VivaChek VivaDiag VIM1000 Instruction Manual

Point-of-care-testing analyzer

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POCT Analyzer

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 information 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

POCT Analyzer.

Principle and Intended Use

The VivaDiag

POCT Analyzer (Model: VIM1000) work with VivaDiag

POCT Test Kit as a system to quantitative measure multiple parameters

(more than thirty items) like hsCRP/CRP, cTnI, HbA1c, T4, 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/hair), 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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Summary of Contents for VivaChek VivaDiag VIM1000

Page 1 POCT Analyzer 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...
Page 2: Table Of Contents
TABLE OF CONTENTS 1. Understanding Your Analyzer..………...... 1 Introduction to Analyzer………………………....1 Important Safety Information…………………....1 2. Components and Structure…………………....2 Standard Components List………………………....2 Main Structure…………………………………....2 3. Installation and Use Conditions........4 Analyzer Installation............4 Use Conditions..............4 4.
Page 3: Understanding Your Analyzer
POCT Test Kit with your 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.
Page 4: Components And Structure
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...
Page 5 Power Adapter (Figure 3) (Figure 3) Quality Control Test Device (Figure 4, optional) (Figure 4) Quality Control Code Chip (Figure 5, 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 5) Test Device (Figure 6, additional purchase) The analyzer can test multiple parameters work with VivaDiag...
Page 6: Installation And Use Conditions
CHAPTER 3: INSTALLATION AND USE CONDITIONS Analyzer Installation Please use the analyzer under the proper conditions. Step 1: Place the analyzer on a stable and level countertop. Step 2: Connect the structure according to your need (Figure 7). COM port USB port Network port...
Page 7 • 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 2.5 Kg. (2)The analyzer should be placed in a well-ventilated place.
Page 8: Operation Instructions
CHAPTER 4: OPERATION INSTRUCTIONS Test Starting Turn on the analyzer, the analyzer will initialize and run to self-testing. The following interface would display after the self-testing (Figure 10). (Figure 10) Analyzer Settings Please set up the analyzer according to your requirements before using. Click the “Settings”...
Page 9 (1) Auto Print On-Print the test result automatically after completing each test. Off-Print the test result manually after completing each test. (2) ID Number Generate On-Generate the ID number automatically according to the date. Off-You need to input the ID number manually. Note: The function of “ID Number Generate”...
Page 10 Update-You can get new version of software from your local dealer or manufacturer, put the software file in USB and insert it into USB port, click “Update” button to update the software. Update splash-You can get new version of splash interface from your local dealer or manufacturer, put the file in USB and insert it into USB port, click “Update splash”...
Page 11 (Figure 17) (Figure 18) Click “QC Test” to start the test after inserting the quality control test device into the analyzer. The analyzer will display the test result after the quality control testing is completed, if the analyzer works normally, the interface will display “Pass!”...
Page 12 Error Conditions (1) If you click “QC Test” to start the quality control test without inserting the quality control code chip into the analyzer, the analyzer will display according to the following conditions. Condition 1: If you turn on “Micro Switch” function, the analyzer will display “Please push the strip to the end”...
Page 13 Condition 2: If you turn off “Micro Switch” function, the analyzer will test directly and display the result with “Result Value is zero and QC Result is NG” (Figure 24). (Figure 24) Note: If your quality control is fail, please do not test any sample and contact your local dealer or manufacturer for debugging soon.
Page 14 After inputting the correct password, the analyzer will allow you to set automatic testing and the interval of automatic testing, upload to cloud server and LIS. In addition, the analyzer will provide the following new tools: calibration, gain adjustment, data preservation, record clearance, etc. (6) Language You can set the analyzer’s language with “English”...
Page 15 Connection-you can input the analyzer’s PC IP Address and PC Port (Figure 30). (Figure 30) Note: The setting will come into effect after the analyzer is restarted. Set the Time Click “Time” button to enter the following interface (Figure 31). (Figure 31) Click the field which needs to be modified and input the correct date and time.
Page 16: Single Test
You can click “Unit Name Set” button to input the unit name. Reset to Factory Click “Factory Reset” to restore to the factory settings (Figure 33). (Figure 33) Press “OK” to resume restoring to factory settings, press “Cancel” to quit. Manage the Test Items Click “Test Items”...
Page 17 (Figure 35) You can click “Sample Info” to input the sample ID manually (Figure 36). (Figure 36) Note: If you turn on “ID Number Generate” function in “Settings”, you do not need to input the sample ID manually, the analyzer will generate the sample ID automatically.
Page 18 Step 6: 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 38). (Figure 38) Note: 1) If you turn off “Micro Switch” function, you need to click “Quick Test” button manually to start the test.
Page 19 Step 8: The result is displayed on the screen after testing (Figure 41). (Figure 41) Operation Steps for Standard Test Before you perform the test, you need to turn off “Micro Switch” function. Steps 1 to 4 are the same as the operation steps for quick test. Step 5: 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.
Page 20 2) If you turn off “Inner Code” function, the analyzer will start to count down directly without scanning the barcode on test device (Figure 44). (Figure 44) Step 7: 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.
Page 21: Batch Test
(Figure 47) Batch Test Before you perform the batch test, you also 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.
Page 22 (Figure 50) Note: You can also delete or clear the item you add by clicking “Delete” or “Clear” button. Step 5: 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 6: Click “START INCUBATE”...
Page 23: History
(Figure 53) (Figure 54) Note: If you turn off “Micro Switch” function, you need to click “START TEST” manually to start the test. Step 8: The result is displayed on the screen after testing, and the test item will never display on the list (Figure 55). (Figure 55) Step 9: Repeat Step 6 to 8 to complete the test of all samples.
Page 24 (Figure 56) History Review (1) Click “Previous” or “Next” to review the historical test result page by page. (2) Click “Search” to search the test result by inputting various screening conditions (Figure 57). (Figure 57) History Management (1) Click “Print” to print the selected test result by built-in thermal printer. (2) Click “Delete”...
Page 25: Maintenance And Troubleshooting
CHAPTER 5: 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.
Page 26: Troubleshooting Guide
• Except for external cleaning, your VivaDiag POCT analyzer also requires thermal printing paper replacement when needed. Replacing printing paper method: VivaDiag POCT analyzer uses 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, and replace the thermal printing paper with a new one (Figure 58), then close the cover.
Page 27 Repeat the test with a new one. Make sure that it is not The code chip does not damaged and you are using match the analyzer or the a code chip from VivaChek code chip is damaged Biotech (Hangzhou) Co., Ltd. Unable to...
Page 28: Technical Information
CHAPTER 6: TECHNICAL INFORMATION System Specifications Feature Specification Principle Fluorescence Immunochromatography Measurement Quantitative 280 mm (Length) x 240 mm (Width) x Dimensions 130 mm (Height) Weight 2.5 Kg Display size 7’’ LCD Sample type Whole blood/Serum/Plasma/Urine/Hair Test items Barcode identification Operating temperature 5-40°C Storage temperature...
Page 29: Limitations
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.
Page 30: Index Of Symbols
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 Catalog number Model Model number...
Page 31: Warranty
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.
Page 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.

VivaChek VivaDiag VIM1000 Instruction Manual

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