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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
1.7.4 Tupos LV/ATx Clinical IDE Study -
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