8
10) Stimulation should not take place while the user is connected to high- frequency
surgical equipment. It may cause burn injuries in the skin under the electrodes, as well
as problems with the stimulator.
11) Do not use the stimulator in the vicinity of shortwave or microwave therapy
equipment, since this may affect the output power of the stimulator.
12) Never use in environments with high humidity such as in the bathroom or when
having a bath or shower.
13) Caution should be used in applying electrical stimulation to patients suspected of
having heart disease. Further clinical data is needed to show there are no adverse
results,
14) Never use near the heart. Stimulation electrodes should never be placed anywhere
on the front of the thorax (marked by ribs and breastbone), but above all not on the two
large pectoral muscles. Here it may increase the risk of ventricular fibrillation and lead to
cardiac arrest.
15) Electrodes should not be placed over the eyes, in the mouth, near the genitals or
internally.
16) Never use on areas of the skin which lack normal sensation
17) Apply the electrodes to clean, dry, and unbroken skin only.
I8) Keep electrodes separate during treatment, electrodes in contact with each other
could result in improper stimulation or skin inflammation.
19) Keep the stimulator out of reach of children.
20) Consult your doctor if you are in any doubt whatsoever.
CAUTIONS:
1) In the USA, Federal law restricts this device to sale by or on the order of a physician.
2) For single patient use only.
3) Be aware of the contraindications.
4) This stimulator not intended for unattended, personal use by patients who are
noncompliant or emotionally disturbed, or have dementia or low IQ.
5) Read, understand, and observe the warnings, cautions and operating instructions.
Know the limitations and hazards associated with using any device. Observe the
precautionary and operational decals placed on the unit. Always follow the operating
instructions prescribed by your healthcare practitioner.
