User Manual
Table Of Contents
- 1. General description
- 2. Intended use and targeted population
- 3. Contraindications and adverse events
- 4. Warnings
- 5. Clinical studies
- 6. Patient selection and treatment
- 7. Patient counseling information
- 8. Declaration of conformity
- 9. Physician guidelines
- 10. Patient information
- 11. How supplied
- 12. Implant procedure
- 13. Pacemaker interrogation and upgrade
- 14. Special modes
- 15. Functions and parameters
- 16. Patient follow-up
- 17. Standby mode
- 18. Medical follow-up
- 19. Physical characteristics
- 20. Electrical characteristics
- 21. Programmable parameters
- 22. Non-programmable parameters
- 23. Warranty
- 24. Explanation of symbols
― absence of unexpected short ventricular cycle
The following table presents the percentage of success and its unilateral 95% confidence
interval.
Number of patients
included
Number of failures
observed
% of successes (unilateral 95% confi-
dence interval)
60 0 100% (95.12%)
To determine the effectiveness of automatic implantation detection function, the function was
activated in all implanted patients.
The following table presents the percentage of success and its unilateral 95% confidence
interval.
Number of patients
included
Number of failures
observed
% of successes (unilateral 95% confi-
dence interval)
70 0 100% (95.80%)
To determine the effectiveness of automatic lead impedance measurement function,
pacemaker memory was read at one month. A success was defined by at least 5 daily
measures of lead impedance available on one week in authorized conditions by the function
at one month.
The following table presents the percentage of success and its unilateral 95% confidence
interval for atrial lead and ventricular lead at one month.
Lead Number of pa-
tients included
Number of fail-
ures observed
% of successes (unilateral 95%
confidence interval)
Atrial 61 0 100% (95.20%)
Ventricular 61 0 100% (95.20%)
5. CLINICAL STUDIES
20 ALIZEA – UA10414A