Nucleic Acid Isolation System Operation Manual Zybio Inc. Product Description Thank you for purchasing Zybio.Inc (hereinafter referred to as “Zybio”) Nucleic Acid Isolation System. Allow us to express our appreciation. Please read this operation manual carefully before using the product. The pictures in this operation manual are used for illustration or example only and are not intended for other purposes. Please consult the actual product for accurate display. Please consult this operation manual whenever necessary. Product Name: Nucleic Acid Isolation System. Specifications and Models:EXM 3200,EXM 3000. Administration Class: The administration category is class I. Manufacturer: Zybio.Inc. Product composition: The product is composed of a mechanical part, an electrical part and a software part. It is used in conjunction with the kit to achieve the separation and extraction of nucleic acids in the sample. The mechanical part is composed of the shell (including the warehouse door), the frame, the motor movement component, the magnet rob component, and the heat transfer component. The electrical part is composed of display screen assembly, heating module, ultraviolet module, lighting module and negative pressure exhaust module. The software of this product is an embedded software. Scope: Used to extract nucleic acid from clinical samples. Registrant / manufacturer Address: Floor 1 to Floor 4, Building 30, No.6 of Taikang Road, Block C of Jianqiao Industrial Park, Dadukou District, Chongqing, China 400082 Production date: refer to product label Service life: 6 years, as determined by lifetime testing. During use, you shall maintain, care and repair this product in accordance with the requirements in this manual to ensure the safety and effectiveness. Operation manual issued date: 2020-5 I Intellectual Property The intellectual property rights of this operation manual and its corresponding products belong to Zybio Inc. (hereinafter referred to as “Zybio”). Zybio Inc. all rights reserved. Nobody can use, disclose or permit others to obtain all or part of the information in this operation manual without the prior written permission of Zybio. Nobody shall, in whole or in part, including but not limited to, take photographs, make copies, reproduce or translate into other languages of this operation manual. is a registered trademark or brand of Zybio. Statement Zybio has the final right to interpret this manual. Zybio will be responsible for the safety, reliability and performance of this product only if all of the following requirements are met, namely: 1) The installing, debugging, expanding, and maintaining of this product shall be carried out by personnel approved by Zybio; 2) All parts, accessories and consumables for maintenance shall be produced or approved by Zybio; 3) The operation of this product shall be carried out in accordance with this operation manual; 4) The relevant electrical equipment shall comply with the national standards and the requirements of this operation manual. Warranty and Services The warranty period of your analyzer shall be subject to the sales contract. Consumable materials: refer to disposable materials or materials that need to be replaced regularly, consumable materials have no warranty. The warranty period starts from the “Date of installation” filled in the “Warranty Card” attached to this product. The “Warranty Card” is the only warranty certificate, and must not be lost. In order to protect your rights and interests, please urge the installation personnel to return the second copy of the Warranty Card to the II company within 30 days from the date of installation; If the "Warranty Card" corresponding to the product you purchased fails to be returned to the company on time, the warranty period will be extended from the "out-of-stock date" of the equipment packaging box by 45 days. During the warranty period, you can enjoy free service; but please note that even during the warranty period, Zybio will charge for the situation that the product needs to be repaired due to the following reasons. Human error; Improper use; Voltage mismatch; Force majeure such as natural disasters; Replace or use parts, accessories, consumables not approved by Zybio or repaired by non-Zybio authorized personnel; Other non-product issues. After the warranty period expires, Zybio can continue to provide repair services for a fee. If you do not pay or delay the payment of the paid maintenance service fee, Zybio will temporarily suspend the maintenance service until you pay it. Service Provider Company Name: Zybio Inc. Address: Floor 1-4, Building 30, No. 6 Taikang Road, C Zone, Jianqiao Industrial Park, Dadukou District, Chongqing Website: www.zybio.com 24-hour service phone: 400-056-7879 Tel: +86(0)23 6865 5509 Fax: +86(0)23 6869 9779 E-mail: info@zybio.com III Warning Your analyzer should only be operated by professionals, doctors and laboratory personnel trained by Zybio or its agents. Failure to prepare a complete set of maintenance/repair plans may result in product fault or personal safety issues. Failure to operate your product under the conditions specified in this operation manual may result in product fault, unreliable test results, product damage or personal safety issues. Attention This operation manual is intended for the following personnel: 1. Operators; 2. Maintenance staff; 3. Trainees. IV Content CONTENT.......................................................................................................................................V CHAPTER 1 OVERVIEW............................................................................................................. 1 1.1 OVERVIEW............................................................................................................................... 1 1.2 SCOPE.......................................................................................................................................1 1.3 READING GUIDE.......................................................................................................................1 1.4 DECLARATION..........................................................................................................................2 1.5 COMMON OPERATIONS............................................................................................................ 2 1.6 SYMBOLS................................................................................................................................. 2 CHAPTER 2 SYSTEM OVERVIEW............................................................................................5 2.1 OVERVIEW............................................................................................................................... 5 2.2 MODEL.....................................................................................................................................5 2.2.1 Mechanical Part...............................................................................................................6 2.2.2 Electrical Part..................................................................................................................6 2.3 MAIN INDICATORS AND PERFORMANCE.................................................................................. 6 2.4 WORKING PRINCIPLE............................................................................................................... 7 2.5 SCOPE.......................................................................................................................................8 2.6 STRUCTURE..............................................................................................................................8 2.6.1 Front Diagram................................................................................................................. 8 2.6.2 Back Diagram.................................................................................................................. 9 2.6.3 Side Diagram................................................................................................................... 9 2.6.4 Iternal Diagram............................................................................................................. 10 2.6.5 Communication Interface...............................................................................................10 2.7 ELECTROMAGNETIC COMPATIBILITY.....................................................................................11 CHAPTER 3 INSTALLATION AND USE PREPARATION.................................................. 13 3.1 OPEN INSPECTION.................................................................................................................. 13 3.2 SPACE REQUIREMENTS.......................................................................................................... 13 3.3 WORKING ENVIRONMENT REQUIREMENTS............................................................................14 3.4 POWER REQUIREMENTS......................................................................................................... 15 3.5 GROUNDING........................................................................................................................... 16 3.6 CHECK THE POWER SUPPLY.................................................................................................. 16 CHAPTER 4 OPERATION GUIDE........................................................................................... 17 4.1 PRE-OPERATION..................................................................................................................... 17 V 4.2 REAGENT KIT INSTALLATION................................................................................................ 18 4.3 MAGNETIC SLEEVE INSTALLATION....................................................................................... 19 4.4 SOFTWARE OPERATION..........................................................................................................19 4.4.1 Start-up Interface........................................................................................................... 19 4.4.2 Main Function................................................................................................................ 20 4.4.3 Shortcut Start-up............................................................................................................ 21 4.4.4 List Start-up....................................................................................................................22 4.4.5 Program Running...........................................................................................................24 4.4.6 Ultraviolet sterilization.................................................................................................. 26 4.4.7 Program Management................................................................................................... 27 4.4.7.1 New Program........................................................................................................................... 28 4.4.7.2 Step Edit...................................................................................................................................29 4.4.7.3 Options..................................................................................................................................... 30 4.4.8 Settings........................................................................................................................... 30 4.4.8.1 System Time Setting................................................................................................................ 31 4.4.8.2 Language Settings.................................................................................................................... 32 4.4.8.3 About........................................................................................................................................32 4.4.8.4 Screen Calibration....................................................................................................................33 4.4.8.5 Upgrade....................................................................................................................................33 CHAPTER 5 PREVENTIVE MAINTENANCE........................................................................34 5.1 CARE AND MAINTENANCE.....................................................................................................34 5.2 FILTER COTTON REPLACEMENT............................................................................................ 34 5.3 CLEANING.............................................................................................................................. 35 5.4 DISPOSAL OF OPERATING MATERIAL.................................................................................... 36 5.5 DISPOSAL OF THE ISOLATION SYSTEM.................................................................................. 36 CHAPTER 6 TRANSPORT AND STORAGE...........................................................................37 6.1 TRANSPORT............................................................................................................................37 6.1.1 Packaging Illustration....................................................................................................37 6.2 TRANSPORT AND STORAGE....................................................................................................38 6.2.1 Transport Conditions..................................................................................................... 38 6.2.2 Storage Conditions.........................................................................................................38 CHAPTER 7 PRECAUTIONS.....................................................................................................39 7.1 INSTALLATION PRECAUTIONS................................................................................................ 39 7.2 PRECAUTIONS FOR USE..........................................................................................................39 7.3 SAFETY PRECAUTIONS........................................................................................................... 39 7.4 BIOSECURITY......................................................................................................................... 40 7.5 PARTS REPLACEMENT............................................................................................................40 7.5.1 Fuse Replacement.......................................................................................................... 40 VI 7.5.2 UV Lamp Replacement...................................................................................................41 7.6 CONTRAINDICATIONS.............................................................................................................41 APPENDIX A TROUBLESHOOTING...................................................................................... 42 APPENDIX B PACKING LIST...................................................................................................44 VII Chapter 1 Overview 1.1 Overview This chapter describes how to use the manual of Nucleic Acid Isolation System. This manual is attached with a detailed description of the use, function and operation of the Nucleic Acid Isolation System. Before using the Nucleic Acid Isolation System, please read and understand the contents carefully to ensure that the Nucleic Acid Isolation System can be used correctly and to ensure the operator’s safety. 1.2 Scope This operation manual is intended for medical laboratory professionals or trained physicians, nurses, or experimenters, for the use of: Learning to use the hardware and software of EXM3X00; Setting system parameters; Performing routine operations; Performing system maintenance and troubleshooting. 1.3 Reading Guide This manual contains 7 main chapters and 2 appendices. The operator searches for the corresponding chapter according to the required information. Please refer to… 1. Overview 2. System Overview 3. Installation and Use Preparation 4. Operation Guide 5. Preventive Maintenance When you need to… Learn how to use the Nucleic Acid Isolation System operation manual. Learn the composition and measurement principle of Nucleic Acid Isolation System Learn the environment and installation requirements of the Nucleic Acid Isolation System. Learn the operation preparation, software interface and software operation of the Nucleic Acid Isolation System. Learn the cleaning and maintenance process of the Nucleic Acid Isolation System. 1 Learn the transportation and storage conditions of the Nucleic 6. Transport and Storage Acid Isolation System. Learn the matters related to the installation, use, safety and parts 7. Precautions replacement of the Nucleic Acid Isolation System. Appendix A Fault Learn the faults and treatment methods of the Nucleic Acid Information Table Isolation System. Appendix B Accessories List Learn the main accessories of the Nucleic Acid Isolation System. 1.4 Declaration In this manual, different fonts and formats are used to distinguish the content with special meaning in the text. Format “××” Meaning ×× is the information displayed on the screen interface All illustrations provided in this manual are examples only, please do not use them for other purposes. The graphics, settings, or data in the illustration may not exactly match the actual display you see on the Nucleic Acid Isolation System. 1.5 Common Operations Name Click Input Operations Press the "××" button Click the "××" edit box to move the cursor to that place, and use the soft keyboard to complete the data input Click the [←] [→] key on the touch screen to move the cursor to the Delete place to be deleted, and then use the [X] key on the soft keyboard to delete the character before the cursor. 1.6 Symbols Symbols used in this manual Symbol Meaning Please follow the instructions corresponding to this symbol or risk biological infections. 2 High temperature, be careful with your hands. High intensity Ultraviolet Light, Please protect your eye and skin. Please refer to the document attached with your equipment. Warning! Handle carefully. Electric shock No one except an authorized maintenance personnel is allowed to disassemble the equipment panel when the power supply is turned on; avoid spilling liquid on the equipment, if any liquid enters the equipment, please immediately turn off the power supply, and contact Zybio service team or its local agent as soon as possible. Protective grounding Alternating current On (power supply) Off (power supply) For in vitro diagnostic use only Serial No. Date of manufacture 3 Manufacturer Please refer to the operation manual. 4 Chapter 2 System Overview 2.1 Overview Mainly introduce the model, main indicators, performance structure and electromagnetic compatibility. 2.2 Model There are two models of this series of products. The working principle, main functions, electrical structure and key components of each model are exactly the same, the only difference is that the function configuration is different. (See Table 2-1 below for details). Table 2-1 Model Differences EXM 3200 EXM 3000 Model The Nucleic Acid Isolation System is divided into mechanical part and electrical part. The mechanical part is composed of a Structure shell, a frame, a motor moving component, a magnetic rob component, and a heat transfer component. The electrical part is composed of a display screen, a heating module, an ultraviolet module and a negative pressure exhaust module. Operating Mode Nucleic Acid Isolation System Sample Size 1-32 samples optional Processing Volume 30 µL — 1000 µL Cell Lysis Heating Temperature Room temperature-105℃ Elution Heating Temperature Room temperature-105℃ Program Management Not programmable Programmable Reagent Magnetic bead kit Alarm Support sound alarm Sterilization Ultraviolet sterilization This operation manual takes the EXM 3200 Nucleic Acid Isolation System as an example, and is applicable to the EXM series. For other models (EXM 3000), please refer to this operation manual. 5 2.2.1 Mechanical Part The mechanical part is composed of a shell, a frame, a motor moving component, a magnetic rob component, and a heat transfer component. There is a transparent door on the shell to observe the equipment internal condition. And the door has a sealing strip to separate the equipment inside and outside to prevent environmental pollution. The frame is used to support the motor moving component and the magnetic rod. The motor movement component is composed of a motor, a magnetic rod frame and a magnetic sleeve frame. The motor drives the magnetic rod frame and the magnetic sleeve frame to move, and is used to complete the magnetic attraction and mixing. The heat transfer component is located on the bottom plate in the equipment and is used to assist the temperature conduction of 'Cell lysis and Elution'. 2.2.2 Electrical Part The electrical part is composed of a display screen, a heating module, an ultraviolet module and a negative pressure exhaust module. The display screen supports touch operation and human-computer interaction with the equipment through touch screen software. The heating module is used to realize the heating requirements of program running. The ultraviolet module is on the equipment compartment top and can be switched by software. It is used for ultraviolet sterilization after nucleic acid extraction. The negative pressure exhaust module is located on the equipment back and is composed of a negative pressure exhaust fan and a HEPA filter cotton, it can be switched by software. Used to exhaust the air in the instrument and to prevent pollution to the external environment. 2.3 Main Indicators and Performance Table2-2 Main indicators Principle Sample Size Sample Volume Number of Magnets Magnetic bead method 1-32 30 μL—1000 μL 32 6 Magnetic Bead Recovery Extraction Hole CV Lysis Heating Elution Heating Temperature Accuracy Oscillating Mixing Operation Interface Internal Program ≥98% CV≤3% Room temperature to 105℃ Room temperature to 105℃ ±1℃ Multi-mode and multi-speed adjustable 8.4 inch color touch screen Can store 500 programs Create, edit, save, and delete programs, and can set shortcut programs Standard USB, Ethernet Ultraviolet sterilization Fan exhaust HEPA filter Storable, Built-in SD card 500VA 375mm*415mm*440mm 27 kg Program Management Expansion Interface Sterilization Exhaust Filter Data Storage Maximum input power Dimensions (L*W*H) Weight 2.4 Working Principle Use the magnetic rod on the magnetic rod holder of the experiment cabin to move the magnetic beads adsorbed with nucleic acid to different reagent holes. The magnetic sleeve repeatedly and rapidly stirs the liquid to evenly mix the liquid and the magnetic beads, after cell lysis, nucleic acid adsorption, magnetic bead transfer, washing and elution, high purity nucleic acid is finally obtained, as shown in the figure2-1. Figure2-1 Schematic diagram 7 2.5 Scope The Nucleic Acid Isolation System can be widely used in scientific research, clinical, disease control, food safety, forensic and other fields. Users only need to add samples, nucleic acid extraction reagents, reaction consumables, the Nucleic Acid Isolation System will complete all operations in accordance with the experimental procedures. Combined with different magnetic bead nucleic acid extraction reagents, the Nucleic Acid Isolation System can quickly extract DNA and RNA from animal and plant tissues, blood, body fluids, and criminal samples. 2.6 Structure 2.6.1 Front Diagram ① ② ③ Figure2-2 Frontal structure ① Touch screen ② Door handle 8 ③ Transparent hatch 2.6.2 Back Diagram ① ② Figure2-3 Posterior structure ① Exhaust fan ② Power switch 2.6.3 Side Diagram ① ② Figure 2-4 Left side structure ① 1 network port ②2 USB ports 9 2.6.4 Iternal Diagram ① ② ③ ④ ⑤ ⑥ Figure 2-5 Structure inside the door ①Magnetic rod holder and magnetic rod ②Magnetic sleeve holder ⑤96-hole kit positioning strip ⑥96-hole kit middle guide ③96-hole kit Edge guide ④Heating bar 2.6.5 Communication Interface Name Type Network Interface RJ45 network port plug USB interface USB 2.0 (2) Note: (1) The network interface is used to connect the computer for data transmission, and the insulation value of the external circuit should not be less than 1MΩ (2) 2 USB ports for external mouse, keyboard or U disk during debugging and maintenance upgrade. The working voltage is DC 5V. Attention Do not use this Isolation System for other purposes. Incorrect use may cause the equipment to be infected with viruses. Computer viruses may spread through USB, programs, and networks. 10 2.7 Electromagnetic Compatibility The radio frequency emission of the equipment is very low, and the possibility of interference with nearby electronic equipment is very low. Portable and mobile radio frequency communication equipment may have a possible impact on the equipment, and other equipment used concurrently in the vicinity of the equipment shall meet the requirements related to electromagnetic compatibility. Be Suitable to use in all facilities not for household use and not directly connected to the public low voltage power supply network of domestic dwellings. Power sockets shall have reliable protective grounding measures and use matching power cords, components and accessories. The floor shall be wood, concrete or tile, and if the floor is covered with synthetic material, the relative humidity shall be at least 30%. Grid power supplies should be of typical quality for using in commercial or hospital environments. If you need to keep the equipment running continuously during a power interruption, it is recommended that you use uninterrupted power supply. This IVD equipment complies with the emission and immunity requirements specified in IEC 61326. The power frequency magnetic field in the intended installation site should be measured to ensure that it is sufficiently low. This equipment should be far away from the power frequency magnetic field source. In special cases, magnetic shielding materials should be installed to ensure the normal operation of the equipment. Warning In addition to accessories and cables sold by the manufacturer of the equipment as spare parts for internal components, using accessories and cables other than those specified may result in increased equipment 11 emissions or reduced. This equipment should not be used in close proximity or overlap with other equipment, and if it must be used in close proximity or overlap, it should be verified to operate normally in the configuration that it uses. Attention Do not use the equipment next to a strong radiation source (e.g., an unshielded RF source), which may interfere with the normal operation of the equipment. In a domestic environment, this equipment may cause radio interference. Need to take protective measures. It is recommended that the electromagnetic environment should be assessed before using the equipment, and it is the responsibility of you to ensure that the electromagnetic environment is compatible with the equipment. 12 Chapter 3 Installation and Use Preparation Before installation, please ensure that the following space, power, and environmental requirements are met. Caution Unpacking or installation by personnel not authorized by Zybio may cause personal injury or equipment damage. Please do not unpack or install without Zybio authorized personnel. 3.1 Open Inspection All products have passed strict inspection from Zybio before shipment. Upon receiving your analyzer, please examine carefully before opening the packing box, and pay attention to the damage, and please notify Zybio or its local agent as soon as the damage is found. Attention During the unpacking process, take care to avoid damage to the magnetic rod After opening the box, please carefully examine your equipment’s appearance and verify completeness with the packing list. In case of transportation damage or missing components, please immediately declare to Zybio or its local agent. 3.2 Space Requirements This equipment is limited to indoor use, with good indoor ventilation, no corrosive gas, and no strong magnetic field interference. Please do not place the equipment in a humid or dusty place. The openings on this equipment are designed for ventilation and heat dissipation. Please do not block or cover these ventilation holes. When the equipment is running, the distance between the equipment ventilation hole and the nearest object should not be less than 25cm to avoid affecting the heat dissipation. To ensure the space required for repairs and maintenance, considering the equipment heat dissipation, the equipment installation must meet: 13 The reserved space between the equipment left and right side doors and the wall ≥ 10 cm; The reserved space between the equipment back panel and the wall≥ 25 cm; The installation table (or floor) can bear a weight of at least about 40 kg. Attention Do not place the equipment in a position where it is difficult to disconnect the power switch. 3.3 Working Environment Requirements Considering the equipment safety and performance, the installation environment and working environment of the nucleic acid should meet the following conditions: The general working environment temperature is 5 ℃ ~ 40 ℃, if the experiment requires high temperature, the operating temperature must be 20 ℃ ~ 30 ℃; The relative humidity should be 30%~80%, and the altitude is less than 3000m; The environment should be as dust-free, no mechanical vibration, no large noise source and no power source interference as possible; It is recommended to evaluate the laboratory electromagnetic environment before operating the equipment; Avoid direct sunlight or heat and wind; Good ventilate; Indoor use. Warning The instrument cannot be used in a flammable and explosive environment 14 Attention If the room temperature exceeds the normal equipment operating temperature range, causing the equipment temperature to exceed the limit, it will affect the extraction effect. 3.4 Power Requirements 1. 100V~240V, 50Hz/60Hz, correctly grounded, grounding resistance less than 10 mΩ. 2. Power supply: Before connecting the AC power supply, please make sure that the power supply voltage is consistent with the voltage required by the equipment (tolerable deviation of ±10%). And ensure that the power socket rated load is not less than the equipment requirements. 3. Power cord: Use the attached power cord. If the power cord is damaged, replace the power cord with the same specifications in time. When the equipment is running, do not put anything on the power cord, and do not place the power cord where people walk around. 4. Insert and unplug the power cord: be sure to hold the plug when inserting and unplugging the power cord. Make sure the plug is fully inserted into the socket when inserting the power cord and do not pull the power cord vigorously when unplugging. Warning The equipment must be used under good grounding conditions. The operator must use the specified fuse. Confirm that the input voltage meets the equipment requirements. If the fuse needs to be replaced, please contact a service engineer. 15 3.5 Grounding 1) The power supply must be properly grounded, otherwise there will be an electric shock risk. 2) The grounding resistance must be less than 10mΩ. Poor grounding can lead to unstable measurement results and housing leakage, and cause an electric shock risk. Attention Please place the equipment on a stable, flat surface, and do not put it with vibration sources such as centrifuges. Do not place the equipment where it may be affected by chemicals, corrosive gases, or strong electromagnetic interference. Please do not place the equipment in direct sunlight, humidity or high temperature. 3.6 Check the Power Supply Check the power supply to confirm it has power and can provide the correct voltage; Check the power cord to make sure it is firmly connected and not loose. Caution Please use the supplied power cord. Other power cords may damage the instrument. 16 Chapter 4 Operation Guide 4.1 Pre-operation Waring The samples may have potential biological infectious hazards. Operators should observe the laboratory's safe operation regulations and wear personal protective equipment (such as laboratory protective clothing, gloves, masks, etc.). Please dispose of samples and discarded reagent kits, magnetic sleeve, reagent strips and other consumables in accordance with local laboratory regulations; This chapter introduces the routine nucleic acid extraction method in this Nucleic Acid Isolation System. Please read it carefully before the first use. Warning Do not place the equipment in direct sunlight during extraction, so as not to affect the equipment performance. Do not use kits beyond the expiration date or deterioration. Before turning the equipment power on, the operator must check the following requirements to ensure that the system is ready. Before starting the equipment, check the equipment is clean and no dirt through the transparent door Care and maintain in accordance with the relevant content in " Chapter 5 Preventive Maintenance". After closing the safety door, power on again. After the power-on self-test, install the kit and magnetic sleeve. 17 4.2 Reagent Kit Installation Open the door, first place the 96-well reagent kit with the sample in the positioning strip, and then press the 96-well reagent kit into the positioning strip. Pay attention to its direction, and its chamfer should be in the lower left corner. After the 96-well kit is installed in place, install the magnetic sleeve. Reagent Kit Figure 4-1 Reagent kit installation. There are four heating blocks on the plate where the 96-hole reagent kit is placed, and there is a limit block on each side to assist positioning. At the same time, there is a shrapnel on each side to fix it Note: The 96-hole kit can only be placed after power-on self-test; It is important to ensure that the 96-hole kit is flat and in place before starting the program. 18 4.3 Magnetic Sleeve Installation Magnetic Rod Cover Figure 4-2 Install magnetic sleeve Insert the magnetic sleeve completely into the fixing groove of the Magnetic rod holder. And install the magnetic sleeve according to the kits number. 4.4 Software Operation 4.4.1 Start-up Interface After turning on the equipment’s power switch, the following startup interface appears. Figure 4-3 Start-up Interface 19 Then enter the quick start interface. Warning When the self-test fails, prompts the error message, please refer to "Appendix Troubleshooting Table" to deal with. The self-test process accompanies the motor movement. Please install the reagent kit and magnetic sleeve after the equipment enters the startup interface. 4.4.2 Main Function Figure 4-4 Main Function Interface The left side of the interface is the main fuction botton, including the key functions: "Run": Enter the quick start/list start interface; "Manage": Enter the program management interface; "UV": Enter the ultraviolet sterilization interface; "Setup": Enter the setup interface; "Shutdown": Close the software interface; "Exhaust Fan": Click the fan icon to turn on/off the exhaust fan; "Lighting lamp": Click on the lamp icon to turn on/off the equipment's lighting lamp. 20 4.4.3 Shortcut Start-up Figure 4-5 Shortcut Start-up Interface If there are a large number of programs, you can operate the page turning keys at the bottom left to check. In the Shortcut start-up interface, click the currently extracted item’s shortcut icon, and a'shortcut start-up confirmation dialog' will pop up. Figure 4-6 Shortcut Start-up Confirmation Dialog 21 Before clicking to confirm the operation, please check that the reagent kit and magnetic sleeve are well installed, and close the door. Click ‘Confirm’, the equipment will run the selected program, and appear the running status on the interface. Click ‘Cancel’ to cancel currently running program. Warning Before starting the program, please check whether the reagent kit and the magnetic sleeve are installed, to avoid extraction failure or instrument contamination due to installation failure or not installation. 4.4.4 List Start-up On the upper right corner of the page, there is a "Shortcut/List" switch button, which can be used to switch between the shortcut star-upt and list start-up. If there are a large number of programs, you can operate the page turning key on the right to view. Single arrow page turning key, turn one table at a time; double arrow page turning key, turn entire page at one time. Figure 4-7 List Start-up Interface 22 In the list display interface, click on the corresponding line of the currently item, and a'List start-up confirmation dialog' will pop up. Figure 4-8 List start-up confirmation Before clicking to confirm the operation, please check that the reagent kit and magnetic sleeve are well installed, and close the door. Click ‘Run’, the equipment will run the selected program, and appear the running status on the interface. If you want to run from the specified step, you can select the corresponding step row in the dialog box (the line changes color after selection), and click ‘Step Run’, Then skip the previous steps, start running from the specified step, and complete the subsequent steps. Click ‘Cancel’ to cancel currently running program. 23 4.4.5 Program Running Figure 4-9 Running interface At the top of the interface is the progress bar, which displays the program name, the running step progress, and the remaining time. At the top of the interface is the reagent kit schematic diagram, which will simultaneously display the corresponding hole-position and real-time temperature status of the current operation. When the program runs to the reagent kit certain column, the corresponding column on the schematic will change color, and the remaining columns remain gray. The temperature corresponding to the hole-position in the T1, T2, T3, T4, T5, T6, T7, and T8 columns marked on the instrument will be displayed in real time above the column, and the temperature will be controlled with the program settings. Click "Pause/Run" to interrupt and continue the program. Click "Stop", a prompt dialog box will pop up. Click "Cancel", the program continues to run, click "OK", the program runs back to the initial position, 24 and the button changes from "Stop" to "Start". Click "Start" to re-execute this program. At the bottom of the interface is a program steps list, which shows the steps, step name, hole-position, waiting time, mixing time, magnetic time, volume, mixing speed and each step program temperature in detail. When a step is run, the list line corresponding to the step will change color. If the equipment door is opened while the program is running, it will prompt ‘Please close the door’ and the equipment will immediately pause. When the door is closed again, it continues to operate. Warning Do not open the door while the program is running, to avoid crosscontamination of the equipment internal and external environment. When the heating function is running in the program, please do not touch the heating bar to avoid burns! 25 4.4.6 Ultraviolet Sterilization Click "UV" in the left to enter the ultraviolet Sterilization interface. Figure 4-11 Ultraviolet sterilization interface Before ultraviolet sterilization, please modify the ultraviolet sterilization time. Click the timing input box to enter the ultraviolet sterilization time. Or Click "+" "-" to adjust the sterilization time, adjust 1 minute for each click. If not modified, ultraviolet sterilization will be performed according to the current time. Click the ultraviolet sterilization icon (circular button in the middle of the page) to turn on the ultraviolet lamp, start ultraviolet sterilization and countdown from the sterilization set time. If you want to stop during the sterilization process, click the ultraviolet sterilization icon, turn off the ultraviolet lamp, to stop UV sterilization and countdown. 26 If the equipment door is opened during the sterilization process, the ultraviolet lamp will automatically turn off, and suspend sterilization. Close the instrument door, the ultraviolet lamp will turn on, and continue sterilization. 4.4.7 Program Management Click "Manage" in the left to enter the "Program Management" interface. Figure 4-12 Program management interface. In the program management list, you can set up a shortcut start-up or lock the program. Click "" in the "Shortcut Start-up" column of the corresponding program. When "" changes to "", this program will appear in the shortcut list; if click "", it will change back to "", indicating that this program does not appear in the shortcut list. In the lock column, when the icon is a locked lock, it means that the program is locked and cannot be edited, deleted, or saved as; when the icon is an open lock, it means that the program is unlocked and it can be edited, deleted, or saved as. 27 At the bottom of the page there are buttons for "New", "Edit", "Save As", and "Delete". 4.4.7.1 New Program Click "New" in the "Program Management" interface. Figure 4-13 New program interface. Enter the entire program name. "Add": Click "Add" to add a new step. "Insert": Click on a step, click "Insert" to insert a new step below it. "Delete": Click on a step, click "Delete", pop up a confirmation prompt, Click "OK" to delete the selected step; click "Cancel" to not delete. "Edit": Click on a step, click "Edit" to pop up the "step editing interface" to edit the selected step. "Save", Click "Save", pop up a prompt. Click "OK" to save the currently edited program; click "Cancel" to not save. Click "Back", if the new program has been saved, return to the "Program Management" interface. If the new program has not been saved, it will pop 28 up a prompt, click "Yes", and the new program will be saved and return to the "program management" interface; click "No", the new program will not be saved and return to "Program management" interface, click "Cancel" to stay in the new program interface. "Options": Click "Options" to pop up the "Options interface". 4.4.7.2 Step Edit Click ‘Edit’ on the new program interface to enter the step editing interface. Figure 4-14 Step editing interface Enter the step name in "Step Name". Click "Pos." to select the desired hole-position. Enter the "mixing time", "magnetic time", "waiting time", "volume", and "mixing speed" for current step. Only The heating function of 1, 6 holes can be set, when select other holes, there is no “temperature” in the corresponding step row, and in which you can enter the temperature number you want; If you enter "0", it means that the hole is not heated when the program runs to this step. 29 "Mixing position", "Mixing range", "Magnetic position" and "Magnetic speed" are extended parameters, which are generally default values and don’t need to be modified. If there are special needs, you can adjust them according to the actual situation. Click "Save" to save the step parameters. Click "Back" to not save the currently edited step. 4.4.7.3 Options "Options" is used to set a program, which are generally default values and don’t need to be modified. If there are special needs, you can be adjust them according to the actual situation. Figure 4-15 Options interface Among them, when click related position of heating module, if "" becomes "", it means that this program is running, the corresponding heating module will not run. Generally all are in "" state. 4.4.8 Settings Click "Setup" in the left column to enter the "Setup" interface. 30 Figure 4-16 Setup interface In the setup interface, you can set "System Time", "Language", "About", and "Screen Calibration". 4.4.8.1 System Time Setting Click "System Time Setting" to enter the "Time & Date" interface. Figure 4-17 System time setting interface You can modify the current date and time, and use the numeric keyboard to enter the value. 31 You can select the date format through the drop-down box. 4.4.8.2 Language Settings You can modify the equipment language. Figure 4-18 Language setting interface 4.4.8.3 About You can view the equipment version information. Figure 4-19 ‘About’ interface 32 4.4.8.4 Screen Calibration Click "Screen Calibration" to enter the touch screen calibration interface. Follow the operation prompts on the calibration interface to perform the calibration. 4.4.8.5 Upgrade Support to use U disk to upgrade equipment software. 33 Chapter 5 Preventive Maintenance This chapter gives instructions on all maintenance work to be performed in order to keep the Nucleic Acid Isolation System in good working condition. 5.1 Care and Maintenance 1. Before using the equipment, please carefully read this operation manual. 2. When using, please ensure that the equipment environment is ventilated; 3. Keep the equipment experiment cabin environment dry and free of water stains. 4. Please do not use the equipment when the voltage is unstable, too high or too low; 5. At the end of the experiment, use 75% ethanol to clean the equipment experiment cabin, and turn on the ultraviolet lamp to irradiation sterilization for more than 30 minutes; 6. When the equipment is not used for a long time, please unplug the power cord and cover the equipment with a dust cover to prevent dust. 7. When the equipment is not used for a long time, to ensure its stable performance, it is recommended to turn on the equipment and run it every 30 days. Attention It is forbidden to maintain the equipment during operation. 5.2 Filter Cotton Replacement To ensure stable performance of the instrument, it is recommended to replace the filter cotton on the back of the instrument every 3 months.When replacing the filter cotton, please remove the 4 screws at the exhaust port on the back of the equipment, remove the old filter cotton, install a new one, put its green side down, and close to the fan. 34 Filter cotton Figure5-1 Filter cotton replacement 5.3 Cleaning Cleaning Agent:①75% Ethanol ;②lint-free tissue. After using the lint-free tissue, please clean and dry it for the next use. After long-term use, replace as necessary. 1. Turn on the ultraviolet lamp to irradiate sterilization for more than 30 minutes before cleaning. 2. After a single experiment and before get off work: Use 75% ethanol to spray the experiment cabin and magnetic rod holder; Wipe the experiment cabin, magnetic rod, and magnetic rod holder with a lint-free tissue moistened with 75% ethanol, and then wipe dry with a dry one; 3. Turn on the ultraviolet lamp to irradiate sterilization for 15~30 minutes. Attention It is strictly prohibited to pour the solution directly into the experiment cabin. 35 Warning Do not clean the equipment when it is powered on; Do not wipe the equipment with organic solvents such as gasoline, paint thinner, or benzene compounds; The lint-free tissue should be made not easy falling down materials or disposable absorbent paper; Wipe the equipment with a soft dry cloth or a soft cloth moistened with mild detergent. Wipe the screen with a soft and non-abrasive cloth, do not clean it with water. 5.4 Disposal of Operating Material The used wastes such as disposable kits, magnetic sleeve, and remaining samples may contain biological contaminants. Please recycle and sterilize them in accordance with relevant national laws and regulations. Caution The waste generated by the equipment has the biological and chemical pollution risk, please handle it properly. 5.5 Disposal of the Isolation System After the equipment expires, stop using it or use it after comprehensive inspection and maintenance by Zybio. 36 Chapter 6 Transport and Storage 6.1 Transport 1. Carton packaging for long-distance transportation; 2. Prevent moisture, water, severe vibration and squeezing during transportation. Handle with care when handling and loading. 3. If you need to transport, please use the cross screw to fix the magnetic rod sleeve on the motion mechanism. After transportation to the designated place, you need to remove the fixed cross screw before installation. 4. Please save the original packaging materials to facilitate the transportation of the equipment. Attention During transportation, in order to avoid the damage of the sampling component, it is necessary to fix the moving component with a clip/tie. After the equipment is in normal operation, it should not be moved in general to prevent the high-precision components and Fragile parts inside the equipment from being damaged by vibration If you really want to move the equipment, you must put the it in the packing box, and then carry it together by more than two people. 6.1.1 Packaging Illustration "Fragile "Upward": The items": Handle transport package the transport should be upright package with when transported. care. "No "Fear of rain": stacking": The The transport transport package package is afraid of can only be rain. placed in a single layer. 37 "Rolling prohibited": The transport package cannot be rolled. 6.2 Transport and Storage 6.2.1 Transport Conditions The Nucleic Acid Isolation System is transported according to the order contract in the packaging state. During the transportation, the ambient temperature: -20℃~+55℃, relative humidity: 10%~90%, atmospheric pressure: 50.0kPa~106.0kPa, must be prevented Subjected to severe shock, vibration, rain, snow and exposure. 6.2.2 Storage Conditions The packaged Nucleic Acid Isolation System should be stored in a clean room with ambient temperature: -20℃~+55℃, relative humidity: 10%~90%, atmospheric pressure: 50.0kPa~106.0kPa, no corrosive gas and good ventilation. Attention The operator should use the magnetic sleeve and kit specified by Zybio, and strictly follow the instructions for storage and use. 38 Chapter 7 Precautions 7.1 Installation Precautions The equipment initial installation can only be carried out by Zybio service personnel and specially trained distributors. 7.2 Precautions for Use Before starting the equipment, make sure that the safety board is turned off. Never use it with the safety panel open. Do not reach into the equipment through the opening under the yellow line on the front of it. If the equipment is stopped due to power failure or other reasons, all processing samples should be abandoned. Please make sure that all test tubes are accurately positioned on the shelf and touching the bottom of the shelf, otherwise the liquid level detection and clot detection may not work correctly. 7.3 Safety Precautions Please do not open the shell at will to avoid unnecessary man-machine injury caused by improper operation. Please pay attention to the equipment sharp parts to avoid human injuries such as scratches and punctures. When the equipment is in operation, never touch its moving parts. All test samples, calibrators, quality control, waste liquid, etc., including the parts that have been in contact with them, should be considered as infectious, medical protective gloves should be worn when in contact and handled them as infection source. During the maintenance and repair of the equipment, the operator needs safety protection. If samples or other items accidentally contaminate any part of the body, please rinse with water and disinfect or other treatment in time. When unplugging the power plug, hold the plug instead of pulling the power cord. Pay attention to the harm of ultraviolet rays. 39 7.4 Biosecurity Operators are not allowed to eat, drink or smoke in the equipment room. Please wear lab coat and medical protective gloves when operating the equipment. All samples and test kit components must be considered potentially hazardous reagents. The operator must wear appropriate protective clothing, goggles and gloves. Avoid splashing and spilling of infectious fluids, resulting in contact with any exposed parts of the body. If you accidentally come into contact with infectious substances, immediately wash your skin thoroughly with water, and then follow the disinfection procedures prescribed by your hospital or laboratory. Be extremely careful when handling patient samples, test cups, and waste, because they may be contaminated with the samples and reagents that have been in contact. The tools used in the inspection must be sterilized before putting back . Before performing repairs, Maintenance personnel should ensure the parts that may have biological contamination on the equipment are properly cleaned and disinfected, and wear the necessary protection clothing. All waste must be disposed of in accordance with local regulations. 7.5 Parts Replacement Among all the parts of the instrument, only fuse and UV lamp can be purchased and replaced by yourself. Any other parts can only be provided and replaced by Zybio or authorized agent, it is strictly forbidden to replace it by yourself. The fuse and UV lamp replacement method is as follows: 7.5.1 Fuse Replacement a) The external fuse used in this equipment is F10AH250V. When the overcurrent occurs, the fuse blows. b) Check the fuse: firstly disconnect the power cord, then pry the fuse holder next to the power cord socket, take out the fuse, use a multimeter to measure whether it is continuity, if it is continuity, it is not fused, otherwise it is fused. 40 c) Replacement method: if it has been fused, replace it with a same model fuse and install it into the fuse holder. 7.5.2 UV Lamp Replacement a) The model of the UV lamp used in this equipment is GPH135T5L-PRO. When the UV lamp is damaged, replace it with a new lamp. b) Check the UV lamp: turn on the UV lamp switch, visually check whether the UV lamp is on, if not, first turn off the power, remove the UV lamp and use multimeter to measure whether the UV lamp electric shock voltage is normal, if it is normal, the UV lamp is damaged, if not, please contact Our Service Engineer. c) Replacement method: disconnect the power supply, remove the damaged UV lamp from the lampshade, and replace it with the same type . 7.6 Contraindications None. 41 Appendix A Troubleshooting No. Malfuction 1 The screen does not display after turning on the power Result The power cord is not plugged in The fuse is broken Black screen or out of control 3 UV lamp/lighting lamp is not on 4 Abnormal sound during operation Replug the power cord Replace a new fuse of the same type Contact Zybio service team Others 2 Measures or authorized agent Improper use or operation error Poor contact of UV lamp/lighting lamp UV lamp/lighting lamp damaged The magnetic sleeve Restart the equipment after cutting off the power Reinstall the lamp is not inserted in Reinsert the magnetic sleeve Replace a new lamp of the same model place 96-hole kit is placed incorrectly Contact Zybio service team others 5 Program cannot start/program is interrupted or authorized agent The safety door is not Contact Zybio service team closed or authorized agent Contact Zybio service team Others 6 Abnormal temperature Replace the kit or authorized agent Temperature module Set the temperature controller is not checked on Contact Zybio service team Others or authorized agent The liquid volume in 7 Crosscontamination in extraction results the kit and the Control the liquid volume in volume extracted by the kit to be consistent with the program are the required volume inconsistent 42 Aerosol contamination during extraction 8 Abnormal magnet action Open the real-time exhaust filter system during extraction Not falling or rising Pause the program, reset again Motor abnormality causes the magnet action position Pause the program,reset again not to be in place 43 Appendix B Packing List No. Material Name Quantity Unit 1 Nucleic Acid Isolation System 1 Set 2 Power Cable 1 pcs 3 Operation Manual 1 pcs 4 Warranty Card 1 page 5 Packing List 1 page 44