Wagner & Guder cubeLITE Directions For Use Manual Download Page 5 | Manualshive

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Wagner & Guder cubeLITE Directions For Use Manual Download Page 5

5

Wagner & Guder Medical GmbH
issue May 2021

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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Summary of Contents for cubeLITE

Page 1: ...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 ...

Page 2: ...f 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 49 3644 51 55 61 Email info wagner guder medical de Inter...

Page 3: ...ty 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 MA...

Page 4: ...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...

Page 5: ... 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 Elec...

Page 6: ... 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 spl...

Page 7: ... 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 complian...

Page 8: ...s 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 inco...

Page 9: ...9 Wagner Guder Medical GmbH issue May 2021 Direction for use cubeLITE Positioning and installation instructions Correct adjustment of the refraction unit Tough floor ...

Page 10: ...tion for use cubeLITE 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 ...

Page 11: ...imum 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 Phorop...

Page 12: ...ed 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 a...

Page 13: ...y 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 ...

Page 14: ...er 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 ...

Page 15: ...ertheless 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 ...

Page 16: ...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 disc...

Page 17: ...ions 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 18: ...ighted 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 ...

Page 19: ...oad 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 ...

Page 20: ...icel 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 Wagne...

Page 21: ...ation 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 product uses RF energy only for its internal function Therefore its RF emissions ...

Page 22: ...e n 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 UT 10ms 0 UT 20ms 70 UT 0 5s fulfil...

Page 23: ...V 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 fi xed RF transmitters as determine...

Page 24: ... 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 to transmission frequency m 150kHz 8...

Page 25: ... 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 1 GSM1800 1900 DECT mobile phone LTE Band 1 3 4 25 UMTS 1700 1990 1720 1845 1970 2 1 Bluetooth WLAN 802 11b g n LTE Band 7 RFID 2450 active passive 2400 2570 2450 2 1 WLAN 802 11a n 5100 5800 5240 5500 5785 2 1 Caution Portable HF telecommunication devices may not be used at a distance of...

Page 26: ...26 Wagner Guder Medical GmbH issue May 2021 Direction for use cubeLITE cubeLITE electric scheme ...

Page 27: ... details Spare parts Description Order number Power cord 2 5m MC B1D12500 Fuse T 6 3 A H Littlefuse 021506 3TXP Pillar patient chair TU401166 E100 Illuminants LED GU5 3 E200 Seat shell ONE S1500 Seat shell highline S1100 Armrest 18825 Adjustable leg STRM 02000 Directions for use WG UGA ...

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