Powered GM320E Operation Manual

Powered Muscle Stimulator (EMS)

Read before using

FDA 510k

Model: GM320E (C)

Operation Manual

TABLE CONTENTS

GENERAL DESCRIPTION 1

SYSTEM COMPONENTS 1

WARR ANTY 1

INDICATIONS AND CONTRAINDICATIONS 1

WARNINGS AND PRECAUTIONS 2

ABOUT THE DEVICE 3

THE DEVICE CONTROLS 4

DANGER 4

ATTACHING THE LEAD WIRES 5

ELECTRODE SELECTION AND CARE 5

TIPS FOR SKIN CARE 5

CONNECTING THE DEVICE 6

BATTERY INFORMATION 6

CHANGING THE BATTERY 7

CLEANING FOR YOUR DEVICE 7

TROUBLESHOOTING 7

TECHNICAL SPECIFICATIONS 8
PROCEDURE OF Compliance meter SETTING (Special

for physician)

9

GENERAL DESCRIPTION

Electric myostimulation has proven its high value as a method of pain therapy and is a
great help to the experienced therapist.
With some indications, physicians can prescribe unit to patients for the use at home.
The unit is a dual-Channel electric stimulator for active treatment application, which is
equipped with a Liquid Crystal Display indicating operation modes and output as well as
an 8-bit micro computer for controlling the system.
The electronics of the unit create electric impulses: the intensity, duration, frequency per
second and modulation of these impulses can be adjusted through the button or knob.

SYSTEM COMPONENTS

Your device may include the following components or accessories:

 Unit
 Carrying case
 Lead wires / Electrodes
 9-volt battery
 Operation Manual

WARRANTY

This device carries a one-year warranty from the date of purchase. The warranty applies
to the device and necessary parts and labor relating thereto. The distributor reserves the
right to replace or repair the unit at their discretion.
The warranty does not apply to electrode, battery, lead wires, carrying case, damage
resulting from failure to follow the operating instructions, accidents, abuse, alterations or
disassembly by unauthorized individuals.

INDICATIONS AND CONTRAINDICATIONS

Read the operation manual before using the device.
Federal law (USA) restricts this device to sale by or on the order of a physician. Observe
your physician’s precise instructions and let him show you where to apply the electrodes.
For a successful therapy, the correct application of the electrodes is an important factor.
Carefully write down the settings your physician recommended.

Indications for use

 Relaxation of muscle spasms.

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 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.

Contraindications

Powered muscle stimulators should not be used on patients with cardiac demand
pacemakers.

WARNI NGS AN D PRE CAUTIONS

Warnings

 The long-term of chronic electrical stimulation are unknown.
 Stimulation should not be applied over the carotid sinus nerves, particularly in

patients with a known sensitivity to the carotid sinus reflex.

 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.

 Stimulation should not be applied transthoracically in that the introduction of

electrical current into the heart may cause cardiac arrhythmias.

 Stimulation should not be applied over swollen, infected, or inflamed areas or skin

eruptions, e.g. phlebitis, thrombophlebitis, varicose veins, etc.

 Stimulation should not be applied over, or in proximity to, cancerous lesions.
 Stimulation should not be applied transcerebrally (across the head).

Precautions/adverse Reactions

 Safety of powered muscle stimulators for use during pregnancy has not been

established.

 Caution should be used for patients with suspected or diagnosed heart problems.
 Caution should be used for patients with suspected or diagnosed epilepsy.
 Caution should be used in the presence of the following:

a. When there is a tendency to hemorrhage following acute trauma of 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.

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