Related Manuals for A.R.C. Laser FOX 514
Summary of Contents for A.R.C. Laser FOX 514
- Page 1 User Manual Medical Diode Laser System 514 nm A.R.C. Laser GmbH Bessemerstr. 14 Phone: +49 911 21779-0 info@arclaser.de 0123 D-90411 Nuremberg Fax: +49 911 21779-99 www.arclaser.de...
- Page 2 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 here and can be reproduced following approval of A.R.C. Laser GmbH. File: User Manual_FOX 514_rev3...
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Page 3: Table Of Contents
User Manual FOX 514 September 2021 Content Introduction ........................6 Marking and Symbols .......................... 6 Intended Use ............................7 General contraindications ........................8 Theory and Technical Set-up ......................8 Transport and Storage ....................9 Shipping and Upacking the Device ....................10 Return Shipment .......................... - Page 4 User Manual FOX 514 September 2021 Starting the Device ..........................30 Programs and Settings ........................31 6.3.1 Display / Main Menu ........................31 6.3.2 Saving parameters ......................... 31 6.3.3 Power settings ..........................31 6.3.4 Pulse length ........................... 32 6.3.5 Pulse pause ........................... 33 6.3.6...
- Page 5 User Manual FOX 514 September 2021 equipment and the laser ........................52 File: User Manual_FOX 514_rev3...
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Page 6: Introduction
September 2021 1 Introduction We are pleased that you have chosen our FOX 514 laser and wish you success in using this versatile laser system. The FOX 514 laser generates a laser beam of high intensity, which can cause injuries if handled improperly. -
Page 7: Intended Use
In Ophthalmology the FOX 514 can be used together with a laser indirect ophthalmoscope (LIO). The Diode-Laser, model FOX 514, is intended to be used for the applications as follows: Otology... -
Page 8: General Contraindications
The device not in use should be protected against unauthorized use. 1.4 Theory and Technical Set-up The FOX 514 laser is a diode laser and emits laser radiation with the wavelength 514nm. By doting the individual transitions as well as the individual manufacturing processes, laser diodes at A.R.C. -
Page 9: Transport And Storage
September 2021 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: Shipping And Upacking The Device
All functions and safety procesdures are discussed and demonstrated here. The FOX 514 will be delivered in a simple and easy to use carrying case for storage and transportation. The carrying case consists of two levels. The carrying case is protected by a special outer box. - Page 11 User Manual FOX 514 September 2021 LEVEL 1: - Accompanying documents, labels, etc. - Laser Safety goggles* - Additional accessories like fiber strippers, hand pieces, eye safety filter, etc..* LEVEL 2: - FOX 514 Laser - Foot switch - Touch Stick...
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Page 12: Return Shipment
User Manual FOX 514 September 2021 2.2 Return Shipment If you ship the device back to A.R.C. Laser GmbH, please use the carrying case for transportation and shipping and the outer package. File: User Manual_FOX 514_rev3... -
Page 13: 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 FOX 514 should be operated in an easily accessible place. The laser should not be operated near a heater, since the device only works when the ambient temperature is not higher than +40°C. -
Page 14: Reflecting Surfaces
The power supply unit can be connected to an AC voltage ranging from 100V - 240V (50 Hz/60 Hz) 3.4 Battery pack The FOX 514 has a lithium ion battery. If the battery pack is mishandled, the battery pack can burst, cause a fire or even lead to chemical burns. Respect the following cautions. •... -
Page 15: Safety Information
The FOX 514 is a laser of laser class 4 according to EN 60601-2-22, EN 60825-1 respectively. Class 4 in the standard describes high-energy lasers and therefore special measures have to be considered before use in order to ensure safe and trouble-free working with the device. -
Page 16: Eye Safety
A.R.C. Laser offers suitable eye safety filters, which can be seen as external accessories of the laser system. For all wavelengths of the FOX 514 the following eye safety filter can be used: •... -
Page 17: Explosion And Fire Hazard
There is danger to life here! 4.5 Protection against Undesired Radiation The FOX 514 emits laser radiation using a foot switch. The foot switch should never be outside the area of the attending doctor. It is forbidden for anyone other than the attending doctor to trigger the foot switch. -
Page 18: Nohd Safety Distance
Permitted Maximum Radiation: 1.9*10³ Jm 4.7 CE Regulations The laser FOX 514 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 19: Connectors And Switches
User Manual FOX 514 September 2021 4.10 Connectors and Switches The following connector sockets are located at the rear panel: Power supply Door interlock AUX 1 & AUX 2 Foot switch The following connector sockets are located at the right side panel:... -
Page 20: External Interlock Switch
Make sure the socket is stucks firmly to prevent unexpected system interlock problems. 4.12 Safety-Shutter / Aiming Beam The FOX 514 has an internal safety shutter. This shutter is opened mechanically when inserting the fiber. The device changes to READY mode only if a fiber is inserted properly and after pressing the READY button. -
Page 21: Reset By Power Failure
Start the device. The system recalibrates and deletes all unsaved settings. If there is still an error, it can only be corrected by trained personnel. Please contact the service of A.R.C. Laser GmbH in this case. 4.15 Stickers and Labels The FOX 514 has various warning labels in accordance with European and worldwide guidelines to prevent the user from being exposed to laser radiation by negligence. - Page 22 User Manual FOX 514 September 2021 WARNING LABELS Warning label fiber exit (Console top) Warning label laser radiation (Cover stand top) Other labels Modification label: Shows the actual product changes done on your device Please read the user manual Only for use with...
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Page 23: Operating Conditions
September 2021 4.16 Operating Conditions The medical laser FOX 514 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. The device is only approved for an air pressure between 1080 hPa and 750 hPa. -
Page 24: Advice For Users
These must also be noted in the device book. 5.2 Laser-Safety-Training The FOX 514 laser is designed for use in medicine. 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, to attend seminars in which working with different laser systems is dealt with. -
Page 25: 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 26 Fibers and Probes / Applicators The FOX 514 is a fiber-guided laser. Various fibers and probes are used to guide the laser radiation to the application site. The appropriate lasers are shown on the label of the applicator. For more information about suitable applicators, please contact A.R.C.
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Page 27: Operation
User Manual FOX 514 September 2021 6 Operation This part of the manual only describes the technical application of the device, without going into the medical application. Settings and adjustments should only be made in accordance with the operating instructions. - Page 28 To protect the fiber port a dust protection is fixed on the device that can be plugged into the fiber port when the laser is not in use (see figure above). For FOX 514 only 300 µm fibers can be used.
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Page 29: Preparation
September 2021 6.1 Preparation The FOX 514 is delivered with a power supply, which can be connected at the back of the device. The power supply is not only used to operate the device it also charges the internal battery pack (with surge protection). Power supply input voltage ranges between 100V and 240V. -
Page 30: Starting The Device
A T T E N T I O N The FOX 514 should not be operated for more than five hours at a time. Restart the laser after five hours at the latest so that it can carry out the system check during the start routine. -
Page 31: Programs And Settings
User Manual FOX 514 September 2021 6.3 Programs and Settings 6.3.1 Display / Main Menu Reset Button Battery mode Pulse counter Settings Power Pulse length Pulse pause Decrease or increase of Aiming beam brightness Modify values using the chosen values using the... -
Page 32: Pulse Length
User Manual FOX 514 September 2021 6.3.4 Pulse length The pulse length which can be chosen in the main menu can be set through the pulse length menu. Therefore, hold the button for at least 2 sec. Highlighted values are preset. Add or deselect values of your interest to modify your presets as necessary. -
Page 33: Pulse Pause
User Manual FOX 514 September 2021 6.3.5 Pulse pause The pulse pause which can be chosen in the main menu can be set through the pulse pause menu. Therefore, hold the button for at least 2 sec. Highlighted values are preset. Add or deselect values of your interest to modify your presets as necessary. -
Page 34: Further Settings
User Manual FOX 514 September 2021 6.4 Further Settings 6.4.1 Submenu 1 Leave the main menu to enter the submenu by pressing the settings button. The individual parameters can be adjusted with the up/down buttons. More settings Brightness READY- LED (5-100%) -
Page 35: Submenu 3
Leave submenu 2 with the arrow key right and get into the next submenu 3. Here you can change the language of your FOX 514 and alter the memory function, restore settings, edit the user password or change the advanced settings. -
Page 36: Inserting The Applicator
Coupling If the plug has not properly connected, the device will not change into READY mode, and the FOX 514 will not work. Please pay attention to the clearly noticeable „click“ when plugging in! If the applicator is inserted correctly and the laser is in READY mode, the aiming beam will be visible at the end of the applicator. -
Page 37: Treatment
This ensures that the fiber coupling does not get damaged by any dirt or dust. If you do not plan to use the FOX 514 Laser for a long time, stow the laser in its carrying case. -
Page 38: Power Save
User Manual FOX 514 September 2021 6.11 Power Save After 5 minutes of inactivity the FOX 514 automatically goes to Power save mode to save power. • The dipslay gets dark • The green status LED indicates with 1 Hz To “wake up”... -
Page 39: Symbol Description
User Manual FOX 514 September 2021 6.13 Symbol Description Display brightness 5-100 % Charging state of battery Aiming beam brightness 1-100 % Internal temperature Deactivation mode time Aiming beam frequency (0-6Hz) Brightness Ready Button (5-100%) Air humidity Tone (5-100%) Choose language... -
Page 40: Technical Data
Fiber 300µm with or without hand piece 7.3 Electrical Connection Data Power supply connection values 100 V - 240 V, 50Hz/60Hz, 1.06-0.45 A Battery 10.8 V, 26.4 Wh, Li-Ion (by A.R.C. Laser) 7.4 Classifications Laser class Laser Beam (Classification EN 60825) Laser class Aiming Beam... -
Page 41: Maintenance
User Manual FOX 514 September 2021 8 Maintenance 8.1 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. -
Page 42: Care By The User
User Manual FOX 514 September 2021 Output power measurements • Check the set power with an external power meter (permissible tolerance + 20%) A T T E N T I O N If one or more safety-related points are objected to after the safety-related inspection (STK), the device may no longer be operated. -
Page 43: Cleaning Of Accessories
8.5 Error Detection The FOX 514 was developed and designed as a modular system. In addition, all its components had undergone a rough shake test as well as temperature testing. In case of an error, you can use this manual to isolate the problem and, in some cases, even solve it yourselfIf the problem persists, please contact your local A.R.C. -
Page 44: Troubleshooting
User Manual FOX 514 September 2021 8.5.2 Troubleshooting The following errors cannot be identified by the system self check and have to be checked by the user: Problem Potential Error Troubleshooting Error Message: F01 Connect the laser to the mains and Battery is empty restart it. -
Page 45: Error Messages
User Manual FOX 514 September 2021 8.5.3 Error Messages State of charge of battery Batteries need to be charged too low before continuing operation Connect the interlock plug Door interlock missing included with the system The environment is too cold... -
Page 46: Status Messages
Under no circumstances should the device be disposed of with domestic waste. 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 within the responsibility oft he buyer. -
Page 47: 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. Laser GmbH. -
Page 48: Guidelines And Manufacturer's Declaration
User Manual FOX 514 September 2021 10 Guidelines and Manufacturer’s Declaration 10.1 Electromagnetic Emissions 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 49: Electromagnetic Immunity (1)
User Manual FOX 514 September 2021 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. - Page 50 User Manual FOX 514 September 2021 Only the voltage of a typical professional healthcare facility Power interruption 0% UT; 250/300 cycles IEC 61000-4-11 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.
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Page 51: Electromagnetic Immunity (2)
User Manual FOX 514 September 2021 10.3 Electromagnetic Immunity (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. -
Page 52: Recommended Separation Distances Between Portable And Mobile Rf Telecommunications
User Manual FOX 514 September 2021 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... - Page 53 User Manual FOX 514 September 2021 Notes: File: User Manual_FOX 514_rev3...
- Page 54 File: User Manual_FOX 514_rev3...
- Page 56 A.R.C. LASER GmbH Bessemerstr. 14 D-90411 Nuermberg Germany Tel: +49 911 217799-0 Fax: +49 911 21779-99 www.arclaser.com...