cefar Direct TENS - Page 9

9
Direct TENS
™
• Accessories. Use this device only with the leads, electrodes, and accessories recommended by the
manufacturer. Use of other accessories may adversely aect the performance of the device or may result in
stronger electromagnetic emissions or reduce the electromagnetic immunity of the device.
• No Modification. No modification of the equipment is allowed.
Precautions
• Supervision. Use this device only under the continued supervision of a licensed practitioner. Electrode
placement and stimulation settings should be based on the guidance of the prescribing practitioner.
• Manufacturer. The manufacturer does not take any responsibility for any electrode placements other than
recommended.
• Pregnancy. The safety of electrical stimulation during pregnancy has not been established.
• Skin irritation. Some patients may experience skin irritation or hypersensitivity due to the electrical
stimulation or electrical conductive medium (gel). The irritation may be reduced by using an alternate
conductive medium or alternate electrode placement. Some patients may experience redness under the
electrodes after a session. This redness usually disappears within a few hours. Advise the patient to consult
the clinician if the skin redness does not disappear after a few hours. Do not start another stimulation
session in the same area if the redness is still visible. Don’t scratch the redness area.
• Heart Disease. Patients with suspected or diagnosed heart disease should follow precautions
recommended by their physicians.
• Epilepsy. Patients with suspected or diagnosed epilepsy should follow precautions recommended by their
physicians.
• Internal Bleeding. Use caution when the patient has a tendency to bleed internally, such as following an
injury or fracture.
• After Surgery. Use caution following recent surgical procedures when stimulation may disrupt the patient’s
healing process.
• Over uterus. Do not place electrodes directly over the uterus or connect pairs of electrodes across the
abdomen if you are pregnant. The reason is that, theoretically, the current could aect the foetus’s heart
(although there are no reports of it being harmful).
• Lack of sensation. Use caution if stimulation is applied over areas of skin that lack normal sensation. Don’t
apply stimulation on patient unable to express themselves.
• Stimulation. The stimulator should only be used with skin electrodes intended for nerve and muscle
stimulation. Muscle soreness may occur after stimulation but usually disappears within a week.
• Hot casing or batteries. Under extreme use conditions, some parts of the casing might reach up to 109 °F
(43 °C). Use caution when manipulating the batteries right after device use or when holding the device.
There is no particular health risk associated with this temperature besides your comfort.
• Children. Keep this device out of the reach of children.
• Electrode Size. Do not use electrodes with an active area less than 16 cm2, as there will be a risk of
suering a burn injury. Caution should always be exercised with current densities more than 2mA/cm2.
• Strangulation. Do not wrap leadwires around your neck, and keep them out of the reach of children.
Strangulation may result from entanglement in the leadwires.
• Tripping. Care should be used to avoid tripping on lead wires.
• Damaged Device or Accessories. Never use the device or any of its accessories if it is damaged (case, cables,
etc.) or if the battery compartment is open as there is a risk of electric shock. Carefully inspect the lead
wires and connectors prior to each use.
• Inspect Electrodes. Inspect electrodes before each use. Replace electrodes when they begin to deteriorate
or lose adhesion. Poor contact between the electrodes and the patient’s skin increases the risk of skin
irritation or burns. Electrodes will last longer if used and stored according to instructions on electrode
packaging. Attach the electrodes in such a way that their entire surface is in contact with the skin.
• Foreign bodies. Do not allow any foreign bodies (soil, water, metal, etc.) to penetrate the device and the
battery compartment.