User guide

ProTime
®
Microcoagulation System
For in vitro Diagnostic Use
Operator’s Manual for Patient Self-Testers
TABLE OF CONTENTS
INTENDED USE ............................................................................2
SUMMARY AND EXPLANATION..................................................2
SYSTEM FEATURES....................................................................3
IMPORTANT LABELS AND SYMBOLS ........................................4
PRINCIPLES OF OPERATION .....................................................4
SAFETY FEATURES AND QUALITY CONTROL .........................5
INSTRUMENT SPECIFICATIONS ................................................6
SERVICE AND MAINTENANCE ...................................................7
PREPARING THE INSTRUMENT .................................................8
TEST PROCEDURE......................................................................9
TROUBLESHOOTING.................................................................14
MAIN MENU OPTIONS ............................................................... 16
SET UP........................................................................................ 19
PERFORMANCE CHARACTERISTICS ......................................22
TECHNICAL ASSISTANCE.........................................................23
SUGGESTED READING .............................................................24
ORDERING INFORMATION ....................................................... 24
APPENDIX I – RUN LQC ............................................................25
APPENDIX II – USE OF PID AND OID NUMBERS..................... 27
SAFETY STANDARDS................................................................ 31
INDEX.......................................................................................... 35
This manual is published by International Technidyne Corporation (ITC) for use with the ProTime®
Microcoagulation System and Tenderlett® Plus fingerstick blood collection device.
Questions or comments regarding the contents of this manual can be directed to the address at the back of
this manual or to your ITC representative.
Please read the instructions before use. Call your ITC representative for help.
©2000, 2001, 2002, 2003, 2004, 2005. This document is the copyright of ITC and must not be copied or
reproduced in any form without prior consent. ITC reserves the right to make technical improvements to
equipment and documentation without prior notice as part of a continuous program of product
development.
0123