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

Sensing threshold:

For appropriate ventricular sensing, the amplitude of the R-wave should be greater than 5

mV.

Pacing impedance measurement:

Ventricular pacing impedance should range from 200 to 3000 ohms (refer to the lead

characteristics, especially if high impedance lead is used).

Please refer to the lead user manual for more details on the expected electrical

performances of the leads.

14.10. LEAD CONNECTION

Implant the ventricular lead.

The lead must be connected to the corresponding connector port. The position of each

connector is indicated on the casing.

Tighten only the distal insert.

To connect the lead, proceed as follows:

1. Clean the lead terminal pins thoroughly, if necessary (device replacement).

2. Lubricate the lead terminal pins with sterile water, if necessary.

3. Do not insert a lead connector pin into the connector block without first visually verifying

that the lead port is not filled with any obstacle.

4. Insert the screwdriver into the pre-inserted screw socket of the appropriate port (in order

to allow excess air to bleed out and to make the insertion of the lead pin easier).

5. Insert the lead pin all the way into the port (check that the pin protrudes beyond the distal

insert).

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

insert, and has not move.

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.

SORIN – PLATINIUM VR – U461A

CAUTION: