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Phoenix User’s Manual
4. Safety Information
This section includes Contraindications, Warnings, Precautions, Dangers, and Adverse
Reactions.
Implanted electronic devices.
Do not use the Empi Phoenix device on patients who have a
cardiac pacemaker, implanted defibrillator, or other implanted electronic device, because this
may cause electric shock, burns, electrical interference, or death.
TENS for undiagnosed pain.
Do not use the Empi Phoenix device as a TENS device (P3) on
patients whose pain syndromes are undiagnosed.
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.
Skin condition.
Apply stimulation only to normal, intact, clean, healthy skin.
Long term effects.
The long-term effects of chronic electrical stimulation are unknown.
Stimulation location
Stimulation over neck or mouth.
Do not apply stimulation over the patient’s neck
(especially the carotid sinus) or the 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.
Stimulation across chest.
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.
Across the head.
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 over compromised skin.
Do not apply stimulation over open wounds or
rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis,
thrombophlebitis, varicose veins).
Stimulation near cancerous lesions.
Do not apply stimulation over, or in proximity to,
cancerous lesions.
Stimulation over metallic implants.
Do not apply stimulation directly over implanted
metallic devices, because this may cause shock or burns.
Stimulation over eyes.
Do not apply stimulation directly on the eyes.
Environment
Electronic monitoring equipment.
Do not apply stimulation in the presence of electronic
monitoring equipment (e.g., cardiac monitors, ECG alarms), which may not operate properly
when the electrical stimulation device is in use.
Bath or shower.
Do not apply stimulation when the patient is in the bath or shower. Do not
apply stimulation in humid atmosphere exceeding 75% of relative humidity.
4.1 Contraindications
4.2 Warnings
