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
- 5.2. SafeR (AAI <> DDD) study
  - Table 1: Summary of Symphony safety data during study
6. Clinical studies
- 6.1. Defender study
- 6.2. SafeR (AAI <> DDD) study
  - Table 1: Summary of Symphony safety data during 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. Atrial tachyarrhythmia management
- 16.3. Ventricular tachyarrhythmia management
- 16.4. Pacing
- 16.5. Sensing
- 16.6. Follow-up function
- 16.7. 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

14.1. NECESSARY EQUIPMENT

Implantation of PLATINIUM DR requires the following equipment:

─ Sorin ORCHESTRA programmer, equipped with the SMARTVIEW software interface

and inductive telemetry head,

─ Sorin ORCHESTRA PLUS programmer, equipped with the SMARTVIEW software

interface, inductive telemetry head and optionally ORCHESTRA PLUS LINK,

─ pacing system analyzer, as well as its sterile connecting cables, to evaluate the pacing

and sensing thresholds,

─ a complete set of leads with corresponding introducers,

─ physiological signal monitor capable of displaying simultaneously the surface ECG and

arterial pressure,

─ an external defibrillator with sterile external paddles,

─ sterile cover for the telemetry head.

14.2. PACKAGING

14.2.1. Contents

PLATINIUM DR and its accessories are ethylene oxide sterilized and hermetically sealed in

two-ply clear packaging meeting international requirements.

The sterile packaging contains:

─ the defibrillator

─ a ratcheting screwdriver

─ a DF-1 defibrillating connector insulating plug for 1510 model

Once delivered, PLATINIUM DR is programmed to as-shipped values that are different from

nominal values (see Chapter “Programmable Parameters” for details).

14.3. OPTIONAL EQUIPMENT

The following equipment may be required during implantation of PLATINIUM DR:

─ an IS-1 insulating plug to close the atrial port

─ a DF4/DF-1 adaptor in case of replacement and use of DF-1 lead in a DF4 connector

─ sterile water to clean traces of blood. Any parts cleaned with sterile water must be

thoroughly dried.

─ mineral oil to lubricate if necessary

─ a lead cap to isolate a lead which is not used

SORIN – PLATINIUM DR – U460A

NOTE: In case you’re implanting a DF4 lead, please verify its compatibility with standard

alligators pin; please refer to the lead user’s manual for more details.