For In Vitro Diagnostic Use Only
Contents
1. ORDERING INFORMATION USA ONLY OUTSIDE OF THE USA Customer Support 1 877 945 0208 Tel 1 408 745 0975 Order Info 1 888 PRETERM Fax 1 408 745 0208 1 888 773 8376 Toll Free Order Info 1 888 567 381 7 Fax 1 913 859 6998 Tech Service 1 877 945 0208 Adeza Biomedical Corporation 1240 Elko Drive Sunnyvale CA 94089 2212 USA October 2003 ADEZA www adeza com 01173 072. S For n Vitro Diagnostic Use Only tore at room temperature 15 to 30 C 59 to 86 F Do not freeze ILI QCette The Adeza Biomedical TLijg QCette is a quality control device used to monitor the performance of the TLijq Analyzer For Professional Use Onl ce Authorized Representative according to VDD 98 79 EC MDSS Burckhardtstrasse 1 30163 Hannover Germany REF 01175 INTENDED USE The TLiiq QCette is a quality control device used to verify that the TLiia analyzer performs within specification The QCette Setup software determines a value for the QCette Daily quality control data collected from the QCette are automatically compared to this setup value to verify analyzer performance PRECAUTIONS AND WARNINGS 1 For in vitro diagnostic use only 2 Donotuse the QCette if it is damaged STORAGE AND STABILITY The QCette should be stored at room temperature 15 to 30 C 59 to 86 F in the container provided Do not store in the cassette insertion site of the analyzer Do not use the QCette unless it is clean and free of lint or moisture If properly stored the QCette should last an indefinite period of time MATERIALS REQUIRED BUT NOT PROVIDED TLi Analyzer Printer and User Manual PROCEDURE INITIAL TLiiqg QCette SETUP Note Setup is performed once for the QCette received with the TLiia System _s From the Main Menu select CHANGE SETUP 2 Select QCette SETUP from t
3. he SETUP menu and enter the information requested until the analyzer prompts to insert QCette Insert QCette and press enter Setup of the QCette will take approximately 15 minutes 3 Upon completion the analyzer will display either SETUP COMPLETE or SETUP ERROR Setup Error indicates that the performance criteria of the analyzer have not been established see the TLiiq User Manual for details DAILY TLiiqg QCette USE Note Daily running of the QCette is a quality control method for analyzer performance as From the Main Menu select DAILY QC 2 Enter the information requested until the analyzer prompts to insert QCette Insert QCette and press enter Analysis of the Qcette will take approximately 2 3 minutes 3 The result for the QCette will be displayed on the analyzer display screen and automatically printed as SYSTEM PASS SYSTEM FAIL or INVALID INTERPRETATION OF RESULTS The TLiiqg QCette is a daily quality control test to verify that the performance of the TLi analyzer is within specification The TLia QCette is a Rapid fFN Cassette replica containing a membrane with printed test and control lines which is read by the TLiia analyzer Three different levels of response are measured with this QC device 1 High Level The blue line at the procedural control position which is in the high positive range must be above a minimum threshold value for QC to pass 2 Low Level The blue printed line at the test line p
4. osition is in the cutoff range This line is measured and compared with a value established during instrument setup and must be within 5 of that value for QC to pass 3 Negative The white space between the blue lines is measured and should always be in the negative range for QC to pass A PASS result indicates that the daily QCette value is within the specification determined at setup A FAIL result indicates that the daily QCette value is outside the specification determined at setup If the QCette fails ensure that it is clean and free of lint or moisture and repeat the test If there is dirt or lint on the QCette a canned air product may be used If the problem persists see the TLiiq User Manual for further details or contact Adeza Biomedical for technical assistance QUALITY CONTROL PROCEDURES Current Good Laboratory Practice includes the periodic use of controls to monitor assay performance The QCette is recommended for use in monitoring the performance of the analyzer The recommended frequency of use of the QCette is at least once every 24 hours or whenever there is uncertainty about the analyzer Do not test patient samples until an acceptable result is obtained from the QCette The TLiio QCette is covered by U S patent number Des 432 244 2003 Adeza Biomedical Corporation All rights reserved The Adeza logo TLiig and TLiig QCette are registered trademarks of Adeza Biomedical TECHNICAL SERVICE AND
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