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1.5 Warnings, Cautions, and Adverse Reactions
Warnings
1.Apply stimulation only to normal, intact, clean, healthy skin.
2.Do not apply stimulation when in the bath or shower.
3.Do not apply stimulation while sleeping.
4.Do not use this device during pregnancy unless directed by your physician.
5.Stimulation should not be applied over the neck, mouth or eyes. Severe
spasm of the laryngeal and pharyngeal muscles may occur, and the
contractions may be strong enough to close the airway or cause difficulty in
breathing.
6.Stimulation should not be applied across the chest in that the introduction
of electrical current into the heart may cause cardiac arrhythmias.
7.Stimulation should not be applied across the head.
8.Stimulation should not be applied over the carotid sinus nerve, particularly
in patients with a known sensitivity tothe carotid sinus reflex.
9.Replacement of a component could result in an unacceptable risk. Please
contact us if you have any problem with the device.
10.Keep this device out of the reach of infants, toddlers, and children.
11.Do not recharge, use or leave the battery and device in any high
temperature environment such as a location near fire or in direct sunlight
which may cause the battery to overheat, ignite or rupture.
12.There is potential hazard from simultaneous connection of a patient to a
high frequency surgical equipment and the stimulator that may result in burns
and possible damage tothe stimulator.
13.Operation in proximity (e.g., 1 m) to a shortwave or microwave therapy
equipment may produce instability in the stimulator output.
14.When the device is transferred to another patient,replace used pads
with new pads.
15.Please avoid the use of the equipment as much as possible in the
following occasions or conditions, as it may result in incorrect operation:
talking on a mobile phone; near the signal emission base station for
broadcasting, television, communication, radar, navigation, etc.; near active
HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM
for magnetic resonance imaging.
16.Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of the equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.