Vcheck m10
Vcheck m10
USER MANUAL
VCM751EA
VCM752EA
VCM753EA
Doc. No.: IM751-1E(CE)
Issued date : 2022-11-21
Authorized Representative
Manufactured by
Head office
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,
Chungcheongbuk-do, 28161, Republic of Korea
Tel: +82-31-300-0400 l Fax: +82-31-300-0499
www.sdbiosensor.com
Distributed by
This user manual contains all information about the analyzer. Please carefully read this user
manual and the instructions included in each test cartridge package before using the analyzer. In
addition, please familiarize yourself with the necessary preparation and the procedures.
For further inquiries about the analyzer, please contact your local dealer.
Product demonstrations can be found at www.bionote.co.kr
TABLE OF CONTENTS
CHAPTER 2 Overview
1. Intended Use 11
2. Product Overview 11
3. Components of Vcheck M10 12
4. Software GUI Description 14
5. Components 15
6. Specifications 16
7. Unpacking 16
8. Precautions Before Measurement 17
CHAPTER 5 QC
1. QC Test 42
General Information
1. Main Menu Structure
Login
Module Result
Select General User Network
Select List
Patient QC Mode
Summary Date/Time Login HIS/LIS
Scan Select
Sample Patient
Amplification Laguage Add New
Scan Scan
Cartridge Sample
Details Brigthness Edit
Scan Scan
Apply Cartridge
Volume Delete
Sample Scam
Insert Apply
Patient
Cartridge Sample
Cartridge Insert
Early Call
Check Cartridge
Cartridge Auto
Scan
Check Logout
Scan Install
Registration
Summary
Update
Amplification
Details
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2. Symbols and Abbreviations
The symbols and abbreviations presented below are stated in the user manual, labels, and
external packages of Vcheck M10 System.
Symbols
Electrical Symbols on analyzer
Symbols Description
Safety Symbols
Symbols Description
Caution
Indicates a situation, which if not avoided, could result in damage to the analyzer or
incorrect results.
Indicates the presence of a laser inside the analyzer and to proceed with appropriate
caution.
Environmental Symbols
Symbols Description
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Symbols
Symbols Description
Manufacturer
Reference number
Date of manufacture
Indicates the date of manufacture
Serial number
Note
Indicates that the analyzer is fragile, and must therefore be handled with care
Indicates to keep the analyzer dry that you should keep the analyzer dry
EU Representative
Temperature limit
Humidity limitation
Abbreviations
Abbreviations Description
Comm Communication
LIS Laboratory Information Systems
HIS Hospital Information System
GUI Graphic User Interface
S/W Software
F/W Firmware
8
3. Precautions
1. If the error message occurs repeatedly, do not use it.
2. Do not use the barcode for any purposes other than inputting the sample and cartridge
barcode.
3. Be careful as the barcode light may damage your eyes.
4. Do not use the analyzer screen with sharp tools. Please note that it may cause malfunction
due to a damaged screen.
5. Only designated technicians can perform related repairs and service activities.
6. Do not touch the switch button or the power supply with your wet hands.
7. Do not apply other products manufactured by the third party.
8. Before use, check the latest software with your dealer or BIONOTE. Then, start your updating.
9. It must be installed where the power supply and power switch are easily accessible, and
easily disconnectable. (Installing the analyzer in an inappropriate location, such as where
the system cannot be easily disconnected from the power supply, may cause fire or lead to a
serious damage to the system.)
10. Use an approved adapter.
11. For accurate result, please refer to the instruction manual provided with each cartridge, on
precautions to take for each measurement item.
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To Reduce the Risk of Inaccurate Results
• Do not use if error messages occur repeatedly.
• Refer to the instructions included in each test cartridge package for
precautions to ensure accurate results for each assay.
• Do not use any expired Vcheck M cartridges. Please make sure to read
the instruction manual for each cartridge before use.
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CHAPTER 2
Overview
1. Intended Use
The Vcheck M10 analyzer measures quantitative or qualitative biomarkers of specimens such as
blood, feces, and nasal mucus in a laboratory or POCT environment.
Vcheck M10 consists of Vcheck M10 Console and Vcheck M10 Module (Cartridge analysis
function). The Vcheck M10 Console is a analyzer that operates the Vcheck M10 Module based on
the information obtained by scanning the 2D barcode of the cartridge.
The Vcheck M10 Console displays the results of monitoring and diagnosis of the inserted
specimen. It must be used with designated test cartridges produced by BIONOTE Inc. For details
on specific tests, refer to the instructions included in each of test cartridge packages.
2. Product Overview
The Vcheck M10 is a real-time PCR analyzer which automatically performs nucleic acid extraction
and amplification, and detection of the target sequences in various specimens. Vcheck M10 is a
closed system which is only used with BIONOTE Vcheck M cartridge. This Vcheck M10 analyzer
consists of the Vcheck M10 Module and the Vcheck M10 Console. The entire PCR process is carried
out inside the Module, and the Console controls the process and shows the results.
The cartridge is inserted into the Module to be nucleic acid extracted and thermo-cycled to
achieve target amplification. In each cycle of the PCR, fluorescence intensity is measured and
analyzed by the Console software to determine the presence of target pathogen in the specimen.
The result is displayed on the Console screen and data is recorded in the memory.
[Vcheck M Cartridge]
Vcheck M
Assay Cartridge
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3. Components of Vcheck M10
1) Vcheck M10 Console
D E F G H
B Barcode reader Used for scanning specimen IDs and cartridges barcodes.
D USB port Used for connecting with keyboard, printer and USB memory.
F D-sub cable port Used for connecting console and module using D-sub cable.
G LAN port Used for communicating through the local area network.
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2) Vcheck M10 Module
A
D
F
B
G
H
I
C
J K L
Cover for replacing the fan filter mounted on the vent that
D Fan Filter Cover
discharges heat to the outside.
F Mini-USB port USB port for developers for FW update (not for users).
H D-sub cable port Used for connecting console and module using D-sub cable.
* G(USB port) and I(LAN port) functions are not provided to user.
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4. Software GUI Description
1 2 3 4 7 8
CAL CAL
5 6
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5. Components
1) Vcheck M10 Console
Item Appearance Description
Connect AC power/
Gender
D-sub between modules
3) Accessory
Item Appearance Description
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6. Specifications
Item Description
Temperature
≥ 3.5 ℃/sec (From 60 ℃ to 95 ℃)
rise speed
Temperature
Temperature ≥ 3.0 ℃/sec (From 95 °C to 60 °C)
drop speed
control
Accuracy ± 0.5 ℃
Uniformity ± 0.3 ℃
7. Unpacking
Unpack the analyzer on a clean, level, and stable surface. The air vents on the analyzer are on the
back. These vents must not be blocked when installing the analyzer. Avoid placing the analyzer
in direct sunlight. Inspect for any obvious signs of damage. Report any damages immediately
to BIONOTE. Allow the analyzer to equilibrate to room temperature at least 30 minutes before
operating.
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8. Precautions Before Measurement
Carefully read and follow this user manual and the instructions for the test
cartridge and controls, so you can prevent inaccurate results and handle the
analyzer safely. No modification of this analyzer is allowed.
Specimen
The Vcheck M10 must be used with a test cartridge suitable for particular tests. In addition, since
different specimens are applied to each test, you must follow the instructions provided with each
test cartridge.
Safety Information
There is the risk of infection. When professional veterinary personnel examines patients with the
Vcheck M10 system, it is recommended to always wear gloves and follow other relevant health
and safety regulations.
Operating Conditions
To correctly operate the Vcheck M10, please follow the guidelines below. The Vcheck M10 system
must be operated in the permitted temperature range. Since the range is different for each test,
please refer to the manual of the test cartridge suitable for the specific test. To perform a test on
the Vcheck M10 system, place the system on a flat surface. Do not use the Vcheck M10 system
near strong sources of electromagnetic radiation, because the strong electromagnetic fields may
impair the function of the analyzer. There must be no foreign objects in the vents of the analyzer.
(Do not block the vents.) If analyzer malfunction suddenly occurred, please unplug the power
cable from the outlet. The power adapter must be IEC 60950-1 and IEC 60601-1 approved.
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CHAPTER 3
A B
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2-1) Installing additional M10 Modules
• Connect the M10 Modules using the bracket and screws supplied with M10 Module.
Bracket
• Connect the supplied gender at the back of the M10 Module (#1) and M10 Module (#2) to
link them together.
#2 #1
Gender
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2-2) Installing additional M10 Modules
• Connect multiple modules using bracket and side bracket.
Bracket
Side Bracket
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1.2 Analyzer LogIn
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• If you enter an incorrect ID or password,
the icon may turn red and the warning
pop-up may appear.
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1.3 Analyzer Status Light
LED sign
LED sign
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When the connection is completed, you can use the analyzer.
• Re-installation is required for following situations.
- When the number of M10 Module has changed.
- When the position of M10 Module has changed.
- If the number of connected M10 Module and the number of M10 Module recognized on UI
are different. Please check the connection cables or gender.
• Re-installation Procedure
- Only the admin account is able to proceed this task.
- Click the install button on the Settings menu to proceed.
- During the process, the yellow LED light may flash.
- If the problem continues, check the connection between the console and modules. Turn off
all power at least for 5 seconds and reboot.
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1.4 Analyzer Settings
• For the cyber security, the admin password must be changed at initial login.
• Important functions of the system, including updating of the system, can be changed and
applied only by admin account. (After resetting the admin's password, it is very recommended
to be noted.)
• While running the assays, the "Update", "Install", and "Network" functions are blocked, as
these functions may affect the results.
• For details of the Settings menu, refer to the following.
Date/Time
Language
Brightness / Volume
Patient ID
Auto Logout
Install
USB Registration
Update
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1. Select on the main menu screen
to enter the Settings menu.
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3. In General category, you can set Date/Time, Language, Brightness/Volume, process updates,
and Module installation.
Menu Description
You can set the year, month, day, hour, and minute. If you click the input box, a
Date/Time
number keyboard will appear.
Patient ID Turns ON/OFF whether to use Patient ID or not when performing a test.
Early If you use the Early Detection Call function, you can check the positive result while
Detection Call running.
If the number of modules changes or there are issues with initial auto installation,
Install
please proceed with the re-installation.
USB For cyber security, only admin account can register or unregister the USB memory
Registration stick by using the Register button and the Unregister button.
Auto Logout Set the automatic logout time. It has 'Off', '12 Hour', '24 Hour', '1 week'.
Update Displays S/W version and F/W version and you can update S/W with USB.
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4. In User category, Operator ID can be registered, edited, and deleted.
5. If you click the input box, a keyboard will appear. In User category, the password is same as
the Password when you logged in.
6. In User category, you can add an Operator ID by clicking the Add New button.
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• Enter the ID and password to be added. Click the Add button.
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• If the same ID exists, 'User ID is already used' will appear.
• Make sure that PW consists of 8 to 15 characters including numbers and lowercase letters.
7. To edit the Operator ID, select the ID to be modified. Press button on the Edit screen.
• After modifying the ID and password, click the Edit button.
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8. To delete the Operator ID, select the ID to be deleted and press button. Then press
the OK button on Delete screen.
9. In Network category, you can set the Network of HIS/LIS and analyzer.
• Set the network IP, Netmask, Gateway, Port of the M10 Console. Apply it through the Save
button.
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• This is the UI for TCP/IP, DHCP, and Additional to use extensions. This is not currently used.
• Protocol has Off/HL7/LAW methods. Select the desired communication method among them.
After that, click the Save button to apply the desired results. (If Off is selected, the result
data for the patient will not be transmitted even if the Auto send function is activated.)
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• Security can be set to Off or SSL. If SSL(Off) is selected, it operates according to the protocol
Off/HL7/LAW set above. If SSL(Off) is selected, a pop-up window will appear.
• When you click Import, the *.crt file in the USB memory will install the certificate into the
M10 Console. When you click Export, the certificate in the M10 Console is saved as a USB
memory address (the top path of the inserted USB memory/Certificate/sddev.crt). Check the
certificate regarding the designated person and the issuer "M10 Self Signed".
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• Auto Send sets whether to send the result data after testing the patient to the server,
applying the set protocol and security. When set to On, the setting is activated. (For example,
if protocol HL7 setting and Security Off are set, the patient's test result is transmitted to the
server without security through HL7 communication.)
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CHAPTER 4
1. Run Test
1. By selecting button, you can check the progress status of M10 on the Main screen.
Depending on the operation status of M10, the progress status is displayed as Running,
Completed, Available.
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2. Select the M10 Module to drive press to move to the next step. (Only M10 Modules in
Completed or Available status can be operated.)
3. Scan the barcode of the sample or manually type the sample ID. If the input is successful,
it automatically moves to the next step. Before starting the test, remove any cartridges or
materials inside the module. If not, a pop-up will appear asking you to remove it.
36
4. Scan the barcode of the cartridge to be used. If the input is successful, it automatically moves
to the next step.
5. Inject the specimens into the test cartridge. Then touch the screen or wait 9 seconds. Place
the cartridge in the M10 Module immediately. Close the M10 Module door manually. (Refer
to Procedure in the assay specific Vcheck M Cartridge instructions for further details.)
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6. If the cartridge is inserted into the M10 Module, the next screen will be displayed. Select
OK to proceed, or select Reset to restart.
7. It automatically checks the surface temperature of the cartridge and the proper operation of
the optical module. After that, the test proceeds.
38
8. When the assay is completed, the M10 Module Door opens automatically. Once the operation
is completed, remove the used cartridge immediately. Dispose of as biohazardous waste and
dispose of immediately.
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2. Result
In Result, you can check the test results.
1. You can check the summary of a result in the Summary tab.
Pathogen IC Valid
2. You can check the target amplification graph for each item in the Amplification tab.
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3. You can check detailed result information in the Details tab.
3. Review
You can check the accumulated test results in Review . You can check the detailed results
of each test.
Pathogen IC Valid
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CHAPTER 5
QC
1. QC Test
1. By selecting button, you can check the progress status of M10 on the Main screen.
Depending on the operation status of M10, the progress status is displayed as Running,
Completed, Available.
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2. Select the M10 Module to move the next step. (Only the analyzer with Completed or Available
status can be operated)
3. The barcode of the specified QC Solution should be scanned. If the barcode of the QC to be
tested is recognized, it automatically moves to the next stage. If you scan the QC barcode
provided by the BIONOTE, the QC check box is automatically checked.
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4. The next step will be proceeded the same as the Run Test.
5. If the test is completed, the result will be recorded in Review. If you click the QC filter, you can
review only QC results.
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CHAPTER 6
Do not use abrasive cloth or antiseptic solution as this may damage the
display screen. Always turn off the analyzer and remove the power cable
before cleaning.
• Be careful that test device insertion and analyzer internal parts should
not be contaminated by dust.
• Transport case is designed to store the supplied components and
protect the analyzer.
• Store the analyzer at -20°C ~ 50°C / 0% ~ 93% RH.
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CHAPTER 7
Warning/Info/Error Messages
1. Warning Messages
Indication Warning Description
Solution
Confirm that USB is correctly inserted into analyzer.
Solution
Input the correct ID or password.
Solution
Open the door and insert the cartridge to re-test.
Solution
Check if there is an update file on the USB. If you confirm
that there is an update file, insert the USB and press ‘OK’.
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Warning: Please reject cartridge.
Please remove any cartridges or stuck material inside the
M10 Module before proceeding the test.
Solution
After removing the cartridge or stuck material inside the
M10 Module, click the OK button..
Solution
In the order of "Setting -> USB Registration -> Register,"
register the use of USB memory.
2. Info Messages
Indication Info Description
Solution
Check for updates.
Solution
Check for reinstall.
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Information: Please scan patient barcode.
Solution
As this error occurs when scanning the Vcheck M Cartridge,
please scan the patient barcode.
Solution
As this error occurs when scanning the Vcheck M Cartridge,
please scan the sample barcode.
Solution
Copy the certificate file (*.crt) you want to install into the USB
memory and try again.
Solution
This is an alarm when trying to register USB security. After
removing all USB memory, insert it again and proceed
registering USB security.
Solution
It is an alarm related to the provided function and the
UI. There is no problem in operation, but a reboot is
recommended.
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3. Error Messages
Indication Error Description
Solution
Discard the failed test cartridge and re-test with a new test
cartridge and new specimen.
Solution
Re-run the test with a new test cartridge that has not expired.
Solution
The analyzer and the inspection cartridge are moved within
an appropriate temperature range and the test is performed.
Do not artificially heat or cool the analyzer.
Solution
If error occurs, the tests will be canceled and the door of
M10 Module will be opened. Proceed the test with a new
cartridge. If the symptom recurs, contact the supplier.
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Error: Operation module Piston Encoder Error
While operating the cartridge in the M10 Module there was
a problem with the operation of the vertical piston motor.
Solution
If error occurs, the tests will be canceled and the door of
M10 Module will be opened. Proceed the test with a new
cartridge. If the symptom recurs, contact the supplier.
Solution
If the Connect number is displayed differently from the Total
number, turn off the power of M10 Console and M10 Module
and check if the cable and gender are properly connected.
Solution
Turn off the power of M10 Console and M10 Module and
check if the cable and gender are properly connected.
Solution
Turn off the power of M10 Console and M10 Module and
check if the cable and gender are properly connected.
Solution
Turn Off the power of M10 Console and M10 Module and
check if the cable and gender are properly connected.
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Error: Not Supported Device
Solution
Use the cartridge barcode provided by BIONOTE.
Solution
Turn off the power of M10 Console and M10 Module and
check if the cable and gender are properly connected.
Solution
If the Connect number is displayed differently from the Total
number, turn off the power of M10 Console and M10 Module
and check if the cable and gender are properly connected.
Solution
Check the network settings again, and contact the network
administrator.
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