A.R.C. Laser FOX 514 User manual
User Manual FOX 514
September 2021
File: User Manual_FOX 514_rev3 2
Please contact for service:
A.R.C. Laser GmbH Headquaters:
A.R.C. Laser GmbH
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
User Manual FOX 514
September 2021
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Content
1Introduction......................................................................................................................6
1.1 Marking and Symbols..........................................................................................................................6
1.2 Intended Use .......................................................................................................................................7
1.3 General contraindications....................................................................................................................8
1.4 Theory and Technical Set-up ..............................................................................................................8
2Transport and Storage ....................................................................................................9
2.1 Shipping and Upacking the Device ...................................................................................................10
2.2 Return Shipment................................................................................................................................12
3Set-up and Installation ..................................................................................................13
3.1 Installation Site..................................................................................................................................13
3.2 Room Requirements..........................................................................................................................13
3.2.1 Marking Access Points...................................................................................................................13
3.2.2 Windows shielding .........................................................................................................................13
3.2.3 Reflecting surfaces ........................................................................................................................14
3.3 Electrical Connection.........................................................................................................................14
3.4 Battery pack.......................................................................................................................................14
4Safety Information.........................................................................................................15
4.1 General..............................................................................................................................................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 and Labels...........................................................................................................................21
4.16 Operating Conditions.........................................................................................................................23
4.17 Electromagnetic Compatibility...........................................................................................................23
5Advice for Users............................................................................................................24
5.1
Technical Introduction .......................................................................................................................24
5.2
Laser-Safety-Training........................................................................................................................24
5.3
Medical Introduction ..........................................................................................................................24
5.4
Medical Device Book.........................................................................................................................24
5.5
Device Parts and Accessories...........................................................................................................25
6Operation........................................................................................................................27
6.1 Preparation........................................................................................................................................29
6.1.1 Installation Site...............................................................................................................................29
6.1.2 Suction Cup Mount ........................................................................................................................29
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6.2 Starting the Device............................................................................................................................30
6.3 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 Pulse Counter ................................................................................................................................33
6.4 Further Settings.................................................................................................................................34
6.4.1 Submenu 1.....................................................................................................................................34
6.4.2 Submenu 2.....................................................................................................................................34
6.4.3 Submenu 3.....................................................................................................................................35
6.5 Inserting the Applicator......................................................................................................................36
6.6 Laser STANDBY / READY................................................................................................................36
6.7 Release Laser Radiation...................................................................................................................36
6.8 Treatment ..........................................................................................................................................37
6.9 Laser-Stop.........................................................................................................................................37
6.10 Switching Off .....................................................................................................................................37
6.11 Power Save .......................................................................................................................................38
6.12 Charging the battery..........................................................................................................................38
6.13 Symbol Description............................................................................................................................39
7Technical Data ...............................................................................................................40
7.1 General..............................................................................................................................................40
7.2 Laser Data.........................................................................................................................................40
7.3 Electrical Connection Data................................................................................................................40
7.4 Classifications....................................................................................................................................40
8Maintenance...................................................................................................................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 Status Messages ...........................................................................................................................46
8.6 Disposal.............................................................................................................................................46
9Customer Service..........................................................................................................47
9.1 Warranty Information.........................................................................................................................47
9.2 Warranty Shipment, Packaging.........................................................................................................47
9.3 Sales and Service Information ..........................................................................................................47
10 Guidelines and Manufacturer’s Declaration.................................................................48
10.1 Electromagnetic Emissions ...............................................................................................................48
10.2 Electromagnetic Immunity (1)............................................................................................................49
10.3 Electromagnetic Immunity (2)............................................................................................................51
10.4 Recommended separation distances between portable and mobile RF telecommunications
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Das Bild ka nn z urz eit
nich t a n ge z e i gt
wer d e n.
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. The user manual should therefore be read carefully before starting 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 A.R.C. Laser GmbH should be
contacted.
The symbol "Attention laser radiation" is intended to warn the user against
directing laser beams to unwanted areas through improper handling or improper
operation of the device.
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1.2 Intended Use
The FOX 514 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, removed or separated by vaporization.
At low power output, heating of tissue or blood results in enzyme denaturation and coagulation
of e.g. blood vessels. For this effect, the laser is used together with application fibers aiming
the laser beam to the target tissue either directly or in contact or non-contact or via further
optics e.g. through hand pieces.
The laser effect allows focused treatment of the disease area with minimal impact on the
surrounding tissue.
The laser can be applied both in unsterile environment, for instance at a physician’s
examination room, and in a sterile environment e.g. operating thater.
It can be used in conjunction with e.g. hand pieces or endoscopes where thefiber 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 adverse effects
Contraindications
General contraindication:
radiation exposure to the
eye (exception:
Ophthalmology)
Otology
Coagulation (e.g. cholesteatoma,
glomus tumor, …), carbonization/
vaporization (e.g.
stapedotomy/stapedectomy,
cholesteatoma, glomus tumor, …)
of soft tissue and bony structures
•Acoustic trauma
•Mechanical trauma (e.g.
floating footplate)
•General or normal
conventional (non-laser)
operation collateral side
effects
-
General Surgery
Treatments requiring heating of
tissue and/or blood up to
coagulation or vaporization
•Edema
•Bleeding
•Pain
•Scar formation
•Granulation
•Swelling
•Tissue injury
•General or normal
conventional (non-laser)
operation collateral side
effects
Oxygen level can’t be
lowered below 30% due to
previous illness if used
nearby intubation tube.
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Medical
application
Indication from clinical
data
Side and adverse effects
Contraindications
General contraindication:
radiation exposure to the
eye (exception:
Ophthalmology)
Ophthalmology
Coagulation (e.g. retina)
•Tissue injury (e.g. burning or
perforation)
•Scar formation
•Edema
•Pain
•General or normal
conventional (non-laser)
operation collateral side
effect
•Bleeding
•Decrease in visual acuity
•inflammation
1.3 General contraindications
The FOX 514 is not intended to be used for interventions of the central circulatory system
(arteriae pulmonales, aorta ascendens, arcus aortae, aorta descendens to the bifurcatio
aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis
interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales,
vena cava superior and vena cava inferior).
Furthermore, the FOX 514 is not intended to be used for treatments on the central nervous
system (brain, meninges and spinal cord).
A T T E N T I O N
The device may only be operated by 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 individual transitions as well as the individual manufacturing processes, laser
diodes at A.R.C. Laser GmbH in this wavelength are available. The laser radiation of the
diode is collimated through the optics in the „fast“ and in the „slow“ axis and consequently
transferred to a surface of approx. 2mm x 4mm.
The laser diode is operated with high current up to 20 amperes and low voltage. Since the
diode is very sensitive to any voltage fluctuations, the battery integrated into the FOX 514
laser has a buffer preventing any voltage fluctuations at the diode.
Via beam deflection mirrors and coupling elements the laser light is coupled into a silica glass
fiber. The transmission of the various wavelengths is independent from the fiber.
Transmissions ranging from 70 to 80 % of the laser power are possible.
The laser beam emitted from the diode is polarized and therefore easy to adjust.
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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. Laser GmbH. Only remove the packaging in
the presence of a representative of the carrier. Make a list 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 I O N
If the laser is transported or stored at a temperature below +5°C, it can be damaged when
starting. Unpack the laser and leave it for at least four hours at normal room temperature
so that the system can warm up to room temperature.
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2.1 Shipping and Upacking the Device
Unpacking and installation of the device may be done by an authorized technician or
authorized representative of A.R.C. Laser GmbH. After installation 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 box.
Storage and transport case of the FOX
diode laser
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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
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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.
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3 Set-up and Installation
3.1 Installation Site
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. Higher temperatures can cause the device to switch off due to
overheating. A place of installation in direct sunlight can cause an early shutdown and must
be avoided in any case.
If the temperature is too low (below +10°C), the device cannot be started to prevent
condensation on the internal optics; this could result in permanent damage to the laser.
•The device should be set up so that the laser beam is not aimed directly at a door,
window or reflective material.
•The device should be operated in a dust-free room. There should be no 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 which a class 4 laser
according to EN 60825-1 is operated.
3.2.1 Marking Access Points
All entrances must be clearly marked so that unintentional or unauthorized entry, which can
lead to a hazard, is avoided.
•Laser warning signs (triangle with laser symbol) and the wavelength labeling must be
attached to each access door.
•A warning lamp must be attached above each access door. This must always light up
when the laser is in operation.
•The laser safety goggles must be easily accessible at the entrance.
3.2.2 Windows shielding
It must be ensured that no laser radiation can escape the room. In particular, the windows
must be secured with suitable materials. If you have any questions, your contact person at
A.R.C. Laser GmbH is available for you.
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3.2.3 Reflecting surfaces
To avoid danger from reflected direct and scattered radiation, there must be no reflective
surfaces in the room.
These can be:
•Mirror
•Pictures behind glass
•Chrome surfaces
•Window
These surfaces must be removed or suspended or matted. In the area of laser use, only
matted, non-reflective and non-flammable instruments and materials should be used.
3.3 Electrical Connection
The laser is operated with a DC voltage of 19 V. The power is supplied by its external power
supply or its internal battery pack which can be charged by the external power supply unit.
A.R.C. Laser GmbH developed this internal battery pack specifically for this device. Only use
battery packs and power supplies made by A.R.C. Laser GmbH and obtained through the
authorized dealer.
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.
•Do not disassemble. Do not handle damaged or leaking lithium ionbatteries
•Do not crush and do not expose the battery pack to any shock or force such as
hammering, dropping or stepping on it
•Do not short circuit and do not allow metal objects to contact the battery terminals
•Do not expose to high temperature above 60°C (140°F) such as indirect sunlight or
place located in the sun.
•The battery may only be charged with a suitable power supply.
Disposal of waste batteries (applicable in the European Union and other European
countries with separate collection systems)
This symbol on the battery or on the packaging indicates that the battery provided
with this product shall not be treated as household waste.
To ensure that the battery will be treated properly, hand over the product at end-of-
life to the applicable collection point for the recycling of electrical and electronic
equipment.
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4 Safety Information
4.1 General
The FOX 514 Laser is a precise working instrument for medical applications. The system
has been carefully developed and tested through intensive testing before shipping. In order
to offer you andthe operating personnel all possible protection, we recommend that youread
this section of the operating instructions carefully.
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.
In particular, it is important to protect the eyes and skin of the operator, the patient and third
parties. Laser safety goggles must 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" and ANSI Z136.1-2014 "American National Standard for the Use of Lasers”
can be achieved.
This manual is limited to the operation, maintenance and control of the device. The manual
is not a guide for the treatment of diseases that can be treated with laser.
With regard to the devices supplied, such as fibers or probes, the safety, operating and
maintenance instructions in the corresponding manuals must be observed. A.R.C. Laser
GmbH cannot be held responsible for damage or damage resulting from improper use.
The warranty for the device expires if the laser has been opened (even partially), modified
or repaired by unqualified personnel.
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4.2 Eye Safety
As a safety measure against direct or indirect laser radiation, it is necessary that all persons
in the room wear laser safety goggles.
Only use laser safety goggles for the appropriate wavelength, with the appropriate protection
class and with CE mark.
A.R.C. Laser GmbH offers a laser safety goggle with following protection levels:
•AS01003: protection class D LB6 + I LB7 + RM LB8 / optical density OD 8+
There are different types of laser safety goggles that also allow spectacle wearers to wear a
tight goggle on top of their own which are protective to all sides. In particular, the scattered
radiation that does not directly come from the front of the eye may present risks resulting
from internal reflections on the glasses. Therefore, we encourage you to wear laser safety
goggles which also guarantee a full protection to the side parts.
When using a microscope, either laser safety goggles 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. 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:
•BG06076/ BG06077: optical density OD5+
The eye safety filters must be firmly installed in the respective microscope and checked by
an employee of A.R.C. Laser GmbH or an authorized representative during delivery.
A T T E N T I O N
Never look directly into the laser beam or into the light reflected by the laser beam. This
will cause serious damage to your eye.
4.3 Electrical Protection
Never remove housing parts of the laser. Work on the device may only be carried out by
authorized A.R.C. Laser GmbH service personnel. The mains may only be replaced by
authorized service personnel.
The room in which the laser is operated should be kept dry. In the event of any cleaning
work, make sure that the floor is dry before starting the device.
A T T E N T I O N
Never work with the laser if you notice any visible defect on the device.
Never work with the device if you notice any visible defect on the power plug, wires or
supply lines are exposed.
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4.4 Explosion and Fire Hazard
Never work with the laser near flammable anesthetics, flammable solutions or other
flammable materials. Flammable plastic parts or paper parts should also be removed from
the working area of the laser. There is a fire or explosion hazard if the laser is used in the
presence of flammable materials, solutions or gases or in an oxygen-enriched environment
A T T E N T I O N
Laser radiation may not 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 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.
Especially in operating theaters where there are multiple foot switches, it is important to
ensure that the laser foot switch is close to the laser device.
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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 FOX514 has been approved bythe 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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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)
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It is prohibited to use the device's sockets for other usages than those detailed here.
Socket
Description
Note
Power supply
Charging device PS01013
To charge internal battery
Door-Interlock
Connecting the door-interlock switch
AUX 1
Currently without use
AUX 2
Isolated port –works as a remote
control to activate warning light
and additionally smoke
evacuation
Max. 24V; do not plug in a lined
device
AUX 3
Connector for the A.R.C. PowerMeter
currently without use
Foot switch
Connector for the A.R.C. foot switch
Flash drive port
(AUX 4)
Flash drive connection for A.R.C. flash
drive
The port for the flash drive may
only be used by the service
personnel during service
maintenance. Password
protected, cannot be used by
the customer.
4.11External 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 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 connecting the door switch can be found underneath the table. Insert the door
switch connector there.
Make sure the socket is stucks firmly to prevent unexpected system interlock problems.
4.12Safety-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.
The aiming beam is only visible when a fiber is plugged in and the laser is in the READY
mode. This aiming beam is a laser beam with very low power.
4.13Manual Reset
If an error occurs, the system switches into STANDBY mode. In that case, you should switch
the laser off and on by closing and open the cover stand. The restart should fix the error due
to the automatic recalibration.
If the error still occurs, this can only be fixed by trained personnel. Please contact the service
of A.R.C. Laser GmbH in this case.
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