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

24. EXPLANATION OF SYMBOLS

The symbols on product labelling have the following meaning:

Use by

Date of manufacture

Manufacturer

Serial number

Batch number

For single use only.

Sterilised using ethylene oxide

Temperature limitation

High voltage

Consult instruction for use.

This icon is used to call your attention to a particularly important

point.

This icon alerts you to a hazard that may result in equipment

damage or personal injury. Carefully read the instructions

provided with this icon.

FCC ID : YSGVR124

IC : 10270A-VR124

Last revision date of this implant manual: 2013-09

SORIN – INTENSIA VR 124 – U153A