Related Manuals for A.R.C. Laser FOX IV 810
Summary of Contents for A.R.C. Laser FOX IV 810
- Page 1 User Manual FOX IV 810 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 Phone: +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. La- ser GmbH.
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Page 3: Table Of Contents
User Manual FOX IV 810 August 2023 Content INTRODUCTION ...................... 6 Marking and Symbols ......................6 Intended Purpose ........................7 1.2.1 General Purpose ........................7 1.2.2 Medical Purpose ........................7 1.2.3 Principles of operation and mode of action ................9 Theory and Technical Set-Up .................... - Page 4 Medical Introduction Training ..................... 27 Device Parts and Accessories .................... 28 5.4.1 Fibers and Probes / Applicators ..................... 29 5.4.2 Fiber port FOX IV 810 ......................30 OPERATION ......................31 Preparation ..........................34 Starting the Device ....................... 35 6.2.1 Entering the password ......................36 Application Menu –...
- Page 5 User Manual FOX IV 810 August 2023 Error detection ........................71 8.5.1 Error Routine .......................... 71 8.5.2 Interlock chain ........................71 8.5.3 System Check ........................72 8.5.4 Troubleshooting ........................73 8.5.5 Error messages ........................74 8.5.1 Interlock messages ......................... 74 8.5.2...
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Page 6: Introduction
August 2023 1 Introduction We appreciate your decision to purchase the FOX IV 810 and wish you a productive and successful usage with this all-round diode laser for ophthalmology. The FOX IV 810 generates a high-intensity laser beam, which may induce injuries in case of improper handling. -
Page 7: Intended Purpose
The laser effect allows focused treatment of the disease area with minimal impact on the surrounding tissue. The diode laser FOX IV 810 is intended to be used for the following application fields and indications: •... - Page 8 User Manual FOX IV 810 August 2023 1.2.2.1 Indications and contraindications Indications Medical Applica- Indication from clinical Side and adverse effects Contraindications tion indi- data cated pain, discomfort, inflammation, abra- sion/lacerated conjunctival or scleral Inflammation or infec- tissue, subconjunctival hemorrhage tion of the eye and swelling.
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Page 9: Principles Of Operation And Mode Of Action
The FOX IV 810 is a fiber guided laser. It is used with sterile single use probes which allow current transmission of the laser beam at 810 nm and aiming beam to the target tissue. -
Page 10: Theory And Technical Set-Up
August 2023 1.3 Theory and Technical Set-Up The FOX IV 810 is a diode laser with a wavelength of 810 nm. Thanks to special man- ufacturing processes for the semiconductor material, the A.R.C. Laser GmbH is able to provide this laser device for a certain wavelength. The maximum output power is 8.0 W respectively 3.0 W for anterior and posterior settings. -
Page 11: Transport And Storage
User Manual FOX IV 810 August 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 12: Shipping And Unpacking The Device
The FOX IV 810 is delivered in a simple and easy to use carrying case for storage and transportation. The carrying case is protected by a special outer box. - Page 13 User Manual FOX IV 810 August 2023 The carry case offers space for e.g. the following: *if ordered Level 1: Accompanying documents, label, etc. Laser Safety Goggles* Level 2: FOX IV 810 Laser Power supply Foot switch File: User_Manual_FOX IV 810_rev1.docx...
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Page 14: Return Shipments
User Manual FOX IV 810 August 2023 2.2 Return Shipments If you ship the device back to A.R.C. Laser GmbH, please use the carrying case and the covering box for transportation and shipping. File: User_Manual_FOX IV 810_rev1.docx... -
Page 15: Setup / Installation
When the device is not in use, it should be stowed in the transport case. 3.2 Room Requirements The FOX IV 810 is a categorized as a class 4 laser. To provide the most possible safety, the following requirements must be met for any room a class 4 laser is operated in. -
Page 16: Reflecting Surfaces
The power supply unit can be connected to an AC voltage ranging from 100V to 240V (50/60 Hz). 3.4 Battery pack The FOX IV 810 is powered by a lithium-ion battery. If handled incorrectly, the battery pack can burst, cause a fire or even chemical burns. Please note the following points. •... -
Page 17: Safety Information
The FOX IV 810 laser device is a 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 must be taken prior to commissioning in order to ensure safe and trouble-free work with the device. -
Page 18: Eye Safety
Therefore we encourage you to wear laser safety glasses which also guarantee a full protection to the side parts. A.R.C. Laser GmbH offers a laser safety glasses for FOX IV 810 – AS01033 with fol- lowing properties: •... -
Page 19: Electrical Protection
4.5 Protection against Undesired Radiation By the usage of a foot switch, the FOX IV 810 emits radiation. 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 20: Nohd Safety Distance
User Manual FOX IV 810 August 2023 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 thus identifies the danger area within which health damage to the eye is to be feared if the laser beam is directly and unprotected. -
Page 21: Ce Regulations
The device has been checked for electrical compliance as well as for mechanical safety. All parts used by A.R.C. Laser for the FOX IV 810 comply with CE regulations or have been tested for approval or suitability by the notified body. -
Page 22: Connector And Plugs
User Manual FOX IV 810 August 2023 4.10 Connector and Plugs Following connectors can be found at the rear panel of the device. Foot switch AUX 1 Door-Interlock Flash drive port AUX 2 Power supply The connector may only be used as follows:... -
Page 23: Safety Shutter / Aiming Beam
4.12 Safety shutter / Aiming beam The FOX IV 810 has an internal safety shutter which is opened up mechanically when a fiber is inserted into the fiber port. As soon as a fiber is connected to the laser cor- rectly, the laser can be set to READY mode by pressing the READY button/ LED. -
Page 24: Stickers And Labels
August 2023 4.15 Stickers and Labels The FOX IV 810 has various warning labels in accordance with the European and world- wide directives, intended to prevent any users to become exposed to laser radiation be- cause of improper use. Following an example is given to explain the labels:... - Page 25 User Manual FOX IV 810 August 2023 WARNING LABELS Warning label laser radiation: Wavelength dependent (Outer side foot stand) Warning label fiber port (on top of the device) OTHER STICKERS: Read manual. Modification-sticker shows the current modification level of the device.
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Page 26: Operating Conditions
August 2023 4.16 Operating Conditions The medical laser FOX IV 810 is not suitable for use in connection with flammable gas mixtures of any kind. 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 27: User Information And System Introduction
5.2 Laser Safety Training The FOX IV 810 diode laser is designed for medical applications. Only physicians who have been instructed in its operation may use the device. A.R.C. Laser GmbH recommends attending additional seminars to train working with different laser systems. -
Page 28: 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 29: Fibers And Probes / Applicators
August 2023 5.4.1 Fibers and Probes / Applicators The FOX IV 810 is a fiber-guided laser. Various probes are used to guide the laser radiation to the treatment area. The appropriate lasers are shown on the label of the applicator. For more information about suitable applicators, please contact A.R.C. La- ser GmbH or the responsible sales partner. -
Page 30: Fiber Port Fox Iv 810
August 2023 5.4.2 Fiber port FOX IV 810 The FOX IV 810 has a fiber port at the head of the device, intended to incorporate the patented A.R.C. Laser click plug for a wide range of hand pieces and applicators. -
Page 31: Operation
User Manual FOX IV 810 August 2023 6 Operation This part of the manual describes the technical aspect of the device functionality without addressing medical applications. Settings and adjustments should only be made in accordance with the operating instruc- tions. Changes or settings that are not described in this manual can lead to malfunctions. - Page 32 For safety of the fiber port, a dust protection is permanently connected to the device. A T T E N T I O N Applicators for the FOX IV 810 are labeled with a FOX IV 810– 300 µm pictogram at the product label.
- Page 33 User Manual FOX IV 810 August 2023 System LED The System LED shows the status of the device. If the LED flashes in green, the system starts. If the LED lights up permanently in green, the device is ready to use.
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Page 34: Preparation
• Has the foot switch been plugged in? It is recommended to place the FOX IV 810 on a dry, solid surface. Make sure that the laser system is standing securely. A T T E N T I O N All warning lights outside the treatment room must be switched on before the laser starts to operate. -
Page 35: Starting The Device
A T T E N T I O N The FOX IV 810 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 36: Entering The Password
User Manual FOX IV 810 August 2023 6.2.1 Entering the password Once the system check has been completed, the locking screen will appear. To continue, the password has to be entered. In the factory setting the pass- word is “0000”. See chapter 6.4 to modify the password. -
Page 37: Application Menu - Select Treatment
LIO. A T T E N T I O N Only LIO provided by A.R.C. Laser can be used with FOX IV 810. Lacrimal Surgery – DCR Treatment: Select DCR for Laser- assisted Dacryocystorhinostomy by the use of DCR Probes. -
Page 38: Select Or Add A User Profile
Every surgeon can adjust the settings according to the preferences and save those settings in his/her own user profile. The A.R.C. Laser - user contains all intended settings for the specific application. Pre- defined A.R.C. values cannot be changed or deleted. - Page 39 User Manual FOX IV 810 August 2023 Edit user profile: Select the profile that needs to be edited. Use the pencil icon in the lower left corner to change the name. After correcting the name, confirm the input by pressing the arrow symbol next to the name.
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Page 40: Programs And Settings
6.3.1.3 Save values As soon as laser parameters were changed the flash-disk icon appears at the display. To save the changed values, press this button. Values and presets of the A.R.C. Laser user can’t be changed or saved. File: User_Manual_FOX IV 810_rev1.docx... -
Page 41: Cpc - Cyclophotocoagulation
User Manual FOX IV 810 August 2023 6.3.2 CPC – Cyclophotocoagulation After choosing CPC appliccation the following screen will be displayed: Change application Application Pulse counter Count-down mode Press arrow change to setting to select count-up mode User Screen lock... - Page 42 User Manual FOX IV 810 August 2023 Pulse table for CPC: µ µs 1.0 2.1 1.0 1.1 2.2 1.1 1.2 2.3 1.2 1.3 2.4 1.3 1.4 2.5 1.4 1.5 2.6 1.5 1.6 2.7 1.6 1.7 2.8 1.7 1.8 2.9 1.8 1.9 3.0 1.9...
- Page 43 Start the treatment by pressing the foot switch after the laser parameters were checked once again. A T T E N T I O N Any serious incident that occurs with this laser must be reported to the A.R.C. Laser GmbH and the responsible state authority. 6.3.2.6 Interrupt or stop the treatment...
- Page 44 User Manual FOX IV 810 August 2023 Stop the treatment When the treatment is finished, it can be stopped by pressing the READY button/ LED. The following screen will appear: To continue treatment, tick the first box “Continue Treatment” and confirm the choice by pressing OK. The treatment can be continued by pressing the READY button/ LED.
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Page 45: Μcpc - Cyclophotocoagulation By The Use Of Microsecond Pulses
User Manual FOX IV 810 August 2023 6.3.3 µCPC – Cyclophotocoagulation by the use of microsecond pulses After choosing CPC application the following screen will be displayed: µCPC Change application Application Energy Counter Indication of Mode selected Count-down mode counting mode... - Page 46 User Manual FOX IV 810 August 2023 Pulse table for µCPC: µs µs CW = continuous wave SP = single pulse Pulse duration To change the pulse duration, press the current setting. The selected value will turn green and can be...
- Page 47 User Manual FOX IV 810 August 2023 Individualization of selectable pause durations The pause duration-choices selectable in the pause settings can be individualized with the pulse table. To open the pulse table, select the pause duration by first clicking on the value and then double click it.
- Page 48 August 2023 6.3.3.5 Further µCPC settings for acoustic feedback To facilitate the application of the laser beam during µCPC the FOX IV 810 has a build in acoustic signalling system containing a voice over and a metronome. Both acoustic signals can be adjusted in the main settings individually.
- Page 49 User Manual FOX IV 810 August 2023 6.3.3.7 Interrupt or stop the treatment Interrupt the treatment During the treatment it might be necessary to adjust different parameters in the settings. To assess the settings, press the settings button. The following screen will appear: To get to the settings, tick the first box “Change to settings...
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Page 50: Retina Coagulation (Endo - Endocoagulation Or Lio Applications)
User Manual FOX IV 810 August 2023 6.3.4 Retina coagulation (Endo - Endocoagulation or LIO Applications) The following information applies for all treatments of the posterior eye such as Endocoagulation, LIO and ROP. Surgeon protection filter 810nm To execute the retina coagulation (posterior applications), the surgeon protection filter has to be connected. - Page 51 User Manual FOX IV 810 August 2023 6.3.4.1 Change parameters Parameters can be changed by clicking on the corre- sponding value. The selected value will turn blue and can be adjusted by sliding the point to a different location on the line or by using the plus/minus keys on the menu bar.
- Page 52 Included values can- not be deleted. 6.3.4.3 Change displayed treatment information The FOX IV 810 provides a variety of information for the user that can be found in the middle of the lower screen such as the emitted energy, pulse counter, DutyCycle, average power and frequency of the laser beam.
- Page 53 User Manual FOX IV 810 August 2023 Selectable parameters: Energy in Joule: The displayed energy value is the product of the set power and the actual exposure time, as well as the number of pulses emitted. The displayed unit changes automatically from Millijoule (mJ) to Joule (J) to Kilojoule (kJ) with in- creased cumulated energy.
- Page 54 Start the treatment by pressing the foot switch after the laser parameters were checked once again. A T T E N T I O N Any serious incident that occurs with this laser must be reported to the A.R.C. Laser GmbH and the responsible state authority. File: User_Manual_FOX IV 810_rev1.docx...
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Page 55: Dcr - Dacryocystorhynostomy
User Manual FOX IV 810 August 2023 6.3.5 DCR - Dacryocystorhynostomy After choosing CPC application the following screen will be displayed: Change application Application Power Laser Power: Watt (W) User Screen lock Cumulative energy Pulse pause up to SP Pulse duration up to CW 6.3.5.1 Change parameters... - Page 56 User Manual FOX IV 810 August 2023 Pulse table for DCR: µs µ CW = continuous wave SP = single pulse Pulse duration To change the pulse duration press the current setting. It will turn orange and can be adjusted by sliding the point to a different location on the line or by using the plus/minus keys on the side bar.
- Page 57 Included values cannot be deleted. 6.3.5.3 Change displayed treatment information The FOX IV 810 provides a variety of information for the user that can be found in the middle of the lower screen such as the emitted energy, speed, DutyCycle, average power and frequency of the laser beam.
- Page 58 Start the treatment by pressing the foot switch after the laser parameters were checked once again. A T T E N T I O N Any serious incident that occurs with this laser must be reported to the A.R.C. Laser GmbH and the responsible state authority. File: User_Manual_FOX IV 810_rev1.docx...
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Page 59: Settings
User Manual FOX IV 810 August 2023 6.4 Settings Enter the settings screen by touching the gearwheel. The following setting categories are available. Memory/ Tone / Pitch Bookmark Save power System ANTERIOR information Counter Settings Advanced settings Aiming Beam Settings Save power Adjust Display brightness and switch-off time. - Page 60 User Manual FOX IV 810 August 2023 Tone / Pitch Adjust system volume. System Volume (10 – 100 %) Audio adjustments for µCPC Voice over The device announces the time/energy in intervals of 10 J or 10 s. Voice over settings (off, low, mid, high)
- Page 61 User Manual FOX IV 810 August 2023 ANTERIOR Counter Settings In the ANTERIOR Counter Settings, the counter for CPC and µCPC can be adjusted. The µCPC counter can be set to Energy counter (see picture in the middle) or time counter (see picture right).
- Page 62 User Manual FOX IV 810 August 2023 System information In this seeting submenu it is possible to access the protocol of the last ANTERIOR treatment, set the language and change the password of the device. Show the last ANTERIOR treatment protocol: To show the last treatment protocol of CPC or µCPC...
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Page 63: Advanced Service Settings
User Manual FOX IV 810 August 2023 6.4.1 Advanced Service Settings Only trained personnel can make changes in the advanced settings. The advanced settings only can be accessed to with the service password at the advanced settings pin mask. 6.4.2 Advanced User Settings The advanced user settings can be accessed with the user password at the advanced settings pin mask. -
Page 64: Insert The Applicator
The connector must click into place. If the plug has not properly clicked into place, the device cannot be switched to READY mode and the FOX IV 810 will not work. Please pay attention to a clearly perceptible "click" when inserting the plug! Once the plug has been locked in place, it is possible to change the device into READY mode and laser radiation can be emitted by using the foot switch. -
Page 65: Release Laser Radiation
To prevent connection issues of the fiber due to dust pollution, insert the red dust protection pin after every usage. If the FOX IV 810 is not used for a longer time period stow it in its transport case. Power button... -
Page 66: Charging The Battery
User Manual FOX IV 810 August 2023 6.11 Charging the battery To charge the battery of FOX IV 810 insert the power supply into its socket at the rear panel. The ongoing charging process is indicated by the animated flashing of the battery symbol. When the device is turned on, the number of illuminated bars of the battery symbol indicates the charging level. -
Page 67: Symbols
User Manual FOX IV 810 August 2023 6.12 Symbols Display brightness 10-100 % Log-out/ Access Sleep mode time (5-60min) protection Tone (10-100%) Pitch (10-100%) Advanced settings Voice over Metronome Aiming beam brightness (1-100 %) Change user password Aiming beam frequency (0-10Hz) -
Page 68: Technical Data
100 - 240 V AC, 50/60 Hz, 1.06-0.45 A Charger output / Console in- 19 V DC, 4.74 A Integrated rechargeable Battery 10.8 V, 26.4Wh, Li-Ion (by A.R.C. Laser), Cooling Active internal with fan Control/ User Interface Touch display Fiber Coupling A.R.C. -
Page 69: Maintenance
User Manual FOX IV 810 August 2023 8 Maintenance 8.1 Introduction The device was designed, developed and tested according to the latest technical knowledge. We have set the product life time to 7 years. Additionally, we guarantee the availability of spare parts for 10 years. However, to ensure that everything is work- ing properly, we have made it possible for you to visually check the status displays from the outside. -
Page 70: Cleaning And Disinfection By The User
User Manual FOX IV 810 August 2023 A T T E N T I O N If one or more safety-related points are objected after the safety-related inspection (STK), the device may no longer be operated. 8.3 Cleaning and disinfection by the user The following maintenance instructions can be carried out by the user. -
Page 71: Accessories Cleaning
Always use soft cloths that do not leave scratches on the sur- face. 8.4.2 Applicators All Fibers and Probes for FOX IV 810 are single use, sterile products. Please follow the instruction in the user manual for the Fibers and Probes. 8.4.3 Foot Switch The general cleaning instructions (see above) must be respected in any case. -
Page 72: System Check
We distinguish between two types of errors: Dynamic errors i.e. errors that can be easily resolved or can be resolved after ordering a spare part from A.R.C. Laser GmbH. These error cases are handled as Interlock elements and may include: •... -
Page 73: Troubleshooting
The following errors cannot be identified by the system self-check and have to be checked by the user: Problem Potential Error Troubleshooting PowerSave Mode - your FOX IV 810 lowers its power consumption. By Screen darkens Laser is in Sleep mode pressing/touching the display you can resume to normal mode. -
Page 74: Error Messages
User Manual FOX IV 810 August 2023 8.5.5 Error messages Device is in an error state, Indicates an error case. which cannot be resolved by Error symbol with error code. the user. “F__” Special error case with low laser power at low battery... -
Page 75: Warning Messages
User Manual FOX IV 810 August 2023 System temperature Let the device warm up. too low. (If message persists, contact service) Battery low (25%, 10% Charge the battery. respectively). Battery very low (<=1%). Plug in power supply and charge the Ready mode activation battery. -
Page 76: Status Messages
User Manual FOX IV 810 August 2023 8.5.1 Status messages Please wait. Data change/transfer successful. Password change successful. Battery charge low. Battery charge very low. Battery charge critical. File: User_Manual_FOX IV 810_rev1.docx... -
Page 77: Confirmation Screens
User Manual FOX IV 810 August 2023 8.5.1 Confirmation screens Delete user entry? User already exists! Stop the treatment/How to proceed? Display lock symbol in main mask? Security question prompt: Protection filter in position? Import data? Confirmation screens must be confirmed by the user in order to proceed. -
Page 78: Disposal
A.R.C. Laser will be glad to assist you with the disposal of the laser. Any costs and risks for the appropriate return of the laser to A.R.C. Laser must be borne by the customer. Please get in touch with our service department. -
Page 79: Customer Service
The insurance and transportation costs are not covered by A.R.C. Laser GmbH. The choice of the return is made by the A.R.C. Laser GmbH communicated to the customer. Changes and amendments in the carrier or the shipping method can lead to delays in transport and processing. -
Page 80: Guidelines And Manufacturer's Declaration
User Manual FOX IV 810 August 2023 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 81: Electromagnetic Immunity (1)
User Manual FOX IV 810 August 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. - Page 82 User Manual FOX IV 810 August 2023 0 % UT; ½ cycle Only the voltage of a typical at 0°to 315° step 45° professional healthcare 0 % UT;1 cycle, 0° Voltage dips IEC 61000-4-11 facility may be used. It is recommended to use an 70 % UT;...
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Page 83: Electromagnetic Immunity (2)
User Manual FOX IV 810 August 2023 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 84: Recommended Separation Distances Between Portable And Mobile Rf Telecommunications Equipment And The Laser
User Manual FOX IV 810 August 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... - Page 85 User Manual FOX IV 810 August 2023 Notes: File: User_Manual_FOX IV 810_rev1.docx...
- Page 86 User Manual FOX IV 810 August 2023 Notes: File: User_Manual_FOX IV 810_rev1.docx...
- Page 87 User Manual FOX IV 810 August 2023 Notes: File: User_Manual_FOX IV 810_rev1.docx...
- Page 88 A.R.C. LASER GmbH Bessemerstr. 14 90411 Nuremberg Germany Phone: +49 911 21779-0 Fax: +49 911 21779-99 www.arclaser.com...