Gebrauchsanweisung Untersuchungseinheit cubeONE,
directions for use, refraction unit cubeONE
6
Wagner & Guder Medical GmbH
issue September 2020
Application area
Intended use (use as directed)
The cubeONE examination unit is an ophthalmological examination unit and is used exclusively for
accommodating testing and measuring examination equipment for ophthalmic optics.
Any use other than that specified is not permitted.
Intended use
The cubeONE examination unit is a versatile device for positioning a sitting patient and/or customer
in front of ophthalmic examination equipment. Both manual and electromotive adjustment options
are available for positioning.
Medical device law
According to the directive of medical devices guideline 2017/745 (MDR), ophthalmologic
examination unit cubeONE a non-invasive, active medical device in category I.
Device class
I
Basic UDI-DI
PP10431UNIT15
EMC
Electromagnetic compatibility page 32 following.
Approvals and requirements
Description
Marking
Electrical version
DIN EN 60601-1: 2006 +
Cor.:2010 + A1:2013
Protection class I
EMC requirements
The device complies with the EMC
requirements of DIN EN 60601-1-2: 2016,
class B
CE- marking
The device complies with the essential
safety requirements according to EU
Regulation 2017/745 on medical devices
The unit is marked
