MicroTransponder 2100, Manual

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26-0002-0005/0 (en) (2022) 48
12 P
RECAUTIONS
, W
ARNINGS
, C
ONTRAINDICATIONS
,
AND
H
AZARDS
Refer to the Microtransponder
®
Vivistim
®
Paired VNS
™
System Implantable Device Manual
for Healthcare Professionals and the Microtransponder
®
Vivistim
®
Paired VNS
™
System
Manual for Patients for additional precautions, warnings, contraindications, and hazards to be
avoided relating to the Vivistim
®
System. Call the physician or contact MicroTransponder if you
have any questions (see Section 18: Information and Support ).
• Use —The Vivistim
®
System should only be prescribed and monitored by physicians who
have specific training and expertise in the management of stroke and the use of this
device. The IPG, Lead, WT, and SAPS should only be used as part of the Vivistim
®
System.
• WT is MR Unsafe —The WT must not be exposed to magnetic resonance imaging
(MRI).
• Magnet is MR Unsafe —The patient must not carry metal (magnets, jewelry, etc.) into the
MR scanner room. Metal objects can become dangerous flying objects if attracted by the
strong magnetic field of the MRI scanner.
• Environmental and medical therapy hazards —Patients should exercise reasonable
caution in avoiding devices that generate a strong electric or magnetic field.
• EMI effects on other devices —The Vivistim
®
System should be moved—typically at least
1.8 m (6 ft)—away from equipment with which it may be interfering. Programming or
interrogating the IPG may momentarily interfere with other sensitive electronic equipment
nearby.
• Communication —The IPG “listens” for a communication signal from the WT.
Communication usually takes less than 2 seconds but may be prolonged or interrupted in
the presence of electromagnetic interference (EMI).
CAUTION: Do not use the Vivistim
®
System in an environment where explosive or
flammable gases are present.
CAUTION: Do not use the Vivistim
®
System in an environment where the non-implantable
components of the system may get wet. These components are not waterproof and
should be kept dry, except for normal cleaning with a damp cloth.
CAUTION: Electrostatic discharge (ESD) discharge precautions should be taken before
handling the system. A grounded metal object should be touched before touching the
laptop, Wireless Transmitter, and push button.
CAUTION: Degradation of the Vivistim® system’s ability to communicate during
exposure to frequency ranges associated with television broadcasts (~203 MHz) and
frequency ranges associated with satellites (~400 MHz), including global positioning
system (GPS) signals found in cellphones and other mobile electronic devices, can
occur. Programming and pairing with the system should be performed either outside of
these environments or with this equipment turned off.