Alma‘ This FOX Diode Laser Operators Manual is property of ARC, Laser GmbH Bessemerstr. 14 90411 Numberg GERMANY As the United States distributor for A.R.C. Laser GmbH, Alma Lasers, Inc. serves as the primary contact for customers using the product in the United States, For your convenience, Alma Lasers, Inc. has replaced its contact information withia this manual where appropriate. In case ofa service call please contact: Alma Lasers, Inc. 485 Half Day Road, Suite 100 Buffalo Grove, Illinois 60089 Phone: (866) 414-2562 Fax: (224)377-2050 Any questions or concerns regarding use of this product will be addressed by Alma Lasers, Inc. ‘Ama Lasers nc. 1485 Half Day toad W Suite 10H Bao Grove 60089 H Tel: 2243772000 W Fax 7243772050 ‘waralmaloserscom B conet@amalserscomA.R.C. OPERATORS MANUAL FOX / Q810 Medical Diode Laser System 810nm 940nm 980nm 1064nm (ce nas Alma Lasers, Inc. 485 Half Day Road, Suite 100 Buffalo Grove, Illinois 60089 Phone: (866) 414-2562 Fax: (224) 377-2050yoru aru cox /ooo ARC. Jan 2009 im Incase fa service call please contact Alma Lasers, Inc. 485 Half Day Road, ult 100, Buffalo Grove, ins 60089 VALIDATION SHEET Dae 10.04.2006 Fie BA-FOX B.2801.09,d00 ae of revision: 2009-01-28 Software version: vityvi2 Athos | Reinhardt Dayz [Norbert Winkler ‘Fle: BA FOX £ 28.01.0800, COperators Manual FOX / 810 Jan 2009 Content VALIDATION SHEET. 4 INTRODUCTION 1.4. Copyight ne 1.2.ymbob ad label mn 2. THEORIES AND DESIGN OF DIODE LASER: S-TRANSPORT AND STORAGE sessennssnsnsn 4 INSTALLATION... 41. Insaaton pace 42 Room equine U1 Murig oe a) 423 How onde inosine om a 425 How tale ipheeectn rl ath om 00 5 SAFETY INSTRUCTIONS AND TECHNICAL INSPECTION 51 Genel irl nen ‘53 Protection gust dec sok, ‘Power adastinen ‘SS spose Nats ‘Ss Protection gut cater han S58 Methane 1 Safty shatter .eadoe 3ormtortinss ARC, cae ae 2 Wan ogee ann 0 6 USERS INFORMATION.. 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"1 Aine bea gs T6IL1 Pe Maser Amin ba 162 Bess dy 783 Conus sje ote diy. 1168 Brighness READY OX rane 4166 Ton othe scours 160 Seog 8, TECHNICAL SPECIFICATIONS.. 1 Dimensions. 2 Tec dt 9. TROUBLE SHOOTING sensi SASymba 9: Falre cn. 10. SAFETY DISTANCE (NOHD) Fe: BAFOK Etats 5Operators Manual Fox /@s10 Jan 20 1 Introduction ‘Congratulation that you have decided to purchase our medical laser system FOX. It is @ veraile tol in medicine, “The Diode laser FX does produce a laser team of high intensity, which can cause bums snd injures iit snot usec as described in this manval. To avoid any injures please read this ‘manual earefilly. If you hive frtber questions cr You would like to know more about ‘medical lasers please coneet our head office Alma Lasers, Inc. {485 Half Day Road, Suite 100, Buffalo Grove nos 60089 Phone: (866) 4142562, Fae (224) 377-2050, 1.4 Copyright ‘Without writen conformation from the company the manual o parts ofthe manual are not allowed tobe copied I pats of this manual are used under the license of A.RC. Laser Gnbit ‘the autor and the paragraph ofthe manual have to be acknowledged. Copyright does also “include translations into ober languages. ‘We would like to confi that his manual has been writen with the best knowledge atthe date of design of this manual ‘We reserve the rights to ctange pars ofthe manual or drawings which may’ become absolute ‘daring the lifetime ofthe laser device. Those changes will be made without any !ouncements holder ofthe previous manual ‘This wll eflet the constint improvements made a the laser device. ies OA FOX a1 cee 6Operator Manual FOX / E10 AR. Ho Jan 2008 41.2 Symbols and labels ‘The international symbol it affixed tall res whereas danger forthe use or the technician is ‘present, Before doing work on areas marked with his sjmbol one should consult the ‘nanufecturer fist, othe anual should be studied carefully “This symbol isthe international sign of dangerous laser light which could cause injuries if not Faded with caution and ear. ‘Be careful with the laser device because the laser ight ofthis device snot visible and may ‘cause ee injutes even i ts only reflected fom polished surfaces. [1s imperative to wea eye protection during the whole time working wih this laser. Fe: BAFOK E tote 7Operators Maal i FOX / aro ARC Jan 08 msi 2 Theories and design of Diode lasers ‘The word “LASER” isan abbreviation ofthe words light emulsification by stimulated emission ofr ‘The Diode lasers a newer laser compared tothe first solid state lasers. Its purely a semiconductor lace whit can emit ar lines with diferent wavelength, Therefore the PROX ‘can be delivered with diflzent wavelength depending onthe applications and use ofthis Following wavelengths ae avilable, 810nm - 940 nm - 980nm - 1064 nm. AS one can se all ‘wavelength ae emitted in he IR region. The laser bear is collimated with fast and alow ‘axis collating optic. The dimension of he laser beam afer olimation is 2x 4mm, {In comparison tothe solid stat lasers the light amplification is achieved by having different ‘materials electing ight aside the chip. With a materiel only arial electing the output of ‘the laser light inthe diferent wavelengths the lasing action is achieved Voltages in the range of2 Volt and currents up to 20 A ae feeding the Diode The Diodes are very sensitive to voltage changes. De tothe fe tha the FX is battery operated no ‘voltage drops or rapid changes ofthe voltage wll occur. The Diode wll fe longer than with ‘other divers, ‘The ouput energies with te different wavelength are diferent. The more powers requested, the more curent has to go thu the Diodes. Therefore lifetime is very much depending of how the Diodes are driven ‘To allow changing the curent thru the Diode a special amplifiers designed to feed the Diode withthe requested carent The power i displayed atthe front panel and can be changed by the user ‘The se of steering miror and focusing opis the lsee Beam is guided into a fiber and transmitted to the tse sie, The transmission ofthe bers independent ofthe wavelength ‘Transmissions of sbout 8090 % are possible. Different pulse length andrep. modes are available o allow the user to choose the bes. possible treatment ‘Since the Diode is polarize itis easy o contol different functions ofthe Diode internally ‘The Diode is affixed toa cooling device which than is cooled by force aio maintain a certain temperature. The Diodes ave very temperature sensitive and therefore itis important to ‘Keep the emperature ata fixed level ‘The cooling fan is electronically regulated and with col environments may noteven switch AF E motos 8Operators Manual sox oete AR.C. Jan 2000 was 3 Transport and storage ‘The Fax is delivered in especial carrying ase, This case is designed t0 allow the use to ‘transport and sen the ase: without having to design a special cas. All accessories needed forthe treatment are packet inside the case tobe readily avaiable when needed, ‘When the lace was shipped an aitionl cardboard box is used to protect the carrying ease for scratches and damages Never send the FOX around the county without the cardboard box, since the laser could te opened or damaged during shipping, For carrying the laser between the offices or hospitals the carrying case isthe prefered method of transporting thelaser Do ever store or operate the lser below 2° centigrade, Duing switch on or operation ‘moisture may build up and destoy the Diode. The environment must be clean and dy. Never ‘operate the laser above 75% humidity. The Diode may gt burnt and no warranty will cover 4 Installation 4.1 Installation place ‘Tho design andthe mechasis are designed in such a way thatthe instalation ofthe onc ean ‘be performed by the user self No spi training i required ifthe manaal followed th, ‘The papers have tobe signed and returned to the company. The code to star the laser is ‘tached and shouldbe used afer the laser is properly unpacked and installed ‘Al papers which ae ataced with the laser bave to billed in and ete to the company. All necessary safety insrutions and operators information are pat ofthis manual and have to ‘ne followed tr very cael Please read al the information and if any questions arise pleate contact your loa dstebuor ofthe service station of ARC diet. Address and phone umber re avslable atthe foot pages of this manu Do ot operate the Fax close oa heater, cause the surounding air may not be cool enough to keep the laser running fra longer tim. Temperatures above 21° centigrade may ese the ase to switch off aftera vile of operation, cause of high temperature. At temperatures below 8° centigrade the ler can no be stared. Internal emp, switches will a et you sesivate the laser. This protect the internal opis from building up of moisture. ‘A temperatures above 4° centigrade the laser wil also cut of (he fn till may run to cool {he unt dowa) This is to otet the Diode from overheating and consequently to burn out ‘Aer the surgery is done we recommend to remove the fiber opti and pace the laser inside the carrying case for proteton. Fi: BAFOXE A108 8Semertenst) Foxconn ARC san ae 4.2 Room requirement ‘The laws do require that sass IV laser should only be switched on, when certain requirements ofthe las: room are File, 4.2.1 Marking of the doors Each Door as tobe marked with laser sign such that everyone knows that laser may be in > Bach door has to cary the laser symbol and an indication of the laser used (vavelogth and power) see chapter 8.13.3 > "Above cath Door a lamp has 0 be installed which s igtening up as son asthe Lasers inuse. This may avoid that persons wil enter the room where the Inver isin se. > "Goggles have tobe place at the entrance ofthe door. They have o he seen wily and should be in each 4.22 How to handle windows In the room 114s imporan that no laser beam can acidenally ext the rom tra the windows. Those ‘windows have to be covered with material which will ot allow the laser ogo thr, Please Tok for material whichis not arse. Ifyou have Further questions about the safety ofthe oom, pleas ak o our representative 4.2.3 How to handle high reflection material in the room ‘To avoid unwanted reflecton ofthe laser beam inside the room no surfaces with high reflecting material shouldbe inthe lake room. Those materials could be > Minors > Paintings being glass > Anodized surfaces > Windows “Those surfaces have tobe sovered or removed fom the tom, In the lser room only non reflecting material or non famsmable material should be used. Special surgical tools are avalable wih ant reflecting surfaces to avoid any unwanted reflections 4.3 Connecting Power supply ‘The FOX is powered vis intemal Bares, To recharge the Batteries & Power supply i part ofthe shiment which canbe attached atthe ear connector ofthe mache, The power supDlY ‘is used torecharge the Bateris after surgery. The inp vltage tothe power supply 90-240 V~. No special requirements othe mains Fu BAFOLE morondoe 10Operators Manual FOX /@s10 Jan 2008 4.4 Shipping and unpacking ‘The unpacking and the ination is handled by the usr die. See chapter3) With the shipment the user will ind papers which have tobe filled out and afterwards send back othe manufactarer cr the distor ofthe country the machine was seat 0. Ite laser is installed by 2 service personal of A.R.C. Laser GmbH or the dstebutor, the papers wil be handled by the company personal Ifthe POX is send vie ail th end izes has to check the box fr damages. Damages a he ‘outside box have tobe reported immediately to the carer and also to the company set the FOX. Wansnty cline can only be charged tothe shiping company. ‘Before operating the last his manual has tobe red very carefully to avoid any damage tothe laser ano fully understand the papers attached. Those papers have tobe filed out and retumed to the company. 5 Safety instructions and technical inspection 5.1 General information “The FOX is a prove motical later system. The system has been developed with eae and boen carefully tested before shipped to your plac. To protect you and make you more familiar withthe system we strongly recommend to red this manual very carefully ‘The system is classified in Europe a clas 1Vsystom based on EN 60825-1 October 2003, inthe USA itis clasiied wa Cass IV medical laser. ach of those classes does require special care when using those lasers. Especially eye protection and protection spins scattered ight are imperaive to be used, Goggles and ‘etan clothes have tobe aked to protect the surounding personal. As described in 4.33. ‘Spec care i veguzed to work with nser inthis class. Non lamamable material hes vo be ‘ore in the room the lise is operated “The fllowing guide lines ae summarized without implying to be complet. All safety infomation or guidelines which wil become avilable during the life tine ofthis product should be attached to the eer manual or communicated tothe users of this product. Ia Europe ‘we would like to recommend the infomation which i avalablefrom the notified bodies of the producer or the distributor ofthe product. n adetion different regulations in diferent ‘coahites wil be enforeedby the authorities and therefore itis recommended to talk tothe ‘istibatrin your country about the regulations avalable In adtion international standards like the US Standard of he bare of National Stndarde ANSIZ 136 31096 American [National Standard forthe ae of lasers shouldbe considered when working with the OX. Aditional questions willbe answered by the distributor or A.R.C, Laser GmbH (Germany "Operators Manual FOXx/Qs10 Jan 2008 5.2 Eye safety ‘Asa safety measur itis inperatve that ll people inside the laser room have to wear eye protection. ‘When the FROX is used nly those gogeles which are specified forthe particular wavelength (810 or 940 o¢ 980 or 106enm) should he used. In addition only goggles approved by the futhoiis wth a CE mark oat least Claes DL9 shoul be uscd. The PCAN wil be delivered ‘with the appropiate gogle forte wavelength, If you request order more safer eye Wea? please specity the wavelength when the ode is paced {If you need more informaton about safety eye wear please contact A.R.C Laser GmbH ‘Since diferent models are avaiable itis posible vo wea a gogae even i you wear ‘prescription slasies. Goggles which ae peotctve to al sides sf imperative, to avoid ‘Scattered light to reach your eyes. If he goggle i not closed tote sides, even reflections rom the inside ofthe gogzes may cause eye bums “The laser room shouldbe locked to avoid persons enter the laser room just by accident. The 00m should not be opened from the outside. A ight at the outside indicates he laser very time the lasers sche on the light tthe ouside comes on. The laser console has an imterlock circuit the cuside to connec the door interlock. Enough goggles shouldbe present and easily aecessibe inthe laser room. ‘As mentioned above the unit is equipped with an ineoek comector To use this connestor ‘ne has to interlock the ensance dor tothe asec. Only when the dor is locked the laser can bestarted (see chapter 59} Fe A FOK § torneo 12Operators Manual Fox /Qs10 Jan 2000 5.3 Protection against electric shock ‘The laser operates with an intemal voltage of 12 Volts, Do never remove the proteetive housing ofthe laser because the laser Diode could be damaged, Service work should ony be performed by A.R.C, Lise: GmbH tained personal ‘The rom shouldbe kept cry where the laser is used. Ifthe rom cleaned with wate please ‘wait unt the lori completely dy ‘The power supply whichis delivered with the unit indicates the power an the voltage onthe top, Other power supplies san be used if they il following specications ‘Outpatvltage 11-28 Vote D.C. ‘Connector polarity OD plus ID minus. In Europea yeayinspecton is mandatory and hasbeen performed by tained service ‘personal We also strongly recommend outside the EU to perform a yearly check onthe ‘specifieations ofthe lser. All changes or repairs have to be documented into the book tached tthe laser at date of delivery 5.4 Power adjustment “Atibe time the foot switch i tiggered the power dial can not be operated (see chapter 7.5.1) to change the power stings, ‘During surgery with the laser the ready bation is presse. Ifyou intermpt the surgery witha longer pans provs tho ready button agin to get th laser into stand by By doing wo an socidentlly pressing of the footswitch doesnot rigger the laser beam, Fes anroKe more 13Operators Manual FOX /Q810 ‘Jan 2000 5.6 Protection against scattering light ‘To avoid any tiggerng ofthe laser by accident the fiber and te hand pieces used should only Delnsrted When the laser as passed the inal test and the patent is seated. ‘Do never fous the laser o tissue not o be treated o on flammable material Sever burns on tissue or even fe hazard ould be caused “The footswitch tiggring te laser should only be inthe close vicinity ofthe physician never eo jo FOX / 810 Jan 2009 = 5 @ i El 6 Users information 6.1 Preparation for laser treatment 6.1.1 Area where laser is used All discussions aout laser safety have tobe taken into consideration before starting to work ‘wth the unit Sine the FRX canbe operated without any acces to power outlets the rom ‘where the treatment wil ke place has fo follow all the guidelines ad ot in his manual ‘previously. The room hao be marked clearly as laser room from the ouside 6.1.2 Laser safety eye wear All people in the room attending the laser surgery have to wear appropiste Ise protection ‘eye Wear. Those goggles a inthe ease delivered with the uni, Blin cae more popes ace needed an order can be piced with ARC. Lasee GmbH 6.2 Preparation of the unit 6.2.1 Treatment place 11s strongly recommended to place the laser on a stable base to avoid king of the {ntrument. To stabilize th nit a xation device delivered with the FRX to secure the laser onthe surface. 6.2.2 Fixation device - Vacuum holder ‘Moisture the vacuum plugs sight to allow them to attach property tothe base, Check by ‘wobbling the holder slighly that the fixation is done propel. (Gee picture page 24) Fis BAFOLE motondoe aOperators Manual A R. Cc. Jn 10 rexreee 6.2.3 Connectors at the roar ‘As soon asthe units removed from the ease you may find a the rear all female connectors: 1 Power Supply 2 Interlock 3 Protection fiter Microscope 44 Extemal service connector 5 Footswitch 1234 5 Before opening the unit by turing the hinge backwards connect the foot switch required and to charge the bateries the connector ofthe Power suppl. imteriock it “Than tum the hinge backwards by holding the bu baseplate and turn the whit hinge tothe ‘backside, Tun the hinge ll the way to the back to use ster a the stand tothe baseplate, Fe BAO gator one 22Operators Manual ot vowsa ARC. Jan 2000 was 6.2.4 Batteries rechargeable — Power supply "The FOX is being wed wih batteries. The fll loaded batterie will supply enough energy to ‘work throughout the whol day at normal operational mode. Does the "Battery Symbol” ‘appear in the display the Bateries have toe recharged during connecting the power supply to the apptopriste connector nthe rear ofthe FIX anda the current supply (ower socked. 6.2.4.1 Changing of the batteries ‘The holder ofthe baterisisin the back ofthe unt Please close the hinge as seen in he picture Grip screw tery holder ‘urn the grip serew turn counterclockwise and posh the serew downwards. The holder can now be opened, Remove the batteries carefilly tothe outside and pall he pg (1.00 o'clock) at the upperside Tonsection othe battery plug ig forthe bateries Cover battery holder lug inthe new butery pack and close the cover. Move the grip screw upwards and ight it by turing I turn clockwise. Make sure the sere is firmly Fa Bn sOx 8 01 cee 23Operators Manual FOX / B10 Jan 200 6.2.5 Safely fix the unit atthe table Install the unit atthe ablesuch the hoe inthe hinge wil it nto the vacuum holder which has tobe insaed a the abl st, The uit is now firmly ied atthe tale rec tr 6.3 Treatment with the device CChoote the right application probe fr the treatment, Open the pouch where's the probe is packed in and put the proke onthe table (obey your sterilization requirements ) 6.3.1 Usage of the FOX for medicine Usage of the FOX for maine ‘The FOX isa laser wititspeimary wavelength at 810 940980 and 1064nm. Those ‘wavelengths are known in medicine for along time already. Based on the good Absorption, the minimal penetration te OX is well suited for Ophthalmology ‘Aesthetic Dental Generel surgery ‘The lasers guided tha an optical fiber tothe issue. For each discipline different hand pieces sae available Fa FOX E2801. 0080 24Operators Manual ox) ae10 AR.C. Jan 2008 LASER 6.3.1.1 Ophthalmology ‘The main application ofthe FOX in Ophthalmology is Endo photocoagulation. The lasers guided thr an 19 gauge handpiece into the eye. The lasers mainly used for spontaneous Dledings atthe retina or fr retinal detachments. The fiber used for thse procedures do have an OD of about 3003 std wll produce a pot between 300 00 pat the retina Another application isthe sclera Cyclophotocongulation. Ata Glaucoma the laser is guided {th the Selera onto the Zens, Using the heat ofthe laser a hole is pinched into the ‘Schlemms channel o produce a drainage forthe aqueous. This procedures used to avoid any higher pressure inte eye. 63.1.2 Dental ‘A root channel procedure involves the ik of nat removing al bacteria and therefore increasing the incidence o infections afr tho weatmest. By using the laser in eoopation with bare fiber al bacteria an be removed. This is achieved by using the eleated temperature ofthe laser treatment. To reach the smallest ‘cavities an smal fiber of 200m i wed. The ber is inserted into the rot channel ‘The lasers also used for Paradnttes to allow a cating of tsue atthe tooth, Cutting and ‘congulaton a the same tine allows fast healing effects 6.3.1.3 Aesthetics “The Fox isused to cut nd congulate at outer surfaces. Duc to the gnod penetration ofthe laser wavelength andthe fine tuning ofthe power cuts without cating ean be achieved. Coagulation of spider vessels and wars can also be performed. 6.3.2 Code for the laser device Ina separate packed envelope you will find the code which will alow Do store the code in a separae room not to allow other person fo aie the laser. Only those essons being tine onthe laser and have signed the introduction papers sould have access {orthecode Fu Aro 8 motonse 25Operators Manual Jan 2000 FOX / QE10 6.3.3 Start the unit ‘Stat the unity pressing the button code described inthe envelope ste chapter 6.3.1). Use {he code, by pressing two butions atthe same time as long asthe display wil ighten up. At this time get off the buttons. The unt wil stat with the self check, LN é& [Emergency Button pressed! ‘Symbol appears, pull Emergency Buton upwards, syetewoneDK Device wil finish its System check Fier is plugged int the wit sysrewoHeDK ‘This symbol wll ighten up Red LED flashes. Signal tone appears Remove fiter from the port = Unit wl finish elfcheck Ventilator blocked or defective! a é ‘Symbol appear, if necessary remove external blockade, Device wil finish the System check levererronenx there sno blockade than the ventilators defective andthe responsible distributor or A.C. Laser has to be contacted Foot swte ‘Red LED fishes. Signal tone appears Remove fot fom the footswitch, press central button Unit wil finish self check ‘See Chapter 92 ror Recovery - or Codes Fae: 84FOK 28010040 26cmoatind ARC, Jan 2009 "The devi isnot suppesed to Be operated outside the abet er temperate 10°C bis + 40" 1s the temperature outside he permitted values are control LED will link. Opeat the 7 Eo FOX / Qe10 Jan aoe TE 7 Controls and Display ‘Aw opto cow spdown tense [READY ON button Main PUSH DIAL, 7.1 READY ON bution ‘Yellow button with impritted back wiangle [By pressing this buton ths FACAX can be switched ino ready mode. The yellow im around the sign will be illuminated for some seconds with 2H end a "peep” sound can be heard “After thatthe Ready buton will brightly light which means thatthe unit i eady to be sed {or aser treatment. ‘The rressing ofthe bution will be accompanied acoustically with a peep sound. Pressing this buton again will cause a deactivation of the READY mode, the illumination of the button wil ease, 7.2 MAIN PUSH DIAL ‘The nit wil estat alway with your last stings used. At the this ie always check the selings ist before stating the testment By using this PUSH DIALall stings forthe machine are controlled. Pushing the dial inwards «small poep will dvayeindest that You fonctions have boen accepted. By puching the knob and keep iin this poston, diferent stings inthe program canbe daled in by turning the knob clockwise or counterclockwise, Those different selected programs wil be highlighted as scon a yor dal them in. Leave the button to come out again and you will ein this selected program. This program is highlighted and you en selected differen settings ‘within inthis program. Te change those stings tur the know clock or counterclockwise without pressing the knob in Fe: ROX E aortas 33Operators Manual rox aet0 AR.C. Jan 2000 was ‘The change ofthe power inside the power program will algo he indicated with large numbers inthe display. If you ike to change the pls length press the pushidial button and ster thu the programs ‘nil you have reached the appropri ld Lette button go int the ote position and ‘change the values ofthe pute length to your preference. This willbe done withthe dial by tuming the knob counter er clock wise, All sting like pulse lng, pulse to pause rato an be selected the way described above. ‘Aer selecting your prefesed values for the surgery the fiber can be inserted andthe 7.3 Arrow button left side By using those buttons you can sleet from the diferent pre-programs which ae available fiom Pl to PO Ath time you pres either one ofthese buttons the system will aufomatically change ito the highlighted feldP. This field canbe found in the let lower comer ofthe display. you choose to change values inside the different programs follow the instructions described at chapter 7.2. As soon a you have chosen different seings and than press the READY ON bouton the valves you have chosen wil be sored under this program. Tas change ef the owen wil ast orediyou nse oes he dl ae he By allowing you todo ths tferent programs fr diferent surgeries canbe calle off quick snd reliable without indrg new stings all the time. 7.4 Arrow button right side ‘Alter the fiber is in place the READY ON baton is pressed the aiming beam can be seen at tn exit ofthe probe. To change the brightness ofthe siming beam you only have to press the ‘upper lower att ow pointing upwards Increae the brightness ofthe siming beam ‘Arrow pointing downwards Decrease the brightness ofthe aiming beam ‘The battons wl be active when you press onthe arrows. ‘The rightness of the sing boas wil lao change wid the diffxent pugsem tgs oO Ie Fox / 9810 Jann 7.8.2 Selection Pulse4ength (PL) ini’ 1 2 a raga Todas] 0809 Pas apie teens Tene [By wsing the PUSH DIAL centre knob one can select the centre field for PL After selecting the fel let the baton come ou from the lowe evel ‘The pale length ssutomatclly delivered as soon asthe footswitch is pressed and eld long enough fo let the time elapse. 'By turing the central knob he PL can be varied based on the table below. CW is the fist ‘vale and 30 sec. ste ast value ofthe pulse tableau Ar any of those values the knob has to bbe turned in tho other diction to allow the selection of othe pulses. CW = Continuous wave 2s 20ms Adjustment in steps of ms 20ms— $0ms __Ajstment in steps of 2s Soms—100ms —_Aijsiment in steps of Sms 100m —250ms _Aijusiment in steps of 10s 250ms—750ms Adjustment in steps of 5Oms see 15sec. Bate 25s. See losee: See see Fie 040K 280,000 36Operators Manual FOX /Qs10 Jan 20 17.8.8 Exposure counter (EC) 1.20% T.20H [A 1o0Rs | O8Ge—}—_Hxvovure counter P=2) Tu 100ns [Menu | ‘The instrument automaticaly counts all exposures which are triggered via the foot switch ‘The numberof exposutes ar indicated in the Field at he right upper side ofthe display. ‘The maximum exposures been abe to nica fs 9999 7.8.3. Reset of the exposure and energy counter 1. By pressing / tuning the cental kno the display panel IZ.can be chook, 2. Leave the knob an the sounter will be reset to 0000. ie selete eis highlighted Push the nol again and than you can leave the field counter agai, ‘The counter ie rvet 00000 We recommend to reset th counter o 0000 before any treatment. With the counter andthe ‘power one can calculate the ma. energy per treatment. Fi: BAFOXE A108 97Operators Manual FOX / 9810 Jan 2000 7.84 Display Energy Counter (EZ) 1.20% °~ pd aw [n Toons. i fieens[ Henw | ‘The energy value shown oo he display isa product of the adjusted power and the real exposition ime aswell asthe numberof the released pulses. ‘The display ofthe enecay changes by itself fom Mill Joule (nu) over Joule (J) to Kilo-Toule (es), according othe added up enerey 7.5.4.1 Reset of Energy Counter see Chapter 7.53.1 7.5 Pre selected programs (P) 1.20% 7.20 [A 100s | 0000 Program? [p—feP-29 us 100ns [Tena | [By using the central PUSH DIAL knob you an select the fel P ‘By turing the knob clock wise o counter clockwise you can select differen programs ‘The maximum numberof programs availabe is 9. Fe: ROK E atone 38Operators Manual FOX /Q810 Jan 2000 17.58 Selection Pulse | Pau: (PP) 1.20% Fparmecw], [E200 tons [one Pilg Pua FP igons [Men ‘By pressing nd turning the central PUSH DIAL knob one can selet the mid field of PP. “The FOX sllows you tosclect the Pulse to Pause ratio by youre. see chapter 75.2PPL) 'By tuming the central PUSH DIAL kaob one can select the following pulse length. SP isthe fiat value which can be selected ~ 30 see i the lst whichis avalabe, After dialing to those ‘values on has totum the You scroll upwards within the display. ‘Amow down > -Youseroll downward win the splay Fb: BAFOXE aot cede “4Operators Manual FOX / 9810 Jan 2009 7.68 FOX manufacturing and service data’s jas Ghzs Pushing and turning the central da you wi @nGn@n change into the fllg in wheres you eve Into te sub men Lat he PUSH DIAL go into @aiesen {he home poston and you wil bein the. 7.8.8.1 Sub menu information Laser Svston 2 | Dental SWE. 1 BFBsibe700 ‘Pushing and turing th conte ‘hangin the ld In whereas you wl ‘vento the main menu ager Atthe information “Type" you will find the wavelength of your FOX 7.8.9 Leaving the base adjustment menu 2s Dias Pushing ang turning to. Qs Gres @zs ‘change into this field. By leaving the central Knob nt the nem postion wil gt inte the OD HLT] —_mainenw again‘Operators Manual FOX / 810 ‘Jan 2008 8. Technical specifications 8.1 Dimensions ‘80am, rin 9 Watt ssa ‘in. | Watt, 83 Technical data Taser Diode Tse Gee chapter 82) Puls length 2s = 30m, CW (see chapter 75. Pulse pause 2ins = 30s, SP_ (See chapter75.6) Power suppl ‘Btery, power supply: 110 = 230Volt Weight 12k, ‘Technical specification sbjet to mosifiation Fi BRO Eon oe 46Oporators Manual A FOX / 9810 Jan 108 TA 9. Trouble shooting 9.1 Symbols a Fiber connected Remove fiber of the coupling. my Ae ncgtey Baton py recy ton pa AG Door inttock not | Adjust connector Paced open | de Aé Ventltor defective or blocked Remove blockade a the velar, i thre no blockade ‘contact your distibutar or ARC. Laser Aa Tiss ed op Batteries discharged Connect power supply A ‘Change from batteries o Powers supply, ‘Syiol will only Tightening up for'S see Panic bution i pressed ‘Release panic baton. If the Contact AR.C. Service OD: CPU Esror > Restart the device, shoud the er appear agin contact your Setibtar FOL: Power > courge te baey, restart the devs, sbuld the err occur again contact your distributor 02: Power > Charge te hatey, restart the device, shuld he eroroccur again contact your distributor FOS: Power > charge the batey, rear the device, shuld he err occur agin contact your distibator FOG: Footswitch Restart the deve do net peste fotswith, shoud the eee ‘ceur again contact your distbuor PUT: Footswitch > Restart the device donot peste fotswtch, should the eee occur again contact your distbutor FR: Buon > Press he buon, rest the deve, should the enor cur again Sona your dtibtoe 22: Conta ob > Press the button, restr the device, sould th ear eur again ona your distibutor FR: Powersupply > Conte your dsebutr 3B: Elecuoae > contact your distributor ST: Checks Ector > Conte your dsb 50: lectonis > conse your atibuoe SL: Cental ach > Presse ttn, restart he device shoud the err acer aga ont your distabutar Fn: FOX Easot.des 49Operators Manual FOX /Qs10 Jan 200 10. Safety Distance (NOHD) P Fiz ‘BeamDvergency P Power: 12 Wats Mazin ening Tle 164m o® comm es vim = aa tim «16s easDlins lg Bam ives: 0 mad Doane iste aes Napa Sour ae woe ae ga NOHDat 810m = 2.8m This safety distance is ielevant however, ashe acces tothe laser tradition is shielded tvough the marked sevice oom, (See therefore chapter, Room Requirement" 4.2 und Eye Protection” chapter 5.2 ofthis wer manual) Fin: AFOK E801 0060 50CERTIFICATE IW COMPLIANCE WITH THE REQUIREMENTS OF THE: eu Directive ‘Applicant ‘Manufacturer Tested regulations Exception / Comment Test Engineer v June 2, 2007 @ EMV TESTHAUS aa “Sj if Directive fr Medical Devices of EU 93/42/8EC [AR Laser GmbH ‘AR. LaserGmbi Diode Laser 26.240 DIN EN s5011: 20038 Group 2/ Class B IN €4 6060112: 200240 DIN EN 61000-4-2: 2001-2, DIN EW 1000-93: 2003-1, DIN EN 6:000-4 DIN EN 6:000-4- DIN EN 6:000-4 2002-07, Stabs Technical Manager Lbs Bip. ng (FH Axel Pebhing anaes em TESTHAUS Gri Gustave State 3 Dens Sabin 9 p2s-se033« wmanvcenauscon DllC€ Declaration of Conformity ‘This declaration is valid for following product Equipment: Diode Laser Type: Fox Hereby the equipment is confirmed to comply withthe requirements set out in the Council Directive on the Approximation ofthe Laws of the Member States relating to Medical Devices ‘99/42/EEC, ‘The followirg company is responsible for this declaration: ARC. Laser GmbH Bossemerstr. 14 90411 Namborg ‘The measurements were carried outin accredited laboratories, For the evaluation of above mentioned Council Directives for Medical Devices following standards were consulted: DIN EN 60601-1-2: 2002-10, DIN EN 55011: 2003-08 Group 1 / Class B (DIN EN 61000-4-2: 2001-12, DIN EN 61000-4-3: 2003-11, | _ DIN EN 61000-4-4; 2002-07, DIN EN 61000-4-5: 2001-12; DIN EN 6100-46: 2001-12, DIN EN 61000.4-8: 2001-12; DIN EN 61000-4-11: 2001-12) | DIN EN 61000-9-2: 2001-12 DIN EN 61000-3-3: 2002-05 DIN EN 60601-1: 1996-03 {#DIN EN 60601-1/A13: 1996-10 Dasa Sanat afro Parson“Guidance ond manufacturers doctarationelectromagaetc emissions [fafon red unin stcragrtcnonnentepealedaebw. The atone ec Paar ia (eared [arcanaaraic oom = omens | [ar enasas carat [Gran Gone |The ones rr oy ae nial non Talo le eran re snr nla aan Irons nny sen ep [aFwmaiom Gaon [Gap Gan rca pisos Sonete [gegen eo Yeon [pene lean“Guleanco and manutaturer’séaclaraton - lcromagnatc many [verona envionment aude [nmaniyiet [EC wr eioal [Eons ns sha own, cer coum er nea apts na he fete my snl be 30% [2 rpwe sna [rca st vitmowouna tee [an pane mai smagpe va To WRT [nner ota omar lie... aac fr is poner any seo aaa aT (oust omtars [suupoenapmu [ranma lerosone sre asa aie femal enna |statmaescsued Cymru lew mane marc, ened. jecenman — [OZueDsaPmUD [srr ve pers loeseree suey etary po xens0%apmuy lo 2seye0 [cob easmunersse lswarteaueny [3m fra teasers noconparans wih ow [cas one eso mnepneichace [NOTE Crista is eg i ono aienana laronetcomagne ely [ha Fox sone a sonag eonan sped non, Th neo at to Fors a a | Tony tst [WD wst at [Camplaneiowl [Enevomngrt emir — dans [Pineal anne episode [etn erry at Fox reg eat. an Pe |ecetncespfon mse aes en [oor ops tq oe rita eeeeseS— fiaiemamre flniciiweomes lye gir wee |1=220mv-WP wr sonaterne 28H esr rca eae ret aang to ad WF vrs, tenn eserangratste may. "sade an setenv ncn Pene oe tana ma orn bevy eonert ma ih {esi ort ()) ) for reece a Se fee, sso [ cra arssertnaetns Wonton enetts ce emrenay in scare, Te sees ha neers sae sn assatc tse ht rari os Cactoncpa sie su head be oer Fens fas srg he ereaetiss sence anestrus ae eae: eurescee } overt ey rnp 50H 6 all rong eet 3 Vn,puta nd ae RF communicators pant a Fox [Rea nae wim hcrmapeicrenne ye a sacl ne [tome ese sn be cnses boon stant nau aap che conmncatos espe ‘ann dan arg gaey oan atetaatmeaite | span some ‘mtr B00 me sno 2,5 ete w eine ae dengan co ae a oa ar 37 ear a7 7 a7 ar 731 7 a7 7 Ba Isinaafachg fa coanes apace agony ft tari, we® ete mona captpsne ange ne [ae Saran eta ance, Rete Nonircno i pee net nrtowmnoyee atin Inote 2 Tes using nl sso Ectamogrets reagent bean and refeton om fons, us ansponLGAPI/InterCert Zenifisionngsgosolsohat mos Unnweitgutachterorganisation QS Certificate (complete quality assurance system) ‘The LGA interCert GmbH - notified body no. 1278 according tothe EC Directive Concerning medical davies ~ herewih cons that the folowing company ARC. A.R.C. Laser GmbH Bessemer Strae 14 90411 Nurnberg Germany seni cna quality assurance system tr sito eth homeo ee omirv sees Directive 93/42/EEC, Annex II {forte desig, manuacue and hal specon one mecle! devices at spactad nthe enclosure “The suvellance though the LGA IneCert nbs tected acorn to anna Il, ston 6. ‘Tis corfete is va un may 31,2011 ‘At ropst no: 1861818 Reniavaton no. 1861016-06-000 ‘of Aad 28, 2008 LoAtncon tT 2-001 Nani Tol +4091 688580LGAIPY/InterCert Zerifcieningsgeselschatt moe Unmweitgutachterorganisation Certificate ‘The LGA InecCert GmbH — notified body no, 1278 according to the EC Directives for medical devices ~ herewith cons tha the folowng company \. R. C. Laser GmbH Bessemer Strafe 14 90411 Nurnberg Germany as inoduced an apoos 2 Quality Management System {or mesa! devices sezrcingto DIN EN ISO 13485:2003 Regurent egy purposes {orth scopes cevlopment, produto, dtibuton ard serviong oftheapa eer davoes wie human mesial Poot of tutinent of te above mentonad standard has been provided bythe croton trough LGA nerCon, “Tos cafate ie vata unl May, 2011 ‘Aut ropot no: 1851818 Resisvaton no 1861846-03-000 ‘of Ap 28, 2008 4275 Arata ime) Se Sn gat areas eA rcotcneh Taj 2-0 40691 Nonbay Te 4901 6585.47 0LGAP / InterCert Zerifsierngsgeselschat moe Enclosure of the Certificate Registration no. 1861816-006-000 of the company AR.G. Laser GmbH, Bessemer Strate 14, 90411 Nuberg, Gormany Date of expiry May 31, 2011 “The abovementioned ceticae refers to following medical devices: Product UMONS-No. | Class: Medical laser devices Including accessories Types: 1. [> ona . to 2 [> aus . u 3. [> FLEXHLAS . ip 4 [> * tb 5. [> with the rade names 2 Mo Nuvolas, Classis G, Chas 6 [> cuss . to 7. [> FOX with the trade names. . Np (0-810, 2.940, 0-980, 0-1064, Fox 8. |> SUT vith metrade name TrabecuLas : ip “At present no UMONS numbers avaiable, _Supplament No.7 of Aust 7, 008 Procore-No 86086; Reitaton No 186101-00800000) pploment No.8 of Osceter 19, 2008 Procadie No: 48082: Rapaten No. 16%646 206 000000) {oA meconni- Tit 2-050! Nome Tol 40911 657 80,Certificate of conformity AR.C. ER WS Manufacturer A.R.C, Laser GmbH Address Bessemerstr. 14 90411 Nurnberg Germany Product Diode laser '810nm, 940nm, 980nm or 1064nm Model FOX (Q-810, Q-940, Q-980, Q-1064) Classification Ib / Ruled Laser Classification 4 We herewith confirm that the product mentioned above has been developed inhouse and Is manufactured at our own company based on the requirements and rules of the EC Standards. All necessary documents or Information can be seen at the company or the notified body. Rules Medical device directive: EG guidelines 93/42/ECC dated 14 June 1993, Standards Following standards are used in testing the device: EN 1041, EN 60601-1, EN 60601-2-22, EN 60825, EN ISO 14971, EN 60601-1-6 Notified Body LGA InterCert (CE 1275) Tillystr, 2, D-90431 Nurnberg Management System Appendix 11.3 Datum OF CE- Approval 2006-06-01 Number of Certificate 1861816 Valid for No. Date of issue Signature Titel