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. 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
15.2. Magnet mode.......................................................................................................................... 38
15.3. Response in the presence of interference..............................................................................38
15.4. Detection characteristics in the presence of electromagnetic fields........................................39
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..................................................................................................................................... 40
16.5. Sensing................................................................................................................................... 41
16.6. Follow-up function................................................................................................................... 41
16.7. Remote Monitoring function....................................................................................................42
17. Patient follow-up................................................................................................................... 44
17.1. Follow-up recommendations...................................................................................................44
17.2. Holter Function........................................................................................................................ 44
17.3. Recommended Replacement Time (RRT)..............................................................................45
17.4. Explantation............................................................................................................................ 45
17.5. Defibrillator identification.........................................................................................................46
18. Physical characteristics.......................................................................................................47
18.1. Materials used......................................................................................................................... 47
19. Electrical characteristics......................................................................................................48
19.1. Table of delivered shock energy and voltage..........................................................................48
19.2. Battery..................................................................................................................................... 48
19.3. Longevity................................................................................................................................. 49
20. Programmable parameters...................................................................................................50
20.1. Antibradycardia pacing............................................................................................................50
20.2. Ventricular tachyarrhythmia detection.....................................................................................53
20.3. Ventricular tachyarrhythmia therapies.....................................................................................54
20.4. Remote alerts and warnings...................................................................................................57
21. Non programmable parameters...........................................................................................59
22. Limited warranty................................................................................................................... 60
22.1. Article 1 : Terms of limited warranty........................................................................................60
22.2. Article 2 : Terms of replacement..............................................................................................61
23. Patents................................................................................................................................... 62
24. Explanation of symbols........................................................................................................63
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SORIN – INTENSIA DR 154 – U152A