Holmium Surgical Laser
Operator's Manual
Lumenis PULSE
60H
®
TM
TEMPORARY
PLACEHOLDER
Page 1: ...Holmium Surgical Laser Operator s Manual Lumenis PULSE 60H TM TEMPORARY PLACEHOLDER...
Page 2: ...057180EN September 2016 Revision A Directive 2012 19 EU on Waste Electrical and Electronic Equipment WEEE In accordance with Directive 2012 19 EU on Waste Electrical and Electronic Equipment WEEE any...
Page 3: ...ropean Community Lumenis Germany GmbH Heinrich Hertz Strasse 3 D 63303 Dreieich Dreieichenhain Germany Tel 49 0 6103 8335 0 Manufactured by Lumenis Ltd Yokneam Industrial park 6 Hakidma Street P O B 2...
Page 4: ...ter 2 Theory of Operation 15 General Theory of Operation 15 Laser Power Parameters 15 Theory of Operation Moses Mode 16 Chapter 3 Safety 18 Introduction 18 Optical Hazards 18 Laser Safety Eyewear 18 A...
Page 5: ...rgery 38 Chapter 5 Preparing the System for Use 39 Moving the Laser Console 40 Connecting the Footswitch 41 Connecting the External Door Interlock Connector 42 Plugging in the Mains Power Cable 43 Ins...
Page 6: ...anced Operations 76 Saving Settings as Presets 76 Preset Management 78 Introduction 78 Choosing Presets 80 Creating New Presets 82 Editing Presets 84 Duplicating Presets 86 Deleting Presets 88 Exporti...
Page 7: ...ack 119 Unrecognized Fiber 119 A Notification or Error Message Appears on the Control Panel 119 System Overheats 120 Non Specific Events of Unusual System Behavior 120 Message Appears Attach an Author...
Page 8: ...30 Tools Optional 131 Electrical Requirements 131 Electrical Utilities 131 Systems Designed for Use in European Communities Under the MDD 132 External Door Interlock Pin Assignments 132 Compliance wit...
Page 9: ...Table of Contents UM 20057180EN Rev A Page 9 Customer Service and Warranty 136 Appendix A EMC Guidance and Manufacturer s Declaration 137 Electromagnetic Emissions 137 Electromagnetic Immunity 138 Rec...
Page 10: ...ulatory sections should be carefully read and comprehended before operation Lumenis medical lasers and laser optical fibers are intended solely for physicians trained in the use of these instruments N...
Page 11: ...tor to the possibility of a problem with the device associated with its use or misuse Such problems include device malfunction device failure and damage to the device or other property The caution sta...
Page 12: ...ain Features The Lumenis Pulse 60H laser system comprises the following main components and features Laser system console Control panel with touch screen technology Dual pedal footswitch Security Iden...
Page 13: ...anel The control panel is an LCD monitor with touch screen technology that allows the operator to select treatment settings outside of the sterile field User Interface Language The user interface lang...
Page 14: ...Optical Fibers A variety of optical fibers are available for use with the Lumenis Pulse 60H laser system Lumenis fibers incorporate Security Identification System SIS technology Refer to the appropri...
Page 15: ...lculi stones also contain a sufficient amount of water that absorbs the laser energy leading to lithotripsy When working in liquid environment the holmium laser energy provides additional safety since...
Page 16: ...ample when blood vessel coagulation is desired The selection of appropriate power parameters and optical fiber is dependent on the procedure and the specific patient condition It is recommended that y...
Page 17: ...odulation to the energy pulse that enables emission of a controlled portion of energy to create the vapor bubble while leaving a larger portion as the effective energy portion that travels through the...
Page 18: ...ance of procedures other than those specified herein may result in hazardous laser radiation exposure Optical Hazards Laser Safety Eyewear The following specifications were calculated for this systems...
Page 19: ...r beam Severe eye or tissue damage could occur Never substitute prescription eyewear for the appropriate laser safety eyewear as severe eye damage could occur Prescription eyewear can concentrate the...
Page 20: ...t only be connected to a supply mains with protective earth Fire Hazards WARNING Do not use this device in the presence of flammables or explosives such as volatile anesthetics alcohol certain surgica...
Page 21: ...s inspect it to ensure that it has not been kinked punctured fractured or otherwise damaged The optical fiber may be damaged if stepped on pulled left lying in a vulnerable position kinked or tightly...
Page 22: ...the person directing the aim of the laser beam should have access to the laser system footswitch Use caution pressing the laser system footswitch when it is in proximity to footswitches for other equ...
Page 23: ...ent audible sound is used for the left and right pedals When lasing a lasing emission indicator appears on the screen The round LED on the front displays the activity mode of the Lumenis Pulse 60H las...
Page 24: ...bels As required by national and international regulatory agencies appropriate warning labels have been mounted in the specified locations Figure 4 displays the identification and certification labels...
Page 25: ...on For illustration purposes only Symbol Description Lumenis Energy to Healthcare CE Compliance Authorized Representative in the European Community Manufacturer Date of Manufacture Catalog Number Seri...
Page 26: ...ASS 4 IV Holmium YAG Laser 2 1 m 6J max 1600 s FWHM Pulse LASER CLASS 3R Illa DPSS Laser 532nm 5mW max CW VISIBLE AND INVISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIAT...
Page 27: ...ation located on shipping crate Humidity Limitation located on shipping crate Atmospheric Pressure Limitation located on shipping crate Symbol Description WARNING Grounding reliability can only be ach...
Page 28: ...0 nm The absorption of the laser energy by water produces an energy density that heats the tissue to greater than 100 C thus vaporizing or ablating the tissue without deep coagulation allowing for pre...
Page 29: ...is advantageous when working in a water filled environment as it enables safe delivery of energy without harming non targeted tissue Any water that interfaces between the laser and the tissue absorbs...
Page 30: ...pulmonary surgery dermatology and plastic surgery podiatry neurosurgery and ophthalmology Contraindications The use of a laser instrument for an application is at the physician s discretion except in...
Page 31: ...e laser system should be used only on tissues that are fully observable Do not use the laser system if the desired target is not visible All available measures to visualize the target tissue e g copio...
Page 32: ...s be practiced As with any conventional surgery discontinue laser treatment immediately if the patient develops any cardiopulmonary problems As with any conventional surgery acute pain may occur immed...
Page 33: ...pplications as follows Urology Endoscopic transurethral incision of the prostate TUIP bladder neck incision of the prostate BNI holmium laser ablation of the prostate HoLAP holmium laser enucleation o...
Page 34: ...y Plica removal Ligament and tendon release Contouring and sculpting of articular surfaces Debridement of inflamed synovial tissue synovectomy Loose body debridement Chondromalacia and tears Lateral r...
Page 35: ...sy pylorostenotomy and removal of polyps of the sigmoid colon Skin incision Tissue dissection Excision of external tumors and lesions Complete or partial resection of internal organs tumors and lesion...
Page 36: ...storhinostomy DCR Functional endoscopic sinus surgery FESS Endonasal surgery ablation vaporization incision excision and coagulation of soft tissue including Lesions or tumors of the oral nasal glossa...
Page 37: ...lculi Benign and malignant neoplasm Polyps Colitis Ulcers Angiodysplasia Hemorrhoids Varices Esophagitis Esophageal ulcer Mallory Weiss tear Gastric ulcer Duodenal ulcer Non bleeding ulcer Gastric ero...
Page 38: ...n of soft mucosal fatty and cartilaginous tissues in therapeutic plastic dennatologic and aesthetic surgical procedures including Scars Vascular lesions Port wine stains Hemangioma Telangiectasia of t...
Page 39: ...aser and optical fibers connecting disconnecting and sterilizing the delivery systems and verifying the aiming beam integrity These procedures are detailed in this manual and in the optical fiber inst...
Page 40: ...t block cover any of the system ventilation openings any such blockage may cause system overheating NOTE Do not move the laser console rapidly over uneven surfaces doing so may damage the equipment 1...
Page 41: ...on top then press it in Figure 6 Connecting the Dual Pedal Footswitch NOTE If the footswitch is not properly connected when the laser system is turned on the message Attach Footswitch appears in the...
Page 42: ...eptacle 2 Insert the external interlock connector into the external interlock receptacle 3 Turn the metal lock clockwise until it screws in 4 If the treatment door is opened or if the external door in...
Page 43: ...plug and socket connect the plug collar to the socket so that the plug is secure from loosening 3 Turn on the laser system s mains power circuit breaker up position CAUTION Ensure that the Lumenis P6...
Page 44: ...plastic cap from the arm port on the top panel of the system s console 2 Take the arm adapter from the kit and screw it into the arm port A 3 Insert threaded knob B on to the proximal end of the arti...
Page 45: ...ng the cable A damaged optical fiber may cause accidental laser exposure or injury to the treatment room personnel or patient and or fire in the treatment room To avoid possible damage to the optical...
Page 46: ...connector and from the system s connection port 5 The circulating nurse secures the laser connector to the laser system by screwing the connector into the optical fiber receptacle on the front of the...
Page 47: ...mage the optical fiber and result in unintended laser exposure CAUTION Do not remove the protective cap from the laser connector in the sterile field Removing the protective cap in the sterile field m...
Page 48: ...e tube to the collection container s Outlet port Connect the other side to the operating room s hazardous waste container WARNING Ensure that the operating room s hazardous waste container not supplie...
Page 49: ...the system s suction pump to the correct drainage tube s inner diameter pull open the suction pump Using the adjustment wheels on both sides of the suction pump 1 adjust the inner diameter of the suct...
Page 50: ...ion pump as shown in Figure 14 and connect it to the outlet port of the collection container 9 Close the suction pump until you feel it snap into place 10 Adjust the suction rate on the control panel...
Page 51: ...Lumenis PulseTM 60H Laser System Main System Screens UM 20057180EN Rev A Page 51 Main System Screens Home Screen Description Figure 15 Home Screen...
Page 52: ...en Here you may select another surgical specialty 3 Utilities Cogwheel Press this icon to access Quick Settings Help About and system Shutdown 4 Help Press this button to access the system s software...
Page 53: ...ppear in this bar 11 Presets Lumenis Presets are hard coded into the system software and are marked with the Lumenis logo Hospital Presets are designed and entered to the system by the hospital s surg...
Page 54: ...stem Specialties Screen Description UM 20057180EN Rev A Page 54 Specialties Screen Description Select the surgical specialty that best meets your needs Presets are defined for each surgical specialty...
Page 55: ...Lumenis PulseTM 60H Laser System Treatment Screen Description UM 20057180EN Rev A Page 55 Treatment Screen Description Figure 18 Treatment Screen...
Page 56: ...added 2 Pedal Name This is the name of the settings chosen for each footswitch pedal This name can be changed by editing the preset 3 Treatment Settings for each pedal Each side of the screen defines...
Page 57: ...y with lasing CAUTION The suction pump will not operate if the door is not closed properly If the door is opened during operation suction will be set to Off In order to resume operation set the suctio...
Page 58: ...The fiber is working within operational limits Grace mode orange You are advised to replace the fiber because it exceeded recommended usage However you can continue to work The Fiber exceeded recommen...
Page 59: ...both pedals including both Lumenis and user generated presets The total energy displayed in the reports is not affected when resetting the total energy on the screen reset dialog shown on left 10 Reca...
Page 60: ...Figure 21 NOTE When the main power cable is connected to the electrical source some internal circuits remain energized To de energize all internal circuits shut the system from the screen or if not po...
Page 61: ...ser system s main power circuit breaker on the rear panel to the On up position There is a green LED adjacent to the power breaker that illuminates when the power breaker is turned on this means that...
Page 62: ...empty field above the Login button a virtual keyboard will appear Type in the 4 digit password and press the green button on the keyboard Figure 23 Login Keyboard 4 Press the Login button the system...
Page 63: ...tem s power cable to the wall electrical socket and before you come to turn the system on you must ensure that the system is turned off If it turns on by itself when connected discontinue use disconne...
Page 64: ...d On the self test is successfully completed and you complete the Login procedure 1 Verify that the correct specialty is selected Figure 26 Location of the Specialty Selection If you need to change th...
Page 65: ...adjust the Energy and Frequency settings Press the or button B to toggle the Pulse Width between Short Medium or Long NOTE The energy and frequency can be changed independently However their maximum s...
Page 66: ...Lumenis PulseTM 60H Laser System Setting the Treatment Parameters and Controls UM 20057180EN Rev A Page 66 Figure 28 How to Change Treatment Settings D A B C E F G...
Page 67: ...s set to high intensity and is still weak or not visible the fiber optic cable may be damaged A damaged cable may cause accidental laser exposure or injury to the treatment room personnel or patient a...
Page 68: ...iate footswitch pedal for the left side or right side parameter settings on the screen 6 Press the footswitch that corresponds to the desired set of parameters to deliver the treatment beam As the las...
Page 69: ...enis Pulse 60H configured to Moses mode When a Moses fiber is connected to the system it will be recognized by the system and the Moses mode feature will be available to the user Selecting Moses Mode...
Page 70: ...utton see Figure 29 When the system transitions from Regular pulse mode to Moses mode it displays a pop up note regarding the distance travelled by the laser pulses through water Press OK to proceed F...
Page 71: ...is set to high intensity and is still weak or not visible the optical fiber may be damaged A damaged optical fiber may cause accidental laser exposure or injury to the treatment room personnel or pati...
Page 72: ...lasing icon also appears and an audible signal sounds to alert you that laser energy is being emitted The audible signal is different for the right and left pedals 8 Press the Ready and Standby button...
Page 73: ...5 Remove and process the suction system s collection container and tubes according to the hospital s bio hazardous waste protocol 6 Fold down the control panel if the system is going to be moved 7 Re...
Page 74: ...the Forced System Shut Down method only when the system does not respond NOTE You can also perform a normal system shut down from the control screen by selecting Shutdown from the cogwheel icon 2 Dis...
Page 75: ...around the cable rack If you want to hang the footswitch on the laser console wrap the power cable around the footswitch and hang it on the rear of the Lumenis Pulse 120H laser console Figure 33 Power...
Page 76: ...s is performed from the Main Treatment screen When changes are made to an existing preset from that screen the preset will be in edited mode fonts change and an asterisk appears Then you can save thes...
Page 77: ...g Settings as Presets UM 20057180EN Rev A Page 77 2 Press inside the Preset Name field and type in the new name using the virtual keyboard When you are done press the green check mark key on the keybo...
Page 78: ...enis Pulse 60H offers the use of predefined presets to select treatment parameters Presets are divided into two groups System Presets hard coded into Lumenis Pulse 60H Hospital Presets defined by the...
Page 79: ...menis PulseTM 60H Laser System Introduction UM 20057180EN Rev A Page 79 You can save any settings defined on the Treatment screen during a procedure as a Hospital Preset Figure 37 Manage Presets Scree...
Page 80: ...ev A Page 80 Choosing Presets On the Home screen press the View All button to display all of the available presets not only those defined as Favorites The presets are organized in two groups System Pr...
Page 81: ...n the list of a preset group press the sign If all of the presets do not fit into the screen a scroll bar appears to the right of the preset group Figure 39 View All Presets Tree Expanded After you pr...
Page 82: ...umenis PulseTM 60H Laser System Creating New Presets UM 20057180EN Rev A Page 82 Creating New Presets 1 From the Home screen press Manage Presets 2 Press the New button Figure 40 Creating a New Preset...
Page 83: ...A Page 83 3 In the New Preset screen create the names and settings that you want Figure 41 New Preset Screen 4 Edit the Preset Name and the names of operations performed by each footswitch pedal When...
Page 84: ...t hospital presets To create a new preset based on an system preset first duplicate the preset then edit it 1 From the Home screen press Manage Presets 2 Press the Hospital Presets button 3 Select any...
Page 85: ...ing Presets UM 20057180EN Rev A Page 85 5 In the Edit Preset screen create the names and settings that you want When you press inside a text field a virtual keyboard pops up Figure 43 Edit Preset Scre...
Page 86: ...g Presets 1 From the Home screen press Manage Presets 2 Select anywhere on the row for the preset that you want to duplicate If you don t see the preset press Hospital Presets button 3 Press the More...
Page 87: ...lseTM 60H Laser System Duplicating Presets UM 20057180EN Rev A Page 87 4 The duplicated preset automatically appears with the Copy_ prefix under Hospital Presets Figure 45 Preset Screen With a Duplica...
Page 88: ...u cannot delete system presets 1 From the Home screen press Manage Presets 2 Press the Hospital Presets button 3 Select anywhere on the row for the preset that you want to delete Figure 46 Manage Pres...
Page 89: ...USB port at the rear of the Lumenis Pulse 60H 2 From the Home screen press Manage Presets 3 Select anywhere on the row for the preset that you want to export If you don t see the preset press Hospita...
Page 90: ...ulseTM 60H Laser System Exporting Presets UM 20057180EN Rev A Page 90 5 In the Export data to USB menu press OK 6 Wait until the export operation is completed successfully Figure 49 Export Operation C...
Page 91: ...ly from the Home screen Changing the Favorite Presets Add Remove and Reorder The Home screen has positions for nine favorite presets You can place any preset in each of the 9 positions 1 From the Home...
Page 92: ...20057180EN Rev A Page 92 3 To add an existing non favorite preset to your list of favorites press the Add a favorite button Figure 51 Select Favorites Manage 4 Press a non favorite preset to select it...
Page 93: ...180EN Rev A Page 93 5 Press the Move Up or Move Down button to position the new favorite in the desired spot number in the list Figure 53 New Preset Added to Favorites 6 Press OK to save the new Prese...
Page 94: ...ck Add The Home screen has positions for 9 favorite presets You can place any preset in each of the 9 positions 1 From the Home screen press Manage Presets 2 Select a preset with an empty star 3 Press...
Page 95: ...k Remove The Home screen has positions for 9 favorite presets You can place any preset in each of the 9 positions 1 From the Home screen press Manage Presets 2 Select a preset with a yellow star 3 Pre...
Page 96: ...ly generates a report of each treatment 1 To view a summary of the reports listed in chronological order with the most recent treatment on top from the Home screen press the Reports button 2 You can e...
Page 97: ...ting the Reports 1 Insert a USB storage device into the USB port at the rear of the Lumenis Pulse 60H 2 From the Home screen press the Reports button 3 Press the Export reports to USB button 4 In the...
Page 98: ...s PulseTM 60H Laser System Exporting the Reports UM 20057180EN Rev A Page 98 5 Wait until the export operation is completed successfully and press the OK button Figure 58 Reports Export Operation Comp...
Page 99: ...Lumenis PulseTM 60H Laser System Exporting the Reports UM 20057180EN Rev A Page 99 Figure 59 Sample of Reports Export for illustration only...
Page 100: ...the Default Specialty When you start up Lumenis Pulse 60H the Home screen automatically displays the default specialty You can change this in the Settings Utilities screen 1 From the Home screen press...
Page 101: ...cialty UM 20057180EN Rev A Page 101 3 From the Change Specialty pop up press the specialty that you want to become the default specialty Figure 61 Default Specialty Button 4 In the Change Specialty po...
Page 102: ...e if the aiming beam has been turned off Operating the laser without the aiming beam may result in laser exposure to non target tissue and possible injury CAUTION If the aiming beam has been turned of...
Page 103: ...gs Figure 62 Select Quick Settings 2 In the Quick Settings screen that opens slide the lower slider to the right to increase screen brightness or to the left to decrease screen brightness Figure 63 Qu...
Page 104: ...Page 104 3 Press OK NOTE You can also edit the screen settings in the Settings Utilities screen Figure 64 Settings Utilities Display Adjustment Adjusting Volume and Sound Indications 1 Press the cogwh...
Page 105: ...ht to increase volume or to the left to decrease the volume of the voice indications or Slide the middle slider to the right to increase volume or to the left to decrease the volume of the beeping ind...
Page 106: ...System Adjusting Volume and Sound Indications UM 20057180EN Rev A Page 106 4 Press OK NOTE You can also edit the screen settings in the Settings Utilities screen Figure 67 Settings Utilities Sound Ind...
Page 107: ...lseTM 60H Laser System Changing Date and Time UM 20057180EN Rev A Page 107 Changing Date and Time 1 From the Home screen press the Settings Utilities button 2 Press the Set button Figure 68 Set Date T...
Page 108: ...s PulseTM 60H Laser System Changing Date and Time UM 20057180EN Rev A Page 108 3 In the Set screen that opens press the up and down arrows to set the date and time Figure 69 Settings Utilities Set Dat...
Page 109: ...anging Date and Time UM 20057180EN Rev A Page 109 If you prefer a 12 hour clock clear the 24H check box Figure 70 Settings Utilities Set Date Time With 12 Hour Clock 4 In the Set menu press OK 5 In th...
Page 110: ...ge 110 Changing the Interface Language 1 From the Home screen press the Settings Utilities button 2 Press the Language button Figure 71 Language Button 3 In the Change Language screen that opens selec...
Page 111: ...ress the OK button see Figure 72 6 On the Settings screen press the OK button see Figure 73 7 Press the Cancel or Home button to return to the Home screen without changing the language NOTE If you acc...
Page 112: ...s you to send data about the system to a Lumenis service person that can help that person understand a problem that you encountered 1 Insert a USB storage device into the USB port at the rear of the L...
Page 113: ...UM 20057180EN Rev A Page 113 4 Insert a USB device 5 Press the Export data to USB button Figure 75 Export Data to USB Button 6 In the Export data to USB pop up menu press one of the following backup p...
Page 114: ...s PulseTM 60H Laser System Exporting Service Log UM 20057180EN Rev A Page 114 8 Wait until the export operation is completed successfully 9 Press OK to close the pop up Figure 76 Export Operation Comp...
Page 115: ...tore System Defaults Case Saver Mode A system state that enables the user to continue using the system safely however with reduced power capability in instances where 1 There is a technical limitation...
Page 116: ...to expand each group of topics 3 The topic that you are interested in appears in the main pane on the right NOTE When a help topic contains more information than can fit on the screen a scroll bar app...
Page 117: ...task as detailed in the message If the error is resolved the message will fade and normal operation may be resumed 3 Several types of errors will not fade in a case like this press the Standby button...
Page 118: ...t breaker to the On up position 3 Turn on the main electrical circuit breaker 4 Use another power outlet or have the outlet professionally tested and repaired if necessary Inadequate or No Aiming Beam...
Page 119: ...Lumenis Service A Notification or Error Message Appears on the Control Panel There are three types of clearable errors An error message that clears automatically i e Attach an Authorized Fiber when a...
Page 120: ...operation Non Specific Events of Unusual System Behavior In the event of the system behaving in an unusual manner or being non responsive i e touch screen not responding screen not responding when fib...
Page 121: ...ed earlier in this manual Message Appears Check footswitch You are pressing either one both footswitch pedals in Standby mode Release the footswitch switch to Ready and press one of the footswitch ped...
Page 122: ...ume normal operation If the condition continues turn off the laser system for five seconds then turn it back on If the condition persists contact Lumenis Customer Service Message Appears Rate high The...
Page 123: ...lists descriptions calibration instructions or other information to assist service personnel to repair system components Inspection Service Frequency Performed By Remarks Routine exterior cleaning As...
Page 124: ...r a hospital grade disinfectant solution CAUTION Do not spray or pour cleaning agents directly on the laser console or control screen You may damage the console screen and laser system electronics Rem...
Page 125: ...ser system 4 Press the Ready button on the LCD or footswitch verify that the system has transitioned to Ready mode 5 Power down the system 6 If this is not the situation discontinue use and contact Lu...
Page 126: ...the debris shield optic to verify that it is free of any burn marks scratches dust or fingerprints Clean the debris shield s optic if it is dirty or replace it if damaged If the optic is free of dirt...
Page 127: ...Shield 1 Holding the debris shield handle position the shield so that the pin is aligned with the pin groove 2 Insert the debris shield into the debris shield receptacle 3 Replace the panel covering...
Page 128: ...n must be performed by an engineer or technician qualified to work with laser equipment Questions regarding this procedure should be referred to Lumenis Customer Service DISCLAIMER Calibration is a se...
Page 129: ...the optical fiber 3 Turn on the laser system as instructed earlier in this manual 4 Set the laser system to deliver 5 Watts of laser energy 5 Target the aiming beam at the detector disc of the extern...
Page 130: ...e nursing staff at your facility will perform the maintenance routines associated with the laser system and any delivery systems used during surgery If your scheduled surgical procedure requires dispo...
Page 131: ...set 27A max single phase Frequency is factory set according to the model ordered Voltage is set by Lumenis certified service technicians to one above available voltages to fit local voltage The line w...
Page 132: ...e with EN 60309 for this device External Door Interlock Pin Assignments The external door interlock is a safety feature that immediately transitions the laser system into Standby mode effectively stop...
Page 133: ...you that laser energy is being emitted the LED ring around the fiber connection port illuminates continuously in orange in Ready mode and blinks orange during lasing During lasing the laser system em...
Page 134: ...situation is resolved Safety Interlocks The laser system has safety interlocks on the optical fiber laser connector Laser energy emission is disabled if a fiber is not connected Precision of Displaye...
Page 135: ...on Class 3R laser Input power parameters Nominal voltage and frequency 200 208 220 230 240V 50Hz factory set 200 208 220 230V 60Hz factory set Current maximum 25A 50 Hz 27A 60 Hz Utility connection Si...
Page 136: ...ge Failure to enclose the Decontamination Certificate will cause the supplier to assume the product is contaminated The supplier will assess the customer with cleaning costs Any decontamination inquir...
Page 137: ...11 Group A The Lumenis Pulse 60H system uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipmen...
Page 138: ...Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 1 kV differential mode Mains power quality should be that of a typical co...
Page 139: ...mined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Radiated R...
Page 140: ...of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 17 P 80 MHz to 800 MHz d 1 17 P 800 MHz to...
