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
- 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 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. SonR CRT optimization
- 16.7. LV Multipoint Pacing (MP)
- 16.8. Follow-up function
- 16.9. Remote Monitoring function
17. Patient follow-up
- 17.1. Follow-up recommendations
- 17.2. Holter Function
  - 17.2.0.1. Stored Tachyarrythmia Episodes:
  - 17.2.0.2. 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
  - 18.1.0.3. 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

14. IMPLANT PROCEDURE

NECESSARY EQUIPMENT

Implantation of PLATINIUM 4LV SonR CRT-D 1844 requires the following equipment:

― Sorin ORCHESTRA programmer, equipped with the SMARTVIEW software interface

and inductive telemetry head,

― Sorin ORCHESTRA PLUS programmer, equipped with the SMARTVIEW software

interface, inductive telemetry head and optionally ORCHESTRA PLUS LINK,

― pacing system analyzer, as well as its sterile connecting cables, to evaluate the pacing

and sensing thresholds,

― a complete set of leads with corresponding introducers,

― physiological signal monitor capable of displaying simultaneously the surface ECG and

arterial pressure,

― an external defibrillator with sterile external paddles,

― sterile cover for the telemetry head.

NOTE: In case you are implanting a DF4 and/or IS4 lead(s), please verify its compatibility

with standard alligators pin; please refer to the lead user’s manual for more details.

PACKAGING

Contents

PLATINIUM 4LV SonR CRT-D 1844 and its accessories are ethylene oxide sterilized and

hermetically sealed in two-ply clear packaging meeting international requirements.

The sterile packaging contains:

― the defibrillator

― a ratcheting screwdriver

As delivered, PLATINIUM 4LV SonR CRT-D 1844 is programmed to as-shipped values that

are different from nominal values (see Chapter “Programmable Parameters” for details).

OPTIONAL EQUIPMENT

The following equipment may be required during implantation of PLATINIUM 4LV SonR CRT-

D 1844:

― an IS-1 insulating plug to close the atrial port

― sterile water to clean traces of blood. Any parts cleaned with sterile water must be

thoroughly dried.

― mineral oil to lubricate if necessary

― a lead cap to isolate a lead which is not used

14.1.

14.2.

14.2.1.

14.3.

14. IMPLANT PROCEDURE

SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 33