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
13. DEVICE DESCRIPTION
─ Programmer-controlled VT induction sequences,
─ Programmer-controlled VF inductions (30 Hz rapid pacing or shock on T),
─ Programmable electrogram vectors (EGM A, EGM V, RVcoil-CAN, SVC-CAN, RVcoil-
SVC, LV bip, LV tip-RV),
─ Real-time annotations displayed with the markers and indicating the majority rhythm,
─ Manual ATP sequences,
─ Manual shocks.
─ Rescue shock
─ Follow-up tests:
─ Pacing lead impedance,
─ Coil impedance,
─ Capacitor charge time,
─ Sensitivity test,
─ Pacing threshold tests.
─ Data storage:
─ Therapy History Report,
─ Statistics (pace/sense, therapy, shocks, and battery voltage),
─ Up to 14 complete Holter records with event logs, marker channel notation, and
electrogram records.
The connector head has three ports:
─ Atrial “SonR” port: performs atrial bipolar pace/sense if a conventional IS-1 lead is
connected,
─ LV “IS-1” port: performs left ventricular bipolar pace,
─ RV “DF-4” port: performs right ventricular bipolar pace/sense, port for RV/SVC
defibrillation coils.
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:
INTENSIA SonR CRT-D 184 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 – INTENSIA SonR CRT-D 184 – U150A
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