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ZetrOZ, Inc.
Product Support
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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.
•
If the
Lock Switch
is in the locked position it must be placed in the unlocked
position to disable the power. Locking the treatment settings is optional and not
required for treatment.
•
ALWAYS administer treatment using a new
sam
Ultrasound Coupling Bandage.
Use one
sam
Ultrasound Coupling Bandage per applicator. Use of the
sam
Ultrasound Applicator without a new
sam
Ultrasound Coupling Bandage MAY
RESULT IN BURN and/or REPEATED SHUTOFF of the
sam
Applicator.
•
The
sam
Device should be kept out of the reach of children.
