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Delivery Device 

Operator Manual 

 

 

 

 

 

 

 

Содержание Array LaserLink

Страница 1: ...Delivery Device Operator Manual...

Страница 2: ...s been made to ensure that the information in this document is accurate the instructions photos figures illustrations tables specifications and schematics contained herein are subject to change withou...

Страница 3: ......

Страница 4: ...Connecting an Eye Safety Filter 13 Installing Observation Equipment 13 Array LaserLink Operation 14 The Treatment Screen 15 Touchpad 16 3D mouse 17 Setting Treatment Parameters 18 Selecting the Shape...

Страница 5: ...lume 33 Standby Backlight and Ready Backlight 33 Options Form 2 34 Controlling Sound 34 Displaying Fluence 34 Resetting Rotation and Micromanipulation 34 Enabling the On Retina Text 34 Options Form 3...

Страница 6: ...ry 57 Introduction 58 Laser Safety Eyewear 59 Additional Ocular Protection 61 Additional Safety Considerations 62 Electrical Hazards 62 Regulatory Compliance 63 Eye Safety Filter 63 Location of Contro...

Страница 7: ...6 Operation Operation...

Страница 8: ...up and installs the Array to ensure that it is working properly In addition Lumenis provides in service training to ensure that your surgical staff is experienced in the performance and safety consid...

Страница 9: ...nd power supply and integrates the Array LaserLink module with the laser system Touchscreen Display Use the touchscreen display to adjust laser treatment settings such as laser mode energy and aiming...

Страница 10: ...ctor and patient positioning Fig 2 Array LaserLink Components 3D Mouse not displayed Array Module Array Console Touchscreen Display Remote Touchpad Eye Safety Filter not part of the Array but required...

Страница 11: ...rray LaserLink consists of the four components which are shown in Fig 2 on the previous page The touch screen and touch pad 3D mouse are mounted by a qualified service technician at a location chosen...

Страница 12: ...Operation 11 laser system by the service technician An aiming beam control port is installed in the laser system Fig 4 Console Ports Fig 5 Cables Footswitch Port Laser Control Port...

Страница 13: ...er system by the user The console cables will only attach one way preventing improper connection To detach the Laser System Detach the laser control cables from the laser system The cables include the...

Страница 14: ...es from laser exposure while looking through the Slit Lamp The Eye Safety Filter is a component that is not connected to the Array LaserLink but is part of the Lumenis Photocoagulator Laser System tha...

Страница 15: ...nit is in appropriate working condition CAUTION To prevent accidental laser exposure always turn off the laser as instructed in your laser operator manual before connecting the delivery device NOTE Re...

Страница 16: ...are adjustable on the treatment screen are also adjustable on the touchpad 3D mouse The treatment screen is composed of panels in the upper left corner One panel is visible at a time and is selected u...

Страница 17: ...rotate the shape and perform fine positional adjustments micromanipulation In addition to the touch sensitive surface the touchpad has two buttons for controlling the power settings and a pair of midd...

Страница 18: ...the power settings Control Titrate mode Pushing the main controller down toggles titrate mode on off Change number of spots Rotating the main controller clockwise will increase the number of spots Rot...

Страница 19: ...pe Seven shapes are available single spot square line triangle circle quarter circle and half circle Select the desired shape by pressing the corresponding shape selector the shape appears in the Shap...

Страница 20: ...the single spot will be visible To return back to the orginal shape press the Titrate button again Fig 12 Titrate Preview Frame Mode Press the Frame button to display only an outline of the shape for...

Страница 21: ...in the upper and lower right corner of the Shape panel see Fig 14 lets you rotate the shape in either direction in 15 degree increments Fig 14 Rotation Buttons You can also use the touchpad to rotate...

Страница 22: ...eatment The middle section of the touchpad 3D mouse as shown in Fig 16 can be used to move the pattern in any direction The amount of movement is limited by the optical range of the Array LaserLink Un...

Страница 23: ...to adjust the spacing between spots The Spacing field is only applicable when a non single spot shape is selected Fig 17 Spacing To adjust the spacing using the touchpad slide your finger horizontally...

Страница 24: ...until the desired setting is reached Whenever the power is changed the new value will be temporarily displayed on the retina on a heads up display Fig 19 Power To set the power from the touchpad press...

Страница 25: ...laser power with repeat mode off should occur prior to initiation of a multi spot pattern If uncertain of expected clinical response users should start with conservative settings and increase laser p...

Страница 26: ...1 0 the On Retina spot size will be something larger than 50 m At the upper end the Array LaserLink limits the On Retina spot size to 1000 m for single spot mode and 500 m for any other shape NOTE The...

Страница 27: ...e laser power fluence and thermal interaction of the laser beam with living tissue before using the laser and delivery device The following table shows how the fluence at the treatment site changes wi...

Страница 28: ...on field Fig 23 until the desired setting is shown The duration refers to the treatment time for each spot Except for single spot shapes the allowed settings are 10 20 and 30 milliseconds For single s...

Страница 29: ...is due to a limitation of the laser systems To obtain an Interval setting press the button repeatedly until the desired value is displayed When a non single spot shape is selected the Interval field b...

Страница 30: ...h back to the previous shape if you did not change any settings while the red laser was selected If however you changed any settings while the red laser was selected the Array LaserLink will remain in...

Страница 31: ...n t have to search the full list of lenses Fig 28 Fundus Lens Window Displaying Favorites List Select the lens by touching the item in the list followed by pressing the OK button To create or customiz...

Страница 32: ...ndent of the selection of the correct Fundus lens Using a Fundus lens with a magnification different than the selected lens will produce a spot size that does not match the size displayed on the touch...

Страница 33: ...light Level Ready Backlight Level Setting the Date Time The date and time are displayed in the reports created by the Array LaserLink To ensure that the date and time in the reports are correct use th...

Страница 34: ...on Select the field you wish to adjust then use the decrease and increase buttons to change the value When you are finished setting the date and time press the field select button until none of the f...

Страница 35: ...Displaying Fluence The fluence value on the treatment screen can be hidden by un checking the Show Fluence checkbox If you prefer to have fluence displayed leave the checkbox checked Resetting Rotatio...

Страница 36: ...Number of Spots Enable Rotation Does not exist with 3D mouse Enable Manipulation This button lets you enable or display the Micromanipulation feature Enable Spacing This button lets you enable or dis...

Страница 37: ...ll of the treatment settings that are stored in a preset Any treatment setting that currently doesn t match what is stored in the preset will be shown in red The parts of the Preset Panel are shown in...

Страница 38: ...the treatment settings will be reflected in the Preset screen for the selected preset For instance select a preset using the Preset selector Now change the Power setting If you view the corresponding...

Страница 39: ...number of spots fired and for listing the names of the surgeons To navigate the five forms use the Back and Forward buttons at the top of the Report Panel as seen in Fig 36 The File Name and Eye fiel...

Страница 40: ...creen keyboard type in a file name for the report and press either the Enter key or the Done key when you are finished Fig 37 Popup Keyboard 3 You may repeat the same process to enter the patient s na...

Страница 41: ...g a diagnosis that is not listed in this form 8 Press the Forward button to proceed to the Pattern form Fig 39 Fig 39 Pattern Form 9 Select the appropriate pattern button If the pattern is not listed...

Страница 42: ...ar in the report The remaining fields on the form are for entering the names of the surgeons 13 If you have skipped here from Step 5 or you have completed filling out all the forms and you want to sav...

Страница 43: ...ar Refer to the Safety and Regulatory section of this manual and your laser operator manual for additional information 7 If using an automatic Eye Safety Filter select the desired Eye Safety Filter mo...

Страница 44: ...the system is out of focus or alignment Stop use and contact your Lumenis Service Representative CAUTION If the pattern or aiming beam spot size that is visualized through the Slit Lamp is not the sam...

Страница 45: ...Place the laser in STANDBY mode 2 Turn the key switch to the OFF position Remove the key to prevent unauthorized use of the laser 3 Turn off the Array LaserLink console using the On Off switch on the...

Страница 46: ...Maintenance 45 Maintenance...

Страница 47: ...nect switch the circuit breaker is turned on Laser console electrical Verify that the laser is on and properly connected to an electrical service outlet Delivery device connections Verify that the del...

Страница 48: ...re not properly connected Refer to the Operation section of this manual and your laser operator manual and check the connections The laser is in standby mode Place the laser in ready mode The wrong fi...

Страница 49: ...ot operating Refer to the Operation section of this manual and check the Eye Safety Filter connections If properly connected contact your local Lumenis Representative The wrong fiber is selected on la...

Страница 50: ...s connected to the laser the filter is improperly connected or the filter is not operating Refer to the Operation section of the laser and Eye Safety Filter manuals and check the Eye Safety Filter con...

Страница 51: ...dog 120 FPGA Checksum 121 Aim Bm Not Cal Contact your local Lumenis Representative 125 CPU Temperature Restart the device if the message persists contact your local Lumenis Representative 302 No Foots...

Страница 52: ...y or pour cleaning agents directly on the device and do not wipe the inside surface Annual Maintenance Preventative maintenance for cleaning of exposed optics safety power and calibration checks shoul...

Страница 53: ...to unplug the machine during any type of maintenance could result in electrical shock 3 Locate the electrical input module which is adjacent to the main power receptacle 4 Unlock the electrical input...

Страница 54: ...reased immunity to such emissions WARNING The Array LaserLink has been tested and approved for both stacked and adjacent placement with a secondary device and not have any interferance or negative imp...

Страница 55: ...cle quarter circle Spot Size 50 100 125 150 175 200 250 300 400 500 m 3 ring half or quarter circle 100 m and 200 m Spot Spacing 0 for single circle only All patterns 0 25 0 50 0 75 1 00 1 50 2 00 2 5...

Страница 56: ...rray LaserLink Module 313 mm x 300 mm x 100 mm 270 mm x 190 mm x 75 mm Equipment classification Class II IP Rating IPX0 Mode of Operation Continuous Operating Conditions 15 C to 30 C Relative Humidity...

Страница 57: ...tenance Warranty Information For specific and detailed warranty information for this instrument please refer to the first page of your purchase Agreement and the last page of the Terms and Conditions...

Страница 58: ...Safety and Regulatory 57 Safety and Regulatory...

Страница 59: ...t fire electrical injury and explosion Lumenis does not make recommendations regarding the practice of medicine Laser treatment parameters are provided as a guide Individual treatment should be based...

Страница 60: ...ectra DP and compatible delivery systems Therefore the values specified here meet or exceed the laser safety eyewear requirements for the Lumenis Array LaserLink delivery systems Fig 42 Formula for NO...

Страница 61: ...ystem Vision One NOHD 31 m Novus Spectra and Spectra DP 35 m All personnel who are within the NOHD are considered to be within the controlled area and shall wear eye protection with a minimum optical...

Страница 62: ...NING 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 tissue damage could occur WARNING...

Страница 63: ...or performance of procedures other than those specified herein may result in hazardous laser radiation exposure CAUTION The laser system should always be in STANDBY mode except during actual treatment...

Страница 64: ...ly designed Eye Safety Filters that guard the operator from exposure to laser radiation The protective filter ensures that all laser radiation returned to the operator s eyes is below the Class I limi...

Страница 65: ...64 Safety and Regulatory Fig 44 Location of regulatory compliance labels Array Module Array Console Manufacturing Label Laser Aperture Label...

Страница 66: ...Safety and Regulatory 65 Fig 45 Regulatory Compliance Labels...

Страница 67: ......

Страница 68: ...Indications for Use 67 Indications for Use...

Страница 69: ...betic retinopathy Macular edema associated with proliferative or non proliferative diabetic retinopathy Choroidal neovascularization Retinal neovascularization associated with retinal occlusive diseas...

Страница 70: ...oagulation No Single Spot no pattern Grid Photocoagulation Yes Square arc line Retinal neovascularization associated with Retinal Occlusive Disease Branch Retinal Vein Occlusion Central Retinal Vein O...

Страница 71: ...to undergo further treatment potentially causing over treatment of the treatment area CAUTION Misaiming the laser movement of the patient uncontrolled eye movement or nystagmus may result in unintenti...

Страница 72: ...rupture of Bruch s membrane from application of high fluence burns which may cause hemorrhage or lead to vascular ingrowth ciliary body and choroidal detachment subretinal fibrosis progressive enlarge...

Страница 73: ...betic retinopathy ETDRS Report Number 9 Ophthalmology 98 766 785 1991 13 Early Treatment Diabetic Retinopathy Study Research Group Focal photocoagulation treatment of diabetic macular edema ETDRS Repo...

Страница 74: ...hthalmol 2008 126 78 85 26 Nagpal M Marlecha S Nagpal K Comparison of laser photocoagulation for diabetic retinopathy using 532 nm standard laser versus multispot pattern scan laser PASCAL Retina 2010...

Страница 75: ......

Страница 76: ...Appendix 1 75 Appendix 1 EMC Guidance and Manufacturer s Declarations...

Страница 77: ...by electronic equipment RF emissions CISPR 11 Class A The Array LaserLink delivery system is suitable for use in all establishments other than domestic and may be used in domestic establishments and t...

Страница 78: ...nment Surge IEC61000 4 5 1kV line s to line s 2kV line s to earth Class A Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltag...

Страница 79: ...mitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the followi...

Страница 80: ...tput power W of transmitter Separation distance m according to frequency of transmitter 150 kHz to 80 MHz 3 5 1 80 MHz to 800 MHz 3 5 1 800 MHz to 2 5 GHz 7 1 0 01 0 116 0 116 0 233 0 1 0 368 0 368 0...

Страница 81: ......

Страница 82: ...Appendix 2 81 Appendix 2 Specifications for Patterns Spacing and Spot Size...

Страница 83: ...0 40 50ms Power Array w Array w Array w Array w Array w Array w 532 Green 50 2000mW Vision One 50 2000mW Spectra 50 2000mW Vision One 50 2000mW Spectra 50 2000mW Vision One 50 2000mW Spectra 50 2000mW...

Страница 84: ...170 180 190 200 210 220 230 240 250 260 270 280 290 300 320 340 360 380 400 420 440 460 480 500 550 600 650 700 750 800 850 900 950 1000 1100 1200 1300 1400 1500 1600 1700 1800 1900 2000 532 nm 50 55...

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