User's Manual

2/2020 CY-0090-018, Rev.A Page 9 of 49
3. 3 C ON TR AIN DIC AT ION
 Powered muscle stimulators should not be used on patients with
cardiac demand pacemakers.
3. 4 W ARN ING S
1. The long-term effects of chronic electrical stimulation are
unknown.
2. Stimulation should not be applied over the carotid sinus nerves,
particularly in patients with a known sensitivity to the carotid
sinus reflex.
3. Stimulation should not be applied over the neck or mouth.
Severe spasm of the laryngeal and pharyngeal muscles may
occur, and the contractions may be strong enough to close the
airway or cause difficulty in breathing.
4. Stimulation should not be applied transthoracically in that the
introduction of electrical current into the heart may cause
cardiac arrhythmias.
5. Stimulation should not be applied transcerebrally.
6. Stimulation should not be applied over swollen, infected, or
inflamed areas or skin eruptions, e.g., phlebitis,
thrombophlebitis, varicose veins, etc.
7. Stimulation should not be applied over, or in proximity to,
cancerous lesions.
8. Do not apply stimulation in the presence of electronic monitoring
equipment (e.g., cardiac monitors, ECG alarms), which may not
operate properly when the electrical stimulation device is in use.
9. No modification of this device is allowed.
10. Use this device only with the leads, electrodes, electrode gel, and
accessories recommended by CyMedica Orthopedics indicated in
this User’s Manual document.
11. Do not use this device while connected to high frequency surgical
equipment. The simultaneous connection may result in burns at
the site of the electrodes and possible damage to the device.
12. Do not use this device in close proximity (e.g. 1 m) of a shortwave
or microwave equipment. The close proximity may produce
instability in device performance.