Intended Use; Intended Users; Target Environment; Contraindications - Optos California P200DTx rg Manuel D'utilisation

Chapter 2 - Introduction

2.2 Intended use

The P200DTx scanning laser ophthalmoscope is indicated for use as a widefield and retinal fluorescence and
autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases and disorders that
manifest in the retina.
It is also indicated for use as a widefield scanning laser ophthalmoscope for viewing choroidal circulation
patterns that are illuminated using Indocyanine Green dye and for aiding in both the assessment of choroidal
circulation and in the diagnosis of choroiditis or choroidal diseases.

2.3 Intended users

The device is intended for professional use only. Users
experience in operating ophthalmic imaging and diagnostic devices.
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.

2.4 Target environment

The device may be operated in an ophthalmology clinic, hospital environment or in an optometrist's commercial
premises.

2.5 Contraindications

There are known contraindications for this device.
NO

2.6 System configuration

The system configuration must include a scan head and an image server. Images are captured on the scan
head and are reviewed on the image server.
The scan head is connected to the touch screen, hand control and image server.
The image server runs the
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 69
English
OptosAdvance software which allows you to review and analyze patient images.
MUST have knowledge of basic eye anatomy and
Copyright 2017, Optos plc. All rights reserved.
Part Number: G108025/4GWE