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Classification; Laser Class; Explanation Of The Signs - schwa-medico MODULAS TOUCH Gebrauchsanweisung

Der multi-laser im ir-spektrum
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The MODULAS TOUCH is only to be operated by suitably qualified personnel.
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Before using the MODULAS TOUCH, the user must be fully aware of the functional
safety and proper condition aspects.
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A warning sign must be displayed at the access point to the treatment room in
accordance with the German Industrial Standard DIN 4844-2:2001 + A1:2004.
Such warning sign is supplied with the MODULAS TOUCH.
»
All patients, therapists and other personnel must wear protective goggles when
present in the laser area.
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The MODULAS TOUCH is protected against unauthorized use by a special code.
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Mobile HF communication equipment can affect medical electric devices.
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To avoid possible mutual interference, please ensure that the laser is not placed
immediately adjacent to other devices and that it is not stacked. If this should
not be possible, other such devices should be monitored to safeguard the proper
functioning of the MODULAS TOUCH.

Classification

The MODULAS TOUCH has been classified as a Class IIa device in compliance with
the classification criteria of the Medical Device Directive 93/42/EU, Appendix IX,
Rule9.

Laser Class

The MODULAS TOUCH has been rated as Laser Class 3B according to EN 60825-
1:2007.
Caution: It is dangerous for the eyes to look directly into a laser beam.
Protective goggles must be worn. The accident prevention regulations
„Laserstrahlung" (BGV B2) (laser radiation) must be complied with.

Explanation Of The Signs

Catalogue number
Serial number
Attention: Read accompanying documents, especially user manual!
Type BF applied part
Date of manufacture
All manuals and user guides at all-guides.com
English
29

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