Wagner & Guder cubeONE Manual

Wagner & Guder Medical GmbH
refraction unit
cubeONE
Directions for use
GA2020_09_08ENG
issue September 2020

Gebrauchsanweisung Untersuchungseinheit cubeONE,
directions for use, refraction unit cubeONE
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Wagner & Guder Medical GmbH
issue September 2020
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 features
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 2020
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

Gebrauchsanweisung Untersuchungseinheit cubeONE,
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Table of contents
Content
Safety instructions............................................................................................................................5
Description of symbols..................................................................................................................5
Application area............................................................................................................................6
Informations for the operator.........................................................................................................7
Requirements for operation..............................................................................................................9
Before the first operation ..............................................................................................................9
Before the operation.....................................................................................................................9
During the operation.....................................................................................................................9
Liability and warranty....................................................................................................................9
Positioning and installation instructions..........................................................................................10
Notes on device installation........................................................................................................11
General structure........................................................................................................................12
Working table..............................................................................................................................14
Phoropter arm.............................................................................................................................14
Mounting bracket projector mount...............................................................................................15
Drawers with lens case holder....................................................................................................16
Patient chair ...............................................................................................................................16
Safety switch, Emergency Stop patient chair..............................................................................17
Electric connection.........................................................................................................................18
Initial operation...........................................................................................................................18
Operation.......................................................................................................................................19
Control panel..............................................................................................................................19
Device installation..........................................................................................................................20
Instrument table - electric connection .........................................................................................20
Slit lamp installation....................................................................................................................21
Phoropter arm.............................................................................................................................22
Patient chair ...............................................................................................................................23
Reading light/ Reading spot........................................................................................................23
Technical structure.........................................................................................................................24
Basic frame ................................................................................................................................24
Control unit.................................................................................................................................25
Basic board - BLP.......................................................................................................................26
External termial block .................................................................................................................27
Patient Surrounding .......................................................................................................................28

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Wagner & Guder Medical GmbH
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Maintenance of the device .............................................................................................................29
Safety check...............................................................................................................................29
Change of the main fuses...........................................................................................................29
Maintenance of the device .............................................................................................................30
Cleaning.....................................................................................................................................30
Environmental protection regulations..........................................................................................30
Device details.................................................................................................................................31
Technical Data............................................................................................................................31
Environmental conditions...............................................................................................................32
Electromagnetic compatibility (EMC)..............................................................................................33
Technical error in the system .........................................................................................................37
Solve technical errors.................................................................................................................37
Eliminating electromagnetic interference ....................................................................................39
System combination medical and non- medical device...................................................................40
1. Isolation transformer (option)...............................................................................................40
2. Network isolator (option)......................................................................................................40
Warranty and warranty conditions..................................................................................................41
Purchase order details ...................................................................................................................42
Spare parts.................................................................................................................................42

Gebrauchsanweisung Untersuchungseinheit cubeONE,
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Wagner & Guder Medical GmbH
issue September 2020
Safety instructions
Description of symbols
sign “Follow instructions for use“
especially read the safety instructions and follow the enclosed documents
Equipment labelling „nameplate“
- Unit name
- Basic UDI-DI
- Type
- Serial number
- Date of production
- Mains input voltage
- Power input
- Main fuses
- Load capacity instrument table
- Operating cycle patient chair
- Manufacturer
- Address
- Type of device
- CE- marking
-Note of professional disposal
Warning note „risk of trapping“
Pay attention to moving or motorised parts which, due to their design,
could present a risk of trapping for the patient.
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.
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 „disposal“
Electrical or electronic devices or assemblies must not be disposed of as
normal household waste.

Gebrauchsanweisung Untersuchungseinheit cubeONE,
directions for use, refraction unit cubeONE
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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

Gebrauchsanweisung Untersuchungseinheit cubeONE,
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Wagner & Guder Medical GmbH
issue September 2020
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,
commissioning and operation of the product. For the purposes of these
operating instructions, qualified personnel are persons who, on the
basis 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 safety
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 unauthorised
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 elements
of the base plate touch the floor. This is the only way to ensure the
stability of the unit and the examination equipment.
In order to guarantee the specified working position of the examination
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 injury!
The maximum load capacity of the instrument table is 40kg, while
instrument position 1 may be loaded with a maximum of 30kg.
Pay attention to the maximum load capacity of the patient chair
of 135 kg.
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.

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Wagner & Guder Medical GmbH
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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. 0.2Ωfor 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.

Gebrauchsanweisung Untersuchungseinheit cubeONE,
directions for use, refraction unit cubeONE
9
Wagner & Guder Medical GmbH
issue September 2020
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 devices
All cables and plug connections are in perfect condition
The mains plug is plugged into a socket with a working protective
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 operation.
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 instructions 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.

Gebrauchsanweisung Untersuchungseinheit cubeONE,
directions for use, refraction unit cubeONE
10
Wagner & Guder Medical GmbH
issue September 2020
Positioning and installation instructions
Correct adjustment of the refraction unit
Tough floor
6x adjustable legs
Create stability
After transport,
Remove safety caps from legs