor analysis area. Description: It consists of a precise thermistor fit into a cuvette of an analysis rotor. The leads of the thermistor are brought to the upper tool surface in order to allow the measuring of the thermistor resistance (with a DVM) through the two dispensing holes on the Rotor Cover. The read resistance value allows through a mathematical calculation written on the label stuck on the tool upper surface, to know the temperature in °C present inside the analysis rotor. The value must be between 36 –38 °C. The procedure to use this tool is very easy but it’s important to pay attention to follow all °C= Xxxx - Read value Xxx Rv 37 °C=xxxxx the steps. 1 2 3 4 TEMPERATURE PROBE P/N 70954-00 Turn On the Instrument and wait at least 20 minutes. Check in the Temperature Control menu that the Rotor Holder Temperature is within range 38 – 39 °C. Place the Temperature Probe on the Rotor Holder as a normal analysis rotor. Wait at least 15 minutes then using your DVM read the resistance of the thermistor on the upper surface of the tool and calculate the corresponding temperature. Chapter 6 – Troubleshooting Page 25 of 37 ACL Elite/ElitePro Service Manual Coagulimetric Optic Test Kit (P/N 97580-50) Purpose: This kit allows the checking of the performance of the Coagulimetric Channel (see subsection 7.2.2). Description: The kit contains four different concentration levels of Wash-Reference Emulsion for a total of 50 ampoules distributed as follows: 13 19 12 6 • ampoules of ampoules of ampoules of ampoules of 2 1 0.5 0.25 Chromogenic Optic Test Kit (P/N 97579-50) Purpose: This kit allows the checking of the performance of the Chromogenic Channel (see subsection 7.3.2). Description: The kit contains four different concentration levels of a yellow solution (ParaNitroAniline, PNA) for a total of 50 ampoules distributed as follows: 13 19 12 6 • ampoules of ampoules of ampoules of ampoules of 160 80 40 20 Graduated Capillary Kit (P/N 82589-00) Purpose: This tool allows the checking of the Sample and Reagent Dilutor lines aspiration and dispensing (see sub-section 7.8.2). Description: The kit contains 3 capillaries. Page 26 of 37 Chapter 6 – Troubleshooting ACL Elite/ElitePro Service Manual Upper Reference lines Lower Reference lines GRADUATED CAPILLARY • RS 232 C Interface Check Connector (P/N 99211-01) and RS 232 C Interface Check Connector (P/N 199992-01) Purpose: These tools can be plugged together on serial line ports (Modem, Mouse and Host communication ports) present on the rear Instrument Interface Board to allow ports to be tested through the relevant Service program (see section 7.13). Description: Following is the RS 232 C Interface Check Connector drawing in order to make it if it’s not available. Chapter 6 – Troubleshooting Page 27 of 37 ACL Elite/ElitePro Service Manual 13 12 11 10 9 8 7 5 6 4 3 2 25 24 23 22 21 20 19 18 17 16 15 1 14 RS 232 C INTERFACE CHECK CONNECTOR P/N 99211-01 The RS 232 C Interface Check Connector Adapter is a standard PC adapter 25/9 Pin Female/Female. Following is the drawing of a serial customized 9 Pin Check Connector Male (for the Bar Code Port) or Female (for Host, Mouse and Modem Port) in order to make it if the RS 232 C Interface Check Connector and its Adapter are not available. RX TX 5 9 4 3 8 2 7 DTR 1 6 D SR C T S RT S Page 28 of 37 Chapter 6 – Troubleshooting ACL Elite/ElitePro Service Manual • Needles Position Tool (P/N 181039-41) Purpose: This tool has to be used to carry out the alignment of the Needles Block in respect to the analysis rotor position (see sub-section 7.7.4). Description: The tool is a plastic block that has to be properly snapped on the Rotor Holder with the “A” face up. The side “A” of the tool has two Reference Points in order to allow the proper alignment of the Needles Block tips. Reference Dots A 4.3 mm NEEDLES POSITION TOOL P/N 181039-41 Chapter 6 – Troubleshooting Page 29 of 37 ACL Elite/ElitePro Service Manual • Sample Arm Centering Tool (P/N 190513-00) Purpose: This tool has to be used to center the Sample Arm Movement Assy in respect to the Fluidic Plate (see sub-section 7.7.1). Description: The tool has a simple cylindrical shape that fits between the Sample Arm Movement Assy shaft and its Fluidic Plate hole. 13,6 mm 19,6 mm 66 mm SAMPLE ARM CENTRING TOOL P/N 190513-00 Page 30 of 37 Chapter 6 – Troubleshooting ACL Elite/ElitePro Service Manual • Rotor Arm Centring Tool (P/N 190503-00) Purpose: This tool has to be used to center the Rotor Arm in respect to the Rotor Transport (see sub-section 7.7.6). Description: The tool has a simple cylindrical shape that fits between the Rotor Arm central finger and the Rotor Transport central hole. 9 mm 12 mm ROTOR ARM CENTRING TOOL P/N 190503-00 Chapter 6 – Troubleshooting Page 31 of 37 ACL Elite/ElitePro Service Manual • Needles Waste Centering Tool (P/N 190515-00) Purpose: This tool has to be used to center the Needles Block (and the Sample Arm) in respect to the Needles Waste/Rinse position on the Fluidic Plate (see sub-section 7.7.1). Description: The tool has a shape very similar at the normal Waste Adapter with the addition of 2 tubes that fits in the 2 holes for the Needles. 9 mm 12 mm NEEDLES WASTE CENTRING TOOL P/N 190515-00 • Peltier Centering Tool (P/N 190507-00) Purpose: This tool has to be used to center the Peltier Assy in respect to its holes in the Fluidic Plate (see sub-section 4.1.2). Description: The tools have a simple cylindrical shape that fits into the reagents adaptor holes of the Peltier. Page 32 of 37 Chapter 6 – Troubleshooting ACL Elite/ElitePro Service Manual 28,3 mm 29,8 mm 32 mm PELTIER CENTRING TOOL P/N 190507-00 • Touch Screen Calibration Tool (P/N 190574-00) Purpose: This tool has to be used during the Touch Screen Calibration test (see section 7.12). Description: The tools have a simple pencil shape with a rounded tip. TOUCH SCREEN CALIBRATION TOOL P/N 190574-00 Chapter 6 – Troubleshooting Page 33 of 37 ACL Elite/ElitePro Service Manual • Rotor Cover Motor Centering Tool (P/N 190510-00) Purpose: This tool has to be used when is needed to put in tension the Belt of the Rotor Cover Movement Assy before the final fixing with the 3 screws (see sub-section 7.6.2). Description: The tool has a simple flat shape that fits into the niche between the Rotor Cover Movement Assy and the support. This tool assures the horizontal alignment of the Rotor Cover Movement Assy. ROTOR COVER MOTOR CENTRING TOOL P/N 190510-00 • Rotor Cover Encoder Centering Tool (P/N 190575-00) Purpose: This tool has to be used to center the Encoder Disk position when the Rotor Cover Movement Assy is replaced (see sub-section 7.6.2). Description: The tool has a simple pencil shape with a thread (M3) at the tip that fits into the setscrew hole. Page 34 of 37 Chapter 6 – Troubleshooting ACL Elite/ElitePro Service Manual M3 ROTOR COVER ENCODER CENTRING TOOL P/N 190575-00 • Rotor Stack Centering Tool (190833-38 or 190501-00) Purpose: Rotor Stack Centering Tool is used to align the Rotor Silo to the Transport Plate (Slider). Description: Tool has a handle to allow user to place tool into rotor stack. Tool also has notches to allow tool to pass by calliper arms in rotor stack. The tool has access holes to access screws on transport (slider) plate. Rotor Stack Centering Tool P/N 190833-38 • Sample Tray Alignment Tools (P/N 190520-00) Purpose: Tools are placed into sample and reagent positions on the tray and tray alignment to the sample arm is verified. Description: Tools are sized to fit into sample or reagent positions on the tray. Each tool has an alignment hole to check position with needle block in arm. Chapter 6 – Troubleshooting Page 35 of 37 ACL Elite/ElitePro Service Manual Sample Tray Alignment Tools P/N 190520-00 • Rotor Snap Alignment Tool (P/N 190800-00) Purpose: After rotor snap is removed from the rotor holder the Rotor Snap Alignment Tool is used to insure the 2 pins on the rotor holder are straight vertically. Tool is placed over the pins on the rotor holder to straighten the pins. Description: Rotor Snap Alignment Tool is cylinder shaped with two (2) small holes in the bottom of the lower end. Align small holes with pins on rotor holder where snap mounts and gently press down on tool to straighten pins. • Rotor Holder Temperature Simulation Tool (p/n190675-48) Purpose: Simulates rotor holder thermistor resistance if at approximately 37.5C . A defective heater coil will cause power supply to shut down due to no load or overcurrent condition. Using this tool the ACL unit can be powered on to allow further troubleshooting. Description: If power supply is in shutdown condition, unplug the rotor holder heater cable and install the rotor holder temperature simulator tool by plugging it into the heater cable connector. This will simulate a rotor temperature of approximately 37.5 C possibly allowing the power supply to power up normally and allow the service personel to further troubleshoot the unit. Page 36 of 37 Chapter 6 – Troubleshooting ACL Elite/ElitePro Service Manual 6.3 Standard Tools This section provides suggestions about the standard tools equipment of the Service Engineer required to perform a replacement or an adjustment on the ACL Elite/ElitePro. Following is the list of the standard tools. • Set of metric hexagonal Allen Screw Driver In particular: 1.5 mm 2 mm 2.5 mm * 3 mm * 5 mm • Set of metric Socket Wrench Driver In particular: 5 mm 5.5 mm 6 mm 7 mm Flat Srew Driver Phillips Screw Driver • • * Note: A special flexible version of these two screwdrivers are both available in the kit “2.5/3 mm Flex Allen Screw Driver” P/N 99208-10 Chapter 6 – Troubleshooting Page 37 of 37 Elite/ElitePro Service Manual Chapter 7 Checkout & Adjustment This chapter is designed to allow the Service Engineer to perform a thorough check out of the whole Instrument. The Service software incorporates proper utilities for the entire checkout and adjustment needed. Following are the specific sections with the check out procedures. Warning: Do not access sample or reagent area while probe arm is operating. Note: For Software version 3.0 to access the Service Menu log on with Username: Service and Password: System Fix User names and passwords are case sensitive. 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.10 7.11 7.12 7.13 7.14 7.15 7.16 Quick Reference Guide to Electronic Adjustment Coagulimetric Channel Chromogenic Channel Liquid Sensor Optic Sensor Motors Adjust Modules Positioning Dilutors Module Magnetic Sensor Rotor Waste Presence Switch Switching Power Supply check out & Adjustment Touch Screen Calibration Interface Test Temperature Control Floppy Disk Drive Test Software checking & loading Chapter 7 – Checkout & Adjustment Page 1 of 98 ACL Elite/ElitePro Service Manual 7.1 Quick Reference Guide for Electronic Adjustment This section is designed to help the service engineer to remember the set value and the conditions to perform the main electronic adjustment. • Acquisition & Sensor Board (Board #3) Coag. Ch. Chrom. Ch. Trimmer Function RV1 Off-Set Coag. Ch. RV2 Gain Coag: Ch. RV3 RV4 RV5 RV6 RV7 Gain Chrom. Ch. Off-Set Chrom. Ch. Rotor Cover Sensor Autosamp. Middle Ring Optic Sensor Autosamp. Inner Ring Optic Sensor RV9 Wash-R Level Sens. RV10 Autosamp. Outer Ring Optic Sensor Reagent Level Sens. Sample Level Sens. RV11 RV12 Page 2 of 98 Condition Reading Point LCD LCD Set Value (V) 0-15 mv 2.6 +/- 0.300V LCD LCD LCD LCD 8.7 +/- 0.050V 0-15 mv >2.7 V >2.8 V 4ml Bottle without label, filled w/ water Flush volume 500ml 2ml Cup LCD >3.2 V LCD Flush volume 500ml LCD >3.5 V 1500ul ref sol. 150ul ref sol. LCD LCD >4.0 V >3.9 V Light blocked 200ul ref sol position 20 No Rotor Light blocked Cover closed 2ml Cup Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual • Rotor Exchange Module Board (Board #4) Trimmer PT1 PT2 PT3 Function Rotor Stack Optic Sensor Rotor Transport Optic Sensor Rotor Waste Optic Sensor Condition Reading Point TP 0 & TP 1 Set Value (V) >8.0 V Rotor in position TP 0 & TP 2 >8.0 V Ten rotors in waste bin TP 0 & TP 3 4.00 V Rotor in position 7.2 Coagulimetric channel Several tests are available to troubleshoot or verify the Coagulimetric Channel. These tests allow verification of electronic circuits (PCB) and optical components (light source and optic fiber). The tests used to verify the Coagulimetric Optical Channel are: Test Name Coagulimetric Channel check out and adjustment Performance check out Light source (LED) verification Optic fiber check out and adjustment procedure 7.2.1 Purpose Sets the reading value and the peak of the bell shaped signal of data acquisition. Verifies that precision and linearity are within specs. Performs match of electronic signals to actual performance of the light source. Optimizes optic performance. See section 7.2.1 7.2.2 7.2.3 7.2.4 Coagulimetric Channel check out and adjustment Materials / tools necessary for the test: - Brand new rotors. - Wash-Reference Emulsion. - 200µl micropipette. Chapter 7 – Checkout & Adjustment Page 3 of 98 ACL Elite/ElitePro Service Manual Precaution Make sure that the instrument has been switched ON for at least 20 minutes (warm-up of light source and thermoregulation) prior to performing the following procedure. 1 2 3 Enter the service program menu. Thoroughly clean the twenty optical path (holes) of the Rotor Holder with distilled water and a cotton swab. Clean also the optical sensor window and the optic fiber of the Coagulimetric Channel. Do not use metal forceps with gauze as this may scratch the rotor holder generating possible stray light affecting the proper system performance. On the windows like menu enter Service then A/D Converter Test. The instrument displays the screen below. 4 Using the Icon on the screen turn off the LED. Lower the analysis compartment cover then locate the trimmer RV1 (on Board # 3) see figure below. 5 Adjust RV1 to read between 0 and 15 mV on screen. Then touch “√” to exit. Note: Turn RV1 CCW to increase offset mV or CW to decrease offset mV. Page 4 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual On the windows like menu enter Service then Optical Module Test and Curve Adjustment. The instrument shows the screen below: 6 7 8 9 10 11 12 13 14 15 Load 200µl of Wash-Reference Emulsion in cuvette number 20 of a new rotor. Place the prepared rotor on the Rotor Holder. Select Coagulimetric Channel, set rotational speed to 1200 rpm and touch Start. The instrument performs an acquisition cycle. Upon completion of the acquisition cycle, scroll the table of values and delays until you find the delay corresponding to the value of 1000. Update, if necessary the current delay, keying in the new value on the window “Select Delay”. Change the rotational speed from 1200 to 600 rpm, and touch Start. The instrument performs an acquisition cycle. Upon completion of the acquisition cycle scroll the table of values and delays until you find the delay corresponding to the value of 1000. Update the delay by keying it on the window “Select Delay” only if necessary. Touch “√” to exit, so the new settings will be saved. On the windows like menu enter Service then Optical Module and Acquisition Adjustment. Leave the rotor previously loaded in place and touch Start (if the rotor loaded was in place for more than 3 minutes load a new one). Adjust RV2 (on board # 3, see figure on previous page) to read 2.6 Vdc on the Coagulimetric Channel line (accept any value from 2.3 to 2.9Vdc). Once adjusted touch Stop, then “√” to exit. On the windows like menu enter Service then Optical Module and Fiber Adjustment. Wait for the motor initialization, then remove the rotor from the analysis compartment. Touch Start and verify that (without a rotor in place) no “cuvette” reads higher than 70 mV. Should this test fail, perform the fiber adjustment as described in sub-section 7.2.4. If the test passes then touch Stop and insert a new rotor into the analysis compartment. Touch Start and verify that cuvette readings are above 130 mV and do not exceed 1500 mV. Touch “Set to Envelope Mode” and verify that all the min/max values are < 50mV. Touch Stop and then “X” to exit. Chapter 7 – Checkout & Adjustment Page 5 of 98 ACL Elite/ElitePro Service Manual 7.2.2 Performance checkout These two tests are designed to verify the overall performance of the Coagulimetric Channel: • • Coagulimetric Precision Test Coagulimetric Linearity Test The Coagulimetric Optic Test Kit (P/N 97580-50) is necessary to perform both tests. The kit consists of 50 vials (2 mL each): 13 vials 19 vials 12 vials 6 vials 2 1 0.5 0.25 Warning: If one of the tests fail then it is necessary to perform all the other check out tests of this section 7.2. • Coagulimetric Precision Test Materials / tools necessary for the test: - Brand new rotors. - Coagulimetric Optic Test Kit - P/N 97580-50 - Clean, empty 4 mL reagent vial or other suitable container 1 2 On the windows like menu enter Service then Optical Module Test and Channel Optic Test. The instrument shows the screen below. Select in sequence Channel type: Coagulimetric; Test Type: Precision Loading Type: Reagent. Page 6 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 3 Put the content of two vials (4ml) labelled 1 (taken from the kit P/N 97580-50) into a clean, empty 4 mL reagent vial with a Green adapter. Note: For this test it is possible to use the Wash-Reference Emulsion in substitution of the Silicon Emulsion labelled 1. 4 5 6 7 Position the 4 mL reagent vial with the adapter onto the reagent position R1. Load 200µl of Wash-Reference Emulsion in cuvette number 20 of a new rotor before placing the rotor onto the Rotor Holder in the analysis compartment. Touch “Start in Manual Rotor Loading”. The instrument will load the rotor cuvettes picking the Silicon Emulsion from the reagent vial using the reagent probe. Wait for the acquisition cycle then verify the following parameters : CV% (cuvette # 1 to # 18) CV% (Reference) Mean Reference :<=5 :<=3 : 2.2 V to 3.0 V Note: Acquisition cycle only can be repeated selecting Skip Loading from the “Loading Type” window. 8 Touch “√” twice to exit. • Coagulimetric Linearity Test Materials / tools necessary for the test: - Brand new rotors. - Coagulimetric Optic Test Kit P/N 97580-50. - Clean, empty reagent vial or other suitable container. 1 On the windows like menu enter Service then Optical Module Test and Channel Optic Test. 2 The instrument shows the screen below. Select in sequence Channel type: Coagulimetric; Test Type: Linearity Loading Type: Reagent. Chapter 7 – Checkout & Adjustment Page 7 of 98 ACL Elite/ElitePro Service Manual 3 4 Put the content of two vials (4ml), of each level (1, 0.5 and 0.25 from the kit P/N 97580-50) into three clean, empty 4 mL reagent vials with their Green adapters. Position the 4 mL reagent vials with the adapters on the reagent tray as follows: Rgt position R1 R2 R3 5 6 7 Level 1 0.5 0.25 Volume 4 ml 4 ml 4 ml Load 200µl of Wash-Reference Emulsion in cuvette number 20 of a new rotor before placing the rotor onto the Rotor Holder in the analysis compartment. Touch “Start in Manual Rotor Loading”. The instrument will load the rotor cuvettes aspirating silicon emulsions from the reagent vials using the reagent probe. Wait for the acquisition cycle then verify the following parameters: CV% (cuvette # 1 to # 6) CV% (cuvette # 7 to # 12) CV% (cuvette # 13 to # 18) CV% (Reference) Mean Reference R2 :<=4 :<=5 :<=5 : < = 2.5 : 2.0 V to 3.0 V : >= 0.997 Note: Acquisition cycle only can be repeated selecting “Skip Loading” from the “Loading Type” window. 8 Touch “√” twice to exit. 7.2.3 Light source (LED) verification These two tests are designed to verify the overall performance of the Coagulimetric Channel LED with fiber: Page 8 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual • • Coagulimetric Channel LED efficiency Test Coagulimetric Channel LED with Fiber replacement • Coagulimetric Channel LED efficiency Test Materials / tools necessary for the test: - Brand new rotors - Wash-Reference Emulsion - 200 µl micropipette 1 On the windows like menu enter Service then Optical Module and Acquisition Adjustment. The instrument shows the screen below. 2 3 4 Load 200µl of Wash-Reference Emulsion in cuvette number 20 of a new rotor. Place the loaded rotor onto the Rotor Holder in the analysis compartment. Locate the trimmer RV2 (on Board # 3) see figure below. 5 Touch Start and then turn RV2 fully clockwise until to read as low as possible on the Coagulimetric Channel line. Check that in the above conditions the value displayed on the screen is higher than 250 mV. If test fails replace the “Coagulimetric Channel LED with fiber” assy 6 Chapter 7 – Checkout & Adjustment Page 9 of 98 ACL Elite/ElitePro Service Manual 7 (see next sub-section). If test passes then adjust RV2 to read 2.6 V ± 0.3V on the screen. Touch Stop and “√” to exit. • Coagulimetric Channel LED with Fibre replacement Materials / tools necessary for the test: - Brand new rotors - Wash-Reference Emulsion - 200 µl micropipette If the LED is replaced follow the procedure here below to adjust the amplifier circuit and the optic fibre. 1 On the windows like menu enter Service then Optical Module and Acquisition Adjustment. The instrument shows the screen below. 2 Load 200 µl of Wash-Reference Emulsion inside cuvette number 20 of a new rotor. Place the loaded rotor onto the Rotor Holder in the analysis compartment, and then touch Start. 3 Page 10 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 4 Locate the trimmer RV2 (on Board # 3) see figure below. 5 6 Adjust RV2 to read 2.600 ± 0.3 V on the screen. Loosen the setscrew, which locks the sleeve with the optic fibre into the socket. Loose this set screw Optic fibre Sleeve 7 8 9 Move the optic fibre upward to obtain the maximum voltage reading on the Coagulimetric Channel line. After reaching maximum value, move fibre in opposite direction until the value decreases by 100mV, then tighten the setscrew. Adjust by means of RV2 the reading to 2.600 ± 0.3 V. Touch Stop then “√” to exit. 7.2.4 1 2 Optic fibre check out and adjustment procedure On the windows like menu enter Service then Optical Module and Fibre Adjustment. Wait for the initialization of the motors then empty the analysis compartment from any rotor. Chapter 7 – Checkout & Adjustment Page 11 of 98 ACL Elite/ElitePro Service Manual 3 Touch Start and verify that (without any rotor in place) no “cuvette” reads a value higher than 70 mV. See screen below: Warning: If this test fails then follow these few points: • • • 4 5 6 7 8 Loose the setscrew that holds the Optic Fibre in place on the Rotor Holder side. Rotate the Optic Fibre CW or CCW (max. 90°) until a reading lower than 70 mV is obtained. Tighten the setscrew to lock the Optic Fibre back in place (the Optic Fibre must be placed in the bottom). Touch “Set envelope mode”. Wait for about 30 seconds and verify that for no cuvette the MIN-MAX reading value is higher than 50 mV. If not then perform the test in the sub-section 7.2.3 paying attention to the reading oscillations on Coagulimetric Channel (higher then 50 mV). Then perform the procedure in the sub-section 7.2.1. If OK touch “Stop”. Raise the Rotor Holder Cover and load a new rotor on the Rotor Holder. Touch Start and check that all cuvettes values read higher than 130 mV and don’t exceed 1500 mV. If exceed 1500 mV then check for rotor integrity. Touch “Set envelope mode” and verify that the MIN-MAX for each cuvette is 50mV or less. Touch Stop and then “X” to exit. Page 12 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 7.3 Chromogenic channel Several tests are available either to troubleshoot or verify the Chromogenic Channel. These tests allow verification of electronic circuits (PCB) as well as optical components (light source and optic fiber). The tests that achieve verification of the Chromogenic Optical Channel are: Test Name Chromogenic Channel check out and adjustment Channel performance check out Light Source (Halogen Lamp) verification 7.3.1 Purpose Sets the read value and the peak of the bell shaped signal of data acquisition. Verifies that precision and linearity are within specs Performs match of electronic signals to actual performance of light source See section 7.3.1 7.3.2 7.3.3 Chromogenic Channel check out and adjustment Materials / tools necessary for the test: - Brand new rotors - Wash-Reference Emulsion - 200 µl micropipette Precaution Make sure that the instrument has been switched on for at least 20 minutes (warm-up of light source and thermoregulation) prior to going through the following procedure: 1 2 Enter to the service program menu. Thoroughly clean the twenty optical path (holes) of the Rotor Holder with distilled water and a cotton swab. Clean also the optical sensor and the Optic Fiber windows of the Chromogenic Channel. Do not use metal forceps with gauze as this may scratch the rotor holder generating possible stray light affecting the proper system performance. Chapter 7 – Checkout & Adjustment Page 13 of 98 ACL Elite/ElitePro Service Manual 3 On the windows like menu enter Service then A/D Converter Test. The instrument displays the screen below. 4 Using the Icon turn off the Halogen Lamp. Lower the analysis compartment cover, then locate the trimmer RV4 (on Board # 3), see figure below: 5 Adjust RV4 to read between 0 and 15 mV on screen. Then touch “√” to exit. Note: Turn RV4 CCW to decrease offset mV and CW to increase offset mV. 6 On the windows like menu enter Service then Optical Module Test and Curve Adjustment. 7 Load 200 µl of Wash-Reference Emulsion inside cuvette number 20 of a new rotor. Place rotor onto rotor holder. 8 Select Chromogenic Channels, set rotational speed at 1200 rpm and touch “Start”. The instrument performs an acquisition cycle. Upon completion of the acquisition cycle scroll the table of values and delays until you find the delay corresponding to the value of 1000. Page 14 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 9 10 11 12 13 14 15 Check that the delay is within 60 µsec. from the “current” delay displayed on the window “Select Delay”. The Chromogenic channel delay cannot be updated, only viewed and compared to the current Coagulametric channel delay. Change the rotational speed from 1200 to 600 rpm and touch “Start”. The instrument performs an acquisition cycle. Upon completion of the acquisition cycle scroll the table of values and delays until you find the delay corresponding to the value of 1000. Check that the delay is within 120 µsec. from the “current” delay displayed on the window “Select Delay”. Remove the rotor. On the windows like menu enter Service then Optical Module Test and Acquisition Adjustment. Touch Start, then adjust RV3 (on board # 3, see figure on previous page) to read 8.7 ± 0.05 Vdc on the Chromogenic Channel line (accept any value from 8.65 to 8.75 Vdc). Once adjusted touch “Stop”. Load a new rotor with 200 µl of Wash-Reference Emulsion on cuvette # 6. Place the loaded rotor in the analysis compartment. Touch “Start” and verify that the reading on Chromogenic Channel line does not exceed 3.5 Vdc. Otherwise replace the 405 nm Optical Filter and repeat the test. Touch “√” to exit Chapter 7 – Checkout & Adjustment Page 15 of 98 ACL Elite/ElitePro Service Manual 7.3.2 Performance checkout These three tests allow you to verify the overall performance of the Chromogenic Channel: • • • Chromogenic Precision test Chromogenic Linearity Test level 80 Chromogenic Linearity Test level 160 The Chromogenic Optic Test Kit (P/N 97579-50) is necessary to perform both tests. The kit incorporates 50 vials (2 mL each), having the following concentration of PNA (ParaNitroAnyline): 13 vials 19 vials 12 vials 6 vials • 160 µmol/L 80 µmol/L 40 µmol/L 20 µmol/L Chromogenic Precision Test Materials / tools necessary for the test: 1 2 - Brand new rotors - Chromogenic Optic Test Kit P/N 97579-50 - Clean, empty reagent vial, or other suitable container. On the windows like menu enter Service then Optical Module Test and Channel Optic Test. Select in sequence Channel type: Chromogenic; Test Type: Precision Loading Type: Reagent. The instrument shows the screen below: Page 16 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 3 4 5 6 7 8 9 Put the content of two vials (4ml) of PNA (ParaNitroAnyline) concentration 80 µmol/L (taken from the kit P/N 97579-50) into a clean, empty 4 mL reagent vial with its Green adapter or other suitable container. Position the 4 mL reagent vial with the adapter onto the reagent position R1. Pour at least 4 mL of distilled water onto a clean, empty reagent vial or other suitable container. Position the reagent vial with the distilled water onto reagent position R4. Take a new rotor and place it in the analysis compartment. Touch “Start in Manual Rotor Loading”. The instrument will load the rotor cuvettes aspirating the PNA from the reagent vials using the reagent probe. Wait for the acquisition cycle, then verify the following parameters: CV% (cuvette # 1 to # 18) CV% (Reference) Mean Reference :<=2 : < = 0.5 : 7.7 V to 8.3 V Note: Acquisition cycle only can be repeated selecting Skip Loading from the “Loading Type” window. 10. Touch “√” twice to exit. • Chromogenic Linearity Test level 80 Materials / tools necessary for the test: 1 - Brand new rotors - Chromogenic Optic Test Kit P/N 97579-50 - Clean, empty reagent vial, or other suitable container. On the windows like menu enter Service then Optical Module Test and Channel Optic Test. Chapter 7 – Checkout & Adjustment Page 17 of 98 ACL Elite/ElitePro Service Manual 2 The instrument shows the screen below. Select in sequence Channel type: Chromogenic, Test Type: Linearity and Loading Type: Reagent. 3 Put the content of two PNA vials (4mL), of each level (80, 40 and 20 from the kit P/N 97579-50) into a clean, empty 4 mL reagent vial with their Green adapters, or other suitable container. Position the reagent vials on the reagent tray as follows: 4 Rgt position R1 R2 R3 5 6 7 Material 80 µmol/L 40 µmol/L 20 µmol/L Volume 4 ml 4 ml 4 ml Place a new rotor in the analysis compartment. Touch “Start in Manual Rotor Loading”. The instrument will load the rotor cuvettes aspirating the PNA from the reagent vials using the reagent probe. Wait for the acquisition cycle then verify that the following results are obtained: CV% (cuvette # 1 to # 6) CV% (cuvette # 7 to # 12) CV% (cuvette # 13 to # 18) CV% (Reference) Mean Reference R2 : < = 1.5 :<=3 :<=5 : < = 0.4 : 7.2 V to 8.8 V : >= 0.997 Note: Acquisition cycle only can be repeated selecting Skip Loading from the “Loading Type” window. 8 Touch “√” twice to exit. • Chromogenic Linearity Test level 160 Materials / tools necessary for the test: Page 18 of 98 - Brand new rotors Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual - Chromogenic Optic Test Kit P/N 97579-50 - Clean, empty reagent vial, or other suitable container. 1 2 3 4 On the windows like menu enter Service then Optical Module Test and Channel Optic Test. The instrument shows the screen below. Select in sequence Channel type: Chromogenic, Test Type: Linearity and Loading Type: Reagent. Put the content of two PNA vials (4 mL), of each level (160, 80 and 40 from the kit P/N 97580-50) into a clean, empty 4 mL reagent vial with theirs adapters or other suitable container. Position the reagent vials onto reagent tray according to the following scheme: Rgt position R1 R2 R3 R4 Material 160 µmol/L 80 µmol/L 40 µmol/L Distilled Water Volume 4 ml 4 ml 4 ml 4 ml 5 6 Place a brand new rotor into the analysis compartment. Touch “Start in Manual Rotor Loading”. The instrument will load the rotor cuvettes aspirating the PNA from the reagent vial using the reagent probe. 7 Wait for the acquisition cycle, then verify that the following results are obtained: CV% (cuvette # 1 to # 6) CV% (cuvette # 7 to # 12) CV% (cuvette # 13 to # 18) CV% (Reference) Mean Reference R2 : < = 1.5 :<=3 :<=5 : < = 0.4 : 7.2 V to 8.8 V : >= 0.997 Chapter 7 – Checkout & Adjustment Page 19 of 98 ACL Elite/ElitePro Service Manual Note: Acquisition cycle only can be repeated selecting Skip Loading from the “Loading Type” window. 8 Touch “√” twice to exit. 7.3.3 Light source (Halogen Lamp) verification Materials / tools necessary for the test: - Distilled Water - Brand new rotors 1 On the windows like menu enter Service then Optical Module and Acquisition Adjustment. Wait for motors initialization then the instrument shows the screen below. 2 3 4 Load 200 µl of distilled water inside cuvette number 6 of a new rotor. Place the loaded rotor onto the Rotor Holder in the analysis compartment. Touch Start then locate RV3 on the Acquisition board (board # 3), see figure below. 5 Turn RV3 fully clockwise to read as low as possible. Page 20 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 6 7 Check that in the above condition the value displayed on the screen is in the range 890 to 4150 mV. If test fails replace the Halogen Lamp Socket Assy and perform the Chromogenic Channel check out & adjustment as described in the sub-section 7.3.1. If test passes, remove the rotor and then repeat the Acquisition test and readjust RV3 to read 8.7 +/- 0.050 V on the Chromogenic Channel line. Touch Stop and “√” to exit. 7.4 Liquid sensors These two tests are designed to troubleshoot and verify the liquid sensors. They are available via Service then Sensors Test. 7.4.1 7.4.2 Wash-Reference Emulsion Volume Test Needle sensor Test 7.4.1 Wash-Reference Emulsion Volume test This procedure allows the adjustment of the reference solution sensor circuit that shall determine the volume of the solution left in the bottle. 1 2 3 4 Prepare a Wash-R Solution bottle with 500 ml of fluid. If a graduated container is not available then use the marks on the side of the bottle paying attention to the horizontal position of the bottle. Install the bottle on board and cork it completely with the Reference Emulsion Sensor. On the windows like menu enter Service then Sensors Test and Flush Volume test. The system displays the screen below: Verify that Flush Volume displayed is 500 mL. Chapter 7 – Checkout & Adjustment Page 21 of 98 ACL Elite/ElitePro Service Manual 5 Adjust if necessary RV9 located on the Acquisition & Sensor Board (Board # 3), see figure below, to obtain a Flush Volume of 500ml displayed. 6 Fill the Wash-R bottle with 1000ml of solution. Install the bottle on board and cork it completely with the Reference Emulsion Sensor. On the windows like menu enter Service then Sensors Test and Flush Volume test. The Flush Volume displayed should be 1000 ± 20% (800 – 1200 ml). 7 Fill the Wash-R bottle with 100ml of solution. Install the bottle on board and cork it completely with the Reference Emulsion Sensor. On the windows like menu enter Service then Sensors Test and Flush Volume test. The Flush Volume displayed should be 100 ± 30% (70 – 130 ml). 8 Press “√” to exit. 7.4.2 Needles sensor test This test allows functional verification of the circuitry that fulfils the task of liquid detection through both the sample and reagent probes. Materials / tools necessary for the test: - Distilled water - Micropipette 100 – 1000 μl - Clean, empty 4 ml reagent vial. Warning: Prior starting procedures execute one or more priming cycles following the route Diagnostic then Priming. Perform these operations until confident that the fluidic path is completely filled and without air bubbles. Verify also that the fluidic lines are smooth and without crimps, etc. 1 2 On the windows like menu enter Service then Sensors Test and Needle Sensor Test. Press Start. The Sample Arm moves across the default test positions (1, 2 and A1 on the Sample Tray positions then R1, R5 and R7 on the Reagent Tray) and stops on the waste position. The system displays the following screen: Page 22 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 3 Verify on the current screen that the value presented on the window “Reference value” is in the range 4.000 - 6.000 V. Note: If it’s out of range then perform the procedure “Wash-Reference Emulsion Volume Test” to adjust the Flush Volume value at 500 mL. If the problem persists then replace the Acquisition & Sensors Board (Board #3). 4 Prepare and position the suitable containers with distilled water or Wash-R Solution as for the table below then press Start. The Sample Arm will scan the positions and system will refresh screen with updated values. 5 Verify that the windows “SENSOR RESULT” display LIQUID. In addition check that the windows “LIQUID” displays values according to table below. Adjust RV 11 and RV 12 if necessary and repeat the test as many times as needed. Position Container Volume Probe LSLIQ Sample tray #1 500 μL Disposable cup 4 mL Reagent vial + Adapter 150 μL SPL 4.1 V (± 200 mV) 1.5 mL RGT 4.2 V (± 200 mV) Reagent tray R1 6 Sensor Trimmer Result to Adjust Liquid RV 12 Liquid RV 11 Locate trimmer position on Acquisition & Sensors Board (Board # 3) as per figure below. Chapter 7 – Checkout & Adjustment Page 23 of 98 ACL Elite/ElitePro Service Manual 7 Repeat the test with the containers positioned and filled as indicated in the table below then check the results. Position Container Volume Probe LSLIQ Sample tray #1 Sample tray # 2 Sample tray A1 500 μL Disposable cup 500 μL Disposable cup 500 μL Disposable cup + Adapter 4 mL Reagent vial + Adapter 4 mL Reagent vial + Adapter 4 mL Reagent vial + Adapter 150 μL 150 μL 150 μL SPL SPL SPL 3.9 – 4.3 V 2.8 – 3.8 V 3.4 – 4.4 V Sensor Result Liquid Liquid Liquid 1.5 mL RGT > 3.5 V Liquid 1.5 mL RGT > 3.0 V Liquid 1.5 mL SPL > 3.0 V Liquid Reagent tray R1 Reagent tray R5 Reagent tray R7 Note: If the “LIQUID” value is correct but the “Sensor Result” is “Air” the meaning is that the liquid level in this position is low. This may indicate a problem with the Sample Arm and/or the Needles Block. This happens when the Needles have touched the liquid (LIQUID value in range) but the mechanical stop has blocked the Sample Arm before the Needles enter 2mm into the liquid for confidence (Sensor Result “Air”). To solve the problem correct the Sample Arm assembly then repeat this procedure. This condition of liquid low level may be present also during the analysis. In this case perform this test (using the specific test quantity of liquid) to clarify if the liquid is really insufficient and if the sensor is working properly. Repeat the test with the containers empty and positioned as indicated in the table below then press “Start” and check the results. Position Container 500 μL disposable cup Sample tray # 2 500 μL disposable cup Sample tray A1 500 μL disposable cup + Adapter Reagent tray R1 4 mL Reagent vial + Adapter Reagent tray R5 4 mL Reagent vial + Adapter Reagent tray R7 4 mL Reagent vial + Adapter Sample tray # 1 8 Volume LSLIQ < 2.4V Sensor Result Air None < 300 mV None < 2.4 V Air < 300 mV None < 2.4 V Air < 300 mV None < 0.8 V Air < 300 mV None < 1.5 V Air < 300 mV None < 1.5 V Air < 300 mV Verify that all windows “SENSOR RESULT” now display AIR. Page 24 of 98 Chapter 7 – Checkout & Adjustment Offset Elite/ElitePro Service Manual 9 Check also that on each of the six small windows the value for offset is below 300mV. The offset is a reading taken on the sensor once the Sample Arm reaches each given position prior to lowering into the liquid (circuit autozero). Note: If the Offset is too high (over 700 mV) we have Sensor Fail. To solve Offset problem it’s advisable to check for liquid on the Needles, dirt and/or insulating lost in the Needles Block. 10 Press “X” to exit. 7.5 Optic sensor test Specific optical sensors are located in the Autosampler with the purpose to detect the presence of cups, primary tubes and auxiliary materials on the Sample Tray. Other optical sensors are located in the R.E.M. (Rotor Exchange Module) with the purpose to detect for rotor presence. The sensors check for rotors present at different locations along the route followed by the rotors during normal operations. Following are the specific sub-sections for optical sensors location. 7.5.1 7.5.2 7.5.3 Rotor Stack. Rotor Waste container. Autosampler housing. 7.5.1 Rotor Stack The Rotor Stack is actually equipped with two optical sensors that have the purpose of detecting the presence of: - Lowest rotor in the Rotor Stack. Rotor on the Rotor Transport ready to be displaced on the Rotor Holder. The two sensors are identified in the system as follows. • • Rotor Stack (Storage) Rotor Transport (Slider) • Rotor Stack (Storage) 1 2 Empty the rotor feed stack from any rotor. Locate inside the Rotor Stack the window of the “Optical Sensor Rotor Stack Upper”. The sensor is located just above the mechanism that holds the stack of rotors when loaded. Check that the sensor is properly faced to its slot. This is to prevent mechanical jam (if too close) or detection problem (if too far). 3 Chapter 7 – Checkout & Adjustment Page 25 of 98 ACL Elite/ElitePro Service Manual 4 Access the Service menu then follow the route: Service, Sensor Test and Optic Sensor Test. The instrument will initialize motors then the screen below is presented. 5 Manually load one new rotor and leave it seated at the lower position of the Rotor Stack lined up to the Optical Sensor Rotor Stack Upper. 6 Check that the voltage being displayed with the rotor in place is 5.00 V (higher than 5 Vdc on the DVM). Last check that the flag on the screen shall indicate the presence of the rotor. Should above reading be less than 5.00 V adjust, proceeding as follows. Locate in the system Card Housing the R.E.M. Board (Board #4). Connect a DVM between TP0 (GND) and TP1 (signal) as shown in the figure below. 7 8 9 Adjust PT1 until the DVM reads 8.000 Vdc. 10 Manually remove the rotor and observe voltage value reported on the screen to drop to less than 1V. The flag that indicates the presence of the rotor shall also disappear. In case the value read is higher than 1.00 V check for sensor position and cleanness. Page 26 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 11 Manually move the rotor in and out a few times and assess for proper rotor detection. Check also that the flag toggles on the screen as rotor is being moved in and out. • Rotor Transport (Slider) 1 2 Empty the Rotor Stack. Locate the “Optical Sensor Rotor Stack Lower” at the bottom of the Rotor Stack lined up with the Rotor Transport. Check that the sensor is properly faced to its slot. This is to prevent mechanical jam (if too close) or detection problem (if too far). Manually load a new rotor on the Rotor Transport. Access the Service software then follow the route: Service, Sensor Test and Optic Sensor Test. The screen shown below is presented. 3 4 5 6 7 8 Check that the voltage being displayed, with the rotor in place is 5.00 V (higher than 5 Vdc on the DVM). In the meanwhile a flag on the screen shall indicate the presence of the rotor. Should above reading be less than 5.00 V adjust, proceeding as follows. Locate in the system Card Housing the R.E.M. Board (Board #4). Connect a DVM between TP0 (GND) and TP2 (signal) as shown in figure below. 9 Adjust PT2 until the DVM reads 8.000 Vdc. Chapter 7 – Checkout & Adjustment Page 27 of 98 ACL Elite/ElitePro Service Manual 10 Manually remove the rotor and observe the voltage value reported on the screen to drop to less than 1V. The flag that indicates the presence of the rotor shall also disappear. In case the reading remains above 1.00 V then check for sensor position and cleanliness. 11 Manually move the rotor in and out a few times and assess for proper rotor detection. Check also that the flag toggles on the screen as rotor is being moved in and out. 7.5.2 Rotor Waste container The Rotor Waste container can accommodate up to eleven used rotors (240 tests). Following are the two conditions detected by the “Optical Sensor Rotor Waste Full”: - Rotor Waste container available (until ten rotors pile-up in the Rotor Waste container). Rotor Waste container full (when eleven rotors pile-up in the Rotor Waste container). The system provides appropriate warning messages to the User any time that the full condition is met. 1 Access the Service environment, then follow the route: Service, Sensor Test and Optic Sensor Test. The instrument will initialize the motors then the screen shown below is presented. 2 Gain access to the Rotor Waste compartment by lowering the door in bottom front of the instrument (this test needs to be performed with the Front Cover and the Lower Support Plate assembled). Remove the Rotor Waste Container from its housing. Fill the waste rotor bag with ten rotors. Place the Rotor Waste Container back into its compartment. 3 4 5 Page 28 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 6 7 Check that, in this condition, the voltage being displayed is 4.25V (accept any value in the range 3.50 to 5.00). Should above reading be out of the specified range then adjust, proceeding as follows. Locate in the system Card Housing the R.E.M. Board (Board #4). 8 Connect a DVM between TP0 (GND) and TP3 (signal), as shown in figure below. 9 Turn PT3 until the DVM reads 4.25 Vdc with ten rotors in the waste container. 10 Manually insert another rotor in the pile. Now 11 rotors are the waste container. 11 The System shall detect the “Rotor Waste full” condition and flag it on the screen as appropriate. 12 Check that the voltage being displayed, with the 11 rotors in place is 5.00 V on the screen (higher than 8.00Vdc on the DVM). 13 Manually remove two rotors from the pile and leave 9 rotors in the waste container. 14 Check that, in this condition, the voltage being displayed drops to less than 1.00V. Accept any value below 1.00 V, the flag that indicates the presence of the rotor shall also disappear. In case reading remains above 1.000 V check for sensor position and cleanness. 15 Manually move the rotors in and out a few times and assess for proper rotor detection. Check also that the flag toggles on the screen as the rotors are being moved in and out. 16 If any of the above voltages cannot be obtained adjust the position of the optical sensors and repeat the procedure. 7.5.3 Autosampler Housing The Autosampler Housing is equipped with two optical sensors used to detect the presence on the Sample Tray of primary tubes, cups, reagents or calibrator vials. It’s also equipped with the internal Barcode Assy, used to read the “Patient ID” labels present on the primary tubes. The two following procedures are required to completely Check out & Adjust the Autosampler Housing sensors. • • Autosampler Sensors Check out & Adjustment. Autosampler / BCR Test. Chapter 7 – Checkout & Adjustment Page 29 of 98 ACL Elite/ElitePro Service Manual • Autosampler Sensors Check out & Adjustment This procedure is designed to verify and adjust the sensitivity of the optical sensors located on the Sample Tray compartment, which detect the presence of cups / primary tubes or other containers. The positions on the Sample Tray covered by each sensor are as follows. Position Name on LCD screen Located on the external Cups (1st and 2nd ring) wall of the sample tray housing Located below the Cups (3rd ring) Sample Tray grey Flange Adjustable. Function Checks for presence on the outer (1st) and mid (2nd) rings for cups or tubes on the Sample Tray. Checks for presence of any container on the innermost (3rd) ring on the Sample Tray. Note: Prior to performing this procedure verify that the Autosampler Movement Assy with its grey Flange Adjustable is properly aligned (see sub-section 7.6.5 and 7.7.1). 1 - Take a Sample Tray with all the positions free and place: In position 33 (1st , outer ring) a new 2 mL cup In position 34 (2nd , middle ring) a new 2 mL cup In aux. ring position A9 (3rd, innermost ring) a 4ml bottle and adaptor Note: Make sure that the cups are new and free from any scratches. 2 Access the Service environment, place the prepared Sample Tray in its compartment then enter Service, Sensor Test and Optical Sensor test. The system displays the screen below: 3 On the window “SELECT RING TO TEST” set the appropriate ring. Page 30 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual Note: Adjust the 2nd ring first because the adjustment made on the trimmer RV6 will affect the voltage reading on the 1st ring. The Acquisition & Sensors Board, through RV6 sets the maximum current in the Outer Sensor, which is used for both the rings, and RV10 sets the gain of the reading circuit for the 1st ring. 4 Select 2nd ring. Manually rotate the Sample Tray positioning the cup in position 34 in front of the optical sensor. Rotate the Sample Tray, to obtain the maximum voltage reading on the screen for the 2nd ring. The voltage for the 2nd ring should read between 2.8 to 4.0V. 5 If not adjust trimmer RV6 located on the Acquisition & Sensors Board (see figure below), to obtain the specified value. Make sure that the Sample Tray does not lose its position (at maximum reading) while adjusting. 6 Remove the cup and check that the voltage indicated on the LCD is <1.00V. 7 Select 1st ring. Manually rotate the Sample Tray positioning the cup in position 33 in front of the optical sensor. Rotate the Sample Tray, to obtain the maximum voltage reading on the screen for the 1st ring. The voltage for the 1st ring should read >3.5V. 8 If not adjust trimmer RV10 located on the Acquisition & Sensors Board (see figure below), to obtain the specified value. Make sure that the Sample Tray does not lose its position (at maximum reading) while adjusting. Note: If the voltage is too high, such as 10.0V trim it down with RV10. 9 Remove the cup and check that the voltage indicated on the LCD is <1.00V. Sample tray ring 2nd – middle ring 1st – outer ring Sample tray ring 2nd – middle ring 1st – outer ring Sample tray pos. Position 34 Position 33 Sample tray pos. Position 34 Position 33 Container Cup 2 mL no-scratches Cup 2 mL no-scratches Value 2.80 to 4.00V Adjust RV 6 > 3.50 V RV 10 Container No container No container Value < 1.00 V < 1.00 V Chapter 7 – Checkout & Adjustment Page 31 of 98 ACL Elite/ElitePro Service Manual 10 Insert a 4mL bottle adaptor (p/n 190763-00) into AUX position A9. Place a 4ml bottle into the adaptor making sure that the glass is facing the adaptor handle and the label is facing away from the handle. 11 Observe the status line for the Inner Ring. Turn RV7 on the Acquisition & Sensors Bd, (bd #3) to the maximum value. Manually rotate the autosampler around the internal ring sensor position and look for the maximum obtainable value. This has to be ≥ 6V. Note: If obtaining ≥ 6V is not possible, remove the autosampler tray and flange. Use sensor alignment tool p/n 190782-03 to check the position of the internal ring sensor. Place the alignment tool over the Autosampler hub and sensor. The front of the sensor should be against the tool. If not, loosen the sensor and adjust the sensor so it is touching the tool. Install the Adaptor Plate (p/n 190782-01) on top of the sensor). Tighten the sensor. Repeat steps 10 and 11. Note: If sensor alignment tool p/n 190782-03 is not available loosen the sensor and adjust the sensor out toward the front of the unit. Adjust sensor so the tip of the sensor is flush with the white sample area inner wall. The tip of the sensor should not protrude out from the hole beyond the white wall. If the positioning of the internal ring sensor (sensor touching the tool), seems to be fine, install a spacer, p/n 190782-02 underneath the sensor. Install the Adaptor Plate (p/n 190781-02) on top of the sensor (see diagram). Recheck sensor alignment. Repeat steps 10 and 11. 12 Insert a 4ml bottle without a label filled with DI water into the adaptor in position A9. Manually move the sample tray around the sensor to get the maximum voltage displayed on the 3rd ring status line. 13 Adjust RV7 on the Acquisition & Sensor Bd, (bd #3), for an output value on the LCD between 3.2 to 3.5V. 14 Remove the bottle and verify that the output value is < 2.2V. (See note below). 15 Remove the empty 2mL adaptor (p/n 190764-00) and observe that the output value is < 2.2V. (See note below). Note: If obtaining < 2.2V is not possible, remove the autosampler and flange. Use sensor alignment tool p/n 190782-03 to check the position of the internal sensor. The front of the sensor should be against the tool. If the positioning seems to be fine, install spacer p/n 190782-02 underneath the sensor and repeat steps 10 - 15. *** A maximum of two spacers (p/n 190782-02) are allowed underneath the sensor. If there are still problems, *** replace the sensor 16 Place an empty 2mL cup into the adaptor and observe that the output value is ≥ 3.6V. 17 Remove the adaptor and cup. Insert an 8mL bottle filled with water in AUX position 9 and observe that the output value is ≥ 3.6V. Page 32 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual Sample tray ring 3rd – inner ring Sample tray ring 3rd – inner ring 3rd – inner ring Sample tray pos. Position A9 Sample tray pos. Position A9 Position A9 Container New 4ml Bottle Without label filled with DI water Value > 3.2 to 3.5 V Container 4ml adaptor with no bottle No adaptor, no bottle Value < 2.2 V Adjust RV 7 < 2.2 V To thoroughly assess the proper functioning of sensors through all available positions of the Sample Tray, it is advisable to perform the “Autosampler / BCR test”. This is the next test described in this sub-section. • Autosampler / BCR test The Autosampler / BCR (Bar Code Reader) test is designed to verify the proper reading of Autosampler Optical Sensors and BCR under dynamic conditions. These conditions replicate the real use during the analysis cycles. Specific Offset can be entered to trigger an early/late reading on the optical sensors. This will compensate for some mechanical play that may produce a small shift of the Sample Tray during rotation. 1 On the windows like menu enter Service then Autosampler / BCR test. The system shows the screen below and positions at home the Sample Tray. Chapter 7 – Checkout & Adjustment Page 33 of 98 ACL Elite/ElitePro Service Manual 2 3 Prepare a Sample Tray with all the even positions (2nd, middle ring) loaded with new empty 2 mL cups. Make sure that the cups are new, free from any scratches. Place the prepared Sample Tray onboard. Touch key “START WITHOUT BCR”. The system will perform a complete turn of the Autosampler reporting on the screen cups presence (1 present; 0 not present) and position. Note: There are 3 other columns in the result area of the screen. The first is the “Offset” column. The second is the “ADC Value” column, read on each position during the test. The last is the “Bar Code Values” column where is reported the value read by the BCR on the Patient ID Barcode Label. This column is compiled only when the test starting by touching the button “START WITH BCR”. 4 5 6 Assess that all the even positions on the screen report “1” for presence. If any positions fail then check that the relevant cup is in good condition, replace the cup and repeat test. Checks also in the “ADC Value” column that the highest value read for this position is close to the set point of the sensor (see the test “Autosampler Sensors Check out & Adjustment” described above in this subsection). If the problem persist then enter on the window “CENTRAL RING OFFSET” a new value close to zero (the value suggested are –5 to +5) and repeat the test a few times until confident that the proper value is found. Once achieved, unload cups from mid ring, place them on outer ring and perform this test for the outer ring. Set “OUTER RING OFFSET” if necessary and enter an offset value close to zero (the value suggested are –5 to +5) and repeat the test a few times until confident that the proper offset value is found. Also, install bottles without labels on the Auxiliary Ring (inner ring) and perform the test again. Set “INNER RING OFFSET” if necessary and enter an offset value close to zero (the value suggested are –5 to +5) and repeat the test a few times until confident that the proper offset value is found. Page 34 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual Test functionality of the internal Bar Code Reader performing the following procedure. Make sure internal BCR is enabled and appropriate symbologies selected. 1 On the windows like menu enter Service then Autosampler / BCR test. The system shows the screen below and positions at home the Sample Tray. 2 Prepare a Sample Tray with primary tubes equipped with Bar Code Labels. Place tubes in both the middle and outer rings. (It is not necessary to place tubes in every position, but make sure tubes are in both the middle and outer ring). Make sure that the labels are valid, in good condition (see also Appendix B Bar Code Label specification) and positioned toward the Bar Code Reader. Place the prepared Sample Tray onboard. Touch key “START WITH BCR”. The system will perform a complete turn of the Autosampler reporting on the “Bar Code Values” column the value read by the BCR on the Patient ID Barcode Label. Confirm that all positions containing tubes indicate a “1” for presence. If any position fails check that the relevant primary tube label is in good condition, replace the primary tube and repeat the test. If any position continues to fail repeat the Autosampler Sensor Adjustment procedure and cup Offset Procedure. Confirm that the barcode value read matches the barcode label and that the bar code value is displayed in the correct tray position. If the barcode values are not in the correct tray positions, then enter on the window “BCR OFFSET” a new value and repeat the test (move the Offset value + or – 1 at any repetition). Repeat several times until confident that the BCR reads correctly all primary tube labels. 3 4 5 6 7 8 Note: The value reported in the “Offset” column is approximately the cup presence Optic Sensors output. Chapter 7 – Checkout & Adjustment Page 35 of 98 ACL Elite/ElitePro Service Manual 7.6 Motor adjust This service program sub-menu includes the utilities designed to allow stepping motors phase adjustments and/or check out of the Optical Sensors (Dual/Single Channel Optical Switch) functionality. Following are the stepper motors check out procedures: 7.6.1 7.6.2 7.6.3 7.6.4 7.6.5 7.6.6 7.6.7 7.6.8 7.6.9 Rotor Motor Rotor Holder Cover Motor Sample Arm Horizontal Motor Sample Arm Vertical Motor Autosampler Motor Sample / Reagent Dilutor Motors Transport (Slider) Motor Rotor Arm Horizontal Motor Rotor Arm Vertical Motor Operator interface for each motor adjustment screen is very similar. Some exceptions exist for the Rotor Holder Cover Motor. The functionality of the commands available and the most common dynamic labels are described in the following sub- section. Most common commands The following section provides a description of the commands whose functionality is replicated in each of the motor adjust screens. Rotation C.W. Arrow/Rotation C.C.W. Arrow Allows the clockwise/counterclockwise stepping of the motor. The number of steps executed for each command is in accordance with the current STEP INCREMENT value present in the windows. Next C.W. Position / Next C.C.W. Position Steps the motor to the next “meaningful position” in the clockwise/counterclockwise direction that can be reached from the current motor position. At each touch the system will update values on the following labels on the screen: PRESENT PHASE COVER SENSOR HOME SENSOR POSITION SENSOR STEP DONE Page 36 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual The following “meaningful positions” can be achieved: Motor Rotor Motor Rotor Holder Cover Sample Arm Motor Horizontal Sample Arm Motor Vertical Autosampler Motor Dilutor Motors Slider Motor (Transport Motor) Rotor Arm Horizontal Rotor Arm Vertical Meaningful position 20 Rotor cuvette positions (Home Position is with cuvette #20 in front of the Optical Fiber). 3 Positions: • Closed. • Intermediate. Utilized only for automatic rotor exchange. • Opened (Home Position). 13 Positions: (17 for ACL ElitePro): • 3 Over the Sample Tray (Elite Home Position is over A1) • 4 Over the Peltier reagent tray. (R1-R4) • 1 Over the waste/wash reservoir. • 4 Over the room temperature reagent tray. (R5-R8) • 1 Over the Rotor Holder position. • 4 Over the 2nd Peltier reagent tray. (R9-R12) (ElitePro only) (ElitePro Home Position is over R12) 3 Positions: • Rotation (Home Position). • Reagent picking / (Sample/Reagent) delivery. • Sample picking. 20 Positions (Home Position is with A1 in the direction of the Sample Arm. Access to 50 positions is achieved through the outer, middle and inner ring. 2 Positions: • Fully upward (Home Position). • Fully downward. 2 Positions: • Under the Rotor Stack (Home Position). • Rotor Arm picking. 2 Positions: • On the Rotor waste / picking (Home Position). • On the Rotor Holder. 2 Positions: • Up for Rotation (Home Position). • Down for Rotor picking/delivery. Home position Brings the stepper motor to the Encoder Home Position. Motor Off De-energizes the motor. The motor status reported on the relevant window “MOTOR STATUS” changes from “Energized” to “De-energized”. Store phase / Store step This command allows saving of a “new” stepper motor phase (or step) that best fits the Optical Sensor with the “optical window” on the encoder. Chapter 7 – Checkout & Adjustment Page 37 of 98 ACL Elite/ElitePro Service Manual Cautions ! Operating within the Service environment no verifications are made concerning illegal operations (e.g. conflicts with other modules), safe movements have to be verified prior to activating any key. Most common dynamic labels Listed are descriptions of the dynamic labels that are available inside each of the Motors Adjustment screens. Motor Name of the label Present phase 0 - 15 Stored phase 0 - 15 All Motor status Energized / Deenergized All Cover sensor On / Off All Home sensor On / Off Position sensor On / Off Steps Done xxxx All All Page 38 of 98 Range Meaning Shows the motor phase currently in use. Shows the motor phase stored at Home Position. Energized: Stepping motor windings powered (motor tensioned). De-energized: Stepping motor windings not powered (motor detensioned). Indicates status of the magnetic sensor that detects the Rotor Cover position. Indicates status of the optical sensor that detects the home position of the current motor. Indicates status of the optical sensor that detects the position of the current motor (e.g. 20 cuvettes position on the rotor holder). Number of steps performed when the motor is being operated in the service program. The steps increment (or decrement) from the Home Position (considered step 0) Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 7.6.1 Rotor motor This procedure is designed to verify and adjust (if required) the central phase of the Home Position of the motor. This is to match the motor phases with the optical sensor reading on the encoder disk. It’s also possible to use it to verify the functionality of the stepper motor and of the optical sensor. 1 2 Turn the Instrument On. Then access the Service program main menu. On the windows like menu enter Service then Motor Adjust and Rotor Motor. The system displays the screen below. 3 On the tool bar touch the small icon of the analysis compartment cover to raise the cover (the icon acts as a toggle switch to raise/lower the Rotor Cover). 4 Home the Rotor Motor by touching the Home Position button on the screen. The system moves to the Home Position the Rotor Motor. The Rotor Holder cuvette #20 is in front of the Coagulimetric Channel Optic Fibre. 5 Verify that the dynamic labels “HOME SENSOR” and “POSITION SENSOR” are both ON. 6 With the Step Increment set to 1, repeatedly press cw arrow (or ccw arrow) button on the screen. The status bars of both the home and position sensors show the actual condition of optical switch (+: light; -: dark). 7 Continue to press cw (or ccw) arrow until both the status changes from light to dark then reverse motion by touching the opposite key until the status of optical sensors becomes dark again after the light window. 8 It is now possible to determine the width of the optical window (notch on the encoder disk). 9 Pressing on the cw (or ccw) arrow keys move to the middle of the window (- - - - + + + + + - - - -). 10 Check that the present phase matches the stored phase on the dynamic labels. If phases are equal then the Rotor Motor is centered on the encoder and the test is over. Press “√” to exit. Chapter 7 – Checkout & Adjustment Page 39 of 98 ACL Elite/ElitePro Service Manual 11 Or, press “STORE PHASE” if active. Unavailability of the “STORE PHASE” key indicates an illegal condition of the Rotor Motor phase exist. Touch the cw (or ccw) arrow key to restore a legal motor phase condition. 12 Visually inspect the Rotor Holder and confirm that the middle of the cuvette position #20 is in front of the coagulation optic fibre. 13 If yes and if the present and stored phase are still in disagreement, touch “STORE PHASE”. 14 Press “√” to return to the Service main menu. 7.6.2 Rotor Holder Cover Motor This procedure is designed to verify and adjust (if necessary), the alignment of the Rotor Cover Encoder Disk and the Optical Sensor. It is also possible to use it to verify the functionality of the stepper motor and the optical sensor. The encoder disk identifies three rotor cover positions which are closed, intermediate and home (fully open). 1 2 Turn the Instrument On. Then access the Service program main menu. If the Rotor Cover Movement Assy was replaced or in any case removed and then assembled, verify that when the Cover is closed the Encoder is in the position indicated in the following drawing (the top edge of the encoder disk should be approximately 1mm above the top edge of the dual channel optical sensor). If the Encoder is not in the correct position then adjust it by loosening the two setscrews that fix the Encoder to the motor shaft and adjust the encoder up or down as necessary. Tighten the encoder set screws after adjustment. Note: On a properly adjusted encoder the upper side of the encoder has to be about 1 mm above the upper side of the Dual Channel Optical Switch Sensor when the Rotor Holder Cover is in the closed position. If available use the Rotor Cover Encoder Centering Tool P/N 190575-00. Encoder Disk Top edge of encoder disk is approximately 1mm above top of optical sensor Encoder Disk Closed position Intermediate position Fully open position Dual Channel Optical Sensor Page 40 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 3 On the windows like menu enter Service then Motor Adjust and Rotor Holder Cover. The system displays the LCD screen below. 4 The Rotor Holder Cover sets to its intermediate position (automatic loading position). 5 Touch the ”HOME POSITION” key, and the Cover Motor opens the cover until the –36 Step (ACL Elite) or –51 Step (ACL ElitePro) is reached. Cover is fully open. 6 The Home and the Position Sensors are ON. 7 Touch the ”STEP UP ARROW” key and verify that the Home and the Position Sensors go to OFF (indicated by minus (--) signs on the relevant status bar) at least 2 to a maximum of 5 steps before the cover hits the mechanical stop. | = Rotor cover has reached mechanical stop Home |--+++++ Position | - + + + + + + Pass Home | - - - - - + + + Pass Position | - - - - + + + + Home | - + + + + + + Fail (encoder requires adjustment) Position | + + + + + + + Home | - - - - - - - ++ Fail (encoder requires adjustment) Position | - - - - - - + + + Note: If there are too many minus signs (greater than 5) loosen the setscrews and rotate the encoder downward. If there are too few minus signs (less than 2) loosen the setscrews and rotate the encoder upward. Repeat steps 3 thru 7 above. 8 Touch the ”HOME POSITION” key and then the “NEXT CW POSITION” key. Step count should be 0. Chapter 7 – Checkout & Adjustment Page 41 of 98 ACL Elite/ElitePro Service Manual 9 10 11 12 13 Press “NEXT CW POSITION” key. The cover should close to form a hermetic seal against the fluidic plate. Touch the “STEP UP” or “STEP DOWN” key as necessary to insure a hermetic seal of the cover and fluidic plate. Once closed verify that the position sensor is ON (+ on the relevant status bar). It is not necessary to set in the middle of the optical window. Touch the “STORE STEP” key, the system will update the value. Touch once the “NEXT CCW POSITION” to raise the cover back to the intermediate position. Once the intermediate position is reached verify that the dynamic label “STEP DONE” sets to a value of 0. The dynamic labels of cover, home and position sensor should be set as specified (see table below). Cover Position Fully Open Intermediate Closed Cover Sensor Status OFF OFF ON Home Sensor Status ON ON OFF Position Sensor Status ON OFF ON Step Done ACL Elite -36 0 Stored Steps Step Done ACL ElitePro -51 0 Stored Steps 14 Touch any time the “NEXT CCW POSITION” and the “NEXT CW POSITION” until confidant that the adjustment is acceptable. 15 Touch “√” to return at the Service main menu screen. 7.6.3 Sample Arm horizontal motor This procedure is designed to verify and adjust (if required) the central phase of the Home Position of the motor. This is to match the motor phases with the optical sensor reading on the encoder disk. It’s also possible use it to verify the functionality of the stepper motor and of the optical sensor. 1 2 Turn the Instrument On. Then access the Service program main menu. On the windows like menu enter Service then Motor Adjust then Sample Arm Motors and Horiz. Sample Arm Motor. The system displays the screen below. Page 42 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 3 4 Manually Raise the Sample Arm to the rotation height. Touch the Home Position button on the screen. The system moves the Sample Arm Horizontal Motor to place the Sample Arm over the Autosampler housing (position A1 on the Sample Tray). 5 Verify that both the “HOME SENSOR” and “POSITION SENSOR” are ON. 6 With the step increment set to 1, repeatedly press cw arrow (or ccw arrow) button on the screen. The status bars of both the home and position sensors show the condition of optical switch (+: light; -: dark). 7 Continue to press cw (or ccw) arrow until status changes from light to dark, then reverse motion by touching the opposite key until the status of optical sensors becomes dark again after the light window. 8 It is now possible to determine the width of the optical window (notch on the encoder disk). 9 Press the arrow keys cw (or ccw) to set the position in the middle of the window (- - - - + + + + + - - - -). 10 Check that the present phase matches the stored phase on the dynamic labels. If phases are equal then the Sample Arm Horizontal Motor is centred on the encoder and the test is over. Press “√” to exit. 11 If not press “STORE PHASE” if active. Unavailability of the “STORE PHASE” key indicates an illegal condition of the current motor phase exist. Touch cw (or ccw) arrow key to restore legal motor phase condition, then touch “STORE PHASE”. 12 Press “√” to return to the Service main menu. 7.6.4 Sample Arm vertical motor This procedure is designed to verify and adjust (if required) the central phase of the Home Position of the motor. This is to match the motor phases with the optical sensor reading on the encoder disk. It’s also possible use it to verify the functionality of the stepper motor and of the optical sensor. 1 Turn the Instrument On. Then access the Service program main menu. Chapter 7 – Checkout & Adjustment Page 43 of 98 ACL Elite/ElitePro Service Manual 2 On the windows like menu enter Service then Motor Adjust then Sample Arm Motors and Vert. Sample Arm Motor. The system displays the screen below. 3 4 Manually move the Sample Arm over the waste/wash position. Touch the Home Position button on the screen. The system moves the Sample Arm Vertical Motor to the rotation position height. Verify that the dynamic labels “HOME SENSOR” and “POSITION SENSOR” are both in ON condition. Touch the “NEXT DOWN POSITION” to lower the Sample Arm to the Reagent picking / (Sample/Reagent) delivery position. Verify that the dynamic labels “HOME SENSOR” and “POSITION SENSOR” are respectively in OFF and ON conditions. Touch once the “NEXT DOWN POSITION” to lower the Sample Arm to the Sample picking position. Verify that the dynamic labels “HOME SENSOR” and “POSITION SENSOR” are respectively in ON and OFF condition. Press “√” to return to the Service main menu. 5 6 7 8 9 10 Note: The Sample Arm Vertical Motor doesn’t require phases to be stored. Page 44 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 7.6.4.1 Vertical Sample Arm Step Position Adjustment Procedure Sample Tray Area 1. 2. 3. 4. 5. Select Service/Motor Adjust/Sample Arm/Vert. Arm Motor. Press “Home Position” key. Select Service/Motor Adjust/Sample Arm/Horiz. Arm Motor. Press “Home Position” key and then insert 4ml bottle and adapter in A1. If the instrument is an ACL ElitePro Press “ Next CCW Position” key until the arm is over A1. Press “√” then, NO to de-energize motor prompt, to exit. 6. Select Service/Motor Adjust/Sample Arm/Vert. Arm Motor. 7. Select “Sample Tray” from menu under “Horizontal Arm Logical Area” on screen. 8. Press “Home Position” key. Then press “Next Down Position” key twice. 9. Increment the sample arm downwards by pressing the “down arrow” icon until the needle hits the bottom of the glass bottle or the “Step Done” box displays a value not greater than 991 steps. 10. Press “up arrow” icon 5 to 7 times to raise the probe away from the glass bottom or to obtain a “Step Done” value of 991 or less. 11. Press “Store Position” key. Note: The maximum “Step Done” value that can be stored is 991. If a value greater than 991 is attempted to be stored the error message “Invalid Input” is displayed. Press “√” then YES to exit. Reagent Area R1-R4 1. 2. 3. 4. 5. Select Service/Motor Adjust/Sample Arm/Vert. Arm Motor. Press “Home Position” key. Insert 4ml bottle and adapter in positions R1 and R4. Select Service/Motor Adjust/Sample Arm/Horiz. Arm Motor. Press “Home Position” key Chapter 7 – Checkout & Adjustment Page 45 of 98 ACL Elite/ElitePro Service Manual 6. Press “ Next CCW Position” key until the arm is over R1 position. Press “√” then NO to exit. 7. Select Service/Motor Adjust/Sample Arm/Vert. Arm Motor. 8. Select “R1-R4” from the menu under “Horizontal Arm Logical Area” on the screen. 9. Press “Home Position” key. Then “Next Down Position” key once. 10. Increment downwards by pressing the “down arrow” icon until the needle hits the bottom of the glass bottle, or the +++ signs change to - - - signs on the position sensor display line. 11. If the probe hits the glass bottle bottom press the “up arrow “ icon to raise the probe 5 to 7 steps. If the +++ signs changed to - - - signs on the position sensor display line, press the “up arrow” icon to display at least 3 +++ signs on the position sensor display line. 12. Make a note of the value displayed in the “Step Done” box. 13. Press “√” then YES to exit. 14. Select Service/Motor Adjust/Sample Arm/Vert. Arm Motor 15. Press “Home Position” key 16. Select Service/Motor Adjust/Sample Arm/Horiz. Arm Motor. 17. Press “Home Position” key 18. Press “ Next CCW Position” key until the arm is over R4 position. Press “√” then NO to exit. 19. Select Service/Motor Adjust/Sample Arm/Vert. Arm Motor. 20. Select “R1-R4” from the menu under “Horizontal Arm Logical Area” on the screen. 21. Press “Home Position” key. Then “Next Down Position” key once. 22. Increment downwards by pressing the “down arrow” icon until the needle hits the bottom of the glass bottle, or the +++ signs change to - - - signs on the position sensor display line. 23. If the probe hits the glass bottle bottom press the “up arrow “ icon to raise the probe 5 to 7 steps. If the +++ signs changed to - - - signs on the position sensor display line, press the “up arrow” icon to display at least 3 +++ signs on the position sensor display line. 24. Observe the value indicated in the “Step Done” box. If the value is the same as the value noted for the R1 position press the “Store Position” button on the screen. If the value in the “Step Done” box is larger for the R4 position than the R1 position press the “up arrow” icon until the R4 value equals the R1 value and press the “Store Position” button on the screen. If the value in the “Step Done” box is lower for R4 position than the value for the R1 position press the “Store Position” button on the screen. Note: If plus signs are not present in the “position sensor” row when attempting to store position, continue to press “up arrow” key until at least 3 plus signs appear then store position. Press “√” then YES to exit. Page 46 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual Reagent Area R5-R8 1. 2. 3. 4. 5. 6. Select Service/Motor Adjust/Sample Arm/Vert. Arm Motor. Press “Home Position” key. Insert 4ml bottle and adapter in positions R5 and R8. Select Service/Motor Adjust/Sample Arm/Horiz. Arm Motor. Press “Home Position” key Press “ Next CCW Position” key until the arm is over R5 position. Press “√” then NO to exit. 7. Select Service/Motor Adjust/Sample Arm/Vert. Arm Motor. 8. Select “R5-R8” from the menu under “Horizontal Arm Logical Area” on the screen. 9. Press “Home Position” key. Then “Next Down Position” key once. 10. Increment downwards by pressing the “down arrow” icon until the needle hits the bottom of the glass bottle, or the +++ signs change to - - - signs on the position sensor display line. 11. If the probe hits the glass bottle bottom press the “up arrow “ icon to raise the probe 5 to 7 steps. If the +++ signs changed to - - - signs on the position sensor display line, press the “up arrow” icon to display at least 3 +++ signs on the position sensor display line. 12. Make a note of the value displayed in the “Step Done” box. 13. Press “√” then YES to exit. 14. Select Service/Motor Adjust/Sample Arm/Vert. Arm Motor 15. Press “Home Position” key 16. Select Service/Motor Adjust/Sample Arm/Horiz. Arm Motor. 17. Press “Home Position” key 18. Press “ Next CCW Position” key until the arm is over R8 position. Press “√” then NO to exit. 19. Select Service/Motor Adjust/Sample Arm/Vert. Arm Motor. 20. Select “R5-R8” from the menu under “Horizontal Arm Logical Area” on the screen. 21. Press “Home Position” key. Then “Next Down Position” key once. 22. Increment downwards by pressing the “down arrow” icon until the needle hits the bottom of the glass bottle, or the +++ signs change to - - - signs on the position sensor display line. 23. If the probe hits the glass bottle bottom press the “up arrow “ icon to raise the probe 5 to 7 steps. If the +++ signs changed to - - - signs on the position sensor display line, press the “up arrow” icon to display at least 3 +++ signs on the position sensor display line. 24. Observe the value indicated in the “Step Done” box. If the value is the same as the value noted for the R5 position press the “Store Position” button on the screen. If the value in the “Step Done” box is larger for the R8 position than the R5 position press the “up arrow” icon until the R8 value equals the R5 value and press the “Store Position” button on the screen. If the value in the “Step Done” box is lower for R8 position than the value for the R5 position press the “Store Position” button on the screen. Chapter 7 – Checkout & Adjustment Page 47 of 98 ACL Elite/ElitePro Service Manual Note: If plus signs are not present in the “position sensor” row when attempting to store position, continue to press “up arrow” key until at least 3 plus signs appear then store position. Press “√” then YES to exit. Reagent Area R9-R12 (ACL ElitePro only) 1. 2. 1. 2. 3. 4. Select Service/Motor Adjust/Sample Arm/Vert. Arm Motor. Press “Home Position” key. Insert 4ml bottle and adapter in positions R9 and R12. Select Service/Motor Adjust/Sample Arm/Horiz. Arm Motor. Press “Home Position” key Press “ Next CCW Position” key until the arm is over R9 position. Press “√” then NO to exit. 5. Select Service/Motor Adjust/Sample Arm/Vert. Arm Motor. 6. Select “R9-R12” from the menu under “Horizontal Arm Logical Area” on the screen. 7. Press “Home Position” key. Then “Next Down Position” key once. 8. Increment downwards by pressing the “down arrow” icon until the needle hits the bottom of the glass bottle, or the +++ signs change to - - - signs on the position sensor display line. 9. If the probe hits the glass bottle bottom press the “up arrow “ icon to raise the probe 5 to 7 steps. If the +++ signs changed to - - - signs on the position sensor display line, press the “up arrow” icon to display at least 3 +++ signs on the position sensor display line. 10. Make a note of the value displayed in the “Step Done” box. 11. Press “√” then YES to exit. 12. Select Service/Motor Adjust/Sample Arm/Vert. Arm Motor 13. Press “Home Position” key 14. Select Service/Motor Adjust/Sample Arm/Horiz. Arm Motor. 15. Press “Home Position” key 16. Press “ Next CCW Position” key until the arm is over R8 position. Press “√” then NO to exit. 17. Select Service/Motor Adjust/Sample Arm/Vert. Arm Motor. 18. Select “R9-R12” from the menu under “Horizontal Arm Logical Area” on the screen. 19. Press “Home Position” key. Then “Next Down Position” key once. 20. Increment downwards by pressing the “down arrow” icon until the needle hits the bottom of the glass bottle, or the +++ signs change to - - - signs on the position sensor display line. 21. If the probe hits the glass bottle bottom press the “up arrow “ icon to raise the probe 5 to 7 steps. If the +++ signs changed to - - - signs on the position sensor display line, press the “up arrow” icon to display at least 3 +++ signs on the position sensor display line. 22. Observe the value indicated in the “Step Done” box. If the value is the same as the value noted for the R9 position press the “Store Position” button on the screen. If the value in the “Step Done” box is larger for the Page 48 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual R12 position than the R9 position press the “up arrow” icon until the R12 value equals the R9 value and press the “Store Position” button on the screen. If the value in the “Step Done” box is lower for R12 position than the value for the R9 position press the “Store Position” button on the screen. Note: If plus signs are not present in the “position sensor” row when attempting to store position, continue to press “up arrow” key until at least 3 plus signs appear then store position. Press “√” then YES to exit. 7.6.5 Autosampler motor This procedure is designed to verify and adjust (if required) the central phase of the Home Position of the motor. This is to match the motor phases with the optical sensor reading on the encoder disk. It’s also possible to use it to verify the functionality of the stepper motor and of the optical sensor. 1 2 Turn the Instrument On. Then access the Service program main menu. On the windows like menu enter Service then Motor Adjust then Autosampler Motor. The system displays the screen below. 3 Touch the Home Position button on the screen. The system moves the Autosampler motor until the Home Position is achieved. Verify that the dynamic labels “HOME SENSOR” and “POSITION SENSOR” are both in ON condition. 4 Chapter 7 – Checkout & Adjustment Page 49 of 98 ACL Elite/ElitePro Service Manual 5 With the step increment set to 1, repeatedly press cw (or ccw) arrow button on the screen. The status bars of both the home and position sensors show the actual condition of optical switch (+: light; -: dark). 6 Continue to press cw (or ccw) until status changes from light to dark, then reverse motion by touching the opposite key until the status of the optical sensors becomes dark again after the light window. 7 It is now possible to determine the width of the optical window (notch on the encoder disk). 8 Press the arrow keys cw (or ccw) to set the middle of the optical window (- - - - + + + + + - - - -). 9 Check that the present phase matches the stored phase on the dynamic labels. If phases are equal then the Autosampler Motor is centered on the encoder and the test is over. Press “√” to exit. 10 If not press “STORE PHASE” if active. Unavailability of the “STORE PHASE” key indicates an illegal condition of the current motor phase exist. Touch once cw (or ccw) arrow key to restore legal motor phase condition and then touch “STORE PHASE”. 11 Press “√” to return to the Service main menu. NOTE: Check the Autosampler Movement Assembly “Backlash” (lag between the belt, pulley and motor). Check the backlash as follows. From the windows like menu, enter Service, then select Motors Adjust, Autosampler. Touch the Home button on the screen to Home the Autosampler. Press the cw or ccw arrow buttons until the “Home Position” sensor status changes from “+” light, to “-“ dark. While observing the status of the Home Sensor press the oppsite direction arrow and continue pressing the arrow until the Home Sensor status changes from “-“ dark to “+” light. There should be 5 or less minus signs “-“ prior to the status changing for the Home Sensor. If there is greater than 5 minus signs the autosampler has excessive play between the belt, pulley and motor and the autosampler should be replaced. - - - - + + + + acceptable backlash - - - - - - + + + + Unacceptable backlash 7.6.6 Sample / Reagent Dilutor motor This procedure is designed to verify and adjust (if required) the central phase of the Home Position of the motor. This is to match the motor phases with the optical sensor reading on the encoder disk. It’s also possible use it to verify the functionality of the stepper motor and of the optical sensor. 1 2 Turn the Instriment On. Then access the Service program main menu. On the windows like menu enter Service then Motor Adjust then Dilutor Motors and Sample / Reagent Dilutor Motor. The system displays the screen below. Page 50 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 3 Touch the Home Position button on the screen. The system moves the Sample/Reagent Dilutor Motor fully upward. 4 Verify that the dynamic labels that the “HOME SENSOR” is in ON condition. 5 Touch the “NEXT DOWN POSITION” to lower the Sample/Reagent Dilutor Motor to the full down position. 6 Verify that the dynamic labels that the “HOME SENSOR” is in OFF condition. 7 Press “√” to return to the Service main menu. Note: The Sample/Reagent Dilutor Motors don’t require phases to be stored. 7.6.7 Transport (Slider) motor (ACL ElitePro only) This procedure is designed to verify and adjust (if required) the central phase of the Home Position of the motor. This is to match the motor phases with the optical sensor reading on the encoder disk. It’s also possible to use it to verify the functionality of the stepper motor and of the optical sensor. 1 2 Turn the Instrument On. Then access the Service program main menu. On the windows like menu enter Service then Motor Adjust and Slider Motor. The system displays the screen below. Chapter 7 – Checkout & Adjustment Page 51 of 98 ACL Elite/ElitePro Service Manual 3 Touch the Home Position button on the screen. The system moves the Rotor Transport (slider) under the Rotor Stack. 4 Verify that the dynamic labels “HOME SENSOR” and “POSITION SENSOR” are both in the ON condition. 5 Touch the “NEXT CCW POSITION” to move the Rotor Transport (slider) to the left (rotor picking position). 6 Verify that the dynamic labels “HOME SENSOR” and “POSITION SENSOR” are respectively in OFF and ON condition. 7 Press “√” to return to the Service main menu. Note: The Transport (Slider) Motor doesn’t require phases to be stored. 7.6.8 Rotor Arm Horizontal Motor (ACL ElitePro only) This procedure is designed to verify and adjust (if required) the central phase of the Home Position of the motor. This is to match the motor phases with the optical sensor reading on the encoder disk. It’s also possible use it to verify the functionality of the stepper motor and of the optical sensor. 1 2 Turn the Instrument On. Then access the Service program main menu. On the windows like menu enter Service then Motor Adjust then Rotor Arm Motors and Horiz. Rotor Arm Motor. The system displays the screen below. Page 52 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 3 4 5 6 7 8 9 10 11 12 13 Manually raise the Rotor Arm to the rotation height. Touch on the tool bar the small icon of the analysis compartment cover to raise the cover (the icon acts as toggles switch to raise/lower the cover). Touch the Home Position button on the screen. System moves the Rotor Arm Horizontal Motor over the rotor picking/waste position. Verify that the dynamic labels “HOME SENSOR” and “POSITION SENSOR” are both in ON condition. With the step increment set to 1, repeatedly press cw (or ccw) arrow button on the screen. The status bars of both the home and position sensors show the actual condition of optical switch (+: light; -: dark). Continue to press cw (or ccw) arrow until status changes from light to dark (use for reference only the home sensor windows), then reverse motion by touching the opposite key until the status of the optical sensor becomes dark again after the light window. It is now possible to determine the width of the home sensor optical window (notch on the encoder disk). Press the arrow keys cw (or ccw) to set the middle of the optical window (- - - - + + + + + - - - -). Check that the present phase matches the stored phase on the dynamic labels. If phases are equal then the Rotor Arm Horizontal Motor is centred on the encoder and the test is over. Press “√” to exit. If not press “STORE PHASE” if active. Unavailability of the “STORE PHASE” key indicates an illegal condition of the current motor phase exist. Touch the cw (or ccw) arrow key to restore legal motor phase condition and then touch “STORE PHASE”. Press “√” to return to the Service main menu. Chapter 7 – Checkout & Adjustment Page 53 of 98 ACL Elite/ElitePro Service Manual 7.6.9 Rotor Arm vertical motor (ACL ElitePro only) This procedure is designed to verify and adjust (if required) the central phase of the Home Position of the motor. This is to match the motor phases with the optical sensor reading on the encoder disk. It’s also possible use it to verify the functionality of the stepper motor and of the optical sensor. 1 Turn the Instument On. Then access the Service program main menu. 2 On the windows like menu enter Service then Motor Adjust then Rotor Arm Motors and Vert. Rotor Arm Motor. The system displays the screen below. Horizontal Arm Logical Area Waste Position T Current Value 0 3 Touch the Home Position button on the screen. The system raises the Rotor Arm to the rotation height. 4 Verify that the dynamic labels “HOME SENSOR” and “POSITION SENSOR” are respectively in OFF and ON condition. 5 Touch the “NEXT DOWN POSITION” to lower the rotor arm to the bottom position. 6 Verify that the dynamic labels “HOME SENSOR” and “POSITION SENSOR” are both in ON condition. 7 Press “√” to return to the Service main menu. Note: The Rotor Arm Vertical Motor doesn’t require phases to be stored. 7.7 Module positioning This service program sub-menu includes the utilities designed to allow matching of the major system modules. Following are the relevant assemblies. • • • • • Autosampler assy. Sample Arm assy. Rotor Holder assy. Rotor Arm assy. Rotor Transport assy. Page 54 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual The Module Positioning Tests options are available under the service programs main menu. On the windows like menu, the sequence Service - Module Positioning Test gives access to the following operational tests: • • • • ST – SA – RH Test RA – SL Test RA – RH Test RA – SL – RH Test To perform a complete alignment of all the modules in the instrument the following sequence must be followed. Note that the Sample Arm is the “Reference Point”. The sample arm drive assy vertical shaft must be centered in the fluidic plate opening and the arm must be aligned to the rinse/waste reservoir prior to performing any other alignments. All other alignments are referenced to the Sample Arm. Also, verify that all motor phase settings are correct prior to performing module alignments. The module alignment sequence is: Sample Arm Autosampler Rotor Module REM NOTE: Sample Arm vertical shaft must be centered in the fluidic plate prior to performing any further alignments. Use alignment tool to center shaft to fluidic plate. All above modules have to properly match to each other to insure proper picking and delivery of samples and reagents as well as rotors for the analysis. Should any module loose its pre-set position (e.g. due to the fact it was dismantled and re-fitted for service purposes) it must be re-adjusted. The following table provides a summary of tests to be done based upon the module that was replaced/adjusted, to restore the proper working conditions. Module replaced Sample Arm assy Autosampler Assy Rotor Holder assy Needles Block Assy Rotor Stack Assy Rotor Arm assy R.E.M. (Rotor Exchange Module) centring Rotor Tilt Adjust. R.E.M. Self Test Mechanical reference to point/assembly Needles Wash/Waste Pot Sample Arm Sample Arm Rotor Holder Adjustment / Verification Test Refer to section ST – SA – RH Test 7.7.1 ST – SA – RH Test ST – SA – RH Test Needles Position 7.7.2 7.7.3 7.7.4 Rotor Transport RA – SL – RH Test Rotor Transport RA – SL Test Rotor Holder Snap RA – RH Test 7.7.5 7.7.6 7.7.7 Fluidic Plate 7.7.8 7.7.9 RA – RH Test RA – SL – RH Test Chapter 7 – Checkout & Adjustment Page 55 of 98 ACL Elite/ElitePro Service Manual 7.7.1 Sample Arm assy The Sample Arm must be aligned with respect to the needles Wash/Waste Pot and represents the mechanical reference to the other major assemblies. It is recommended to verify the proper positioning of the Sample Arm prior to starting any position adjustment on other modules. In case the Sample Arm module was adjusted/replaced the following procedure needs to be completely carried out, in other situations follow it only for verification. Materials / tools necessary for the test: 1 2 3 4 5 6 7 8 9 - Needles Waste Centring Tool P/N 190515-00 - Sample Arm centring tool P/N 190513-00 - Needles Position Tool P/N 181039-41 Position the Sample Arm module in place from the bottom of the system and secure it by using the 3 black column screws but without tightening completely. Re-connect cables as required. Insert the Sample Arm Centering Tool (P/N 190513-00) on the shaft of the Sample Arm Movement assy, between the shaft and the Fluidic Plate hole. Tighten the 3 black column screws making sure that the Sample Arm Movement shaft is in the middle of the Fluidic Plate hole. Remove the Sample Arm Centering Tool (P/N 190513-00). Carefully tilt up the Instrument by holding the keyboard drawer guides and fold back the two stands and then lower the instrument on the bench. Replace the needles Wash/Waste Pot adapter with the Needles Waste Centring Tool (P/N 190515-00). Turn On the Instrument then access at the Service program main menu. On the windows like menu enter Service then Module Positioning test and (ST – SA – RH Test). Upon entry the system performs motors initialization and displays the screen below. Page 56 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 10 Put the Sample Arm on the Sample Arm Movement shaft (at the bottom) using caution not to lose the current shaft position. 11 Manually move the Sample Arm (with the needle block assembled) over the needles Waste/Rinse Reservoir. 12 Lower the Sample Arm Movement shaft to allow the Needles Block to enter the Waste Centering tool. 13 Adjust the Sample Arm (rotational and horizontal adjustment) to match the 2 needles with the 2 reference points on the Waste Centering tool. Note: Use the 2 screws located on the top of the aluminium support to set the depth of the Needles Block assy (if required). 14 Tighten the 3 setscrews located at 120° on the aluminium support that holds the Sample Arm in place. Tighten the 2 allen head screws that secure the horizontal movement of the arm. 15 Place the Needles Position Centring Tool (P/N 181039-41) on the Rotor Holder. 16 Raise the Sample Arm Movement assy. Touch the key “NEXT POSITION”, the Sample Arm moves over the Rotor Holder and lowers to dispensing position. 17 Adjust the Needles Block height by setting the needles tip on the 2 white points of the Needles Centring tool surface. Note: Loosen and secure the Needles Block by using the white knob located on the rear of the Sample Arm. If during this check out it is necessary to move the Rotor Holder module position then perform the R.E.M. module positioning as described in the section 7.7.7. 18 Remove the Wash Centering tool from the Wash/Waste Pot and install the Waste/Rinse Reservoir. 19 Raise the Sample Arm Movement assy. Touch the key “NEXT POSITION”, the Sample Arm moves over the Autosampler to position #1of the Sample Tray. 20 Remove the Needles Position Tool P/N 181039-41 from the Rotor Holder. 21 Touching the key “NEXT POSITION” the Sample Arm raises, moves over the Rinse Waste Pot and lowers on the Rinse Waste Reservoir. 22 Visually inspect that needless are centered with respect to the Rinse Waste Reservoir. 23 Touch the icon “STOP” and then “Ok” to return at the Service main menu. Note: Before resume normal operation it is advisable to perform a Needle Sensor Test as detailed in section 7.4.1. 7.7.2 Autosampler assy The Autosampler must be aligned with respect to the Sample Arm. It is recommended to verify the proper positioning of the Sample Arm prior to starting any position adjustment on other modules. If the Autosampler module was repaired/replaced the following procedure needs to be completely carried out, in other situations follow it only for verification. Chapter 7 – Checkout & Adjustment Page 57 of 98 ACL Elite/ElitePro Service Manual Materials / tools necessary for the test: 1 2 3 4 5 6 7 8 - 0.5 mL disposable sample cups or primary tubes Position the Autosampler assy in place from the bottom of the system. Secure it by using the 4 black column screws but without tightening completely. Re-connect cables as required. Tighten the 4 black column screws making sure that the Autosampler shaft is in the middle of the fluidic plate hole. Install the inner ring optical sensor and lock it in place. Carefully tilt up the Instrument by holding the keyboard drawer guides folding back the two stands and then lower the instrument on the bench. Put the grey Flange Adjustable in place on the top of the Autosampler movement. Secure it by the 2 screws but not completely tightened (it shall still be possible to turn it by hand). Turn On the Instrument then access the Service program main menu. On the windows like menu enter Service then Module positioning test and (ST – SA – RH Test). Upon entry the system performs modules initialization and displays the screen below. 9 Touch the key “NEXT POSITION”, the Sample Arm moves over to the Rotor Holder and lower to dispensing position. 10 Load a Sample Tray with a 0.5 mL cup in the position #1. Put it on the Flange Adjustable. 11 Touch the key “NEXT POSITION” again, the Sample Arm raises, moves over to the Autosampler housing and lowers on the position #1 of the Sample Tray. 12 Visually inspect that Sample Needle is centered in the cup. If off-center gently turn the Sample Tray to achieve best fit. Note: May be necessary to adjust the Autosampler assy if the Sample Needle is not in the middle of the cup. In this case, to adjust the Autosampler Movement position loosen the 4 black column screws, move the Autosampler to achieve best fit and then tighten the 4 black column screws again. Visually inspect that (with the Sample Tray inside) the distance between the Sample Tray and the external wall of the Autosampler housing circumference is at least 2mm. Page 58 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual It’s also advisable to test the middle and inner rings positions (#2 and A1) by using together the Motor Adjust options for the Autosampler and for the Sample Arm Horizontal Motor. During this test on #1, #2 and A1 it is not possible to align all 3 positions perfectly, so obtain a best fit alignment. The following positions may also be tested. Sample tray rotation 0° - 360° (Home) 90° 180° 270° Outer Ring Mid Ring Inner Ring 1 11 21 31 2 12 22 32 A1 None A6 None 13 Touch the toggle key “TO RAISE / LOWER ARM”, the Sample Arm moves up and down. Repeat the operation to verify proper centering. 14 With the Sample Arm fully raised and paying attention that you are not moving the Flange Adjustable from current position, remove the Sample Tray and tighten the two fixing screws. 15 Refit the Sample Tray with the cup in position #1 and verify that the Sample Needle is centered. 16 Once proper matching is achieved touch the icon “STOP” and then “OK” to return at the Service main menu. 7.7.3 Rotor holder assy The Rotor Holder must be aligned with respect to the Sample Arm. It is recommended to verify the proper positioning of the Sample Arm prior starting any position adjustment on other modules. If the Rotor Holder module was repaired/replaced the following procedure needs to be completely carried out, in other situations follow it only for verification. Materials / tools necessary for the test: 1 2 3 4 5 - Needles Position Tool P/N 181039-41 - Disposable rotor Put the Rotor Holder assy in place from the bottom of the system. Secure it by using the 3 black column screws but without tightening completely. Re-connect cables and optic fibres as required. Carefully tilt up the Instrument by holding the keyboard drawer guides and folding back the two stands then lower the instrument on the bench. Turn On the Instrument then access at the Service program main menu. On the windows like menu enter Service then Module Positioning test and (ST – SA – RH Test). Upon entry the system performs the modules initialization and displays the screen below. Chapter 7 – Checkout & Adjustment Page 59 of 98 ACL Elite/ElitePro Service Manual 6 7 Place the Needles Position Tool (P/N 181039-41) on the Rotor Holder. Touch the key “NEXT POSITION”, the Sample Arm raise, moves over the Rotor Holder and lower to dispensing position. 8 Adjust the Rotor Holder position to achieve best fit between the needles tip and the 2 white points on the Needles Centering tool surface then tighten the 3 black column screws. 9 Touch the toggle key “TO RAISE / LOWER ARM”, the Sample Arm will move up and down. Repeat this operation to insure proper centering. 10 Once proper matching is achieved Touch the icon “STOP” and then “OK” to return at the Service main menu. Note: Once Rotor Holder has been centered with respect to the Sample Arm then perform verification against the R.E.M. (see section 7.7.7. for the details). Before normal operation is resumed it is advisable to perform a Needle Sensor Test as detailed in the sub-section 7.4.1 and a Needles Position test available in the Diagnostic menu using a plastic rotor. 7.7.4 Needles Block Assy This test has the purpose to Adjust/Verify the Needles Block Position every time that is needed (Replacement, Maintenance, accidental hit or for service action). Materials / tools necessary: - Needles Position Tool P/N 181039-41 - Brand new rotor. WARNING ! BIOLOGICAL HAZARDS EXIST. Avoid touching, with bare hands, any parts of the system which may have come in contact with potentially infectious fluids. ALWAYS wear gloves when performing any type of Maintenance/Service action on this area. Page 60 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 1 2 3 4 Turn the Instrument On. Then access the Analytical Main Program. On the tool bar touch the small icon of the Analysis Compartment Cover to raise the cover (the icon acts as a toggle switch to raise/lower the Rotor Cover). On the windows like menu enter Diagnostic then Needles Position. The system initializes the Sample Arm, the Rotor Holder and displays the screen below. Pushing the Rotor Holder Snap Button, properly insert the Needles Centering Tool with the side “A” facing up. Reference Dots A 5 6 7 8 Press Raise/Lower Arm. The Sample Arm is lowered over the Rotor Holder. Using the knob located on the rear of the Sample Arm adjust the height of the Needles Block so that the needle tips come in contact with the upper surface of the Needles Position Tool. During this operation pay attention to put them in a vertical position. Secure the Needles Block by tightening the relevant knob without losing the current position. Make sure that the needle tips match with the 2 reference dots of the tool. If the needle tips don’t match then verify the Sample Arm and the Rotor Holder positioning as described in the section 7.7. Chapter 7 – Checkout & Adjustment Page 61 of 98 ACL Elite/ElitePro Service Manual 9 10 11 12 13 14 Once the Needles Block adjustment with the tool is achieved, press the Raise/Lower Arm button. The arm is raised. Remove the Needles Centering Tool. Pushing the Rotor Holder Snap Button, properly insert a brand new plastic rotor. Press Raise/Lower Arm. The Sample Arm is lowered over the plastic rotor on the Rotor Holder. Visually inspect for the proper position of the needles in the center of the 2 holes of the cuvette. Press Raise/Lower Arm. The Sample Arm is raised. By touching the Rotate button (now active) the plastic rotor on the Rotor Holder is rotated 90°. Repeat steps 11 thru 13 to be sure that in the 4 test positions the Needles Block adjustment is acceptable. Note: The needles alignment may not be identical in the 4 rotor cuvettes. However insure that the needles enter the cuvette holes without touching the edges, etc. for each test position. A B C Sample probe centred or biased Left 15 When the needles adjustment is acceptable press the red “Stop” icon on the tool bar and confirm the operation with OK to end the test. Page 62 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 7.7.5 Rotor Stack assy (ACL ElitePro only) The Rotor Stack must be aligned with the Rotor Transport (slider). Both the Rotors Stack and the Rotor Transport (slider) are sub-assemblies of the R.E.M. (Rotor Exchange Module). The R.E.M. itself is aligned with the Rotor Holder assy. This procedure is designed to center the Rotor Stack (silos) to the Rotor Transport (slider). Materials / tools necessary for the test: - Disposable rotor 1. Turn On the Instrument then access the Service program main menu. 2. Fill the Rotor Stack with new rotors. 3. On the windows like menu enter Service then Module Positioning Test. Select RA-SL-RH test. 4. During the test visually inspect for the proper feeding of rotors from the Rotor Stack to the Rotor Transport (slider). Rotors should drop freely and align on the slider. 5. If the Rotor Transport (slider) is not aligned then loosen the 3 locking screws that secure the Rotor Stack (located below the R.E.M. support Plate). 6. Gently move the Rotor Stack assembly to obtain best alignment. Also, the slider “Home” sensor and/or flag may be adjusted left or right to set the stop position of the slider under the rotor stack. 7. Secure the Rotors Stacks in place by tightening the 3 locking screws again. 8. Verify the proper position of the Rotor Stack repeating the RA-SL-RH test until confident that adjustment is acceptable. Note: The Rotor Stack Cover Sensor needs to detect the presence of the magnet in the cover to perform the test correctly (use an external magnet). 7.7.6 Rotor Arm assy (ACL ElitePro only) The Rotor Arm assy must be aligned with respect to the Rotor Transport assy. Both the Rotor Arm assy and the Rotor Transport are sub-assemblies of the R.E.M. (Rotor Exchange Module). The R.E.M. must be aligned to the Rotor Holder assy. If the Rotor Arm was repaired/replaced the following procedure needs to be completely carried out, in other case follow it only for verification. Materials / tools necessary for the test: 1 2 3 - Rotor Arm Centring Tool P/N 190503-00 - Disposable rotor Turn On the Instrument and access the Service program main menu. On the windows like menu enter Service then Motor Adjust and Slider Motor. Touch in sequence “Home Position” then “Next CCW Position”. Touch “√” to return at Service main menu and touch “NO” on the dialog box “De-energize motor?” Put the Rotor Arm alignment bushing on Rotor Transport. Chapter 7 – Checkout & Adjustment Page 63 of 98 ACL Elite/ElitePro Service Manual 4 5 On the windows like menu perform the sequence Service – Motor Adjust – Rotor Arm Motors – Rotor Arm Horiz. Motor. Touch in sequence “Home Position”, then touch “√” to return to service main menu and “NO” on the dialog box “Deenergise motor?” On the windows like menu enter Service then Motor Adjust then Rotor Arm Motors and Rotor Arm Vert. Motor. The system displays the screen below. Horizontal Arm Logical Area Waste Position T 6 7 8 9 10 11 12 13 14 15 16 17 Current Value 0 Touch the key “Home Position”. Now both the Rotor Arm and the Transport motors are initialized. Install now the Rotor Arm on its shaft (do not tighten the 3 setscrews). Raise the analysis compartment cover by touching the relevant icon on the screen tool bar. Touch on the current value of the window “Chose Step Increment”. The value goes in reverse video. Press “Canc/Delete” on the main keyboard to delete the value. Key in 40 as new value. Press the cw arrow in the left bottom side of the screen. The Rotor Arm will lower by 40 steps. Repeat last operation as many times as necessary to lower the Rotor Arm to the Rotor Arm alignment bushing (in the meantime visually inspect for best fit, if necessary manually guide the Rotor Arm paying attention to don’t move the shaft from the previously set position). Once the Rotor Arm is lowered and matching achieved tighten the 2 screws on the Rotor Arm aluminium support. Gently tighten the 3 setscrews paying attention not to move the shaft from the previously set position. The adjustment is now complete, press “√” to return to service main menu. Touch “YES” on the dialog box “De-energize motor?” Remove the alignment bushing and place a new rotor on the Rotor Transport. On the windows like menu enter Service then Module Positioning Test and RA – SL – RH Test. The instrument exercises the Rotor Arm and Rotor Transport in sequence. Let the system operate for a suitable number of cycles and verify for proper matching, touch “Abort” once confident that adjustment is acceptable. Page 64 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 7.7.6.1 Rotor Arm Vertical Height Adjustment (ACL ElitePro only) 1. 2. 3. 4. 5. From service environment, press “cover open” icon. Select Service/Motor Adjust/Rotor Arm Motor/Horiz. Arm Motor. Press the “home position” key. Push the “next CW position” key. The pliers will move on top of the rotor holder. Remove tool p/n 190503-00 if necessary, from transport plate and place a rotor onto the plate. 6. Push the “next CCW position” key. The pliers will move over the transport plate. 7. Press “√” then NO to exit. 8. Select Service/Motor Adjust/Rotor Arm Motor/Vert. Arm Motor. Horizontal Arm Logical Area Waste Position T Current Value 0 9. Select “Waste Position” for horizontal arm logical area. 10. Press “Home Position”. 11. Open the pliers arms manually by pressing the pin inwards. 12. While holding the pliers open, press the “Next Down” position Key. 13. Release the pin and verify that the pliers arms do not lift the rotor from the plate (pliers are too low) or sit on the edge of the rotor (pliers are too high). Use the “up arrow” or “down arrow” buttons to make appropriate adjustment. Note: Over the Waste Position the arm may be adjusted +/- 27 steps. 14. Press “store position” , then YES. 15. Press “Home Position”. 16. Press “√” then NO to exit. 17. Select Service/Motor Adjust/Rotor Arm Motor/Horiz. Arm Motor. 18. Manually place rotor in the pliers arms. 19. Push the “next CCW position” key. 20. Press “√” then NO to exit. 21. Select Service/Motor Adjust/Rotor Arm Motor/Vert. Arm Motor. 22. Select “Rotor Position” for horizontal arm logical area. 23. Press “Home Position”. 24. Press “Next Down Position”. Check for alignment between the the pliers and the rotor holder. The rotor should drop perfectly over the snap assembly and onto the Chapter 7 – Checkout & Adjustment Page 65 of 98 ACL Elite/ElitePro Service Manual rotor holder. Switch between “next up position” and “next down position” buttons as needed. Note: To center the pliers onto the rotor, you may need to loosen the five set screws located on top of the REM assembly and move the REM assembly left or right, forwards or backwards to achieve perfect centering. 25. With a rotor seated on the rotor holder and the pliers in home position, open pliers manually by pushing solenoid pin in. 26. Press “next down position”. Verify that the pliers arms do not lift the rotor from the plate (pliers are too low) or sit on the edge of the rotor (pliers are too high). Use the “up arrow” or “down arrow” buttons to make appropriate adjustment. Note: Over the Rotor Position the arm may be adjusted +/- 7 steps. 27. Press “Store position” key, then YES. 28. Press “home position”. 29. Press “√” then NO to exit. 30. Select Service/Motor Adjust/Rotor Arm Motor/Horiz. Arm Motor. 31. Press “home position”. Verify that the pliers do not make contact with the fluidic plate during movement. If contact is made, make the necessary adjustments and verify the stored positions for the vertical motor. Press “√” then YES to exit. 7.7.7 R.E.M. (Rotor Exchange Module) centering (ACL ElitePro only) The Rotor Exchange Module is a major assembly that incorporates Rotor Stack, Rotor Transport and Rotor Arm assy. The R.E.M. must be aligned with respect to the Rotor Holder. This procedure is designed to center the R.E.M. to the Rotor Holder. Materials / tools necessary for the test: - Disposable rotor 1 2 Turn On the Instrument then access the Service program main menu. On the windows like menu enter Service then Motor Adjust then Rotor Arm Motors and Rotor Arm Vert. Motor. Touch “Home Position”, and then touch “√” to return to service main menu. Touch “NO” on the dialog box “De-energize motor?” 3 Raise the Rotor Cover by touching the relevant icon on the screen tool bar. 4 On the windows like menu enter Service then Motor Adjust then Rotor Motor. Touch “Home Position”, and then touch “√” to return to service main menu. Touch “NO” on the dialog box “De-energize motor?” 5 On the windows like menu enter Service then Motor Adjust then Rotor Arm Motors and Rotor Arm Horiz. Motor. Touch in sequence “Home Position”, “Next CCW Position”. Touch “√” to return to service main menu. Touch “NO” on the dialog box “De-energize motor?” 6 On the windows like menu enter Service then Motor Adjust then Rotor Arm Motors and Rotor Arm Vert. Motor. The system displays the screen below. Page 66 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual Horizontal Arm Logical Area Waste Position T 7 8 9 10 11 12 13 14 15 Current Value 0 Touch “Home Position” and then on the current value of the window “Chose Step Increment”. The value goes in reverse video. Press “Canc/Delete” on the main keyboard to delete the value. Key in 40 as new value. Press the cw arrow in the left bottom side of the screen. The Rotor Arm will lower by 40 steps. Repeat last operation as many times as necessary to lower the Rotor Arm down until it actuates the Rotor Holder Snap mechanism located in the center of the Rotor Holder. Visually inspect for best matching. Set “Step Incerment” back to 1. If off center loosen the 5 R.E.M. locking screws located over the Fluidic Plate, gently move the whole R.E.M. assembly to obtain the best matching then secure the R.E.M. in place again. The adjustment is now complete, press “√” to return to service main menu. Touch “YES” on the dialog box “De-energize motor?”. Manually load a new rotor on the Rotor Holder. On the windows like menu enter Service then Module Positioning Test and RA – RH Test. The instrument exercises the Rotor Arm performing repeated picking/loading of rotor from/to the Rotor Holder. Let the system operate for a suitable number of cycles and verify for proper operation, touch “Abort” once confident that adjustment is acceptable. Note: While performing RA-RH test check that rotor is carried freely to/from the Rotor Holder. Should the rotor touch the fluidic plate during the motion then follow the “Rotor Arm Tilt Adjustment” procedure as detailed in section 7.7.8. 7.7.8 Rotor Arm tilt adjustment (ACL ElitePro only) If during the Rotor Arm movement the rotor carried touches the Fluidic Plate, it is necessary to repeat the Rotor Arm Centring procedure as described in the sub-section 7.7.6 with an additional operation at point 13. Before tightening the 3 setscrews put Chapter 7 – Checkout & Adjustment Page 67 of 98 ACL Elite/ElitePro Service Manual the aluminium support at the top of the shaft housing (about 2 mm over) to lift up the Rotor Arm. If the problem persists it can be solved also with the tilt up of the Rotor Arm through the setscrew located below the electromagnet pin. To tilt up the Rotor Arm proceed as follows: 1 2 Remove the Rotor Arm Electro-Magnet. Locate the setscrew which allows tilt adjustment (see figure below). Setscrew located under electromagnet shaft 3 4 5 6 7 Loosen a little the 2 cap screws that hold the Rotor Arm in place. Turn cw the setscrew to raise the Rotor Arm and obtain best condition (inserting a rotor in the Rotor Arm and then, with the vertical motor raised, inspecting the distance from the bottom of the rotor and the Fluidic Plate). Tighten the 2 cap screws that hold the Rotor Arm on the aluminium support. Replace the Rotor Arm Electromagnet paying attention to the distance of the magnet and the run of the pin (too close won’t open enough; too far jam and won’t close). Perform the R.E.M. self test as detailed in section 7.7.9. to insure proper fit. NOTE: Also insure that the Hex Nut securing the two rotor arms is tightened sufficiently to allow the arms to securely grasp the rotor edge in the arm slot. If the Hex Nut is loose one arm may be lower or higher than the other and may ride above the rotor edge preventing the rotor from being picked up. 7.7.9 R.E.M. (Rotor Exchange Module) self test (ACL ElitePro only) The Rotor Exchange Module is a major assembly that incorporates the Rotor Stack, Rotor Transport and Rotor Arm. The R.E.M. must be aligned to the Rotor Holder. The procedure is detailed in section 7.7.7. Page 68 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual This test is designed to verify the proper alignment of the major sub-assembles of the Rotor Exchange Module and the Rotor Holder. Materials / tools necessary for the test: - Disposable rotors 1. Turn On the Instrument then access the Service program main menu. 2. Load a stack of 10 new rotors in the Rotor Stack. Empty the Rotor Waste container and place it back onto its housing. 3. On the windows like menu enter Service then Module positioning test and RA – SL – RH test. 4. The instrument initializes the motors of the R.E.M., the Rotor Holder and the Rotor Cover. 5. Once initialization is completed the system starts loading / unloading rotors until the stack of rotors is exhausted. Note: If the R.E.M. cover is open or is out of place then the Rotor Stack Cover Sensor detects this condition and the system, for safety purposes, won’t allow opening of the Rotor Stack Upper Electro-Magnet. To override this situation and achieve a good visual inspection without the R.E.M. Cover, put a little magnet on the magnetic sensor (try both the 2 sides of the magnet to find the proper polarization). Visually inspect for proper movement of rotors. If any problem is present then perform the relevant check out and adjustment procedure. 7.8 System Dilutors Test This service program sub-menu includes two different options, these are available via Service then Dilutors Test: 7.8.1 7.8.2 Dilutor Test Volume Check 7.8.1 Dilutor Test This test is designed to verify the overall system precision. The test is automatically performed by the instrument and performs three series of six replicates with each solution at three different concentrations (undiluted, diluted 1/2 and diluted 1/4). CV % are then calculated for each series, and reported on the screen. The test can be configured for one Channel (Coagulimetric / Chromogenic) and one dilutor (sample / reagent) at a time. Any imprecision of the system could be generated either by the fluidics system (Fluidic parts obstruction, Electro-Valves, air bubbles and/or dilutors compensation value) or by the optical system (light sources and/or detectors). Chapter 7 – Checkout & Adjustment Page 69 of 98 ACL Elite/ElitePro Service Manual Note: Should this test fail, it would be advisable to perform the “Optical channel check out and adjustment procedure” to verify the system optics. If the system optics pass the tests then troubleshoot the fluidic system. Following are described the procedures to test the Reagent Dilutor with both the Coagulimetric and Chromogenic Channels. • • Reagent Dilutor Test with Coagulimetric Channel. Reagent Dilutor Test with Chromogenic Channel. Note: To test the Sample Dilutor with both Channels, set the Loading Type with “Sample Dilutor”. The only additional operation required is to temporarily exchange (only for the duration of the test with the Sample Dilutor) the two fluidic tubes that are connected to the Needles Block. • Reagent Dilutor Test with Coagulimetric Channel Materials / tools necessary for the test: - Brand new rotors. - Wash-Reference Emulsion. - Clean, empty 4 mL reagent vial Precaution Make sure that the instrument has been turned On for at least 20 minutes (warm-up of light source and thermoregulation) prior going through the following procedure: 1 2 3 Gain access to the service program menu. Thoroughly clean, using distilled water and a cotton swab, the optical path (holes) of the Rotor Holder, as well as the optical sensor window and optic fiber of the Coagulimetric Channel. On the windows like menu enter Service then Dilutors Test and Dilutor Test. The system presents the screen below. Page 70 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 4 5 6 7 8 9 Select on the screen “Coagulimetric” on the left window and “Reagent Dilutor” on the right window. Load 4 ml of Wash-Reference Emulsion into a clean, empty 4 mL reagent vial and place it with its adapter in the reagent position R1. Load 4 ml of distilled water into a clean, empty 4 mL reagent vial and place it with its adapter in the reagent position R4. Place a brand new rotor into the analysis compartment. Press “Start in Manual Rotor Loading”. The instrument will load the rotor cuvettes picking the Wash-Reference Emulsion and the distilled water from the reagent vials by using the reagent needle and the Reagent Dilutor. Wait for the completion of rotor loading and acquisition cycle then verify that the following results are obtained. CV% (cuvette # 1 to # 6) CV% (cuvette # 7 to # 12) CV% (cuvette # 13 to # 18) CV% (Reference) Mean Reference R2 :<=4 : < = 4.5 :<=5 :<=3 : 2.2 V to 3.0 V : >= 0.996 10 Press “√” twice to exit. • Reagent Dilutor Test with Chromogenic Channel Materials / tools necessary for the test: - Brand new rotors - Chromogenic Optic Test Kit P/N 97579-50 - Clean, empty 4 mL reagent vial Precaution Make sure that the instrument has been turned On for at least 20 minutes (warm-up of light source and thermoregulation) prior going through the following procedure: 1 2 3 Gain access to the service program menu. Thoroughly clean, use distilled water and a cotton swab, the optical path (holes) of the Rotor Holder, as well as the optical sensor window and optic fiber of the Chromogenic Channel. On the windows like menu enter Service then Dilutors Test and Dilutor Test. The system presents the screen below. Chapter 7 – Checkout & Adjustment Page 71 of 98 ACL Elite/ElitePro Service Manual 4 5 6 7 8 9 Select on the screen “Chromogenic” on the left window and “Reagent Dilutor” on the right window. Take the content of two vials (4 mL) with PNA concentration 160 µmol/L (taken from the kit P/N 97579-50) into a clean, empty 4 mL reagent vial with their Green adapters and place it in reagent position R1. Load 4 ml of distilled water into a clean, empty 4 mL reagent vial and place it with its adapter in reagent position R4. Place a new rotor into the analysis compartment. Press “Start in Auto Rotor Loading. The instrument will load the rotor cuvettes picking the PNA and the distilled water from the reagent vials, by using the reagent needle and Reagent Dilutor. Wait for the completion of rotor loading and acquisition cycle, then verify that the following results are obtained: CV% (cuvette # 1 to # 6) CV% (cuvette # 7 to # 12) CV% (cuvette # 13 to # 18) CV% (Reference) Mean Reference R2 : < = 1.5 :<=3 :<=5 : < = 0.5 : 7.2 V to 8.8 V : >= 0.996 10. Press “√” twice to exit. 7.8.2 Volume Check This test is designed to verify and/or adjust the overall accuracy of the dispensation of the dilution system. The accuracy of the dispensation is verified by means of a special tool called “Graduated Capillary”. It allows a visual verification of the volumes being delivered. The test can be performed using distilled water, however as the results are based on visual inspection of liquid being actually drawn into the capillary, a dye based Page 72 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual aqueous material works better. If an inaccuracy is found a correction can be made through the system software introducing either a positive or a negative offset. Materials / tools necessary for the test: 1 2 3 4 5 6 7 8 - Graduated Capillary Kit P/N 8258900 - Small beaker (10 ml) or other suitable container. - Distilled water (or dye based aqueous solution). Prepare a small beaker with a few ml of either distilled water or a dye based aqueous solution (if available). Gain access to the service program menu. On the windows like menu enter Diagnostic then Priming. The system performs a fluidic priming cycle. Once the priming is over go through the sequence Service then Dilutors Test then Volume Check and Sample Dilutor/Reagent Dilutor. The system presents the screen below. Disconnect the Sample/Reagent needle tubing (the tubes on the Needles Block) and connect it to a Graduated Capillary (connect the capillary to the upper tubing to test the Sample Dilutor line or to the lower tubing to test the Reagent Dilutor line). While holding the capillary above a small beaker out of the liquid press “Start”. The system will perform a short prime cycle (to fill the capillary) followed by a re-aspiration. At this time an air bubble is withdrawn in the Graduated Capillary and a dialogue box is presented on the screen Immerse the Graduated Capillary into the distilled water, or a dye based aqueous solution then press “OK“. The system aspirates about 10 μL of water or a dye based aqueous solution (if available) into the capillary. Verify that the head of the liquid sets between the two upper marks of the Graduated Capillary. Chapter 7 – Checkout & Adjustment Page 73 of 98 ACL Elite/ElitePro Service Manual 9 10 11 12 13 14 After 10 seconds the instrument will automatically deliver most of the content out of the Graduated Capillary. Check that the liquid that remains sets between the two lower marks of the Graduated Capillary (more close to the middle as possible). In this condition (dispensed volume within range) no adjustments are needed, but if the liquid sets above or below the two lines then a correction is required. The correction can be entered in the window “Select Correction Value”. Increase value if too much water stays in the Graduated Capillary at the end of step 9 (dispensed volume insufficient), while decrease value if the water is too close or below the lowest mark on the Graduated Capillary (dispensed volume too high). Repeat test to assure that entered value achieves proper volume dispensing. If value has changed with respect to the original setting, record the new value on the paper label located on the right side of the instrument. Press “√” to exit, remove the Graduated Capillary and refit tubing to the Sample/Reagent needle. Following are the Graduated Capillary conditions during the test: Page 74 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual U p p e r R e fe re n c e lin e s Lo w e r R e fe re n c e lin e s A s p ira tio n Le v e l D is p e n s e d V o lu m e IN S U F F IC IE N T D is p e n s e d V o lu m e W IT H IN R A N G E Chapter 7 – Checkout & Adjustment D is p e n s e d V o lu m e TO O H IG H . Page 75 of 98 ACL Elite/ElitePro Service Manual 7.9 Magnetic Sensors Specific Magnetic sensors are located under the Fluidic Plate and on the Rotor Stack with the purpose to detect for Rotor Holder and Rotor Stack Covers positions. Following are the two sensors check procedures. 7.9.1 7.9.2 Rotor Holder Cover Sensor Rotor Stack Cover Sensor 7.9.1 Rotor Holder Cover Sensor This procedure is designed to verify the functionality of the Rotor Holder Cover Sensor. 1 2 3 4 5 6 7 Remove the side and rear covers to gain access to the cardcage. Connect a DVM between TP21 on the Acquisition & Sensors board (bd#3), and ANA GND, TP0 on board #4. From the Service menu select Optical Module Test, Acquisition Adjustment. Push “Start”. The rotor cover will close. While the rotor module is rotating adjust VR5 on the Acquisition & Sensors Board (Bd #3) to read 2700mv +/- 10mv on the DVM. Also check that LED DL3 is “ON”. Push the “Stop” key to end the acquisition cycle. When the rotor cover opens, check that the voltage indicated on the DVM is between 1400mv to 1900mv. Also, check that LED DL3 is “OFF”. If the values are not met check the position of the Hall Sensor (located underneath the rotor module), with respect to the magnet (located in the rotor cover). If necessary loosen and move the Hall Sensor and repeat procedure. Press “√” to exit. Note: To work properly, this sensor needs correct assembly and the presence of its permanent magnet. This is placed inside the Rotor Cover Assembly and must be correctly polarized. 7.9.2 Rotor Stack Cover Sensor This procedure is designed to verify the functionality of the Rotor Stack Cover Sensor. 1 2 Gain access to the Service program menu. On the windows like menu enter Service then Sensor Tests and Optic Sensor Test. The system presents the screen below: Page 76 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 3 Open the Rotor Stack Cover. 4 Check that on the “Rotor Storage Sensor Open” line there is displayed a “√”. 5 Close the Rotor Stack Cover. 6 Check that on the “Rotor Storage Sensor Open” line the “√” disappears. 7 Press “√” to exit. Note: To work properly, this sensor needs the presence of a permanent magnet. It’s placed inside the Rotor Stack Cover and must be correctly polarized. This sensor doesn’t need adjustment because it works with a digital output signal (On or Off). Chapter 7 – Checkout & Adjustment Page 77 of 98 ACL Elite/ElitePro Service Manual 7.10 Rotor Waste Presence Switch This procedure is designed to verify the functionality of the Rotor Waste Presence Switch. 1 2 Gain access to the Service program menu. On the windows like menu enter Service then Sensor Tests and Optic Sensor Test. The system presents the screen below. 3 Open the Rotor Waste compartment door and verify the presence of the Rotor Waste Container (if absent put it in place) then close the door. 4 Check that on the “Rotor Waste Presence Switch” line there is displayed a “√”. 5 Open the Rotor Waste compartment door and remove the Rotor Waste Container then close the door. 6 Check that on the “Rotor Waste Presence Switch” line the “√” disappears. 7 Press “√” to exit. Note: This sensor doesn’t need electronic adjustments because it works with a digital output signal (On or Off). Page 78 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 7.11 Switching Power Supply Check Out and Adjustment This procedure is designed to verify the functionality of the Switching Power Supply Board. Materials / tools necessary for the test: - DVM Note: Prior to starting this procedure it’s advisable to remove the Metallic Drip Tray located between the Dilutors Module and the Switching Power Supply. 1 2 3 4 5 Turn On the Instrument. Gain access to the service program menu. This turn “On” the Halogen Lamp. Set the DVM to read dc voltages. Connect the ground cable of the DVM to the Test Point TP9 on the Switching Power Supply. Check that on the other Test Points the values read are in accordance with the table below. Test Point Names TP1 TP2 TP3 TP4 TP5 TP6 TP7 TP8 +70VPW +12VPW +9VPW –15VANA +15VANA +6VLAMP +5VDGT +12VDGT Voltages Output Set Values (V) 68.5 12 9 -15 +15 6 5.1 12 Acceptable Ranges (V) 64 to 73 10.8 to 14.5 8.5 to 9.5 -14.25 to -15.75 14.25 to 15.75 5.94 to 6.06 4.85 to 5.25 11.4 to 12.6 Trimmers for Adjustments RV5 RV4 RV2 RV3 RV6 Note: The trimmers are located on the Switching Power Supply in the zone under the CPU Master Board. To gain access to them it is required that the Instrument is Turned Off and is necessary to remove the entire CPU Master package (CPU Master, PC104 and HDD). 6 If there are voltages Out of Range, try to check the S.P.S. Board without loads. If without loads the problem persists then replace the S.P.S. Board. Note: The S.P.S. Board has many protection circuits on board (see sub-section 3.3.10). When one of them is activated the S.P.S. enters into “Protection Mode” (Turn Off all the voltages and put the LED DL1 On). Chapter 7 – Checkout & Adjustment Page 79 of 98 ACL Elite/ElitePro Service Manual 7.12 Touch Screen Calibration This procedure is designed to calibrate the parameters in the Touch Screen Control Board in respect to the physical dimension of the Touch Screen surface. Materials / tools necessary for the test: - Touch Screen Calibration Tool P/N190574-00 Note: If the Touch Screen Calibration Tool is not available then it’s advisable use an object with the tip rounded. Don’t use any object that can damage the Touch Screen surface. 1. The serial Connection COM1 must be disconnected from the PC104 Board (connector CN-6) and reconnected to the CPU Mother Board connector CN25. To gain access to CN-25 on the Main CPU board it is also necessary to disconnect COM2 (CN-7), COM3 (CN-8) and COM4 (CN-9) from the PC104 Board. Leave COM 2, COM 3 and COM4 connectors disconnected for this procedure. 2. Insert the DOS 6.2 Boot Diskette into the floppy drive and power the instrument ON. 3. At the C:\ prompt type cd touch (and press ENTER) to get to the Touch directory. From the Touch directory type Smartset (and press ENTER) to open the Series Setup Utility. 4. Check the following and change if necessary: • Interface type: Serial (default) and press ENTER. • Communications Port: COM1 (default) and press ENTER. Ignore error messages displayed on the screen and press ENTER to continue. 5. The Touch Screen has to be configured as follows, (use the arrow keys to move to items and ENTER to change options). • Communication: o Hardware Handshaking: select Disabled • • • • Touch Mode: o Stream Touches: o Calibration: o Scaling: select select select Disabled Enabled Enabled Touch Reporting: o Report Delay (x 10ms): select 15 Scaling: o X high: o Y high: select select 800 600 ASCII Setup: Page 80 of 98 press ENTER Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual o Type C2 (C must be upper case) and press ENTER 6. With the proper pointed tool (IL part number 190574-00), touch the following corners of the display screen. Upper Left Corner Lower Right Corner Several lines of touch screen communication data should be displayed after each successful touch. 7. Save the calibration by typing: N$01$07 and press ENTER then press ESCAPE (Esc) to save the calibration and exit. 8. To check the calibration select Touch Testing and press ENTER. The following Touch Testing screen will appear. Press ESCAPE to get back to main Menu. Touch packet format: Smartset Binary X Y Z Status: Touch Flag: 9. Touch the top left and then the bottom right corners of the display screen with the pointed tool (IL part number 190574-00) and confirm that the displayed coordinates for X and Y are approximate to the theoretical values 0 to 800 for X, and 0 to 600 for Y. The maximum acceptable tolerance for these readings is +/-2. For example: X 0 0 800 800 Y 0 0 600 600 Z 255 255 255 255 Status: 1 4 1 4 Touch Flag: Initial Un Touch Initial Un Touch Note: If the touch screen cannot be set within the specified tolerance, return to the Main Menu and repeat steps 5. thru 8. 10. Upon successful completion press ESCAPE to return to the Main Menu. 11. Check and if necessary select the following settings. Touch Mode: Stream Touches Enabled Load/Save Setup: Data Source Destination To NVRAM Load/Save Setup: Setup Press ENTER (to save modifications) 12. After the configuration has been saved, select EXIT to exit the Smartset program. Remove the boot disk and power off the ACL. 13. The serial Connection COM1 must be reconnected to the PC104 Board. Disconnect the COM1 cable from the CPU Mother Board connector CN-25 Chapter 7 – Checkout & Adjustment Page 81 of 98 ACL Elite/ElitePro Service Manual and connect it to the PC104 Board connector CN-6. Reconnect COM2 (CN7), COM3 (CN-8) and COM4 (CN-9) to the PC104 Board. 14. Reboot the ACL. Confirm touch screen operation using the ACL system software by pressing the selection buttons and pull down menus on the screen. Using your finger, confirm that pressing the center of the icon, button or pull down menu tab, the function is activated. An alternative method to check/calibrate the touch screen is as follows. This method is not as accurate as the method described above. 1 2 3 Gain access to the Service program menu. On the windows like menu enter Service then Touch Calibration. A window appears with inside the information that “The current Touch Screen calibration will be lost. The operation cannot be reverted. It’s OK to proceed?” 4 Press “OK”. 5 A window appears with inside the instruction “Please touch into red rectangle 1”. 6 In the upper left corner of the screen a red rectangle has appeared. Touch it with care using the Touch Screen Calibration Tool. 7 Repeat the same operation with the red rectangle 2 located on the lower right of the screen. 8 In order to verify the calibration repeat the operation also the check red rectangle 3. 9 A window appears with inside the information that “Touch Screen successfully calibrated. Save the calibration?” 10 Press “OK” to save the calibration and exit. Note: During the calibration procedure any error may occur or the time out to touch the proper red rectangle on the screen has expired (15 seconds). In this case a windows appears with inside the information that the touch screen calibration is aborted. In this condition the Touch Screen is “out of order” and is needed to use the TAB key (or the mouse if available) to select the Retry button and then press the Enter key. Repeat the entire procedure until the Touch Screen is successfully calibrated. Page 82 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 7.13 Interfaces Test This section provides information in order to verify through the Interfaces Test the proper functionality of the interfaces relevant circuitry. Following are the specific procedures to test the proper functionality of each circuit. 7.13.1 7.13.2 7.13.3 7.13.4 RS 232 Serial Mouse HW loop RS 232 Host HW loop USB Ports Parallel Printer 7.13.1 RS 232 Serial Mouse HW loop This test is designed to verify the functionality of the Mouse interface serial port. Materials / tools necessary for the test: - RS 232 C Interface Check Connector P/N 99211-01 - RS 232 C Interface Check Connector Adapter P/N 71467-70 Note: If the RS 232 C Interface Check Connector and its Adapter are not available then it’s advisable use the customised 9 Pin Check Connector (Female) as reported in the section 6.2 “Service Tools”. 1 2 Gain access to the Service program menu. On the windows like menu enter Service then Interfaces Test. The instrument shows the screen below. 3 Touch the little arrow on the side of test name then select the “RS 232 Mouse HW loop” option. Press “Continue”. 4 Chapter 7 – Checkout & Adjustment Page 83 of 98 ACL Elite/ElitePro Service Manual 5 6 7 8 9 A window appears with inside the instruction “Please install RS 232 Check Connector on Mouse serial port”. Properly install the RS 232 C Check Connector with the RS 232 C Check Connector Adapter on the Mouse serial port. Press “Start”. The next window with the results may be “Test Passed” or “Test Failed”. If the test failed then it is necessary to troubleshoot the Mouse serial line. Press “OK” to exit. Note: In case of the result “Test Failed” then investigate the Interface Board, the Flat Cable, and the CPU Master & PC104 Boards. 7.13.2 RS 232 Host HW loop This test is designed to verify the functionality of the Host interface serial port. Materials / tools necessary for the test: - RS 232 C Interface Check Connector P/N 99211-01 - RS 232 C Interface Check Connector Adapter P/N 71467-70 Note: If the RS 232 C Interface Check Connector and its Adapter are not available then it’s advisable use the customised 9 Pin Check Connector (Female) as reported in the section 6.2 “Service Tools”. 1 2 Gain access to the Service program menu. On the windows like menu enter Service then Interfaces Test. The instrument shows the screen below. 3 Touch the little arrow on the side of test name then select the “RS 232 Host HW loop” option. Press “Continue”. 4 Page 84 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 5 6 7 8 9 A window appears with inside the instruction “Please install RS 232 Check Connector on Host serial port”. Properly install the RS 232 C Check Connector with the RS 232 C Check Connector Adapter on the Host serial port. Press “Start”. The next window with the results may be “Test Passed” or “Test Failed”. If the test failed then it is necessary to troubleshoot the Host serial line. Press “OK” to exit. Note: In case of the result “Test Failed” then investigate the Interface Board, the Flat Cable, and the CPU Master & PC104 Boards. 7.13.3 USB There is no Diagnostic test available for the USB ports. To test a USB port connect a USB device such as a USB mouse and verify system operation. 7.13.4 Parallel Printer This test is designed to verify the functionality of the Parallel Printer interface parallel port. Materials / tools necessary for the test: - External Printer Cable P/N 84864-50 - PC Standard Parallel Printer (ESCP2 / PCL5 Protocols compatible) Before turn on the Instrument connect through the External Printer Cable the PC Standard Parallel Printer. 1 2 Turn on the Instrument then gain access to the Service program menu. On the windows like menu enter Service then Interfaces Test. The instrument shows the screen below. Chapter 7 – Checkout & Adjustment Page 85 of 98 ACL Elite/ElitePro Service Manual 3 Touch the little arrow on the side of test name then select the “Parallel Printer” option. 4 Press “Continue”. 5 A window appears with inside the instruction “Please connect an external printer on the parallel printer port”. 6 Turn on the printer and verify the presence of the paper inside then put the printer “On Line”. 7 Press “Continue”. 8 The next window with the results may be “Printer Test Passed” or “Printer Test Failed”. If the test failed then it is necessary to troubleshoot the Parallel Printer line. 9 Visually inspect the print out of the External Printer in order to detect data transmission problem. 10 Press “OK” to exit. Note: In case of the result “Test Failed” or “Wrong” print out then investigate the Interface Board, the Flat Cable and the CPU Master & PC104 Boards. 7.14 Temperature Control This section provides information in order to verify all the temperatures of the devices onboard the Instrument as well as all the other temperature over heating protection checks. More information on the instrument assemblies temperatures and the internal cooling system are also provided in the drawing “Operating Temperature and Internal Ventilation” reported in the figure 7.14 Drawing 1 of the chapter 10 “Drawings”. Materials / tools necessary for the test: - Temperature Probe P/N 70954-00 Note: Before performing this check procedure make sure that the Instrument is turn on at least for 30 minutes. Page 86 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 1 2 Gain access to the Service program menu. On the windows like menu enter Diagnostic then Temperature Control. The instrument shows the screen below. 3 Verify that all the devices are in the proper range of Temperature. Note: If the System detects a temperature out of range, after few seconds a warning is displayed and the temperature is displayed in red color. If the instrument has been turned on for only a few minutes or there is a problem on a specific device then the temperature may be out of its range. In this case the temperature is displayed with “– – –“ when the temperature is too low or with “* * *” when the temperature is too high in respect to its working range. 4 In order to troubleshoot the device with a temperature problem, verify the reading of the temperature sensor (thermistor) by touching with the hand the device (Ex: Rotor Holder at room temperature and “ * * * ” on the display). Important: For Rotor Holder temperature verification use the Temperature Probe P/N 70954-00 to measure temperature inside the analysis plastic rotor. The relevant test is described with the tool in the section 6.2 “Service Tools”. The Instrument is provided with an internal cooling system. This is composed of the Instrument Fan Assy, located on the rear-right side of the instrument, that forces airflow inside the instrument and cleans it from dust through the Air Filter. A Secondary Fans system, located on the left side of the instrument, forces the heated air outside. A specific Fan Control Board with onboard a temperature detector is also present. This board provides power to the Peltier Fan that is always working and turns on the Auxiliary Fan when the temperature of the air around the board exceeds 36 °C (over 36 °C turn on the Auxiliary Fan, under the 34 °C turn off the Auxiliary Fan). The functionality of this board may be tested using a hair-drier. Chapter 7 – Checkout & Adjustment Page 87 of 98 ACL Elite/ElitePro Service Manual The maintenance of the Air Filter is very important for the maximum efficiency of the internal air cooling system. Note: The inefficiency of the internal air cooling system may be critical for the Switching Power Supply Board. The SPS is provided with a temperature control circuit which displays a temperature warning (over 60 °C) and then shuts down the instrument if the temperature exceeds 75 °C. 7.15 Floppy Disk Drive Test This section provides information in order to verify through the Floppy Disk Drive Test the proper functionality of the Floppy Disk Drive and its relevant circuitry. Materials / tools necessary for the test: - 1,44 MB Floppy Disk formatted Note: If a 1,44 MB Floppy Disk formatted is not available it’s possible to format a new one with a Personal Computer with standard operative system (DOS / Windows). 1 2 Gain access to the Service program menu. On the windows like menu enter Service then Floppy Disk Drive Test. The instrument shows the screen below. 3 At the beginning of the floppy presence test verify that there is no floppy disk in the Floppy Disk Drive. Press “Continue”. A window appears with inside the message “Operation in progress. Please wait”. In case of test failure, a window appears with inside the message “Disk present in drive. Extract floppy before proceeding”. 4 5 6 Page 88 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 7 At the beginning of the floppy write protected test insert a write protected floppy disk in the Floppy Disk Drive. Press “Continue”. A window appears with inside the message “Operation in progress. Please wait”. In case of test failure, a window appears with inside the message “The inserted Floppy disk is not write protected”. At the beginning of the floppy usability test insert a formatted blank floppy disk in the Floppy Disk Drive. Press “Continue”. A window appears with inside the message “Operation in progress. Please wait” then another window with the test progress bar is displayed. At the end another window appears with inside the message “Floppy disk drive test successfully completed”. In case of test failure, a window appears with inside the message “Usability floppy disk test failed (on creating file)!”. Press “OK” and then “Cancel” to exit. 8 9 10 11 12 13 14 15 Note: In any of the tests fail then investigate the Floppy Disk Drive, the Flat Cable and the CPU Master Board. 7.16 Software checking & loading This section provides information in order to completely explain the upgrade procedure of the software in the system. The software is stored on the Hard Disk Drive and in the Flash Memory Chips on the boards. Following are the specific procedures. 7.16.1 7.16.2 7.16.3 7.16.4 7.16.5 7.16.6 7.16.7 7.16.8 Software Identification Databases Check Backup / Restore of the system configuration Upgrade IL Library Complete Software Re-install Hard Disk Drive Formatting Main CPU Board BIOS Setup PC104 Board Expanaion Module Settings 7.16.1 Software Identification 1 2 Gain access to the Service program menu. On the windows like menu enter Utility then Software and Software Identification. The instrument shows the screen below. Chapter 7 – Checkout & Adjustment Page 89 of 98 ACL Elite/ElitePro Service Manual 3 4 Verify that all the Software releases are in the latest versions available. Press “√” to exit. Note: The Master and the IL Library software version displayed are the software version stored on the HDD, while the Slave and the REM software version displayed are the software version stored in the boards Flash EPROMS memories (Boards #2 and #4). If for troubleshooting purposes the current Slave Board #2 or REM Board #4 are replaced it’s required to perform the Upgrade procedure. This will program the new board memories with the last software revision that is Uploaded (stored) on the Hard Disk Drive. Only after the Upgrade procedure will the last software revision be written to the boards Flash EPROM memory. The “Upgrade” program allows the software to be loaded from the Hard Disk Drive to the specific board memory. 7.16.2 DataBases Check This sub-section is designed to clarify the actions that are possible when a Database Error is encountered. If the Checking Database during the Init System phase (at Turn On) detects a problem then the system shows the following menu. Database check reported some errors. Please select one of these options. 1 – Restore last saved Database (on “Date” and “time”) Page 90 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual If this option is selected then the system proceeds with the restore of the last valid database saved. Caution! That means that all the data and modifications stored from the last selfbackup (on “date” and “time”) to now will be lost! 2 – Power off and call service If this option is selected then the system proceeds showing the message “System halted. You can safely turn off ACL.” NOTE: It is recommended to select option 1 Restore Last Saved Database if a database error is encountered and this message is displayed. By selecting option 1 the chance of saving a possibly corrupted database is minimized. Caution! It is possible that after the Init System the instrument is halted with a database failure message. This may result in the instrument database being corrupted and the access to the Operator Main Program is denied. In this case the only option is to turn off and then on again the instrument, and choose 1 (Restore last saved database) in the menu. Caution! If, after the Init System, is possible gain access to the Service Program then it’s advisable try to perform an “Archive” of all the data not saved yet (QC, AR, Calibrations and Patient data) and also a Backup of the system configuration (if an other one is not available) as described in the sub-section 7.16.3. After this, on the windows like menu enter Service then DataBases Check. The system shows a window where it is possible to select one of the four following options. - Restore whole Database Restore Setup and Calibration Database deleting other data Restore Setup Database deleting other data Ignore error If also through this menu it’s impossible to recover Data and/or Setup configuration then Log-Out, switch off and then On the Instrument and in the menu select the option “1 – Restore last saved Database”. 7.16.3 Backup / Restore of the system configuration This sub-section is designed to provide information about the Backup / Restore of the system configuration. The following procedure allows the service engineer to save on a floppy disk the current configuration of the instrument with the purpose to create a backup copy that may be restored in the future on the same but also on other instruments. The databases that will be saved contain information about the setup of: Chapter 7 – Checkout & Adjustment Page 91 of 98 ACL Elite/ElitePro Service Manual • • • • • • • Liquids Tests Profile QC AR Interface configuration System configuration Materials / tools necessary for the test: 1 2 3 4 5 6 7 - Available Floppy Disk 1,44 MB formatted. Gain access to the Analysis / Service program menu. On the windows like menu enter Utility then Backup / Restore. The instrument shows a window with inside 3 choice buttons. Touch “Backup”. The system takes a few minutes to prepare the data for the backup displaying the message “Backup of database in progress, please wait”. When required insert the floppy disk in the Floppy Drive and press “OK”. The system writes the data on the disk displaying a progress bar. When finished extract the floppy disk and put an identification label on it. Following is the procedure is to restore the backup data file on the instrument. 1 2 3 4 5 6 7 Gain access to the Analysis / Service program menu. On the windows like menu enter Utility then Backup / Restore. The instrument shows a window with inside 3 choice buttons. Touch “Restore”. The system displays a choice box with the message “Restoring the saved instrument configuration some results in the databases could be erased” then press “Yes”. When required insert the proper floppy disk in the Floppy Drive and press “OK”. The system reads the data on the disk displaying a progress bar and then takes few minutes to restore the data. When finished extract the floppy disk. Touching the button “View Backup Date” it is also possible to check the date of the Backup file on the floppy disk without proceeding with the Restore. 7.16.4 Upgrade IL Library This sub-section is designed to provide information about the Upgrade of the IL Library. The following procedure allows the service engineer to perform the IL Library Upgrade. The databases that will be updated contain information about: • New Liquids • New Profiles • New Interference Table • New Tests Page 92 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual For all the tests updated in the databases with a new revision the calibration, AR, QC and patients data will be lost. In the end of the operation the system provides to the service engineer / customer the list of all the data erased. Materials / tools necessary for the test: 1 2 3 4 5 6 - IL Library Upgrade Disk Gain access to the Analysis / Service program menu. On the windows like menu enter Utility then Upgrade IL Library. The instrument shows a window with the message “Load DB file from floppy disk” then touch “continue”. Insert the first disk as required and touch “OK”. The system takes a few minutes to read the data and Upgrade the libraries. When finished extract the floppy disk from the Floppy Drive and press “OK”. 7.16.5 Complete Software Install Software Re-install This installation procedure is suggested for the following circumstances: • To re-install software on an instrument that is unable to successfully complete start-up sequence. 7.16.5.1 Slave Code Upgrade and Software Installation The Slave software upgrade must be selected before the application software is installed. To select Slave Upgrade and install software perform the following steps: 1. 2. 3. 4. 5. 6. 7. 8. 9. From ACL Main Menu, select the “UTILITY” menu Select the “SOFTWARE” option Select the “SOFTWARE UPGRADE” option Select the “SW SLAVE” option Select the “UPGRADE” option. The “Upgrade Slave Code” window appears with the following text: “Upgrade Code Selected. Do you confirm?” Select the “Yes” button, the text will change briefly to state: “Upgrade in progress. . .” The text will automatically change to state: “The Device is ready to receive the code, please Logout, Switch the system off, wait a few seconds and switch it back On, to continue the Upgrade”. Select the “OK” button. Select the “Log Out” button from the toolbar (key on the far right). When the “Logout” message appears that states: “Do you really want to shutdown ACL?” appears select “Yes”. Wait for the “Login” window and power down the ACL. Chapter 7 – Checkout & Adjustment Page 93 of 98 ACL Elite/ElitePro Service Manual 10. Insert the floppy disk labeled “ACL Elite/ElitePro SW DISK 1” into the floppy drive and power on the ACL. 11. The “Scandisk” program will start automatically. When completed it will be followed by the “Defrag” program. 12. Wait until “Defrag” is completed. 13. You will be prompted to insert the last disk of the set, insert the disk titled “ACL Elite/ElitePro SW DISK 4”, then the disks “ACL Elite/ElitePro SW DISK 1”, “ACL Elite/ElitePro SW DISK 2”, “ACL Elite/ElitePro SW DISK 3” and “ACL Elite/ElitePro SW DISK 4” when prompted.. 14. When the following prompt appears: “Do you want to install a new database?” with the following options: “Press “Y” if you want to install a new Data Base” “Press “N” if you want to maintain the actual Database” Press “N” to keep the database. (If upgrading existing software or reloading software onto an existing Hard Drive). Press “Y” if loading software onto a New or Re-Formatted Hard Drive or if the Database is suspect of corruption). Automatically the “Scandisk” program will start, when completed it will be followed by the “Defrag” program. 15. Wait for the instrument to finish with the disks as indicated by the C:\TEMP> prompt and remove “ACL Elite/ElitePro SW DISK 4” from the floppy drive. 16. Power Off and then Power On the ACL to start the SLAVE UPGRADE procedure. 17. Several screens appear before the ACL initialization. During the machine initialization, the message “Erase Flash Memory in progress. . .Please wait!” is displayed, followed by “Slave Code Upgrade in progress. . .Please wait!” 18. At the end of the SLAVE UPGRADE procedure the ACL is upgraded at new release of software for the Slave and the Master boards. 19. At the end of the start-up the “ACL Login” window should be displayed. Log into the machine using the user “Service” and password “System Fix”. 7.16.5.2 REM Code Upgrade After installation of the application software it may be necessary to perform the REM Upgrade. To upgrade the REM software use the following steps: 1. 2. 3. 4. 5. From ACL Main Menu, select the “UTILITY” menu Select the “SOFTWARE” option Select the “SOFTWARE UPGRADE” option Select the “SW REM” option Select the “UPGRADE” option. The “Upgrade REM Code” window is displayed with “Upgrade code selected. Do you confirm?” as text. 6. Select the “Yes” button, the text will change briefly to state: “Upgrade in progress. . .” Page 94 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 7. The text will automatically change to state: “The Device is ready to receive the code, please Logout, Switch the system of, wait few seconds and switch it back On, to continue the Upgrade”. Select the “OK” button. 8. Select the “Log Out” button from the toolbar (key on the far right). When the “Logout” message appears that states: “Do you really want to shutdown ACL?” appears select “Yes”. 9. Wait for the “Login” window and power down the ACL. 10. Wait for a few seconds and turn the ACL on. 11. Several screens appear before the ACL initialization. During the machine initialization, the message “REM Code Upgrade in progress. . .Please wait!” 12. At the end of the UPGRADE procedure the ACL is upgraded at the new release software for the REM board. 7.16.5.3 Upgrade IL Library The IL Library upgrade procedure must be used for re-installing the IL Library. The IL Library upgrade is divided into the following steps: 1. From ACL Main Menu, select the UTILITY menu 2. Select the UPGRADE IL LIBRARY option 3. A message box pops up that reads “LOAD DATABASE FILE FROM FLOPPY DISK” Select “Continue” 4. Insert into the floppy drive the floppy disk labeled “ACL Elite/ElitePro IL LIBRARY UPGRADE DISK”, click ”OK” and then follow the instructions that prompt the operator to UPGRADE the IL Library. (At this time, the above steps for upgrading the library are executed) A “Upgrade completed, please wait” message is displayed. The IL Library upgrade is divided into the following steps: Step Time IL Liquids Upgrade 3 minutes IL Tests Upgrade 10 minutes IL Profile Upgrade (no IL Profile at 1 second this moment) IL Test Groups Upgrade 30 seconds IL Interference Table upgrade 1 minute 30 seconds 5. At the end of this procedure the ACL is upgraded to the new IL LIBRARY and displays the “Upgrade IL Library” window; select the “Confirm” button to close the window. 6. Select Setup->Tests->Default Tests from the main menu. If a series of beeps occurs when entering this window, record the tests present in the list to the right of the window, and select Setup->Tests->View/Define Chapter 7 – Checkout & Adjustment Page 95 of 98 ACL Elite/ElitePro Service Manual from the main menu. Verify that all tests recorded are enabled, and if they are not, enable them. 7.16.5.4 Configuring Instrument for Elite or ElitePro Once logged onto the ACL, you must make sure that the machine knows if it is an Elite or ElitePro. To do this, use the following steps: • Select the “Utility” menu option and click “Software”, then “Software Identification” • Verify that the correct versions of software for the Master, Slave, REM and IL Test Library are displayed: Select the confirm button to exit the window. • Select the “Diagnostic” menu option and click on the “Service” option. • If you did not log onto the machine as user name “Service” you will be asked to now, the password is “System Fix” and is case sensitive. • Once you are logged in as “Service”, select “Service” menu option and click on the “Hardware Configuration” option. • If the instrument is an ACL Elite, the box labeled “Additional Reagents” should be de-selected, and the box labeled “REM Installed” should be de-selected. • If the instrument is an ACL ElitePro, the box labeled “Additional Reagents” should be selected, and the box labeled “REM Installed” should be selected. • The “Instrumentation Model” text box will display the type of instrument that has been selected. • Press the “Confirm” button to save this setting. 7.16.6 Hard Disk Drive Formatting Note: Replacement Hard Disk Drives will not have the ACL Application Software installed. Replacement Hard Disk Drives must be prepared to accept the ACL Application Software. Preparation of the hard disk drive includes partitioning and formatting the drive. 1 Insert the floppy disk labelled “Boot Disk & DOS 6.2 SW” into the floppy drive and turn the instrument on to boot up in the DOS environment. 2 To partition the hard disk drive, at the A:\ prompt type the “fdisk” command and press the Enter key. 3 A Menu is displayed indicating 4 options. Select option 1 “Create DOS Partition or Logical DOS Drive”, and press “Enter”. 4 A new Menu is displayed with 3 options. Select option 1 “Create Primary DOS Partition” and press “Enter”. 5 The system will display “Do you want to use the maximum available size for a Primary DOS Partition and make the Partition active?” Select “Y” and press “Enter”. Page 96 of 98 Chapter 7 – Checkout & Adjustment Elite/ElitePro Service Manual 6 The Partition routine will start. When finished the partition status will be displayed as follows: Partition C: 1 7 8 9 10 11 12 13 14 Status A Type Pri DOS Vol Label Mbytes 2047 System FAT16 Usage 26% When the partition has been created press ESC to exit from the “fdisk” command. With the Boot Disk & DOS 6.2 SW disk in the floppy drive power the instrument off and on again to reboot. At the A:\ prompt type “format c:” and press the Enter key. Confirm the message “Warning: All data will be lost. Non-Removable Disk Drive C will be lost” by pressing “Y” and press the Enter key. This will start the formatting routine. After format completion the display will indicate “Volume Label (11 characters, Enter for none)”. Press “Enter” for no volume label. When the formatting is complete press the Enter or ESC key to finish. Remove the Boot Disk & DOS 6.2 SW disk from the floppy drive and power the instrument off. To install the application software follow the procedure outlined in section 7.16.5. After formatting harddrive and loading software the motor phases, instrument configuration, (ie Interfaces, Barcodes, etc.) must be performed. 7.16.7 Main CPU BIOS Check If the Main CPU board is replaced the System BIOS Setup should be checked. To check System BIOS Setup perform the following. 1 2 To enter the BIOS Setup environment turn the instrument power on and hold down the [Del] or [Canc] key. When you are in the BIOS Setup environment the following options will be displayed: SYSTEM BIOS SETUP -- UTILITY VERSION 2.05 Basic CMOS Configuration Advanced CMOS Configuration Chipset Configuration Reset CMOS to Last Known Values Reset CMOS to Factory Defaults Write to CMOS and Exit Exit Without Changing CMOS To select an option, use “↑” or “↓” key followed by Enter key. 3 Confirm BIOS is configured as indicated below, and modify if necessary. 4 BASIC CMOS CONFIGURATION Date: Insert date and correct hour Floppy Drive A: not installed Floppy Drive B: 1.44MB, 3.5 5 ADVANCED CMOS CONFIGURATION Chapter 7 – Checkout & Adjustment Page 97 of 98 ACL Elite/ElitePro Service Manual Swapping of A: and B: Seek Hard Drive at Boot: Seek Floppy at Boot: Boot Sequence: Enabled Enabled Enabled A: → C: 6 CHIPSET CONFIGURATION Internal VGA Boot On: CRT + FP Internal COM 1: Enabled Internal COM 2: Enabled Internal COM 3: Disabled Internal COM 4: Disabled Internal COM 5: Disabled Internal Audio: Disabled 7 After confirming or modifying BIOS Setup, select “Write to CMOS and Exit” and press the Enter key. 7.16.8 PC104 Board Expansion Module Setting If the PC 104 Board is replaced the Module Settings should be checked. To check settings perform the following. 1. Disconnect cables CN7, CN8 and CN9 form the PC 104 Board. Leave these cables disconnected. 2. Disconnect the video cable, CN6 from the PC 104 Board and connect it to CN25 on the Main CPU Board. 3. Insert the Boot Disk & DOS 6.2 SW disk into the floppy drive and boot the instrument. 4. From the C:\ prompt type “new_set4” command and press the Enter key. Instructions to configure the system with the following options will be shown: Check that the system is configured as indicated below. Type = PRIMARY Net Node = 2 COM 1 = Enable COM 2 = Enable COM 3 = Enable COM 4 = Enable Com BaseAdd = 380H Net Base Add = 240H Base Add = 380H* Base Add = 388H* Base Add = 390H* Base Add = 398H* Alternative IRQ = 2 Net IRQ = 2 IRQ Line = 10 IRQ Line = NONE IRQ Line = 11 IRQ Line = 5 * Note: The values identified with an (*) may not be changeable. Continue with the configuration. 5. To exit from the “new_set4” environment saving the configuration, press the “End” or “Fine” key. 6. Remove the disk from the floppy drive and power off the instrument. Connect all cables (CN6, CN7, CN8 and CN9) to their original positions. 7. Power on the instrument and confirm system boots. (Note: If the touch screen is inoperative it may be necessary to perform the touch screen calibration described in section 7.12). Page 98 of 98 Chapter 7 – Checkout & Adjustment ACL Elite/EliteProService Manual Chapter 8 System Interfacing This chapter provides the main information related to the configuration of the instrument interface for the communication with external devices. The devices that are possible connecting to the instrument are following. 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 Keyboard External Parallel Printer Network Modem Mouse Host Computer Internal Bar Code Reader External Bar Code Reader Chapter 8 – System Interfacing Page 1 of 7 ACL Elite/ElitePro Service Manual 8.1 Keyboard On the windows like menu select “Setup” then “Interfaces” and “Keyboard”. The system displays the screen below. The window in this screen allows configuring the ACL Elite/ElitePro PC standard keyboard for the language and layout used. Also the enabling of the on-screen keypad is configurable by selecting: KEYBOARD TYPE: English (United Kingdom) French German Spanish Italian USA NUMERICAL KEYPAD: Disabled All numerical fields All numerical fields and Sample ID Page 2 of 7 Chapter 8 – System Interfacing ACL Elite/EliteProService Manual 8.2 External Parallel Printer On the windows like menu select “Setup” then “Interfaces” and “Printer”. The system displays the screen below. The window in this screen allows configuring of an external printer selecting: PRINTER PROTOCOL: ESC/P2 (for Epson-like printers) HP-PCL (for HP-like printers) PAPER DIMENSION: A4 (210 x 297 mm.) Letter (8½ x 11 inch) PAPER FORMAT: Single sheet Continuous sheet REPORT TYPE: Cumulative Sample Report PRINTED SAMPLES: Any (analyzed) Completed AUTOMATIC PRINT OUT: Checked (Enable) Empty (Disable) SAMPLE REPORT DATA: Instrument Name (Checked Enable) Normal Ranges (Checked Enable) Date/Time (Checked Enable) Chapter 8 – System Interfacing Page 3 of 7 ACL Elite/ElitePro Service Manual CUSTOMIZE HEADER: Enter in the “Custom Header” screen. 8.3 Network Not supported in this Software Revision. 8.4 Modem Not supported in this Software Revision. 8.5 Mouse The mouse may be used as a selecting device in place of touching the screen. At instrument turn on, during the “Init. System” phases, the instrument checks the proper serial port or USB port for the presence of a mouse. If the mouse is detected then the cursor arrow appears on the display. If the mouse is connected after the “Init. System” phases then the instrument will not detect it until the next time the instrument is powered off and on. 8.6 Host Computer On the windows like menu select “Setup” then “Interfaces” and “Host”. The system displays the screen below. Page 4 of 7 Chapter 8 – System Interfacing ACL Elite/EliteProService Manual The window in this screen allows configuring of Host Computer interface selecting: BAUD RATE: 2400 4800 9600 19200 38400 AUTOMATIC DATA TX (TRANSMISSION): Not Required Patient Samples Only QC, AR and Patient Samples HOST QUERY: Checked (Enable) Empty (Disable) DELETE AUTOMATICALLY AFTER TX (TRANSMISSION): Checked (Enable) Empty (Disable) UNIQUE INSTRUMENT ID: Checked (Enable, from 1 to 9) Empty (Disable) Information about the “Host Communication Protocol” is detailed in chapter 12 Appendix A of this manual. The ACL to Host Computer Interconnect Cable is P/N 184202-38. The following table provides information regarding the wiring of the interconnection cable between the ACL and Host Computer. ACL Side Host Computer Side Interface Type: DTE 9 Pin Female Delta Connector PIN DESCRIPTION 1 N.C. 2 TXD 3 RXD 4 DTR 5 Signal GND 6 DSR 7 RTS 8 CTS 9 N.C. Shield to connector shell Interface Type: DTE 9 Pin Female Delta Connector PIN DESCRIPTION 1 N.C. 2 RXD 3 TXD 6 DSR 5 Signal GND 4 DTR 8 CTS 7 RTS 9 N.C. Shield to connector shell Chapter 8 – System Interfacing Page 5 of 7 ACL Elite/ElitePro Service Manual 8.7 Internal Bar Code Reader On the windows like menu select “Setup” then “Interfaces” and “Internal Barcode”. The system displays the screen below. The first step is enable (Checked) the Internal Barcode Reader. The four fields visible on the screen correspond to the four families of barcodes that may be activated on the ACL, along with their corresponding subtypes of barcodes. Choose for each field one of the options below according to the laboratory’s needs. CODABAR: Disabled No Checksum AIM Mod 16 NW7 Mod 11 NW7 Mod 16 CODE 39: Disabled No Checksum Mod 43 INTERLEAVED 2 OF 5: Disabled No Checksum USS Mod 10 OPCC Mod 10 CODE 128: Disabled No Checksum Page 6 of 7 Chapter 8 – System Interfacing ACL Elite/EliteProService Manual 8.8 External Bar Code Reader On the windows like menu select “Setup” then “Interfaces” and “External Barcode”. The system displays the screen below. The External Bar Code Reader is used to Identify IL Reagent Bar Code labels. Enable the external barcode reader by selecting the box labelled External BCR Enabled. Select additional fields as appropriate. Chapter 8 – System Interfacing Page 7 of 7 Elite/ElitePro Service Manual Chapter 9 Part List This chapter contains information about the service parts as well as the expendable materials that are available for use with the ACL Elite/ElitePro System. A large number of the expendable materials are shipped in the “Startup Kit” included with the ACL Elite/ElitePro system. These items may be ordered using their Part Numbers as shown in the tables. Following are the specific sections. 9.1 9.2 9.3 Startup Kit Expendable Materials Service Parts List (Includes ACL 8-9-10000 unique service parts) Chapter 9 – Part List Page 1 of 9 ACL Elite/ElitePro Service Manual 9.1 Startup Kit The following expendable materials are contained in the Startup Kit that is shipped with the ACL Elite/ElitePro System. • Sample Trays Three types of sample trays are available as shown below. The startup kit includes two of them, chosen by the user according to the desired system configuration. Tray type 3 mL 5 mL S 11.5 Used for Primary tube, 3 or 3.5 mL total volume (13x75 mm) Primary tube, 5 mL total volume (13x75 or 13x100 mm) Sarstedt type tube, 3 mL (11.5x66 mm) or 5 mL (11.5x92 mm) • Sample Tray Adapters for plastic cups - 4 pieces for 4 mL glass vials - 6 pieces • Reagent Vial Adapters for 10 mL vials, reagents requiring magnetic stirring (grey) - 4 pieces for 10 mL vials, reagents not requiring magnetic stirring (purple) - 6 pieces for 4 mL vials, reagents not requiring magnetic stirring (green) - 4 pieces • Magnetic Stirrers for reagent stirring - one package containing 6 pieces • Small Sample Cups 0.5 mL sample cups - one package containing 1000 pieces • Large Sample Cups 2.0 mL sample cups - one package containing 1000 pieces • Diluent/Buffer/Reagent Cups 4.0 mL cups, with labels - one package containing 100 pieces • Diluent/Buffer/Reagent Glass Vials 10 mL glass vials - one package containing 10 pieces • Block and Probes Assembly an assembly consisting of an acrylic block with the sample and reagent needles and their associated liquid sensors Page 2 of 9 Chapter 9 – Part List Elite/ElitePro Service Manual • Sample and Reagent Tubing 1.5 meter piece of tubing to be cut and used as needed • Insertion Tool for Tubing a tool to be used when replacing sample and reagent tubing • Wash/Reference Emulsion a 1-liter bottle of Emulsion • Waste/Rinse Reservoir a reservoir for needle wash and rinse • Waste Bottle a 5-liter bottle to collect ACL waste • Waste Tubing a 1.5 meter piece of tubing to be used for collection of liquid waste • Adjustment Tool for Needles a tool to be used for adjusting the position of the needles in the arm • Rotors 20-Cuvette Rotors - package containing 100 pieces • Rotor Insertion Tool a tool used for inserting rotors into the system • Rotor Waste Container a removable container used inside the system to hold the used rotors • Moulded Air Filter One air filter for the analyzer body • Fuses 6.3 AT 2 fuses for the system • Power Cord a power cord for the system: the cord included is consistent with the voltage with which the system will be used • Host Computer Cable a cable to connect the optional host computer • Software System Disk Kit kit containing the main system software • Test Library Disk Kit kit containing the test library software • Operator’s Manual the Operator’s Manual for use of the ACL system • Mouse USB Optical mouse Chapter 9 – Part List Page 3 of 9 ACL Elite/ElitePro Service Manual • Hand Held Barcode Scanner USB Hand held barcode scanner with mounting hardware (ElitePro only) • Compliance Certificate a specific system compliance certificate Page 4 of 9 Chapter 9 – Part List Elite/ElitePro Service Manual 9.2 Expendables Materials Following are the expendable materials available for the ACL Elite/ElitePro System. Part Number 181108-99 181108-98 181812-85 190764-00 190763-00 181812-65 190762-00 190761-00 097466-06 189241-00 067992-00 055751-00 067994-00 068000-00 181812-77 181108-97 181108-43 181039-41 073289-01 181080-65 181812-72 181057-69 099095-03 181812-71 068931-02 197255-00 148821-00 189462-00 184202-38 200024-00 190870-00 Item Description Sample Tray for 13x75 mm, (3-3.5 mL) tubes Sample Tray for 13x75 & 13x100 mm, (5 mL) tubes Sample Tray for Sarstedt 11.5x66 mm (3 mL) & 11.5x92 mm (5 mL) tubes Sample Tray adapter for plastic cup Sample Tray adapter for 4 mL vials Adapter for 10 mL reagent vials with magnetic stirring (grey) Adapter for 10 mL reagent vials without magnetic stirring (purple) Adapter for 4 mL reagent vials without magnetic stirring (green) Magnetic Stirrer Glass Vials, 10 mL Sample Cups, 0.5 mL Sample Cups, 2 mL Cups, 4 mL, plus Labels Rotors- 20 cuvettes Rotor Insertion Tool Rotor Waste Container Block Probe Assembly Needles Adjustment Tool Sample and Reagent Tubing, 1.5 m Sample and Reagent Tubing Extractor Tool Waste Reservoir, for needles wash Assy, Tank for Waste Waste Tube, 1.5 m Air Filter, molded Fuses 6.3 AT VDE Approved Power Cord 220V Cord Power, Shielded 110V External Printer Cable Host Computer Cable (9 pin – 9 pin) Wash/Reference Emulsion, 1 litre Software System Disk Kit Chapter 9 – Part List # Pieces in Package Unit 1 1 1 4 4 4 6 4 6 10 1000 1000 100 100 1 2 1 1 1 1 1 1 1 1 2 1 1 1 1 1 1 Page 5 of 9 ACL Elite/ElitePro Service Manual 074068-00 189241-04 190595-00 181121-11 181121-12 Page 6 of 9 Connector, Tubing 3 Way “T” Bottle kit, 10 x 4 ml Compliance Certificate Operator’s Manual, ACL Elite Operator’s Manual, CD ACL Elite Chapter 9 – Part List 1 1 1 1 1 Elite/ElitePro Service Manual 9.3 Service Parts List The following Service Parts are available for the ACL Elite / ElitePro System. Part Number Item Description 181120-23 182355-30 182355-40 182356-00 182355-50 182355-61 182355-20 182356-60 182355-70 181120-70 182355-80 182356-30 182356-10 182356-20 070908-00 182356-80 182356-90 065011-10 065033-01 082627-00 089721-00 084869-44 084869-46 181108-26 181108-27 181108-28 181108-29 181108-30 084869-38 084869-39 181108-33 190798-00 181106-34 181108-34 181021-28 Pentium 266MHz CPU Master Board #1 CPU Slave Board #2 Acquisition & Sensors Board #3 Rotor Exchange Module Board #4 Motors Board #5 Photometric & Temp. Control Board #6 PC104 Board Switching Power Supply Bd. Mother Board Interface Board, USB Loading Area Interconnection Bd. Photometer Interface Bd. REM Upper Interconnection Bd. REM Lower Interconnection Bd. Dual Channel Optical Switch Dual Channel Optical Switch (flat) Fan control Bd. Floppy Disk Drive Hard Disk Drive Kit (see note below) Chrom Sensor Bd. Filter Optical 405 nm Chrom Coaxial cable Coag. Sensor w/cable Instrument Fan Assy Secondary Fan Assy Peltier Fan Assy Auxiliary Fan Assy Autosampler Movement Assy Autosampler Internal ring sensor Autosampler External rings sensor Barcode Assy (for sample tray area) Belt Timing Autosampler rotation Peltier 2 Assy (ACL ElitePro only) Peltier 1 Assy Peltier Temperature Sensor Chapter 9 – Part List Area PCB PCB PCB PCB PCB PCB PCB PCB PCB PCB PCB PCB PCB PCB PCB PCB PCB Miscellaneous Miscellaneous Optics Assy Optics Assy Optics Assy Optics Assy Miscellaneous Miscellaneous Miscellaneous Miscellaneous Mech. Assy. Optics Assy Optics Assy Optics Assy Mech. Assy. Mech. Assy. Mech. Assy. Miscellaneous Page 7 of 9 ACL Elite/ElitePro Service Manual Part Number 181108-35 181108-58 190856-47 181108-38 070907-00 074068-00 073289-01 181108-40 190856-06 181108-95 181108-43 190804-55 190804-56 182356-40 190675-75 181108-46 181108-47 181106-48 066675-60 181108-02 181108-50 181024-43 181108-51 181025-15 067218-05 181021-95 181021-81 181108-53 181108-54 190804-57 190804-58 181108-96 181103-06 181108-57 082433-00 181108-94 181108-60 181103-22 182356-70 084869-36 181104-55 084869-37 Page 8 of 9 Item Description Stirrer motor Dilutor Drive Assy Dilutor Chamber with Electrovalves Dilutor Electro-Valve 3 Way Single Channel Optical Switch Connector, Tubing 3 Way “T” Tubing URH .040ID x .100 OD Clear (mtr) Reference Emulsion Sensor Tip Movement Assembly Universal Tip Assy (sample arm) Needles Block Belt Timing Tip Movement vertical Belt Timing Tip Movement rotation Liquid Level Detection Board Liquid Level Detection Cable Rotor Cover Assy Rotor Cover Movement Assy Elite Rotor Cover Movement Assy ElitePro Rotor Cover Belt Rotor Cover Sensor Rotor Holder Movement Assy Brushes Assy Rotor Holder Snap (Coagulimetric Channel) LED Socket Assy Fiber Optic for LED Optical Collimator Assy Halogen Lamp Rotor Exchange Module Assy (Basic) Pliers Movement Assy Belt Timing Rotor Caliper Arm rotation Belt Timing Rotor Caliper Arm vertical Rotor Arm Spring for Rotor Arm Rotor Transport Rotor Transport motor Rotor Stack Assy Electro-Magnet Spring for Rotor Stack Silos Hall Sensor Bd Optical Sensor Silos Upper REM and Silos Cover Assembly Optical Sensor Silos Lower Chapter 9 – Part List Area Mech. Assy. Mech. Assy. Miscellaneous Miscellaneous PCB Fluidic Assy Fluidic Assy Miscellaneous Mech. Assy. Mech. Assy. Mech. Assy. Mech. Assy. Mech. Assy. PCB Miscellaneous Mech. Assy. Mech. Assy. Mech. Assy. Mech. Assy. PCB Mech. Assy. Miscellaneous Mech. Assy. Optics Assy Optics Assy Optics Assy Optics Assy Mech. Assy. Mech. Assy. Mech. Assy. Mech. Assy. Mech. Assy. Mech. Assy. Mech. Assy. Mech. Assy. Mech. Assy. Miscellaneous Mech. Assy. PCB Optics Assy Miscellaneous Optics Assy Elite/ElitePro Service Manual 084869-47 084869-60 182353-50 190856-02 182356-50 064252-45 065456-10 099635-03 190693-00 181121-05 181121-06 190653-00 181121-27 181121-79 065011-20 181103-64 190850-20 181109-31 181109-25 181109-26 181109-27 181109-06 181103-85 181121-31 181121-45 181103-65 Optical Sensor Rotor Waste Full Rotor Waste Micro Switch Assy Speaker Board Assy Power Entry Module Needles & Wash-R Sensor Interc. Board O-Ring for Sample Tray Indexing Pin Push-Push Latch Set Screw M4x10 for Caliper Arm Leveling PM Kit ACL 8-9-10K, Elite, ElitePro Visor Elite Visor ElitePro Kit Service Tools Door, Rotor Waste Area Mouse USB, Optical 2 Button with Wheel Keyboard Protective Glass, Barcode scanner Kit, Dilutor Gasket LCD Monitor ACL Cable VGA LCD Cable RS232 LCD Cable Power LCD Preheater, Rotor, Elite Cover Interface Cable Ref-E Cable Connection Barcode Scanner Linear Handheld Kit, Upgrade, Barcode Scanner Linear Flange Adjustable (Grey plastic flange to support sample tray Optics Assy Miscellaneous Miscellaneous Miscellaneous PCB Miscellaneous Miscellaneous Miscellaneous Miscellaneous Miscellaneous Miscellaneous Miscellaneous Miscellaneous Miscellaneous Miscellaneous Miscellaneous Miscellaneous Miscellaneous Miscellaneous Miscellaneous Miscellaneous Miscellaneous Miscellaneous Miscellaneous Miscellaneous Miscellaneous ACL 8-9-10000 unique service parts 182352-10 181121-30 190750-00 181103-58 181106-41 181103-49 190833-47 181121-80 CPU Master Board #1 Interface Board Visor ACL 9000 instrument s/n 0186 and below Visor ACL 8-9000 instrument s/n 0187 and above Visor ACL 10000 Door, Rotor Waste Mouse, Serial, 9-pin Pentium Hardware Upgrade Kit ACL 8-9-10000 ACL 8-9-10000 ACL 9000 ACL 8-9000 ACL 10000 ACL 8-9-10000 ACL 8-9-10000 ACL 8-9-10000 Note: The Hard Disk Drive Kit, part number 065033-01 does not contain software. After replacement of the hard drive the hard drive must be partitioned and formatted prior to the application software being loaded. Refer to section 7.16. Chapter 9 – Part List Page 9 of 9 ACL Elite / ElitePro Service Manual Chapter 10 Drawings This chapter is designed to group all the main drawings related to the specific chapters included in this service manual. The drawings are organized by section number (chapters where referenced) and then for number of drawing used in the section (chapter). Following is the index of the drawings. 2.5.1 2.5.2 3.1.2 3.3.1 3.3.3 3.3.4 3.3.4 3.3.5 3.3.5 3.3.5 3.3.5 3.3.6 3.3.6 Drawing Drawing Drawing Drawing Drawing Drawing Drawing Drawing Drawing Drawing Drawing Drawing Drawing 1 1 1 1 1 1 2 1 2 3 4 1 2 Analysis Windows Like Menu Bar Service Windows Like Menu Bar Instrument Fluidic System Cycles Mother Board & Interconnections Quick Reference Board Functions CPU Master Board PC104 Board Slave Board Slave Board Slave Board Slave Board Acquisition & Sensors Board Acquisition & Sensors Board 3.3.6 Drawing 3 Acquisition & Sensors Board 3.3.6 Drawing 4 Acquisition & Sensors Board 3.3.6 Drawing 5 Acquisition & Sensors Board 3.3.6 3.3.6 Drawing 6 Drawing 7 Acquisition & Sensors Board Acquisition & Sensors Board 3.3.6 Drawing 8 Acquisition & Sensors Board 3.3.7 3.3.7 3.3.7 Drawing 1 Drawing 2 Drawing 3 Rotor Exchange Module Board Rotor Exchange Module Board Rotor Exchange Module Board 3.3.7 Drawing 4 Rotor Exchange Module Board 3.3.7 3.3.7 Drawing 5 Drawing 6 Rotor Exchange Module Board Rotor Exchange Module Board Chapter 10 - Drawings Expanded Diagram Expanded Diagram Diagram General Block Diagram Diagram General Block Diagram General Block Diagram General Block Diagram Communication Section Memory Section Main Logic Section General Block Diagram Multiplexer & Acquisition Section Channel Amplifier Section Sample Tray Detectors Emitter Section Sample Tray Detectors Receiver Section Needles Sensors Section Reference Emulsion Presence Sections Analysis Compartment Cover Sensor Section General Block Diagram Transport Motor Section Rotor Arm Motors Section Memory & Communication Section Infra Red Sensors Section Electro Magnet Control Section Page 1 of 41 ACL Elite / ElitePro Service Manual 3.3.8 3.3.8 Drawing 1 Drawing 2 Motors Board Motors Board 3.3.8 Drawing 3 Motors Board 3.3.8 Drawing 4 3.3.8 Drawing 5 Motors Board Motors Board 3.3.9 3.3.9 3.3.9 Drawing 1 Drawing 2 Drawing 3 Photom & Temp Control Board Photom & Temp Control Board Photom & Temp Control Board 3.3.9 Drawing 4 Photom & Temp Control Board 3.3.9 Drawing 5 Photom & Temp Control Board 3.3.9 Drawing 6 Photom & Temp Control Board 3.3.10 3.3.11 4.1.5 4.2 7.14 Drawing Drawing Drawing Drawing Drawing Switching Power Supply Board Instrument Ground Circuit Rotor Exchange Module Replacement Instrument Covers Operating Temperatures & Internal Ventilation Page 2 of 41 1 1 1 1 1 Chapter 10 - Drawings General Block Diagram Autosampler Motor Section Sample Arm Motors Section Dilutors Motors Section Magnetic Stirrer Motors Section General Block Diagram Rotor Motor Section Analysis Compartment Cover Motor Section Rotor Thermoregulation Section Peltiers Thermoregulation Section Rotors Transport & Feed Stack Section General Block Diagram ACL Elite / ElitePro Service Manual Chapter 10 - Drawings Page 3 of 41 ACL Elite / ElitePro Service Manual Page 4 of 41 Chapter 10 - Drawings ACL Elite / ElitePro Service Manual Chapter 10 - Drawings Page 5 of 41 ACL Elite / ElitePro Service Manual Page 6 of 41 Chapter 10 - Drawings ACL Elite / ElitePro Service Manual Chapter 10 - Drawings Page 7 of 41 ACL Elite / ElitePro Service Manual Page 8 of 41 Chapter 10 - Drawings ACL Elite / ElitePro Service Manual Chapter 10 - Drawings Page 9 of 41 ACL Elite / ElitePro Service Manual Page 10 of 41 Chapter 10 - Drawings ACL Elite / ElitePro Service Manual Chapter 10 - Drawings Page 11 of 41 ACL Elite / ElitePro Service Manual Page 12 of 41 Chapter 10 - Drawings ACL Elite / ElitePro Service Manual Chapter 10 - Drawings Page 13 of 41 ACL Elite / ElitePro Service Manual Page 14 of 41 Chapter 10 - Drawings ACL Elite / ElitePro Service Manual Chapter 10 - Drawings Page 15 of 41 ACL Elite / ElitePro Service Manual Page 16 of 41 Chapter 10 - Drawings ACL Elite / ElitePro Service Manual Chapter 10 - Drawings Page 17 of 41 ACL Elite / ElitePro Service Manual Page 18 of 41 Chapter 10 - Drawings ACL Elite / ElitePro Service Manual Chapter 10 - Drawings Page 19 of 41 ACL Elite / ElitePro Service Manual Page 20 of 41 Chapter 10 - Drawings ACL Elite / ElitePro Service Manual Chapter 10 - Drawings Page 21 of 41 ACL Elite / ElitePro Service Manual Page 22 of 41 Chapter 10 - Drawings ACL Elite / ElitePro Service Manual Chapter 10 - Drawings Page 23 of 41 ACL Elite / ElitePro Service Manual Page 24 of 41 Chapter 10 - Drawings ACL Elite / ElitePro Service Manual Chapter 10 - Drawings Page 25 of 41 ACL Elite / ElitePro Service Manual Page 26 of 41 Chapter 10 - Drawings ACL Elite / ElitePro Service Manual Chapter 10 - Drawings Page 27 of 41 ACL Elite / ElitePro Service Manual Page 28 of 41 Chapter 10 - Drawings ACL Elite / ElitePro Service Manual Chapter 10 - Drawings Page 29 of 41 ACL Elite / ElitePro Service Manual Page 30 of 41 Chapter 10 - Drawings ACL Elite / ElitePro Service Manual Chapter 10 - Drawings Page 31 of 41 ACL Elite / ElitePro Service Manual Page 32 of 41 Chapter 10 - Drawings ACL Elite / ElitePro Service Manual Chapter 10 - Drawings Page 33 of 41 ACL Elite / ElitePro Service Manual Page 34 of 41 Chapter 10 - Drawings ACL Elite / ElitePro Service Manual Chapter 10 - Drawings Page 35 of 41 ACL Elite / ElitePro Service Manual Page 36 of 41 Chapter 10 - Drawings ACL Elite / ElitePro Service Manual Chapter 10 - Drawings Page 37 of 41 ACL Elite / ElitePro Service Manual Page 38 of 41 Chapter 10 - Drawings ACL Elite / ElitePro Service Manual Chapter 10 - Drawings Page 39 of 41 ACL Elite / ElitePro Service Manual Page 40 of 41 Chapter 10 - Drawings ACL Elite / ElitePro Service Manual Chapter 10 - Drawings Page 41 of 41 ACL Elite / ElitePro Service Manual Chapter 11 Service Notes This chapter is designed to allow the service engineer to add to the service manual any service product information (service notes) that will be released in the future This is to allow the service engineer to add all the notes in a specific place or otherwise to move the service notes to the specific chapter where the notes need to be added. Chapter 11 – Service Notes Page 1 of 1 ACL Elite / ElitePro Service Manual Chapter 12 ACL Elite/Elite Pro Host Communication Protocol Revision 2.3 Dec 2005 Chapter 12 – Appendix A Page 1 of 42 ACL Elite / ElitePro Service Manual Revision Date December 07-2002 December 16-2002 Comments Added transmission examples Specified ASTM field numbers Add Notes for information Total number of pages Reviewed Test Codes Review some Notes April 2004 Error code update December 2005 Elite/Elite Pro update Chapter 12 – Appendix A Page 2 of 42 ACL Elite / ElitePro Service Manual Index 1.0 1.1 2.0 2.1 3.0 Introduction Purpose General Description Product Perspective Specific Requirements ERROR! BOOKMARK NOT DEFINED. 3.1 Protocol Specification 3.2 Low Level Interface 3.3 Data Link and Logical Layer 3.4 Sessions 4 4 5 5 6 6 6 6 3.4.1 Message Header and Message Terminator Records 3.5 3.5.1 3.5.1.1 3.5.1.2 Test Order Downloading Receive Session from DMS Test Request Message Test Order Message 7 8 8 10 11 3.5.1.2.1 3.5.1.2.2 Patient Information Record Test Order Record 10 12 3.5.2 3.5.3 3.5.4 3.6 3.7 4.0 4.1 Host Query Test Request Message Test Order Message Rejected Test Order Download Session Volumes Test Results Uploading Test Result Message 15 15 16 18 19 20 21 4.1.1 Patient Information Record 20 4.1.2 4.1.3 4.1.4 4.1.5 4.2 5.0 6.0 7.0 8.0 8.1 8.2 8.3 9.0 Test Order Record Result Record Comment Record Error Codes Upload Session Volumes Not Supported Records Transmission Abort Appendix - ACL Elite/Elite Pro Test Codes Appendix - ACL Elite/Elite Pro Supported Characters Supported Characters for Sample ID Supported Characters for Patient name and Department Supported Characters for delimiters Appendix - ACL Elite/Elite Pro Supported Units 23 24 23 24 26 27 27 28 31 31 31 31 32 Chapter 12 – Appendix A Page 3 of 42 ACL Elite / ElitePro Service Manual 1.0 Introduction 1.1 Purpose This document is a guide to integrate a Laboratory Information Management system with the Instrumentation Laboratory ELITE/ELITE PRO family instruments using the ASTM (American Society for Testing and Materials) specification to transfer information between clinical instruments and computer systems. ASTM specification E-1394-91 Standard Specification for Transferring Information between Clinical instruments and Computer Systems and E-1381-91 Standard Specification for the Low Level Protocol to transfer Messages between Clinical Laboratory Instruments and Computer Systems have been used as standard to develop ELITE/ELITE PRO Host Communication Protocol. Specification E-1394 defines the logical layer of ASTM standard; all significant information for ELITE/ELITE PRO instruments application can be found in chapters Specific Requirements and following. Specification E-1381 refers to low level protocol; significant information for ELITE/ELITE PRO family instruments application can be found later on in this document. Chapter 12 – Appendix A Page 4 of 42 ACL Elite / ElitePro Service Manual 2.0 General Description 2.1 Product Perspective Communication sessions with host computer can be started on ELITE/ELITE PRO family instruments by operator request or automatically at session completion. If the operator requires a manual download session, the instrument will open communication with the host computer that will provide transmission of all test orders. If the operator requires an upload session, the instrument will transmit a subset of sample results (identified by the user) stored in the instrument patient database or QC database or Analytical Reference database. If the instrument is properly configured, automatic downloading or uploading sessions can be started by ELITE/ELITE PRO instrument. Automatic downloading will occur at session start if host query is configured. In this condition the instrument will request test orders for specific sample IDs recognized on the sample tray. The second condition will occur, if automatic uploading has been requested, at session completion. In case the communication session is not generated from the instrument, any host computer message is ignored. All information received by the host computer must be associated with a Sample ID which is the primary key of the database. In addition to programmed tests a certain amount of information can be associated with a Sample ID (patient data) and stored in ELITE/ELITE PRO database. This information is optional. The sample ID is the primary key to access information in the database. If the checks fail, any downloading operations will be aborted. See Test Order Downloading section. At most 1000 samples can be stored in ELITE/ELITE PRO database; each sample can have a maximum of 30 tests associated (double tests are considered as 3 tests). The system behavior when these limits are exceeded is explained in the paragraph Test Order Downloading. If 1000 samples are present in the database, the FIFO (First In First Out) will not accept additional samples during a Manual Downloading. The test ordering operation, to identify the type of ordered test, by host computer must refer to a computer code that is instrument specific. Refer to Test Order Downloading for further details and to the Appendix at the end of this document for the test codes table. Chapter 12 – Appendix A Page 5 of 42 ACL Elite / ElitePro Service Manual Note: for the downloading the Host should send to the ELITE/ELITE PRO string information in single frame (single line) during the transmission or up to 240 bytes maximum during the transmission. . 3.0 Specific Requirements 3.1 Protocol Specification 3.2 Low Level Interface Low level interface conforms to ASTM specification E-1381-91. The following characteristics are supported and are configurable by Operator Interface: Baud Rate 2400, 4800, 9600, 19200, 38600 Character Length 8 bit Parity No parity Stop Bits 1 3.3 Data Link and Logical Layer For the Data Link and Logical Layer the ASTM specification E-1381-91 has been maintained as a reference. Protocol limits and constraints are those declared by the standard. To mention some of them, the data part of the frames exchanged between the instrument and the host computer should be done as single frame. As a consequence during transmission sessions specific routines provide the ability to divide large records into multiple frames and during a reception session they re-build partial frames in a single record. The application level has no evidence of this mechanism. According to ASTM standard the following characters cannot be part of data records: <SOH>, <STX>, <ETX>, <EOT>, <ENQ>, <ACK>, <DLE>, <NAK>, <SYN>, <ETB>, <LF>, <DC1>, <DC2>, <DC3>, <DC4>. Timeout and retry logic are those specified by the standard; the Low Level Clinical Message State Diagram representing the implemented automatic is the reference. In interrupt request status the instrument accept remote EOT. 3.4 Sessions There are two types of sessions that the instrument handles with the ASTM interface: the test orders download and the test results upload. These sessions can be initiated by the operator or automatically activated by the instrument. Chapter 12 – Appendix A Page 6 of 42 ACL Elite / ElitePro Service Manual When the user/operator requests a download operation (Receive Command), the instrument will send a request to the host for available test orders (all) or for test orders requested for specific samples, and the host will answer with the test orders available for the instrument. Test results upload (Transmit Command) are initiated by the user or automatically by the instrument at the same way. The host is not allowed to transmit unsolicited messages, any type of inquiries or test orders not explicitly required by the instrument. 3.4.1 Message Header and Message Terminator Records Following ASTM specification, each type of transaction between the instrument (DTE) and the host computer (DCE) has two common records that are the Message Header record and the Message Terminator record. These records open and close data transmission between ELITE/ELITE PRO instruments and host computer. Their fields are described in the following: Message Header Record: Record Type ID Delimiter Definition Message Control ID Access Password Sender Name or ID Sender Street Address Reserved Fields Sender Telephone Number Characteristics of Sender Receiver ID Comment or special Instructions Processing ID Always set to ‘H’ The 5 ASCII characters composing this field define the type of delimiters that will be used in the following records. See Appendix B for supported delimiters. Not provided Not provided Set to ‘ACL9000’ when transmitting to host or receiving. As an option, the ability to identify univocally the instrument by means of an extension to the instrument name is also supported: the name syntax becomes ‘ACL9000-xx’ where xx is a two digit code in the range 01-99. The extension to the instrument name is user configurable in the set-up environment. The instrument ID is always ACL9000 independently from the model; ELITE/ELITE PRO. Not provided Not provided Not provided Not provided Must be set to ‘ACL9000’ when receiving from host. Depending on the instrument set-up, the ability to identify univocally the instrument by means of the extension to the instrument name is also supported: the name syntax becomes ‘ACL9000-xx’ where xx is a two digit code in the range 01-99. If the ID is different from the expected one, the session is interrupted. Not provided Always set to ‘P’ meaning Production Chapter 12 – Appendix A Page 7 of 42 ACL Elite / ElitePro Service Manual Version No. Date and Time of Message Set to the current ASTM standard version = ‘1’ Format is YYYYMMDDHHMMSS Example of message sent from the ELITE/ELITE PRO : H|\^&|||ACL9000|||||||P|1|20021205123956<CR> Example of message sent from Host: H|\^&||||||||ACL9000||P|1|20021205123956<CR> Message Terminator Record: Record Type ID Sequence Number Termination Code always set to ‘L’ always set to ‘1’ set to ‘N’ for normal termination and to ‘E’ for abnormal termination while transmitting to host; not considered for received data Example of Terminator: L|1|N<CR> 3.5 Test Order Downloading Test order downloading is used to request test orders available on the host and to have them on the instrument. This operation can be obtained in two ways: manually opening a download session from the DMS environment or enabling on the instrument the host query function. In the first case the host will have to transmit to the instruments all pending test requests; in the second case the instrument will automatically require specific information for the samples placed on the sample tray and without any test requests. Details for both modalities are explained in Receive Session from DMS and Host Query paragraphs. 3.5.1 Receive Session from DMS The operator manually initiates the test order download from the DMS environment. The host will provide to the instrument all available test requests. The host can send zero or more test orders in one or more messages, but all messages will be part of the same transmission session. During a transmission session more test orders can be required for the same sample. The host sends usually all test orders for which it has not yet received results even if they have been previously transmitted. Chapter 12 – Appendix A Page 8 of 42 ACL Elite / ElitePro Service Manual ELITE/ELITE PRO instruments will process each received test order to validate fields supported; some information will be extracted from the received record while other information will be ignored. Only test orders related to patient samples are considered, if the required sample ID does not exist in the patient database and the required sample ID is not used in the QC database, a new record is created. If the database is full, the transmission session will be aborted. If the test orders are for a sample already existing in the sample data base, the new orders will be added to the existing tests but all tests already ordered or performed will remain unchanged. If a test order with more than the maximum number of programmable tests is sent, the request is rejected. The limit is 30 single tests or 10 double tests. If the test order is not recognized as one of those supported by ELITE/ELITE PRO family instruments, it is rejected. The instrument will inform the host computer using a record containing the list of rejected test orders. During a downloading session the listed error conditions can be detected, the associated instrument behavior and actions are listed as well: Error Condition Action User Message Sample ID used in the QC data base Abort communication Bad Sample ID (long, unsupported characters) Data Base full Abort communication Sample ID already used in the QC data base Invalid Sample ID Abort communication Patient record has no associated test order record Test order has no associated patient record Instrument Identifier different from ACL9000 or extended name Too many test requests for the same sample ID Unknown test request Bad Test Reject test order Patient Data Base is full Not identified sample ID for patient data No patient record for ordered tests Invalid instrument identifier - Reject test order Reject test orders - Illegal record format Abort communication Incorrect record format in host messages Abort communication Abort communication Abort communication All abort conditions imply that ELITE/ELITE PRO family instruments will send to the host computer a message with the reason for transmission interruption (see Reject Test Order) while a message is presented to the user on the instrument. When Chapter 12 – Appendix A Page 9 of 42 ACL Elite / ElitePro Service Manual transmission abort is not implied, at transmission completion one or more records will follow (see Reject Test Order) with an indication of rejected test orders. Information rejected is typically unknown test requests or test requests exceeding the sample record size in ELITE/ELITE PRO Data Management System. It must be observed that if any of this information is rejected, it does not imply that all sample data have been rejected. The set of legal test requests are normally stored while the illegal requests for the same sample ID will be rejected. It also must be underscored that ELITE/ELITE PRO limits the size of handled records (independently from the record type supported by ASTM) to 1024 byte during downloading session. Note: for the downloading the Host should send to the ELITE/ELITE PRO string information in single frame (single line) during the transmission or up to 240 bytes maximum during the transmission. 3.5.1.1 Test Request Message The Test Request Message is used by ELITE/ELITE PRO to start the test order download session. It is composed from a Message Header record, a Request Information record and a Message Terminator record. The “Request Information record” requests from the host ALL test orders available for the specific instrument. Following the ASTM specification the fields composing the Request Information are described in the following. Request Information Record: Record Type ID Sequence Number Starting Range ID Number Ending Range ID Number Universal Test ID Nature of Request Time Limit Beginning request Results Date and Time Requesting Physician Name User Field #1 User Field #2 Request Information Status Code always set to ‘Q’ as defined by the standard set to ‘1’ when query is sent set to the string ‘ALL’ not provided not provided not provided not provided not provided not provided not provided always set to ‘O’ (requesting test orders and demographics only) An example for the complete message (composed by header message, request information record and message terminator record) is given by: Chapter 12 – Appendix A Page 10 of 42 ACL Elite / ElitePro Service Manual H|\^&|||ACL9000|||||||P|1|19960210103227<CR> Q|1|ALL||||||||O<CR> L|1|N<CR> 3.5.1.2 Test Order Message To answer the ELITE/ELITE PRO Test Request Message, the host computer sends the Test Order Message. It contains the records specifying which tests are being requested for each specified sample. The host computer may answer with one or more message; each one contains one or more test order specifications. The test order specification consists of a Patient Information record followed by one or more Test Order records. The host can send for the same sample ID a Patient Information record followed by many Test Order records or, for each test to be ordered, a pair composed by the Patient Information record followed the Test Order record. Comment Record messages during downloading operations are ignored by ELITE/ELITE PRO. 3.5.1.2.1 Patient Information Record The fields characterizing this record are specified in the following: Patient Information Record: Record Type ID Sequence Number Practice Assigned Patient ID Laboratory Assigned Patient ID Patient ID #3 Patient Name Must be ‘P’ Must begin with ‘1’ and then must increment by one for each new Patient Information record Ignored Stored, if available, as a string in the Patient ID field of the sample record. No checks are performed for this field and the string will be truncated to 15 characters. Ignored Stored, if available, as a unique string in the ‘name’ field of sample record considering only the first two sub fields in this data field (second and first name). The string will be truncated to 30 characters. If a character not supported is found (see Appendix for supported characters), the patient name and all the other strings in the same patient record will be ignored. If the patient name is not available 4 separators must be transmitted: ^^^^. Mother’s maiden Name Birth date Ignored Stored, if available. The data will be converted and displayed in the following in according to ELITE/ELITE PRO supported format. Expected format, conforming to ASTM Chapter 12 – Appendix A Page 11 of 42 ACL Elite / ElitePro Service Manual Patient Sex Patient Race-Ethnic Origin Patient Address Reserved Field Patient Telephone Number Attending Physician ID Special Field #1 Special Field #2 Patient Height Patient Weight Patient’s Known or Suspected Diagnosis Patient Active Medications Patient’s Diet Practice Field #1 Practice Field #2 Admission and Discharged Dates Admission Status Location Nature of Alternative Diagnostic Code and Classifiers Alternative Diagnostic Code and Classifiers Patient Religion Marital Status Isolation Status Language Hospital Service Hospital Institution Dosage Category 3.5.1.2.2 standard, is YYYYMMDD Stored if available. Allowed characters are ‘M’, ‘m’, ‘F’, ‘f’, ‘U’, ‘u’; any other character is interpreted as ‘U’. Ignored Ignored Ignored Ignored Ignored Ignored Ignored Ignored Ignored Ignored Ignored Ignored Ignored Ignored Ignored Ignored Stored if available as a free string in the ‘department’ field of sample record. The string will be truncated to 30 characters. See Appendix B for supported characters. Ignored Ignored Ignored Ignored Ignored Ignored Ignored Ignored Ignored Test Order Record The fields characterizing this record are specified in the following: Test Order Record: 1. Record Type ID 2. Sequence Number 3. Specimen ID Must be ‘O’ (letter) Must begin with ‘1’ and then must increment by one for each new test order record for the same patient This is the ELITE/ELITE PRO sample ID; the field must be less than or equal to 15 Chapter 12 – Appendix A Page 12 of 42 ACL Elite / ElitePro Service Manual 4. Instrument Specimen ID 5. Universal Test ID 6. Priority 7. Requested/Ordered Date and Time 8. Specimen Collection Date and Time 9. Collection End Time 10. Collection Volume 11. Collector ID 12. Action Code 13. Danger Code 14. Relevant Clinical Information 15. Date/Time Specimen Received 16. Specimen Descriptor 17. Ordering Physician 18. Physician’s Telephone Number 19. User Field No. 1 20. User Field No. 2 21. Laboratory Field No. 1 22. Laboratory Field No. 2 23. Date/Time Results Reported or Last Modified 24. Instrument Charge to Computer System 25. Instrument Section ID 26. Report Types 27. Reserved Field 28. Location of Ward of Specimen Collection 29. Hospital Information Flag 30. Specimen Service 31. Specimen Institution characters and must be consistent with rules on sample ID (ID already in use for QC database are not legal). Non conforming sample IDs will cause an abort of the download process. See Appendix B for ELITE/ELITE PRO supported characters. Ignored The field is composed of 4 parts; only the Manufacturer’s Code component is used as a 4 character code (user configurable on board); unknown test ID will be rejected. If the field contains in any of the sub fields the S char the sample ID will be considered a priority sample; any additional flag will be ignored. If the field does not contain the S char or it is empty, the sample will be identified as a routine sample. Ignored Ignored Ignored Ignored Ignored Ignored Ignored Ignored Ignored Ignored both fields Stored if available as a free string in the ‘physician’ field of sample record. The string will be truncated to 30 characters. See Appendix for supported characters. Ignored Ignored Ignored Ignored Ignored Ignored Ignored Ignored Set to O (letter); other codes will cause records rejection Ignored Ignored Ignored Ignored Ignored Chapter 12 – Appendix A Page 13 of 42 ACL Elite / ElitePro Service Manual An example for a complete test ordering is given by: H|\^&||||||||ACL9000||P|1|19982110134700<CR> P|1||PTNT1||ROSSI^MARIO^^^||19391127|M|||||||||||||||||DEP 1||||||||||<CR> O|1|SMP01||^^^0001|S||||||||||^|DR. VERDI||||||||||O||||||<CR> O|5|SMP02||^^^0001|||||||||||^|||||||||||O||||||<CR> P|2||PTNT2||GIALLI^LUCA^^^||19551028|F||||||||||||||||||DEP 2||||||||||<CR> O|1|SMP10||^^^0001|||||||||||^|||||||||||O||||||<CR> L|1|N<CR> Example of download without patient name: H|\^&||||||||ACL9000||P|1|20021205123956<CR> P|1||||^^^^|||||||||||||||||||||||||||||<CR> O|1|LAURA01||^^^0001|||||||||||^|||||||||||O||||||<CR> L|1|N<CR> Note: Separators are always expected from Host and are always transmitted independently from the information contained in the string. Chapter 12 – Appendix A Page 14 of 42 ACL Elite / ElitePro Service Manual 3.5.2 Host Query Host query is automatically activated by the instrument each time the system is properly configured. Beginning the pre-analysis phase of a single test or profile or test group, one or more samples have no type of test requests associated. The instrument will send, using the requested information record, the sample IDs requiring test programming and will accept only test orders for those sample IDs. The instrument will accept for the queried samples any test orders independently by the type of test which will be executed in the starting session. The mechanism supported by ASTM requires sending to the host a Request Information record for each sample ID or sending to the host a range of queried sample IDs. The mechanism supported by ELITE/ELITE PRO is the first option, so will be independent of the sorting system used by instrument or host computer on the samples. As a consequence the instrument will send a query for the first sample, will wait for the host information and will send later a new query for the next samples (if any). All the host query sessions will be organized in this manner. Because the instrument is asking for information regarding a specific sample ID, it will reject any type of information associated with different sample IDs. The host will provide to the instrument all available test requests. The host can send zero or more test orders in one or more messages, but all messages will be part of the same transmission session. During a transmission session more test orders can be required for the same sample. ELITE/ELITE PRO will process each received test order validating the fields that ELITE/ELITE PRO supports; some information will be extracted from the received record while other information will be ignored. If the test order is not recognized as one of those supported by ELITE/ELITE PRO it will be rejected. The instrument will inform the host computer using a record containing the list of rejected test orders. Host Query is only performed if the Sample ID is not located in the database for the ACL system. During a download session the listed error conditions can be detected, the associated ELITE/ELITE PRO action is listed as well: Chapter 12 – Appendix A Page 15 of 42 ACL Elite / ElitePro Service Manual Error Condition Action User Message Sample ID used in the QC data base Abort communication Bad Sample ID (long, unsupported characters) Data Base full Abort communication Sample ID already used in the QC data base Invalid Sample ID Patient record has no associated test order record Test order has no associated patient record Instrument Identifier different from ACL9000 or extended name Too many test requests for the same sample ID Unknown test request Bad Test Illegal record format Abort communication Abort communication Abort communication Abort communication Reject test order Reject test order Reject test orders Abort communication Patient Data Base is full Not identified sample ID for patient data No patient record for ordered tests Invalid instrument identifier Incorrect record format in host messages All abort conditions imply that ELITE/ELITE PRO family instruments will send to the host computer a message with the reason of transmission interruption (see Reject Test Order) while a message is presented to the user on the instrument. When transmission abort is not implied, at transmission completion one or more records will follow (see Reject Test Order) with an indication of rejected test orders. Information rejected is typically unknown test requests or test requests exceeding the sample record size in ELITE/ELITE PRO Data Management System. It must be observed that if any of this information is rejected, it does not imply that all the sample data have been rejected. The set of legal test requests are normally stored while the illegal requests for the same sample ID will be rejected. It also must be underscored that ELITE/ELITE PRO limits the size of handled records (independently from the record type supported by ASTM) to 1024 byte during downloading session. Note: If the Sample ID is not present at the Host level during the Host Query, the Host will return only the Header and the terminator. H|\^&||||||||ACL9000||P|1|20021205123956<CR> L|1|N<CR> Note: If the Host requests a test that is disabled on the ELITE/ELITE PRO, the test will not be programmed on the ELITE/ELITE PRO and a reject message of this type will be returned back to the Host. Chapter 12 – Appendix A Page 16 of 42 ACL Elite / ElitePro Service Manual C|1|I|UKNOWN_T|PatientID^0080|I<CR> 3.5.3 Test Request Message The Test Request Message is used by ELITE/ELITE PRO to require information for each specific sample that has no test orders in the instrument database. It is composed from a Message Header, a Request Information and a Message Terminator record. The Request Information record requests in this case information for one specific ID at time. The ASTM protocol limits the number of Request Information records to one. As a consequence the instrument will wait for the host answer before sending a second Request Information record for a second sample. Following the ASTM specification the fields composing the Request Information are described in the following. Request Information Record: Record Type ID Sequence Number Starting Range ID Number Ending Range ID Number Universal Test ID Nature of Request Time Limit Beginning request Results Date and Time Requesting Physician Name User Field #1 User Field #2 Request Information Status Code always set to ‘Q’ as defined by the standard set to ‘1’ when query is sent set to the specific sample ID to require information on; the meaningful component is the second one not provided not provided not provided not provided not provided not provided not provided always set to ‘O’ (requesting test orders and demographics only) An example for the complete message (composed by header message, request information record and message terminator record) is given by: H|\^&|||ACL9000|||||||P|1|19960210103227<CR> Q|1|^S001^||||||||O<CR> L|1|N<CR> Answer from Host: H|\^&||||||||ACL9000||P|1|19960210103256<CR> P|1||||ROSSI^MARIO^^^||19391127|M|||||||||||||||||DEP 1||||||||||<CR> O|1|S001||^^^0001|||||||||||^| DR. VERDI ||||||||||O||||||<CR> O|5|S001||^^^0002|||||||||||^|||||||||||O||||||<CR> L|1|N<CR> Chapter 12 – Appendix A Page 17 of 42 ACL Elite / ElitePro Service Manual 3.5.4 Test Order Message As an answer to the ELITE/ELITE PRO Test Request Message the host computer sends the Test Order Message. It contains the records specifying which tests are being requested for the queried Sample ID. See Test Order Message for details. 3.6 Rejected Test Order At completion of download operations, or at completion of the download operation for a single sample in the host query mechanism, ELITE/ELITE PRO can transmit a message to inform host computer about rejected test orders and samples or about the reasons for transmission interrupt. The Rejected Test Order Message consists of a Message Header record followed by one or more Comment records and completed by the Message Terminator Record. A comment record will be transmitted for each rejected information. It must be observed that if no legal information has been received, the download process is interrupted and the rejected test order message will signal the reason for the interruption. If the download process has been completed normally, the possible following rejected test order message will report no legal test orders. Comment Record structure is described in the following table: Record Type ID Sequence Number Comment Source Comment Text Always set to ‘C’ Must begin with ‘1’ and then it will increment by one for each new comment record Always set to ‘I’ (as ASTM: clinical instrument system) This field indicates the reason of the test order rejection. It is a string with two components, each one can assume the reported values: Rejection Reason: BAD_TEST: the transmitted test code is invalid QC_MA_ID: the specified ID is already used as a material in the QC data base BAD_S_ID: the specified ID is invalid WRONG_ID: the host is sending information for a sample ID different from the expected one PDB_FULL: patient data base is full M_TEST_E: more tests than expected UKNOWN_T: unknown test requested INSTR_ID: invalid instrument identifier NO_TESTS: no test ordered for patient record Chapter 12 – Appendix A Page 18 of 42 ACL Elite / ElitePro Service Manual NO_PATIE: no patient record for ordered test BAD_RECO: incorrect record format Identification: This string contains the identification of the sample causing the problem; if a test order caused the problem the sample ID and test ID are transmitted sequentially. The character used to separate the rejection reason, and the two strings used for the identification field is ‘|‘. Lacking information will be signaled as “UNKNOWN”. If BAD_RECO is the reason of the rejection the field will contain the record number and the field number caused the failure. Always set to ‘I’ (as ASTM: instrument flag comment) Comment Type To summarize the possible values for the rejection reason and identification fields are reported in the following table: Rejection Reason QC_MA_ID Transmissio n Interrupted yes BAD_S_ID yes PDB_FULL yes NO_TESTS NO_PATIE yes yes INSTR_ID M_TEST_E UNKWOWN_T BAD_TEST BAD_RECO yes no no no yes Identification: first sub_field Identification: second sub_field sample ID (causing the problem) sample ID (causing the problem) sample ID (causing the problem) UNKNOWN sample ID (causing the problem) UNKNOWN sample ID sample ID sample ID Record No. (debug purpose) UNKNOWN UNKNOWN test_ID UNKNOWN test_ID UNKNOWN test ID (causing the problem) test ID (causing the problem) test ID (causing the problem) Field No. (debug purpose) An example for a complete rejection phase is given by: H|\^&|||ACL9000|||||||P|1|19982110103227<CR> C|1|I|M_TEST_E|SMP01 ^010|I<CR> C|2|I|BAD_TEST|SMP01 ^000|I<CR> L|1|N<CR> 3.7 Download Session Volumes Approximate data volumes for download sessions is provided as a guide for estimating the time required completing typical sessions. System latencies (both in ELITE/ELITE PRO and host computer) are not considered. The minimal session would occur if the host has no test orders available for ELITE/ELITE PRO. In this condition ELITE/ELITE PRO sends the test request Chapter 12 – Appendix A Page 19 of 42 ACL Elite / ElitePro Service Manual message, the host would respond with a message containing no test orders (only message header and message terminator record). In conditions in which the host has test orders for the instrument, the estimated data volume is: Test Request Message = Message Header (41) +17 + Message Terminator Record (6) = 64 Test Order Message = Message Header (41) + Number of patient records (82 + 55 *number of ordered test) + Message Terminator Record (6) Test Order Rejected = Message Header (41) + + 41 * number of rejected records + Message Terminator Record (6) So considering the following situation: the host has 50 sample IDs to be download, each one with 4 tests, consider 10 rejected records the data volume can be estimated in: Test Request Message = 64 Test Order Message = 41+ 50 (82 + 55 *4) + 6 = 15147 Test Order Rejected = 41 + (41 * 10) + 6 = 457 Total = 15668 characters At 9600 “baud rate” and with no system overhead it would take approximately 17 seconds and considering a system efficiency of 60% it becomes about 27 seconds. All estimations have been done using the maximum expected length for string fields. 4.0 Test Results Uploading Test Result Uploading allows transmission of results of the tests performed on ELITE/ELITE PRO to the host computer. Results, related to patient, QC samples and Analytical Reference materials, are transmitted on explicit user request or automatically at session completion. In the first case the user must require the transmission command in the DMS or in the QC or in the AR environment, select the patient samples or QC samples or AR set of data to be transmitted (in according with one of the supported selection criteria) and start operation. In the second case the transmission will happen automatically at session completion and the instrument will provide to upload patient and/or QC samples data and/or AR data. The type of data to be transferred during an automatic upload session depends upon the instrument set-up (the automatic data transmission can be set to “patient samples only” or “QC and patient samples” or “QC and AR patient samples”). If upload is manually requested, all data are transmitted independently from the transmission flag. Chapter 12 – Appendix A Page 20 of 42 ACL Elite / ElitePro Service Manual If transmission is performed automatically at session completion, the instrument will upload for patient samples all the data available for the sample IDs just analyzed and will upload, for QC data, the results just obtained. From a general point of view the automatic data transmission of the patient samples is equivalent to the manual data transmission, requested in DMS, of patient samples belonging to a specific load-list. While the automatic data transmission of the QC data or AR data is equivalent to the manual data transmission, requested in QC database or AR database, or the data in a specified interval for the QC material present in the load-list. Considering that ELITE/ELITE PRO fills the strings used for Sample ID, department and patient name with space characters (to align data), the host computer must ignore space characters on the right of these fields. If uploading is completed successfully for patient, QC samples and AR data, the transmission flag associated to the single record will be updated from ‘L’ to ‘T’ (transmitted). It must also to be underscored that on ELITE/ELITE PRO, modifications to sample data already transmitted (such as adding of a new test result or modifications of sample data) cause the transmission flag to change from ‘T’ to ‘L’. It does not apply to QC or AR data because the only modification the user can request on these data is to omit or to clear statistic. The effect of omit operation is to exclude the data from the statistic but the data is not modified. Modifications in the set-up values and note field do not modify the transmission status of QC data and AR data. While transmission is in progress the user will be updated on the number of the sample being transmitted. ELITE/ELITE PRO does not accept inquiries for test results. 4.1 Test Result Message The Test Result Message is used by ELITE/ELITE PRO to transmit any available test results for a sample. All available test results will be transmitted for patient samples even if data have been already transmitted partially. The message consist of a Message Header record, a Patient Information record, one or more pair Test Order records followed by one or more Results records (depending upon the number of available test results and the number of results for each specific test). The Result record can be completed with a Comment record containing flags associated to the executed test. Tests are uploaded using the same sorting used on board. The complete set of available test results is globally uploaded to the host computer independently by the set of results defined as to show in the sample list. In some conditions, depending by the instrument status (i.e. calibrated, not calibrated, AR used, etc.) only a subset of the results supported by the test will be transmitted to the host computer. Chapter 12 – Appendix A Page 21 of 42 ACL Elite / ElitePro Service Manual The Message Terminator record completes the transmitted data. The same structure is used also to upload QC and AR data. In the following paragraphs any differences in the way to treat patient, QC and AR data will be underlined. 4.1.1 Patient Information Record This information is transmitted to the host only if available on the instrument. The Patient Information structure is: Patient Information Record: File Type Patient Sample QC Sample or AR Record Type ID Sequence Number Must be ‘P’ Must begin with ‘1’ and then must increment by one for each new Patient Information record must be ‘P’ must begin with ‘1’ and then must increment by one for each new Patient Information record not provided not provided Practice Assigned Patient ID Laboratory Assigned Patient ID Patient ID #3 Patient Name Not provided Provided if defined as a string containing up to 15 characters. Not provided Provided if known as a single string containing up to 30 characters Mother’s Maiden Name Not provided Birth date Provided if known as a single string without any checks Patient Sex Provided if known as a single character Patient Race-Ethnic Origin Not provided Patient Address Not provided Reserved Field Not provided Patient Telephone Number Not provided Attending Physician ID Not provided Special Field #1 Not provided Special Field #2 Not provided Patient Height Not provided Patient Weight Not provided Patient’s Known or Suspected Not provided Diagnosis Patient Active Medications Not provided Patient’s Diet Not provided Practice Field #1 Not provided Practice Field #2 Not provided Admission and Discharged Not provided Chapter 12 – Appendix A not provided not provided not provided not provided not provided not provided not provided not provided not provided not provided not provided not provided not provided not provided not provided not provided not provided not provided not provided not provided Page 22 of 42 ACL Elite / ElitePro Service Manual Dates Admission Status Location Nature of Alternative Diagnostic Code and Classifiers Alternative Diagnostic Code and Classifiers Patient Religion Marital Status Isolation Status Language Hospital Service Hospital Institution Dosage Category 4.1.2 Not provided Provided if known as a 30 characters free string not provided not provided Not provided not provided Not provided not provided Not provided Not provided Not provided Not provided Not provided Not provided Not provided not provided not provided not provided not provided not provided not provided not provided Test Order Record The fields characterizing this record are specified in the following: Test Order Record: File Type Patient Sample Record Type ID Sequence Number Must be ‘O’ Must begin with ‘1’ and then must increment by one for each new test order record for the same patient Provided, is the ELITE/ELITE PRO sample ID. See Appendix for ELITE/ELITE PRO supported characters. Specimen ID Instrument Specimen ID Universal Test ID Priority Requested/Ordered QC Sample or AR data Must be ‘O’ Must begin with ‘1’ and then must increment by one for each new test order record for the same patient Provided, is the ELITE/ELITE PRO QC material ID for QC data; or is the ‘AR’ keyword for AR data. See Appendix for ELITE/ELITE PRO supported characters. Not provided Not provided The field is composed of 4 The field is composed of 4 parts, only the parts; only the Manufacturer’s Code Manufacturer’s Code component is used as a 4 component is used as a 4 character code (host codes are character code (host codes user configurable on board). are user configurable on board). Provided if set as a ‘S’ char Not provided for priority samples. Not provided Not provided Chapter 12 – Appendix A Page 23 of 42 ACL Elite / ElitePro Service Manual Date/Time Specimen Collection Date and Time Collection End Time Collection Volume Collector ID Action Code Danger Code Relevant Clinical Information Date and Time Specimen Received Specimen Descriptor Ordering Physician Physician’s Telephone Number User Field #1 User Field #2 Laboratory Field #1 Laboratory Field #2 Date/time Results Reported or Last Modified Instrument Charge to Computer System Instrument Section Report Type Reserved Field Location of Ward of specimen Collection Hospital Information Flag Specimen Service Specimen Institution 4.1.3 Not provided Not provided Not provided Not provided Not provided Not provided Not provided Not provided Not provided Not provided Not provided Set to ‘Q’ Not provided Not provided Not provided Not provided Not provided both fields Provided, if available, as a string containing up to 30 chars Not provided Not provided both fields Not provided Not provided Not provided Not provided Not provided Not provided Not provided Not provided Not provided Not provided Not provided Not provided Not provided Not provided Set to F Not provided Not provided Not provided Set to F Not provided Not provided Not provided Not provided Not provided Not provided Not provided Not provided Not provided Result Record The fields characterizing this record are specified in the following table. A result record is send to the host computer for each available test result. For double tests all available single values will be transmitted to the host computer (no mean values). Each result record will contain one of available test results. Result Record: File Type Patient Sample QC Sample or AR data Record Type ID Sequence Number Set to ‘R’ Must begin with ‘1’ and Set to ‘R’ Must begin with ‘1’ and Chapter 12 – Appendix A Page 24 of 42 ACL Elite / ElitePro Service Manual Universal Test ID Data or Measurement Value Units Reference range Result Abnormal Flag Nature of Abnormality Flag Result Status Data of Change in Instrument Normative Values or Units Operator Identification Date/Time Test Started Date/Time Test Completed Instrument Identification then must increment by one for each result record for the same patient test record for the same patient record The field is composed of 4 parts, only the Manufacturer’s Code component is used as a 4 character code (host codes are user configurable on board). The field contains the obtained numeric value or qualitative message (Error xx). All numerical results are sent. * Provided if the previous field is a numeric value; is a free string (see Appendix C for standard units) maximum number of characters is 8). Not provided Not provided Not provided Set to ‘F’ Not provided then must increment by one for each result record for the same patient test record for the same patient record The field is composed of 4 parts, only the Manufacturer’s Code component is used as a 4 character code (host codes are user configurable on board). The field contains the obtained numeric value or qualitative message (Error xx). All numerical results are sent. * Provided if the previous field is a numeric value; is a free string (see Appendix C for standard units) maximum number of characters is 8). Not provided Not provided Not provided Set to ‘F’ Not provided Not provided Not provided Execution time, string of the type YYYYMMDDHHMMSS Not provided Not provided Not provided Execution time, string of the type YYYYMMDDHHMMSS Not provided * Specific ranges must be set at the Host level. 4.1.4 Comment Record The Comment record allows integration of the transmitted test results with possible error messages. One or more comment records can follow the result records. Fields characterizing this record are specified in the following. Comment Record: Record Type ID Sequence Number set to ‘C’ must begin with ‘1’ and then must increment by one Chapter 12 – Appendix A Page 25 of 42 ACL Elite / ElitePro Service Manual Comment Source Comment Text Comment Type for each comment record set to ‘I’ this field specifies the instrument errors (see table) as a numeric code (2 characters) plus the associated message set to ‘I’ Chapter 12 – Appendix A Page 26 of 42 ACL Elite / ElitePro Service Manual 4.1.5 Error Codes TEMPERATURE WARNING ROTOR STACK TEMPERATURE Out of Range SLIDER TEMPERATURE Out of Range REAGENT TEMPERATURE Out of Range INCUBATION TEMPERATURE Out of Range = = = = 41, 43, 45, 49, = = = = = = = = = = = 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, = = = = = = = = = 73, 74, 75, 76, 77, 78, 79, 80, 83, = = 86, 87, = = = = = = = = = = = = 98 99 205, 206, 207, 208, 209, 210, 211, 212, 213, 214, MECHANICAL WARNING AUTOSAMPLER WARNING ROTOR MOTOR WARNING HORIZONTAL MOTOR WARNING VERTICAL MOTOR WARNING REAGENT DILUTOR WARNING SAMPLE DILUTOR WARNING PHOTOMETRIC COVER WARNING STIRRER1_FAIL STIRRER2_FAIL STIRRER3_FAIL STIRRER4_FAIL LIQUID WARNING LIQUID_SENSOR OFF (SAMPLE) LIQUID_SENSOR OFF (REAGENT) LIQUID_SENSOR_FAIL (SAMPLE) LIQUID_SENSOR_FAIL (REAGENT) MATERIAL_SHORT MANDATORY_MATERIAL_SHORT FLUSH_PRE_WARNING FLUSH WARNING CLEANING_NOT_PERFORMED MISCELLANEOUS WARNING COVER_OPEN_DURING_LOADING_OR_INCUBATION TIMEOUT_EXPIRED_DURING_LOADING ERRORS ON RESPONSE OUTSIDE SCALE RANGE LOW OUTSIDE SCALE RANGE HIGH SATURATION_ERROR FIRST_THRESHOLD_ERROR SECOND_THRESHOLD_ERROR DELTA_ERROR INITIAL_SLOPE_ERROR FINAL_SLOPE_ERROR FINAL_REACTION CURVE ERROR FIRST_DERIVATIVE_ERROR SECOND_DERIVATIVE_ERROR FIRST_PART_REACTION CURVE ERROR Chapter 12 – Appendix A Page 27 of 42 ACL Elite / ElitePro Service Manual ERRORS ON CALIBRATION CURVES INSUFFICIENT_STANDARD POINTS IN ONE_SEGMENT INVALID CURVE INSUFFICIENT DATA NUMBER OF_STANDARD OUT OF RANGE INVALID_TRANSLATION_OR_MANDATORY_STANDARD INVALID_STD_INSUFFICIENT_REPLICATES INSUFFICIENT_REPLICATES INVALID_REPLICATES CV_OUT_OF_RANGE SLOPE OUT OF RANGE: INVALID CALIBRATION CURVE R2_OUT_OF_RANGE NOT MONOTONIC CURVE = = = = = = = = = = = 215, 216, 217, 219, 220, 221, 222, 223, 225, 226, 228, ERRORS ON ANALYTICAL REFERENCE, QC, RATIO AND NORMALIZED RATIO AR_INVALID AR_OUT_OF_RANGE AR_NOT_CHECKED DUPLICATE OUT OF RANGE QC_INVALID QC_OUT_OF_RANGE RATIO_CALCULATION_ERROR RATIO_CALCULATION_ERROR: S/Sa out of range NORMALIZED RATIO ERROR: AR/Ara out of range NORMALIZED RATIO: CALCULATION ERROR STD_NOT_FOUND AR_NOT_FOUND ACTIVATE SAMPLE NOT_FOUND ARa_NOT_FOUND RATIO_NOT_FOUND AR_OUT_OF_RANGE AR_NULL STD_NULL SAMPLE_NULL REF_NULL AR_RATIO_ NULL_ ACTIVATED_AR NULL_ NULL_DIFFERENCE = = = = = = = = = = = = = = = = = = = = = = = 229, 230, 233, 239, 240, 242, 249, 250, 251, 252, 253, 254, 255, 256, 257, 258, 259, 260, 262, 263, 264, 265, 266, Out of range indications referring to normal or test ranges are not transmitted to the host computer. The * symbol (outside Normal Range) is presented only on the Cumulative and Sample Reports. An example for a complete test uploading sequence is given by: Chapter 12 – Appendix A Page 28 of 42 ACL Elite / ElitePro Service Manual Sample H|\^&||||||||ACL9000||P|1|19982110134700<CR> P|1||PTNT1||BLU^^^^||19391127|M|||||||||||||||||DEP 1||||||||||<CR> O|1|SMP01||^^^0001|S||||||||||^|DR. VERDI||||||||||O||||||<CR> R|1|^^^0001|12.8|||||F||||19960119114215|<CR> C|1|I|31^ Invalid for QC |I<CR> P|2||PTNT1||Gialli^^^^||19391127|M|||||||||||||||||DEP 1||||||||||<CR> O|1|SMP10||^^^0001|S||||||||||^|DR. VERDI||||||||||O||||||<CR> R|1|^^^0001|14.5|s||||F||||19960119114215|<CR> C|1|I|31^ Invalid for QC |I<CR> L|1|N<CR> QC H|\^&|||ACL9000|||||||P|1|20021205123956<CR> P|1||||||||||||||||||||||||||||||||||<CR> O|1|Normal C.||^^^0001|||||||Q||||^|||||||||||F||||||<CR> L|1|N<CR> AR H|\^&|||ACL9000|||||||P|1|20021205123956<CR> P|1||||||||||||||||||||||||||||||||||<CR> O|1|AR||^^^0001|||||||Q||||^|||||||||||F||||||<CR> L|1|N<CR> 4.2 Upload Session Volumes Approximate data volumes for upload sessions is provided as a guide for estimating the time required to complete typical sessions. Obviously, system latencies (both in ELITE/ELITE PRO and host computer) are not considered. The minimal session would occur if ELITE/ELITE PRO has no test results to be transmitted; no data is sent and the data volume is zero. In conditions in which the ELITE/ELITE PRO has results to be transmitted, the data volume can be estimated on the Test Order and Test Result record size base. Test Order Message = Message Header (41) + Number of patient records (82 + Results) + Message Terminator Record (6) Results = number of ordered test (55 + 60*number of test result + 56* number of error messages) Consider the following situation: ELITE/ELITE PRO has 50 sample IDs to be uploaded each with 4 tests, each test with 3 results and each test with 2 flags, the data volume can be estimated in: Chapter 12 – Appendix A Page 29 of 42 ACL Elite / ElitePro Service Manual Test Result Message = 41+ 50 (82 + 4(55 + 60*3 + 56*2)) + 6 Total = 69547 characters At 9600 “baud rate” and with no system overhead it would take approximately 73 seconds and considering a system efficiency of 60% it becomes about 116 seconds. 5.0 Not Supported Records The Scientific record and the Manufacturer Information record are not supported by ELITE/ELITE PRO protocol. As a consequence the instrument ignores any type of information they contain. 6.0 Transmission Abort The download or upload transmission session can be interrupted for an explicit user request detected on the instrument, because the host computer is not responding or because the host computer required interruption of the transmission process. Further, as reported above, the download process can be interrupted because an illegal sample Identifier has been received. Instrument behavior in this particular condition was defined in and Reject Test Orders. ELITE/ELITE PRO family instruments behavior in each of the listed conditions is described in the following: Condition Action ELITE/ELITE PRO’s operator requested stop download process ELITE/ELITE PRO will signal the end of transmission to the host and will discard any following messages. The host must consider the interrupt request. It must be emphasized that ELITE/ELITE PRO will signal the transmission interruption with a message that is a rejected test order message if any information has been rejected or with a message header plus a message terminator record if no information has been rejected. ELITE/ELITE PRO will complete the message in progress with the message terminator and will not transmit any further test results. During download and upload transmission sessions, operation by ELITE/ELITE PRO is stopped. If download was in progress, no rejected test messages will be transmitted. ELITE/ELITE PRO ’s operator requested stop upload process Host computer is not responding Host computer required EOT A message will inform the user that the transmission has been interrupted: “Host Computer not responding” Both during download and upload sessions, operation by ELITE/ELITE PRO is stopped. If download was in progress, no Chapter 12 – Appendix A Page 30 of 42 ACL Elite / ElitePro Service Manual rejected test messages will be transmitted. It must be emphasized that the host computer must request the transmission interruption with a message composed by a message header plus a message terminator record. Incorrect record format 7.0 A message will inform the user that the transmission has been interrupted: “Host Computer required interrupt transmission” Transmission/reception is aborted and the user is informed: “Incorrect format in host messages” Appendix- ELITE/ELITE PRO Test Codes Test codes are user definable. Codes from 1 to 500 are assigned to IL pre-defined tests. Codes greater than 500 are assigned to the user definable tests. IL Library proposes the default test codes reported in the following table. Test Code 001 002 003 004 005 006 007 008 009 010 011 012 013 014 015 016 017 018 023 024 Test Code for host 0001 0002 0003 0004 0005 0006 0007 0008 0009 0010 0011 0012 0013 0014 0015 0016 0017 0018 0023 0024 Test ID (8 char. max) PT PT e PT d PT ed PT HS PT HS e PT HS d PT HS ed PT HS + PT HS + e PT HS + d PT HS + ed R-PT R-PTe PT R PT R e PT R d PT R ed R-PT d R-PT ed Extended Test Name (15 char. max) PT PT Extended PT Double PT Ext. Db. PT HS PT HS Extended PT HS Double PT HS Ext. Db. PT PLUS PTPLUS Extended PT PLUS Double PT PLUS Ext. Db. Recombipl-PT Recombipl-PTex PT Rec. PT Rec Extended PT Rec. Double PT Rec Ext. Db. Rec-PT Double Rec-PT Ext Db 030 031 032 033 034 035 036 037 038 039 040 041 042 043 044 045 046 047 048 049 0030 0031 0032 0033 0034 0035 0036 0037 0038 0039 0040 0041 0042 0043 0044 0045 0046 0047 0048 0049 FIB_ FIB FIB e_ FIB e FIB d_ FIB d FIB ed_ FIB ed FIB HS_ FIB HS FIB HSe_ FIB HSe FIB HSd_ FIB HS d FIBHSed_ FIB HSed FIB HS+_ FIB HS+ FIB HS+e_ FIB HS+e FIB (PT) FIB (PT) FIB (PT e) FIB (PT e) FIB (PT d) FIB (PT d) FIB (PT ed) FIB (PT ed) FIB (PT HS) FIB (PT HS) FIB (PT HS e) FIB (PT HS e) FIB (PT HS d) FIB (PT HS d) FIB (PT HS ed) FIB (PT HS ed) FIB (PT PLUS) FIB (PT PLUS) FIB (PLUS e) FIB (PLUS e) Chapter 12 – Appendix A Page 31 of 42 ACL Elite / ElitePro Service Manual Test Code 050 051 052 053 054 055 056 057 058 059 060 061 062 063 064 065 074 075 076 077 Test Code for host 0050 0051 0052 0053 0054 0055 0056 0057 0058 0059 0060 0061 0062 0063 0064 0065 0074 0075 0076 0077 Test ID (8 char. max) FIB HS+d_ FIB HS+d FIB+ed_ FIB+ed R-FIB_ R-FIB R-FIBe_ R-FIBe FIB R_ FIB R FIB Re_ FIB Re FIB Rd_ FIB Rd FIB Red_ FIB Red R-Fibd_ R-Fibd R-Fibed_ R-Fibed Extended Test Name (15 char. max) FIB (PLUS db) FIB (PLUS db) FIB (PLUS ed) FIB (PLUS ed) Recombipl-FIB Recombipl-FIB Recombipl-FIBex Recombipl-FIBex FIB (Rec) FIB (Rec) FIB (Rec e) FIB (Rec e) FIB (Rec d) FIB (Rec d) FIB (Rec ed) FIB (Rec ed) Recombipl-FIBd Recombipl-FIBd Recombipl-FIBed Recombipl-FIBed 080 081 082 083 084 085 086 087 088 089 090 091 092 093 094 095 096 097 098 099 0080 0081 0082 0083 0084 0085 0086 0087 0088 0089 0090 0091 0092 0093 0094 0095 0096 0097 0098 0099 APTT Ly APTT Lye APTT Lyd APTTLyed APTT-SP APTT-SPe APTT-SPd APTTSPed APTT-C APTT-C e APTT-C d APTT-Ced APTTSYS APTTSYSe APTTSYSd APTTSSed APTTSYF APTTSYFe APTTSYFd APTTSFed APTT Ly APTT Ly Ext. APTT Ly Db. APTT Ly Ext.Db. APTT-SP APTT-SP Ext. APTT-SP Db. APTT-SP Ext.Db. APTT-C APTT-C Ext. APTT-C Db. APTT C-Ext.Db. APTT SynthASil APTT SynthASile APTT SynthASild APTTSynthASiled APTT SynthAFax APTT SynthAFaxe APTT SynthAFaxd APTT SynthAFaxed 102 107 112 117 0102 0107 0112 0117 FVIII SF FIX SF FXI SF FXII SF FVIII SynthAFax FIX SynthAFax FXI SynthAFax FXII SynthAFax 120 121 122 123 124 125 126 127 128 129 130 131 0120 0121 0122 0123 0124 0125 0126 0127 0128 0129 0130 0131 TT-5 TT e-5 TT d-5 TT ed-5 TT-8 TT e-8 TT d-8 TT ed-8 TT-2 TT e-2 TT d-2 TT ed-2 TT - 5 TT Ext. 5 TT Dbl. 5 TT Ext. Dbl. 5 TT - 8 TT Ext. 8 TT Dbl. 8 TT Ext. Dbl. 8 TT - 2 TT Ext. 2 TT Dbl. 2 TT Ext. Dbl. 2 150 151 152 153 0150 0151 0152 0153 PCX HPX P-ClotLy P-ClotSP Pro-IL-Complex Hepatocomplex Pro-Clot Ly Pro-Clot SP Chapter 12 – Appendix A Page 32 of 42 ACL Elite / ElitePro Service Manual Test Code 154 159 160 161 199 200 Test Code for host 0154 0159 0160 0161 0199 0200 Test ID (8 char. max) P-ClotC PS Free PS Pro S AT* AT Extended Test Name (15 char. max) Pro-Clot C Protein S Free Protein S Protein S Antithr. Liquid Antithr. In cup 201 202 203 204 205 206 0201 0202 0203 0204 0205 0206 FIB-C_ FIB-C FIB-C l_ FIB-C l FIB-C h_ FIB-C h Fib. Clauss Fib. Clauss Fib. Clauss low Fib. Clauss low Fib Clauss high Fib. Clauss high 225 208 210 212 213 214 220 221 225 250 251 275 276 0225 0208 0210 0212 0213 0214 0220 0221 0225 0250 0251 0275 0276 APCR-V HEP LMW HEP UHF PLG PL-IN P-C F8 Chr H F8 Chr L APCR V D-Dimer D-Dh F8SP-P F9SP-P APCR V Heparin LMW Heparin UHF Plasminogen Plasmin Inhib. Protein C F8Chr High F8Chr Low APCR V D-Dimer D-Dimer high FVIII SP Par FIX SP Par 300 302 304 305 0300 0302 0304 0305 FVIII Ly FVIII SP FVIII C FVIII SS F VIII - Ly F VIII - SP F VIII – C FVIII SynthASil 310 312 314 315 0310 0312 0314 0315 FIX Lyo FIX SP FIX C FIX F IX - Ly F IX - SP F IX - C FIX SynthASil 320 322 324 325 0320 0322 0324 0325 FXI Lyo FXI SP FXI C FXI SS F XI - Ly F XI - SP F XI - C FXI SynthASil 330 332 334 335 0330 0332 0334 0335 FXII Lyo FXII SP FXII C FXII SS F XII - Ly F XII - SP F XII - C FXII SynthASil 336 338 340 342 343 0336 0338 0340 0342 0343 FVII PT FVII HS FVII HSP FVII R R FVII F VII - PT F VII - HS F VII - HS Plus F VII - R FVII RecombPT 350 352 354 356 357 0350 0352 0354 0356 0357 FX PT FX HS FX HSP FX R R FX F X - PT F X - HS F X - HS Plus FX-R FX RecombPT 360 362 364 366 0360 0362 0364 0366 FV PT FV HS FV HSP FV R F V - PT F V - HS F V - HS Plus FV-R Chapter 12 – Appendix A Page 33 of 42 ACL Elite / ElitePro Service Manual Test Code 367 Test Code for host 0367 Test ID (8 char. max) R FV Extended Test Name (15 char. max) FV RecombPT 370 372 374 376 377 0370 0372 0374 0376 0377 FII PT FII HS FII HSP FII R R FII F II - PT F II – HS F II - HS Plus F II – R FII RecombPT 155 156 400 401 155 156 0400 0401 SCT-S SCT-C VWF:Ag vWF:AgH SCT Screen SCT Confirm vWF Antigen vWF Antigen Hig 410 411 0410 0411 LAC_S LAC_C LAC_S LAC Confirm Note: This table represents the situation for the IL Library 7. 8.0 Appendix – ELITE/ELITE PRO Supported Characters 8.1 Supported Characters for Sample ID The ASCII set of characters considered is in the decimal range 32 to 126, because a Sample ID can be accepted only if it contains at least one character different from a space. 8.2 Units Supported Characters for Patient name, Department and Is the ASCII set of characters considered in the decimal range 32 to 255. 8.3 ! & + @ _ Supported Characters for delimiters “ ‘ / [ { # ( : \ | $ ) ; ] } % * = ^ ~ ASCII character 127 is not allowed as delimiter. Note: Separators are always expected from Host and are always transmitted independently from the information contained in the string. Chapter 12 – Appendix A Page 34 of 42 ACL Elite / ElitePro Service Manual 9.0 Appendix - ELITE/ELITE PRO Supported Units Unit Abbreviation Time Activity Ratio International Normalized Ratio s % R INR NR mg/dL g/L ng/mL U/mL μg/L μmol/L IU/mL mg/L ug/mL Concentration Delta Optical Absorbance Delta Activated Sample Sa Curve behavior Δ Abs Δ (Δ ASCII code is 7F) Sa (Hex code EC) offset min max Final User defined free string containing up to 8 chars Notes: For duplicate (d) and extended duplicate (ed) tests only the individual replicate results are sent to the host system. The mean value is not sent from the ACL8/9/10000 system. This applies to all sample types including patient, QC and Analytical reference. Chapter 12 – Appendix A Page 35 of 42 ACL Elite / ElitePro Service Manual Chapter 12 – Appendix A Page 36 of 42 ACL Elite / ElitePro Service Manual Chapter 12 Appendix B ACL Elite / ElitePro Bar Code Label Specification (REV 0.0) Chapter 12 – Appendix A Page 37 of 42 ACL Elite / ElitePro Service Manual Index 1.0 1.1 1.2 1.3 2.0 2.1 2.2 2.3 2.4 2.5 Introduction Purpose Definitions, Acronyms and Abbreviations References General Description Supported Codes and Checksum type Barcode Symbol Specifications Barcode Parameters Barcode Label Positioning Barcode Label Dimensions 1.0 Introduction In the following sections the characteristics of the bar code labels that can be read with the Welch Allyn SCANTEAM 3700 scanner installed on ACL 9000 family instruments are described. 1.1 Purpose Purpose of this document is to give indication of the scanner characteristics in terms of readable codes, identify the requirements the barcode labels have to satisfy and define constraints in terms of label positioning within ACL 9000 instrument. 1.2 Definitions, Acronyms and Abbreviations WA Walch Allyn SCANTEAM 3700 Near Distance is the nearest distance that a scanner can accurately digitize a given bar code. Far Distance is the farthtest distance that a scanner can accurately digitize a given bar code. Scan Width is the length of the widest bar code that can be successfully interpreted by the scanner. Quiet Zone is the blank area located just before and just after the bar space pattern. Chapter 12 – Appendix A Page 38 of 42 ACL Elite / ElitePro Service Manual 1.3 References Ref. 1 2.0 SCANTEAM 3700 - Technical Manual - Walch Allyn General Description The WA is a fixed mount CCD bar code scanner with integrated decoder for easy integration into host equipment (ACL 9000 family instruments in our case). The 3700 features Walch Allyn’s time-proven decoding algorithms in a microprocessor-controlled bar code scanner/decoder and offers configurable operating parameters. The following mean features are available with every WA: • • • • • 2.1 High scan rate per second (100 is the standard) Flexible scan trigger configurations Decoder configurable for high security Scan voting to ensure bar code data integrity Ease of configuration through RS-322 interface Supported Codes and Checksum type Code Type Code 128 Code 39 Interleaved 2 of 5 Codabar Checksum Type No checksum Modulus 43 No Checksum USS - Modulus 10 OPCC - Modulus 10 No checksum AIM - Modulus 16 with start/stop digits NW7 - Modulus 11 NW7 - Modulus 16 with start/stop digits No Checksum Chapter 12 – Appendix A Data Digits up to 15 up to 15 up to 15 up to 15 up to 15 up to 15 up to 15 up to 15 up to 15 up to 15 Page 39 of 42 ACL Elite / ElitePro Service Manual 2.2 Bar Code Symbol Specifications All bar code symbols have to satisfy the appropriate AIM Uniform Symbology Specification. In particular the following characteristics have to considered: • Background substrate The barcode symbol should be printed on a material type that is reflective and has a matte (not glossy) finish. A background diffuse reflectance of at least 70% to 80% is suggested for optimum contrast. • Ink color and type The ink type has to be compatible with 660 nm LEDs used in the scanner. The barcode symbols inked bars should not exceed 10% reflectance at 660 nm that is being used for reading, whether printed with black ink or colored ink. • Voids and Specks The code has to be printed clearly, free of voids, specks, blemishes and lines which could “fool” the scanner. • Definition The bars in the barcode symbols should be well defined. Their edges should not be rough or fuzzy, so that bar and spaces have the proper widths intended for the used barcode symbology used. Definition should be sharp and consistent. • Tolerance The ratio of the widths and spaces in a barcode symbol must conform to the appropriate AIM barcode specifications and can cause problems if not correct throughout the barcode. Problems can occur if bar edges are smeared or rough, or when they exhibit voids. Chapter 12 – Appendix A Page 40 of 42 ACL Elite / ElitePro Service Manual 2.3 Barcode Parameters Parameters have to be considered in that context are: • Density (bar code): refers to the number of cheracters in a linear inch of bar code. • Ratio: refers to the ratio of the nominal wide element width to the nominal narrow element width. In order to ensure a good bar code reading (in addition to what indicated in the 2.2 section) the parameters above mentioned should be as follows: • Density: not less 10 Mils • Ratio: not less 2.5 These values are valid for all the above mentioned bar code types. The relationship between reading distances, scan width and bar code density are displayed in the following: Near Distance Far Distance 63.5 mm (161.29’’) 34.3 mm (87.122’’) 114.5 mm (290.83’’) 130.3 mm (330.962’’) Scan Width (near distance) 101.6 mm (258.064’’) 82.3 mm (209.042’’) Scan Width (far distance) 152.4 mm (387.096’’) 178.3 mm (452.882’’) Density (bar code) 7.5 MIL 13 MIL In Appendix Decoder Zone Map the attached drawing defines the “decoder zone map” for the data above displayed. The displayed graph has been experimentally obtained from Welch Allyn Laboratories because the WA equipped for the IL requirement has not a standard optics. Chapter 12 – Appendix A Page 41 of 42 ACL Elite / ElitePro Service Manual 2.4 Barcode Label Positioning In Appendix Barcode Label Dimension the attached drawing defines the barcode labels dimensions and identifies constraints in positioning labels on vacutainers. The 13x75 vacutainers have been considered. The proposed barcode labels dimension and positioning apply to all sample tray models. The following measurements are reported: Barcode label feature Maximum label length (global label size) Maximum barcode length (printed area) Quite zone (white area before and after the printed area) Label position (it is identified as the label edge measured starting from the vacutainer lower part) 2.5 Dimension 52.6 mm (2.071”) 39.6 mm (1.559”) 6.35 mm (0.256”) 58 mm (2.283”) Barcode Label Dimensions Quite Zone 6.5 mm (.256”) Label Length 52.6 mm max (2.071”) Barcode Length 39.6 mm max (1.559”) Quite Zone 6.5 mm (.256”) Tube L standard - 13x75 mm Vacutainers Label position 58 mm (2.283”) Chapter 12 – Appendix A Page 42 of 42