Wagner & Guder cubeLITE Manual

WAGNER & GUDER MEDICAL GMBH
r
re ef fr ra ac ct ti io on n u un ni it t
c
cu ub be eL LI IT TE E
Direction for use
GA05-2021_cubeLITE_ENG
issue May 2021

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Wagner & Guder Medical GmbH
issue May 2021
Direction for use, cubeLITE
To this manual
The instructions for use are part of the scope of
delivery.
Please read manual before use refraction unit
Make yourself familiar with the safety regulations
Store at the place of use of the appliance
Keep for the lifetime of the appliance
Pass on to any subsequent owner or user of the
equipment
We reserve the right to make changes to the design
and scope of delivery in the course of technical
developments.
Guidance
The table of contents at the beginning of the instructions for
use gives you an overview of the topics contained
Pictures and signs warn of dangers or point out special fea-
tures
Manufacturer
Wagner & Guder Medical GmbH
OT Hermstedt
Hermstedter Straße 57
99518 Bad Sulza, Germany
phone: [phone]
Email: [e-mail]
Internet: www.wagner-guder-medical.de
© Wagner & Guder Medical GmbH 2021
All rights reserved. Reprinting and duplication - even in extracts -
is not permitted. The digital form of the instructions for use can be
found on our website: www.wagner-guder-medical.de

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Table of contents
SAFETY INSTRUCTIONS................................................................................................ 4
Description of symbols...................................................................................................... 4
Application area................................................................................................................ 5
Informations for the operator............................................................................................. 6
REQUIREMENTS FOR OPERATION............................................................................... 8
Before the first operation................................................................................................... 8
Before the operation ......................................................................................................... 8
During the operation ......................................................................................................... 8
Liability and warranty........................................................................................................ 8
POSITIONING AND INSTALLATION INSTRUCTIONS.................................................... 9
GENERAL CONSTRUCTION CUBELITE........................................................................10
Phoropter arm Type II......................................................................................................11
Patient chair.....................................................................................................................12
OPERATION ...................................................................................................................13
Electrical connection........................................................................................................13
Control panel...................................................................................................................14
Cleaning ..........................................................................................................................15
Maintenance/ Technical service.......................................................................................15
MAINTENANCE OF THE DEVICE...................................................................................16
Safety check....................................................................................................................16
Change of the main fuses................................................................................................16
ENVIRONMENTAL CONDITIONS...................................................................................17
PATIENTS SURROUNDING ...........................................................................................18
TECHNICAL DATA..........................................................................................................19
WARRANTY AND WASTE DISPOSAL............................................................................20
MANUFACTURER'S DECLARATION..............................................................................21
Eliminating electromagnetic interference..........................................................................25
PURCHASE ORDER DETAILS.......................................................................................27
Spare parts......................................................................................................................27

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Safety instructions
Description of symbols
sign “Follow instructions for use“
especially read the safety instructions and follow the enclosed
documents
Equipment labelling „nameplate“
- MD medical device I
- Unit name
- UDI-DI
- Type
- Serial number
- Date of production
- Mains input voltage
- Power input
- Main fuses
- Operating cycle patient chair
- Manufacturer
- Address
- Type of device
- CE- marking
-Note of professional disposal
- UDI (QR code)
Warning note indicate a potential risk to the health and safety of
users and/or patients. The warnings explain the nature of the
hazard and how it can be avoided.
DANGER OF VOLTAGE; ELECTRICITY
If you do not take into account the information given under
Electricity, it can lead to exposure to electricity.
Mains voltage/ mains input
Please disconnect the unit from the mains when opening the
housing.
Grounding
Indicates grounding (protective conductor) for safety reasons.
CE- marking
Indicates compliance with standards for medical devices.
WEEE- marking: DE 67707987
Regard to the proper disposal of a waste disposal service

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Wagner & Guder Medical GmbH
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Direction for use, cubeLITE
Application area
Intended use (use as directed)
The cubeLITE 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 cubeLITE 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 cubeLITE a non-invasive, active medical device in category I.
Device class
I
Basic UDI-DI
PP10431UNIT15
EMC
Electromagnetic compatibility page 22 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

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Direction for use, cubeLITE
Informations for the operator
Before using the device, make yourself thoroughly familiar with the
contents of the operating instructions. Also observe the operating
instructions for accessories and other system components.
The examination unit may only be installed and commissioned by
qualified personnel who are familiar with the installation, commis-
sioning and operation of the product. For the purposes of these op-
erating instructions, qualified personnel are persons who, on the ba-
sis of their technical training, knowledge and experience and their
knowledge of the relevant standards, are able to assess the work
assigned to them and recognise possible risks.
Keep the operating instructions ready to hand at all times for the
operating and service personnel.
Observe the legal regulations for accident prevention and work safe-
ty valid in the respective country.
Changes and repairs to the examination unit may only be carried
out by our service personnel or by designated authorised dealers.
The manufacturer is not liable for possible damage caused by unau-
thorised interventions on the unit. In this case, all warranty claims
are void.
The examination unit must not be installed and operated in damp
rooms. Avoid dripping and splashing water.
The examination unit must not be operated in a potentially explosive
environment.
The examination unit was adjusted to a level when it was installed. If
the unit has to be moved, please make sure that all adjusting ele-
ments of the base plate touch the floor. This is the only way to en-
sure the stability of the unit and the examination equipment.
In order to guarantee the specified working position of the examina-
tion equipment, it is necessary to swivel and move the telescopic
table and the phoropter arm. Please make sure that the patient
does not come into contact with moving parts. There is a risk of inju-
ry!
Pay attention to the maximum load capacity of the patient chair
of 135 kg.

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The lifting column of the patient chair is not designed for permanent
operation. After an operating time of more than 1 minute, the lifting
column of the patient chair requires a cooling time of 9 minutes.
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 equip-
ment.
If the protective conductor is damaged or electrical lines are dam-
aged, 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 re-
quirements 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 norma-
tive requirements.
Each device has a protective conductor resistance and a leakage
current. These add up if you connect mains-operated devices direct-
ly to the examination unit. According to IEC/VDE, the limit values
are max. 0.5mA for the touch current and max. 0.2Ωfor the protec-
tive conductor resistance.
Possible risks for the operation of the examination unit and the in-
stallation of further devices are considered in the product FMEA and
in the risk management.

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Direction for use, cubeLITE
Requirements for operation
Before the first operation
Check the stability of the examination unit
Check the fixing points of the installed equipment
Pay attention to the maximum permissible weights of the de-
vices
All cables and plug connections are in perfect condition
The mains plug is plugged into a socket with a working pro-
tective conductor.
Check safety-relevant circuits
Before the operation
Check the fixing points of the installed devices
Clean the permissible surfaces of the examination unit and
contact surfaces of the installed devices.
Advise patients/customers of possible risks
During the operation
Never leave patients/ customers unattended at the devices
Do not leave an instrument unattended with the light source
switched on.
The lifting element of the patient chair has a maximum load
capacity of 135kg and is not designed for continuous opera-
tion.
After the operation
Switch OFF the examination unit or installed devices if they
are not in use
Insufficient hygiene or incorrect cleaning contrary to the in-
structions for use can contribute to the risk of infection for the
patient/customer and damage surfaces of the examination
unit or lead to discoloration
Liability and warranty
Warranty and liability are based on the conditions specified in the
contract
NOTCIE
Loss of warranty
The manufacturer is not liable for damage caused by
unauthorised intervention in the device or improper handling. In
addition, all warranty claims are void.

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Direction for use, cubeLITE
Positioning and installation instructions
Correct adjustment of the refraction unit
Tough floor

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General construction cubeLITE
projector-
mounting
phoropter-
mounting
d= 22mm
reading spot
pillar
patient seat
control panel
base frame
(phoropter
control unit)
electric
pillar
adjustable
base plate
Figure: 1: general structure cubeLITE