BioSensory SD A1cCare User manual
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Thank you for your purchase of SD A1cCare™ analyzer!
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.
If you cannot reach SD Biosensor Customer Care Service, please contact your healthcare
professional or local distributor. You can also visit www.sdbiosensor.com for product
demonstrations. Thank you again for choosing SD A1cCare™ analyzer.
ALL - ROUND HbA1c Test System
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The packaging materials, labels and instruction for use for SD A1cCare™ analyzer may
contain the following symbols or abbreviations which are listed below with their meaning:
* Symbols
Please consult instructions for use.
Caution, consult accompanying documents.
Consult instructions for use.
Manufacturer.
Catalogue number.
Serial number for this analyzer.
This side up.
In vitro diagnostic medical device
This system is intended to use outside the body (in vitro diagnostic use).
Date of manufacture:
To indicate the date of manufacture for this analyzer.
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Batch code:
To indicate the lot number for this system.
Crossed out wheeled bin:
To discard it separately from other household waste.
Contains Sucient for <n> Tests.
To indicate that the product is fragile and you need to handle it with care.
Symbol for“KEEP DRY”
To indicate the temperature limitations in which the transport package
has to be kept and handled.
This product fulfills the requirements of Directive 98/79/EC on in vitro
diagnostic medical devices.
Use by / Expiry date.
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Contents
CHAPTER 1. Understanding Your New Analyzer 10
1. Indication for Use; Purpose of the analyzer 10
2. Test principle 10
3. Before You Start Testing 11
4. SD A1cCare™ analyzer 12
5. Power supply 16
6. SD A1cCare™ Test kit 17
7. SD A1cCare™ Accessories 18
CHAPTER 2. Testing SD A1cCareTM Analyzer 20
1. Operating the analyzer 20
2. Preparing a measurement 32
3. Performing HbA1c Test 35
CHAPTER 3. Using the Analyzer Memory 42
1. Memory Map 42
2. Displaying stored measured values 42
3. Delete Memory 44
CHAPTER 4. Printing 45
CHAPTER 5. Data transfer 46
CHAPTER 6. Control Solution Test 46
1. Control Solution Test 46
2. Control Solution Test for HbA1c 47
3. Troubleshooting control solution 48
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CHAPTER 7. Performing Check Strip Test 49
1. How to Use SD HbA1c Check Strip 49
CHAPTER 8. Maintenance and Troubleshooting 51
1. Cleaning your Analyzer 51
2. Maintenance, Testing and Transportation 52
CHAPTER 8. Screen Messages and Troubleshooting 54
1. Warning messages 54
2. Error messages 54
CHAPTER 9. Warnings, Precautions and Limitations 57
1. Test Kit for HbA1c 57
CHAPTER 10. Product Technical Information 59
1. Analyzer Specications 59
2. Test kit for HbA1c 59
3. Electromagnetic Compatibility 59
Annex 1: Information for Healthcare Professionals 60
Annex 2: References 60
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Abbreviations
HbA1c Hemoglobin A1c
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CHAPTER 1. Understanding Your New Analyzer
1. Indication for Use; Purpose of the analyzer
SD A1cCare™ analyzer work to measure the quantitative measurement of the
glycohemoglobin(HbA1c) in the blood. The analyzer is indicated for monitoring the blood
parameter in fresh capillary or venous whole blood. SD A1cCare™ analyzer should be used
with SD A1cCare™ test kit. Testing is done outside the body (in vitro diagnostic use). This
analyzer is indicated in clinical settings by healthcare professionals.
2. Test principle
SD A1cCare™ System is based on a reflectometry and immunoassay technology. SD
A1cCare™ Test kit uses an anti-HbA1c(%) antibody which is specic for the rst few amino
acid residues of the glycated N-terminus of the β-chain of hemoglobin A0. SD A1cCare™
Test Kit contains the test panel, latex-tablet and buffer solution. The buffer solution is
instantly lysed to release the glycated hemoglobin(HbA1c) and the latex-tablet included
the blue dyed latexmicroparticles conjugated to specific antibodies. When whole blood
is added to the buffer solution and is mixed with the latex-tablet, the erythrocytes are
instantly lysed to release the glycated hemoglobin (HbA1c).
When sample mixture is loaded onto the sample port of the Test panel, the mixture uid
migrates along the membrane of Test panel by capillary action and then HbA1c has been
immobilized onto the anti-HbA1c antibody coated line. The amount of the blue conjugates
on the anti-HbA1c line reflects the amount of HbA1c in the sample. For measuring of
total hemoglobin in the sample, the intensity of the hemoglobin color measured from the
desired area on the membrane of test panel is measured. Chemical and immuno reaction
that occurs on the test panel are measured by optical system in SD A1cCare™ Analyzer.
SD A1cCare™ analyzer measures both fractions and an algorithm converts the result into
the percentage HbA1c in the sample.
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3. Before You Start Testing
Samples
HbA1c
SD A1cCare™ analyzer for HbA1c testing is designed for monitoring fresh capillary or
venous whole blood. Do not use the frozen blood or the articial materials not allowed.
Safety Information
There is a potential risk of infection. We recommend that healthcare professionals using
SD A1cCare™ analyzer to perform measurements for more than one patient use gloves and
follow all other locally applicable health and safety regulations.
Operating conditions
To ensure proper function of SD A1cCare™ analyzer, observe the following guidelines:
t SD A1cCare™ analyzer is only for
in-vitro
diagnostic use.
t Operate the analyzer only within the acceptable temperature range. This temperature
range is test-dependent at 15-32°C (59-89°F).
t In order to perform a measurement, place the analyzer on a level surface or hold it in
your hand.
t Strong electromagnetic elds may impair the function of the analyzer. Do not use the
analyzer close to sources of strong electromagnetic radiation.
t The analyzer's air vents must be free for air (Do not cover the air vents).
t If the analyzer cause a sudden malfunction, unplug the AC adapter from the outlet.
Carefully read and follow the instructions in the User Instruction Guide and Package Insert
for the test kits and control solutions. It is very important to follow the instructions in
order to prevent an incorrect result or improper treatment.
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4. SD A1cCare™ Analyzer
Cat.No. 03HA10
Analyzer SD A1cCare™ Analyzer
Check Strip SD HbA1c Check Strip
Battery Four batteries (1.5V, AA)
AC Power supply Input: AC100~240V, 50/60Hz (Voltage tolerance ±10%)
Output: 5V/2A
Power consumption Max 2W
Over Voltage Category ǥ
Pollution Degree ǥ
Table of contents
