Precautions - Sam -12 Directions For Use Manual

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• DO NOT apply the
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replacement for the
coupling media in lieu of the
the eff ectiveness of treatment, lead to automatic shutoff of the applicator, or
cause a burn.
• DO NOT administer treatment if the applicator is not connected to a
Ultrasound Coupling Bandage.
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• Applicators and Ultrasound Coupling Bandages are not sterile. DO NOT
apply this device over an open wound or infl amed skin.
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• DO NOT use the
Media is dried out. Indications of a dried out bandage include: the cup is not
full of gel, there is dry residue or fi lm in the cup, or there is any cut, break, or
opening in the bandage 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 refl ective 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
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• When using the Ultrasound Coupling Bandage, 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 fl ammable anesthetics,
open fl ame, or oxygen-rich environment
Applicator with alternative coupling media as a
Ultrasound Coupling Bandage. Use of alternative
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Ultrasound Coupling Bandages may reduce
Ultrasound Coupling Bandage if the
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Ultrasound
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