User's Manual

TABLE OF CONTENTS
1. General description................................................................................................................ 5
2. Indications............................................................................................................................... 6
3. Contraindications....................................................................................................................7
4. Warnings and precautions.....................................................................................................8
4.1. Risks related to medical environment.......................................................................................9
4.2. Sterilization, storage and handling..........................................................................................10
4.3. Implantation and device programming....................................................................................10
4.4. Lead evaluation and lead connection......................................................................................11
4.5. Generator explant and disposal..............................................................................................12
5. Adverse events...................................................................................................................... 13
5.1. Defender study........................................................................................................................ 13
6. Clinical studies...................................................................................................................... 15
6.1. Defender study........................................................................................................................ 15
7. Patient selection and treatment...........................................................................................18
7.1. Individualization of treatment..................................................................................................18
7.2. Specific patient populations....................................................................................................19
8. Patient counselling information..........................................................................................20
9. Declaration of conformity.....................................................................................................21
10. Physician guidelines.............................................................................................................23
10.1. Physician training.................................................................................................................... 23
10.2. Directions for use.................................................................................................................... 23
10.3. Maintaining device quality.......................................................................................................23
11. Patient information............................................................................................................... 24
12. How supplied......................................................................................................................... 25
12.1. Sterility.................................................................................................................................... 25
12.2. Warranty and replacement policy............................................................................................25
13. Device description................................................................................................................ 26
14. Implant procedure................................................................................................................. 28
14.1. Necessary equipment.............................................................................................................28
14.2. Packaging............................................................................................................................... 28
14.3. Optional equipment.................................................................................................................28
14.4. Before opening the package...................................................................................................29
14.5. Prior to implantation................................................................................................................29
14.6. Device placement.................................................................................................................... 29
14.7. Choosing the type of lead.......................................................................................................29
14.8. Shock configuration (+ -> -).....................................................................................................30
14.9. Measurement of thresholds at implant....................................................................................30
14.10.Lead connection ..................................................................................................................... 31
14.11. Device implantation.................................................................................................................32
14.12.Tests and programming...........................................................................................................32
15. Special modes....................................................................................................................... 34
15.1. Safety mode (nominal values).................................................................................................34
15.2. Magnet mode.......................................................................................................................... 34
15.3. Response in the presence of disturbance...............................................................................34
SORIN – PLATINIUM VR – U461A
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