
Chapter 2 - Introduction
wide field, en-face reflectance images, auto fluorescence images, fluorescein angiography images,
indocyanine green angiography images, and axial cross-sectional images of the posterior ocular
structures.
The system enables practitioners to capture multi-modal images in support of detection, investigation and
monitoring of retinal conditions.
2.4 Intended users
The system is intended for use by ophthalmic and optometry health care professionals.
Note
l
The system prevents the operator altering laser power or exposure times, therefore no specific
pre-requisite training is required prior to receiving Optos training. The review of images, as an
assist to diagnosis, may only be conducted by a healthcare professional qualified in optometry or
ophthalmology.
l
The system shall be capable of being operated by a single operator.
2.5 Target environment
The device shall be operated in an ophthalmology clinic, hospital environment or in an optometrist's
commercial premises. Operation shall be conducted within a range of lighting conditions from 'dark indoor'
to 'normal indoor' lighting conditions.
2.6 Contraindications
There are
NO
known contraindications for this device.
2.7 System configuration
The system configuration must include a scan head and an image server. Images are captured on the scan
head and are processed on the image server and stored as DICOM image files for review on compatible
viewers.
The scan head is connected to the touch screen, hand control and image server.
The standard image server configuration runs the Optos
Advance
software which allows you to review and
analyze patient images. Administrators can also manage images located on local or network resources.
Any browser-based review clients connected to your network can be used to review and analyze patient
images.
Page 22 of 84
Part Number: G110230-003-ENG
English
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