Thank you for your purchase of the STANDARD LipidoCare Analyzer!

This User Manual contains all of the information needed to use the
Analyzer. Please read this User Manual carefully before using the
Analyzer. Familiarize yourself with the required preparations and the
measurement procedure before performing the first measurement.
Also read the package insert of the lipid test strips 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 the STANDARD LipidoCare Analyzer. 

1
 Abbreviations
TC Total Cholesterol
TG Triglycerides
HDL High Density Lipoprotein cholesterol
LDL Low Density Lipoprotein cholesterol

The packaging materials, labels and instruction of use for STANDARD LipidoCare Analyzer may
contain the following symbols or abbreviations which are listed below with their meaning:

Please consult instructions

Batch code
for use

Caution, consult accompanying To discard it separately from

documents other household waste

To indicate the temperature limitations in

Consult instructions for use which the transport package has to be
kept and handled

In Vitro diagnostic use Use by / Expiry date

EC REP
Authorized Representative in the
Manufacturer EC REP
European Community
EC REP
EC REP
EC REP
Reference number EC REP Contains Sufficient for <n> Tests

Date of manufacture Serial number of the analyzer

Do not reuse

2
CONTENTS
CHAPTER 1. Understanding Your New Analyzer 4
1. Indication for Use; Purpose of the Analyzer 4
2. Test principle 4
3. Before You Start Testing 4
4. The STANDARD LipidoCare Analyzer 5
5. Power supply 7
6. Test Strips 7
7. Accessories 8
CHAPTER 2. Testing the STANDARD LipidoCare Analyzer 8
1. Operating the Analyzer 8
2. Preparing for measurement 15
3. Running a test - Lipid 18
4. Running a test - Glucose 20
5. Running a test - Lipid/Glucose 21
6. Understanding Your Results 22
CHAPTER 3. Using the Analyzer Memory 24
1. Analyzer Memory 24
2. Displaying stored measured values 25
3. Displaying Glucose Averages 27
4. Delete Memory 28
CHAPTER 4. Printing 28
CHAPTER 5. Data transfer 29
CHAPTER 6. Bluetooth communication 29
1. Data Trasfer 29
2. Technical Information 30
CHAPTER 7. Control Solution Test 31
1. Control Solution Test 31
2. Control Solution Test for Lipid 31
3. Control Solution Test for Glucose 32
4. Troubleshooting control solution 33
CHAPTER 8. Check Strip Test 33
1. How to Use a Lipid Check Strip 33
2. How to Use a STANDARD Glucose Check Strip 34
CHAPTER 9. Maintenance and Troubleshooting 34
1. Cleaning your Analyzer 34
2. Maintenance, Testing and Transportation 36
CHAPTER 10. Screen Messages and Troubleshooting 36
1. Warning message 36
2. Error message 37
CHAPTER 11. Warnings, Precautions and Limitations 40
1. Test Strip for Lipid 40
2. Test Strip for Glucose 40
CHAPTER 12. Product Technical Information 40
1. Analyzer Specifications 40
2. Test strip for Lipid 41
3. Test strip for Glucose 41
4. Electromagnetic Compatibility 41
Appendix 1: Information for Healthcare Professionals 42
Appendix 2: References 42

3
 CHAPTER 1. Understanding New Analyzer
1. Indication for Use; Purpose of the Analyzer
The STANDARD LipidoCare Analyzer is designed to measure the quantitative measurement of the blood parameters: Total Cholesterol(‘TC’), Triglycerides(‘TG’),
High-Density Lipoprotein Cholesterol(‘HDL’), calculated ‘LDL’, ‘LDL/HDL’, ‘non-HDL’ and glucose. This system is intended for in vitro diagnostic use to test fresh
capillary whole blood, venous whole blood plasma or serum. The STANDARD LipidoCare Lipid Test system should be only used with the STANDARD LipidoCare
Lipid Test Strip and either the STANDARD LipidoCare Blood Glucose Test Strip or the SD Codefree Blood Glucose Test strip. The system is suitable for professional
use as well as for self-testing, and is a valuable tool in monitoring diabetes and cholesterol levels, but it is not intended to diagnose diabetes or cholesterol-
related cases.

2. Test principle
LIPID
By means of a codechip, the Analyzer reads the lot-specific characteristics of the lipid test strips currently in use. Then an unused test strip is inserted into the
Analyzer. While inserted, the application area of the test strip is illuminated by an LED (light-emitting diode) from below. Before the actual measurement is
performed, the reflection behaviour of the test strip is determined by means of the light which is reflected (from the application area). The blood sample is then
applied to the application area and the measurement chamber flap is closed. The constituent to be determined in the applied sample undergoes an enzymatic
reaction with formation of a dye. The amount of dye formed increases with the concentration of the substance to be determined. After a certain period of time,
the colour intensity is measured by illuminating the application area again from below using the LED. The intensity of the reflected light is measured with a
detector (reflectance photometry). The measured value is determined from the signal strength of the reflected light, with the previously measured blank value
and the read lot-specific information (codechip) also being considered. Finally, the result is displayed and simultaneously stored in the memory.
GLUCOSE
The glucose test strip is designed with an electrode that measures glucose levels. Glucose in the blood sample mixes with reagent on the test strip that causes
a small electric current. The amount of current that is created depends on how much glucose is in the blood. The STANDARD LipidoCare Analyzer measures the
current that is created and converts the measurement to the amount of glucose that is in the blood. The blood glucose result is displayed on the LCD display. By
touching a drop of blood to 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 STANDARD LipidoCare Analyzer starts to measure the blood glucose level.

3. Before You Start Testing

Carefully read and follow the instructions in the measuring and package inserts for the lipid test strips and control solutions. It is very
important to follow the instructions in order to prevent an incorrect result or improper treatment.

Samples
Lipid
The STANDARD LipidoCare Analyzer for lipid testing is designed for measuring fresh capillary whole blood or venous blood (venous whole blood, serum or
plasma) sample.
* Professional use only for venous blood.

Glucose
The STANDARD LipidoCare Analyzer for glucose is designed for testing fresh capillary whole blood samples (for example, blood from your fingertip, palm, upper
arm, or forearm). Do not use the STANDARD LipidoCare Analyzer for glucose of serum or plasma or arterial, venous whole blood.

Refer to the Safety Information

There is a potential risk of infection. We recommend that healthcare professionals using the STANDARD LipidoCare 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 your STANDARD LipidoCare Analyzer, observe the following guidelines:
• Operate the analyzer only with the acceptable environmental conditions; temperature: 5°C to 45°C, humidity: maximum relative humidity 80 % for
4
 temperatures up to 31°C decreasing linearly to 39% relative humidity at 45°C, altitude: up to 3,776m.
• In order to perform a measurement, place the Analyzer on a level surface or hold it in your hand.
• Strong electromagnetic fields may impair the function of the Analyzer. Do not use the Analyzer close to sources of strong electromagnetic radiation.

4. The STANDARD LipidoCare Analyzer

The Analyzer includes:
* STANDARD LipidoCare Analyzer
* STANDARD Lipid Check Strip
* STANDARD Glucose Check Strip
* User Manual
* Quick Guide
* 4 AAA 1.5 V batteries

STANDARD LipidoCare Analyzer

Display Shows a test result, messages, and the test
F A
results stored in memory.

Arrow Buttons
A B Used for setup and review of memory moving to the
right and left.
B
ON/OFF Button Press to turn Analyzer ON or
C
OFF.

D Lipid test strip slot Insert a lipid test strip here.

C
E E Measurement chamber flap Open to apply sample.
Glucose Test Strip Slot Insert a glucose test strip
D F
here.

Battery compartment lid

G Provide access to the battery compartment (4 AAA 1.5
V alkaline manganese batteries).
L
Codechip Slot
G H
Insert a codechip for lipid test strip.
J K
Measurement chamber cover
I
You can remove this cover to clean the test strip guide.
I Data port
H J Download test results to a personal computer if you
have the software. (SD LMS)
Printer port
K
Print test results to external thermal printer.
SET/PRT Button
L
Press to set the Analyzer or print the test result.

5
 Display of STANDARD LipidoCare Analyzer

SE BL

The symbols in the display have the following meaning.

Indicate Codechip sign Warning when the battery is low or must be replaced

Indicate printing Indicate index number of memory

Codechip number or memory number stored in

Indicate during the analyzer setting
memory

Indicate blood checking Indicate beep setting

Indicate if environmental
Indicate the Lipid Profile and TC·HDL strip
temperature is exceeded during testing

Indicate open or close flap Unit of the test result

Indicate a test result stored in memory (Single parameter

Test result
mode)

Indicate the average result Indicate a test result stored in memory (All parameter mode)

Indicate the blood sample type.

Indicate a control
SE
SE BL
BL SE BL
BL: Capillary or Venous whole blood
SE BL solution test result
SE BL
SE SE: Serum or plasma SE BL
SE BL SE BL
SE BL
SE BL
SE BL Indicate blood checking
SESE BL
BL
Indicate beep setting

SE BL SE
SE BL
BL
6 SE BL
SE BL
 Glucose test strip Lipid test strip

Indicate if the lipid test strip is exceeded the Date

expiration date Indicate the Bluetooth ('bt') only for 02LA20G

Indicate Measurement time Indicate Triglycerides

Indicate Total cholesterol Indicate LDL cholesterol

Indicate HDL cholesterol Indicate non-HDL cholesterol

SE BL
SE BL
SE BL Indicate glucose Indicate LDL/HDL
E BL
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 obtained so far remain in the memory. Battery life is expected at approximately 1000 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 re-enter the date and time. Use only AAA alkaline manganese batteries.
Measurement results including the related measurement date and time as well as all other Analyzer settings, remain stored even when no batteries are inserted.
Please respect the environment and dispose of used batteries according to your local regulations and laws.
Do not throw batteries onto an open fire. There is a risk of explosion.

6. Test Strips
- Lipid strip -
Item Lipid Profile TC TG
Color Blue Red Yellow

Glucose strip Lipid Check Strip Glucose Check Strip

Glucose

Arming Knob Electrode

7
 7. Accessories
Optional Accessories
STANDARD Micropipette 35µl
STANDARD Micropipette 10µl
STANDARD Ezi Tube+ 35µl
STANDARD Ezi Tube+ 10µl
STANDARD Lancets (30G)
STANDARD Lancing Device
STANDARD Safety Lancets (23G)
STANDARD Alchol Swab
STANDARD Thermal Printer (model: MPT-700)
STANDARD Thermal Printer (model: SPP-R200)
STANDARD Thermal Printer Cable
STANDARD Thermal Printer Paper (Nomal type)
STANDARD Thermal Printer Paper (Label type)
STANDARD Lipid Manegement Software
Universal Mini USB Cable

CHAPTER 2. Testing the STANDARD LipidoCare Analyzer

1. Operating the Analyzer
Before using the Analyzer for the first time, perform the following steps:

STEP 1. Insert 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 centre of the Analyzer.
3. Lift the lid upwards to remove it from the Analyzer.

4. Insert four batteries into the compartment according to the illustrations. Please note the orientation of the “+” (battery head) and “–” terminals (flat
end). Use only alkaline manganese batteries (1.5 V, AAA).

8
5. Close the battery compartment lid.
6. Turn the Analyzer on to test the function of the new batteries.
7. Check the display is functioning correctly to prevent misinterpretations due to defective display elements.

• If you think the display screen does not appear for long enough, you can hold down the button (the next time you switch
on the Analyzer). The display screen is then shown for the time the button is pressed.
• After inserting or replacing batteries, confirm that the time and date are set correctly. If they are not, reset the Analyzer before
testing.
• Always replace all four batteries at the same time because batteries with different capacities may impair the function of the
Analyzer. Do not use rechargeable batteries.

STEP 2. Set the Analyzer

Brief overview of the Analyzer settings

The following table provides an overview of the available settings.
Stage Setting Options
1 Beep On, Off
2 Year YYYY
3 Date Format m-d, d-m
4 Date mm-dd, dd-mm
5 Time Format 12h, 24h
6 Time hh:mm
7 Sample. Type (for Lipid) SE, BL
8 Unit of the Test Result mg/dL, mmol/L
9 Auto Printing On, Off
10 Printing Page P-1, P-2
11 Hypo warning (for glucose) Off, 60, 70, 80
12 Alarm Off, 4 Alarms
13 Bluetooth with PC* On, Off
14 Bluetooth with Printer* On, Off
15 Repairing Printer* On, Off
* Only for 02LA20G
Stage 0) Entering set mode
1. Turn on the meter and then press and hold the ( ) button (on the
top side of the Analyzer) for 3 seconds to enter set mode. If you want to leave the
set mode, press the ( ) button.

2. Press the or button to change the currently flashing setting. You can
press the or button as many times as needed (or keep it pressed) until
the desired setting (value) is reached.

9
 3. Press the button again to confirm (store) the current setting and go to the
next setting.

You can only move forward through the settings. Returning to the previous setting is not allowed. Corrections can only be made by repeating
the settings. The setting procedure can be terminated at any time by pressing the ( ) button. The settings made up to that
point will be stored.

4. Once the setting is completed, the Analyzer will be automatically turned off.
Stage 1) Setting - Beep
At the first stage, you set the Beep function.
1. When you enter the set mode, the display for setting the beep will be the first
step of the setting mode.

Ex) On

2. Set the beep mode on or off by pressing either or button and then
select the preferred feature by pressing the button. If you select the beep
on feature, a ‘beep’ sound is made at the same time; otherwise, if you select the
beep off feature, no sound is made.

Stage 2) Setting – Year

In the second stage, you set the Year in Date & Time setting.
1. After setting the Beep funtion, the display for setting the Year will appear. Set
the correct year by pressing or button and then select the correct year
by pressing the button.

Ex) 2011

Stage 3) Setting – Date Format

In stage 3, you set the Date Format in Date & Time setting.
1. Next will appear the setting display for Date Format. The Analyzer can display
either a Month-Day (m-d) format or a Day-Month (d-m) format. Set the
preferred format on the screen by pressing either or button and select
by pressing the button.

10
Stage 4) Setting – Date
In stage 4, you set the date Ex) 1- 1
1. After setting the Date Format, set the correct month or day on the display by
pressing either or button and select by pressing the button.

Stage 5) Setting – Time Format

In stage 5, you set the Time Format in Date & Time setting.
1. Next will appear the display for setting the Time Format. The Analyzer can
display the time in either the 12h format or the 24h format. Set the preferred
format on the display by pressing either or button and select by
pressing the button.

Stage 6) Setting – Time

In stage 6, you set the Time, in Date & Time setting.
1. Next will appear the display for setting the current Time. Set the hour and minute on the display by pressing either or button and select by
pressing the button.
a. 12h Format Ex) 12:00AM
sub-step 1) set AM or PM,
sub-step 2) set hour(1 to 12),
sub-step 3) minute(1 to 59)

b. 24h Format
sub-step 1) set hour(1 to 24),
sub-step 2) minute(1 to 59)

Stage 7) Setting – Sample Type

In stage 7, you set the Sample Type for lipid test.
1. After setting the Time, the display for setting the Sample Type (SPL) for the
lipid test will appear.

- Capillary or Venous Whole Blood

BL
BL

- Serum or Plasma
SE

11
 2. Set the Sample type for lipid test, ‘BL’ or ‘SE’, by pressing either or
button and then select the preferred feature by pressing the button.

SE

Stage 8) Setting – Unit of the Test Result

In stage 8, you set the Unit of the result.
1. After setting the Sample Type, the display for setting the Unit of the result will
appear.

2. You can set the preferred unit by pressing or buttons and select by pressing buttons.
Stage 9) Setting – Auto Printing
In stage 9, you set the Auto Printing function.
1. After setting the Unit, the display for setting the Auto Printing function will
appear.

- Auto Printing

2.Set the Auto Printing function, ‘On’ or ‘Off ’, by pressing either or button and then select the preferred feature by pressing the button. If you set Auto
Printing to 'On', then your results will be automatically printed when a test is completed.
Stage 10) Setting – Printing Page
In stage 10, you set the Printing Page.
1. After the Auto Printing function setting, the display for setting the Printing
Page mode will appear.
2. Set the Printing Page mode, - ‘P-1’ (1 copy) or ‘P-2’ (2 copies) - by pressing
either or button and then select the preferred feature by pressing the
button.

Stage 11) Setting – Hypo Warning

In stage 11, you set the Hypo Warning function.
3. After the Printing Page setting, the display for setting the
Hypo Warning will appear.

Ex) Off

12
4. Set the Hypo Warning ‘off ’ or the result you want to select
- 60, 70 or 80 mg/dL - by pressing either or button
and then selecting the preferred feature by pressing the
button.

• You can set the Analyzer to let you know when your glucose result indicates possible low blood glucose (hypoglycemia). You
can also select what blood glucose level you want this indicator to have - 60, 70 or 80 mg/dL.
• If your glucose results are lower than the selected hypo result, the hypo symbol will appear on the LCD with a ‘beep’ sound. It
is very important to manage your hypoglycemia.
Stage 12) Setting – Alarm
In stage 12, you set the Alarm function. You can set a maximum
of 4 alarms to remind you to test your glucose.
1. After the Hypo Warning setting, the display for setting the
Alarm will appear.
2. Set the first Alarm function, ‘On’ or ‘Off ’, by pressing either
the or button and then select the preferred feature
by pressing the button. If you select the Alarm ‘Off ’
feature, the Analyzer automatically powers off.
3. If you select the Alarm ‘on’ feature in first alarm mode, the
clock will blink. Set the desired hour and minute for the
alarm by pressing either the or button and then
select the preferred time by pressing the button.

4. The 2nd Alarm setting mode appears next. Set the Alarm in
the same way as above. [2, 3]

5. You can set the third and fourth Alarm modes in the same way as above. [2, 3]
6. When you finish setting the last alarm, the Analyzer automatically power off.
Stage 13) Setting – Bluetooth with PC *Only for 02LA20G
You can set Bluetooth communication with your PC. If the analyzer is paired with a PC, the test results are transferred automatically via Bluetooth.
1. After the alarm setting, the display for bluetooth with PC function will appear on
the screen.
2. Select ON or OFF by pressing the left or right button and then save it by pressing
the ON/OFF button.

13
 Stage 14) Setting – Bluetooth with Printer *Only for 02LA20G
You can set Bluetooth communication with a printer.
1. After the setting of Bluetooth with a PC, the display for bluetooth with printer
function will appear on the screen.
2. Select ON or OFF by pressing the left or right button and then save it by pressing
the ON/OFF button.

If you set both auto-printing and Bluetooth with Printer as ON, you can get the test results printed automatically via Bluetooth
communication.

Stage 15) Setting – Re-Pairing Printer *Only for 02LA20G

You can set the analyzer to be automatically paired with the previously paired printer
whenever the printer is near the analyzer.
1. After the Bluetooth with printer setting, the display for re-pairing printer function
will appear on the screen.
2. Select ON or OFF by pressing the left or right button and then save it by pressing
the ON/OFF button. BL BL

STEP 3. Insert a codechip

Lipid Test Strip

Coding BL BL

The codechip provides the Analyzer with important information on the production-specific characteristic of the respective lipid test strip to measure your results
accurately. The codechip is required when a new Lipid test strip package is opened. Before you use your Analyzer with a new box of lipid test strips, you should
set the Analyzer to “match” the lipid test strips. The number on the codechip should match the number on the outer box and the test strip foils.

Lipid Profile TC TG
Blue Case Red Case Yellow Case
Code Setting
1. Make sure the Analyzer is turned off. Remove the old codechip if one is installed.
2. Insert a new codechip until it clicks into place.

001

3. Turn the Analyzer ON. The 3-digit code number of the inserted codechip and the appropriate parameter name appears with the flashing lipid test strip

14
 symbol. This number and parameter name must match the codechip. If it does not, repeat the steps above (1-2).
Lipid Profile TC TG

BL BL BL BL BL BL BL BL BL

A codechip is included in each test strip package. Store the lipid test strips together with the codechip in the package.

Glucose Test Strip

A codechip is not necessary for glucose testing.

2. Preparing for measurement

Lipid Test System - components required:

• STANDARD LipidoCare Analyzer
• Lipid test strips for the desired parameter with the related codechip
• Lancets and Lancing device
• Tool for collecting the blood such as the STANDARD Ezi tube+ or micropipette

Only use STANDARD LipidoCare Lipid Test Strip and either STANDARD LipidoCare Blood Glucose Test Strip or SD Codefree Blood Glucose test
strip.

Precaution

Do
• Read the test strip package insert.
• Operate the Analyzer at the acceptable test-specific temperatures.
- For Lipid testing 18-32 °C (64-90°F)
- For Glucose testing 10-45 °C (50-113°F)
• Place the Analyzer on a level surface or hold it steady in your hand.
• Keep the guidelines for cleaning.
• Make sure that all display elements are displayed.
• Keep the STANDARD Lipid Check Strip away from sunlight.

Do not
• Use lipid test strips beyond the expiration date, this may cause inaccurate results.
• Touch or remove the test strip during actual measurement.
• Subject the Analyzer to sudden movements during a measurement.

15
 • Reuse the test strip.

1
2
• Store the Analyzer and strips at extreme temperatures.

3
• Store the Analyzer and lipid test strips under humid or damp conditions without suitable protection.
• Open the chamber flap during the measurment.

Not following these precautions can lead to inaccurate results.

1
2
Getting a Drop of Blood

3
Sample type

1
2
• For Lipid testing : Only use fresh capillary whole blood or venous blood in heparin or an EDTA treated vacuum tube. The venous blood sample should be

3
used within 6 hours after collection.
- Fresh Capillary Whole Blood
- Venous Whole Blood
- Venous Blood - Serum
- Venous Blood - Plasma

1
2
Only professional use for venous blood.

3
1
2
1

3
2
3
• For Glucose testing : Only use fresh capillary whole blood.

Capillary Whole Blood

1. Wash your hands in warm, soapy water. Rinse well and dry
completely. Warming fingers can increase blood flow.
2. Turn the lancet insert cap counterclockwise to remove it, insert
1 2
the lancet into the lancing device holder and push down firmly 3
1
2

2
1
until it is fully seated. Twist the lancet protective disk until it
3

2
3
3
4
separates from the lancet.

3. Replace the cap and turn it clockwise, until it is snug. Adjust the
puncture depth setting by turning the comfort dial. The dial has

1
1 to 5 steps, and the higher the step number, the stronger the

2
3
2

blood sampling pressure on the puncture site.

3 1 42

2
3

The comport tip offers 5 different levels of skin penetration.

4
4
3

• 1-2: for soft or thin skin

1
2

• 3: for average skin

3

• 4-5: for thick or callused skin

4. After cocking the lancing device back, hold the lancing device
2

firmly against the side of finger and then press the release
4 3

button.
1
2

4
4

3
3

2
4

3
4
3

2
2

16
4

4
3

3
2
2

2
3

4
4

3
2
3
 2
3
4
How to use STANDARD Ezi Tube+ *Only for lipid testing
1. Touch the tip of a STANDARD Ezi Tube+ to the edge of the blood
drop. Blood will automatically be drawn up the tube by capillary
action. Keep the tube in contact with the blood until it is filled to
the black line. You should squeeze your finger if you need more
blood.
2. Transfer the collected sample to the sample well on the test strip

4
by gently squeezing the bulb of the STANDARD Ezi Tube+.

3
2
3. Close the flap to start the test.

4
3
2

• Used STANDARD Ezi Tube+ can cause infection. Please discard the used STANDARD Ezi Tube+ according to local regulations.
• Collect the blood sample carefully to try and avoid air bubbles.

How to use the micropipette *Only for lipid testing

1 2 3

Place the tip securely on the micropipette. Push the plunger down and hold it in this position. Touch the tip to the blood drop.

4 5 6

Slowly release the pluger and check the blood Remove the tip from the micropipette and dispose
Open the flap and apply the blood sample.
is drawn into the tip. of the tip in a biohazardous waste container.

17
 3. Running a test - Lipid
Test Procedure

Check the following before performing a measurement:

1. Are date and time correct?
2. Does the battery symbol appear? If it appears, only a few more measurements can be performed. Replace the batteries as soon as possible.
3. Check the expiration date of the lipid test strip. Always use lipid test strips which are not expired.
4. Check the code number on the analyzer. Ensure it matches the code number on the codechip.
5. With lipid and glucose test strips, check the reaction area for discolouration before starting measurement. If you detect discolouration, this
test strip is unusable.

1. Remove a lipid test strip from the foil pouch and hold it by the
black handle with your thumb and index finger so that the
horizontal lines and triangle are facing upwards.
2. Open the Measurement Chamber Flap and insert the lipid test
strip into the ' Lipid Test Strip Slot ' of the Analyzer. Make sure it
is fully inserted - you will know when it is fully inserted as the BL BL

meter will beep and the display will instruct you to close the
Measurement Chamber Flap.

3. Close the Measurement Chamber Flap and then re-open it when BL

instructed to do so on the display. When the Chamber Flap is

opened, the blood drop icon will flash on the screen.

BL

4. Apply the blood sample from the pipette or capillary tube to the
sample application area of the lipid test strip. Do not touch the
application area.

5. When sufficient blood has been added, the display will instruct
you to close the Measurement Chamber Flap. Once the flap is
closed, the meter will start counting down from 3 minutes.

18
6. When the countdown reaches 0, your result appears on the
screen. If using a lipid profile test strip, use the left and right
arrows to view the results for the different parameters.

BL

7. When the test is complete, pull out the used test strip and
discard in a biohazardous waste container. The Analyzer shuts off
automatically 3 seconds after you remove the test strip.

• Do not open the Measurment chamber flap during the test.

• If you do not close the measurement chamber flap immediately after applying blood, the analyzer display flashes the close
flap icon with countdown and beep.

• If you do not close the flap within 20 seconds of applying the blood, the Analyzer displays the ' E-7 ' message.

• The blood drop must fill the entire blood application hole.

Example of not Example of

enough blood enough blood

19
 4. Running a test - Glucose
Test Procedure
1. Remove a new glucose test strip from its container. Be sure to tightly
replace the container cap immediately after removing a glucose test
strip.
2. Insert the glucose test strip into the 'Glucose Test Strip Slot' of the
Analyzer. The Analyzer will automatically enter the glucose testing
mode.

BL

3. When the blood drop symbol flashes, you are ready to perform a
glucose test.

BL

4. Obtain a blood sample using the lancet and lancing device.

0.9µL
actual size
5. Hold your finger to the tip of the glucose strip until the yellow window is completely filled with blood. Do not place the blood drop on top of the
glucose strip.
6. The blood will be drawn into the glucose strip automatically. If the beeper is turned on, the Analyzer will beep to let you know the glucose test is beginning.
7. When blood is applied to the glucose strip, the display counts down from 5 to 1 and your result appears on the display in just 5 seconds.
8. When the test is done, pull out the used glucose test strip. The Analyzer shuts off automatically 3 seconds after you remove the test strip.

STEP 1 Narrow Channel

Gently touch the glucose test strip to

the blood drop. Do not press the
glucose test strip against the finger.

STEP 2
Proper glucose test
strip appearance.

20
5. Running a test - Lipid/Glucose
Test Procedure
1. Open the Measurement Chamber Flap and insert the lipid test strip into the ' Lipid Test Strip Slot ' of the Analyzer. Make sure it is fully inserted - you will
know when it is fully inserted as the meter will beep and the display will instruct you to close the Measurement Chamber Flap.
2. Insert a glucose test strip into the ‘Glucose Test Strip Slot’ of the Analyzer.

Either lipid or glucose test strip can be inserted first.

3. The icons for glucose and lipid parameters will be displayed together on the screen. You should test your glucose first.

When the ‘GLU’ icon flashes in Lipid/Glucose mode, you should not apply blood sample to the LIPID test strip.

- Glucose Testing -
4. Obtain a blood sample using the lancet and lancing device.
5. Hold your finger to the tip of the glucose test strip until the yellow window is completely filled with blood. Do not place the blood drop on top of the
glucose test strip.
6. The blood will be drawn into the glucose test strip automatically. If the beeper is turned on, the Analyzer will beep to let you know the test is
beginning.
7. When blood is applied to the glucose test strip, the screen counts down from 5 to 1 and your result appears on the display in 5 seconds.
8. The LCD display will then switch to lipid test mode after 3 seconds.

- Lipid Testing -
9. Open the Measurement Chamber Flap.
10. Apply the blood directly from the pipette or capillary tube to the sample application area of the lipid test strip. Do not touch the application area.
11. When sufficient blood has been added, the display will instruct you to close the Measurement Chamber Flap. You must close the flap within 20 seconds
or E-7 will appear. Once the flap is closed, the meter will start counting down from 3 minutes.
12. When the countdown reaches 0, your result appears on the screen. If using a lipid profile test strip, use the left and right arrows to view the results for
the different parameters.
13. When the test is complete, pull out the used test strip and discard in a biohazardous waste container. The Analyzer shuts off automatically 3 seconds
after you remove the test strip.

If the auto print function is turned on, then the test result will be printed automatically after finishing the test.

21
 6. Understanding Your Results
Understanding lipid Results

Your Lipid Results

Single Test Results

BL BL BL

BL BL BL

Lipid Profile Test Results

BL BL BL

Measuring range
Measuring range For results outside the measuring range, the STANDARD LipidoCare displays :
mg/dL(mmol/L) Low High
TC 100~450 (2.59~11.64) <100mg/dL (<2.59mmol/L) >450mg/dL (>11.64mmol/L)
TG 45~650 (0.51~7.34) <45mg/dL (<0.51mmol/L) >650mg/dL (>7.34mmol/L)
BL BL BL

HDL 25~95 (0.65~2.46) <25mg/dL (<0.65mmol/L) >95mg/dL (>2.46mmol/L)

If the results are out of the measuring range, the analyzer displays "N/A" for the calculated parameters related to the measurement
parameters.

Expected Value
The National Heart, Lung and Blood Institute issued the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation,
and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) in May 2011. The ATP III report presented the NCEP’s updated clinical guidelines for
cholesterol testing and management and described the following classifications for cholesterol and triglyceride testing:

22
 mg/dL mmol/L Classification mg/dL mmol/L Classification
LDL <100 <2.59 Optimal HDL <40 <1.03 Low
100~129 2.59~3.34 Near optimal/ ≥60 ≥1.55 High
above optimal Triglycerides <150 <1.69 Normal
130~159 3.36~4.11 Borderline high 150~199 1.69~2.25 Borderline high
160~189 4.14~4.89 High 200~499 2.26~5.64 High
≥190 ≥4.91 Very high ≥500 ≥5.65 Very high
Total <200 <5.18 Desirable
Cholesterol 200~239 5.18~6.19 Borderline high
≥240 ≥6.22 High
The ATP III identified HDL levels below 40 mg/dL (1.03 mmol/L) as associated with increased risk of coronary heart disease (CHD) in men and women. A high
HDL level greater than or equal to 60 mg/dL (1.55 mmol/L) is protective and decreases CHD risk.

HDL
HDL is valid only if Triglyceride level is below 650 mg/dL (7.34 mmol/L).

non-HDL
ATP III identifies non-HDL (total cholesterol minus HDL) as a secondary target of therapy in persons with high triglycerides (≥200 mg/dL).
The goal for non-HDL in persons with high serum triglycerides can be set at 30 mg/dL higher than that for LDL on the premise that a VLDL level ≤30 mg/dL is
normal. non-HDL can be calculated using the equation below.
*non-HDL(calculated) = Total Cholesterol - HDL

LDL
LDL can be calculated using the equation below. Calculated LDL is an estimation of LDL and valid only if Triglyceride level is 400 mg/dL (4.52 mmol/L) or below.
*LDL (calculated) = Total Cholesterol - HDL - (Triglycerides/5) (mg/dL)
*LDL (calculated) = Total Cholesterol - HDL - (Triglycerides/2.17) (mmol/L)

• If Triglyceride level is above 400mg/dL (4.52mmol/L), the analyzer displays "N/A" for LDL and LDL/HDL.
• If Triglyceride level is "Hi", the analyzer displays "N/A" for HDL, LDL, LDL/HDL and non-HDL.
• If HDL level is "Lo", the analyzer displays "N/A" for HDL, LDL, LDL/HDL and non-HDL.

TC/HDL

BL BL BL BL BL

23
 Understanding Glucose Results
The STANDARD LipidoCare Analyzer is plasma-equivalent for glucose testing. Your Analyzer glucose results may be different from clinical lab results. This is due
to normal variation. To compare your Analyzer with lab results, follow the guidelines below.

Your glucose results

1. 5 seconds after applying blood to a glucose strip, you will receive a test result between 10mg/dL and 600mg/dL (0.6mmol/L and 33.3mmol/L)

BL

2. If your blood glucose is above 600 mg/dL (33.3mmol/L), you will receive a “HI” and if below 10 mg/dL(0.6mmol/L), you will receive “Lo”. In these cases,
repeat the test with a new glucose test strip. If these messages are displayed again, contact your healthcare professional immediately.

BL BL BL

• Range of Expected Values

Self-testing may help to monitor your blood glucose levels. Consult with your physician to determine the best range of expected blood glucose values
for you.
• Expected blood glucose values for non-diabetic adults are as follows:
» Before eating < 100 mg/dL (5.6 mmol/L)
» One to Two hours after meals < 140 mg/dL (7.8 mmol/L)

These test strips deliver results that correspond to blood glucose concentrations in plasma as per the recommendation of the International Federation of Clinical
Chemistry and Laboratory Medicine (IFCC). Therefore, the STANDARD LipidoCare analyzer displays blood glucose concentrations that refer to plasma although
whole blood is always applied to the test strip.

What This Means For You

Frequent blood glucose testing is the best means to track how well you are doing with your diabetes management. It helps you track the effects of medications,
diet, exercise, and stress management. Test results can also tell you if your diabetes is changing. This may alert you to adjust your treatment plan. Always
consult your healthcare professional before making any adjustments.

Frequency of Testing
Work with your healthcare professional to decide when and how often to test. This will depend on such things as age, type of diabetes, and medications. It is
important to make testing part of your daily routine.

CHAPTER 3. Using the Analyzer Memory

1. Analyzer Memory
The STANDARD LipidoCare Analyzer has 7 memory modes, each of which can be used to store up to 500 results, together with date, time and flags, letting you
review them in order from the most recent to the oldest. If the memory is full and a new result is added, the Analyzer deletes the oldest result.
The STANDARD LipidoCare Analyzer also has the function to review the averages for glucose results.

24
 • ALL mode
• Lipid/Glucose mode : 7 sub-parameters: 1)TC, 2)TG, 3)HDL, 4)LDL, 5)LDL/HDL, 6)non-HDL, 7)Glucose
• TC·HDL mode : 3 sub-parameters: 1)TC, 2)HDL, 3)non-HDL
• TC mode
• TG mode
• HDL mode
• Glucose mode

LCD Symbol of Memory

Symbol Details

• Indicates you are in memory mode.

• Indicates you are in ALL memory mode.

Each Parameter title flashes when you are in ‘ Lipid/Glucose ’ and ‘ TC·HDL ’ mode.
L When you enter ‘ ALL ’ mode, the initial ‘ A ’ appears in the center of the memory symbol.
L
2. Displaying stored results
All mode
1. Switch on the Analyzer, then press the or button to enter
memory mode.
BL BL BL
BL

• press : You can check the latest test result.

• press : You can check the oldest test result.

The date and time on the display indicates the time the measurement was performed, not the current time.

Mode change

Memory Parameter Chain

< Press the ( ) button >

ALL TC TC TG HDL GLU

Lip./Glu. HDL
Mode Mode Mode Mode Mode Mode
Mode

25
 1. Press the ( ) button to change the memory mode.

2. Each time you press the ( ) button, the last stored value of each memory mode is displayed.

BL BL BL

‘ALL’ Parameter Mode 'Lipid/Glucose' Mode 'TCㆍHDL' Parameter Mode

BL BL BL BL

'GLU' Parameter Mode 'HDL' Parameter Mode 'TG' Parameter Mode 'TC' Parameter Mode
3. Press the button to show the next most recent result in that specific memory mode.
4. You can exit memory mode by pressing the button in any memory display.

Lipid/Glucose Mode
Press the or button to switch between the memory areas of the seven different parameters when in Lipid/Glucose mode.

Previous Next

non
TC
-HDL

( ) ( )

LDL/ non
TC TG HDL LDL
HDL -HDL
GLU

BL BL BL
BL BL BL

26
 If the memory is empty, three dashes (– – –) will appear on the display.

3. Displaying Glucose Averages

The Analyzer calculates 7, 15 and 30-day averages of glucose test results stored in the memory. HI/Lo results (results outside of the reading range) and results
with control solution symbol are not included in averages.

Searching Glucose Averages

1. Switch on the Analyzer and press the or button to enter "All" memory mode.
2. Press the ( ) button until you enter glucose mode.
3. Press the button to review three kinds of 7, 15 and 30 day averages of glucose test results
stored in the memory in sequence. You can also review the number of glucose results at each
average in the bottom right of the LCD window. If you Press the arrow button once more after
displaying the 30 day average, the 7-day average result will appear again.

BL

4. If there aren’t any stored 7, 15 and 30-day averages, the following display will appear on the LCD.

BL

You cannot search the stored results or average of results in the Analyzer if a glucose test strip is inserted in the Analyzer. After
removing the strip from the Analyzer, you can search the results and average of results stored in the memory by pressing the or
button.

27
 4. Delete Memory
Delete Individual Memory
1. Switch on the Analyzer and press the or button to enter memory mode.
2. Find the stored result you want to delete and then press and hold the and arrow buttons
together for 3 seconds, whilst the result you want to delete is displayed.

3. 'dEL' will now appear on the screen. Press and hold the 'SET/PRT' button for 3 seconds to confirm the deletion of the result.

( )

BL BL BL

Delete Total Memory

1. Switch on the Analyzer and then press the or button to enter memory mode.
2. Press and hold the button, button and ( ) button together for 3 seconds.

3. 'All' and 'dEL' will now appear on the screen. Press and hold the ( ) button for 3 seconds to confirm you want to blank the meter
memory.

CHAPTER 4. Printing
How to Print
Auto Printing
If you set Auto Printing function to "ON" in the setting mode, the Analyzer will not display the "Printing" symbol.

Manual Printing
If you press ( ) button in any memory mode, the printer will print that result and display the "Printing" symbol.

BL BL BL

28
 If you select 'P-1' in setting mode, the Analyzer prints only one copy in printing mode. If you select 'P-2', the Analyzer automatically
prints two copies.

Print one copy function Print two copies function

If you have the 02LA20G model, you can print via Bluetooth or by using a mini USB cable. If you do not have the Bluetooth model, you
will need a mini USB cable to be able to print.

CHAPTER 5. Data transfer

Please contact your local distributor for more information on downloading results.

You can download LMS Software at www.sdbiosensor.com.

CHAPTER 6. Bluetooth communication

Only the 02LA20G model can be used to transfer data from an analyzer through Bluetooth. The model number is indicated on the label
of the analyzer.

1. Data Trasfer
The data measured by the analyzer can be transferred to a PC via Bluetooth (02LA20G model only).

If you want the analyzer to be paired with a PC, the pairing step is necessary. And the STANDARD Lipid Management Software (LMS)
should be installed on the PC. To start the pairing step, follow the steps below;

Pairing
1) At the strip stand-by state for either a lipid or glucose, press the ON/OFF button for 2 seconds. Then, ‘bt’ icon will appear on the left side of the screen with
the setting icon which means pairing is ready. When you run the device for the first time, press the setup button and execute BT ON in the BT setup step.

BL BL

29
 2) Open the STANDARD Lipid Management Software (LMS) installed
on the PC. Click ‘Setting’ menu on the left side and then, check the
bluetooth equipment at the check box.

3) Click ‘Pairing’ button on the screen to look for the device for
pairing. It will start to search the STANDARD LipidoCare Home
analyzer near.

4) After finishing searching, the available analyzer will be listed up

on the screen. Select the available analyzer by clicking the address
of the analyzer.

BL BL

5) When the pairing is done, ‘Pairing is done’ message will appear on

the screen.
At the same time, the analyzer will display ‘OK’ message on
the screen. If you receive the both messages on the PC and the
analyzer, pairing is done successfuly.

6) After pairing processes are done, the analyzer is now ready for testing.

2. Technical Information
Hereby, SD Biosensor declares that STANDARD LipidoCare Analyzer is in compliance with the essential requirements and other relevant
provisions of Directive 1999/5/EC. You can view your product’s Declaration of Conformity(DoC) to Directive 1995/5/EC(R&TTE) at www.
sdbiosensor.com.

Changes or modifications made to this equipment not expressly approved by SD Biosensor, Inc. for compliance could void the user’s
authority to operate the equipment.

30
 This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to ETSI EN 301 489-1 and 17.
These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment
generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause
harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off
and on, the user is encouraged to try to correct the interference by one or more of the following measures:
• Rotate or relocate the receiving antenna.
• Increase the distance between the equipment and receiver.
• Connect the equipment into an outlet on a different circuit to which the receiver is connected.
• Consult your local distributor or an experienced radio/TV technician for help.

CHAPTER 7. Control Solution Test

1. Control Solution Test
It is important to perform Control Solution Tests with more than one level of Control Solution to assure your System is working properly. Control Solution is used
to check that the Analyzer and the test strips are working together as a system and that you are performing the test correctly. It is very important that you do
this simple check routinely to make sure you get an accurate result.

When to use STANDARD Lipid & Glucose Control Solution

• Before using your Analyzer for the first time.
• When you open a new vial or pouch of strips.
• Whenever your result does not agree with the way you feel.
• When replacing the batteries or cleaning the Analyzer.

• Use only the specified Control Solution.

• Check the expiration date on the control solution container. Do not use STANDARD Glucose Control Solution after expiration or the
discard date (date opened plus three months), whichever comes first.
• Do not swallow control solution; it is not for human consumption.
• Do not apply control solution to the skin or eyes as it may cause irritation.

2. Control Solution Test for Lipid (recommended for medical professionals only)
What you need:
• STANDARD LipidoCare Analyzer
• Lipid test strips for the desired measurements with the related codechip
• SDB Lipid Control Solution - Level 1 , Level 2

Performing a SDB Lipid Control Solution Test

1. Prepare the test strip for the desired measurement (e.g. measurement of Lipid Profile).
2. Insert a test strip into the Analyzer.
3. Make sure the number on the display matches the codechip and the test strip package and that the test strip is inserted correctly.
4. ‘OPE’ will appear on the screen, indicating that you should open the chamber flap.
5. Leave the chamber flap open and press and hold the button for 3 seconds to enter control solution mode. If you don't want to perform a lipid
control solution check, press the button.
6. Gently mix the lipid control solution and apply the exact volume for the particular parameter by using a micropipette or capillary tube.

31
 7. After 3 minutes, the test result will appear on the screen.

SE SE

8. Compare the result to the range printed on the control solution insert. If the results are not within the lipid control range printed on the insert, then the
Analyzer and test strip may not be working properly. Repeat the control test.
If the control solution result is still not acceptable, please call your local customer support and service center.
9. Remove the used test strip from the Analyzer and discard it.

- This solution is made by human and animal source materials. Treat as potentially infectious.
- The human source material used to produce this product has been tested by using FDA- accepted methods and found nonreactive
for hepatitis B surface antigen (HBsAg), and for antibodies to hepatitis C(HCV) and human immunodeficiency viruses(HIV-1 and
HIV-2). Because no test can offer complete assurance that infectious agents are not present, this product should be considered
potentially infectious and handled with the same precautions used with patient specimens.
- Store upright and refrigerated at 2-8˚C(36-46˚F). Stored under this condition, SDB Lipid Control Solution can be expected to give
stable results through the expiration date printed on the label. Minimize exposure to bright light.
- Do not use SDB Lipid Control Solution:
• If it is cloudy or has an odour.
• If it has been shipped or stored improperly.

3. Control Solution Test for Glucose

Performing a Glucose Control Solution Test
1. Remove a new glucose test strip from the test strip container. Be sure to tightly replace the container cap after removing a glucose test strip.
2. Insert a glucose test strip (yellow window printed arrow symbol facing up)into the glucose test strip slot. The Analyzer turns on automatically.
3. Press the or button for 3 seconds to check the testing system using a STANDARD Glucose control
solution. If you don’t want to perform a glucose control solution check, press the or button.

BL

4. Shake the STANDARD Glucose control solution container and then remove the cap. Gently squeeze the container to form one small drop. Bring the drop
to the edge of the glucose strip, and allow the glucose strip to automatically draw the STANDARD Glucose control solution into the yellow window.
When STANDARD Glucose control solution is applied to the glucose test strip, the Analyzer counts down from 5 to 1 on the screen.
5. The STANDARD Glucose control solution result appears on the screen in just 5 seconds.

BL

32
6. Compare the glucose control solution result to the range printed on the glucose test strip container. If the results are not within the glucose control
range printed on the glucose test strip container, then the Analyzer and glucose strips may not be working properly. Repeat the STANDARD Glucose
control solution test. If the control solution result is still not acceptable, please call your local customer support and service center.
7. Remove the used glucose test strip from the Analyzer and discard it.

• The STANDARD Glucose Control Solution range printed on the glucose test strip container is for STANDARD Glucose Control Solution
only. It is not a recommended range for your blood glucose level.
• Store STANDARD Glucose Control Solution tightly closed at temperatures between 8-30°C (46-86°F ). Do Not refrigerate.
• STANDARD Glucose Control Solution should be tested at room temperature 18-30°C (64-86°F).

4. Troubleshooting control solution

Check Action
Did you do the test in control solution mode? Did you see If not, insert a glucose test strip, press the or button for 3 seconds to display
“control solution container icon” on the screen with the result? a control solution container icon.
Make sure that the glucose test strips and STANDARD Glucose Control Solutions are not
Have the glucose test strips and/or glucose control solution beyond their expiration dates. This date is shown on the container/bottle. Make sure
expired? the containers have not been open for longer than the specified period (6 months for
the test strips and 3 months for the control solution).
Were STANDARD glucose control solutions at room temperature
If not, warm up/cool down to room temperature (18-30°C, 64-86°F) and retest.
(18-30°C, 64-86°F) when used?
Did you insert a lipid or glucose test strip firmly into the Make sure a lipid or glucose test strip is inserted into the lipid or glucose test strip slot
Analyzer? until it will go no further.
Did you follow the procedure correctly? Read the instruction for use again and retest.
Were the lipid or glucose test strips stored correctly? If not, retest with a new lipid or glucose test strip.
Is the Analyzer damaged? Does it show an error code? If yes, please call your local customer support and service center.
Repeat the test. If you get the same results, do not use your Analyzer and test strips
Is the control solution result outside the appropriate acceptable
until you solve the problem. If you cannot solve the problem, please call your local
range?
customer support and service center.

CHAPTER 8. Check Strip Test

A Check Strip test is used to check that the Analyzer is working well.

When to use the STANDARD Lipid & Glucose check strips?

• When you want to easily check the function of the Analyzer.
• Before using your Analyzer for the first time.
• Whenever your result does not agree with the level you feel.
• If you have repeated a test and the blood glucose result is still lower or higher than expected.

The Check Strip test does not replace a Control Solution test.

1. How to Use a STANDARD Lipid Check Strip

1. For entering the "Checking" mode of lipid, turn on the meter and press and hold the and buttons for 3 seconds, until 'CHE' appears on the
screen.

33
 2. Insert the STANDARD Lipid Check Strip.
3. The check result will appear on the screen in just 10 seconds. If there is no problem with the Analyzer, 'OK' will appear on the screen; if there is a
problem with the analyzer, ‘EEE’ will appear on the screen and you should contact your local distributor.

2. How to Use the STANDARD Glucose Check Strip

1. Insert the STANDARD Glucose Check Strip (with the words ‘check strip’ facing upwards) into the glucose test strip slot. The Analyzer will turn on
automatically.
2. The check result will appear on the screen in 5 seconds. If there is no problem with the Analyzer, 'OK' will appear on the screen; if there is a problem
with the analyzer, ‘EEE’ will appear on the screen and you should contact your local distributor.

BL

CHAPTER 9. Maintenance and Troubleshooting

1. Cleaning your Analyzer

Caring for the STANDARD LipidoCare Analyzer is easy. If you need to clean it, follow these guidelines carefully to help you get the best performance possible;

To prevent malfunction of the Analyzer, keep the test strip slot free of blood, moisture, dirt, or dust. Use a lint-free cloth dampened with water to clean the
Analyzer. Ensure the cloth is damp, and not wet. Do not use an abrasive cloth or antiseptic solution, as these may damage the display screen.

A clean optical measuring system is a basic prerequisite for determining precise measured values.
Therefore clean the Analyzer regularly and immediately after it becomes dirty. Always switch off the Analyzer before cleaning it.
Use only the following items for cleaning:
• Ordinary lint-free cotton buds
• Ordinary lint-free tissues
• Ordinary disinfecting tissues

Do not use any disinfectant sprays or tissues or cotton buds which are dripping wet as the liquid may enter the Analyzer and damage it.

34
Cleaning the outer Analyzer components
• Ensure the Analyzer is switched off.
• Wipe the outside of the Analyzer with a lightly moistened, lint-free cotton cloth.

Cleaning the inner Analyzer components

1. Open the measurement chamber flap.
2. Remove the measurement chamber cover (including the lipid test strip guide) by slightly
pushing it to the center of the Analyzer and then pulling it upwards.

3. In case of significant dirt, you can rinse the measurement chamber cover (separately from
the Analyzer) under warm running water. Dry the measurement chamber cover with a fresh
cloth.

Cleaning the optical measuring system

1. Clean the easily accessible areas of the optical measuring system with a lint-free pad or
a moistened cotton swab. Make sure that no liquid enters the Analyzer. Do not insert any
objects into the Analyzer.

2. Allow the Analyzer to dry thoroughly.

3. Do not fit the measurement chamber cover into the Analyzer until it is completely dry. Press
the front end of the measurement chamber cover slightly downwards until you feel it click
into place.

4. Close the measurement chamber flap. The Analyzer is now ready for operation again.

35
 2. Maintenance, Testing and Transportation
Analyzer
1. Keep the test strip slots free of dust.
2. Protect the internal Analyzer from humidity.
3. If the analyzer is stored with the batteries inserted, it is best to keep it in a low humidity environment to prevent defects.

Test Strips
1. Lipid and glucose test strips should be stored between 2-32°C(36-90°F). Lipid test strips may be stored in the refrigerator between 2-8°C(36-46°F), but
must be brought to room temperature for 30 minutes before using.
2. Keep away from heat and direct sunlight.
3. Keep the codechip either in the analyzer or stored in the lipid test strip package.
4. Keep the glucose test strip container closed tightly.
5. Use test strip immediately after opening the pouch for lipid or taken from the container of glucose.
6. Keep the STANDARD Lipid Check Strip away from direct sunlight. The STANDARD Lipid Check Strip can become discoloured if it is exposed to sunlight.

Control solution
1. Do not use STANDARD Glucose/Lipid Control Solution beyond the expiration date.
2. For STANDARD Glucose Control Solution, store between 8-30°C(46-86°F) but not refrigerate or freeze.
3. For SDB Lipid Control Solution, store upright and refrigerated at 2-8°C(36-46°F). Stored under this condition, SDB Lipid Control Solution can be expected
to give stable results through the expiration date printed on the label.
4. The STANDARD Glucose Control Solution can be used for 3 months after opening the container. Write the opened date on the STANDARD Glucose Control
Solution container when you first open it.
5. Wipe the container tip clean and reseal the container tightly after each use.

CHAPTER 10. Screen Messages and Troubleshooting

1. Warning message
Indication Warning description

Warning : Hypo Warning Message

If you set a Hypo warning, then this message will appear if your blood glucose level falls below the set value.
BL

Indication Warning description

Warning
Your test result is higher than the measuring range.
BL *This indication is for Glucose.

36
 Indication Warning description

Warning
Your test result is lower than the measuring range.
BL *This indication is for Glucose.

Indication Warning description

Warning: Low Battery

At this time, battery is getting low but you can still perform about 50 tests.
BL

Indication Warning description

Warning: Replace Battery

Battery power is low.
If the battery is empty and you press the power button, the battery icon will flash for 10 seconds and then the
BL
analyzer will turn off automatically.

2. Error message
Indication Error description
In case of lipid test strip

Error: Strip Error

The lipid or glucose test strip is dirty, used, damaged or inserted improperly.

In case of glucose test strip

Solution
Discard this test strip and test again using a new test strip.

37
 Indication Error description

In case of lipid test strip

Error: blood sample Error

An insufficient amount of blood was applied.

In case of glucose test strip

Solution
Discard this test strip and test again using a new test strip with a larger sample.

Indication Error description

Error: Expired strip (Only for a Lipid test strip)

The Lipid test strips are expired.

Solution
Discard this test strip and test again using a new lipid test strip that has not expired. If the strips are not expired
and you still get E-3 then this means the year and/or date are not set correctly. Please refer to the section on
setting the Analyzer.

Indication Error description

Error: Temperature Error
If the environmental temperature is above or below the operation range of the Analyzer, a thermo Analyzer icon
will appear on the display.

Solution
Move to an area between 18-32°C(64-90°F) for lipid or 10-45°C (50-113°F) for glucose, wait for 30 minutes, and
perform a test. Do not artificially heat or cool the Analyzer.

Indication Error description

Error: Communication Error

The communication between Analyzer and computer or printer is failed.

Solution
Connect the Analyzer and external device again.
If the error message persists, please contact your local distributor.

38
Indication Error description

Error: Code mismatching Error

The inserted test strip and codechip do not match.

Solution
Change the appropriate test strip or codechip.

Indication Error description

Error: Flap Open

The chamber flap of the Analyzer is open during measurement.

Solution
Close the chamber flap and do not touch or open the flap during measurement.

Indication Error description

Error: Blood Error

Measurement chamber flap is closed for testing without blood sample.

Solution
Re-test with sufficient blood sample.

Indication Error description

Error: Communication Error with codechip

The Analyzer cannot communicate with the inserted codechip.

Solution
Re-insert the codechip. If the error message persists, please contact your local distributor.

Indication Error description

Error: Internal Error

There is an internal error of the analyzer.

Solution
Turn the Analyzer off and then back on again. If the error message persists, please contact your local distributor.

39
 CHAPTER 11. Warnings, Precautions and Limitations
− Discard test strip after using. Strips are to be read once. Never insert or read a used test strip.
− Do not ingest.
− Discard the used test strip according to local regulations.
− Store and transport analyzer at -20~50°C (-4~122°F) and 10%-93%RH.

1. Test Strip for Lipid

1. Make sure the codechip number matches the lipid test strip code number. Never use a codechip from a different lot.
2. Out-of-date or expired strips cannot be used in your test system. Check the expiration date in the package or pouch.
3. Add all of the blood to the lipid test strip at one time. If you do not get all of the blood on the strip, do not add more blood to the same strip. Test again
with a new test strip and fresh blood sample.
4. Venous whole blood, serum and plasma is only for professional use.

2. Test Strip for Glucose

1. Use only fresh capillary blood. Do not use serum or plasma or venous whole blood.
2. The STANDARD LipidoCare System is not designed to be a substitute for pathology laboratory equipment and should not be used for the diagnosis of
diabetes.
3. Extremes in hematocrit may affect test results. Hematocrit levels less than 20% may cause falsely high readings. Hematocrit levels greater than 60%
may cause falsely low readings.
4. Not intended for screening or diagnosis or for use on neonates.
5. Never make significant changes to your diabetes control program or ignore physical symptoms without consulting with your healthcare professional.
6. Severe dehydration (excessive water loss) may cause false low results. If you believe you are suffering from dehydration, consult your healthcare
professional right away.
7. Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a
hyperglycemichyperosmolar state, with or without ketosis. Critically ill patients should not be tested with the Analyzer.

CHAPTER 12. Product Technical Information

1. Analyzer Specifications
Battery Operation 4 AAA 1.5 V, Alkaline batteries
Battery Life Around 1,000 tests
Display LCD
Controls 4 Buttons (SET/PRT, ON/OFF, arrow: >/<)
Memory 500 results
• 1 minute after last user action without inserting test strip into the Analyzer
Automatic Shutoff
• 5 minutes after last user action when inserting test strip into the Analyzer

40
2. Test strip for Lipid
TC: 100 - 450 mg/dL ( 2.59 - 11.64 mmol/L )
Measuring Range TG: 45 - 650mg/dL ( 0.51 - 7.34 mmol/L )
HDL: 25 - 95 mg/dL ( 0.65 - 2.46 mmol/L )
Fresh capillary whole blood or
Sample
venous whole blood, serum or plasma
Sample Size 10 µl(Single) / 35 µl (Lipid Profile)
Test Time 3 minutes
Test Strip Storage Temperature 2 - 32°C (36 - 90°F)
TC and TG parameter: 30 - 50%
Hematocrit
HDL parameter: 30-52%
Testing Temperature 18 - 32°C (64 - 90°F)

3. Test strip for Glucose

Measuring Range 10 - 600 mg/dL (0.6 - 33.3 mmol/L)
Sample Fresh capillary whole blood
Sample Size 0.9 µl
Test Time 5 seconds
Test Strip Storage Temperature 2 - 32°C (36 - 90°F)
Hematocrit 20 - 60%
Testing Temperature 10 - 45°C (50 - 113°F)
Altitude Up to 3,776m(12,388 ft)
Calibration Plasma-equivalent

4. Electromagnetic Compatibility
This Analyzer meets the electromagnetic immunity requirements as per EN ISO 15197 Annex A. The chosen basis for electrostatic discharge immunity testing
was basic standard IEC 61000-4-2. In addition, it meets the electro -magnetic emissions requirements as per EN 61326. Its electromagnetic emission is thus
low. Interference from other electrically driven equipment is not to be anticipated.

41
 Appendix 1: Information for Healthcare Professionals
Protection against infections
There is a potential risk of infection. Medical staff using the STANDARD LipidoCare Analyzer to perform measurements for more than one patient must be aware
that any object coming into contact with human blood is a potential source of infection.
• Use gloves.
• Apply blood outside the Analyzer. When measuring glucose in several persons clean and disinfect the Analyzer before each measurement as blood
cannot be applied using capillary pipettes.
• When measuring cholesterol and triglycerides in several persons, always use capillary pipettes to apply blood outside the Analyzer.
• Dispose of used capillary pipettes and lipid test strips in a clinical waste bin.
• Follow all other locally applicable guidelines and regulations on health and safety.

Appendix 2: References
1. American Diabetes Association: Standards of Medical Care in Diabetes-2013, Diabetes Care, Volume 36, Supplement 1, January 2013, S11-S66.
2. Siedel J, Hagele EO, Ziegenhorm J, Wahlefeld AW. Reagent for the enzymatic determination of serum total cholesterol with improved lipolytic efficiency.
Clin Chem 1983;29:1075-80.
3. Expert Panel on Detection, Evaluation, and Treatment of High Cholesterol in Adults. Executive summary of the Third Report of the National Cholesterol Education
Program(NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Cholesterol in Adults(Adult Treatment Panel III). JAMA 2001;285:2486-97.

Return
You should contact SD Biosensor Customer Service before returning your Analyzer. You will be instructed how to return the Analyzer to SD Biosensor, Inc.
Returned Analyzers without this authorization will not be accepted.

42
MEMO

43
 MEMO

44
MEMO

45