Wagner & Guder cubeONE Manual

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

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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

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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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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

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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“
- 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.

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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

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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,
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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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.

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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 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.

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Positioning and installation instructions
Correct adjustment of the refraction unit
Tough floor
6x adjustable legs
Create stability
After transport,
Remove safety caps from legs

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Notes on device installation
Refraction unit with single device working
1. Working position 1: max. 30kg
2. Working position 2: Keep space free
Attention! Single device working
Fix the 2nd table position with a suitable fixing
screw M4x25mm
Refraction unit with multiple device working
1. Working position 1: max. 15kg
2. Working position 2: max. 25kg

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General structure
1
2
3
4
5
6
7
8
9
10
1
Mounting of projector, D=30mm
2
Reading Spot/ reading lamp
3
Phoropter rail with mounting hole, D=22mm
4
Functional column with slot system
5
Working table with control panel, application part
6
Lens case
7
Patient chair with tiltable armrests
optional: sliding seat position, seat turning, foot rest, backrest inclination
8
Lifting pillar
9
Basic frame
10
Base plate with adjustable legs

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11
12
13
11 cable exit functional column
12 eyewear desposit
13 Mains connection refraction unit,
In case of error disconnect HERE!
Mains connection
with fuses
2x T 6,3 A / H
Nameplate
Manufacturer
Specification

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Working table
The instrument table enables smooth and safe swivelling in front of the patient. When the end position
is reached, an electromagnet locks automatically. The table is swivelled back by releasing the holding
magnet by pressing the table button. When changing the examination device to the second holding
position, the table is moved to the second table position by passing a mechanical lock. Patient and user
can keep their sitting position. The maximum permissible load of the two-device table is 40kg.
14
GND
15
14 Press button to release the holding magnet
15 control panel
Phoropter arm
Telescopic rail system
16 adapter phoropter rail with mounting hole
17 mounting hole phoropter d=22mm with
clamp screw 2x M5 Inbus
18 handle phoropterarm
16
17
18

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Swivel mounted phoropter arm
19
20
21
22
23
19
20
21
22
23
Clamp handle
Cable guide
Phoropter mount
Make sure that the phoropter head with the corresponding safety
screw is fixed correctly!
Handle to loose and adjust working heigh (gas spring system)
Clamp handle and swivel mount
Mounting bracket projector mount
24
25
24
25
Projector mount, D=30mm Mounting with screw lock,
M5 Inbus
Fixing point on the function column with sliding blocks

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Drawers with lens case holder
The drawer is designed in such a way that it can contain a measuring glass insert.
This is included in the scope of delivery (space for 238 glasses).
24 Lens case for measuring glases (238pcs)
25 drawer
24
25
Patient chair
The patient chair is fixed to the unit and has an electromotive height adjustment. The maximum
permissible lifting load of the patient chair is 135kg.
26 Seat shell
27 Turnable arm rest
26
27

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28
29
30
28 Sliding seat position
29 Seat rotation, 4x 90°=360°
30 Foot rest, tiltable
Please make sure that the patients do not put their feet under the
footrest! The lifting column does not recognize any obstacle as a
result of the construction!
Safety switch, Emergency Stop patient chair
31
31
Safety switch
Make sure that all adjustable accessories do not endanger the patient. Especially seat
displacement, footrest and rotation are a source of danger for the patient when the patient chair is
moved in height. Although the unit has a safety switch strip under the instrument table, this is not
always in operation because of its design.

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Electric connection
The electrical connection of the examination unit is made to a properly installed grounded contact
socket or the wall mounting box included in the delivery. Please use only the included power cable,
connection length 2,5m, cable cross-section 1mm2or the connection cable of the wall connection box.
Fuse box
2x T 6,3A / H
Mains switch
Power input
(2,5m, 1mm2)
In case of error
disconnect HERE!
Initial operation
- Plug the enclosed power cord into the power input socket provided
- Connect the power cord to a properly installed grounded outlet.
- Set the power switch to "I".
- Press the operating switch on the device table, the control lamp lights up green,
Page 19 (Position 8)

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Operation
Control panel
The operating switch with the control lamp is located at the instrument table, see page 14
(position 15). The examination unit is ready for operation as soon as the button is pressed and
the lamp lights up green. This also applies to already installed examination units or additional
components, if they are supplied with voltage via the switchable socket strip 230VAC/4A. The
examination devices on the telescopic table are automatically ready for operation when table
position 1 or table position 2 is reached. Next to the operating button there are further control
functions.
1Patient chair DOWN
2Patient chair UP
if you put both buttons, patient chair will move „Automatic down“ to lowest position
this function is working by a time delay of 10sec. After finish this time patient chair is able to
move UP again
3Button reading lamp ON/ OFF
4Button roomlight control
5Blind control Down
6Blind control UP
7AUX, free button
8operation button with LED light (green), Stand- By- Mode
1
2
3
5
4
6
8
1
7

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Device installation
Instrument table - electric connection
2
1
3
4
1
3pol socket 1 for device connection
PIN 2: GND- protective earth
PIN 1+3: 6 VDC or 12 VDC (on basic board –page 26)
K11 Outlet 6V: PIN 25/ 27
K11 Outlet 12V: PIN 25/ 26
2
3pol socket 2 for device connection, free port e.g. LED- slit lamp
PIN 2: GND- protective earth
3
Brightness control, dimmabke –for socket 1
4
Button to loose electromagnetic brake