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

20. PROGRAMMABLE PARAMETERS

Post-shock mode Values

Mode OFF-VVI

Duration 10s-20s-30s-1min-2min-3min-4min-5min

Basic rate (bpm) From 50 to 90 by steps of 5 ; 60 (± 4 %)

V amplitude (V) 1-1.5-2-2.5-3-3.5-4-4.5-5-6 (± 20 %)

V pulse width (ms) 0.12-0.25-0.35-0.5-0.6-0.75-0.85-1 (± 10 %)

Sensitivity margins Values

Ventricular post pacing margin (mV) From 0 to 2 by steps of 0.2 ; 0.8

Response to noise Values

Automatic sensitivity on noise ON-OFF

V pacing on noise ON-OFF

20.2. VENTRICULAR TACHYARRHYTHMIA DETECTION

Therapy zones Values

Slow VT detection zone

(1)

Slow VT ON-Slow VT OFF

VT detection zone VT ON-VT OFF

Fast VT / VF detection zone Fast VT+VF ON-VF ON

Slow VT rate (lower limit) (bpm) From 100 to 200 by steps of 5 ; 190

VT rate (lower limit) (bpm) 130-135-140-145-150-155-160-165-170-175-180-185-190-

195-200-210-220-230

VF rate (lower limit) (bpm) 150-155-160-165-170-175-180-185-190-195-200-210-220-

230-240

Fast VT rate (upper limit) (bpm) 155-160-165-170-175-180-185-190-195-200-210-220-230-

240-255

Slow VT persistence (cycles) 4-6-8-12-16-20-30-50-100-200

VT persistence (cycles) 4-6-8-12-16-20-30-50-100-200

VF persistence (cycles) From 4 to 20 by steps of 1 ; 6

(1) The Slow VT zone should be programmed ON only if the VT zone is programmed ON.

SORIN – INTENSIA VR 124 – U153A