Mintek LV-T Benutzerhandbuch
Stratos LV/LV-T Technical Manual i
Contents
1.
General ..............................................................................1
1.1
Device Description ........................................................1
1.2
Indications .....................................................................2
1.3
Contraindications ..........................................................3
1.4
Note to Physician ..........................................................3
1.5
Warnings and Precautions ............................................3
1.5.1
Interactions with Other Medical Therapy...............4
1.5.2
Storage and Sterilization .......................................6
1.5.3
Lead Connection and Evaluation ..........................7
1.5.4
Programming and Operation.................................8
1.5.5
Home Monitoring .................................................11
1.5.6
Electromagnetic Interference (EMI) ....................13
1.5.7
Home and Occupational Environments...............13
1.5.8
Cellular Phones ...................................................14
1.5.9
Hospital and Medical Environments....................15
1.5.10
Device Explant and Disposal...............................15
1.6
Potential Effects of the Device on Health....................16
1.7
Clinical Studies............................................................17
1.7.1
Stratos LV Clinical Study – AVAIL CLS/CRT ......17
1.7.2
Stratos LV Clinical Study – OVID study ..............39
1.7.3
AVAIL and OVID Combined Primary
Endpoint-Complication-free Rate (Safety) ..........47
Endpoint-Complication-free Rate (Safety) ..........47
1.7.4
Tupos LV/ATx Clinical IDE Study -
OPTION CRT/ATx...............................................49
OPTION CRT/ATx...............................................49
1.7.5
Conclusions Drawn from Studies ........................61
2.
Programmable Parameters............................................63
2.1
Pacing Modes..............................................................63
2.1.1
Rate-adaptive Modes ..........................................63
2.1.2
DDD.....................................................................63
2.1.3
DDI ......................................................................67
2.1.4
DVI.......................................................................67
2.1.5
VDD .....................................................................67
2.1.6
AAI and VVI .........................................................68
2.1.7
AAI, VVI ...............................................................68
2.1.8
AOO, VOO...........................................................68
2.1.9
DOO ....................................................................68
2.1.10
VDI.......................................................................68