User's Manual
Table Of Contents
- 1. General description
- 2. Indications
- 3. Contraindications
- 4. Warnings and precautions
- 5. Adverse events
- 6. Clinical studies
- 7. Patient selection and treatment
- 8. Patient counselling information
- 9. Declaration of conformity
- 10. Physician guidelines
- 11. Patient information
- 12. How supplied
- 13. Device description
- 14. Implant procedure
- 14.1. Necessary equipment
- 14.2. Packaging
- 14.3. Optional equipment
- 14.4. Before opening the package
- 14.5. Prior to implantation
- 14.6. Device placement
- 14.7. Choosing the type of lead
- 14.8. Shock configuration (+ -> -)
- 14.9. Measurement of thresholds at implant
- 14.10. Leads connection
- 14.11. Device implantation
- 14.12. Tests and programming
- 15. Special modes
- 16. Main functions
- 17. Patient follow-up
- 18. Supplemental Information
- 19. Physical characteristics
- 20. Electrical characteristics
- 21. Programmable parameters
- 22. Non programmable parameters
- 23. Limited warranty
- 24. Patents
- 25. Explanation of symbols
7. PATIENT SELECTION AND TREATMENT
7.2. SPECIFIC PATIENT POPULATIONS
Pregnancy:
If there is a need to image the device, care should be taken to minimize radiation exposure
to the foetus and the mother.
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 18 years of age.
Geriatric Patients:
Most of the patients receiving this device in clinical studies were over the age of 60 years.
Handicapped and Disabled Patients:
Special care is needed in using this device for patients using an electrical wheel chair or
other electrical (external or implanted) devices.
SORIN – PLATINIUM SonR CRT-D – U463A
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