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Disposal of the devic

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33

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. Dispose of the end of life device according to local 
regulations.

Содержание MGISTP-3000

Страница 1: ...10 00 MGISTP 3000 MGI service mgi tech com E mail Building 24 Stage 3 1 BioLake Accelerator No 388 2nd Gaoxin Road East Lake High Tech Development Zone 430075 Wuhan P R China www mgi tech com Website Address W u h a n M G I T e c h C o L t d Version 1 0 ...

Страница 2: ...luding 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 However MGI is not responsible for any missing parts in the manual and reserves the right to revise the manual and the device so as to improve the reliability performance or design Figures in this manual are all illustrations The conten...

Страница 3: ...Revision history Date Version Initial release March 30 2021 1 0 ...

Страница 4: ...5 Label 6 Packaging 7 Device overview Intended use 10 Working principle 10 Structural composition 10 Basic components 11 Front view 11 Right view 13 Top view of operation deck 14 Control software 15 Getting started Site requirements 18 Network requirements 18 Operating environments of the computer 18 Software security 19 Inspecting the device 19 ...

Страница 5: ... the device 25 Preparing for a workflow 25 Installing consumables 25 Setting parameters 25 Starting a workflow 26 Post processing 26 Processing abnormal tubes 26 Processing consumables 27 Processing the device 27 Maintaining the device Cleaning and disinfecting the device 30 Auto cleaning and disinfection 30 Post experiment cleaning and disinfection 30 Weekly disinfection 30 Monthly disinfection 3...

Страница 6: ...Contents III Storage and transportation 32 Disposal of the device 33 Specifications 35 Compliance information 37 Manufacturer information 39 European representative information 41 Index 43 ...

Страница 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 ...

Страница 8: ...escribes 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 ...

Страница 9: ...ing the instructions Boldface Indicates the printings and on screen characters on the device General safety z Ensure that the device is operated under the conditions specified in this manual Otherwise it might result in unsuccessful workflow running device damage or even cause personal injury z Ensure that the components of the device are completely installed before operation Otherwise it might re...

Страница 10: ...t reuse the disposable items z Only the peripheral devices and consumables specified by the manufacturer can be used z If you have maintenance questions that are not mentioned in this manual consult the technical support z Only the components provided by the manufacturer can be used for device maintenance Unapproved components might damage the device or degrade performance z The device is verified...

Страница 11: ...uter 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 If the fuse blew replace the fuse with the specified type For details contact the technical support z Do not uninstall the control software by yourself If any problem occurs during software operation contact the technical su...

Страница 12: ...tes connection to the mains supply OFF power Indicates disconnection from the mains supply General warning sign Signifies a general warning Warning biological hazard Warns of a hazard from a biological hazard Warning dangerous voltage Indicates hazards arising from dangerous voltages Protective earth Indicates the terminal of a protective earth ground electrode UV Warning ultraviolet radiation Tak...

Страница 13: ...owing table describes symbols on the label Symbol Name Description In vitro diagnostic medical device Indicates a medical device that is intended to be used as an in vitro diagnostic medical device Manufacturer Indicates the medical device manufacturer EC REP Authorized representative in the European Community Indicates the Authorized representative in the European Community Date of manufacture I ...

Страница 14: ...cates that waste electrical and electronic equipment must not be disposed of as unsorted municipal waste a n d m u s t b e c o l l e c t e d separately Please contact an authorized representative o f t h e m a n u f a c t u re r fo r information concerning the decommissioning of your equipment Packaging The following table describes symbols on the packaging or on the label of the packaging Symbol ...

Страница 15: ...no load shall be placed on the transport package Temperature limit Indicates the temperature limits to which the medical device can be safely exposed Humidity limitation Indicates the range of humidity to which the medical device can be safely exposed Atmospheric pressure limitation I n d i c a t e s t h e r a n g e o f atmospheric pressure to which the medical device can be safely exposed ...

Страница 16: ...9 Device overview This chapter describes the intended use working principle and structural composition of the device ...

Страница 17: ...e Tubes with inactivated samples can directly be processed by one click software operation and then samples are transferred to the plates and all necessary information about the samples are recorded Structural composition The device consists of the sample transfer modules and is connected with other necessary functional modules It is used for fractionating the samples before detection and does not...

Страница 18: ...t view 7 8 9 4 5 6 1 2 3 Figure 1 Front view No Name Description 1 Door Used to access the deck and to observe the inside of the device during operation The door is equipped with a sensor and will automatically lock when the device is running ...

Страница 19: ... to open or close the door 4 Fixing frame of the waste bag Fixes the waste bag 5 Port interface Used for cable connections 6 Waste tip outlet Waste tips are discarded to the waste bag through this outlet 7 Monitor Facilitates the on screen operation and displays information 8 Air outlet Ventilates the device The inner air is filtered and discharged through this outlet 9 Air inlet The outer air is ...

Страница 20: ...he main unit to ensure stability 2 Power switch Powers on or off the device z Switch to the position to power on the device z Switch to the position to power off the device 3 Network port Connects to the network of the computer and server 4 IO port Used for communicating with the IO board 5 CAN2 port Controls the motor ...

Страница 21: ...re installed in the port Top view of operation deck 1 2 4 3 5 6 7 8 Figure 3 Top view of operation deck No Name Description 1 Robotic arm Moves the gripper to the specified position 2 Tube rack position Places the tube rack 3 Position 2 Places the consumables according to the fractionation requirement 4 Position1 Places the consumables according to the fractionation requirement 5 Tip removing posi...

Страница 22: ...an be flexibly extended according to actual needs The system supports a variety of tube specifications and different sample transfer volumes It has the following features pure interface operation one click operating process no complex scripts visual workflow processing monitoring real time display of sample processing progress and support for exporting barcodes for subsequent experiments The follo...

Страница 23: ... 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 ...

Страница 24: ...17 Getting started This chapter describes laboratory preparations and experiment preparations ...

Страница 25: ...u refer to the standard of a biosafety level BSL 2 laboratory z Ensure that enough space is provided around the device for ventilation cable connection and power switch operation The following figure indicates distances that are required for optimal operation and access 500 mm 20 inches 500 mm 20 inches 500 mm 20 inches 500 mm 20 inches 500 mm 20 inches Device Device Operation area Figure 4 Space ...

Страница 26: ...f you need to install antivirus software contact the technical support in advance Data and device ports z PCIe port connects to the CAN card serial port card and network card of the device and computer z Network port connects to the network z USB port connects to the keyboard mouse or for future use Access control Only the user authorized by the manufacturer can use the control software Inspecting...

Страница 27: ...unaffected Indicates that no tilt occurs or the gradient does not exceed the limit Red Indicates that tilt occurs and the gradient exceeds the limit 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 o...

Страница 28: ...s described in Preparing the power supply on Page 20 z Ensure that the grounding cable is connected in accordance with the relevant standard or under the guidance of the experienced electrician z We recommend that you use the power cord provided by the manufacturer to connect to the power supply and the power cord can be only used with this device Failure to do so might damage the power cord or de...

Страница 29: ... to the position Preparing consumables Prepare the following items z Deep well plate z Tips z Tube and tube rack Preparing peripheral devices Name Specification Recommended brand Frost free freezers or refrigerators 2 8 36 46 General laboratory supplier Waste bag The bag should be printed with biological risk symbol General laboratory supplier Heat sealer General laboratory supplier Barcode printe...

Страница 30: ...23 Performing a workflow This chapter describes the sample transfer workflow Read and follow the instructions to ensure correct operations ...

Страница 31: ...ctive glasses mask gloves and shoe covers Logging in to the control software You can start an experiment only after you log in to the control software Perform the following steps 1 Power on the device and then power on the computer 2 Log in to the computer with the password that is provided by the technical support 3 Wait about 3 minutes on the desktop double click the control software icon to lau...

Страница 32: ...1 Place the left side of the tip plate into the groove of the tip box and press the right side of the tip plate Ensure the tip plate is securely fixed To avoid contamination try not to touch the tips during placement 2 Place the deep well plate in the corresponding positions Ensure that the direction of the numbers and letters on the deep well plate is correct 4 Fix the waste bag with biological r...

Страница 33: ...troubleshoot and solve the problem For information about the troubleshooting refer to Troubleshooting on Page 32 If the problem persists contact the technical support After parameter settings click Start and reconfirm the workflow information The workflow starts During experiment you can do the following z Click Pause the workflow is paused The button changes to Resume Click it to resume the workf...

Страница 34: ...ext time The software will also automatically calculate the remaining number of tips prompting whether the tips are sufficient 5 Check whether the waste bag is full If it is full remove the waste bag and discard it into a laboratory designated container Processing the device Do not violently open the door during clean Otherwise the eyes and skin will be directly exposed to ultraviolet rays which m...

Страница 35: ... 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 ...

Страница 36: ...29 Maintaining the device This chapter describes maintenance procedures of the device and its parts Perform maintenance regularly to ensure that the device runs smoothly ...

Страница 37: ...nt cleaning and disinfection Ensure that the dust free wipe is wet but leaves no droplets Performing cleaning After each experiment perform the following steps 1 Wipe the surfaces of the device operation deck and pipette with a dust free wipe moistened with Milli Q water or pure water 2 Let the device air dry Performing disinfection After each experiment perform the following steps 1 Wipe the surf...

Страница 38: ...ually replacing the UV lamp and filter of the fan filter unit once inspecting and maintaining the pipette and lubricating the motor screw and guide rail sliders Maintaining the power supply z When the device is not in use for seven days or longer perform a maintenance wash power off the device and disconnect the power cord z Check whether the power cord and cables are connected correctly and in go...

Страница 39: ...h is turned to the position 3 Check whether the voltage of the mains supply outlet is within the required range 4 If the problem persists contact the technical support Error occurs when I start the software 1 Check whether the power switch is turned to the position 2 Check whether the door is closed 3 Check whether the network cable of the device is connected securely 4 Restart the software and de...

Страница 40: ... 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 Dispose of the end of life device according to local regulations ...

Страница 41: ... 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 ...

Страница 42: ...sound pressure level 75 dB D e g re e s o f p ro t e c t i o n provided by enclosures IP Code IPX0 Operating environment requirements z Temperature 19 to 25 66 to 77 z Relative humidity 20 RH to 80 RH non condensing z Atmospheric pressure 80 kPa to 106 kPa z Maximum altitude 2000 m z Pollution degree 2 z Indoor use Storage transportation environment requirements z Temperature 20 to 50 4 to 122 z R...

Страница 43: ...Specifications 36 Item Description Pipetting range 10 μL 1000 μL Pipetting precision z 10 μL CV 5 accuracy 10 z 10 μL CV 2 accuracy 5 z 1000 μL CV 1 accuracy 2 ...

Страница 44: ...rical equipment for measurement control and laboratory use EMC requirements Part 2 6 Particular requirements In vitro diagnostic IVD medical equipment Safety requirements z IEC 61010 1 2010 AMD1 2016 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements z IEC 61010 2 101 2018 Safety requirements for electrical equipment for measurement ...

Страница 45: ... 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 ...

Страница 46: ...urer Wuhan MGI Tech Co Ltd Address Building 24 Stage 3 1 BioLake Accelerator No 388 2nd Gaoxin Road East Lake High Tech Development Zone 430075 Wuhan P R China Technical support Wuhan MGI Tech Co Ltd T e c h n i c a l s u p p o r t E mail MGI service mgi tech com ...

Страница 47: ... 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 ...

Страница 48: ...European representative information 41 European representative information Manufacturer Shanghai International Holding Corp GmbH Europe Address Eiffestrasse 80 20537 Hamburg Germany ...

Страница 49: ... 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 ...

Страница 50: ...shock and anti tilt labels 20 Anti shock label 20 Anti tilt label 20 antivirus software 19 B Biological safety 4 C computer 4 antivirus software 4 control software 4 D device damage 2 E electromagnetic environment 3 F fuse 4 ...

Страница 51: ...Index 44 N Network requirements 18 P Power switch 13 R re position 3 ...

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