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AL8000 SERVICE MANUAL

1. 11 TM VIREACIVITYDATA _ _ Stability ee ee ee MESES Unstable A void Keep away from exceaaive Sable heat Incacaratsb lity _ Hamidas MoterielstoAyvcid Fluorine Ammonia Ozone Polyramization Unsatureted Organic com pounls and bases WilNctOccur x ConciterstoAvod Keep away from excceaaivc HazadousDecompesitonreducts Hycregen aud Zhicrineare formed hear VILEN VY IRONMENTAT PROT CITONPROLELCRES SpillResponse Syacuate the area f possib e saut oit the of gas Person nel with acid suits and self ooalained treating a2paralus attempt to stop the leak Ventilate the arca Waste Method Replace the ovtlet plug in the cylinder valve Replace the cylinder cap Ifno leaks are detectec eturn the cylinder to your supplier RS 81 MILSPEGIALPRCTECTIONIS FORMATION EysProte ton Sefetv goggles SkinProtection Leather work gloves Respirotcry P oectior LE nzedac self conrained 4 Mechanical 3reathing apparacs Pretecton Safety shoes IX SPEETATPRECALITIONS HygiexucPracticesin Handling S amp Siocge Use only in well vertilated areas Store away from excessive leat PrecauticnsforRepeicsdvainteranceofCentaninaled Equipment Make sure that all resiclual vapors are removed prior to 5eg naing Mo
2. inen nennen enin enin enini nene 28 18 2 VERIFY LASER CHAMBER ALIGNMENT ccscseseseseseseseseseseseveeeseceseeeseceseeeseseseseseseseseseseeeseseeeeeseseseresereseeeeenees 29 19 0 XTRAC TROUBLESHOOTING AND EVENT CODE GUIDE 2 ccccccecccecececececscecececececscecececsceees 29 19 1 TROUBLESHOOTING GUIDE c c csssesssssssssscsssssssssesssesessssssssssevssssssesssesssevssssssssesesssssssssesssssesssssssessssnesesess 29 192 EVENT CODE AND GAS HISTORY GUIDES 30 20 0 MAINTENANCE siisssssccssinsccsccstscscceiecccacescscosseslecesesscesssestnstascescsossesbassoevcessecseecesccecevecensveloceesvesdeosssesessvsceseceess 33 20 1 SCHEDULE OF PREVENTIVE MAINTENANCE cccccccscseeeeseseseseeeceseeeeecececececeseeceesereeeseseseseseseeeseseeeeeseeeseneeenens 33 20 2 ENERGY DETECTOR CALIBRATION VALIDATION PER 15 9001401 34 203 GQEEANING THE SYSTEM e Eee E E HEP Re ET Eb ee EE HR te vere seers 35 PABLIMEE HU UM Lel oce 35 211 INTELUECT AL PROPERTY FE Tee EAE EFE CE vedo dee 35 21 2 REFERENCE DOCUMENTATION ccccssessssecececsesesaeccecececseseeaeceecsessaaesecececseneaeseeeeeesesesaaeeeeeceeseaaaeseeseeeeenees 35 DIS TEE 36 22 0 REPLACEMENT PARTS wssessssssssssssonseccssesssvsnsecscssssesssceacessobssdonevescesessssoseetes cons
3. 12 95306 01 Rev G Insert the spanner wrench into the window assembly Page 28 of 36 AL8000 SERVICE MANUAL 2 Rotate the assembly to line the next highest number on the window with the registration mark Note This type of rotating window has six positions If the window is already on position number six 6 then the window assembly must be replaced See Section 17 for replacement procedure 18 2 Verify laser chamber alignment Always check the alignment of the laser cavity and turning mirrors after rotation of the windows Re align the laser per Section 15 19 0 XTRAC Troubleshooting and Event Code Guide Use of the following tables will be useful in helping the technician isolate and resolve system malfunctions If resolution cannot be obtained after exhausting these guides please contact PhotoMedex to discuss possible resolution 19 1 Troubleshooting Guide Common system malfunctions with solutions SYMPTOM POSSIBLE CAUSES SUGGESTED ACTION XTRAC ULTRA Circuit breaker not Turn XTRAC ULTRA breaker to on set to on position position Laser Will Not Start Power cable not plugged into system or Check power cable connections wall outlet Supply room breaker is turned off Check room breaker Thyratron not up to temperature Letlaser warm up for an additional 15 minutes and try again Footswitch not connected nnect footswitch Laser Will Not Fire ot connected Connect footswitc Internal system
4. C 70 C Humidity 90 RH max non condensing Atmospheric Pressure 500 hPa 1060 hPa UNPACKING THE SYSTEM AND PERFORMING SYSTEM SET UP If the XTRAC system has been subjected to extreme temperatures follow the directions in the section titled Transport and Storage prior to applying power to the system Remove the carton straps then open carton top and lift the ramp out at the front end of machine Next remove the carton baseboards 4 sides by removing the screws then lift the carton over the top of the machine Remove the accessory boxes under the machine and platform and unbolt the machine from the platform Place ramp at the front of the crate and guide the machine down the ramp off the crate platform Save the shipping container in the case that the system may be moved to another location Inspect the condition of unit If there is evidence of damage due to shipment contact your PhotoMedex representative for instructions INSTALLING THE FOOTSWITCH Locate the foot switch that was shipped with the unit part number 01 08230 01 NOTE The XTRAC ULTRA footswitch is NOT compatible with any other XTRAC model XTRAC XTRAC XL or XTRAC XL Plus The foot switch 1s located inside the XTRAC system restrained in the location where gas bottle is to be placed e Insert the foot switch in the receptacle on the Rear Interface panel located on the rear ofthe unit The footswitch label identifies the correct receptacle e Veri
5. PhotoMedex Excimer Laser Phototherapy System AL8000 SERVICE MANUAL XTRAGE ULTRA AL8000 SERVICE MANUAL Printed in USA The information contained in this document is subject to change without notice PhotoMedex shall not be liable for errors contained herein or for incidental or consequential damage in connection with furnishing performance or use of this material Use of this manual is not intended for individuals who have not received appropriate training Individuals who have not received formal training by an authorized PhotoMedex trainer cannot service Phototherapy System Attempts to service the XTRAC system without authorized training may cause serious injury to the service technician and or operator and will also void the warranty This manual provides no information on the clinical use of the laser Page 2 of 37 12 95306 01 Rev F 12 95306 01 Rev G AL8000 SERVICE MANUAL REVISION HISTORY Pages Sections Revision ECO Date All A 2530 2 15 05 Initial Release Page 36 B 2548 03 09 05 Pages 12 14 29 34 35 Appendix A B 2575 4 22 05 Pages 1 12 36 D 2609 7 11 05 Sections 3 3 6 1 15 2 15 3 17 3 19 1 19 2 E 2669 11 17 05 20 2 21 2 22 0 Sections 3 2 3 3 4 3 19 0 19 1 19 2 21 2 2817 2 12 07 Appendix A Pages 30 32 G 2896 5 22 07 Page 3 of 36 XTRAS LT AL8000 SERVICE MANUAL Table of Contents REVISI
6. 3 6 AL8000 SERVICE MANUAL Open AP1 and vent Neon gas for 5 seconds then close AP 1 amp 2 Open the laser manual valve 2 IF NO XECL LASER GAS CYLINDER IS ATTACHED CONTINUE WITH STEP 7 IF THE LASER SYSTEM HAS A XECL LASER GAS CYLINDER ATTACHED THAT NEEDS TO BE EXCHANGED PROCEED TO STEP 15 Note The laser should have 18 psia in the chamber prior to performing this procedure 7 8 9 11 10 12 13 14 No XeCl Cylinder Attached Open manual valve 3 and AP 1 for 3 seconds Close manual valve 3 and AP 1 Open 2 to provide a Neon gas purge flow Open solenoid valve 1 FILL from the control panel Remove the threaded metal cap plug from the XeCl regulator pigtail Neon gas should be flowing from the disconnected tube If this is not occurring stop the procedure immediately and identify why Neon is not flowing Neon purge gas must be flowing while the regulator pigtail is disconnected to prevent system contamination Note Cycle XeCl regulator handle CW and CCW one turn to facilitate neon gas flow through it This may need to be done more than one time With the Neon gas flowing connect a full laser gas cylinder to the XeCl flex tube wiping both mating surfaces with Alcohol wipes and using a new gasket NOTE New gasket must be tightened to approximately 70 in lbs If nut holding gasket is loosened for any reason the gasket must be replaced or the gas bottle WILL leak Close
7. 6 VaporDensity Aa 1 n a EvaporaionRate 71 Solubilityin Water Slight Appearance amp Odor Pungert toxic corrosive gas with sharp pungent odor FlashPoint TestMethod TlamnxbleLimits Extinguishinglvieca Wher fighting lires in which Hydrogen Chloride is involved firefighters must SpecialFireFightingProceduies wear protective suits and self contained breathing apparatus InusualFite amp c ExplosicalHaza Cylinders exposed to fire may rupture with explosive force Spray water on them al them cool See section II SyraptormsofExposure Irritation of the eyes skin OSHA ThteshokdLamitVahie 5 ppm ceiling mucous membranes and ACGIH ThiesboldLirnit Value 5 ppm ceiling breathing passages Causes 3 choking coughing and burns NIPPiogram not listed not listed Appendix B Page 1 of 2 12 95306 01 Rev G XTRAG ULTRA AL8000 SERVICE MANUAL APPENDIX B continued THIAZARDDATA MedicalConditens A gaavaledBy Nose amp throat irriza ion Expose Prissy Route s of2nny naziation aud contact with body tissues EmewencyFirstAd Ina lation Move victim to fresh air If breathing has stopped give ar ficial respiration amp if necessary oxyg r Get medical aid Eye amp Skin irritation Flush area with large amounts of water for minimum of 15 minutzs Get medical aid
8. VENT 2 TOQ LONG TO PURGE a a TOO TONG ee 23 NOT USED N A 24 THYRATRON CHECK MCU OR CHECK WIRE W14 25 HVPS FAILURE m EM charge 37 NB SERVICE MANDATORY cu pied An re EU xd last service visit NB only wor uU 32 WRONG VERSION CORRECT VERSION 40 NOT USED N A 12 95306 01 Rev G Page 30 of 36 AL8000 SERVICE MANUAL even after a gas exchange the system couldn t achieve min energy 41 UNABLE 2 ACHIEVE TWICE CHECK ALIGNMENT ROTATE REPLACE WINDOWS CHECK POWER SUPPLY OR PFN THYRATRON 42 50 NOT USED N A system couldn t verify handpiece in cal port during calibration HANDETECE CHECK CALPORT MICROSWITCHES 53 SENSOR RATIO LESS THAN 40 ratio of energy from end of fiber and PFD is lower than allowed NT CHECK ALIGNMENT CHECK LLG CHECK OPTICS PANEL BOARD 4 UNABLE 2 ACHIEVE MIN ENERGY ilg EVENT CODE IS NEITHER SEEN NOR RECORDED ss Foorswren macnve 56 KEYSWITCH INACTIVE stuck 57 NOT USED N A a CHECK ALL INTERLOCKS CHECK SHUTTER CABLES 59 NB SERVICE NEEDED ub M POE in un last service visit NB only 60 HVPS DAC MALFUNCTION LM EROR 62 OPENED EPON OF LID SWITCH AND CONNECTIONS 63 ESTOP_PRESSED the ESTOP button is pressed 64 PROCESS_ABORTED user cancelled an operation in
9. radiation exposure WARNING At all times during the installation or operation of the laser avoid possible exposure to laser radiation WARNING Users and support staff must wear eye protection during laser operation The recommended optical density for Safety eyewear is an optical density OD of 2 at a wavelength of 308 nm The patient s eyes should be protected with a covering of wet gauze WARNING High voltage circuits are contained within the XTRAC system enclosure Page 7 of 36 12 95306 01 Rev G ULTRA AL8000 SERVICE MANUAL 3 2 Labeling Throughout the system you will find labels applied to various areas which are designed to warn or caution of certain hazards or other precautionary information This section will provide an outline of each symbol and it s meaning The current revisions of each label are filed with Document Control Description Circuit Breaker On Description Foot switch 2 Description Remote Interlock fad Description Defeatable Interlock Description Label Calibration Port CALIBRATION PORT Page 8 of 36 12 95306 01 Rev G AL8000 SERVICE MANUAL Optical Fiber Label Nameplate AL8000 REF ALS8000 SN Carlsbad 100 230 V 50 60 Hz C Complies with 21 CFR 1040 10 and 1040 11 except for deviations pursuant to Laser Notice No 50
10. Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation If it causes unwanted interference the operator should consult the laser service representative Changes or modification not expressly approved by PhotoMedex could void the user s authority to operate the equipment CAUTION Do not operate the laser in the presence of flammable anesthetics or oxidizing gases such as nitrous oxide N2O and oxygen 2 0 GENERAL SAFETY FOR OPERATING PERSONNEL AND PATIENTS Laser equipment not in use should be protected against unqualified use for example by removal of the key from the key switch The invisible ultraviolet laser radiation emitted from the XTRAC system output laser aperture can cause eye and or skin injury from either direct radiation Only a trained user should operate the laser The use of controls or adjustments or performance of procedures other than those specified in this labeling may result in hazardous radiation exposure Users and support staff must wear eye protection during laser operation The recommended safety eyewear should have an optical density OD of 2 wavelength of 308 nm Do not look into the end of the handpiece when the laser is firing Do not point the handpiece at operating room personnel when the laser 15 firing Page 6 of
11. State Din Rail for ordering 06 80022 17 Air Filter 5 5x5 5 01 08223 99 MCU Assembly 05 70233 06 Pyroelectric Energy Detector 06 80023 12 Fan Tangential 01 08224 99 Optics Panel Board 06 80023 13 Fan Galaxy DC Bottom of 01 08229 99 Relay Panel Board System 06 80023 14 Fan Sprint 24V Front of 01 08230 01 Footswitch Assembly PFN 01 08231 99 Photodiode Assembly we Mutin XE ZAV Rear ot 03 08420 01 Remote Interlock Plug 06 80064 23 Regulator VCO Inlet SS 04 07802 01 Micro Switch X Y Positioner Fiber 06 80071 14 Washer KEL F Switch 05 70098 26 FUSE 1 25A 250V 5X20MM FAST ACT 06 80071 13 Gas Bottle Optics Board 06 80275 12 Key 311 05 70098 27 FUSE 6 3A 250V 5X20MM FAST ACT Relay Board 06 80275 26 Tubular Key Top Panel Key 05 70098 28 FUSE 1 6A 500V Slo Blo Inside PFN 06 80280 09 Polyethylene Dust Cover 06 803 10 02 Velcro Fastener 12 95306 01 Rev G Page 36 of 36 MIT LT RAY AL8000 SERVICE MANUAL Appendix A Definition of Terms 0 Excimer Laser A pulsed 308 nanometer XeCl laser that in the XTRAC system provides the Phototherapy action spectrum required to provide dermatological treatment o Fiberoptic Liquid Light Guide In the XTRAC system this term is used to describe the probe cable that carries laser energy to the patient o HVPS High Voltage Power Supply Kilovolts Millijoules is used to express laser energy Pulses Per Sec
12. dated July 26 2001 Scanlan Group B V Postbus 75664 1118 ZS Schiphol Triport The Netherlands PhotoMedex Inc 2375 Camino Vida Roble Ste B Carlsbad CA 92011 USA U S Patent Numbers 4891818 5044717 Other Patents Pending Laser Warning Danger Laser Warning Explanation Class IV Page 9 of 36 12 95306 01 Rev G AL8000 SERVICE MANUAL Label Physician Use Only FDA Reqd i CAUTION Federal Law restricts this device to sale by or on order of a physician A Attention Yellow or White Caution Invisible Page 10 of 36 12 95306 01 Rev G XT RAG ULTRA 3 3 Symbols Symbol e i TS m 15 of x m o 6B 4 12 95306 01 AL8000 SERVICE MANUAL Description Batch Code B Equipment Date and location of Manufacture Emergency Laser Stop European Representative Fiberoptic Applicator Footswitch Fragile Keep Dry Laser Aperture Symbol On Part of System Off Symbol REF LASER APERTURE zw SN 0c MED Description Model Number Laser Aperture Location On Main Off Product complies with Directive 93 42 EEC for medical devices Read Instructions For Use Ready Key Remote Interlock Serial Number Temperature Limitation Laser Emission MED Ready Mode Page 11 of 36 XTRAGE ULTRA 4 0 DEVIC
13. lime calcium oxide and sodium hydroxide Soda lime reacts exothermally with water to form an alkaline solution so caution should be taken when mixing with water A solution of the soda lime may be neutralized with common baking soda or a mild acid such as vinegar by appropriately trained personnel 22 0 Replacement Parts Listed below is a list of replacement parts for the XTRAC Excimer laser phototherapy system Assy Part Description Assy Part Description 01 05280 01 Gas Scrubber 05 70098 29 FUSE 0 6 500 Slo Blo Inside PFN 01 07795 02 Rotating Window Assembly 6 position 05 70204 24 Power Supply High 01 08040 99 Control Panel Assembly Voltage Output 120VAC 10K VDC 24VDC 01 08097 01 Handpiece Tip and Ink Pad Assembly 05 70204 24 Power Supply High Voltage 01 08100 01 Cleaning Kit for LLG Output 120VAC 10KVDC 24VDC 01 08104 01 Liquid Light Guide Delivery System Kit 05 70225 16 Switch Modification includes tips and cleaning kit Cal Port 01 08208 99 PFN Top Assembly 05 70225 18 Switch Panel Mount DPST 01 08222 xx Software PROMS A and B Assembly 05 70236 07 Led High Intensity Yellow Version of software needs to be provided for ordering 05 70236 08 Led High Intensity Green 01 08225 xx Software PROMS A and B Assembly 05 70399 04 Relay Panel Mount Solid Version of software needs to be provided
14. problems Contact PhotoMedex Interlock circuit was opened Close interlock circuit breaker located at the back of the laser then press Reset No Response to button OR if the interlock circuit has been Buttons or Foot switch connected to a door in the room close the door and press Reset Key Switch was turned off Turn Key Switch to ON position No Display No Sound XTRAC Ultra breaker switch is off Turn breaker switch on then restart unit From Unit Supply room breaker is turned off Check room breaker Page 29 of 36 12 95306 01 Rev G XTRAG ULTRAJ AL8000 SERVICE MANUAL 19 2 EVENT CODE AND GAS HISTORY Guides Event codes are displayed on the XTRAC front panel and are used to report functional abnormalities that are monitored by the MCU Master Control Unit A comprehensive listing of all event codes is provided for reference EVENT CODE GUIDE Software Version 4 10 1 EVENT 2 NUMBER SYSTEM EVENTS BRIEF DESCRIPTION ACTION 0 9 UNDEFINED M 10 CRITICAL_VALUE_ERROR a sen ERROR oo 2 MEMORY INIT FAILED is CAM variables MemCheck failed 14 OUT OF GAS E m CU D calculated from bottle pressure 16 RETENTION FAILED MU m 17 CHAMBER PRESSURE LOW test at power on implies leak in chamber 19 UNINITIALIZED CODE SD EU billing vs non billing Too rona
15. progress 65 ACCOUNT_DEPLETED no more codes in the treatment bank 66 INVALID_CODE_ENTRY invalid number entered in billing 67 NOT USED N A 68 REMOTE_INTERLOCK BROKEN remote interlock was de activated during calibration or treatment 69 NOT USED N A 71 SYSTEM NOT WARMED UP PINI DIODE VALUE ZERO but system hasn t been active for at least 5 min CHECK DIP SWITCHES ALL MUST BE OFF 12 95306 01 Rev G Page 31 of 36 ULTRA AL8000 SERVICE MANUAL 72 SYSTEM NOT YET aes e routine diode hasn t been tuned yet 73 FOOTSWITCH ACTIVE footswitch active when it shouldn t be 74 CAL PORT ACTIVE cal port active when it shouldn t be 75 79 NOT USED N A 80 LOW ENERGY 0 81 LOW ENERGY 1 82 LOW ENERGY 2 83 LOW ENERGY 3 84 LOW ENERGY 4 85 LOW ENERGY 5 86 LOW ENERGY 6 87 LOW ENERGY 7 Low energy Auto Gas Pressure Adjustment to Follow Gas Code 105 GAS HISTORY GUIDE 101 CHAMBER TOP OFF topping off chamber pressure too low 102 CHAMBER VENTING venting off chamber pressure too high 103 PULSE COUNT EXCEEDED too many pulses since last exchange 104 TIME ELAPSED too much time since last exchange 105 CAL FAILURE gas exchange after event 80 87 calibration failed 106 EXCHANGE RESTART gas exchange restarting never finished last time powered up 107 MANUAL gas exchange started from service mode manually
16. 0 60 Hz 1 kVA universal 220 Ib 100 kg approximate Self Contained Supply approx 20 refills 46 cm x 99 cm x 86 W x Lx H 18 inches x 39 inches x 34 inches Class IV per 21 CFR 1040 10 IEC 60825 1 Class per 21 CFR 1040 1 IEC 60825 1 20 cm from the handpiece tip 15mJ 750 mRad Page 12 of 36 XTRA LTRA AL8000 SERVICE MANUAL 4 4 XTRAC Equipment Classification per UL 60601 1 Type of protection against electric shock Class I equipment Degree of protection against electric shock Type B equipment Degree of protection against harmful Ordinary equipment without ingress ingress of water protection Degree of safety in the presence of Equipment is not suitable to use in the flammable anesthetic mixture with air or presence of flammable anesthetic mixture oxygen or nitrous oxide with air or oxygen or nitrous oxide Mode of Operation Continuous operation Liquid Lightguide and Handpiece MODEL H7 4 0 LLG Material Proprietary liquid filled housing Length 2 0 meters Diameter 3 0 mm nominal Input Custom connector user replaceable Output Custom connector HP Material Aluminum housing Projected Field 0 75 in square 4 0 cm Handpiece Tip amp Ink pad Kit MODEL K7 4 0 Supplied non sterile with reusable Handpiece Marking Tip 5 0 INDICATIONS Phototherapy with the XTRAC UVB Excimer Laser Phototherapy system 15 indicated for patients with Psoriasis Vitiligo Atopic Dermatitis or Leukoderma 6 0 TRAN
17. 108 PRESSURE BUMP gas pressure increased from 35 to 45psia 12 95306 01 Rev G Page 32 of 36 XTRAG ULTRA AL8000 SERVICE MANUAL 20 0 MAINTENANCE All service and preventive maintenance is to be performed by qualified PhotoMedex representatives A schedule of required maintenance is provided in this section It is required that the areas listed be serviced on the schedule as indicated in order to maintain proper system performance and operation Failure to perform required maintenance will result in the inability of the XTRAC to perform as designed A copy of all preventative maintenance as performed must be sent to PhotoMedex Carlsbad CA as evidence of completion 20 1 Schedule of Preventive Maintenance See following table for list of required preventive maintenance Schedule of Required Preventative Maintenance Visit me EL t Gas Bottle Regulator System Plumbing Shutter Assembly mmm p wwe xL I I TE It ee TGR 1 1 R Replace I Inspect Clean Clean Tf the calibration date on the energy detector has expired the energy detector must be replaced and or re verified against a traceable standard see Section 20 2 Page 33 of 36 12 95306 01 Rev G XTRAGE ULTRAJ AL8000 SERVICE MANUAL 20 2 Energy Detector Calibration Validation per 15 90014 01 1 Inspect Nova Exposure Meter adapter and Standard Energy Detector standard for p
18. 36 12 95306 01 Rev G XTRAGE ULTRAJ AL8000 SERVICE MANUAL 2 1 User Responsibilities for Appropriate Operation It is the responsibility of the health care professional who is using the laser to be aware of requirements for safe use 15 strongly recommended that a hospital Laser Safety Officer be responsible for the overall control of the laser and safety training Note Laser equipment not in use should be protected against unqualified use e g by removal of the key from the key switch The responsibilities of a Laser Safety Officer are described in American National Standard for Safe Use of Lasers in Health Care Facilities ANSI Z136 3 2000 The user is responsible for reading and following the XTRAC Operations Manual and for exercising all safety precautions recommended in the Operations Manual and product labeling including the use of eye protection at all times that the system is activated 3 0 WARNINGS LABELING and SYMBOLS 3 1 Warnings WARNING The invisible ultraviolet laser radiation emitted from system output port aperture can cause severe eye and or skin injury from radiation Only a trained user should operate the laser WARNING The repair technician must exercise extreme care when operating the laser safety glasses must be worn and skin exposure must be avoided WARNING The use of controls or adjustments or performance of procedures other than those specified in this labeling may result in hazardous
19. AP2 Turn the XeCl regulator pressure adjustment knob fully CCW slowly open XeCl main cylinder valve and then adjust the output pressure to 36 40 psig However under any circumstances never exceed the red marking on the gauge 40psig When this step is complete go to Step 22 12 95306 01 Rev G 17 XeCl Cylinder Attached 15 16 Open solenoid valve 1 FILL using the control panel Check to make sure the XeCl main cylinder valve is closed and then slowly open 1 to vent any residual laser gas in XeCl gas regulator Close Open 2 to pressurize XeCl regulator with Neon gas pressure 5 10 psig Page 18 of 36 14 3 18 19 20 21 22 23 24 25 26 AL8000 SERVICE MANUAL Carefully disconnect the high pressure regulator pigtail from XeCl gas cylinder Neon gas should be flowing from the disconnected line If this is not occurring stop the procedure immediately and identify why Neon is not flowing Neon purge gas must be flowing while the flex tube is disconnected to prevent system contamination NOTE Cycle the XeCl regulator handle CW and CCW turn to facilitate neon gas flow through it This may need to be done more than one time Exchange the used XeCl gas cylinder for a full one and tighten the flex tubeO connection using a new gasket NOTE New gasket must be tightened to approximately 70 in Ibs If nut holding gasket is loosened for any re
20. Code 14 at 200 psi remaining which will disable the laser This gives the system approximately 4 fills between the first low gas warning and the critical Event Code 14 Enter Service Mode 2 Press the CYLINDER then DONE buttons to access the gas management screen 3 Record the displayed and actual values 4 Enter the value of the XeCl cylinder pressure in the laser control panel screen This screen should automatically display the approximate number of laser fills available 5 Press the ENTER key to accept the new values and exit If the value between the pressure in the cylinder and the displayed pressure is more than 80 psi then the OFFS value should be checked in the gas management screen access the OFFS value perform the following 1 Enter Service Mode 2 Press the CYLINDER button to access the gas management screen 3 The TOP OFF information will be visible in the middle of the screen If the laser shows more than 15 TOP OFFS per month on average then a gas leak from the chamber or plumbing may be suspected Most systems will exhibit some degree of thermal expansion and contraction of laser gas in chamber This expansion and contraction is the reason that most lasers will have some small value of TOP OFFS displayed on the screen The TOP OFFS value should be reset after any work is performed to the pressure barriers on the chamber such as a window exchange or a pressure transd
21. E DESCRIPTION 4 1 Manufacturer and EU Representative Manufacturer PhotoMedex Inc 2375 Camino Vida Roble Suite B Carlsbad CA 92011 4 2 Standards AL8000 SERVICE MANUAL EU Representative Scanlan Group B V Postbus 75664 1118 ZS Schiphol Triport The Netherlands The XTRAC model AL8000 Excimer laser phototherapy system is a class IV Laser product which complies with US Code of Federal Regulations 21 CFR 1040 10 and 1040 11 amp IEC 60825 1 The XTRAC system has tested in compliance with the safety laser requirements and electromagnetic compatibility per the following international standards EMC STANDARDS EN 60601 1 2 EN 55011 Class A Group 1 SAFETY STANDARDS EN 60601 1 EN 60601 2 22 EN 60825 2 CFR 1002 UL 60601 1 IEC 60601 2 22 4 3 XTRAC XeCl Excimer Laser Phototherapy System Specifications The XTRAC system 15 an Excimer laser designed for use in phototherapy treatment The XTRAC has been designed around a pulsed 308 nanometer excimer laser which provides Wavelength Pulse Repetition Rate Pulse Width FWHM Beam Diameter Operating Energy Electrical Weight Gas System Dimensions Excimer Laser Product Classification Diode Laser Product Classification Nominal Ocular Hazard Distance Maximum Laser Energy Beam Divergence 12 95306 01 Rev G 308 nanometers Up to 250Hz 30 nanosecond nominal 0 75 in square 2cm X 2cm 2 3 8 mJ cm nominal per pulse 100 230 VAC 5
22. Energy Detector and record on Form AF 0205 11 If the error is less than or equal to 6 the System detector has passed calibration validation a Fill out a Calibration Label P N 12 95272 01 completely Enter date of calibration calibration due date 18 months after Cal date S N of Reference Energy Detector attached to Nova II and the Service Engineers initials b Attach securely to the back of the AL8000 System Energy Detector Head c Return completed Form AF 0205 to PhotoMedex Carlsbad QA Department ASAP 12 If the error is greater than 6 re test per Steps 3 to 10 and record data 0205 13 If the error is greater than 6 for a second time the system detector has failed calibration validation a Remove the System Energy Detector and MCU and return along with Form AF 0205 to PhotoMedex Carlsbad QA Department ASAP b Install anew MCU and System Energy Detector and repeat Steps 3 to 10 c Complete paperwork and return to QA department at PhotoMedex in Carlsbad CA Page 34 of 36 12 95306 01 Rev G XTRAGE ULTRA 20 3 AL8000 SERVICE MANUAL Cleaning the XTRAC System The exterior of the laser unit may be cleaned using water with a mild detergent Never use solvents or other harsh chemicals to clean the exterior portion of the system Never attempt to clean the output lens of the handpiece assembly 21 0 REFERENCES 21 1 21 2 Intellectual Property PhotoMedex Inc is the owner of United Sta
23. ON HIS TOR Y A E 3 1 0 CAUTION 5055 926060569556655 6 2 0 GENERAL SAFETY FOR OPERATING PERSONNEL AND PATIENTS 10 6 2 1 USER RESPONSIBILITIES FOR APPROPRIATE OPERATION cscsceeeeeeeseeeeseessesesseceveseeeeececeseseseseseseresesesereeesenens 7 3 0 WARNINGS LABELING AND SYMBOLS sseseseessesesecescessseseocceesscsoceceseessoscosceesssseocceessseocceessesosecessessos 7 3 1 WARNINGS 7 3 2 I wil 8 4 0 DEVICE DESCRIPTION 4 ee coe eo sese eee eoo eo Pea ae Saa Pav aee 12 4 1 MANUFACTURER AND EU REPRESENTATIVE ceee eene enne ene sese se essen sese sese sese eis 12 4 2 STANDARDS NEA IEEE UMEN EEUU III 12 4 3 XTRAC XECL EXCIMER LASER PHOTOTHERAPY SYSTEM SPECIFICATIONS eee eene 12 4 4 XTRAC EQUIPMENT CLASSIFICATION PER UL 6060111 13 5 0 INDICATIONS 13 6 0 TRANSPORT AND STORA GI oe Sa eto ro rne seas ro See en SERE TE Ke a sees oncsaseucesesbsseccsseds 13 BEFORE SHIPPING THE XTRAC 14 6 2 TRANSPORT AND STORAGE CONDITIONS A
24. RE DEFINED AS 14 7 0 UNPACKING THE SYSTEM AND PERFORMING SYSTEM SET UP 14 8 0 INSTALLING THE FOOTSWIT CH ccccccscscssescscscscscscscccccccecccccccccccecccscccecccecsceccccececececececececesececececes 14 9 0 USING THE SYSTEM ROOM DOOR INTERLOCK OPTIONAL u cccssssscssssscecssccececssseesssssceees 15 10 0 ADJUSTING SYSTEM VOLTAGE AND FREQUENCY 15 11 0 POWER ON WARM UP MODE cccccccscscscsccccececececececececececececececececececececececececececececececececececececececececes 15 12 0 EMERGENCY LASER STOP 16 13 0 OPERATING THE SYSTEM IN THE SERVICE MODE ccccccccocecececscecccscecececscececseecscesececececececes 16 13 1 ACCESSING SERVICE MODE IN THE XTRAC 16 14 0 GAS BOTTLE INSTALLATION cissccssccccesccectcccecessussosesecesoceseossocvsncesesessessocesscesoseseosooceseseseceosesoecesscesosesvseves 17 14 1 NEON PURGE SET UP ccccssccccccecsessessaececccsesenseaececesessseaecececsesensaaeeeeeescsesasecesececsensuaeeecececsensaaeaeceeeeseneneea 17 14 2 CONNECTING NEON PURGE amp ATTACHING OR EXCHANGING XECL 17 143 REMOVING THE NEON PURGE Q cccceeseeeseseseseseseceseseseeeseseseeeseseseresereseseseseseseseseseseseseseseseeeseseseseeeseseresereeeeees 19 15 0 ALIGNMENT AND LIQUID LIGHTGUIDE INSTALLATION e
25. SPORT AND STORAGE Preparing the XTRAC system is to be performed only by PhotoMedex authorized service representatives If the system has been exposed to extreme temperatures the unit must be returned to room temperature 15 25 C before operating This is best accomplished by allowing the system to be left in a room temperature environment overnight before operation Caution DO NOT attempt to lift the unit with the handles NEVER attempt to pull the unit by the power cord or the handpiece Page 13 of 36 12 95306 01 Rev G ULTRA AL8000 SERVICE MANUAL 7 0 8 0 Before Shipping the XTRAC system Enter CYLINDER routine in service mode and vent the chamber to 17 psig Remove the gas cylinder by performing the following steps from section 14 2 e Perform Steps 2 through 6 then 15 through 18 e Next immediately install the aluminum shipping plug with KEL F washer into the flex line to XeCl gas bottle and tighten Failure to do so will contaminate the laser and void the warranty e Finally perform steps 20 and 23 and exit from the cylinder screen and shut the laser off e Remove the Neon purge per section 14 3 then remove gas cylinder Remove the foot switch assembly Remove the lightguide and handpiece assembly t is illegal to transport a pressurized cylinder which is not properly prepared with an appropriate safety cap 6 2 Transport and storage conditions are defined as follows Temperature 40
26. aser cavity Because the laser mirrors can be set parallel but also at substantial angles that will all give nearly maximum energy there needs to be a way to define the optimal alignment axis 2 The second challenge in the alignment process is the coupling of laser light into the fiber delivery system Proper alignment into the fiber is critically important to fiber lifetime The beam should be input directly and precisely perpendicular into the face of the Liquid Light Guide The beam should also be centered precisely into the 3mm light guide core and there should be no laser light hitting the outer portion of core The adjustment process should also be tolerant of minor misalignment of the optical hardware that is inherent in the XTRAC ULTRA laser system Proper Alignment XY Positioner In the above example the laser mirrors are parallel with each other as well as being perpendicular to the laser discharge This alignment will yield the optimal beam shape and energy Page 20 of 36 12 95306 01 Rev G LTRA AL8000 SERVICE MANUAL Improper Mirror Alignment XY Positioner In the above example the laser mirrors are parallel but are NOT perpendicular to the laser discharge This alignment will yield less than optimal energy and beam shape while aiming the beam away from the center of the fiber The second challenge in the alignment process is the coupling of laser light into the lightguide delivery system The beam sh
27. ason the gasket must be replaced or the gas bottle WILL leak Close AP2 Open the XeCl main cylinder valve and make sure the pressure is set to 36 40 psig However under any circumstances never exceed the red marking on the gauge 40psig Carefully crack open and vent laser gas for 5 seconds then close AP 1 amp manual valve 2 Close solenoid valve 1 FILL from the laser control panel Open manual valve 3 Enter the value of the XeCl cylinder pressure in the laser control panel screen This screen should automatically display the approximate number of laser fills available Exit Gas Service screen and press the Yes button to refill the laser chamber Return service key switch to the OFF position Removing the Neon Purge 1 12 95306 01 Rev G Open AP2 and then to purge the line with Neon gas for 5 seconds then close 1 Disconnect the purge line from the AUX inlet connection and while continuing to purge the line seal the purge line and the AUX inlet using the VCO caps Close the Neon cylinder main valve and valve AP2 Page 19 of 36 XTRAG ULTRA AL8000 SERVICE MANUAL 15 0 ALIGNMENT AND LIQUID LIGHTGUIDE INSTALLATION 15 1 Introduction The alignment of the XTRAC ULTRA laser system presents two independent challenges to the technician The alignment process therefore must be viewed as and performed in two separate steps 1 The first challenge is achieving proper alignment of the l
28. ce alignment chuck insert into alignment chuck NOTE side with smaller hole is inserted first then return chuck to XY Positioner c Loosen but do not remove the four screws holding XY Positioner to front optical mount plate d Run laser observing the beam on the white paper Using a screwdriver adjust the X and Y axes on the stage until no circular aperturing of the rectangular beam exists e Tighten the four screws securing the XY Positioner Run laser to insure there is still no circular aperturing f Install external detector holder onto alignment chuck and attach energy detector g Run laser for about one minute and record Apertured pulse energy h Remove alignment chuck insert from alignment chuck and replace alignment chuck i Run laser for about one minute and record Initial laser energy j Calculate minimum acceptable energy by multiplying above Initial energy by 0 97 and record minimum acceptable energy If Apertured energy is less than minimum acceptable then repeat steps b through k otherwise procedure is complete l Remove alignment tools and re bolt strain relief mounting plate such that strain relief and XY Positioner are concentric use alignment chuck as a guide 5 Always perform PIN diode calibration after laser mirror or XY positioner adjustments 15 3 PIN Diode Calibration 1 Place unit in Service Mode 2 Insert alignment chuck into XY positioner and attac
29. e paper to top skin interior directly in front of laser outlet iv Run laser and adjust laser mirrors to maximize square ness and brightness of beam c Moderate alignment i Install one 1 Laser Alignment Pin Hole on rear of laser chamber ii Align vertical mirror axes iteratively until spots line up along horizontal axis iii Align horizontal mirror axes iteratively until spots overlap d Fine alignment i Install second Laser Alignment Pin hole on front of laser chamber output beam shape on white paper is a small bright donut within a larger faint circle ii Repeat iterative alignment on the horizontal and vertical axes until the donut is centered in the larger faint circle of light e Re tighten the clamps around each of the four alignment screws and ensure that the alignment did not change 3 XY Positioner Alignment Check a Open top skin and remove left skin as viewed from front of unit b Tape a piece of white paper to top skin interior directly in front of laser outlet Page 22 of 36 12 95306 01 Rev G ULTRA AL8000 SERVICE MANUAL c Place alignment chuck insert into alignment chuck NOTE side with smaller hole is inserted first then return chuck to XY Positioner d Operate laser at 50 Hz and 7 kV e Alignment is OK if the beam is rectangular with no clipping of the corners If there is clipping then proceed with full alignment 4 XY Positioner Alignment a Remove strain relief mounting plate b Pla
30. eben 36 APPENDIX A DEFINITION OF TERMG cccccccecscecscecececccesececcecccecccececccecccccecececcecececececececececececececececececeses 44 APPENDIX B MSDS FOR XECL cccccscscsssscscssscscscscscccccecccccccecccscccecccsccccceccccceecececececececececececececececececesecececes 45 APPENDIX C ADDITIONAL DOCUMENT cccccccccccccecscscececscececesececececececececececececececececececececececececesecececes 46 Page 5 of 36 12 95306 01 Rev G XTRAGE ULTRA AL8000 SERVICE MANUAL 10 CAUTION This Service Manual is intended to be used only by persons who have been trained to service this product Procedures and instructions are to be followed as indicated AII cautions precautions and warnings should be thoroughly understood prior to unpacking assembling and operating the XTRAC system CAUTION AVOID DIRECT OR SECONDARY LASER RADIATION The XTRAC phototherapy system is a laser based device When interlocks have been placed in the service mode there is the potential for laser energy to be present Use precaution when operating the system in this mode Always wear appropriate safety glasses which are designed to block 308nm UVB wavelength energy CAUTION Potentially lethal voltages are present within the XTRAC system Always use caution when performing any service or maintenance to the system CAUTION This device complies with part 15 of the FCC
31. er the laser mirror on the middle optics plate to prevent damage or being touched during the window change 16 Slide walk the middle optics plate back toward the laser Use the two delrin spacers to precisely set the gap between the middle and front optics plates then tighten the clamps on the middle plate Replace the shutter assembly 17 Close manual valve 3 17 4 Removing the Neon Purge 1 Close manual valve 2 and verify that AP2 is still open 2 Disconnect the purge line from the AUX inlet connection and while continuing to purge the line seal the purge line and the AUX inlet using the VCO caps 3 Close the Neon cylinder main valve and valve AP2 17 5 Re gassing and re alignment of the laser chamber 1 Open manual valve 3 2 From the laser control panel press the DONE button and then the YES button to perform a gas exchange 3 Verify that the XeCl regulator is set between 36 40 psig Do not exceed the red marking on the gauge 36 psig under any circumstances 4 Re align the laser per Section 15 5 Return the laser to standard operating mode 6 The procedure is now complete Carefully package and return the used window assemblies to PhotoMedex for re work Ensure that the windows are returned under an RMA number 18 0 WINDOW ROTATION PROCEDURE Windows should only be rotated when the laser is no longer able to produce 20mJ at 8 0kV after alignment and gas exchange 18 1 Rotating the Chamber Window Assemblies l
32. fy that the action of the foot switch is smooth and positive Page 14 of 36 12 95306 01 Rev G ULTRA AL8000 SERVICE MANUAL 10 0 11 0 USING THE SYSTEM ROOM DOOR INTERLOCK OPTIONAL The safety remote interlock is a black colored plug P N 03 08420 01 that is plugged into the main power panel You may hardwire this interlock in series to a switch on the entry door of the room where you use the XTRAC using the Interlock wiring assembly P N 01 08234 01 Authorized individuals such as an electrician can only perform this When anyone opens the room s entry door the interlock 1s activated preventing the laser from firing until the door is closed Once the interlock circuit is normalized and the RESET key is pressed the laser will function normally The current voltage running through the interlock is 0 005 amps and 0 7 volts Neither the plug nor the interlock wiring can be used with any other equipment other than the XTRAC ULTRA If you remove the safety interlock at any time after you turn on the laser lasing will stop A matching plug with the pins internally connected is provided for service personnel to test the XTRAC system If the safety interlock has an open circuit the room entry door 15 open laser functions are inhibited Once the interlock circuit is normalized the room entry door closes and you press the Reset Key the laser will function normally ADJUSTING SYSTEM VOLTAGE AND FREQUENCY The AL8000 power supp
33. g with the message RELEASE EMERGENCY STOP BUTTON This is normal and should not be interpreted as a system fault If the button is pressed while the laser is firing the laser will stop firing While this button is down the laser will not fire Note that this button is easily accessed as is necessary in case a quick stop is required Note also that there are arrows on the button to indicate a rotation direction To release the button turn in the direction indicated by the arrows 13 0 OPERATING THE SYSTEM IN THE SERVICE MODE The XTRAC system can be operated in a Service Mode by using the service key switch located on the Rear Interface panel located on the rear of the unit By using this feature you can perform special functions that will allow you to isolate and verify specific functions of the system 13 1 Accessing Service Mode in the 1 Turn system power off 2 Insert service key part of the XTRAC ULTRA Specialty Tool Kit into the switch located on the rear of the unit and turn on to set the laser to Service Mode 3 Turn system on The laser will now allow the technician to manually manipulate the high voltage repetition rate and gas system settings Page 16 of 36 12 95306 01 Rev G ULTRA AL8000 SERVICE MANUAL 14 0 GAS BOTTLE INSTALLATION PhotoMedex Gas System Connections Using Laser Gas Purge Laser window Rupture Disc 70 psig AUX Ii i Neon Purge Regulator I
34. h external energy detector holder and system energy detector 3 Ensure that interlocks will not prevent shutter from opening 4 Press the CALIB touch key then the DIODE key 5 Press the footswitch then the START key Keep footswitch depressed until machine stop firing PIN Diode is now tuned 6 Verify PIN Diode Calibration 12 95306 01 Rev G a b Fire laser and adjust input kV to achieve 10 15 and 20 mJ 2 Verify efficiency EFF is 100 390 and record value If efficiency 15 out of spec repeat PIN diode calibration If it continues to be out of spec contact PhotoMedex to discuss possible resolution Page 23 of 36 XTRAC ULTRA AL8000 SERVICE MANUAL Ca 1 Remove the Laser Handpiece Delivery Cable from its packaging Inspect for any damage If damage is noted contact PhotoMedex Customer Service immediately NEVER use a Handpiece Delivery Cable you may suspect has been damaged 15 4 Install the Lightguide 2 If supplied remove the protective caps from the Delivery Cable ends NOTE NEVER hold the assembly by the fiber when removing the protective caps always hold the handpiece or input end bezel while removing the caps 3 Place the Laser Handpiece Delivery Cable into the mating connection carefully inserting the input end as far as it will go into its locating mount until it clicks into place Do not use any tools to complete this step NOTE The click noise made during
35. hysical damage If damaged the complete unit must be re calibrated at PhotoMedex Carlsbad before using 2 Verify that the software version on the AL8000 is 3 00 or greater If not upgrade the unit to latest software revision 3 Place the AL8000 laser system in service mode and warm up the machine for at least five minutes 4 Place the liquid light guide into the machine then after pressing the CALIBRATE button and the STANDARD button insert the LLG hand piece into the Cal Port and calibrate After calibration the system shows the calibration summary screen Hit EXIT once to continue 5 Insert hand piece into the Standard Energy Detector and press the footswitch to deliver a 1000 mJ dose Observe the actual dose displayed on the exposure meter and record on Form AF 0205 Press the display screen once to reset 6 Repeat Step 5 for three more doses and record 0205 7 Insert hand piece into the cal port and press the footswitch to deliver a 1000 mJ dose to the System Energy Detector Observe the actual dose on the system display and record the value on Form AF 0205 Press the display screen once to reset 8 Repeat Step 7 for three more doses and record on AF 0205 9 Touch the screen abort button to return to stand by mode 10 Average the four doses into the Standard Energy Detector and the four doses into the Cal Port System Energy Detector and determine the error of the AL8000 Energy Detector relative to the Standard
36. insertion indicated that the fiber detection switch has been activated There are two small switches used for this purpose If you do not hear this noise or suspect that the switches are not being activated you must adjust the position of the switches in order to ensure activation The switches are active when the end portion of the barrel assembly on the fiber cable depresses the curved portion of the switch assembly It is extremely important that this adjustment be made correctly as improper adjustment will prevent the system from operating correctly Page 24 of 36 12 95306 01 Rev G XTRA LTRA AL8000 SERVICE MANUAL 16 0 GAS BOTTLE CAPACITY MAINTENANCE Note The system must be in Service Mode for this procedure During routine maintenance of the XTRAC laser system it will be necessary to verify the accuracy of the FILLS remaining counter Check the pressure of the gas cylinder as read on the high pressure side of the gas regulator and compare it to the displayed pressure reading on the gas screen Adjust the displayed pressure reading up or down as needed to achieve an accurate reading The laser will perform automatic gas exchanges every 5 million pulses or 4 weeks whichever comes first The laser operator cannot initiate gas exchanges at any time The system will count down as gas exchanges are performed giving a warning at lt 600 psi remaining Refill supply low X fills remaining Contact Service Soon and an Event
37. l the O ring to the outer edge of the window flange Roll O ring outward E 8 Place the replacement window assembly in front of the laser window flange allowing neon purge gas to flush the air from the window assembly 9 To prevent O ring damage tilt the window so that the bottom edge of the window 15 first inserted into the end flange Press downward on the window assembly to compress the bottom edge of the O ring and then press the window into place 10 Be sure to leave the white registration line in the uppermost position The window flange is a metal to metal fit so don t over tighten these screws 11 Snug down all six hex head screws used to attach the window assembly 12 Rotate the window one full turn this will help to identify if the O ring was damaged when the chamber is pressurized Page 27 of 36 12 95306 01 Rev G ULTRA AL8000 SERVICE MANUAL 13 Align position 71 with the white registration line using a spanner wrench 14 Replace the rear optical plate assembly using the spacing tool to maintain proper optical plate gapping Then replace the Rear Interface Panel 15 Repeat steps 4 13 for the front window assembly Note To gain access to the front window remove the two screws holding the shutter assembly and move shutter assembly out of the way Next loosen but do not remove the four middle optics plate clamps Slide walk the middle optics plate toward the front optics plate Note cov
38. ly accepts supply voltage of 100 thru 230 Volts AC and frequencies of 50 or 60Hz No manual adjustments are required for voltages and frequencies within these ranges The XTRAC system is supplied normally with a hospital grade AC male connector within the United States For International systems the power cord has flying leads You will need to install a plug that is appropriate for your installation CAUTION Failure to install the proper AC connector for the XTRAC system may result in damage POWER ON WARM UP MODE Power On Mode enables the XTRAC system to perform power on self tests prior to its clinical use It also provides access to the system SET UP options and the treatment billing information screen Power On is activated when you turn on the main power switch The warm up period enables the Thyratron tube within the XTRAC system to warm up to an adequate temperature prior to firing the laser This period lasts five minutes 1 The footswitch is inactive in this operating mode 2 The software version is displayed on the top line of the display panel 3 The setup mode and system information modes are available during system warm up Page 15 of 36 12 95306 01 Rev G XTRAC ULTRA AL8000 SERVICE MANUAL 12 0 EMERGENCY LASER STOP On the top of the control panel is a red Emergency Laser Stop button The button will remain down when pressed When the laser is fired with the button depressed a system error will be displayed alon
39. ng the laser control panel open solenoid valve 1 FILL and carefully crack open AP1 and vent laser gas for 5 seconds then close AP1 Close solenoid valve 1 FILL from the laser control panel Open solenoid valve 4 VENT from the laser control panel and vent the laser chamber to 17 psia then close solenoid valve 4 VENT Open manual valve 3 and AP2 to introduce neon into the chamber for positive pressure when the chamber windows are removed 17 3 Replacing the Chamber Window Assemblies 12 95306 01 Rev G 1 Lock front wheels of laser 2 Remove Rear Interface Panel two bolts and drape over the side 3 4 Remove the rear optical plate to gain access to windows Verify cleanliness of the replacement window assemblies and locate them where they can be easily accessed Page 26 of 36 XTRA ULTRAJ AL8000 SERVICE MANUAL 5 Remove the rear window assembly by removing the six 6 outer most screws on the window flange A small amount of laser gas will escape the chamber and the neon gas should begin to immediately flow If this is not occurring stop the procedure immediately re attach the window and identify why Neon is not flowing Neon purge gas must be flowing while the chamber is open to atmosphere to prevent system contamination 6 Ifany white powder dirt or other contamination is observed carefully clean the window flange area on the laser chamber with an alcohol wipe or a cotton swab with methanol 7 Rol
40. nlet d 2 0 to 100 psia pressure transducer Manual valve 5 Closed for factory service only Manual iValve 2 Solenoid valve 1 Y Solenoid Valve 4 LN m F 725 psia safety vent 2 Stage SS Regulator Scrubber E 1 1 2 psi check valve BS 02 11 05 Exhaust to atmosphere 14 1 Neon Purge Set up 1 With both AP 1 amp 2 valves closed and the Neon purge line VCO cap in place open the Neon cylinder main valve and set the pressure to 5 10 psig 2 Crack open valve AP 1 amp 2 and purge the line with Neon for 5 seconds then close AP1 3 Remove the VCO cap on the Neon purge line and continue to slowly vent Neon gas through AP2 and the Neon purge line for 5 seconds 4 With AP2 still open replace the VCO cap on the purge line until ready to use 14 2 Connecting Neon Purge amp Attaching or Exchanging XeCl Cylinder 1 Enter CYLINDER routine in the laser Service Mode solenoid valve 1 FILL should be closed 2 Ifthe laser system has XeCl laser gas cylinder attached close the XeCl main cylinder valve now Make sure the laser manual valve 2 is closed then close manual valve 3 4 Carefully remove the laser AUX line VCO cap and the VCO cap on the Neon purge line Neon gas will begin to flow since AP2 is open Clean the mating surfaces with an alcohol wipe and connect the Neon purge line to the laser AUX line inlet Page 17 of 36 12 95306 01 Rev G ULTRA
41. ond In the XTRAC system this refers to the number of LASER firing pulses per second System Events Events that necessitate a system power down or diagnostic procedure to allow continued operation assuming the condition has been corrected Often this 1s to assure starting the system from a known state Tube A component within the XTRAC system that is used to switch on and off the current from the high voltage capacitor bank enabling the activation of the laser OVE Vacuum fluorescent Appendix A 12 95306 01 Rev G Page of 1 XTRAG ULTRA AL8000 SERVICE MANUAL APPENDIX B MSDS for MATERIALSAFETYDATASHEET ESUEANDREVISIONS March 16 2001 ChemicalNamedSynonyms Hydrogen Chloride Xenon Fama n a Neon gas mixture ChemicalFamily Inorganic Acid Rare Gas Manufacturer Nova Gas Technologies Inc Prope Slupping Name Compressed gas nos Manufacturer s Address 913 Commerce Circle Charleston SC 20406 DOTHoezadClass 22 PhoneNurnber 843 747 0956 DOTHazardLabel Nonflammable Gas i ChemirecPhoneNumber 800 424 9300 UN1956 Hydrogen Chloride Xenon lluesholdLimitValue unis 5 ppm amp Percent Neon gas mixture 5 ppm is the TLY for 2 Hydrogen Chloride Neon and Xenon has none but may act a an asphyxiant WPHYSICALDATA BoilingPoint Specific Gravity H20 1 e 100 0 VapecPressure mmHg n a PeicentVola leby Volume
42. ould be input directly and precisely perpendicular into the face of the lightguide The beam should also be centered precisely into the lightguide face The adjustment process should also be tolerant of minor misalignment of the optical hardware that is inherent in the XTRAC laser system Laser Beam Lightguide end view Proper beam alignment Improper beam alignment Page 21 of 36 12 95306 01 Rev G XTRAG ULTRA AL8000 SERVICE MANUAL 15 2 Alignment and Alignment Check Procedures 1 Laser Mirror Alignment Check a Open top skin and remove left skin as viewed from front of unit b Insert Alignment chuck into LLG port c apiece of white paper to top skin interior directly in front of laser outlet Install Laser Alignment Pin Holes on front and rear laser mirrors e Operate laser at 50 Hz and 7 kV f Check alignment i Alignment is OK if a donut is centered in the larger faint circle of light ii Ifthe donut is visible but not centered then loosen clamps and iteratively adjust the laser mirrors until centered Retighten clamps after centering and recheck alignment iii If the donut is not visible then proceed with full alignment 2 Laser Mirror Alignment a Place unit in Service Mode and set Rep rate to 50Hz and Charge Voltage to 7 0 kV unless otherwise noted b Rough alignment i Open top skin and remove left skin as viewed from front of unit ii Insert Alignment chuck into LLG port iii Tape a piece of whit
43. see ee 20 IS INTRODUGTION z eterne e oases os Ses HS Ris LL eL ee LLL ee ixi SE MENOS 20 15 2 ALIGNMENT AND ALIGNMENT CHECK PROCEDURES sscssesesesesesssesesevesesesesesecececesesesesesereseseceresereeenesenees 22 15 3 PIN DIODE CALIBRATION Ris sats eost EEEE RAT Gases ss eee 23 15 4 INSTALL THE LIGHT GUIDE dius seas tons tese cuire bass eases 24 16 0 GAS BOTTLE CAPACITY MAINTENANCE ccccccccecccecscecccececececececececececececececececececececececececesececececes 25 Page 4 of 36 12 95306 01 Rev G XTRAS k AL8000 SERVICE MANUAL 17 0 WINDOW CHANGE PROCEDURE essssesseeseessosceoeceessoscoececsessooeceseessoseoeceessssosececeesseseceseessoseoecesssssoseeecseesss 26 171 NEON PURGE 26 17 2 CONNECTING NEON PURGE 26 17 3 REPLACING THE CHAMBER WINDOW ASSEMBLIES ccscsesesesesesesesssesecessseseseeeceseceseseeeseseseeesereceresereseseseeees 26 17 4 REMOVING THE NEON PURGBE etse oetara nea 28 17 5 RE GASSING AND RE ALIGNMENT OF THE LASER CHAMBER cscsseeeseseeeseeseeseseceseseseseeeseeeseseeesesesesereeeseeenees 28 18 0 WINDOW ROTATION PROCEDURE eee ee eren nennen ee ttn sete tasas esee eese tasas esee eese seas asse eese cua 28 18 1 ROTATING THE CHAMBER WINDOW
44. tes patent number 4891818 and 5044717 that covers the XTRAC laser system Additional patents pending Reference Documentation Operating instructions for the XTRAC system can be found in the Operations Manuals 12 95305 01 and 12 95350 01 Premarket Notification Approvals 510k number that FDA has granted for the AL8000 is K0419343 Summaries of the application and approval order are available from FDA NOTE SOP s or Standard Operating Procedures which comprise the PhotoMedex Quality System are required to be followed by all PhotoMedex employees SOP 026 Complaint Handling Procedure SOP 019 Servicing AF 0037 Complaint Form AF 0192 Field Service Report AF 0135 Return Material Authorization Tag 15 90014 01 Energy Detector Calibration Validation Procedure AF 0205 XTRAC ULTRA Energy Detector Calibration Validation Report 12 95272 01 Calibration Label Page 35 of 36 12 95306 01 Rev G ULTRA 21 3 AL8000 SERVICE MANUAL Disposal The laser consists of the following items which may be pertinent to disposal in accordance with the laws and ordinances governing the site of disposal 1 The laser consists of an aluminum frame steel panels a nickel plated aluminum chamber and miscellaneous plastic parts 2 The laser system contains printed circuit boards with standard commercial components 3 The halogen scrubber contains inert molecular sieve and indicating soda
45. ucer replacement Page 25 of 36 12 95306 01 Rev G XTRAS LTRA AL8000 SERVICE MANUAL 17 0 WINDOW CHANGE PROCEDURE This window change procedure uses the neon purge gas and regulator assembly If you DO NOT have a bottle of neon purge gas or the regulator assembly then DO NOT attempt to change the windows The laser will be contaminated and the warranty of the laser will be voided See Section 14 for valve diagram 17 1 Neon Purge Set Up 1 With both 1 amp 2 valves closed and Neon purge line VCO cap in place open the Neon cylinder main valve and set the pressure to between 5 2 psig 2 Crack open valve AP 1 amp 2 and purge the line with Neon for 5 seconds then close AP1 3 Remove the VCO cap on the Neon purge line and continue to slowly vent Neon gas through AP2 and the Neon purge line for 5 seconds 4 With AP2 still open replace the VCO cap on the purge line until ready to use 17 2 Connecting Neon Purge 1 Enter WINDOW routine in the laser Service Mode 2 Make sure the laser manual valve 2 is closed and then close manual valve 3 Carefully remove the laser AUX line VCO cap and the VCO cap on the Neon purge line Neon gas will begin to flow since AP2 is open from step I 3 above Clean the mating surfaces with an alcohol wipe and connect the Neon purge line to the laser AUX line inlet 4 Open and vent Neon gas for 5 seconds then close AP 1 amp 2 5 Now open the laser manual valve 2 Usi
46. ve cylinders w th a hand track Ofhcrlhozzu oas E E EE ee ea Appendix B 12 95306 01 Rev G Page 2 of 2 XT AL8000 SERVICE MANUAL APPENDIX C ADDITIONAL DOCUMENTS 00 08000 01 AL8000 Domestic Assembly Tree 00 08030 01 Optics Wiring Schematic 00 08205 01 Power Supply Wiring Schematic 00 08218 01 Wiring Harness Assembly Schematic 15 08005 03 Wiring Inspection Guide AF 0192 AL8000 Field Service Report SP 006 AL8000 Installation Procedure AF 0205 XTRAC ULTRA Energy Detector Calibration Validation Report 12 95272 01 Calibration Label 12 95306 01 Rev G Appendix C Page 1 of 1 ULTRA AL8000 SERVICE MANUAL Replace this page with current revision of documents listed in Appendix C 12 95306 01 Rev G

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