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
15.2. Magnet mode.......................................................................................................................... 37
15.3. Response in the presence of interference..............................................................................37
15.4. Detection characteristics in the presence of electromagnetic fields........................................38
15.5. Protection against short-circuits..............................................................................................38
16. Main functions....................................................................................................................... 39
16.1. Automatic lead measurements................................................................................................39
16.2. Atrial tachyarrhythmia management.......................................................................................39
16.3. Ventricular tachyarrhythmia management...............................................................................39
16.4. Pacing..................................................................................................................................... 39
16.5. Sensing................................................................................................................................... 40
16.6. SonR CRT optimization...........................................................................................................40
16.7. Follow-up function................................................................................................................... 41
16.8. Remote Monitoring function....................................................................................................41
17. Patient follow-up................................................................................................................... 43
17.1. Follow-up recommendations...................................................................................................43
17.2. Holter Function........................................................................................................................ 43
17.3. Recommended Replacement Time (RRT)..............................................................................44
17.4. Explantation............................................................................................................................ 44
17.5. Defibrillator identification.........................................................................................................45
18. Supplemental Information....................................................................................................46
18.1. Adverse events in the SafeR (AAI <> DDD) study..................................................................46
18.2. SafeR (AAI <> DDD) clinical study..........................................................................................47
19. Physical characteristics.......................................................................................................49
19.1. Materials used......................................................................................................................... 49
20. Electrical characteristics......................................................................................................50
20.1. Table of delivered shock energy and voltage..........................................................................50
20.2. Battery..................................................................................................................................... 50
20.3. Longevity................................................................................................................................. 51
21. Programmable parameters...................................................................................................52
21.1. Antibradycardia pacing............................................................................................................52
21.2. Ventricular tachyarrhythmia detection.....................................................................................55
21.3. Ventricular tachyarrhythmia therapies.....................................................................................56
21.4. Remote alerts and warnings...................................................................................................59
22. Non programmable parameters...........................................................................................61
23. Limited warranty................................................................................................................... 62
23.1. Article 1 : Terms of limited warranty........................................................................................62
23.2. Article 2 : Terms of replacement..............................................................................................63
24. Patents................................................................................................................................... 64
25. Explanation of symbols........................................................................................................65
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SORIN – INTENSIA SonR CRT-D 184 – U150A