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.
Conformance to standards..................................................................................................21
10.
Physician guidelines.............................................................................................................24
10.1. Physician training....................................................................................................................24
10.2. Directions for use....................................................................................................................24
10.3. Maintaining device quality.......................................................................................................24
11.
Patient information...............................................................................................................25
12.
How supplied.........................................................................................................................26
12.1. Sterility.................................................................................................................................... 26
12.2. Warranty and replacement policy............................................................................................26
13.
Device description................................................................................................................27
14.
Implant procedure.................................................................................................................29
14.1. Necessary equipment.............................................................................................................29
14.2. Packaging............................................................................................................................... 29
14.3. Optional equipment.................................................................................................................29
14.4. Before opening the package...................................................................................................29
14.5. Prior to implantation................................................................................................................30
14.6. Device placement....................................................................................................................30
14.7. Choosing the type of lead.......................................................................................................30
14.8. Shock configuration (+ -> -).....................................................................................................31
14.9. Measurement of thresholds at implant....................................................................................31
14.10.Lead connection .....................................................................................................................31
14.11. Device implantation.................................................................................................................33
14.12.Tests and programming...........................................................................................................33
15.
Special modes.......................................................................................................................34
15.1. Safety mode (nominal values).................................................................................................34
15.2. Magnet mode..........................................................................................................................34
15.3. Response in the presence of interference..............................................................................34
SORIN – INTENSIA VR 124 – U153A
3
Содержание Intensia VR 124
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