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
14. IMPLANT PROCEDURE
Replacement of an existing atrial lead:
If the initial lead which was connected to the atrial port of the INTENSIA SonR CRT-D 184
was not a SonR lead (i.e.a conventional lead or plug), then do not implant a SonR lead as
replacement; possible blood infiltration at the entrance of the connector port may prevent
proper measurement of the SonR signal.
Connectors:
The ventricular connectors are compatible with the IS-1 standard and the quadripolar
connector is compatible with the DF-4 standard (refer to the “Lead evaluation and lead
connection” sub-section in the “Warnings and precautions” section).
14.8. SHOCK CONFIGURATION (+ -> -)
The shock configuration is the energy pathway between the defibrillation electrodes. If an
atrial coil is present, the shock configuration can be programmed for bi-directional shocks.
Programming:
When active case and SVC are both programmed to Yes, the shock configuration can be
programmed to:
─ RV to Case (or Case to RV),
─ or RV to SVC (or SVC to RV),
─ or RV to Case+SVC (or Case+SVC to RV).
RV to Case+SVC RV to Case RV to SVC
The polarity of shock is determined by the parameter itself.
14.9. MEASUREMENT OF THRESHOLDS AT IMPLANT
Pacing and sensing thresholds should be measured at implant.
34
SORIN – INTENSIA SonR CRT-D 184 – U150A
NOTE1: Please note that DF-1 standard compliant lead is not compatible with DF-4
connector. In the opposite, DF-4 standard compliant lead is not compatible with DF-1
connector. In case of defibrillator replacement and use of a DF-1 lead or any other lead type
that require an adaptor for this device, please contact your Sorin representative for any
information on lead / connector compatibility question.
NOTE2: In case no atrial lead is implanted, the atrial port should be plugged with IS-1
insulating plug and a single chamber mode (VVI-VVIR) should be programmed. PARAD and
PARAD+ should not be used.