OSANG Healthcare Infopia Clover A1c Instruction Manual

TABLE OF CONTENTS

1. INTENDED USE

2. GENERAL INFORMATION

3. PRINCIPLES OF OPERATION

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

8~9

11~12

13~15

16~25

26~27

28~38

39~43

44~46

48~49

19. DISPOSAL

20. PRECAUTION

21. SYMBOL & DESCRIPTION

52~54

55~56

1. INTENDED USE

3. Principles of Operation

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.

2. General Information

The CLOVER A1c 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 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) recommends 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.

Analyzer uses the reflectance spectrophotometer for measuring the

Analyzer has been programmed to produce results that are

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

Total Hemoglobin

'A' and 'B' are the slope and intercept factor to correct the value for DCCT calibration.

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4. CLOVER A1c® Contents

6. Device Description

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.

Contents

1. CLOVER A1c

2. Instructions for Use

3. Exclusive Power Adapter

4. Fan Filters

5. Daily Check Cartridge

6. Monthly Check Cartridge

Analyzer

6.1 Analyzer

Lid

LCD Display

Arrow Buttons

6.2 Test Cartridge

[ Cartridge ]

Reagent Solution

Mode Button

Printer Button

[ Reagent Pack ]

Rinsing Solution

5. Storage Instructions

The CLOVER A1c (50~95°F). Test Cartridges must be stored between 2~32°C (36-90 °F) and at a relative humidity between 10% to 90%.

WARNING:

Do not modify this equipment without authorization of the manufacturer.

Analyzer must be stored at temperatures between 10°C~35°C

6 7

Cartridge Code Area

Sample Area

CAUTION:

Do not touch the cartridge code area. Fingerprints and scratches may affect the recognition of cartridge barcode.

7. LIST OF ICONS

Icon

Warming up

CHECK

Warming up

Open the lid

Insert

Check Cartridge

Insert

Check Reagent

Pack

Insert

Test Cartridge

Apply sample to

sample area

FunctionName

It is displayed on the analyzer LCD once it is powered on.

Open the lid of the analyzer.

Analyzer is under 'Check Mode‘. Insert Check Cartridge into the analyzer.

Insert Check reagent pack into the analyzer.

Insert Test Cartridge into the analyzer.

Apply sample to sample area of reagent pack.

Icon

Close the lid

Remove cartridge

PC Connection

Printer

Memory

FunctionName

Close the lid of the analyzer.

Remove the cartridge from the analyzer.

Indicates that the analyzer is connected to a PC.

Indicates that the thermal printer use is active.

Select this icon to view the test results in memory.

Select this icon to set up the analyzer.Set up

Insert Reagent

Pack

Insert reagent pack with sample into the analyzer.

8 9

8. INSTALLATION

9. OPERATION

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.

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 and must be handled accordingly.

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.

Self is a precision system

9.1 Power On

Connect the DC 9V adapter to the power port on the back side of the analyzer.

On/off 9V USB Barcode Printer

Make sure that the lid is closed before connecting the adapter.

After the system is properly installed, you can start the CLOVER A1c®.

To start the CLOVER A1c switch to the 'ON' position.

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AM10:03

, turn the power

If the lid is open, the icon of "Close the lid " will be displayed. Close the lid, and the warming up will start.

Installing Connections

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)

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.

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AM10:04

Remove

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.

armi

9. OPERATION

10. SETTING THE ANALYZER

9.2 Warming up

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.

While warming up, the CLOVER A1c® performs hardware functionality test to verify that the internal optics and the

ng u

mechanical system are operating correctly.

9.3 Stand-by

After warming up, the analyzer goes into 'Stand-by' mode.

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Note: The analyzer will automatically go into 'stand-by' mode after a test.

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.

Getting into set up mode

Set up Memory

Date

DATE yy/mm/dd

13 / 03 / 30

TIME 12h

AM 08 : 00

Time

DATE yy/mm/dd

13 / 03 / 30

TIME 12h

AM 08 : 00

In stand-by mode, press the button and hold for 3 seconds. Choose between set up and memory mode by pressing

G

or Gbuttons. Then, press button

to select.

Select the date format ('yy/mm/dd' or 'mm/dd/yy' or 'dd/mm/yy') by pressing the Next, set the date by pressing the

G

or , then press

G

or Gbottens. You may hold the arrow keys to scroll through the dates faster.

Select the time format by pressing the

G

G

buttons, then press . 12h for standard time / 24h for military time

12 13

10. SETTING THE ANALYZER

HbA1c test result unit

HbA1c Unit

NGSP IFCC

Barcode use

Barcode Use

Use Not Use

Select the desired HbA1c test unit by pressing the  or



, then press .

[ NGSP ][ IFCC ]

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AM10:08

7.3%

ID:

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mmol/mol

ID:

AM10:08

Select whether or not to use the barcode system by pressing

G

or , then press .

Printer use

Printer

Use Not Use

Printer mode

LCD contrast control

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.

Once the printer option is selected, choose either 'Automatic' or 'Manual' by pressing the

G

and Garrows.

• Automatic: Result is printed automatically after each test.

• Manual: Result will only be printed when the print button

is pressed.

Set up the contrast desired, by pressing the Gor , then

LCD Contrast

press .

+ 10

14 15

11. TESTING HbA1c

PROCEDURE

The CLOVER A1c® test can be performed on capillary blood sample or on venous whole blood collected using K sodium fluoride/ oxalate as an anticoagulant.

EDTA, lithium heparin, sodium citrate or

2∙K3

Test Procedure

IMPORTANT : Please read through and familiarize yourself with the contents of this

instruction manual and the CLOVER A1c before using the system for the first time.

System operation

STEP 1.

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.

While warming up, the CLOVER A1c® performs hardware funtionality test to verify that the internal optics and the mechanical system are operating

correctly.

Warming up

STEP 2.

Open the lid of the CLOVER A1c mode, displaying the 'Open the lid' icon.

08/03/30 AM10:00

analyzer, when the analyzer is in 'Stand-by'

STEP 3.

Open the Test 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.

Use the test cartridge within 2 minutes of opening.

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.

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

16 17

Cartridge Code Area

Bead Window

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.

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NOTE : Do not force the cartridge into the analyzer. The cartridge is designed to fit only in one way.

STEP 5.

The display will show the ‘'Apply sample to sample area'' and 'Insert Reagent Pack' icon.

STEP 5-1.

Gently mix the reagent pack 5 ~ 6 times before applying blood sample.

CAUTION : Do not mix too vigorously, it may cause air bubbles. If bubbles are present wait until they disappear before testing.

STEP 5-2.

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.

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

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+ 21 hidden pages

OSANG Healthcare Infopia Clover A1c Instruction Manual

Specifications and Main Features

Frequently Asked Questions

User Manual