Vcheck V2400 User manual

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
+HDGRࢇFH
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: [phone] l Fax: [phone]
www.sdbiosensor.com
Distributed by
22, Samsung 1-ro 4-gil, Hwaseong-si, Gyeonggi-do 18449, Republic of Korea
Tel: [phone] l Fax: [phone]
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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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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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.
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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&'ȁ3URࢉOH6XSSRUW
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”.

20 21
Step 2: Setting Mode
1. Touch ‘Utility’ on the main menu screen to enter the setting mode.
2. Utility menu consists of submenus: System, Maintenance, Statistics, Operator, and
Network. System submenu can be used to set the Date/Time, Language, Print,
Brightness/Volume and proceed with the update.
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System Menu
1) Date/Time Setting
΍Press an Up( ) or Down( ) button to change the year, month, date,
hour, and minute.
ΎThe display type of year, month and date and be changed.
Change the date style setting.
- Year-Month-Day
- Month-Day-Year
- Day-Month-Year
ΏTime unit is changeable between 12 hours (12h) and 24 hours (24h).
2) Print Setting
You can set the number of result sheet to 1 sheet or 2 sheets. Once press “Auto
Print”, the test result will be printed automatically after all.
3) Language Setting
Press a down arrow( ) to select the desired language from the drop-down
list.
4 ) Update
΍S/W Update
Items needed for S/W update
· BIONOTE V2400 Analyzer
· 6RIWZDUHXSGDWHࢉOH
· USB (Not provided)
· Personal computer (Not provided)
How to update the software
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ii. )RUPDW86%DV)$7ࢉOHV\VWHP
iii. &RS\WKHVRIWZDUHࢉOHWR86%PHPRU\
b. Connect the USB(that V2400 Software is copied) to the USB port on the
bottom left of the V2400 Analyzer.
c. If the USB is connected normally, “USB connected successfully” will be
displayed.
d. Press the S/W Update button. Then, “S/W Update?” will pop up. Press “OK
“ to start the S/W update.

22 23
c. Press “OK”.
d. Run the PC program.
e. When the button is enabled, click the button.
f. Click “Update Firmware” on the PC and then press “OK” on the Analyzer.
e. If the S/W Update is completed, “S/W Update OK” will be displayed on the
screen. Press “OK” to reboot the analyzer.
`
f. Make sure that the latest S/W version is displayed in the lower left corner
of the screen.
ΎF/W Update
Items needed for F/W update
· BIONOTE V2400 Analyzer
· )LUPZDUHXSGDWHࢉOH
· Mini-5pin USB cable
· Personal computer (Not provided)
How to update the F/W
a. Connect your PC and device with a Mini USB cable. If the driver is not
recognized on PC, install the CP2101 driver.
b. Press FW update ( )on the screen.

24 25
g. When the update is completed on the PC, press the “OK” button
h. Press “OK” on the screen to complete FW Update.
5) Brightness/Volume setting
΍Use , buttons or the slider to adjust screen brightness.
ΎUse , buttons or the slider to adjust the volume.
Maintenance Menu
1) On the Maintenance tab, you can check the maintenance status and log of each
item.
΍ Ύ Ώ ΐ Α
Β
΍Maintenance Area: Tested items are displayed.
ΎStatus Area: QC scheduled date for tested item is displayed. The QC period
can be set from due date in AreaΏ above.
ΏDue Date Area: You can set the period of test items. Press button to
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ΐEvent Log Date & Time Area: Date and time of event log are displayed.
ΑEvent Log Area: History of all items tested by V2400 Analyzer is displayed in
chronological order.
Caution
Log Clear Button: Delete the selected event log.

26 27
Statistics Menu
1) On the Statistics tab, you can check the number of tests, calibration, and QC
tests for each item.
΍
ΐΑ
Ύ
Ώ
΍The number of times that each test has been performed is displayed.
ΎThe type and number of times of errors that occurred are displayed.
ΏThe number of times of calibrations and Q.C. for each test is displayed.
ΐPeriod setting: Press button to set the period that you want to check.
Caution
Top Clear: Delete selecte.
Bottom Clear: Delete selected Cal & QC Log.
Operator Menu
1) An Operator item can be registered, edited, and deleted.
· Password in Operator is the same as the password used for log-on.
· To add an Operator ID, press “Add” .

28 29
· To modify the Operator ID, select the ID, press “Edit”, type ID you wish to
modify, and then press “OK”
· To delete the Operator ID, select the ID, select the ID, press “Delete”, then
press “ OK”
Network Menu
1) On the Network tab, you can set the HIS/LIS and Analyzer network.
For the methods of setting, consult with your interface specialist.

30 31
Chapter 4. Work Place
Performing a Test & Reviewing data
Before proceeding a test, check the following :
Is the power cable connected to the Analyzer?
Are the date and time settings of the Analyzer correct?
Are all other settings correct?
1. Select the “Work Place” from the Main Menu.
2. The “Work Place” consists of 3 items: “Run Test”, “Test Status”, and “Result
Review”.
1) Run test Menu
“Run test” is a mode for testing the samples from patients.
΍After entering patient information in “Patient ID”, press to move to
the next step.
Patient ID can be entered by using the touch keyboard. You can also enter
Patient ID by using a barcode scanner or by an external keyboard connected
by USB.
** You can also press button to proceed with the test without entering
the Patient ID.
ΎInsert the test device in the “Insert Device” step and the Analyzer will move
to the next step automatically.

32 33
ΏAnalyzer checks the conditions of the inserted test device. If the test device
has already been used, E-1 error pops up.
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samples should be prepared according to the instruction for each test and
applied to the sample well of the test device.
Caution
Press the “Test Start” immediately after applying the
sample to the test device.
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ΒWhen the sample checking is completed, the test device is mounted inside
the Analyzer.
ΓWhen the mounting is completed, you can start a new test procedure.

34 35
2) Test Status Menu
“Test Status” menu shows the progress of test in the Analyzer.
Blue section is shown in the following cases:
If the test is completed correctly
If the result of qualitative test is Negative
If the result of quantitative test is within the normal range
Red section is shown in the following cases:
If the test is completed correctly
If the result of qualitative test is positive
If the result of quantitative test is out of normal range
Black section is shown in the following cases:
If the test result is Invalid
Green section is shown in the following cases:
If the test is in progress
΍If you select a completed item, you can check details of the test(Test Result,
Name Label, Procedural Control, Test Date and Time, Operator ID, Patient
ID, Manufacturing Date of the test deivce, Software Version). In this window,
you can print the test result by pressing on “Print”. Press “OK” to close the
window.
3) Result Review Menu
“Result Review” allows you to check the test results from “Run Test”

36 37
΍Select from the drop-down list on the right. And select a
test from list shown in [Area A]. All of the test results belonging to the
selected Patient ID will be shown in [Area B]. If you select a particular test
from the drop-down list, you can see the tests in order from the most recent
ones.
ΎIf you select a test from the list in [Area B], you can see the test details.
· Test details window for quantitative test – Example) Canine CRP
· Test details window for quantitative test – Example) Canine CRP
For quantitative test, you can change the measurement unit by pressing the
item under “Units” in the list on the right side[Area B]. (Available only when
there are 2 or more types of measurement units.)
AB

38 39
Chapter 05. Calibration
Calibration Set Test
Calibration Set Test is an essential function that ensures optimal performance of the
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Time for use of Calibration Set
Whenever the Analyzer is turned on
When Analyzer is dropped
When the result does not match the desired result
When you want to check the performance of the Analyzer and test device
Caution
Calibration Set test is independent from QC test and cannot
replace QC test.
Calibration mode consists of “Run Calibration” and “Calibration Review”.
1. Run Calibration Menu
Calibration can be performed in “Run Calibration”. After preparation of Calibration
Set, press button to start calibration.
΍Insert the Cal-1 Device into the test slot of the Analyzer.
ΎAfter checking the Cal-1 Device, insert the Cal-2 Device into the test slot of
the Analyzer.
ΏAfter checking the Cal-2 Device, insert the Cal-3 Device into the test slot of
the Analyzer.