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
6. PATIENT SELECTION AND TREATMENT
SPECIFIC PATIENT POPULATIONS
― Pregnancy: If there is a need to image the device, care should be taken to minimize the
radiation exposure to the fetus and the mother.
― Labor and delivery: If minute ventilation mode is enabled breathing patterns associated
with birthing may drive the pacing rate to the programmed maximum sensor rate.
― Nursing mothers: Although appropriate biocompatibility testing has been conducted for
this implant device, there has been no quantitative assessment of the presence of
leachables in breast milk.
― Pediatric patients: This device has not been studied in patients younger than 25 years of
age. Breathing rates, particularly in neonates, are typically higher than in adults and care
should be taken in selection of parameter values associated with minute ventilation (see
Warnings and Precautions).
― Geriatric patients: Most of the patients receiving this device in clinical studies were over
the age of 60 years (see Clinical Studies).
― Handicapped and disabled patients: Special care is needed in using this device for
patients using electrical wheel chair or other external or implanted electrical devices.
6.1.
6. PATIENT SELECTION AND TREATMENT
ALIZEA – UA10414A 21