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.
Do not apply stimulation when the patient is in the bath or shower. Do not apply stimulation in humid
Bath or shower.
atmosphere exceeding 75% of relative humidity.
. Do not apply stimulation while the patient is sleeping.
Sleeping
Driving or operating machinery.
Do not apply stimulation while the patient is driving, operating machinery, or during any
activity in which electrical stimulation or involuntary muscle contraction can put the patient at risk of injury.
Disconnect the Empi Phoenix stimulation electrodes before using electrosurgical
Electrosurgical equipment or defibrillators.
equipment or defibrillators. Otherwise skin burns may be caused below the electrodes and the Empi Phoenix device might be
destroyed.
Do not wear electrode or the Empi Phoenix device during Magnetic Resonance Imaging
Magnetic Resonance Imaging.
(MRI) scans as this may result in metal overheating and causing skin burns in the area of the electrode.
Do not use the Empi Phoenix device in areas where there is a risk of fire or explosion,
Flammable or explosive environment.
such as oxygen-rich environments, in the vicinity of flammable anaesthetics, etc.
Never connect stimulation cables to an external power supply as there is a risk of electric shock.
Power supply.
Do not use the Empi Phoenix device beside or stacked on top of any other equipment. If you must
Near other equipment.
use it side by side or on top of another system, you should check that the Empi Phoenix device works properly in the chosen
configuration.
Miscellaneous
Do not share electrodes or garments with other persons. All users should have
Garment and electrodes for single patient.
individual set of electrodes to prevent undesirable skin reactions or disease transmission.
Accessories.
Use this device only with the leads, electrodes, and accessories recommended by Empi. Use of other
accessories may adversely affect the performance of the device or may result in stronger electromagnetic emissions or
reduce the electromagnetic immunity of the Empi Phoenix device.
No modification of the equipment is allowed.
No Modification.
4.3 Precautions
Supervision.
Use this device only under the continued supervision of a licensed practitioner. Electrode placement and
stimulation settings should be based on the guidance of the prescribing practitioner.
The safety of electrical stimulation during pregnancy has not been established.
Pregnancy.
Skin irritation.
Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical
conductive medium (gel). The irritation may be reduced by using an alternate conductive medium or alternate electrode
placement. Some patients may experience redness under the electrodes after a session. This redness usually disappears
within a few hours. Advise the patient to consult the clinician if the skin redness does not disappear after a few hours. Do not
start another stimulation session in the same area if the redness is still visible. Don't scratch the redness area.
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Phoenix User's Manual