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. Defender study
  - Table 1: Summary of European Clinical Complications
  - Table 2: Summary of European Clinical Complications
6. Clinical studies
- 6.1. Defender 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
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. Lead 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. Ventricular tachyarrhythmia management
- 16.3. Pacing
- 16.4. Sensing
- 16.5. Follow-up function
- 16.6. 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. Physical characteristics
- 18.1. Materials used
19. Electrical characteristics
- 19.1. Table of delivered shock energy and voltage
- 19.2. Battery
- 19.3. Longevity
20. Programmable parameters
- 20.1. Antibradycardia pacing
- 20.2. Ventricular tachyarrhythmia detection
- 20.3. Ventricular tachyarrhythmia therapies
- 20.4. Remote alerts and warnings
21. Non programmable parameters
22. Limited warranty
23. Patents
24. Explanation of symbols

20. PROGRAMMABLE PARAMETERS

20.3. VENTRICULAR TACHYARRHYTHMIA THERAPIES

Common parameters Values

Enable ATP therapy Yes-No

Enable shock therapy Yes-No

Polarity alternation (42J) Yes-No

Atrial coil (SVC) present Yes-No

Active case Yes-No

Shock configuration (+ --> -) Case to RV-SVC to RV-Case + SVC to RV-RV to Case-RV to

SVC-RV to Case + SVC

SVC exclusion (shock < 15J) Yes-No

20.3.1. Therapy parameters in slow VT zone

ATP 1 program Values

ATP program OFF-Burst-Burst+Scan-Ramp-Ramp+Scan

Number of sequences 1-2-3-4-5-6-7-8-9-10-11-12-13-14-15

Cycles in first sequence 1-2-3-4-5-6-7-8-9-10-11-12-13-14-15

Cycles added per sequence 0-1-2-3-4-5-6-7-8-9-10-11-12-13-14-15

Coupling interval (%) 50-55-60-65-70-75-80-85-90-95

Ramp decrement (per cycle) (ms) 0-4-8-12-16-20-30-40-50-60

Scan decrement (per sequence) (ms) 0-4-8-12-16-20-30-40-50-60

Time limit (min) 0.5-1-1.5-2-2.5-3-3.5-4

Minimum cycle length (ms) 95-110-125-140-155-170-190-205-220-235-250-265-280-

295-310

SORIN – PLATINIUM VR – U461A