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EN109-1498751-47 IFU
Combination therapy
The combined Contra-indications of ultrasound therapy and electrotherapy apply.
Precautions and warnings
Ultrasound therapy
Precaution should be taken when using therapeutic ultrasound on patients with hemorrhagic
diathesis.
Ultrasound treatment presents a potential safety hazard in patients whose pain response has
been decreased because of disease, previous surgery, ionizing radiation therapy,
chemotherapy, general or regional anaesthesia. It may cause blisters. Do not use on insensitive
areas or in the presence of poor circulation.
Large thermal doses may result in regions of thermal aseptic necrosis which may not be
apparent on inspection of the skin.
Always ensure proper hygiene (see chapter 14 for cleaning). Only apply the applicator on intact
skin. When treating damaged skin (for example ulcers), only place the applicator on the edges
of the wound, never on the wound itself.
Dual Channel Ultrasound is intended for a single patient only.
See also chapter 9 for general warnings and precautions.
Electrotherapy
–
Pain management
Benefits of TENS currents have not been established for pain of central origin.
This device is to be used as a symptomatic treatment for pain and has no curative value.
Patients should be cautioned and their activities regulated if pain that would otherwise serve
as a protective mechanism is suppressed.
The long-term effects of chronic electrical stimulation are unknown.
Safety has not been established for the use of therapeutic electrical stimulation during
pregnancy.
Stimulation should not be applied over swollen, infected, or inflamed areas of skin eruptions
e.g., phlebitis, thrombophlebitis, varicose veins, etc.
Isolated cases of skin rash may occur at the site of electrode placement following long-term
applications. The irritation may be reduced by use of an alternate conductive medium or an
alternative electrode placement.
Effectiveness of this treatment is dependent upon patient selection.
See also chapter 9 for general warnings and precautions.
Electrotherapy
–
Muscle stimulation
The long-term effects of chronic electrical stimulation are unknown.
Safety has not been established for the use of therapeutic electrical stimulation during
pregnancy.
Stimulation should not be applied over swollen, infected, or inflamed areas of skin eruptions
e.g., phlebitis, thrombophlebitis, varicose veins, etc.
Adequate precautions should be taken when treating individuals with suspected or diagnosed
heart problems, or epilepsy.
Caution should be used when there is a tendency to hemorrhage following acute trauma or
fracture.
Caution should be used following recent surgical procedures when muscle contraction may
disrupt the healing process.
Caution should be used over the menstruating uterus.
Caution should be used over areas of the skin which lack normal sensation.
Some patients may experience skin irritation or hypersensitivity due to electrical stimulation or
electrical conductive medium. The irritation can usually be reduced by using an alternative
