Related Manuals for A.R.C. Laser Nuvolas
Summary of Contents for A.R.C. Laser Nuvolas
- Page 1 User Manual A.R.C. Laser GmbH Bessemerstr. 14 Tel.: +49 911 21779-0 info@arclaser.de 0123 D-90411 Nürnberg Fax: +49 911 21779-99 www.arclaser.de...
- Page 2 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.
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Page 3: Table Of Contents
User Manual NUVOLAS April 2023 INTRODUCTION ......................5 1.1 Marking and Symbols ....................5 1.2 Intended Use ......................6 1.3 General Contraindications ..................8 1.4 Theory and Technical Set-up ..................8 TRANSPORT AND STORAGE ..................9 2.1 Shipping and unpacking the device ................9 2.2 Return Shipment .................... - Page 4 User Manual NUVOLAS April 2023 TECHNICAL DATA ....................39 7.1 General ........................39 7.2 Laser-Data ......................39 7.3 Electrical Connection Data ..................39 7.4 Classification ......................39 MAINTENANCE ......................40 8.1 Introduction ......................40 8.2 Safety Check (STK) ....................40 8.3 Care by the user .....................
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Page 5: Introduction
User Manual NUVOLAS April 2023 1 Introduction We thank you for having chosen our NUVOLAS and wish you every success in using this versatile laser system. The NUVOLAS laser generates a laser beam of high intensity, which can cause injuries if handled improperly. -
Page 6: Intended Use
User Manual NUVOLAS April 2023 Intended Use The NUVOLAS is intended to be used for treatments requiring coagulation or carbonization/vaporization of tissue, bony structures or blood. At high power outputs, tissue can be carbonized and removed or separated by vaporization. - Page 7 User Manual NUVOLAS April 2023 • Palatoplasty / LAUP • Trismus • Cordotomy • Oral benign lesions • dryness • edema • bleeding Treatments requiring • pain coagulation or carbonization/vaporization of • granulation tissue, bony structures or • crust formation Rhinology blood.
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Page 8: General Contraindications
When not in use, the device should be protected against unauthorized use. Theory and Technical Set-up The NUVOLAS is a diode laser with a wavelength of 514 nm. The laser radiation of the diode is collimated by optics and coupled into the applicator. -
Page 9: Transport And Storage
User Manual NUVOLAS April 2023 2 Transport and Storage We at A.R.C. Laser GmbH will make sure that the device is packed and transported with the greatest possible care. Before unpacking the laser, please check the packaging for damage and report any damage immediately to the shipping agent and A.R.C. -
Page 10: Return Shipment
User Manual NUVOLAS April 2023 Return Shipment If you ship the device back to A.R.C. Laser GmbH, please use the carrying case for transportation and shipping. The transport packaging is designed so that the unit fits exactly in the foam. -
Page 11: Set-Up And Installation
Before the device is delivered, it must be ensured that the laser can be set up in a suitable location. The NUVOLAS should be operated in an easily accessible place. The laser should not be operated near a heater, since air cooling works best when the ambient temperature is not higher than 28°... -
Page 12: Reflecting Surfaces
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). -
Page 13: Safety Information
4 Safety Information General The NUVOLAS laser is a precision instrument for medical applications. The system has been carefully developed and tested through intensive testing before shipping. In order to offer you and the operating personnel all possible protection, we recommend that you read this section of the operating instructions carefully. -
Page 14: Eye Safety
Optionally, it is also possible to equip each individual beam path with an eye safety filter. The following eye safety filters from A.R.C. Laser GmbH are suitable for the NUVOLAS and can be seen as external accessories of the laser system: •... -
Page 15: Electrical Protection
There is danger to life here! 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. -
Page 16: Nohd Safety Distance
Permitted Maximum Radiation: 1.9x10³ Jm CE Regulations The laser system NUVOLAS has been approved by the notified body in accordance with the European Directive 93/42/EEC for medical devices. Accordingly, the device bears the CE mark CE 0123. The device has been checked for electrical and mechanical safety. All parts we use comply with the CE regulations or have been tested for approval or suitability by the notified body. -
Page 17: Connectors And Switches
User Manual NUVOLAS April 2023 4.10 Connectors and Switches On the back of the device the following connect Service connector ● ● AUX III Grounding Ventilation Do not block ● Touch On/Off Power Foot Door AUXII AUXI ● ● ●... -
Page 18: External Interlock Switch
April 2023 It is prohibited to use the device's sockets for other usages than those detailed here. Port Description Note Color Touch Connector for the A.R.C. Laser To control the NUVOLAS Green screen touch screen AUX 1 Currently without use... -
Page 19: Safety Shutter / Aiming Beam
April 2023 4.12 Safety shutter / Aiming Beam The NUVOLAS has an internal safety shutter. This shutter is opened mechanically by inserting the fiber. Only if a fiber is properly plugged in, the laser can be switched into READY mode by pressing the READY button. -
Page 20: Labels And Markings
User Manual NUVOLAS April 2023 4.15 Labels and Markings The NUVOLAS is provided with various warnings in accordance with European and worldwide guidelines. This is to prevent the laser user from being exposed to laser radiation due to carelessness. TYPE PLATE (on the backside of the device) 1. -
Page 21: Operating Conditions
Please read the user manual Modification label 4.16 Operating Conditions The medical laser NUVOLAS is not suitable for use in connection with combustible gas mixtures of all kinds. The device is not approved for operation at altitudes above 2,000 m above sea level. And only for an air pressure between 1080 hPa and 750 hPa. -
Page 22: Advice For Users
Laser-Safety-Training The NUVOLAS laser is designed for medical users. It may only be used by personnel who have been instructed in its operation. The A.R.C. Laser GmbH recommends, in addition to the briefing, participation in seminars in which working with different laser systems is dealt with. -
Page 23: Device Parts And Accessories
A T T E N T I O N Only spare parts and applicators which are approved by A.R.C. Laser GmbH are to be used with the device. Accessories that have not been approved can significantly impair the safety and reliability of the device. - Page 24 April 2023 Fibers and Probes / Applictors The NUVOLAS is a fiber guided laser. There are different fibers and hanpieces that are used to guide the laser radiation to the application side. The appropriate laser for the applicator is indicated on the label. For more information about suitable applicators, please contact A.R.C.
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Page 25: Operation
Status LED green 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. - Page 26 User Manual NUVOLAS April 2023 Status LED The status LED indicates the state of the device. If it is blinking the device is booting. In case the LED is continuously green the booting process is finished and the device is ready for use.
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Page 27: Preparation
April 2023 Preparation A power supply unit is integrated in the NUVOLAS, which needs to be connected to the mains. This is the standard power supply. Input voltage ranges between 100 V and 230 V. Only use the power supply distributed by A.R.C. Laser GmbH. -
Page 28: Switch On The Laser
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 can carry out the system check during the start routine. -
Page 29: Select / Add / Edit / Delete A User
User Manual NUVOLAS April 2023 6.2.1 Select / Add / Edit / Delete a user Select user: The desired name can be chosen by directly touching Afterwards will automatically redirected to chose program. If you use the device for the first time, you should include your name. -
Page 30: Programs And Settings
User Manual NUVOLAS April 2023 Programs and Settings A T T E N T I O N With some devices, programs and preset values are already stored. This does not release the surgeon from checking the values according to his knowledge and the desired interaction with the tissue. - Page 31 User Manual NUVOLAS April 2023 6.3.1.4 Pulse length The pulse length can be changed using the arrow keys. Only the values selected in the pulse table are displayed. To change possible values for the pulse length that are available in the main screen press on the pulse length value for approx.
- Page 32 April 2023 6.3.1.6 Aiming beam brightness If a fiber is connected to the NUVOLAS the aiming beam brightness icon automatically changes to purple. The aiming beam brightness can be changed using the arrow keys. If the laser is in STANDY-BY mode, the aiming beam brightness fades out after a few seconds.
- Page 33 6.3.1.9 Setting of the beam diameter to calculate the density of energy The NUVOLAS offers the possibility to calculate the specific density of energy according to the used accessories. This parameter, similar to the mean power Ø P and the cumulated energy Σ...
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Page 34: Settings
Display Brightness Setting the value of the brightness for the display from 5-100% in 5%-steps. Volume signal tone Setting the volume of the acoustic signal tone of the NUVOLAS from 10-100 % in 10 %-steps. Volume warning tone Setting the volume of the acoustic warning signal of the NUVOLAS from 10- 100 % in 10 %-steps. -
Page 35: Service Settings
If the paper clip is highlighted bright, the laser remembers the Not selected last settings and starts the device with the same settings than it was switched off. Otherwise, the NUVOLAS will start again with the user request. Selected 6.3.2.2 Change user password The user password, for which you will be asked after system check, can be changed by the user. -
Page 36: Inserting The Applicator
Make sure that only one person at a time touches the NUVOLAS. A T T E N T I O N Any serious incident that occurrs with this laser must be reported to the A.R.C. Laser GmbH and the responsible state authority. -
Page 37: Laser-Stop
If the Laser-Stop is pressed while starting the device, the devie won’t work, only the fan starts. The display will remain black and no LEDs will light up. If the laser stop is activated during treatment with NUVOLAS, the device is deactivated immediately. The display and the LED will fade out. -
Page 38: Symbols Description
User Manual NUVOLAS April 2023 6.10 Symbols Description Volume Signal tone (5- Display brightness (5-100%) 100%) Volume warning tone (10-100%) Select language Continue / Increase/ Memory function Decrease value Edit name STANDBY time setting Symbol for changing date/ Delete value/ input... -
Page 39: Technical Data
User Manual NUVOLAS April 2023 7 Technical Data General Model NUVOLAS Diode laser Cooling Air internal Weight 24 kg Dimensions H 16.1 cm / W 47.8 cm / D 42.1 cm Controlling Touch screen display Laser-Data Wavelength Power Tolerance ± 20% of displayed power 0.5 –... -
Page 40: Maintenance
User Manual NUVOLAS April 2023 8 Maintenance Introduction The device was designed, developed and tested according to the latest technical knowledge. We have set the product life to 7 years. In addition, the availability of spare parts is guaranteed by us within a period of 10 years. However, in order to ensure that everything works properly, we have made it possible for you to carry out a visual check of the status indicators from the outside. -
Page 41: Care By The User
User Manual NUVOLAS April 2023 Care by the user The following care instructions can be carried out by the user. These serve to make your work easier. For cleaning, the system must be disconnected from the mains. Always use a damp, but never wet, soft cloth for cleaning and disinfecting. -
Page 42: Cleaning Of Accessories
This could lead to a short circuit. 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 yourself. -
Page 43: System Check
• Footswitch pressed down or defective when turning on device Static errors are errors which require contacting A.R.C. Laser service department or the local representative. For these usually an error message will appear on the display and can assist to identify the problem when calling for service. -
Page 44: Error Codes
User Manual NUVOLAS April 2023 8.5.3 Error Codes Following errors can be detected by the NUVOLAS during system check or use of the device. If such an error occurs, restart the device. If the error still occurs contact A.R.C. Laser service. -
Page 45: Error Messages
A.R.C. Laser GmbH is happy to assist with the disposal of the system; Costs for the proper return of the laser to A.R.C. Laser GmbH is the responsibility of the customer. Please contact our service department. -
Page 46: Customer Service
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. -
Page 47: Guidelines And Manufcaturers Declaration
User Manual NUVOLAS April 2023 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. -
Page 48: Electromagnetic Immunity (1)
User Manual NUVOLAS April 2023 10.2 Electromagnetic Immunity (1) The laser is intended for use in the electromagnetic environment specified below. The customer or the user of the laser should ensure that it is used in such an environment. Electromagnetic environment –... - Page 49 User Manual NUVOLAS April 2023 Only the voltage of a typical professional healthcare facility Power 0% UT; 250/300 cycles IEC 61000-4-11 may be used.It is recommended interruption to use an uninterruptible power supply. NOTE: UT is the AC mains voltage prior to application of the test level.
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Page 50: Electromagnetic Immunityy (2)
User Manual NUVOLAS April 2023 10.3 Electromagnetic Immunityy (2) The laser is intended for use in the electromagnetic environment specified below. The customer or the user of the laser should ensure that it is used in such an environment. Immunity tests... -
Page 51: Recommended Separation Distances Between Portable And Mobile Rf
User Manual NUVOLAS April 2023 10.4 Recommended separation distances between portable and mobile RF telecommunications equipment and the laser The laser is intended for use in an electromagnetic environment in which the RF disturbances are controlled. The customer or the user of the laser can help to avoid electromagnetic interference by maintaining the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the laser - depending on the output power of the communication device, as stated below. - Page 52 User Manual NUVOLAS April 2023 Notes: File: User Manual_NUVOLAS_rev3.docx...
- Page 53 User Manual NUVOLAS April 2023 Notes: File: User Manual_NUVOLAS_rev3.docx...
- Page 54 User Manual NUVOLAS April 2023 Notes: File: User Manual_NUVOLAS_rev3.docx...
- Page 55 User Manual NUVOLAS April 2023 Notes: File: User Manual_NUVOLAS_rev3.docx...
- Page 56 A.R.C. LASER GmbH Bessemerstr. 14 D-90411 Nürnberg Tel: +49 911 21779-0 Fax: +49 911 21779-99 www.arclaser.com...