Use Instructions

12
GENERAL
The safety and effectiveness of Barostim has been demonstrated in clinical trials.
General Warnings
• Only trained physicians may use this system.
• Prescribing physicians should be experienced in the diagnosis and treatment of
hypertension and heart failure and should be familiar with the use of this
system.
• Monitor blood pressure and heart rate during Carotid Sinus Lead placement and
when adjusting stimulation parameters intra-operatively.
• Post-implantation, program the system to avoid the following:
o Heart rate falls below 50 beats per minute (BPM), or
o Systolic pressure falls below 90 mmHg, or
o Diastolic blood pressure falls below 50 mmHg, or
o Problematic adjacent tissue stimulation is noted, or
o Undesirable interaction indicated by monitoring of any other implanted
electrical device (see description below), or
o Any other potentially hazardous patient responses are observed.
• The system may affect the operation of other implanted devices such as cardiac
defibrillators, pacemakers, or neurological stimulation systems. For patients
who currently have an implanted electrical medical device, physicians must
verify compatibility with the implanted device during implantation of the
system as well as whenever settings are changed in either implant interactions
are more likely in devices that contain a sensing function, such as an
implantable cardiac defibrillator or pacemaker. Refer to the manufacturer’s
documentation regarding evaluation of sensing performance in such devices. If
an interaction is observed, the Barostim NEO & NEO2 should be programmed to
reduced therapy output settings in order to eliminate the interaction. If
necessary, change settings in the other implant only if the changes are not
expected to negatively impact its ability to perform its prescribed therapy.
During the implant procedure, if problematic device interactions cannot be
eliminated, the Barostim System should not be implanted.
• Improper system implantation could result in serious injury or death.
• Do not use Magnetic Resonance Imaging (MRI) on patients implanted with the
system.
• Do not use diathermy therapy including shortwave, microwave, or therapeutic
ultrasound diathermy on patients implanted with the system.
• Patients should be counseled to stay at least 15 cm (6 inches) away from
devices with strong electrical or magnetic fields such as strong magnets,
loudspeaker magnets, Electronic Article Surveillance (EAS) system tag
deactivators, arc welders, induction furnaces, and other similar electrical or
electromechanical devices. This would include not placing items such as
earphones in close proximity to the implanted pulse generator.