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Chapter 5: ADVERSE REACTIONS
Skin irritation and burns beneath the electrodes have been reported
with the use of powered muscle stimulators.
Chapter 6 : GENERAL DESCRIPTION
The EMS 5.0 is a battery operated pulse generator that sends
electrical impulses through electrodes to the body and reaches the
underlying nerves or muscle group. The device is provided with two
controllable output channels, each independent of each other. An
electrode pair can be connected to each output channel.
The electronics of the EMS 5.0 create electrical impulses whose
Intensity, Pulse Width, Pulse Rate, Contraction, Relaxation and Ramp
may be altered with the switches. Dial controls are very easy to use
and the slide cover prevents accidental changes in the setting.
Chapter 7 : CONSTRUCTION
9. Portable powered muscle stimulators should not be used while
driving, operating machinery, or during any activity in which
involuntary muscle con tractions may put the user at undue risk
of injury.
Chapter 3 : WARNINGS
1. The long-term effects of chronic electrical stimulation are
unknown.
2. Stimulation should not be applied over the carotid sinus nerves,
particuarly 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.
Chapter 4: CONTRAINDICATION
Powered muscle stimulators should not be used on patients with
cardiac demand pacemakers.
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