Warnings and Precautions
WARNINGS
• The device must be kept out of reach of children.
• The safety of the device for use during pregnancy or delivery has not been
established.
• Do not place electrodes on front of the throat. This may result in spasms of the
laryngeal and pharyngeal muscles.
• Do not place the electrodes over the carotid nerve (the front and sides of the neck).
• The device is not effective for headaches.
• Caution should be used when applying the device to patients suspected of having
heart disease. Further clinical data is needed to show if there are adverse side
effects on those with heart disease.
• The device may interfere with electronic monitoring equipment (such as ECG
monitors and ECG alarms).
• Electrodes should not be placed over the eyes, in the mouth, or internally.
• These devices have no curative value. The Interferential is a symptomatic treatment
that suppresses the sensation of pain which would otherwise serve as a protective
mechanism.
• Interferential devices should be used only under the continued supervision of a
physician or licensed practitioner.
• Do not use on broken skin.
• Effectiveness is highly dependent upon patient selection by a person qualified in pain
management.
• If the device treatment becomes ineffective or unpleasant, stimulation should be
discontinued until re-evaluation by a physician or licensed practitioner.
• Always turn the device off before applying or removing electrodes.
• The device does not have AAP/APG protection. An explosion hazard is possible if
used in the presence of explosives, flammable materials or flammable anesthetics.
ADVERSE REACTIONS
• Skin irritation and electrode burns are potential adverse reactions. Stimulation
should be stopped and electrodes removed until the cause of the irritation or burns
can be determined.
• Isolated cases of skin irritation may occur at the site of electrode placement
following long-term application. Always properly clean skin before use. If skin
irritation occurs, discontinue use. Do not resume use of the ZZAIF400 unit until you
have seen your physician or licensed practitioner.
