Country-specific information and labels
000000-1520-928_GA_EN_021013
Country-specific information and
labels
Classification/Manufacturer's declaration
WARNING - GENERAL HAZARDS
This device may only be set up, operated, and used for the specified
purpose and according to national regulations and occupational safety and
accident prevention regulations. Further notes on classification are to be
found in section
Technical data.
The device complies with EC Directive 93/42/MDD concerning medical
devices.
Device class according
to MDD: IIa
Laser class: Class 1 (EN 60825-1:2003)
EMC: See chapter Electromagnetic compatibility,
page 56 and following.
UMDNS No.: 13-313
This declaration shall be rendered invalid if changes are made to the product
without the manufacturer’s authorization.
Intended use
The i.Profiler
® plus
is a diagnostic device for the measurement and analysis of
imaging errors in the human eye.
0297
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