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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. Remove batteries if the unit is not used for a long period of time.
9.Keep the unit away from sources of high magnetic fields such as TV’s,
microwave ovens and hi-fi speakers, as these may affect the LCD screen.
10. Do not apply stimulation before attaching electrodes on the skin.
11. During stimulation, do not touch the patient and treatment site at a time
12. 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.
Chapter 4: PRECAUTIONS
1. Safety of powered muscle stimulators for use during pregnancy has not been
established.
2. Caution should be used for patients with suspected or diagnosed heart problems.
3. Caution should be used for patients with suspected or diagnosed epilepsy.
4. Caution should be used in the presence of the following:
a) When there is a tendency to hemorrhage following acute trauma or fracture;
b) Following recent surgical procedures when muscle contraction may disrupt
the healing process;
c) Over the menstruating or pregnant uterus; and
d) Over areas of the skin which lack normal sensation.
5. Some patients may experience skin irritation or hypersensitivity due to the
electrical stimulation or electrical conductive medium. The irritation can usually
be reduced by using an alternate conductive medium or alternate electrode
placement.
6. Electrode placement and stimulation settings should be based on the guidance
of the prescribing practitioner.
7. Powered muscle stimulators should be kept out of the reach of children.
8. Powered muscle stimulators should be used only with the leads and electrodes
recommended for use by the manufacturer.
9. Portable powered muscle stimulators should not be used while driving, operating
machinery, or during any activity in which involuntary muscle contractions may
put the user at undue risk of injury.
Chapter 5: ADVERSE REACTIONS
Skin irritation and burns beneath the electrodes have been reported with the use
of powered muscle stimulators.
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Chapter 1: INTRODUCTION
EXPLANATION OF EMS
Electrical Muscle Stimulation is an internationally accepted and proven way of
treating muscular injuries. It works by sending electronic pulses to the muscle
needing treatment: this causes the muscle to exercise passively.
EMS has low frequency and this, in conjunction with the square wave pattern,
allows direct work on muscle groupings. This is being widely used in hospitals
and sports clinics for the treatment of muscular injuries and for the re-education
of paralyzed muscles, to prevent atrophy in affected muscles and improving
muscle tone and blood circulation.
INTENDED USE
EMS Unit is applicable to patients diagnosed with wide range of orthopedic and
neurologic deficiencies who demonstrate difficulties during voluntary movements.
This is a prescription device and should be used under continued medical supervision.
And it is intended use as below:
1. Relaxation of muscle spasms.
2. Prevention or retardation of disuse atrophy.
3. Increasing local blood circulation.
4. Muscle re-education.
5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
6. Maintaining or increasing range of motion.
Chapter 2: CONTRAINDICATION
Powered muscle stimulators should not be used on patients with cardiac demand
pacemakers.
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, 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.
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