CONTRAINDICATIONS, PRECAUTIONS, and WARNINGS

Electrical and ultrasound stimulation can mask pain, impairing detection and diagnosis of disease.  Careful evaluation by a physician and/or therapist should precede the use of any electrical stimulation or ultrasound device. 

1. The safety of electrical stimulation has not been established for use during menstruation or during pregnancy, labor and delivery. Ultrasound should never be used on the pelvis, abdomen and lumbar (lower back) region in pregnant or potentially pregnant females.
2. Do not use around the heart, particularly patients who have demand type cardiac pacemaker. Adequate protection should be taken in the care of a person with suspected heart problems. Patients suffering from cardiac disease should not receive treatment over the cervical ganglia, the stellate ganglion, the thorax in the region of the heart, or the vagus nerve, as a reflex coronary vasospasm might result. Only low intensities and short treatment times should be used if these patients are treated in other areas since the stimulation of practically any afferent autonomic nerve (especially the vagus nerve) in the body may cause a change in cardiac rate. Do not use ultrasound over blood vessels in poor condition as the vessel walls may rupture as a result of the exposure.
3. Do not stimulate over the carotid sinus nerves, especially in patients with a known sensitivity to the carotid sinus reflex. Severe spasm of the laryngeal and pharyngeal muscles may occur when electrodes are positioned over the throat or the mouth.  The contractions may be strong enough to close airways or cause difficulty in breathing. Do not use ultrasound on the front of the upper neck (thyroid region)
4. Do not use electrical stimulation transcerebrally, along regions of the phrenic nerve or over laryngeal muscle. Do not use ultrasound over highly ultrasound-sensitive organs eyes and ears or over mucous membranes (mouth, nose, rectum/anus, vagina)
5. Do not use electrical stimulation over infection (osteomyelitis etc.) or wound with hemorrhage. Do not use ultrasound over areas suspected to be cancerous or pre-cancerous. Ultrasound treatment of acute infection of bone or tissue could force areas of pus into surrounding tissue, thereby spreading infection.
6. Do not use ultrasound on patients with spina bifida or surgical laminectomies of the spine or de-sensitized areas of the skin (eg. diabetic neuropathy) or over cortisone injections within 30 days.
7.  Do not use ultrasound over sensitive organs such as ovaries, testicles, brain, spinal cord, heart, or kidneys
8. Do not use ultrasound on patients with phlebitis, deep venous thrombosis or hemophilia. Patients with thrombophlebitis or other potentially thromboembolic diseases should not be treated since a partially disintegrated clot could result in an obstruction of the arterial supply to the brain, heart or lungs.
9. Adequate protection should be taken in the care of a person with suspected or diagnosed epilepsy.
10. Always turn the stimulation device off before applying or removing electrodes. If irritation develops at electrodes sites, discontinue use of those sites.

Operator Safety – The operator of ultrasound therapy devices should minimize exposure to themselves as follows:

The applicator face must not be touched by the operator when the device is emitting ultrasound. The operator should hold it firmly by the rubberized grip. 

Patient Safety

Ultrasound therapy devices should only be turned on when the operator is holding the soundhead by the handle.

Since ultrasound is almost totally reflected at an air-tissue interface, coupling media must always be used between the applicator surface and the patient. Never use ultrasound unit for treatment without using the conductive gel.  The face of the applicator must be in acceptable acoustic contact with the patient.

The transducer should be kept moving slowly, angled at 90° to the treatment area, during the course of treatment to minimize the risk of causing hot spots and tissue damage. Another reason to avoid the use of a stationary transducer, prolonged standing waves might result in blood flow arrest and cause possible damage to the endothelial cells in the blood vessel walls. This could also lead to the formation of blood clots.

To minimize potential adverse health effects, the operator should use the minimum patient exposure required to achieve the desired benefit.

Records should be kept of each patient, noting the exposure levels, times, and couplant used. Maintaining well documented, reproducible records help to minimize unnecessary exposure.

Thermal Applications - If any pain or uncomfortable "prickly" sensation is felt by the patient, this may be an indication that the bones or nerve endings in the vicinity of the ultrasonic beam are becoming, or are already, overheated. In this case the ultrasound power or intensity must be immediately reduced.