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2-18

UM-1151140EN, Rev. C, May 2016

Smart532

™

Laser Safety and Regulatory

Symbol

Description

Electrical and Fuses Requirements

Auxiliary Monitor Connection Port

Service (Ethernet) Connection Port

USB Connection Port

Footswitch Connection Port

Eye Safety Filter Connection Port

LIO Connection Port

Pattern Link Connection Port

Remote Interlock Connection Port

Water Ingress Protection Level – Standard &
Smart Footswitches

Water Ingress Protection Level – PowerEase
Footswitch

Содержание smart532

Страница 1: ...Solid State 532 nm Green Laser Operator Manual...

Страница 2: ...art532 laser device is designed to meet international safety and performance standards Personnel operating the device must have a thorough understanding of the proper operation of the device This manu...

Страница 3: ...ymbol must not be disposed of as unsorted municipal waste but segregated from other waste types for eventual treatment and recovery at an approved recycling facility By returning waste electrical and...

Страница 4: ......

Страница 5: ...Laser Treatment Operating Area 2 3 2 3 Laser Safety Eyewear 2 4 2 3 1 Additional Ocular Protection 2 6 2 4 Additional Safety Considerations 2 7 2 5 Fire Hazards 2 8 2 6 Electrical Hazards 2 8 2 6 1 G...

Страница 6: ...top Button 3 4 3 1 5 System Description Rear Panel 3 5 3 1 6 Touch Screen LCD Control Panel 3 6 3 1 7 Optical Bench Assembly 3 6 3 1 8 System Specifications 3 7 3 1 8 1 Outputs 3 7 3 1 8 2 Operation a...

Страница 7: ...ements 5 2 5 3 1 Delivery System Selection 5 3 5 3 2 Power Setting 5 3 5 3 3 Exposure Time Setting 5 4 5 3 4 Pulse Interval Selection 5 4 5 3 5 Aiming Beam Intensity Adjustment 5 4 5 3 6 SmartPulse Mo...

Страница 8: ...ooting Guide 6 5 APPENDIX A Clinical Guide Page A 1 General Information A 1 A 1 1 Tissue effects A 1 A 1 2 General Warnings and Precautions A 2 A 1 3 Adverse Effects AEs A 2 A 1 3 1 Pain A 2 A 1 3 2 I...

Страница 9: ...Trabeculoplasty A 16 A 7 Ophthalmology Bibliography A 16 A 8 Ear Nose and Throat ENT Laser Applications A 19 A 8 1 Indications A 19 A 8 2 Contraindications A 19 A 8 3 Uses A 19 A 8 4 Warnings A 20 A...

Страница 10: ...4 7 Figure 4 6 Connecting the Main Power Cable 4 8 Figure 4 7 Connecting a Delivery System for illustration purposes only 4 11 Figure 4 8 LIO Illumination and DVI Connections 4 12 Figure 5 1 Login Sc...

Страница 11: ...ssages Requiring Contact with Lumenis Service 6 7 Table 6 3 Undisplayed System Malfunctions Troubleshooting Guide 6 8 Table A 1 Typical Treatment Parameters for Ophthalmic Applications A 9 Table A 2 S...

Страница 12: ...Table of Contents Smart532 TOC 8 UM 1151440EN Rev C May 2016...

Страница 13: ...ing disconnecting the accessories These procedures are detailed in this manual or in the appropriate operator manuals of the delivery systems and accessories Most nursing staff prefer to inspect the l...

Страница 14: ...occur during operation their probable causes and what actions to take Appendix A Clinical Guide Offers information about staff training indications and contraindications for use recommended setup par...

Страница 15: ...is technician and all parts must be purchased from Lumenis Failure toobtain service and parts through Lumenis voids all warranties expressed and implied Please call Lumenis or your local representativ...

Страница 16: ...aphic User Interface J cm2 Joules per square centimeter Kg Kilogram s Lbs Pounds LCD Liquid Crystal Display LIO Laser Indirect Ophthalmoscope m Meters mm Millimeters ms Milliseconds mW MilliWatts NHZ...

Страница 17: ...the manual includes the minimum information required to operatethe system safely In addition to the guidelines presented here follow all applicable institutional procedures Read this chapter complete...

Страница 18: ...t and recommend or approve alternates when the primary ones arenot feasible 4 Approve operational procedures including any procedural checklists 5 Recommend or approve protective equipment and assure...

Страница 19: ...should ensure that 1 The surroundings are safe for both the patient and the operator 2 The floor is uncluttered and clear access is maintained tothe footswitch Cables are secure and not crimped 3 The...

Страница 20: ...he following formula was used to calculate the worst case NOHDfor Lumenis Smart532 lasers and compatible deliverysystems Where Z the distance of the beam waist from the lasersystem a the beam waist di...

Страница 21: ...ight 0 010 2 5 0 00137 1 0 100 9 8 Array LaserLink 0 010 2 5 0 00137 1 0 100 9 8 Which results in a worst case NOHD of NOHD m LaserLink HS 24 2 LaserLink Z 48 3 LIO Keeler 28 8 LIO Heine 31 3 Endoprob...

Страница 22: ...2 3 1 Additional Ocular Protection Always verify that the delivery device is properly connected to the laser An improper connection may result in an inadvertent secondary laser beam Severe eye or tis...

Страница 23: ...r application The lowest energy repetition rate exposure duration and power settings that are effective for the intended application should be used until familiar with the instrument s capabilities Ex...

Страница 24: ...in operating rooms private and out patient clinics shouldbe aware of the following safety considerations and potential firehazards when using laser equipment Laser energy can ignite most non metallic...

Страница 25: ...r service must be performed only by Lumenis trainedpersonnel Never open the laser console protective covers Opening the covers will expose personnel to high voltage components the laser resonator and...

Страница 26: ...on in this manual should be used in conjunction with not as a substitute for formaltraining Power Settings Lumenis suggests that you begin new orunfamiliar procedures at the lowest recommended power s...

Страница 27: ...tionality of the electronic components Safety monitoring circuits If the self test is successfully completed the system enters Standbymode The test circuits continuously monitor the operation of the s...

Страница 28: ...creen A complete discussion of system faults may be found in theTrouble shooting chapter of this manual To prevent accidental delivery of excessive energy to tissue laserenergy is monitored continuous...

Страница 29: ...ety and guidelines for medicallaser use These standards were developed in the earliest days of lasers andare routinely revised to keep up with growing technology ANSI Z136 3and EN 207 are written spec...

Страница 30: ...egistration Evaluation Authorization and Restriction of Chemicals WEEE Waste Electrical and Electronic Equipment Directive In compliance with these standards the system is equippedwith Laser emission...

Страница 31: ...Community 2 Laser Emission Danger the label contains thefollowing information Warns against possible exposure to laser beam radiationand specifies the type and classification of laser beamspresent Sy...

Страница 32: ...2 16 UM 1151140EN Rev C May 2016 Smart532 Laser Safety and Regulatory Figure 2 2 System Regulatory Labels...

Страница 33: ...nthe Smart532 laser system Symbol Description Danger Laser Radiation Emergency Stop Type B Equipment Type BF Equipment Follow Instructions for Use CE Compliance CSA Compliance Serial Number Catalog Nu...

Страница 34: ...Monitor Connection Port Service Ethernet Connection Port USB Connection Port Footswitch Connection Port Eye Safety Filter Connection Port LIO Connection Port Pattern Link Connection Port Remote Inter...

Страница 35: ...Guidance RF emissions CISPR 11 Group 1 The Smart532 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 electr...

Страница 36: ...rge 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 should be that of a typical commercial or hospital environment Voltage dips...

Страница 37: ...d strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipm...

Страница 38: ...ximum output power of the communications 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 t...

Страница 39: ...sentative Lasers generate a highly concentrated energy beam that may cause injury if improperly used To protect the patient and the operating personnel the entire laser and the appropriate delivery sy...

Страница 40: ...of see Figure3 1 1 A laser console with a touch screen control panel 2 All electrical cables necessary for proper connection 3 Remote interlock connection plug 4 A footswitch 5 Safety eyewear Note Del...

Страница 41: ...the laser treatment beam when you press itwhile the laser is in Ready mode Three different types of footswitch are available for the Smart532 system1 Standard Footswitch press the footswitch to emit l...

Страница 42: ...aser emergency stop button on the front ofthe laser console to immediately turn off the laser Note When the main power cable is connected to the electrical source some internal circuits remain energiz...

Страница 43: ...aiming beam 3 DVI connection port 4 Ethernet connection port 5 USB connection ports 6 Fiber connection port FC 7 Disabled 8 Footswitch connection port 9 Eye safety filter ESF connection port 10 LIO i...

Страница 44: ...he Operating Instructionschapter later in this manual Figure 3 4 Touch Screen LCD Control Panel The optical bench assembly is comprised of the optical resonatorthat generates the 532 nm green laser be...

Страница 45: ...ous Waveform 10 to 1 500 ms SmartPulse Waveform 0 5 to 10 ms Aiming Laser Type Red diode laser Wavelength 635 nm 5 nm Intensity 7 settings from minimal to 1 mW max Operational mode Continuous Control...

Страница 46: ...ica Wild microscopes LIO both Keeler and Heine models Standard PowerEase or Smart Footswitch 100 240 VAC 4A 50 60 Hz single phase Dimensions and Weight Height 13 7 centimeters 5 4 inches Width 29 5 ce...

Страница 47: ...Parts Type B Equipment CDRH Classification Class IV European MDD Laser Classification Class 4 Suitability for use in Presence of Flammable Mixture Not suitable Protection against Ingress of Water IPX0...

Страница 48: ...3 UM 1151140EN Rev C May 2016 Smart532 System Description...

Страница 49: ...ing beam These procedures are detailed in this manual and in the delivery device operator manuals In Canada this instrument must be installed and operated according to CAN CSA Z386 08 Laser Safety in...

Страница 50: ...20 from the wallor from other obstructions to air flow Figure 4 1 Physical Dimensions The system is equipped with a universal power supplymodule Accordingly the system will require a separate line sup...

Страница 51: ...borne dust particles should be kept to a minimum Dustparticles absorb light and heat up Hot particles located on the optical lensescan damage them Metallic dust is destructive to electricalequipment...

Страница 52: ...tand should be operational upon delivery The front panel of the Smart532 laser system is shown in Figure4 2 Figure 4 2 Smart532 Laser System Front Panel Description 1 Touch screen control panel 2 Main...

Страница 53: ...1 Power cable connection port and fuse housing 2 Array connection port to aiming beam 3 DVI connection port 4 Ethernet connection port 5 USB connection ports 6 Fiber connection port FC 7 Disabled 8 Fo...

Страница 54: ...d in the appropriate delivery device operatormanual Contact your Lumenis representative if any component appearsdamaged Do not touch any optical lens finger oils may damage the delicate coatings 4 5 1...

Страница 55: ...interlock The laser will be inoperative unless the plug is inserted into the receptacle For your convenience the Smart532 laser system is delivered from the factory with an interlockplug pre installed...

Страница 56: ...tion port onthe system s rear panel see Figure 4 6 Insert the other end of the power cable into the wall socket and ensurethat the plug is secured The supplied hospital grade power cable should be use...

Страница 57: ...lly inspect any delivery system s sterile packaging to ensure that it has not been torn or punctured If there is any damage to the sterile packaging do not use the delivery system A variety of deliver...

Страница 58: ...jury In addition some slit lamps and microscopes require an auxiliary eye safety filter to protect persons observing the procedure through an observation tube To determine if an auxiliary eye safety f...

Страница 59: ...UM 1151140EN Rev C May 2016 4 11 Smart532 System Installation and Initial Setup Figure 4 7 Connecting a Delivery System for illustration purposesonly...

Страница 60: ...perly Otherwise inspect and clean the delivery system s as instructed in the appropriate operator s manual s 3 Disconnect the footswitch from the laser 4 Disconnect the remote interlock or the remote...

Страница 61: ...mode The footswitch isdisabled not allowed to operate the system when the system is in Standby mode When not actively lasing set the system to Standby mode 1 Press the On Off switch on top of the sys...

Страница 62: ...Treatment Screen Description See Section 1 Delivery system selection buttons 5 3 1 2 Power setting display 5 3 2 3 Exposure time setting pulse duration 5 3 3 4 Pulse interval display 5 3 4 5 Aiming be...

Страница 63: ...tibility and safety information 5 3 2 Power Setting The available power level settings are from 50 mW up to 2 500 mW when Between 50 to 100 mW the increments are 5 mW Between 100 to 300 mW the increme...

Страница 64: ...e at the existing power and exposure time settings the laser changes to meet the duty cycle requirements for that power setting You must reduce the power or exposure time setting to make available the...

Страница 65: ...ter SelectionPop Up Reconfigure the parameter levels of the Duration and or DutyCycle and or Interval by pressing the or buttons in each of the parameters Press the OK button the pop up will close and...

Страница 66: ...When the Smart532 laser system is turned on and has finishedwarming up it defaults to Standby mode The aiming beam is present but the footswitch is disabled and the treatment laser cannot beactivated...

Страница 67: ...eyboard will appear on thescreen where you may assign a name to the new preset and save it to thesystem Press the Done button a new screen will appear and on it all of the selected parameters will be...

Страница 68: ...ns Screen Pressing any of the Options icons in the screen will navigate the systemto that particular Option screen Pressing the or button at the top leftor top right corner of the screen will navigate...

Страница 69: ...6 you may adjust the illumination level ofthe connected laser indirect ophthalmoscope LIO by pressing the or buttons Figure 5 6 Option Screen Adjust LIO Illumination In this screen see Figure 5 7 you...

Страница 70: ...rfacelanguage by pressing the appropriate language icon on the screen Theavailable language selection is English Italian German Japanese Simplified Chinese Russian French Spanish Dutch andPortuguese F...

Страница 71: ...Backlight Setting Screen In this screen see Figure 5 10 you may adjust the backlightillumination level of the user interface screen by pressing the or buttons Youcan set the backlight separately for...

Страница 72: ...ving the eye safety filter moves into position when you pressthe footswitch while the laser is in ready mode available only with automatic eye safety filters Selectable the eye safety filter moves int...

Страница 73: ...laser safety eyewear information 6 Turn on the laser system 7 Perform the aiming beam integrity check as instructed later inthis chapter Lasers generate a highly concentrated beam of light that may ca...

Страница 74: ...system is properly connected to theSmart532 laser as described in the Connection Instructions sections earlierin this chapter 2 Turn on the Smart532 laser system 3 Verify that there are no error mess...

Страница 75: ...treatment beam to the tissue 5 The laser emission icon will illuminate on the control panel andthe system will emit a beep for each pulse delivered 6 If surgery must be interrupted set the laser syst...

Страница 76: ...5 16 UM 1151140EN Rev C May 2016 Smart532 Operating Instructions...

Страница 77: ...per laser performance All laser system repairs should be performed by aLumenis certified service engineer For detailed information contact your Lumenis representative Use a cloth dampened with a hospi...

Страница 78: ...receptacle on the rear of the laser console 3 Locate the fuse holder directly to the right of the main power receptacle 4 Unlock and pull out the fuse holder by inserting a small insulated flathead sc...

Страница 79: ...ser equipment Questionsregarding this procedure should be referred to your Lumenisrepresentative Disclaimer warning Calibration is a service procedure to be performed only by Lumenis certified service...

Страница 80: ...Certificate obtained from Customer Service must be enclosed in the shippingpackage Failure to enclose the Decontamination Certificate will cause thesupplier to assume the product is contaminated The s...

Страница 81: ...contact Lumenis Service The following troubleshooting tables do not attempt to list allpossible system failures Any fault not listed should be referred toauthorized service personnel Table 6 1 Trouble...

Страница 82: ...ency Button Pressed Pull the laser emergency stop button out and restart the system 34 On Off Button Pressed Release the button and resume normal operation 35 Invalid Password Enter the correct login...

Страница 83: ...iming Beam Error 7 Display Press Buttons Error 9 Temperature Error LBO 10 Temperature Range Error LBO 12 Temperature Error Diode 13 Temperature Range Error Diode 20 Internal Clock Error 26 Shutter Err...

Страница 84: ...ission does not occur when footswitch is pressed 1 System is not in Ready mode 2 Damaged delivery system 3 Footswitch malfunction 4 System malfunction 1 Set system to Ready mode 2 Replace delivery sys...

Страница 85: ...duration and incidence angle of the laser beam onto the target tissue Tissue effects are caused by the absorption of electromagnetic laser radiation and its conversion to heat Diffusion of heat throu...

Страница 86: ...vide such instructions and is not to be considered a substitute Caution The laser unit should be handled carefully Maintenance and service should be performed only by Lumenis trained personnel In usin...

Страница 87: ...ertent delivery of laser energy to the fovea and parafoveal areas Tissue effect may be controlled by altering the distance between hand held fiber optic delivery devices and the target tissue Once the...

Страница 88: ...acular Edema or Proliferative Retinopathy associated with Central Retinal Vein Occlusion CRVO or Branch Retinal Vein Occlusion BRVO Choroidal Neovascularization CNV secondary to Age related Macular De...

Страница 89: ...ry telangiectasia Capillary cavernous hemangiomas Lymphangioma AV malformation of the tongue Hemangio lymphangiomas Photocoagulation of superficial vessels Vaporization of superficial blood or lymph c...

Страница 90: ...is not absorbed in aqueous media and has minimal effect on transparent tissues and materials Hence the laser energy can efficiently penetrate the cornea aqueous humor lens and vitreous humor to target...

Страница 91: ...ery system In this case the delivery system includes a lens system that focuses the laser energy and changes the size of the laser spot in the slit lamp observation plane It may include a mechanism th...

Страница 92: ...peripheral location starting from low values and gradually increasing the power until the desired endpoint such as blanching in posterior segment indications is achieved Once power settings Pvis are i...

Страница 93: ...0 m can cause severe and permanent visual loss Excessively high power settings should not be used as they can cause damage to tissues adjacent to the target of interest Ophthalmic problems are success...

Страница 94: ...e glaucoma17 400 600 Blanching 0 1 50 CNV18 200 Mild whitish 0 2 150 250 11 P Romero Aroca J Reyes Torres M Baget Bernaldiz and C Blasco Su e Laser treatment for diabetic macular edema in the 21st cen...

Страница 95: ...rategies may be employed to address this issue For example visible landmarks e g light gray burns obtained with continuous waveforms could delimit an area to be treated for example the corners of a sq...

Страница 96: ...25 125 200 Range 0 1 0 3 1 7 1 9 0 2 125 200 Most commonly used value 0 3 1 7 02 125 Macular Edema or Proliferative Retinopathy associated with Branch Retinal Vein Occlusion BRVO 22 2 0 X test burn CW...

Страница 97: ...ndary to photocoagulation or by an inadvertent Valsalva maneuver by the patient Only a contact lens specifically designed for use with laser energy should be used Use of a standard diagnostic contact...

Страница 98: ...ens specifically designed for use with laser energy is placed on the eye note a standard diagnostic contact lens will result in a power loss due to reflection from the surface of the lens The reflecte...

Страница 99: ...It may be splitin two or more consecutive sessions Note Users should be aware of general laser warnings precautions and adverse effects listed in General Information in this chapter Refer to the Opht...

Страница 100: ...tered when careful focusing is employed A snuff out of the central visual acuity has been reported as a complication of an intraocular pressure spike Patients with advanced field loss should be carefu...

Страница 101: ...ith a typical power of 500 mW and a typical pulse duration of 0 2 0 5 sec The purpose of these large burns is to soften the iris and to find a good site for the smaller penetrating burn for finalizing...

Страница 102: ...hould decrease within several weeks Usually this decrease is maintained for 1 2 years or more Sramek M Mackanos R Spitler L Leung H Nomoto C Contag and D Palanker Non damaging retinal phototherapy dyn...

Страница 103: ...Br J Ophthalmol vol 69 no 5 pp 368 72 1985 E Rosenfeld G Shemesh and S Kurtz The efficacy of selective laser trabeculoplasty versus argon laser trabeculoplasty in pseudophakic glaucoma patients Clin O...

Страница 104: ...nd cryotherapy Klin Monbl Augenheilkd 1977 Sep 171 3 317 21 J Wise Errors in laser spot size in laser trabeculoplasty Ophthalmology vol 91 no 2 pp 186 90 1984 Spiegel E Wegscheider and O Lund Argon la...

Страница 105: ...esion spot welding 28 One investigator reported that the laser was not indicated in the removal or vaporization of cortical bone or dense bone as found in obliterative otosclerosis26 Uninflamed mastoi...

Страница 106: ...logical procedures specifically are to be followed Formal instruction in operative procedures is the responsibility of the physician and should be obtained on a formal basis from recognized sources Ca...

Страница 107: ...reatment and the desired tissue effect Endoprobes are supplied pre packaged and sterile for one time use only Fibers are precision cut and polished to rigid optical specifications to provide maximum e...

Страница 108: ...ing equations E P TS 2 2 0 7854 2 Where F Fluence J cm2 TS Pulse duration sec I Irradiance W cm2 A Spot area cm2 E Energy J d Spot diameter cm P Power W Table A 3 lists resulting spot sizes using appr...

Страница 109: ...the spot size as a function of distance from the fiber Figure A 2 illustrates the relationship between irradiance and the distance from the fiber tip Figure A 1 Spot Size versus Distance of fiber tip...

Страница 110: ...n the irradiance which is effective for each procedure the user can determine the different laser power settings Table A 4 Spot Size and Irradiance at 1 W Delivered Fiber Optic Distance from tissue mm...

Страница 111: ...for use with a Lumenis argon laser krypton laser or diode green Smart532 laser Only the filter material and electrical characteristics differ The LIO consists of an indirect ophthalmoscope that has b...

Страница 112: ...focal length can have an effect on the laser spot size if the user is not aware of this phenomenon while adjusting the image of the retina Because this condensing lens is the last optical element that...

Страница 113: ...ming over a range of 50 1000 m It also incorporates an internal protective physician s filter Refer to the appropriate delivery system operator manual for specific instructions regarding the use of a...

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