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. MSP study...............................................................................................................................13
5.2. Potential adverse events.........................................................................................................14
6. Clinical studies......................................................................................................................16
6.1. MSP clinical study...................................................................................................................16
7. Patient selection and treatment...........................................................................................20
7.1. Individualization of treatment..................................................................................................20
7.2. Specific patient populations....................................................................................................21
8. Patient counselling information..........................................................................................22
9. Declaration of conformity.....................................................................................................23
10. Physician guidelines.............................................................................................................25
10.1. Physician training....................................................................................................................25
10.2. Directions for use....................................................................................................................25
10.3. Maintaining device quality.......................................................................................................25
10.4. V-V Programming Recommendation.......................................................................................26
11. Patient information...............................................................................................................27
12. How supplied.........................................................................................................................28
12.1. Sterility....................................................................................................................................28
12.2. Warranty and replacement policy............................................................................................28
13. Device description................................................................................................................29
14. Implant procedure.................................................................................................................31
14.1. Necessary equipment.............................................................................................................31
14.2. Packaging...............................................................................................................................31
14.3. Optional equipment.................................................................................................................31
14.4. Before opening the package...................................................................................................32
14.5. Prior to implantation................................................................................................................32
14.6. Device placement.................................................................................................................... 32
14.7. Choosing the type of lead.......................................................................................................32
14.8. Shock configuration (+ -> -).....................................................................................................33
14.9. Measurement of thresholds at implant....................................................................................34
14.10.Leads connection....................................................................................................................34
14.11. Device implantation.................................................................................................................36
14.12.Tests and programming...........................................................................................................36
15. Special modes.......................................................................................................................37
15.1. Safety mode (nominal values).................................................................................................37
SORIN – PLATINIUM SonR CRT-D – U463A
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