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
13. DEVICE DESCRIPTION
─ Rescue shock
─ Follow-up tests:
─ Pacing lead impedance,
─ Coil impedance,
─ Capacitor charge time,
─ Pacing threshold tests.
─ Data storage:
─ Therapy History Report,
─ Statistics (pace/sense, therapy, shocks, and battery voltage),
─ Up to 16 complete Holter records with event logs, marker channel notation, and
electrogram records.
The PLATINIUM DR 1510 connector has four ports:
─ atrial bipolar pace/sense,
─ ventricular bipolar pace/sense and
─ wo ports for RV and SVC defibrillation coils.
The PLATINIUM DR 1540 connector head has two ports:
─ atrial bipolar pace/sense,
─ one ventricular bipolar pace/sense and RV & SVC defibrillation coils.
For PLATINIUM DR 1510, both pace/sense ports are compatible with the IS-1 standard and
both defibrillation ports are compatible with the DF-1 standard.
For PLATINIUM DR 1540, pace/sense port is compatible with the IS-1 standard and
defibrillation ports is compatible with the DF4 standard.
Distal lead terminal connections are secured with set-screws accessed via self-sealing
silicone plugs. All lead connections pass through the header into the device via
feedthroughs.
Programming System:
The Sorin programmer is used in conjunction with specific programmer software to
interrogate and program the implanted device at implant and during patient follow-up
procedures.
Remote Monitoring:
PLATINIUM DR is also equipped with the RF wireless technology which enables to remotely
monitor the patients who have the Sorin SMARTVIEW Monitor installed at home.
SORIN – PLATINIUM DR – U460A
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