Chapter 1 - Warnings and cautions
1 Warnings and cautions
Your system is a medical device and must be operated within the safety parameters and instructions
defined in this User Guide.
If you identify a serious issue related to the safety and performance of your device or a public health risk
you should forward the details to the relative authority and your Optos representative (see
If the device appears faulty or has non-functioning components, please contact your Optos representative.
If you have any questions regarding the correct use of your device, please contact your Optos
representative before attempting to operate the device.
Read the warnings and cautions before using your device.
1.1 General safety
WARNING
Guidance for use on patients with Epilepsy
The device uses flashes of light. Some patients with epilepsy may be sensitive to
flashes of light. Caution should be exercised for patients who have a history of reaction
to camera flashes or strobe lighting.
Equipment modifications
No modification of this equipment is allowed.
Positioning scan head on table
The scan head should be positioned in the middle of the table width. The front of the
scan head should be inline with the front of the table to allow the patient to get into the
correct alignment position.
The chin rest should slightly overhang the edge of the table.
Suitability of images
The suitability of using an image or print for viewing is determined by the clinician.
Fluorescence Imaging
Optos does not offer any guidance or advice on the injection of imaging dyes. It is
recommended that only authorized and appropriately qualified physicians or MD's can
use angiography modalities that require medical interventions.
Part Number: G110230-003-ENG
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