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. 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. 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. 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 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. Atrial tachyarrhythmia management
- 16.3. Ventricular tachyarrhythmia management
- 16.4. Pacing
- 16.5. Sensing
- 16.6. Follow-up function
- 16.7. 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. 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
24. Patents
25. Explanation of symbols

21. PROGRAMMABLE PARAMETERS

Detection criteria Values

Slow VT and VT detection criteria Rate Only-Stability-Stability+-Stability/Acc-Stability+/Acc-

PARAD-PARAD+

Fast VT detection criteria Rate+Stability-Rate Only

Majority: (X/Y), Y (cycles) 8-12-16

Majority: (X/Y), X (%) 65-70-75-80-90-95-100

Window of RR stability for Slow VT

and VT (ms)

30-45-65-80-95-110-125

Window of RR stability for fast VT

(ms)

30-45-65

Acceleration (%) 6-13-19-25-31-38-44-50

Long cycle persistence extension

(cycles)

From 0 to 16 by steps of 1 ; 10

Long cycle gap (ms) 15-30-45-65-80-95-110-125-140-155-170-190-205

Atrial monitoring Yes-No

21.3. VENTRICULAR TACHYARRHYTHMIA THERAPIES

Common parameters Values

Enable ATP therapy Yes-No

Enable shock therapy Yes-No

ATP pacing chamber Right-Left-R+L

Polarity alternation (42J) Yes-No

Atrial coil (SVC) present Yes-No

Active case Yes-No

Shock configuration (+ --> -) Case to RV-SVC to RV-Case + SVC to RV-RV to Case-RV to

SVC-RV to Case + SVC

SVC exclusion (shock < 15J) Yes-No

SORIN – PLATINIUM CRT-D – U459A