User's Manual

ManualsBrandsSORIN CRM ManualsElectronicsImplantable cardioverter defibrillator with RF wireless communication availability

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. Declaration of conformity
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 disturbance
- 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 Tachyarrythmia 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
24. Patents
25. Explanation of symbols

21. PROGRAMMABLE PARAMETERS

1,75* 1,89 1,60

1,85* 2,02 1,71

2,00 2,10 1,78

2,10* 2,21 1,87

2,25* 2,34 1,98

2,35* 2,47 2,09

2,50 2,60 2,20

2,60* 2,73 2,31

2,75* 2,87 2,42

2,85* 3,00 2,53

3,00 3,15 2,67

3,10* 3,26 2,76

3,25* 3,39 2,87

3,35* 3,52 2,98

3.50 3,65 3,09

3,60* 3,78 3,20

3,75* 3,91 3,31

3,85* 4,04 3,42

4,00 4,20 3,55

4,10* 4,30 3,64

4,25* 4,43 3,75

4,35* 4,56 3,86

4,50 4,69 3,97

4,60* 4,82 4,08

4,75* 4,95 4,19

4,85* 5,08 4,30

5,00 5,25 4,44

5,10* 5,34 4,52

5,25* 5,47 4,63

5,35* 5,60 4,74

5,50* 5,73 4,85

SORIN – PLATINIUM SonR CRT-D – U463A

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