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
15.3. Response in the presence of disturbance...............................................................................37
15.4. Detection characteristics in the presence of electromagnetic fields........................................37
15.5. Protection against short-circuits..............................................................................................39
16. Main functions.......................................................................................................................40
16.1. Automatic lead measurements................................................................................................40
16.2. Atrial tachyarrhythmia management.......................................................................................40
16.3. Ventricular tachyarrhythmia management...............................................................................40
16.4. Pacing.....................................................................................................................................41
16.5. Sensing...................................................................................................................................41
16.6. Follow-up function...................................................................................................................42
16.7. Remote Monitoring function....................................................................................................42
17. Patient follow-up...................................................................................................................45
17.1. Follow-up recommendations...................................................................................................45
17.2. Holter Function........................................................................................................................45
17.3. Recommended Replacement Time (RRT)..............................................................................46
17.4. Explantation............................................................................................................................46
17.5. Defibrillator identification.........................................................................................................47
18. Supplemental Information....................................................................................................48
18.1. Adverse events in the SafeR (AAI <> DDD) study..................................................................48
18.2. SafeR (AAI <> DDD) clinical study..........................................................................................49
19. Physical characteristics.......................................................................................................51
19.1. Materials used.........................................................................................................................51
20. Electrical characteristics......................................................................................................52
20.1. Table of delivered shock energy and voltage..........................................................................52
20.2. Battery.....................................................................................................................................52
20.3. Longevity.................................................................................................................................53
21. Programmable parameters...................................................................................................55
21.1. Antibradycardia pacing............................................................................................................55
21.2. Ventricular tachyarrhythmia detection.....................................................................................60
21.3. Ventricular tachyarrhythmia therapies.....................................................................................61
21.4. Remote alerts and warnings...................................................................................................64
22. Non programmable parameters...........................................................................................66
23. Limited warranty...................................................................................................................67
24. Patents...................................................................................................................................68
25. Explanation of symbols........................................................................................................69
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SORIN – PLATINIUM CRT-D – U459A