Home

Application Manual MEL 70 G-Scan

1. Index The TSC BS Si i esreatreecde itrnrdc cic nine msdr teain er cine eit rsdn mciadaninincedindaiente 40 Preparation of the laser s ccccwace eae 41 Preparation of the patient cccccct cecagetcaccentagucegsdueccrandecrcage tua ncumnescacterdapecpadse canadien 44 Theeye tacker reee r aa E A 45 Centration with the MEL 70 G Scan using the Artificial Limbus Ring 47 Centre of PUPian E E EAEE EEOAE 47 Purkinje EMG 2 5 saacconscbiinessnnsdenscentdnrnnanianadanadenbonunieaioadedqnadeuaiannieeidanasnnngohies 47 The treatment session 8 ciciciccncs dcadeicocuetcasetstinse dae descneadeicausapdusbcuctdncieneadiitnccuetcemncinest 48 Termination of the program ccccececeeeeeeeeeeeeeeeeeeeeeeceeeeeeeeeeeeeeeenceeeeeeeeeeeeteees 49 Switching off of the AS GI cacessaceccuseccceueasscisasssseceacuneatusiseccsucdsunanitausaedcacinnliae 49 Follow up treatment OMOpOSEd xciccs entice thereientivstie MectieriieexinetdenieetivesineRiewaueta 49 PIK SNaping oea dein tute aaa a eea Ea EE eaae aaea Ee EEEa 50 ApplicatONS oninia a n a airan iia 50 Activation of the laser we ccccccwcsdesadsocceincncedssnenelductenotdnannechtnrsgnatdnanenehdneheneiduonteantnend 50 Initial heating phase and gas ExChange ccccccceeeeeeeeeeeeeneeeeeeeeeeeeeeeeaees 51 The Main WGI geceetsscesctacscicosdedcuocutascentacndecnnt aouacteaninesedagtecaeeependerenatudstacteasneante 52 Data input for PTK Shaping treatment ccceccceceeeeeeeeeeeenee
2. MEDITEC Su Appendix By clikcing on Extended data you open the Extended data menu Extended Data Fig 52 Extended Data Menu You can extend the patient data by entering additional data and values in these fields Confirm your entries with OK Press Cancel to exit the menu without saving the entries in the patient list The program takes you back to the CREATE EDIT PATIENT menu 7 3 2 Search patient Fig 53 Search Patient menu 94 96 Art Nr 170299045 1 299 AESCULAP Appendix Enter the patient data you know in the SEARCH PATIENT section Clicking on Search displays a list of all patients satisfying the search criteria Clicking on All displays a list of all patients Click on Cancel to exit the menu The program returns you to the Patient Management menu 7 4 Failure indicator 7 4 1 Unexpected interruption of a treatment session In any case the patient will receive a proportional correction 10 30 etc 7 5 Cleaning instructions The suction ring may be cleaned with every usually applied method alcohol steam or gas It is of particular importance to see to it that the small holes for the flue gas extraction and mask fixation are clean Remove any foreign particles from these holes with a suitable needle The surface of the laser may be cleaned by wiping with a moist not a wet cloth and disinfected with a disinfection agent Th
3. Topographic treatment MEDITEC Click on this symbol in order to open the patient management cf Appendix Patient management Click on this symbol in order to open the application manual Application manual Click on this symbol in order to perform the configuration adjustments Here you may input the data of your clinic or select the printer for the journal printout cf Appendix D Configuration Click on this symbol in order to terminate the computer program and switch off the laser You should not switch off horoia the laser until the message YOU MAY NOW SWITCH OFF THE COMPUTER appears on the screen 6 4 Program entry for topographic treatment The topographic treatment is carried out on the basis of the patient s data obtained from a corneal topographic system The corneal topographic system stores all patient data on a ZIP disk Start the program Load the ZIP dsik with the patient data in the ZIP drive of the PC and select Operation topographic from the main menu The patient data are now transferred to a directory of the data base and deleted on the ZIP disk Art Nr 170299045 1299 77 96 AESCULAP w MEDITEC 2 Topographic treatment Operator Dr Meier y oK X Cancel EE Fig 42 Operator menu Enter the operator s name and confirm your entry with OK The OPERATION BASED ON TOPOGRAPHY menu opens Klicking Cancel returns you to the main
4. The treatment diameter the optical zone plus the transition zone for all programs is 9 mm As a rule the subjective spectacles refraction values are used as the basis for any data input These values are directly input into the OP Assistant This applies also to angles The refractometry shall be performed with utmost care in particular with young patients and if possible in a state of cycloplegia Exclusively positive values are to be used e g sph 3 cyl 2 x 459 Do not try and combine different hyperopia programs in order to achieve so called multipass treatments The in built nomogram is bound to cause Danger severe overcorrections On principle it is recommended to conduct an examination with a cornea topography system in order to be sure that the patient does not suffer from asymmetric astigmatism or an early stage of keratoconus Art Nr 170299045 1299 33 96 AESCULAP MEDITEC m2 LASIK 3 2 Activation of the laser Fig 13 MEL 70 G Scan switch Unlock the EMERGENCY OFF switch 7 Switch on the main switch 8 the green light in the switch lights up Turn the key switch 9 fully to the right the key will automatically return to centre position After approx 30 seconds the menu of the initial heating phase will appear on the screen 34 96 Art Nr 170299045 1 299 H AESCULAP LASIK MEDITEC 2 3 2 1 Initial heating phase and gas exchange OPASS 2 2 for MEL 7
5. A progress indicator will display the progress of the treatment By clicking on the Cancel pushbutton the treatment may be discontinued following the release of the foot pedal After the termination of the correction program the OP Assistant will automatically interrupt the laser triggering The treatment is interrupted by releasing the foot pedal and may be resumed by actuating the pedal again 28 96 Art Nr 170299045 1 299 AESCULAP PRK MEDITEC 2 2 10 Termination of the program By clicking on the PROTOKOLL pushbutton you will receive a print out of the surgery data via the connected printer You may return to the main menu by clicking on the OK pushbutton In order to treat further patients commence again in the main menu and follow the instructions in the applications manual 2 11 Switching off of the laser In order to switch off the laser click on the OFF Laser off End and confirm the switch off by clicking on the pushbutton Yes Wait for the message NOW YOU MAY SWITCH OFF THE COMPUTER appears on the screen Turn the key switch 9 fully to the left Switch off the main switch 8 the green light in the switch will go out Art Nr 170299045 1299 29 96 AESCULAP VA MS PRK 2 12 Follow up treatment proposal 2 12 1 Immediate postoperative treatment Immediately following the surgery the below medicines shall be applied to the eye Tobradex
6. Danger Art Nr 170299045 1299 13 96 AESCULAP MEDITEC 2 PRK 2 2 Activation of the laser Fig 2 MEL 70 G Scan switch Unlock the EMERGENCY OFF switch 7 Switch on the main switch 8 the green light in the switch lights up Turn the key switch 9 fully to the right the key will automatically return to centre position After approx 30 seconds the menu of the initial heating phase will appear on the screen 14 96 Art Nr 170299045 1 299 GJAESCULAP BRK MEDITEC X4 2 2 1 Initial heating phase and gas exchange OPASS 2 2 for MEL 70 G Scan x MEL 7O scan G AESCULAP MEDITEC Me F Operation topographic Operation Operation refractive Gas exchange Patient App canon f Laser off management manual Configuration End D Press F1 for Help Software version PC V 2 2 01 00 ZUK M V 2 2 01 00 ZUK S V 2 2 01 00 therapeutic Fig 3 Menu Initial heating phase The laser requires a period of six minutes to heat up to the necessary operating temperature A progress indicator will advise you of the status of the initial heating phase The symbols with a grey background cannot be selected during this period In order to perform an automatic gas exchange click the symbol Gas exchange during the initial heating phase The gas exchange takes approx five minutes Confirm the gas exchange with clicking Yes Another progress indicator will adv
7. Topographic treatment When the eye tracker is switched on you will see a graticule in the video image This graticule will be automatically placed in the object centre However since the optical axis is not always in the object centre you have the opportunity to modify this setting You can change the position of the graticule by clicking with the right mouse key on the arrow keys on the left of the video image The right mouse key will move the graticule in larger steps Click the round pushbutton in the centre in order to readjust the graticule to the geometrical centre You can also move the graticule with the arrow keys The keyboard button must be enabled for this You can adjust different parameters of the video image such as brightness contrast etc by clicking on the Video pushbutton The eye tracker is switched off by clicking on the Off pushbutton The eye tracker window is closed by clicking on the Close pushbutton When the eye tracker is switched off the laser beam will not be automatically traced i e any eye movements will not be compensated Art Nr 170299045 1299 AESCULAP Topographic treatment 6 8 Centration with the MEL 70 G Scan using the Artificial Limbus Ring PRK LASIK Centre of Pupil Centre of Pupil Input patient data Input patient data Perform fluence test Perform fluence test Have the patient look at the green LED Press ready Use a blunt c
8. 0S Fig 27 Menu Operations Assistant for PTK Shaping Select the treatment method PTK Shaping from the OP menu Input the desired ablation depth Depending on the relevant ablation depth a transition zone from 7 mm to 6 mm or 5 mm will result In the process the edges of the ablation zone will be rounded Following the completion of the input click on the pushbutton Fluence Test The pushbutton Close will take you back to the main menu Art Nr 170299045 1299 55 96 AESCULAP MEDITEC u2 PTK Shaping 4 4 3 The fluence test Fluence test Fig 28 Menu fluence test By clicking on the pushbuttons High or Low you may increase or decrease the energy set point You start the fluence test by operating the pushbutton Ready Clicking on the pushbutton Close will abort the fluence test 56 96 Art Nr 170299045 1 299 AESCULAP PTK Shaping MEDITEC 4 5 Preparation of the laser Height adjust your operating chair Switch on the ring shaped lamp 11 and check the ocular adjustment Swivel the laser arm and switch on the distance control laser 12 412 20 21 ia Fig 29 Control panel laser arm Position the patient bed together with the blue test base at the appropriate height The two focusing points require to be brought into an overlapping position Operate the below keys on the operating panel of the laser arm towards this end Height adjustm
9. J AESCULAP MEDITEC Application Manual VY ey Kod Version 2 2 12 99 MEL 70 G Scan Excimer Laser for application in corneal surgery Software version PC V 2 2 as of December 1999 Master computer version 2 2 as of December 1999 AESCULAP MEDITEC GMBH PRUSSINGSTRASSE 41 07745 JENA GERMANY EXCIMER HOTLINE Phone 49 36 41 65 22 78 Fax 4936 41 65 21 21 170299045 1299 AESCULAP Index gt 1 Safety INStruUChONS vvcisiecsccsdieesecesscesarerdicerewecsveracasinacscaceuesavativatanedsuevevetstecatatsnewaweusaes 6 1 1 Precautionary Measures ccccceeeeeeeeeeceeeeeeeeeeeeeeeeeeaaaeeeeeeeeeeeeeeeeaaeeeeeeeeeeeenees 6 1 2 Significant advice for the first treatment cccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeaaees 7 1 3 General PRK contraindications ssisecdcnsccennceutervenevevensuentnesdennkvextauntuameeesioenkoereneuteens 8 1 4 General guidelines for the selection of patients cceeeeeeseeeeeeeeeeeeeeeeeeeneees 9 1 5 LASIK TAMING fadadncscceticicrsed dickce aciondnid teint cease cenit tna aca esud ands atradaneuencnanbenaes 9 1 6 General CompliCations cccceceeeecsecceceeeeeeeeeeeeeeeeeeeeeeeeeeseeaaeaeeeeeeeeeeseeseaaeees 10 2 PRK TRCGUIMOIN sicisciensadessteceancsaaducaesencedncnandndncuansuiscranesdncuanswdussiaseancrancudacsescsanenaaase 11 2 1 The opportunities of PRK treatment ccccceeceeeceeeeeeeeeeeeeeeeeneeeeeeeeeeeeeeeeeeaaees 11 2 1 1 PRK Myopi
10. Blindmann Rober OS 24 12 1951 aA Search ES Printlist ex New s Edit Delete Print journal v4 OK 5 Import Ei Export add iik Fig 50 Patient Management menu 92 96 Art Nr 170299045 1 299 AESCULAP Appendix MEDITEC 2 Klick on New to create a new patient data record in the data base Klick on Edit if you want to change or add data to the patient data record You can search for a patient or a patient group in the patient data base by entering various search words and clicking on the Search button You can delete the blue highlighted data record from the patient data base by clicking on Delete You can print out the patient list by clicking on Print list The operation journal of a patient is printed with a click on Print journal You can import patient data with a click on Import Clicking on Export exports patient data When all patients have been entered close the patient management by clicking on OK 7 3 1 Create edit patient Create edit patient Name fo First name fo DOB fo Patient a Eye cos cob Sphere 0 00 3 Cylinder 0 00 B Axis 0 Operator z B Extended data y K x cancel Fig 51 Patient Management menu Enter the patient data and the subjective spectacle refraction in the dialog section and select the treating doctor from the list of operators Art Nr 170299045 1299 93 96 8 AESCULAP
11. MEDITEC 3 2 PTK Spot Initial heating phase and gas exchange OPASS 2 2 for MEL 70 G Scan x AAEI 7fi 3 AV llela amp W G Scan O AESCULAP MEDITEC tt Operation refractive Operation therapeutic Operation Gas topographic exchange Patient f Laser off management Configuration End in Press F1 for Help Software version PC V 2 2 01 00 ZUK M V 2 2 01 00 ZUK S V 2 2 01 00 Application manual Fig 33 Menu Initial Heating Phase The laser requires a period of six minutes to heat up to the necessary operating temperature A progress indicator will advise you of the status of the initial heating phase The symbols with a grey background cannot be selected during this period In order to perform an automatic gas exchange click the symbol Gas exchange during the initial heating phase The gas exchange takes approx five minutes Confirm the gas exchange with clicking Yes Another progress indicator will advise you of the status of the gas exchange A filling level indicator of the gas cylinders is located at the left bottom corner of the screen If one of the cylinders is empty please notify your hotline officer so that the cylinder will be replaced during the next service cycle The state bar is located at the lower screen margin Situation related reports and the currently used software version are displayed in this box Following the i
12. Repeat marking the optical centre centre of the entry pupil with an eye cannula Re check the working distance by means of the focusing laser combine points Subsequently switch off the focusing laser Art Nr 170299045 1 299 AESCULAP PTK Shaping 4 6 1 The treatment session Check the values which have been adjusted in the Assistant Click on the Ready pushbutton in the OP Assistant Actuate the right foot pedal and keep it depressed A progress indicator will display the progress of the treatment By clicking on the Cancel pushbutton the treatment may be discontinued following the release of the foot pedal After the termination of the correction program the OP Assistant will automatically interrupt the laser triggering The treatment is interrupted by releasing the foot pedal and may be resumed by actuating the pedal again 4 7 Termination of the program By clicking on the PROTOKOLL pushbutton you will receive a print out of the surgery data via the connected printer You may return to the main menu by clicking on the OK pushbutton In order to treat further patients commence again in the main menu and follow the instructions in the applications manual 4 8 Switching off of the laser In order to switch off the laser click on the OFF Laser off End and confirm the switch off by clicking on the pushbutton Yes Wait for the message NOW YOU MAY SWITCH OFF THE COMPUTER
13. configuration menu You may perform different configuration adjustments in this dialog patient data import export Fig 49 The Configuration menu Enter into or if need be modify in the pushbutton CLINIC ADDRESS the data of your surgery Enter the names of the doctors treating patients with the Excimer laser in the LIST OF OPERATORS This list appears in the patient data menu and in the patient management when the treating doctor s name is selected You can make various settings in the SETTINGS dialog section If the expert mode is selected you have access to the integrated data base Art Nr 170299045 1299 91 96 AESCULAP MEDITEC 2 Appendix In the DIRECTORIES section you define the directories in which data is saved T O S C A data is imported and the import or export of patient data occurs The pushbutton SERVICE PASSWORD is reserved for the service engineer You must not make any entries in this field By clicking the pushbutton PRINTER you may choose a new printer or modify printer adjustments and also any new printer will be configured under Windows 95 7 3 Patient management data base You can optimize the clinic organization with the patient management functionality by defining a patient list prior to surgery The data entered there can be viewed in a list in the patient data menu before to the operation is performed on the patient Patient management Name first name Eye DOB Op date Patient
14. of the gas exchange A filling level indicator of the gas cylinders is located at the left bottom corner of the screen If one of the cylinders is empty please notify your hotline officer so that the cylinder will be replaced during the next service cycle The state bar is located at the lower screen margin Situation related reports and the currently used software version are displayed in this box Following the initial heating phase the main menu will appear on the screen Art Nr 170299045 1299 51 96 CE AESCULAP MEDITEC 2 PTK Shaping 4 3 The Main Menu OPASS Y 2 2 for MEL 70 G Scan Fig 25 The Main Menu PTK Shaping Click on this symbol in order to perform a refractive operation Click on this symbol in order to perform a therapeutic treatment PTK Shaping or PTK Spot treatment Click on this symbol in order to perform a topographic operation cf Chapter 6 Click on this symbol in order to perform an automatic gas exchange duration approx five minutes The gas exchange may be conducted during the initial heating phase 52 96 Art Nr 170299045 1 299 PTK Shaping Patient management Application manual LA Configuration Laser off End Art Nr 170299045 1299 AESCULAP MEDITEC 2 Click on this symbol in order to open the patient management cf Appendix Click on this symbol in order to open the application manual Click on this symbol in order t
15. on the pushbutton Ready in the menu of the fluence test Now the laser may be actuated by means of the right hand foot pedal Danger 30 31 Fig 10 Foot pedal 22 96 Art Nr 170299045 1 299 AESCULAP PRK Place the red target beam with the joystick 22 onto a free area of the test paper Now make the fluence test as described in the Instruction Manual Following the successfully completed test click on the pushbutton OK and turn the laser arm to the side Only continue after a successfully completed fluence test A faulty fluence value will result in false treatment Danger Repeat this procedure with each new patient Remove the blue test base 2 6 Preparation of the patient Thirty minutes prior to the laser treatment a topical anaesthetic e g Novesine Kerakain and Pilocarpin shall be administered If required a sedative agent e g Diazepam shall be given The minus cylinder axis of the patient is marked on e g the sclera with a colour pen Alternatively the patient may be temporarily placed under the surgery microscope with the test frame put on The height adjustment is carried out by means of the focusing laser Art Nr 170299045 1299 23 96 AESCULAP PRK The head of the patient is aligned horizontally as much as possible so that the pupil is at the centre of the eye slit when the patient looks into the surgery microscope When treat
16. print out of the surgery data via the connected printer You may return to the main menu by clicking on the OK pushbutton In order to treat further patients commence again in the main menu Chapter 3 3 and follow the instructions in the applications manual 3 11 Switching off of the laser In order to switch off the laser click on the OFF Laser off End and confirm the switch off by clicking on the pushbutton Yes Wait for the message NOW YOU MAY SWITCH OFF THE COMPUTER appears on the screen Turn the key switch 9 fully to the left Switch off the main switch 8 the green light in the switch will go out 3 12 Follow up treatment proposed Put the flap back into the stromal bed If required the flap may be moistened with BSS and cleaned before being put back There must be no epithelium cells remain under the flap Wait for some two to five minutes until the flap has slightly dried and is fixed to the stroma Use a sponge for drying and also for pressing the wound edges into the stromal bed Confer to the current literature for further postoperative treatment Art Nr 170299045 1299 49 96 AESCULAP 4 4 1 WV MEDITEC 4 PTK Shaping PTK Shaping Applications The PTK Shaping program is designed to remove corneal scars near the surface up to a max depth of approx 100 um The treatment diameter for all programs is max 6 mm the linear transition zone is max 7 mm and the t
17. required laser impulses is relatively low Under normal circumstances and depending on the size of the area to be treated 50 150 laser impulses will suffice The ablation depth of one pulse is 1 5 um This is the reason why not more than 10 laser pulses may be directed at any one specific spot Adjust the number of shots at 150 shots Adjust the frequency at 3 5 Hz The procedure during the treatment depends on the individual clinical characteristics In case of a closed erosion without an epidermolysis a laser ablation is performed which is evenly distributed across the whole affected area laser spots In case of an extended erosion with a partially detached or only loosely attached epithelium first loose remnants of the epithelium are removed with a triangular swab Subsequently the marginal zones of the erosion are treated with the laser spot laser spots Art Nr 170299045 1 299 AESCULAP a N 2 al a Gy PTK Spot Actuate the right foot pedal 30 and keep it depressed a 30 31 Fig 38 Foot pedal A progress indicator will display the progress of the treatment By clicking on the Cancel pushbutton the treatment may be discontinued following the release of the foot pedal After the termination of the correction program the OP Assistant will automatically interrupt the laser triggering The treatment is interrupted by releasing the foot pedal and may be resumed by actuating the peda
18. so enter the desired target refraction by clicking on the scroll arrows with the left mouse key you will modify the value in 0 25 D steps by clicking with the right mouse key you will modify the value by 1 D The OP Assistant will automatically calculate and display the correction in the appropriate field In the case of a false mixed astigmatism e g 4 2 x 10 By clicking on the Diagram symbol you will get a graphical representation of the working ranges The red arrow indicates the preoperative refraction the green arrow the target refraction You can close the diagram by clicking on the button with the hook In the event that the preoperative values are outside of the valid working ranges the refractive error cannot be completely corrected i e a residual sphere or a residual cylinder will result the red arrow in the diagram is outside of the coloured range the green arrow is not in the zero point AR In this case the program suggests a calculation click a Fig 17 2 2 x 180 After inputting the refraction data the optical zone can be varied but the thickness of the cornea should be observed Art Nr 170299045 1299 39 96 AESCULAP MEDITEC 2 LASIK 3 4 3 The fluence test Fluence test Fig 18 Menu fluence test By clicking on the pushbuttons High or Low you may increase or decrease the energy set point You start the fluence test by operating the pushbut
19. suction ring of the flue gas extraction installation serves as the object for the tracker This ring needs to be attached first as much centred as possible Click on the pushbutton Eye Tracker in the menu of the OP Assistant Eye tracker Keyb Ei 4o Threshold IS lt Tracker Fig 48 Menu eye tracker The menu of the eye tracker will open This window remains open during the treatment session and enables you to make different adjustments and check the functioning of the tracker A video image of the eye tracker is displayed on the right while the left shows the configuration pushbuttons Activate the eye tracker by clicking on the pushbutton On The tracker status indicator is located above the latter pushbutton If the eye is displayed against a black background the object was recognised by the eye tracker If the pupil was not recognised the background will remain grey In the latter case check the below items Has the eye tracker been switched on Is the pupil still in the HOT ZONE The HOT ZONE is the area where the laser follows the patient eye movement If the pupil leaves the HOT ZONE the sequence of shots is automatically interrupted until the pupil is again in the area of this zone In such case reposition the head of the patient in such a way that the eye is at the centre of the camera image Art Nr 170299045 1299 85 96 AESCULAP J Danger 86 96
20. than the treatment zone Hyperopia 9 0 mm ring marker Perform abrasion of the epithelium by means of a Hockey knife when treating pure astigmatisms extend the abrasion area in the axis of the minus cylinder by approx 9 5 mm Art Nr 170299045 1299 83 96 AESCUL A HV gor MTEC e Topographic treatment Repeat marking the optical centre centre of the entry pupil with an eye cannula Re check the working distance by means of the distance control laser combine points Subsequently switch off the distance control laser 6 6 2 Procedure for LASIK Make the lamellar cut according to the guidelines of your microkeratome The flap should have a size of not less than 8 5 mm in diameter Remove the suction ring of the microkeratome Remove excessive lacrimal fluid from the conjunctival sac by means of a swab wick and dry the corneal stroma by means of a spatula Hockey knife If required dry the hinge of the flap with a triangular swab Repeat the marking the optical centre centre of the entry pupil with an eye cannula Re check the working distance by means of the distance control laser combine points Subsequently switch off the distance control laser 84 96 Art Nr 170299045 1 299 AESCULAP Topographic treatment MEDITEC uz 6 7 The eye tracker An active eye tracker will follow the patient s eye movements during the treatment and if need be the laser beam will be traced accordingly The
21. the suction ring red marking Shortly tap on the left foot pedal 31 in order to switch on the mask fixation and check its correct functioning with your thumb or by squeezing the red hose Adjust the vacuum 28 to approx 0 4 bar by means of the red turning button 29 Switch off the mask fixation by shortly tapping on the foot pedal Disinfect the suction ring by wiping it with 70 alcohol or rather use another suction ring that has been steam sterilised Repeat this procedure with each new patient Art Nr 170299045 1299 59 96 AESCULAP gt PTK Shaping 4 6 Preparation of the patient Thirty minutes prior to the laser treatment a topical anaesthetic e g Novesine Kerakain or 0 5 Proparacaine and Pilocarpin shall be administered If required a sedative agent e g Diazepam shall be given The height adjustment is carried out by means of the focusing laser The head of the patient is aligned horizontally as much as possible so that the pupil is at the centre of the eye slit when the patient looks into the surgery microscope An eyelid speculum is to be placed between the eyelids preferably of the Barraquer type Ask the patient to fixate on a green LED and mark the optical centre centre of the entry pupil with an eye cannula Attach the ring marker diameter 8 5 mm and turn by 20 to 30 under slight pressure Perform the abrasion of the epithelium by means of a Hockey knife
22. this symbol in order to perform the configuration adjustments Here you may input the data of your clinic or select the printer for the journal printout cf Appendix Click on this symbol in order to terminate the computer program and switch off the laser You should not switch off the laser until the message YOU MAY NOW SWITCH OFF THE COMPUTER appears on the screen 17 96 AESCULAP MEDITEC 2 PRK 2 4 Data input for PRK treatment Select the option Operation refractive from the main menu by mouse click 2 4 1 Input of patient data Name Blindmann Firstname Rober DOB feara Patient 0o01 Eye OS c oD Operator Dr Meier gt 3 Select A OK x Cancel Fig 5 Menu Patient Data To begin with input the patient data and the name of the operating surgeon Mark whether the left or the right eye is to be treated You may either enter the data directly into the input field or select a patient from the patient database When you click on Select with the left mouse key the list of patients entered previously in the PATIENT MANAGEMENT screen opens for details of PATIENT MANAGEMENT see annex These entries are printed in the operation journal Confirm the correct entry with OK The Cancel pushbutton takes you back to the main menu 18 96 Art Nr 170299045 1 299 PRK AESCULAP MEDITEC 2 2 4 2 The OP Assistant Operation refractive PRK Patient Blindmann Robe
23. 0 G Scan x MEL 7O scan G AESCULAP MEDITEC Me F Operation topographic Operation Operation refractive Gas exchange Patient App canon f Laser off management manual Configuration End D Press F1 for Help Software version PC V 2 2 01 00 ZUK M V 2 2 01 00 ZUK S V 2 2 01 00 therapeutic Fig 14 Menu Initial heating phase The laser requires a period of six minutes to heat up to the necessary operating temperature A progress indicator will advise you of the status of the initial heating phase The symbols with a grey background cannot be selected during this period In order to perform an automatic gas exchange click the symbol Gas exchange during the initial heating phase The gas exchange takes approx five minutes Confirm the gas exchange with clicking Yes Another progress indicator will advise you of the status of the gas exchange A filling level indicator of the gas cylinders is located at the left bottom corner of the screen If one of the cylinders is empty please notify your hotline officer so that the cylinder will be replaced during the next service cycle The state bar is located at the lower screen margin Situation related reports and the currently used software version are displayed in this box Following the initial heating phase the main menu will appear on the screen Art Nr 170299045 1299 35 96 AESCULAP MEDITEC 2 LASIK 3 3 The m
24. Nr 170299045 1299 47 96 AESCUL A HV b Tg A WAN e Reposition aiming beam by using the mouse or keypad to find again the Purkinje reflex e Protect flap with a wet sponge from the nasal side in case of a cylindrical ablation around the zero degree axis classical flap or 90 degrees down up flap respectively e Start ablation Stop every once in a while to verify eyetracker centration and to dry the stromal bed Caution 3 9 The treatment session When you press the Center button the target beam of the laser will always be in the center of the surgical microscope in whatever position the joystick may be In this way the target beam instead of the fixation light can be used for centering Check the values which have been adjusted in the Assistant Click on the Ready pushbutton in the OP Assistant Actuate the right foot pedal and keep it depressed A progress indicator will display the progress of the treatment By clicking on the Cancel pushbutton the treatment may be discontinued following the release of the foot pedal After the termination of the correction program the OP Assistant will automatically interrupt the laser triggering The treatment is interrupted by releasing the foot pedal and may be resumed by actuating the pedal again 48 96 Art Nr 170299045 1 299 AESCULAP LASIK 3 10 Termination of the program By clicking on the PROTOKOLL pushbutton you will receive a
25. Preparation of the laser Height adjust your operating chair Switch on the ring shaped lamp 11 and check the ocular adjustment Swivel the laser arm and switch on the distance control laser 12 412 20 21 ia Fig 37 Control panel laser arm Position the patient bed together with the blue test base at the appropriate height The two focusing points require to be brought into an overlapping position Operate the below keys on the operating panel of the laser arm towards this end Height adjustment higher 13 deeper 14 Horizontal alignment forward 15 backward 16 to left 17 to right 18 Click on the pushbutton Ready Now the laser may be actuated at any time by means of the right hand foot pedal Danger Art Nr 170299045 1299 69 96 AESCULAP MEDITEC MZ PTK Spot 5 6 Treatment of recurrent erosion 5 6 1 Preparation of the patient Administer a topical anaesthetic e g Novesine Kerakain Fluorescin may be used to mark the area of the cornea which is to be subjected to Excimer Laser treatment Place an eyelid speculum 5 6 2 The treatment session 70 96 The Excimer Laser is used to knock tight the loose epithelium In order to do so about 10 um 20 um of the epithelium are ablated This ablation depth should not be exceeded so as to avoid any damage at the Bowman s membrane The laser spot will be controlled with a joystick 22 The total number of
26. a amen en oe re ee eee ee 11 2 1 2 PRK INYO sc ccc passe Stee peers cokes toaceyaetdie nate speemenedglesusesouopectelendteass 13 2 2 Activation OF the IASON vcccesccisendecccecedsatenesesenennndenndnendrestueutsandnesdvanseesecednerdeeneneneses 14 2 2 1 Initial heating phase and gas EXCHANGE ccccceceeeeeeeeeeeeeeeeeeeeeeeeeeseneeeeeeeees 15 2 3 Tie MANA ssrsrmen trasenie a a A A a 16 2 4 Data input for PRK treatment seeeeeeseeennnneeeeeerrrrnrrrrenserrrrnnnnnnnnseerrrnnnnnnneeeet 18 2 4 1 Input of patient data oc cain essa eee cay ears nae arcades eenstone Venta ee antennas 18 2 4 2 The OPP ASSIS AN eoe a e E EET 19 2 4 3 The fluence test nrerin nananana aaa i neia iine 20 2 5 Preparation of the laSer cccccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeaeeeeeeeeeeeeeeecaeeeeeeeeeeeeeeees 21 2 6 Preparation of the patient cccceeeecsccccceeeeeeeeeeeeeeeaeeeeeeeeeeeeeeeecaeeeeeeeeeeeeeeees 23 2 7 WING CVC TACK GM sepcent a aiaa a e a a aaa 25 2 8 Centration with the MEL 70 G Scan using the Artificial Limbus Ring 27 2 8 1 MNES ON PUM eee eo esas aa tee ete 27 2 8 2 Purkinje pic amen ee in remote ea eee ee ee een 27 2 9 The treatment SESSION cc soecesencecctenetccestueienntenctoeebonetranteaedunepdentonntenedeachonedeeckenckents 28 2 10 Termination of the PROG ANN associate cece cterenntanteancnssecastilaadicnundasinasideubdenpentacenoacaibs 29 211 Switching OH ofthe NAS Clio xe ccvesecncsiesestexsuoroteesuesdeustexsieu
27. ain menu OPASS Y 2 2 for MEL 70 G Scan Fig 15 Main menu LASIK Click on this symbol in order to perform a refractive operation Click on this symbol in order to perform a therapeutic treatment PTK Shaping or PTK Spot treatment cf Chapters 4 and 5 Click on this symbol in order to perform a topographic operation cf Chapter 6 Click on this symbol in order to perform an automatic gas exchange duration approx five minutes The gas exchange may be conducted during the initial heating phase 36 96 Art Nr 170299045 1 299 LASIK Patient management Application manual LA Configuration Laser off End Art Nr 170299045 1299 AESCULAP MEDITEC 2 Click on this symbol in order to open the patient management cf Appendix Click on this symbol in order to open the application manual Click on this symbol in order to perform the configuration adjustments Here you may input the data of your clinic or select the printer for the journal printout cf Appendix Click on this symbol in order to terminate the computer program and switch off the laser You should not switch off the laser until the message YOU MAY NOW SWITCH OFF THE COMPUTER appears on the screen 37 96 AESCULAP MEDITEC m2 LASIK 3 4 Data input for LASIK treatment Select the treatment option Operation refractive from the main menu by mouse click 3 4 1 Input of patient data Nam
28. annula marker to set centre of Perform keratome cut abrasion Apply limbus ring roughly centred Press ready Open flap Use ring marker to set area of abrasion Have the patient look to the green LED Remove epithelium Use cannula marker to set centre of ablation Again have the patient look at the green LED centre of pupil move bed or head if necessary Press eye tracker button the joystick will be Again use cannula marker to set centre of deactivated ablation centre of the entrance pupil Set aiming beam to your mark on the cornea Press eye tracker button the joystick will be by using the mouse or keypad deactivated Protect flap with a wet sponge from the nasal Apply limbus ring in a way that the aiming side in case of a cylindrical beam sits roughly on your mark ablation around the zero degree axis Set aiming beam to your mark on the cornea classical flap or 90 degrees down up flap by using the mouse or keypad respectively Start ablation Start ablation Purkinje Reflex Stop every once in a while to verify eyetracker centration Input patient data and to drythe stromal bed Perform fluence test Caution Press center to set the red HeNe beam in the center of microscope Purkinje Reflex Have the patient look at the red HeNe beam Input patient data Use a blunt cannula marker to set centre of Perform fluence test abrasion Pres
29. appears on the screen Turn the key switch 9 fully to the left Switch off the main switch 8 the green light in the switch will go out Art Nr 170299045 1299 61 96 AESCULAP MEDITEC 2 PTK Shaping 4 9 Postoperative treatment proposed Remove the eyelid speculum Administer an antibiotic ointment e g Gentamicin Give analgesic medication for the first postoperative day e g Valoron N Apply an eye dressing for two to three days with daily follow up checks of the healing process again administer an antibiotic ointment 62 96 Art Nr 170299045 1 299 AESCULAP PTK Spot MEDITEC 2 5 PTK Spot 5 1 Applications In the PTK Spot mode corneal tissue may be manually removed at great accuracy The laser will be controlled with a joystick during the surgery It depends on the individual decision whether the treatment will consist of the ablation of part of the epithelium of epithelial or stromal tissue or even of a perforation like in Excimer Laser keratoplasty 5 2 Activation of the laser Fig 32 MEL 70 G Scan switches Unlock the EMERGENCY OFF switch 7 Switch on the main switch 8 the green light in the switch lights up Turn the key switch 9 fully to the right the key will automatically return to centre position After approx 30 seconds the menu of the initial heating phase will appear on the screen Art Nr 170299045 1299 63 96 AESCULAP 5 2 1 64 96
30. c treatment 6 1 Application Fundamentally all PRK and LASIK treatments can be made with the topography link In particular this treatment mode can be used for repairing decenterings irregularities and asymmetries For more detailed information please refer to the T O S C A Workstation user s manual 6 2 Activation of the laser Fig 39 MEL 70 G Scan switch Unlock the EMERGENCY OFF switch 7 Switch on the main switch 8 the green light in the switch lights up Turn the key switch 9 fully to the right the key will automatically return to centre position After approx 30 seconds the menu of the initial heating phase will appear on the screen 74 96 Art Nr 170299045 1 299 CE AESCULAP Topographic treatment MEDITEC 2 6 2 1 Initial heating phase and gas exchange OPASS 2 2 for MEL 70 G Scan x MEL 7O scan GJAESCULAP MEDITEC 2 F Operation topographic Operation Operation refractive Gas exchange Patient f Laser off management Configuration End D Press F1 for Help Software version PC V 2 2 01 00 ZUK M V 2 2 01 00 ZUK S V 2 2 01 00 therapeutic Application manual Fig 40 Menu Initial heating phase The laser requires a period of six minutes to heat up to the necessary operating temperature A progress indicator will advise you of the status of the initial heating phase The symbols with a grey backg
31. ccccccccsescsentdcceneectetsnaicnecetstetedesiactocecctebewesenauess 96 Art Nr 170299045 1299 5 96 AESCULAP Safety Instructions 1 Safety Instructions A Danger Caution The following symbols are used throughout the application manual to indicate hazards and special advice Warning advice for possible accident and injury hazards Warning advice for possible technical damage 1 1 Precautionary measures Danger 6 96 Lasers have been employed for medical purposes for more than three decades Only a very small number of incidents have occurred in comparison to the large number of successful treatments Nevertheless one should never allow the necessary attention to slacken when using laser devices Any careless handling of laser beams may result in serious injuries in both user and patient Lasers emit a very intensive radiation which may be hazardous even at quite some distance from the laser outlet aperture proper Inappropriate application may result in burns of body tissue and damage at optical equipment The non observance of the instructions for use and the application manual may constitute a potential source of hazards for both the attending physician and the patient This present application manual describes the application and operation of the MEL 70 G Scan Excimer Laser as a medical device The decision on the suitability of the device and the selection of the method of treatment is the exclusive res
32. e Blindmann First name Robert DOB 24 12 1981 Patient jon Eye OS coD Operator Dr Meier Fig 16 Menu Patient Data To begin with input the patient data and the name of the operating surgeon Mark whether the left or the right eye is to be treated You may either enter the data directly into the input field or select a patient from the patient database When you click on Select with the left mouse key the list of patients entered previously in the PATIENT MANAGEMENT screen opens for details of PATIENT MANAGEMENT see annex These entries are printed in the operation journal Confirm the correct entry with OK The Cancel pushbutton takes you back to the main menu 38 96 Art Nr 170299045 1 299 AESCULAP LASIK MEDITEC lt 2 3 4 2 The OP Assistant Operation refractive LASIK Patient Blindmann Robert 0S Assistent pE PRK d2 LASIK Fluence test Sphere Cylinder Axis Gad Eye racker Preoperative 4 25 5 00 Zz 17 Journal ay Targstret 1 00 0 00 E A ad CE Corecion 3 25 5 00 X Close a ola opia Extended data Optical zone 5 00 M Lock diameter Se Center Fig 17 Menu Operations Assistant LASIK Select the treatment method LASIK from the menu Input the preoperative subjective spectacles refraction values directly into the OP Assistant In some cases it may be desirable to undercorrect the patient In order to do
33. e LASIK Laser In situ Keratomileusis software differs from the PRK software in many aspects LASIK allows for the correction of considerably higher refractive visual defects than PRK the limits which had been set for PRK have been extended to make an adjustment up to a max of 24 D possible however without considering the clinical relevance LASIK does not remove tissue from the surface hence the Bowman s membrane will be left unaffected but at the stromal level The ablation values in this region are differing and hence the nomograms i e the deviations in the program in relation to the theoretical formula will differ from the PRK nomograms In addition to the above difference LASIK entails quite a number of new factors which may have an impact on the refraction results Such factors include for instance the thickness of the flap the moistening during the incision and hence the moistening of the stromal bed the drying of the stromal bed with a triangular swab even the very brand of the microkeratome may play a role However all the above factors could not be considered in the software system since they cannot be expressed in numeric terms The aforesaid is the reason why every new user should commence the application of this treatment method with a small number of patients with individual corrective values and if need be use the obtained results to modify the program selection for the subsequent cases Thu
34. e control buttons of the surgery microscope can be removed and steam sterilised Art Nr 170299045 1299 95 96 AESCULAP ITEC Appendix 7 6 MEL 70 G Scan general view 1 2 11 3 2021 22 Fig 54 MEL 70 G Scan general view Basic device Key move patient bed to the left Laser arm 18 Key move patient bed to the right Surgery microscope Key reset the patient bed Screen loo Hose connection debris removal a A E T e Mainswion Fowmeterdebrisremova o keyswion a7 Rotary switch debris removal O 16 Key move patientbedbackwards d y O 96 96 Art Nr 170299045 1 299
35. e is achieved Actuate the right foot pedal 30 and keep it depressed A progress indicator will display the progress of the treatment By clicking on the Cancel pushbutton the treatment may be discontinued following the release of the foot pedal After the termination of the correction program the OP Assistant will automatically interrupt the laser triggering The treatment is interrupted by releasing the foot pedal and may be resumed by actuating the pedal again Art Nr 170299045 1 299 AESCULAP PTK Spot MEDITEC 2 5 7 3 Results Re epithelialisation at a fast rate Excellent healing of the wound 5 8 Termination of the program By clicking on the PROTOKOLL pushbutton you will receive a print out of the surgery data via the connected printer You may return to the main menu by clicking on the OK pushbutton In order to treat further patients commence again in the main menu and follow the instructions in the applications manual 5 9 Switching off of the laser In order to switch off the laser click on the OFF Laser off End and confirm the switch off by clicking on the pushbutton Yes Wait for the message NOW YOU MAY SWITCH OFF THE COMPUTER appears on the screen Turn the key switch 9 fully to the left Switch off the main switch 8 the green light in the switch will go out Art Nr 170299045 1299 73 96 AESCULAP MEDITEC 2 Topographic treatment 6 Topographi
36. e with a larger diameter of the optical zone As arule we recommend to use the largest possible treatment diameter However for higher corrections the diameter of the optical zone should be reduced in order to prevent too large ablation depths 1 35 7 9111915 1719212325 2729 Fig 12 Ablation centre depth for different optical zone diameters um theoretical values As a rule the subjective spectacles refraction values are used as the basis for the data input These values are directly input into the OP Assistant Alternatively in case of cylinders lt 1 D the spherical equivalent can also be input 32 96 Art Nr 170299045 1 299 AESCULAP LASIK Exclusively negative values are to be used e g 10 10 x 20 Do not try and combine different myopia programs in order to achieve so called multipass treatments The in built nomogram is bound to cause Danger severe overcorrections On principle it is recommended to conduct an examination with a cornea topography system in order to be sure that the patient does not suffer from asymmetric astigmatism or an early stage of keratoconus In case of patients who are presbyopic or are likely to soon become presbyopic it should be considered whether a low level of residual myopia could be left untreated 3 1 2 LASIK hyperopia The hyperopia programs are employed in corrections of hyperopias and hyperopic symmetrical astigmatisms totalling not more than 16 dioptres
37. ecaaaeeeeeeeeeeeeseecaaaeeeeeeeeeeeeenees 88 6 10 Termination of the program cccccceeceeeeeeeeeeeeeeeeneeeeeeeeeeeeeceeneeeeeeeeeeeteeeeeeaaees 89 6 11 Switching off of the NASP a wiccctcetccesiacierwndactensntucdavescandecentacbereniunbanctestersssacseuekiuces 89 6 12 Post operative treatment eeeeeeeeeeceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeaaeaeeeeeeeeeeenee 89 7 ADDONIX vecssecececsvesscesncssesestacawesaceracesinasaandenesavetacaranadsuevecedsseesentsneweweuasarenetareraewen 90 7 1 Bases for software operation sxcsic ciccticeeic Savetieetecebieeeivetacniic ee ieadexerieedixebieetieemesis 90 7 1 1 Use of a pointer device ooo 2 cee eeeeeeeceeccee eee eeeeeeeeeaaeeeeeeeeeeeeesencaaaaeeeeeeeeeeeene 90 7 1 2 Use of a dialog OOK oz cso ce piste reassess eeeag cs eected tea geceeaaupescancaeccsanesbedceueatee 90 7 2 The configuration Menu srceccnssuctenentcneteentsaonctdeemoiebsausbaatiausbeutiadbdastoaunoetoakoasteats 91 7 3 Patient management data base ccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeenaeeeeeeeeeeeeeeees 92 7 3 1 Greate editpatieni soeren a e eee ener ener ee EE 93 7 3 2 Search OUNCE sacs cece tas gas cccwecdetee diinisiasi Kinna SANEA NKTA ANT Naa Cia Ki NNK ee 94 7 4 Pie IMGICAUOR a a E EE E A 95 7 4 1 Unexpected interruption of a treatment SCSSION ccceeeeeeeeeeeeeeeeeeeeeeeeeees 95 7 5 Cleaning INS UCUONS aici CS rtocnamanemecencecnacng eceretnncmene dapat eceare i uadnes 95 7 6 MEL 70 G Scan general VIQW cecc
38. eeeeeeeeeeeeeeeeaaeees 54 Input of patient data scat essai eet ened en vs sd ed nape deeded nee een nae 54 The OP ASSIST AUN ols a sdececaciccetea tadeitenti de trmetndeuegsi aul aaan aaa 55 The TIC ST ace teeters nee teectee te obixees eabeecetecerees teaboumntecbaues nabavestuenel 56 Preparation of the laser a scctiescccectcasccanscccnendpannnsasansncedibendpenndsasindadicennennmeanidanoaadecd 57 Preparation of the Pan cscsuscscsscesucscsnnannnsnnnene eti nmaKi 60 The treatment session ccceeeeeeceeeeeeee eee eeeeeeeeaaaeeeeeeeeeeeeessecaaaeeeeeeeeeenenee 61 Termination of the program sss ssssssssssssserrrrttssstrrrtnnnrrtnsstttrnnnnnnnnnneeennnnnnn eneee 61 Switching off of the lASCM cece eee eeeeeeee eee e etre ee eeeeceaaeeeeeeeeeeeeeeecaaeeeeeeeeeeeteee 61 Postoperative treatment proposed eeeeeeeeccceceeeeeeeeeeeeenaceceeeeeeeeeeeeeeeeeees 62 PIK SpOt osioissa aiaee aaaeaii aana daadaa aeiaai aiiai 63 Applications ossis tresnerien esanean aii ee aa ae ukna a ESen fuidu ayer NTa leila ana 63 Activation of the laser ssicscecsccuscessncctnieaseetcndwctabsacecundcueadtudseencts isi sstadsanesseccedanantens 63 Initial heating phase and gas exChange cccceeeeeeeseeeeeceeeeeeeeeeeeeeeneeees 64 The Main WIN i iateacte tne odetecatteeatecte aan cdevanaliaddusathas i etbnedtadbad ed Sac Ain itiatMekaelcdadad 65 Program input for PTK Spot treatment cccecccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeneaeeee
39. ent higher 13 deeper 14 Horizontal alignment forward 15 backward 16 to left 17 to right 18 Art Nr 170299045 1299 57 96 AESCULAP MEDITEC 2 PTK Shaping Put a piece of test paper onto the blue test base Fig 30 Control panel Connect the blue hose for the flue gas extraction suction to the laser arm 2 and the PRK suction ring blue marking Adjust the value for the flue gas extraction to maximum at the flow meter 26 Click on the pushbutton Ready in the menu of the fluence test A N Now the laser may be actuated by means of the right hand foot pedal Danger pas 30 31 Fig 31 Foot pedal 58 96 Art Nr 170299045 1 299 PTK Shaping Danger AESCULAP Place the red target beam with the joystick 22 onto a free area of the test paper Now make the fluence test as described in the Instruction Manual If required modify the energy set point in the fluence test menu by clicking on the pushbuttons stronger or weaker Repeat the test by operaiting again the pushbutton Ready in the fluence test menu Only continue after a successfully completed fluence test A faulty fluence value will result in false treatment Following the successfully completed test click on the pushbutton OK and turn the laser arm to the side Remove the blue test base and lower the patient bed Connect the red hose for mask fixation to the laser arm 2 and to
40. er Remove the suction ring of the microkeratome Remove excessive lacrimal fluid from the conjunctival sac by means of a swab wick and dry the corneal stroma by means of a spatula Hockey knife If required dry the hinge of the flap with a triangular swab Repeat the marking the optical centre centre of the entry pupil with an eye cannula Re check the working distance by means of the distance control laser combine points Subsequently switch off the distance control laser Art Nr 170299045 1 299 AESCULAP LASIK MEDITEC 2 3 7 The eye tracker An active eye tracker will follow the patients eye movements during the treatment and if need be the laser beam will be traced accordingly The suction ring of the flue gas extraction installation serves as the object for the tracker This ring needs to be attached first as much centred as possible Click on the pushbutton Eye Tracker in the menu of the OP Assistant Eye tracker Keyb Ei 4o Threshold IS lt Tracker Fig 22 Menu eye tracker The menu of the eye tracker will open This window remains open during the treatment session and enables you to make different adjustments and check the functioning of the tracker A video image of the eye tracker is displayed on the right while the left shows the configuration pushbuttons Activate the eye tracker by clicking on the pushbutton On The tracker status indicator is l
41. er to chapters PRK 2 12 and LASIK 3 12 Art Nr 170299045 1299 89 96 VW Appendix 7 Appendix 7 1 Bases for software operation 7 1 1 Use of a pointer device The operating principle of a mouse or another pointer device is that you first point at an element on the screen and subsequently click one of the mouse keys in order to perform an action at the aforementioned element If the pointer is pointed at the desired element or the desired area you may perform the following actions Clicking Depress the left mouse key shortly once and let go again Double clicking Depress the left mouse key shortly twice and let go again Double clicking with right mouse key Depress the right mouse key shortly once and let go again A context menu will be overlaid Dragging f you want to move a window to another position point at the title bar Keep the left mouse key depressed and drag the window into the desired position 7 1 2 Use of a dialog box A dialog box is displayed when you want to input information or defined options The following types of options may be used in dialog boxes F Extends the list of options Click on the desired element Selects always but one option The circle will be filed when an option has been chosen M Activates one or more stetting A hook will be overlaid when a setting has been activated 90 96 Art Nr 170299045 1 299 AESCULAP Appendix MEDITEC 2 7 2 The
42. eye drops Alcon 1 drop or a topical antibiotic e g Gentamicin Voltaren eye drops CibaVision Oph 1 drop Therapeutical soft bandage contact lenses may be applied following large corrections The below lens types are recommended for use Acuvue Johnson and Johnson 9 1 14 4 8 4 14 0 8 8 14 0 or New Vu Ciba 8 4 14 0 8 8 14 0 Examine the patient by means of a slit lamp and check the fit of the contact lenses In case of excessive slipping the lens should be placed again into its correct position If the lens is fitting well there is no need to use an eye patch Alternatively to the use of contact lenses Gentamicin ointment and an eye dressing may be applied 2 12 2 Postoperative treatment until complete re epithelialisation 30 96 Ask the patient to come to your surgery everyday for follow up visits Pass on to the patient a sheet of instructions with detailed instructions for their behaviour following the surgery Remove the soft bandage contact lenses if they have slipped or if the epithelium fails to cover up within the anticipated period of time Administer Tobradex eye drops 4 times per day until the epithelium has healed alternatively give a topical antibiotic Administer Voltaren eye drops 3 times per day on the day of the surgery 2 times per day on the first and second postoperative day then stop administering them Do not use these drops longer than for two postoperative days Art N
43. fter a successfully completed fluence test A faulty fluence value will result in false treatment Danger Repeat this procedure with each new patient Remove the blue test base Art Nr 170299045 1299 43 96 AESCULAP J LASIK 3 6 Preparation of the patient 44 96 Thirty minutes prior to the laser treatment a topical anaesthetic e g Novesine Kerakain and Pilocarpin shall be administered If required a sedative agent e g Diazepam shall be given The minus cylinder axis of the patient is marked on e g the sclera with a colour pen Alternatively the patient may be temporarily placed under the surgery microscope with the test frame put on The height adjustment is carried out by means of the focusing laser The head of the patient is aligned horizontally as much as possible so that the pupil is at the centre of the eye slit when the patient looks into the surgery microscope Cover with sterile sheets the area around the eye and head of the patient An eyelid speculum is to be placed between the eyelids preferably of the Barraquer type When treating astigmatisms the reticule of the ocular by turning is adjusted to the 0 axis of the patient Ask the patient to fixate on a green LED and mark the optical centre centre of the entry pupil with an eye cannula Make the lamellar cut according to the guidelines of your microkeratome The flap should have a size of not less than 8 5 mm in diamet
44. he optical axis is not always in the object centre you have the opportunity to modify this setting You can change the position of the graticule by clicking with the right mouse key on the arrow keys on the left of the video image The right mouse key will move the graticule in larger steps Click the round pushbutton in the centre in order to readjust the graticule to the geometrical centre You can also move the graticule with the arrow keys The keyboard button must be enabled for this You can adjust different parameters of the video image such as brightness contrast etc by clicking on the Video pushbutton The eye tracker is switched off by clicking on the Off pushbutton The eye tracker window is closed by clicking on the Close pushbutton When the eye tracker is switched off the laser beam will not be automatically traced i e any eye movements will not be compensated Art Nr 170299045 1 299 AESCULAP PRK 2 8 Centration with the MEL 70 G Scan using the Artificial Limbus Ring 2 8 1 Centre of Pupil e Input patient data e Perform fluence test e Have the patient look at the green LED e Use a blunt cannula marker to set centre of abrasion e Press ready e Use ring marker to set area of abrasion e Remove epithelium e Again have the patient look at the green LED move bed or head if necessary e Again use cannula marker to set centre of ablation centre of the entrance pupil e Pres
45. he values which have been adjusted in the Assistant Click on the Ready pushbutton in the OP Assistant Actuate the right foot pedal and keep it depressed A progress indicator will display the progress of the treatment By clicking on the Cancel pushbutton the treatment may be discontinued following the release of the foot pedal After the termination of the correction program the OP Assistant will automatically interrupt the laser triggering The treatment is interrupted by releasing the foot pedal and may be resumed by actuating the pedal again 88 96 Art Nr 170299045 1 299 7 ge d AESCULAP Topographic treatment 6 10 Termination of the program By clicking on the PROTOKOLL pushbutton you will receive a print out of the surgery data via the connected printer You may return to the main menu by clicking on the OK pushbutton In order to treat further patients commence again in the main menu Chapter 3 3 and follow the instructions in the applications manual 6 11 Switching off of the laser In order to switch off the laser click on the OFF Laser off End and confirm the switch off by clicking on the pushbutton Yes Wait for the message NOW YOU MAY SWITCH OFF THE COMPUTER appears on the screen Turn the key switch 9 fully to the left Switch off the main switch 8 the green light in the switch will go out 6 12 Post operative treatment Please ref
46. ing astigmatisms the reticule of the ocular by turning is adjusted to the 0 axis of the patient It may be necessary to temporarily reduce the magnification of the surgery microscope in order to make the angle marks visible when a test frame is used An eyelid speculum is to be placed between the eyelids preferably of the Barraquer type Ask the patient to fixate on a green LED and mark the optical centre centre of the entry pupil with an eye cannula Attach the ring marker and turn by 20 to 30 under slight pressure Recommended ring markers Myopia always 1 mm larger than the treatment zone Hyperopia 9 0 mm ring marker Perform abrasion of the epithelium by means of a Hockey knife when treating pure astigmatisms extend the abrasion area in the axis of the minus cylinder by approx 9 5 mm Repeat marking the optical centre centre of the entry pupil with an eye cannula Re check the working distance by means of the distance control laser combine points Subsequently switch off the distance control laser 24 96 Art Nr 170299045 1299 AESCULAP PRK MEDITEC 2 2 7 The eye tracker An active eye tracker will follow the patients eye movements during the treatment and if need be the laser beam will be traced accordingly The suction ring of the flue gas extraction installation serves as the object for the tracker This ring needs to be attached first as much centred as possible Click on the pushbu
47. ise you of the status of the gas exchange A filling level indicator of the gas cylinders is located at the left bottom corner of the screen If one of the cylinders is empty please notify your hotline officer so that the cylinder will be replaced during the next service cycle The state bar is located at the lower screen margin Situation related reports and the currently used software version are displayed in this box Following the initial heating phase the main menu will appear on the screen Art Nr 170299045 1299 15 96 AESCULAP MEDITEC X4 2 3 The Main Menu 16 96 OPASS Y 2 2 for MEL 70 G Scan PRK Fig 4 The main menu for PRK Click on this symbol in order to perform a refractive operation Click on this symbol in order to perform a therapeutic treatment PTK Shaping or PTK Spot treatment cf Chapters 4 and 5 Click on this symbol in order to perform a topographic operation cf Chapter 6 Click on this symbol in order to perform an automatic gas exchange duration approx five minutes The gas exchange may be conducted during the initial heating phase Art Nr 170299045 1 299 PRK Patient management Application manual LA Configuration Laser off End Art Nr 170299045 1299 AESCULAP MEDITEC 2 Click on this symbol in order to open the patient management cf Appendix Click on this symbol in order to open the application manual Click on
48. l again 5 6 3 Postoperative treatment The patient will have to wear an eye dressing for twelve hours Apply a topical antibiotic for three days and artificial lacrimal fluid during the following four weeks 5 6 4 Results Re epithelialisation at a fast rate Three days after the operation the re epithelialisation is completed and the patient is free from pain The relapse rate is significantly lower in comparison to conventional treatment methods Art Nr 170299045 1299 71 96 AESCULAP J PTK Spot 5 7 Treatment of pterygia 5 7 1 Preparation of the patient Administer a topical anaesthetic e g Novesine Kerakain Remove the pterygium in the conventional way e g by means of scissors or Hockey knife The haemorrhage will be stopped either by cauterisation or coagulation by means of an Argon laser The Excimer Laser is employed to smooth the rough surface of the cornea 5 7 2 The treatment session 72 96 Adjust the number of shots at 3000 shots Adjust the frequency at 10 20 Hz The procedure during the treatment depends on the individual clinical Characteristics Click on the pushbutton Ready in the OP Assistant The cornea requires to be kept dry during the treatment use e g triangular swabs for this purpose This is necessary since any bleeding or weeping would prevent the ablation of the tissue As a rule there are several thousand laser ablations required before a smooth surfac
49. l zone We recommend to use an optical zone of 6 mm for corrective surgery procedures up to 6 D um 200 8 9 10 11 12 13 14 15 dpt Fig 1 Ablation centre depth as a function of the optical zone diameter Art Nr 170299045 1299 11 96 AESCULAP A Danger Danger 12 96 PRK As a rule the subjective spectacles refraction values are used as the basis for the data input These values are directly input into the OP Assistant Exclusively negative values are to be used e g 2 2 x 45 On principle it is recommended to conduct an examination with a cornea topography system in order to be sure that the patient does not suffer from asymmetric astigmatism or an early stage of keratoconus In case of patients who are presbyopic or are likely to soon become presbyopic it should be considered whether a low level of residual myopia could be left untreated The current subjective refraction is also adjusted in the OP Assistant during any re treatments The refraction should be stable over a period of not less than six months Caution should be exercised when treating dry eyes or post keratoplasty cases since there the degree of hydration and the healing progress may differ from case to case We recommend for such cases a more conservative approach with an undercorrection of 20 per cent Do not try and combine different myopia programs in order to achieve so called multipass trea
50. ly completed fluence test A faulty fluence value will result in false treatment Danger Repeat this procedure with each new patient Remove the blue test base 82 96 Art Nr 170299045 1299 AESCULAP Topographic treatment 6 6 Preparation of the patient Thirty minutes prior to the laser treatment a topical anaesthetic e g Novesine Kerakain and Pilocarpin shall be administered If required a sedative agent e g Diazepam shall be given The minus cylinder axis of the patient is marked on e g the sclera with a colour pen Alternatively the patient may be temporarily placed under the surgery microscope with the test frame put on The height adjustment is carried out by means of the focusing laser The head of the patient is aligned horizontally as much as possible so that the pupil is at the centre of the eye slit when the patient looks into the surgery microscope Cover with sterile sheets the area around the eye and head of the patient An eyelid speculum is to be placed between the eyelids preferably of the Barraquer type When treating astigmatisms the reticule of the ocular by turning is adjusted to the 0 axis of the patient Ask the patient to fixate on a green LED and mark the optical centre centre of the entry pupil with an eye cannula 6 6 1 Procedure for PRK Attach the ring marker and turn by 20 to 30 under slight pressure Recommended ring markers Myopia always 1 mm larger
51. menu 6 4 1 The OP Assistant 78 96 Hyperopia Asti Lens OD Hyperopia Lens OD pr Fluence Test Myopia Asti Lens OD Myopia Lens OD ae ae Eye Tracker wi Protocol x Close Hyperopia Asti Lens fff Delete OD Extended data Sphere 0 00 Cylinder 1 75 Axis 0 Max 26 um Duration 18 Center ORBSCAN Device Fig 43 Operation Based on Topography operation assistant menu Select the patient for treatment from the patient list The selected data record is highlighted blue The click on the Fluence Test button The FLUENCE TEST menu opens You can view additional patient data by clicking on the Extended data button Art Nr 170299045 1 299 AESCULAP Topographic treatment MEDITEC n You can delete a data record from the patient list by clicking on Delete Clicking Close returns you to the main menu 6 4 2 The fluence test Fluence test Re Eo x f 4 Energy set point 4 10 a 0 6 10 Fig 44 Menu fluence test By clicking on the pushbuttons High or Low you may increase or decrease the energy set point You start the fluence test by operating the pushbutton Ready Clicking on the pushbutton Close will abort the fluence test Art Nr 170299045 1299 79 96 AESCULAP MEDITEC 2 Topographic treatment 6 5 Preparation of the laser Height adjust your operating chair Switch on the ring shaped lamp 11 and check the
52. nitial heating phase the main menu will appear on the screen Art Nr 170299045 1 299 CE AESCULAP PTK Spot MEDITEC 2 5 3 The Main Menu OPASS Y 2 2 for MEL 70 G Scan Fig 34 The Main Menu PTK Spot Click on this symbol in order to perform a refractive operation Click on this symbol in order to perform a therapeutic treatment PTK Shaping or PTK Spot treatment Click on this symbol in order to perform a topographic operation cf Chapter 6 Click on this symbol in order to perform an automatic gas exchange duration approx five minutes The gas exchange may be conducted during the initial heating phase Art Nr 170299045 1299 65 96 AESCULAP MEDITEC 2 Patient management Application manual LA Configuration Laser off End 66 96 PTK Spot Click on this symbol in order to open the patient management cf Appendix Click on this symbol in order to open the application manual Click on this symbol in order to perform the configuration adjustments Here you may input the data of your clinic or select the printer for the journal printout cf Appendix Click on this symbol in order to terminate the computer program and switch off the laser You should not switch off the laser until the message YOU MAY NOW SWITCH OFF THE COMPUTER appears on the screen Art Nr 170299045 1 299 AESCULAP PTK Spot MEDITEC 5 4 Program input for PTK Spot trea
53. nly be performed under supervision of an _ authorised AESCULAP MEDITEC representative Our recommendation for every user is to study the current literature on this topic and to establish contacts with clinics which are equipped with the described device in order to familiarise themselves with the methods of treatment employing an Excimer Laser before they start their independent treatment of patients AESCULAP MEDITEC will be happy to help you making contact with other MEL 70 G Scan users In addition we should like to offer you continued support by our specialists during your operations over a longer period of time Please turn to our responsible field officer if you request further information Art Nr 170299045 1299 7 96 AESCULAP Safety Instructions 1 3 General PRK contraindications A photorefractive keratectomy PRK by means of an Excimer Laser should only be conducted after a careful definition of the indications Patients to which one or more entries in the below list apply should not be subjected to a PRK surgery procedure Progressive myopia or keratoconus Residual chronical or active ophthalmic diseases or corneal anomalies with the exception of refractive anomalies in both eyes such as iritis uveitis keratitis sica blepharitis or a cataract with an essential visus impact The regular taking of medication which cause a disturbance of the wound healing process such as corticosteroids from an
54. o perform the configuration adjustments Here you may input the data of your clinic or select the printer for the journal printout cf Appendix Click on this symbol in order to terminate the computer program and switch off the laser You should not switch off the laser until the message YOU MAY NOW SWITCH OFF THE COMPUTER appears on the screen 53 96 AESCULAP MEDITEC 2 PTK Shaping 4 4 Data input for PTK Shaping treatment Select the treatment method Operation therapeutic from the main menu by mouse click 4 4 1 Input of patient data Name Blindmann First name Rober DOB 2412 1951 Patient jon Eye OS c OD Operator Dr Meier 3 Select ov OK x Cancel Fig 26 Menu Patient Data To begin with input the patient data and the name of the operating surgeon Mark whether the left or the right eye is to be treated You may either enter the data directly into the input field or select a patient from the patient database When you click on Select with the left mouse key the list of patients entered previously in the PATIENT MANAGEMENT screen opens for details of PATIENT MANAGEMENT see annex These entries are printed in the operation journal Confirm the correct entry with OK The Cancel pushbutton takes you back to the main menu 54 96 Art Nr 170299045 1 299 AESCULAP EE MEDITEC 4 4 4 2 The OP Assistant Operation therapeutic Patient Blindmann Robert
55. ocated above the latter pushbutton If the eye is displayed against a black background the object was recognised by the eye tracker If the pupil was not recognised the background will remain grey In the latter case check the below items Has the eye tracker been switched on Is the pupil still in the HOT ZONE The HOT ZONE is the area where the laser follows the patient eye movement If the pupil leaves the HOT ZONE the sequence of shots is automatically interrupted until the pupil is again in the area of this zone In such case reposition the head of the patient in such a way that the eye is at the centre of the camera image Art Nr 170299045 1299 45 96 AESCULAP Danger 46 96 LASIK When the eye tracker is switched on you will see a graticule in the video image This graticule will be automatically placed in the object centre However since the optical axis is not always in the object centre you have the opportunity to modify this setting You can change the position of the graticule by clicking with the right mouse key on the arrow keys on the left of the video image The right mouse key will move the graticule in larger steps Click the round pushbutton in the centre in order to readjust the graticule to the geometrical centre You can also move the graticule with the arrow keys The keyboard button must be enabled for this You can adjust different parameters of the video image such as brightness con
56. ocular adjustment Swivel the laser arm and switch on the distance control laser 12 Fig 45 Control Panel Laser Arm Position the patient bed together with the blue test base at the appropriate height The two focusing points require to be brought into an overlapping position Operate the below keys on the operating panel of the laser arm towards this end Height adjustment higher 13 deeper 14 Horizontal alignment forward 15 backward 16 to left 17 to right 18 80 96 Art Nr 170299045 1 299 AESCULAP Topographic treatment MEDITEC Put a piece of test paper onto the blue test base 26 27 28 29 Fig 46 Control panel Connect the blue hose for the flue gas extraction suction to the laser arm 2 and the PRK suction ring blue marking Adjust the value for the flue gas extraction to maximum at the flow meter 26 Click on the pushbutton Ready in the menu of the fluence test A N Now the laser may be actuated by means of the right hand foot pedal Danger a 30 31 Fig 47 Foot pedal Art Nr 170299045 1299 81 96 AESCULAP MEDITEC 2 Topographic treatment Place the red target beam with the joystick 22 onto a free area of the test paper Now make the fluence test as described in the Instruction Manual Following the successfully completed test click on the pushbutton OK and turn the laser arm to the side Only continue after a successful
57. otal ablation is max 9 mm 4 2 Activation of the laser 50 96 Fig 23 MEL 70 G Scan switches Unlock the EMERGENCY OFF switch 7 Switch on the main switch 8 the green light in the switch lights up Turn the key switch 9 fully to the right the key will automatically return to centre position After approx 30 seconds the menu of the initial heating phase will appear on the screen Art Nr 170299045 1 299 AESCULAP PTK Shaping MEDITEC 4 2 1 Initial heating phase and gas exchange OPASS 2 2 for MEL 70 G Scan x AAEI 7A 3 AV ilele FS G scan AESCULAP MEDITEC T Operation therapeutic Patient Application management manual ii Press F1 for Help Software version PC V 2 2 01 00 ZUK M V 2 2 01 00 ZUK S 2 2 01 00 Operation topographic i Gas exchange f Configuration oe Fig 24 Menu Initial heating phase The laser requires a period of six minutes to heat up to the necessary operating temperature A progress indicator will advise you of the status of the initial heating phase The symbols with a grey background cannot be selected during this period In order to perform an automatic gas exchange click the symbol Gas exchange during the initial heating phase The gas exchange takes approx five minutes Confirm the gas exchange with clicking Yes Another progress indicator will advise you of the status
58. ow is not in the zero point In this case the program suggests a calculation Click a Fig 6 2 2 x 180 After inputting the refraction data the optical zone can be varied but the thickness of the cornea should be observed Art Nr 170299045 1299 19 96 AESCULAP MEDITEC 2 PRK 2 4 3 The fluence test Fluence test Fig 7 Menu fluence test By clicking on the pushbuttons High or Low you may increase or decrease the energy set point You start the fluence test by operating the pushbutton Ready Clicking on the pushbutton Close will abort the fluence test 20 96 Art Nr 170299045 1 299 AESCULAP PRK MEDITEC 2 2 5 Preparation of the laser Height adjust your operating chair Switch on the ring shaped lamp 11 and check the ocular adjustment Swivel the laser arm and switch on the distance control laser 12 Fig 8 Control Panel Laser Arm Position the patient bed together with the blue test base at the appropriate height The two focusing points require to be brought into an overlapping position Operate the below keys on the operating panel of the laser arm towards this end Height adjustment higher 13 deeper 14 Horizontal alignment forward 15 backward 16 to left 17 to right 18 Art Nr 170299045 1299 21 96 AESCULAP MEDITEC 2 PRK Put a piece of test paper onto the blue test base Fig 9 Control panel Click
59. ponsibility of the attending physician It is indispensable to conduct an energy test prior to each treatment session On no account any treatment may be administered when there is the slightest doubt at the proper functioning of the device Art Nr 170299045 1 299 AESCULAP Safety Instructions of a treatment in a different form than described in the present application manual may result in a release of hazardous laser radiation The employment of control elements as well as adjustments or the giving Danger The cover of the device must not be removed under any circumstances The laser device may only be opened by qualified technical personnel of Saaier the company AESCULAP MEDITEC Any attempt at performing maintenance activities at the device by personnel which has not been commissioned by AESCULAP MEDITEC will result in the immediate cessation of our warranty obligation Persons with heart pacemakers are required to keep a distance of 2 metres from the MEL 70 G Scan Danger 1 2 Significant advice for the first treatment This present Application Manual for the MEL 70 G Scan is deemed to be merely a guideline for the performance of the first treatment steps and shall facilitate the familiarisation with treatments by means of an Excimer Laser It can by no means be a substitute for on site instructions on the device given by a qualified AESCULAP MEDITEC staff The treatment of the first patient should o
60. r 170299045 1 299 ME Q AESCULAP PRK MEDITEC 2 If the re epithelialisation is delayed remove the soft bandage contact lenses and apply an eye dressing Remove the eye dressing at least three times a day for the application of the eye drops In case that an analgesic medication is required we recommend e g Tylenol N 3 or Mepergan Forte Meperidine Promethazine 2 12 3 Postoperative treatment after complete re epithelialisation Stop the application of the antibiotic agent and if need be switch to steroids Fluormetholon 0 1 Alcon 4 times per day during the first month 3 times per day during the second month 2 times per day during the third month once in the morning for the next two weeks then discontinue the application In the event that the patient requires a lubricant use solutions without preservatives e g Refresh Plus In the event that the patient requires an ointment as lubricant use Refresh Plus PM ophthalmic ointment Allergan Inc Art Nr 170299045 1299 31 96 AESCULAP MEDITEC uz LASIK 3 LASIK treatment 3 1 The opportunities of LASIK treatment 3 1 1 LASIK myopia The myopia programs are designed to perform corrections of up to a theoretical value of 24 D without and with astigmatism An optical zone from 4 0 mm to 6 0 mm may be selected The larger the optical zone the more the risk of a postoperative glare sensitivity will be reduced However the ablation centre depth will increas
61. round cannot be selected during this period In order to perform an automatic gas exchange click the symbol Gas exchange during the initial heating phase The gas exchange takes approx five minutes Confirm the gas exchange with clicking Yes Another progress indicator will advise you of the status of the gas exchange A filling level indicator of the gas cylinders is located at the left bottom corner of the screen If one of the cylinders is empty please notify your hotline officer so that the cylinder will be replaced during the next service cycle The state bar is located at the lower screen margin Situation related reports and the currently used software version are displayed in this box Following the initial heating phase the main menu will appear on the screen Art Nr 170299045 1299 75 96 CE AESCULAP MEDITEC Topographic treatment 6 3 The Main Menu OPASS Y 2 2 for MEL 70 G Scan Fig 41 Topographic treatment main menu Click on this symbol in order to perform a refractive operation Click on this symbol in order to perform a therapeutic treatment PTK Shaping or PTK Spot treatment cf Chapters 4 and 5 Click on this symbol in order to perform a topographic operation Click on this symbol in order to perform an automatic gas exchange duration approx five minutes The gas exchange may be conducted during the initial heating phase 76 96 Art Nr 170299045 1 299 AESCULAP
62. rt 0S Assistent yE PRK 47 LASIK bp Fluence test Sphere Cylinder Axis Eaa EOE Preoperative 4 25 50 S n7 Journal Target refr Ho 0 00 A in Correction 3 25 5 00 X Close Ablation 75 ym Myopia 2l T Optical zone 5 00 E MV Lock diameter e Center Fig 6 The OP Assistant Select the treatment method PRK from the menu Input the preoperative subjective spectacles refraction values directly into the OP Assistant In some cases it may be desirable to undercorrect the patient In order to do so enter the desired target refraction by clicking on the scroll arrows with the left mouse key you will modify the value in 0 25 D steps by clicking with the right mouse key you will modify the value by 1 D The OP Assistant will automatically calculate and display the correction in the appropriate field In the case of a false mixed astigmatism e g 4 2 x 10 By clicking on the Diagram symbol you will get a graphical representation of the working ranges The red arrow indicates the preoperative refraction the green arrow the target refraction You can close the diagram by clicking on the button with the hook In the event that the preoperative values are outside of the valid working ranges the refractive error cannot be completely corrected i e a residual sphere or a residual cylinder will result the red arrow in the diagram is outside of the coloured range the green arr
63. s eye tracker button the joystick will be deactivated e Apply limbus ring in a way that the aiming beam sits roughly on your mark e Set aiming beam to your mark on the cornea by using the mouse or keypad e Start ablation 2 8 2 Purkinje Reflex e Input patient data e Perform fluence test e Press center to set the red HeNe beam in the center of microscope e Have the patient look at the red HeNe beam e Use a blunt cannula marker to set centre of abrasion e Press ready e Use ring marker to set area of abrasion put joystick aside e Remove epithelium Art Nr 170299045 1299 27 96 I S PRK e Again have the patient look at the red HeNe beam move bed or head if necessary joystick must be centred e Press eye tracker button the joystick will be deactivated e Reposition patient have him look straight e Apply limbus ring in a way that it is lying horizontal e Align aiming beam by using the mouse or keypad that you can see the Purkinje refelex e Start ablation 2 9 The treatment session When you press the Center button the target beam of the laser will always be in the center of the surgical microscope in whatever position the joystick may be In this way the target beam instead of the fixation light can be used for centering Check the values which have been adjusted in the Assistant Click on the Ready pushbutton in the OP Assistant Actuate the right foot pedal and keep it depressed
64. s 67 The patient data MON occcccctccrenssslonccceessnehebeiceebsecconsietebenaiabenticbehenseebanaeabeneets 67 The OP ASS SUN acre de seco sre ense eesiegee eee nee cea vines bees nen eaten eesenesecenweneceneenu 68 Preparation of the laser ceesre sa eana an EAEN EREA RENES 69 Treatment of recurrent erosion cccceeeeeeeeeeeeeeeeeeeeeeeseeeaaeeeeeeeeeeeesessneeeeeeeeeees 70 Preparation of the patient 2 cceccccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeessecaaeeeeeeeeeeeeeeee 70 The treatment session issececscinsctereevcdsasseisnctinedevsideadssadieneliadeesdewadeuadebidevadeundtlendad 70 Postoperative TEALIMOIN sccce cic cccincit ceacadendictentndencatencbergacndeanadeedeinenendaccgunceenten 71 PS SUMEG depe e i etal ete eaaa wheat aaia 71 Treatment OF PLCIY Gleb cai ceccccacecetse su anesuneceesusedencdede deveeesedeessedeceheneteecnedededevecetecenenes 72 Preparation of the patient cca cctee sve ccvers ceuehereeeesveeevves a vaneedveesueesvareueneeeernederendes 72 The treatment SESSION 5 secu cnsoretuiuspasteconcnetobendhiheassseneuiepondhonedthvbeaesonobubonnaeleds 72 Art Nr 170299045 1 299 AESCULAP EC w Index EC ms 5 7 3 Results ccc cet tdci tected dine adicaid mee 73 5 8 Termination of the PrOQrarm ccccccccccceeeeeeeeeeeceeeeeeeeeeeeeeeeeeaaeaeeeeeeeeeeeeeeeaaees 73 5 9 Switching off of the laser a2 ccsc pce cscecec crore vasendsacerantiaccagetaaauentacdiextaccaaamercuece 73 6 Topographic TreatMeNh srissrciiisesd
65. s every user will gradually develop their own nomograms Nevertheless the currently available AESCULAP MEDITEC Software is particularly well suited for new users provided that the below recommendations are adhered to Art Nr 170299045 1299 9 96 AESCULAP MEDITEC Safety Instructions n spite of the fact that a greater level of sterility during hand washing and the disinfection of equipment parts is urgently required such should not be done immediately prior to the operation or in the operating theatre since the released alcoholic gases will absorb a large amount of the Excimer Laser light The latter is a frequent reason for uncontrolled defective corrections The software is programmed with the patient s eye glass refraction values 1 6 General Complications LASIK and PRK are known to cause the following complications in some single cases glare haze halos decreased night vision regression 10 96 Art Nr 170299045 1 299 PRK 2 PRK treatment AESCULAP 2 1 The opportunities of PRK treatment 2 1 1 PRK myopia The myopia programs are designed to perform corrections of myopia of a maximum total of 12 D with or without astigmatism An optical zone from 4 0 mm to 7 0 mm may be selected The larger the optical zone the more the risk of a postoperative glare sensitivity will be reduced However the ablation centre depth will increase with a larger diameter of the optica
66. s ready Press ready Perform keratome cut Use ring marker to set area of abrasion put Press eye tracker button the joystick will be joystick aside deactivated Remove epithelium Apply limbus ring in a way you can see the Again have the patient look at the red Purkinje reflex HeNe beam move bed or head if necessary Open flap joystick must be centred Reposition aiming beam by using the mouse or keypad to find again the Purkinje reflex Art Nr 170299045 1299 87 96 AESCULAP J PRK Press eye tracker button the joystick will be deactivated Reposition patient have him look straight Apply limbus ring in a way that it is lying horizontal Align aiming beam by using the mouse or keypad that you can see the Purkinje refelex Start ablation 6 9 The treatment session Topographic treatment LASIK Protect flap with a wet sponge from the nasal side in case of a cylindrical ablation around the zero degree axis classical flap or 90 degrees down up flap respectively Start ablation oO Caution Stop every once in a while to verify eyetracker centration and to drythe stromal bed When you press the Center button the target beam of the laser will always be in the center of the surgical microscope in whatever position the joystick may be In this way the target beam instead of the fixation light can be used for centering Check t
67. senennesenadensmsmeesmereeni 29 2 12 Follow up treatment proposal cccceceeeeeeeeeeeeneeeeeeeeeeeeeeeeneeeeeeeeeeeeeeeeenaaees 30 2 12 1 Immediate postoperative treatment cccceeeeeeeeeeeeeceeeeeeeeeeeesesnneeeeeeeeeees 30 2 12 2 Postoperative treatment until complete re epithelialisation 0 cee 30 2 12 3 Postoperative treatment after complete re epithelialisation cee 31 3 LASIK TPOQtMO seiscidacicsciseciseniiactsnnicacadeeidanisinidawssantieneuantdavasenidenseenisnsadenidannnncesnn 32 3 1 The opportunities of LASIK treatment ceeeceesccceeeeeeeeeeeeeneeeeeeeeeeeeeeeeeeaeees 32 3 1 1 LASIK MYOPIA ieena ae saa TaK eaaa Saaai e E KAASE ENEON 32 3 1 2 LASIK NypErOpi J repesin a ra ERK aa aKa 33 3 2 Activation of the laSer cccccceeeeeeeseeeeeceeeeeeeeeeseeeeaeeeeeeeeeeeeeeesnaaeaeeeeeeeeeeenees 34 3 2 1 Initial heating phase and gas EXCHANGE cccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeteneeeeeeeees 35 3 3 The main 0 1 epeeeeene leer ee cree eer tere tee ener erate ern tener r tree et errnenntr eee errr tn am 36 3 4 Data input for LASIK treatment eceeeecceceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeaaeeeeeeeeeeeeeeees 38 3 4 1 inp t fpatent 2 F Emenee te eeertee Naren eeinOnne enn ene yo a E Rn oe ee ee 38 3 4 2 The OP SASSISI AN scciecce cece ssc veces yee soeextucepesyaeseeesteaeaies pees oeeeeeepeesueaeaces tte oenseneete 39 Art Nr 170299045 1299 3 96 AESCULAP
68. sivstasdsanednnnesssianissnadsndnnnadewanswedaninendunswenannsananadans 74 6 1 PSII CATION ssa sstiserstserteleetntslnestradledeedvesminniaadnvemtuavavenbenlauenbeaduea Eit aiaa 74 6 2 Activation of the IAS Glia yass cndic cess cadcatsesncsatoucaseptcedeseeeduengupedinvatedddusgtescineoteedienstgade 74 6 2 1 Initial heating phase and gas EXCNANGE ccccccceeceeeeeeeeeeeeeeeeeeeeeeeetenteeeeeeees 75 6 3 The Main PAS ats ctseeiceesaeidacensenitinndeletslondtssdlsidindetdevmideatcenddncdersiteasuacinibeilnataldade 76 6 4 Program entry for topographic treatment ceeeeeeeeeeeeeeeeeeeeeeeeeceeeeeeeeeeeeeeees 77 6 4 1 TING OP ASSISUAIM tei cian Maritet tire pecateceut ato reget eeeheace eto 78 6 4 2 The fluence test race atetinnt sd et ecient nance pre ated sd aetna nea vereiaetscoustonmenate 79 6 5 Preparation of the TAG OF cee tacteteedteetcae sven ved suet onesies seelsteeesmeuevecsvelsluetsuoierecoadeeuies 80 6 6 Preparation of the Patient iciccccsecccesshseteerasecceccelshsvessnanccenciebseeesbestnceblieessuseenniale 83 6 6 1 Procedure for PAK cecisicsisenecduatcncndcancnantuecceedemnasaituescnae nancies etka tuonenmetmenenintne 83 6 6 2 Procedure for LASIK wccccsetecscevnccdeensedssccsnsdeaceuadiendatedscndnvadedadessdevedsnadeenenundeeeds 84 6 7 The CVC WACO sustos a a a e e a 85 6 8 Centration with the MEL 70 G Scan using the Artificial Limbus Ring 87 6 9 The treatment session cccceeeeeeeeeeeeeeeeeeeeeeeeeeee
69. timetabolites or implanted hormones such as Norplant Immunosuppression Corneal neo vascularisation up to 1 mm to the ablation zone An augmentation of the spherical or cylindrical portions in an existing refraction by more than 0 5 dioptres year since a first examination Previous corneal operations or injuries in the ablation zone Any system disease which causes a disturbance of the wound healing process such as a systemic connective tissue disease diabetes and serious atopy Vascillating medium level keratometry indications with irregular meridian marks or corneal photographs with interrupted central rings Patients with large pupil diameters in excess of 7 mm Female patients who are or soon intend to become pregnant Please refer to the topical literature for further contraindications 8 96 Art Nr 170299045 1 299 AESCULAP Safety Instructions 1 4 General guidelines for the selection of patients The ideal patients particular for any new user are deemed to be patients with a moderately severe myopia who cannot or do not want to wear spectacles for professional or personal reasons and who do not regard contact lenses as an alternative solution On principle also anisometropia is a well suited indication The patient should be at least twenty years of age Children should be if at all subjected to PRK surgery only in exceptional cases 1 5 LASIK treatment Th
70. tment Select the treatment method Operation therapeutic from the main menu by mouse click 5 4 1 The patient data menu Name Blindmann First name Robert DOB 24 1 2 1951 Patient Joao Eye 0S c OD Operator Dr Meier 3 Select v4 OK X Cancel Fig 35 Menu Patient Data To begin with input the patient data and the name of the operating surgeon Mark whether the left or the right eye is to be treated You may either enter the data directly into the input field or select a patient from the patient database When you click on Select with the left mouse key the list of patients entered previously in the PATIENT MANAGEMENT screen opens for details of PATIENT MANAGEMENT see annex These entries are printed in the operation journal Confirm the correct entry with OK The Cancel pushbutton takes you back to the main menu Art Nr 170299045 1299 67 96 AESCULAP MEDITEC 2 PTK Spot 5 4 2 The OP Assistant Operation therapeutic Patient Blindmann Robert 0S Fig 36 The Operations Assistant PTK Spot Select the treatment method PTK Spot from the OP menu Input the maximum number of shots the shot sequence of the laser will be interrupted when this max number is reached and the frequency of shots number of laser pulses per second The pushbutton Close will take you back to the main menu 68 96 Art Nr 170299045 1 299 AESCULAP PTK Spot 5 5
71. tments The in built nomogram is bound to cause severe overcorrections The correction of more than 6 D of astigmatism can result in reduced contrast sensitivity increased blurring undercorrection and regression Art Nr 170299045 1 299 AESCULAP iii MEDITEC 32 2 1 2 PRK hyperopia The hyperopia programs are employed in corrections of hyperopias and hyperopic symmetrical astigmatisms totalling not more than 8 dioptres The treatment diameter the optical zone plus the transition zone is 9 0 mm for all programs As a rule the subjective spectacles refraction values are used as the basis for any data input These values are directly input into the OP Assistant This applies also to angles The refractometry shall be performed with utmost care in particular with young patients and if possible in a state of cycloplegia Exclusively positive values are to be used e g sph 3 cyl 2 x 45 On principle it is recommended to conduct an examination with a cornea topography system in order to be sure that the patient does not suffer from asymmetric astigmatism or an early stage of keratoconus Do not try and combine different hyperopia programs in order to achieve so called multipass treatments The in built nomogram is bound to cause Danger severe overcorrections The correction of more than 6 D of astigmatism can result in reduced contrast sensitivity increased blurring undercorrection and regression
72. ton Ready Clicking on the pushbutton Close will abort the fluence test 40 96 Art Nr 170299045 1 299 AESCULAP LASIK MEDITEC 2 3 5 Preparation of the laser Height adjust your operating chair Switch on the ring shaped lamp 11 and check the ocular adjustment Swivel the laser arm and switch on the distance control laser 12 Fig 19 Control Panel Laser Arm Position the patient bed together with the blue test base at the appropriate height The two focusing points require to be brought into an overlapping position Operate the below keys on the operating panel of the laser arm towards this end Height adjustment higher 13 deeper 14 Horizontal alignment forward 15 backward 16 to left 17 to right 18 Art Nr 170299045 1299 41 96 AESCULAP MEDITEC 2 LASIK Put a piece of test paper onto the blue test base Fig 20 Control panel Click on the pushbutton Ready in the menu of the fluence test Now the laser may be actuated by means of the right hand foot pedal Danger 30 31 Fig 21 Foot pedal 42 96 Art Nr 170299045 1 299 AESCULAP LASIK MEDITEC 2 Place the red target beam with the joystick 22 onto a free area of the test paper Now make the fluence test as described in the Instruction Manual Following the successfully completed test click on the pushbutton OK and turn the laser arm to the side Only continue a
73. trast etc by clicking on the Video pushbutton The eye tracker is switched off by clicking on the Off pushbutton The eye tracker window is closed by clicking on the Close pushbutton When the eye tracker is switched off the laser beam will not be automatically traced i e any eye movements will not be compensated Art Nr 170299045 1299 AESCUL AP ey C K I LASIK 3 8 Centration with the MEL 70 G Scan using the Artificial Limbus Ring 3 8 1 Centre of Pupil e Input patient data e Perform fluence test e Press ready e Perform keratome cut e Apply limbus ring roughly centred e Open flap e Have the patient look to the green LED e Use cannula marker to set centre of ablation centre of pupil e Press eye tracker button the joystick will be deactivated e Set aiming beam to your mark on the cornea by using the mouse or keypad e Protect flap with a wet sponge from the nasal side in case of a cylindrical ablation around the zero degree axis classical flap or 90 degrees down up flap respectively e Start ablation Stop every once in a while to verify eyetracker centration and to dry the stromal bed Caution 3 8 2 Purkinje Reflex e Input patient data e Perform fluence test e Press ready e Perform keratome cut e Press eye tracker button the joystick will be deactivated e Apply limbus ring in a way you can see the Purkinje reflex e Open flap Art
74. tton Eye Tracker in the menu of the OP Assistant Eye tracker Keyb 2 KODLA gt Threshold lt gt Tracker Fig 11 Menu Eye Tracker The menu of the eye tracker will open This window remains open during the treatment session and enables you to make different adjustments and check the functioning of the tracker A video image of the eye tracker is displayed on the right while the left shows the configuration pushbuttons Activate the eye tracker by clicking on the pushbutton On The tracker status indicator is located above the latter pushbutton If the eye is displayed against a black background the object was recognised by the eye tracker If the object was not recognised the background will remain grey In the latter case check the below items Has the eye tracker been switched on Is the pupil still in the HOT ZONE The HOT ZONE is the area where the laser follows the patient eye movement If the pupil leaves the HOT ZONE the sequence of shots is automatically interrupted until the pupil is again in the area of this zone In such case reposition the head of the patient in such a way that the eye is at the centre of the camera image Art Nr 170299045 1299 25 96 AESCULAP A Danger 26 96 PRK When the eye tracker is switched on you will see a graticule in the video image This graticule will be automatically placed in the object centre However since t

Application Manual MEL 70 G-Scan

Contents

Download Pdf Manuals

Related Search

Related Contents