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
13. DEVICE DESCRIPTION
The PLATINIUM VR ICD device and programming system. The programming system
includes the Sorin dedicated programmer with the SMARTVIEW programming software
connected to a CPR3 programming head. The programming system is configured and
furnished by Sorin.
The PLATINIUM VR can serve as a defibrillation electrode (active housing) with a total
surface area of 63 cm².
The PLATINIUM VR is designed to recognize and treat slow or fast VT and VF by
continuously monitoring ventricular activity to identify persistent ventricular arrhythmias and
to deliver appropriate therapies. PLATINIUM VR features DISCRIMINATION algorithm,
which is specifically designed to differentiate ventricular tachycardias from fast rhythms of
supraventricular origin. DISCRIMINATION continuously monitors R-R interval stability,
searches for long cycles and evaluates sudden onset.
In addition to the advanced detection scheme, PLATINIUM VR offers programmable single-
chamber pacing therapy with or without rate-responsive capabilities using an acceleration
sensor.
PLATINIUM VR offers tiered therapy. Therapies can be programmed independently in each
zone:
─ in the Slow VT and VT zones: two ATP programs, up to two shocks with programmable
energy and up to four shocks with maximum energy can be programmed;
─ in the VF zone: one ATP program, up to two shocks with programmable energy and up
to four shocks with maximum energy can be programmed.
When the rhythm changes from one zone to another, the device delivers the therapy
programmed in this zone, starting with the same or more aggressive program for the area.
The ATP program in the VF zone will only be applied if the VT coupling interval is longer
than the programmed fast VT cycle length.
The PLATINIUM VR offers biphasic shocks with a maximum stored energy of 42 J. The
shock configuration (electrodes used to apply the shock) can be chosen by programming
one of the following combinations: can and one coil, can and two coils, two coils only.
Other features are as follows:
─ Automatic ventricular sensitivity control
─ Non-committed shocks
─ Electrophysiological studies (EPS) with real-time markers or electrograms:
─ Programmer-controlled VT induction sequences,
─ Programmer-controlled VF inductions (30 Hz rapid pacing or shock on T),
─ Programmable electrogram vectors (RV coil-CAN / SVC coil-CAN /RV coil-SVC
coil /RV tip-CAN / RV ring-CAN) and RV EGM,
─ 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,
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SORIN – PLATINIUM VR – U461A