Avie™ A1c Reader User’s Manual TABLE OF CONTENTS I. Installation and Information Introduction Installation II. PRINCIPLES OF OPERATION The Avie™ A1c Reader The Avie™ A1c Test Cartridge III. PERFORMANCE CHARACTERISTICS & PRODUCT SPECIFICATIONS Performance Characteristics Product Specifications IV. OPERATING INSTRUCTIONS Initial Setup Performing a Test Collecting a Fingerstick Sample V. READER FUNCTIONS VI. CALIBRATION AND QUALITY CONTROL Calibration Quality Control VII.
I. INSTALLATION AND INFORMATION 1.1 Introduction This manual will provide you with useful information that you will need to know in order to perform Hemoglobin A1c (A1c) testing on the Avie™ A1c Reader. Note: Please read the entire manual before using the Avie™ system The Avie™ A1c System provides quantitative measurement of the percent of glycated hemoglobin levels in fingerstick (fresh capillary) whole blood samples.
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II. PRINCIPLES OF OPERATION The Avie A1C test system utilizes immunochemistry and general chemistry to quantify %A1C levels (glycated hemoglobin) in whole blood. The system consists of a small electronic instrument (Reader), a single-use diluent solution vial, and single-use reagent test cartridge. To perform one test, the Reader is turned on. When the LCD display denotes “Ready” a test cartridge is inserted into an unambiguous slot in the reader. A small amount of whole blood is added to the diluent vial.
Power Button: Turns the Reader on Display: Screen shows test results and error messages Test Cartridge Guide: Holds a test cartridge in place during testing Avie™ A1c Test Cartridge Application Well
III. PERFORMANCE CHARACTERISTICS AND PRODUCT SPECIFICATIONS 1.4 Performance Characteristics 1.4.1 Expected Values Approximate Mean Plasma Glucose* GHB(%) mg/dL mmol/l 4 65 3.5 5 100 5.5 6 135 7.5 7 170 9.5 8 205 11.5 9 240 13.5 10 275 15.5 11 310 17.5 12 345 19.5 Interpretation Non-Diabetic Range ADA Target# Above Target * Mean blood glucose results are 10-15% lower. Most blood glucose Readers are calibrated to read as plasma glucose. # Diabetes Care 2004;27 (Suppl.
Product Specifications 1.5 Battery lifetime: Variable. Approximately 50 tests. Mode of operation: Continuous Operating Conditions: Operating temperature: 65 to 82°F (18 to 28 °C) Operating humidity: 10% to 80% (non-condensing) Degree of protection against ingress of water: Ordinary equipment Power supply: AC: Input 120V 4 AA Alkaline 1.5-volt batteries Output: 6V @ 700 mA Battery voltage: 6V @ 700 mA Result range: A1c values 5% to 14% are reported.
Consult Instructions for Use prior to using the Avie™ A1c System Serial Number: The Reader serial number is located on the bottom of the Reader Temperature Limitation: The Avie™ A1c system is intended to be used between 65 to 82°F (18 to 28 °C) 10 to 80% non-condensing relative humidity Do Not Reuse: The Test Cartridges and Diluent vial are intended for one time use only Use By: Test Cartridge, Diluent, and Controls must be used by the expiration date marked on their labels.
IV. OPERATING INSTRUCTIONS 1.8 Initial Set-up Your Avie™ A1c Reader is ready to test when you receive it. Just plug it in and follow the instructions below. If you prefer to run the Reader on batteries, see section IX. Maintenance and Cleaning, for use of the battery pack. Running an A1c Test Check the expiration date on the cartridge vial, the diluent vial, and the control bottles. Do not use items after their expiration date.
6. Open the Diluent vial by holding on the bottom fin of the vial and twisting off the vial cap. You may lay the vial down as it will not leak unless squeezed. 7. Firmly apply a clean unused pipette tip onto the end of the pipette giving it a slight twist to make sure there is an airtight seal. 8. Obtain a sample by means of a fingerstick. If you are performing a control test pipette a control sample directly from the control bottle (see step 9). Performing a fingerstick a.
10. Place the sample in the diluent vial: a. Holding the vial upright by the fin, insert the pipette tip into the liquid. b. Slowly depress the plunger to add all the blood to the liquid. c. Keeping the pipettor depressed, remove the pipette tip out of the vial before releasing the plunger. This will prevent blood sample from being drawn back into the tip. d. Remove the pipette tip and discard it in a biohazard waste container. e. Invert the vial 5 times to mix the blood with the diluent. DO NOT SHAKE.
14. If the meter has timed out (left idle for 5 minutes) and shutdown, press the power button to briefly show the last test result. 15. Discard the lancet, pipette tip, and used cartridge using Universal Biohazard Precautions. V. READER FUNCTIONS When the Reader is turned on, it performs a self-check (optics and software). If a malfunction is detected, the Reader displays an error message on the LCD display. See the troubleshooting section if this should occur. VI.
Caution: Use only Avie™ A1c AC Adapter or damage to Reader may result. Class II Equipment: The Reader is double insulated. Biological Risk: Disposable items pose biological risks. Use Universal Precautions Type BF materials supplies IX. MAINTENANCE AND CLEANING Use Universal Biohazard Precautions. Clean the Reader only as needed. Do not turn the meter on when cleaning. External Cleaning Use clean cloth lightly dampened with bleach solution. Use only 10% household bleach solution, i.e.
These messages are possible errors that may occur. If your problem still persists, please MEC Dynamics Technical support at 408-844-9280 or 888-376-1081 Error Code ERROR CAUSE ACTION Monitor has shut No display down after sitting Press power button. idle for 5 minutes.
Error Code ERROR 03 ERROR Meter Error CAUSE ACTION Meter malfunctions Repeat test with after self-check new cartridge and new sample. If error continues call MEC Technical Support ERROR LO Result out of Range Result below 5% AIC Repeat test, if error recurs, test by another method ERROR HI Result out of Range Result more than 14% A1C Repeat test, if error recurs, test by another method ERROR LA Result out of Range Result below 0.
