Woodley InSight V-IA User manual

Veterinary Immunoassay Analyser
User Manual

Contents
I Product Introduction ..................................................................................................1
I.1 Analyser Structure ...........................................................................................1
I.2 Intended Use....................................................................................................1
I.3 Technical Specifications...................................................................................1
II Contents.....................................................................................................................2
III Installation.................................................................................................................3
III.1 Installation........................................................................................................3
III.2 Instructions ......................................................................................................3
III.3 Operation Procedures......................................................................................3
III.4 Warnings..........................................................................................................4
IV Software Introduction................................................................................................5
IV.1 Main Interface..................................................................................................5
IV.2 Testing Interface ..............................................................................................6
IV.3 Batch Testing ...................................................................................................7
IV.4 Results Record Interface .................................................................................8
IV.5 Item Interface...................................................................................................9
IV.6 Settings..........................................................................................................10
V Quality Control.........................................................................................................13
VI Further Product Information....................................................................................13
VI.1 Security Classification of Medical Electrical Equipment .............................13
VI.2 Contraindications.........................................................................................13
VI.3 Warnings, Precautions and Limitations........................................................13
VII Maintenance and Care ..........................................................................................18
VII.1 Daily Maintenance and Care ......................................................................18
VII.2 Troubleshooting - Common Faults and Solutions.........................................18
VII.3 Error Codes..................................................................................................19
VIII Interpretation for Medical Device Label ................................................................23
VIX Transportation Conditions ....................................................................................23
VIX.1 Transportation .............................................................................................23

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I Product Introduction
I.1 Analyser Structure
I.2 Intended Use
InSight V-IA Veterinary Immunoassay Analyser uses Immunofluorescence technology to
provide accurate, quantitative laboratory results.
For in vitro diagnostic use only.
For veterinary use only.
InSight V-IA Veterinary Immunoassay Analyser is suitable for use in veterinary
laboratories.
I.3 Technical Specifications
I.3.1 Main Parameters
◆Software Version: Version 1
◆LED or Diode laser
◆Outputs: 1. USB interface (4)
2. Ethernet interface (1)
3. Double serial port
3.1 Serial Port 1: Automatic LIS uploading
3.2 Serial Port 2: PC adjustment
◆Display: 24-bit true colour LCD screen
◆Specimen Type: Whole blood, serum and plasma
◆Power Supply: Host Input DC: 24V 2.5A
Adaptor Input: 100-240VAC; 50/60Hz
◆Standard curve
Storage Method: ID card with 4K memory
◆Dimensions: 213 (W) x 303 (D) x 210 (H) mm
◆Weight: 4kg
◆Operating Temperature: 10-30°C
◆Relative Humidity: ≤ 70%

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I.3.2 Performance Specifications
◆Repeatability: CV≤10%
◆Stability: σ≤±8%
◆Linear Correlation: r≥0.97
◆Accuracy: Δn≤±15%
II Contents
No.
Accessories
Quantity
Remark
1
Power Adaptor
1
Included
2
Instruction for Use
1
Included
3
Ethernet Cable
1
Included

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III Installation
III.1 Installation
III.1.1 Unpacking and checking
1. Gently remove the analyser and accessories from the packaging box. Save the
packaging materials for future transport or storage of the analyser. Check the
accessories against the packing list.
2. Check the analyser and accessories to see if they are in good condition.
Notice: If there are any problems, please contact Woodley Equipment Company.
III.1.2 Analyser placement
1) The analyser should be placed in a clean and ventilated room with temperature
between 10°C ~ 30°C, relative humidity of less than 70%, away from direct sunlight.
2) Make sure the vents are not obstructed and that there is at least 5cm of clearance
around the analyser.
3) Connect the power adapter to the power interface of the analyser and turn on the
power.
4) Do not place any items on top of the analyser.
III.2 Instructions
Please note that the operating temperature of test reagents is based on each test kit’s
instructions. Perform tests in strict accordance with the cartridge operating instructions
provided in each test kit.
III.3 Operation Procedures
III.3.1 Preparation
1) When switched on, the analyser will run a self-test and the cartridge holder retracts
as shown below.
2) The software will start automatically and display the main home screen.
3) For the use and storage of reagents, please refer to the cartridge operating
instructions.
4) Insert ID code chip for the test to be analysed. Select “Read ID Card”.
5) Enter patient details in the ‘detail’ section.
2. Cartridge holder
1. Cartridge

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6) Select standard test or instant test (refer to Section IV.2).
7) Place the test cartridge with specimen (follow cartridge operating instructions) onto
the cartridge holder and run prepared test.
Notice:
⚫Do not touch the cartridge holder when it’s moving.
⚫Do not interfere with the software during testing.
III.3.2 After analysis
1) The test cartridge will be released from the analyser once the test is complete.
2) The cartridge holder will reset.
3) Used test cartridges and pipette tips should be disposed as medical waste in
accordance with local regulations.
III.4 Warnings
The sign denotes notifications and errors.

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IV Software Introduction
IV.1 Main Interface
Figure 4.1
As shown in Figure 4.1, there is a home [Menu] key at the bottom of all screens. Click the
[Menu] key and the screen in Figure 4.1 will display. From left to right, the screen will
display [Test], [Batch Testing], [History Record], [Parameter] and [Setting]. Select an icon
to enter into the corresponding screen.

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IV.2 Testing Interface
Figure 4.2.1
1. Click [Test] option on the main home screen and Figure 4.2.1 will display.
2. Insert ID chip in the ID Port on the side of the analyser and select “Read ID Card”
before using a new lot of test cartridges.
3. After the ID chip is recognised, select sample type and manually input sample number
if required.
4. Select [Detail] to input more detailed patient information (patient name, age).
5. Select [Standard Test] or [Instant Test] after inputting patient information. Standard
Test means the analyser will countdown the reaction time, then analyse the cartridge
and report results. This option is recommended for routine testing. Instant Test means
the user needs to use a timer to countdown the reaction time before putting the
cartridge in the analyser. Once the timer has completed, the user inserts the cartridge
into the analyser to analyse the cartridge and report results. This option is
recommended for multiple sample batch testing.
6. Prepare sample according to each test kit insert. Then apply sample to the test
cartridge. If Standard Test selected, insert the test cartridge into the cartridge port. If
Instant Test selected, start the timer and leave the cartridge on the bench.
7. When patient information has been inputted, the user can select [Test] option to start
the analysis.
8. After each test, the result will be displayed on the screen and will automatically print
on the internal thermal printer.

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IV.3 Batch Testing
Figure 4.3.1
1. The screen for batch testing is shown in Figure 4.3.1. The user can select the sample
type and test item and add or delete the item to be tested.
2. Select the test item to determine the time that is displayed in the interface [Time].
3. Select [Sample +1] to add another sample. Select the corresponding sample and
select [Delete] to delete a sample.
4. After the specimen is added, a sample No. will be automatically assigned. The user
has the option to customise the code, select the sample and select the [Sample
Number] to edit the code.
5. Select [Start], the analyser will start to count down. Simultaneously, the next sample
will count down.

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IV.4 Results Records Interface
Figure 4.4.1
Figure 4.4.2