Quality Control - Medtronic LR-ACT Instrucciones De Uso

ACTCART_CH_EN.FM 6/1/04 9:51 am
UC199600212b ML
7 x 9 inches (177.8 x 228.6 mm)
Low Range ACT Cartridge
a
Heparin Level Avg. Clot Time
0.0
1.0
2.0
3.0
4.0
5.0
6.0
0.0
1.0
2.0
3.0
4.0
5.0
6.0
0.0
1.0
2.0
3.0
4.0
5.0
6.0
a
Heparin level in units of heparin per ml of whole blood. Heparin was added to each blood sample just prior to running the cartridge.
13 SPECIFIC PERFORMANCE CHARACTERISTICS
The Medtronic Activated Clotting Cartridges in the clotting time range of 0–600 seconds, typically do not exceed a variation
of 12% between duplicate samples for any one individual. In subjects with extreme sensitivity to heparin, an activated clotting
time in excess of 600 seconds is generally not considered to be adequately reliable enough to predict heparin effect by
coagulation times.
The LR-ACT cartridge (Catalog #402-01) is intended for therapeutic heparin monitoring via the activated clotting time of fresh
drawn whole blood. Its increased sensitivity to heparin allows better control of heparin anticoagulation at therapeutic heparin
levels.
The RACT cartridge (Catalog #402-02) is a general-purpose recalcified activated clotting time cartridge.
The instrument's operable range is up to 999 seconds.

14 QUALITY CONTROL

Two levels of controls should be run when the instrument is in operation to ensure adequate quality control of the instrument
and cartridges.
Results should fall within the specified ranges listed by the manufacturer or ranges determined by the user.
Details concerning Quality Assurance can be found in the Medtronic QA Manual, (catalog # 300-29).
®
CLOTtrac CWB Coagulation Controls (Catalog #550-01) are available to verify the correct functioning of the RACT and
LR-ACT cartridges, and the Automated Coagulation Timers. LR-ACT cartridges require the addition of 0.1M Calcium
Chloride (Catalog #550-11) (see calcium chloride package insert for directions).
Instructions for Use
231036-00
Table 3.
Recalcified ACT Cartridge
Heparin Level
Donor 1
118 0.0
357 1.0
591 2.0
712 3.0
926 4.0
>999 5.0
>999 6.0
Donor 2
106 0.0
258 1.0
387 2.0
652 3.0
790 4.0
879 5.0
>999 6.0
Donor 3
106 0.0
254 1.0
426 2.0
516 3.0
648 4.0
734 5.0
>999 6.0
Medtronic Confidential
SPECIFIC PERFORMANCE CHARACTERISTICS
High Range ACT Cartridge
Avg. Clot Time Heparin Level
130 0.0
294 1.0
472 2.0
615 3.0
842 4.0
>999 5.0
>999 6.0
105 0.0
221 1.0
310 2.0
404 3.0
509 4.0
624 5.0
850 6.0
121 0.0
308 1.0
440 2.0
572 3.0
804 4.0
>999 5.0
>999 6.0
CS009
Avg. Clot Time
132
183
286
414
474
622
850
109
145
214
282
334
389
477
116
164
264
323
427
497
679
English 7