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User Manual FOX 514

September 2021

File: User Manual_FOX 514_rev3

18

4.6 NOHD Safety Distance

The NOHD (Nominal Ocular Hazard Distance) is the distance at which the irradiance is equal
to the exposure limit value of the cornea of the eye. The NOHD identifies the danger area
within which there is a risk of damage to the health of the eye if you look directly into the
laser beam without protection.

The NOHD is calculated according to EN 60825-1 and taking into account the permitted
power fluctuations (+/- 20%) according to EN 60601-2-22 using the following equation:

𝑁𝑂𝐻𝐷 =

√

4𝑃

𝑀𝑃𝐸 ∗ 𝜋 – 𝐷𝑖𝑎𝑚𝑒𝑡𝑒𝑟 𝐵𝑒𝑎𝑚 𝐵𝑢𝑛𝑑𝑙𝑒

𝐵𝑒𝑎𝑚 𝐷𝑖𝑣𝑒𝑟𝑔𝑒𝑛𝑐𝑒

For the FOX 514 variants the following NOHD applies:

Wavelength λ:

514 nm

NOHD:

0.78 m

Beam divergence α

(full angle)

:

25.4°

Permitted Maximum Radiation:

1.9*10³ Jm

-2

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.

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.

A device book and the test approval number are included to the device.

4.8 RoHS3-Rregulations

Our company operates worldwide and regards the protection of the environment and natural
resources as an entrepreneurial obligation. Based on individual tests, A.R.C. Laser GmbH
confirms that, to the best of our knowledge, our products do not contain any substances in
concentrations whose placing on the market is prohibited according to the applicable
requirements of Directive 2015/863 / EU (RoHS 3).

4.9 Protective Housing

The FOX 514 laser has a protective housing. It prevents radiation from the laser from
escaping and protects users from touching live parts. This housing must not be removed.

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Содержание FOX 514

Страница 1: ...User Manual Medical Diode Laser System 514 nm A R C Laser GmbH 0123 Bessemerstr 14 D 90411 Nuremberg Phone 49 911 21779 0 Fax 49 911 21779 99 info arclaser de www arclaser de ...

Страница 2: ...mbH Bessemerstr 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 here and can be reproduced following approval of A R C Laser GmbH Local distributor ...

Страница 3: ...al 15 4 2 Eye Safety 16 4 3 Electrical Protection 16 4 4 Explosion and Fire Hazard 17 4 5 Protection against Undesired Radiation 17 4 6 NOHD Safety Distance 18 4 7 CE Regulations 18 4 8 RoHS3 Rregulations 18 4 9 Protective Housing 18 4 10 Connectors and Switches 19 4 11 External Interlock Switch 20 4 12 Safety Shutter Aiming Beam 20 4 13 Manual Reset 20 4 14 Reset by Power Failure 21 4 15 Stickers...

Страница 4: ...General 40 7 2 Laser Data 40 7 3 Electrical Connection Data 40 7 4 Classifications 40 8 Maintenance 41 8 1 Introduction 41 8 2 Safety Check STK 41 8 3 Care by the user 42 8 4 Cleaning of Accessories 43 8 4 1 Laser Safety Goggles 43 8 4 2 Applicators 43 8 4 3 Foot switch 43 8 5 Error Detection 43 8 5 1 System Check 43 8 5 2 Troubleshooting 44 8 5 3 Error Messages 45 8 5 4 Warning Messages 45 8 5 5 ...

Страница 5: ...User Manual FOX 514 September 2021 File User Manual_FOX 514_rev3 5 equipment and the laser 52 ...

Страница 6: ...rting up the device If you 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 ...

Страница 7: ...ere the fiber is fed through the fiber working channel to allow the physician to to treat the desired area with the laser 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 General surgergy Ophthalmology Medical application Indication from clinical data Side and adve...

Страница 8: ...specially trained personnel who are experts in the medical effects and possible dangers of the device You must have the necessary skills to use the laser in accordance with this instruction manual 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 ind...

Страница 9: ...of the damaged parts and have this list signed by the courier The device must be transported at temperatures between 10 C and 60 C The air pressure during transport must be between 1080 hPa and 750 hPa During storage a temperature range of 5 C to 40 C must be maintained The environment air must be dry and clean The relative humidity during transport and storage must be between 5 and 85 A T T E N T...

Страница 10: ...on and the correct connection of the device the technician will out the device into operation and explain the function of 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 ...

Страница 11: ...514_rev3 11 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 Power supply Device holder Laser safety goggles if ordered ...

Страница 12: ...ual FOX 514 September 2021 File User Manual_FOX 514_rev3 12 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 ...

Страница 13: ...o carpets on the floor or on the walls When the device is not in use it should be stored in the carrying case The wiring must be installed 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 Legislation imposes the following requirements to any room in wh...

Страница 14: ...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 Do not disassemble Do not handle damaged or leaking lithium ion batteries Do not crush and do not expose the battery pack to any shock or force such as hammering dropping or stepping...

Страница 15: ...t be 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...

Страница 16: ...scope the eye safety filter is installed below the beam splitter to protect all outgoing beams above at the same time Optionally it is also possible to equip each individual beam path with an eye safety filter 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 BG...

Страница 17: ... be applied if the oxygen concentration of the treatment environment is greater than 30 e g during centilation There is risk of fire If an intubation tube is used for treatments in pharynx larynx and oral cavity a laser safe intubation tube is required 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 shoul...

Страница 18: ...al 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 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 t...

Страница 19: ...ual_FOX 514_rev3 19 4 10Connectors and Switches The following connector sockets are located at the rear panel The following connector sockets are located at the right side panel Power supply Door interlock AUX 1 AUX 2 Foot switch AUX 3 USB Port AUX 4 ...

Страница 20: ...r is open An error message appears on the control panel When the door is closed the error message disappears and the laser can be switched READY again When installing a door interlock switch note the following The switch and wiring must be provided for at least 12 V and 20 mA The wires should end with a standard male connector The choice of polarity is expedient in both variants The socket for con...

Страница 21: ...nly be corrected by trained personnel Please contact the service of A R C Laser GmbH in this case 4 15Stickers 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 Following labels are exemplary for the FOX 514 laser TYPE PLATE FOX 514 located on the inner side of the cover sta...

Страница 22: ..._rev3 22 WARNING LABELS 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 LIO optional if ordered Warning label fiber exit Console top ...

Страница 23: ...hPa The following environmental conditions must be met Ambient temperature 10 C to 40 C Relative humidity 75 4 17Electromagnetic Compatibility The FOX 514 laser meets the EMC requirements according to EN 60601 1 2 Guidelines and manufacturer s declaration are described in section 10 A T T E N T I O N Avoid using this device next to other devices or with other devices in a stacked form as this coul...

Страница 24: ... 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 personnel is additionally offered to an instruction from an A R C Laser GmbH employee or by an authorized representative when installing the device During instruction the use of laser safety goggles and laser safety are particu...

Страница 25: ... FOX 514 can be adapted to different surgical microscopes For this purpose eye safety filters are available and can be ordered optionally Part Name Description Article No Laser Safety Goggles Laser safety goggle AS01003 Eye safety filter for microscope Eye safety filter 510nm 522nm BG06076 Zeiss BG06077 Leica For information about other accessories please contact A R C Laser GmbH or the responsibl...

Страница 26: ...ppropriate lasers are shown on the label of the applicator For more information about suitable applicators please contact A R C Laser GmbH or the responsible sales partner Suitable for FOX 514 A T T E N T I O N The applicators are glass fibers that can break easily Handle them with the necessary care when removing them from the packaging and during treatment to avoid fiber breakage A broken fiber ...

Страница 27: ...mode during treatment If interruption is necessary the laser must be returned to STANDBY mode The device must always be switched off when unattended to prevent operation by unauthorized third The front panel of the device consists of the following controls and keys Laser STOP Touch screen Rotary wheel for adjusting laser power Arrow up and down for pulse length Yellow signal LED for READY mode REA...

Страница 28: ...figure above For FOX 514 only 300 µm fibers can be used 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 indi...

Страница 29: ...tch for the external interlock been plugged in or if applicable has the door interlock contact been connected to the laser Be aware that no fiber is connected Are the fibers and hand pieces that are to be used free of any damage Is there sufficient number of safety goggles ready to be used Has the footswitch been plugged in A T T E N T I O N All warning lights outside the treatment room must be sw...

Страница 30: ...ser executes its system check automatically upon startup Once the system check has been completed you have to enter the password 0000 See section 6 4 3 3 to modify the password After inserting the correct password you will be automatically redirected 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 c...

Страница 31: ... 3 Power settings The power can be set by using the rotary wheel Doing so the color of the value changes from black to white In this case the font color of the power changes from black to white This color scheme can also be reversed if desired For a description see chapter 6 4 3 2 The displayed value may vary from the emitted value at the distal tip by a range of 20 Reset Button Settings Power Pul...

Страница 32: ...m this table Screen with highlighted values Selected values are indicated with white background and can be chosen later on in the main screen The new preset table is activated by leaving this screen via the home button µs ms s 100 1 12 26 48 100 210 600 1 7 200 2 13 28 50 110 220 650 1 5 8 300 3 14 30 55 120 230 700 2 9 400 4 15 32 60 130 240 750 2 5 10 500 5 16 34 65 140 260 800 3 15 600 6 17 36 ...

Страница 33: ...en The new preset table is activated by leaving this screen via the home button 6 3 6 Pulse Counter The triggered pulses are accumulated The device automatically counts the laser pulses triggered by means of the foot switch or set by pulse repetition rate The maximum number of pulses registered is 9999 To reset the counter you need to tip on the Reset button µs ms s 100 1 12 26 48 100 210 550 1 8 ...

Страница 34: ...ness 6 4 2 Submenu 2 Leave submenu 1 with the arrow key right and get into the next submenu Here you can only modify the automatic deactivation by pressing the according key to increase or decrease the time until deactivation Display brightness 5 100 Aiming beam brightness 5 100 Aiming beam frequency 0 6 Hz Home Signal tone 10 100 Tone pitch 5 100 for signals Brightness READY LED 5 100 Systeminfo ...

Страница 35: ...r sheme is then inverted in the main menu 6 4 3 3 Edit Password This screen is to modify your user password Factory setting 0000 for which you will be asked after system check A password consists of 4 numbers The routine for changing the password will guide you through the menu Old Password Enter the present password New Password Enter your new password Confirm Password Re Enter your new password ...

Страница 36: ...s if no aiming beam is visible Please refer to chapter 8 5 2 which contains several possibilities to solve the problem Please do not insert any objects or liquids into the port 6 6 Laser STANDBY READY The READY button is a black circular push button with two yellow LEDs Press the READY button to switch to READY mode Upon pressing the two yellow LEDs will start flashing accompanied by a noticeable ...

Страница 37: ...arting the device the screen will remain black no LED will highlight and the device will not be able to start as its power supply voltage is cut off Pressing the Laser STOP button while working with the FOX 514 Laser will instantly cut off the laser output Solution Pull up Laser STOP and restart the device see scection 6 2 A T T E N T I O N The Laser Stop should only be used in emergencies The Las...

Страница 38: ...lly For that use the shut down button in the settings The automatic shut down time can be set between 10 and 100 minutes After reaching the set time the device has to be restarted 6 12Charging the battery Insert the Power supply into its socket at the rear panel of the FOX 514 The charging process starts as soon as the orange LED shows up There is no need to switch the FOX 514 on when charging The...

Страница 39: ...ghtness 1 100 Internal temperature Aiming beam frequency 0 6Hz Deactivation mode time Brightness Ready Button 5 100 Air humidity Tone 5 100 Choose language Pitch 10 100 State of power supply Pulse length field Advanced settings Pulse pause field Home Settings submenu Attention Next screen Previous screen Change font color Change password Reset pulse counter ...

Страница 40: ...y according to IEC 60601 2 22 Pulse length 100 µs to 45 sec CW Shot frequency Single pulse SP 0 11 Hz to 5000 Hz Aiming beam 650 nm red 1mW continuously cw or pulsed 1 6Hz Porwer transmisstion 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 c...

Страница 41: ... the laser 8 2 Safety Check STK Once within 24 months the laser must be subjected to a safety check STK by trained personnel The execution of the STK and any faults are to be noted in the device book Please note that a medical device book and a regular technical safety check are not required in every country Note local requirements and laws Scope of Safety Check STK Visual Check laser marking lase...

Страница 42: ...choosing the disinfectant pay attention to the following according to the manufacturer of the disinfectant 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 be based on alcohol and or quaternary compounds the disinfectant should be suita...

Страница 43: ... Laser authorized dealer for technical support However we do hope that the device will work flawlessly for many years When an error occurs in the system the error will be displayed along with a symbol to identify the error Common error might be Battery operation Make sure the battery has been charged and the laser is switched on Interlock The interlock plug should be fully inserted into the device...

Страница 44: ...ble when the laser is in READY mode Switch the laser to READY mode Aiming beam brightness set too low Increase the parameter for aiming beam brightness Fiber is not properly inserted Twist the fiber connector inside the socket with a light movement in wards Fiber is broken Replace the broken fiber with a new one Aiming beam diode defective Contact your A R C Laser representative No laser beam but ...

Страница 45: ...luded with the system Temperature too low The environment is too cold for operating the laser Operating temperature too high Please wait until laser cools down to reach a working temperature Air humidity too high The laser should not be operated in this environment Fiber missing or plugged in incorrectly Check fiber plug Ventilation blocked Contact your A R C Laser agent 8 5 4 Warning Messages Foo...

Страница 46: ...e The TFT Display Fiber LED Status LED are dark Laser STOP button is pressed Pull up Laser STOP button and the device can be started 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 with the disposal of the system Costs for the proper ret...

Страница 47: ...that 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 ...

Страница 48: ...nment 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 healthca...

Страница 49: ...ay 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 domestic or clinical areas 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 Surge ...

Страница 50: ...ev3 50 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 51: ...ecommended protective distance which is calculated according to the equation applicable to the transmission frequency Recommended protecty distance d 1 17 V1 P d 1 17 E1 P for 80 MHz to 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 specifications and d as the recommended protective distance in meter...

Страница 52: ...on 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 CDMA...

Страница 53: ...User Manual FOX 514 September 2021 File User Manual_FOX 514_rev3 53 Notes ...

Страница 54: ...File User Manual_FOX 514_rev3 54 ...

Страница 55: ......

Страница 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 ...

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