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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CHAPTER 2. USING THE SD LIPIDOCARE PROFESSIONAL ANAL
YZER
1. Changing the batteries
Before using the Analyzer for the first time, perform the following steps:
1) Ensure the analyzer is switched off, and turn it over.
2) Open the battery compartment lid by slightly pressing the tab toward the center of
the analyzer.
3) Lift the lid upward to remove it from the analyzer.
4) Insert four batteries into the compartment. Please note the orientation of the"+"
(battery head) and “-“ terminals (flat end). Use only alkaline manganese batteries (1.5
V, AAA).
5) Close the battery compartment lid.
6) Turn the analyzer on to test the functionality of the new batteries.
7) Check to ensure that the display is functioning correctly to prevent misinterpretations
due to defective display elements.
NOTE:
•After inserting or replacing the batteries, confirm that the time and date are set correctly.
If they are incorrect, reset the analyzer before using.
•Always replace all four batteries at the same time. Do not use rechargeable batteries.
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2. Setting the analyzer
The following table provides an overview of the available settings.
Stage
Setting
Options
Default Setting
1
Beep
On, Off
On
2
Year
YYYY
2015
3
Date Format
m-d, d-m
m-d
4
Date
mm-dd, dd-mm
1- 1
5
Time Format
12h, 24h
12h
6
Time
hh:mm
12:00 AM
7
Units of the Test Result
mg/dL, mmol/L
mg/dL
8
Auto Printing
On, Off
On
9
Printing Page
P-1, P-2
P-1
10
Hypo warning (for glucose)
Off, 60,70,80
Off
11
Alarm
Off, 4 Alarms
Off
12
Bluetooth (PC)*
On, Off
Off
13
Bluetooth (Printer)*
On, Off
Off
14
Bluetooth Repairing(Printer) *
On, Off
Off
* These functions are only for the 02LA20G with Bluetooth module.
STAGE 0) Entering the setting mode
1) Press the SET/PRT button (on the top of the analyzer) for three seconds to enter the setting
mode after turning the analyzer on or in the standby state. If you want to leave the setting
mode during any of the steps, press the SET/PRT button quickly.
2) Press the left or right button to change the current flashing setting. You can press the left or
right button as many times as needed (or keep it pressed) until the desired setting (value) is
reached.
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3) Press the ON/OFF button to store the selected setting and go to the next setting. If you
want to quit the setting stage, press the SET/PRT button.
4) If the settings are completed, the analyzer will be automatically turned off.
CAUTION
You can only move forward through the settings. Corrections can only be made by
repeating the settings. The setting procedure can be terminated at any time by pressing the
SET/PRT button.
Stage 1) Setting – Beep
In the 1st stage, you can set the beep function.
1) If you enter the setting mode, the first step of the setting mode will appear.
2) Turn the beep sound on or off by pressing either the left or right button and then save the
preferred feature by pressing the ON/OFF button. If you select the
beep sound on feature, a
“beep” sound will be made at the same time. Otherwise, if you select the
beep off feature,
no sound will be made.
Stage 2) Setting – Year
In the 2nd stage, you can set the year. After setting the beep, the display for setting the year
will appear. Select the correct year by pressing the left or right button, and then save it by
pressing the ON/OFF button.
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Stage 3) Setting – Date Format
In the 3rd stage, you can set the date format.
1) The analyzer can display the month and day in either Month-Day (m-d) format or Day-
Month (d-m) format. Select the preferred format by pressing either the left or right button,
and then save it by pressing the ON/OFF button.
Stage 4) Setting – Date
In the 4th stage, you can set the date.
1) After setting the date format, select the actual date by pressing either the left or right
button, and then save it by pressing the ON/OFF button.
Stage 5) Setting – Time Format
In the 5th stage, you can set the time format.
1) The analyzer can display the time in either the 12h format or the 24h format. Select the
preferred format by pressing either the left or right button, and then save it by pressing the
ON/OFF button.
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Stage 6) Setting – Time
In the 6th stage, you can set the time, the current hour, and the minutes. Select the hour and
minute by pressing either the left or right button and then save them by pressing the ON/OFF
button.
a) 12h Format:
Sub-step 1) Set AM or PM.
Sub-step 2) Set hour (1 to 12).
Sub-step 3) Set minute (1 to 59).
b) 24h Format:
Sub-step 1) Set hour (1 to 24).
Sub-step 2) Set minute (1 to 59).
Stage 7) Setting – Unit of the Test Result
In the 7th stage, you can set the units for the test results.
1) The unit of the test result stage will appear.
2) You can select the preferred units by pressing the left or right button, and then
you can save your selection by pressing the ON/OFF button.
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Stage 8) Setting – Auto Printing
In the 8th stage, you can set the auto printing function.
1) Following the test unit setting, the display for the auto printing function will appear.
2) Turn the auto printing function on or off by pressing either the left or right button, and then
save your selection by pressing the ON/OFF button.
NOTE:
The Auto Printing function allows a person to print the results automatically, right after
testing.
Stage 9) Setting – Simplex/Duplex Printing
In the 9th stage, you can set either single-sided or double-sided printing options.
1) After the auto printing function is set, the display for setting single-sided or double-sided
printing will appear.
2) Set the preferred feature by pressing the left or right button, and then save it by pressing
the ON/OFF button.
NOTE:
If you select the P-1, it will be set to print the test results in simplex (on one side of paper).
If you select the P-2, it will be set to print the test results in duplex (on both sides of the
paper).
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Stage 10) Setting – Hypo warning for glucose
In the 10th stage, you can set the hypo warning function for the glucose testing only.
1) After the printing setting, the display for setting the hypo warning will appear.
2) You can turn the hypo warning off or select the hypo level as 60, 70, or 80 mg/dL by
pressing the left or right button. Then save it by pressing the ON/OFF button.
NOTE:
•Please consult your healthcare provider for an appropriate hypo level, from among 60,
70, or 80mg/dL, to be set for you.
•If your glucose results are lower than a selected hypo result, the hypo symbol will
appear on the screen with a beep
sound. It is very important to manage your
hypoglycemia. Contact your healthcare provider immediately.
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Stage 11) Setting – Alarm
In the 11th stage, you can set up to four alarms to remind yourself to do a glucose test.
1) After the hypo warning setting, the display for setting the alarm will appear.
2) Turn the first alarm on or off by pressing the left or right button, and then save it by
pressing the ON/OFF button. If you select
Off , the analyzer will automatically turn off. For
the model 02LA20G, additional setting stages remain. Please refer to the next page for the
additional setting steps.
3) If you select ON for the first alarm, the clock icon will blink. Select the desired time for the
alarm by pressing the left or right button, and then save it by pressing the ON/OFF button.
4) Next, the second alarm setting mode will appear. Set the second alarm by following steps 2
and 3 above.
5) You can set the third and the fourth alarm modes in the same way, by following steps 2 and
3 above.
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Stage 12) Setting – Bluetooth with PC, only for 02LA20G
In the 12th stage, you can set the Bluetooth communication with your PC or smartphone. If the
analyzer is paired with the PC or smartphone, the test results are transferred automatically, via
Bluetooth.
1) After the alarm setting, the Bluetooth setting will appear on the screen.
2) Turn it on or off by pressing the left or right button, and then save it by pressing the
ON/OFF button.
Stage 13) Setting – Bluetooth with Printer, only for 02LA20G
In the 14th stage, you can set the Bluetooth communication with a printer.
1) After setting the Bluetooth with a PC, the Bluetooth and printer icons will appear on the
screen.
2) Turn the selection on or off by pressing the left or right button, and then save it by pressing
the ON/OFF button.
NOTE: If you set both auto-printing and Bluetooth with printer to ON, you can get the test
results printed automatically, via the Bluetooth communication.
Stage 14) Setting – Repairing the Printer, only for 02LA20G
In the 14th stage, you can set the analyzer to be automatically paired with the previous paired
printer, whenever the printer is near the analyzer.
1) After the Bluetooth with printer setting, the repairing setting will appear on the screen.
2) Turn it on or off by pressing the left or right button, and then save it by pressing the
ON/OFF button.
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STEP 4. Insert a code chip
For measuring cholesterol (Lipid)
Coding
The code chip is included in the test strip package. The code chip provides the analyzer with
important information on the production-specific properties of the SD LipidoCare Professional
Lipid Profile Test Strip in order to measure your results accurately. Before you use the SD
LipidoCare Professional Analyzer with a new test strip for the first time, you should check that
the code numbers on the analyzer and the test kit are the same.
Code Setting
1) Make sure that the analyzer is turned off. Remove the old (or inserted) code chip from the
analyzer.
2) Insert a new code chip until it snaps into place. Then turn the analyzer on.
3) The 3-digit code number of the inserted code chip will appear with a flashing lipid test strip
symbol. This number must match the information provided in the lipid test strip package or
pouch. If it doesn’t match, repeat steps 1 and 2 above.
For measuring glucose
The blood glucose testing requires no coding. Therefore, a code chip is not needed for glucose
testing.
CAUTION:
The SD LipidoCare Professional
Lipid test strip
package includes a code chip with test strips.
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