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

19. ELECTRICAL CHARACTERISTICS

Usable capacity Between BOS and RRT: 1530 mAh. Between BOS and EOS:

1910 mAh.

Voltage BOS: 3.24 V. RRT: 2.62 V. EOS: 2.5 V.

19.3. LONGEVITY

The longevities are calculated by taking into account 6 months storage with the following

conditions:

─ Mode: VVI

─ EGM:ON

─ 2 battery reformings per year (at 34J), replaced by shocks if any

─ Remote monitoring: ON, daily check, 4 follow-ups and 5 full alert reports per year

─ RF telemetry: ON, 45min at implantation + 15min at discharge + 15min for in-clinic

quarterly follow-ups

Longevity projection at 500 Ω pacing impedance:

Basic Rate (ppm) 60 60 60 60 60 40 60

V pacing (%) 100 100 1 15 15 6 0

Pacing amplitude (V) 3.5 3.5 3.5 4.5 2.5 2.5 -

Pulse width (ms) 0.35 0.35 0.35 0.50 0.35 0.35 -

Sensor OFF ON OFF OFF OFF OFF OFF

Max shocks (42J) per year 4 4 4 4 0 4 4

Longevity (years) 10.8 10.5 14 12.9 17.5 14.3 14.1

Longevity projection at 600 Ω pacing impedance:

Basic Rate (ppm) 60 60 60 60 60 40 60

V pacing (%) 100 100 1 15 15 6 0

Pacing amplitude (V) 3.5 3.5 3.5 4.5 2.5 2.5 -

Pulse width (ms) 0.35 0.35 0.35 0.50 0.35 0.35 -

Sensor OFF ON OFF OFF OFF OFF OFF

Max shocks (42J) per year 4 4 4 4 0 4 4

Longevity (years) 11.2 10.9 14.1 13.0 17.6 14.3 14.1

Longevity projection at 700 Ω pacing impedance:

SORIN – PLATINIUM VR – U461A