Diabetes Management Technology

INSTRUCTION FOR USE

infopia Co., Ltd.

891, Hogye-Dong, Dongan-Gu,
Anyang, Kyunggi, 431-080, Korea
www.infopia21.com

Obelis S.A.
Bd. General Wahis 53
1030 Brussels, Belgium
Tel : +(32) 2.732.59.54
Fax : +(32) 2.732.60.03
E-Mail : [email protected]

INFH01AS

For measuring Hemoglobin A1c

IMH12-008 Rev.2011-12-01
TABLE OF CONTENTS

1. INTENDED USE 4

2. GENERAL INFORMATION 4

3. PRINCIPLES OF OPERATION 5

4. CLOVER A1c™ Self COMPONENTS 6

5. STORAGE INSTRUCTIONS 6

6. DEVICE DESCRIPTION 7

7. LIST OF ICONS 8

8. INSTALLATION 10

9. OPERATION 11

10. SETTING THE ANALYZER 13

11. TESTING HbA1c 16

12. REVIEWING RESULTS 26

13. CHECKING THE SYSTEM 28

14. OPTION 40
15. PRODUCT LIST 50

16. TROUBLESHOOTING 51

17. SPECIFICATION 55

18. MAINTENANCE 56

19. SAFETY 58

20. DISPOSAL 58

21. PRECAUTION 59

22. SYMBOL & DESCRIPTION 62

CLOVER A1c Self • 3 •

1. INTENDED USE 3. PRINCIPLES OF OPERATION
The CLOVER A1c Self analyzer is an IVD(In Vitro Diagnostic Device) device for The CLOVER A1c™ Self system is a fully automated boronate affinity assay for the
measuringHemoglobin A1c by the well established method of boronate affinity. It is able determination of the percentage of Hemoglobin A1c (HbA1c %) in whole blood(capillary
to analyze bothcapillary whole blood and venous blood. Anticoagulants may be used, and venous).
such asEDTA(ethylenediaminetetraacetic acid) and heparin etc. This CLOVER A1c Self
system is designedto help controlling diabetes and it is intended to be used by patients The Test Cartridge is composed of a cartirdge and a reagent pack containing the
and professionals at home,laboratories, clinics and hospitals. Same as all diagnositc reagents necessary for the determination of hemoglobin A1c.
tests, do not make a definitivediagnosis of diabetes based on the result of a single test.
A physician should make a diagnosisafter all clinical and laboratory findings are A cartridge should be inserted into the analyzer cartridge holder first and later assembled
evaluated. with areagent pack which was applied with 4ul blood sample at the sample collecting
area. A reagentpack is composed of reaction solution and washing solution. The reaction
solution containshemolyzing agent which lyses the red blood cells, and boronate resin
IMPORTANT : Please read through and familiarize yourself with the contents of this which binds to the cis-diolsof glycated hemoglobin. The washing solution cleans the non-
operation manual before using the system for the first time. specific glycated hemoglobin(except HbA1c)

The blood sample(4uL) is collected at the collection area of the reagent pack, then the
reagent pack is inserted into the cartridge, where the blood is instantly lysed releasing the
hemoglobin and the boronate resin binding the glycated hemoglobin.

The assembled cartridge is inserted into the CLOVER A1c™ Self Analyzer and rotated
so that the sample mixture is placed at the measurement zone of the cartridge, where the
2. INTRODUCTION amount of total hemoglobin in the blood sample is photometrically the diffused
reflectance of the optical sensor composed with LED(Lgiht Emitting Diode) andPD(Photo
The CLOVER A1c Self system is a small, portable and fully automated point-of-care Diode)
system forHbA1c test. The system delivers rapid tests of HbA1c.
Then, the assembled cartirdge is rotated so that the washing solution washes out non-
The CLOVER A1c™ Self System may be used as a basic test system where the user glycated hemoglobin from the blood sample, thus the amount of glycated hemoglobin
purchases the Analyzer and manually records the results, or as an advanced system can be photometrically measured.
where a suite of accessories enable automatic printing of results, input of patient and
operator identification numbers, and full connectivity to a PC. In this manner, the system The ratio of glycated Hemoglobin with respect to total hemoglobin in the blood sample is
is highly versatile and can be tailored to specific user needs. calculated.

This manual contains all the information needed to operate and maintain the CLOVER
A1c™ Self Analyzer. A
Total Hemoglobin
B

Where ‘HbA1c’ and ‘Total Hemoglobin’ are the signal obtained from the CLOVER A1c™
Self system, ‘A’ and ‘B’ are the slope and intercept factor to correct the value for
DCCT(Diabetes Control and Complication Trial) calibration.

CLOVER A1c Self • 4 • CLOVER A1c Self • 5 •

4. CLOVER A1c™ Self Contents 6. Device Description

Upon receipt of the product, carefully inspect for any obvious physical damage.If any 6.1 Analyzer
damage is evident to the CLOVER A1c™ Self Analyzer, please consult our authorized-
representative in your area.
Cover

Contents
1. CLOVER A1c Self Analyzer LCD Display
2. Instruction Manual
3. Exclusive Power Adapter
4. Fan Filters Mode Button
5. Daily Check Cartridge
6. Monthly Check Cartridge

Arrow Buttons Printer Button

6.2 Cartridge

[ Test Cartridge ] [ Reagent Pack ]

For checking CLOVER A1c Self Analyzer only. For checking CLOVER A1c Self Analyzer only.
For self-testing use. For self-testing use.
For not reuse. For not reuse.

Reaction Washing
Solution Solution
Cartridge Mixing
5times

For use with CLOVER A1c Self Test Cartridge only

For measuring hemoglobin A1c
For Self-testing use
Code Area

5. Storage Instructions

The CLOVER A1c™Self analyzer must be stored at 10°C~35°C. Test Cartridges must Sample Collecting Area
be stored at 2°C~32°C(36°F-90°F) and 10%~90% R.H( Relative Humidity)

WARNING: • Caution: Be careful not to touch or contaminate the cartridge code area in any
Do not modify this equipment without authorization of the manufacturer. way. Any stain on the testcartridge code may cuase incorrect test result.

CLOVER A1c Self • 6 • CLOVER A1c Self • 7 •

7. LIST OF ICONS 7. LIST OF ICONS

Icon Name Function Icon Name Function

It is displayed on the analyzer LCD

Warming up Warming up Close the cover Close the cover of the analyzer.
once it is powered on.

Remove the cartridge from the

Power Save mode Analyzer is under 'Power Save Mode' Remove cartridge
analyzer.

Insert the blood glucose test strip into the

Open the cover Open the cover of the analyzer. Insert strip
glucose module.

Analyzer is under “Check Mode”.

Insert Apply sample to Apply blood sample to the blood glucose
Insert daily check cartridge or monthly
Check Cartridge glucose test strip test strip.
check cartridge into the analyzer.
CHECK

Insert Insert monthly check reagent pack into the

Check Reagent PC Connection Indicates that the analyzer is connected
analyzer. In case of daily check cartridge,
Pack to a PC.
CHECK
the iconwill not be shown up.

Insert Indicates that the thermal printer use

Test Cartridge Insert Test Cartridge into the analyzer. Printer
is active.

Apply sample to Select this icon to view the test results

Apply blood sample to sample collecting Memory
capillary tip in memory.
area.

Insert Reagent Insert reagent pack with blood sample

Pack into the analyzer. Set up Select this icon to set up the analyzer.

CLOVER A1c Self • 8 • CLOVER A1c Self • 9 •

8. INSTALLATION 9. OPERATION

Overview 9.1 Power On

This section provides detailed installation instructions for the CLOVER A1c Self. You
TM Connect the DC 9V adapter to the power port on the back side of the analyzer.
must follow the installation steps correctly to ensure proper installation, operation, and On/off 9V USB Barcode Printer

service.

CAUTION
Do not drop or handle the system roughly. The calibrated optics, electronics orother
internal parts can be disrupted or damaged. Always handle the system with care.
The CLOVER A1cTM Self ia s precise system and must be handle carefully.
Make sure that the cover is closed before connecting the adapter.

Place the system where it will not be subjected to extreme temperature variations. Avoid After the system is properly installed, you can start the CLOVER A1cTM Self.
open windows, direct sunlight, ovens, hot plates, open burners, radiators and dry ice
baths. To start the CLOVER A1cTM Self, turn the power
switch to the 'ON' position.
Do not place the CLOVER A1cTM Self on the same place with a source of vibration
Provide large space to allow free air circulation around the system - 8cm(3 inches) on all
sides.

Unpacking the System 08/03/30 AM10:03

HbA1c Glucose If the cover is open, the icon of "Close the cover" will
Your CLOVER A1c Self is delivered in 1 shipping carton.
TM

1.Carefully take out the contents of the shipping carton. be displayed.

2.Please check physical damage on the carton and system Close the cover, and the warming up will start.
3.If the system is damaged, please contact to your representative in your area.
4. Make sure all items are included with your system, and keep them for future use.

Installing Connections
System Connections:
1. Power Button
2. DC 9 V 08/03/30 AM10:04
3. USB port HbA1c Glucose
Remove
If the cartridge is inserted, the icon of "Remove the
4. Barcode Scanner port cartridge" will be displayed.
1 2 3 4 5 5. Thermal Printer port (Serial port RS 232) Take out the cartridge and close the cover.
Warming up will start.
Connect the System Power
1. Ensure that the system power button is in the off position.
2.Connect the power code of the system to appropiately grounded AC electrical outlet.

CLOVER A1c Self • 10 • CLOVER A1c Self • 11 •

9. OPERATION 10. SETTING THE ANALYZER

9.2 Warming up Getting into set up mode

When the power is connected, the LCD will display 'Warming up' until the device gets
ready for the test. In stand-by mode, press the button and hold for
Warming up will take approximately 5 minutes depending on the ambient temperature
3 seconds. Choose between set up and memory mode
by pressing or buttons. Then, press
Set up Memory button to select.
While warming up, the CLOVER A1cTM Self performs
hardware function test to check internal opticsand the
mechanical system.

Date
9.3 Stand-by
After warming up, the analyzer goes into 'Stand-by' mode. Two different 'Stand-by' Select the date format ('yy/mm/dd' or 'mm/dd/yy' or
icons will be displayed when glucose module is used. DATE yy/mm/dd 'dd/mm/yy') by pressing the or , then press
08 / 03 / 30 .
08/03/30 AM10:00 08/03/30 AM10:01
HbA1c Glucose HbA1c Glucose Note: The analyzer will automatically go into Next, set the date by pressing the or bottens
TIME 12h
'stand-by' mode after a test. You may hold the arrow keys to scroll through the
The cartridge has to be pulled out and AM 08 : 00
dates faster.
the cover closed.

• Glucose Module Inactive • Glucose Module Active

9.4 Power Save

After 30 minutes in 'stand-by' mode, without any action, the Analyzer goes into 'Power
Save' mode. Time
To come back to 'Stand-by' mode, press shortly, or just open the cover for
testing.
DATE yy/mm/dd Select the time format by pressing the or
08 / 03 / 30 buttons, then press .
TIME 12h
12h for standard time / 24h for military time
AM 08 : 00

CLOVER A1c Self • 12 • CLOVER A1c Self • 13 •

10. SETTING THE ANALYZER 10. SETTING THE ANALYZER

HbA1c test result unit Printer use

Select the desired HbA1c test unit by pressing the
or , then press . Select whether or not to use the printer by pressing
[ NGSP ] [ IFCC ] or , then press .
HbA1c Unit If 'Use' is selected, Printer mode option is displayed.
Printer
08/03/30
HbA1c
AM10:08
Glucose
08/03/30
HbA1c
AM10:08
Glucose
If 'Not Use' is selected, LCD contrast control is
NGSP IFCC
7.3% 56 Use Not Use displayed.
mmol/mol
ID: ID:

Glucose test result unit

Printer mode
Select the desired blood glucose test unit by pressing
Once the printer option is selected, choose either
the or , then press .
'Automatic' or 'Manual' by pressing the and arrows.
Glucose Unit [ mg/dL ] [ mmol/L ] • Automatic: Result is printed automatically after each
test.
08/03/30 AM10:08 08/03/30 AM10:08
mg/dL mmol/L HbA1c Glucose HbA1c Glucose • Manual: Result will only be printed when the print
137 7.5 button is pressed.
mg/dL mmol/mol
ID: ID:

Barcode use LCD contrast control

Select whether or not to use the barcode system by
pressing or , then press .
Set up the contrast desired, by pressing the or ,
Barcode Use LCD Contrast then press .

+ 10
Use Not Use

CLOVER A1c Self • 14 • CLOVER A1c Self • 15 •

11. TESTING HbA1c 11. TESTING HbA1c

PROCEDURE STEP 2.
Open the cover of the CLOVER A1c™ Self analyzer, when the analyzer is in 'Stand-by'
The CLOVER A1c™ Self test may be performed on capillary blood taken from a mode, displaying the 'Open the cover' icon.
fingerstick or on venous blood collected using EDTA, heparin, oxalate as an
anticoagulant.
08/03/30 AM10:00
HbA1c Glucose
Test Procedure

IMPORTANT : Please read thtough and familiarize yourself with the contents of this
instruction manual and the CLOVER A1c™ Self System operation
before using the system for the first time.

IMPORTANT : Details on analyzer functionality, please refer the analyzer

instruction for use.
STEP 1.
When the power is connected, the LCD will display 'Warming up' until the device gets
ready for the test. STEP 3.
Approximately 5 minutes depending on the environment temperature. Remove one pouch from storage.
Tear the pouch open on the side with the serrated edge.
DO NOT use scissors to cut open pouch.
Scissors can damage the reagent pack.
While warming up, the CLOVER A1c™
Self performs hardware funtionality test Please use the test cartridge within 30 minutes after tearing the pouch.
to verify that the internal optics and the
mechanical system are operating correctly. Warming up CAUTION: When handling the reagent pack and cartridge, be careful not to touch
the Code Area of the front side, nor the bead window at the back side. Any dirt or
contamination of both areas, may cause erroneous test values.

Code Area
IMPORTANT : Do not move the analyzer during the ‘Warming up’.

Bead Window

CLOVER A1c Self • 16 • CLOVER A1c Self • 17 •

11. TESTING HbA1c 11. TESTING HbA1c

STEP 4. STEP 5-1.

Carefully insert the cartridge into the cartridge compartment once the 'cartridge insert' Gently mix the reagent pack 5 ~ 6 times before applying blood sample.
icon is displayed. Hold the cartridge so that the barcode faces to the left.
Make sure a gentle snap is either heard or felt to ensure proper placement.

08/03/30 AM10:00
HbA1c Glucose

CAUTION : Do not mix it too violently. It may make some bubbles. If you drop the
test cartridge and the bubble is arisen in the test cartridge, please wait
until the bubble sinks.
NOTE : Do not force the cartridge into the system. The cartridge is designed to fit
only in one way.
Environmental influences(e.g. air humidity and light) on the test cartridge
may cause damage to the test cartridges and lead to false measurements
or error messages.
STEP 5-2.

STEP 5.
The LCD will then display the ‘Reagent Pack’ and ‘Applying sample’ icon.
Place the blood sample up to the sample collecting
area by softly touching the blood sample.
make sure that the sample area is completely filled.

08/03/30 AM10:02 08/03/30 AM10:02

HbA1c Glucose HbA1c Glucose

IMPORTANT : After the capillary tip is filled with sample, analysis must begin
within 5 minutes.

CLOVER A1c Self • 18 • CLOVER A1c Self • 19 •

11. TESTING HbA1c 11. TESTING HbA1c

Sample Collection and Handling. - Venous Blood Process

Capillary whole blood obtained from a fingertip can be used for HbA1c test. For venous whole blood samples, acceptable Anti-coagulants are EDTA, heparin and
A 4uL blood sample is needed for the HbA1c. these blood samples may be stored at -70°C to 5°C(-94°F to 41°F) for two weeks, or
up to 25°C(77°F) for one week.
Stored blood should be whole blood, not as hemolysate. Allow blood samples to reach
- Capillary Blood Process room temperature, 20~25°C(68-77ºF).
Prick the fingertip of the patient to get a minimum of 4uL of capillary blood sample, and Anticoagulated blood should be mixed well prior to testing. Remove the stopper from
touch softly the blood sample with the capillary tip of the Reagent Pack. The blood is the holder and take out a drop of blood sample on a clean container. Softly touch the
automatically drawn up. Make sure that the sample area is completely filled. sample collection area of the Reagent Pack on the blood sample, and wait until the
sample area is completely filled.

Sample Collecting Area of Reagent Pack

NOTE : If blood is stained outside the sample area, carefully wipe the stain out with
a tissue. Do not allow the wiping tissue to touch the open end of the sample
area of the capillary tip.

CAUTION : There is a potential risk of infection. Medical staff and other persons
using the CLOVER A1c™ Self analyzer to perform measurements for more than
on patient must be aware that any object coming into contact with human blood is
a potential source of infection.

▪ Use gloves.
▪ Dispose of used test cartridges in a sturdy container with lid.
[ adequate ] [ inadequate ] ▪ Follow all hygiene and safety regulations in force locally.

IMPORTANT : Once the reagent pack is filled with the blood sample, analysis must
begin immediately.

CLOVER A1c Self • 20 • CLOVER A1c Self • 21 •

11. TESTING HbA1c 11. TESTING HbA1c

STEP 6. STEP 8.
Insert the reagent pack into the cartridge in the analyzer. The ‘close the cover’ icon will The timer will countdown from 5 minutes until the HbA1c% is displayed.
be displayed.

08/03/30 AM10:03 08/03/30 AM10:08

HbA1c Glucose
HbA1c Glucose

5.4%
ID:

NOTE : Do not force the reagent pack into the system. The reagent pack is NOTE : If you see “>14.0%” or “<4.0%” displayed, HbA1c% level may be above
designed to fit only in one way. 14.0% or below 4.0%, repeat testing. If the second result is again outside
this range, please contact your local customer support and service center.

STEP 7. STEP 9.
The test starts automatically once the cover is closed. After the test is done, open the cover of the analyzer. The display will show the 'cartridge
remove' icon. Take out the cartridge from the analyzer by gently pushing to the left and
pulling out.
08/03/30 AM10:03
HbA1c Glucose
08/03/30 AM10:09
4:30 HbA1c Glucose
Remove

IMPORTANT : Do not open the analyzer during the test.

Do not vibrate or move the analyzer during the test. CAUTION : Do not give strong impact to cartridge. Dispose all waste in
accordance with applicable national and /or local regulations.

CLOVER A1c Self • 22 • CLOVER A1c™ Self • 23 •

11. TESTING HbA1c 11. TESTING HbA1c

Expected values HbA1c standard test results

Code confirmation display after the test Mean blood glucose results are 10.0-15.0% Approximate Mean
Plasma Glucose*
lower.
In the event of an error in the process of recongnizing the cartridge code, the Non-Diabetic Range is 4.0~6.0% and the ADA GHB(%) mg/dL mmol/L Interpretation
analyzer asks for the type and code of the cartridge. most recent Clinical Practice Recommenda-
4 65 3.5
tion for diabetes specifies a treatment goal of
1. It asks to confirm if the cartridge is a test cartridge or a less than 7%. 5 100 5.5 Non-Diabetic
08/03/30 AM10:08 Range
HbA1c Glucose check cartridge. Take out the cartridge, and use the
6 135 7.5
Test to match the type of cartridge, and press to [Reference]
Cartridge confirm. The Diabetes Control and Complications Trial 7 170 9.5 ADA Target
OK?
(DCCT) : 8 205 11.5
a five-year progress report. Clin Chem 47
9 240 13.5
:1985–1992, 2001. Action
Defining the relationship between plasma 10 275 15.5 Suggested
glucose and HbA1c: analysis of glucose
08/03/30 AM10:08 2. After selecting the type of cartridge, use the to profiles and HbA1c in the Diabetes Control
11 310 17.5
HbA1c Glucose
match the code number of the cartridge, then press and Complications Trial. Diabetes Carel 25: 12 345 19.5
CODE
3961 to confirm, and the test result is displayed. 275-278, 2002
OK?
*Perform the A1C test at least two times a year in patients who are meeting treatment
goals (and who have stable glycemic control).
*Perform the A1C test quarterly in patients whose therapy has changed or who are not
meting glycemic goals.

Limitation of Procedure
The CLOVER A1c™ Self assay gives accurate and precise results over a range of total
Hemoglobin of 7 to 20 g/dL. Most patients will have hemoglobin concentrations within
those values. However, patients with severe anemias may have Hemoglobin concentra-
tions ower than 7 g/dL, and patients with polycythemia may have Hemoglobin concentra-
tions above 24 g/dL. Patients known to have these condition should be assayed by a test
employing a different assay principle if their Hemoglobin concentrations are outside of
the acceptable range.

CAUTION : Discard cartridge in proper container, according to your standard

laboratory procedures.

CLOVER A1c Self • 24 • CLOVER A1c Self • 25 •

12. REVIEWING RESULTS 12. REVIEWING RESULTS

STEP 1. STEP 3.

In stand-by mode, press the button for 3 seconds for or . The test results will appear chronologically starting with the most recent date.
Press either t he or button to select 'memory', then press . Press the and buttons to scroll through.

Memory HbA1c
No.47

7.2% 55
mmol/mol
ID:
Set up Memory 08/12/08 PM12:05

Memory HbA1c
STEP 2. No.46

Press either the or button to select between 'HbA1c' and 'Glucose', 5.4% 35 mmol/mol
then press . ID:
08/11/08 PM12:03

Memory

Memory HbA1c
HbA1c / Glucose No.45

5.9% 41 mmol/mol
ID: 22356789012341
08/10/08 PM12:35

CLOVER A1c Self • 26 • CLOVER A1c Self • 27 •

13. CHECKING THE SYSTEM 13. CHECKING THE SYSTEM

QUALITY CONTROL Daily check cartridge

The CLOVER A1c™ Self Check Cartridge checks that the optical and operating
systems of the Analyzer are working correctly.

For checking CLOVER A1c Self Analyzer only.

For self-testing use.

IMPORTANT : Please read through and familiarize yourself with the contents
of theCLOVER A1c™Self Analyzer Operation Manual before
using the system for the first time.

- Check Cartridge
When to Use the Daily check cartridge
• CLOVER A1c™ Self Daily Check Cartridge
• Once a day before samples are tested.
• CLOVER A1c™ Self Monthly Check Cartridge • After the analyzer has been moved.
• After an error message. (Er 1-7 or Er 7 or Er 3)
Storage Instruction
- The Check Cartridge must be protected from sunlight during storage; The Daily check cartridge, used to check the Analyzer, is composed of a cartridge
do not leave the check cartridge in direct sunlight for long periods of time.
in a pouch, without a reagent pack.
- Store the Check Cartridge at 2 ~ 32°C (36 ~90°F)
- Store the Check Cartridge at a Humidity < 90% Life-time : Up to the expiry date on the cartridge label.
- Always store the Check Cartridge in its protective packaging to prevent
scratchs that may affect the test result.
- If the Check Catridge is stored in the refrigerator, it must be allowed for an NOTE
hour to reach the room temperature before use. - Be careful in maintaining the Daily Check
Cartridge by keeping in the provided green
color pouch when not in use. Daily Check Cartridge

Precautions/Warings - The Daily check cartridge can be purchased

For checking CLOVER A1c™ Self Analyzer only.
For self-testing use only.

- For In Vitro Diagnostic Use. from local distributors. INFHC01AS

- Do not use the Check Cartridge beyond the expiration date printed on the Check
Cartridge Label and Pouch.
- Do not use the Check Cartridge if it has been stored incorrectly, or if it is dirty,
IMH09-09-018 Rev.2011-04-00

scratched, or damaged in any way.

CLOVER A1c Self • 28 • CLOVER A1c Self • 29 •

13. CHECKING THE SYSTEM 13. CHECKING THE SYSTEM

How to use the Daily check cartridge 4) Close the cover. The test starts automatically.

1) Open the Cover of CLOVER A1c™ Self Analyzer.

5) After 1 mimute ‘OK’ or ‘Er 2’ will be displayed.

2) Press for 3 seconds to enter into the Daily check cartridge mode.

‘OK’ : When the analyzer is ready to

be used.

‘Er 2’ : When the analyzer is not ready

to be used.

6) After the test is complete. Take out the cartridge.

3) Insert the Daily check cartridge while ‘Daily’ and ‘CHECK’ are
blinking.

NOTE : If an errer message is displayed, repeat the test. If is still displays Er 2

message ‘Do Not use the analyzer’.
NOTE : To leave the Daily check cartridge mode, press for 3 seconds.
Please contact your local representative for customer support.

CLOVER A1c Self • 30 • CLOVER A1c Self • 31 •

13. CHECKING THE SYSTEM 13. CHECKING THE SYSTEM

Monthly check cartridge How to use the Monthly check cartridge

1) Open the Cover of CLOVER A1c™ Self Analyzer.

2) Press to enter into the Monthly Check Cartridge mode.

When to Use the Monthly check cartridge

• Once a month before samples are tested.

• When there is a concern that the test result may be incorrect.
• After an error message. (Er 4 or Er 5)

The Monthly check cartridge, used to check the Analyzer, is composed of a cartridge
and a regent pack, just like the test cartridge, but without the capillary rod.

3) Insert the Monthly Check Cartridge while ‘Monthly’ and ‘CHECK’.

CAUTION
- Do not reuse.
- Do not use the Monthly Check Cartridge after the expiry date.

NOTE
- If Monthly Check Cartridge be reused, analyzer show up ‘Do not reuse!’.
- The Monthly check cartridge can be purchased from local distributors.

NOTE : To leave the Monthly check cartridge mode, press for 3 seconds.

CLOVER A1c Self • 32 • CLOVER A1c Self • 33 •

13. CHECKING THE SYSTEM 13. CHECKING THE SYSTEM

4) Gently mix the reagent pack 5 ~ 6 times before applying blood sample. 6) Close the cover. The test starts automatically.

IMPORTANT :
CAUTION : Do not mix it too violently. It may make some bubbles.
- Do not open the analyzer during the test.
If you drop the test cartridge and the bubble is arisen in the test
- Do not vibrate or move the analyzer during the test.
cartridge, please wait until the bubble sinks.

7) After 5 minutes ‘OK’ or errer message will be displayed.

5) Insert the Monthly Check Reagent Pack, when the ‘insert check reagent pack’
icon is displayed. Insert it respectively.

8) After the test is complete. Take out the cartridge.

08/03/30 AM10:09
HbA1c Glucose
Remove

NOTE : Do not contaminate sample collecting area(Capillary tip) of reagent pack.

NOTE : If an error message is displayed, repeat the check again. If it still displays
error message ‘Do Not use the analyzer’.
Please contact your local representative for customer support.

CLOVER A1c Self • 34 • CLOVER A1c Self • 35 •

13. CHECKING THE SYSTEM 13. CHECKING THE SYSTEM

HbA1c Control Solution 3) Gently mix the reagent pack 5~6 times and touch softly the control solution
If external quality control testing is desired, commercial controls from other with the capillary tip, so that the control solution is automatically drawn up
vendors may be purchased. into the sample area. Wait until the sample area is campletely filled with
Controls of human whole blood only can be used with the CLOVER A1c™ Self. control solution.
Please contact your local representative for technical support.

When to run a control test

ȳ
1) With each new shipment of test cartridges, even if the cartridge are from the same
lot as previously received.
2) With each new lot of test cartridges.
3) If there is concern that test result may be incorrect

WARNING
Use only CLOVER A1c™ Self HbA1c Control Solution with the CLOVER A1c™ Self CAUTION : Do not mix it too violently. It may make some bubbles.
system. If you drop the test cartridge and the bubble is arise in the test
cartridge, please wait until the bubble sinks.
How to test with the Control Solution
1) Open the Cover of CLOVER A1c™ Self Analyzer.
Reagent pack sample area

2) Insert the cartridge when the ‘Cartridge insert’ icon displayed.

[ adequate ] [ inadequate ]

IMPORTANT : Once the reagent pack is filled with the control solution,
analysis must begin immediately.

CLOVER A1c Self • 36 • CLOVER A1c Self • 37 •

13. CHECKING THE SYSTEM 13. CHECKING THE SYSTEM

4) Insert the reagent pack into the cartridge and close the cover to the analyzer. 7) After the test is complete. Take out the cartridge.

NOTE : Do not contaminate sample collecting area(Capillary tip) of reagent

pack.
NOTE : If an error message is displayed, repeat the check again. If it still displays
5) Close the cover. The test starts automatically. error message ‘Do Not use the analyzer’.

If the control test results fall outside the designated range, the following
sources of error may have occurred :
- Deterioration of the cartridge due to high humidity, heat, or over exposure to light.
- Deterioration of the control solution.

NOTE
IMPORTANT - Always repeat the QC test using a fresh cartridge from a new box or new box
- Do not open the analyzer during the test. or new lot. If the repeat test falls out of range at second time, proceed to the
- Do not vibrate or move the analyzer during the test. next possible cause.
- Repeat the quality control procedure with a fresh bottle of control solution
- Please contact your local representative for customer support.
6) The HbA1c% is displayed after 5 minutes.

NOTE :
The test result should be within the range speccified
on the manual of the respective control solution.

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14. OPTIONS 14. OPTIONS

14.1 Blood Glucose Test STEP 3. Once the strip icon display on the CLOVER A1c™ Self analyzer LCD,
The CLOVER A1c™ Self can test the blood glucose by simply connecting the glucose insert the blood glucose test strip into the blood glucose module.
module.

STEP 1. Prepare the test item for measuring glucose level using the module.

or

(3Sec glucose module) (5Sec glucose module)

STEP 4. Check the same code number between strip vial and CLOVER A1c™ Self
anlayzer LCD.

CAUTION
1. Yellow Glucose Module is for 3 Seconds product and the glucose test strip
should be ELEMENT™ test strip.
1. Green Glucose Module is for 5 Seconds product and the glucose test strip
C17
should be GlucoLab Auto-coding™ test strip C17 C17 or

STEP 2. Connect the blood glucose Module to the port located in the front side of
the Analyzer. STEP 5. Check the applying sample blood icon on the CLOVER A1c™ Self
anlayzerLCD.

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14. OPTIONS 14. OPTIONS

STEP 6. Collect the sample blood using the lancing device and apply it on the 14.2 Printing Test Results with the Thermal Printer
glucose test strip.
Connect the thermal printer to the analyzer with the interface cable(RS-232C).
The analyzer should be in stand-by mode.
On/Off 9V USB Código de barras Impressora

The printer is already pre-set to either manual or automatic printing.

STEP 7. The analyzer will display the blood glucose test result.. Please refer to page 15.
• Automatic : Prints automatically after every test.
• Manual : Prints only when printer button pressed.

When printer is in manual mode

or STEP 1. Press the printer button after the result is displyed.
3 5 123
mg/dl

STEP 8. Once the test is complete, slide the ejector button forward to remove
the glucose test strip from the glucose test module.
You don’t want more glucose test, disconnect the glucose test module
from the CLOVER A1c™ Self analyzer.
STEP 2. LCD will displayed ‘Current’ and ‘ALL’
STEP 3. Press or to select one or the other and or press .

• Current : Only that result will print.

• ALL : Every result in memory will print.

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14. OPTIONS 14. OPTIONS

Unpacking Installation

The below pictures show the items which should be included for the standard of
SRP-III Package. If any items are damaged or missing, please contact with our
local representatives for technical assistance. STEP 1.
Push both cover latches and open the cover.

STEP 3.
Insert a paper roll and close the cover.

SPR-III AC-DC adaptor(9V, 2A)

STEP 3.
After closing the cover cut the paper.

CAUTION
Interface cable(RS-232C) Paper Roll
- Don’t touch the print head. It can be very hot
after printing continuously for a long time.
- Make sure that the paper direction is correct.

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14. OPTIONS 14. OPTIONS

Specification 14.3 Scanner

CLOVER A1c™ Self accepts data input from the following barcode symbologies
Specification SRP-III
Code 93 standard includes check digit
Print Method Horizontal Direct Thermal Code 39 with optional check digit required
Code 128 standard includes check digit
CodaBar without check digit
Resolution 8dots/mm(384dots)

Number of Column 42 columnas ( 9x17) The analyzer is pre-set to use the barcoding system appropriately during the
32 columnas ( 12x4) set-up process. Please refer to page 14.

95 Alphanumeric, UPCA, UPCE, JAN8(EAN), The barcode scanner can be used to scan the patients ID.
Character set
CODE39, CODE93, COLE128, ITF, CODABAR All the patients’ information is stored in the analyzer for future reference. Connect
the barcode scanner to the analyzer.
Character Per Inch 16CPI
On/Off 9V USB Barcode Printer

Interface RS-232C/Parallel

Data biffer 4Kbytes or 45bytes

Print speed 35mm/sec (Max.)

Power 9V DC ± 10%
When performing your test with the barcode system
Power consumption Approx 2.0A(mean) STEP 1. Open the cover of CLOVER A1c™ Self
analyzer
Dimensions(mm) 136(M) x 202(L) x 89(H)
STEP 2. Insert the cartridge when the ‘Cartridge
insert’ icon is displayed.
Weight 500 g
STEP 3. The LCD display will prompt you to ‘scan
Design, Specifications are subject to change without notice. Ask factory for technical carcode’.
specifications before purchase and/or use. Whenever a doubt arises form this products,
please inform us immediately for technical cosultation without fail.

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14. OPTIONS 14. OPTIONS

14.4 Transfer Test Results to a Computer

STEP 4. Scan the desired barcode until the

Patient ID is displayed on the LCD.

NOTE
It is important that the labels be printed to the required specifications.
Reading errors may occur if any of the following conditions exist : Analyzer Computer
- The narrow bar width is too small
- The barcode length is too great
STEP 1. Connect the RS-232 cable from the analyzer to the PC while in
- The height is too small stand-by mode.
- The reader is held too far from the label
- The background reflection is too high or low On/Off 9V USB Barcode Printer

If the reader is not able to consistently read your labels, apply a test label of the format
being used to a new specimen tube and perform the barcode test.

If the reader is able to read the test label, the quality of your labels may be inadequate.
If the test label cannot be read, the reader itself could be the problem. STEP 2. Once connected, the analyzer will display ‘PC’.

Contact with our local representatives for technical assistance. STEP 3. Download the PC application program.

STEP 4. Once the program is downloaded, click the ‘Date Transfer’ icon
on your PC. The results from the analyzer will be transferred over.

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15. PRODUCT LIST 16. TROUBLESHOOTING

COMPONENTS GENERAL INFORMATION

If an operational or system problem occurs, an error code may display on the system
PRODUCT screen with an explanation of the problem. This section of the guide lists the various
ITEM CONTENTS
CODE errors and messages, along with a description and corrective actions. If the problem
1 Analyzer persists, record the error code and contact your local representative for technical
CLOVER A1c™ Self 1 Instruction for use
INFH01AS
support provider for assistance.
Analyzer 1 Exclusive Power Adapter
5 Fan Filters
ERROR CODE DESCRIPTION CORRECTIVE ACTION
1 Daily Check Cartridge
1 Monthly Check Cartridge Please power switch off and on again. If
Problem with the
>>> Optional Products
Er 1 analyzer system
the problem persists contact your local
representative.

CLOVER A1c™ Self 10 Test cartridges INFHS01AS Check cartridge may be damaged (bar
Test Cartridge 1 Instruction for use code label, reagent pack, surface of
Check Cartridge
CLOVER A1c™ Self
Er 2 error
cartridge etc.) or alien substance was
inserted into the check cartridge.
10 Monthly check cartridge INFHMC01AS
Check Cartridge
CLOVER A1c™ Self Press the button, remove the test
1 Daily check cartridge INFHDC01AS
Check Cartridge Problem with cartridge and then insert again. If the
CLOVER A1c™ Self 1 Glucose Test Module (3Sec) AC-CL0-1A1-02
Er 3 reading bar code
of test cartridge
‘reagent pack’ icon is displayed, you can
Glucose Test Modules 1 Instruction for use start the test. If the error persists, contact
(3Sec) your local representative.

CLOVER A1c™ Self 1 Glucose Test Module (5Sec)

Test cartridge may be damaged or has
Glucose Test Modules AC-CL0-1A1-02 residue on the outside (coding area).
1 Instruction for use Test Cartridge
(5Sec) Er 4 error
Please press button and remove the
cartridge. Insert a new test cartridge and
Thermal Printer 1 Thermal printer AC-CLO-1B0-01
1 Instruction for use perform the test again.

1 Barcode scanner The analyzer is unable to recognize the

Barcode Scanner AC-CLO-1C0-01 solutions (within the reagent pack). The
1 Instruction for use
Problem with
reagent pack may be damaged and leak
PC Cable 1 PC Cable AC-CLO-1D0-01 Er 5 reagent pack of
the test cartridge
reagent solution. Please press button
and remove the cartridge. Insert a new test
CLOVER A1c™ Self cartridge and perform the test again.
1 Fan fileter AC-CL0-1A2-01
Fan Filter

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16. TROUBLESHOOTING 16. TROUBLESHOOTING

ERROR CODE DESCRIPTION CORRECTIVE ACTION ERROR CODE DESCRIPTION CORRECTIVE ACTION

The cartridge is left Please insert a new test strip and

Test strip is
in the analyzer for Please press button and remove Er 11 damaged perform test again.
Er 6 an extended
period of time or
the cartridge. Insert a new test cartridge
and perform the test again.
the cover is left
open

Please wait for the LCD to display

The sample was
Opening the
cover while test or
Please press button and remove Er 12 inse rted too soon
‘Apply bood sample’ icon before
applying the sample for the test.
the cartridge. Insert a new test or check
Er 7 check is in
progress
cartridge and perform again.

Please make sure the equipment is

The ambient
within normal operating temperatures for
Problem with the Please re-connect the cable again. Lo temperature is
too low
at least 10 minutes and re-test.
Er 8 glucose module
connection
If problem persist, contact your local
representative.

Please make sure the equipment is

The ambient
within normal operating temperatures
Damaged
Please insert a new test strip and Hi temperature is
for at least 10 minutes and re-test
Er 9 glucose test
perform the test agaim. If the problem
paersists, open a new bottle and repeat
too high
strip
test.

The HbA1c test

Please insert a new test strip and Please use the check cartridge to
Problem with the tesult is lower
Er 10 auto-coding label
perform the test again. If the problem
persist, contact your local representa-
<4 % than 4.0%
validate the analyzer and re-test the
blood sample.
(20mmol/mol)
tive.

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16. TROUBLESHOOTING 17. SPECIFICATION

ERROR CODE DESCRIPTION CORRECTIVE ACTION Capillary whole blood,

SampleType
Venous blood with anticoagulant
The HbA1c test
Please use the check cartridge to
result is higher Sample Volume 4
>14% than 14.0%
validate the analyzer and re-test the
blood sample.
(130mmol/mol) Test Range 4.0~14.0%

Reading Time 5 minutes

Lo mg/dl The blood glucose
Please double check the accuracy of the Memory Capacity 200 test results
test result is lower
ou than 10mg/dl or
test strip by performing a control solution
test and re-test with blood sample. Wavelength 415 nm (normal)
0.6mmol/L
Lo mmol/L
Power Required DC 9 V-1.5 A

Hi mg/dl The blood glucose Please double check the accuracy of the Dimensions/Weight 200*200*139(mm) / 1.4kg
test result is higher test strip by performing control solution
ou than 600mg/dl or test and re-test with a fresh blood sample. Storage Temperature 10 ~ 35 (50 ~ 95 )
33.3mmol/L
Hi mmol/L Operating Temperature 17 ~ 32 (63 ~ 90 )

Relative Humidity Range 10% ~ 90%

The There is a problem Unplug the power adaptor and reconnect.

Analyzer with the power Option Glucose Test Module
If the problem still persists,
does not adaptor or the contact your local representative. PC Connection Cable
power on analyzer itself Thermal Printer
Barcode Scanner

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18. MAINTENSNCE 18. MAINTENSNCE

Recommended maintenance routine Replacing the Fan Fileter :

1) Cleaning the exterior Check the fan filters located on the backside of the analyzer regularly. Replace the
2) Changing the air filter fan filter if it is clogged by dust. Extra filters come with your system.
3) Cleaning the cartridge compartment

Cleaning the analyzer

1) Disconnect the analyzer before cleaning.
2) Dust the Analyzer by wiping with a soft, clean cloth.
3) Do not use liquid or aerosol cleaners.
4) If necessary, alcohol swab can be used to wipe out dirt, but other chemical
solutions should not be used. Cleaning solutions may cause damage to the
analyzer surface.
Filter Cover
Cleaning the cartridge compartment Filter
STEP 1. Turn the power off and disconnect the power cord before cleaning.

STEP 2. Rotate the cartridge compartment

forward with the compartment door STEP 1. Remove the fan filter cover.
open.

STEP 2. Take out the used fan filter and replace

STEP 3. Dampen a sponge swap with water or ethanol. with a new one carefully.

STEP 4. Gently wipe the cartridge compartment. Be careful not to drip any
liquids into the system. STEP 3. Close the fan filter cover.

NOTE
Additional Fan Filter can be purchased from our representatives, nearest in
your area.

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19. SAFETY 21. PRECAUTION

The analyzer has been fully tested according to the Electrical Safety Regulations 1. Analyzer should be located on the flat table.
(EN 61010-1).
2. CLOVER A1c™ Self system is a precise optical equipment. So, it should be
SAFETY TIPS installed in a stable place without vibration.

1) Do not disassemble the Analyzer. 3. Electric power should be stable.

2) Do not place the analyzer in places with high humidity.
3) Do not place the analyzer in polluted or dusted areas. 4. Analyzer and Cartridge should not be
4) Do not expose the analyzer to any impact, shock, or vibration. exposed to the direct sunlight.
5) Do not place the analyzer next to any chemical products.
6) Keep away from direct sun light.
7) Do not cover the ventilation openings on the back with any materials.
8) Do not touch the analyzer with any metallic or inflammable materials.
9) Keep away from strong electromagnetic fields.
10) Do not install near any potential electromagnetic sources.
5. Users should carefully follow the indicated Analyzer operating temperature and
Cartridge storage temperature.

20. DISPOSAL For checking CLOVER A1c Self Analyzer only.

For self-testing use.
For not reuse.

The Analyzer must be disposed accoding to the local regulations concerning the
disposal of electrical and electronic equipment.
6. Do not move or give any kind of impact while the Analyzer is under testing.
The Waste Electrical and Electronic Equipment (WEEE) regulation implement
provisions of the European Parliament and Council Directive 2002/96/EC 7. The bead inside the Reaction Solution of the Reagent Pack, might sink and be
ailmed to reducing the amount of EEE waste going for final disposal. coagulated after some period of time. So, users should shake the Reagent Pack
before testing, and visually check if the beads are not coagulated.
infopia Co., Ltd. as the manufacturer, has specific instructions for the recovery
of the analyzer.
Please contact our representatives in your area for the respective instructions
before disposing. Check Reaction Solution

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21. PRECAUTION 21. PRECAUTION

8. Cartridge should be kept at the same test environment beside the Analyzer 13. When test is done, after removing cartridge, if users find the below symptoms
at least 30 minutes before test. in inspecting the cartridge, users should test again because the test result may not
be orrect.
9. While collecting blood, users should contact the end of capillary tip slightly
to the blood sample not putting the tip deep into the blood sample.
Putting the capillary tip deep into the blood sample may cause high results
due to excessive blood sample.

Bead Window
Absorption Pad

1) If the bead window is not colored uniformly.

10. Do not apply too much pressure to the Reagent Pack when inserting it into 2) If Reagent is left in the cartridge not be absorbed
the Cartridge. Insert the Reagent Pack gently. Much pressure may cause fully into Absorption Pad.
the mixture of the two reagents resulting in bad result.

3) If bead is not accumulated fully in the bead

window. If the bead is accumulated just like
11. Firmly combine a reagent pack into half sized an so on.
cartridge with a mild pressure until
‘Tick’ sound from the cartridge.
4) If the cartridge has residue or some scratch
on the bead window.

5) If unusual sounds comes while operating.

12. If there is some material inside cartridge

holder, a cartridge cannot be firmly
positioned into the analyzer. In such
case, check the cartridge holder.
14. Besides, when any kind of errors happen as specified in the manual, refer
to the troubleshooting instructions from the Analyzer instruction for use.

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22. SYMBOL & DESCRIPTION 22. SYMBOL & DESCRIPTION

Symbol Description Symbol Description

This symbol indicates that the product complies This symbol indicates the position of inserting the
with the applicable directives of the European Union. reagent pack.

Consult instruction for use.

This symbol indicates a temperature hazard.

Used by
Temperature Limitation

Caution, consult accompanying documents

Do not reuse

Authorised representative in the European

Community. Date of Manufacturer

In vitro diagnostic medical device.

Keep away from sunlight

Batch code
Direct Current

Catalog number
Waste Electrical and Electronic Equipment

Serial number
This symbol indicates that the system is type A
equipment, which provides a particular degree of
Manufacturer protection against electric shock.

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CLOVER A1c Self • 64 • 65