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•
DO NOT
apply the
sam
Applicator with alternative coupling media as a
replacement for the
sam
Ultrasound Coupling Bandage. Use of alternative
coupling media in lieu of the
sam
Ultrasound Coupling Bandages may reduce
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
sam
Ultrasound Coupling Bandage.
•
Applicators and
sam
Ultrasound Coupling Bandages are not sterile.
DO NOT
apply this device over an open wound or infl amed skin.
•
DO NOT
use the
sam
Ultrasound Coupling Bandage if the
sam
Ultrasound
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
•
When using the
sam
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
