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Medical Diode Laser System

1. There are two versions of the fiber port the silver 300 micron port and the yellow 400 micron fiber port 600 um 300 micron 400 micron Fibers and hand pieces single use to be used in systems with the 300 micron port do have a white or red connector in case of the 400 micron port they do have a yellow connector File User Manual Fox IIl EN dOCX 26 Manual FOX A K C September 2012 ATTENTION Fibers and hand pieces which are designed to be reused do have a green plug They cannot be assigned to the appropriate system in accordance with the color of the plug In this case the user has to be carefully look at the label of the packaging of the fiber or hand piece ATTENTION Never work with a tool at the fiber or at the fiber port Fibers may break do not bend Protect fiber ends against dust and dirt Never use defective fibers 6 6 1 1 READY Key The READY Key is a black circular push button with two lateral yellow LED guides Press the READY Key button once and release to switch to READY mode The two yellow LED guides will start flashing accompanied by a beeping sound After approx 3sec the two lateral yellow LED guides will remain on indicating that the device is now ready for operation Pressing the READY Key button again will deactivate the READY mode A confirmation beeping sound will be heard and the two lateral yellow LED guides will turn off 6 6 1 2 Laser STOP E STOP The E STOP button
2. Manual FOX Medical Diode Laser System 810 nm 980 nm 1064 nm A R C Laser GmbH C 1 27 5 Bessemerstr 14 Phone 49 911 21779 0 info arclaser de D 90411 Nuremberg Fax 49 911 21779 99 www arclaser de Manual FOX September 2012 LASER Please contact for Service in A R C Laser main office A R C LASER GmbH Bessemerstr 14 D 90411 Nuremberg Phone 49 911 21779 0 Fax 49 911 21779 99 service arclaser de Version number Fl 00 User Manual Fox Ill EN Revision Date September 09 2012 MG Markus Graf Inspected R Walker File User Manual Fox Ill EN dOCX 2 Manual FOX A R C September 2012 LASER FOX Laser The multi functional diode laser with green aiming beam touch screen and programmable power File User Manual Fox IIl EN dOCX Manual FOX September 2012 LASER CONTENT 1 1 1 1 2 1 3 2 3 4 4 1 4 2 4 2 1 4 2 2 4 2 3 4 3 4 4 5 1 5 2 5 3 5 4 5 5 5 6 5 7 5 8 5 9 5 10 5 11 5 12 5 13 5 14 6 6 1 6 2 6 3 6 4 6 5 6 6 INTRODUC TION rc 7 eio el rufo l Re M sexs 7 Marking and Symbols ec n 7 Intended USe NER NR RE TU 8 THEORY AND TECHNICAL BACKGROUND OF A DIODE LASER 9 TRANSPORT AND STORAGE 1 eoeereeree nnne nennen nnns na nnns ha hu annua annua enu 10 INSTACCA TION DM 1
3. Automatic deactivation in min editable INFO State of charge of the battery in percentage 7 3 4 Settings Submenu 3 CO 29 J 49 1 H 0 6 25 INFO Air humidity in percent INFO Internal temperature TYPE 810 nm IC09501 V1 1a 10 02 12 S Nr 610756 AAA IC09509 V0 9 05 02 12 INFO FO1d IC07001 V1 3 18 01 12 Leave submenu 2 with the arrow key right and get into the next submenu 3 Here you can change the language of your FOX and alter the memory function Language 7 3 4 1 Hemember surgeon application 7 3 4 2 7 3 4 1 Language E Settings EXIT HOME TYPE 810 nm S Nr 610396 AAE IC09502 VO 11 INFO FOOb Advanced Settings 7 3 4 5 Edit Password 7 3 4 4 RESTORE 7 3 4 3 IC09501 V1 1a 10 02 11 IC07001 V1 3 18 01 11 Pick your desired language with the arrow buttons 7 3 4 2 Remember surgeon and application Once you choose the remember icon indicated dark you set the Gy dark Memory function and the FOX will remember the last settings for Surgeon and application At the next Starting Routine the screen for Surgeon and Application will be skipped The Memory is switched off when the clip icon is bright 7 3 4 3 RESTORE bright This function restores default settings and deletes all kind of user settings and modified parameters Programs and Settings are restored 7 3 4 4 Edit Password lt ENTER PASSWORD This screen is to modify your user
4. Pulse interval Energy Counter Joules P s or Hz Minus Plus to increase or decrease the chosen value Pulse Counter Foot pedal wireless foot pedal optional USB Flash drive status Power supply status 7 3 1 1 Saving parameters oection 7 2 3 describes how to modify program names In addition you can also change the parameters for power pulse length pulse interval as described in the following 3 sections To store the modified parameters please press the save button This button appears only after you change a value 7 3 1 2 Power Dr A Mustermann After pressing the power display Watt you can adjust its do peels value with its plus or minus button By keeping the field pressed down for a little while a power bar will appear in which you can directly scroll to the required power value The displayed value may vary from the emitted value at the distal tip by a range of 20 7 3 1 3 Status USB Flash Drive If inserted the Flash drive icon will show up In case the drive is defective or not en inserted the display does not show this icon File User Manual Fox Ill EN dOCX 33 Manual FOX IK September 2012 LASER 7 3 1 4 Pulse Length Adjustment You can adjust the pulse length through the pulse length menu Dr A Mustermann JN Application NN V JPN Impe a ys ms SEC 100 1 12 26 48 100 210 eo 1 7 200 2 13 28 so 110 220 eso 15 8 ao
5. September 2012 LASER The TFT Display Fiber LED E STOP button is pressed Pull up E STOP and the device can Status LED are dark be started File User Manual Fox Ill EN dOCX 56 Manual FOX September 2012 12 Guidelines and Manufacturer s Declaration 12 1 Electromagnetic Emissions The laser is intended for use in an environment as specified below The customer or the user of the laser should ensure that it is used in such an environment Immunity tests Compliance Electromagnetic environment guideline RF emissions CISPR 1 1 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 1 1 Group 1 Class B Harmonic emissions IEC Complies 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 The laser is suitable for use in any and all establishments including establishments in residential areas and those directly connected to the public power supply network which also supplies buildings used for domestic purposes File User Manual Fox Ill EN dOCX 57 Manual FOX September 2012 12 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 I
6. The fibers at the front must have sufficient space to avoid accidental bending The air humidity in the treatment room should be monitored and kept below 75 Room Requirements Legislation imposes the following requirements to any room in which a class 4 laser according to EN 60825 1 is operated 4 2 1 Warning signs All ingresses shall be clearly marked to prevent an outside person from entering as this might be hazardous e Please attach the laser warning sign triangle with laser symbol as well as the wavelength marking at each access door e Please mount a warning lamp above each access door which always has to light up when the laser is in operation This ensures warning to prevent accidental entry to the room without protective goggles e Please store the laser protective goggles at the entrance of the room and make sure they are readily accessible 4 2 2 Windows shielding Windows need to be covered with suitable masking or shielding to prevent laser radiation leakage For any question or in case of any doubt please contact your local A R C Laser authorized dealer or contact directly to A R C Laser GmbH at any time File User Manual Fox Ill EN dOCX 11 Manual FOX September 2012 LASER 4 2 3 Reflecting surfaces 4 3 4 4 To avoid possible danger caused by reflected radiation direct or scattered reflecting surfaces must not be present in the room during operation Such surfaces may include mirrors pictur
7. 3 14 30 ss 120 zoo 700 2 9 400 4 15 s2 60 120 240 750 25 10 Fe 6 17 26 70 150 2o eso 4 2o 700 7 18 88 75 160 300 900 5 45 800 8 t9 40 80 170 350 950 6 few 900 9 20 42 85 80 40 1022 44 90 190 450 tt 24 de 95 200 s0 CW continuous wave Choose your favorite values from this table below Screen with highlighted Pulse on values Therefore hold the button for at least FL Puls on Table 2 sec Highlighted values are preset 99 us 300 us Add or deselect values of your interest 1 190 130 150 160 170 180 190 to modify your presets as necessary 200 210 220 230 240 250 260 270 280 290 450 700 750 800 850 900 The new Preset table is activated by ues leaving this screen via this HOME button File User Manual Fox Ill EN dOCX 34 Manual FOX IN September 2012 LASER 7 3 1 5 Pulse Interval Adjustment While keeping the pulse interval field pressed down you will reach the interval release table where you can select marked and preset individual parameters Dr A Mustermann JN Application NN 900 9 20 42 85 180 400 950 1022 44 90 190 450 tj24 46 05 200 500 Choose your favorite values from this table below Screen with highlighted Pulse on values Therefore hold the Pulse off button for at least 2 LJ Puls off
8. 940nm Maximum Permissible Exposure MPE 76 88W m NOHD 1 24m Power P 14 4W Wavelength A 980nm Maximum Permissible Exposure MPE 92 42W m NOHD 1 96m Power P 12W Wavelength A 1064nm Maximum Permissible Exposure MPE 31 82W m NOHD 3 05m However this hazard distance is irrelevant as the access to the laser radiation is blocked by the marked operation room for the laser device See also Hoom Requirements Section 4 2 and Eyewear Protection Section 5 2 herein CE Regulations The FOX Laser system was accredited by LGA InterCert Nuremberg in accordance with the European directive 93 42 for medical equipment Therefore the device is labeled with the CE mark CE 1275 The device was tested for electrical compliance as well as for mechanical safety All parts used by A R C Laser for the FOX Laser comply with CE regulations Any additional equipment that needs to be attached to the device must require the official approval of the local inspection authority No modifications for the device are allowed as these may have a serious risk potential and will void the regulatory approval as well as the warranty File User Manual Fox Ill EN dOCX 18 Manual FOX ARC September 2012 BN Lied 5 8 External Interlock Plug 5 9 At the rear of the console a removable plug is inserted through a circular socket see photo below The plug when fully inserted enables main power to the console internal circuitry Should this plug pull
9. Dsena oien ard nM Oda EE Opis anh cue desma IG CI DEVI EL UI MU RESL ld up 54 11 1 2 Warning MCSSAGCS uxsaxemtiesxkxEkasipuiaaadb alid mese xata n KEA AKEE VR Rc ao n NL i 55 1125153 Ste 2118 HODDOLD ise meee ee en uic en eee exin hanno unde ne eee eee ges puede 55 12 GUIDELINES AND MANUFACTURER S DECLARATION 57 12 1 Electr m gnelic EMISSIONS cesecicccsceeicoe cs scpseasataecesensnteereeeduterawottensseseoncceensevinwssautwcasavunysedececesas 57 12 2 Bl ectromagnelc Immunity T uei ecae a cecens a uu CUu aqu EE Le E Ra usa Aue EL van Du SaaS cdeEE E 58 12 9 Eleculomagnele IMMUNITY 2 sresruk 60 12 4 Recommended Separation Distance between Portable and Mobile RF Telecommunications Equipment and the Laser e ee ceeeeee eee rennen 61 File User Manual Fox Ill EN dOCX 6 Manual FOX September 2012 LASER 1 Introduction We appreciate your decision to purchase the FOX Laser and wishing you a productive and successful usage with this multi functional laser system The FOX Laser generates high intensity laser beam which may induce injuries in improper handling Therefore this User Manual should be read carefully before using the device Should you have any further questions regarding safety the use of the device or concerning laser and laser radiation please contact A R C Laser GmbH or your local authorized dealer see Section 10 3 Sales and Ser
10. applicator If the plug has not properly clicked into place the device will not change into READY mode and the FOX Laser will not work Please pay attention to a clearly perceptible click when inserting the plug You may need to twist the plug a bit while its partially inserted in order to be able to fully click it into place Once the plug has been locked in place you can hold the applicator hand piece in your hand At this point infrared radiation can be emitted through the applicator upon activation of the foot pedal Therefore please ensure the applicator is aimed away from any person other than the patient target area and is not pointed toward flammable materials 7 6 Ready Key The READY Key is a black circular push button with two lateral yellow LED guides Press the READY Key button once to switch to READY mode Upon pressing the two yellow LED guides will start flashing accompanied by a noticeable beeping sound After approx 3sec the two lateral yellow LED guides will remain constantly on indicating that the device is now ready for operation Pressing the READY Key button once again will deactivate the READY mode After pressing a single confirmation beep sound will be heard and the two lateral yellow LED guides will turn off and the aiming beam will go out File User Manual Fox IIl EN dOCX 39 Manual FOX A R C September 2012 Pushes 7 7 USB flash drive INFO FIASH DRIVE You can connect the USB flash driv
11. cc 31 rA MEN o dioutiue dioe PEE m u A A 31 7 2 2 Select a Surgeon Add a new surgeon ssseessssssssssseseeee eene 32 E Oee miele tz RP en me ene eens en eee ee 32 7 3 Working with Selected Programs 1111 eeee eL ieeeeeee e ieeeee nene nenne enhn hann enhn nnn 33 731 Display 7 Main MOM M 33 7 3 1 1 Said i IC USS asa E A EE E E A I A E A E N E E EA 33 7 3 1 2 POWO ae e E a E 33 7 3 1 3 Stats USB Flas DIVE m 33 7 3 1 4 Pulse Length Adjustment usd ancendaudensccaassautariieaenciearetianseuartaasedenanaia same Cae true tau nua ed daas 34 723 1 5 Pulse Interval Adjustment ssdeussnssduzkxntzkexksuaUexRstasY rug esikduikEtu tal esl duiiiexBau Md ez Re dd vEA autas qd uu adu 35 7 3 1 6 PIS SO GUISE qM T E 36 s Energy Counter J or P s or HZ cccccccccsssseeeecceeeeeceeeceeeseeeeeeeeaeeeeeesseaeeeeeesseaseeeessaageeeeseaas 36 ToL OWNS SUDMENU 36 7 3 3 Settings Submenu 2 0 ccccccceseeceeecceeeeeeessccseeeeesncseecensecsseneeessoseneeesccseeeeesccseeeeesscoseeeesssees 37 7 3 4 Settings Submenu 3 eessssssssssesseseese nennen nnne nnnna nnn nis nna ann rssesa assis sena sanis sns a aan sna aa 37 7 3 4 1 EDO oT EP 37 7 3 4 2 Remember surgeon and application l
12. controlled area within the facility e Post appropriate laser warning signs at the entry way to the laser controlled area e Use a door blocking barrier screen or curtains to attenuate laser radiation in the entryway A laser treatment controlled area is simply an area that is appropriately enclosed so that laser radiation which is above the maximum permissible exposure MPE does not inadvertently escape the treatment area to injure unsuspecting persons Additionally during laser usage it is necessary to e Be under the direct control of authorized laser personnel trained in laser safety and laser operation e Have only diffusely reflecting materials in or near the beam path i e reflective items such as mirrors or jewelry must be removed or covered Provide personnel and patients with appropriate eye protection Have high background illumination Have all accessible windows doorways etc covered Have room walls that are rough in texture dark and non reflecting Have limited amounts of flammable compounds or substances Provide adequate ventilation respirators firefighting equipment etc to control all laser hazards According to Class 4 Laser Product regulations the FOX Laser is equipped with e A secure storage and a power off switch for the laser when not in use to prevent unauthorized operation File User Manual Fox Ill EN dOCX 13 Manual FOX September 2012 LASER e A large visible Red Stop button
13. for deactivating the laser in the event of an emergency Audible and visible activation warning system to indicate that the laser is in ready mode and operation e A master switch to control patient exposure e A door interlock switch which is an interlock plug switch that can be connected to the door When the door is opened the device will immediately switch off however we also recommend to manually lock the door from the inside to prevent unintentional entry Even though the safety information included in this manual is detailed it is not intend to replace industry standards and guidelines for laser safety We would recommend keeping the document Operation of Laser Facilities and Accident Prevention Regulations for Laser Radiation which may be obtained through your local authorized dealer In addition you can refer to the regulations of the American National Standard Agency ANSI Z136 3 1996 American National Standard for the Safe Use of Lasers in Health Care Facilities and ANSI Z136 1 1995 American National Standard for the Use of Lasers Our local dealer s technical support department will gladly answer any questions you may have and provide you with appropriate training as well as assist with obtaining additional industry standards and guidelines for laser safety File User Manual Fox Ill EN dOCX 14 Manual FOX September 2012 LASER 5 2 Eyewear protection ATTENTION Never look directly into the laser beam or to the
14. is on the top left side of the device If the E STOP button is pressed while starting 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 sen Solution Pull up E STOP and the device can be started see 7 2 Pressing the E STOP button while working with the FOX Laser will instantly cut off the laser output Solution Pull up E STOP and restart the device see 7 2 File User Manual Fox III EN dOCX 27 Manual FOX A R C September 2012 LASER 6 6 2 Rear Panel The following connector sockets are located at the rear panel Power supply Door interlock AUX 1 AUX 2 Service Ports Foot Switch 6 6 3 Right Side Panel The following connector sockets are located at the right side panel AUX 3 Power Meter AUX 4 USB port only for the A R C flash drive It contains valuable information Do not connect any other USB device to this Port File User Manual Fox IIl EN dOCX 28 Manual FOX September 2012 LASER 6 6 4 Sockets It is prohibited to use the device s sockets for other usages than those detailed here Socket Description Noe Charging device PS01013 To charge internal batteries Door Interlock Connecting the door interlock switch pe AUX 1 External eye protection filter Umax 3 3 V Imax 330mA AUX 2 Isolated port works as a remote Max 24V do not plug in a device contro
15. password Standard is aes 0000 you need it at the end of the starting process A vmm password consists of 4 numbers By pressing the numeric ES File User Manual Fox Ill EN dOCX 37 Manual FOX September 2012 LASER keypad you fill the input box After 4 numbers there is an automatic Return The Routine 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 7 3 4 5 Advanced Settings Only trained personnel should use the features of the advanced setting screen 7 4 Charging the battery Insert the Power Supply Art Nr PS01013 into its socket at the rear side of the FOX owitch on the device see 7 2 and enter your password Charging Process is initiated The orange LED shows up If you might want to switch off your FOX the charging process will be continued As soon as the battery is completely charged the orange LED will switch off The green LED will shine on File User Manual Fox Ill EN dOCX 38 A D f Manual FOX A K C September 2012 LASER 7 5 Inserting the Applicator When the preselected power and pulses comply with the treatment parameters the applicator can be plugged into the laser aperture Gently push the applicator plug into the socket until it firmly clicks into place In case it does not click in correctly try to twist the plug inside the socket Plugging in the
16. within the warranty period We reserve the right to modify the design of the device if necessary thus increasing the safety or the functioning of the device The responsibility for the design as well as any modifications of the device is exclusively incumbent on A R C Laser GmbH The customer will be informed about any changes which will be carried out on the premises of A R C Laser GmbH Sales and Service Information For information about sales and service please contact A R C Laser main office A R C LASER GmbH Bessemerstr 14 D 90411 Nuremberg Phone 49 911 21779 0 Fax 49 911 21779 99 Email info arclaser de www arclaser de File User Manual Fox Ill EN dOCX 53 gl m B pm anual FOX ARC September 2012 HS 11 Symbols Description Display brightness 5 100 96 ld Charging level of battery Aiming beam brightness 1 100 Temperature inside Aiming beam frequency 0 6Hz Sleep mode time 7 Air humidity Pick language State of power supply Flash Drive inserted State of wireless foot switch Fully charged d Your wireless footswitch is charged Please charge your well wireless foot switch p You have to charge your wireless foot amp 3 Cable version of foot switch e switch is pre selected Next screen Previous screen Attention 11 1 1 ERROR MESSAGES m C amr umi ER h Brightness Ready Button 5 100956 R oder das Bild ist nn weiterhin das rote x angezeigt wird m
17. 1 MsSlalalon SNe ecc M 11 aleeni iu uccBeetc c 11 WY ALN SIQING TNNT E 11 Windows shielding sees nennen nnne nennen nn nnns nnn nnn nnn nnn 11 Reflecting SUNaACE S esarete mmm 12 Electrical Connection PB RE n 12 sila ioci E eee 12 SAFETY INFORMATION AND TECHNICAL ACCEPTANCE 13 c e 13 Eyewear PIOlCCHOIN te 15 leue ger tejiio Met 16 EXDIOSION and Fire AZ ANG 16 Protection against Undesired Radiation ccccsscsscccsssesseeeseeessseeeseeeesseeeseoenseeeseoensseesseoenss 16 NORD SAL y DIST eiciia 18 CE Heduldllolls uude a dane oan Hi di ves nee ceuee rent eeaderemanucdtiyeeteeeteeeics 18 icai aite dam c c 19 Console Protecting Housing 2 ce rii oresa ce rna race c nna apa nra na auvX SEE e ea Yu eC MEUS n KEEN CCo E rara nn 19 SEY jr me 19 Manual RS e M 19 Stickers Labels and Markings Ete T nn en ne ene ener 20 Operating Conditions icicsccsstiecbcdeenccectdissecctesiceyicdvenndadeawcteedcavenectestevseciaveeivinswessediaveussiasvedseeiavetee 22 Electromagn
18. 4 Recommended Separation Distance between Portable and Mobile RF Telecommunications Equipment and the Laser The laser is intended for use in an electromagnetic environment in which radiated RF are controlled The customer or the user of the laser can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the laser as indicated below according to the maximum output power of the communication equipment Maximum output Separation distance according to frequency of transmitter in power rating meter m of the transmitter W 150 kHz to 80 MHz to 800 MHz to 80 MHz 800 MHz 2 5 GHz d 1 17 1 V vP d 1 17 1 V vP d 2 2 33 m V vP 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 73 1 1 17 1 17 2 33 10 3 69 3 69 7 30 100 11 66 11 66 23 30 For transmitters with a maximum output power rating not listed above the recommended separation distance d in meters m can be determined by using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to transmitter manufacturer list NOTE 1 NOTE 2 At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people File User Manual F
19. Table ps us sec Highlighted values are preset Add or une uu 1 348 qum wxy Gn dm dm deselect values of your interest to modify your 200 210 220 230 240 250 260 270 280 290 presets as necessary 450 500 600 650 700 750 800 850 900 The new Preset table is activated by leaving this screen via this HOME ft button Thus the highlighted fields constitute an individual preselecting and only these parameters will be available Example If the pulse length is 10 ms and the pulse interval is also 10 ms 50 pulses per second will be applied when the pedal switch is pressed down Intervals between the individual laser pulses are important to make sure the tissue treated has sufficient time to cool down File User Manual Fox Ill EN dOCX 35 Manual FOX September 2012 LASER 7 3 1 6 Pulse Counter The triggered pulses are accumulated The device automatically counts the laser pulses triggered by means of the foot pedal or set by pulse repetition rate The maximum number of pulses registered is 9999 To reset the field 0000 you need to tip on it 7 3 1 7 Energy Counter J or P s or Hz Three versions are available in this tally field Energy joule The displayed energy value is the product resulting from the set power and the actual time of exposure as well as the number of pulses triggered The unit automatically changes from mill joules mJ through Joules J to kilojoules kJ acco
20. aser Please follow the following steps when preparing the device to operation in order to avoid unnecessary troubleshooting or even possible malfunctions e ls the battery charged or is the mains cable at the rear panel connected e Please connect the mains when the device is switched off Has the strapping port for the external interlock been plugged in or if applicable has the door interlock contact been connected to the laser The fiber port should be empty Has the A R C Laser USB stick been unplugged from the USB port Are the fibers and hand pieces that are to be used free of any damage Is there sufficient number of protective goggles ready to be used Has the pedal switch been plugged in ATTENTION A warning lamp s outside the treatment room door s must be switched on as soon as the laser starts to operate the doors have to be marked as laser rooms visible from outside with the warning signs ATTENTION oince the green aiming beam shares with the infrared laser beam the same optical delivery system it provides a very good indication for checking the intactness of the laser optical delivery system If the target spot does not appear at the distal end of the laser delivery system or if it has low intensity or appears to be diffused this may indicate a damaged or not properly installed delivery system of the unit File User Manual Fox Ill EN dOCX 30 Manual FOX cA LS September 2012 LASER 7 1 1 Install
21. ation Site We recommend placing the FOX Laser on a solid even surface A suction cup mount is included in the carrying case to secure the device 7 1 2 Suction Cup Mount Moisturize the cups and press them firmly onto the even surface Verify if they position firmly by slightly shaking or pushing the suction cups 7 2 Starting the Device owitch on the device by pressing the two arrow keys simultaneously for at least two seconds The red status LEDs at the fiber port will light continuously and the green starting LED will begin to flash After about 30 seconds the startup screen will appear The FOX Laser ENTER PASSWORD executes its LASER ERES system check Bessemer Str 14 D 90411 N rnberg automatically _4 jJ E LER Fon 49 0 911 21779 0 Fax 49 0 911 21779 99 upon startup ia n j info arclaser de www arclaser de 0 J ae Once the system check has been completed you have to enter the password 0000 See chapter 7 3 4 4 to modify the password 7 2 1 Fiber Port Fiber Coupler The fiber coupler has a control mechanism which can prevent the device from switching into the READY mode as long as no fiber has been connected Please do not insert any objects or liquids into this port as this might damage the ceramic disk used for centering the fiber File User Manual Fox Ill EN dOCX 31 Manual FOX A R C September 2012 Peak m Ww 7 2 2 Select a Surgeon Add a new surgeon Choose
22. cians unless they went through the recommended training for the device The fact that even personnel not working directly with the laser should attend the laser safety or laser application courses has proven to be very useful Laser safety the basic principles of the laser and of laser treatment is mainly discussed in these courses It is particularly important that the operating personnel attend the laser safety courses In these courses extensive training is given to master precautionary measures when working with lasers e g caution in case of combustible material the importance of laser protective goggles etc are dealt with in detail File User Manual Fox Ill EN dOCX 23 Manual FOX September 2012 LASER 6 4 Training for the accompanying personnel is offered in addition to the introductory and is given by the local A R C authorized dealer service person when installing the device In this training special attention is given for safety in general like the laser protective goggles It also covers clinical information as well as references to the indication but does not intend to be complete and to be used as is since each patient may require different parameters A R C Laser GmbH holds a list of recommended courses as well as laser safety courses available and can be retrieved from us through our local dealer at any time Medical Introduction Training The scope of the device medical introduction training is to provide bas
23. e 2 Static errors errors which require contacting A R C Laser service department or the local authorized dealer For these usually an error message will appear in the display and can assist to identify the problem when calling for service File User Manual Fox Ill EN dOCX 46 Manual FOX September 2012 LASER 9 6 Troubleshooting The following errors cannot be identified by the system self check and have to be checked by the user Problem Potential Error Troubleshooting Laser is in Sleep mode As a standard the laser falls asleep after 5 min of inactivity Touch the display or a blue arrow key to activate the device Laser is in Stand By mode Aiming beam becomes visible only when the laser is in READY mode Switch the laser to READY mode Aiming beam brightness Increase the parameter for No aiming beam visible set at 0 aiming beam brightness Twist the fiber connector inside the socket with a light movement inwards Pedal switch non plugged in Check if pedal switch is correctly nad dnd Kea cp Switch is empty mu foot switch batteries Wireless Foot Switch is out of Place the foot switch at a place Fiber optics not connected to Check the correct fitting of the No aiming beam and no laser laser or hand piece not fiber or hand piece beam correctly plugged in Screen is black For a complete list of error codes please see Section 11 File User Manual Fox Ill EN dOCX 47 Manual FOX September 2012 9 7 Pow
24. e included with the DERMA 1 system to the USB port located on the right side of the DERMA 2 DERMA 3 console To access the content of the flash drive you need to touch the question mark on the A R C E DERMAS O infoscreen see Section 7 3 4 In the provided flash D NAIL CARCINOM drive you can find useful information including videos 1 NAIL FUNGUS for a wide range of applications Enjoy paging through 7 8 Switching Off Switch off the FOX by folding back the cover stand If you do not plan to use the FOX Laser for a long time stow the laser in its carrying case 7 9 Power Save After 5 minutes of inactivity the FOX automatically goes to Stand By to save power e he TFT screen gets dark e he green status LED indicates with 1 Hz To wake the laser just tip the touch screen or one of the blue arrow keys After 5 more minutes of inactivity the laser switches off completely You will need to restart it by pressing both blue arrow keys File User Manual Fox IIl EN dOCX 40 Manual FOX September 2012 8 Technical Data 8 1 Dimensions device open 8 2 General Model FOX Cooling Weight Dimensions 8 3 Laser Data Wavelength 810 nm 940 nm 980 nm 1064 nm Display Pulse lengths Shot frequency Power transfer Aiming beam Operation mode 8 4 Power Requirements External power requirement Charger output Console input Battery File User Manual Fox IIl EN dOCX device clo
25. e protective eyewear For all Fox models use laser safety goggles with either protection class OD 7 or protection class DL5 DIRL5 Your FOX Laser package is supplied with two units of laser safety goggles according to the wavelength model intended to be wear directly i e not to be wear on top of glasses Protective goggles that meet all safety requirements can be obtained through your local A R C Laser authorized dealer including special models someone can wear on top of glasses e Keep laser eyewear in an opaque case when it is not in use as the coating can be degraded by exposure to daylight over time e Follow the laser eyewear manufacturer s recommendations on shelf life storage conditions and appropriate cleaning methods e Inspect protective eyewear regularly In case you suspected of any physical damage cracks dents scratches discoloration layers peeling DO NOT use please contact your local A R C Laser authorized dealer for replacement File User Manual Fox Ill EN dOCX 15 Manual FOX September 2012 LASER 5 3 Should you require any additional information on protective goggles please contact your local A R C Laser authorized dealer Electrical Protection The FOX Laser works with a low internal voltage of 19 V Do not disassemble the unit Never remove any housing parts as this can cause a serious risk hazard as it may immediately destroy the laser diodes Any service to the unit or its accessories s
26. e symbol for the status of the wireless foot switch appears on the display Once the wireless foot switch is recognized the symbol changes to normal condition There are 4 versions which show the current state of charge of the battery b Battery is fully charged m Battery is sufficiently charged bh perd Battery ought to be charged kh ry Battery must be charged Otherwise a failure free connection cannot be assured File User Manual Fox IIl EN dOCX 50 Manual FOX September 2012 9 8 1 Charging the battery for the wireless foot switch Retreat the battery from the battery compartment Therefore unscrew the cap counterclockwise Retreat the battery from the battery compartment Therefore unscrew the cap counterclockwise The charging over night normally ensures a fully charged battery After charging the battery can be used as usual 9 8 2 Cable connected foot switch As an alternative to the wireless solution you can always switch to the cable connected version By pressing the symbol for the wireless foot switch here red as an example it changes after a few seconds to the y 2s symbol for the cable connected version amp 3 4 9 8 3 Go back to the regular foot switch By pressing the symbol for the cable connected foot switch it changes automatically after a few seconds into the wireless function mode 25S File User Manual Fox IIl EN dOCX S Manual FOX Se
27. ececeeeeeceeessaeeceeecsaaeceeeeseaeceessuaaeeeeesseaeeeesssaageeeeesaags 44 9 3 1 3 Applicators for non sterile use cccccssseccccsececceseeecseseecsaseesseaeeeecsaeeesseuseesssaseeessageees 45 9 4 Eror DEtEC HON emm V 45 9 5 VSEM OSI CNCC a a a sauass oteewenkdnemesetanseeedecseeeaesteceetias 46 9 6 ME OUDISS HO QUIN upina E EE EEEE ENE E E E EEEE a a 47 9 7 OV ST Calibration NP E 48 9 8 Wireless foot pedal optional cu neut coo asupuu chc anke duca clisuus qs oucu sa sauu cona uu crus asi aaa aa 50 9 8 1 Charging the battery for the wireless foot switch ccccccseeeeeceeeeeeeeeeseeeeaeeeeeeeeeeeeeseaeeeesaneeeeas 51 9 8 2 Cable connected foot switch ccccccccssescceeceeeeeeeecceeeeceeecseeseeeesssaaueeeesseaaeeeeesesaaseeeesseageeeesssaaaes 51 9 8 3 Go back to the regular foot switch eeesssssssesessesssssseseennn ennemis 51 9 9 Proper DISDOSd sree cece a eins cn es i see eee ee mre du elec madens een ane cee cee dE eer 52 10 SOI ee Oh VS een ee sues Ea cnnsesme gees baroninon anaana iiaiai inaidai iani 53 10 1 Warranty InfOFmidllOT sisside aE 53 10 2 Warranty Consignments Packaging 111 ee eee Lieeee eee e ieeeee enne nenne nnmnnn mnnn 53 10 3 Sales and Service Information uei coc sese eiducvL ve eau UBL veut cu Ua aas Edu coU quus Casu cN E dvo UE nnmnnn 53 11 SYMBOLS DESCRIPHON sa EEIUE PESE bu EE 54 Edd ERROR MESSAGE
28. ed out the console will instantly shut down The plug is intended to be used as an additional safety switch by connecting it to the door of the treatment room Should the door be unexpectedly opened laser radiation will immediately drop to zero Please be advised that the laser can only operate when the plug is fully inserted into the Socket Console Protecting Housing The FOX Laser has a protection housing optically sealed to prevent laser radiation leakages and is electrically isolated Housing should never be opened or modified Non authorized personnel should never attempt to carry out any type of service to the console Console parts should only be removed and replaced by trained A R C Laser GmbH service technicians 5 10 Safety Switch The FOX Laser has an internal safety shutter This safety switch enables the release of laser beam and will open when pressing the READY key followed by the pedal switch After starting the laser the FOX begins with internal tests After he has passed all its internal tests and calibrations the safety switch can give way for the laser radiation The aiming beam becomes active only when the laser is switched to a READY mode the aiming beam is a low power green laser similar to laser pointers 5 11 Manual Reset When an error occurs e g power instable etc the device changes into the STAND BY mode Simply close the FOX Laser cover stand and re open to make sure the device can reactivate i
29. en old and new value is less than 2096 As soon as the fiber is plugged out the calibration is deleted and the pre settings are imported back again ATTENTION Should you have several FOX Laser devices with different wavelengths take care that the wavelength of the measure head corresponds with the wavelength of the laser Otherwise the measurements will be faulty and may result in incorrect output power and cause damage Nevertheless it is important to calibrate the power display externally with a power meter at two year intervals This may be affected by the service team in the course of the safety check at two year intervals In case of any deviations out of tolerance between measurement and power delivered by the system the customer or even the field service technician should not perform any optical adjustment inside the device Should the displayed parameters do not correspond with the actual parameters Do not continue using the device any longer and ask for our customer service immediately File User Manual Fox IIl EN dOCX 49 Manual FOX ARC September 2012 P eae n 9 8 Wireless foot pedal optional As an option your FOX will be delivered with a wireless foot pedal Protection hood B Battery Cover Storage for the battery During the start routine the FOX discovers you will be asked to connect the foot pedal with the laser This Symbol tells you to push the pedal In the same time th
30. er Calibration To this effect the measuring head has to be connected as shown on the right By connecting the laser measuring head with the FOX Laser the power meter menu will open The power display will then Connection to the FOX laser socket Connected to the FOX AUX 3 socket show the actual parameter the laser gives you at the fiber end To this effect keep the pedal switch pressed down The display may now be subject to minor fluctuations in decimal places Connecting the power meter md Fiber coupling Fiber has to be inserted MM 0 Bn gl 5 y dod A AUX 3 H arrow keys the laser has to be switched on and in READY mode While keeping the pedal switch pressed down simultaneously press the two blue arrow keys This is how the FOX Laser calibrates itself thus displaying the real output power measured The FOX Laser can be disconnected from the measure head You can continue your work safe in the knowledge of getting real power parameters displayed You can recognize the calibrated parameters by the fact that they are shown in yellow File User Manual Fox IIl EN dOCX 48 Manual FOX ARC September 2012 Paseo POWER METER POWER METER 1 10 w Press both blue arrow keys to save the new calibrated The power calibration will be preserved as long as the POWER METER fiber remains in the device Calibration will only be stored when the deviation betwe
31. er beam on easily flammable materials as this may cause a fire The pedal switch controlling the laser pulse should never be outside the range of the operator holding the laser hand piece fiber It is prohibited that any person other than the operator controls the pedal switch File User Manual Fox Ill EN dOCX 16 Manual FOX September 2012 LASER In operating rooms in which several pedal switches are available it is particularly important to make sure that the laser pedal switch is in within the operator vicinity and recommended to be clearly marked as the FOX Laser pedal switch ATTENTION During a laser treatment the system is in Ready mode Should the operator need to pause the treatment for any reason the laser must be switched back to Stand by mode In case of pauses exceeding 1 minute please press the Ready key The device must be turned off when left without supervision to prevent usage by unauthorized individuals ATTENTION Installing and or operating the FOX Laser in any other way differing from the one described herein may cause hazardous exposure to radiation File User Manual Fox Ill EN dOCX 17 Manual FOX September 2012 LASER 5 6 NOHD Safety Distance 4P NOHD Beam Divergence For all FOX models 5 7 Diameter beam bundle 240um Beam divergence in rad 0 227 Power P 9 6W Wavelength 810nm Maximum Permissible Exposure MPE 42 26W m NOHD 2 3 M Power P 4 8W Wavelength A
32. es with front glass chrome surfaces windows These surfaces must be either removed or covered with suitable matt type material Even at the area around the laser fiber port use only matted non reflecting as well as non combustible instruments and materials Electrical Connection The laser is operated with a DC voltage of 19 V supplied by its internal battery pack and charged by an external power supply unit The internal battery pack is developed by A R C Laser 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 a AC voltage ranging from 100V to 240V at 50Hz 60Hz Specifications are as labeled Battery pack If the battery pack is mishandled the battery pack can burst cause a fire or even chemical burns Observe the following cautions e Do not disassemble Do not handle damaged or leaking lithium ion batteries e Do not crush and do not expose the battery pack to any shock or force such as hammering dropping or stepping on it e Do not short circuit and do not allow metal objects to come into contact with the battery terminals e Do not expose to high temperature above 60 C 140 F such as indirect sunlight or place located in the sun e Do not incinerate or dispose of in fire Disposal of waste batteries applicable in the European Union and other European countries with separate collection s
33. esired surfaces by improper handling The laser beams of this device are not visible When using the protection goggles filtering such beams the user can neither identify nor see the beams File User Manual Fox Ill EN dOCX 7 Manual FOX September 2012 LASER 1 3 Intended Use The FOX Laser is intended to be used for treatments requiring heating of tissue and or blood up to coagulation or vaporization 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 blood vessels To this effect the laser is used together with application fibers aiming the laser beam to the target tissue either directly or via further optics e g through hand pieces other illustrating optics The laser effect has been designed to allow focused treatment of the disease area with minimal impact on the surrounding tissue Therefore selecting the right laser parameters are essential to allow minimal pain avoid injuries and achieve maximum results Using the laser in any and all other treatment methods is far superior in terms of traumatization and efficiency and the laser treatment is part of the innovative treatment methods in modern surgery The laser can be applied both in unsterile environment for instance at a physician examination room and in a sterile operating room CAUTION The device may only be used by physicians t
34. essen nnne 37 7 3 4 3 RESTORE cesa D Ou IUNII IH MUNI 37 7 3 4 4 zeli ASS WON NORTE 37 7 3 4 5 Advanced Eo NAS cece T 38 7 4 Cnarging the AO ETE 38 7 5 Inserting the Applicator gore m 39 7 6 POY qc 39 7 7 lccsirtnEs g femc T 40 7 8 reme sirain 40 7 9 wol M 40 8 TECHNICAE DAA 41 8 1 DImensioliS sxaccccssanecassevecsatecncecasasaeascssweasasinecescetecucccatecdasnnPeouadsecestaunensccgecedescnauedesmnecesacueesaeseenwedsce 41 8 2 SNC t 41 8 3 Laser rcm 41 8 4 Power FROCUIN CII NS t 41 8 5 SIrCTIepp cme E 42 9 SERVICE c 43 9 1 MEOGUCHON 43 File User Manual Fox Ill EN dOCX 5 Manual FOX September 2012 LASER 9 2 SAEI C DECK an E AE 43 9 3 Care and Maintenance by the USE P ccccccessseeeeeeessseeeeeeeesseeesecensseeeseoeasseeesooaaseeessoonneees 44 93T Accessones lS MAG sorn E EE ARAR E ARRENE RERNE 44 9 3 1 1 FS WC a NT n 44 9 3 1 2 Protective GOQGIES ccccccccssssececcceeeee
35. etic Compatibility ccceeeeeescccssseeeeeeeeeeeceesseseeeeeeseceesssseeeeeseeooessseeeeeessaoes 22 USER INFORMATION AND SYSTEM INTRODUCTION 23 Dispatching and Unpacking the Device ll leeeeee eei eeeeeere sienne nnne nnn 23 Technical Introduction Tal MING s iieuioouees peace sunt euu uo qoos yicou anas xw cc npau RE e cues cx Es cH EGP nns va E EEOSa i MEr SS 23 Laser Safety Training UTI E E 23 Medical Introduction Training uses iuuaaunue i uhiuu an cuu xau EU uS cesta CUsd nud UE caumexnaseaceusssienenussexseuesasusevweceweas 24 List of Medical Devices T 24 Medical Device Parts and Accessories cccccsesseeeeceeenseeeeseeenseeeeeeoenseeeeeeoenneeeeseoenneeessooeeas 24 File User Manual Fox Ill EN dOCX 4 Manual FOX September 2012 LASER 6 5 1 Housing FFM sisssadecesdnadesdiasudssarannsivaiaeadusaad naai iR Aiai bats uiia na t3 aad aaia REAT A AAEN aA 26 6 6 1 1 READY EOV e M 27 6 6 1 2 Lacer TOR E OTOR pae E E E tage eens 27 COo Pe ENE a N E E A E R 28 663 PRON Sode Ae Nm 28 OOA beoe G enrera 29 T OPERA HON cisean TE EEE a E a 30 7 1 Prepara ToN RR C 30 MEE eel ERNEREm 31 PAZ Suction Cup MOU MERETUR T 31 7 2 irjadiein 3b l e moo
36. g power mains interruptions it is recommended that the laser is powered from its battery or an uninterruptible power supply or an external battery Magnetic field with power frequency 50 60 Hz IEC 61000 4 8 3 A m 3 A m Magnetic fields in mains frequency should be those of a typical commercial or hospital environment NOTE U is the A C mains voltage prior to the application of the test level File User Manual Fox Ill EN dOCX 59 Manual FOX September 2012 LASER 12 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 Immunity tests IEC 60601 Compliance level Electromagnetic environment test level guidelines 3 Ver 3 Vas Vi Portable and mobile RF communications 150kHzi0 450 kHz to 30 MHz equipment should be used no closer to 80 MHz the laser including cables than the Conducted RF IEC 61000 4 6 recommended separation distance calculated for the equation applicable to the frequence of transmitter Recommended separation distance d 1 17 V VP d2 1 17 E NP for 80 MHz to 800 MHz d 2 33 m V vP for 800 MHz to 2 5 GHz where P maximum output power rating of the transmitter in watts W according to 3 V m Ei transmitter manufacturer and d is the 80 MHz to 2 5 GHz recommended separation dis
37. hat undergone appropriate training and have extent knowledge of the medical effects and risks involved in using this device as well as the understanding for using this device in accordance with this manual Laser equipment not in use should always be protected against unqualified use File User Manual Fox Ill EN dOCX 8 Manual FOX September 2012 LASER 2 Theory and Technical Background of a Diode Laser This laser is a mere diode laser with a laser diode as the beam source The laser diode can radiate light in the range of various wavelengths The FOX Laser can be supplied with the wavelengths of 810 nm 980 nm or 1064 nm 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 word laser means light amplification by stimulated emission of radiation All laser types include three fundamental elements The lasing medium providing atoms or molecules allowing to amplify the light An excitation source the abovementioned molecules or atoms are excited with and an optical resonator which similar to a resonant circuit supports or generates the radiation stimulated by the internal reflection Atoms and molecules may have different energy states which can generate electromagnetic phosound radiation changing from one state to the next by means of absorption and consequently by radiation In their normal state t
38. he electrons of an atom are in the so called basic or normal state By supplying energy through light or though plasma formation as noble gas lasers do electrons are transported into the higher state The dwell time in the higher state is very short though and the electrons sink back into their original state During this short phase the previously stored energy is released again by sending out photons The consequently emitting photons have the same wavelength and the same direction within the laser Inside the resonator cavity the photons between the two mirrors are compelled to pass through the cavity several times During this time they hit further photons thus generating a monochromatic light To make the light built up this way in the resonator also accessible outside the initial mirror of the laser is made permeable in parallel 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 Laser has a buffer preventing any voltage fluctuations at the diode Doping the individual junctions as well as the individual production processes allows A R C Laser to provide the laser diodes in these wavelengths The power output varies per individual wavelengths Through PN junctions only certain layer thicknesses can be reached and consequently only certain wavelengths can be generated The current running through the
39. hould only be carried out by an authorized personnel by A R C Laser GmbH The room in which the laser is operated should be kept dry For room that needs to be cleaned with the use of water please make sure the floor has dried out before using the laser ATTENTION Never work with the device if you notice any visible damage to the console or to the accessories ATTENTION Never work with the device if you notice any visible damage to outlet plug or notice the wires have become exposed as a consequence of improper handling 9 4 The FOX Laser should undergo a safety inspection every 24 months carried out by qualified personnel Explosion and Fire Hazard ATTENTION Never work with the laser in the vicinity of easily flammable anesthetics easily flammable solutions or material In particular please remove combustible plastic or paper elements from and around the working area of the laser Focusing the green or IR laser beam on flammable materials may ignite these and cause a fire or expulsion 9 9 When working with the laser make sure the laser is switched from READY mode to STAND BY mode in case the treatment has to be interrupted This will assure that no laser radiation will be emitted due to unintentional stepping on the pedal switch Protection against Undesired Radiation Never grip the hand piece or fiber tip with their exit pointing or touching your exposed skin as this may cause burns to the skin do not focus the las
40. ic information on selected medical applications for the users specific intended use Where required it is possible to attend a comprehensive training course held by an experienced physician Upon request please contact your local A R C Laser authorized dealer or contact us directly ATTENTION Do not attempt to perform any type of service or maintenance work to the device Any calibrations or adjustments that require opening the protective housing should only be carried out by a service technician trained by A R C Laser GmbH This includes also any type of optics cleaning within the laser system as well as battery pack replacement 6 5 List of Medical Devices The FOX Laser packaging includes an enclosed document that contains a list of medical accessories which should be stored in the carrying case or in the event of larger number of accessories in a similar protected manner In case of any damage or suspected malfunction in any of the accessories please contact your local A R C Laser authorized dealer for technical support 6 6 Medical Device Parts and Accessories ATTENTION Only the parts and applications as specified by A R C Laser GmbH can be used with the FOX Laser Any use of other non approved accessories may pose a serious risk hazard to the operator and or patient As well as not provide the expected result Available applicators like fibers endo probes hand pieces and similar parts are described in detail in the cor
41. l Fox Ill EN dOCX 43 Manual FOX September 2012 LASER 9 3 Care and Maintenance by the user The following care and maintenance can be done by the user Before any type of maintenance always remove the battery charger plug from the FOX Laser console and any applicator that may have left still attached The housing may be cleaned with a damp cloth Clear water or a neutral cleaning solution e g mild common cleaning solution for household may be used Pay attention to never use a wet cloth because water must not enter the device in any case A disinfection of the surface by wiping the surface is possible Disinfection solutions like DescoseptAF or a comparable disinfectant e g Mikrozid AF can be used DescoseptAF Dr Schumacher GmbH www schumacher online de DescoseptAF solution contains about 42 Ethanol and about 0 05 Didecyldimethylammoniumchlorid Also other disinfectants can be used as if they are not aggressive or contain acids which affect the material surfaces of medical devices Following the guidelines of the manufacturers also agents on the basis of quaternary ammonium compounds as e g TPH protect company Sch lke or Mikrobac forte from Bode are suitable According to the manufacturers these agents can be used on sensitive surfaces e g acrylic glas or metal stainless steel V2A aluminium copper brass and plastic PA PE PP PS PU PVC ABS silicon rubber latex Makrolon Plexiglas Teflo
42. l to activate warning light AUX 3 Connector for the A R C powerMeter re Foot switch Connector for the A R C foot switch re Contains helpful information AUX 4 USB USB connection for A R C flash drive Do not connect any other USB device File User Manual Fox Ill EN dOCX Manual FOX September 2012 LASER T Operation ATTENTION The FOX Laser may only be operated by personnel that undergone relevant training for the device and that proves the necessary knowledge for the laser s applications 7 1 This part of the manual describes mainly the technical aspect of the device functionality without providing extensive details on its medical use A more elaborated medical use is detailed at A R C Laser application manuals which can be obtained through your local authorized distributer Device settings as well as various parameters adjustments should only be carried out in compliance with the operating instructions manuals Any modifications or settings not indicated in the operation manuals may cause malfunctions Preparation The FOX contains an internal rechargeable battery A power supply unit is included with the basic system which needs to be connected to the charger port at the rear panel The power supply unit will shut the charging current when the battery is fully charged Charger input voltage ranges between 100V and 240V Due to security reason your FOX can only be operated with the power supply distributed by A R C L
43. lacement of defective parts However we reserve the right to renew even complete units and to adjust them to the technical progress Refer any and all claims or defects to A R C LASER GmbH Bessemerstr 14 D 90411 Nuremberg Phone 49 911 21779 13 0 Fax 49 911 21779 99 Email service arclaser de Repair works carried out by third parties or modifications of the device void the warranty claim The use of parts other than those approved together with the device or purchased from other suppliers also voids the warranty for the complete device Any parts units or modifications of the device require the explicit written consent of A R C Laser GmbH Warranty Consignments Packaging 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 Laser GmbH Detailed packaging instructions and information on how to return the device will be provided by A R C The return consignment shall be insured and the costs arising hereof from shall be borne A R C will notify the customer of the return consignment opted for Any changes as well as the change of the transporter or the type of dispatch may result in delays in transport and handling Any other components covered by the warranty claim will be renewed by A R C free of charge
44. laser diode is generated by current drivers in the electronic system thus allowing the user to control the output power through the touch screen display Via beam deflection mirrors and coupling ceramic 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 diode is controlled by internal electronic system that is adjustable through the device control monitor The FOX laser output power as well as pulse length and pulse width can be controlled individually The laser beam emitted from the diode is polarized and therefore easy to ramp up or down By means of direct cooling the diode gets the specified temperature which kept stable The File User Manual Fox Ill EN dOCX 9 Manual FOX September 2012 LASER cooling circuit is passive and control the internal fans to allow natural or forced convection heat dissipation depending on the load 3 Transport and Storage The FOX Laser is supplied in a custom made carrying case for ultimate protection during transportation Accessories such as fibers and hand pieces are fully protected as well as they have dedicated spaces within the carrying case and can transported together with the laser console For deliveries by mail the carrying case is protected by a special outer cardboard box The carrying case is designed to ensure the user can
45. late the problem The solutions given therein will most likely allow you to solve the problem yourself However if the problem cannot be solved please contact your local A R C Laser authorized dealer for technical support ATTENTION Do not attempt to perform any type of service or maintenance work to the device Any calibrations or adjustments that require to open the protective housing should only be carried out by a service technician trained by A R C Laser GmbH This includes also any type of optics cleaning within the laser system as well as battery pack replacement 9 2 Safety Check ATTENTION The device needs to undergo a safety inspection every 24 months carried out by qualified personnel In the event where the device is out of order and or not safe to operate remedial maintenance is required and or the operator shall be informed of the hazard originating from this device The device must not be operated any longer as soon as it reveals any faults which may pose hazard to the patients to the operating personnel or third persons In this case the operator shall immediately inform the responsible regulatory authority thereof ATTENTION Please note that the laser device may only be operated by people who can guarantee proper handling due to their training and knowledge as well as due to their practical experience Responsible people have to be instructed at the place of operation when the device is installed File User Manua
46. level e To ensure steady operation in continuous laser mode device internal cooling must be allowed to operate without any obstruction and in following ambient conditions o Ambient temperature 10 C to 40 C o Air humidity lt 75 Examples of some applications Nasal mucosa hyperplasia ENT Parodontose treatment dental application Vessel coagulation Dermatology Ciliary body destruction Ophthalmology etc 5 14 Electromagnetic Compatibility The FOX Laser complies with the EMC requirements according to DIN EN 60601 1 2 2007 12 Guidelines and manufacturer s declaration are described in Section 12 File User Manual Fox Ill EN dOCX 22 Manual FOX September 2012 LASER 6 6 1 6 2 6 3 User Information and System Introduction Dispatching and Unpacking the Device case unpacking and installing the device is done under the responsibility of the user Enclosed documents included in the shipment with the FOX laser system need to be filled out and sent back to A R C Laser GmbH Outside Germany these documents will be filled out by your local A R C Laser dealer In the event where the device is transported to the user via a courier delivery services the consignee should take special care that the parcel was delivered in a proper and undamaged condition Any visible damage to the outer packaging shall immediately be reported to the transporter and your local A R C Laser authorized dealer In this case
47. light reflected by the laser beam Never look directly into the exit of the fiber optics or into the exit of a laser optics e g hand piece as this will Cause serious eye injury gt Eyewear safety goggles is the single most important piece of protective equipment needed by persons within the laser treatment controlled area Protective eyewear for both the operator and the patient needs to be able to stop laser radiation coming from all directions from striking the eye This means the eyewear must have side and top guards and fit snugly around the nose Laser protective eyewear for the laser operator must also allow visible light to pass through it so that the wearer can see adequately to perform their tasks safely while at the same time preventing the wavelength emitted by the laser from passing through gt The most important factor for protective eyewear is that it must protect against the specific wavelength emitted by the laser Therefore use only goggles labeled with the same wavelength as the model of FOX Laser you are about to use 810 nm or 980 nm or 1064 nm NOTE Eyewear will NOT provide protection for lasers that emit radiation of a different wavelength from that which the eyewear is designed for Simple safety goggles or glasses must NEVER be used for laser eye protection gt The second important factor is the optical density number which defines how much of the laser radiation is reduced when it passes through th
48. mmunity tests IEC 60601 test level Compliance level Electromagnetic environment guidelines Electrostatic discharge ESD IEC 61000 4 2 6 kV contact discharge 8 kV air discharge Complies with IEC 60601 Floors should be wood concrete or ceramic tiles Where floors are covered with synthetic material the relative air humidity should be at least 30 Fast transient 2 kV for power Not applicable The supply voltage quality electrical burst supply lines should be that of a typical IEC 61000 4 4 1 kV for inputand 1kV commercial or hospital output lines environment Surge 1 kV differential Not applicable The supply voltage quality IEC 61000 4 5 mode voltage should be that of a typical 2 kV common mode voltage commercial or hospital environment File User Manual Fox Ill EN dOCX 58 Manual FOX September 2012 LASER Immunity tests IEC 60601 Compliance Electromagnetic test level level environment guidelines Voltage dips short lt 5 UT Not applicable The supply voltage interruptions and variations on power supply input lines IEC 61000 4 11 gt 95 96 dip in UT for 1 2 cycle 40 UT 60 96 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT gt 95 dip in UT for 5 S quality should be that of a typical commercial or hospital environment When the user of the laser requires continued operation durin
49. n In case the FOX is combined with another device please check the regulations hereof Protect the device against water do not expose to rain or splashes Penetrating water may cause a serious malfunction Do not drop or rinse in any solution or water Please avoid wet cloths in all cases Do not use any chemicals or aggressive agents Chemicals or aggressive agents can lead to damage at the surface of the device and damage inside if they penetrate the device ATTENTION Never look directly into the laser beam emitted from the fiber once the foot switch has been activated as this will cause a severe eye injury Always switch off the laser and disconnect it from the power cable when cleaning the console and components 9 3 1 Accessories Cleaning 9 3 1 1 Pedal Switch Please refer to 9 3 Cleaning of the FOX 9 3 1 2 Protective Goggles Please follow to the letter the cleaning instructions provided with the protective goggles that were supplied with the system As a general rule never use abrasive chemicals that may harm the goggles coatings nor use cloth with fiber that can scratch the goggles surface File User Manual Fox Ill EN dOCX 44 Manual FOX September 2012 LASER 9 3 1 3 Applicators for non sterile use Please refer to 9 3 Cleaning of the FOX 9 4 Error Detection The FOX was developed and designed as a modular system In addition all its components had to undergo rough shake tests as well as temperatu
50. ox Ill EN dOCX 61 Manual FOX A R C September 2012 LASER A R C LASER GmbH Bessemerstr 14 D 90411 Nuremberg Phone 49 911 21779 0 Fax 49 911 21779 99 www arclaser de File User Manual Fox IIl EN dOCX 62
51. perfectly stow and transport the FOX Laser when changing rooms and or site location The device should never be exposed to temperatures below 2 C or above 40 C The ambient air must be dry and clean Ambient air humidity exceeding 80 may result in diode layers burning down when switching on the device The FOX Laser should be transported and stored only in its original carrying case to avoid damage ATTENTION The FOX Laser should be protected against water and moisture File User Manual Fox Ill EN dOCX 10 Manual FOX September 2012 LASER 4 4 1 4 2 Installation Installation Site Usually the Fox Laser is installed by A R C Laser GmbH or its authorized dealer and you will be given full training for the device Prior to delivery however the user need to make sure a suitable location was prepared for the installation The FOX Laser should be installed at a readily accessible place not too close to a heater or next to a sink The laser should not be operated close to a heater as its air cooling system works best when the ambient temperature does not exceed 21 C Higher ambient temperature may result in shorter working times as the device will be switching off earlier to prevent overheating If the ambient temperature is too low below 10 C the device cannot be started in order to avoid possible condensation on its internal optics as this might cause a permanent damage All control elements need to be readily accessible
52. ptember 2012 LASER 9 9 Proper Disposal When electronics and other potentially hazardous wastes are improperly disposed of they can harm public health and the environment Batteries and e waste contain toxic heavy metals such as lead mercury and cadmium Many local governments offer assistance to companies that wish to safely dispose of these products Contact your local government s recycling or solid waste management department to learn more about the services it provides This laser must not be disposed in your garbage A R C Laser would be very happy to assist you in the question of how to dispose the device properly All the applicators and probes should be disposed according to the valid laws rules and guidelines of your country A R C Laser will help you to find out which materials have been used to produce your specific probe applicator A R C LASER GmbH Bessemerstr 14 D 90411 N rnberg Tel 49 911 21779 13 0 Fax 449 911 21779 99 E Mail service arclaser de File User Manual Fox Ill EN dOCX 52 Manual FOX September 2012 LASER 10 10 1 10 2 10 3 Customer Service Warranty Information A R C Laser GmbH provides a two year warranty Within these two years any parts showing a defect will be replaced free of charge This does not include any optical parts such as hand pieces fiber optics or built in elements and purchased parts acquired from a third party Our warranty covers the repair works and the rep
53. rding to the energy added Power second P s stands for the result of the power set and the actual time of exposure depending on the pulse length and the pulse interval The display of the unit also changes automatically from mW to W according to the setting Frequency Hz The displayed frequency value is calculated from the pulse length and the pulse interval per second displayed in Hz 7 3 2 Settings Submenu 1 Leave the main menu to enter the submenu by pressing the MENU key Contrast of display 5 100 96 Next settings screen HOME amp SETTINGS aiming beam lightness 1 100945 Tone Pitch 10 100 ready brightness 5 100976 valid for all signals aiming beam frequency 0 6 Hz TYPE 810 nm IC09501 V1 1a 10 02 12 S Nr 610756 AAA IC09502 V0 9 05 02 12 INFO FO1d IC07001 V1 3 18 01 12 System info The individual parameters can be adjusted with the up down buttons Reduce Power Consumption If you do not work with the maximum brightness of the aiming beam we recommend you to reduce the parameter settings and to vary the aiming beam frequency as maximum power is consumed with maximum setting The brighter the display the higher the power consumption File User Manual Fox Ill EN dOCX 36 Manual FOX September 2012 7 3 3 Settings Submenu 2 Leave submenu 1 with the arrow key right and get into the next submenu Here you can only modify the automatic deactivation
54. re testing In case of an error you can start by isolating the problem with this manual In most cases you should be able to resolve the problem yourself If the problem persists please contact your local A R C 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 A symbol to identify the error see section 11 Symbols Description Other error causes might be due to 1 Battery operation Make sure the battery has been charged 2 Interlock The strapping plug should be fully inserted to the device and the door contact switch should be closed 3 The red DEACTIVATION button on the top of the device needs to be pulled up File User Manual Fox Ill EN dOCX 45 Manual FOX September 2012 9 5 System Self Check In general a system self check will run after turning on the device and intended to check all important functions If a failure occurs you will be informed immediately and the error detail shows up on the screen We distinguish between two types of errors 1 Dynamic errors interlock errors i e errors that can be easily resolved or resolved after ordering a spare part from A R C Laser GmbH Such errors may include Laser STOP button was pressed down Interlock plug missing disconnected or defective Pedal switch pressed down when turning on device or defectiv
55. responding application manuals File User Manual Fox Ill EN dOCX 24 Manual FOX September 2012 LASER The basic FOX Laser system includes the following parts which can be ordered separately at any time Port Protection Dust cover plug for the fiber port MEOS3855 Protective metal case for storage and Carrying Case transportation of the FOX Laser and its VP03101 3 accessories Protective Goggles Protective eyewear against laser light AS01009 Protective Goggles are wavelength dependent There are several models available including types that fit over glasses Please provide your FOX Laser model when ordering For further information about accessories please contact your local distributor File User Manual Fox Ill EN dOCX 25 Manual FOX A R C September 2012 6 6 1 Housing Front The front panel of the device consists of the following controls and keys Port Protection inside the fiber port FOX Fiberport E Stop emergency stop Red status LED lights touch screen arrow down key arrow up key Green LED READY Mode Yellow LED lights for laser READY Yellow LED Battery charging status Red LED Interference Error READY push button FOX Fiber port The FOX Laser has a fiber port at the head of the device see Section 7 4 intended to incorporate the patented A R C Laser click plug for a wide range of hand pieces and applicators To protect the fiber port A R C inserted the protective cap
56. sed diode laser internal forced air convection 1 2 kg H 17 4 cm W 14 2cm T 16 3cm with opened foot Power 8 Watts max 5 Watts max 12 Watts max 10 Watts max Digital touch screen display 100 us to 30 sec CW Single pulse SP 0 02 Hz to 5 000 Hz Fiber 200um 300um 400Um 600um with or without hand piece 532 nm green 1mW Continuous wave CW or pulsed in variable brightness 100 240 V AC 47 63 Hz 1 06 0 45 A 19 V DC 4 74 A 10 8 V 26 4 Wh Li lon by A R C Laser 41 Manual FOX September 2012 8 5 Classifications Laser class Classification according to EN 60825 1 2007 Aiming beam laser class Classification according to EN 60825 1 2007 Electrical protection class Classification according to IEC 60601 1 File User Manual Fox Ill EN dOCX 42 Manual FOX September 2012 LASER 9 9 1 Service Introduction The device was designed developed and tested according to research based on state of the art technology As a rule similar devices have a service life exceeding 5 years This product service life is defined to be 10 years in order to guarantee the availability of its spare parts during this period of time However to make sure the product is in good working order the device can display its internals working status through the touch screen display In the rare situations when the device does not work you can use the Troubleshooting section included in this manual to iso
57. ssen Sie das Bld m glichenwelse l schen und dann emeut einf gen Tone 10 100 oder das Bi die Datei Wenn weiterhin das rote x angezeigt wird m ssen Sie das Bld m gichenveise l schen und dann erneut einf gen Pitch 5 100 m CW CW in pulse on field ur SP Single Pulse in pulse off field State of charge of battery Batteries need to be charged too low before continuing operation Connect the interlock plug included with the system Door interlock missing The environment is too cold for Temperature too low operating the laser File User Manual Fox IIl EN dOCX 54 Manual FOX September 2012 Please wait until laser cools Operating temperature too down to reach a working high temperature The laser should not be operated Air humidity too high in this environment Fiber missing or plugged incorrectly Check fiber plug Ventilation fan blocked Contact your A R C Laser agent Change power supply Cooling element too hot Error Repeat Calibrated parameter is stored Detect Wireless Foot Switch Double Click the wireless Foot Switch 11 1 3Status Report The TFT Display and Fiber LED are getting dark and the green PowerSave Mode Your FOX Laser lowers its power consumption By pressing any button despite of TouchScreen Status LED starts to blink you can resume to normal mode with 1 Hz File User Manual Fox IIl EN dOCX 55 Manual FOX EA R Q
58. tance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range 3 V m 80 MHz to 2 5 GHz Radiated RF IEC 61000 4 3 CCo Interference may occur in the 7 A vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with battery To determine to electromagnetic environment resulting from the fixed RF transmitters an electromagnetic site survey should be considered Where the measured field strength in the location in which the laser is used exceeds the applicable RF compliance level indicated above the laser should be observed to verify the normal operation Where abnormal power is observed additional measures may be necessary such as reorienting or relocating the laser b Over the frequency range 150 kHz to 80 MHz the field strengths should be less than 3 V m File User Manual Fox Ill EN dOCX 60 Manual FOX September 2012 12
59. tself If the device cannot be started again there is an error which can only be resolved by a qualified personnel Please contact your local A R C Laser GmbH authorized dealer File User Manual Fox IIl EN dOCX 19 ITO m gm Z2 Manual FOX A K C September 2012 LASER 5 12 Stickers Labels and Markings The FOX Laser has various warning labels in accordance with the European directives and Health Canada intended to prevent any laser users to become exposed to laser radiation as a result of improper use You can identify the arrangement of these labels with the following drawings IDENTIFICATION PLATE FOX According to model 810 980 1064 nm located on the inner side of the cover stand Manufacturer M XXQUEAX Date of manufacture bao en Eat es G Serial Nr em omnes Inside the cover stand Seem aser Fox CUM Diode 810nm 8W Battery powered No disposal in domestic waste Applied Part Type BF File User Manual Fox IIl EN dOCX 20 Manual FOX September 2012 WARNING LABELS Warning label laser radiation Cover stand top File User Manual Fox IIl EN dOCX Warning label fiber exit Console to Warning label laser radiation Cover stand top 21 Manual FOX September 2012 LASER 5 13 Operating Conditions e The FOX Laser is not suitable for use with combustible gas mixtures e he FOX Laser has not been tested for operation in heights exceeding 2 000 m above sea
60. vice Information ATTENTION We are obliged by local laws to sell this device only to licensed physicians through our local authorized dealer which holds a valid Canadian MDEL Medical Device Establishment Licence 1 1 Copyright This user manual is protected under copyright The copyright prohibit any duplication of parts or of the entire user manual without an explicit written consent by A R C Laser GmbH Approved copy or parts extracted from this user manual as licensed by A R C Laser GmbH shall include references to the original document and author as stated in this original document Furthermore this copyright applies to any translated copy of the user manual to other languages We would like to point out that this user manual was prepared based on A R C Laser proprietary data and to the best of our knowledge A R C Laser reserve the rights to revise renew or modify any of the included drawings images or text without further notice In case of any content change the revised document will be readily available for the regulatory authorities 1 2 Marking and Symbols The international sign Attention is mounted on all surfaces which are hazardous for the user Before carrying out any further works at such marked parts please read the user manual or contact your local dealer or contact directly to A R C Laser GmbH service department The laser radiation sign is intended to warn the user against aiming laser beams to und
61. warranty claims shall only be addressed to the transporter Before initial start up please read the user manual carefully to fill out the accompanying documents correctly Technical Introduction Training Upon installation a staff member from A R C Laser or the local authorized dealer will provide introductory training for the Laser system The introductory training will cover the device technical abilities as well as overall safety associated with the installation and use of lasers in general and the FOX Laser in particular All individuals working at the vicinity of the laser should attend this introductory training One individual with the training and experience to knowledgeably administer a laser safety programe will be chosen as the person responsible for monitoring and overseeing the control of laser safety Laser Safety Training The FOX diode laser is designed for medical applications It may only be used by a physician who received training by an authorized personal In addition to the trainings offered by A R C Laser A R C Laser GmbH recommends to attend seminars offered by us These seminars contain topics like working with different laser systems such as the diode laser Moreover introductions into the laser safety and the use of lasers in general will be covered in these seminars We recommend you to make sure that only the person holding the password will use the laser The password should not be handed to other physi
62. your name Select the desired name by touching the specific line at the touch screen With OK you proceed to select a program Change a name with pressing a line for more than 2 seconds EDIT SURGEON DR ERNST MUS Q wy gj RI T vj Uy 1 oJ Pj A s bj rj e Hy J KJ t EY Z x cl vi Bl N v BEJ sac EZ Insert your name via keypad and press OK to leave the screen 7 2 3 Select a Program APPLICATION Select your application In this case program no 2 has been selected Select the desired application with a finger tip With the arrow keys you will get to other applications programs TURBINOPLASTY The application selected is highlighted in blue and will be confirmed when you press the OK field The names of the programs were preset you can change them at any time Change the names of the programs by keeping the EDIT APPLICATION relevant field pressed down 2 sec Stapededectomy_3 W_ The input screen will appear Enter the desired name and confirm with the OK key With the 123 Q wi E R TJ Yj ul tf oJ Pj key you leave the alphabet screen A s D F e HJ J KJ L Ea 2x cl v 8 N vj EE srace EEN File User Manual Fox IIl EN dOCX 32 Manual FOX E hk September 2012 LASER 7 3 Working with Selected Programs 7 3 1 Display Main Menu Select Surgeon Move to Settings screen Select Program Application NM Next application Power setup mW or W Pulse length selected
63. ystems This symbol on the battery or on the packaging indicates that the battery provided with this product shall not be treated as household waste In case of products that for safety performance or data integrity reasons require a permanent connection with an incorporated battery this battery should be replaced by qualified service staff only 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 File User Manual Fox Ill EN dOCX 12 Manual FOX September 2012 LASER 5 Safety Information and Technical Acceptance 5 1 General The FOX Laser is a precision instrument for medical applications A R C Laser has devoted the utmost care for safety aspects during its design and manufacturing as well as implementing intensive testing procedures prior shipment to ensure the device you are receiving is safe to use Following the Radiation Emitting Devices Act of your Couniry it is highly advisable to keep with the device detailed laser safety instructions and inform the person using the device on their location FOX laser devices are classified according to EN 60601 2 22 and EN 60825 1 as a Class 4 Laser Product As such to ensure that individuals are not exposed to direct reflected or scattered laser radiation without appropriate protection it is necessary prior usage to e Create a laser treatment

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