Electrotherapy Warnings & Precautions; Warnings - Accelerated Care Plus OMNISTIM FX2 PRO User Manual

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ELECTROTHERAPY WARNINGS & PRECAUTIONS
CAUTION: Federal law restricts this device for sale or use by, or on the order of, a Practitioner
licensed by the laws of the state in which he/she practices to use or order the use of the device.
Please note that Accelerated Care Plus cannot provide medical advice. If you have specific
medical questions, please contact your healthcare professional.

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.

Stimulation should not be applied directly over external stimulator systems with lead wires

Neuromuscular electrical stimulation (NMES) should not be applied directly over or in close proximity to Deep
Vein Thrombosis (DVT), as it activates the muscle and causes muscle contractions. This should be avoided in
tissue following an acute DVT when the thrombosis is not completely resolved. Therapists should follow the
guidelines provided by the referring physician on recommended activity level and modality use. If the patient is
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Warnings

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OMNISTIM FX Pro USER MANUAL