User 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. Conformance to standards..................................................................................................23
10. Physician guidelines.............................................................................................................26
10.1. Physician training.................................................................................................................... 26
10.2. Directions for use.................................................................................................................... 26
10.3. Maintaining device quality.......................................................................................................26
10.4. V-V Programming Recommendation.......................................................................................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....................................................................................34
14.10.Leads connection.................................................................................................................... 35
14.11. Device implantation................................................................................................................. 36
14.12.Tests and programming........................................................................................................... 36
15. Special modes....................................................................................................................... 37
15.1. Safety mode (nominal values).................................................................................................37
SORIN – INTENSIA SonR CRT-D 184 – U150A
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