BBB MARK-B 1 Manual de usuario
MARK-B™ 1 analyzer
User Manual
MARK-B™ 1 analyzer (Immunoassay analyzer) *Model: MB-100
MARK-B™ 1 analyzer detects specific biomarkers via immunoassay (MESIA;
Magnetic Electrochemical Sandwich ImmunoAssay) from a small amount of test
sample (e.g. whole blood). MARK-B™ 1 analyzer is intended to be used as an in
vitro diagnostic medical device. Please read this user manual thoroughly for
correct use and keep it for future reference.
IVD
Table of Content
1. Product Introduction ﹒﹒﹒﹒﹒ ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 4
1-1. Intended Use ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ ﹒ 4
1-2. Principle﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒4
1-3. Precautions & Warnings ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 4
1-4. Components﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 5
1-5. Symbol Guide﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 5
1. Product Description ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒7
2-1. MARK-B™ 1 analyzer ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒7
2-2. Check Cartridge ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 8
2. Screen Description ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒9
3-1. Home Screen ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ ﹒﹒ ﹒9
1. Initial Setup ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ ﹒﹒10
2. Running a Test ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ ﹒﹒15
5-1. How to perform RUN TEST ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 15
5-2. Result Management ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒20
3. Running a QC Test (Control Solution Test) ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 21
4. Function Setting ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 27
7-1. Setup Screen ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒27
7-2. Administrator Settings ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 28
7-3. Wi-Fi Settings ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 30
7-4. Printer Settings ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 31
7-5. Date & Time Settings ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 32
7-6. Lock Settings ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 34
1. Maintenance ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 36
8-1. System Check ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒36
8-2. Version Information and Update ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 40
8-3 Device Registration﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒43
8-4. Auto Power Off Settings ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 45
8-5. Cleaning ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 46
8-6. Storage Requirements ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 46
1. Error Messages ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒47
10-1. Notifications ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 47
10-2. Error pop-ups﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒51
1. Technical Information ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 57
2. Product Warranty ﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒﹒ 58
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1. Product Introduction
1-1. Intended Use
The MARK-B™ 1 analyzer is an instrument that performs immunoassay on test cartridges. It reads
specific biomarkers within the test sample.
When discarding the analyzer, discard in a safe place in accordance with the WEEE Directive
(2002/96/EC).
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1-2. Principle
MARK-B™ 1analyzer is an instrument based on an immunoassay technique called MESIA (Magnetic
Electrochemical Sandwich Immunoassay). MARK-B™ 1analyzer can be used to analyze asingle or
multiple analyte(s) by detecting electrochemical signals on the test cartridge, which is for aone-time in
vitro diagnostic (IVD). The magnets within the device form magnetic fields, which facilitate the
interaction of nanoprobes in the test cartridge to induce antibody-antigen reactions and remove
unbound magnetic nanoprobes. The MARK-B™ 1analyzer measures the concentration of any
antigensor antibodies by detecting electrochemical signals from the reaction-completed magnetic
nanoprobes. MARK-B™ 1analyzer transmits the test data to the designated server via Wi-Fi.
1-3. Precautions &Warnings
Please read this user manual thoroughly for appropriate use.
MARK-B™ 1analyzer is for use in IVDs.
MARK-B™ 1analyzer and test cartridges are indicated for use in clinical laboratories.
Check that all components are present in the package.
Read this user manualbefore operating the analyzer.
The analyzer needs AC power connection to operate for an extended period of time and charge.
Please ensure your power supply is compatible with the analyzer’s power specifications.
Increasing the inner temperature activates the cooling fan inside the air vent.
Establish afree distance of at least 10 cm (4 inches) from the face of the air vent when installing the
device.
Keep the air vent free from inflow of foreign substances.
Accidental entry of metals into the analyzer may cause breakdown or electric shock.
Please refer to product-specific package inserts included in each test kit for more information.
Turn off the powerandremove the adapter if you do not expect to use the analyzer for an extended
period of time.
Do not use or store the product in alocation exposed to open flames.
Do not expose or store the product in alocation subject to high temperature and high humidity.
Prevent water and dust from entering the device.
Do not apply excessive force, drop or step on the product.
Avoid dropping the device while moving it.
Do not assemble or modify the analyzer.
The analyzer is not water-resistant. Do not wash it with water or touch it with wet hands.
Do not use the product to diagnose specific illnesses and conduct screening tests, such as neonatal
screening.
Use the analyzer only to assist medical decision-making.
Keep this product out of thereach of children.
In order to comply with radio frequency (RF) exposuer limits, antennas should be located at a
minimum of 20cm or more from the body all persons.
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1. Product Introduction
1-4. Components
The following are the components you should check upon opening the package of MARK-B™
1 analyzer.
Please check that all components are included in the box.
Please contact the purchase location if any of the following components are not included or
damaged.
✔ MARK-B™ 1 analyzer, 1EA
✔ User manual
✔ Quick guide
1-5. Symbol Guide
Please refer to the following symbols that can be found on the external package, package
descriptions, enclosed papers, etc.
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1. Product Introduction
2. Product Description
2-1. MARK-B™ 1 analyzer
Power button
Buttons to turn the device on or off.
Tray (closed)
A component to insert the test cartridge.
Opening and closing of the tray are controlled by the
software.
Screen
Interface that the user can touch to operate the analyzer
and check the results.
Tray (open)
The tray is open with the cartridge inserted.
(Component as closed status shown in .)
Air vent
A component to control temperature inside the analyzer.
Power supply connector
An adapter connection port to supply power to the
device.
Electrode connector for test cartridge
A connector for cartridge reading.
Cartridge recognition switch
A switch to check cartridge insertion.
USB port
A USB-A port for barcode scanner and mobile printer.
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The check cartridge is used to evaluate instrumental and electronic operations of the
analyzer.
An alignment sensor is embedded in the check cartridge to check the alignment of magnets at
the top and bottom of the analyzer.
2-2. Check Cartridge
2. Product Description
Cartridge contact pad
Contact pad for the operation check of MARK-B™ 1
analyzer
3. Screen Description
3-1. Home Screen
Status bar
Indicates MARK-B™ 1 analyzer’s network
connection, battery level and time.
Status indicating icon
is displayed when QC test result shows
“fail” or the QC test is not carried out.
is displayed when battery level is 15%
or lower.
is displayed when temperature is either
15℃ or lower, or at least 30℃.
is displayed when the first System Check
is not performed, or System Check result
is Fail.
Time
Displays day, date and month.
Run test
Touch the button to start the test.
QC Test interval and test information
Check QC Test intervals and recent/next test
schedule of the QC test
Run QC Test
Touch the button to run the QC test.
Test results
Check all test results.
Admin login / logout
Login to / logout of the admin account.
Settings
Change settings.
Check device information and update it.
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4. Initial Setup
Touch the ‘Select Time Zone’ → Select the time zone where the user is located.
→ When setting is completed, touch the ‘DONE’ button.
STEP 1. Connect the power adapter. STEP 2. Touch the ‘power’ button to start.
STEP 3. Time Zone setting
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