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• DO NOT administer treatment if the applicator is not connected to a sam
Ultrasound Coupling Patch.
• Applicators and sam Ultrasound Coupling Patches are not sterile. DO NOT apply
this device over an open wound or inflamed skin.
• DO NOT use the sam Ultrasound Coupling Patch if the sam Ultrasound Media
is dried out. Indications of a dried out Patch include: the cup is not full of gel,
there is dry residue or film in the cup, or there is any cut, break, or opening in
the Patch or seals.
• DO NOT apply directly over a bone that is near the skin surface.
3.3. PRECAUTIONS
Precaution should be taken when using the device:
• Over an area of the spinal cord following a laminectomy, i.e. when major covering
tissues have been removed
• On patients with hemorrhagic diatheses
• Over areas where metal prosthesis or other metallic implants are embedded
in tissue which may form a reflective surface to the ultrasound energy causing
unintended irradiation of tissue and excessive heating
• Over an acute infection or sepsis
• On patients with peripheral artery disease
• Over a deep vein thrombosis
• Over an anesthetized area or in conjunction with a condition that causes
impairment of sensation, such as caused by chemotherapy
• When using the sam Ultrasound Coupling Patch, ensure the top and bottom
seals have been completely removed before attaching the applicator to the skin
3.4. INFLAMMABLE GASES AND ANESTHETICS
• Warning: Explosion hazard if used in the presence of flammable anesthetics,
open flame, or oxygen-rich environment
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