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. MSP study
- 5.2. Potential adverse events
6. Clinical studies
- 6.1. MSP clinical 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
- 10.4. V-V Programming Recommendation
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. Leads 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. Atrial tachyarrhythmia management
- 16.3. Ventricular tachyarrhythmia management
- 16.4. Pacing
- 16.5. Sensing
- 16.6. SonR CRT optimization
- 16.7. Follow-up function
- 16.8. 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. Supplemental Information
- 18.1. Adverse events in the SafeR (AAI <> DDD) study
  - Table 1: Summary of Symphony safety data during study
- 18.2. SafeR (AAI <> DDD) clinical study
19. Physical characteristics
- 19.1. Materials used
20. Electrical characteristics
- 20.1. Table of delivered shock energy and voltage
- 20.2. Battery
- 20.3. Longevity
21. Programmable parameters
- 21.1. Antibradycardia pacing
- 21.2. Ventricular tachyarrhythmia detection
- 21.3. Ventricular tachyarrhythmia therapies
- 21.4. Remote alerts and warnings
22. Non programmable parameters
23. Limited warranty
- 23.1. Article 1 : Terms of limited warranty
- 23.2. Article 2 : Terms of replacement
24. Patents
25. Explanation of symbols

21. PROGRAMMABLE PARAMETERS

─ System integrity

Lead Alerts Values

Abnormal A lead impedance ON-OFF

Abnormal A lead low limit (Ohm) 200-250-300-350-400-450-500

Abnormal A lead high limit (Ohm) 1500-1750-2000-2500-3000

Abnormal RV lead impedance ON-OFF

Abnormal RV lead low limit (Ohm) 200-250-300-350-400-450-500

Abnormal RV lead high limit (Ohm) 1500-1750-2000-2500-3000

Abnormal LV lead impedance ON-OFF

Abnormal LV lead low limit (Ohm) 200-250-300-350-400-450-500

Abnormal LV lead high limit (Ohm) 1500-1750-2000-2500-3000

Abnormal RV coil impedance ON-OFF

Abnormal SVC coil impedance ON-OFF

Abnormal Shock impedance

(1)

ON-OFF

(1) Normal impedance range [20 Ohm-200 Ohm]

Clinical status Values

V oversensing ON-OFF

High AT/AF burden ON-OFF

AT/AF limit (on 24h) (h) 0.5-1-3-6-12-24

Fast V Rate during AT/AF ON-OFF

Fast V Rate limit (bpm) 80-90-100-110-120

Fast V Duration limit (h) 0.5-1-3-6-12-24

Limited % of V pacing in CRT ON-OFF

Limited % of V pacing (%) 50-70-80-85-90-95

Therapy information Values

Shock disabled ON-OFF

Shocks delivered OFF-All shocks-Inefficient shock-Inefficient max shock

SORIN – INTENSIA SonR CRT-D 184 – U150A