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User Manual NUVOLAS

April 2023

File: User Manual_NUVOLAS_rev3.docx

10 Guidelines and manufcaturers declaration

The NUVOLAS does not have essential performance

10.1 Electromagnetic Emission

The laser is intended for use in an environment as specified below. The customer or user of the laser
should ensure that it is operated in such an environment.

Immunity tests

Compliance

Electromagnetic environment -

guideline

RF-Emissions

CISPR 11

EN 55011

Group 1/Class B

The laser uses RF energy exclusively for its

internal function. Hence, RF emission is very

low and not likely to cause any interference in

nearby electronic equipment

RF- Emissions

CISPR 11

EN 55011

Group 1/Class B

The laser is only suitable for the environment

in professional healthcare facilities.

Harmonic emission

IEC 61000-3-2

Class A

Voltage fluctuations/flicker

IEC 61000-3-3

Содержание Nuvolas

Страница 1: ...User Manual A R C Laser GmbH 0123 Bessemerstr 14 D 90411 Nürnberg Tel 49 911 21779 0 Fax 49 911 21779 99 info arclaser de www arclaser de ...

Страница 2: ...semerstr 14 D 90411 Nürnberg Tel 49 911 21779 0 Fax 49 911 21779 99 service arclaser de Copyright A R C Laser GmbH All rights reserved This document contains confidential and copyrighted information and may only be used with the devices described herein Reproduction is prohibited without written permission from A R C Laser GmbH Local distributor ...

Страница 3: ...E Regulations 16 4 8 RoHS3 regulations 16 4 9 Protective Housing 16 4 10 Connectors and Switches 17 4 11 External Interlock Switch 18 4 12 Safety shutter Aiming Beam 19 4 13 Manual Reset 19 4 14 Reset by Power Failure 19 4 15 Labels and Markings 20 4 16 Operating Conditions 21 4 17 Electromagnetic Compatibility 21 5 ADVICE FOR USERS 22 5 1 Technical Introduction 22 5 2 Laser Safety Training 22 5 3...

Страница 4: ...t switch 42 8 5 Error Detection 42 8 5 1 System check 43 8 5 2 Troubleshooting 43 8 5 3 Error Codes 44 8 5 4 Error Messages 45 8 5 5 Status message 45 8 6 Disposal 45 9 CUSTOMER SERVICE 46 9 1 Warranty Information 46 9 2 Warranty Shipment Packaging 46 9 3 Sales and Service Information 46 10 GUIDELINES AND MANUFCATURERS DECLARATION 47 10 1 Electromagnetic Emission 47 10 2 Electromagnetic Immunity 1...

Страница 5: ...have any further questions regarding the safety or the use of the device or regarding the laser and laser radiation please contact A R C Laser GmbH 1 1 Marking and Symbols The symbol Attention is attached to all surfaces that mean danger to the user Before carrying out any further work on such marked parts the operating instructions should be consulted or the service of A R C Laser GmbH should be ...

Страница 6: ...in conjunction with e g handpieces or endoscopes where the fiber is fed through the fiber working channel to allow the physician to treat the desired area with the laser The NUVOLAS is intended to be used for the following applications Laryngology Otology Rhinology General Surgery Medical field Indication Risks Contraindication General contraindication radiation exposure to the eye exception Ophth...

Страница 7: ...ation of tissue bony structures or blood Tympanoplasty with and without ossicular reconstruction Tympanoplasty with mastoidectomy Glomus Tympanicum tumor acoustic trauma mechanical trauma e g floating footplate vertigo tinnitus sensorineural hearing loss general or normal conventional non laser operation collateral side effects General Surgery Treatments requiring coagulation or carbonization vapo...

Страница 8: ...elength of 514 nm The laser radiation of the diode is collimated by optics and coupled into the applicator The laser light is coupled into a quartz fiber via deflection mirrors and coupling parts The transmission of the different wavelength is independent for the fiber Transmissions in the range of 80 to 90 of the laser power are possible The laser source is brought to and maintained at the prescr...

Страница 9: ...nd 750 hPa During storage a temperature range of 10 C to 60 C must be maintained The environment air must be dry and clean The relative humidity during transport and storage must be below 85 2 1 Shipping and unpacking the device Unpacking and installation of the device will be carried out by an authorized technician or authorized representative of A R C Laser GmbH After the installation and the co...

Страница 10: ...portation and shipping The transport packaging is designed so that the unit fits exactly in the foam All accessories are stored in a suitable extra packaging inside the transport box A distance holder is placed between the laser and the display packaging If all the foam parts are in the right place and the box is closed the unit is ready for shipping Distance holder VP01093 ...

Страница 11: ...en the device is not in use it should be stored in the acrrying case The wiring must be installed so that there are no tripping hazards or other hazards All control elements must also be free and easily accessible The air humidity is monitored internally and must be below 75 3 2 Room Requirements The legislation imposes the following requirements to any room in which a class 4 laser according to I...

Страница 12: ... and materials should be used 3 3 Electrical Connection The laser is operated with 230 V AC by an integrated power supply The power supply is approved by A R C Laser GmbH especially for the NUVOLAS only this power supply is approved to be used The power supply unit can be connected to 100 V to 240 V AC voltage 50 Hz 60 Hz A T T E N T I O N To protect against electric shock the unit must be connect...

Страница 13: ... used for eye protection The following explanations are not exhaustive All users of laser devices should enclose applicable legal regulations and provisions with the device and inform the staff accordingly If the device is operated outside Germany provisions of the American National Standard Office ANSI Z136 3 2018 American National Standard for the Safe Use of Lasers in Health Care Facilities and...

Страница 14: ...sses which also guarantee a full protection to the side parts When using a microscope either laser safety glasses can be worn or it is possible to install an eye safety filter firmly into the beam path of the microscope Please note that when using a beam splitter in the microscope the eye safety filter is installed below the beam splitter to protect all outgoing beams above at the same time Option...

Страница 15: ...gen enriched environment 4 5 Protection against Undesired Radiation By using a foot switch the NUVOLAS emits laser radiation The foot switch should never be outside the area of the attending doctor It is not allowed for anyone other than the attending doctor to trigger the foot switch Especially in operating theaters where there are multiple foot switches it is important to ensure that the laser f...

Страница 16: ...ety All parts we use comply with the CE regulations or have been tested for approval or suitability by the notified body Additional devices that you attach to the device require approval from an official test center Changes to the device or interventions on your part will void the approval and warranty The test approval number is included with the device 4 8 RoHS3 regulations Our company operates ...

Страница 17: ...nual_NUVOLAS_rev3 docx 17 4 10 Connectors and Switches On the back of the device the following connect On Off switch Foot switch AUXII Power connection Door interlock Ventilation Do not block Touch screen Grounding AUXI Service connector AUX III ...

Страница 18: ...ssories only 4 11 External Interlock Switch A door interlock switch is required by the accident prevention regulations The device is equipped with an interlock connector as standard which can be replaced by a door interlock switch The laser switches off when the door is opened In addition the laser cannot be switched to the READY mode when the door is open An error message appears on the control p...

Страница 19: ...or occurs the system switches into STANDBY mode and an error message is shown A restart should fix the error due to the automatic recalibration Please refer to chapter 8 5 3 to identify the error messages If the error still occurs this can only be remedied by trained personnel Please contact the service of A R C Laser GmbH in this case 4 14 Reset by Power Failure If the device is disconnected from...

Страница 20: ...E on the backside of the device 1 Manufacturer 2 Laser name 3 Wavelength Power 4 Power consumption 5 Serial number SN 6 Manufacturing date 7 Medical device MD 8 No disposal in domestic waste 9 Unique Device Identification UDI SN GTIN manufacturing date 10 Global Trade Item Number GTIN 11 CE mark 12 Applied part type BF 13 See instructions for use WARNING LABELS Marks the laser exit and the used wa...

Страница 21: ... an air pressure between 1080 hPa and 750 hPa The following environmental conditions must be met Ambient temperature 18 C to 28 C Relative humidity 75 without condensation 4 17 Electromagnetic Compatibility The NUVOLAS laser system meets the EMC requirements according to EN 60601 1 2 2015 Guidelines and the manufacturer s declaration are described in Chapter 10 A T T E N T I O N Avoid using this d...

Страница 22: ...lt with In addition instructions are given on laser safety and the use of lasers in general It has also proven useful that people who do not work directly with the laser attend courses on laser safety Training for the accompanying staff is additionally accompanied by an instruction from an A R C Laser GmbH employee or by an authorized representative when installing the device During instruction th...

Страница 23: ... nurse patient etc The NUVOLAS can be adapted to different surgical microscopes For this purpose various eye safety filters are available and can be ordered optionally Part Description Article No Laser safety goggles Laser safety goggles AS01003 Eye safety filter for microscopes Eye safety filer 510 nm 522 nm BG06076 BG06077 For information about other accessories please contact A R C Laser GmbH o...

Страница 24: ...ide The appropriate laser for the applicator is indicated on the label For more information about suitable applicators please contact A R C Laser GmbH or the responsible sales partner Suitable for NUVOLAS A T T E N T I O N The applicators are glass fibers that can break easily Handle with the necessary care when taking them out of the packaging and during treatment to avoid fiber breakage A broken...

Страница 25: ...s of the following elements and buttons Fiber port The NUVOLAS has a fiber port at the front of the device The fiber port is for connecting patented A R C Laser fibers and probes only All fibers and probes which are marked with U C can be used without any restriction Laser emission LED The laser emission LED indicates if laser radiation is emitted If laser radiation is emitted the laser emission L...

Страница 26: ... change the settings of the system A T T E N T I O N Since the aiming beam takes the same way through the laser transmission system as the working beam it is a good way to check the integrity of the laser transmission system If the aiming beam does not appear at the distal end of the laser transmission system its intensity is weak or if it looks diffuse this is a possible indication of a damaged o...

Страница 27: ...ower supply only has to be connected if the device is switched off Has the door interlock connector for the external interlock been plugged in or if applicable has the door interlock contact been connected to the laser Is a fiber or probe still connected Are the fibers and probes free of any damage Is there a sufficient number of protective glasses ready to be used Has the footswitch been plugged ...

Страница 28: ...status LED now flashes continuously The NUVOLAS performs a system check during the start routine During that no fiber may be connected to the device After system check you will be asked to insert the password In the factory settings the password is 0000 A T T E N T I O N The NUVOLAS should not be operated for longer than 5 hours at a time Restart the laser after 5 hours at the latest so that it ca...

Страница 29: ...oppy disk to safe it Edit or delete name Chose Edit Surgeon to change or delete a name By the use of the pencil symbol you can change the name If you use the delete symbol the name can be deleted In the drop down list you can see all user names added By using the arrow keys you can scroll through the list By clicking on the name the name is selcted and you will be re directed 6 2 2 Select Add Edit...

Страница 30: ...rs as needed 6 3 1 2 Power Watt The power controller is touch sensitive so that you can directly choose the correct value Alternatively you can change the power by using the arrow keys The displayed power corresponds to the power at the fiber tip with a tolerance of 20 6 3 1 3 Safe values To safe changed values type on the floppy disc The floppy disc is only visible if the parameters power pulse l...

Страница 31: ...ues will be safed automatically Light green highlighted values are now default values and can be chosen in the main screen 6 3 1 5 Pulse pause The pulse pause can be changed using the arrow keys Only the values selected in the pulse pause table are displayed To change possible values for the pulse pause that are available in the main screen press on the pulse paise value for approx 2 seconds The p...

Страница 32: ...e main screen The parameters which should be displayed can be chosen by yourself Therefore the information setting icon has to be selected The parameters are selected if the dot next to the parameter is colored white The following values can be selected Frequency in Hz The shown frequency is generated by pulse length and pulse pause per second Energy in Joule The shown energy value is the product ...

Страница 33: ...ameter for the accessories used with the NUVOLAS Fibers and Probes Optic hand pieces Name Article number Beam diameter Name Article number Beam diameter HiFlex Fiber 300µm LL28062s 0 3 mm Focus hand piece blue HS18002 0 3 mm HiFlex Fiber 400µm LL28066s 0 4 mm Focus hand piece red HS18003 0 6 mm HiFlex Fiber 600µm LL28068s 0 6 mm Focus hand piece green HS18004 1 0 mm Otology Probe LL28058s 0 3 mm T...

Страница 34: ...uage Choose between different languages German English Spanish Italian or French Deactivation time Ready Mode Select the switch over time between READY and STAND BY mode 2 5 min in 1 min steps 5 min 15 min in 5 min steps Runtime smoke evacuation Set the time the smoke evacuation is active after the release of the foot switch 5 seconds 10 60 seconds in 10 s steps The smoke evacuation ZU01049 can be...

Страница 35: ...rd can be changed in the lower area of the touch screen The password consists of four numbers factory set is 0000 The routine to change the password will guide you through the menu 1 Enter old password 2 New password Enter a new four digit password 3 Confirm password Repeat the new password 6 3 2 3 Calendar With the calendar function you can change the date and time of the device 6 3 3 Service set...

Страница 36: ...pressing the button the device changes into READY mode The transition from STANDBY to READY takes a few seconds which is accompanied by an acoustic signal and a blinking attention symbol As soon as the NUVOLAS is in READY mode you can emit laser radiation using the foot switch By pressing the READY button again the READ mode will be left and the device returns to STANDBY 6 6 Release laser radiatio...

Страница 37: ...atment with NUVOLAS the device is deactivated immediately The display and the LED will fade out Solution Pull the Laser Stop out The power supply will be released againg and the device can be started as usual restarted respectively 6 9 Switch Off The NUVOLAS can be turned off by pressing the on off switch at the back of the device You should cover the display after each use to prevent the display ...

Страница 38: ...tinue Increase Decrease value Edit name STANDBY time setting Delete value input Symbol for changing date time Runtime smoke evacuation Safe current settings Exit Submenu settings Read treatment data Information settings Pulse counter Back Aiming beam brightness 5 100 Continous wave mode SP Single pulse in pulse pause field Pulse length Pulse pause Fiber diameter spot size Reduce or Increase time A...

Страница 39: ...ength Pulse pause Frequency 514 nm 20 ms 60 s CW 20 ms 60 s SP 0 008 Hz 25 Hz SP Aiming Beam 635 nm red 1 mW variable brightness continuous wave CW Power transmission Fiber 300 μm 400 μm 600 μm with or without handpiece 7 3 Electrical Connection Data Power supply connection values 100V 240V 50Hz 60Hz 6 3 A 3 15 A 7 4 Classification Laser class Laser Beam 4 Classification EN 60825 1 Laser class Aim...

Страница 40: ...e book Condition of the supply line Condition of laser safety glasses eye safety filter protective device Overall condition Functionality Check Foot switch Manual trigger Check the necessary monitoring msafety display and signaling unit Laser safety glasses eye safety filter Emission controls acoustic visual Laser Stop check for function Interlock device check for function Electrical Safety Check ...

Страница 41: ...ant the disinfectant should be suitable for non invasive medical devices according to the manufacturer of the disinfectant the disinfectant should be suitable for wipe disinfection of surfaces the disinfectant should based on alcohol and or quaternary compounds the disinfectant should be suitable for lacquers aldehyde free disinfectant recommended When wiping disinfection the manufacturer s instru...

Страница 42: ...tion of water or cleaning agents Never place the foot switch in water or cleaning agent This could lead to a short circuit 8 5 Error Detection The NUVOLAS was designed and developed as a modular system In addition all components were subjected to a rough shaking and termperature test In the event of a fault yo can use these instrucions to isolate the problem and in some cases even rectify it yours...

Страница 43: ...e following errors cannot be identified by the system self check and have to be checked manually Problem Potential Error Troubleshooting Display black Display cable is losen not connected Check if the display cable is properly connected You may have to disconnect and reconnect it again No aiming beam visible Laser is in Standby Mode Aiming beam is only visible if the Laser is in READY mode and the...

Страница 44: ...age Short Description F00 Error system start F23 Voltage test error 12 V F01 Power too low 20 F24 Voltage test error 5 V F02 Power too high 20 F25 Voltage test error 24 V F03 Laser radiation in STAND BY F32 Error diode current F04 Time out of opto coupler F33 Peltier temperature too high F06 Short circuit foot switch left F38 Error DA converter F07 Short circuit foot switch right F47 Error check s...

Страница 45: ... reach working temperature Air humidity too high The laser should not be operated in this environment Fiber missing or plugged incorrectly Plug in fiber 8 5 5 Status message Please wait 8 6 Disposal The relevant locally applicable laws and regulations must be observed during disposal Under no circumstances should the device be disposed of with domestic waste A R C Laser GmbH is happy to assist wit...

Страница 46: ...hat are returned during the warranty period at the express request of A R C Laser GmbH must be confirmed in writing by A R C Laser GmbH Detailed packaging instructions and information on how to return the device are provided by A R C Laser GmbH The return must be insured and paid for by shipper The insurance and transportation costs are not covered by A R C Laser GmbH The choice of the return is m...

Страница 47: ...erated in such an environment Immunity tests Compliance Electromagnetic environment guideline RF Emissions CISPR 11 EN 55011 Group 1 Class B The laser uses RF energy exclusively for its internal function Hence RF emission is very low and not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 EN 55011 Group 1 Class B The laser is only suitable for the environment ...

Страница 48: ...be used Magnetic fields with energetic design frequencies 30 A m 50 Hz or 60 Hz IEC 61000 4 8 Magnetic fields at the grid frequency that are usuallty available in professional healthcare facilities may be used Electrical fast transient burst 2 kV for power lines 1 kV for IO lines 100 kHz repetition frequency IEC 61000 4 4 Only the voltage of a typical professional healthcare facility may be used S...

Страница 49: ...ocx 49 Power interruption 0 UT 250 300 cycles IEC 61000 4 11 Only the voltage of a typical professional healthcare facility may be used It is recommended to use an uninterruptible power supply NOTE UT is the AC mains voltage prior to application of the test level ...

Страница 50: ...ding to the equation applicable to the transmission frequency If those information are not respeted it may result in a reduction in the performance characteristics of the unit Recommended protected distance d 1 17 V1 P d 1 17 E1 P for 80 MHz tos 800 MHz d 2 33 m V vP for 80 MHz to 2 7 GHz with P as the nominal power of the transmitter in watts W according to the transmitter manufacturer s specific...

Страница 51: ...ion device as stated below Test frequency MHz Frequency band MHz Radio service Modulation Maximum performance W Distance m Immunity test level V m 385 380 to 390 TETRA 400 Pulse modulation 18Hz 1 8 0 3 27 450 430 to 470 GMRS 460 FRS 460 FM 5 kHz Hub 1 kHz Sinus 2 0 3 28 710 745 780 704 to 787 LTE Band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 810 870 930 800 to 960 GSM 800 900 TETRA 800 iDEN 820 CDM...

Страница 52: ...User Manual NUVOLAS April 2023 File User Manual_NUVOLAS_rev3 docx 52 Notes ...

Страница 53: ...User Manual NUVOLAS April 2023 File User Manual_NUVOLAS_rev3 docx 53 Notes ...

Страница 54: ...User Manual NUVOLAS April 2023 File User Manual_NUVOLAS_rev3 docx 54 Notes ...

Страница 55: ...User Manual NUVOLAS April 2023 File User Manual_NUVOLAS_rev3 docx 55 Notes ...

Страница 56: ...A R C LASER GmbH Bessemerstr 14 D 90411 Nürnberg Tel 49 911 21779 0 Fax 49 911 21779 99 www arclaser com ...

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