User Manual

TABLE OF CONTENTS
1. GENERAL DESCRIPTION ...................................................................................... 10
2. INTENDED USE AND TARGETED POPULATION................................................. 11
Intended use............................................................................................................. 11
Indications and targeted population ......................................................................... 11
3. CONTRAINDICATIONS AND ADVERSE EVENTS ................................................ 13
General considerations ............................................................................................ 13
Adverse events, risks and side effects ..................................................................... 13
4. WARNINGS ............................................................................................................. 16
Pacemaker dependent patients................................................................................ 16
Warnings to patients................................................................................................. 16
Risks related to medical environment ...................................................................... 16
Storage..................................................................................................................... 18
Packaging................................................................................................................. 18
5. CLINICAL STUDIES ................................................................................................ 19
Methods.................................................................................................................... 19
Patients studied........................................................................................................ 19
Safety results............................................................................................................ 19
Effectiveness results ................................................................................................ 19
6. PATIENT SELECTION AND TREATMENT............................................................. 21
Specific patient populations...................................................................................... 21
7. PATIENT COUNSELING INFORMATION............................................................... 22
8. DECLARATION OF CONFORMITY ........................................................................ 23
9. PHYSICIAN GUIDELINES ....................................................................................... 24
Physician training ..................................................................................................... 24
Directions for use ..................................................................................................... 24
Maintaining device quality ........................................................................................ 24
Implantation and device programming ..................................................................... 25
Lead evaluation and lead connection....................................................................... 25
Programming and pacemaker operation .................................................................. 26
Rate increases ......................................................................................................... 26
Generator explant and disposal ............................................................................... 27
10. PATIENT INFORMATION........................................................................................ 28
11. HOW SUPPLIED...................................................................................................... 29
Sterility...................................................................................................................... 29
Warranty and replacement policy............................................................................. 29
12. IMPLANT PROCEDURE.......................................................................................... 30
2.1.
2.2.
3.1.
3.2.
4.1.
4.2.
4.3.
4.4.
4.5.
5.1.
5.2.
5.3.
5.4.
6.1.
9.1.
9.2.
9.3.
9.4.
9.5.
9.6.
9.7.
9.8.
11.1.
11.2.
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