Medtronic CLOTtrac Manual Del Usuario página 10

clottrac_chap.fm 10/27/04 10:55 am
3.875 x 3.187 inches (98 mm x 81 mm)
7 RESULTS
Results of control testing are reported in seconds. The control results should not be
used in interpreting patient results. The mean clotting time between the two channels,
as well as each channel, should fall within the listed range for the specified control lot.
There should be less than 10% variation between channel clotting times.
Sample Calculation:
Listed Control Range = 70-110 secs
Channel 1 Result = 90 secs
Channel 2 Result = 93 secs
Mean Result = 91 secs
10% of the Mean = 9 secs
Difference = 3 secs
The data are acceptable because 1) the mean clotting time, as well as both channel
clot times, falls within the listed range and 2) the difference between channel 1 and
channel 2 (3 secs) is less than 10% of the mean (9 secs).
8 LIMITATIONS
®
The CLOTtrac CWB Coagulation Control is intended for in vitro diagnostic use only.
The results are dependent on good technique and proper adherence to protocol. Strict
adherence to rehydration requirements is recommended.
8 English Instructions For Use
A08718002-01
Medtronic Confidential
CS003