Healy Medical Edition

• Not for use by pregnant women
• Not for use by those with epilepsy
• Do not place the electrodes on the eyes, neck or over your heart (area below both collarbones down to the end of the breastbone and midline from the left axilla to the level of the end of the sternum)
• Not for use by those with a pacemaker or heart disease
• Do not apply electrodes on skin affected by abrasions, rash or wounds
• Intended users are adults

Consult a medical professional before using if you have any of these contraindications.

Possible Side effects

Possible side effects are usually mild and self-limiting. Possible side effects from market research are:

Occasional (1 in 1,000 applications):

• Strong tingling under the electrodes
• Allergic reaction to the electrodes
• Skin irritation
• Dizziness
• Headaches

Rare (1 in 10,000 applications):

• Punctiform wounds after stimulation

Very rare (1 in 100,000 applications):

• Pain at the electrodes

Unlikely (less than 1 in 1,000,000):

• Temporarily loss of vision
• Stiffness of the locomotor system
• Tachycardia
• Hematoma formation at the electrodes

Prolonged Cranial Electrotherapy Stimulation (CES) treatment at currents higher than necessary may cause dizziness or nausea that can last for hours to days. Treatment immediately prior to going to sleep may cause difficulty sleeping. Paradoxical reactions such as increased anxiety, and sleep disturbances may occur, but are rare.

Important note: Rarely, excessive use can lead to discomfort. In this case we recommend pausing the application until the symptoms subside and planning the re-application with 2 to 3 sessions per week.

Safety Notes

• Keep this device out of the reach of children.
• Do not immerse the device in liquids.
• Do not use while driving motor vehicles or operating heavy machinery. The ability to drive or to operate heavy machinery may be impaired immediately after application.
• Only charge with the supplied cable from an USB-Socket with 5V dc and max 2500 mA.
• In the case of a defect please contact the manufacturer. Any attempt to repair the device will void the warranty.
• Use with care as the cables may cause a tripping or strangulation hazard.
• Don’t use in presence of flammable gases or in an oxygen enriched environment.
• Stop application and remove the electrodes if any irritation, sensation, allergic reaction or burning occurs at the electrode contact points and contact us. Pay attention when using the stimulation and currents higher than 2 mA (ear-clip electrodes) or 4 mA (surface electrodes).
• Take care that the units output connectors are always pointed towards the floor. This way the device is protected against damage by water or liquids.
• Do not place electrodes on the chest; this can cause ventricular fibrillation.
• The device is designed for indoor use only.
• The device should only be stored and transported under the conditions defined in these instructions.
• Do not use the device in shielded locations, such as intensive care units in hospitals, airplanes or wherever the use of mobile phones is prohibited.
• The device has no life-sustaining functions.
• The device must be operated only with supplied accessories and together with compatible smartphones.
• Portable and mobile HF-communication devices, e.g. mobile phones, may influence medical electrical devices. You should keep a safety distance of 30 cm (12 inchs) from HF-communication devices of parts and cables of the Healy, when the device is in use. Don’t stack it with such devices or put it next to other electrical equipment when used.
• Simultaneous use of implanted or invasive medical devices (e.g., glucose sensor) may be influenced by the use of the Healy device. Please contact the manufacturer for clearance.
• Avoid damages to the electrode cables and the charging cables caused by sharp objects. If the cables are damaged do not use them and contact the manufacturer for a replacement. Don’t use cables that are damaged.
• To protect the device and its accessories against pollution and damage keep it closed and away from children, dust, sunlight, moisture, pets and vermin.
• Only use cables and electrodes supplied with the equipment. Other accessories, cables or electrodes could result in higher electromagnetic field emissions or less electromagnetic immunity and may lead to loss of function.
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation.
• Do not use the adhesive electrode if the gel is dry or visible damage is present or the connecting cable is damaged.
• Do not use if recurrent episodes of skin irritation occur.
• The equipment and the connecting leads used with this device must all be in good condition.
• Do not carry out maintenance while the equipment is in use.
• Operation in close proximity (i.e., less 3 feet) to a shortwave or microwave therapy ME equipment may produce instability in the stimulator output.
• Simultaneous use together with HF-surgical equipment is prohibited.

Important note on using the adhesive electrodes:

• Never place electrodes in the region of the carotid artery
• Do not place the electrodes on open wounds
• Before use clean the application area and if necessary shave the area
• Choose an area free from hair, skin lesions or scars, folds in the skin, or bony protuberances and which is not in the vicinity of metallic implants.
• Clean and dry the application area before placing the electrode on it
• Avoid the use of solvents as these could cause skin irritation and reduce the adherence of electrodes.
• If using alcohol to clean the area, make sure that it has completely dried before applying the electrodes.
• Check the functioning of the system before beginning the procedure.
• Connect the electrode to the cable of the device.
• If the procedure is interrupted, check the functioning of the system again before recommencing the session.
• Remove the liner and apply the electrode to the skin surface.
• Before switching on the device, check the adherence of the electrode to the skin surface.

Warnings related to adhesive electrodes:

• A reduced contact between the skin and the electrode may cause the electric current to concentrate in one point and cause burning.
• Interrupt the application if there is discomfort or a burning sensation.
• After the session, turn off the device, disconnect the cable from the electrode and gently remove the electrode from the skin by lifting it up by one corner.
• Rapid removal of the electrode could cause skin traumas.
• Do not remove by pulling the connection part of the cable.
• After use, reposition the electrodes in the plastic liner and put them back in the pouch.
• Electrodes may be reused: Reuse only for the same person.
• Verify the adhesion of the electrode before use. When electrodes lose adhesion, gently rub one or two drops of water onto the gel surface. This may extend the lifetime. If there is no improvement, replace with new electrode.
• Do not reposition the electrode during use.
• Keep the packet closed in order to prevent the unused electrodes from becoming dehydrated.