Chapter 2: Safety
6
Accutome A-Scan Plus Connect User’s Guide
2
Safety
Safety Information
The section lists:
• Safety Precautions associated with the Accutome A-Scan Plus Connect
• 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 A-Scan Plus Connect
This instrument has no user operated controls or settings that affect the acoustic
output. The Accutome A-Scan Plus Connect is noninvasive. The ultrasonic
biometry probe touches the surface of the anesthetized cornea during the
scanning process. Energy in the form of ultrasound is transmitted into the eye.
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.
Indications for use
This instrument is used for measuring the axial length, anterior chamber depth
and lens thickness of the eye. It also is used for calculating the optical power of
the IOL to be implanted during cataract surgery.
Side Effects
There are no known side effects associated with the use of A-scan ultra sound
imaging.
Any side effects associated with the use of the Accutome A-scan Plus Connect
are related to the topical anesthetic chosen by the physician, used to anesthetize
the eye of the patient.
Please consult the warning label of the chosen topical anesthetic for further
information.
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