System Manual

26-0002-0003/5 (en) (2021) 3
TABLE OF CONTENTS
1 DEVICE DESCRIPTION ................................................................................................. 7
1.1 Intended Use / Indication .......................................................................................... 8
1.2 SAPS Warnings ....................................................................................................... 9
1.3 SAPS Package Contents ......................................................................................... 9
1.4 WT Package Contents ............................................................................................. 9
2 GETTING STARTED ................................................................................................... 10
2.1 Stroke Application & Programming Software (SAPS) Hardware Setup ................... 10
2.2 How to Use the Stroke Application & Programming Software (SAPS) .................... 11
3 USING THE SOFTWARE (SAPS) ................................................................................ 13
3.1 Buttons Versus Tabs .............................................................................................. 14
3.2 Parameter Text Color ............................................................................................. 15
3.3 Overview of SAPS Menus (Tabs) Used for Therapy ............................................... 15
3.3.1 Program Implant Overview ........................................................................ 15
3.3.2 VNS Pairing Therapy Overview ................................................................. 16
3.3.3 Patient Log File Overview ......................................................................... 16
3.3.4 On-Demand Mode Overview ..................................................................... 16
3.3.5 Entire Session VNS Scheduler Overview .................................................. 16
3.3.6 Independent Mode .................................................................................... 16
3.3.7 Study ......................................................................................................... 16
4 PROGRAMMING THE IMPLANT .................................................................................... 17
4.1 Connecting to a Specific IPG ................................................................................. 17
4.2 Patient Information (Optional) ................................................................................ 20
4.3 Implant Settings ..................................................................................................... 20
4.4 Therapy Modes ...................................................................................................... 23
4.4.1 Stim Test Mode ......................................................................................... 23
4.4.2 Therapist Trigger Mode ............................................................................. 25
4.5 Impedance ............................................................................................................. 26
5 DELIVERING PAIRED VNS
™
...................................................................................... 29
5.1 On-Demand Mode Menu ........................................................................................ 29
5.1.1 On-Demand Mode Therapy via the VNS Pairing Therapy Menu ............... 31
5.2 Entire Session VNS Scheduler ............................................................................... 36
5.2.1 Therapy Trigger Mode ............................................................................... 37
5.2.2 Magnet Mode ............................................................................................ 39
5.2.3 Setting Parameters ................................................................................... 41
6 STOPPING STIMULATION ........................................................................................... 42
6.1 Magnet Mode ......................................................................................................... 42
6.2 Therapist Trigger Mode .......................................................................................... 42