User Manual

ManualsBrandsSORIN CRM ManualsElectronicsImplantable cardioverter defibrillator

Table Of Contents

1. General description
2. Indications
3. Contraindications
4. Warnings and precautions
- 4.1. Risks related to medical environment
- 4.2. Sterilization, storage and handling
- 4.3. Implantation and device programming
- 4.4. Lead evaluation and lead connection
- 4.5. Generator explant and disposal
5. Adverse events
- 5.1. MSP study
- 5.2. Potential adverse events
6. Clinical studies
- 6.1. MSP clinical study
7. Patient selection and treatment
- 7.1. Individualization of treatment
- 7.2. Specific patient populations
8. Patient counselling information
9. Conformance to standards
10. Physician guidelines
- 10.1. Physician training
- 10.2. Directions for use
- 10.3. Maintaining device quality
- 10.4. V-V Programming Recommendation
11. Patient information
12. How supplied
- 12.1. Sterility
- 12.2. Warranty and replacement policy
13. Device description
14. Implant procedure
- 14.1. Necessary equipment
- 14.2. Packaging
  - 14.2.1 . Contents
- 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
- 15.1. Safety mode (nominal values)
- 15.2. Magnet mode
- 15.3. Response in the presence of interference
- 15.4. Detection characteristics in the presence of electromagnetic fields
- 15.5. Protection against short-circuits
16. Main functions
- 16.1. Automatic lead measurements
- 16.2. Atrial tachyarrhythmia management
- 16.3. Ventricular tachyarrhythmia management
- 16.4. Pacing
- 16.5. Sensing
- 16.6. SonR CRT optimization
- 16.7. Follow-up function
- 16.8. Remote Monitoring function
17. Patient follow-up
- 17.1. Follow-up recommendations
- 17.2. Holter Function
  - Stored Episodes
  - Therapy history
- 17.3. Recommended Replacement Time (RRT)
- 17.4. Explantation
- 17.5. Defibrillator identification
18. Supplemental Information
- 18.1. Adverse events in the SafeR (AAI <> DDD) study
  - Table 1: Summary of Symphony safety data during study
- 18.2. SafeR (AAI <> DDD) clinical study
19. Physical characteristics
- 19.1. Materials used
20. Electrical characteristics
- 20.1. Table of delivered shock energy and voltage
- 20.2. Battery
- 20.3. Longevity
21. Programmable parameters
- 21.1. Antibradycardia pacing
- 21.2. Ventricular tachyarrhythmia detection
- 21.3. Ventricular tachyarrhythmia therapies
- 21.4. Remote alerts and warnings
22. Non programmable parameters
23. Limited warranty
- 23.1. Article 1 : Terms of limited warranty
- 23.2. Article 2 : Terms of replacement
24. Patents
25. Explanation of symbols

24. PATENTS

The INTENSIA model described in this manual is covered by the following US patents:

5 167 224, 5 226 415, 5 271 394, 5 312 451, 5 325 856, 5 339 820, 5 350 406, 5 411 533, 5

462 060, 5 513 645, 5 545 181, 5 558 097, 5 564 430, 5 591 218, 5 626 619, 5 645 574, 5

674 265, 5 697 960, 5 702 424, 5 702 426, 5 713 928, 5 741 315, 5 776 164, 5 776 165, 5

818 703, 5 836 980, 5 868 793, 5 891 170, 5 891 184, 5 899 931, 5 931 856, 5 935 153, 5

954 660, 5 978 708, 6 181 968, 6 230 058, 6 236 111, 6 251 703, 6 256 206, 6 307 261, 6

337 996, 6 397 105, 6 408 209, 6 487 451, 6 487 452, 6 505 068, 6 532 238, 6 556 866, 6

604 002, 6 622 039, 6 625 491, 6 711 441, 6 738 665, 6 830 548, 6 889 080, 6 898 845, 6

912 421, 6 937 898, 6 975 905, 7 065 402, 7 072 716, 7 076 297, 7 113 826, 7 142 924, 7

164 946, 7 251 526, 7 366 566, 7 400 921, 7 400 922, 7 953 483.

SORIN – INTENSIA SonR CRT-D 184 – U150A