Gebrauchsanweisung Untersuchungseinheit cubeONE,
directions for use, refraction unit cubeONE
8
Wagner & Guder Medical GmbH
issue September 2020
The examination unit may only be put into operation at a correctly
installed grounded contact socket 230V/AC mains voltage with the
mains cable supplied or in connection with the wall connection box.
Extension cords and portable multiple sockets must not be used to
operate the refraction unit.
Interruption of the protective conductor is not permitted, as this can
lead to danger for the user/patient and damage to installed equipment.
If the protective conductor is damaged or electrical lines are damaged,
the examination unit must be disconnected from the electrical
connection and secured against unintentional operation.
Never open the device! There are voltage-carrying parts inside.
The examination unit may only be opened by authorised specialist
staff.
Only the main power fuses accessible from the outside may be
changed.
Please disconnect the mains power plug before cleaning. Please make
sure that no detergent or water enters the examination unit.
Additional devices that you connect to the examination unit must
demonstrably be in compliance with the relevant IEC standards.
Furthermore, all configurations must comply with the normative
requirements for medical systems
(see IEC 60601-1 and IEC 60601-1-2). The system configurator is
responsible for ensuring that the system complies with the normative
requirements.
Each device has a protective conductor resistance and a leakage
current. These add up if you connect mains-operated devices directly
to the examination unit. According to IEC/VDE, the limit values are
max. 0.5mA for the touch current and max. 0.2
Ω for the protective
conductor resistance.
Possible risks for the operation of the examination unit and the
installation of further devices are considered in the product FMEA and
in the risk management.
