System Manual

26-0002-0003/5 (en) (2021) 8
The SAPS and WT allow the implanted components (the IPG and Lead) to stimulate the vagus
nerve while a rehabilitation movement occurs. The therapist initiates the stimulation using a
USB push button or mouse click, so as to synchronize the stimulation with an appropriate
timepoint during rehabilitation movements. When directed by a physician and with appropriate
programming to the IPG, the patient can initiate at-home use by swiping a magnet over the IPG
implant site. Swiping activates the IPG to deliver stimulation for ~ 30 minutes
1
while
rehabilitation movements are performed at home. At-home use does not require the use of
SAPS or the WT. In addition, the magnet provided to the patient to initiate home therapy also
has a safety feature; if the patient desires to stop stimulation, holding the magnet over the
device stops stimulation for as long as it is held over the device.
The physician or therapist is responsible for training the patient on use of the magnet and
providing the Microtransponder
®
Vivistim
®
Paired VNS
™
System Manual for Patients. The
Microtransponder
®
Vivistim
®
Paired VNS
™
System Quick Start Guide for Patients is
located in the Microtransponder
®
Vivistim
®
Paired VNS
™
System Manual for Patients, and an
additional copy is on the last page of this manual.
Software capabilities include:
• Use of SAPS with the WT by a rehabilitation therapist or neurologist or other physician to
interrogate and program an IPG’s parameters and assess IPG function
• Use of SAPS with the WT by a rehabilitation therapist or neurologist or other physician to
initiate a therapy session during rehabilitation at the clinic
• Use of SAPS without the WT to display the operating histories of all the IPGs interrogated
with the laptop
• Use of screen displays that provide prompts and messages to aid in interrogating and
programming
Other User Manuals:
• Microtransponder
®
Vivistim
®
Paired VNS
™
System Manual for Patients
• Microtransponder
®
Vivistim
®
Paired VNS
™
System Implantable Device Manual for
Healthcare Professionals
1.1 Intended Use / Indication
The MicroTransponder
®
Vivistim
®
Paired VNS
™
System is intended to be used to stimulate the
vagus nerve during rehabilitation therapy to reduce upper extremity motor deficits and improve
motor function in chronic ischemic stroke patients with moderate to severe arm impairment.
SAPS is intended for use only with the MicroTransponder Implantable Pulse Generator (IPG)
and MicroTransponder Wireless Transmitter.
1
The clinician is responsible for establishing the duration of stimulation according to clinical best practices.