Optos P200 Einführungshandbuch Seite 14

Chapter 3 - Safety Guidelines
3.2 Medical safety
Laser Safety
The device is a Class 1 laser device at the eye, and
complies with EN60825-1 and 21 CFR1040.10
and 1040.11. Based on current scientific
knowledge, a Class 1 laser device can be
considered as safe by engineering design, and
safe under reasonably foreseeable conditions of
operation.
Danger of Laser Injury
Do not remove the device cover or attempt to
replace the lasers. Only Optos trained technical
personnel are permitted to service the device.
The use of this device or any other device which
uses light for ocular examination should not be
prolonged unnecessarily.
While no acute optical radiation hazards have been
identified for direct or indirect ophthalmoscopes,
some patients may be less tolerant to an exposure
of light. This may be the case for infants, aphakic
patients and persons with diseased eyes. Patients
who have had any exposure with the same device
or with any other ophthalmic device using a visible
Warning
light source within the previous 24 hours may also
be less tolerant to a further exam using light.
However, the benefits of an eye exam will almost
always outweigh any discomfort associated with
the exposure to light.
While the scan head covers are fitted the risks are
minimized. The following items are monitored by
the Laser Radiation Management System:
The Laser Management System maintains a Class
1 accessible emission limit (AEL) at the eye for
normal operation and under foreseeable fault
conditions.
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English
Images may only be captured when the
l
scanning system is within safe
operating conditions
Internal power monitoring prevents
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excess power at the eye
An internal shutter and associated
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controls prevent early or prolonged
laser exposure
Copyright 2014, Optos plc. Allrights reserved.
Part Number: G95990/9GWE