4. Safety Information
This section includes Contraindications, Warnings, Precautions, Dangers, and Adverse Reactions.
4.1 Contraindications
Implanted electronic devices.
defibrillator, or other implanted electronic device, because this may cause electric shock, burns, electrical interference, or
death.
TENS for undiagnosed pain.
are undiagnosed.
4.2 Warnings
Consult with physician
. Consult with the patient's physician before using the Empi Phoenix device, because the device may
cause lethal rhythm disturbances to the heart in susceptible individuals.
Apply stimulation only to normal, intact, clean, healthy skin.
Skin condition.
The long-term effects of chronic electrical stimulation are unknown.
Long term effects.
Stimulation location
Stimulation over neck or mouth.
patient's mouth, 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
Stimulation across chest.
into the chest may cause rhythm disturbances to the patient's heart, which could be lethal.
Since the effects of stimulation of the brain are unknown, stimulation should not be applied across the
Across the head.
head, and electrodes should not be placed on opposite sides of the head.
Stimulation over compromised skin.
inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins).
Stimulation near cancerous lesions.
Stimulation over metallic implants.
cause shock or burns.
Do not apply stimulation directly on the eyes.
Stimulation over eyes.
Phoenix User's Manual
Do not use the Empi Phoenix device on patients who have a cardiac pacemaker, implanted
Do not use the Empi Phoenix device as a TENS device (P3) on patients whose pain syndromes
Do not apply stimulation over the patient's neck (especially the carotid sinus) or the
Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or
Do not apply stimulation over, or in proximity to, cancerous lesions.
Do not apply stimulation directly over implanted metallic devices, because this may
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