Wagner & Guder cubeONE Directions For Use Manual Download Page 2

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Gebrauchsanweisung Untersuchungseinheit cubeONE,
directions for use, refraction unit cubeONE

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:

+49 3644 51 55 61

Email:

[email protected]

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

Summary of Contents for cubeONE

Page 1: ...Wagner Guder Medical GmbH refraction unit cubeONE Directions for use GA2020_09_08ENG issue September 2020 ...

Page 2: ...e 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 49 3644 51 55 61 Email ...

Page 3: ...ng 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 lam...

Page 4: ...eaning 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 conditio...

Page 5: ...e 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 disco...

Page 6: ...hthalmic 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 req...

Page 7: ... 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 t...

Page 8: ... 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...

Page 9: ...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 i...

Page 10: ... 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 ...

Page 11: ...0 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 ...

Page 12: ...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 ...

Page 13: ...tion unit cubeONE 13 Wagner Guder Medical GmbH issue September 2020 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 ...

Page 14: ...e 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 r...

Page 15: ... 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 ...

Page 16: ...igned 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 ...

Page 17: ...r 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...

Page 18: ...delivery Please use only the included power cable connection length 2 5m cable cross section 1mm2 or 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 s...

Page 19: ...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 1 Patient chair DOWN 2 Patient chair UP if you put both buttons patient chair will move Automatic down to lowest position this function is wo...

Page 20: ...t 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 ...

Page 21: ...September 2020 Slit lamp installation No Example description 1 Slit lamp assembly on base plate with integrated chin rest socket 1 2 Slit lamp assembly on base plate with or without integrated chin rest socket 1 3 Slit lamp assembly with or without base plate and 2nd moveable device Chin rest is fixed on 1st position socket 1 ...

Page 22: ... Guder Medical GmbH issue September 2020 Phoropter arm 1 2 3 1 Slot nut to mount phoropter rail on function pillar 2 Mount 3 Phoropter rail Swivel mounted arm 1 2 3 4 1 Basic mount 2 Adjustable screw for weight control 3 Slot nut to mount phoropter rail on function pillar 4 Clamping lever for rotation ...

Page 23: ... chair 1 2 3 4 5 6 7 8 9 1 Seat shell 2 Arm rest mount 3 Spacers 4 basic base plate for seat shell 5 seat moving forward backward option 6 Turning seat position optional 7 Base plate sliding seat shell 8 Electric pillar 9 Foot rest Reading light Reading spot 1 2 1 Mount of reading lamp adjustable in high and turnable 2 illuminants GU5 3 4 6VA 4000K ...

Page 24: ...er Guder Medical GmbH issue September 2020 Technical structure Basic frame 1 2 GND 3 GND 1 Table bearing 2 Holding magnet instrument table in working position 3 plate of control unit page 25 4 5 6 7 4 spring loaded thrust piece 5 End switch 6 Holding magnet 7 fixation plate turning instrument table ...

Page 25: ...mber 2020 Control unit 1 2 3 4 5 6 7 8 9 1 2 3 4 5 6 7 8 9 Base plate control unit cubeONE 3times power socket swiched 230VAC max 4A Basic board BLP Reading spot 230VAC switched over control panel power socket 230VAC switched by working position power supply 12VDC power socket 230VAC current voltage external connection cable guide ...

Page 26: ... H switch between 1 and 2 Table position of outlet 6V 12V socket 1 fuse Si3 230V T 4 A H RESET buttom 6V outlet max 5 5A switch position 1 2 3 4 5 according to 3V 4V 5V 6V 7V 12V Ausgang max 3A switch position 1 2 3 4 5 according to 10V 11V 12V 13V 14V LED 6V Fixierleuchte switch position 1 2 3 4 5 according to 3V 4V 5V 6V 7V switchover 6V R dimmable 6V fixed voltage switchover 12V R dimmable 12V ...

Page 27: ...eONE 27 Wagner Guder Medical GmbH issue September 2020 External termial block 1 2 3 4 1 connection to blind control External voltage switchable to 8 A 2 connection to rommlight control 3 connection to free switch AUX Potential free Push button or switch by software 4 GND ground terminal ...

Page 28: ...ng In this area the patient is guaranteed the maximum possible protection In the area of the patient s environment dangerous spots can occur Here the treating physician or optician has a special duty of care especially in connection with the installed devices In this area a patient may intentionally or unintentionally create an electrically conductive connection This must be prevented by suitable ...

Page 29: ...ent 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 ...

Page 30: ...ed for cleaning Clean the paint parts and the seat upholstery on the examination unit exclusively with a damp cloth and mild cleaning agents Stubborn soiling on varnished surfaces can be removed with petroleum ether or methylated spirits Repeated use can lead to colour changes of the components Environmental protection regulations Disposal This symbol indicates that the electrical or electronic eq...

Page 31: ...230 VAC 10 Frequency 50 Hz Protection class I Type of device B Connection load 6 3 A Reading lamp 6 VA Low voltage 6 VDC 5 5 A 12VDC 3A Working high 875 mm Maximum high 1780 mm Duty cycle ED 10 Patient chair 1 min ON 9 min OFF Lifting speed 10 mm s Net weight 140 170 kg Loading capacity 135 kg Loading capacity instrument table 40 kg Wagner Guder Medical GmbH Hermstedter Straße 57 D 99518 Bad Sulza...

Page 32: ...September 2020 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 ...

Page 33: ...d and included with the device power cord 2 5m Guidance and manufacturer s declaration Electromagnetic emissions This product is intended for use in the electromagnetic environment specified below The customer or the user of this product should assure that it is used in such an environment Emission test Compliance Electromagnetic enviroment guidance RF Emissions according to CISPR 11 Group 1 This ...

Page 34: ... kV für Eingangs und Ausgangsleitungen fulfilled Mains power quality should be that of a typical commercial or hospital environment Surge according to EN 61000 4 5 1 kV Leiter Leiter 2 kV Leiter Erde fulfilled Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply lines According to EN 61000 4 11 0 ...

Page 35: ...1 kHz AM Modulation 3 Vrms 6 Vrms 3V m 80Mhz 1 Ghz 10 V m 80Mhz 1 Ghz 80 1 kHz AM Modulation d 0 35 P d 0 7 P 80MHz 800MHz d 1 4 P 800MHz 2 7GHz Proximity Field from HF transmitter 9 V m to 28 V m fulfilled Where P is the maximum output power rating of thet ransmitter in watts W according to the transmitter manufacturer and D is the recommended separation distance in metres m Field strengths from ...

Page 36: ...nt in which radiated HF interference is controlled The customer or user of this product can help to prevent electromagnetic interference by maintaining minimum distances between portable and mobile HF communication systems transmitters and this product as recommended below in accordance with the maximum output of the communication system Nominal output of the transmitter W Safe distance according ...

Page 37: ...failure Notify home electrican Power supply defective Contact distributor page 24 Main fuse defective Change mains fuse page 18 Devices on instrument table without working Installed instruments disconnected or disabled Enable device or check connection Operating manual of devices Instrument table not in working position Move table in end position page 14 End switch defective Contact distributor pa...

Page 38: ...20 Cable break Contact distributor Disconnection to circuit board Contact distributor page 25 Reading lamp do not work Power supply or illuminants defective Contact distributor Power output reading lamp defective Contact distributor page 25 Safety switch not working switch defective Contact distributor page 17 Safety switch damaged Schaltkontakt wieder herstellen page 17 Cable break Contact distri...

Page 39: ...stributor page 21 Electro magnetic See below Table E interference Increase distance Potential equalization Eliminating electromagnetic interference Service Band MHz Test frequency MHz Max power P W Distance d m Different services TETRA 400 380 390 385 1 8 1 FRS 460 GMRS 460 430 470 450 2 1 LTE Band 13 17 704 707 710 745 780 0 2 1 GSM800 900 LTE Band 5 Mobile phone CT1 CT2 CT3 800 960 810 870 930 2...

Page 40: ...rinters operation in medical protected areas is intended with an isolating transformer accessory The isolating transformer to be used is supplied with mains voltage must meet the DIN EN 60601 1 standard and have protection class I Power input 1x 230 VAC Power output 4x 230 VAC 2 Network isolator option The network isolators prevent galvanic connection between MED and non MED devices in the signal ...

Page 41: ...hange For electronic components such as power supplies or motherboard defects will be repaired free of charge within 12 months Requirements for a warranty case The invoice with date of delivery is available The device was used correctly or for its intended use Repairs have only been done by customer service or by persons authorized by us Warranty services do not extend the warranty period or start...

Page 42: ...fuse 0215004 TXP Fuse T 6 3 A H Littlefuse 021506 3TXP Power supply 12VDC GSM90B12 P1M Control panel instrument table 2014 400 065 Cable control panel MAT904134158 Pillar patient chair TU401166 E100 Basis board BLP E150 Illuminants LED GU5 3 E200 Seat shell ONE S1500 Seat shell highline S1100 Armrest 18825 Sheet metal armrest 2014 400 041 Potentiometer with cable 3m instrument table MAT904134159 A...

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