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. 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
1. GENERAL DESCRIPTION
PLATINIUM 4LV SonR CRT-D 1844 is an implantable cardioverter defibrillator for the
recognition and treatment of ventricular tachycardia and fibrillation, with ventricular
resynchronization, in patients with spontaneous or inducible tachyarrhythmias.
PLATINIUM 4LV SonR CRT-D 1844 is equipped with an accelerometer to allow adaptation of
pacing to suit the patient’s activity.
PLATINIUM 4LV SonR CRT-D 1844 is also equipped with the RF wireless technology which
enables:
― Remote monitoring of patients who have the Sorin SMARTVIEW Monitor installed at
home,
― wireless interrogation and device programming by Orchestra Plus programmer equipped
with ORCHESTRA PLUS LINK accessory.
If used in conjunction with a dedicated atrial lead featuring the SonR sensor, PLATINIUM 4LV
SonR CRT-D 1844 can analyze micro-accelerations of the heart walls to derive information
pertaining to cardiac contractility. The signal picked-up by the SonR sensor can be processed
by PLATINIUM 4LV SonR CRT-D 1844 in order to automatically adjust AV and VV delays for
optimal resynchronization therapy.
PLATINIUM 4LV SonR CRT-D 1844 features simultaneous multipoint left ventricular pacing
allowing LV pacing on 2 differents vectors at the same time.
PLATINIUM 4LV SonR CRT-D 1844 provides high energy shocks (42 J) for enhanced safety,
as well as automatic lead measurements to monitor system integrity.
Device and lead connections:
1*IS4, 1*DF4, 1*SonR (IS-1 bipolar compatible)
1. GENERAL DESCRIPTION
8 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A