Chapter 1 - Warnings and cautions
CAUTION
Signal to Noise Ratio
SNR has a major impact on OCT image quality and therefore could determine the ability
to distinguish the retinal layers (see
How to optimize OCT scan quality
Images with SNR below 6 should be re-taken if possible or interpreted with caution.
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 45 kg (100 lbs) maximum. This requires two people to lift or carry
the unit.
Please consult your Optos representative before moving the device.
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
In accordance with IEC 60825-1 Ed. 3, the Laser Management System maintains a
Class 1 accessible emission limit (AEL) at the eye for normal operation and under
foreseeable fault conditions. Based on current scientific knowledge, a Class 1 laser
device can be considered as safe by engineering design.
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 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: G110230-003-ENG
Page 13 of 84
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