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Warning, Certification and Identification Labels

Lumenis Pulse 120H UM-10012510 Rev. F

Page 21

Warning, Certification and Identification Labels

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 affixed to the

system and the symbols displayed in the labels:

Figure 4: Location of Warning, Identification and Certification Labels Affixed to the System

(for illustration purposes only)

STOP

LASER CLASS 4 / IV
Holmium:YAG Laser: 2.1μm, 6J max, 1300μs pulse max

LASER CLASS 3R / Illa
DPSS Laser: 532nm, 5mW max, CW

VISIBLE AND INVISIBLE LASER RADIATION
AVOID EYE OR SKIN EXPOSURE TO DIRECT
OR SCATTERED RADIATION

CLASS 4 LASER PRODUCT per IEC 60825-1: 2007
CLASS IV LASER PRODUCT per

21 CFR 1040.10 AND 1040.11

LB - 10032650_B

except for deviations pursuant to laser Notice No.50
dated June 24, 2007

LUMENIS LTD
Yokneam Induﬆrial Park
Hakidma Street 6, P.O.B. # 240
Yokneam 2069204, ISRAEL
Tel: +972 4 959 9000

Lumenis (Germany) GmbH
Heinrich-Hertz-Str 3 D-63303
Dreieich-Dreieichenhain GERMANY
Tel: +49 (0) 6103 8335 0

EC REP

Lumenis Pulse 120H

RR-RRRRRRRR

(01) 0 0000000 00000 0

(11) 000000

(21) 0000

(240) 0000000000

LB-20037970_A

0483

Rx ONLY

SERIES: XXX

SSSS

MODEL: XXXXXXXXXX

YYYY-MM-DD

GS1

THIS DEVICE CONTAINS: FCC ID: Z97-1149466

230V

50HZ

37 A, 1

Содержание PULSE 120H

Страница 1: ...Holmium Surgical Laser Operator s Manual TM...

Страница 2: ...ysician Copyright Lumenis Ltd Catalog Part Number UM 10012510 March 2017 Revision F Directive 2012 19 EU on Waste Electrical and Electronic Equipment WEEE In accordance with Directive 2012 19 EU on Wa...

Страница 3: ...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 240 Yok...

Страница 4: ...derations 18 Protecting Non Target Tissues 19 Safety Indicators 20 Warning Certification and Identification Labels 21 Clinical Guide 25 Effect on Soft Tissue 25 Effects on Stones 26 Indications for Us...

Страница 5: ...ing the Treatment 60 Starting Laser Treatment 63 Shutting Down the System 65 Moving the Laser Console 66 Advanced Operations 69 Moses Capability 69 Saving Settings as Presets 71 Preset Management 73 F...

Страница 6: ...ts 125 Compliance With International Standards 126 Space Requirements 128 Specifications 128 Customer Service 133 Warranty 133 Returning Equipment 133 Customer Feedback 133 Appendix A EMC Compliance 1...

Страница 7: ...ns should be carefully read and comprehended before operation Lumenis medical lasers and laser delivery systems are intended solely for physicians trained in the use of these instruments In the USA CA...

Страница 8: ...he 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 statement i...

Страница 9: ...e Lumenis Pulse 120H laser comprises the following main components and features Laser console Rotatable control screen Dual pedal footswitch Integrated suction pump1 Fiber support arm Security Identif...

Страница 10: ...e treatment site Control Screen The control screen is an LCD monitor that allows you to select treatment settings outside of the sterile field Integrated Suction Pump1 An integrated suction pump and s...

Страница 11: ...ptic delivery systems are available for use with Lumenis Pulse 120H laser Refer to the appropriate delivery system instruction guide for specific operating instructions CAUTION Use only Lumenis approv...

Страница 12: ...hen working in liquid environment the holmium laser energy provides additional safety since laser energy will be absorbed by the surrounding liquid limiting its reach to non target tissue The holmium...

Страница 13: ...on of appropriate power parameters and delivery system is dependent on the procedure and the specific patient condition It is recommended that you become familiar with laser characteristics and techni...

Страница 14: ...quires the use of dedicated Lumenis Moses fibers and it is available only for systems that incorporate Moses capability which has been activated A complete discussion of Moses capability and fibers ma...

Страница 15: ...al injury and explosion CAUTION Read this operator s manual carefully Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous laser radiat...

Страница 16: ...the patient with dulled metal eye shields as severe and irreversible eye damage and scarring may occur from direct or indirect exposure to the treatment beam Laser safety eyewear must meet all additi...

Страница 17: ...ngths are most damaging to the cornea and sclera Severity of injury depends on how concentrated or diffused the treatment beam is and the length of exposure A thorough understanding of the specific oc...

Страница 18: ...can be protected with towels or gauze sponges moistened with sterile saline solution or sterile water If allowed to dry protective towels and sponges can increase the potential fire hazard A UL approv...

Страница 19: ...e accidental laser exposure to the treatment room personnel or patient and or fire in the treatment room Except during actual treatment the laser must always be in standby mode Maintaining the laser i...

Страница 20: ...signal is emitted during lasing A different audible sound is used for the left and right pedals A warning tone or audible voice message is emitted if the system is transitioned to READY mode while th...

Страница 21: ...0 s pulse max LASER CLASS 3R Illa DPSS Laser 532nm 5mW max CW VISIBLE AND INVISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION CLASS 4 LASER PRODUCT per IEC 60825 1 20...

Страница 22: ...identification and certification labels affixed to the system Symbol Description Lumenis Energy to Healthcare CE Compliance Authorized Representative in the European Community Manufacturer Date of Man...

Страница 23: ...ser 2 1 m 6J max 1300 s pulse max LASER CLASS 3R Illa DPSS Laser 532nm 5mW max CW VISIBLE AND INVISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION CLASS 4 LASER PRODUC...

Страница 24: ...thernet Connection Keyswitch On Off Power Cable Label Symbol Description WARNING Grounding reliability can only be achieved when the EQUiPMENT is connected to an equivalent receptacle marked Hospital...

Страница 25: ...shown to be a safe and effective tool for the ablation vaporization incision excision and coagulation of a variety of soft tissues This has been demonstrated by both clinical and preclinical studies...

Страница 26: ...d to perform this application can be controlled by the pulse energy that is delivered to the tissue and the frequency at which the pulses are emitted Both of these factors affect stone fragmentation T...

Страница 27: ...roenterology surgery dermatology and plastic surgery and general surgery In China Korea and Taiwan the Lumenis Pulse 120H system with Delivery Devices and Accessories are intended for use in surgical...

Страница 28: ...ld be practiced e g avoid administration of inhaled general anesthetics reduce oxygen levels during mechanical ventilation use of laser resistant endotracheal tubes The flammability of methane gas mus...

Страница 29: ...red in conventional endoscopic surgery Refer to updated literature for specific procedure related complications As with conventional surgery the possibility of complications and adverse events such as...

Страница 30: ...ay result from an embolus The use of carbon dioxide gas for insufflation will minimize patient risk as it is highly soluble in blood Insufflation pressure should be set to minimum settings for effecti...

Страница 31: ...endoscopic urological surgery ablation vaporization incision excision and coagulation of soft tissue including treatment of Bladder Superficial and invasive bladder urethral and ureteral tumors Condyl...

Страница 32: ...removal Ligament and tendon release Contouring and sculpting of articular surfaces Debridement of inflamed synovial tissue synovectomy Loose body debridement Chondromalacia and tears Lateral retinecul...

Страница 33: ...stenotomy 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 lesions Mastect...

Страница 34: ...stomy 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 glossal pharyn...

Страница 35: ...nign and malignant neoplasm Polyps Colitis Ulcers Angiodysplasia Hemorrhoids Varices Esophagitis Esophageal ulcer Mallory Weiss tear Gastric ulcer Duodenal ulcer Non bleeding ulcer Gastric erosions Co...

Страница 36: ...l fatty and cartilaginous tissues in therapeutic plastic dermatologic and aesthetic surgical procedures including Scars Tattoo removal Vascular lesions Port wine stains Hemangioma Telangiectasia of th...

Страница 37: ...ning the laser and delivery systems connecting disconnecting and sterilizing the delivery systems and verifying the aiming beam integrity These procedures are detailed in this manual and in the delive...

Страница 38: ...ectional movement by positioning the rear brake pedals in the neutral position Unlock the back wheels with unidirectional movement by positioning the left rear brake pedal down 2 Move they system to t...

Страница 39: ...ollar knob clockwise to lock the fiber support arm in place 2 Adjust the position of the fiber support arm and turn the arm knob clockwise to lock it in place Figure 6 Adjusting the Fiber Support Arm...

Страница 40: ...Lumenis Pulse 120H UM 10012510 Rev F Page 40 Adjusting the Screen 1 Unfold the LCD panel 2 Turn the LCD panel counter clockwise to the position needed 3 Adjust the angle of the LCD panel Figure 7 Adj...

Страница 41: ...rear of the Lumenis Pulse 120H laser console Align the red dot of the footswitch connector with the red dot of the receptacle then push it in Figure 8 Connecting the Dual Pedal Footswitch NOTE If the...

Страница 42: ...al door interlock connector with the socket of the external interlock receptacle 2 Insert the external interlock connector into the external interlock receptacle 3 Turn the metal lock clockwise until...

Страница 43: ...ing in the Main Power Cable 1 Insert the laser main power plug into the mains power socket If the laser has a locking plug and socket connect the plug collar to the socket so that the plug is secure 2...

Страница 44: ...g in a vulnerable position kinked or tightly coiled Do not clamp the cable with a hemostat or other instruments If sterile tape is used always remove the tape before lifting the cable A damaged fiber...

Страница 45: ...culating nurse 4 The circulating nurse removes the protective cap from the laser connector 5 The circulating nurse secures the laser connector to the laser by screwing the connector into the fiber rec...

Страница 46: ...n container into the designed holder in the laser system 2 The circulating nurse connects one side of a non sterile drainage tube to the collection container s Outlet port Connect the other side to th...

Страница 47: ...System Lumenis Pulse 120H UM 10012510 Rev F Page 47 Figure 12 Suction System Figure 13 Pulling open the Suction Pump Collection Container Holder Collection Container Kit Suction Pump Suction Rate Knob...

Страница 48: ...ion tube is loaded in the required direction Figure 14 Directional Arrow for the Aspiration Tube 7 Close the suction pump until you feel it snap into place 8 Turn the Suction Rate knob clockwise to in...

Страница 49: ...Main System Screens Lumenis Pulse 120H UM 10012510 Rev F Page 49 Main System Screens Home Screen Description Figure 15 Home Screen...

Страница 50: ...may select another surgical specialty 3 Utilities Cogwheel Press this icon to access Quick Settings Help About and to Turn Off System 4 Help Press this button to access the system s software help uti...

Страница 51: ...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 surgeons Any...

Страница 52: ...escription Lumenis Pulse 120H UM 10012510 Rev F Page 52 Specialties Screen Description Select the surgical specialty that best meets your needs Presets are defined for each surgical specialty Figure 1...

Страница 53: ...Treatment Screen Description Lumenis Pulse 120H UM 10012510 Rev F Page 53 Treatment Screen Description Figure 18 Treatment Screen...

Страница 54: ...me 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 the Energy Frequency and Pulse wi...

Страница 55: ...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 suction mode to On Auto mode 7...

Страница 56: ...ber 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 recommend of u...

Страница 57: ...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 Pulse Width This button op...

Страница 58: ...ge 58 Laser Emission Indication Lasing appears on the control screen and an audible signal sounds at all times during treatment to alert you that laser energy is being emitted The audible signal is di...

Страница 59: ...ication of Connections 1 Verify that the delivery system is properly connected to the laser WARNING When using a fiber optic delivery device always inspect the fiber optic cable to ensure that it has...

Страница 60: ...e system self test and warm up procedure takes approximately one minute to complete A progress bar appears on the control screen during the self test and warm up procedure NOTE If any fault conditions...

Страница 61: ...of the View All Button 3 Verify that the parameters for the preset are correct for the treatment Do not exceed the maximum energy or power settings for your delivery system as specified in the instru...

Страница 62: ...the Energy and Frequency settings A Press the Pulse Width button B to open a pop up menu shown on the left where you may select the use of short medium or long pulse width In order to revert to the o...

Страница 63: ...tor WARNING Do not use the delivery system if the aiming beam is 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...

Страница 64: ...off the voice signals 5 Verify that your foot is on the appropriate footswitch pedal for the left side or right side parameter settings on the screen 6 Press the footswitch that corresponds to the de...

Страница 65: ...n press the main On Off button for at least five seconds long press NOTE Use the Forced System Shut Down method only when the system does not respond 2 Disconnect the delivery system from the laser If...

Страница 66: ...le around the footswitch and hang it on the rear of the Lumenis Pulse 120H laser console Figure 25 Power Cable on the Cable Rack 7 Disconnect the external door interlock 8 Clean the exterior surfaces...

Страница 67: ...loosen the arm knob before you fold upper section of the arm Tighten the knob when you are done Figure 27 Adjusting the Fiber Support Arm 4 Unlock the laser console wheels for unidirectional movement...

Страница 68: ...laser to the desired site CAUTION As with any heavy equipment use caution when tilting the laser console or moving it up or down an incline For optimum safety use a second person when moving up or do...

Страница 69: ...n on the left where you may select the Moses operation mode Contact or Distance When the Moses button indicator is Off the system is operating in regular mode The pop up menu shown on the left shows a...

Страница 70: ...de button When transitioning to Moses mode from regular pulse mode the system displays a note regarding the distance travelled by the laser pulses in a liquid environment Figure 30 Moses Mode Alert Po...

Страница 71: ...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 these settings as a new preset 1 From the Treatmen...

Страница 72: ...ulse 120H UM 10012510 Rev F Page 72 2 Press inside the Preset Name field and type in the new name using the virtual keyboard that pops up When you are done press the green check mark key on the keyboa...

Страница 73: ...lse 120H offers the use of predefined presets to select treatment parameters Presets are divided into two groups System Presets hard coded into Lumenis Pulse 120H Hospital Presets defined by the hospi...

Страница 74: ...Introduction Lumenis Pulse 120H UM 10012510 Rev F Page 74 You can save any settings defined on the Main Treatment screen during a procedure as a Hospital Preset Figure 34 Manage Presets Screen...

Страница 75: ...5 Choosing Presets On the Main Menu 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 Presets...

Страница 76: ...list of a preset group click 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 36 View All Presets Tree Expanded After you press t...

Страница 77: ...Presets Lumenis Pulse 120H UM 10012510 Rev F Page 77 Creating New Presets 1 From the Main Menu screen press Manage Presets 2 Press the Hospital Presets button 3 Press the New button Figure 37 Manage P...

Страница 78: ...you want Figure 38 New Preset Screen 5 Edit the Preset Name and the names of operations performed by each footswitch pedal When you press inside a text field a keyboard pops up 6 Click SAVE NOTE Moses...

Страница 79: ...presets To create a new preset based on an system preset first duplicate the preset then edit it 1 From the Main Menu screen press Manage Presets 2 Press the Hospital Presets button 3 Select anywhere...

Страница 80: ...nis Pulse 120H UM 10012510 Rev F Page 80 5 In the Edit Preset screen create the settings that you want When you press inside a text field a keyboard pops up Figure 40 Edit Preset Screen With Keyboard...

Страница 81: ...1 From the Main Menu 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 butto...

Страница 82: ...plicating Presets Lumenis Pulse 120H UM 10012510 Rev F Page 82 4 The duplicated preset automatically appears with the Copy_ prefix under Hospital Presets Figure 42 Preset Screen With a Duplicated Pres...

Страница 83: ...ing Presets You can only delete hospital presets You cannot delete system presets 1 From the Main Menu screen press Manage Presets 2 Press the Hospital Presets button 3 Select anywhere on the row for...

Страница 84: ...Deleting Presets Lumenis Pulse 120H UM 10012510 Rev F Page 84 4 Press the Delete button 5 In the Delete Preset confirmation screen press Yes Figure 44 Delete Preset Confirmation Screen...

Страница 85: ...t the rear of the Lumenis Pulse 120H 2 From the Main Menu 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 Hospital Pre...

Страница 86: ...xporting Presets Lumenis Pulse 120H UM 10012510 Rev F Page 86 5 In the Export data to USB menu press OK 6 Wait until the export operation is completed successfully Figure 46 Export Operation Completed...

Страница 87: ...in Menu screen Changing the Favorite Presets Add Remove and Reorder The Main Menu screen has positions for 9 favorite presets You can place any preset in each of the 9 positions 1 From the Main Menu s...

Страница 88: ...v F Page 88 3 To add an existing non favorite preset to your list of favorites press the Add a favorite button Figure 48 Select Favorites Manage 4 Press the non favorite preset PCNL for example to sel...

Страница 89: ...Rev F Page 89 5 Press the Move Up or Move Down button to position the new favorite PCNL in the desired spot number in the list Figure 50 New Preset Added to Favorites 6 Click OK to save the new Preset...

Страница 90: ...in Menu screen has positions for 9 favorite presets You can place any preset in each of the 9 positions 1 From the Main Menu screen press Manage Presets 2 Select a preset with an empty star 3 Press Fa...

Страница 91: ...Main Menu screen has positions for 9 favorite presets You can place any preset in each of the 9 positions 1 From the Main Menu screen press Manage Presets 2 Select a preset with a yellow star 3 Press...

Страница 92: ...cally 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 press the Reports button 2 You can export the reports...

Страница 93: ...Reports 1 Insert a USB storage device into the USB port at the rear of the Lumenis Pulse 120H 2 From the Home screen press the Reports button 3 Press the Export reports to USB button 4 In the Export R...

Страница 94: ...Exporting the Reports Lumenis Pulse 120H UM 10012510 Rev F Page 94 5 Wait until the export operation is completed successfully and press the OK button Figure 55 Reports Export Operation Completed...

Страница 95: ...ecialty When you start up Lumenis Pulse 120H the Main Menu screen automatically displays the default specialty You can change this in the Settings Utilities screen 1 From the Main Menu screen press th...

Страница 96: ...alty pop up press the specialty that you want to become the default specialty Figure 57 Default Specialty Button 4 In the Change Specialty pop up press OK 5 In the Settings Utilities screen press OK N...

Страница 97: ...ut the aiming beam may result in laser exposure to non target tissue and possible injury CAUTION If the aiming beam has been turned off and you leave the treatment screen when you return to the Treatm...

Страница 98: ...re 58 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 59 Quick Set...

Страница 99: ...99 3 Press OK NOTE You can also edit the screen settings in the Settings Utilities screen Figure 60 Settings Utilities Display Adjustment Adjusting Volume and Sound Indications 1 Press the cogwheel in...

Страница 100: ...crease 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 indications...

Страница 101: ...nd Sound Indications Lumenis Pulse 120H UM 10012510 Rev F Page 101 4 Press OK NOTE You can also edit the screen settings in the Settings Utilities screen Figure 63 Settings Utilities Sound Indications...

Страница 102: ...ing Date and Time Lumenis Pulse 120H UM 10012510 Rev F Page 102 Changing Date and Time 1 From the Main Menu screen press the Settings Utilities button 2 Press the Set button Figure 64 Set Date Time Bu...

Страница 103: ...Changing Date and Time Lumenis Pulse 120H UM 10012510 Rev F Page 103 3 In the Set screen that opens press the up and down arrows to set the date and time Figure 65 Settings Utilities Set Date Time...

Страница 104: ...nis Pulse 120H UM 10012510 Rev F Page 104 If you prefer a 12 hour clock clear the 24H check box Figure 66 Settings Utilities Set Date Time With 12 Hour Clock 4 In the Set menu press OK 5 In the Settin...

Страница 105: ...nging Language 1 From the Main Menu screen press the Settings Utilities button 2 Press the Language button Figure 67 Language Button 3 In the Change Language screen that opens select the language that...

Страница 106: ...ton see Figure 69 6 Press the Cancel or Home button to return to the Main Menu screen without changing the language NOTE If you accidentally change the language to one that you do not know how to read...

Страница 107: ...nd 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 Lumenis Puls...

Страница 108: ...120H UM 10012510 Rev F Page 108 4 Insert a USB device 5 Press the Export data to USB button Figure 71 Export Data to USB Button 6 In the Export data to USB pop up menu press one of the following All O...

Страница 109: ...Exporting Service Log Lumenis Pulse 120H UM 10012510 Rev F Page 109 8 Wait until the export operation is completed successfully Figure 72 Export Operation Completed...

Страница 110: ...e Time Button 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 In suc...

Страница 111: ...ach 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 appears on the...

Страница 112: ...ion 2 For notifications press the Acknowledge all button A check mark will appear to show that you have acknowledged the message and the notification will fade If the notification is ignored it will r...

Страница 113: ...ling Error Messages and Notifications Lumenis Pulse 120H UM 10012510 Rev F Page 113 5 Press the Close button to exit the Notification screen Figure 76 Examples of Error Notification Area and Pop Up Wi...

Страница 114: ...end them to Lumenis service System Does Not Turn On The control screen does not illuminate No blue light in the On Off switch and around the delivery system port 1 Plug in the laser 2 Set the laser s...

Страница 115: ...al Lumenis service representative Cooling System Notification The following notification appears on the control screen System overheated 1 Press the Show Notifications icon to open a pop up window tha...

Страница 116: ...rolonged procedures especially when using higher power 1 Renew the fiber tip by stripping and cleaving the fiber Power Limited A limitation may be the result of a specific fiber that is used 1 Choose...

Страница 117: ...l Clinic Staff If damage is found call Lumenis Service Check remote interlock connection and emergency stop button Weekly Hospital Clinic Staff If interlock and or button do not perform as required ca...

Страница 118: ...pped in 70 isopropyl alcohol or 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 an...

Страница 119: ...on the LCD to enable lasing If this is not the situation discontinue use and contact Lumenis Service Inspect Replace the Debris Shield If you hear an abnormal popping sound while delivering the treatm...

Страница 120: ...e receptacle CAUTION To avoid contamination do not touch the surface of the debris shield optic with your fingers 3 Inspect the debris shield optic to verify that it is free of any burn marks scratche...

Страница 121: ...M 10012510 Rev F Page 121 5 Close the panel Figure 79 Reinsert the Debris Shield Spare debris shields are located in the compartment at the rear of the laser console A notification appears in the noti...

Страница 122: ...sonnel Energy Detectors Calibration Energy detectors check and calibration must be performed by an engineer or technician qualified to work with laser equipment Questions regarding this procedure shou...

Страница 123: ...ear 2 Position a calibrated external power meter 15 cm 6 inches from the output end of the optical fiber 3 Turn on the laser as instructed in the Normal Operation chapter of this manual 4 Set the lase...

Страница 124: ...hat your surgical staff is experienced with the performance and safety considerations of the laser Thereafter you or the nursing staff at your facility will perform the daily maintenance routines asso...

Страница 125: ...ies Fiber cutting scissors Optical fiber strippers Cleaving tool SlimLine steam sterilization tray Safety eyewear Electrical Requirements Electrical Utilities The Lumenis Pulse 120H holmium laser is a...

Страница 126: ...ction kit locally Compliance With International Standards In accordance with regulations a recommended routine inspection and maintenance schedule is provided in the System Requirements and General In...

Страница 127: ...aser radiation No sections of the protective housing can be easily opened without special tools This housing is to be opened only by a Lumenis certified technician Safety Shutter The laser features a...

Страница 128: ...ent Following 5 such occurrences in a single session this becomes a fatal error and lasing cannot continue laser shuts down Space Requirements Position the laser console a minimum of 50 centimeters 20...

Страница 129: ...us wave Settings Low medium high Wavelength 532 nm Laser classification Class IIIa Class 3R Color Green Operation Continuous Type of Protection against Electric Shock Class I Degree of Protection agai...

Страница 130: ...water Cooling Air Requirements Minimum 50 cm 20 in from walls Input Power Voltage VAC Input Power Frequency Hz Input power phases Long time maximum current Amp Momentary current Amp Comments 200 50 1...

Страница 131: ...portation Laser Safety Eyewear The following laser safety eyewear complies with DIN EN 207 and ANSI Z136 1 standards as noted in the laser safety section of this manual Dimensions W x H x L 47 x 105 x...

Страница 132: ...external door interlock connector is removed while the laser is in ready mode The interlock can be set up with a remote switch or an external switch can be wired to the external door interlock connec...

Страница 133: ...ur local Lumenis representative or the closest Customer Service Center http www Lumenis com contact1 to obtain a Return Material Authorization RMA tracking number To comply with postal and transportat...

Страница 134: ...y for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The Lumenis Pulse 120H is...

Страница 135: ...quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality sh...

Страница 136: ...om fixed RF transmitters as deter 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 wi...

Страница 137: ...cations equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 117 0 117 0 233...

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