Related Manuals for A.R.C. Laser FOX IV
Summary of Contents for A.R.C. Laser FOX IV
- Page 1 User Manual 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
Medical device book ......................26 Device Parts and Accessories .................... 27 5.5.1 Fibers and Hand pieces / Applicators ..................28 5.5.2 Fiberport FOX IV ........................29 OPERATION ......................30 Preparation ..........................32 Starting the Device ....................... 32 6.2.1 Low level laser therapy (LLLT) ....................33 6.2.2... - Page 4 User Manual FOX IV August 2021 6.2.3 Select or add category ......................34 6.2.4 Select or add a program ......................35 Programs and Settings ......................36 6.3.1 Display / Main menu ....................... 36 6.3.2 Settings ........................... 40 6.3.3 Advanced Settings ........................42 6.3.4...
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Page 5: Introduction
User Manual FOX IV August 2021 Introduction We appreciate your decision to purchase the FOX IV and wish you a productive and successful usage with this multi-functional laser system. The FOX IV generates a high-intensity laser beam, which may induce injuries in case of improper handling. -
Page 6: Intended Use
User Manual FOX IV August 2021 1.2 Intended Use The FOX IV is intended to be used for treatments requiring coagulation/vaporization of tissue, bony structures or blood. At high power outputs, tissue can be carbonized and removed or separated by vaporization. - Page 7 User Manual FOX IV August 2021 Examples for indications and contraindications: Medical Application Indication Side and adverse effects Contraindications from clinical data General Contraindication: Di- recting the radiation to the eye. - edema - bleeding/hemorrhage - pain - scar formation/web for-...
- Page 8 User Manual FOX IV August 2021 Medical Application Indication Side and adverse effects Contraindications from clinical data General Contraindication: Di- recting the radiation to the eye. Thermal damage to pulpa Endodontics Blistering and scar forma- Soft tissue surgery on tion...
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Page 9: General Contraindications
When not in use, the device should always be protected against unqualified use. 1.4 Theory and Technical Set-Up The FOX IV is a diode laser with wavelengths of 445 nm, 810 nm or 980 nm. Thanks to special manufacturing processes for the semiconductor material, the A.R.C. Laser GmbH is able to provide this laser device for a certain wavelength range depending on the variant. -
Page 10: Transport And Storage
User Manual FOX IV August 2021 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 11: Shipping And Unpacking The Device
All functions and safety procedures are discussed and demonstrated here. The FOX IV 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 12 User Manual FOX IV August 2021 The carry case offers space for e.g. the following: Level 1: Accompanying documents, label, etc.. Laser Safety Goggles* Additional accessories like fiber stripper or eye protection filters* Level 2: FOX IV Laser Power supply...
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Page 13: Return Shipments
User Manual FOX IV August 2021 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_rev2... -
Page 14: Setup / Installation
Before the device is delivered, it must be ensured that the laser can be set up in a suitable location. The FOX IV should be operated in an easily accessible place. The laser should not be operated near a heater as the air cooling works best when the ambient temperature does not exceed 35°... -
Page 15: 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 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 16: Safety Information
The FOX IV 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 17: Eye Safety
CE mark and the protection class are noted, may be used. For all wavelengths offered for the FOX IV, the same laser safety goggle can be used. A.R.C. Laser GmbH offers a laser safety goggle with following protection levels: •... -
Page 18: Electrical Protection
There is danger to life here! 4.5 Protection against Undesired Radiation By using the foot switch the FOX IV emits laser radiation. The foot switch should never be outside the range of the operator holding the applicator. It is prohibited that any person other than the operator triggers the foot switch. -
Page 19: Nohd Safety Distance
(+/- 20%) according to EN 60601-2-22 using the following equa- tion: 4�� √ ������ ∗ �� – ���������������� �������� ������������ �������� = �������� �������������������� For the FOX IV variants following NOHD applies: Wavelength λ: 445 nm NOHD: 1.8 m Beam divergence α 25.4°... -
Page 20: 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 comply with CE regulations or have been tested for approval or suitability by the notified body. -
Page 21: Connector And Plugs
User Manual FOX IV August 2021 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 Module plug The connector may only be used as follows:... -
Page 22: Safety Switch / Aiming Beam
August 2021 4.12 Safety Switch / Aiming beam The FOX IV has an internal safety shutter. This safety switch enables the release of the laser beam mechanically. If the fiber is connected correctly, the laser can be set to ready when pressing the READY button. -
Page 23: Stickers And Labels
August 2021 4.15 Stickers and Labels The FOX IV has various warning labels in accordance with the European and worldwide di- rectives, intended to prevent any users to become exposed to laser radiation because of im- proper use. Following an example is given to explain the labels:... - Page 24 User Manual FOX IV August 2021 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 25: Operating Conditions
User Manual FOX IV August 2021 4.16 Operating Conditions The medical laser FOX IV 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 26: User Information And System Introduction
These must also be noted in the device book. 5.2 Laser Safety Training The FOX IV diode laser is designed for medical applications. Only physicians who have been instructed in its operation may use the device. In addition, A.R.C. Laser GmbH recommends to attend seminars in which working with different laser system is dealt with. -
Page 27: 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 28: Fibers And Hand Pieces / Applicators
August 2021 5.5.1 Fibers and Hand pieces / Applicators The FOX IV is a fiber-guided laser. Various fibers and probes are used to guide the laser radiation to the treatment area. The appropriate lasers are shown on the label of the applicator. -
Page 29: Fiberport Fox Iv
August 2021 5.5.2 Fiberport FOX IV The FOX IV 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. The U.C. port is compatible with fiber diameters from 300 - 600 microns. -
Page 30: Operation
User Manual FOX IV August 2021 Operation This part of the manual only describes the technical aspect of the device functionality without going into the medical applications. Settings and adjustments should only be made in accordance with the operating instruc- tions. - Page 31 READY mode is deactivated the LED changes back to green. Fiber port The fiber port is used to connect the patented A.R.C. Laser “click” connector for different hand pieces and applicators. For safety of the fiber port, a dust protection is permanently connected to the device (see above).
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Page 32: Preparation
Is there a sufficient number of protective goggles ready to be used? • Has the foot switch been plugged in? It is recommended to place the FOX IV 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 33: Low Level Laser Therapy (Lllt)
A T T E N T I O N The FOX IV 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 rou- tine. -
Page 34: Select Or Add Surgeon
User Manual FOX IV August 2021 6.2.2 Select or add surgeon Select surgeon: Choose a name by touching it and the color will change to green. Use the arrow in the upper right to get to the next screen where you can select a category. -
Page 35: Select Or Add A Program
User Manual FOX IV August 2021 6.2.4 Select or add a program Select program: Choose a program by touching it and the color will change to green. Use the arrow in the upper right corner to select a program and to get to the main menu. Alternatively, a double click will also redirect you to the main menu. -
Page 36: Programs And Settings
User Manual FOX IV August 2021 6.3 Programs and Settings A T T E N T I O N With some devices, programs and preset values are already stored. This does not exempt the surgeon from checking the values according to his knowledge and the desired inter- action with the tissue. - Page 37 User Manual FOX IV August 2021 6.3.1.2 Save values To save the changed values, press the Save button. It will only appear when values of the basic setting have been changed. In addition, the values for power / pulse length / pulse pause can also be changed, as described in the following chapters.
- Page 38 User Manual FOX IV August 2021 6.3.1.4 Pulse pause To change the pulse pause, touch on the column of the pulse pause and the symbol as well as the number will change to green. Now the pulse pause can be adjusted by either using the scroll bar or the plus/minus keys.
- Page 39 User Manual FOX IV August 2021 6.3.1.5 Cumulated energy In the field on the left, the delivered energy is ac- cumulated. In relation to the set pulse length, pulse pause, power and shots applied the laser cumulates the emitted energy. It is also possible to show different parameters instead of the en- ergy.
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Page 40: Settings
6.3.1.7 LLLT Mode with 500 mW max Power output When starting the laser with „1111“ the maximum power will be lim- ited to 500 mW. This allows to use the FOX IV as a Low Level Laser Therapy system, indicated by the icon shown on the left. - Page 41 User Manual FOX IV August 2021 Tone / Pitch Save power Aiming beam Settings for display brightness and Adjust system volume and tone. Set aiming beam brightness and sleep time flashing frequency Memory Lock Screen Language Just follow the instructions on the Enable or disable the lock screen.
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Page 42: Advanced Settings
User Manual FOX IV August 2021 Change user password In this screen, you can change the user password that is requested after the startup routine. The password consists of four digits (default is "0000") and the input field is filled by pressing the number keys. After 4 numbers have been entered, the action is completed. -
Page 43: Insert The Applicator
The connector must snap into the fiber coupling of the laser. If the plug has not properly clicked into place, the device will not change into READY mode and the FOX IV 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 44: The Treatment
READY button afterwards. The READY LED lights up in orange. The aiming beam will be visible and the treatment can be started. The software of the FOX IV permanently sums up the emitted energy which is shown in the lower area of the display. -
Page 45: Switch-Off
On / Off button 6.11 Charging the battery Insert the power supply into its socket at the rear panel of the FOX IV. The charging process will start, as soon as the orange LED shows up. As soon as the battery is completely charged, the orange LED will switch off and the green LED will be lit. -
Page 46: Symbols
User Manual FOX IV August 2021 6.12 Symbols Display brightness 10-100 % Log-out/ Access Sleep mode time (5-60min) protection Tone (10-100%) Advanced settings Pitch (10-100%) Aiming beam brightness (1-100 %) Change user password Aiming beam frequency (0-10Hz) Remember previous mode System information CW in “pulse on”... -
Page 47: Additional Laser Module
The additional laser module can be connected simply by putting the FOX IV on top. Just connect the FOX IV with the plug connection of the module as can be seen in the pictures below. - Page 48 User Manual FOX IV August 2021 To use the module, remove the fiber from the main unit and insert it into the module. The module is controlled using the display of the main device. To change to the wavelength of the module, just press die wavelength of the module in the lower area of the dis- play.
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Page 49: Technical Data
100 - 240 V AC, 50/60 Hz, 1.06-0.45 A Charger output / Console input 19 V DC, 4.74 A Battery 10.8 V, 26.4Wh, Li-Ion (by A.R.C. Laser) 8.4 Classifications Laser class: (Classification according to EN 60825) Laser class aiming beam:... -
Page 50: Service
A.R.C. Laser GmbH. This also includes any type of optics cleaning within the laser system as well as battery pack replacement. -
Page 51: Care By The User
User Manual FOX IV August 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 after the safety-related inspection (STK), the device may no longer be operated. -
Page 52: Accessories Cleaning
Probes. 9.5 Error detection The FOX IV 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 yourself. -
Page 53: 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. Such errors may include: • Interlock plug missing, disconnected or defective •... -
Page 54: Troubleshooting
User Manual FOX IV August 2021 9.5.2 Troubleshooting The following errors cannot be identified by the system self-check and have to be checked by the user: Problem Potential Error Troubleshooting As a standard, the laser falls in power Screen is black Laser is in Sleep mode safe mode after 5 min of inactivity. -
Page 55: Error Messages
User Manual FOX IV August 2021 9.5.3 Error messages An explanation follows in the Indicates a warning message text lines below Check the door interlock connection, connect the Door interlock missing/ Door open interlock plug included with the system or close the door... -
Page 56: Status Messages
The device must never be disposed with household waste. 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 cus- tomer. -
Page 57: Customer Service
A warranty claim for defective parts, malfunction or damage of the housing of the device shall be passed on to A.R.C. Laser GmbH within 24 hours. Parts returned during the warranty period (upon the explicit request of A.R.C. Laser GmbH), are subject to the written confirmation by A.R.C. -
Page 58: Guidelines And Manufacturer's Declaration
User Manual FOX IV August 2021 11 Guidelines and Manufacturer’s Declaration 11.1 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 59: Electromagnetic Immunity (1)
User Manual FOX IV August 2021 11.2 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 60 User Manual FOX IV August 2021 Only the voltage of a typical professional healthcare facility 0% UT; 250/300 cycles Power interruption 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 61: Electromagnetic Immunity (2)
User Manual FOX IV August 2021 11.3 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 62: Recommended Separation Distances Between Portable And Mobile Rf Telecommunications Equipment And The Laser
User Manual FOX IV August 2021 11.4 Recommended separation distances between portable and mobile RF telecommunications equipment and the laser The laser is intended for use in an electromagnetic environment in which the RF disturbances are controlled. The customer or the user of the laser can help to avoid electromagnetic interference by maintaining the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the laser - depending on the output power of the communication device, as stated below. - Page 63 User Manual FOX IV August 2021 Notes: File: User_Manual_FOX IV_rev2...
- Page 64 A.R.C. LASER GmbH Bessemerstr. 14 90411 Nuremberg Germany Phone: +49 911 21779-0 Fax: +49 911 21779-99 www.arclaser.com...
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