CSO MS39 AS-OCT - Medical Devices Classification

MS-39 AS-OCT| IFU302EN00 - 03/2019
INSTRUCTIONS FOR USE
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The device must be only used by specialist practitioners and
operators (such as
optometrists), within the limits of the law and the
regulations for the exercise of the profession.
Patient area: any volume in which intentional or unintentional
contact can occur between patient and parts of the system or
between patient and other persons touching parts of the system.
Fig 4 - Patient area
2.4 MEDICAL DEVICES CLASSIFICATION
Technical data
Value
Classification in compliance with the
attached IX to the Directive
93/42/EEC and subsequent
modifications
Class IIa