HemoCue HbA1c 501 Operating Manual

TABLE OF CONTENTS 2

2. GENERAL INFORMATION

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3. PRINCIPLES OF OPERATION

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4. HemoCue® HbA1c 501 Analyzer CONTENTS

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5. STORAGE INSTRUCTIONS

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6. DEVICE DESCRIPTION

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7. LIST OF ICONS

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8. INSTALLATION

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9. OPERATION

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10. ANALYZER SET UP

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11. RUN a HbA1c TEST

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12. REVIEWING RESULTS

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13. SYSTEM CHECK

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14. OPTIONS

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15. PRODUCT LIST

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16. TROUBLESHOOTING

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17. SPECIFICATION

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18. MAINTENANCE

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19. SAFETY

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20. DISPOSAL

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21. PRECAUTION

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22. SYMBOLS & DESCRIPTIONS

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1. INTENDED USE

1. INTENDED USE The Hemocue® HbA1c 501Test Cartridge, together with the Hemocue® HbA1c 501 Analyzer, which are parts of the Hemocue® HbA1c 501 system provides a convenient method for measuring the percentage of hemoglobin A1c (HbA1c %) in both capillary and anticoagulated venous whole blood samples. The test is for point of care use to monitor glycemic control in patients with diabetes mellitus. The Hemocue® HbA1c 501 system uses a boronate affinity assay to separate the glycated hemoglobin fraction from the nonglycated fraction. The Hemocue® HbA1c 501 system is intended to be used by professionals in laboratories, clinics and hospitals. IMPORTANT: Please read through and familiarize yourself with the contents of this operating manual before using the system for the first time.

2. GENERAL INFORMATION The HemoCue® HbA1c 501 system is a small, portable, and fully automated pointof-care system for all healthcare environments. The system delivers rapid results with laboratory equivalent accuracy and precision across all test parameters. The HemoCue® HbA1c 501 system may be used as a basic test system where the user manually records the results, or as an advanced system where accessories enable automatic printing of results, input of patient and operator identification numbers, and full connectivity to a PC. This makes the system highly versatile as it can be tailored to specific user needs. This manual contains all the information needed to operate and maintain the HemoCue® HbA1c 501 system.

3. PRINCIPLES OF OPERATION The HemoCue® HbA1c 501 system is a fully automated boronate affinity assay for determination of the Hemoglobin A1c percentage (HbA1c %) in whole blood. The Test Cartridge consists of a cartridge and a reagent pack containing the reagents necessary for the determination of hemoglobin A1c, with a sampling area for blood collection. The reagent pack is pre-filled with reagent solution and rinsing solution. The reagent solution contains agents that hemolyse erythrocytes and bind hemoglobin specifically as well as a boronate resin that binds to the cis-diols of glycated hemoglobin. 2

3. PRINCIPLES OF OPERATION

The reagent pack containing the blood sample is inserted in HemoCue® HbA1c 501 Analyzer (in which the cartridge has been placed). The cartridge is automatically rotated, placing the blood sample in the measuring zone. The total hemoglobin is photometrically measured by the diffused reflectance of the optical sensor composed of both a LED (Light Emitting Diode) and a PD (Photo Diode). The assembled cartridge is rotated and the rinsing solution washes out nonglycated hemoglobin from the blood sample, enabling photomectical measurement of glycated hemoglobin. The ratio of glycated hemoglobin and total hemoglobin is calculated. HbA1c % = A x [

HbA1c x 100 ] + B Total Hemoglobin

Where ‘HbA1c’ and ‘Total Hemoglobin’ are the signals obtained from the HemoCue HbA1c 501 system, ‘A’ and ‘B’ are the slope and intercept factors to correct the value for the calibration standard of NGSP. * NGSP: National Glycohemogolbin Standardization Program

4. HemoCue® HbA1c 501 Analyzer CONTENTS At delivery carefully inspect the product for any obvious physical damage. If any damage is evident, please consult your local distributor. Contents 1. Hemocue® HbA1c 501 Analyzer

4. Fan Filters

2. Operating Manual

3. Exclusive Power Adapter

6. Monthly Check Cartridge

5. Daily Check Cartridge

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

5. STORAGE INSTRUCTIONS The HemoCue® HbA1c 501 Analyzer must be stored at 10-35°C (50-95°F). Test Cartridges must be stored at 2-32°C (36-90 °F) and at a relative humidity of 10-90% until expiry date printed on the package.

6. DEVICE DESCRIPTION 6.1 Analyzer Lid Display Mode Button Arrow Buttons

Printer Button

Power & Connector

6.2 Test Cartridge Cartridge

Reagent Pack Reagent Solution

Rinsing Solution

Cartridge Code Area Safety Guard Sampling Area

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7. LIST OF ICONS Name

Function Displayed on the analyzer when turned on.

Warming up

Open the lid of the analyzer.

Open the lid Monthly Check Mode

Display Monthly Check mode on Analyzer.

Daily Check Mode

Display Daily Check mode on Analyzer.

Insert Cartridge

Insert Cartridge into the analyzer.

Filling sample to Sampling area

Fill blood sample to Sampling area of reagent pack.

Insert Reagent Pack

Insert reagent pack with blood sample into the analyzer.

Close the lid

Close the lid of the analyzer.

Remove cartridge

Remove the cartridge from the analyzer.

PC Connection

The analyzer is connected to a PC.

Printer

The thermal printer use is active.

Memory

View saved test results.

Set up

Select this icon to set up the analyzer. 5

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Icon

8. INSTALLATION Overview This section provides detailed installation instructions for the HemoCue® HbA1c 501 Analyzer. The installation steps must be followed correctly to ensure proper installation, operation, and service. CAUTION Always handle the analyzer with care. Do not drop or misuse. The calibrated optics, electronics or other internal parts may be disrupted or damaged. Do not expose the HemoCue® HbA1c 501 Analyzer to extreme temperature variations. Avoid open windows, direct sunlight, ovens, hot plates, open burners, radiators and dry ice baths. Place the Hemocue® HbA1c 501 Analyzer on a rigid surface, free from any vibration. Unpack the Analyzer Your Hemocue® HbA1c 501 Analyzer is delivered in a shipping carton. 1. Carefully remove the contents from the shipping carton. 2. Inspect the carton and analyzer for any visible damage. 3. Make sure that all items are included. 4. If any damages is found or parts are missing, contact your local distributor. Installing Connections Analyzer Connections: 1. Power Button 2. DC 9 V adaptor port 3. USB port 4. Barcode Scanner port 5. Thermal Printer port & PC Connection Port (RS 232) 1

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3

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Power connection 1. Ensure that the analyzer power button is off and the lid is closed. 2. Connect the power adaptor to the analyzer (port 2) to appropriate grounded AC electrical outlet.

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9. OPERATION

On/Off 9V

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9.1 Power On USB Barcode

Printer

After proper installation, start the HemoCue® HbA1c 501 Analyzer by turning the power switch “ON”. If the lid is open, the icon "Close the lid" is displayed. Close the lid - warming up will start.

If the cartridge is inserted, the icon "Take out the cartridge" is displayed. Take out the cartridge and close the lid. Warming up will start.

9.2 Warm up When the power is connected, the display will show 'Warming up' until the device is ready for use. Warming up will take approximately 5 minutes depending on the ambient temperature. While warming up, the HemoCue® HbA1c 501 Analyzer performs hardware functionality test to verify that the internal optics and the mechanical system are operating correctly.

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9. OPERATION 9.3 Stand-by After warming, the Analyzer switches to 'Stand-by' mode.

9.4 Power Save After 30 minutes in 'stand-by' mode, without action, the Analyzer switches to 'Power Save' mode. To return to 'Stand-by' mode, press quickly, or open the lid for testing.

10. ANALYZER SET UP Getting into set up mode In stand-by mode, press the button and hold for 3 seconds. Choose between set up and data mode by pressing or button. Press button to select. Choose set-up mode. Date Select the date format ('yy/mm/dd' or 'mm/ dd/yy' or 'dd/mm/yy') by pressing or , press . Next, set the date by pressing or button. Hold the arrow keys to scroll through the dates faster. Time Select the time format by pressing the or button, then press . 12h for standard time / 24h for military time.

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10. ANALYZER SET UP

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HbA1c test result unit Select HbA1c test unit by pressing the or , then press . [ NGSP ]

[ IFCC ]

Barcode use Select to use the barcode system or not by pressing or , then press .

Printer use Select to use the printer or not by pressing or , then press If 'Use' is selected, Printer mode option is displayed.

Printer mode After printer option is selected, choose 'Automatic' or 'Manual' by pressing the or . • Automatic: Result is printed automatically after each test. • Manual: Result will only be printed when print button is pressed.

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11. RUN a HbA1c TEST Procedure Blood Sample The HemoCue® HbA1c 501 test can be performed on a capillary blood sample or on venous whole blood collected using K2EDTA, lithium heparin, sodium citrate or sodium fluoride/oxalate as an anticoagulant. Test Procedure STEP 1. When the power is connected, the display will show 'Warming up' until the device is ready for use. This will take approximately 5 minutes depending on the ambient temperature.

IMPORTANT: Do not move the Analyzer during ‘Warming up’. STEP 2. Open the lid of the HemoCue® HbA1c 501 Analyzer, when the 'Open the lid' icon is shown.

STEP 3. Open the cartridge package by tearing the pouch on the side with the 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. 10

11. RUN a HbA1c TEST

Cartridge Code Area Bead Window

STEP 4. Carefully insert the cartridge into the cartridge compartment when the ‘Insert Cartridge’ icon is displayed. Hold the cartridge with barcode facing left. Ensure gentle snap is heard or felt to confirm proper placement.

NOTE: Do not force the cartridge into the compartment. The cartridge is designed to only fit one way. STEP 5. The display will show the icon ‘Insert Reagent Pack’ and ‘Filling sample to sampling area’.

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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 areas may cause erroneous values.

11. RUN a HbA1c TEST STEP 5-1. Gently mix by turning the reagent pack back and forth 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. Capillary whole blood from fingertip and venous whole blood can be used for HbA1c test. 4 µL capillary whole blood from fingertip or venous whole blood is needed for HbA1c 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. IMPORTANT: Place the reagent pack in the cartridge compartment and start test within 30 seconds once blood has been applied. Sample Collection and Handling - Use of Capillary Blood Puncture the fingertip to get a minimum of 4μL of capillary blood sample. Gently touch the blood sample with the tip of the sampling area of the Reagent Pack. The blood is automatically drawn in via capillary action. Ensure that the sampling area is completely filled.

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11. RUN a HbA1c TEST [adequate]

sampling area [inadequate] Use of Venous Blood Venous whole blood collected in tubes with K2EDTA, lithium heparin, sodium citrate or sodium fluoride/oxalate as an anticoagulant can be used. Venous whole blood can be stored at 2-8°C for 7 seven days with unbroken seal (only 3 days when seal is broken) and at 20-25°C for 3 days. Mix the tube thoroughly prior to testing. Open the lid and take out one drop of blood with a pipette. Place a drop of blood on a hydrophobic surface. Gently touch the drop of blood with the tip of the sampling area of the reagent pack. Ensure that 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 parts of the HemoCue® HbA1c 501 System should be considered potentially infectious. • • •

Use gloves Dispose used test cartridges in a sturdy container with lid Consult local environmental authorities for proper disinfection procedures as well as disposal of consumables

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Reagent pack sampling area

11. RUN a HbA1c TEST STEP 6. Insert the reagent pack in the cartridge and gently push into cartridge compartment of the analyzer. The icon ‘Close the lid’ will be displayed.

NOTE: Do not force the reagent pack into the cartridge, it will only fit one way. STEP 7. The test starts automatically when the lid is closed.

IMPORTANT: Do not open the lid during testing. Do not move the analyzer during testing. Do not expose the analyzer to vibration during testing. STEP 8. The HbA1c result displays after 5 minutes.

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11. RUN a HbA1c TEST

STEP 9. After the test is completed, open the analyzer lid. The display will show 'Remove Cartridge'. Take out the cartridge from the analyzer by gently pushing it to the left and pulling it out.

CAUTION: Do not force the cartridge to remove it from the analyzer. Dispose all waste in accordance with applicable national and/or local regulations. Code confirmation display after testing If an error in the cartridge code recognition process occurs, the analyzer will ask for type and code of the cartridge. 1.Take out the cartridge, use and to match the type of cartridge, press to confirm.

2. After selecting the type of cartridge, use and to match the code number of the cartridge, press to confirm, and the test result is shown.

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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.

11. RUN a HbA1c TEST Expected values ADA's most recent Clinical Practice Recommendation for diabetes specifies a treatment goal of less than 7.0 HbA1c %, 53 mmol/mol. [Reference] The American Diabetes Association’s (ADA’s) 2012 Clinical Practice. Recommendation for diabetes specifies a treatment goal of less than 7 HbA1c %, 53 mmol/mol. Limitation of Procedure The HemoCue® HbA1c 501 assay gives accurate and precise hemoglobin results in the range 7 to 20 g/dL. Most patients will have hemoglobin concentrations within this range. However, patients with severe anemia may have hemoglobin concentrations below 7 g/dL, and patients with polycythemia may have hemoglobin concentrations above 20 g/dL. Patients known to have these conditions should be tested with another method for determination of HbA1c%.

12. REVIEWING RESULTS STEP 1. In stand-by mode, press button for 3 seconds for Press or button to select Data, then press

or .

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STEP 2. The test results will appear chronologically starting with the most recent date. Press and buttons to scroll through the test results.

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13. SYSTEM CHECK

Type of Check Cartridges • HemoCue® HbA1c 501 Daily Check Cartridge • HemoCue® HbA1c 501 Monthly Check Cartridge Storage Instruction The Check Cartridges must be protected from sunlight during storage; • Store the Check Cartridge at 2 - 32°C (36 -90°F) and humidity < 90% • Always store the Check Cartridge in its protective packaging to prevent scratches which may affect the result. • If the Check Cartridge is refrigerated, allow to reach room temperature before use. (~1 hour). Precautions/Warings • For In Vitro Diagnostic Use. • Do not use the Check Cartridge beyond the expiration date. • Do not use the Check Cartridge if stored incorrectly or if it is dirty, scratched or damaged. Daily Check Cartridge

When to Use the Daily Check Cartridge • Once a day before samples are tested. • After moving the analyzer. • After an error message. (Er 1 or Er 3) The Daily Check Cartridge consists of a cartridge without a reagent pack (packed in a pouch). Life-time: Until stated expiration date printed on the cartridge label.

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Quality Control The HemoCue® HbA1c 501 Check Cartridge screens the optical and operating systems of the Analyzer.

13. SYSTEM CHECK NOTE: • Store the Daily Check Cartridge in its original package when not in use. • The Daily Check Cartridge can be purchased separately from your local distributor.

How to use the Daily Check Cartridge 1) Open the lid of the HemoCue® HbA1c 501 Analyzer.

2) Press

to enter Daily Check Cartridge mode.

3) Insert Daily Check Cartridge while ‘Daily Check’ is displayed.

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13. SYSTEM CHECK

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

6) After test completion, take out the cartridge.

NOTE: • If an error message is displayed, repeat the test. • Do not use the analyzer if the error persists. • To leave Daily Check mode, press .

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4) Close the lid. The test starts automatically.