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. LV Multipoint Pacing (MP)
- 16.7. Follow-up function
- 16.8. 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

― Electrophysiological studies (EPS) with real-time markers or electrograms:

― Programmer-controlled VT induction sequences,

― Programmer-controlled VF inductions (30 Hz rapid pacing or shock on T),

― Programmable electrogram vectors (A / RAring –CAN / RVcoil – CAN / RVtip – CAN

/ RVring – CAN/ RVcoil – SVC / SVC – CAN / LVtip1 - LV2 / LVtip1 - RVring / LVtip1

– LV4 / LVtip1 – CAN / LV2 - CAN / LV3 – LV2 / LV3- RVring / LV3 - LV4 / LV3 – CAN

/ LV2-LV4 / LV4 – CAN) and RV EGM,

― Real-time annotations displayed with the markers and indicating the majority rhythm,

― Manual ATP sequences,

― Manual shocks.

― Rescue shock

― Follow-up tests:

― Pacing lead impedance,

― Coil impedance,

― Capacitor charge time,

― Sensitivity test,

― Pacing threshold tests.

― Data storage:

― Therapy History Report,

― Statistics (pace/sense, therapy, shocks, and battery voltage),

― Up to 10 episodes and 5 min EGM on significant events: AV block switch, lead

impedance out of range,

― Up to 16 complete Holter records with event logs, marker channel notation, and

electrogram records.

The PLATINIUM 4LV CRT-D 1744 connector head has three ports:

― Atrial “IS-1” port: performs atrial bipolar pace/sense,

― LV “IS4” port: performs left ventricular pace,

― RV “DF4” port: performs right ventricular bipolar pace/sense, port for RV/SVC

defibrillation coils.

For PLATINIUM 4LV CRT-D 1744, the atrial port is compatible with the IS-1 standard; the

quadripolar left ventricular port is compatible with the IS4 standard and the quadripolar right

ventricular port is compatible with the DF4 standard."

Distal lead terminal connections are secured with set-screws accessed via self-sealing

silicone plugs. All lead connections pass through the header into the device via feedthroughs.

Programming System:

The Sorin programmer is used in conjunction with specific programmer software to

interrogate and program the implanted device at implant and during patient follow-up

procedures.

Remote Monitoring:

PLATINIUM 4LV CRT-D 1744 is also equipped with the RF wireless technology which

enables to remotely monitor the patients who have the Sorin SMARTVIEW Monitor installed

at home.

13. DEVICE DESCRIPTION

32 SORIN – PLATINIUM 4LV CRT-D 1744 – U904A