Nikon Optos Monaco P200TE, User Manual

Page: 13 / 318

Chapter 1 - Warnings and cautions
CAUTION
Installation and maintenance
Your device will be installed by Optos trained personnel. Do
NOT
operate the device until
they have completed the installation and training.
Your Optos representative will configure the settings when the device is installed. These
settings should
NOT
be changed in the course of normal operation.
Please consult your Optos representative before changing the settings.
Do
NOT
remove the scan head covers. Only Optos trained technical personnel are
permitted to service the device.
The scan head weighs 40 kg (89 lbs). This requires two people to lift or carry the unit.
You should be aware of your contractual obligations before disposing of any equipment.
Only Optos trained personnel are permitted to install and service the device.
Do
NOT
service the device when imaging a patient.
1.2 Laser safety
WARNING
Danger of laser injury
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 light source within the previous 24 hours may also be less tolerant to a further
exam using light.
CAUTION
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:
l
Internal power monitoring prevents excess power at the eye.
l
An internal shutter and associated controls prevent early or prolonged laser
exposure.
Using the controls, adjustments or performance of procedures other than those specified
herein may result in hazardous radiation exposure.
The P200TE is a Class 1 laser device at the eye, and complies with IEC/EN 60825-
1:2014 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: G108707/8GSE Page 13 of 76
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