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3. Safety
3.1. CONTRAINDICATIONS
Contraindications for the use of ultrasound include:
• Over an area of the body where a malignancy is known to be present
• Over the eyes
• Over or near growth centers until bone growth is complete
• Over the reproductive organs
• Over the pregnant uterus
• Over a healing bone fracture
• On the thoracic area if the patient is using a cardiac pacemaker
• Over an active implanted medical device such as an implanted deep brain
stimulation device
• On the brain, spinal cord, or large subcutaneous peripheral nerves
• Ischemic tissues in individuals with vascular disease where the blood supply
would be unable to follow the increase in metabolic demand and tissue necrosis
might result
3.2. WARNINGS
• If the treatment is reported as painful or too hot at any point during treatment,
turn off device and remove the device from the skin.
• Instruct the patient to inform the practitioner if the patient feels any pain or
burning during treatment.
• Instruct the patient how to turn off the sam Device and remove the sam
Applicator if the patient feels any pain or burning during treatment.
• ALWAYS administer treatment using a new sam Ultrasound Coupling Patch. Use
one sam Ultrasound Coupling Patch per applicator. Use of the sam Ultrasound
Applicator without a new sam Ultrasound Coupling Patch MAY RESULT IN BURN
and/or REPEATED SHUTOFF of the sam Applicator.
• The sam Device should be kept out of the reach of children.
• DO NOT apply the sam Applicator with alternative coupling media as a
replacement for the sam Ultrasound Coupling Patch. Use of alternative
coupling media in lieu of the sam Ultrasound Coupling Patches may reduce the
effectiveness of treatment, lead to automatic shutoff of the applicator, or cause a
burn.
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