Vcheck V2400 Manuel utilisateur
V2400
FLUORESCENT IMMUNOASSAY SYSTEMS
USER MANUAL
FOR VETERINARY USE ONLY
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VC7403EA
Doc. No.: I7403-2E
Issued date : Apr. 28, 2020
Manufactured by
+HDGRࢇFH
C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si,
Gyeonggi-do, 16690, Republic of Korea
Manufacturing site
74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si,
Chungcheongbukdo, 28161, Republic of Korea
Tel: +82-31-300-0400 l Fax: +82-31-300-0499
www.sdbiosensor.com
Distributed by
22, Samsung 1-ro 4-gil, Hwaseong-si, Gyeonggi-do 18449, Republic of Korea
Tel: +82-31-211-0516 l Fax: +82-31-8003-0618
www.bionote.co.kr
Thank you for your purchase of the BIONOTE V2400
This User manual contains all information about the Analyzer. Please read this User
manual carefully and familiarize yourself with the required preparations and test
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Please read the instructions carefully which are included in each test device package
before using the Analyzer.
If you have any questions about the analyzer, please contact your local distributor.
You can also visit www.bionote.co.kr for product demonstrations.
Again, thank you for purchasing the BIONOTE V2400.
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TABLE OF CONTENTS
Chapter 01. General Information
Main Menu Structure..............................................................................6
Symbols and Abbreviation......................................................................8
Precautions........................................................................................... 10
Chapter 02. Overview
Intended Use ........................................................................................ 12
Product Overview .................................................................................12
Precautions before perform a test........................................................13
6SHFLࢉFDWLRQV........................................................................................15
Appearance of BIONOTE V2400 Analyzer .............................................16
Included of the BIONOTE V2400 Analyzer ............................................ 18
Chapter 03. Log On and Setting
Operation of Analyzer........................................................................... 19
Chapter 04. Work Place
Performing a test & Reviewing data..................................................... 30
Chapter 05. Calibration
Calibration Set Test............................................................................... 38
Chapter 06. Quality Control
Quality Control Test .............................................................................. 43
Chapter 07. Cleaning & Maintenance
Cleaning of Analyzer.............................................................................52
Maintenance & Transportation.............................................................52
Chapter 08. Messages & Troubleshooting
Warning Messages ...............................................................................53
Error Messages..................................................................................... 54
ANNEX 01. Information for Professional Medical Personnel
Protection from Infection ..................................................................... 57
Electromagnetic compatibility..............................................................57
Disposal ................................................................................................ 57
Warranty............................................................................................... 57
6 7
Chapter 01. General Information
Run
Calibration
QC with
Control
solution
External
QC
Prepare
CAL Device
Input
Control ID
Input
Control ID
Device
Checking
Device
Checking
Select
Control
Information
Insert
Device CAL-3
Mounting Mounting
Device
Checking
Sample
Checking
Sample
Checking
Analyzing
Insert
Device CAL-1
Insert
Device
Device
Checking
Insert
Device CAL-2
Apply
Sample
Apply
Sample
Device
Checking
Result
Work Place
Start
(Input Operator
ID)
Device
Checking
Sample
Checking
Insert
Device
Apply
Sample
Mounting
Test
Status
Result
Review
Test
Status System Statistics
Date
/Time Add Network
Language Delete
Brightness
/Volume
Print Edit HIS/LIS
Update
Maintenance
Operator Network
QC Result
Review
Run QC Monthly
review
Work Place Calibration QC Utility
8 9
Main Menu Structure
Symbols and Abbreviation
The symbols and abbreviation presented below are indicated on the User Manual,
labels and external package.
Symbols
Symbols Description
Manufacturer
In Vitro diagnostic use
Consult instructions for use
Reference Number
Date of Manufacture
To indicate the date of manufacture
Serial Number
Note
To indicates that the analyzer is fragile and you need to handle it with care
Batch code
Indicate the lot number of the system
Crossed out wheeled bin
Discard it separately from other household waste
Indicate that you should keep the analyzer dry
Caution
Indicate a situation, which if not avoided could result in damage to the
device or incorrect results
Abbreviations
Abbreviation Description
Comm Communication
LIS Laboratory Information System
HIS Hospital Information System
GUI Graphic User Interface
S/W Software
F/W Firmware
10 11
Precautions
Caution
To reduce the risk of damage to Analyzer
Use the Analyzer for in vitro diagnostics only.
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Do not expose the analyzer to strong light. Otherwise, serious
interference to the test results may occur.
Do not move the Analyzer during the test.
Do not drop the Analyzer. Otherwise, the Analyzer may be
damaged.
Do not attempt to disassemble the Analyzer.
Do not immerse the Analyzer in water or cleaning solution.
To reduce the risk of inaccurate results
This Analyzer should be used only by trained operators.
If the error message occurs repeatedly, stop using the Analyzer.
For accurate results, refer to the manual that comes with each test
device.
Do not use test devices which have expired.
To prevent electric shock
Ensure the Analyzer is completely grounded. Do not connect the
Analyzer to an ungrounded outlet.
When using a power board, use a grounded power board.
Make sure that all cables are connected to the Analyzer correctly
and completely.
There is a risk of electric shock if Analyzer is not grounded. Use the
power cable provided by the Bionote. It is recommended to use a
power cable of 250V ~, 10A, 0.75mm2 (18 AWG).
Do not share power supply with other instruments and/or devices.
Biohazard!
To reduce the risk of biological hazards
Discard the used specimens in accordance with federal, state and
local requirements.
Treat specimens as potentially biohazardous material.
If you have no experience with collection and handling of
specimens, appropriate education or guidance should be
received.
Nitrile or latex gloves are recommended when handling patient
specimens.
12 13
Chapter 2. Overview
Intended Use
The BIONOTE V2400 Analyzer is effective for measuring quantitative or qualitative
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IURPWKHERG\ࢊXLGSDUDPHWHULQFOLQLFDOVHWWLQJVE\KHDOWKFDUHSURIHVVLRQDOV,QDOO
cases, the Analyzer should be used with designated test devices produced by Bionote,
Inc.
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device package.
Product overview
The BIONOTE V2400 Analyzer scans the 2D barcode of inserted test device. Based
on the scanned result of the inserted test device, the analyzer determines the
appropriate LED (UV, RGB) settings for the test device.
An antigen-antibody reaction takes a certain period of time after samples are
dispensed.
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UHࢊHFWWKHOLJKWIURP/('DQGWKLVUHࢊHFWHGYDOXHZLOOEHPHDVXUHG
Then the measured value will be calculated based on the formula that is input to the
2D barcode.
Precautions before perform a test
Note
Read and follow the instructions carefully in the user manual
and Instructions for use of the test device and control. It is very
important to follow the instructions in order to prevent an inaccurate
result or improper treatment.
Be sure to check with your distributor and Bionote for the most up-
to-date software and to update before use.
Fatal consequences, such as fire or serious system damage, may
occur when the system is installed at an inappropriate location, since
the Analyzer cannot be replaced or removed from power supply.
The Analyzer must be installed in such a way that easy access to
power supply and power switch is ensured.
14 15
Specimens
The BIONOTE V2400 Analyzer should be only used the specific test devices for the
analyzer. Because specimens are quite different for each parameter, follow the
instructions from the each test device instructions.
Safety Information
There is a potential risk of infection. Professional medical personnel should always
wear gloves when handling patient samples with the BIONOTE V2400 Analyzer and
test device. It is recommended that you follow all other locally applicable health and
safety regulations.
Operating Conditions
To operate the BIONOTE V2400 Analyzer correctly, the following guidelines should be
observed :
The operating conditions of the Analyzer are: 0oC-50oC / 32oF-122oF, 10%-93% RH.
7KHRSHUDWLQJWHPSHUDWXUHVXLWDEOHIRUDQDO\VHVGLࢆHUVLQHDFKWHVW)RUHDFKWHVW
refer to the instruction manual of the test device that you will use for analyses.
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Do not use the Analyzer near strong electromagnetic radiation sources. Otherwise,
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If the Analyzer malfunctions suddenly, unplug the power cable from the outlet.
Note
It shall be lifted and carried by holding the bottom of an instrument
frame zones.
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Input Voltage AC 100~240V, 50/60Hz
Display 10.1” Color TFT LCD (1024 X 600)
Display Control Graphic User Interface
Power Consumption Up to 84W
Number of Memories 5,000 (Run Test)
Real Time Clock Including RTC Backup Battery
LIS / HIS +/3&'ȁ3URࢉOH6XSSRUW
Dimension 510 X 566 X 297 mm
Inserts User Manual
Bar Code Scanner (Option) USB Barcode Scanner
Weight 20 kg
LAN transfer rate (bps) 100M
LAN cable CAT 5
16 17
Appearance of BIONOTE V2400 Analyzer
A
D
F
G
B
C
E
I
J
K
H
A. Color TFT LCD
Used for test screen display and interaction with graphical user interface
B. Inlet for insertion of test device
Used for insertion of test device into the Analyzer
C. Test device outlet
Used for discharge of test device that has completed the test
D. Printer cover
Used to cover and protect printer paper
E. Printer cover open button
Used to open printer cover
F. Mini USB
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G. LAN
Used for communication using LAN Cable
H. AC power connection
Used for AC power cable connection
I. Power switch
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J. USB x 4
Used to connect the Analyzer to keyboard, barcode scanner and USB memory
Note
USB should be formatted as FAT32, so that the USB can be
recognized by BIONOTE V2400 Analyzer.
K. Additional device connection part
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18 19
Included of the BIONOTE V2400 Analyzer
Included
Calibration Set
CAL-1 CAL-2 CAL-3
AC Power cable
Optional
Test Device
Barcode scanner
Printer paper
(57mm width Thermal paper is used)
If the paper is small, "no paper" may be
displayed due to sensor malfunction.
Chapter 3. Log On and Setting
Operation of Analyzer
Step 1. Connecting the power cable
1-1. Place the Analyzer in a proper environment where it can be plugged
into outlet and barcode scanner (optional) can be positioned together.
1-2. Connect the power cable to the power connector on the back of the
Analyzer and to the outlet.
1-3. Once the connection is complete, the analyzer is ready for use.
Step 2. Analyzer Log On
2-1. Press log on button.
2-2. The initial log on ID is admin and the password is 1111.
Step 3. Analyzer Setting
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be registered.
3-2. For initial setup, select the Utility screen on the main screen. The
details of the setting (Utility) menu are shown below.
Step Menu Submenu
1 System
Date/Time
Print
Language
Update
Brightness/Volume
2 Operator Add, Edit, Delete
3 Network Network, HIS / LIS
Step 1: Log On Mode
1. Enter the Operator ID and password on the Log On screen and press the Log On
button. Operator ID is “admin” and password is “1111”.
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