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

measured at 37 °C under a 500 ohm load

Legend:

Value in bold: "as shipped" value

Underlined value: nominal value

21.1. ANTIBRADYCARDIA PACING

Basic parameters Values

Mode VVI-VVIR-DDD-DDDR-DDD/DDIR-DDI-DDIR-SafeR (AAI

<=> DDD)-SafeR-R (AAIR <=> DDDR)

Basic rate (bpm)

(1)

From 30 to 90 by steps of 5 ; 60 (± 4 %)

Maximum rate (bpm) From 100 to 145 by steps of 5 ; 120 (± 6 %)

Rate hysteresis (%) 0-5-10-20-35 (± 18 ms)

Rest AV delay (ms) 30-40-45-55-65-70-80-85-95-100-110-115-125-135-140-150-

155-165-170-180-190-195-205-210-220-225-235-250

(± 19 ms)

Exercise AV delay (ms) 30-40-45-55-65-70-80-85-95-100-110-115-125-135-140-150-

155-165-170-180-190-195-205-210-220-225-235-250

(± 19 ms)

AVD Paced/Sensed Offset (ms) 0-10-15-25-30-40-45-55-65-70-80-85-95-100-110-115-125

(± 1 ms)

(1) The corresponding periods are (in ms): 2000-1714-1500-1333-1200-1091-1000-923-857-800-750-

706-667 ms.

Special features Values

Smoothing OFF-Very slow-Slow-Medium-Fast

Mode Switch ON-OFF

Physical activity Very low-Low-Medium-High-Very high

Exercise AV opt. rate (bpm) From 70 to 120 by steps of 5 ; 90

CRT optimization OFF-AV+VV

SORIN – INTENSIA SonR CRT-D 184 – U150A