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
5.2. SafeR (AAI <> DDD) study.....................................................................................................14
6. Clinical studies...................................................................................................................... 16
6.1. Defender study........................................................................................................................ 16
6.2. SafeR (AAI <> DDD) study.....................................................................................................18
7. Patient selection and treatment...........................................................................................22
7.1. Individualization of treatment..................................................................................................22
7.2. Specific patient populations....................................................................................................23
8. Patient counselling information..........................................................................................24
9. Declaration of conformity.....................................................................................................25
10. Physician guidelines.............................................................................................................27
10.1. Physician training.................................................................................................................... 27
10.2. Directions for use.................................................................................................................... 27
10.3. Maintaining device quality.......................................................................................................27
11. Patient information............................................................................................................... 28
12. How supplied......................................................................................................................... 29
12.1. Sterility.................................................................................................................................... 29
12.2. Warranty and replacement policy............................................................................................29
13. Device description................................................................................................................ 30
14. Implant procedure................................................................................................................. 32
14.1. Necessary equipment.............................................................................................................32
14.2. Packaging............................................................................................................................... 32
14.3. Optional equipment.................................................................................................................32
14.4. Before opening the package...................................................................................................33
14.5. Prior to implantation................................................................................................................33
14.6. Device placement.................................................................................................................... 33
14.7. Choosing the type of lead.......................................................................................................33
14.8. Shock configuration (+ -> -).....................................................................................................34
14.9. Measurement of thresholds at implant....................................................................................35
14.10.Lead connection ..................................................................................................................... 35
14.11. Device implantation.................................................................................................................36
14.12.Tests and programming...........................................................................................................37
15. Special modes....................................................................................................................... 38
15.1. Safety mode (nominal values).................................................................................................38
SORIN – PLATINIUM DR – U460A
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