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

― Non-committed shocks

― 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 SonR CRT-D 1844 connector head has three ports:

― Atrial “SonR” port: performs atrial bipolar pace/sense if a conventional IS-1 lead is

connected as well as SonR capability if the SonR atrial lead is connected,

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

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

defibrillation coils.

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 SonR CRT-D 1844 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 SonR CRT-D 1844 – U906A