• Caution should be used for patients with suspected or diagnosed epilepsy.
• Effectiveness of TENS is highly dependent upon patient selection by a person
qualified in the management of pain patients.
• Caution should be used in the presence of the following:
• When there is a tendency to hemorrhage following acute trauma or
fracture.
• Following recent surgical procedures when muscle contraction may
disrupt the healing process.
• Over the menstruating or pregnant uterus.
• Over areas of the skin which lack normal sensation.
• Some patients may experience skin irritation or hypersensitivity due to the
electrical stimulation or electrical conductive medium. The irritation can
usually be reduced by using an alternate conductive medium, or alternate
electrode placement.
• Electrode placement and stimulation settings should be based on the guidance
of the prescribing practitioner.
• Avoid use of electrodes, conductive gels, lead wires, or accessories other than
those supplied with the system or recommended by Empi. The safety of other
products has not been established, and their use could result in injury to the
patient.
• Portable NMES devices should not be used while driving, operating
machinery, or during any activity in which involuntary muscle contractions
may put the user at undue risk of injury.
• NMES/TENS therapy should not be used for conditions other than those
for which the device is prescribed. If there are any changes in an existing
condition, or if a new condition develops, the patient should consult a
physician.
• Patients who react negatively to the stimulation sensation after an adequate trial
period or who find stimulation intolerable should not undergo future NMES/
TENS treatment.
• Skin irritation, hypersensitivity and burns beneath electrodes have been
reported with the use of NMES/TENS. Electrodes should not be left in place
for long periods of times without checking or cleaning the skin underneath
them. Electrodes sites should be rotated with long term use when possible.
DO NOT CONTINUE STIMULATION OVER IRRITATED SKIN. Consult
a clinician if any skin irritation or reaction develops at the electrode site
following use of the device.
• Do not use in the bath or shower. The device should not be submerged in water
or other liquids as this may startle the patient and possibly damage the device.
If the device should be accidentally immersed in water, do not attempt to use
the device immediately afterward. Remove the battery and allow the excess
water to drain away. Air dry the device thoroughly for at least 48 hours at
room temperature before attempting to operate it.
• The use of heat and cold producing devices, such as electric heating blankets,
heating pads, or ice packs, may impair the performance of the electrode or alter
the patient's circulation and increase the risk of injury to the patient.
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