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
13. DEVICE DESCRIPTION
The INTENSIA SonR CRT-D system includes the model 184 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 INTENSIA SonR CRT-D 184 can serve as a defibrillation electrode (active housing) with
a total surface area of 76 cm².
The INTENSIA SonR CRT-D 184 is designed to recognize and treat slow or fast VT and VF
by continuously monitoring atrial and ventricular activity to identify persistent ventricular
arrhythmias and to deliver appropriate therapies. INTENSIA SonR CRT-D 184 features the
PARAD/PARAD+ algorithm, which is specifically designed to differentiate ventricular
tachycardias from fast rhythms of supraventricular origin. PARAD/PARAD+ continuously
monitors R-R interval stability, searches for long cycles, assesses the degree of P-R
association, evaluates sudden onset and determines the chamber of arrhythmia
acceleration.
In addition to the advanced detection scheme, INTENSIA SonR CRT-D 184 offers
programmable single, dual or triple-chamber pacing therapy (DDD, DDI, VVI or SafeR (AAI
<> DDD) modes) with or without rate-responsive capabilities (DDDR, DDIR, VVIR,
DDD/DDIR and SafeR-R (AAIR <> DDDR) modes) using an acceleration sensor. An
automatic AV delay algorithm as well as a mode switching function are available.
INTENSIA SonR CRT-D 184 enables an adjustment of the interventricular delay, and
provides the possibility of adapting pacing to each ventricle. The ICD is intended to
resynchronize uncoordinated contraction of the heart by simultaneously or sequentially
pacing both ventricles.
INTENSIA SonR CRT-D 184 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.
The ATP can be applied in RV, LV or RV and LV pacing with a VV delay equal to 0 ms. ATP
pacing configuration is independent of ventricular pacing configuration.
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 INTENSIA SonR CRT-D 184 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:
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SORIN – INTENSIA SonR CRT-D 184 – U150A