WOODLEY V-IA Plus Veterinary Immunoassay Analyser User Manual

WOODLEY V-IA Plus Veterinary Immunoassay Analyser

Product Information

• Specifications
  • Main Parameters:
  • Software Version: Version 1
  • LED or Diode laser
• Outputs:

  •   * USB interface (2)

  • Ethernet interface (1)
  • Serial port: Automatic LIS uploading & PC adjustment
  • Display: 24-bit true colour LCD screen
  • Sample Type: Whole blood, serum and plasma
• Power Supply:
  • Host Input DC: 12V 5A
  • Adaptor Input: 100-240VAC; 50/60Hz
• Performance Specifications:
  • Hardware Core: ARM CortexTM
  • Software: Android 5.1
  • Memory: 8G
  • Data Capacity: 10,000 sets of patient and quality control data
• Product Introduction
  • The InSight V-IA Plus Veterinary Immunoassay Analyser is designed with the following components:
  • Analyser Hardware Core: ARM CortexTM
  • Software: Android 5.1
  • 24-bit true colour LCD screen display
  • USB interface (2)
  • Ethernet interface (1)
  • Serial port for Automatic LIS uploading & PC adjustment
• Intended Use
  • The InSight V-IA Plus Veterinary Immunoassay Analyser utilizes immunofluorescence technology to provide accurate and quantitative laboratory results. It is intended for in vitro diagnostic use only and is suitable for use in veterinary laboratories.

Product Usage Instructions

• Cartridge Usage
  • When using the InSight V-IA Plus Veterinary Immunoassay Analyser, follow these steps:
  •  Ensure you are using genuine InSight V-IA cartridges provided by Woodley Equipment Company.
  • The cartridge has a barcode that indicates the Lot Number and name of the cartridge. The InSight V-IA Plus analyzer will read the barcode to recognize the items and the Lot being tested.
  • The arrow on the cartridge indicates the direction it should be inserted into the analyzer. The sampling port is where the sample should be added. Follow the instructions provided with the test.
  • Insert the test kit into the end of the cartridge holder, making sure to avoid any obstructions that may hinder proper insertion.
  • All parameters and information of the cartridge are saved in the ID chip. Each Lot Number of tests has a unique ID chip. You can read the ID chip information on the Item page.
  • The test principle involves adding the sample to the cartridge, which migrates to the fluorescent antibody labeled on the cartridge.
  • A laser light source excites fluorescence, and the emitted light is collected and converted into electrical signals. The concentration is calculated from the signal and ID chip parameters.
• FAQ
  • Q: What are the main parameters of the InSight V-IA Plus Veterinary Immunoassay Analyser?
  • A: The main parameters of the analyzer include the software version, LED or Diode laser, outputs (USB interface, Ethernet interface, and Serial port), display (24-bit true color LCD screen), sample type (whole blood, serum, and plasma), and power supply.
  • Q: Can I use cartridges from other manufacturers with the InSight V-IA Plus Veterinary Immunoassay Analyser?
  • A: No, you should only use genuine InSight V-IA cartridges provided by Woodley Equipment Company.

Product Introduction

Analyser Structure

Intended Use

• InSight V-IA Plus 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 Plus Veterinary Immunoassay Analyser is suitable for use in veterinary laboratories.

Technical Specifications

Main parameters

• Software Version:
  • Version 1 LED or Diode laser
• Outputs:
  • USB interface (2)
  • Ethernet interface (1)
  • Serial port: Automatic LIS uploading & PC adjustment
  • Display: 24-bit true color LCD screen
  • Sample Type: Whole blood, serum, and plasma
  • Power Supply: Host Input DC: 12V 5A
  • Adaptor Input: 100-240VAC; 50/60Hz
• Standard curve
  • Storage Method: ID card with 4K memory
  • Dimensions: 213 (W) x 243 (D) x 195 (H) mm
  • Weight: 4kg
  • Operating Temperature: 10-30°C
  • Relative Humidity: ≤70%

Performance Specifications

• Repeatability: CV≤10%
• Stability: σ≤±8%
• Linear Correlation: r≥0.97
• Accuracy: Δn≤±15%

Analyser System

• Hardware Core: ARM Cortex™
• Software: Android 5.1
• Memory: 8G
• Data Capacity: 10,000 sets of patient and quality control data

Analyser Test Information Cartridges

• Only use genuine InSight V-IA cartridges provided by Woodley Equipment Company.
• There is a barcode on the cartridge. It shows the Lot Number of the cartridge. InSight V-IA Plus will read the barcode to recognize which items and which Lot is being tested.
• The Lot Number and the name will show on the information of the barcode.

Lot Number Name Rule:

• Long Lot Number: H0ABYYMMXX
• Short Lot Number: ABXX

• The arrow indicates the direction the cartridge is inserted into the analyser.
• The sampling port is where the sample is added. Please follow the instructions provided with the test
• The detection window is the area the analyser will read the fluorescent signal.

C Line:

• This cannot be seen by the user. It is a fluorescent control line which the analyser will use to check the result of the cartridge.

T Line:

• This cannot be seen by the user. It is a fluorescent test line. The analyser will read the fluorescent signal and ID chip information to give the result.

Blue Line:

• This can be seen at the end of the detection window.
• When the sample has been added to the cartridge correctly, the blue line will disappear after the sample has flowed over the detection window. If the blue line is still visible after the incubation time, the analyser will show ‘Test invalid’ after the test has been completed.
  • Caution: If the blue line is still obviously visible after analysis, please check if the test has been completed correctly.

Insert the Test Kit:

• Notice: Please insert the test kit to the end of cartridge holder.

chip

• All the parameters and information of the cartridge is saved in the ID chip. Each Lot
• Number of tests has a unique ID chip.
• You can read the ID chip information on the Item page.

Test principle

• Sample is added to cartridge and migrates to the fluorescent antibody that is labelled on the cartridge.
• Laser light source excites fluorescence.
• The emitted light is collected and converted into electrical signals.
• The concentration is calculated from the signal and ID chip parameter.

Contents

Installation

1. Unpacking and checking
2. 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.
3. Check the analyser and accessories to see if they are in good condition.

  *  **Notice:** If there are any problems, please contact Woodley Equipment Company.

2. Analyser placement
3. 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.
4. Make sure the vents are not obstructed and that there is at least 5cm of clearance around the analyser.
5. Connect the power adapter to the power interface of the analyser and turn on the power.
6. Do not place any items on top of the analyser.
7. Instructions
8. 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.
9. Operation Procedures Preparation
10. When switched on, the analyser will run a self-test and the cartridge holder retracts as shown below.
11. The software will start automatically and display the main home screen.
12. For the use and storage of reagents, please refer to the cartridge operating instructions.
13. Insert ID code chip for the test to be analysed. Select “Read ID Card”.
14. Enter patient details in the ‘detail’ section.
15. Select standard test or instant test (refer to Section IV.2).
16. Place the test cartridge with sample (follow cartridge operating instructions) into the cartridge holder and run prepared test.
17. Notice:
    • Do not touch the cartridge holder when it’s moving.
    • Do not interfere with the software during testing.
18. After analysis
19. The test cartridge will be released from the analyser once the test is complete.
20. The cartridge holder will reset.
21. Used test cartridges and pipette tips should be disposed as medical waste in accordance with local regulations.
22. Warnings
23. The sign denotes notifications and errors.

Software Introduction

Main Interface

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 Test], [History], [Item], [QC] and [Settings]. Select an icon to enter into the corresponding screen.

Testing Interface

1. Click [Test] option on the main home screen and Figure 4.2.1 will display. (Test interface will be change in Bi-directional mode (see chart 6.2.5 below).
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 etc).
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.
   • Caution: Wrong test mode will cause incorrect test result.
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.

Batch Test

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. (Figure 4.3.2)
4. After the sample 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. The analyser will prompt the user to insert the correct test kit when the countdown is complete.

Results Records Interface

1. In the [History] 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 LIS/HIS.
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 [Delete] in Figure 4.4.1 to delete the selected records or all records.
8. Select [Advanced] in Figure 4.4.1 to check the advanced information. You can input or modify the patient information on the Advanced page as shown in Figure 4.4.2.
9. Select [History Search] in Figure 4.4.1, set the search date range and press confirm to search the results as shown in Figure 4.4.3
10. Select [Classified Statistics] in Figure 4.4.4. After selecting a date range, press confirm to view the statistics of how many tests have run within the selected time frame.

Item Interface

1. As shown in Figure 4.5.1, saved test lists can be viewed and reference ranges can be set in the [Item] screen.
2. The user can edit reference ranges as shown in Figure 4.5.2.
3. Import ID Chip Information:
   • If the ID chip of the test item is lost, you can import the item information of the ID chip using the method below.
   • Read ID chip from USB device the Lot No. of the test item and contact Woodley Equipment Company to get the ID chip Hex file.
   • Set a folder name of “Hex” in the USB device root directory. Transfer the Hex file, provided by Woodley Equipment Company, of the test item into the “Hex” folder as shown in Figure 4.5.3.
   • Press [Read Hex] in the Item setting page.
   • Select the Hex file and press confirm as shown in Figure 4.5.4.
   • Item information will be saved on the ‘Save item’ window.
   • Download ID chip from Cloud
   • Note: The analyser must be connected to the Wi-Fi before downloading the ID chip. Please see Section IV Software Introduction for instructions on how to connect to the Internet.
   • Download ID chip before test
   • Click ‘Download ID chip’ on the Item setting page. Input the Lot No. of the test kit (4 digit number). Click confirm to download as shown in Figure 4.5.5.
   • Download ID chip while testing (analyser must be connected to Wi-Fi)
   • If the ID chip has never been read before, when the test kit is inserted into the analyser to test, the analyser will show ‘Barcode doesn’t match any items in analyser’.
   • Press ‘Download ID chip’ and it will show the barcode number of the test kit.
   • Click confirm to download and new item information will save on the right window as shown in Figure 4.5.6.
   • Select the item and press ‘Set as current’ and test. Alternatively, press cancel and retest again. The new items that have just been downloaded will match the test kit.
4. ID chip parameter
   • Click ‘Main item parameter’ to enter the ID chip parameter page. You can check detailed information about the current Lot of ID chip. See Figure 4.5.7.

Settings

In the [Setting] screen, Institution Information, Test Setting, LIS Setting, System Setting, and Software Version can be viewed.
About and Institution About Analyser

• The analyzer model and name will show on the About page as shown in Figure 4.6.1.
• The software version information is also shown on the About page.
• Users can upgrade the software online after connecting to the Wi-Fi.
• Users can also transfer software onto a USB device and then insert it into the USB port of the analyzer.
• The software will automatically update after detecting the USB.

Version:

• Version + Release Version Number + Version Build

Caution:

• Do not change the upgrade document name or change the file.
• Please ensure that the power is on during the upgrade before restart.
• The analyser supports FAT32 format USB devices. It does not support NTFS format.
• Other settings like reference of reagent items will be reset to the original settings.
• Do not uninstall the software apk, the analyzer will be reset by uninstalling the software.

Institution Information will be shown on the title of print paper.

There are two methods of changing institution information:
Change the institution directly:

1. Press the ‘Institution’ space.
2. Input the Institution name, press ‘Done’ and it will be saved automatically.

Change the institution by Register

1. Press the [Register] button to enter the register page.
2. Input the institution. The following shows an example of registering the institution ‘Woodley Equipment Company Ltd’. The registration code will be created by the  analyser and shown in the ‘Registration code’ space.
3. If analyser does not show the registration code, please contact Woodley Equipment Company. Provide the following information, [Serial number] and [Institution] on theregister page (see the sample of Figure 4.6.1.3).
   • Caution: Please provide the correct word, include uppercase and lowercase letters. The serial number on the register page consists of 8 characters. Do not use the SN (serial number) on the back label of analyser.
4. Key in the [registration code] from Woodley after providing the information of [Serial number] and [institution]. Please note the case of the letters (see Figure 4.6.1.4).
5. Restart the analyser to make the change.

Software update

• Upgrade the software by USB device
• Transfer the upgrade software onto the root directory of the USB device. Insert the USB device into the USB port of the analyser.
• Click ‘System upgrade’. If there is a new version on the USB device, the analyser will show a message asking you to confirm the software update. Press confirm and the analyser will install the software update. See Figure 4.6.1.3.

Upgrade the software by USB device on Android system

• Insert the USB and the software will automatically update after detecting the USB device.
• Click the button on the Menu page, exit the software to the Android system. Click the button on the left to enter the menu of the Android program. See Section IV.7 Android Setting.
• Open XAPK Installer, and select the new version of FCFluorescenceWoodley.apk.
• The software will restart when it has finished installing. See Figure 4.6.1.4.

Upgrade the software online

• The analyser will ask if you need to upgrade once it has connected to the network after being powered on.
• Click confirm to upgrade. See Figure 4.6.1.5.
• Click ‘Online Upgrade’ on the About page. The analyser will check if there is a new software version to upgrade. See Figure 4.6.1.6.

Caution:

• Do not change the upgrade document name or change the file. The name of the install program APK is FCFluorescenceWoodley.apk.
• Please ensure that the power is on during the upgrade before restarting.
• The analyzer supports FAT32 format USB devices. It does not support the NTFS format.
• Other settings like Reference of reagent items will be reset to their original settings.
• Do not uninstall the software APK, the analyzer will be reset by uninstalling the software.

Test Setting

1. In Figure 4.6.3, the sample code, sample ID length, and alignment can be set in the [Test Setting] screen.
2. Switch on ‘Auto-print’ to automatically print results after analysis.
3. Switch on/off [Sound] to turn on/off the beep of the analyzer.
4. Users can switch on ‘Autotest’, the system will automatically start analysis once the system detects any test cartridge has been inserted.

System

1. To set the analyzer time and date, click [Date Setting] in Android System. Restart the analyzer and save the change.
2. To reset the analyzer, press the [clear Data] button.
   • Caution: All data will be deleted and the analyzer will be reset.
3. Select the language and save it to change the software language. Restart the analyzer to save the change.

Wi-Fi Settings

• Click the ‘Wi-Fi settings’ tab. Click ‘On’, select the SSID and input the password to connect to your chosen Wi-Fi network. See Figure 4.6.5.
• Note: If you are connecting the analyser to Wi-Fi via a router, insert the ethernet cable into the analyser and it will automatically connect to the Wi-Fi.

Android Setting

• Click the button on the menu page and exit the software to Android system. See Figure 4.7.1.1.
• Click the button on the left to enter the menu of the Android system. See Figure
• Click Settings to enter the settings page of the Android system.

Android date setting

• Click Date & Time to set the date and time. The date and time will automatically change when connected to the network.

Android languages and input setting

• Only Android system languages can be set here. For software languages, please see Section IV.6 Point 4.6.4 System.
• Caution: Please restart the analyser after changing the settings on the Android system to save the change.

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.

QC test

1. ID chip information can be saved by pressing ‘Read ID card’. You can press ‘USB’ to upgrade the QC reference Range by USB that contains the newest upgrade progress.
2. Put the QC card in the cartridge holder and press ‘Test’. The analyser will give the QC result, check the value is within the set QC reference range (see Figure 5.1.1).
3. Print the QC test result.

QC record
You can search, print, export or delete the test record on this page (see Figure 5.1.2).

1. Press search to find the record during the setting time.
2. Print the QC test record by pressing ‘Print’.
3. Export the QC test record to USB device by pressing ‘Export’.
4. Delete the QC test record by pressing ‘Delete’.

Further Product Information

• Security Classification of Medical Electrical Equipment
  • The type of protection against electric shock is Class I.
  • Pollution grade is Class 2.
  • The facility category (overvoltage category) is Class II.
• Contraindications No.
• Warnings, Precautions, and Limitations
  • Notices: For veterinary use only.

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 analyzer is damaged or has been dropped, please contact Woodley Equipment Company.
• Do not use this analyzer in unstable environments such as on unlevel or vibrating surfaces etc.
• Do not place the analyzer in a location where it is difficult to disconnect the device.
• Water or debris should not enter the analyzer. If this occurs, please contact Woodley Equipment Company.

Notices:

• Turn off the power and unplug the analyzer before moving it.
• When moving the analyzer, try to avoid vibration.
• Desktops supporting the analyzer should be able to hold at least 2.5kg.
• The analyzer should be placed carefully, with at least 5cm of space all around to ensure good air circulation.
• The analyzer should not be covered to prevent the air vents from being blocked.
• Avoid using the analyzer 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 analyzer should not be near radios, televisions, printers, fax machines or any other sources of interference.
• The analyzer cannot be used near instruments such as microwaves and any other high-frequency equipment to avoid electromagnetic interference that may cause errors in operation.

precautions When in Use

Warnings:

• Read the instructions carefully before starting the analyzer.
• Set the test parameters under the guidance of trained personnel.
• When handling potentially hazardous substances such as animal samples or reagents, protective gloves or other protective measures are required.

Notices:

• Ensure the analyzer 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 analyzer.
• After testing, confirm that the test cartridge has been removed.

Precautions for Faults, Storage and Inspection
Warnings

• If abnormal conditions occur (for example, if there is smoke or a burning smell), stop using the analyzer immediately. Turn off the power immediately, unplug the analyzer, and contact Woodley Equipment Company.
• Other than service personnel from Woodley Equipment Company and service personnel authorized by Woodley Equipment Company, other users are not permitted to remove, modify or repair the analyzer.
• Any violation will invalidate the analyzer warranty. Woodley Equipment Company will not bear any responsibility for possible personal injury, fire risk, or electric shocks caused by violation of the warranty.

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

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)

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%.

Maintenance and Care

Daily Maintenance and Care Maintenance

• The users must check the analyzer 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 analyzer, turn off the power and disconnect the power cord.
• When cleaning the analyzer, 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 analyzer.

Troubleshooting – Common Faults and Solutions

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.

Error Codes
A list of common faults is shown in the table below – if an issue not listed occurs, please contact Woodley Equipment Company.
Error Codes

1

| Problem reading the barcode and ID Chip| The current test kit cannot find any ID chip information in the analyser. It could be misreading the ID chip or the analyser has

read the test kit barcode incorrectly. Reinsert the ID chip.

2| Barcode not recognised| Cannot read the barcode of the test kit. Check barcode.
3|

C line abnormal/test invalid

| It means the test is invalid and that the control line on the test kit is invalid. There are a few reasons why the test may be invalid including reagent operation and analyser. Retest with new cartridge and contact Woodley Equipment Company.
4|

The test results are not accurate

| Check sample quality and procedure and repeat test. Contact Woodley Equipment Company.
5| Abnormal communication| It means there is error on the communication between hardware in the analyser. Restart the analyser.
6| Printer has no paper| There is no paper in printer or the printer cannot detect the paper. Check printer module and replace paper.
7| Please select data| No data has been selected before operation.
8| Time cannot be saved| The button cell battery of the mainboard in the analyser is no longer working. Contact Woodley Equipment Company.
9|

Touch screen is unresponsive

| If the touch point does not match the arrow pointer, please calibrate the screen on the settings page. If the touch screen is broken, please contact Woodley Equipment Company.
10| The screen does not switch on| Hardware broken or power supply problem. Contact Woodley Equipment Company.
11| Cartridge holder does not move| Hardware broken or power supply problem. Contact Woodley Equipment Company.
12| Analyser stopped during testing| Hardware broken or power supply problem. Contact Woodley Equipment Company.
13|

QC out of range

| Hardware broken or the analyser needs to be calibrated. Retest with a new QC and contact Woodley Equipment Company.

Error Codes Troubleshooting.
Here are the common ways to deal with the problem with common reasons. If the problem is not solved by following the instructions below, please contact Woodley Equipment Company.

 | Error| Related

Issue

| Possible Cause| Troubleshooting
---|---|---|---|---

1

|

Problem reading the barcode and ID Chip

|

Operation

|

ID Chip does not match cartridge barcode

| If corresponding ID Chip not used press cancel to abort this test. If “confirm” is pressed, the analyser will automatically select the first item of the left and right as the matching ID chip information by default. If the ID information does not match the reagent card, an incorrect test result will appear.

2

|

Barcode not recognised

|

Operation

| Reagent cartridge in the wrong way, unable to read

barcode

|

Insert the reagent cartridge in the correct direction, holding the non-slip position upward.

Operation

| The reagent cartridge is not

inserted correctly

| Ensure the reagent cartridge is inserted into the cartridge holder correctly.

Reagent

| Reagent cartridge barcode unclear /

contaminated

| Barcode contaminated or damaged. Repeat with new cartridge.
Analyser| The analyser cannot

read the barcode

| Contact Woodley Equipment Technical Support.

Operation

| The reagent cartridge is not inserted to the

bottom

|

Make sure the reagent cartridge is inserted into the innermost contact slot.

Analyser

| The analyser sensor could not detect the

reagent cartridge

|

Contact Woodley Equipment Technical Support.

 |

C line abnormal / Test invalid

|

Operation

| The reagent cartridge was placed in the analyser too long after the sample

was added

|

Reagent cartridge inserted too long after the normal detection time, indicating abnormal c- line.

Operation

|

The reaction time after adding the reagent cartridge was too short.

| If the test is conducted in instant test mode, there is not enough time for the reaction after the reagent cartridge is added to the sample and the test result is invalid, showing abnormal c- line. Please ensure the correct test method is

used.

3

|  |

Operation

| The reagent cartridge is contaminated| Verify that the sample type is correct.

If the reagent cartridge or sample is taken out of

the refrigerator, please leave to warm to room temperature before testing.

---|---|---|---|---

Operation

| Wrong buffer tube is used| Confirm the buffer tube is from the correct kit. Check buffer volume is correct. Check correct

sample volume used.

Operation

| Wrong blood tube type| Please refer to the instructions to use the correct anticoagulant tube. Different anticoagulants may

affect the test.

Sample

| The sample well on the cartridge is red| Sample haemolysed, repeat with a fresh sample.

Sample

| The blood sample was contaminated| Ensure that blood samples are collected, transported and stored in accordance with the

requirements. Check for sample interference.

Reagent

| Reagent cartridge failure| The reagent cartridge is damaged. Check temperature of reagents.

Analyser

|

Analyser not detecting C-line

| Use the QC standard cartridge to confirm the test value of the analyser. If it exceeds the standard cartridge detection range, please

contact Woodley Equipment Company.

4

|

The test results are not accurate

|

Operation

| The reagent cartridge was placed in the analyser too long after the sample

was added

|

There was a delay inserting the test cartridge into the analyser.

Operation

| The reaction time after adding the reagent cartridge

was too short

| If tested in instant mode, the sample was not incubated for long enough and the test result is abnormal. Please repeat and follow the correct

test method.

Operation

| The corresponding batch chip card was

not read correctly

|

Please ensure correct ID chip is used.

Operation

|

Incorrect buffer used

| Please confirm the protocol for running a test in the reagent instructions.

Check the buffer tube is from the correct kit. Buffer tubes of different tests should not be mixed.

Is the buffer sample quantity correct?

Is the buffer well mixed?

Operation| Incorrect sample

type selected

| Please refer to the instructions to select the

correct sample type for the test.

 |  |

Operation

| Wrong blood tube type used| Please refer to the instructions to use the correct anticoagulant tube. Different anticoagulants may

affect the test.

---|---|---|---|---

Sample

|

The sample well on the cartridge is red

| Sample haemolysed, repeat test with a fresh sample.

Sample

| The blood sample was contaminated| Ensure that blood samples are collected,

transported and stored in accordance with the requirements. Check for sample interference.

Reagent

| Reagent cartridge failure| The reagent cartridge packaging is damaged. Check storage temperature of reagents.

Analyser

|

Analyser not detecting reaction

| Use the QC standard cartridge to confirm the test value of the instrument. If it exceeds the standard cartridge detection range, please

contact Woodley Equipment Company.

5

|

Abnormal communicati on

| Install| The power is not

connected properly

| Plug in the power and check the indicator light of

the adapter.

Install| Wrong adapter used| Replace with the original adapter (12V/5A).
Hardware| The cable between

two PCBA board

| The cable is loose or has been damaged

between detection board and system board.

Hardware| Detection board

damaged

| Detection board damaged by wrong power

adaptor.

Software| Software failure| Update to the new version of the software with a

USB flash drive.

6

|

Printer has no paper

| Install| No printer paper| Replace thermal paper.
Install| Incorrect printer

paper used

| Ensure thermal printer paper used and installed

correctly.

Analyser| Printer failure| Contact Woodley Equipment Technical Support.

7

| Please select data|

Operation

| Data was not selected when

printing

| Click √ the square inside the box to the left of the historical data.

8

| Time cannot be saved|

Analyser

|

Circuit board failure

|

Contact Woodley Equipment Technical Support.

9

|

Touch screen is unresponsive

|

Analyser

|

Touch screen needs recalibrating

| Operate the cursor through an external mouse via the USB interface, click on the main menu- Settings-System Settings-Screen Calibration.
Analyser| Touch screen failure| Contact Woodley Equipment Technical Support

10

| The screen does not switch on| Analyser| The power is not

connected properly

| Plug in the power and check the indicator light of

the adapter.

Analyser| The wrong adapter

was used

| Replace with the original adapter (12V/5A).
Analyser| Screen failure| Contact Woodley Equipment Technical Support.

11

| Cartridge holder does not move| Install| Cartridge holder

needs resetting

| Restart the analyser self-check reset, confirm

whether the self-check is normal.

---|---|---|---|---
Analyser| Cartridge stuck in

holder

| Contact Woodley Equipment Technical Support.
Analyser| Motor failure| Contact Woodley Equipment Technical Support.

12

| Analyser

stopped during testing

| Analyser| Power connection

failure

| Check power connection and restart analyser.
Analyser| Analyser failure| Contact Woodley Equipment Technical Support.

13

|

QC out of range

| Analyser| QC expired| Repeat with fresh QC.
Analyser| QC stored incorrectly| Check QC storage conditions meet

requirements. Repeat test with fresh QC.

Analyser| Analyser issue| Stop using the analyser and contact Woodley

Equipment Technical Support.

Interpretation of Medical Device Label

Transportation Conditions

Transportation

1. The InSight V-IA Plus should be transported in the original packaging.
2. Avoid severe vibration during loading and transportation.
3. Keep away from dampness.
4. Do not transport with flammable and corrosive substances.

CONTACT

• Old Station Park Buildings
• St. John Street
• Horwich
• Bolton
• BL6 7NY, UK
• Tel: +44 (0) 1204 669033
• Fax: +44 (0) 1204 669034
• Email: [email protected].
• Web: www.woodleyequipment.com.

References

• INSIGHT V-IA® PLUS VET

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