7
Safety
Safety
Information
The section lists:
Safety Precautions associated with the
Accutome B-Scan Plus
Safety Precautions of a general nature
FEDERAL LAW RESTRICTS THIS DEVICE TO
SALE BY OR ON THE ORDER OF A
PHYSICIAN.
Safety Issues to Consider When Using the Accutome
B-Scan Plus
The Accutome B-Scan Plus is non-invasive. The
ultrasound probe touches the surface of the
anesthetized eye during image acquisition, and energy
in the form of ultrasound is transmitted into the eye. The
power level of the ultrasound pulses is controllable by
the Application Software, and the user has control of this
power setting. The maximum power allowed to be set by
the Application Software, and/or by the user is below the
FDA, Health Canada, and EU maximum power limits.
The Accutome B-Scan Plus Probe must be cleaned and
disi
nfected before use.
Indications for use
This instrument is used for imaging the internal structure
of the eye including the opaque media and posterior
pathology for the purpose of diagnosing pathological or
traumatic conditions in the eye.
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