User Manual Part 4

D-22
CLINICAL STU DY - CONTAK CD
10
5
0
BiV R-wave Amplitude (mV)
02418126
Acceptance Boundary
Implant Duration (months)
15
Mean
Figure D -8. EASYTRAK biventricular-sensed R-wave amplitude
Tab le D-16. EASYTRAK biventricular-sensed R-wave amplitude
Statistic
a
Implant 3 Months 6 Months 12 Mon ths 18 Months 24 Months
N 433 346 326 220 99 23
Mean ± SD
10.0 ± 5.2 9.9 ± 4.4 9.9 ± 4.5 9.8 ± 4.4 8.9 ± 3.5 8.5 ± 3.3
Upper Tolerance Limit 1.9 - 25.0 1.4 - 25.0 1.7 - 25.0 1.2 - 25 .0 2.6 - 20.4 2.2 - 13.6
The imp ed ance measured by the CONTAK CD device is th e parallel
combination of the left ventricular (EASYTRAK) and right ventricular
(ENDOTAK) leads simultaneously. Therefore, the biventricular lead impedance
will be substantially less than that of either lead alone. It was hypothesized
that the lower limit of the 95% confidence interval of the mean chronic
biventricular lead impedance would be greater than 200 Ω to ensure proper
pulse generator function. The lower limit of the 95% confidence interval of the
chronic biventricular lead impedance exceeds this value (Figure D-9 on page
D-23, Table D-17 on page D-23).
- DRAFT -