Encore Medical Chattanooga Intelect Instruction Manual

Intelect
®
NMES
Chapter Page
1 GENERAL INFORMATION
1.1 What is a Neuromuscular Stimulator? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
1.2 How does a Neuromuscular Stimulator work? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
1.3 The Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
2 SAFETY
2.1 Caution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
2.2 Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
2.3 Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
2.4 Precaution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
2.5 Adverse Reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
3 TECHNICAL SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
4 CONTROLS AND INDICATORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-8
5 INSTRUCTIONS FOR USE
5.1 Check Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
5.2 Connect electrodes to lead wires . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
5.3 Connect lead wires to unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Contents
Chapter Page
5.4 Place electrodes on skin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
5.5 Adjust Contraction (ON) Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
5.6 Adjust Relaxation (OFF) Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
5.7 Select the Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
5.8 Select the Ramp Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
5.9 Adjust Channel Amplitude . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
5.10 Turn Unit Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
5.11 Portability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
5.12 Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
5.13 Care of Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
5.14 Care of Electrode cords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
6 DO'S AND DON'TS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
7 HANDLING AND STORAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
8 ACCESSORIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
9 TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
10 WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
1.1 What is a Neuromuscular Stimulator?
Neuromuscular Stimulation is achieved by sending small electrical impulses through the skin to the underlying motor units (nerves and muscles) to create an involuntary muscle contraction. Neuromuscular stimulation has many uses beyond its traditional application to prevent disuse atrophy, including:
An increased range of motion: As a substitute for passive stretching exercise performed by the patient or therapist.
Muscle re-education: for example, teaching patients how to set their quads.
1.2 How does a Neuromuscular Stimulator work?
Because the transdermal stimulation of nerves and muscles may be accomplished by electrical pulses, this modality can help prevent disuse atrophy. Accordingly, incapacitated patients can receive therapeutic treatment to create involuntary muscle contractions thereby improving and maintaining muscle tone without actual physical activity.
1.3 The Instrument:
The Neuromuscular Stimulator is an easy to use system. A marvel of miniaturized electronics, the lightweight power unit transmits electrical pulses through the skin surface and stimulates motor units (nerve and muscles). The electrical impulses are "ramped" so they closely emulate natural muscle contractions.
1. GENERAL INFORMATION
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2.1 Caution:
Federal law (USA) restricts this device to sale by or on the order of practitioners licensed by the State in which they practice to use or order the use of the device.
2.2 Indications:
This NMES is intended to be used in:
1. Relaxation of muscle spasm.
2. Prevention or retardation of disuse atrophy.
3. Increase 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.
2.3 Warnings:
The long-term effects 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.
2. SAFETY
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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.
Keep electrodes separate during treatment. Electrodes in contact with each other could result in improper stimulation or skin burns.
2.4 Precautions:
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 or fracture b. Following recent surgical procedures when muscle contraction may disrupt the healing process c. Over the menstruating or pregnant uterus d. Over areas of the skin which lack normal sensation.
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.
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Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner.
Stimulators should be kept out of the reach of children.
Stimulators should be used only with the leads and electrodes recommended for use by the manufacturer.
Machinery Operation: Patient should never operate potentially dangerous machinery such as power saws, automobiles, etc. during stimulation.
2.5 Adverse Reactions:
Possible skin irritation or electrode burn under the electrodes may occur.
Possible allergic skin reaction to tape or gel may occur.
If the stimulation levels are uncomfortable or become uncomfortable, reduce the stimulation amplitude to a comfortable level and contact your physician if problems persist.
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Channel Dual channels, isolated between channels Pulse Amplitude 0 ~ 80 mA = 0 ~ 40 volts, adjustable (at 500 ohm load) Pulse Frequency (Hz) 5, 30, 100 Pulse Width (µs) 250, fixed Contraction (On) Time (sec) 1 ~ 30, adjustable Relaxation (Off) Time (sec) 1 ~ 45, adjustable Waveform Asymmetric biphasic square pulse. Timer Control (mins) No Stimulation Mode One Power Supply 9V DC square shape battery Size (D x W x H) 1.0" x 2.5" x 3.6" (26 mm x 62 mm x 91 mm) Weight (including battery) 4.4 oz (126 g) Safety standard EN 60601-1, EN 60601-1-2, IEC 60601-2-10 Operation Ambient Temperature Range 50 ~ 95ºF (10 ~ 35ºC) Operation Ambient Humidity Range 20 ~ 90% RH Storage & Transportation Temperature Range 32 ~ 158ºF (0 ~ 70ºC) Storage & Transportation Humidity Range 20 ~ 90% RH
*All values have 10% tolerance.
3. TECHNICAL SPECIFICATIONS
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