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. Lead connection
- 14.11. Device implantation
- 14.12. Tests and programming
- 15. Special modes
- 16. Main functions
- 17. Patient follow-up
- 18. Physical characteristics
- 19. Electrical characteristics
- 20. Programmable parameters
- 21. Non programmable parameters
- 22. Limited warranty
- 23. Patents
- 24. Explanation of symbols
14. IMPLANT PROCEDURE
Connectors:
PLATINIUM VR 1210:
The pacing/sensing connector is compatible with the IS-1 standard and the right ventricular
defibrillation connectors are compatible with DF-1 standard.
PLATINIUM VR 1240:
The quadripolar right ventricular connector is compatible with the DF4 standard.
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.
Pacing threshold:
Acute threshold should be lower than 1 V (or 2 mA) for a 0.35 ms pulse width.
30
SORIN – PLATINIUM VR – U461A
NOTE 1: Please note that DF-1 standard compliant lead is not compatible with DF4
connector. In the reverse, DF4 standard compliant lead is not compatible with DF-1
connector. In case of defibrillator replacement, choose the appropriate device compatible
with DF-1 or DF4 leads. For any other lead type that require an adaptor for this device,
please contact your Sorin representative for any information on lead / connector
compatibility question.
NOTE 2: 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).