Analyzer User Manual REF 12-656
Analyzer User Manual Refer to the CD in the analyzer package for instructions in English. The instructions are available from your local distributor. Der henvises til den vedlagte CD i analysatorpakken for instruktioner på dansk. Instruktionerne fås hos den lokale forhandler. Consulte el CD incluido en el envase del analizador para obtener instrucciones en español. También puede pedir las instrucciones a su distribuidor local. Se CD:n i analysatorförpackningen beträffande instruktioner på svenska.
TABLE OF CONTENTS Cholestech GDX Analyzer User Manual Table of Contents General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 Unpacking the Cholestech GDX Analyzer . . . . . . . . . . . . . . . . . . . .1 Storage Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
GENERAL INFORMATION TABLE OF CONTENTS / UNPACKING THE CHOLESTECH GDX ANALYZER Table of Contents Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17 1 Cholestech GDX Analyzer User Manual Cholestech GDX Analyzer User Manual General Information The Cholestech GDX Analyzer is a small, portable analyzer for use with Cholestech GDX A1C Test Cartridges.
2 STORAGE INSTRUCTIONS / FEATURES DISPLAY Cholestech GDX Analyzer User Manual 3 Cholestech GDX Analyzer User Manual Storage Instructions Display The Cholestech GDX Analyzer must be stored at a temperature between 10 and 35ºC (50–95ºF). It is important to prevent dust and dirt from getting into the analyzer. So keep the analyzer covered. Make sure the Cholestech GDX Optics Check Cartridge is protected from sunlight during storage.
4 PRINCIPLES OF THE CHOLESTECH GDX A1C TESTING SYSTEM CHOLESTECH GDX ANALYZER BASIC OPERATION Cholestech GDX Analyzer User Manual Principles of the Cholestech GDX A1C Testing System Cholestech GDX Analyzer Basic Operation The Cholestech GDX A1C Testing System uses boronate affinity chromatography to separate the glycated hemoglobin fraction.
6 TO RUN AN OPTICS CHECK CARTRIDGE TO RUN AN OPTICS CHECK CARTRIDGE Cholestech GDX Analyzer User Manual 7 Cholestech GDX Analyzer User Manual To Run an Optics Check Cartridge Intended Use Running an Optics Check Cartridge The Optics Check Cartridge is supplied with the Cholestech GDX Analyzer to check that it is working correctly. Replacement Optics Check Cartridges are available from Cholestech. 1. Plug in the analyzer and allow to warm up. 2.
TO RUN A CHOLESTECH GDX AIC TEST / DISPLAYING RESULTS IN MEMORY / CALIBRATION CALIBRATION Cholestech GDX Analyzer User Manual / TO USE THE 10 µL MINIPET PIPETTE 9 Cholestech GDX Analyzer User Manual To Run a Cholestech GDX A1C Test Refer to the Cholestech GDX A1C Test Cartridge package insert which is in each pack of test cartridges or use the Cholestech GDX Quick Reference Guide supplied with the analyzer.
10 PERFORMANCE CHARACTERISTICS PERFORMANCE CHARACTERISTICS Cholestech GDX Analyzer User Manual Cholestech GDX Analyzer User Manual 11 Performance Characteristics Clinical Trial Results Abnormal Hemoglobins Clinical studies were carried out to assess the performance of the Cholestech GDX System for the measurement of A1C in diabetic patients. The results were compared with those for a number of laboratory-based systems.
12 TROUBLESHOOTING CONTACTING TECHNICAL SERVICE Cholestech GDX Analyzer User Manual Cholestech GDX Analyzer User Manual Troubleshooting 13 Contacting Technical Service The Cholestech GDX Analyzer has been programmed to detect any analyzer or test problems. An error code will appear on the display if any mistakes arise during the test. For technical assistance, please contact your local distributor. Look at the following table to see the cause of the error code and the possible correction.
14 SAFETY / LIMITATIONS OF USE SHUTDOWN INFORMATION Cholestech GDX Analyzer User Manual Safety / DISPOSAL 15 Cholestech GDX Analyzer User Manual Shutdown Information Following testing, the instrument may be left on ready for the next test or switched off at the main socket. If unused for a period it should be placed in its carton to protect the optical window. The Cholestech GDX Analyzer requires a 12-volt (±5%) DC supply regulated at greater than 250 milliamps. This is provided.
16 SPECIFICATION REFERENCES Cholestech GDX Analyzer User Manual Specification References Precision: <1%CV 1. American Diabetes Association. Diabetes Care 2002; 25(Suppl.1):S33–S49. Wavelength: 440 nm (nominal) 2. Goldstein DE et al. Diabetes Care 1995; 18:896–909.
18 NOTES NOTES Cholestech GDX Analyzer User Manual Notes Cholestech GDX Analyzer User Manual Notes 19
Analyzer User Manual Cholestech GDX is a trademark of Cholestech Corporation. MiniPet is a trademark of TriContinent Scientific, Inc. This product is sold under license from Provalis Diagnostics Ltd. Distributed by Cholestech Corporation. U.S. Patent 6,300,142. Provalis Diagnostics Ltd, Newtech Square, Deeside Industrial Park, Deeside, Flintshire, UK. CH5 2NT. T: + 44 1244 288888 F: + 44 1244 833441. 201412E Rev. 01/06 003 12710 Rev. B © 2006 Cholestech Corporation. Distributed by 3347 Investment Blvd.