Chattanooga VitalStim Plus, Quick Start Manual

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VitalStim® Plus Electrotherapy System
• 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 .
GENERAL INFORMATION
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
REF
Output channel Jack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ch
Back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Resource Library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Home . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Protection against ingress of solid foreign objects of
12 .5mm and greater . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
I P 2 0
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
disorders; cardiovascular accidents; respiratory disorders with swallowing
complications; latrogenic conditions (conditions caused by surgery); fibrosis/
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
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 .
Additional Precautions
• 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
Adverse Effects
• Skin irritation and burns beneath the electrodes have been
reported with the use of powered muscle stimulators