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.
Conformance to standards..................................................................................................25
10.
Physician guidelines.............................................................................................................28
10.1. Physician training....................................................................................................................28
10.2. Directions for use....................................................................................................................28
10.3. Maintaining device quality.......................................................................................................28
11.
Patient information...............................................................................................................29
12.
How supplied.........................................................................................................................30
12.1. Sterility.................................................................................................................................... 30
12.2. Warranty and replacement policy............................................................................................30
13.
Device description................................................................................................................31
14.
Implant procedure.................................................................................................................33
14.1. Necessary equipment.............................................................................................................33
14.2. Packaging............................................................................................................................... 33
14.3. Optional equipment.................................................................................................................33
14.4. Before opening the package...................................................................................................34
14.5. Prior to implantation................................................................................................................34
14.6. Device placement....................................................................................................................34
14.7. Choosing the type of lead.......................................................................................................34
14.8. Shock configuration (+ -> -).....................................................................................................35
14.9. Measurement of thresholds at implant....................................................................................35
14.10.Lead connection .....................................................................................................................36
14.11. Device implantation.................................................................................................................37
14.12.Tests and programming...........................................................................................................37
15.
Special modes.......................................................................................................................38
15.1. Safety mode (nominal values).................................................................................................38
SORIN – INTENSIA DR 154 – U152A
3
Summary of Contents for Intensia DR 154
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