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. 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. Conformance to standards
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 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. 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 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
- 22.1. Article 1 : Terms of limited warranty
- 22.2. Article 2 : Terms of replacement
23. Patents
24. Explanation of symbols

19. ELECTRICAL CHARACTERISTICS

Usable capacity Between BOS and RRT: 1278 mAh. Between BOS and EOS:

1675 mAh.

Voltage BOS: 3.25 V. RRT: 2.66 V. EOS: 2.5 V.

19.3. LONGEVITY

The longevities mentioned below are calculated by taking into account 6 months storage.

7.3 years Pacing in VVI mode, 100%, 500 ohm, 3.5 V, 0.35 ms, 60 bpm, one 42 J shock

per quarter, sensor OFF

7.1 years Pacing in VVI mode, 100%, 500 ohm, 3.5 V, 0.35 ms, 60 bpm, one 42 J shock

per quarter, sensor ON

9.1 years Pacing in VVI mode, 1%, 500 ohm, 3.5 V, 0.35 ms, 60 bpm, one 42 J shock

per quarter, sensor OFF

8.5 years Pacing in VVI mode, 15%, 500 ohm, 4.5 V, 0.50 ms, 60 bpm, one 42 J shock

per quarter, sensor OFF

9.3 years 0% pacing, one 42 J shock per quarter, sensor OFF

The mean longevity as a function of shocks delivered at maximum energy, with and without

pacing, is as follows:

The mean longevity as a function of yearly remote follow-ups

(1)

, with and without pacing, is

as follows:

(1) An excessive number of remote follow-ups can have a non-negligible impact on device

longevity.

SORIN – INTENSIA VR 124 – U153A