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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.

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

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Manufacturer of the device

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Date of manufacture of the device

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Serial number of the device

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Item number of the device

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

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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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