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
― one DF4 right ventricular lead with bipolar sensing/pacing electrodes and one or two
defibrillation coils (DF4-LLHO or DF4-LLHH)
― one IS4-LLLL left ventricular pacing lead
The choice of leads and their configuration is left to the implanting physician’s judgment.
NOTE1: Please note that in the event of defibrillator replacement, DF-1 standard compliant
lead is not compatible with DF4 connector and DF4 standard compliant lead is not
compatible with DF-1 connector. Choose the appropriate device compatible with DF-1 or
DF4 leads. For any other lead type that requires an adaptor for this device, please contact
your Sorin representative for any information on lead / connector compatibility question.
NOTE2: Please note that in the event of defibrillator replacement, IS-1 standard compliant
lead is not compatible with IS4 connector. Choose the appropriate device compatible with
IS-1 or IS4 leads. For any other lead type that requires an adaptor for this device, please
contact your Sorin representative for any information on lead / connector compatibility
question.
NOTE3: In the event that 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.
NOTE4: In the event of a warning on a low shock impedance, and after lead replacement
or reconnection: it is recommended to check the system integrity (sensing and pacing
thresholds and the impedance of the shock electrodes).
Connectors:
The atrial connector is compatible with the IS-1 standard.
The quadripolar right ventricular connector is compatible with the DF4 standard and the
quadripolar left ventricular connector is compatible with the IS4 standard.
SHOCK CONFIGURATION (+ -> -)
The shock configuration is the energy pathway between the defibrillation electrodes. If an
atrial coil (SVC) is present, the shock configuration can be programmed for bi-directional
shocks.
Programming:
When active case and atrial coil (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.
14.8.
14. IMPLANT PROCEDURE
SORIN – PLATINIUM 4LV CRT-D 1744 – U904A 35