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EN 20_070_0009I v1.5
6
Country-specific information and exterior labeling
Country-specific information and exterior
labeling
Manufacturer classification/declaration
This device fulfills the Medical Devices Directive 93/42/MDD.
Device class under MDD:
IIa
Laser class:
Class 1 in accordance with DIN EN 60825-
1:2007
EMC:
GMDN Code:
UMDNS Classification:
See chapter
Electromagnetic compatibility
,
Page 52 et seqq.
36386
13-313
This declaration will be rendered null and void if modifications are made to
the product that were not authorized by the manufacturer.
The product is RoHS-compliant under Directive 2011/65/EU.
Intended use
The i.Profiler
plus
is a diagnostic device for the measurement and analysis of
imaging errors in the human eye.
Normal Use / Indication
The i.Profiler
plus
can be used on humans to measure and analyse the
imaging errors of the human eyes. The patient shall be awake and
collaborative during measurement, as he/she shall be able to follow the
instructions from the operator.
WARNING - GENERAL HAZARD
This device may only be set up, operated and used according to its
intended purpose and in accordance with country-specific provisions,
occupational protection and accident prevention regulations. Further
information on classification is provided in the section
Technical data
.