Integrated Nucleic Acid Testing Device

Service Manual

PM001
 Table of Contents
Important Notice .......................................................................... 1
Chapter I Overview ..................................................................... 6
1. TECHNICAL INTRODUCTION............................................................................ 6

2. INTENDED USE.................................................................................................... 6

3. DEVICE CHARACTERISTICS ............................................................................. 6

Chapter II Features ..................................................................... 7

1. NORMAL WORKING CONDITIONS................................................................... 7

2. TRANSPORTATION AND STORAGE CONDITIONS ........................................ 7

3. PARAMETERS ...................................................................................................... 7

4. DEVICE STRUCTURE AND INDICATOR LIGHT STATUS .............................. 8

Chapter III Operation Introduction ........................................ 12

1. PRE-AMPLIFICATION PREPARATION............................................................ 12

2. START OF AMPLIFICATION ............................................................................ 12

3. ERROR ................................................................................................................ 12

4. END OF AMPLIFICATION ................................................................................. 12

Precautions.................................................................................. 13
Manufacturer Information ........................................................ 13
 Important Notice
1. Important safety operation information
Users need to have a complete understanding of how the device works before
operating it safely. Please read the instruction carefully before operating the device.

It is prohibited to operate the device before reading these

instructions. If the device is not operated as instructed, the heat
generated by the device during operation may cause serious burns,
and electrical shock accidents may occur. Please carefully read the
following safety guidance, and implement all of these precautions.

2. Safety
The following basic safety precautions shall be observed during the whole
processes of operation, maintenance and repair of this device. Failure to comply with
these measures or the warnings noted in these instructions may damage the protection
provided by the device and affect its intended range of use.

This device conforms to the relevant requirements of IEC

61010-1 and IEC 61010-2-101 (EN 61010-1 and EN 61010-2-101).
This device is for indoor use.

Please read the instructions carefully before operating the

device, otherwise personal injury may occur. This device can only
be operated by qualified personnel trained in the installation and
use of electrical equipment.

Operators must not disassemble or repair the device, as doing so

will invalidate the device warranty and may also result in electric
shock. If repair is required, please contact the manufacturer.

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 Before connecting the power supply, ensure that the voltage of
the power supply matches the voltage required by the device. Also
ensure that the rated load of the power outlet is not less than that
required by the device.
The power cord must be replaced if damaged. All replacement
parts must match the original type and specification. Do not hang
anything on the power cord when this device is in use. Place the
power cord away from foot traffic.
Be sure to hold the plug when plugging or unplugging the power
cord. Ensure that the plug is fully inserted into the socket when
plugging in, and do not pull the power cord when unplugging. If the
supplied power adapter does not fit your local outlet, replace or add
a suitable power adapter to ensure that the power supply matches
the conditions required by the device.

The device should be stored in an environment with low

humidity and dust. Store away from direct sunlight and strong light
sources. The room should be well ventilated and free from
corrosive gas or strong magnetic field interference. Keep away
from heating, stoves and all other heat sources. Do not place the
device in damp or dusty places. Do not place the device where will
be difficult to access and disconnect the device in an emergency.

Turn off the power supply to the device when it is not in use.
When the device will not be used for an extended period, the cable
should be unplugged and the device covered with a soft cloth or
suitable plastic cover, to prevent dust from entering it.

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 Under the following circumstances, immediately remove the
power plug of the device from the power socket and contact the
supplier or trained maintenance personnel to deal with the situation:
◼ Liquid spilled on the device
◼ Device is exposed to rain or water
◼ Device is dropped or casing is damaged
◼ The functions of the device have changed significantly

3. Electromagnetic compatibility
The device has been tested and meets the electromagnetic compatibility (EMC)
technical standards.
The device complies with the emission and disturbance resistance requirements
specified in IEC 61326-1 and IEC 61326-2-6.
a) This device can generate and radiate radio wave energy and may interfere with
wireless communication if not installed and used in accordance with these instructions.
The use of the device in residential areas may cause harmful interference, and the user
shall be responsible for solving interference issues. If the device does cause harmful
interference to other equipment, and it only occurs while the device is turned on, it is
recommended to take one or more of the following measures to overcome this
interference:
■ Reorient or relocate the disturbed device
■ Increase the spacing between the two devices
■ Connect the device to an independent socket that does not share a circuit with
other equipment
■ Consult the manufacturer or field technician for assistance
b) Do not use equipment that can generate and radiate radio wave energy (e.g.,
mobile phone, radio transceiver, etc.) close to the device. Otherwise, interference of
electromagnetic waves may cause this device to malfunction.

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c) You are advised to evaluate the electromagnetic environment before using the
device.

Warning: The device may cause damaging electrostatic

discharge in a dry environment with artificial materials (artificial
fabrics, carpets, etc.), which may lead to incorrect conclusions.

Warning: Do not use the device near strong radiation sources

(such as unshielded radio frequency sources); otherwise it may
interfere with the normal operation of the device.

Warning: Uses of accessories and cables other than those

originally supplied by the manufacturer of this device may result in
increased device interference, or decrease its immunity to outside
interference.

Warning: The device should not be used close to or stacked with

other devices. If it must be used close to or stacked with other
devices, its operation should be observed to verify that it works
properly in the configuration in which it is used.

Warning: Interference generated during the operation of this

device may adversely affect the operation of other electronic
devices.

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4. Device maintenance
The device module and thermal cover should be cleaned regularly with a clean
soft cloth dipped in a small amount of anhydrous alcohol, to ensure sufficient contact
between the microfluidic chip and module, good thermal conductivity, and to avoid
contamination.
If the surface of this device is stained, it can be cleaned with a soft cloth dipped in
clean water.

The power must be disconnected when cleaning the device.

The device surface must not be cleaned with corrosive
cleaning agents.

5. After-sales service
The service lifetime of this device is 2 years. (This service period is valid if the
usage precautions are observed and regular maintenance is correctly performed.)
There may be safety or performance issues after the 2-year use period expires.
Please consult with the corresponding technical support personnel.
a) Warranty
Within one month after the date of delivery, the manufacturer will be responsible
for replacement of the device due to material and manufacturing defects.
This device is guaranteed for 12 months from the date of delivery in the event of
material or manufacturing defects. During the warranty period, the company will repair
or replace the device if it is proven to be defective.
Warranty products must be sent by the user to the company for repair. The cost of
sending the device to the maintenance department shall be borne by the user. The
manufacturer will bear the shipping cost for returning the device to the user.
For repairs outside the warranty period, the company will charge the cost of the
repairs to the user.
b) Scope of Warranty
The above warranty is not suitable for damage caused by inappropriate
maintenance, operating in conditions that do not meet the requirements, unauthorized
repair or modification.

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 Chapter I Overview
1. Technical introduction
1.1 Microfluidic technology: Microfluidics refers to the science and technology
involved in systems that microtubes (tens to hundreds of micrometers in size) to
process or manipulate tiny volumes of fluids (ranging from nanoliters to attoliters). It is
an emerging interdisciplinary discipline involving chemistry, fluid physics,
microelectronics, new materials, biology and biomedical engineering. Because of the
characteristics of miniaturization and integration, microfluidic devices are commonly
referred to as microfluidic chips, and also known as lab-on-a-chip devices and micro
total analysis systems.
1.2 Isothermal nucleic acid amplification technology: this is the general term for
a class of molecular biology technology that expands the copy number of a particular
DNA or RNA fragment at a particular temperature. At present, the main isothermal
amplification technologies include: rolling circle nucleic acid amplification,
loop-mediated isotemperature amplification, strand displacement amplification,
nucleic acid sequence-based amplification and helicase-dependent amplification. They
all share common characteristics: constant temperature, high efficiency, special, no
need for special equipment.

2. Intended use
It can be used with adaptive microfluidic chips for in vitro amplification detection
of sample nucleic acid.

3. Device characteristics
■ The thermal circulation system adopts metal film heating technology, which has
stable and reliable performance.
■ The temperature changes rapidly, and the heating and cooling rate is no less than
10°C/min.
■ It is compatible with microfluidic chips independently developed by Guangzhou
Pluslife Biotech Co., Ltd.

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 Chapter II Features
1. Normal working conditions
Environmental temperature: 15°C–30°C
Relative humidity: ≤70%
Power supply: 5V 3A
Input power: 15W

2. Transportation and storage conditions

Temperature: -20°C–55°C
Relative humidity: ≤80%

3. Parameters
3.1 Basic parameters
Sample size: 1
Dimensions (mm) (length × width × height): 101 × 91 × 65
Weight (g): 210g

3.2 Performance parameters

Sample module operating temperature range: 37°C–70°C
Maximum heating rate of sample module: ≥ 10°C/min
Temperature control accuracy of sample module: ±0.5°C
Sample module temperature uniformity: ±1.5°C (after 5 mins)

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4. Device structure and indicator light status
4.1 Schematic diagram of the device construction

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Type-C cable

DC power cable

Power adapter

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4.2 Indicator light status:

Power indicator light flashing, temperature preparation

stage (measurement cannot be started)

When the power indicator light stops flashing and turns

blue, the preparation is complete and the test can be started.
The power indicator light will flash blue during the test.

When the positive indicator light is on, the sample is

determined to be positive.

When the negative indicator light is on, the sample is

determined to be negative, or the sample concentration
value is too low to be detected.

When the negative and positive indicator lights are both

on, this indicates invalid test result. It may also indicate
insufficient sample volume, suppressed reaction, sampling
error or sample contamination during the test process.

When the power indicator flashes red and the beeper

sounds simultaneously, this indicates that the device is in
error state.

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Chapter III Operation Introduction
1. Pre-amplification preparation
Connect the power supply, press the power button to start the device and enter
warm-up state. After about 2 mins, warm-up is completed and the device enters
standby state (Figure 1).

Figure 1

2. Start of amplification
Insert the reaction card into the device and close the top cover. Press the power
button to start amplification.

3. Error
When the power indicator flashes and the buzzer beeps simultaneously, the device
is in Error state, press the button for 3 seconds to end the test.

4. End of amplification
After amplification, you can start the next test. For the next test, press the power
button to eliminate the last test result (the power indicator is steady on), insert the

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reaction card to be tested, and then press the power button for the next normal test.

Press the power button for 3 seconds to turn off the device.

Precautions
1. Do not press the power button during amplification, otherwise an invalid result may
occur.

2. If power to the device fails while it is running a test, the test will fail and should be
repeated with a new sample.

3. The device top cover must not be opened during operation, otherwise the test result
may be affected.

4. Do not pick up the device while a test is in progress to avoid interrupting data
transmission by the device.

5. Do not use non-original plugs or cables for testing.

6. Testing must be performed on a flat and clean surface.

Manufacturer

Guangzhou Pluslife Biotech Co., Ltd.

Address: Room 402, 6 Lianhuayan Road, Huangpu District, Guangzhou,
Guangdong,China
Tel.: +86-20-31703986
E-mail: [email protected]

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 SUNGO Europe B.V.
Add.: Fascinatio Boulevard 522, Unit 1.7,2909VA Capelle aan den
IJssel, The Netherlands
Tel.: +31(0)10 3034500, +31(0)2021 11106
E-mail: [email protected]

Explanation of symbols
In vitro diagnostic
CE Mark
medical device

Consult instructions for use Keep dry

This way up Temperature limits

Manufacturer Caution

Authorized representative in the

Potential biosafety risks
European Community

The product should not be

discarded as unsorted waste but
Model
must be sent to separate collection
facilities for recovery and recycling

Version: A/2
Date:Apr., 2023

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