Zeiss VISULAS YAG III, Руководство пользователя

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Country-specific information and labels
000000-1272-175-GA-GB-060613
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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, consistent with the applicable
industry standards and occupational safety and accident prevention
regulations. Further notes on classification are to be found in section
Technical data , page 104.
The device VISULAS YAG III complies with EU Medical Device Directive
93/42/EEC and its national implementation in the form of the German
Medical Products Act (MPG).
Device class: 2 pursuant to ISO 15004-2:2007
Device class according to the Medical
Products Act:
IIb
Laser class in accordance with
DIN EN 60825-1-2003: 4 (VISULAS YAG III)
EMC: See section Electromagnetic
compatibility , page 107 and
following.
UMDNS No.: 16-947 (VISULAS YAG III)
UMDNS No.: 12-281 (laser slit lamp)
This declaration shall be rendered invalid if changes are made to the product
without the manufacturer’s authorization.
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