Adverse Reactions - Hollywog WiTouch Pro TENS User Manual

Introduction
Congratulations on your purchase of the WiTouch Pro Bluetooth
relief wireless device incorporating Transcutaneous Electrical Nerve Stimulation (TENS) technology and Bluetooth
wireless technology to specifically target back pain. The thin and flexible design perfectly contours to the back for
maximum surface contact. The advanced electronics design maximizes energy use, providing over 100 30-minute
treatment sessions per battery life. This device is safe, drug-free, easy to use, discreet and comfortable to wear,
and most importantly allows you to control your pain to help keep you moving and maintain an active lifestyle. This
innovative device can be controlled by your smartphone with the WiTouch Pro app or with the buttons on the device.
Indications for Use: To be used for temporary relief of pain associated with sore and aching muscles in the back
due to strain from exercise or normal household and work activities and relief of pain of the upper and lower back
associated with arthritis.
Safety
Do not use this device if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device, or are connected to high
frequency surgical equipment. Such use could cause electric shock, burns, electrical interference, or death. It may also damage the stimulator.
• Do not allow children to swallow or ingest accessories or detachable parts (e.g., screwdriver, alkaline batteries).
• Do not use this device across or through your chest because the electrical currents introduced into the chest may cause rhythm disturbances to your heart,
which may be lethal.
• Do not use this device if you are susceptible to rhythm disturbances to the heart unless under the direction of your physician.
• Do not use this device over your eyes, mouth, face, front of neck (especially in the carotid sinus), head, or across your heart because this could
cause severe muscle spasms resulting in closure of your airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure.
• Consult with your physician before using this device if you are in the care of a physician.
• Consult with your physician before using this device if you have had medical or physical treatment for your pain.
• Stop using this device and consult your physician if your pain does not improve, becomes more than mild, or continues for more than five days.
• Do not use this device while driving, operating machinery, or during any activity in which electrical stimulation can put you at risk of injury.
• Do not use this device over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis,
varicose veins).
• Do not use this device over, or in proximity to, cancerous lesions.
• Do not use this device on children because it has not been evaluated for pediatric use.
• Do not use this device 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 immerse in water or use in a wet environment, such as the bath, shower or other sources of moisture.
• Do not use this device while sleeping.
• Do not use this device on abnormal skin, or skin that is not intact, clean, or healthy.
• Do not operate in close proximity (e.g. 1 m) to shortwave or microwave therapy equipment as it may produce instability in the stimulator output.
• Do not heat up the device/battery or place near a direct flame. These actions can heat the battery and cause an explosion.
• This device could interfere with communication equipment operating in radio frequency.
• Device may not work properly when applied over a sweaty part of the body during work and exercise.
• Other equipment could interfere with the medical device or device system, even if the other equipment complies with CISPR8 emission requirements.
• Do not start stimulation of the device prior to application of the device to the back.
• Keep this device out of the reach of children.
• The safety of nerve stimulation has not been established during pregnancy; therefore, do not use this device if you are pregnant, or suspect that you are
pregnant, unless under the direction of your physician.
• This device is for use by adults over 21 years of age.
• This device should not be applied on or across your head or face since the effects of stimulation of the brain are unknown.
• This device is for symptomatic treatment and, as such, suppresses the sensation of pain that would otherwise serve as a protective mechanism.
• If you have suspected or diagnosed heart disease, you should follow precautions recommended by your physician.
• If you have suspected or diagnosed epilepsy or experience convulsions, you should follow precautions recommended by your physician.
• Use this device with caution if you have a tendency to bleed internally, such as following an injury or fracture.
• Consult with your physician prior to using this device after a recent surgical procedure, because stimulation may disrupt the healing process.
• Do not use this device for pain of central origin, including headache.
• This device does not provide curative value.
• The long-term effects of nerve stimulation are unknown.
• You may experience skin irritation or hypersensitivity due to the electrical stimulation or adhesive medium (gel pads).
• Use this device with caution if stimulation is applied over the menstruating or pregnant uterus.
• Use this device with caution if stimulation is applied over areas of skin that lack normal sensation.
• Use this device only with the gel pads and accessories recommended by the manufacturer.
• Gel pads should be for single person use to avoid skin disease or any other transmissible disease.
• Do not remove this device from your skin with the stimulation mode of operation activated.
• Do not place your finger, or any object, between or near your skin and the adhesive gel pads during stimulation treatment.
• This device is not to be used in the presence of flammable or anesthesia gasses or liquids.
• Do not allow young children, pets, or pests contact with the device as alterations to the device may compromise product safety and/or performance.
• Handle the unit with care. Inappropriate handling of the unit may adversely affect its characteristics.
• Remove metallic objects around the treatment area, such as jewelry, piercings or belts.
• Isolated cases of skin irritation or burns may occur due to electrical stimulation or adhesive medium (gel pads).
• Stop using the device and consult with your physician if you experience adverse reactions from use of this device.
• Prolonged use may cause discomfort or sore muscles.
• Burns may occur when the gel pads are not used properly, or if the gel pads are removed from the device or get damaged.
TENS Therapy device. WiTouch Pro is a pain
®
CONTRAINDICATIONS
WARNINGS!
PRECAUTIONS

ADVERSE REACTIONS