9
INDICATIONS FOR USE
The Scanmate Flex ultrasound system is a multi
-
purpose computer
-
based ultrasonic diagnostic
system for ophthalmic application, intended to both visualize the interior of the eye by means of
ultrasound and to make measurements inside the eye, including the measurement of axial
length for determination of IOL Power. The Scanmate Flex is intended for the examination of
adult patients.
CONTRAINDICATIONS
None.
PRESCRIPTION DEVICE STATEMENT
CAUTION:
Federal law restricts this device to sale by or on the order of a physician.
OPERATOR QUALIFICATIONS
CAUTION:
Operators of the device should be trained medical professionals with knowledge
of the use of ultrasonic imaging devices and imaging protocols.
ALARA STATEMENT
The ultrasound energy emitted by the Scanmate Flex is of low intensity and will have no adverse
effects on the patient and/or operator. However, the operator is still cautioned to perform
examinations using the principle of ALARA (As Low As Reasonably Achievable). All examinations
should be done so that the patient receives as little ultrasound radiation as possible. Do not hold
the probe against the eye or other tissue with the system activated except when performing an
exam. Do not perform unnecessary exams.
