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

17. PATIENT FOLLOW-UP

17.1. FOLLOW-UP RECOMMENDATIONS

Before the patient is discharged and at each subsequent follow-up visit, it is advisable to:

─ check the occurrence of system warnings

─ check the battery status,

─ check the integrity of the pacing and defibrillation leads,

─ check for proper sensing (sensitivity, crosstalk) and pacing ; set the pacing amplitude to

twice the pacing threshold,

─ interrogate the implant memories (AIDA+),

─ check the efficacy of the therapies delivered,

─ keep a printout of programmed parameters, test results, and memory data,

─ reset the memory data and statistics.

These operations should be performed by medical personnel in an appropriate care unit,

with resuscitation equipment present.

It is recommended that a routine follow-up examination be done one month after discharge,

and then every three months until the device nears the replacement date.

After a device reset, the magnet rate is equal to 87 bpm; it will be updated within the next 24

hours.

Refer to the online help for a description of displayed warning, and the necessity to contact

Sorin for an evaluation.

Implant software upgrade:

In case a new implant software is downloaded in the device memory through the

programmer, a warning message could be displayed by the programmer to inform the user

and give the proper instructions to follow.

17.2. HOLTER FUNCTION

The Holter records up to 14 tachyarrhythmia episodes as well as the therapy history.

Stored Episodes

INTENSIA SonR CRT-D 184 stores up to 14 episodes (VF, VT, Slow VT, SVT/ST, non-

sustained).

For each episode four levels of details are presented:

─ Tachogram (to visualize PP and PR intervals)

─ Event log for the entire episode:

─ PARAD/PARAD+ analysis for each majority,

─ Delivered therapies,

SORIN – INTENSIA SonR CRT-D 184 – U150A

NOTE: If the last reforming, charge or shock occurred during the week preceding the

interrogation, the last battery value may be still impacted by the event. One week post

event, the battery will recover its steady state value.