Description Of Device Markings; Additional Precautions - Chattanooga VitalStim Plus Guía Rápida

VitalStim® Plus Electrotherapy System

DESCRIPTION OF DEVICE MARKINGS

The markings on the unit are assurance of its conformity to the high-
est applicable standards of medical equipment safety and electro-
magnetic compatibility . One or more of the following markings may
appear on the device:
Refer to Instructional Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Neuromuscular Stimulation (STIM) and sEMG +Stimulation
should not be used by Patients fitted with demand
style cardiac pacemakers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Testing Agency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Electrical Type BF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ON/OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Remote Switch Jack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
sEMG Reference Jack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Output channel Jack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Resource Library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Home . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Protection against ingress of solid foreign objects of
12 .5mm and greater . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Do not dispose in normal dustbin . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ELECTROTHERAPY, sEMG+VMS INDICATIONS
For VMS™ - VitalStim Waveforms and sEMG Triggered Stimulation .
• Muscle re-education by application of external stimulation to the
muscles necessary for pharyngeal contraction .
Intended Uses- VMS™ Waveform
VMS waveform is a square symmetrical biphasic waveform with the
application for use on the musculature of the face .
The intended uses are:
Optional application of sEMG biofeedback with Muscle Stimulation VMS™
waveform for prevention or retardation of disuse atrophy, for muscle
re-education, and for relaxation of muscle spasms in the treatment of
swallowing musculature dysfunction in post-traumatic conditions or after
neurological insult with impaired neuromuscular function .
Intended Uses- VitalStim Waveform
VitalStim waveform is a square symmetrical biphasic waveform with
interphase interval pulse with the application for use on the swallowing
musculature in the anterior portion of the neck .
The intended uses are:
The VitalStim waveform intended uses are muscle re-education of the
swallowing musculature in the treatment of dysphagia (swallowing
problems) from any etiology except mechanical causes that would
need surgical intervention (for instance, obstructing tumors) . Non-
mechanical causes of dysphagia include: neurological and muscle
REF
disorders; cardiovascular accidents; respiratory disorders with swallowing
complications; latrogenic conditions (conditions caused by surgery); fibrosis/
Ch
stenosis arising from radiation; disuse due to stroke, intubation, or birth-
related anoxic injuries; and trauma to the head and neck . This device is a
prescription device intended for use by or on the order of a physician or other
licensed health professional .
Intended Uses- Surface EMG
sEMG is surface biofeedback for use on the swallowing musculature of the
face and/or anterior portion of the neck . The intended uses are:
The sEMG intended uses are surface electromyography biofeedback for
relaxation training and muscle re-education
I P 2 0
Cautions and Contraindications
• This device should not be used when cancerous lesions are present in
the treatment area .
• Stimulation should not be applied over swollen, infected, inflamed areas
or skin eruptions, e . g . , phlebitis, thrombophlebitis, varicose veins, etc .
• This device should be used with caution on patients with cardiac
demand pacemakers or other implanted electronic devices .
• Stimulation should not be applied over the carotid sinus nerve
particularly in patients with a known sensitivity to the carotid sinus reflex .
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Additional Precautions

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Adverse Effects
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GENERAL INFORMATION
Other contraindications are patients with the following:
- who are severely demented and exhibit non-stop verbalization .
Constant verbalization could result in aspiration during trials of oral
intake .
- with significant reflux due to use of a feeding tube . Such patients are
prone to repeated cases of aspiration pneumonia, and the device has
not been studied in this population .
- with dysphagia due to drug toxicity . Patients suffering from drug
toxicity could aspirate during trials of oral intake .
- undiagnosed syndromes or until etiology is established .
- carrying serious infectious disease and/or disease where it is
advisable, for general medical purposes, to suppress heat or fevers .
Safety has not been established for the use of therapeutic electrical
stimulation during pregnancy .
Caution should be used for patients with suspected or
diagnosed epilepsy
Caution should be used for patients with suspected or
diagnosed heart problems
Caution should be used in the presence of the following:
- When there is a tendency to hemorrhage following acute
trauma or fracture
- Following recent surgical procedures when muscle
contraction may disrupt the healing process
- Over areas of the skin that 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 alternative
conductive medium or an alternative electrode placement .
Electrode placement and stimulation settings should be based
on the guidance of the prescribing practitioner
Powered muscle stimulators should be used only with the lead
wires and electrodes recommended for use by the manufacturer
Isolated cases of skin irritation may occur at the site of electrode
placement following long term application
The effective management of dysphagia by NMES waveforms is
highly dependent upon patient selection by a person qualified in
the management of dysphagia
Skin irritation and burns beneath the electrodes have been
reported with the use of powered muscle stimulators