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. Defender study
  - Table 1: Summary of European Clinical Complications
  - Table 2: Summary of European Clinical Complications
6. Clinical studies
- 6.1. Defender 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. Lead 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. Ventricular tachyarrhythmia management
- 16.3. Pacing
- 16.4. Sensing
- 16.5. Follow-up function
- 16.6. Remote Monitoring function
17. Patient follow-up
- 17.1. Follow-up recommendations
- 17.2. Holter Function
  - Stored Tachyarrythmia Episodes:
  - Therapy history
- 17.3. Recommended Replacement Time (RRT)
- 17.4. Explantation
- 17.5. Defibrillator identification
18. Physical characteristics
- 18.1. Materials used
19. Electrical characteristics
- 19.1. Table of delivered shock energy and voltage
- 19.2. Battery
- 19.3. Longevity
20. Programmable parameters
- 20.1. Antibradycardia pacing
- 20.2. Ventricular tachyarrhythmia detection
- 20.3. Ventricular tachyarrhythmia therapies
- 20.4. Remote alerts and warnings
21. Non programmable parameters
22. Limited warranty
23. Patents
24. Explanation of symbols

14. IMPLANT PROCEDURE

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.

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.

14.11. DEVICE IMPLANTATION

PLATINIUM VR should be implanted with the device identification engraved side facing

outwards for optimal communication with the programming head and radiographic

identification.

Carefully wind excess lead and place in a separate pocket to the side of the defibrillator.

It is recommended not to place any excess wire between the can and the heart.

Suture the casing connector to the muscle using the hole provided for this purpose, in order

to avoid potential migration of the device into the pectoral muscle.

14.12. TESTS AND PROGRAMMING

During the implant testing procedure:

It is recommended that a security margin of at least 10 J be demonstrated between the

effective shock energy and maximum programmable energy.

Enable shock therapies, then program the defibrillator.

Verify that the defibrillation lead impedance for each shock delivered is within the range of

30 to 150 ohms. Check the lead connection if the values are outside these boundaries.

SORIN – PLATINIUM VR – U461A

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.

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 to prevent damaging the defibrillator.