Indications; Contraindications; Safety - Zynex Medical E-wave User Manual

Indications, contraindications, precautions, safety and warnings.
Safety References
Zynex Medical (Zynex) is only responsible for the safety, reliability and
function of the device when repairs, adjustments and changes have been
carried out by persons authorized by Zynex for such work and the device is
used according to the user manual. Repairs and technical safety tests shall
only be carried out by trained personnel.

Indications

This Zynex device has been designed for muscle re-education, prevention of
retardation of disuse atrophy, increase local blood circulation, maintain or
increase range of motion, relaxation of muscle spasms, and edema reduction.
Relaxation of muscle spasms.
Prevention or retardation of disuse atrophy.
Increasing local blood circulation.
Muscle re-education.
Immediate post-surgical stimulation of calf muscles to prevent venous
thrombosis.
Maintaining or increasing range of motion
This stimulator should only be used under supervision for adjunctive therapy
for the treatment of medical diseases and conditions.

Contraindications

•
The device must not be used on patients with cardiac pacemaker.
•
The device must not be used with stimulation over carotid sinus nerves.
•
The stimulation must not be applied transcerebrally.
•
The device must not be applied with undiagnosed pain syndromes until
etiology is established.
•
This stimulator should not be used on patients with cardiac demand
pacemakers.
Electrodes should not be placed so that current will be applied to the carotid
sinus (neck) region or transcerebrally (through the head).
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