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
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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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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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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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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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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

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Phoropter arm Type I
The Phoropterarm type I allows a smooth and safe moving in front of the patient. The
arm reaches its final position by pulling the handle into the manual end position. The
maximum permissible load of the arm is 15 kg. The correct working high can adjust
at the pillar.
mounting
phoropter
handle
Figure: 2: phoropter arm telescopic rail
Phoropter arm Type II
The phoropter arm type II allows easy and safe slew in front of the patient. When
reaching the end position, the arm is to be fixed with the clamping lever. The
maximum permissible load of the arm is 15 kg.
Cable guide
Phoropter mounting
handle
clamping
Figure: 3: swivel mounted phoropter arm

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Patient chair
Patient chair is solid connected to the base plate. The electric movement has a
stroke of 200 mm. The basic seat „ONE“ is equipped with fixed arm rest and a
standard letherette qualitiy. Different seat shells are available.
The permissible standard load of the patient chair is max.135 kg.
Figure: 4: patient chair
Basic seat shell „ONE“
with fixed arm rest
option:
- footrest
- armrest, turnable
- sliding seat position, forward
backward
- seat turing
Please take care of all adjustable accessories that no danger occurs to the patient.
Precisely because the seat movement is a source of danger to the patient when used
at actuated seat module of the patient's chair in height. The unit is staffed with a
security bar for the legs, but this is by design not always engaged.
Attention!
Do not place your feet under the moveable patient chair. Risk of physical injury!
seat rotation: to place an patient on seat, moveable 4x 90°= 360°. Be careful, if you
have a seat rotation and sliding system.

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Operation
Electrical connection
The electrical connection of the unit is on a properly installed safety socket or the
included wall mounted box. Please use only the cable of mains connection, 2,5m
cable length, wire size 1.0 mm2 or the cable of the wall connection box.
box of fuses
2x T6,3 A H 250V
(2x T10 A H 100V)
power switch
power connection
( 2,5m, 1mm2)
Figure: 5: power connection
connection to DIN rail
connection
reading lamp
connection
phoropter control box
Figure: 6: base frame

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Commissioning
Connect power cord to refraction place
Connect the power cord to a properly installed power outlet.
Putt the operating button „I“ green lighting
The unit is ready for operation when the green switch is shining.
This also applies to already installed equipment or analysis of additional components.
Control panel
Figure: 7: control panel
1 operating button
2 reading lamp ON/ OFF
3 patient chair UP/ DOWN
4 window control UP/ DOWN
5 roomlight connection BRIGHT/ DARK
1
2
3
5
4

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Cleaning
For cleaning the varnished parts and the seat upholstery of cubeLITE
please use a wet cloth. Into the water you can add a mild cleaning agent
(if necessary „scouring milk“). Obstinate dirt at varnished surfaces can be
removed with the help of cleaning solvent or rectified spirits.
In case of cleaning the installed examination devices, please follow the
hints and comments of each device producers or ask authorized
specialist staff.
Maintenance/ Technical service
The examination unit cubeLITE and its accessories are low-
maintenance when proper used. Nevertheless periodic maintenance
works, which serve the units safety, have to be carried out either self-
supporting or by our service partners:
1 Check the proper fastening of the examination devices regularly.
2 Check the safety advices affixed at the supplied products.
3 Check the safety inscriptions at your examination unit. When in-
scription elements are missing or damaged contrary to the user
manual please contact our service technician.
4 Check the integrity of housing an isolations
5 Check the operational reliability of safety-relevant circuits (switch-
off panel and current limitations)
6 Regular measuring (annual) of substitute leakage current
7 Complete check of examination unit’s and accessory's operational
reliability
In case of technical problems or decline of handling please consult your
dealer or our service center.

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Maintenance of the device
Safety check
The examination unit is maintenance-free and designed for a
service life of 6 years. To ensure safe and proper operation and a
long service life at all times, regular preventive maintenance must
be carried out. The electrical safety of the device may deteriorate
due to aging and usage.
At least the following safety checks should be done for the system
by the manufacturer or qualified persons.
Check the directions for use is available
Visual inspection of device and accessories for damage
Legibility of the labels
Check the function of safety relevant circuits!
Function test of the operating functions
Leakage current test
Protective conductor test
Documentation of the results
Failure to observe the inspection intervals may result in a risk of
healthy.
Attention! Duty cycle patient chair
The lifting system of the examination unit is not suitable for
designed for continuous operation.
Operating time: 1 min, continuous operation with full load
Resting time: 9 min
Change of the main fuses
The main fuses may only be changed when the mains plug is
disconnected. You should only consider changing the fuses if the
control lamp does not light up despite the power and operating
switch being switched on.
Themains fuses can be found in thefuse box at the
mainsconnectionof the examination unit.
Pressthe plastic tongue attached to the box(e.g. with
a screwdriver or similar). This will release the lock of
the fuse box.
Pull thefuse box out of the opening by hand.
Replace the defectivefuses with newfuses
(marking: T 6,3 A / H).
Slide the fuse box back into the provided opening
until the plastic spring locks intoplace.

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Environmental conditions
1. For operations
Feature
Permited value range
Temperature
+5°C … +40°C
Relative humidity
30% … 75% no condensation
Operating height
till 2000m a.n.z
2. For Transport and storage
Feature
Permited value range
Temperature
-20°C … +70°C
Relative humidity
10% … 90% no condensation
Air pressure
500hPa … 1060hPa

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Patients surrounding
D=3m
Figure: 8: Patients surrounding
As patients surrounding the above areas is highlighted. In this area will ensure for the
patient, the maximum possible protection. In the area surrounding the patient may
experience dangerous areas. Here is a special duty of care of the doctor or optician
is precisely in connection with the installed equipment.
Outside of this region must share the doctor or optician to patients accordingly, does
not reside in a different area.

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Technical data
Anschlussspannung
nominal input voltage
Anschlussleistung
connected load
Beleuchtung
electric lighting
Gerätetyp
class of unit
Schutzklasse
class of protection
Gesamthöhe
maximum height
Maximalgewicht Einheit
maximum weight of unit
Belastbarkeit
Patientenstuhl
loading capacity chair
Raumlichtanschluss
roomlight connection
Vorhangsteuerung
100- 230VAC /
50-60Hz
6A (10A)
5VA (LED)
B
I
1765mm
90kg
135kg
potentialfrei
potential free

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Warranty and waste disposal
If there are defects from installation, assembly or materials within 24 months after
purchase, we guarantee the fastest and free repair of the refraction unit, or after our
decision, a free exchange. For electronic components such as power supply or
motherboard defect within 12 months will be set free repair.
Conditions for a warranty claim:
The invoicel with the date of purchase is available
The refraction place was used properly and as intended
Repairs were carried out exclusively by the customer or by authorized persons
Warranties cause any extension of the warranty periods, nor does it set a new
warranty period. Consumable or normal signs of use are not covered under warranty.
Please have a look at the General Conditions of the company
Wagner & Guder Medical GmbH
This refraction place contains components that cannot be
disposed of in normal household waste. Please instruct
them for the disposal of a waste management company or
our services.
only for EU countries
WEEE-Reg.-Nr. DE 67707987