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

6. Tighten, check the tightness and ensure the lead pin still protrudes beyond the distal

connector block, and has not moved.

CAUTION:

1. Do not tighten the pre-inserted screws when there is no lead (this could damage the

connector).

2. Do not loosen the screws before inserting the connector (subsequent risk of being unable

to reinsert the screw).

3. When mineral oil or sterile water is used to make lead insertion easier, the screwdriver

should remain inserted into the pre-inserted screw socket when checking the tightness.

As a matter of fact, when the lead port is filled with a liquid, the physics piston effect can

give the feeling the lead is properly tightened.

4. One single set screw is located on the side of the connection header.

5. Use only the screwdriver provided with the defibrillator. Keep the screwdriver's shaft

perpendicular to the plane of the defibrillator (see figure below).

6. Removing the screwdriver: to avoid all risk of loosening screws during removal, hold the

screwdriver by its metal part and not by the handle.

WARNING: Ensure that the screwdriver's tip is fully inserted in the setscrew; otherwise the

screwdriver can damage the setscrew and prevent connection with or disconnection from the

lead.

To ensure full insertion, push the screwdriver's hex tip smoothly into the setscrew until it

reaches the bottom of the hex chamber in the screw, which can be felt as a solid metallic

contact. Do not implant the defibrillator if there is no feeling of solid metallic contact. Do not

implant the defibrillator if the wrench does not click when attempting to tighten the setscrew

on the lead pin.

NOTE: To optimize cardioversion/defibrillation shocks, electrodes must be positioned so that

the electric field between anode(s) and cathode covers the largest myocardial mass. In

normal conditions, the anode and cathode are adequately separated. In case of a short-

circuit, the shock may be aborted.

In the case of an external defibrillation shock delivered to the patient, always check the

programming and functioning of the device, in particular its capacity to deliver shocks.

14. IMPLANT PROCEDURE

SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A 37