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Part No.: H-020-000419-00
Address:
Building 24, Stage 3.1, BioLake Accelerator, No.388, 2nd Gaoxin Road, East Lake
High-Tech Development Zone, 430075, Wuhan, P.R.China
E-mail:
MGI-service@mgi-tech.com
Website:
www.mgi-tech.com
Genetic Sequencer
DNBSEQ-T7
W u h a n M G I T e c h C o . , L t d .
Version: 1.0

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  • Page 1 Part No.: H-020-000419-00 Genetic Sequencer DNBSEQ-T7 Version: 1.0 Address: Building 24, Stage 3.1, BioLake Accelerator, No.388, 2nd Gaoxin Road, East Lake High-Tech Development Zone, 430075, Wuhan, P.R.China E-mail: MGI-service@mgi-tech.com W u h a n M G I T e c h C o . , L t d .
  • Page 2 MGI. Any unauthorized person should not use this manual. MGI does not make any promise of this manual, including (but not limited to) any commercial of special purpose and any reasonable implied guarantee. MGI has taken measures to guarantee the correctness of this manual.
  • Page 3 Revision history Date Version Initial release February 24, 2022...
  • Page 4: Table Of Contents

    Contents Safety Conventions General safety Electrical safety Mechanical safety Components safety Biological safety Symbols Device Label Packaging Device overview Intended use Working principle Structural composition Basic components Front view Keyboard and ports Reagent compartment Flow cell Rear view Ports Control software Self-test interface Main interface Menu area...
  • Page 5 Settings interface Maintenance interface Shutdown or restart interface About interface Getting started Site requirements Network requirements Operating environments of the computer Software security Data and computer ports Access control Installing the device Powering on or off the device Powering on the device Powering off the device Inspecting the device Preparing the power supply...
  • Page 6 Loading the flow cell Reviewing parameters Performing a sequencing run Automatic post-wash Disposing of reagent cartridge and flow cell Maintaining the device Maintaining the main unit Daily maintenance Weekly cleaning Monthly cleaning Maintaining the power supply Maintaining the software Performing a wash Maintaining the pure water container Replacing the waste container Troubleshooting...
  • Page 7 - - - T h i s p a g e i s i n t e n t i o n a l l y l e f t b l a n k . - - -...
  • Page 8: Safety

    Safety This chapter describes basic safety information about the device. Carefully read and understand the information before use to ensure correct operations, best performance, and personnel safety. Keep this manual at hand for reference at any time.
  • Page 9: Conventions

    Conventions The following table describes conventions that are used in this manual: Item Description Indicates that the operator should operate the device by following the instructions. Otherwise, it might result in personal injury. Indicates that the operator should operate the device by following the instructions.
  • Page 10 Only the technical support authorized by the manufacturer or the qualified and trained personnel can unpack, install, move, and maintain the device. Incorrect operation might cause inaccurate experiment results or damages to the device. Do not move the device after the technical support have installed and debugged the device.
  • Page 11: Electrical Safety

    Electrical safety Before initial use of the device, assess the electromagnetic environment in which the device will be used. Do not use the device in close proximity to the source of strong electromagnetic fields, such as unshielded sources of radiated emissions. Radiated signals can reduce the accuracy of the results.
  • Page 12: Biological Safety

    Ensure that the peripheral devices meet the IEC/EN 60950-1 standards. Biological safety Chemicals in reagents and waste might cause personal injury through contact with the skin, eyes and mucosa. Follow the safety standards of your laboratory and wear protective equipment (such as laboratory coat, and disposable bouffant cap, protective glasses, mask, gloves, and shoe covers) when performing an experiment.
  • Page 13: Label

    Symbol Name Description Indicates that the marked item can Caution; hot surface be hot and should not be touched without taking care. Warning; dangerous Indicates hazards arising from voltage dangerous voltages. I n d i c a t e s t h e t e r m i n a l o f a Protective earth p r o t e c t i v e e a r t h ( g r o u n d ) electrode.
  • Page 14 Symbol Name Description Date of Indicates the date when the medical manufacture device was manufactured. Authorized Indicates the authorized representative representative in the European in the European Community. Community Unique device Indicates a carrier that contains identifier unique device identifier information. Indicates that this device meets the requirements of Directive 2011/65/ RoHS mark...
  • Page 15: Packaging

    Packaging The following table describes symbols on the packaging or on the label of the packaging: Symbol Name Description Indicates the correct upright position This way up o f t h e d i s t r i b u t i o n p a c k a g e fo r transport and/or storage.
  • Page 16: Device Overview

    Device overview This chapter describes the intended use, working principle, and structural composition of the device.
  • Page 17: Intended Use

    Intended use The device is an automatic sequencer for NGS applications.It is intended to be used with specific validated reagents and analytical software for decoding the DNAs or RNAs sequence of human clinical sample prepared into specific sequencing libraries such as DNA nanoball libraries.
  • Page 18: Structural Composition

    The following figure demonstrates how to load DNBs: DNBs Flow cell Decorated sites evenly spread on the flow cell. Each site contains a single DNB. Figure 2 Loading DNBs The DNB and sequencing reagent are pumped into the sequencing flow cell through the device’s liquid system. Each DNB combines with the fluorescence group.
  • Page 19 Item Description Connects the flow cell to fluidics lines and Flow cell stage controls the temperature of the flow cell. Provides the gas-liquid support that is required Gas-liquid system for the biochemical reaction. Electric control Controls the electric system. system Reagent storage Provides the reagent storage environment.
  • Page 20: Basic Components

    Basic components Front view Figure 3 Front view Name Description T o u c h s c re e n Facilitates on-screen operation and displays monitor information. Flow cell drive Touch to eject the flow cell drive. button...
  • Page 21 Name Description Entry of the flow cell. Tap the flow cell drive Flow cell drive button to eject the flow cell drive. You can power on or off the IPC, and connect Operation panel USB devices in this area, such as the keyboard and mouse.
  • Page 22: Keyboard And Ports

    Keyboard and ports Figure 4 Keyboard and ports Name Description Keyboard tray Used to fix the keyboard tray. latch Used to support the keyboard and mouse. When not in use, fold the keyboard tray and Keyboard tray press it towards the latch until you hear a click.
  • Page 23: Reagent Compartment

    Reagent compartment The reagent compartments include the sequencing cartridge compartments and washing cartridge compartments. The system automatically identifies the QR code of the reagent cartridges by built-in RFID readers. Figure 5 Reagent compartment Name Description Sequencing H o l d s t h e s e q u e n c i n g c a r t r i d g e s a t cartridge appropriate temperatures.
  • Page 24: Rear View

    Name Description Flow cell orientation Shows the direction of placing the flow cell. marker Rear view Figure 7 Rear view Name Description Holds it to easily disassemble the rear panel Handle during maintenance.
  • Page 25: Ports

    Name Description Ventilation outlet Ventilates the device. Power inlet Connects to the power cord. Ports Used for cable connections. Pure water Connects to the pure water container. container port Optics Used by the technical support to maintain maintenance door the optical system. Maintenance door Used for opening the door after unlocking.
  • Page 26: Control Software

    Name Description Powers on or off the device: z Switch to the ON position to power on the Power switch device. z Switch to the OFF position to power off the device. Control software The system control software initiates the communication protocol through physical ports to coordinate with the hardware, control gas lines, fluidics lines, temperature, mechanical components, and optical components.
  • Page 27: Main Interface

    2. Follow the on-screen instructions or the solutions that are mentioned in Troubleshooting on Page 50. 3. Perform self-test again: ¾ Tap , select Maintenance > Self-test. ¾ Tap , select Shut down > Restart. If the problem persists, contact the technical support. Main interface The main interface appears after a successful self-test, as shown in the figure below:...
  • Page 28: Menu Area

    Tap on a flow cell stage name and you can enter the main interface of the selected flow cell stage. Wash Sequence Figure 10 Main interface A Menu area The following table describes the function of menu buttons. Item Description Tap to return to the main interface when the flow cell stage is not preparing for sequencing or washing.
  • Page 29 Item Description After logging into the system, you can tap this button to lock the screen. The following table describes the function of the sensor status indicators in the menu area. Item Description Connection status with ZLIMS. Disk space status. Device temperature status.
  • Page 30: Operation Area

    Operation area The following table describes the function of icons or information in the area: Item Description Flow cell stage name. If an error occurs in a flow cell stage, an error indicator appears on the progress bar. Task progress The flow cell stage is under sequencing.
  • Page 31: Settings Interface

    The following table describes the function of controls in the interface: Item Description Tap to exit the log interface and return to the previous interface. Tap to view all types of logs. Info Tap to view information-type logs. Warning Tap to view warning-type logs. Error Tap to view error-type logs.
  • Page 32: Maintenance Interface

    Recipe Customize a recipe Recipe name Read1 Read2 Barcode DualBarcode Read length Read1 Read2 Dark reaction cycles Save Figure 12 Recipe interface The following table describes the function of controls in the interface: Item Description Tap Recipe to enter the Recipe interface. In this interface, you can: z Tap Sort to change the display order of the recipes.
  • Page 33: Shutdown Or Restart Interface

    To open the maintenance interface, log in to your account, tap and select Maintenance. The following table describes the function of controls in the interface: Item Description Cleaning tool Tap to replace the cleaning tool. replacement Tap this button and select a flow cell Empty stage to discharge the residual liquid in fluidics line...
  • Page 34: Getting Started

    Getting started This chapter describes laboratory preparations and sequencing preparations.
  • Page 35: Site Requirements

    Site requirements z Ensure that the laboratory floor is level and with a gradient of less than 1/200. z Ensure that the laboratory is free of dust, corrosive and flammable gas, and heat and wind sources. z Ensure that the laboratory is away from direct sunlight and is well ventilated.
  • Page 36: Software Security

    Software environments Only the software that has been provided by the manufacturer can be installed and used on the computer. Because unknown software might interfere with normal device functions, or even cause data loss. If you need to install antivirus software, contact the technical support in advance. z Software architecture: C/S z Pre-installed software on the computer includes: ¾...
  • Page 37: Powering On Or Off The Device

    T o e n s u re t h a t t h e p e r fo r m a n ce o f t h e d e v i ce m e e t s t h e specifications, the technical support will perform a standard sequencing run before customer training and use.
  • Page 38: Inspecting The Device

    Inspecting the device z Only the technical support of the manufacturer or trained personnel can unpack the device. Contact the technical support to unpack and install the device upon delivery. Failure to do so will void the warranty. z Ensure that the outer package is intact and the indicator status of the anti- shock and anti-tilt label is normal upon delivery.
  • Page 39: Preparing The Power Supply

    Preparing the power supply z To ensure a steady and uninterrupted power supply to the device during operation, we recommend the use of a separate UPS. For details about the UPS installation protocol, consult the UPS supplier. z The required power supply of the UPS should be no less than 5 kVA. Connect the power cord of the device to the output port of the UPS.
  • Page 40: Preparing Samples

    Recommended Device Remarks supplier Temperature ranges (according to Frost-free requirements): freezers or z 2 ℃ to 8 ℃ (36 ℉ to 46 ℉ ) refrigerators z -18 ℃ to - 25 ℃ (-0.4 ℉ to -13 ℉ ) Preparing samples We recommend that you use the library preparation system of the manufacturer to prepare samples.
  • Page 41: Washing Cartridge And Washing Flow Cell

    Washing cartridge and washing flow cell Washing cartridges are delivered with the device for wash procedures. Used sequencing flow cells function as washing flow cells. For how to prepare the cartridge, contact the technical support. And for how to perform a wash manually, refer to Performing a wash on Page 48 .
  • Page 42 2) Secure the fixing plate and lid. Figure 15 Securing the fixing plate and lid 3) Open the airway. Figure 16 Opening the airway 3. If you need to add pure water into the pure water container during sequencing, perform the following steps: 1) Open the lid in position 1 according to the direction indication on the lid.
  • Page 43: Preparing The Waste Container

    3) Fill the pure water container with fresh pure water. 4) Remove the water output tube of the pure water machine from position 2 and secure the lid in position 1. Preparing the waste container The waste container is connected to the device through the tubes. Ensure that the space is sufficient before connecting the waste container to the device.
  • Page 44: Sequencing

    Sequencing This chapter describes the sequencing workflow and washing procedures. Read and follow the instructions to ensure correct operations.
  • Page 45: Workflow

    Workflow Log in ABCD Select a flow cell stage Load the reagent cartridges and flow cell Review parameters Perform a sequencing run Automatic post-wash z Chemicals in reagents and waste might cause personal injury through contact with the skin, eyes, and mucosa. Follow the safety standards of your laboratory and wear protective equipment (such as laboratory coat, and disposable bouffant cap, protective glasses, mask, gloves, and shoe covers) when performing a sequencing run.
  • Page 46: Selecting A Flow Cell Stage

    4. Log in to the control software with the user name and password that are provided by the manufacturer. Selecting a flow cell stage In the operation area of the main interface, select a flow cell stage. Loading the reagent cartridge Perform the following steps: 1.
  • Page 47 If RFID scanning fails, input the ID with the on-screen keyboard. Sequencing cartridge ID REF+SN, e.g. 1000000000S0000000000 Washing cartridge ID REF+SN, e.g. 1000000000S0000000000 xxxxxxxx Flow cell ID Recipe SE100+10 1-128 Split barcode Advanced settings Previous Next Preparing Figure 18 Sequencing information input interface z Ensure that the ID format is correct when you input ID manually.
  • Page 48 If you need to import Barcode files, select Import from the list. 6. Tap Advanced settings and you can enable Custom primers and Auto wash if needed. In the sequencing process, you can tap to enable or disable Auto wash if needed. 7.
  • Page 49 Item Description Estimated completion Shows the estimated time when sequencing completes. time You can select a QC value graph from the QC type list to QC type assess the sequencing quality. Tap it and a confirmation dialog box appears. Select Yes to pause sequencing.
  • Page 50 Used sequencing flow cells function as washing flow cells. The washing flow cell can be reused for three times. Dispose of the flow cell according to local regulations and safety standards of your laboratory. 3. Open the reagent compartment door and remove the reagent cartridges.
  • Page 51 - - - T h i s p a g e i s i n t e n t i o n a l l y l e f t b l a n k . - - -...
  • Page 52 Maintaining the device This chapter describes maintenance procedures of the device and its parts. Perform maintenance regularly to ensure that the device runs smoothly.
  • Page 53 Maintaining the main unit We recommend that you annually calibrate and maintain critical components, such as the robotic arm and motion platform. For details about the service plan, contact the technical support. Daily maintenance z Perform the following maintenance when the device is powered ¾...
  • Page 54 2. Clean the touch screen and exterior of the reagent compartment door, sequencing cartridge compartment door, and washing cartridge drawer with a 75% alcohol wipe. Ensure that the surface is free of DNBs, reagents, blood, and saliva. Monthly cleaning z We do not recommend that you use other disinfectants or wash solutions except for those that are mentioned in this manual.
  • Page 55 Performing a wash Chemicals in reagents and waste might cause personal injury through contact with the skin, eyes, and mucosa. Follow the safety standards of your laboratory and wear protective equipment (such as laboratory coat, and disposable bouffant cap, protective glasses, mask, gloves, and shoe covers) when performing a sequencing run.
  • Page 56 ¾ Tap and a confirmation dialog box appears. Select Yes to stop wash. 5. After wash, tap Finish to return to the main interface. 6. Remove the washing flow cell, sequencing cartridge, and washing cartridge. 7. Store the washing flow cell at room temperature. The washing flow cell can be reused for only one month.
  • Page 57 The waste container is connected to the device through tubes. To avoid liquid leakage and biological hazard, monitor the waste container status frequently and dispose of the waste and waste container in time when the waste reaches the maximum volume. Maximum volume Figure 20 Maximum waste volume Perform the following steps:...
  • Page 58 Problem Possible cause Recommended action 1. Perform a self-test in the maint enance int er f ace. Check the record of the z The parameters hardware that fails the self- are not set test. properly. Error messages 2. C h e c k e r ro r m e s s a g e s appear when the z Errors occur in the log, and solve the...
  • Page 59 Disposal of the device The service life of this device is seven years, which is determined by the simulated service life evaluation method. For the date of manufacture, refer to the label on the device. Perform the maintenance according to the requirements mentioned in this manual.
  • Page 60 Appendixes This chapter provides additional important information about the device.
  • Page 61 - - - T h i s p a g e i s i n t e n t i o n a l l y l e f t b l a n k . - - -...
  • Page 62 Specifications Item Description Class A in accordance with the rule 5(b) set out in Category Annex VIII of IVDR Laser classification Class 1 laser product of the device Throughput 6 TB/RUN 1656 mm (W) × 1815 mm (H) × 903 mm (D) Dimensions (65.2 inches ×...
  • Page 63 Item Description Temperature 19 ℃ to 25 ℃ (66 ℉ to 77 ℉ ) 3 0 % R H t o 8 0 % R H , n o n - Relative humidity condensing Atmospheric 80 kPa to 106 kPa pressure ≤2000 m Altitude...
  • Page 64 Electromagnetic Compatibility This device complies with the electromagnetic compatibility, emission and immunity requirements specified with EN/IEC 61326 series of product family standards. Such equipment is equipment suitable for use in all establishments other than domestic and those directly connected to a low voltage power supply network which supplies buildings used for domestic purposes.
  • Page 65 - - - T h i s p a g e i s i n t e n t i o n a l l y l e f t b l a n k . - - -...
  • Page 66 Manufacturer information Manufacturer Wuhan MGI Tech Co., Ltd. Building 24, Stage 3.1, BioLake Accelerator, No.388, 2nd Gaoxin Road, East Lake High- Address Tech Development Zone, 430075, Wuhan, P.R.China Technical support Wuhan MGI Tech Co., Ltd. Technical support E-mail MGI-service@mgi-tech.com...
  • Page 67 - - - T h i s p a g e i s i n t e n t i o n a l l y l e f t b l a n k . - - -...
  • Page 68 European representative information Name Shanghai International Holding Corp. GmbH (Europe) Address Eiffestrasse 80, 20537 Hamburg, Germany...
  • Page 69 - - - T h i s p a g e i s i n t e n t i o n a l l y l e f t b l a n k . - - -...
  • Page 70 Index anti-shock and anti-tilt labels 31 antivirus software 29 Biological safety 5 combinatorial probe-anchor synthesis (cPAS) 10 empty the fluidics line 25 Flow cell 16 Flow cell drive 14 Flow cell drive button 13 Flow cell retrieval compartment 14 Host power button 15 LED status bar 14...
  • Page 71 Main interface 20 Maintenance 25 Network requirements 28 Performing a wash 48 Washing cartridges 34 peripheral devices 32 Pollution degree 56 Power switch 19 Reagent cartridge and sequencing flow cell 33 Reagent compartment 16 safety information 1 Self-test 19 sensor status indicators 22 Settings interface 24 Troubleshooting 50 Workflow 38...

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