User's Manual

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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

16. MAIN FUNCTIONS

16.1. AUTOMATIC LEAD MEASUREMENTS

Automatic pacing lead impedance measurement:

A lead impedance measurement is automatically performed on the lead every 6 hours.The

daily mean impedance is stored.

Automatic coil impedance measurement:

A continuity measurement is automatically performed on defibrillation coil(s) once per day.

The continuity is stored for each coil.

Automatic sensing measurement:

The amplitude of R waves are automatically measured at each cycle. Every 8.5 minutes, the

amplitude of the last 8 R detections are averaged and stored.

16.2. VENTRICULAR TACHYARRHYTHMIA MANAGEMENT

Arrhythmia discrimination algorithm Stability/Acceleration and

Stability+/Acceleration:

Stability/Acceleration is the algorithm used to discriminate sinus tachycardias (ST) and

supraventricular tachycardias (SVT) from ventricular tachycardias (VT).

Stability+/Acceleration is based on the Stability/Acceleration algorithm but additionally takes

into account the “AFdetect” discrimination criteria: the occurrence of a ‘long ventricular cycle’

characteristic for AF patients which is an additional arrhythmia classification criterion to

improve identification of atrial fibrillation and avoid inappropriate shocks.

Fast VT treatment:

Applies detection criteria on fast ventricular tachycardia that are different from those of the

VT zone, as well as different therapies. The fast VT zone is included in the VF zone: its

lower limit is determined by the programmed value for the VF zone and its upper limit by the

programmed value for the fast VT zone.

Polarity alternation on Max shock:

Reverses the programmed polarity of every second shock set at maximum energy. The

number, type, and energy of shocks is independently programmable by detection zone.

Defibrillation threshold (DFT):

Be aware that the changes in the patient’s condition, drug regimen, and other factors may

change the defibrillation threshold (DFT) which may result in non-conversion of the

arrhythmia post-operatively. Successful conversion of ventricular fibrillation or ventricular

tachycardia during arrhythmia conversion testing is no assurance that conversion will occur

post-operatively.

SORIN – PLATINIUM VR – U461A