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Instruction Manual Data Analysis

18

4 Data Analysis

These following symbols represent the reaction result and their meaning are listed as below.

It means the reaction result is positive.

It means the reaction result is negative.

Figure4-1

It means the reaction result is unknown.

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Summary of Contents for SWM-01

Page 1: ...PCR Nucleic Acid Analyzer SWM 01 Instruction Manual Technical requirement No Q SWM01201801 Version 2018 05 first edition V1 0 Product life 5 years ...

Page 2: ... 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 ...

Page 3: ... 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...

Page 4: ...ice 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 ...

Page 5: ... 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 s...

Page 6: ...V Figure All the figures listed in this instruction manual are only for illustration or example purposes ...

Page 7: ...e 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 Cha...

Page 8: ... 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...

Page 9: ...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 Inst...

Page 10: ...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 Ana...

Page 11: ... 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 unau...

Page 12: ...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...

Page 13: ... 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...

Page 14: ... 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 co...

Page 15: ...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 ...

Page 16: ... 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 ...

Page 17: ... 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...

Page 18: ...n 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...

Page 19: ...n 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 ...

Page 20: ...e 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 ...

Page 21: ...nual Assembly and Operation 15 3 3 7 After completing the test parameter settings click the Start button then the reaction starts The interface automatically jumps to the Temperature Profile page Figure3 8 Figure3 9 ...

Page 22: ...in real time Figure3 10 3 3 9 After the reaction is finished the instrument automatically pops up the result window Here is a positive sample as an example Figure3 11 3 3 10 After clicking Abort you can insert a USB flash drive on the USB interface 2 and click the Save Data button to complete the data transfer Then the interface will Pop up prompt box Save Succeed ...

Page 23: ...Instruction Manual Assembly and Operation 17 Figure3 12 Figure3 13 3 3 11 To start the next experiment click the Refresh button and repeat steps 3 3 3 to 3 3 10 ...

Page 24: ... Data Analysis These following symbols represent the reaction result and their meaning are listed as below It means the reaction result is positive It means the reaction result is negative Figure4 1 It means the reaction result is unknown ...

Page 25: ...is 86 0kPa 106 0kPa Relative humidity is lower than 80 Transportation method Put the instrument into a carton with anti collision cotton and move it normally to avoid severe vibration Placement Location Put the instrument in a horizontal position 5 3 Cleaning Table5 1 When the instrument stop working the power should be turned off Every one year a known test sample is used to verify that whether t...

Page 26: ...n the chip According to the local regulations the waste should be treated as soon as possible to avoid contamination of the environment and instruments Do not open the chip cap after reaction otherwise the high concentration of nucleic acid aerosol will contaminate the environment 5 6 Waste instrument disposal When the instrument reaches its expiry date the user should contact the supplier or manu...

Page 27: ...tem are fastened Fuse is overloaded Check if the fuse is overloaded 3 Fault indicator is on The instrument stops running due to a fault Restart the instrument Contact the supplier or manufacturer if the fault indicator is still on 4 Temperature error Temperature sensor is damaged Contact the supplier or manufacturer Program failure The ambient temperature is not maintained between 15 35 C Make sur...

Page 28: ...t the supplier or manufacturer Chip card slot damage 9 Fluorescence detection value is abnormal Strong external light source Turn off the external light source Photoelectric system damage Contact the supplier or manufacturer 10 Timing error Program error or clock battery is exhausted Contact the supplier or manufacturer 11 A pop up dialog box prompts Please insert a USB flash drive No USB flash dr...

Page 29: ...earby electronic equipment Radiated emissions CISPR11 Class B The PCR Nucleic Acid Analyzer SWM 01 is suitable for use in professional healthcare environments but if used directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes whatever additional measures are necessary Harmonic emissions IEC 61000 3 2 Not applicable Voltage fluctuations ...

Page 30: ...arning This equipment has been designed and tested to CISPR 11 Class A In a domestic environment it may cause radio interference in which case you may need to take measures to mitigate the interference Do not use this device in close proximity to sources of strong electromagnetic radiation e g unshielded intentional RF sources as these may interfere with the proper operation ...

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