Country-Specific Information And Exterior Labeling; Manufacturer Classification/Declaration; Intended Use; Normal Use / Indication - Zeiss i.Profiler plus Instructions For Use Manual

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EN 20_070_0009I v1.5

Country-specific information and exterior labeling

Country-specific information and exterior
labeling

Manufacturer classification/declaration

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.
This device fulfills the Medical Devices Directive 93/42/MDD.
Device class under MDD:
Laser class:
EMC:
GMDN Code:
UMDNS Classification:
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 can be used on humans to measure and analyse the
plus
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.
IIa
Class 1 in accordance with DIN EN 60825-
1:2007
See chapter Electromagnetic compatibility,
Page 52 et seqq.
36386
13-313