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

17. PATIENT FOLLOW-UP

For each episode four levels of details are presented:

─ Tachogram

─ Event log for the entire episode:

─ "Arrhythmia Discrimination" analysis for each majority,

─ Delivered therapies,

─ Markers: Ventricular markers, sensed, paced and in relative refractory periods,

─ EGM: onset and detection of the arrhythmia, on two therapies, and the return to slow

rhythm by recording electrogram.

Therapy history

For each arrhythmia detection, each therapy delivered (either automatically or during an

electrophysiological study) and at the end of each arrhythmia, PLATINIUM VR records the

type of majority rhythm, the number of ATP sequences delivered, the energy and the

number of shocks delivered.

17.3. RECOMMENDED REPLACEMENT TIME (RRT)

Recommended Replacement Time (RRT)

(1)

is controlled by: battery voltage equal to 2.62 V

± 0.01 V

Between the RRT and the EOS (End of Service)

(2)

, PLATINIUM VR can still function for:

─ 14 months (100% pacing in VVI mode, 500 ohms, with as shipped settings), and deliver

15 shocks at 34 J or

─ 10,4 months (0% pacing, sensors OFF, one shock every 2 weeks) and deliver 21 shocks

at 34 J.

Once the Recommended Replacement Time (RRT) point has been reached, the device

operates normally, except that the charge time increases. Under normal conditions (and

without programmer use) the charge times are as follows:

Shock energy Charge time (sec)

BOS

(3)

42 J 10 (± 2)

RRT 42 J 13 (± 3)

(1) Recommended Replacement Time (RRT) corresponds to Elective Replacement

Indicators (ERI) previously used.

(2) End of Service (EOS) corresponds to End of Life (EOL) previously used.

(3) Beginning of Service (BOS) corresponds to Beginning of Life (BOL) previously used.

17.4. EXPLANTATION

The defibrillator should be explanted in the following cases:

─ The Recommended Replacement Time (RRT) point is reached

─ Confirmed malfunction

─ Burial of the patient (for environmental reasons, the local regulation may require the

explantation of the devices containing a battery supply)

SORIN – PLATINIUM VR – U461A

CAUTION: The defibrillator should be replaced as soon as the Recommended Replacement

Time (RRT) point is reached.