SD Biosensor MultiCare 03MA10 User manual

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ALL-ROUND MAU Test Device
This User Instruction Guide contains all the information needed to use the analyzer
and keep it ready to operate. Please read this User Instruction Guide carefully
before using the analyzer. Familiarize yourself with the required preparations and
the measurement procedure before performing the rst measurement. Also read
the package insert of the test kits to be used for the planned test.
Thank you for your purchase of MultiCare analyzer!

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The packaging materials, labels and instruction for use for MultiCare
Analyzer may contain the following symbols or abbreviations which are
listed below with their meaning:
Symbols
Crossed out wheeled bin: To discard it separately from other
household waste
Caution, consult accompanying documents
Consult instructions for use
In vitro diagnostic medical device
This system is intended to use outside the body (in vitro diagnostic
use).
Manufacturer
Reference number
Date of manufacture:
To indicate the date of manufacture for this analyzer
Serial number for this analyzer.
Batch code:
To indicate the lot number for this system
To indicate the temperature limitations in which the transport
package has to be kept and handled
Use by / Expiry date
Contains Sufcient for <n> Tests
This product fullls the requirements of Directive 98/79/EC on in vitro
diagnostic medical devices.

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CONTENTS
CHAPTER 1. UNDERSTANDING YOUR NEW ANALYZER....................6
1. Intended Use...................................................................................................6
2. Test Principle....................................................................................................6
3. Before You Start Testing...................................................................................7
4. MultiCare Analyzer...................................................................................7
5. Power Supply.................................................................................................11
6. Components..................................................................................................11
CHAPTER 2. TESTING THE MultiCare ANALYZER...............12
1. Operating the Analyzer...................................................................................12
2. Preparing a Measurement.............................................................................20
3. Performing a Test.........................................................................................21
CHAPTER 3. USING THE ANALYZER MEMORY.................................23
1. Memory Map..................................................................................................23
2. Displaying Stored Measured Values.................................................................24
3. Delete Data Stored in Memory.........................................................................24
CHAPTER 4. PRINTING AND DATA TRANSFER.................................25
1. Printing...........................................................................................................25
2. Data Transfer................................................................................................26
3. Data transfer via Bluetooth............................................................................26
CHAPTER 5. CONTROL TEST...........................................................28
CHAPTER 6. CHECK STRIP TEST.......................................................30
CHAPTER 7. MAINTENANCE AND TROUBLESHOOTING.................32
1. Cleaning and Disinfection................................................................................32
2. Maintenance, Testing and Transportation.........................................................33
CHAPTER 8. SCREEN MESSAGES AND TROUBLESHOOTING........34
1. Warning Messages..........................................................................................34
2. Error Messages...............................................................................................34
CHAPTER 9. WARNINGS, PRECAUTIONS AND LIMITATIONS..........37
CHAPTER 10. PRODUCT TECHNICAL INFORMATION......................38
1. Specications..................................................................................................38
2. Electromagnetic Compatibility..........................................................................38
RETURN.................................................................................................38
DISPOSAL.............................................................................................38

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CHAPTER 1.
Understanding Your New Analyzer
1. Intended Use
The MultiCare System is a reectometry immunoassay instrument for the
quantitative measurement in human blood, urine and other specimens. This
system is for in vitro diagnostic use and professional use in hospital and
clinic.
2. Test Principle
The MultiCare System is based on a reectometry and immunoassay
technology. MultiCare Analyzer is a reectometry scanning instrument to be
used in conjunction with the various MultiCare Test Kits which are based
on antigen-antibody reaction. MultiCare Analyzer uses the optic sensor
to measure the reected light from the membrane of the test panel as the
quantity source.
The specimen from human should be processed for the preparation using the
components of the MultiCare Test Kit. When applying the sample mixture to
the test panel, the complex will be formed on the membrane as the result of
the antigen-antibody reaction. The intensity of the reected light is scanned
and converted into an electric signal which is proportional to the intensity
of reected light produced on the membrane. The MultiCare Analyzer can
calculate the concentration of the analyte in the clinical specimen based
on a pre-programmed calibration and display the test result on the screen.
Membrane
Capture antibody
Antigen
Blue Latex Detector antibody

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3. Before You Start Testing
CAUTION
Carefully read and follow the instructions in all labeling material related
with the MultiCare System. It is very important to follow the instructions
in order to prevent an inaccurate result or improper treatment.
Samples
The sample type of the MultiCare System is different according to the
specic parameter you want to measure. Please refer to each test kit insert.
Operating Conditions
To ensure proper function of the MultiCare System, observe the following
guidelines:
• MultiCare System is only for in-vitro diagnositc use.
• Place the analyzer on a level surface.
• Strong electromagnetic elds may impair the function of the analyzer.
Do not use the analyzer close to sources of strong electromagnetic
radiation.
• The analyzer’s air vents must be free for air to ow. (Do not cover the
air vents.)
• If the analyzer causes a sudden malfunction, unplug the AC adapter
from the outlet.
4. MultiCare Analyzer
Model Name MultiCare Analyzer
Check Strip SDB MultiCare Check Strip
Power
Battery: Four Batteries (1.5 V, AA type)
AC Adapter: Input - AC100-240V, 50/60Hz
(Voltage tolerance ±10%)
Output - 5V/2A
Power Consumption Max 2W
Over Voltage
Category II
Pollution Degree II
Reference Number
03MA10
03MA20 Bluetooth function

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Overview of MultiCare Analyzer
A
B
C
D
E
F
H
I
G
JKL M

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A. Left Button Use it when reviewing the memory or searching the
setting value in the setting mode
B. SET/PRT Button Press to set the analyzer or print the test result
C. Right Button Use it when reviewing the memory or searching the
setting value in the setting mode
D. Enter Button Press to go to the next step in the setting mode
E. Start/Eject Button Press to start a measurement or quit a measurement
and eject the test panel
F. Test Panel Slot Part for inserting a test panel into an analyzer
G. LCD Display Shows test results, messages, and test results
stored in memory
H. Battery
compartment lid
Provides access to the battery compartment
(4 AA 1.5V alkaline batteries)
I. Code-chip slot Location for inserting a code chip
J.
Barcode reader port
Connect to external barcode reader
(If you have a SD BIOSENSOR Barcode Reader)
K. USB cable Port
Connect a PC with a USB cable for the
communication
(Download test results to a PC)
L. Printer port Print test results to external thermal printer
(If you have a STANDARDTM Thermal Printer)
M. AC Jack port Connect power supply adapter 5V/2A.

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Display of MultiCare Analyzer
The symbols in the display have the following meanings:
Indicate the parameter
 HbA1c : HbA1c
 CRP : CRP
 U-ALB : U-Albumin
 Lipid : Lipid Prole
Unit of the glycated
hemoglobin
Indicate the code Indicate the setting mode
Processing Indicates the beep sound
Communication with a PC Printing
Indicate pressing the start
button
Indicate the operating
temperature is out of the
range.
Unit of a test result for all
parameter Indicate the time format
Capacity of batteries Indicate the connection
with adapter
Display;
 ID number
 Date
 Temperature
Estimated average glucose
Control Test
Display;
 Test result
 Hi/Lo message
 Setting value
 Code number
 Index number
 Counting the testing time
Display;
 Time
 Estimated average
glucose value
Indicate the sample type
 WB: whole blood
 S/P: Serum/Plasma
Indicate the clinical
specimen

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5. Power Supply
A 5V/2A AC power adapter or 4 AA alkaline batteries can be used. The
analyzer saves battery power by automatically turning off after 1 minute
without inserting a test panel or from non-use.
When the batteries are dead or the connection between the analyzer and
adapter is failed, the analyzer can still retain the test results stored in the
memory and the setting values except date and time. They will be maintained
until your analyzer turns back on.
When the analyzer turns itself off, all test results obtained so far remain in the
memory. With a set of fresh batteries, you will normally be able to perform at
least 200 measurements. When the battery warning is displayed for the rst
time, approximately 10 measurements can still be performed. In this case,
replace the batteries as soon as possible.
Please respect the environment and dispose of used batteries according to
your local regulations and laws.
CAUTION
If the MultiCare Analyzer is not connected with the AC adapter or does
not have the batteries, the set time of the analyzer will stop. After sup-
plying the power with the AC adapter or batteries, a user should set the
actual time according to the setting steps.
6. Components
Check Strip
This is for checking the malfunction of the optic sensor in the analyzer.

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CHAPTER 2.
Testing the MultiCare Analyzer
1. Operating the Analyzer
Before using the analyzer for the rst time, perform the following steps:
STEP 1. Insert four batteries or connect the AC adapter jack.
STEP 1-1. Insert four batteries
1) Ensure the analyzer is switched off and turn it over.
2) Open the battery compartment lid by slightly pressing the tab towards
the center of the analyzer.
3) Lift the lid upwards to remove it from the analyzer.
4) Insert four batteries into the compartment. Please note the orientation
of the “+” (battery head) and “–” terminals (at end). Use only alkaline
batteries (1.5 V, AA).
NOTE
• If you think the display screen does not appear for long
enough, you can hold down the Enter button (the next time
you switch on the analyzer). The display screen is shown
during the time while the button is pressed.
• After inserting or replacing batteries, conrm that the time
and date are set correctly. If they are not, reset the analyzer
before testing.
NOTE
Always replace all four batteries at the same time, because
the different capacities of batteries cause the analyzer to
malfunction. Do not use rechargeable batteries.
5) Close the battery compartment lid.
6) Turn the analyzer on to test the functionality of the new batteries.
7) Check that the display is functioning correctly to prevent misinterpretations
due to defective display elements.
STEP 1-2. Connect AC Adapter Jack
1) AC adapter is not provided with MultiCare. Power supply adapter
5V/2A must be used.
2) Connect the AC adapter jack to the AC jack port in the back of the analyzer.