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Zeisberg GmbH

Labeling, standards and safety

Symbols and standards

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The device fulfills the basic safety and performance requirements of the

Regulation (EU) 2017/745 on medical devices (Class I)

and the

Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment

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The device complies with the requirements of EN 60601-1 with type B applied parts.

This symbol requires the user to observe the corresponding warnings in the accompanying documents or in the instructions for use.

Manufacturer of the device

Date of manufacture of the device

Serial number of the device

Item number of the device

The symbol reminds the user to follow the instructions for use.

Do not dispose of the appliance with household waste.

See also https://zeisberg.atlassian.net/wiki/spaces/DPET/pages/edit-v2/2373713976#Entsorgung

Safety instructions

  • Before each use of the device on test subjects, a functional check and test for mechanical integrity must be carried out.

  • The appliance may only be operated in dry rooms.

  • The appliance must not be used in the presence of flammable gases.

  • The device may only be operated by trained medical personnel.

  • If the appliance is not under constant supervision, it must be ensured that unauthorized personnel do not have access to the appliance.

  • Parts such as pens, hearing aids or batteries etc. must be kept out of the reach of

    Keep away from children (risk of swallowing).

  • Only accessories approved for this appliance by the manufacturer may be used.

    is.

  • The device must not be exposed to mechanical loads.

  • The device can project a laser point for use as fixation target. DO NOT STARE INTO BEAM.

Gutenbergstrasse 39 * 72555 Metzingen

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