Shineway Tech SWM-01 User manual

PCR Nucleic Acid Analyzer
（SWM-01）
Instruction Manual
Technical requirement No: Q/SWM01201801
Version: 2018.05 first edition V1.0
Product life: 5 years

I
Preface
Thanks for choosing PCR Nucleic Acid Analyzer SWM-01. The manual instruction
mainly illustrates the function and operation procedures of the devices. Please read this
instruction manual carefully to ensure the proper use. Please keep this instruction
manual. If encountering any problem while using, please refer to the manual
instruction.
Open-package Inspection
Please check the device and the accessories in accordance with the packing list after
opening the package carton. If any problem is found, such as wrong device or accessories,
missing accessories or defective accessories, please contact the distributor or the
manufacturer.

II
Contents
1 Summary........................................................................................................1
1.1 Introduction of the Device..................................................................................................................1
1.2 How to Use the Instruction Manual....................................................................................................1
1.3 Important Safety Operation Information............................................................................................1
1.4 After-sales Service Warranty...............................................................................................................5
2 Design and Illustration..................................................................................6
2.1 Parameters...........................................................................................................................................6
2.2 Model ..................................................................................................................................................7
2.3 Product Usage .....................................................................................................................................7
2.4 Mechanism..........................................................................................................................................8
2.5 Product Composition...........................................................................................................................9
2.6 Structure..............................................................................................................................................9
2.7 Indicator State Description ...............................................................................................................10
3 Assembly and Operation .............................................................................11
3.1 Instrument assembling......................................................................................................................11
3.2 Sample preparation and introduction................................................................................................11
3.3 Startup of software............................................................................................................................12
4 Data Analysis................................................................................................18
5 Maintenance and Cleaning..........................................................................19
5.1 Operating Conditions........................................................................................................................19
5.2 Transportation and Storage Conditions ............................................................................................19
5.3 Cleaning ............................................................................................................................................19
5.4 Instrument validation ........................................................................................................................20
5.5 Waste disposal...................................................................................................................................20
5.6 Waste instrument disposal.................................................................................................................20
6 Fault Diagnosis and treatment....................................................................21
7 Appendix ......................................................................................................23
Appendix I Electromagnetic compatibility warning ..............................................................................23

III
Symbol Interpretation
The symbols listed below are applicable to this instruction manual only.
Table A
Symbol
Meaning
Notice! This might cause damages on the device or affect the test result.
This might cause the biological contamination.
This might cause electric shock
High Temperature. This might result in bodily injuries.
Hard Light. This might result in eye injuries.
This might result in bodily injuries.
Flammable Material. This might cause a fire.

IV
Silk Printing and Label
The silk printing and labels listed below are applicable to this instruction manual only.
Table B
Symbol
Description of symbol
Indicates the manufacturer's batch code so that the
batch or lot can be identified.
Indicates the manufacturer's catalogue number so
that the medical device can be identified.
Indicates the manufacturer's serial number so that
a specific medical device can be identified.
Indicates the medical device manufacturer.
Indicates the date when the medical device was
manufactured.
Indicates the authorized representative in the
European Community.
Indicates a medical device that is intended to be
used as an in vitro diagnostic medical device.
Power switch / Power on state
Operating status
Stop running status
USB
Data Transfer Interface
Fuse
Fuse

V
Figure
All the figures listed in this instruction manual are only for illustration or example purposes.

Instruction Manual Summary
1
1 Summary
1.1 Introduction of the Device
PCR Nucleic Acid Analyzer SWM-01 performs qualitative detection of nucleic acid samples
(DNA/RNA) derived from human body by single fluorescence PCR, including nucleic acid detection and
gene analysis of pathogens. The product can be used under various scenarios including CDC, emergency
medical treatment, specialist examination, primary care and blood screening. The instrument consists of the
control system, power system, photoelectric system, temperature control system, case component, reaction
chips, software modules (including control software, version 1.0).
Features:
⚫7.5inch colorful touch screen with a user-friendly control surface;
⚫Streamlined shell design with stylish appearance;
⚫Low reagent consumption, saving detection cost, and improve the efficiency of PCR reaction;
⚫High detection sensitivity;
⚫Advanced design of optical path to eliminate interference of the external light and further
increase detection reliability;
⚫Employ accurate and efficient data processing system with artificial intelligence image
segmentation algorithm;
⚫Equipped with a large-capacity USB flash drive for data storage.
1.2 How to Use the Instruction Manual
The instruction manual gives an introduction of how to operate this PCR Nucleic Acid Analyzer
SWM-01 safely and effectively.
⚫Chapter 1 illustrates the information of instruction manual;
⚫Chapter 2 illustrates the basic information of PCR Nucleic Acid Analyzer SWM-01;
⚫Chapter 3 illustrates how to assemble the device and the software operation;
⚫Chapter 4 illustrates the date analysis function of PCR Nucleic AcidAnalyzer SWM-01;
⚫Chapter 5 illustrated how to properly maintain PCR Nucleic Acid Analyzer SWM-01;
⚫Chapter 6 illustrates how to deal with machine faults and maintenance information.
1.3 Important Safety Operation Information
Before safely operating PCR Nucleic Acid Analyzer SWM-01, the user must have a complete
understanding on how the device operates, and please read this instruction manual carefully before using
PCR Nucleic Acid Analyzer SWM-01.

Instruction Manual Summary
2
Below are the warning signs of PCR Nucleic Acid Analyzer SWM-01. If ignoring, it might pose a
threat to the personal safety. This list is in no particular order of importance. Please read it carefully and
take preventive measures.
1.3.1 Safety
Table 1-1
Electric Shock
（1）When the power is on, please do not open the panel and the anti-collision box
except for those authoritative operators.
（2）Please avoid any liquid splashing on the table. If any liquid flows into the
device, please shut down the power immediately and do not hesitate to contact
the after-sales staff from Shenzhen Shineway Technology Corporation.
High Temperature
（1）When the product is performing PCR amplification reaction, don't open the
cover and don't touch high temperature objects such as chip and heater.
Biological Contamination
（1）The operator should take protective measures and prohibit direct contact with
biochemical reagents and reactants，because there is operation of biochemical
reagents during the product use.
（2）All the tips, sample test tubes, and disposable microfluidic chips should be
considered contagious. Gloves should be worn when in contact. Discharge and
treatment of biological waste should be in accordance with the regulations and
laws of local Health and Environmental Department.
Flammable
（1）Don't use flammable hazardous such as alcohol or ether near the PCR device.

Instruction Manual Summary
3
Hard Light
（1）Don't gaze the light on the PCR device with the naked eyes to avoid threats to
the eyes.
1.3.2 Notice
Table 1-2
Application Scope
（1）The product adopts a rapid fluorescence qualitative and quantitative PCR system
for detection of nucleic acid samples (DNA/RNA) derived from human body,
including nucleic acid detection and gene analysis of pathogens.
（2）Product can also be used together with the matched detection reagents to detect
food-borne pathogens, food origin, GMF identification, plant bacteria and
viruses, animal diseases, etc.
Operator
The operator must be an inspector with biological knowledge and needs to own
the following capabilities:
（1）Practised basic skills in molecular biology experiments;
（2）Master the basic knowledge of molecular biology;
（3）Correct operation of the PCR device;
（4）Correctly analyze the sample fluorescence quantitative test results.
Application Environment
（1）Install PCR device properly in accordance with the installation environment
specified in this instruction manual. Installation and use out of accordance with
the specified conditions may result in unreliable results and damage to the PCR
instrument.
（2）Not to position the equipment so that it is difficult to operate the disconnecting

Instruction Manual Summary
4
device.
（3）If you need to change the working environment of the PCR machine, please
contact the Shenzhen Shineway Technology Corporation or the agent in your
area.
Electromagnet Interference
（1）The PCR device is susceptible to electromagnetic interference during operation,
which may affect the measurement results and cause malfunctions. Please do not
use equipment such as electric drills, mobile phones, walkie-talkies, etc. that
generate electromagnetic waves during operation.
（2）The electromagnetic wave will be radiated outside during the operation of the
PCR instrument. Don't install or use electromagnetic sensitive equipment near
the PCR instrument.
Ground Fault
（1）The power supply must be properly grounded, otherwise there may be a risk of
electric shock;
（2）The grounding impedance must be less than 10 Ω. Poor grounding may result in
unstable results and leakage of the casing, causing a risk of electric shock.
Water Quality
（1）According to the provisions of GB/T 6682-2008 "Analysis Laboratory Water
Specifications and Test Methods", the water quality used in the experiment is
Grade 1 water, and the water quality must meet the following requirements.
Otherwise, the experiment may fail, and make the error testing results.
⚫Particles less than 1 units/ml;
⚫The resistivity is greater than 18 MΩcm;
⚫The number of colonies is less than 1 cfu/ml;
⚫The dissolved silicon is less than 0.01 mg/L.

Instruction Manual Summary
5
Analytical Parameters
（1）Incorrect experimental parameters may lead to erroneous measurement results,
please contact Shenzhen Shineway Technology Corporation for more details.
1.4 After-sales Service Warranty
Our company is responsible for returning the instrument due to defects in materials and manufacturing
within one month from the date of delivery.
Our company provides the instrument with a free warranty due to the faults caused by defects in materials
and manufacturing within 12 months from the date of delivery. During the warranty period, the company
will selectively repair or replace the instruments that prove to be defective.
Warranty Scope
Damage caused by improper operation of the user, use under unsatisfactory conditions, unauthorized
repair or modification, etc., is not covered by the warranty.
After the warranty period, the maintenance cost is appropriately charged according to the repair items.

Instruction Manual Design and Illustration
6
2 Design and Illustration
2.1 Parameters
2.1.1 Basic parameters
Table 2-1
Technical Index
Parameters
Temperature Control Range
40-105℃
Heating Rate
≥1.5℃/s
Cooling Rate
≥1.5℃/s
Temperature Accuracy
±0.5℃
Temperature Uniformity
±1℃
Chip Reaction Volume Range
2 μL
Fluorescence Channel
FAM
Input Voltage
AC100~240V（50/60Hz）
Net Weight
2.5kg
Dimension
330mm×250mm×180mm（exclude packaging）
Operating Software
PCR Nucleic Acid Analyzer control system 1.0
Hardware version
PCR Nucleic Acid Analyzer hardware system V1.0
Operating System
Linux system
Signal Interface
USB, Ethernet
2.1.2 Functionality index
2.1.2.1 Module operating temperature range
a) Module minimum operating temperature: 40C, error: 1C;
b) Module maximum operating temperature: 105C, error: 1C.
2.1.2.2 Average heating rate of the module: from 50C~90C，≥ 1.5C/s.
2.1.2.3 Average cooling rate of the module: from 50C~90C，≥ 1.5C/s.
2.1.2.4 Module temperature control accuracy (temperature control fluctuation): ≤0.5C.
2.1.2.5 Module Temperature Accuracy:
Difference between measured temperature and the set temperature ≤ 0.5C.
2.1.2.6 Module temperature uniformity:
Temperature difference ≤ 1.0C.
2.1.2.7 Temperature Duration Accuracy:
The relative deviation of the actual temperature duration from the set temperature duration is ≤ 5.0%.
2.1.2.8 Fluorescence intensity detection
a) Repeatability of fluorescence intensity detection (intra-assay measurement repeatability):
Repeatedly detect the high-, medium-, and low-concentrated calibration dye, and the coefficient
of variation (CV) shall be ≤ 3.0%.

Instruction Manual Design and Illustration
7
b) Repeatability of sample detection (intra-assay measurement repeatability):
Repeatedly detect the high-, medium-, and low-concentrated nucleic acid samples, and the
coefficient of variation (CV) of the Ct value (or the logarithm of the concentration) shall be ≤
3.0%.
2.1.2.9 Linearity
a) Sample linearity
A serial dilution of samples (at least 5 concentrations) shall be detected, and the Ct value of each
concentration and the logarithm of each concentration shall has a linear regression coefficient of r
≥ 0.990;
b) Fluorescence linearity
A serial dilution of fluorescent dye (at least 5 concentrations) shall be detected, and the
fluorescence intensity and the dilution ratio of each concentration shall has a linear regression
coefficient of r ≥ 0.990.
2.2 Model
SWM −01
2.3 Product Usage
Based on the principle of fluorescent polymerase chain reaction, the product is clinically only
used with specified IVD reagents (approved by local medical device management department) for
qualitative detection of nucleic acid samples (DNA/RNA) derived from humans, including nucleic acid
detection and gene analysis of pathogens. The clinical sample includes serum or plasma sample, throat
swabs, eye or tooth secretions, tissue slice and etc. from human. The operator should be an inspector of
a professional medical facility and must have the following capabilities:
1. Practiced basic skills in molecular biology experiments;
2. Master the basic knowledge of molecular biology;
3. Correctly regulate and operate PCR NucleicAcid Analyzer;
4. Analyze the test results of fluorescence quantitative properly.
Product Code
Company Name for Short +Medical

Instruction Manual Design and Illustration
8
2.4 Mechanism
A silicon-based thin film microheater is used as a rapid heating component, and a microfluidic
chip is used as a carrier for the PCR reaction. The PCR reaction system uses a fluorescent probe as an
indication of the reaction signal. As the PCR reaction progressed, the fluorescence of the positive
reaction will accumulate, and the signal is collected as images by a CMOS camera. Finally, the control
system completes data collection and makes digital image processing.
2.4.1 Control Systems：Embedded Control Systems
2.4.2 Temperature Control：Based on Joule heating principle, a silicon thin film micro-heater with
metal coating is used as a heating element, which has high thermal conductivity and good
temperature-resistance linear curve, thereby achieving rapid and accurate temperature rise. In addition,
the cooling system is equipped with a high-speed and small fan and an optimized duct was designed to
effectively increase the cooling rate.
2.4.3 Reaction Carrier：The silicon-based microfluidic chip can be used as a disposable carrier for the
PCR reaction. The internal reaction chamber has a volume of 2 μL. The silicon substrate is tightly
contacted with the thin film micro-heater, which is beneficial to improve heat transfer efficiency and
temperature uniformity. Covering the silicon substrate with a glass wafer to form a PCR reaction
chamber can effectively avoid sample contamination.
2.4.4 Fluorescence signal detection: The reaction system of PCR utilize a fluorescent probe or a
general dye as an indication of the signal. As the PCR reaction proceeds, the fluorescence of the
positive reaction will accumulate and the signal is collected as images by the CMOS camera. At last,
the control system completes data collection and processing.

Instruction Manual Design and Illustration
9
2.5 Product Composition
Table 2-2
No.
Item
Model
Unit
Qty
Note
1
PCR Nucleic Acid
Analyzer
SWM-01
Set
1
2
Power Cord
0.75mm2*3，1.5m
Pcs
1
Accessory
3
USB Flash Drive
16GB
Pcs
1
Accessory
4
Instruction Manual
Set
1
Attaching File
5
Warranty Card
Set
1
Attaching File
6
Certificate of Quality
Set
1
Attaching File
2.6 Structure
Figure2-1
1 Air Inlet 2 Power Indicator 3 Running Indicator 4 Fault Indicator 5 Reaction Chip Holder
6 Cover of the Reaction Room 7 Touch Screen

Instruction Manual Design and Illustration
10
Figure2-2
2.7 Indicator State Description
Table 2-3
Indicator State
Instrument State
Power off
Power on
Running
Fault
8 Power Button 9 Fuse Holder 10 USB Interface 11 Air Outlet 12 Supply Hub

Instruction Manual Assembly and Operation
11
3 Assembly and Operation
3.1 Instrument assembling
After unpacking, there is no additional installation for PCR Nucleic Acid Analyzer SWM-01. The user
must use the supporting microfluidic chip as reaction carrier for experiment. In addition, the user also needs
to prepare the pipette, EP tube and other basic experimental accessories for molecular biology experiment.
One end of the matching power cord is connected to the Supply Hub 12 of the instrument, and the
other end is connected to the earthed socket. Always use the matching power cord to connect the instrument
to a suitable power source. The voltage of the power supply should meet the requirements of the
instrument.
3.2 Sample preparation and introduction
3.2.1 Sample preparation
The clinical sample(serum or plasma sample, throat swabs, eye or tooth secretions, tissue slice）should
be processed for nucleic acid extraction by using a related kit and then stored at -20 ℃or -70 ℃for no
more than 3 months, and the samples cannot be frozen and thawed more than 4 times.
After thawing the sample, add the PCR kit according to the relevant instructions, and then proceed to
3.2.2.
3.2.2 Sample introduction
After sample preparation, aspirate the reaction solution in the EP tube by pipette, and then the pipette
tip was pressed against the chip inlet, and the reaction solution entered the chip under the action of capillary
force. Finally, the chip sealing cap was stoppered above the chip roof. (As shown in the figure below)
Figure3-1
Open the Cover of the Reaction Room 6 of the instrument and insert the chip into the reaction
chamber, and then press the Reaction Chip Holder 5 to clamp the chip. Finally close the cover and set the
experimental parameters.

Instruction Manual Assembly and Operation
12
3.3 Startup of software
The software version currently used by the instrument is "PCR Nucleic Acid Analyzer control system
V1.0".
3.3.1 Turn on the Power Button 8, the instrument automatically starts the PCR Nucleic Acid Analyzer
control system V1.0, and the following interface appears：
Figure3-2
3.3.2Enter the operating interface，the function of the buttons are listed as follow: is a data
saving button，is a start button of reaction，is a refreshing button for resetting input
information and restarting reaction，is a abort button for stopping reaction.
Figure3-3

Instruction Manual Assembly and Operation
13
3.3.3 Choose "Chip Type" and enter the user information, the sample name of each well and the folder
name in turn.
Figure3-4
3.3.4 Fill in the user information as follows：
Figure3-5

Instruction Manual Assembly and Operation
14
3.3.5 Click "Temperature Settings" and select "Detection Item".
Figure3-6
3.3.6 If you select the "custom" mode, set the parameters in turn according to the experimental
requirements. (Note: The temperature setting cannot be higher than 105 °C; the cycle time of collecting the
fluorescence stage is not less than 20s.) “Add New”is a button for adding a new temperature setting, and
“Remove”is a button for removing a temperature setting.
Figure3-7