Summary of Contents for MEC Dynamics Avie A1c
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Page 1: Table Of Contents
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... -
Page 2: Installation And Information
The Avie™ A1c System is for in vitro diagnostic use only. Please see the Package Insert that accompanies the Avie™ A1c Cartridge for additional information. MEC Dynamics Technical Support and Customer Care contact information: MEC Dynamics Corp 2225 Martin Ave. Suite I... -
Page 3: Installation
Installation Your Avie™ A1c Test System includes: • Avie™ A1c Reader (Battery power pack is optional) • Universal Power adapter • Avie™ A1c System Users Manual • Quick Reference Guide • Avie™ A1c Test Cartridge • Pipette and Tips • Diluent •... -
Page 4: Principles Of Operation
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. - Page 5 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...
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Page 6: Performance Characteristics & Product Specifications
III. PERFORMANCE CHARACTERISTICS AND PRODUCT SPECIFICATIONS Performance Characteristics Expected Values 1.4.1 Approximate Mean Plasma Glucose* GHB(%) Interpretation mg/dL mmol/l Non-Diabetic Range ADA Target 11.5 13.5 Above Target 15.5 17.5 19.5 * Mean blood glucose results are 10-15% lower. Most blood glucose Readers are calibrated to read as plasma glucose. -
Page 7: Product Specifications
Product Specifications 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... - Page 8 2225 Martin Ave. Suite I Santa Clara, California 95050 Ordering Information You may order the following products through your authorized MEC Dynamics Corp. distributor or by contacting the Customer Service Department at MEC at 408 844 9280 Part Number Description FIN0003 Avie™...
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Page 9: Operating Instructions
OPERATING INSTRUCTIONS 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. - Page 10 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.
- Page 11 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.
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Page 12: Reader Functions
VI. CALIBRATION AND QUALITY CONTROL The MEC A1C System is Factory Calibrated. MEC Avie A1C System Control Level I and Level II are available for purchase. MEC Dynamics recommends that external controls be tested at the following times: •... -
Page 13: Maintenance And Cleaning
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. - Page 14 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.
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Page 15: Warranty
Error Code ERROR CAUSE ACTION ERROR 03 Meter Error 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 Repeat test, if error 5% AIC recurs, test by another method...
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