SD Biosensor SD LipidoCare User manual

TABLE OF CONTENTS
CHAPTER 1. UNDERSTANDING THE NEW ANALYZER....................................... 4
1. Indication for use; purpose of the analyzer.................................................................................. 4
2. Test principle............................................................................................................................................... 5
3. Before you start a test............................................................................................................................ 6
4. The SD LipidoCare Professional Analyzer....................................................................................... 7
5. Power supply............................................................................................................................................10
6. Test strips...................................................................................................................................................10
CHAPTER 2. USING THE SD LIPIDOCARE PROFESSIONAL ANALYZER ........... 11
1. Changing the batteries.........................................................................................................................11
2. Setting the analyzer...............................................................................................................................12
3. Pairing, only for 02LA20G....................................................................................................................21
4. Analyzer Memory....................................................................................................................................23
5. Reviewing stored test results.............................................................................................................24
6. Displaying the average of glucose test results...........................................................................26
7. Deleting test data...................................................................................................................................27
8. Printing........................................................................................................................................................28
CHAPTER 3. COLLECTING BLOOD SAMPLES .................................................. 29
1. Getting a blood sample from fingersticks.....................................................................................29
2. Getting a blood sample from alternative sites............................................................................30
CHAPTER 4. PERFORMING A TEST FOR LIPID OR GLUCOSE.......................... 32
1. Before testing for lipid or glucose....................................................................................................32
2. Test Procedure for cholesterol (lipid) only ...................................................................................33
3. Procedure for glucose...........................................................................................................................36
4. Understanding Your Results...............................................................................................................37
CHAPTER 5. CONTROL SOLUTION TEST ........................................................ 40
1. Control Solution Test.............................................................................................................................40
2. Procedure for the lipid control solution.........................................................................................41
3. Procedure for the glucose control solution..................................................................................42
4. Troubleshooting the control solution..............................................................................................43
CHAPTER 6. CHECK STRIP TEST.................................................................... 44
1. Check Strip Test......................................................................................................................................44
2. When to use the Lipid and Glucose check strip.........................................................................44
3. How to Use the SD Lipid Check Strip.............................................................................................44
4. How to use the SD Glucose check strip........................................................................................45
CHAPTER 7. MAINTENANCE AND TROUBLESHOOTING.................................. 46
1. Cleaning and Disinfection....................................................................................................................46
2. Maintenance, Testing, and Transportation..................................................................................49
CHAPTER 8. SCREEN MESSAGE AND TROUBLESHOOTING ....................... 50
1. Warning message...................................................................................................................................50
2. Error message..........................................................................................................................................51
CHAPTER 9. WARNINGS, PRECAUTIONS, AND LIMITATIONS ..................... 53
1. Test Strip for Lipid..................................................................................................................................53
2. Test Strip for Glucose...........................................................................................................................53
CHAPTER 10. TECHNICAL INFORMATION................................................... 54
1. Analyzer Specifications.........................................................................................................................54
2. Test Strips..................................................................................................................................................54
Appendix 1: References ................................................................................... 55
Appendix 2: Warning ....................................................................................... 56
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Important Safety Instructions
Before using the SD LipidoCare Professional Analyzer, please read the following information.
Important Safety Instructions
The lancing device are for single patient use. Do not share them with anyone including other
family members! Do not use on multiple patients!
All parts of the kit are considered biohazardous and can potentially transmit infectious diseases,
even after you have performed cleaning and disinfection.
The Food and Drug Administration and the Center for Disease Control have issued warnings and
notifications regarding the risk of bloodborne pathogen transmission when more than one
individual uses a blood glucose monitoring system. For important instructions for disinfecting your
meter and lancing device, please read the following references:
•U.S. Food and Drug Administration. FDA Public Health Notification: Use of Fingerstick Devices
on More Than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial
Communication. (2010).
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm
•Centers for Disease Control and Prevention. CDC Clinical Reminder: Use of Fingerstick Devices
on More than One Person Poses Risk for Transmitting Blood Borne Pathogens. (2010).
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
Special Information for Healthcare Providers and Caregivers
•Do not use this analyzer to measure the cholesterol and glucose in people who are
experiencing cardiovascular collapse (severe shock) or decreased peripheral blood flow.
•Hematocrit: Extremes in hematocrit may affect test results. The following hematocrit ranges for
each parameter will not affect the accuracy of the measurements:
-TC, TG: 30 – 55%
-HDL: 30 – 52%
-Glucose: 20 – 60%
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CHAPTER 1. UNDERSTANDING THE NEW ANALYZER
1. Indication for use; purpose of the analyzer
The SD LipidoCare Professional Analyzer is intended to be used by individuals in the
Professional to measure total cholesterol (TC), triglycerides (TG), HDL cholesterol (HDL), and
glucose in capillary whole blood with the SD LipidoCare Professional Lipid Profile Test Strips and
SD LipidoCare Professional Blood Glucose Test Strips; it is also intended to calculate low density
lipoprotein (LDL), the LDL/HDL ratio, and non-HDL. This analyzer is to be used outside the
body (in vitro diagnostic).
The SD LipidoCare Professional Lipid Profile Test Strips are intended to be used by medical
professionals to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in
capillary whole blood and venous blood on an SD LipidoCare Professional Analyzer. Cholesterol
measurements are used in the diagnosis and treatment of disorders involving excess cholesterol
in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used
in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis,
and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and
treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases
involving lipid metabolism, or various endocrine disorders. Calculated LDL-cholesterol values are
reported only when triglycerides are ≤400mg/dL; when triglycerides are >400 mg/dL, the
calculated LDL-cholesterol and LDL/HDL (LDL-cholesterol and HDL-cholesterol ratio) are not
reported.
The SD LipidoCare Professional Blood Glucose Test Strips are intended to be used by medical
professionals to measure glucose in capillary whole blood on an SD LipidoCare Professional
Analyzer. Glucose measurement is for the quantitative measurement of the concentration of
glucose in capillary whole blood that can be taken from the fingertip, palm, upper arm, and/or
forearm as an aid in the management of diabetes. Glucose measurement is not to be used for
the diagnosis of or screening for diabetes or neonatal use. Alternate site testing should be done
during steady-state times, when glucose is not changing rapidly.
The SD Lipid Control Solution and SD Glucose Control Solution are used as quality control
materials for the SD LipidoCare Professional System.
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2. Test principle
LIPID
The SD LipidoCare Professional System combines enzymatic methodology and solid-phase
technology to measure total cholesterol (TC), HDL cholesterol (HDL), and triglycerides (TG).
Blood sample used for testing is whole blood from a fingerstick. The sample is applied to an SD
LipidoCare Professional Test Strip. The test strip is then placed into the SD LipidoCare
Professional Analyzer, where a unique system on the test strip separates the plasma from the
blood cells. A portion of the sample flows to the bottom layer of the test strip and is transferred
to the total cholesterol, triglyceride, and HDL cholesterol (HDL) reaction pads. The SD
LipidoCare Professional Analyzer measures TC, TG, and HDL by an enzymatic method based on
the method formulation of Allain et al.6and Roeschlau.7To measure TC, TG, and HDL in the
blood, the following formulations are used:
GLUCOSE
The SD LipidoCare Professional Blood Glucose test strip is designed with an electrode that
measures glucose levels. Glucose in the blood mixes with the reagent on the test strip and
causes a small electric current. The amount of current created depends on how much glucose
is in the blood. The SD LipidoCare Professional Analyzer measures the current created and
converts it to the amount of glucose. The blood glucose result is displayed on the LCD display.
Once a drop of blood touches the tip of the glucose test strip, the strip's reaction chamber
automatically draws the blood into the strip through capillary action. When the chamber is full,
the SD LipidoCare Professional Analyzer starts to measure the blood glucose level.
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3. Before you start a test
CAUTION
Carefully read and follow the instructions and package inserts for the lipid/glucose test strips
and control solutions. It is very important to follow the instructions in order to prevent an
incorrect result or improper treatment.
Samples
For measuring lipid (cholesterol)
The SD LipidoCare Professional Analyzer for lipid testing is designed for testing a fresh capillary
whole blood sample from the fingertip.
For measuring glucose
The SD LipidoCare Professional Analyzer for glucose is designed for testing a fresh capillary
whole blood sample from the fingertip, palm, upper arm, or forearm.
Refer to the Safety Information
There is a potential risk of infection. To clean and disinfect this analyzer, please refer to the
Chapter 6 Maintenance and Troubleshooting section.
Operating conditions
To ensure proper function of the SD LipidoCare Analyzer, observe the following guidelines:
Operate the analyzer within the acceptable temperature and the humidity range. This
range is test-dependent:
For Lipid Testing : 64–90°F (18–32°C), 10–90%RH
For Glucose Testing: 50–113°F (10–45°C), 10–90%RH
To perform a measurement, place the analyzer on a level surface or hold it in your
hand.
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4. The SD LipidoCare Professional Analyzer
The Analyzer package includes following:
SD LipidoCare Professional Analyzer
SD Lipid Check Strip
SD Glucose Check Strip
User Manual
Quick Guide
4 AAA 1.5 V batteries
NOTE:
The SD LipidoCare Professional Lipid Profile Test Strips, SD LipidoCare Professional Blood
Glucose Test Strips, SD Lipid Control Solution, and SD Glucose Control Solution are required,
but not included, and must be purchased separately.
If you want to purchase these products, please contact our customer service center at 855-
486-2888.
Appearance
A Display Shows a test result, messages, and stored values in the memory
B Arrow Buttons Used for setting and review of the memory
C On/Off Button Press to turn Analyzer on or off
D
Lipid Test Strip
Slot
Insert a lipid test strip here
E Door Block the light for an accurate test result
F
Glucose Test Strip
Slot
Insert a glucose test strip here.
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G
Battery
compartment lid Provides access to the battery compartment (4 AAA 1.5 V alkaline batteries)
H Codechip slot Insert a codechip for lipid testing
I Optic cover Holds the inserted test strip to prevent the
movement of the test strip
when you are testing
J Data port Download test results to a personal computer
K Printer port Print test results on an external thermal printer
L SET/PRT Button Press to set the analyzer or print the test results
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Display of the SD LipidoCare Professional Analyzer
The symbols in the display have the following meanings:
Indicate
s a codechip sign Warning when the battery is low
Indicate
s printing Indicates the index number of the
memory
Codechip number or memory
number stored in
the memory
Appears during setting mode
Indicate
s measurement being
performed
Indicates beep sound setting
Indicate
s the operating
temperature
is out of the range Indicates Lipid Profile test strip
O
pen or close the flap Units of test results
Test Result
Indicates
a test result stored in the
memory (all parameters)
Indicate
s the days of the
calculated average result
Indicates alarm setting
Indicate
s application of the sample
Indicates a control solution test result
Glucose test strip
Date
Indicate
s an expired test strip
Lipid test strip
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Indicate
s the testing time Low Density Lipoprotein
Total Cholesterol
Triglycerides
High Density Lipoprotein
Glucose
LDL
to HDL ratio
non-HDL
5. Power supply
To save power, the analyzer turns itself off after 5 minutes, unless a button is pressed or a new
test strip is inserted. When the analyzer turns itself off, all test results are stored in the memory.
Battery life is expected to last for approximately 1,000 measurements. When the battery
warning is displayed for the first time, approximately 50 measurements can still be performed.
In this case, replace the batteries as soon as possible. When replacing the new batteries, you
must reset the date and time. Use only AAA alkaline manganese batteries. The stored test
results, including the testing date and time as well as all other analyzer settings, will remain,
even when no batteries are inserted. Do not throw batteries into a fire. There is a risk of
explosion!
6. Test strips
SD LipidoCare Professional Lipid Profile Test
Strip
SD LipidoCare Professional Blood
GlucoseTest Strip
Lipid Check Strip
Glucose Check Strip
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