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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. OPERATIONAL PRECAUTIONS AND LIMITATIONS
VIII. HAZARDS AND SYMBOLS
IX. MAINTENANCE AND CLEANING

Batteries
Troubleshooting
Warranty

Содержание Avie A1c

Страница 1: ...CHARACTERISTICS PRODUCT SPECIFICATIONS Performance Characteristics Product Specifications IV OPERATING INSTRUCTIONS Initial Setup Performing a Test Collecting a Fingerstick Sample V READER FUNCTIONS...

Страница 2: ...professional use and physician directed home use at the point of care to monitor glycemic control in diabetic patients The Avie A1c Test System provides a simple reliable way to monitor glycemic contr...

Страница 3: ...Battery section for more information and instructions on installing the batteries if a battery power pack is to be used Special Requirements To ensure that your Avie A1c Reader operates correctly be...

Страница 4: ...is less than 4 minutes The A1C test consists of two distinct quantitative areas of measurement The first area consists of a chamber where the met hemoglobin is photometrical read at 420 nm The optica...

Страница 5: ...Avie A1c Test Cartridge 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 Application Well...

Страница 6: ...sma Glucose GHB mg dL mmol l Interpretation 4 65 3 5 5 100 5 5 6 135 7 5 Non Diabetic Range 7 170 9 5 ADA Target 8 205 11 5 9 240 13 5 10 275 15 5 11 310 17 5 12 345 19 5 Above Target Mean blood gluco...

Страница 7: ...ally powered and Class II equipment Type BF patient applied parts System complies with EN 61326 EN61326 1 EMC Medical Products Warning This equipment generates uses and can radiate radio frequency ene...

Страница 8: ...Manufacturer MEC Dynamics Inc 2225 Martin Ave Suite I Santa Clara California 95050 1 7 Ordering Information You may order the following products through your authorized MEC Dynamics Corp distributor o...

Страница 9: ...hour before running the test Leave the cartridge in the sealed vial while doing this Avoid running the test in direct sunlight on hot cold or vibrating surfaces or near sources of heat or cold Do not...

Страница 10: ...y calluses or scars c Use the lancet as directed to puncture the skin d Apply gentle continuous pressure across the entire finger to form a hanging drop do not milk the finger see step 9 for collectio...

Страница 11: ...vial 5 times to mix the blood with the diluent DO NOT SHAKE The tube will not spill in the inverted position unless squeezed 11 Apply the sample Squeeze 3 drops of the mixture diluted sample into the...

Страница 12: ...trols are tested identically to a blood sample See section IV Operating Instructions If the results are out of range when compared to the number supplied with the control bottle repeat the test with a...

Страница 13: ...e test cartridge guide needs cleaning CAUTION DO NOT FLOOD READER WITH CLEANING SOLUTION 1 Check for blood lint or debris on the test cartridge guide If present 2 Remove by wiping with lint free cloth...

Страница 14: ...art Reader and reinsert cartridge If cartridge is used discard it ERROR REMOVE STRIP Remove Cartridge Cartridge not properly inserted or used cartridge inserted Be sure cartridge is fully inserted and...

Страница 15: ...14 A1C Repeat test if error recurs test by another method ERROR LA Result out of Range Result below 0 45 g dL A1C Repeat test if error recurs test by another method ERROR HA Result out of Range Result...

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