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Number: 1205076401

© 2019 VivaChek Laboratories, Inc. Effective Date: 2019-xx-xx


Dear VivaDiag POCT Analyzer User,

Thank you for choosing the VivaDiag Point-of-Care-Testing Analyzer! The analyzer
has the advantages of easy operation, strong stability, reliable results, and simple
maintenance. It can be used widely in many areas, such as hospital, medical
center, clinic, pharmacy, laboratory, etc.
This User’s Manual applies to VivaDiag POCT analyzer, it provides detailed
descriptions of the analyzer’s characteristics, graphical operation steps and other
relevant informations for your convenience. Please read this User’s Manual
carefully before you use your analyzer and keep your User’s Manual in a safe
place, you may want to refer it in the future.

Thank you again for choosing the VivaDiag Point-of-Care-Testing Analyzer.

Principle and Intended Use


The VivaDiag POCT Analyzer (Model: VIM01) work with VivaDiag POCT Test Kit as
a system to quantitative measure multiple parameters (more than thirty items) like
CRP, cTnI, HbA1c, etc. The analyzer is an immunofluorescence detection device
that is based on photoelectric detection principle. With the fluorescence
immunochromatography technology and tiny sample (whole blood/plasma/serum/
urine), the analyzer gives reliable result(s) in just few minutes, which is ideally
suitable for professionals to make quick and correct decision at the point of care. It
is intended for professional use outside the body (in vitro diagnostic use).

The analyzer can be used in central laboratories of medical institutions, outpatient


or emergency departments, clinical departments, pharmacies, medical services
(such as health center), clinics, etc. It can also be used in research laboratories.

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TABLE OF CONTENTS

1. Understanding Your Analyzer........………………………..……......... 1


Your Analyzer Overview………………………………………................ 1
Important Safety Information………………………………………........ 2
2. Components and Structure………………………………………........ 3
Standard Equipment List……………………………………………....... 3
Main Structure…………………………………………………...…......... 3
3. Installation and Use Conditions....................................................... 6
Analyzer Installation........................................................................... 6
Use Conditions................................................................................... 7
4. Operation Instructions……………………………….......................... 8
Test Starting……………………………………………………................ 8
Analyzer Settings……………………………........................................ 8
Quick Test……………………………………………………................... 12
Standard Test...................................................................................... 17
History................................................................................................. 20
5. Quality Control…………………………………………………….......... 23
Why Perform Quality Control Test……………...…………………........ 23
Operation Steps……………………............………………………........ 23
6. Maintenance and Troubleshooting.................................................. 26
Caring for Your POCT Analyzer........................................................... 26
Maintenance Method and Plan........................................................... 26
Troubleshooting Guide........................................................................ 27
7. Technical Information....................................................................... 29
System Specifications......................................................................... 29
Index of Symbols…………………….................................................... 31
Warranty………………………………………….................................... 32
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CHARPTER 1: UNDERSTANDING YOUR ANALYZER
Your Analyzer Overview
Model: VIM01
Basic size: 173mm (Width) x 210mm (Depth) x 75.8mm (Height)
Total weight: 1.5Kg

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Analyzer Use and Precautions
• Do not get water or other liquids inside the analyzer.
• Keep your analyzer dry and avoid exposing it to extremely temperature or
humidity.
• Do not drop the analyzer or get it wet. If you do drop the analyzer or get it wet,
check the analyzer by running a quality control test. Refer to Quality Control
Test for instructions.
• Do not take the analyzer apart. Taking the meter apart will void the warranty.
• Refer to the Caring for Your Analyzer for details on cleaning the analyzer.
• Keep the analyzer and all associated parts out of reach of children.
Note: Follow proper precautions and all local regulations when disposing of the
analyzer and relevant accessories.

Important Safety Information


• It is for in vitro diagnostic use by professionals.
• Use only VivaDiag POCT Test Kit with your VivaDiag POCT Analyzer. Do not
use other brand, otherwise it will not guarantee the reliability of the measured
data.
• Use the accessories provided by VivaChek with your VivaDiag POCT Analyzer.
Do not use other brand, because other brand will not suitable for your analyzer.
• Please read this User’s Manual carefully before you use your analyzer and
keep your User’s Manual in a safe place for referring it in the future.
• If the analyzer emits peculiar smell, smoke or the liquid flows into the analyzer,
please cut off the power immediately and contact with your local dealer.
Continous use of the analyzer may cause fire, electric shock or personnel
injury.
• Please comply with all the national standards for health and safety. This
includes (but not limited to) protective cover, gloves, and suitable experimental
installation when operating and maintaining the analyzer.
• If the analyzer is used in a manner not specified by the manufacturer, the
protection provided by the analyzer will be impaired.

Caution
All products or objects, which come in contact with blood/urine, even after
cleaning, should be handled as if capable of transmitting viral disease.

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CHAPTER 2: COMPONENTS AND STRUCTURE
Please check whether any component is missing or damaged against the list below
after opening the package.
Note: If some parts are missing or damaged, please contact your local dealer or
manufacturer immediately.

Standard Components List


Number Component Quantity
1 VivaDiag POCT analyzer 1
2 Power adapter 1
3 Power line 1
4 Print paper roll 1
5 User’s manual 1
6 Packing bag of the analyzer 1
7 Sponge gasket 1
8 Quality control test device Optional
9 Quality control code chip Optional

Main Structure
The actual appearance of analyzer and accessories should may vary with specific
model.
Analyzer
(1) Main structure of the front (Figure 1)
Built-in thermal printer
LCD touch screen

Keys

Slot for test device

Slot for code chip


Figure 1

(2) Main structure of the rear (Figure 2)


The power switch and power adapter port are on the back side of the analyzer,
power switch can be used to turn on or off the analyzer, power adapter port can be

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used to connect with the power adapter.

Power switch Power adapter port

Figure 2

(3) Main structure of the left side (Figure 3, 4)


A cover protects the power connector, COM and USB interface on the left side of
the analyzer, the method to open it is as shown in Figure 3.

Cover

Figure 3
After opening the cover, the structure is as shown in Figure 4.

COM interface
Power connector
USB interface

Figure 4
The power connector, COM and USB interface on the left side of the analyzer have
the purpose of connecting the analyzer with a computer, LIS (Laboratory
Information System) or HIS (Hospital Information System).
Note: There is no need to open the cover if you do not need to communicate with a
computer, LIS or HIS.

(4) Main structure of the right side (Figure 5)

Figure 5

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Power adapter with power line (Figure 6)

Figure 6

Quality control test device (Figure 7, optional)

Figure 7

Quality control code chip (Figure 8, optional)


The quality control code chip is a specific test device with calibration curve, and
can be only used with the quality control test device.

Figure 8

Test device (Figure 9, additional purchase)


VivaDiag POCT analyzer can test multiple parameters work with VivaDiag POCT
test kit, the test devices below are only supplied in VivaDiag POCT test kit.

Figure 9

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CHARTER 3:INSTALLATION AND USE CONDITIONS
Analyzer Installation
Please use the analyzer under the proper conditions.
Step 1: Place the analyzer on a stable platform.

Step 2: Open the left side cover and connect the structure according to your need.
COM interface
Power connector
USB interface

Step 3: Connect the power adapter of the analyzer.

Power adapter port

Step 4: Turn on the power switch and start the analyzer.

Power switch

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Use Conditions
Basic Parameters
Excitation light source: LED
Excitation spectrum: Center wavelength λ0=365nm
Reception spectrum: Center wavelength λ1=610nm
Connector: RS232, USB
Printer: Built-in thermal printer
Repeatability: CV<10%
Stability: CV<10%

Positioning and placement requirements


(1) The analyzer should be placed on a stable and level countertop, and in an
indoor environment free of dust, direct sunlight or corrosive gases. The countertop
must be able to sustain a weight of at least 1.5kg.
(2) The analyzer should be placed in a well-ventilated place. There should be at
least 10cm space around the analyzer to ensure the necessary space for operation
and maintenance.
(3) The place of the analyzer placed should without strong vibration source and
electromagnetic fields around.

Storage and Transport Conditions


(1) Storage conditions
Storage temperature: -10 to 40 °C
Relative humidity: 20 to 90%
Atmospheric pressure: 86 to 106 kPa
(2) Transport conditions
Avoid moisture, impact and severe vibration.

Power supply voltage requirements

Caution
The power supply of the analyzer varies between 220V/50Hz AC depending
on countries where the analyzer is used. The input voltage is 12V DC, the
power is 36W. Avoiding short circuit and electric shock during use.

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CHAPTER 4: OPERATION INSTRUCTIONS
Test Starting
Connect the power adapter and turn on the power switch to start the analyzer, the
analyzer will initialize and run to self-testing (Figure 10).

Figure 10
The following interface would display after the self-testing. (Figure 11).

Figure 11

Analyzer Settings
Please set up the analyzer according to your actual requirement before using.
Click the “SETTINGS” button, then enter the following interface (Figure 12).

Figure 12

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Set system functions
Click “FUNCTIONS” button, then enter the following interface (Figure 13).

Figure 13
Slide the button to the right or left to turn on or off the function of the
corresponding item.
(1) Barcode scan
On-Scan the barcode on test device and match the setting information before each
test automatically.
Off-Use the current selected setting information of the analyzer. There is no need
to start the barcode scan to match and find out a setting. In this case, the setting
defaults to the selected item in “SETTINGS”-“TEST ITEMS”.
(2) Micro Switch
On-Start the test automatically after inserting the test device. There is no need to
press the “NEW TEST” manually before starting the test.
Off-Click the “NEW TEST” manuallly to start the test after inserting the test
device.
Note: If you do the test at the interface of Figure 14, you also need to click the
“NEW TEST” manually first to enter the corresponding test interface, then the
analyzer will start the test automatically or manually according to your setting.
(3) Built-in barcode
On-Scan the barcode on test device and then start the test.
Off-Start the test directly without scanning the barcode on test device.
Note: The “Built-in barcode” can be set to On and plays its function only when the
“Barcode scan” is On. When they are both set to On, the analyzer have the
function of scanning barcode on test device and finding errors.
(4) Auto-print
On-Print the test result automatically after completing each test.
Off-Print the test result manually after completing each test.

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Click “BACK” to return to the parent directory.
Note: If you need any other setting, please contact your local dealer or
manufacturer to get the correct password. Click the “ADVANCED” and input the
password you get, then you can do other setting.

Manage the test items


Click “TEST ITEMS” and enter the interface as shown in Figure 14. You can
choose the appropriate setting information for the current test by clicking the item
number.

Figure 14
(1) Click “UP” or “DOWN” to browse the saved test items.
(2) Click “NEW TEST” with the icon of to start the QUICK TEST of the item
you selected.
(3) Click “NEW TEST” with the icon of to start the STANDARD TEST of
the item you selected.
(4) Click “DELETE” to delete the item you selected.
(5) Click “BACK” to return to the parent directory.

Quality control
Click “QUALITY CONTROL” and enter the interface as shown in Figure 15.

Figure 15

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(1) Click “QC” to do the quality control testing after inserting the quality control
code chip or select the item showed on the screen, and inserting the corresponding
quality control test device. Refer to the Charpter 5 Quality Control for details on
doing the quality control test.
(2) Click “UP” or “DOWN” to browse the saved items.
(3) Click “DELETE” to delete the item you selected.
(4) Click “BACK” to return to the parent directory.
(5) Click “MENU” to return to the home page.

About the analyzer


Press “ABOUT” to enter the following interface. Model, hardware version, software
version and serial-number information of the analyzer will be displayed (Figure 16).

Figure 16
(1) Reset to factory settings
You can clear all data and restore to the factory settings by clicking “FACTORY
RESET”. The analyzer will restart automatically after reset to factory settings.
(2) Parameter calibration
Press “CALIBRATION” and enter into the following interface (Figure 17).

Figure 17
Note: This function is for professional technicians to debug the analyzer, and
needs the correct password to enter.

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Quick Test
Before you perform a quick test, you need to prepare the VivaDiag POCT Analyzer
and VivaDiag POCT Test Kit.

Operation steps
Step 1: Connect the power adapter and turn on the power switch to start the
analyzer and wait for 5 minutes.
Note: 5 minutes is the preheating time for analyzer to make its system stable.
Step 2: Click “QUICK TEST” to enter the following interface (Figure 11, 18).

Figure 11, 18
Step 3: Remove the code chip from VivaDiag POCT test kit of the item you need to
test, and insert the code chip into the code chip slot until you hear a beep, you will
see the following interface, the analyzer will get the item’s information
automatically and display them on the screen (Figure 19).

Figure 19
Step 4: Remove the test device from foil bag in VivaDiag POCT test kit of the item
you need to test, refer to the package insert to add the sample and wait for the
corresponding reaction time.

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Step 5: Insert the test device into the test device slot after the reaction time
completed, the analyzer will start the test automatically and scan the barcode on
test device first (Figure 20).

Figure 20
Note: If the “Micro switch” is set to Off, you need to click “NEW TEST” manually to
start the test after inserting the test device.
If the button of “Barcode scan” and “Built-in barcode” are not On at the same time,
the analyzer will fail to scan the barcode on test device and find errors.
Step 6: The analyzer enter to the test processing after scanning the barcode on
test device (Figure 21).

Figure 21
Step 7: The result is displayed on the screen after testing (Figure 22).

Figure 22

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(1) Click “NEW TEST” to go back to test interface for a new quick test.
(2) Click “PRINT” to print the test result by built-in thermal printer (Figure 23).

Figure 23
Note: If the “Auto-print” is set to On, the analyzer will print the test result
automatically after completing each test
(3) Click “MENU” to return to the home page.

Operation error analysis


Error 1: The code chip and test device you insert are not match.
If the button of “Barcode scan” and “Built-in barcode” are both On at the same time,
the analyzer will display the information of barcode on test device finally instead of
code chip, you will see the following interface (Figure 24).

Figure 24
If the button of “Barcode scan” and “Built-in barcode” are not On at the same time,
the analyzer will start the test directly and you will see the interface of Figure 25.

Figure 25

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Error 2: You insert the code chip only and click “NEW TEST” to start the test
without inserting the test device into the analyzer.
If the button of “Barcode scan” and “Built-in barcode” are both On at the same time,
you will see the following interface after scanning process (Figure 20, 26).

Figure 20, 26
Note: This situation will also occur if the analyzer failed to scan the barcode on test
device after you inserting the test device.
(1) If you choose OK, you will see the following interface (Figure 27).

Figure 27
(2) If you choose CANCEL, you will see the following interface (Figure 28).

Figure 28
If the button of “Barcode scan” and “Built-in barcode” are not On at the same time,
you will see the interface of Figure 28.

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Error 3: You insert the test device only and start the test without inserting the
code chip into the analyzer.
(1) The item you test is in “SETTINGS”-“TEST ITEMS”
If the button of “Barcode scan” and “Built-in barcode” are both On at the same time,
the analyzer will scan the barcode on test device and match the corresponding
item information in “SETTINGS”-“TEST ITEMS”, then start the normal testing
process.
If the button of “Barcode scan” and “Built-in barcode” are not On at the same time,
the analyzer will enter the testing process directly without scanning the barcode on
test device and matching the corresponding item information in “SETTINGS”-
“TEST ITEMS”.
(2) The item you test is not in “SETTINGS”-“TEST ITEMS”
If the button of “Barcode scan” and “Built-in barcode” are both On at the same time,
you will see the interface of same as Figure 24 after the analyzer scanning the
barcode on test device.

Figure 24
If the button of “Barcode scan” and “Built-in barcode” are not On at the same time,
the analyzer will enter the testing process directly without scanning the barcode on
test device, you will see the following interface (Figure 29).

Figure 29

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Standard Test
Before you perform a standard test, you need to prepare the VivaDiag POCT
Analyzer and VivaDiag POCT Test Kit.

Operation steps
Step 1: Connect the power adapter and turn on the power switch to start the
analyzer and wait for 5 minutes.
Note: 5 minutes is the preheating time for analyzer to make its system stable.
Step 2: Click “STANDARD TEST” to enter the following interface (Figure 11, 30).

Figure 11, 30
Step 3: Remove the code chip from VivaDiag POCT test kit of the item you need to
test, and insert the code chip into the code chip slot until you hear a beep, you will
see the following interface, the analyzer will get the item’s information
automatically and display them on the screen (Figure 31).

Figure 31
Step 4: Remove the test device from foil bag in VivaDiag POCT test kit of the item
you need to test, refer to the package insert to add the sample.
Step 5: Insert the test device into the test device slot, the analyzer will start the test
automatically and scan the barcode on test device first (Figure 32).

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Figure 32
Note: If the “Micro switch” is set to Off, you need to click “NEW TEST” manually to
start the test after inserting the test device.
If the button of “Barcode scan” and “Built-in barcode” are not On at the same time,
the analyzer will fail to scan the barcode on test device and find errors.
Step 6: The analyzer will start to count down after scanning the barcode on test
device, the count down time is the reaction time of the item you test. Please wait
for the pre-determined incubation time for each test (Figure 33).

Figure 33
Step 6: The analyzer enter to the test processing after the count down is ending
(Figure 34).

Figure 34

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Step 7: The result is displayed on the screen after testing (Figure 35).

Figure 35
(1) Click “NEW TEST” to go back to test interface for a new standard test.
(2) Click “PRINT” to print the test result by built-in thermal printer (Same as Figure
23).
Note: If the “Auto-print” is set to On, the analyzer will print the test result
automatically after completing each test
(3) Click “MENU” to return to the home page.

Operation error analysis


The error will happen is the same as Quick Test, please refer to the Operation
error analysis section of Quick Test for details on analysing the operation error.

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History
Click “HISTORY” to enter the following interface. You can review or management
the history information (Figure 11, 36).

Figure 11, 36

History review
Press “HISTORY REVIEW” to enter the following interface (Figure 37). You can
review all the historical tests.

Figure 37
(1) Main information and result of each test will be displayed on the screen.
Record ID: Serial number, it will be incremented by one after each test
automatically.
Sample ID: A sample’s unique identifier.
Item: Test item.
Lot No.: Test device’s lot or batch number.
Date and time: The date and time you test.
Value and Unit: Test result, including concentration and unit.
RS: Positive or negative determination of test result.
(2) Click “PREVIOUS” or “NEXT” to review the historical test one-by-one.

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(3) Click “PRINT” to print the current history result by built-in thermal printer.
(4) Click “BACK” to return to the parent directory.

History management
Press “MANAGEMENT” to enter the following interface (Figure 38). The interface
show the total number of the saved records, you can upload or clear them.

Figure 38
(1) UPLOAD
Click “UPLOAD” to enter the following interface with the tips including “upload all
the records” and the way of next operation ( Figure 39).

Figure 39
According to the tips, press “UPLOAD” again to resume uploading all the records,
press “BACK” to quit uploading all the records and return to the parent directory .
Note: The function of uploading records needs to be used in conjunction with the
PC software.

(2) CLEAR
Click “CLEAR” to enter the following interface with the tips including “clear all the
records” and the way of next operation ( Figure 40).

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Figure 40
According to the tips, press “CLEAR” again to resume clearing all the records,
press “BACK” to quit clearing all the records and return to the parent directory .

(3) BACK
Click “BACK” to return to the parent directory.

Note: The interface in Chapter 4 use item of hsCRP+CRP (sample type is serum,
the sample type you can choose on the screen) and HbA1C as the example to
guide users to operate the analyzer, the actual interface will change according to
the item, the sample type you test or whether you add the sample.

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CHAPTER 5: QUALITY CONTROL
Why Perform Quality Control Test
The analyzer needs irregular quality control to guarantee result’s reliability, please
perform the following procedures to ensure the right performance.
You should perform a quality control test when:
• At least once a week
• You want to check the analyzer
• Your test result does not match with how you feel

Operation Steps
Before you perform the quality control test, you need to prepare the VivaDiag
POCT Quality Control Test Device and VivaDiag POCT Quality Control Code Chip.
Note: VivaDiag POCT quality control test device and its corresponding quality
control code chip are provided by manufacturer (optional).
Step 1: Connect the power adapter and turn on the power switch to start the
analyzer and wait for 5 minutes (Same as Figure 11).

Figure 11
Note: 5 minutes is the preheating time for analyzer to make its system stable.
Step 2: Click the “SETTINGS” to enter the setting interface, then click “QUALITY
CONTROL” to enter the quality control test interface (Same as Figure 12, 15).

Figure 12, 15

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Step 3: Insert the quality control code chip into the code chip slot, and then insert
the quality control test device into the test device slot, click QC to start the quality
control testing process, the interface will display as follows (Figure 41).

Figure 41
Note: Before you perform the quality control test, you need to turn off the button of
“Barcode scan” or “Built-in barcode” for the quality control test device has no
barcode. You also need to click “QC” manually to start the quality control test after
inserting the test device whether the “Micro switch” is set to On or Off,
Step 4: After the quality control testing completed, If the analyzer works normally,
the interface will display “Pass” (Figure 42).

Figure 42
Otherwise, it will display “Failed” (Figure 43).

Figure 43

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(1) Click “UP” or “DOWN”, the analyzer will back to Figure 15.
(2) Click “DELETE” to delete the current quality control test result, the interface
after you click “DELETE” is as shown in Figure 44.

Figure 44
(3) Click “BACK” to return to the parent directory.
(4) Click “MENU” to return to the home page.

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CHAPTER 6: MAINTENANCE AND TROUBLESHOOTING
Caring for Your POCT Analyzer
(1) VivaDiag POCT analyzer does not require special maintenance except for
keeping it clean and replacing thermal printing paper when needed.
(2) The internal structure of VivaDiag POCT analyzer can only be inspected or
replaced by manufacturer, not by any third-party vendors, including the important
part of the circuit boards, optical detection modules, display, built-in thermal printer,
etc. If you require the inspect or replace service, please contact your local dealer or
manufacturer.
(3) The technical support and software maintenance of VivaDiag POCT analyzer
can only be provided by manufacturer, not by any third-party vendors, including
functional maintenance, software fixes, software upgrade, etc. If you require the
service, please contact your local dealer or manufacturer, they are only
responsible and provide service when the analyzer is properly used in compliance
with the User's Manual, otherwise any damages incurred will not be covered.
Note: If the analyzer occurs the problem of internal structure, technical or software,
it maybe need to send back to manufacturer. Please follow User’s Manual and
send it back if it needs to send back, it normally takes about a week to investigate
the problem. After the investigation, If the problem occurs within warranty period,
we will replace it with a new one.
(4) If the analyzer needs to be destroyed for any reason, please follow the
procedures and rules of destruction for Class B electric devices.

Maintenance Method and Plan


Maintenance Method
• Your VivaDiag POCT analyzer does not require special maintenance or
cleaning. Basic maintenance is to keep the external clean of the analyzer.
External cleaning and maintenance method: A cloth dampened with 70%
alcohol can be used to wipe the outside of the analyzer. Do not use strong bleach
(≥0.5% bleach solution), because oxidizing substances and solvents may damage
the analyzer's parts and touch screen. Take care to avoid getting liquids, dirt, blood
or buffer into the analyzer through the slot or data port.

Caution
Turn off the power switch before cleaning! Ensure the power line is
disconnected to avoid the risk of short circuit and electric shock!

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• Except for external cleaning, your VivaDiag POCT analyzer also require
replace thermal printing paper when needed.
Replacing printing paper method: VivaDiag POCT analyzer use the built-in
thermal printer, it does not require change the cartridge, just require replace the
thermal printing paper when needed. After the thermal printing paper is run out,
open the built-in thermal printer’s cover of the analyzer, replace the thermal
printing paper with a new one (Figure 45), then close the cover.

Figure 45
Note: When the red edge appears on the printing paper, it indicates that the
printing paper is running out. So the printing paper should be replaced as soon as
possible.
• Your VivaDiag POCT analyzer is a precision electronic instrument. Please
handle it with care.

Maintenance Plan
Maintenance item Every week When needed
External cleaning X
Dedust X
Replace printing paper X
Quality control (Optional) X

Troubleshooting Guide
Appearance Possible reason What you should do
Power switch is unopened Turn on the power switch.
Power failure Power plug or power Contact your local dealer or
adapter is damaged manufacturer.
Bad wire contact between Pull off the power line and

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the analyzer and power reconnect, If the problem
adapter continues, contact your local
dealer or manufacturer.
Turn off the power switch,
replug the power line, and
then turn on the power switch
No response The analyzer is crashed
again, if the problem
continues, contact your local
dealer or manufacturer.
Ground and release the static
Electrostatic effect electricity or reopen the
Abnormal analyzer.
display
Contact your local dealer or
Circuit fault
manufacturer.
Repeat the test with a new
The code chip do not one. Make sure that it is not
match the analyzer or the damaged and you are using a
code chip is damaged code chip from VivaChek
Laboratories, Inc.
Discard the test device and
repeat the test with a new
The test device do not
one. Make sure that it is not
match the analyzer or the
over the validity period and
test device is over the
you are using a test device
Unable to test validity period
from VivaChek Laboratories,
Inc.
Make sure that the code chip
and test device you are using
The code chip and test
is matched and gained from
device are not match
the same VivaDiag POCT
Test Kit.
The analyzer is
Contact your local dealer or
uncalibrated or the
manufacturer.
calibration data is missing
The button of “Barcode Turn on the button of
Unable to find
scan” and “Built-in “Barcode scan” and “Built-in
errors when
barcode” are not both turn barcode”, make sure they are
testing
on at the same time both On at the same time.

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CHAPTER 7: TECHNICAL INFORMATION
System Specifications:
Feature Specification

Principle Fluorescence Immunochromatography

Measurement Quantitative

Dimensions 173 mm x 210 mm x 75.8 mm

Weight 1.5 Kg

Display size 3.5’’ LCD

Sample type Whole blood/Serum/Plasma/Urine

Test time 10 ± 5s

Test items 30+

Barcode identification 2D

Operating temperature 5-40°C

Storage temperature -10-40°C

Relative humidity 20-90%

Atmospheric pressure 86-106 kpa

Connectivity Direct LIS/HIS

Battery AC/DC adapter

Printer Built-in thermal printer

Memory 50000 test results

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Limitations
The VivaDiag POCT Analyzer, VivaDiag POCT Test Kit are been designed to work
together to provide accurate results for multiple parameters. Do not use
components from other brands.
• Do not place the analyzer in a position that is difficult to operate or inconvenient
to disconnect.
• Please use the analyzer strictly according to the User’s Manual provided by
manufacturer.
• Do not insert anything into the code chip/test device slot except for the code
chip/test device provided by or purchased from manufacturer.
• Fresh whole blood may be collected into test tubes containing sodium heparin,
lithium heparin if the blood is used within 10 minutes. Do not use sodium
fluoride/oxalate, other anticoagulants or preservatives.
• If the tested samples are potentially contagious, please use the protective
gloves or other protective measures to avoid skin contacting with sample.
• Please dispose the analyzer that no longer use according to the procedures
and rules of destruction for Class B electric devices.
• Please dispose the used test device according to “Medical Waste Management
Regulations” to avoid biohazards.
• Dispose of blood samples and materials carefully. Treat all blood samples as if
they are infectious materials. Follow proper precautions and obey all local
regulations when disposing of materials.

30
Index of Symbols
These symbols may appear on the packaging and in the instructions for the
VivaDiag POCT system.

Symbols Explanation

Consult instructions for use

Manufacturer

Temperature limitations

Contains sufficient for <n> tests

Use by

Lot Number

Authorized representative

Sterilized using irradiation

REF Catalog number

Model Model number

SN Serial Number

Do not re-use

Caution, consult accompanying documents

IVD In vitro diagnose

Dispose items according to local relevant laws regarding


disposal and recycle

Keep away from sunlight and heat

31
Warranty
Please complete the warranty card that came with the product and mail it to your
dealer to register your purchase.
If the analyzer fails to work for any reason other than obvious abuse within the first
three (3) years from purchase, we will replace it with a new one free of charge. For
your records, also write the purchase date of your product here.
Date of purchase: _____________________________________________
Note:
This warranty applies only to the analyzer in the original purchase, and does not
apply to the battery supplied with the analyzer.

32
Warranty Card

Please complete this warranty card to validate your warranty. Mail it


within 30 days of purchase to the local dealer address labeled on the
product.
If the analyzer does not work for any reason other than obvious abuse in
the first 3 years after purchase, we will replace it with a new or
equivalent analyzer free of charge.

Date of purchase / /
Analyzer serial number(e.g.201A0000001)
Where purchased
Telephone number
Email address

Suggestion/Comments
VivaChek Laboratories, Inc.
www.vivachek.com

© 2019 VivaChek Laboratories, Inc.