DGH TECHNOLOGY SCANMATE FLEX - Device Usage and Safety Guidelines; Intended Use and Contraindications; Regulatory and Operator Requirements; Radiation Safety Statement (ALARA)

9
INDICATIONS FOR USE
The Scanmate Flex ultrasound system is a mul-purpose computer-based ultrasonic diagnosc
system for ophthalmic applicaon, 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 determinaon of IOL Power. The Scanmate Flex is intended for the examinaon of
adult paents.
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 emied by the Scanmate Flex is of low intensity and will have no adverse
eects on the paent and/or operator. However, the operator is sll cauoned to perform
examinaons using the principle of ALARA (As Low As Reasonably Achievable). All examinaons
should be done so that the paent receives as lile ultrasound radiaon as possible. Do not hold
the probe against the eye or other ssue with the system acvated except when performing an
exam. Do not perform unnecessary exams.