Medtronic CLOTtrac Manual Del Usuario página 11

clottrac_chap.fm 10/27/04 10:55 am
3.875 x 3.187 inches (98 mm x 81 mm)
The clotting time ranges listed are valid only when the control and cartridge have been
stored as indicated.
Failure to obtain clotting times within the established range invalidates the use of both
the instrument and the test until the problem is resolved.
Even though controls are of nonhuman origin, all biological samples should be
considered potentially hazardous and handled appropriately.
The deionized water is nonsterile. Each vial of water is intended for single use only (to
prevent contamination).
To ensure that the control performs properly, reconstitution should be achieved using
only the enclosed deionized water. It is recommended that the contents of the box be
kept intact to ensure availability of all components at all times.
Allow at least 30 minutes to perform a complete quality control procedure from
reconstitution to final results.
If the results obtained do not agree with the range given in the package insert:
1. Ensure that the instrument is functioning properly according to the Maintenance
and Quality Control section in the instrument Operator's Manual.
2. Ensure the cartridge, instrument, and controls have incubated properly.
3. Ensure that the cartridges and controls used have not exceeded their respective
expiration dates and have been properly stored.
4. Ensure that the control was properly reconstituted.
A08718002-01
Medtronic Confidential
CS003
English Instructions For Use 9