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

3
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

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1. In the [Results] screen, users can view previous test results.
2. After each test has completed, the system will automatically save the results to the
analyser memory.
3. Adjust the dates to search for a sample. Select [OK].
4. Select [Upload] in Figure 4.4.1 to upload the selected records or all records to the
PNS.
5. Select [Print] in Figure 4.4.1 to print the selected records or all records on the internal
printer.
6. Select [Export] in Figure 4.4.1 to export the selected records or all records to a USB.
7. Select [Statistics] in Figure 4.4.2. After selecting a date range, select [OK] to view the
statistics of how many tests have run within the selected timeframe.
IV.5 Item Interface
Figure 4.5.1
1. As shown in Figure 4.5.1, saved test lists can be viewed and reference ranges can
be set in the [Setting] screen.
2. The user can edit and delete reference ranges.

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IV.6 Settings
Figure 4.6.1
Figure 4.6.2

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Figure 4.6.3
Figure 4.6.4

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Figure 4.6.5
1. In the [Setting] screen, Institution Information, Test Setting, LIS Setting, System
Setting and Software Version can be viewed.
2. In [Institution Information] of Figure 4.6.1, the user can add the clinic name and
address.
3. In Figure 4.6.2, the sample code, sample ID length and alignment can be set in [Test
Setting] screen.
4. Switch on ‘Auto print’ to automatically print results after analysis.
5. User can switch on ‘Auto test’, the system will automatically start analysis once the
system detects any test cartridge has been inserted.
6. In Figure 4.6.3, to set the LIS settings, the user first needs to input the correct IP
address. Please refer to document ‘LIS Protocol’ for detailed information.
7. To set the analyser time and date in Figure 4.6.4, select ‘save’.
8. To calibrate the screen, after clicking the calibrate button, touch the arrows that
appear and follow the onscreen instructions. Restart the analyser for changes to be
saved.
9. The user can save the upgrade software onto the USB disk and then insert into the
USB port of the analyser. Switch on the analyser, the system will automatically update
after detecting the USB.

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V Quality Control
Quality control can be carried out by testing the InSight V-IA quality control cartridges.
Use InSight V-IA Veterinary Immunoassay Analyser to determine the concentration of the
test cartridges. There are 3 control level cartridges – low, mid and high.
Continue to use the analyser if the quality control result falls within the target value range
provided. If results fall outside the target value, repeat the QC with a fresh QC cartridge
and if results fall again outside the target value, stop using the analyser and contact
Woodley Equipment Company.
VI Further Product Information
VI.1 Security Classification of Medical Electrical Equipment
⚫Type of protection against electric shock is Class I.
⚫Pollution grade is Class 2.
⚫Facility category (overvoltage category) is Class II.
VI.2 Contraindications
No.
VI.3 Warnings, Precautions and Limitations
Notices: For veterinary use only.
VI.3.1 Precautions
Warnings:
⚫To avoid electrical overload and potential fire risk, do not use a multi-socket adapter.
⚫Use a 12V/5A power adapter and an effectively grounded outlet.
⚫A damaged, non-original or modified power cord is a potential fire and electric shock
risk. Do not bend or roll the power cord so as to avoid a fire or electric shock.
⚫If the analyser is damaged or has been dropped, please contact Woodley Equipment
Company.
⚫Do not use this analyser in unstable environments such as on unlevel or vibrating
surfaces etc.
⚫Do not place the analyser in a location where it is difficult to disconnect the device.
⚫Water or debris should not enter the analyser. If this occurs, please contact Woodley
Equipment Company.

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Notices:
⚫Turn off the power and unplug the analyser before moving it.
⚫When moving the analyser, try to avoid vibration.
⚫Desktops supporting the analyser should be able to hold at least 2.5kg.
⚫The analyser should be placed carefully, with at least 5cm space all around to ensure
good air circulation.
⚫The analyser should not be covered to prevent the air vents from being blocked.
⚫Avoid using the analyser in the following conditions:
Areas in direct sunlight;
Areas with high humidity;
Environments close to water;
Areas with vibration and inclination;
Areas with a strong magnetic field;
Areas with electromagnetic waves and surge voltage;
Storage sites of chemicals;
Areas exposed to corrosive gas.
⚫The analyser should not be near radios, televisions, printers, fax machines or any
other sources of interference.
⚫The analyser cannot be used near instruments such as microwaves and any other
high-frequency equipment in order to avoid electromagnetic interference that may
cause errors in operation.
VI.3.2 Precautions When in Use
Warnings:
⚫Read the instructions carefully before starting the analyser.
⚫Set the test parameters under the guidance of trained personnel.
⚫When handling potentially hazardous substances such as animal specimens or
reagents, protective gloves or other protective measures are required.
Notices:
⚫Ensure the analyser is in normal running status before use.
⚫Ensure that all cables are properly connected and secure.
⚫Read the operation precautions before use.
⚫Only trained personnel should operate the analyser.
⚫After testing, confirm that the test cartridge has been removed.
VI.3.3 Precautions for Faults, Storage and Inspection
Warnings
⚫If abnormal conditions occur (for example, if there is smoke or a burning smell), stop
using the analyser immediately. Turn off the power immediately, unplug the analyser

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and contact Woodley Equipment Company.
⚫Other than service personnel from Woodley Equipment Company and service
personnel authorised by Woodley Equipment Company, other users are not permitted
to remove, modify or repair the analyser. Any violation will invalidate the analyser
warranty. Woodley Equipment Company will not bear any responsibility for possible
personal injury, fire risk or electric shocks caused by violation of the warranty.
VI.3.4 Precautions for Electromagnetic Compatibility
Warnings:
⚫The analyser is designed and tested according to the Class A equipment standard of
GB 4824.
⚫Do not use this equipment near strong radiation sources such as unshielded RF
sources. Otherwise, it may interfere with operation of the analyser.
Notices:
⚫The user should ensure that the analyser is in an electromagnetic compatible
environment so that it can work properly.
⚫It is recommended to evaluate the electromagnetic environment before using the
analyser.
⚫This analyser complies with the noise immunity and emission requirements specified
in the part of GB/T 18268.26. Details are shown in the following table.
Table 1:
Electromagnetic Immunity
Immunity test
item
Basic standard
Test value
Compliance
criteria
Electrostatic
discharge (ESD)
GB/T 17626.2
Contact Discharge：±2kV, ±4kV
Air Discharge：±2kV, ±4kV, ±8kV
B
Radiofrequency
electromagnetic
field
GB/T 17626.3
3V/m, 80MHz~2.0GHz, 80%AM
A
Pulse group
GB/T 17626.4
Power Cable: ±1kV(5/50ns,5kHz)
B
Surge
GB/T 17626.5
Cable to Ground: ±2kV
Cable to Cable: ±1kV
B
Radiofrequency
conduction
GB/T 17626.6
Power Cable: 3V/m, 150kHz~80MHz,
80%AM
A

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Power frequency
magnetic field
GB/T 17626.8
3A/m，50/60Hz
A
Voltage sag,
interrupt
GB/T 17626.11
1 cycle 0%；
5 cycle 40%；
25 cycle 70%；
250 cycle 5%
B
C
C
C
Performance judgement:
A. Normal performance within the standard limiting value.
B. Function or performance is temporarily reduced or lost but can be self-recovered.
C. Function or performance is temporarily reduced or lost but requires operator intervention or
system reset.
Table 2：
Electromagnetic Emission
Emission test
Compliance
GB 4824 RF Emission
Group One
GB 4824 RF Emission
Class A
GB 17625.1 Harmonic Emission
N/A
GB 17625.2 Voltage fluctuation / flashing emission
N/A

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VI.3.5 Limitation Requirements for Toxic and Hazardous Substances
This analyser meets the limitation requirements of toxic and hazardous substances
in SJ/T11363-2006 Regulation.
Table 3 Classification of Electronic Information Products
Classification
Definition
EIP-A
homogeneous materials constitute electronic information
products
EIP-B
Metal coating of all parts of electronic information products
EIP-C
Small parts or materials in electronic information products
which cannot be further split in the existing conditions,
generally refers to products with the specifications less than
or equal to 4mm3
Table 4 Limitation Requirements for Toxic and Hazardous Substances
(Unit: Mass fraction)
Classification
Limitation Requirements
EIP-A
In this type of unit, the content of lead, mercury, hexavalent
chromium, polybrominated biphenyls, PBDE (except
decabromodiphenyl ether) should not exceed 0.1%, cadmium
content should not exceed 0.01%.
EIP-B
In this type of unit, lead, mercury, cadmium, hexavalent
chromium and other harmful substances shall not be
intentionally added.
EIP-C
In this type of unit, the content of lead, mercury, hexavalent
chromium, polybrominated biphenyls, PBDE (except
decabromodiphenyl ether) should not exceed 0.1%, cadmium
content should not exceed 0.01%.

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VII Maintenance and Care
VII.1 Daily Maintenance and Care
VII.1.1 Maintenance
◆The users must check the analyser and accessories regularly.
◆Ensure the power outlet is connected correctly.
◆Check if the power cord is damaged or broken by visual inspection. If the power cord
is faulty, please replace.
◆Before cleaning the analyser, turn off the power and disconnect the power cord.
◆When cleaning the analyser, wipe using a damp, lint free cloth. The following solutions
can be used for cleaning: alcohol or mild detergent.
Notices:
Please do not use gasoline, diluent or other organic solvents to clean the analyser.
VII.2 Troubleshooting –Common Faults and Solutions
Error
Reason
Solution
The analyser won’t switch on
Power switch is not turned on
Turn on the switch
The power adapter is not
connected
Reconnect the power adapter
The screen doesn’t display
Screen has broken
Please contact Woodley
Equipment Company.
Problem with operating
system
Please contact Woodley
Equipment Company.
Software system failure
Fault of operating system
Please contact Woodley
Equipment Company.
Please record the complete error code and message and then
contact Woodley Equipment Company
Abnormal sound during
testing
The cartridge holder may be
stuck
Turn off the Analyser and turn it on
again. Let it reset itself and repeat
the test.
Mechanical motion failure
Please contact Woodley
Equipment Company.
Analyser stops during testing
Power interruption
Restart the analyser and retest.
Communication failure
Restart the analyser and retest.
Please contact Woodley Equipment Company.