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The Laser Management System maintains a Class 1 accessible emission limit (AEL) at the
eye for normal operation and under foreseeable fault conditions.
While the scan head covers are fitted the risks are minimized. Images may only be
captured when the scanning system is within safe operating conditions. The following
items are monitored by the Laser Radiation Management System:
Internal power monitoring prevents excess power at the eye.
l
An internal shutter and associated controls prevent early or prolonged laser
l
exposure.
Using the controls, adjustments or performance of procedures other than those specified
CAUTION
herein may result in hazardous radiation exposure.
All P200T product variants are Class 1 laser devices at the eye, and comply with IEC/EN
60825-1:2007 and 21 CFR1040.10 and 1040.11 except for deviation pursuant to Laser
Notice 50, dated June 24, 2007.
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.
The patient may experience some discomfort from exposure to light. It should be noted that
the benefits of an eye exam outweigh any discomfort.
Part Number: G102748/11_ENG
Copyright 2021, Optos plc. All rights reserved.
Chapter 1 - Warnings and cautions
Page 13 of 60
English
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