User 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. Conformance to standards
- 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
23. LIMITED WARRANTY
link to a component failure or a production hazard. The device battery longevity varies
with the type and number of delivered therapies.
8. Legal requirements of jurisdictions where the INTENSIA device is distributed will
supersede any warranty conditions indicated in this manual that conflict with such laws.
23.2. ARTICLE 2 : TERMS OF REPLACEMENT
1. In case of INTENSIA failure because of a component failure, a production defect, or a
conception error, occurring within two-year period starting from the implantation date,
Sorin is committed to:
─ replacing free of charge the explanted device by a Sorin device with equivalent
features,
─ or issuing a replacement credit equal to the purchase price for the purchase of any
other Sorin replacement device.
2. After a two-year period and up to 4 years after the implantation, Sorin, because of limited
warranty terms, will issue a replacement credit to the buyer of an amount equivalent to
half of the initial purchase price minus prorata temporis during this two-years period.
3. In any case the credit issued by the limited warranty terms cannot exceed the purchase
price of a Sorin replacement device.
SORIN – INTENSIA SonR CRT-D 184 – U150A
63