Easy@Home EHE019 User Manual page 9

Do not apply stimulation of this device in the following conditions:
(1) across the chest because the introduction of electrical current into the chest may cause rhythm
disturbances to the heart, which could be lethal;
(2) over painful areas. Please consult with your physician before using this device if you have painful
areas;
(3) over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g.,
phlebitis, thrombophlebitis, varicose veins). Apply stimulation only to normal, intact, clean, healthy
skin;
(4) in the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms). The
electronic stimulator may not operate properly when the electrical stimulation device is in use;
(5) while operating machinery, or during any activity in which electrical stimulation can put you at
risk of injury;
(6) on children.
Be aware of the following:
(1) to consult with your physician before using this device. The simulation with the device may:
i. cause lethal rhythm disturbances to the heart in susceptible individuals, and,
ii. disrupt the healing process after a recent surgical procedure;
(2) that the device is not effective for pain of central origin, including headache;
(3) that the device is not a substitute for pain medications and other pain management therapies;
(4) that the device has no curative value;
(5) that the device is a symptomatic treatment and, as such, suppresses the sensation of pain that
would otherwise serve as a protective mechanism;
(6) that the long-term effects of electrical stimulation is unknown;
(7) that the user may experience skin irritation, burns, or hypersensitivity due to the electrical
stimulation or electrical conductive medium (gel);
(8) if the user has suspected or diagnosed epilepsy, the user should follow precautions recommended
by his or her physician;
(9) to use caution if the user has a tendency to bleed internally, such as following an injury or
fracture;
(10) use caution if stimulation is applied over the menstruating uterus;
(11) use caution if stimulation is applied over areas of skin that lack normal sensation;
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(12) stop using the device if the device does not provide pain relief;
(13) use this device only with the leads, electrodes, and accessories that the manufacturer
recommends;
(14) Do not share the use of the electrode pads with others;
(15) Do not use the device while it's charging;
(16) The device contains the lithium battery. If overheating of the device occurred during the
charging, stop the charging or operation immediately and report to the distributor/seller;
(17) Dispose of the battery-containing device according to the local, state, or federal laws.
The long-term effects of electrical stimulation are unknown.
Since the effects of stimulation of the brain are unknown, stimulation should not be applied across
the head, and electrode should not be placed on opposite sides of the head.
The safety of electrical stimulation during pregnancy has not been established.
Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or
electrical conductive medium (gel).
Patients with suspected or diagnosed heart disease should follow precautions recommended by
their physicians.
Patients with suspected or diagnosed epilepsy should follow precautions recommended by their
physicians.
Use caution if stimulation is applied over the menstruating or pregnant uterus.
Adverse reactions
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Patients may experience skin irritation and burns beneath the stimulation electrodes applied to the
skin;
Patients may experience headache and other painful sensations during or following the application
of electrical stimulation near the eyes and to the head and face;
Patients should stop using the device and should consult with their physicians if they experience
adverse reactions from the device.
Safety test standards:
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- Medical Devices Directive 93/42/EEC
- IEC 60601-1:2005+A1:2012/EN 60601-1:2006 Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
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