OSANG Healthcare Infopia Clover A1c User manual
IMC01452 Rev.2017-11-02
INFH02B
OSANG Healthcare Co., Ltd.
132, Anyangcheondong-ro, Dongan-gu,
Anyang-si, Gyeonggi-do, Korea (14040)
www.osanghc.com
Obelis S.A
Bd.General Wahis 53,
1030 Brussels, Belgium
Tel : +(32) 2.732.59.54
Fax : +(32) 2.732.60.03
3
TABLE OF CONTENTS
1. INTENDED USE
2. GENERAL INFORMATION
3. PRINCIPLES OF OPERATION
4. CLOVER A1c®CONTENTS
5. STORAGE INSTRUCTIONS
6. DEVICE DESCRIPTION
7. LIST OF ICONS
8. INSTALLATION
9. OPERATION
10. SETTING THE ANALYZER
11. TESTING HbA1c
12. REVIEWING RESULTS
13. CHECKING THE SYSTEM
14. OPTION
15. TROUBLESHOOTING
16. SPECIFICATION
17. MAINTENANCE
18. SAFETY
19. DISPOSAL
20. PRECAUTION
21. SYMBOL & DESCRIPTION
4
4
5
6
6
7
8~9
10
11~12
13~15
16~25
26~27
28~38
39~43
44~46
47
48~49
50
51
52~54
55~56
4 5
1. INTENDED USE
2. General Information
The CLOVER A1c® analyzer is an IVD(In Vitro Diagnostic Device) device for measuring
Hemoglobin A1c by the well established method of boronate affinity. It is able to analyze
both capillary whole blood and venous blood. Anticoagulants may be used, such as
EDTA(ethylenediaminetetraacetic acid) and heparin etc. This CLOVER A1c® system is
designed to help controlling diabetes and it is intended to be used by professionals in
laboratories, clinics and hospitals. Same as all diagnostic tests, do not make a definitive
diagnosis of diabetes based on the result of
a single test. A physician should make a diagnosis after all clinical and laboratory
findings are evaluated.
The CLOVER A1c® Analyzer uses the reflectance spectrophotometer for measuring the
Hemoglobin A1c. It is easily validated with the Check Cartridge provided with the Analyzer
kit for quality assurance.
The Analyzer also includes a DC 9 V, 2A adapter. Using other adapters may affect the
analyzer and give inaccurate test results.
Calibration
The CLOVER A1c®Analyzer has been programmed to produce results that are
standardized to DCCT (Diabetes Control and Complications Trial).
The DCCT is a landmark multi-center trial which conclusively linked elevated HbA1c
level to the complications associated with Diabetes.
The DCCT showed the importance of improved glycemic control in reducing the risk and
progression of the complications of diabetes. Glycemic control was determined by the
measurement of Hemoglobin A1c. The ADA (American Diabetes Association) recom-
mends measurement of the Hemoglobin A1c levels of two to four times per user, with
less frequency in patients with stable control, and more frequency in patients with
unstable control.
3. Principles of Operation
3.1 Reflectance Spectrophotometry
The CLOVER A1c®system is a fully automated boronate affinity assay for the
determination of the percentage of Hemoglobin A1c(HbA1c%) in whole blood.
The CLOVER A1c®system Test Cartrideg includes a cartridge and reagent pack.
The reagent pack is pre-filled with reagent solution and rinsing solution. The reagent
solution contains agents that lyse erthrocytes and boronate bead that binds cis-diols of
glycated hemoglobin.
The blood sample (4µL) is collected at the sampling area of the reagent pack.
The reagent pack is then inserted into the cartridge, where the blood is instantly lysed
releasing the hemoglobin and the boronate resin binding the glycated hemoglobin.
The blood sample mixture is rotated to the measurement zone of the cartridge, where
the amount of total hemoglobin in the blood sample is measured by the reflectance of
the photo sensor, which consists of LED (Light Emitting Diode) and PD (Photo Diode).
The cartridge is then rotated so that the rinsing solution washes out non-glycated
hemoglobin from the blood sample, thus the amount of glycated hemoglobin can be
photometrically measured.
The ratio of glycated hemoglobin with respect to total hemoglobin in the blood sample
is calculated.
3.2 calculation of Results
'A' and 'B' are the slope and intercept factor to correct the value for DCCT calibration.
Total Hemoglobin
AB
6 7
4. CLOVER A1c
®
Contents
5. Storage Instructions
Contents
Upon receipt of the product, carefully inspect for any obvious physical damage.If any
damage is evident to the CLOVER A1c
®
Analyzer, please consult our authorizedrepre-
sentative in your area.
TheCLOVER A1c
®
Analyzer must be stored at temperatures between 10°C~35°C
(50~95°F). Test Cartridges must be stored between 2~32°C (36-90 °F) and at a relative
humidity between 10% to 90%.
1. CLOVER A1c
®
Analyzer
2. Instructions for Use
3. Exclusive Power Adapter
4. Fan Filters
5. Daily Check Cartridge
6. Monthly Check Cartridge
WARNING:
Do not modify this equipment without authorization of the manufacturer.
Lid
Printer Button
Mode Button
LCD Display
Arrow Buttons
6. Device Description
6.1 Analyzer
6.2 Test Cartridge
[ Cartridge ][ Reagent Pack ]
CAUTION:
Do not touch the cartridge code area. Fingerprints and scratches may affect
the recognition of cartridge barcode.
Reagent
Solution
Rinsing
Solution
Sample Area
Cartridge
Code Area
8 9
7. LIST OF ICONS
Icon FunctionName
Warming up
Warming up
It is displayed on the analyzer LCD
once it is powered on.
CHECK
CHECK
Open the lid of the analyzer.
Open the lid
Insert Test Cartridge into the analyzer.
Insert
Test Cartridge
Apply sample to sample area of reagent pack.
Apply sample to
sample area
Insert reagent pack with sample
into the analyzer.
Insert Reagent
Pack
Insert
Check Cartridge
Insert Check reagent pack into the analyzer.
Insert
Check Reagent
Pack
Analyzer is under 'Check Mode‘.
Insert Check Cartridge into the analyzer.
7. LIST OF ICONS
Icon FunctionName
Indicates that the analyzer is connected
to a PC.
PC Connection
Indicates that the thermal printer use
is active.
Printer
Select this icon to view the test results
in memory.
Memory
Select this icon to set up the analyzer.Set up
Remove the cartridge from the
analyzer.
Remove cartridge
Close the lid of the analyzer.
Close the lid
10 11
8. INSTALLATION
Overview
This section provides detailed installation instructions for the CLOVER A1c®.
You must follow the installation steps correctly to ensure proper installation, operation,
and service.
Place the system where it will not be subjected to extreme temperature variations. Avoid
proximity to open windows, direct sunlight, ovens, hot plates, open burners, radiators
and dry ice baths.
Do not place the CLOVER A1c®on the same bench with a source of vibration.
Provide bench space large enough to allow free air circulation around the system - 8cm
(3 inches) on all sides.
Your CLOVER A1c®is delivered in 1 shipping carton.
1. Carefully remove the contents of the shipping carton.
2. Inspect the carton and system for visible signs of damage.
3. If damage to the system exists, immediately file a complaint with the carrier.
4. Make sure all items are included with your system, and keep them for future use.
CAUTION
Do not drop or handle the system roughly. This can disturb internal calibrated optics
and electronics or cause other damages.
Always handle the system with care. The CLOVER A1c®Self is a precision system
and must be handled accordingly.
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.
Installing Connections
12345
System Connections:
1. Power Button
2. DC 9V adapter port
3. USB port (PC connection port)
4. Barcode Scanner port
5. Thermal Printer port (Serial port RS 232)
9. OPERATION
9.1 Power On
Connect the DC 9V adapter to the power port on the back side of the analyzer.
Make sure that the lid is closed before connecting the adapter.
On/off 9V USB Barcode Printer
After the system is properly installed, you can start the CLOVER A1c
®
.
To start the CLOVER A1c
®
, turn the power
switch to the 'ON' position.
If the lid is open, the icon of "Close the lid "
will be displayed.
Close the lid, and the warming up will start.
If the cartridge is inserted, the icon of
"Remove the cartridge" will be displayed.
Remove the cartridge and close the lid.
Warming up will start.
AM10:03
AM10:04
13/03/30
13/03/30
Remove
12 13
After warming up, the analyzer goes into 'Stand-by' mode.
W
a
rm
i
ng u
p
9. OPERATION
Note:The analyzer will automatically go into
'stand-by' mode after a test.
9.3 Stand-by
9.4 Power Save
After 30 minutes in 'stand-by' mode, without any action, the Analyzer goes into 'Power
Save' mode.
To Return to 'Stand-by' mode, press shortly, or just open the lid for testing.
When the power is connected, the displays shows 'Warming up' until the device is ready
for test.
Warming up will take approximately 5 minutes depending on the ambient temperature.
9.2 Warming up
While warming up, the CLOVER A1c®performs hardware
functionality test to verify that the internal optics and the
mechanical system are operating correctly.
13/03/30 AM10:00
Set up Memory
DATE yy/mm/dd
TIME 12h
13 / 03 / 30
AM 08 : 00
DATE yy/mm/dd
TIME 12h
13 / 03 / 30
AM 08 : 00
10. SETTING THE ANALYZER
Date
Getting into set up mode
In stand-by mode, press the button and hold for 3
seconds. Choose between set up and memory mode
by pressing
G
or
G
buttons. Then, press button
to select.
Time
Select the time format by pressing the
G
or
G
buttons, then press . 12h for standard time / 24h
for military time
Select the date format ('yy/mm/dd' or 'mm/dd/yy' or
'dd/mm/yy') by pressing the
G
or
, then press
Next, set the date by pressing the
G
or
G
bottens.
You may hold the arrow keys to scroll through the
dates faster.
14 15
10. SETTING THE ANALYZER
HbA1c test result unit
Select the desired HbA1c test unit by pressing the
or
, then press .
[ NGSP ][IFCC ]
NGSP IFCC
HbA1c Unit
ID: ID:
Barcode use
Select whether or not to use the barcode system by
pressing Gor , then press .
Barcode Use
Use Not Use
13/03/30
7.3%
13/03/30
56
mmol/mol
AM10:08 AM10:08
Set up the contrast desired, by pressing the
G
or
, then
press .
10. SETTING THE ANALYZER
Printer mode
Once the printer option is selected, choose either
'Automatic' or 'Manual' by pressing the
G
and
G
arrows.
• Automatic: Result is printed automatically after each test.
• Manual: Result will only be printed when the print button
is pressed.
LCD contrast control
Printer use
Select whether or not to use the printer by pressing
G
or
, then press .
If 'Use' is selected, Printer mode option is displayed.
If 'Not Use' is selected, LCD contrast control is
displayed.
Printer
UseNot Use
+ 10
LCD Contrast
16 17
11. TESTING HbA1c
The CLOVER A1c®test can be performed on capillary blood sample or on
venous whole blood collected using K2∙K3 EDTA, lithium heparin, sodium citrate or
sodium fluoride/ oxalate as an anticoagulant.
When the power is connected, the display will show ‘Warming up’ until the device is
ready for use. This will approximately 5 minutes depending on the ambient temperature.
IMPORTANT : Please read through and familiarize yourself with the contents of this
instruction manual and the CLOVER A1c® System operation
before using the system for the first time.
IMPORTANT : Do not move the analyzer during the ‘Warming up’.
PROCEDURE
Test Procedure
STEP 1.
Warming up
While warming up, the CLOVER A1c® performs
hardware funtionality test to verify that the internal
optics and the mechanical system are operating
correctly.
11. TESTING HbA1c
Open the Te st Cartridge pouch by tearing the pouch
on the side with serrated edge.
DO NOT use scissors to open the pouch
Scissors can damage the reagent pack.
STEP 3.
STEP 2.
CAUTION
When handling the Reagent pack and Cartridge, do not touch the cartridge code
area on the front or the bead window at the back. Any contamination of these area
may cause of erroneous values.
Open the lid of the CLOVER A1c
®
analyzer, when the analyzer is in 'Stand-by'
mode, displaying the 'Open the lid' icon.
Use the test cartridge within 2 minutes of opening.
08/03/30 AM10:00
Bead Window
Cartridge
Code Area
18 19
11. TESTING HbA1c
STEP 4.
Gently insert the cartridge into the cartridge compartment when ‘Insert Test Cartridge’ is
shown. Hold the cartridge with barcode facing left.
Ensure a gentle snap is either heard or felt to confirm proper placement.
STEP 5.
The display will show the ‘'Apply sample to sample area'' and 'Insert Reagent Pack' icon.
NOTE : Do not force the cartridge into the analyzer. The cartridge is
designed to fit only in one way.
13/03/30 AM10:00
13/03/30 AM10:02
13/03/30 AM10:02
Gently mix the reagent pack 5 ~ 6 times before applying blood sample.
STEP 5-1.
Apply the blood sample by gently touching the drop of
blood with the tip of the sampling area.
Ensure that the sampling area is completely filled.
STEP 5-2.
11. TESTING HbA1c
CAUTION : Do not mix too vigorously, it may cause air bubbles. If bubbles are
present wait until they disappear before testing.
IMPORTANT : Once the reagent pack is filled with the blood sample, analysis must
begin immediately.
20 21
11. TESTING HbA1c
Capillary whole blood obtained from a fingertip can be used for HbA1c test.
A 4uL blood sample is needed for the HbA1c.
Sample Collection and Handling.
Sample Collecting Area of Reagent Pack
- Capillary Blood Process
Prick the fingertip of the patient to get a minimum of 4uL of capillary blood sample, and
touch softly the blood sample with the capillary tip of the Reagent Pack. The blood is
automatically drawn up. Make sure that the sample area is completely filled.
IMPORTANT : Once the reagent pack is filled with the blood sample, analysis must
begin immediately.
11. TESTING HbA1c
- Venous Blood Process
Venous whole blood collected in tubes with K
2
∙ K
3
EDTA, lithium heparin, sodium citrate
or sodium fluoride/ oxalate as anticoagulants can be used.
Venous whole blood can be stored at 2~8ఁ (36~46ሥ) for 7 days with unbroken seal
(only 3 days when seal is broken) and at 20~25 ఁ (68~77ሥ) for 3 days.
Allow blood samples to reach room temperature. Anti-coagulated blood should be mixed
well prior to testing. Remove the stopper from the holder and take out a drop of blood
sample on a clean container. Softly touch the sampling area of the reagent pack on the
blood sample, and wait until the sampling area is completely filled.
NOTE : Do not wipe off excess blood outside the sampling area.
Do not touch the open end of the sampling area.
CAUTION : There is a potential risk of biological hazard.
All part of the CLOVER A1c® system should be considered potentially infectious.
• Use gloves.
• Dispose of used test cartridges in a sturdy container with lid.
• Follow all hygiene and safety regulations in force locally.
22 23
11. TESTING HbA1c
Insert the reagent pack into the cartridge in the analyzer. The ‘close the lid’ icon will be
displayed.
STEP 6.
The test starts automatically when the lid is closed.
STEP 7.
NOTE :Do not force the reagent pack into the cartridge, it will only fit one way.
IMPORTANT : Do not open the lid during test.
Do not vibrate or move the analyzer during test.
AM10:03
AM10:03
13/03/30
4:30
13/03/30
11. TESTING HbA1c
The measuring time is 5 minutes and the test result will be displayed (in % or mmol/mol).
STEP 8.
After the test is completed, open the analyzer lid. ‘Remove cartridge’ will be shown.
Remove the test cartridge from the analyzer by gently pushing it to the left and
pulling it out.
STEP 9.
CAUTION : Do not force the cartridge to remove it from the analyzer. Dispose all
waste in accordance with applicable national and/or local regulations.
NOTE : If the results “>14%” or “<4%” are displayed, repeat testing to confirm
result. If the second result also is outside the range, contact your local
distributor.
ID:
AM10:09
13/03/30
5.4%
13/03/30
Remove
AM10:08
24 25
11. TESTING HbA1c
Code confirmation display after the test
In the event of an error in the process of recongnizing the cartridge code, the
analyzer asks for the type and code of the cartridge.
1. It asks to confirm if the cartridge is a test cartridge or
a check cartridge. Take out the cartridge, and use the
G
to match the type of cartridge, and press to
confirm.
2. After selecting the type of cartridge, use the
G
to match the code number of the cartridge, then press
to confirm, and the test result is displayed.
AM10:08
AM10:08
Test
OK?
Cartridge
13/03/30
13/03/30
CODE
OK?
3961
11. TESTING HbA1c
Limitation of Procedure
TheCLOVER A1c
®
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
this range.
However, patients with severe anemia may have Hemoglobin concentrations lower than
7 g/dL, and patients with polycythemia may have Hemoglobin concentrations above 20
g/dL. Patients known to have these condition should be tested with another method for
HbA1c determination.
Expected values
The American Diabetes Association’s (ADA’s) 2012 Clinical Practice Recommendation
for diabetes specifies a treatment goal of less than 7% HbA1c.*
Expected values
26 27
12. REVIEWING RESULTS
In stand-by mode, press the button for 3 seconds for or .
Press either the
or
G
button to select 'memory', then press .
STEP 1.
Set up Memory
12. REVIEWING RESULTS
The test results will appear chronologically starting with the most recent date.
Press the
G
and
G
buttons to scroll through.
STEP 2.
13/11/02 PM12:05
ID:
7.2%55
mmol/mol
13/11/02 AM11:45
ID:
5.4%35
mmol/mol
13/11/02 AM11:45
5.9%41
mmol/mol
ID:22356789012341
No.47
No.46
No.45
28 29
13. CHECKING THE SYSTEM
QUALITY CONTROL
The CLOVER A1c
®
Check Cartridge checks that the optical and operating systems of the
analyzer.
Type of Check Cartridges
• CLOVER A1c
®
Daily Check Cartridges
• CLOVER A1c
®
Monthly Check Cartridges
Storage Instruction
• The Check Cartridge must be protected from sunlight during storage.
• Store the Check Cartridge at temperature 2-32ఁ (36-90ሥ).
• Store the Check Cartridge at humidity < 90%.
• Always store the Check Cartridge in its protective packaging to prevent scratches which
may affect the result.
• If refrigerated allow Check Cartridge reach room temperature for at least 1 hour before
use.
Precautions/ Warnings
• For In Vitro Diagnostic use.
• 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 stored incorrectly or if it is dirty, scratched or damaged.
13. CHECKING THE SYSTEM
13.1 Daily Check Cartridge
When to Use the Daily Check Cartridge
• Once a day before samples are tested.
• After the analyzer has been moved.
• After an error message. (Er 1 or Er 3)
The Daily Check Cartridge, used to check the analyzer, is composed of a cartridge
in a pouch, without a reagent pack.
Life-time : Up to the expiry date on the cartridge label.
NOTE ：Be careful in maintaining the Daily Check Cartridge by keeping in the
provided blue color pouch when not in use.
＊ The Daily Check Cartridge can be purchased from local distributors
。
30 31
13. CHECKING THE SYSTEM
3) Insert the Daily Check Cartridge while ‘Daily’ and ‘CHECK’ are blinking.
2) Press
G
for 3 seconds to enter into the ‘Daily Check’ mode.
1) Open the lid CLOVER A1c
®
Analyzer
How to use the Daily Check Cartridge
NOTE :To leave the ‘Daily Check’ mode, press
G
for 3 seconds.
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13/03/30
13/03/30
13. CHECKING THE SYSTEM
4) Close the lid. The test starts automatically.
5) After 1 mimute ‘OK’ or error message will be displayed.
6) Press ( ) and remove the Daily Check Cartridge when the test is completed.
NOTE : If an error message is displayed, repeat the test. If it still displays error
message, do not use the analyzer.
Please contact your local representative for customer support.
13/03/30 13/03/30
13/03/30
13/03/30
32 33
13. CHECKING THE SYSTEM
NOTE
- If Monthly Check Cartridge be reused, analyzer show up ‘Do not reuse!’.
- The Monthly Check Cartridge can be purchased from local distributors.
13.2 Monthly Check Cartridge
CAUTION
• Do not use the Monthly Check Cartridge after the expiry date.
• The Monthly Check Cartridge can be purchased from local representative.
• Do not reuse.
[ Monthly Check Cartridge ][Monthly Check Reagent Pack ]
Reagent
Solution
Rinsing
Solution
When to Use the Monthly Check Cartridge
• When there is a concern that the test result may be incorrect.
• After an error message. (Er 4 or Er 5)
• Once a month before samples are tested.
The Monthly Check Cartridge, used to check the analyzer, is composed of a reagent
pack, just like the Test Cartridge, but without the sampling area.
Cartridge
Code Area
13. CHECKING THE SYSTEM
2) Press
G
for 3 seconds to enter into the 'Monthly Check'
mode.
3) Insert the Monthly Check Cartridge while ‘Monthly’ and ‘CHECK’ are blinking.
NOTE :To leave the 'Monthly Check' mode, press
for 3 seconds.
How to use the Monthly Check Cartridge
1) Open the lid CLOVER A1c®Analyzer
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13/03/30
13/03/30
34 35
13. CHECKING THE SYSTEM
CAUTION :
5) Insert the Check Reagent Pack, when the ‘Insert Check Reagent
Pack’ icon is displayed, Insert it respectively.
4) Gently mix the Check Reagent Pack before use.
Do not mix too vigorously, it may cause air bubbles.
If bubbles are present wait until they disappear.
6) Close the lid. The test starts automatically.
13/03/30
13/03/30 13/03/30
13. CHECKING THE SYSTEM
7) After 5 minutes ‘OK’ or error message will be displayed.
8) Press ( ) and remove the Monthly Check Cartridge when the
test is completed.
NOTE : If an error message is displayed, repeat the test again. If it still
displays error message, do not use the analyzer. Please contact
your local representative for customer support.
AM10:09
13/03/30
Remove
13/03/30
36 37
13. CHECKING THE SYSTEM
2) Insert the cartridge when the ‘Insert Test Cartridge’ icon displayed.
13.3 HbA1c Control Solution
If external quality control testing is desired, commercial controls from other vendors
may be purchased.
Controls of human whole blood only can be used with theCLOVER A1c®.
Please contact your local representative for technical support.
1) Open the lid of the CLOVER A1c®analyzer.
How to test with the Control Solution
3) Mix the reagent pack gently 5~6 times and touch softly the control solution with the tip
of sampling area, so that the control solution is automatically drawn up into the sampling
area. Wait until the sampling area is completely filled with the control solution.
13/03/30
13/03/30
13. CHECKING THE SYSTEM
[ adequate ][inadequate ]
4) Insert the reagent pack into the cartridge compartment of the analyzer and close
the lid.
13/03/30
13/03/30
13/03/30
38 39
13. CHECKING THE SYSTEM
5) Close the lid. The test starts automatically.
The test result should be within the range specified on the manual of the respective
control solution.
13/03/30 13/03/30
If the control 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.
Corrective action
- Always repeat the QC test using a fresh cartridge from a new box or new lot.
If the repeat test falls out of range a second time, proceed to the next possible cause.
- Repeat the quality control procedure with a fresh bottle of control solution.
- Contact your local representative for customer support.
5.9%41
mmol/mol
No.030
13/11/02 AM11:45
ID:
14. OPTIONS
Printer in manual mode
STEP 1. Press the printer button after the result is displyed.
STEP 2. LCD will displayed ‘Current’ and ‘ALL’
14.1 Printing Test Results with the Thermal Printer
Connect the thermal printer to the analyzer with the interface cable(RS-232C).
The analyzer should be in stand-by mode.
The printer is already pre-set to either manual or automatic printing.
Please refer to page 15.
• Automatic :Prints automatically after every test.
• Manual :Prints only when printer button pressed.
On/Off 9V USB Barcode Printer
• Current :Only that result will print.
• ALL :Every result in memory will print.
STEP 3. Press
G
or
G
to select one or the other and or press .
NOTE : Refer to the printer manual for details of printer setting.
Table of contents
