MGI MGISTP-3000 User manual

Sample Transfer Processing System
Part No.: H-020-000310-00
MGISTP-3000
[email protected]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.comWebsite:
Address:
Wuhan MGI Tech Co., Ltd.
Version: 1.0

About the user manual
This user manual is applicable to MGISTP-3000 Sample Transfer
Processing System. The manual version is 1.0 and the software
version is V1.
This manual and the information contained within are proprietary to
Wuhan MGI Tech Co., Ltd. (hereinafter called MGI), and are intended
solely for the contractual use of its customer in connection with the
use of the product described herein and for no other purpose. Any
person or organization can not entirely or partially reprint, copy,
revise, distribute or disclose to others the manual without the prior
written consent of 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. 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 contents might
be slightly different from the device, please refer to the device
purchased.
Microsoft®and Windows®are trademarks or registered trademarks
of Microsoft Corporation in the U.S. and/or other countries.
Intel®and Intel CoreTM are trademarks of Intel Corporation or its
subsidiaries in the U.S. and/or other countries. Other names and
brands mentioned in this manual may be claimed as the property of
others.
©
2021 Wuhan MGI Tech Co., Ltd. All rights reserved.
Initial release: March 30, 2021

Revision history
Date Version
Initial release March 30, 2021 1.0

I
Contents
Safety
Conventions 2
General safety 2
Electrical safety 3
Mechanical safety 4
Components safety 4
Biological safety 4
Symbols 5
Device 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

Contents
II
Preparing the power supply 20
Installing the device 21
Powering on or off the device 21
Powering on the device 21
Powering off the device 21
Preparing consumables 22
Preparing peripheral devices 22
Performing a workflow
Workflow 24
Logging in to the control software 24
Initializing 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 31
Service plan 31
Maintaining the power supply 31
Maintaining the software 31
Troubleshooting 32

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

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1
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.

Safety
2
Conventions
The following table describes conventions that are used in the
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. Otherwise, it might result
in unsuccessful workflow running, device malfunction,
or damage.
Indicates that the operator should pay special attention
to the note information, and operate the device by
following the instructions.
Indicates biological risk. The operator should operate
the device by following the instructions.
Boldface Indicates the printings and on-screen characters on the
device.
General safety
zEnsure 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.
zEnsure that the components of the device are completely installed before
operation. Otherwise, it might result in personal injury.
zMaintain the device by following the instructions in
Maintaining the device
on Page 29 to ensure best performance. Otherwise, it might result in
device malfunction or even personal injury.
zEnsure that the sleep mode is inactivated. The device will stop operating if
sleep mode is enabled.
zDo not open the door when powering on the device for maintenance.
Otherwise, it might cause personal injury.

Electrical safety
3
zEnsure that the power supply is disconnected before cleaning the device.
Otherwise, it might cause personal injury.
zOnly 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 damage to
the device.
zDo not move the device after the technical support have installed and
debugged the device. Incorrect operation will result in unsuccessful
workflow running. If you require to re-position the device, contact the
technical support.
zOnly trained professionals such as doctors, technicians, or laboratory
assistants can operate the device.
zDo not operate the device in the presence of flammable or explosive
liquids, vapors or gases. Otherwise, it might result in device malfunction.
zDo not disconnect the power cord under the power-on status.
zDo not reuse the disposable items.
zOnly the peripheral devices and consumables specified by the manufacturer
can be used.
zIf you have maintenance questions that are not mentioned in this manual,
consult the technical support.
zOnly the components provided by the manufacturer can be used for
device maintenance. Unapproved components might damage the device or
degrade performance.
zThe device is verified before delivery. If serious deviation occurs during use,
contact the technical support for calibration.
Electrical safety
zBefore initial use of the device, assess the electromagnetic environment in
which the device will be used.
zDo not use the device in close proximity to the sources of strong
electromagnetic fields, such as unshielded sources of radiated emissions.
Radiated signals can reduce the accuracy of the workflow.
zEnsure that the device is properly grounded, and the grounding resistance
is less than 4 Ω. Failure to do so might result in unsuccessful workflow
running or even electric shock.
zDo not remove the device cover and expose the inner component outside.
Otherwise, it might cause electric shock.

Safety
4
zOnly the power cord supplied by the manufacturer can be used.
zPrepare the laboratory and power supply according to
Getting started on
Page 17 .
zEnsure that the input voltage meets the device requirement.
Mechanical safety
zTo avoid personal injury, place the device on a level surface and ensure that
the device cannot be easily moved.
zDo not stretch out your hands or head into the device during operation.
Otherwise, it might cause personal injury.
Components safety
Only the software that have been provided by the manufacturer can be
installed and used on the computer. 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.
zIf the fuse blew, replace the fuse with the specified type. For details,
contact the technical support.
zDo not uninstall the control software by yourself. If any problem occurs
during software operation, contact the technical support.
zEnsure that the peripheral devices meet the IEC/EN 60950-1 standards.
Biological safety
zSamples in the sample tubes might cause cross contamination 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).

Symbols
5
zIf you accidentally splash the sample on the skin or into eyes, immediately
flush the affected area with large amounts of water and get medical aid
immediately.
zUse a strong biological waste bag to avoid tips piercing the bag. Pierced
bags might result in waste leakage and cross contamination.
zWhen disposing of the expired samples and consumables, comply with local
regulations.
Symbols
Device
The following table describes symbols on the device:
Symbol Name Description
"ON" (power) Indicates 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
Taking care to avoid injury
to eyes and skin when in the
vicinity of ultraviolet radiation.
Warning; crushing of
hands
Taking care to avoid injury
to hands when in the vicinity
of equipment with closing
mechanical parts.
T1 AH250V10 A 250V Fuse specification Indicates the fuse specification
of the device.

Safety
6
Symbol Name Description
POWER Power for device Power switch and power port
of the device.
SCAN1 PCIe port Used for communicating with
the IO board and scanner.
SCAN2 PCIe port Used for communicating with
the IO board and scanner.
WLAN Network port Connects to the network.
CAN1 CAN1 port Controls the motor.
CAN2 CAN2 port Controls the motor.
IO IO port Used for communicating with
the IO board.
Label
The following 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
Indicates the date when
the medical device was
manufactured.
SN Serial number
Indicates the manufacturer’s
serial number so that a
specific medical device can be
identified.

Symbols
7
Symbol Name Description
CE Mark of
Conformity
Indicates that this device
conforms with the specified
Council Directive.
RoHS mark
Indicates that this device meets
the requirements of Directive
2011/65/EU on the restriction
of the use of certain hazardous
substances in electrical and
electronic equipment.
Consult instructions
for use
Indicates the need for the user
to consult the instructions for
use.
WEEE symbol
Indicates that waste electrical
and electronic equipment
must not be disposed of as
unsorted municipal waste
and must be collected
separately. Please contact
an authorized representative
of the manufacturer for
information concerning the
decommissioning of your
equipment.
Packaging
The following table describes symbols on the packaging or on the
label of the packaging:
Symbol Name Description
This way up
Indicates the correct upright
position of the transport
package for transport and/ or
storage.
Fragile, handle with
care
Indicates a medical device that
can be broken or damaged if
not handled carefully.

Safety
8
Symbol Name Description
Keep dry
Indicates a medical device that
needs to be protected from
moisture.
Do not stack
Indicates that stacking of
the transport package is not
allowed and 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
Indicates the range of
atmospheric pressure to which
the medical device can be
safely exposed.

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

Device overview
10
Intended use
The device is used for processing and handling clinical samples and
sample containers in pre- and post-analysis processes.
Working principle
The device supports functions of automated decapping and capping,
automatic sample information input, negative pressure air exhaust,
and sample tube to plate. 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 include the function
of precise filling of reagents or samples before analysis by clinical
detection and analysis instruments.

Basic components
11
Basic components
Front view
7
8
9
4
5
6
1
2
3
Figure 1 Front view
No. Name Description
1Door
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.

Device overview
12
No. Name Description
2LED status bar
Displays the current status of the device.
zBlue: the device is in standby status.
zGreen: the device is running.
zYellow: a warning appears.
zRed: a malfunction or an error occurs.
3Door handle Holds to open or close the door.
4Fixing frame of the
waste bag Fixes the waste bag.
5Port interface Used for cable connections.
6Waste tip outlet Waste tips are discarded to the waste bag
through this outlet.
7Monitor Facilitates the on-screen operation and
displays information.
8Air outlet
Ventilates the device. The inner air is
filtered and discharged through this
outlet.
9Air inlet The outer air is filtered and enters into
the device through this inlet.

Basic components
13
Right view
11
2
98 7
3 4
5
6
Figure 2 Right view
No. Name Description
1Supporting feet Supports the main unit to ensure
stability.
2Power switch
Powers on or off the device.
zSwitch to the position to power on
the device.
zSwitch to the position to
power off the device.
3Network port Connects to the network of the
computer and server.
4IO port Used for communicating with the IO
board.
5CAN2 port Controls the motor.