- Frank`s Hospital Workshop
Contents
1. ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL ig of 79 Picture 3 Dimensions ESIRIS front 2118 1991 n 9 e oa EI a 2 i LO i 4 Picture 4 Dimensions ESIRIS side Input Requirements SCHWIND ESIRIS needs as electrical input Electric connections 1 2 Power supply voltage 230 V 1 phase Fuse protection 16 A slow C characteristic Frequency 50 60 Hz Connections 3 pol CEKON blue ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL T o 79 Installation and room preparations for the installation Minimum room dimensions or room requirements appr 3 m x 4m 12 m Stickstoff Flasche Nitrogene bottle Picture 5 Room requirements or room dimentions ideally 12 m Requirements for the floor can be seen in above ground plan drawing Floor requirements e Laser system and beam delivery system 250 kg e Point weight through supporting feet at the laser max 75 kg Base of supporting feet appr 28 cm per support Patientbed 220 kg e No of supporting feet for the laser 4 e No of supporting feet for the patient bed 4 e Door width min 80 cm e Floor covering PVC or stable vibration free underground Installation Requirements e Stable unyielding vibration free underground no carpet2. eye tech solutions EXCIMERLASER ESIRIS SERVICE MANUAL Schwind GmbH Mainparkstrasse 6 10 D 63801 Kleinostheim SERVICE MANUAL 79 ESIRIS Version 1 0 Date 22 09 00 SCHWIND SERVICE MANUAL se C 3 79 INDEX PAGE ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL INANE MR o oi 79 REMOVAL OF GAS BOTTLES PREMIX AND HELIUM ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL i 5 of 79 1 Security of Device Laser beam General The SCHWIND ESIRIS is working with a pulsed UV Laser The Laser belongs to class 4 which is the one with the highest danger potential In any case exposition of eye or skin through direct or scattered laser beams has to be avoided A professional instrument maintenance done in the planned intervals secures that unintended beams can not be exposed of the unit Opening of the device is only allowed through trained technicians All persons assisting the treatment or attending the procedure have to be informed about danger potentials and have to wear protection glasses Besides the high performance laser the SCHWIND ESIRIS uses three diodelasers as positioning and fixation device The output of the fixation laser is below 10 uW Therefore it belongs to class 1 which allows an undefined exposition time of the eye The positioning lasers are used to adjust the exact working distance to the corneal surface Their output is 50 100
3. ESIRIS Version 1 0 Date 22 09 00 Schum SERVICE MANUAL S NU 79 Power supply for the laser Voltage 1 phase 230 Volt 10 96 Current 16A Fuse protection Safety switch min 16A with C characteristic connections wall plug 230 V 16 A 3 pole e An UPS system uninteruptable power supply is necessary optional to the delivery range of the ESIRIS e Nitrogen provision 50 quality 5 0 99 999 min otherwise the system could be damaged 50 Igas bottle should be wall mounted besides or behind the laser e Pressure reduce valve at nitrogen bottle with flow control and adjustable flow of 5 10 per minute included into the delivery range of the ESIRIS adjusted at 8 l min flow e Darkening shutter e Air conditioning in countries with temperatures of more than 25 C or differences of more than 10 e An air drier is absolutely necessary in countries with an humidity of more than 60 e Voltage constant provider 230 Volt 10 e The ESIRIS laser is operated with a premix gas mixture with is stored inside the laser Laser warning lamp e Possibility to connect a warning lamp at the room wall e Warning lamp near the entrance door of the laser room e Warning lamps will not be delivered but there is a possibility of a 24V relay connections with a warning lamp switch connection laser beam output side interlock Dimensions of boxes for the delivery The deliv
4. 5 0 has been proved as very good Nitrogen can be stored and transported easily in pressure bottles is in a low price limit and non toxic For optimising consumption of rinsing gas the gas flow is controlled automatically inside the containment of optical system A flow control checks the nitrogen flow If the gas is getting empty inside the pressure bottle the monitor of the control unit displays a message ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL uli 79 Unit can not be used anymore in this case The pressure bottle with nitrogen has to be changed immediately To avoid a slow loss of nitrogen through little leaks at the valve of the bottle it should be closed while the ESIRIS is not in use Often the above mentioned message appears when opening of the valve had been forgotten Important note Flow of nitrogen must be 8 l min in order to guarantee constant ablation values ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL Hee Me 17 of 79 3 Installation requirements and preparations Installation of SCHWIND ESIRIS is performed through trained service personnel To enable a proper installation some prerequisites have to be fulfilled which are described below Working Room The room where ESIRIS will be installed should have a minimum of 3 x 4m 12 m At the outer side of the entrance door a laser warning lamp and the official laser warning symbol have t
5. P 79 Picture list Picture Picture Picture 18 Picture 19 Picture Picture Picture Picture Picture 25 Picture Picture Picture Picture 34 Picture Picture Picture Picture Picture Myopia Picture 70 1 Optex Laser 12 2 Dimensions ESIRIS upside 18 3Dimensions ESIRIS front 4Dimensions ESIRIS side 5 Room requirements or room dimsions ideally 12m 20 6 Truck Dimension 7Main menu 8 Parameter menu 9Distributors adress 10 Service Menue 11 Laser menu 12 Scanner menu 13Digital input 14Digital output 15 Gascontainment 16 Adjustment menu 17 Schematic drawing of corneal correction in section 67 18Simplified basis for calculation even corneal 68 193 Dimensional scheme of beam delivery system surface 22 23 24 26 27 33 35 36 37 for ESIRIS Version 1 0 Date 22 09 00
6. and store packing material until installation Check the components for damage and completeness according to delivery list The customer is not allowed to perform electrical connection Disregard would invalid warranty Device has been packed properly in perfect condition at factory Transportation damages are in the responsibility of transporting agent In case such damages are recognised during receipt or unpacking please follow this list a In case of outer damage transporting agent has to check damage and record it at the delivery note b Write a report for insurance company with estimated costs c In case of inner damage which could be recognised with unpacking inform transport agent and follow A and B d Store packing material until all questions with transport agent and insurance company are cleared ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 7 79 Putting into operation Installation and instruction according to MDD 93 42 EWG is done through a service technician engineer from SCHWIND or authorised distributor A not permitted installation starting or use of the device invalidates warranty The service technician inspects the room for necessary installations space voltage connection security regulations and ventilation He confirmes the correspondance at the inspection protocol and connects the system to the power supply After a system check and after necessary adjustments he perform
7. functions which are necessary for the adjustment of the laser or to test and check the systems in case of troubles Menu Service Picture 10 Service menu In this menu the service can select following items Laser Scanner Input output Gascontainment Adjustment TSC ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL Misi ud P 79 On the next pages all menus will be explained in detail ESIRIS Version 1 0 Date 22 09 00 EPR tah a SERVICE MANUAL Menu lLaser Picture 11 Laser menu On the left side in the top the service can see the laser type the bios version of the laser and the COM interface The TX RX icons are blinking in case of a right connection between the PC and the laser Pressure On the top the current pressure in the laser tube will be displayed Change laser mirror By pressing this button the mirror change procedure will be activated Please follow the instructions on the screen because this is an automatic function ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL En m o g 79 Laser error In case of laser problems the sytem will read out the error codes of the laser The following lines gives you a short explanation of the meaning of each errorcode If the service need more information please take a look at the Optex manual from Lambda Physiks for detailed information Errorcode 1 Check error occurr
8. horizontal down from the output opening to the next surface Normally this is the patient bed or in case of treatment the patient eye Diameter of beam at the output opening is app 1 0 mm In the treatment area which is 290 mm under the output opening the beam has a diameter of 1 0 mm Output and energy density of beam decreases accordingly with increasing distance from treatment area Protection Glasses All persons inside the room except the patient have to wear protection glasses according to DIN EN 207 when the laser is working These glasses must have protection level 7 for beams of 193 nm The operating surgeon can put off the glasses when he looks through the microscope The glass optics of the microscopes weaken the laserbeam so that the necessary protection level is achieved Protection level of glasses depends on maximum existing middle output density at max pulse following frequency or the maximal energy density These values are 5 x 102 J m2 ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 7 i t 79 Working Gas Danger through the working gas fluoride 0 106 96 argon 3 33 96 and neon 96 56 has not to be feared The laser head contains only a small quantity of fluoride It is checked according to the pressure containment regulations An unintentional output of working gas is very unlikely Fluoride can be recognised through its pungent smell long before the concentration will come to maximum allowed val
9. input window shows the current pressure If the pressure is OK the lamp is light green Premix VEla closed Press this button to switch the VE1a valve Premix VElb closed Press this button to switch the VE1b valve Helium VE2 closed Press this button to switch the VE2 valve ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL a 40 of 79 Change premix bottle By pressing this button the gas bottle change procedure will be activated Please follow the displayed instructions The current bottle pressure will be displayed in the premix bottle pressure window Menu adjustment The adjustment menu was created for the service to make a perfect adjustment of the ESIRIS laser SETTE eye A iech ribhae OO O M m t D Da mm Q Shutter me un eu Di offset Dim Dik offset Um dift dui offset Picture 16 Adjustment menu Laser Intern trigger Switch the laser in the internal trigger mode ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL ee 79 Watchmode Switch the laser in the watch mode Off switch the laser in the stand by mode Frequency Set the laser frequency what is necessary Quantity Set number of laser pulses for watch mode Watchmode Shows the number of pulses the user had done Laser energy Shows the current laser energy Scanner X axis set a drift of the scanner
10. system could be coursed This is to fix into a Service and Maintenance Agreement The gas bottle will be changed by a SCHWIND service engineer technician or a trained service technician of a SCHWIND dealer f these instructions will not be kept any claims of guarantee and responsibility laps Gascontainment The Laser operates with premixed PREMIX gas The capacity of one bottle is sufficient for about 12 months at standard operation approx 180 fillings ESIRIS Version 1 0 Date 22 09 00 Schum SERVICE MANUAL 79 Delivery System The optical system for beam guiding and forming is flanged to the laser at the side of beam output The beam guide is angled three times to 90 so that the patient bed can be placed parallel to the laser Output of treatment beam is horizontally down collinearly with the optical axis of the video control system which is used for centration and focussing The treatment area is about 290 mm under the beam output Focusing of ablation field and the centering at the eye is performed with two positioning lasers and a video camera At the monitor of the video computer a video picture with crosshair is produced The ablation field has a maximum diameter of 14 0 mm Minimal ablation diameter is 1 0 mm These values as well as the centration of the field at the crosshair can easily be checked through ablation pulses at a piece of illuminated photo paper or Kodak Wratten Filter Diode lasers
11. the device tower besides the patient bed It includes all voltage delivery units input fuses and the control computer Monitor and using keyboard are located at the front wall of the ESIRIS The controller can easily interact with the SCHWIND ESIRIS through input keyboard and monitor Inputs into the computer are menu controlled so that input mistakes can be avoided mostly Release of treatment procedure is done with the footswitch Patient Bed The patient bed should enable a simple way of exact and stable storing of the patient as well as the adjustment of the treated eye at the ablation area Foot Switch The footswitch is used to release the treatment procedure This switch has two switch points to avoid unintentional release of pulses The treatment procedure can be interrupted any time by releasing the footswitch The program remains active so the treatment can be continued afterwards by pushing the footswitch again Rinsing of Optical Beam Delivery System Radiation of ArF Excimer laser is 193 nm and so it is at the outer limit of spectrum area of ultra violet that is air transmitted Partially absorption through air oxygen lowers the radiation noticeably and ozone is produced This would damage the optical components if it would accumulate inside the delivery system Based on this itis useable to flood the way of radiation with an oxygen poor gas which is also good transparent at 193 nm For rinsing nitrogen with a quality of
12. to the ablation level For the several kinds of treatment and there profile the scanning mirror takes over the main task The single profile parameter are transmitted directly form the software to the mirror and will be worked off Through this splitting mirror the patient eye can be watched with a video camera An automatic observation of the eye movements enables a quick interruption of the treatment procedure if the patient leaves the fixation ESIRIS Version 1 0 Date 22 09 00 SCHUM SERVICE MANUAL onem 78 of 79 A red blinking diode laser is used as fixation target which can be seen from the patient through the beam splitting mirror The output of this laser is weakened to an optical power of lt 10 uW laser class 1 The correct working distance is aligned under control of the operating microscope with two red pilot laser beams one from the left and one from the right which are directed to the cornea in an angle They meet at the cornea at the working distance As the light spot at the cornea can not be well seen in practice the light spots at the iris are used In the working distance these light spots are at the right and left margin of the small fixed iris With enlarging the distance driving down the patient bed the light spots have to move outside With this fixation of the working distance the patient is moved until the cornea is in the ablation point ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL
13. with low energy are used as positioning laser Therefore they are directed punctually at the eye in an angle from left and right so that the points do cross at exact distance of focus A diode laser beams through the optical axis of the unit onto the eye This is used as fixation target for the patient The laser power is below 10 uW so that a longer lasting illumination at the eye would not cause any danger Microscope and lllumination For exact control of corneal surface a coaxial stereo microscope is used It allows a coaxial stereoscopic control of the eye without the control beam path being guided through the working optic of the device Therefore very good quality of the stereo picture is possible Abrasion of the epithelium and LASIK can be performed under optimal control conditions Further the control of treatment result is possible The cross hair is only constructed for a magnification of 14x If another magnification is used this might result in a decentralised position For illumination of treatment area a cold light lamp is integrated into the unit This lamp can be adjusted in brightness with a potentiometer and if necessary it can also be switched off The light is directly provided from a ring formed positioning of the lightening end of the fiber below the beam output opening ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 79 Controlling The system controlling is located inside
14. Hyperopia myopic Astigmatism and hyperopic Astigmatism On the right side the user can limitate the maximum refraction values for myopia hyperopia myopic astigmatism and hyperopic astigmatism Laser On the bottom of the formular the service can store the laser energy which is responsible for all treatment methodes The laser frequency is only displayed but not changeable The number of test pulses has the meaning that the service can increase or decrease the number of laser pulses during the necessary tests on photo paper like scanner test scanner drift concentic test and so on Sometimes if is it necessary because the service is using different types of photopaper with different thickness Distributor adress By selecting the menu distributor adress the service can store the adress of the manufacturer Schwind or the distributor This is interesting to show the user who is responsible for gas orders or service cases Everytime when something is happening or necessary the software will display the adress on the screen Mura Hazm E 0 2 T eh Back ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 26 of 79 Picture 9 Distributor adress ESIRIS Version 1 0 Date 22 09 00 Bpr tach SERVICE MANUAL By using the service menu in the menu task bar the service can use several service
15. RS 232 cable from the OpTex laser 13 Loosen the connection of gas tube to valves of OpTex laser by using an open end wrench 9 16 ESIRIS Version 1 0 Date 22 09 00 erre tac ini n SERVICE MANUAL m 79 14 Use gyrolock screw cab to prevent Optex valves 15 Use plastic yellow screw cabs to prevent the gas tube 16 Connect again the optical trigger cable and the optical RS 232 cable to the Optex laser 6 2 Unplug electrical connections of patient bed CAN BUS module and gascontainment 1 Unplug the following electrical connections 24VDC Gas 9 pole sub D plug Gas M patient bed T RS232 cable for bed control com 1 Remove power cable of patient bed from power socket Esiris ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 79 ESIRIS Version 1 0 Date 22 09 00 C E SERVICE MANUAL 754 of 79 2 Then bring back these cables to stick them to the patient bed 3 Afterwards loosen the screw 13 mm key of the earthing socket 6 3 Dismantling of optical parts Dismantling of microscope 1 Loosen the 4 screws of the microscope base plate 3 mm allenwrench 2 After removal of the microscope tighten the screws again with the hands to prevent them from loosing ESIRIS Version 1 0 Date 22 09 00 Bph tqzh nmigtinnn SERVICE MANUAL a 79 7 55 of Dismantling CCD camera tower 1 Re
16. able to the camera Connect cable of the fixation laser ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL A 70 79 Assembling the Scanner Remove the tape of both apertures at laser and scamer Connect scanner with four screws to the laser arm Connect the cables of the scanner to the cables that come out of the electronic box Connection of the Nitrogen Bottle Pull the nitrogen tube through the bottom plate of the laser and connect it to the nitrogen pressure management ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 79 Assembling Fluence Detector Connect the according cable to the fluence detector and tighten it Connection of the Gas Management to the Optex Laser 1 Remove yellow protection cap from the Gyrolock connector at the gas pipe 2 Remove yellow protection cap from the valve block of the Optex laser 3 Connect the gas pipe from the gas containment with the the valve block of the Optex laser and tighten it using the screw wrench 9 16 4 Connect light fiber for laser trigger and RS 232 light fiber to the Optex 5 Open the gas containment with the according key 6 Remove protection caps from the gas bottles and from the pig tails 7 Insert the gas bottles into the gas containment and connect the pig tails to the according gas bottles 8 Open the bottles 9 Control all the connections by using the Snoop ESIRIS Versio
17. aximum High voltage energy output The system is using general the energy constant mode By pressing the button the user can switch between both modes Above the current energy or the current HV will be displayed In the nominal HV or energy input mask the user can set different values Attention Please change the settings only when the laser is in standby mode OFF Reset PEM Error To reset the internal powermeter error press this button PEM calibration To calibrate the internal powermeter you have to press this button In this case you have to use an external powermeter The energy value which was measured the user has to input the value in the input mask Counter To reset the second pulse counter for the service press this button ESIRIS Version 1 0 Date 22 09 00 Spe tah Beppe SERVICE MANUAL 79 Menu Scanner The menu Scanner has to be used if the scanning mirror should be calibrated and tested during the adjustment and technical security check Picture 12 Scanner menu In this menu the user has the possibility to set the X and Y offset of the scanner The first X and Y offset is responsible for the zero position of the scanner Reference position The second X and Y offset is a correction factor to expand the scanning range Attention This has to be checked If the user is changing these parameter then he has to press the teach in button Test new p
18. d put them away 3 Screw down all the 4 feet step by step not one after the other otherwise the laser could cant Danger Screw the feet down to a distance of 8 cm from floor to the bottom edge of the laser rack 4 Align the laser rack with a spirit level by minimally moving the feet Assembling of the Patient Bed 1 Disconnect the light fibers for lasertrigger and to the RS 232 interface 2 Move the patient bed carefully to the laserrack until both fit together Be careful not to snap off the gas pipe ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 7 79 3 Screw down the 4 feet of the bed until the wheels rotate free unscrew them and put them away 4 Screw down all the 4 feet to a distance of 8 cm from floor to the bottom edge of the lasser rack 5 Align the patient bed with a spirit level by minimally moving the feet Use the accessable three sides of the rack by minimally moving the feet ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL ee 79 ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL UT m 66 of 79 Electrical Connection of Patient Bed CAN Bus Module and Gas Containment 1 First put all the cables and light fibers through the laser rack 2 Connect the following cables 3 De 24 VDC Gas 9 pin Sub D Connector CAN Gas M Patient bed T RS 232 cable of patient bed controller to COM2 of the PC put power plug into the socket ledge at
19. ed Eregakt Current energy set value is valid Status 3 MedReady Reservoir module is activated NewFill New fill procedure is activated Gpre Premix gas valve is open GHV Laser head valve is open 32 of ESIRIS Version 1 0 Date 22 09 00 ScHuuw SERVICE MANUAL Lapin S Pr 79 GVp Vaccum pump is switched on and vaccum valve is open Inert valve Inert valve is open MedCheck Laser is in warm up period In the center of the formular the user can switch the laser in different modes To start the laser the user has to press the Laser On button After this it is possible to activate different laser modes Modus Intern Trigger Start the internal trigger Extern Trigger Laser is waiting for external trigger QuantityBurst Number of pulses will be fired Watchmode Laser trigger will be activated by pressing the foot switch Off Switch of the laser modus Frequency In the input mask Frequency the user can change the laser frequency from 1 Hz upto 200 Hz This setting is no effect of the treatment frequency Quantity In the input mask Quantity the user can set the number of pulses for the Quantity burst mode ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL Gi S m 79 Energy control mode off Energy control mode on The laser has to control modes The energy control mode is for the constant energy output the HV control mode is for the m
20. ed statical error Errorcode 2 Time out error operation error laser device is to be switched off Errorcode 3 Laser head chamber open or temperature to high more then 60 C Errorcode 4 External interlock circuit open Errorcode 5 Electronics chamber open or temperature to high more then 60 C Errorcode 6 Reservoir pressure out of range less than 2 9 bar or more then 4 5 bar Errorcode 7 Pressure is not reached in the present time limit time out error Errorcode 8 Heating circuit error less then 5 8V or more than 7 5V Errorcode 9 HV charging time exceeded more than 4 5 ms ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL en e 79 Errorcode 10 Reservoir pressure too low Errorcode 11 Internal energy powermeter error occurred Errorcode 12 HV too high error occurred Errorcode 13 CPU error occured Errorcode 14 HV temperture error occurred Status 2 and Status 3 The Status 2 and Status 3 shows the service the current status of the machine Status 2 Online Laser online Laser On High voltage module activated and ready to be switched on Las Ready Laser ready for operation high voltage module can be activated ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 79 Rep Repetition mode ext trigger external trigger is activated Quant Quantity burst mode is activated Watchmode Watchmode is activated RegEn Energy Const mode is enabl
21. er e Wavelength e Power average beam output e Mode e Pulse energy beam output e Pulse frequency e Pulse duration e Pulse to pulse stability e Power density e Energy density Beam diameter output Treatment area e Beam diameter treatment area e Beam divergence Pilotlaser 193 nm 2 W pulsed 15 mJ max 200 Hz max 8 ns 5 96 1 5 x 105 W m 800 mJ cm 7x4mm app 280 mm under beam output 1 0 mm max 2 1 mrad Diodelaser e Wavelength e Power middle beam output e Mode Fixationlaser 635 nm lt 100 uW continued Diodelaser e Wavelength e Power average beam output e Mode 650 nm lt 10 uW pulsed ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 79 11 Controlling Industry PC 586AT or better e Hard Disc 13 6 GB or more e Processor Pentium 500 MHz or higher e Memory 64 MB Monitor 12 1 VGA flat monitor e Interlock 1 opener external Monitor output Cooling VGA socket Air Cooling Circulation Electrical Connection internal fan 3 5 Voltage Protection Frequency Connecting Plug Dimensions and Weight Floor Space Total weight 230 V 1 phase 16 A sluggish C character 50 Hz 60 Hz switchable 3 pole CEKON blue see next chapter appr 400 kg ESIRIS Version 1 0 SERVICE MANUAL ein of 79 Excimer Laser Laser p
22. ery consists of three wooden boxes with the following dimensions 1 150 110 180 cm gross weight 180 kg Laser attachments 2 220 x 110 130 cm gross weight 220 kg bed attachments 3 180 110 114 gross weight 150 kg covers cases ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL aoe 22 of 79 For transport a truck is necessary with a minimum height of 2 15 and inside dimensions of 2 38 m Picture 6 Truck Dimensions During opening of the boxes a trained service technician should be present Delivery The device is delivered in two parts packed separately the laser with the optical system the patient bed and containment and necessary spare parts control monitor and keyboard Packing consists of two screwed wooden boxes With delivery the customer has to check if these crates are undamaged A storage of the boxes outside has to be avoided It is recommended to unpack the boxes immediately after receipt and to check the goods for damage and completeness Inform SCHWIND or your distributor that you have received the device in order to organise visit of a service technician engineer for the installation ESIRIS Version 1 0 Date 22 09 00 EPR ac weep SERVICE MANUAL 4 Software description by Service Login The following chapter gives you a description of the service software functions in the ESIRIS software By using the service password the service g
23. et following main menu with the pull down menu Extra and Service Menu Extra Menu Logfile Picture 7 main menu By clicking on the menu point Logfile the technician has the chance to see all error messages and necessary informationen during the last techincal security check This ESIRIS Version 1 0 Date 22 09 00 EPR tah weep 24 of SERVICE MANUAL 79 is very helpful because on this way the service stuff gets the complete history of the machine since the installation Menu Parameter In the parameter menu the service can change necessary parameter for the surgeon which have an influence of the treatment By changing these parameters the techician has to be very careful and has to do the changes only in consence with Schwind and the surgeon ag gt ss ES vm Ss _ Schein Ferh Pls Picture 8 parameter menu General In this section the user can change the minimum and maxium treatment diameter and the maximum ablation depth ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL Po m 79 Treatment factor over undercorrection If the clinical study shows in some parts over or undercorrections the user has to change here the treatment factors for spherical part for myopia and hyperopia for the myopic astigmatism neg and the hyperopic astigmatism pos the cylindrical value Myopia
24. for testing Y axis set a drift of the scanner for testing Clear drift offset By pressing the button the current scanner drift will be reset to 0 0 Measure drift offset By pressing the button the scanning drift procedure will be activated Input output Shutter By pressing the button the shutter will be opened N2 By pressing the button the nitrogene will be opened ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL PE 79 Camera Active Eye Tracking The measurement of the concentric of the video camera the user has to use this menu point The video image which displays the ablation area has to be checked with the Check optical alignment procedure Check optical alignment By pressing the button the laser will shot following image Now the user has to check if the cross hair is in the center and has the same outlook like in the image above Stop show histogram With this function the intensity and contrast has to be checked On the right side the user can see a standard histogram which is guilty for the adjustment The red second histogram has to be overlapped with the standard histogram By moving the intensity and contrast scrollbar it is very easy to bring both histograms together If the user had done this the alignment of the camera is OK If ahuman eye is positioned in the ablation zone the service can check once again the functionality of the eye tracking Attention The quality val
25. ication is the assumption of an even surface In this area a positive or negative lens is made Consideration of actual corneal bending is not necessary For adaptation of power density which influences an area element to an angle of incidence it is enough to take the norm bending radii of cornea R 7 8 mm A2 Correction of Myopia Geometric relations at myopia correction under easier assumption of a flat basic area are displayed in picture 3 ll p 1 376 Picture 18 Simplified basis for calculation even corneal surface for Myopia An area with negative focal distance is worked in to the basis area The bending radii of this new limited area results on the following formulae R mm 1 n D 376 D The refractive index of cornea is taken with n 1 376 The requested correction of refraction D has to be taken in diopters m ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 79 For the correlation between diameter of optical zone d and the central ablation depth h the following formulae is valid d 2V2hR h 2V2h 1 n d d 8h 1 n D Diameter d of single ablation zones is pre set through diameter input into the software Appendix B Beam Delivery System B1 Optical System The beam delivery system forms the beam of the excimer laser in the requested way and produces radiation areas at the patient s eye with supervised featu
26. les for the keyboard and the trackball at the back side of the PC left keyboard right trackball 3 Unplug VGA connector and pull both cables to the front of the system 4 Unplug the power cable 12V DC for the monitor 5 Remove the monitor and the keyboard ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 61 of 79 6 Dismantle the monitor keyboard holder with allenwrench 8mm Disconnection of the fluence detector 1 Unplug the fluence cable at the fluence detector 2 Fixate the cable with tape at the system Dismantling the Patient Bed 1 Screw up the 4 feet to a height of 14 cm from floor to bottom edge of the rack 2 Fixate the wheels into the allocated drills 3 After that carefully rolling out of the patient bed to the back ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL ae 69 of 79 Dismantling Laser 1 The 4 feet of the laser must be screwed up step by step and not one after the other otherwise the laser could cant Danger Screw the feet up to 15 cm distance from the floor to the bottom edge of the laser rack 2 Fixate the wheels into the allocated drills ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 63 GE 79 7 Installation of the ESIRIS Laser Assembling the Laser 1 Move the laser rack to the correct place in the room Then screw down the 4 feet of the rack until the wheels rotate free 2 Unscrew all 4 wheels an
27. move the 25 pole plug of the CCD camera 2 Loosen the BNC cable of CCD camera ESIRIS Version 1 0 Date 22 09 00 Bph tqzh nmigtinnn SERVICE MANUAL a 79 7 56 of 4 Loosen the 4 screws of the CCD camera tower 5 After removal of the CCD camera tower tighten the screws again with the hands to prevent them from loosing 6 Cover the opening with tape 7 Protect the CCD camera tower with plastic hood ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL Pd 79 7 57 of 8 Fixate the cables at the optical arm with tape Dismantling Scanning mirror 1 Open the electronic box 2 Unplug both connections of the galvos ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL nn A 79 3 Loosen the 4 srews allenwrench 4mm of the scanner and hold the scanner with your hands attention do not touch the mirrors mounted on the galvos 4 After removal of scanner tighten the screws again with the hands to prevent them from loosing 5 Protekt both beam openings with tape to protect them against dust ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL EO of 79 Nitrogen gas cylinder 1 Unplug nitrogen tube at nitrogen management 1 Dismantle Monitor and Keyboard 1 Loosen the 2 screws at the bottom of the monitor table and remove the cover ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL Meen T o of 79 2 Unplug the cab
28. n 1 0 Date 22 09 00 SERVICE MANUAL aciertan 72 of 79 10 Connect the ESIRIS to the UPS and switch it on with the main key switch Log in with service authority 11 Choose menu SERVICE gt gas containment 12 Press button Change Premix Bottle 13 Follow the messages on screen until the end of the procedure ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL diva ge 79 8 Alignment of the ESIRIS 1 Check the laser beam behind the Optex and make sure that the laser beam is central to the first mirror For the check use fax paper 2 Remove all optical and mechanical parts of the first optic tube integrator 1 lense pinhole and 2 mirror Align the laser beam to the center of the tube opening behind the 2 mirror 3 Insert the 1 lense and check if the beam is still in the center 4 Insert all the other parts into the optical tube integrator pinhole 2 mirror and all the covers Pay attention to the lense direction 5 Remove the scanner and check if the beam is in the center of the outcoupling hole in front of the scanner Align the beam by moving the 27 mirror 6 If the beam is centered assemble the scanner again 7 Check the lenses behind the scanner that they are in the correct direction 8 Select the service login at the PC and follow the messages on the screen for Adjustment see chapter Service me
29. nu adjustment ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 79 Appendix The following appendixes include details of the laser and precise descriptions which provides the user a better understanding They are not necessary for ordinary use and so they are not part of user manual Appendix A Calculation Basis A1 Introduction For correction of myopia and hyperopia on human eyes it is necessary to flatten the bounding of the corneal surface or to rise it If furthermore an astigmatism should be corrected the bounding of the cornea has to be changed differently in two meridians Picture 17 Schematic drawing of corneal correction in RSS IDEA 820265 section Correction of Myopia R4 lt Ro Correction of Hyperopia Ry gt Ro The areas treated with excimer laser are darkened d diameter of optical zone h maximum depth of corneal incision b width of transition zone at hyperopic correction R4 bending radii of cornea before treatment Ro bending radii of cornea after treatment Based on the change of bending on corneal surface the power of refraction is changed referring to the following formulae D 1 n x 1 R2 1 R1 ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL A I 79 Value for cornea n 1 376 has to be taken for refraction index Unit for R is m Calculation of new corneal contour with above mentioned formulae is very lavish A great simplif
30. o be installed The warning lamp has to lighten during the laser is in use A switch which interrupts the laser if the door is opened can be connected through the interlock input at the device But this is only recommended when it is guaranteed that the door is not opened during treatment Inside the laser room explosive or inflammable material must not be stored Near the opening door protection glasses according to DIN EN 207 have to be available in sufficient quantity Protection glasses have to be available in following specifications D L9 IL2 calculated by DIN EN 207 according to Laser Vision Nitrogen gas bottles necessary for use of the laser can be stored inside the laser room They must be fixed to avoid falling down Important note Do not use any liquid containing ammoniac to clean the room Ammoniac vapours attenuate the laser energy and create varying ablation rates and treatment results ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL ASA 1 9 Dimensions ESIRIS 1581 r bI 41 y H ZW N N e I CN l t T I D 2 Hal 2131 Picture 2 Dimenstions ESIRIS upside 1073 1106
31. osition For checking the reference position press this button ESIRIS Version 1 0 Date 22 09 00 Spe tah Beppe SERVICE MANUAL Concentric test 10 x 10 This function has to be used if the user has to changed the expanding offset After pressing this button the laser is shooting a cross on the photopaper After the procedure the user has to check with a lens meter the distance from one point to the other point and to measure if he has a rectangle of 10 X 10 mm In case it is not ok he has to re check the expand faktor Test Scanner and Get Status Both buttons are responsible for internal test The result will be displayed in the status frame Menu digital inputs outputs The input output window shows the current input status The outputs can be activated by pressing the lamp icon General light green lamps show an activity ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL T lt D 79 Picture 13 Digital input ESIRIS Version 1 0 Date 22 09 00 ERBETEN Picture 14 Digital output The Output window shows the switchable functions By clicking the lamps the electronic switch is activated ESIRIS Version 1 0 Date 22 09 00 Spe tah Beppe SERVICE MANUAL Gascontainment The gascontainment menu allows the user to switch the gas valves and to do a gas bottle change So de ge Picture 15 Gascontainment The digital
32. res diameter shape and direction For a wavelength of 193 nm the optical components have to be well transparently They are made of synthetic quartz glass The way of beams inside the SCHWIND ESIRIS is schematically displayed in the following picture ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 79 um Fixationslaser Abbildungslinse Filter T Scanning Spiegel ii Spiegel Ne 47 Spiegel 1 3 Umlenkspiegel 2 Umlenkspiegel gt Ic Blende Abbildungslinse Abbildungslinse Positionier laser Abbildungslinse CF gslinse f Positionier laser Patientenauge Gau Integrator Picture 19 3 dimensional scheme of beam delivery system The beam output of the laser has a doubled working mechanical shutter after the first bending mirror Usually it is always closed It is only opened when the operator presses the footswitch The cross section of the rough beam which is emitted by the laser is 4x 7 mm It is formed to a gaus laser profile with an integrator optic The beam is then deviated by a mirror and comes then to the 2 bending mirror and is changed to 90 Through a further lens which enlarges the beam the beam comes to a scanning mirror Then the beam is enlarged through two further lenses until it meets the 3 Bending mirror From here the beam is focused circularly focused through the last lens to the treatment level and so it comes
33. rincipal Excimer gas lasers are stimulated with an electric pulse in a mixture of rare gases and halogens The output lifts the rare gas atoms to a higher energy level so that they reacts with the halogen molecules and connect as ArF or KrCl These special molecules known as excimers are stable only for a short time They destroy and put out a high ultraviolet beam If the gas is arranged in an optical resonator of two parallel mirrors the laser effect is achieved and light impulses with very high maximum outputs are beamed The laser gas consumes itself partially during the output and must be changed after 10 x 10 impulses or after 2 3 days The OPTEX laser used with the SCHWIND ESIRIS is produced by Lambda Physik Goettingen It is a very compact unit which is optimised in reliability and low gas consumption Above mentioned specifications describe the data of the laser and the necessary voltage connections Picture 1 Optex Laser Power supply voltage 230 V AC 10 96 1 Phase Frequency 50 Hz or 60 Hz Power Input 1 5 Security for the phase 6 3A Device connections acc to IEC standard ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL ee 79 Gas Supply The noble gas mixture has to be received directly by SCHWIND or the responsible SCHWIND dealer because only by this purity ranks and strictly check criterions are guaranteed Otherwise damages to the
34. s containment 2 Press button Exchange Gas Premix Bottle ESIRIS Version 1 0 Date 22 09 00 Bphstazh mmigrligmg C SERVICE MANUAL P 749 of 79 ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 750 of 79 3 Follow the messages screen until Now you can change the premix bottle 4 Now you can press the button Abort to interrupt the whole premix bottle exchange procedure 5 Loosen the connection pig tail to premix bottle with open end wrench 6 Mount screw cab onto Premix gas bottle and pig tail HntcasEvae cms ncs tine laser wita cargo you have to remove the premix gas bottle 7 Close helium gas bottle valve and loosen the connection pig tail to helium bottle with open end wrench 8 Mount screw cab onto helium gas bottle and pig tail ESIRIS Version 1 0 Date 22 09 00 C SERVICE MANUAL a TO sl of 79 Hint By transportation of the laser with air cargo you have to remove the helium gas bottle 9 Close the gas containment 10 Shut down the PC switch off the system by turning the main key and unplug the power line connection Hint in fact of using an uninterruptable power supply UPS Switch it off and also switch off the in and outputbreaker 11 Disconnect the power cable of Esiris from the UPS 2 Unplug the optical trigger cable and the optical
35. s examining checks After installation the device must not be transported to another room and there installed and started without getting knowledge to SCHWIND or distributor ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL a T a g 79 Warranty e Time of warranty starts with operational by handing over and confirmation at the delivery note through the customer e Warranty time for SCHWIND ESIRIS lasts 12 months e Warranty includes all defects of the device caused through defective parts or manufacturing Further malfunctions that are not coursed through improper use are repaired under warranty Further wilfully damage is not repaired under warranty SCHWIND or distributor have to be informed about damages or malfunctions immediatelly e Defective parts have to be returned to SCHWIND ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 48 of 79 6 Dismantling of the ESIRIS lasers To prepare the Esiris laser for transportation you have to remove the patient bed together with the gas containment from the complete laser system Before disconnecting the gas tube from valve plugs of the Optex laser you have to be sure that no more premix gas is inside the tube So please follow the instructions below Removal of gas bottles premix and helium Turn on the Esiris laser with the main key switch and log in with service authority 1 Choose menu SERVICE gt ga
36. the laser rack Anschliefend Erdungskabel der Liege am Lasergestell anbringen 13 mm Connect the Ground cable of the bed with the allocated screw at the laser rack 13 mm screw wrench ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL OU 79 Assembling of Monitor and Keyboard 1 Assemble the metal arm for the table of monitor and keyboard to the laser rack 2 Build in the monitor and keyboard in the table and thread in the three cables of monitor keyboard and power supply Connect the monitor with the according cables Then fix the cover with the screws ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 79 3 Connect the keyboard to the according jacks at the back side of the PC left keyboard right mouse Connect the monitor cable to the according jack at the back side of the PC Assembling of the Laser Beam Delivery System Assembling the Microscope Connect the four screws of the basic plate with the laser arm ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 79 Assembling CCD Camera Tower 1 Remove tape of the cable of the camera tower Bi UE 2 Remove dust cover of radiation exit aperture 3 Remove tape of the camera aperture on the laser arm Remove the four screws for the camrea tower out of the laser arm Fixate the camera tower with the four screws to the laser arm Connect the BNC and the 25 pin SubD c
37. uW As the beams are aimed in a angle to the eye an influence at the retina is impossible Warnings Laser beam The laser emits high performance beams Wave lengths 193 nm Pulse energy max 8 mJ Energy density 800 mJ cm2 Laser beams with these data are potentially dangerous but in our case possible danger is minimised through some details e the beam diverges after passing the ablation area so only in this area a high energy density exists e the beams are partially absorbed in the air e the cornea does not reflect beam during treatment These effects reduce the energy density of the beam quickly with growing distance to the working area which is about 280 mm under the beam output opening In spite of this the following warnings have to be followed for a safety use ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL QUT UP A 79 Never look into the laser beam Never put your skin into the laser beam Wear protection glasses Make sure that no reflection devices are placed in the area of the laserbeam Follow the instructions of the trade association VBG 93 Persons not used with the lasers have to be informed about possible risks Alarm Shields and Type Shield Beam output is marked with laser warning signs 1 2 Warnschilder They are looking as following ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL a 7 47 of 79 Accessible Beam Area The beam area of the device is
38. ue should be higher than 120 The position POS shows the coordinates of the center of the pupil compare it with the red cross hair ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 7 ie 79 Check optical area With this function the service can check the concentric of the scanning mirror If the user is starting this function the laser is shooting such profile by pressing the foot switch After this test the user has to check with a lensmeter if he has such profile If not then the adjustment of the optics has to be checked again Pinhole adjustment By selecting the pinhole adjustment function the user can check the intensity of the laser beam itself It is very recommend to do this with this function because only there the service can be sure that the pinhole is well adjustet By pressing the foot switch the laser begins to fire During the movement of the pinhole the intensity which will be displayed in the histogram shows the maximum what is possible Corra rimi ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 79 Menu Technical Secutity Check TSC If the user is selecting this menu he will asked if he had done the TSC By confirming with the print button a protocol will be printed out ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 45 of 79 5 Unpacking and Controllin SCHWIND ESIRIS is delivered in three separate crates Remove
39. ues for working places In such case open the window leave the room and call service department of your distributor or directly Gas containment Pressure gas bottle with working gas is stored inside a gas containment This gas containment is airtight and has a filter which would absorb the fluoride in case of a leak For service demands there is a pressure gas bottle with helium stored inside the gas containment too ESIRIS Version 1 0 Date 22 09 00 SCHUTI SERVICE MANUAL T apeina NT 79 Declaration of Manufacturer MPG The device has been developed according to the Medical Device Regulations MPG The named T V office Munich mark 0123 manufacturer Co Herbert Schwind GmbH is allowed to produce laser devices for medicine purposes and to put them into circulation Conformity with the construction authorisation of the device according to the MPBetreibV is ensured under the precondition that e delivery is done through SCHWIND or authorised distributor e all service and maintenance works are only performed through authorised personnel e accessories consumables and disposable are only allowed if a completely harmless use safety technique is confirmed through a test of this device performed by an authorised testing authority This is especially important for patient bed ESIRIS Version 1 0 Date 22 09 00 SERVICE MANUAL 79 2 Description Specification Working Laser 10 of ArF Excimer Las
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