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OMNISTIM
®
FX
2
PORTABLE PENS PATIENT USER MANUAL
COPYRIGHT © 2008 - 2021, ACCELERATED CARE PLUS CORP., ALL RIGHTS RESERVED
Patients may experience headache and other painful sensations during or following the
application of electrical stimulation near the eyes and to the head and face.
Patients should stop using the device and should consult with their physicians if they experience
adverse reactions from the device.
Warnings
•
The long-term effects of electrical stimulation are unknown;
•
Do not apply stimulation over the patient’s neck because this could cause severe muscle
spasms resulting in closure of the airway, difficulty in breathing, or adverse effects on heart
rhythm or blood pressure
•
Do not apply stimulation across the patient’s chest because the introduction of electrical
current into the chest may cause rhythm disturbances to the patient’s heart, which could be
lethal. Stimulation should not be applied transthoracically in the vicinity of the heart, as
introduction of electrical current into the heart may cause cardiac arrhythmias.
•
Do not apply stimulation when the patient is in the bath or shower
•
Do not apply stimulation while the patient is sleeping; and
•
Do not apply stimulation while the patient is driving, operating machinery, or during any
activity in which electrical stimulation can put the patient at risk of injury.
•
Consult with the patient’s physician before using this device because the device may cause
lethal rhythm disturbances to the heart in susceptible individuals
•
Apply stimulation only to normal, intact, clean, healthy skin.
•
Do not operate this device until the User Manual, including all Indications for Use,
Contraindications, Warnings and Precautions, have been carefully read and understood.
•
Operation of this device or placement of lead wires, probes, pads and electrodes in close
proximity (less than 5 feet) to an operating shortwave or microwave diathermy unit may
produce instability in the device output or burns at the treatment site. Lead wires and
device can pick up the magnetic field output of the diathermy and through induction
convert it into an electrical field, transmit the energy into the patient increasing the current
density at the electrodes of applicators. Since the patient may not feel the 27 MHz
frequency, they lack the protective sensation and tissue burns could result. Short-wave
field could potentially damage or reset medical devices in close proximity to the drum
applicator.
•
Treatment should not be applied over the carotid sinus nerves, (located in the anterior neck
triangle), including, stellate ganglion, vagus nerve, or laryngeal or pharyngeal muscle.
Particular care should be taken for patients with a known sensitivity to the carotid sinus
reflex, as carotid sinus stimulation may alter blood pressure and cardiac contractility.
•
Do not apply treatment over testes, heart or eyes. Electrical stimulation may affect organ
function.
•
Do not apply over or in close proximity to active cancer (except in terminal / palliative /
hospice care), as therapy may increase blood flow to the tumor.
•
Treatment should not be applied when high fever is present over swollen, severe infection
(osteomyelitis, sepsis, tuberculosis, etc.) or inflamed areas/skin eruptions (phlebitis,
thrombophlebitis, varicose veins, etc.).
•
Do not apply over the lumbar or abdominal region, or over the uterus during pregnancy (to
prevent uterine contraction), or during menstruation as therapy may temporarily increase
menstrual flow.
•
Treatment should not be applied transcranially. Since the effects of stimulation of the brain
are unknown, stimulation should not be applied across the head, and electrodes should not
be placed on opposite sides of the head;
•
Stimulation should not be applied to patients connected to patient monitoring equipment,
as the stimulation may have an effect on the proper operation of the monitoring equipment.
Summary of Contents for OMNISTIM FX2
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