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User Manual AWE1010 - Frank`s Hospital Workshop

1. Figure 78 Popup Window Copying Data From USB stick Page 114 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description WaveLight After finishing the imported data set is shown in the Measurement Field Patient Data Planriecl F2 Seg Patient DAY rea 3 Import F3 000000000 Hew ID P1001 P1001 29 04 1979 P1002 P1002 29 04 1979 KAN P1003 P1003 29 04 1979 Exarninaton P1004 P1004 29 04 1979 Fa P1005 P1005 29 04 1979 First Name P1006 P1006 29 04 1979 P500 P500 01 01 1950 Date of Birth P501 P501 01 01 1950 Serien P502 P502 01 01 1950 RAA F5 P503 P503 01 01 1950 sender P504 P504 01 01 1950 P505 P505 01 01 1950 P506 P506 01 01 1950 P507 P507 01 01 1950 ye Summary P508 P508 01 01 1950 F P509 P509 01 01 1950 P510 P510 01 01 1950 P511 P511 01 01 1950 Measurement count P512 P512 01 01 1950 P513 P513 01 01 1950 P514 P514 05 03 2004 F7 P515 P515 05 03 2004 P516 P516 05 03 2004 P517 P517 04 03 2004 ayer Print FS ed 51 of 51 Measurement session Laser Figure 79 Measurement Data Window Loaded Data e Click on the patient A tree view is opened of all available measurements The patient data will be imported with the ALLEGRO Analyzer ALLEGRO Topolyzer or ALLEGRO Oculyzer If t
2. C Setup Menu Manual Input of Input of Treatment Treatment Data Data via Notebook Treatment m Setup Menu Figure 11 Firmware Structure The system has to be turned on via the System Main Switch the Main Power Switch and the Key Switch see chapter 5 3 Turning On The System on page 37 The ALLEGRETTO WAVE EYE Q will automatically conduct a Self Test of the control module The System Check follows once the Self Test has been completed The user has to actively participate during the procedure of the System Check The system proceeds to the Standby Mode after completing the System Check The Standby Mode is exited by pressing the OK Key or by starting the remote notebook software In the first case data is entered directly via the control panel Data is entered into the notebook in the case that the remote notebook software is being used This gives the user the possibility to enter data prior the treatment After completing the treatment the ALLEGRETTO WAVE EYE Q conducts an internal check and returns to the Standby Mode The Setup Menu can be activated in the Standby Mode as well as in the Treatment Mode This enables the user to enter parameters and conduct system related procedures The ALLEGRETTO WAVE EYE Q can be turned off via the Key Switch Page 36 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description A Wa
3. Start Center Test with CENTER PEDAL Figure 44 LCD Screen Center Test Must Be Performed Before Treatment After the parameters have been entered and the Ready Key A on the control panel has been pressed the system is ready to start the treatment see figure 8 Control Panel With Joystick on page 30 The eyetracker is always active This is indicated by the eyetracker symbol lt gt displayed in the bottom right hand corner of the LCD screen The ALLEGRETTO WAVE EYE Q will prompt you now to conduct the Center Test For this the patient must be aligned correctly and lying on the patient bed Press the CENTER pedal and the aiming beam shows you where the center of the pupil is defined The Center Test must be performed before every treatment Eyetracker distance diodes aiming beam and fixation light are reset to the default values Do not change them for the treatment Page 68 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description ZA WaveLight 5 6 Navigation And Data Entry With The Notebook Portal Software The ALLEGRETTO WAVE EYE Q can also be operated by remote control via a program Portal Software installed on an external notebook The advantage of operating the system via the Portal Software is that this option enables a staff member to assist the physician The notebook can be used for entering storing and importing treatment data in adv
4. Median Value Calculation Window is shown please refer to the A CAT or the Topo guided User Manual At this part of the program measurement data can be compared and uncertain measurements can be taken out of the data stream Please verify the measurement data Page 116 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description A WaveLight SPELL LEEELELEL ELE EEEELELELEL ELLE TELE EEE EEE Ee gt USB stick Deactivation A CAUTION Always deactivate the USB stick before removing it from the notebook to avert damage to the USB stick e Press the assigned key amp on your keyboard to remove the USB stick Figure 81 Keyboard USB Deactivation Key A Popup Window confirms the permissible replacement of the USB stick Safe To Remove Hardware x i The USB Mass Storage Device device can now be safely removed from the system Figure 82 Popup Window Permissible Replacement Of The USB stick ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 117 of 232 A A Wave Lig ht Functional Description 5 6 10 Setting Menu Patient Data Data Bar Language Timer Settings Treatments Save Logfiles Treatment Counter search 7 Patient F3 Filter a a Recreate Datafiles Service Musterfrau Paula 24 02 1974 oD ast Name xamination pi PTK 15 05 2006 Last Name Examination
5. ETT LEE LCE TCEE TET EL ELEC LE TLCEPTTPTeLerrTererrieriiieerereeererriererriererreer rrr ieee reece gt 5 17 5 Fluence Test And Calibration Procedure A CAUTION Before performing the Fluence Test the Energy Check and the Eyetracker Test must be done Note the energy in the Fluence Test Report which you will find in your Archive Folder e Always begin with side 1 of the Fluence Test Disk e Mark the Fluence Test Disk AFTER taking the measurement as the thickness of the ink will lead to erroneous measurements e Make sure that the position of the Test Adapter is correct see figure 132 Test Adapter With Test Target Holder And Test Disk on page 169 To be sure the Ablation Depth Micrometer is working correctly a glass disk with a certified depth is delivered with the system Please check the alignment of the Ablation Depth Micrometer with the glass disk every 10 treatment with the help of the following described points from 1 7 Please see also chapter 5 17 6 Ablation Depth Normal Glass Standard from page 177 This test allows you to determine whether the energy density in the treatment plane is correct To perform this test a PMMA specimen Fluence Test Disk is ablated and the ablation depth measured with an ablation depth micrometer Fluence Test ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 165 of 232 WaveLight Functional Description Vacuum Pump ON OFF
6. MES 76 Gas Menu MES 82 Gas Menu Display Checksum error eyetracker Cont OK Key Off ET Key NOTE Gas volume for only approx treatments Continue with Gas Key NOTE Cylinder is still closed Order new gas cylinder within the next days Continue with OK Key Perform NEW FILL and repeat ENERGY CHECK Continue with OK Key ae WA Reasons The data communication of the eyetracker is incorrect e This warning message is displayed as soon as the remaining pressure is below the given value e It is just possible to perform some few treatments e Valve has not been opened Error of the magnetic valve electronics e This warning message is displayed as soon as the remaining pressure is below a certain warning value e Just a few treatments are possible depending on the number of the daily treatments The energy of the laser head is not sufficient It is necessary to perform a gas change ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 WaveLight Solution Press the OK key and try again If the error reappears the handling is to be aborted Inform the service immediately Shut down the device until it was checked by the service Please order a gas cylinder immediately Open the gas valve and perform a gas change Please order a gas cylinder within the next days Perform a gas change and repeat the e
7. 6638 2001 A F e Functional Description A WaveLight 15 Activate the function Fluence Test in the Setup Menu see figure 105 LCD Screen Fluence Test Program on page 143 and Press the LASER pedal and start the ablation procedure until the laser stops automatically FLUENCE TEST finished leave LASER PEDAL Figure 139 LCD Screen Fluence Test Finished 16 Clean the Fluence Test Disk with the felt wiper i e pull the felt over the Fluence Test Disk see figure 129 Cleaning The Test Disk on page 167 17 Then turn on the vacuum pump with the Vacuum Pump ON OFF Key green LED ON 18 Using the Test Target Holder press the Fluence Test Disk into the centering ring until the vacuum holds it on its own see figure 131 Fluence Test Disk With Test Target Holder on page 168 Alignment of the Fluence Test Disk is mandatory The WaveLight AG lettering must point to the blower and the number to the left 19 Briefly wait until the value indicator ceases to change Read the measured value in mm on the display and enter it in the Fluence Test Report in your Archive Folder ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 173 of 232 A j WaveLight Functional Description 20 Now turn off the vacuum pump and withdraw the Fluence Test Disk together with the Test Target Holder the Fluence Test Disk will fall out of the centering ring automa
8. Date of Birth Treatment 5 Surnay F Laser selected 0 of 0 Figure 76 Measurement Data Window a a e Now press the Import button in the Measurement Data Window Page 112 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description SA WaveLight A Popup Window asks you to insert the USB stick See also table 22 Data Communication on page 223 Patient Data Planned F2 Patient F3 Filter import Data from Data medium Please insert a volume and pre Everninattions F4 Treatrient T ba Surnimary F5 Laser F7 Generic Flash Disk USB Device 256MB X Ready for Data Import on drive W Figure 77 Popup Window Load Data From USB stick And USB stick Identification Please insert the USB stick with the exported ALLEGRO Analyzer ALLEGRO Topolyzer or ALLEGRO Oculyzer data A further Popup Window shows the identification of the USB stick ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 113 of 232 A j SA WaveLight Functional Description e Once the USB stick has been identified see figure 77 on page 113 press the Start button to start the data transfer All available data will be imported The import function will be indicated by a progress bar e Press the button if you want to cancel the data transfer
9. Labeling WaveLight ETTET TOT terre reer errr rere rere rere errr rere rrr etree rrr errr rrr reer rrr errr rrrer irri gt 11 4 Labeling Of The Laser Area According to DIN EN 60825 1 IEC 60825 1 the current warning labels must be attached at eye level to all entrance doors of the laser room Additionally all entrance doors of the laser treatment room must be equipped with warning lights It is the responsibility of the system operator to mount a warning sign on every door to the laser treatment room In addition to the warning signs warning lights may be installed based on local safety regulations Two warning labels are included in the Product Folder Figure 163 Labeling Of The Laser Area A CAUTION The regulation listed above are European regulations when using the laser outside of Europe local regulations must be taken into consideration ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 221 of 232 ZA WaveLight Technical Data 12 TECHNICAL DATA 12 1 Device Data Page 222 of 232 Laser Device Wavelength Ablation diameter Pulse frequency Laser transmission Eyetracker frequency Aiming beam focus diodes cross line projector Microscope Controls Gas supply Cooling Dimensions Length Width Height Weight Table 20 Laser Device Data Excimer laser ArF Laser class 4 DIN EN 60825 193 nm UV 0 95 mm 0 037 inches 0 004 inches
10. Rev 9 09 06 08 Item No 6638 2001 FA WaveLight L lin Fine E ne aac ev ae a k 11 2 Labeling Of The Ablation Depth Micrometer The manufacturer s identification label is located on the rear side and the power supply label is located on the right side of the Ablation Depth Micrometer The labels are to be positioned as indicated below VACUUM Stromversorgung ON OFF VACUUM power supply ON OFF 12 V 600 mA On the side near Receptacle 0 fe ae ZERO ON OFF ZB WaveLight 10081402 j Ablation Depth Micrometer Target ablation depth S N 62 5 Micron Am Wolfsmantel 5 91058 Erlangen Germany Figure 161 Labeling Of The Ablation Depth Micrometer Identification label at bottom side ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 219 of 232 A WaveLight Labeling 11 3 Labeling Of The Test Adapter The manufacturer s identification label is located on the bottom and the power supply label is located on the rear side of the Test Adapter The labels are to be positioned as indicated below ZB Wavelight 12 V DV 600 mA 10081401 Use only WaveLight Calibration Test Adapter power supply S N Am Wolfsmantel 5 91058 Erlangen Germany FAN OK Light ON OFF Brightness Figure 162 Labeling Of The Test Adapter Page 220 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001
11. Shift the sensor head back to the stop after use The External Energy Check measures laser energy as it exits the laser aperture The external energy value is compared to a preset internal energy value The procedure is self adjusting No adjustments or interventions can be made by the user Page 54 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description ZA WaveLight At every Energy Check the following values are checked or taken into consideration e relative desired energy for the laser head without dimension e absolute pulse energy at laser aperture in mJ A relative desired energy for the laser head is always set It is then checked whether the correct pulse energy is available at the aperture The laser energy is one of the most important parameters for a successful treatment For this reason this calibration procedure is conducted during the System Check This procedure must also be repeated before every treatment or if the last calibration occurred more than 30 minutes ago by selecting the corresponding function in the Setup Menu A sensor head is used that is integrated in the eyetracker illumination lever Press the LASER pedal to emit laser pulses After every 1 200 pulses the E V value pair E relative laser head energy value V relative laser head high voltage value is updated and appears on the right side of the LCD screen It shows up the fi
12. ON OFF Key Display Measurement Power Supply Micrometer Display ZERO Key Protection Cap Figure 126 Ablation Depth Micrometer To start the Fluence Test please activate the function Fluence Test in the Setup Menu The system warms up the laser head SYSTEM CHECK Warming Up Laser Head Figure 127 LCD Screen Warming Up Laser Head Page 166 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description A WaveLight 1 Turn on the Ablation Depth Micrometer press the small ON OFF Key for approximately 2 seconds and then release see figure 126 Ablation Depth Micrometer on page 166 ON will be displayed 2 Remove the Fluence Test Disk s protective foil on the appropriate side only hold the Fluence Test Disk laterally and place it in the Test Target Holder see figure 130 Orientation Of The Fluence Test Disk and figure 131 Fluence Test Disk With Test Target Holder on page 168 amp NOTE Do not touch the Fluence Test Disk surface with your hand so as to avoid finger oil contamination 3 Remove the protective cap from the Ablation Depth Micrometer 4 Clean the Fluence Test Disk with the felt wiper pull the felt over the Fluence Test Disk Centering Ring Protective Cap With Felt Wiper Figure 128 Removing Protective Cap Figure 129 Cleaning The Test Disk 5 Now switch on the vacuum pump with the
13. Treatment limit for selected type reached You cannot use this measurement file because it does not contain useful data No data medium found Data medium full Table 16 Errors Notebook ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 FA WaveLight Solution Contact service Contact service Contact service Please choose a valid path Please change the asphericity to a valid value Contact service To unlock more treatments of this type right click in headline and select Treatment Counter Click button Get more for the selected treatment type Contact service Please insert a data medium USB stick and retry Please insert another data medium USB stick and retry Page 197 of 232 i ZA WaveLight List Of Messages And Warnings 9 LIST OF MESSAGES AND WARNINGS a LCD Screen Laser Console In the following table 17 messages and warnings are shown which could be displayed during the System Check or treatments If a fault cannot be corrected by means of this summary then please contact your authorized ALLEGRETTO WAVE EYE Q service representative see chapter 10 1 Service Hotline on page 210 No These numbers serve only for the internal organization Menu This column gives information in which menu the message occurs Display Here you will find the display messages Reasons In this column possible reasons are shown which lead to the me
14. Vacuum Pump ON OFF Key LED glows GREEN see figure 126 Ablation Depth Micrometer on page 166 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 167 of 232 ZA WaveLight Functional Description 6 Using the Test Target Holder insert the Fluence Test Disk into the centering ring until the vacuum holds the Fluence Test Disk on its own and remove the Test Target Holder Aa NOTE Alignment of the Test Disk is always important The WaveLight AG lettering must point to the rear and the number to the left side Fluence Test Disk With Test Target Holder ii Front User Fig 130 Orientation Of The Fluence Test Disk Fig 131 Fluence Test Disk With Test Target Holder 7 Wait one minute until the value indicator ceases to change then set the Ablation Depth Micrometer to 0 000 by pressing the ZERO Key see figure 126 Ablation Depth Micrometer on page 166 If 000 000 is displayed press the ZERO Key again for a short time 8 Leave the device on place the Test Target Holder under the centering ring Page 168 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A aht Functional Description ee SA WaveLight 9 Subsequently turn off the vacuum pump only with the Vacuum Pump ON OFF Key green LED OFF and withdraw the Fluence Test Disk with the Test Target Holder Do not press the ZERO Key again N NOTE The Fluence Test Disk
15. during the automatic movement of the patient bed ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 139 of 232 A SA WaveLight Functional Description 5 16 Setup Menu The LCD screen shows the current operational status of the laser console and provides an interface to perform system calibration and testing which is described in chapter 5 17 Routine Test Procedures With The Control Systems from page 152 e The Setup Menu is opened by pressing the Setup Key Z on the control panel The menu can be activated only if the laser is in Standby Mode or in Ready Mode Figure 99 Setup Key e Inside the menu functions and sub menus can be selected by shifting the joystick up down The selected function is displayed in contrasting color The default selection is DEF CENTER The navigation symbol on the Setup Menu upper right corner indicates that the control panel joystick has to be used next page FLUENCE TEST ET TEST GAS CHANGE ATF SCANNER TEST ENERGY CHECK CONTRAST LCD AOOO ONNO OOOO I UOOO UOTIN DISTANCE DIODES UII AIMING BEAM IIIT VD mm 14 FLAT K D 43 SETUP Return Press OK KEY Figure 100 LCD Screen Setup Menu Figure 101 Select A Menu Item By Shifting The Joystick Up Down Page 140 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e
16. 02 and notebook software version 2 020 or later The use of mobile telephones or similar appliances is not allowed while the device is working On account of the possible risk of interference from electromagnetic radiation while the ALLEGRETTO WAVE EYE Q laser system is in operation persons 4 with heart pacemakers may not be present in the room The effect of electromagnetic radiation of the device on embryos or pregnant women has not been specifically studied However the device fulfils the international electromagnetic safety standard DIN EN 60601 1 2 Local laws and regulations beyond this safety standard in regards to pregnant women in the vicinity of the device during start up stand by or operation must be followed Should the laser system or any accessory require service please do not attempt to perform service yourself Only WaveLight AG authorized service technicians or service technicians who have been specifically authorized by WaveLight AG are allowed to service the AALEGRETTO WAVE EYE Q laser system Servicing or any kind of manipulation of the system by non authorized personnel will result in a termination of the warranty and a nullification of any liability on the part of WaveLight AG There exist no rightful claims to system upgrades upon the introduction of product improvements based on new technological developments Always use original packaging for returns WaveLight AG will help you for the waste disposal of
17. 126 Browse Customer Info cccccceeeeesececccceeeeeeeeeeeeeeaeeeeeeeeeeeeeenesnsaeees 126 Recreate Data Files 00 ceeeessececceeeeeteeeesssceeeeeeeeeeeeeesssseeeeeeeeeeees 126 NS TC ate to N E E AE T AEE EE TA AE E EE EE 127 Notebook Software Info sessssneneneeeseeeenrrnnreesserrrrnnnnnesereennnnnnnneneet 127 Shutdown The Program sssssssesssesessnnrrreseerrerrnnnrreseerrrennnnnneseernene 128 Positioning The Patient ocscnctcdacccimermasiarnoctasmasuedejoteetegsiuasmastins 129 Checking The Eyetracker Function ccceeeeeeeeeeeeeeteeeeeeeeeeeeeees 130 Hints For KeratectOmy cccccccceescsecccceeeeeeeeeseeeeeaeeeeeeeeeeeeeeeeeaaeees 132 Ready Mode cccccceeeeeeeeeeeneneeeeeeeeeeeeseaaaeeeeeeeeeeeesnenseaaeeeeeees 133 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 7 of 232 F WaveLight Contents sad cs sie cs nes ine erase vin leo enn i tales icc waa ew Sa buna A T Page 5 11 Patient s Eye Alignment Fixation And Centering cceee 134 5 12 Starting Laser Treatment ccccceeeeeeeeeeeeeeeeeeeeeeeeeeeessseeeeeeeeeees 136 5 13 Interrupting Treatment cccceeeeeescesececeeeeeeeeeeseeneeeeeeeeeeeeeeseenaaeees 138 5 14 Aborting THCAMM SIM isis csssssetsesctrcrccoaidaecdenscdaiaveincdatiddetensebaseiedetidulyddataieeadelbe 139 5 15 Finishing TREAINIGMIL c2 c0ii Mnieitepetereheuetientecu tia iwtiey Reese
18. ALLEGRETTO WAVE EYE Q LCD screen also appears on the notebook display The LCD screen of the ALLEGRETTO WAVE EYE Q is the master In the case of a defective connection between the notebook and the ALLEGRETTO WAVE EYE Q the error message Laser Not Ready appears In the case of incomplete parameter selection the error message Entry Incomplete appears In the case of unavailable treatment parameters the error message Selected Treatment Not Released appears on the LCD screen of the ALLEGRETTO WAVE EYE Q laser Control panel functions of the laser console can be switched by clicking on the buttons of the control panel display of the ALLEGRETTO WAVE EYE Q Treatment Window Default settings should not be changed ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 107 of 232 A j SA WaveLight Functional Description Finish Treatment Once the treatment has been completed gS e enter a COMMENT if desired The treatment has been successfully finished Figure 73 Popup Window Final Comments S amp S e and press the button Once this window is closed the notebook portal software automatically returns to the Summary Window see figure 69 Summary Window PTK on page 101 For more information regarding Test Mode see page 85 Test Treatment see page 88 Finish Treatment see page 89 Interrupt Treatment see page 90 Abor
19. Adapter in the place provided on the patient bed head support so that the green LED faces the direction of the doctor 2 Connect the voltage supply cable 3 pin connector of the Test Adapter on the right side of the Ablation Depth Micrometer see figure 126 on page 166 The correct function can be tested with the integrated green LED Power OK green LED lights up Rear Patient T i Grey Side pge Point And Crosshair f A ma Inscription Label ZB WaveLight Logo Figure 145 Orientation Of The Ablation Target For Scanner Test Front User Page 180 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A he Functional Description A Wavelight A CAUTION The grey side of the frame of the ablation target must always face up during the Scanner Test 3 Place the ablation target for the Scanner Test in so that the grey side shows up and the logo WaveLight on the ablation target for the Scanner Test can be read 4 Turn on the white light individual brightness regulation 5 Focus the ablation target for the Scanner Test This means adjust the height of the patient bed to the level where both points of the red distance diodes join red points on top of each other see figure 136 Wrong Focus and figure 137 Correct Focus on page 172 6 Keep the focus and re center the crosshair Ablation Target For Scanner Test Figure 146 Test Adap
20. ArF Premix Gas Pressure Purpose Inspection of the pressure in the ArF Premix gas cylinder User Assistance Opening and closing the ArF Premix gas cylinder valve Feedback Request for the user to open and close the ArF Premix gas cylinder pressure values in the laser head warning in case of premix low pressure error messages in case of defects The ArF Premix gas cylinder must first be opened To do so turn the upper valve on the rear side of the cylinder counter clockwise at least one full turn See figure 5 Elements On The Rear Side Of The Device on page 27 SYSTEM CHECK Open Gas Cylinder and confirm with GAS KEY Figure 18 LCD Screen Open Gas Cylinder ArF If the ArF Premix gas cylinder contains only enough gas for a few fills a message will appear on the display bringing this to the user s attention The user must confirm this message As a reminder the gas cylinder symbol then appears on the display during treatment As soon as the content of the ArF Premix gas cylinder descends below a certain minimum level a service message appears on the display In such case beginning another treatment will no longer be possible ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 45 of 232 A j SA WaveLight Functional Description The following sequence appears on the LCD screen of the laser console SYSTEM CHECK Pressure Check Please wait Figure 19 LCD
21. Care Of Device And Accessories on page 188 Page 186 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Accessories FA WaveLight eer TTC LTT LTET ETE LTTE PETE C EET LTEPeTEe rei LCerrTrrererreererreeriieeerereeererrrererriere reer rrr ie eer eeee gt 6 1 Patient Bed A CAUTION The patient bed s positioning interlock must be connected to the laser to prevent patient injury Pushing the eyetracker illumination assembly upwards will stop the bed Always use the proper electrical connections for the patient bed to ensure that it cannot be moved when the LASER pedal is engaged It is important to pay attention to the electrical switching configuration The patient bed is used for alignment of the patient in relation to the laser beam Please refer to the separate operating instructions for the patient bed see Product Folder 6 2 Video Adapter Refer to the separate operating instructions for the video adapter 6 3 Notebook The notebook may only be used with the operating system Windows 2000 For purposes of operating the ALLEGRETTO WAVE EYE Q program installed in the notebook please refer to the separate operating instructions Only the notebook WaveLight AG delivered with the ALLEGRETTO WAVE EYE Q has to be used ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 187 of 232 EAN 7 SA WaveLight Care Of Device And Accessories 7 CARE OF DEVIC
22. D Doctor Table 11 Enter Examination Data e Click the confirm the entries button or the A button to Or e click the button to switch to the patient data Page 98 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description ZA WaveLight TTT TTT eee TEEPE LCL ELETEe LE TLCETTTPTeLerreererrieeriiieerererererrrererrrereiieer err ier eee gt Flap thickness Corneal thickness Stroma Figure 67 Warning Message In The Treatment Data Window Check if all data have been entered correctly e Enter Optical zone e Enter Ablations depth e Enter Flap thickness If an entry is missing or not valid a warning message is displayed see figure 67 above ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 99 of 232 A j SA WaveLight Functional Description e Set the treatment type to PTK and exit the drop down box using the TAB button Treatment type WFoptimized Nomogram 001 VWF optimized PTK The program switches to the PTK Treatment Data Window The ablation profile is visualized Treatment Plan Planned Musterfrau Paula 24 02 1974 Fal Treatment type Nomogram none Patient F3 Depth Examination F4 Ablation Depth Optical zone BOONE mm Ablation Zone 99 mm aes Flap thickness 130 um mm Corneal thickness 550 um Stroma 410 um max 10 00m
23. Do not switch off NOTE Pupil detected Remove patient and MES 28 Eyetracker Continue with OK Key OPM 1 Eyetracker No pupil detected OPM7 Eyetracker Pupil position out of range Page 202 of 232 List Of Messages And Warnings Reasons Solution The system detected a e Interrupt treatment deviation of the given energy The measured energy comes to of the given energy The treatment progress is displayed The calibration of energy sensors is checked While releasing laser pulses during a test the device has identified a pupil or test target No pupil is detected by the eyetracker The position of the pupil is outside the acceptable area and perform energy measurement Contact the service immediately Close down the device until the service has tested and released the system It is possible to proceed the treatment but on your own responsibility The system then proceeds with the outcome parameters No user interaction Do not switch off Remove the patient or the test target respectively and continue the test Align the patient Check the eyetracker settings Check whether the eyetracker illumination is shifted into position or the lights are blocked Center the pupil ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 List Of Messages And Warnings No OPM 36 Eyetracker Menu MES 3 Gas Menu MES 38 Gas Menu
24. EET EL ELEC LE TLCETTTPTeLerrTererreeriiieererrrererreererriere reer err ree eee gt Carry Out The Wavefront Optimized Or The Test Treatment After the data transfer a Popup Window prompts the user to select between the Test or Treatment Mode The Test Mode is to verify the geometry of the ablation profile Figure 56 Popup Window Select Mode Here you can select between the TEST MODUS and the TREATMENT MODUS Test Perform as many test ablations as desired using the generated treatment pattern e g on paper or test plates to cross check once more again the result of the ablation process ablation geometry This window can be disabled with the option in the Setting Menu Enter Default Settings see chapter 5 6 13 on page 121 such that the Treatment Mode is set as Default Mode e Press the Test button to start the TEST MODUS or e press the button to start the TREATMENT MODUS ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 85 of 232 A wA WaveLight Functional Description After this the following Wavefront Optimized Treatment Window is shown It is divided in five fields 1 Patient Data 3 Treatment Data 5 Menu Bar 2 Laser Panel 4 Laser Status Table 8 Sections Of WFoptimized Treatment Window Laser WFoptimized O B Mustermann Peter 18 08 1973 Treatment Data i Patient 3 Correction Pa Treatment type Optical z
25. ENERGY CHECK 1 Mount ext Energy Sensor 2 Continue with OK KEY Figure 31 LCD Screen External Energy Measurement Page 52 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description WaveLight PEELE ELE Le gt A CAUTION Make sure that the measurement head holder is completely slipped to the stop before pressing the LASER pedal Figure 32 Calibrate Energy Mount Sensor amp OK Keys e Shift the eyetracker illumination in Be sure that it is pushed completely in e Shift the holder of the sensor head beyond the laser aperture completely to the stop ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 53 of 232 A SA WaveLight Functional Description LASER Pedal Figure 33 Press LASER Pedal e Press the LASER pedal Laser pulses are emitted onto the sensor head The measured energy is displayed The so called E V value pair E relative laser head energy value V relative laser head high voltage value is updated every 1 200 pulses and appears on the lower right of the LCD screen of the laser console e After at least 15 seconds lift the foot off the LASER pedal and check whether the measured value is within the tolerance of the target value that is shown on the LCD screen amp NOTE Always press the LASER pedal for as long as it takes to get an updated E V value pair This procedure can be repeated
26. Gaussian beam profile 400 Hz Scanning Spot Excimer Laser System Nitrogen Purged Synchronized Eyetracker and Laser Trigger 400 Hz Active IR Eyetracker system Diode 635 nm red continuous wave Laser class 2 DIN EN 60825 Zeiss Zoom or Zeiss OPMI Pico Working distance 20 cm 7 87 inch Optional integrated camera system Membrane key switch joystick Notebook computer Calibration Objective calibration PMMA verified through Ablation Depth Normal Glass Standard Energy check Closed loop control 1 ArF Premix Gas cylinder 20 integrated 1 Nitrogen Gas cylinder 20 integrated Ambient air 120 x 145 x 130 cm with OPMI 47 24 x 57 09 x 51 18 inches 256 kg 564 pounds Basic laser console without gas cylinders ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Technical Data Power Supply Mains Power consumption Fuses Table 21 Power Supply Data Communication USB stick Table 22 Data Communication ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 FA WaveLight 208 240 V AC 1 phase 16 A 50 Hz 5 1 0 kW Integrated over current circuit breaker Electrical Connection e The operating voltage is provided via the USB port A separately power supply is not allowed e Voltage DC 4 5V 5 5V Current lt 150 mA operating Mechanical Connection e USB connector type A according DIN EN 61076 3 107 Interface e Com
27. Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 175 of 232 A j SA WaveLight Functional Description A CAUTION The test depth of ablation on the Fluence Test Disk is 62 5 micron depth Test Disk 0 0625 0 0015 mm 62 5 1 5 micron Attached with the delivery of the Calibration Tool Kit you will receive a label Target Ablation Depth 62 5 Micron This label is fastened on the front of the Ablation Depth Micrometer as a reminder Target Ablation Depth 62 5 Micron Figure 141 Reminder Label Fastened On The Front Of The Ablation Depth Micrometer A CAUTION If the measured ablation depth deviates for the target value by more than 3 0 microns 0 0030 mm please call your ALLEGRETTO WAVE EYE Q service representative In this case do not attempt to change the energy as described above Example The target value with allowed tolerance is 0 0625 0 0015 mm 0 0610 to 0 0640 mm The user is allowed to change the energy if the depth measures between 0 0595 and 0 0655 mm otherwise he has to call his ALLEGRETTO WAVE EYE Q service representative see chapter 10 Technical Assistance from page 210 Page 176 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description A WaveLight 5 17 6 Ablation Depth Normal Glass Standard A CAUTION Handle the Ablation Depth Normal Glass Standard with great care Do not drop it scratch it or touch t
28. Routine Test Procedures With The Control Systems from page 152 e Regular checks by the operator on visible damages on power and data cords e Calibration of the external energy sensor every two years by a WaveLight AG authorized service representative Half yearly inspection of the complete system by a WaveLight AG authorized service representative Inspection of the ArF gas system while changing the ArF Premix gas cylinder e Inspection of the Nz gas system while changing the Nz gas cylinder Changing the Round PMMA Cleaning Felt every 6 months ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 211 of 232 A j SA Wave Lig ht Technical Assistance 10 3 Technical Safety Inspection WaveLight AG recommends to carry out technical safety inspections at regular intervals by your WaveLight AG authorized service representative and to document them in the Product Folder Included in the inspection are accessories wearing parts disposable articles and the device interfaces used in connection with the deployment of the device whenever the safety of system use can be significantly influenced by these secondary components We recommend to carry out the technical inspections after system start up after all repairs and after intervals of not more than 6 months The following technical inspections are to be carried out e visual inspection of device and accessories e inspection of system func
29. Solution e To continue the treatment press the LASER pedal e For the eyetracker Center Test the CENTER pedal can be activated To continue the treatment press the LASER pedal Choose an option and follow the instructions on the display e Choose another list e Contact your Distributor Choose an option and follow the instructions on the display The system asks to check the blower of the Test Adapter Examination whether an air flow is clearly perceptible and the Test Adapter is connected with the ALLEGRETTO WAVE EYE Q If yes confirm with OK Key ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 List Of Messages And Warnings b Notebook Messages FA WaveLight In the following table 18 messages and warnings are shown which could be displayed during the System Check or treatments Please also refer to the warning messages of the ALLEGRETTO WAVE EYE Q laser console page 198 If a fault cannot be corrected by means of this summary call your authorized ALLEGRETTO WAVE EYE Q service representative see chapter 10 1 Service Hotline on page 210 No Error Message Solution No ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 These numbers serve only for the internal organization Here you will find the display messages Here you will find suggestions to take remedial measures and to be able to continue the treatment
30. Standby Mode The user can repeat all main test procedures in between the treatments e The microprocessor monitors many sensors and displays messages and alerts if necessary e The adjusted laser and treatment parameters are checked cyclically and shown on the LCD screen of the laser console e The ArF Premix gas cylinder must be re closed after every procedural step in which ArF Premix gas is required e The laser system is equipped with a remote interlock connector that can be connected to the door of the treatment room so that the laser will stop firing if the door is opened during a treatment see chapter 4 3 Switching Elements And Interfaces figure 5 Elements On The Rear Side Of The Device on page 27 e The ALLEGRETTO WAVE EYE Q laser is a stable stationary device that should not be moved by the user Page 22 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 System Description WaveLight 4 4 1 TTT TTL Pe TITTLE LETTE EEE gt SYSTEM DESCRIPTION System Overview Eyetracker Monitor ne Notebook Operation Microscope Ablation Depth Micrometer Optics Arm LED Slit Illumination System Patient Bed Pivoting optional Laser Aperture A LCD Screen Control Panel Laser Pedal Center Pedal ALLEGRETTO WAVE EYE Q Laser Console Figure 1 ALLEGRETTO WAVE EYE Q Laser System With Optional Accessories ALLEGRETTO WAVE EYE Q 1010
31. User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 23 of 232 WaveLight System Description 4 2 Lighting Plume Evacuation Air Intake Eyetracker LED s For Neuro Track Red Continuous Distance Diodes Green Flashing Fixation Light AND Cross Line Projector concealed Red Aiming Beam Eyetracker Illumination Infrared Light Microscope Illumination White Light Figure 2 Integrated Radiation Sources Figure 2 gives an overview of the integrated radiation sources Two superimposing red diode laser beams distance diodes define the treatment plane at the intersection point of the two diodes In addition a green flashing LED serves as a fixation target for the patient It is coaxial to the optical axis The patients can see this target only in a small area based on the viewing angle A cross line projector enables the alignment of the patient s head The beam axis of the aiming beam laser diode is coaxial to the excimer beam axis and used as the centering check The infrared lighting is necessary for the function of the eyetracker The infrared lighting arrays are mounted on a lever that can be turned for comfortable preparation of the eye Special white light emitting LED arrays are integrated for the illumination of the eye They are responsible for the bright high contrast picture of the operation microscope A plume evacuator can be used to remove the ablation debris option Page 24 of 23
32. WaveLight gt Before the Eyetracker Test is being performed the energy check has to be successfully completed See chapter 5 4 5 Check And Calibration Of The Internal Laser Energy on page 50 The Eyetracker Test ET Test verifies alignment of the eyetracker with the laser The test is performed on a daily basis before surgery and involves ablation of an Eyetracker Test Target Alignment of the eyetracker can be adjusted in the ET Test sub menu Calibration Eyetracker This sub routine can be opened in the ET Test Menu after the ET Test has been performed To carry out the Eyetracker Test please refer to chapter 5 17 Routine Test Procedures With The Control Systems on page 152 All parameters adjusted in this menu by the user will be saved after leaving the ET Test Menu ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 61 of 232 A gt j SA WaveLight Functional Description 5 4 7 Fluence Test Before the Fluence Test is being performed the energy check and the ET Test have to be successfully completed See chapter 5 4 5 Check And Calibration Of The Internal Laser Energy on page 50 and chapter 5 4 6 Eyetracker Test on page 61 The Fluence Test allows determination of the energy density of the laser at the treatment plane The test is performed on a daily basis before surgery and involves an ablation of the Fluence Test Disk and allows
33. Wavefront Optimized Treatment eee 72 5 6 3 Examination Data Range Wavefront Optimized cceeeeeeeeee 92 5 6 4 Treatment Data Range Wavefront Optimized ceceeeeeeeeeeeees 93 Ss PUM senn a aE E Eaa 94 5 6 6 Screenshot ccccccceceeeeeeeeeceeeeeeeeeeeeeeeeegaaaeaeeeeeeeeeeeesenaaeeeeeeeeeeeeeee 95 Page 6 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Contents 5 6 7 5 6 8 5 6 9 5 6 10 5 6 11 5 6 12 5 6 13 5 6 14 5 6 15 5 6 16 5 6 17 5 6 18 5 6 19 5 6 20 5 7 5 8 5 9 FA WaveLight E E idea E A gt Page How To Perform a PTK Treatment ceeeeceeeceeeeeeeeeeeeeeeeeneeeeeeees 96 Treatment Data Range PTK cccccceeeeessseseeceeeeeeeeeeesesnseeeeeeeeees 109 IDO a DIe ire soos centoventarsraaicedisasditidadaiabioonmiabedeaitadetanasiataghtadeaasyesetaniss 110 Setting MENU cesc erissidssiiairei erda nidaaia eedan ida e dae iiai aa iaaa Eain 118 How To Change The Language And The Date Time Format 119 How t S t The TIMET siessce seceteeehcpyecefaeetcee tery v ce Santen lapyneardenecntaenien 120 Enter Default Settings 2cgtscuciiicnccrnadndaenctcusidventntnenssducudnandntnerdadmeadueubnan 121 Treatment Counter sas naniconmecnetnasicaancacnrmasuetaooitnanexnasiomnoents 123 Connect To Service Center cccccceeessceecceeeeeeeeeeeeseeeeeeeeeeeeeeeeeeee
34. a grid failure it is not allowed to start a new treatment The ALLEGRETTO WAVE EYE Q laser system is optionally powered through an Uninterruptible Power Supply UPS This device shall safeguard the system against sudden power loss that could cause abortion of a started treatment or test procedures The UPS provided by the manufacturer does also a power and a frequency conversion to meet the power requirements of laser console and certain accessories For details please refer to the Site Preparation Instructions Make sure that the UPS is permanently connected to mains and the Main Switch on the rear side of the UPS is always in RUN position Otherwise the batteries inside the UPS will not be charged This may lead to failure of the UPS in case of a power loss Please refer to the User Manual of the UPS Figure 10 Uninterruptible Power Supply Page 34 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 ELA LoL lh 7 0L ee eae ed CR TA k 5 5 1 FA WaveLight FUNCTIONAL DESCRIPTION A WARNING Should signs of erroneous treatment data or system malfunctioning become apparent do not continue with the treatment to avoid irreversible injury to the patient For said reason only qualified and experienced personnel may operate the laser system A WaveLight AG authorized service technician performs the installation and functional check of the laser An authorized clinical trainer will instruct the su
35. agricultural broadcast services radio amateur stations AM and FM radio and TV senders cannot be determined in advance To determine the electromagnetic environment as a result of stationary HF senders an examination of the installation site is recommended If the field intensity at the installation site of the ALLEGRETTO WAVE EYE Q system exceeds the indicated upper compliance level the ALLEGRETTO WAVE EYE Q device is to be kept under observation at each site of use with respect to its normal operation In the event of detecting unusual performance features taking additional measures might be necessary such as e g a reorientation or relocating the ALLEGRETTO WAVE EYE Q system P Across the frequency range of 150 kHz to 80 MHz the field intensity is smaller than 3 V m Table 28 Electromagnetic Immunity Page 228 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Technical Data FA WaveLight gt Recommended Safety Distances Recommended safety distances between portable and mobile HF communications devices and the system model ALLEGRETTO WAVE EYE Q The ALLEGRETTO WAVE EYE Q system has been designed for use and operation in an electromagnetic environment where radiated HF interferences are controlled The customer or user of the ALLEGRETTO WAVE EYE Q system may contribute to the prevention of electromagnetic interferences by strictly observing the minimum distances between portable and mobile HF co
36. as default value Ready Key Pressing the Ready Key places the laser system in the Ready Operational Mode after which the treatment may begin Status indicators are the LED above the key as well as the Ready sign of the LCD screen Repeated pressing the Ready Key switches the laser system back into the Standby Mode Using the notebook program to activate the ALLEGRETTO WAVE EYE Q s remote control option the Ready Key of the notebook has to be pressed first After the Ready Key has been pressed the laser energy is once again checked internally resulting in a delay between the moment the key is pressed and the appearance of the READY symbol on the display After several minutes the system resets the READY state if the treatment has not been started and switches into the Standby Mode By default the eyetracker is active at this point Thus after switching the system to READY and before starting with the treatment the function of the eyetracker must be checked by pressing the CENTER pedal right pedal This will be prompted on the display The default settings for treatments are Eyetracker ON Distance Diodes ON Aiming Beam OFF Cross Line Projector final selected setting These settings have to be used during treatment Page 32 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 System Description S WaveLight ee PEREPOETETT ETT TTLITTTT TCE TELE LEE CLEELEELELELEEL
37. as soon as it is turned on The following precautionary measures should be taken when the machine is turned off e Keep the ArF Premix gas cylinders closed when the machine is turned off e Follow the system instructions when changing the gas i e whenever opening and closing the ArF Premix gas cylinders Fluorine is part of the Premix gas mixture necessary for running the excimer laser Fluorine is an extremely reactive and highly toxic gas that can cause serious chemical and toxic irritations It can even in sufficiently high concentrations lead to death due to respiratory failure It distinguishes itself through an extremely piercing odor that can be detected by nose at a concentration below that of the maximum permissible workplace concentration of 0 1 ppm In case the Premix is inadvertently released into the room air the user must avoid exposure for periods longer than those permitted according to local safety regulations A further potential chemical hazard occurs in the formation of hydrofluoric acid which occurs if the fluorine comes into contact with water Ozone A further potential danger consists in the formation of ozone which arises from the interaction of oxygen and either ultraviolet radiation or high voltage Ozone can also be detected by its pungent odor and is not critical at concentrations of lt 0 1 ppm Purging the beam path with Nitrogen gas N2 reduces the formation of ozone in the laser system Pa
38. black on a yellow background 11 1 Labeling Of The Laser Unit Device Nameplate The manufacturer s identification label is located on the rear side of the laser system see figure 160 EU Labeling Of The AALEGRETTO WAVE EYE Q Laser Console on page 218 ZA WaveLight ALLEGRETTO WAVE ArtNr EYE Q Art No 230 V 50 Hz max 16 A max 3 2 kW Schutzklasse 1 Class 1 equipment N ArF Excimer 193 nm Laserklasse 4 Laser class 4 1010 X Pilot Laser 635 nm Aiming Beam Laser 635 nm m Laserklasse 2 Laser class 2 C 1275 Abstands und Kreuzliniendiodenlaser 635 nm Distance and Cross Line Diode Lasers 635 nm Laserklasse 2 Laser class 2 Manufactured MM YYYY Serien Nr Serial No 1010 X YYY Klasse Ilb nach EG Richtlinie 93 42 EWG class Ilb according to EC directive 93 42 EEC WaveLight AG Am Wolfsmantel 5 91058 Erlangen Germany Figure 153 Identification Label Laser Console Position 1 Page 214 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Labeling WaveLight Symbol Meaning The symbol indicates the type of the applied part and the protection AN against electric shock see chapter 12 1 Device Data table 25 Classification on page 224 The triangular symbol on the identification label indicates that the AN operating instructions are to be adhered to when operating the device C 1275 The CE ma
39. by pressing the Setup Key on the panel e The patients eye must be brought into position via patient bed adjustments e Focusing of the cornea is carried out with the help of the distance diodes Both beams must cross on the corneal vertex Make sure that the height adjustment is precisely correct The cornea must only be roughly centered within the treatment plane but precisely focused during the whole treatment in z direction The ablation will be centered and kept centered by the eyetracker e The eyetracker will center the ablation on the eye automatically e The aiming beam reflex must then lie in the center of the pupil Subsequently the aiming beam will be switched off and the latter will then follow the eye movement Page 134 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description A WaveLight ETT TTT Lee ELECT LETLEPET EC LETLCETTTPTeLerrererrrerriieererrrererrrererriere reer irre reer gt A CAUTION When the aiming beam reflex is far away from the middle of the pupil gt 0 5 mm offset values for intended decentration may have been defined If not the system is not adjusted properly In any such case please call your WaveLight AG authorized service representatives immediately and do not perform a treatment To evaluate the position of this red tracked aiming beam it may be helpful to move the eye head a little bit to distinguish between dista
40. day before switching off the ALLEGRETTO WAVE EYE Q laser to make sure that you have enough treatments available for the next treatment days The ALLEGRETTO WAVE EYE Q laser system does not assist with warning messages referring running out released treatments No treatments can be carried out if the Treatment Counter shows 0 or GS e Press the button to get more treatments activated e press the OK button to confirm The respective Treatment Key appears e g Topo guided Topo guided Your treatment key send this to WaveLight Service Type in the new treatment code Figure 88 Treatment Key Page 124 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description A WaveLight To get more treatments activated you have to transfer your Treatment Key via Treatment License Form to WaveLight AG You will get this form from your ALLEGRETTO WAVE EYE Q service representative NOTE Once you have sent a Treatment Key you cannot carry out any treatments until you have entered the new Treatment Code Fill out the Treatment License Form with name location Fax No date and signature Complete the form with the serial numbers of your respective devices the software version of your notebook and your Treatment Keys for the respective treatment you want to get released see figure 88 Treatment Ke
41. e Functional Description A WaveLight TTT TT eee TET ETC LET EL ELEC LE LLCE TTT PTCLeTLererrieeriieerrrrrererrrererriere reer rrr ie rere gt WFoptimized Here the treatment type can be changed subsequently Set the treatment type to WFoptimized Wavefront Optimized and exit the drop down box using the TAB button Sph 2 00 jD Cyl R xis gt VD 120 mm Sph 0 00 D PA is Sph 2 00 o Correction Type Myopic Astigmatism Clinical shows refractive values entered in Examination Data Target shows refractive target values Correction These values are used for the treatment composed from Clinical and Target Correction Type shows differently colored visualization for better determination Myopia and Myopic Astigmatism yellow Hyperopia and Hyperopic Astigmatism magenta Astigmatism and Mixed Astigmatism white Check if all data have been entered correctly e Enter a target value for sphere and cylinder if not zero e Enter Optical zone e Enter Flap thickness An alert will occur if the calculated remaining stoma thickness is thinner than the limit that is defined in the setup ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 79 of 232 A j SA WaveLight Functional Description Wavefront Optimized Treatment Calculation qQ e Now the Summary Window can be opened by pressing the Summary F6 e Click the button to go to the
42. ee 5 p List Of Accessory Products SA WaveLight 14 LIST OF ACCESSORY PRODUCTS Item Number 1056 1057 1059 1084 1157 1152 1175 1185 6136 6148 6323 1007 1506 Designation Patient bed Chair with backrest Monitor TFT Notebook Plume evacuator LED Slit Illumination System External nitrogen gas connector Video system with camera UPS Uninterruptible Power Supply Sterile set Operation microscope Please also see chapter 5 17 Routine Test Procedures With The Control Systems table 14 Contents Of Control Systems on page 153 Table 30 List Of Accessory Products Subject to change without prior notice A current list of accessories is available from WaveLight AG at any time ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 gt Page 231 of 232 End Page 232 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001
43. gt Patient Bed The patient is brought into proper position via the patient bed control unit Precise information on adjusting the bed can be found in the patient bed User Manual Since the ALLEGRETTO WAVE EYE Q automatically switches off the power to the bed during laser emission for safety reasons the patient bed cannot be moved during treatment Because of this safety switching feature the patient bed can only be moved when the ALLEGRETTO WAVE EYE Q is turned on In case of collision hazard between eyetracker illumination and patient head the patient bed power is switched off automatically if the patient s head touches the eyetracker illumination assembly LCD Screen Instructions for the user as well as important laser and application parameters are indicated on the LCD screen of the laser console Notification For example the system SYSTEM CHECK is in System Check Instruction and General Indication Information Lines Status notifications Symbols For example a gas cylinder symbol Figure 7 Display Instructions ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 29 of 232 WaveLight System Description Control Panel With Joystick Gas Key OK Key Joystick Not Used Not Used Eyetracker e lt gt e Eyetracker Key Adjustment ON OFF Cross Line Key Cross Line ON OFF Brightness Aiming Beam Key ON OFF Microscope Illumination B
44. is able to store about 3000 treatments dependent on the number of events during treatment Choose an option and follow the instructions on the display e Choose another list e Contact your Distributor e Contact service e Follow the instructions on the display Follow the instructions on the display Page 205 of 232 ZA WaveLight No OPM 10 OPM 13 OPM 16 OPM 25 OPM 26 MES 113 Menu Treatment Treatment Treatment Treatment Treatment Test Adapter Display Continue at Laser Pedal Test Center Pedal Continue at Laser Pedal Interrupt at Test Center Pedal Selected data not released Continue with OK Key Interrupt at Continue Ready Key End OK 2s Check blower Test Adapter Continue with OK Key List Of Messages And Warnings Reasons Interruption of the treatment at because the LASER pedal has been released Interruption of the treatment at because the LASER pedal has been released Interruption of the treatment at because the LASER pedal has been released The laser device is in Ready Mode A treatment list is selected which is not released with your system Interruption of the treatment at and the laser device is in Standby Mode The function of the blower Test Adapter is to be checked Table 17 Messages And Warnings Laser Console Page 206 of 232
45. is ok no user interaction is necessary but it is important not to switch off the system during the calibration procedure If the calibration is not ok please follow the instructions displayed on the LCD screen of the laser console Purpose Warming up of the laser head setting of the recommended energy User Assistance If the laser energy is too low the system automatically conducts a gas change and requires the user to open and close the valve of the ArF Premix gas cylinder Feedback Status reports possible request for the opening and closing the ArF Premix gas cylinder error message should the laser energy be too low or too high SYSTEM CHECK Warming Up Laser Head Figure 29 LCD Screen Warming Up Laser Head This routine will check the internal energy after gas change and does not always occur The system reports Warming Up Laser Head This phase lasts 10 seconds Page 50 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description A WaveLight ETT TTT eee LEE TELE EE TEP ELEC LETC ETTTPTeLerLererreeriieerrrrrererriererrrere reer Tree eee gt The system then reports Setting Laser Energy This involves the re setting of the internal energy value used during the previous treatment SYSTEM CHECK SETTING LASER ENERGY Preparing laser Please wait Figure 30 LCD Screen Setting Laser Energy The user will hear the pulsating noise
46. it is necessary to operate the system next to or stacked with other devices the ALLEGRETTO WAVE EYE Q system shall be kept under observation to check whether the system in its configuration and arrangement operates in accordance with its intended use Guidelines and manufacturer s declaration Electromagnetic emissions The ALLEGRETTO WAVE EYE Q system has been designed for use in an environment as specified below The customer or user of the ALLEGRETTO WAVE EYE Q system has to ensure that the system is used in such an environment Emission measurements In accordance with Electromagnetic environment guideline HF emissions Group 1 The ALLEGRETTO WAVE EYE Q system uses according to CISPR 11 HF energy exclusively for its internal functioning For this reason the HF emission is very poor and it is unlikely that this results in an interference with adjacent electronic devices HF emissions Class B The ALLEGRETTO WAVE EYE Q device is according to CISPR 11 suitable for use in all facilities including those in living areas and such ones that are directly Harmonic oscillations according Class A connected to a public supply network that also to DIN EN 61000 3 2 supplies electricity to buildings being used for Voltage fluctuations flicker fulfilled sete purnpescs according to DIN EN 61000 3 3 Table 27 Electromagnetic Emissions Page 226 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Technical Dat
47. kinebutan eini 210 10 2 Maintenance ssssseeeeeesseseerrrrrtreserrrttrnnnttestettrttnnnnnnesennrntnnn nennen neen 211 10 3 Technical Safety INSPeOCtiION c ccceceeeeeeeeeeeeeeeeeeeeeeeeeeeneeeeaeeees 212 10 4 Disposal eran e ase ee secs tn ets Besser eee cepa 213 Ws LABELING issscatsissisnsascaassoncesacntnanaanranesancudvasanceansieacuansutannaacsaacnaceadanesarianceanexe 214 11 1 Labeling Of The Laser Unitbesiaccscsccewciescilitscteniicecdatedvsadenidenedelsinecdate 214 11 2 Labeling Of The Ablation Depth Micrometet 2 cceeeeeeeeeeeees 219 11 3 Labeling Of The Test Adapter ccccccccceeeeeeeeeeeeeeeeeeeeeeeeeeeneees 220 11 4 Labeling Of The Laser Area 0 cceeeeeeeeceececeeeeeeeeeeneeneaeeeeeeeeeeeeeeees 221 12 TECHNICAL DA A casocaccnawecsiisaecaconapaccch vinancabeanecacastuntiab sannana dinana naranai ina eee 222 12 1 Device Data ooeesseeeeeeeeeoeeeeettrrtteeetrrtttnnnrtrseettttttnnntreeerertennnnnneeeee 222 12 2 Electromagnetic Compatibility cccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 225 13 WARRANTY sassscinsciicctcsanisactsnasdsacesanisasssaasatnsanceasssadcsaassaaivasanaianaaasanesajavananunsae 230 14 LIST OF ACCESSORY PRODUCTS sisssiecsdessccceccsccsnntncnccesssonierncsnasessdeucdsnsdecsuce 231 Page 10 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Introduction FA WaveLig ht 1 INTRODUCTION Intended Us
48. measurement of the central ablation depth The Target Energy of the laser is set with the Fluence Test Once the Target Energy has been set it must not be changed until another Fluence Test is performed To carry out the Fluence Test please refer to chapter 5 17 Routine Test Procedures With The Control Systems on page 152 After the System Check the ALLEGRETTO WAVE EYE Q laser system will perform a final Internal Nitrogen Pressure Check Once the final Pressure Check has been completed the laser switches into Standby Mode Window see figure 42 LCD Screen Standby on page 65 All parameters adjusted in this menu by the user will be saved after leaving the Fluence Test Menu Page 62 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description A WaveLight ETT eT E Eee TeTELCEE TL EP ETE CLE LLCE TTT ELeLerrererrreriiieerrrerererriererrieererreer err ie ee eeeee gt 5 5 Treatment Direct Entry Without Notebook Treatments may be carried out with or without the notebook In either case the system behavior and the types of treatment remain identical It is recommended to use the Portal Software to enter the treatment data Please see chapter 5 6 Navigation And Data Entry With The Notebook Portal Software on page 69 The notebook computer serves as a tool for pre programming and storing treatment data It serves also as a kind of remote contro
49. of 232 A SA WaveLight Functional Description Procedure 1 Place the Test Adapter on the headrest of the patient bed Align the Test Adapter properly so that the Test Target Holder is parallel to the optics arm under your microscope Eyetracker Illumination Test Target Holder Test Adapter Headrest Figure 116 Test Adapter With Eyetracker Test Target CET Page 158 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 ee e Functional Description SA WaveLight 2 Insert an unused Eyetracker Test Target into the Test Target Holder of the Test Adapter 3 Fixate the target with the square metal weight against sliding and bending The target should lie flat and aligned on the Test Target Holder Square Metal Weight Pictogram patient head Eyetracker Test Target Test Target Holder Tray Figure 117 Inserting The Eyetracker Test Target CET 4 Move the bed to the center of the target and focus onto the surface of the target The red distance diode spots must be superimposed in the center of the pupil print Recommended useful magnification 1 x or 1 6 x ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 159 of 232 A i A WaveLight Functional Description Pee EEE EET errr itt t ttt ttttey sees EEE Eee see see PEPE eee ett t Pupil Figure 118 Alignment Of The Eyetracker Test Target CET 5 Swing and lock eyetracke
50. of 232 Display Measurement lt 15sec Continue with OK Key Measuring time exceeded Continue with OK Key Deviation of energy OK Continue Setup E check OTHER Key abort Edit measured energy with JOYSTICK Continue with OK Key List Of Messages And Warnings Reasons The secondary energy was measured less than 15 seconds The waiting period was too long The device is waiting for new instructions The system detected a deviation of the given energy The measured energy comes to of the given energy The treatment progress is displayed Adjust the displayed energy from the external energy measuring system with the joystick Solution Please proceed with the measurement until a measuring time of min 15 seconds has been reached Press the OK Key The device then flushes the beam path and proceeds with the energy measurement e Interrupt treatment and perform energy measurement If the energy measuring has been performed successfully the treatment can be continued If an error occurs during the energy measurement the treatment has to be interrupted Close down the device until the service has tested and released the system Contact service e Insert the measured value and confirm with the OK Key e Follow the instructions on the display ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 List Of Message
51. refraction No 7 5 mm optical zone Table 10 Treatment Data Range WFoptimized ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 93 of 232 ZA WaveLight Functional Description 5 6 5 Printout e Press the button to print out the treatment and patient data If you prefer to get the printout automatically please activate the function Please refer to chapter 5 6 13 Enter Default Settings on page 121 ALLEGRETTO ZA WaveLight Treatment report Test Eye os 01 01 1970 Male ID 000100002 Status Initiated Treatment Ablation Profile Type F CAT No 1 Date 02 02 2004 Correction 3 00D 0 00D oa Clinical 3 00D 0 00D 0 Target Ref 0 00D 0 00D 0 Optical Zone 6 50 mm Transition Zone 4 25 mm Vertex Distance 0 0 mm K reading K1 43 00D 0 K reading K2 43 00D 90 0 00 0 0 00 90 0 00 Maximum Depth 48 22 um Pupil Diameter 6 50 mm Central Depth 48 22 um Applied Drugs Test Drug Corneal Thickness 520 pm Device SP 3000 Examination by Doctor Flap Thickness 160 pm Surgeon Doctor Confirmed by Doctor Stroma 311 pm Memo and postOP Comments Test Note WaveLight AG Am Wolfemantol amp D 91058 Erlangen Germany ALLEGRETTO NOTEBOOK PORTAL Version 1 208 build 0023 Figure 64 Example For A Printout Page 94 of 232 ALLEGRETTO WAVE EYE Q 101
52. screen of the ALLEGRETTO WAVE EYE Q laser Control panel functions of the laser console can be switched by clicking on the buttons of the control panel display of the ALLEGRETTO WAVE EYE Q Treatment Window Default settings should not be changed ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 87 of 232 A j SA WaveLight Functional Description Test Treatment e Check the eyetracker e The laser can now be switched to the Ready Mode by moving the cursor to the laser warning symbol A and clicking on the left mouse button Instead of this it is also possible to press the SPACEBAR on the keyboard of the notebook e The ALLEGRETTO WAVE EYE Q will now conduct internal tests e If tests are successful the ALLEGRETTO WAVE EYE Q laser console and the notebook portal software will indicate the Ready Mode The treatment time and a green Ready Mode indicator will be shown in the ALLEGRETTO WAVE EYE Q Treatment Window e Follow the orders on the notebook screen and the LCD display of the laser console e The system is now ready to perform a Test treatment To do so press the LASER pedal Once the laser ablation has been started a progress bar in the laser status field shows the progress of the laser treatment i 80 i 68 Laser running AIF N2 Progress PAKA Figure 58 ALLEGRETTO WAVE EYE Q Treatment Window Page 88 of 232 ALLEGRETTO WAVE EYE Q 1010 User M
53. the Ablation Depth Normal Glass Standard 13 Atleast two of the three measured values should be within 0 0005 mm 0 5 um of the marked depth value Figure 144 Example Of The Marked Depth Value 14 Note all values in the Test Report in the Archive Folder 15 Call your ALLEGRETTO WAVE EYE Q service representative if more than one gt 1 value is outside the tolerance range In the pictured example the depth of the recess on the Glass Standard is 0 0430 mm 43 microns With the tolerance of 0 0005 mm the allowed limits would range from 0 0425 to 0 0435 mm The measured value in the displayed example is 0 0432 mm and therefore is well within the limits of the example Glass Standard Depth of 0 0430 mm with its tolerance limits ranging from 0 0425 to 0 0435 mm amp NOTE Your Ablation Depth Normal Glass Standard may have a different depth than that provided in the example above ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 179 of 232 ZA WaveLight Functional Description 5 17 7 Scanner Test This test is used to check the alignment and setting of the scanner mirrors that are responsible for the laser spot positioning 5 17 8 Scanner Test Procedure Do not touch the surface of the ablation target for the Scanner Test with your hand so as to avoid finger oil contamination Only touch the frame of the ablation target for the Scanner Test 1 Put the Test
54. the desired direction stop as soon as the aiming beam reflex has reached the desired location for the center of the ablation e Engage the CENTER pedal and hold e The aiming beam now indicates the center of the pupil e Adjust the desired position with the joystick Here you may change the values while engaging the CENTER pedal abort the procedure and start the test again after entering new values NOTE Exiting this menu is only possible if the OK Key is pressed and held for more than 2 seconds The selected values are saved and remain valid only for the following laser treatment e Leave this screen by pushing the OK Key for 2 seconds ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 147 of 232 A j SA WaveLight Functional Description 5 16 9 LCD Contrast The Contrast LCD setting allows the user to increase or decrease the contrast of the LCD screen Select the Contrast LCD Menu item by moving the joystick forward or backward Move the joystick to the left to decrease contrast and to the right to increase contrast next page FLUENCE TEST ET TEST GAS CHANGE AFF SCANNER TEST ENERGY CHECK DEF CENTER CONTRAS MECR TTT DISTANCE DIODES TTT AIMING BEAM TTT VD mm 14 FLAT K D 43 SETUP Return Press OK KEY Figure 108 LCD Screen Contrast LCD Intensity Bar Page 148 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manua
55. the device see chapter 10 4 Disposal on page 213 Page 12 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A Safety Instructions WaveLig ht POP TTT Ter TET errr TET ETE TTT E PETE CeeTLEreTETe rei LCerrTrreeerreererreeriiieerererererirererriere reer err ie rere gt 3 SAFETY INSTRUCTIONS A CAUTION It is absolutely necessary to read this User Manual carefully before using the ALLEGRETTO WAVE EYE Q laser system Please also refer to the User Manuals of other accessories and equipment that are used in conjunction with the ALLEGRETTO WAVE EYE Q laser system National regulations for installing and operating medical products and medical lasers respectively have to be taken into consideration The ALLEGRETTO WAVE EYE Q laser device is an active medical device of class Ilb according to the Medical Device Directive 93 42 EEC Any laser can cause physical harm if used improperly The ALLEGRETTO WAVE EYE Q contains a class 4 laser Please remember that reflective materials or instruments can deflect the laser beam haphazardly Special attention must be paid to glass surfaces Similarly high gloss polished metal surfaces within a few meters of the laser can cause dangerous laser irradiation Prescribed laser protective goggles must be worn in case of laser emission in the laser area Except for therapeutic purpose never look directly at the laser beam If the laser beam is d
56. will decenter nasally on e g negative dx values will decenter nasally on the patients OS eye the patients OD eye Figure 107 Center Of Ablation Page 146 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description A WaveLight ETT TT eee TEC LET LEL ETE CLEC ETTTPTCLeTiTererrieeriiieerrrrrererriererriere reer Tree eee gt Procedure e Position the patient To do this adjust the patient bed so that the patient s pupil lies roughly centered inside the visual field of the operating microscope e Adjust the height so that the distance diodes cross on the surface of the cornea e Shift the eyetracker illumination into position e Check if the eyetracker catches the pupil e Start the routine Def Center in the Setup Menu by shifting the joystick to the right Ref to 1 enter exact values for x and y by pushing the joystick in the desired direction of decentration Check the desired decentration with the microscope engage the CENTER pedal and hold The aiming beam is switched on blinks and indicates the entered position relative to the pupil center displaying either a spot or a concentric ring on the currently chosen center point Ref to 2 engage the CENTER pedal first the aiming beam is switched on it blinks first and indicates the pupil center continuously Keep the pedal depressed and shift the aiming beam reflex across the cornea by tilting the joystick in
57. will fall out of the centering ring automatically Be aware to catch it 10 Center the Test Adapter in the space provided on the patient bed head support and connect the voltage supply 3 pin connector to the right side of the Ablation Depth Micrometer see figure 113 Ablation Depth Micrometer and figure 114 Test Adapter on page 156 Blower Opening Test Target Holder Pupil 4 0 mm Green LED Figure 132 Test Adapter With Test Target Holder And Test Disk ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 169 of 232 A j SA WaveLight Functional Description A CAUTION Proper blower function is necessary for the ablation as this will otherwise result in an erroneous ablation depth 11 The Test Adapter s blower starts automatically The function can be checked with the integrated green LED green LED ON After start of the Fluence Test the system asks to check the proper function of the blower within the Test Adapter Check blower test adapter Continue with OK KEY Figure 133 LCD Screen At Start Of Fluence Test If The ALLEGRETTO WAVE EYE Q Has Automatically Detected A Non functioning Blower If you get this message the control does not receive a feedback from the blower of the Test Adapter Please check whether an air flow is clearly perceptible and the Test Adapter is connected with the ALLEGRETTO WAVE EYE Q Page 170 of 232 ALLEGRETTO WAVE EYE Q 1010 U
58. with a medical device featuring maximum control and safety thus offering the patient highest customer satisfaction If you have any questions please call SA WaveLight Am Wolfsmantel 5 91058 Erlangen Germany Hotline Tel 49 1805 52 62 62 Fax 49 9131 6186 221 E Mail Service ophtha service wavelight com E Mail Application ophtha applications wavelight com ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 11 of 232 2 A SA WaveLight General Notices To Users GENERAL NOTICES TO USERS A CAUTION As with every technologically sophisticated medical device the use of this laser system requires special training and skills The laser may only be used by specially trained physicians who are well versed in its therapeutic effects and possible dangers and who possess the necessary skills to use it in conformity with the operating instructions contained in this User Manual The ALLEGRETTO WAVE EYE Q laser is a medical device currently designed for use according to its intended use as described in this User Manual Applications other than those described in this User Manual are prohibited and are the exclusive responsibility of the operator This User Manual refers only to operation maintenance and care of the device All treatment data in the figures are given as example values In this User Manual modifications are described which are valid for firmware version PR V4 1
59. 0 User Manual en Rev 9 09 06 08 Item No 6638 2001 A Functional Description A Wavelight 5 6 6 Screenshot To perform a screenshot insert a USB stick into the USB port see also figure 77 on page 113 e Then press CTRL P The current screen is saved as jpeg file Please also see section USB stick Deactivation on page 117 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 95 of 232 ZA WaveLight Functional Description 5 6 7 How To Perform a PTK Treatment Entering Patient Data e Either select a patient from the treatment list or create a new one For creating a new patient click the New Patient button If the patient already exists a Popup Window asks to create a new ID EG e Now enter the patient s personal data e select the eye you wish to treat e and click the i button or the F4 button For detailed information please refer to chapter 5 6 Navigation And Data Entry With The Notebook Portal Software section Entering Patient Data on page 73 Patient Data Planned F2 Treatments Pati ent F3 Filter PTK Ba H Musterfrau Paula 24 02 1974 oD Last Name Examination D1 PTK 22 02 2006 F4 ID First Name Date of Birth Treatment F5 Gender Treatment No 1 Treatment method PTk Treatment status Initiated Figure 65 Patient Data Window Page 96 of 232 A
60. 0 User Manual en Rev 9 09 06 08 Item No 6638 2001 Labeling WaveLight PP TTT TTC TTT LTET ETE TTT ET eT Peer TLTErerETe rei LCerrTrTererrrererrreriiieerererererriererriere reer err er eee gt Labeling Of The Gas Valve Handles The labels of the ArF and the Nz gas valve handles are attached at the rear side of the laser console see figure 160 on page 218 Figure 157 Labeling Of The ArF Gas Valve Handles Position 5 Figure 158 Labeling Of The N2 Gas Valve Handles Position 6 Labeling Of The Beam Output The labels marking the laser beam exit aperture are visible from the user side see figure 160 on page 218 Figure 159 Labeling Of The Beam Output Position 7 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 217 of 232 A WaveLight Labeling The labels are to be positioned as indicated below 4 val So P gt Position 7 Laser Aperture N K dK NEA 1 Position 4 Position 3 Position 2 Position 1 Position 5 Position 6 Figure 160 EU Labeling Of The ALLEGRETTO WAVE EYE Q Laser Console Position 1 Device nameplate of the ALLEGRETTO WAVE EYE Q laser console 2 U S Patent Labeling 3 WaveLight AG ALLEGRETTO WAVE Patent Labeling 4 Laser warning signs 5 Labeling of the ArF Premix gas valve handle 6 Labeling of the nitrogen gas valve handle 7 Laser aperture label Page 218 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en
61. 2 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A System Description SA WaveLight 4 3 Switching Elements And Interfaces System Main Switch All components of the ALLEGRETTO WAVE EYE Q laser system that require mains voltage are powered from the Mains Distribution Box The System Main Switch on the Mains Distribution Box controls all system power The switch is lit when it is switched on Components typically powered from the Mains Distribution Box Laser Console Eyetracker Monitor Patient Bed LED Slit Illumination System Notebook Computer The Mains Distribution Box is located between laser console and patient bed It must only be opened by authorized service personnel System Main Switch Mains Distribution Box Figure 3 Mains Distribution Box With System Main Switch ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 25 of 232 WaveLight System Description Emergency Laser Emission Stop Switch Key Switch Figure 4 Key Switch And Emergency Laser Emission Stop Switch On The Front Of The Device Key Switch The Key Switch is for turning the laser device on and off The key can also be removed to prevent unauthorized system use It has three positions 1 OFF 2 ON 3 START Emergency Laser Emission Stop Switch The Emergency Laser Emission Stop Switch allows the laser system to immediately shut down the laser emissio
62. A Wave Lig ht Safety Instructions The device has been tested for electromagnetic conformity EMC Despite adherence to all applicable EMC requirements malfunctioning cannot be ruled out entirely If this equipment does cause harmful interference to other devices which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures e Reorient or relocate the receiving device e Increase the space between the devices e Connect the equipment into an outlet on a circuit different from that to which the other device s are connected Do not exert strong force to connect electrical plugs and sockets If it is not possible to connect them check whether the plug is correct for the socket If you find damage in either a plug or a socket have them repaired by our service personnel To disconnect electric plugs from their sockets do not pull on the cable but rather on the plug itself Do not use the units contained in the standard equipment list e in places where there is danger of explosion e inthe presence of combustible anesthetics or volatile solvents such as alcohol benzine or the like Do not store or use the unit in damp rooms Avoid placing the unit near dripping or splashing water and make certain that no liquids can enter the unit For this reason please do not place any containers of liquid on top of the unit and also take care when clean
63. ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description WaveLight Data to ALLEGRETTO button is enabled and the data of the surgery is stored in the schedule list Planned e Press the button screen Mode Window If the data transmission is not successful the message Laser Not Ready will appear The transmitted data will appear on the LCD screen of the laser unit The surgeon must confirm the data and follow the prompts on the The laser must be in Standby gt o A e Click the Puen button to see the calculated planned treatment patterns in the schedule list Calculated Treatments ammm Since only one data set has been imported confirmed and calculated a Planned data set is displayed Planned Treatments Planned F2 Pati ent F3 Calculated Treatments Transmitted Treatments Mustermann Peter OD 02 Musterfrau Paula OD01 Treatment FS sterfrau Paula OD 01 Figure 70 Planned Treatment Window PTK ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 103 of 232 ZA WaveLight p Functional Description e Press the button aise in the Summary Window and follow the prompts on the screen amp NOTE A data transfer is only possible if the ALLEGRETTO WAVE EYE Q laser device is in the Standby Mode If the d
64. E AND ACCESSORIES A WARNING Cleaning agents containing evaporating solvents like alcohol isopropanol or acetone may influence test and treatment results if present in the air around the laser system during test and treatment Routine cleaning and disinfecting should be conducted only when the System Main Switch on Mains Distribution Box has been disconnected A CAUTION Aggressive cleaning agents especially those containing abrasives can damage component surfaces While cleaning the surfaces of the ALLEGRETTO WAVE EYE Q laser system make sure that cleaning fluids do not seep inside of the device as this can lead to damage and malfunctioning Do not spray or pour cleaning agents directly on the ALLEGRETTO WAVE EYE Q laser console or on the accessories You may damage the ALLEGRETTO WAVE EYE Q accessories or system electronics Do not leave any cleaning agent residues Do not use aggressive cleaners containing chlorine solvents abrasives or powerful chemicals It is best to clean the outer surface of the housing with a soft cloth and an antistatic cleaner The outer surfaces can also be wiped with a damp cloth In this case please wipe away residues using a mixture of equal parts of alcohol and distilled water to which a splash of a standard commercial dishwashing liquid has been added Wet tissues and solvents like alcohol or acetone must not be used to clean the ALLEGRETTO WAVE EYE Q or the patient bed Please r
65. EELLLe gt Fixation Light Block Out Key The blinking green fixation light cannot be permanently switched off However in order to check whether the patient is correctly fixating on the light it can be switched off temporarily via the corresponding switch located on the front cover see figure 9 below Eyetracker Dynamic Test Key For the purpose of determining whether the eyetracker can accurately track the pupil in the entire permissible treatment field four blinking yellow LED s are mounted around the beam emission aperture as alternative fixation targets They can be activated by the corresponding switch located on the front cover see figure 9 below White Balance Control Key The white balance of the video system is automatically set and fixed by detecting the characteristic color temperature of the light source through the lens and controlling the amplification of red and blue signal The white balance can be activated by pressing the corresponding switch located on the front cover see figure 9 below Eyetracker Dynamic Test Key Hi i Fixation Light Block Out Key P gt White Balance Control Key gt gt Change Input TFT Monitor OJ currently not available Figure 9 Switches Located Below The LCD screen ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 33 of 232 F WaveLight System Description Optional UPS Uninterruptible Power Supply A WARNING If there is
66. EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description A WaveLight 5 5 2 Entering Treatment Data The ALLEGRETTO WAVE EYE Q is ready to start with a treatment after successfully completing the System Check e Activate the system for direct parameter entry via control panel by pressing the OK Key from the Standby Mode Window or e import the treatment data via the notebook please refer to chapter 5 6 Navigation And Data Entry With The Notebook Portal Software on page 69 Press OK KEY or start Notebook Program Figure 42 LCD Screen Standby A NOTE Once the OK Key has been activated the data have to be entered via the control panel gt ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 65 of 232 A j SA WaveLight Functional Description The Treatment Window will appear on the screen A Compass Rose symbol PTK Ps joystick is used for DEPTH DIA Re parameter selection 3 00 2 00 28 6 50 LASIK D SPH D SPH AXIS MM OZ Version Of Used 1 Select data with JOYSTICK4 Nomogram 2 Press OK KEY for Nomogram s001 VD 13 0 mm Vertex Distance mm Flat K Reading D Figure 43 LCD Screen Treatment Without Notebook the treatment parameters as soon as the joystick symbol appears on the LCD screen The selected treatment type is represented inve
67. F4 Mustermann Peter 18 08 1973 Treatment F5 Summary F6 Treatment No E 15 05 2006 Treatment method PTK Treatment status New Figure 83 Pop up Menu Settings gt gt e To enter the Setting Menu click with the right mouse button on the Data Bar In the Setting Menu the following entries are available e Language e Connect to Service Center currently not available Timer currently not available e Browse Customer Info currently not available Recreate Data Files e Settings e Save Logfiles see chapter 5 3 1 Logfile Option on page 38 e Treatment Counter e Service e Info Page 118 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description ZA WaveLight ETT eee EEE CEE TL EL ELEC LE LLCETTTPLeLeriererrieriiieererreererriererrrere rire rrr rere eee gt 5 6 11 How To Change The Language And The Date Time Format Open the Setting Menu and select the Language menu option see figure 83 Pop up Menu Settings on page 118 Please choose your Language Please choose your Language English Deutsch Please choos youruare English Ei Please choose your date and time format You have to activate both th language and d m Y x You have to restart this program to activate both the choosen language and date time format Figure 84 Language and D
68. Figure 68 Treatment Data Window PTK Page 100 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 F neona DESTO i E ee gate tea oe gt PTK Treatment Calculation Check all light blue entries for correctness and or e click the The Summary Window is displayed button or the FA WaveLight Summary F6 button button to go to the examination data Musterfrau Paula 24 02 1974 Last Name First Name ID Date of Birth Eye Treatment No Treatment method nZone um depth Central depth Stroma Corneal thickness Musterfrau Paula 100002 24 02 1974 oD 1 PTK 15 05 2006 10 um 8 00 mm 9 00 mm 10 um 10 um 550 um 410 um Figure 69 Summary Window PTK ALLEGRETTO Planned F2 Patient F3 Examination F4 Treatment F5 Print F8 The Summary Window shows all important data required to start the calculation of the ablation pattern needed for the treatment ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 101 of 232 A SA WaveLight Functional Description e Check the treatment data e enter a SURGEON button e and press the e Click the button to start the ablation pattern calculation of the treatment A progress bar shows the progress of the calculation ALLEGRETTO Page 102 of 232
69. Functional Description 5 8 Checking The Eyetracker Function e Shift the eyetracker illumination into position e Press the Switch Key on the eyetracker monitor so that the eyetracker picture is displayed e Perform the following tests Determine whether the eyetracker Detects the pupil in the entire treatment field Press the Eyetracker Dynamic Test Key located on the front cover see figure 9 Switches Located Below The LCD screen on page 33 This will activate four blinking yellow LED s configured around the laser aperture Ask the patient to look at these LED s in succession Using the eyetracker monitor check if the eyetracker can detect the pupil in all positions e Neuro Track Keep the LED s switched on during treatment That gives the function of Neuro Track Pupil Tracked By The Eyetracker lris Figure 93 Image Detected Pupil Page 130 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description A WaveLight ETT TTT eee ECE T ELC LE TL EPET Ee LELLCETTTPTeLerreererrieerieeerererererriererrrere reer Tree eee gt A WARNING Do not perform a treatment if the pupil is extremely deformed A CAUTION Make sure that the pupil diameter does not change significantly during the course of treatment Therefore apply the same microscope illumination brightness during the Center Test as well as during the treatment I
70. Functional Description A WaveLight SPELL EEEELELELEL EEE LEE EEE LEe gt Aa NOTE For safety reasons only a limited amount of setup functions are available during the Treatment Mode e Move the joystick left or right to open a selected menu function and access sub menus or change values or settings e Selected sub menu and Setup Menu can be left again by pressing one of the OK Keys This will always result in returning to the previous menu screen Figure 102 Open Setup Menu Function Select A Menu Item By Shifting The Joystick Left Right ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 141 of 232 A j SA WaveLight Functional Description 5 16 1 General Settings Next Page Move the joystick forward or backward to select a Main Menu item FLUENCE TEST ET TEST GAS CHANGE AFF SCANNER TEST ENERGY CHECK DEF CENTER CONTRAST LCD DISTANCE DIODES AIMING BEAM VD mm FLAT K D UVUATTAUTUTULAUA TAHT TNIV AULON UNIONO UINN 14 43 SETUP Return Press OK KEY Figure 103 LCD Screen Select Menu Item next page Next Page contains e Language setting for the laser unit e Date setting for the laser unit e Time setting for the laser unit LANGUAGE DAY Month YEAR MINUTE HOUR ENGLISH 19 10 07 06 SETUP Return Press OK KEY Figure 104 LCD Screen Next Page Functi
71. If a message or warning does not disappear then please contact your authorized ALLEGRETTO WAVE EYE Q service representative Error Message The patient data in the measurement file you selected differs from the patient data previously loaded No List available No treatment data available Ablation depth exceeds limit values for calculation Ablation depth too high Optical zone larger than pupil diameter Optical zone larger than measured wavefront Solution Make sure that the correct file was loaded Contact service Change treatment data Reduce optical zone or treatment parameters Reduce optical zone reduce modified sphere or switch tilt off Reduce optical zone size Reduce optical zone size choose Wavefront Optimized treatment repeat wavefront measurement and import process or agree by proceeding Page 207 of 232 ZA WaveLight 10 11 12 13 14 15 16 17 18 19 20 Page 208 of 232 Error Message No transition zone defined No optical zone defined No PTK depth defined No flap thickness defined No higher orders included Tilt was switched off manually SEQ exceeds treatment limits Modified sphere outside approved range Modified cylinder outside approved range The safety and effectiveness of modifying the wavefront guided treatment has not been assessed This program requires a display resolution of at least 1024 x 768 wi
72. LLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description A WaveLight ETT eee LETC CLE TLEL ELEC LE LLCETTTPLCLerLererreeririeerererererrrererrieere reer rrr er eee gt Entering PTK Examination Data The following data can be entered or edited in the Examination Data Window PTK Photo Therapeutic Keratectomy This function has no refractive influence on the cornea therefore O can be specified for the sphere cylinder and axis Musterfrau Paula 24 02 1974 Patient Diameter F3 O Central thickness Applied drugs Test Drug z gt achymeter SP 3000 gt Treatment F5 Summary F6 Laser F7 Test Note ee rer m l Print F8 Exit Esc S Figure 66 Examination Data Window PTK Example With Data A CAUTION For the s1 and 2 values only use the ALLEGRO Topolyzer Please refer to the Topo guided User Manual ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 97 of 232 A gt j SA WaveLight Functional Description A wrong Vertex Distance leads to wrong corrections please check this value carefully e Fill out all light blue textboxes and check the entries for their correctness The dark blue textboxes can be filled out optionally Pupil Diameter mm Pachymetry Central thickness um Clinical Refraction SPH D CYL D Axis VD mm Keratometry K1 D K2
73. Mice 139 5 16 Set p Ment Renee ene ree none ner err eer irha ere reer er ere eres rer ere rere rere 140 5 16 1 General Settings Next Page eeeeeeeeccceeeeeeeeeeeeeeneeeeeeeeeeeeeeeees 142 Dlo2 PIUGHNCE TS cacicncdcicnnecirndsncancstimnadiernoanisasnereacmanasnonmes 143 5163 Ei ose cence estes eee te nee se ee aces ee eare aa 143 5 16 4 Gas Change Ath cceceecese edie eawerieaenedis 144 5 16 5 Scanner TGS tassels sctasitscincatetdalensatbectinadalbdatnadalbadeiealeih adem bedsleadelaabeinrdcbinislnadess 144 5 16 6 Micrometer TOS lisse peu cetiicutrcatdensrautiaptocutdantunntiquenenticntenutiapeuctievsunetnesiass 144 5 16 7 External Energy CMCC gaciceviceleeeeteiv tea yieedeeutesceeey iealeeeelusdivey dene aybeaue 144 5 16 8 Definition Center Of Ablation sisceis cecccipeeisceteereeesseees nesence eae vine 145 516 9 LOD Commas serana i ET ASES 148 5 16 10 Brightness Setting Distance Diodes sssnnnneeeseeesnnrrnrereserrrrreren 149 5 16 11 Brightness Setting Aiming Beam cccceeeeeeeeeeeeeeneeeeeeteeeeeees 150 5 16 12 Vertex Distance 20 0 cece eecceeeeee cece eeeeeeeeeaeeeeeeeeeeeeeencaaaaaeeeeeeeeeeeeeas 151 5 16 13 Setting Flat Fu iecette street estnantdenteentantrantdecteenboantreetasieniiasecntbareontmesess 151 Page 8 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Contents FA WaveLight 5 17 Routine Test Procedures With The Control Systems 5 17 1
74. ON Please check the Vertex Distance value carefully Incorrect values may lead to under or over corrections The amount of laser ablation is determined by the refractive error Refractions must be corrected for Vertex Distance VD in units of mm to prevent over or under corrections As soon as treatment parameters are downloaded from the notebook computer to the laser console the values of the downloaded treatment will set the new values automatically Once data are downloaded the Vertex Distance cannot be changed The current Vertex Distance is displayed Select the value of the Vertex Distance of the device which was discovered from the measurement If the entered vertex distance is smaller than the default value the entered vertex distance will be automatically set as new default value 5 16 13 Setting Flat K A CAUTION Please check the Flat K carefully Incorrect values may lead to under or over corrections Keratometry readings are used to determine the dioptric power of the cornea Ablations must be corrected for lowest dioptric power of cornea Flat K Value in units of diopter to prevent over or under corrections As soon as treatment parameters are downloaded from the notebook computer to the laser console the values of the downloaded treatment will set the new values automatically Once data are downloaded the Flat K can no longer be changed The current Flat K is displayed Set the value of the Flat K Reading
75. Screen ArF Premix Gas Pressure And Leakage Test SYSTEM CHECK Check premix pressure Laser Head Figure 20 LCD Screen Pressure Check Laser Head SYSTEM CHECK Pressure Test Laser Head Figure 21 LCD Screen Leakage Test Laser Head Page 46 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description WaveLight Follow the instructions on the LCD screen and press the Gas Key at the control panel If the Gas Key has not been pressed within 10 min the system will turn itself off The system checks to see whether the ArF Premix gas cylinder has been opened If the cylinder has not been opened the system after running the corresponding inspection will again request that the ArF Premix gas cylinder must be opened A gas change of the ArF Premix gas in the laser head should be carried out at least once a day when turning on the system for the first time The system will generally ask if a gas change should take place This procedure is skipped when any other button on the control panel is pressed except the Gas Key SYSTEM CHECK Perform manually activated GAS CHANGE Yes GAS KEY Skip OTHER KEY A Figure 22 LCD Screen Gas Change 5 4 4 Laser Head Pressure Purpose Pressure inspection of the laser head valve block air tightness inspection User Assistance None Feedback Pressure values error messages in case of defects ALLEGRET
76. T EC LELLCETTTPTCLeTiererrieeriieererrrererrrererrrererieer irre reer gt The target is a square yellow disc Eyetracker Test Target CET Item No 1007 3401 it is made of plastic dimensions 50 x 50 mm A pupil with surrounding ruler grid is printed on one side It has to be used together with the Test Target Holder To fixate the test target during the ablation the attached square metal weight Square Ring Weight has to be applied which is delivered together with the ALLEGRETTO WAVE EYE Q laser system Rear Patient i Paliants badi Y rs ole X Physician Coordinate System oe ete Signature Mark For Crosswires ET Monitor List Control Systems T FA WaveLight Logo Date Eyetracker Target 10073401 U Front User Figure 115 Eyetracker Test Target The purpose of this test is to check the proper calibration of the eyetracker Principle of the test The eyetracker recognizes the printed pupil on the target During the test a ring structure will be ablated around the pupil The eyetracker centers the ablation automatically during the test The centering of the ablation has to be evaluated by using the grid around the pupil Calibration values can be changed in the ET Test Menu After changing the values another test ablation on a new target has to be performed ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 157
77. TO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 47 of 232 gt A j SA WaveLight Functional Description The following sequence appears on the LCD screen of the laser console SYSTEM CHECK Pressure Check Please wait Figure 23 LCD Screen Pressure Check Laser Head SYSTEM CHECK Evacuation ArF Premix line 4560 mbar Figure 24 LCD Screen Evacuation Of The ArF Premix Line SYSTEM CHECK Check of pressure ArF Cylinder Figure 25 LCD Screen Pressure Check ArF Cylinder Page 48 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description A WaveLight SYSTEM CHECK GAS CHANGE ArF 10 80 mbar Figure 26 LCD Screen Running Gas Change SYSTEM CHECK GAS CHANGE ArF 5940 mbar Figure 27 LCD Screen Status Gas Change SYSTEM CHECK Close ArF Gas Cylinder and confirm with GAS KEY 5945 mbar ma Figure 28 LCD Screen Close ArF Cylinder The Gas Change Has Been Finished ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 49 of 232 gt A j SA WaveLight Functional Description 5 4 5 Check And Calibration Of The Internal Laser Energy A routine is integrated that checks intensively the relation between the internal energy sensors After each GAS CHANGE ArF this procedure starts automatically If the calibration of the sensors
78. TTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 17 of 232 ZA WaveLight Safety Instructions When positioning or moving the patient bed or other moving parts please make sure that patients system operators and other personnel cannot be squeezed or pinched To avoid possible skin irritations of the patient all areas of the patient bed coming into direct contact with the patient shall be covered with paper Do not perform a treatment if any component is broken The use of any component not validated for use with the ALLEGRETTO WAVE EYE Q laser system is not permitted and is the sole and exclusive responsibility of the user Page 18 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A o Safety Instructions WaveLig ht 3 4 Use Restrictions A CAUTION The laser device ALLEGRETTO WAVE EYE Q has been tested according to DIN EN 60601 1 2 EMC see chapter 12 2 Electromagnetic Compatibility on page 225 Accessories not authorized by WaveLight AG may not be used The ALLEGRETTO WAVE EYE Q laser system may only be operated with the components that are delivered with it or are provided by WaveLight AG Each component has been inspected and approved for use See chapter 6 Accessories on page 186 Running any software that has not been approved and released by the manufacturer is not permitted The ALLEGRETTO WAVE EYE Q and its components may not b
79. The Calibration Tool Kit ceeeeeeeeeeeeeeeeeeeeeeeees 5 17 2 Check Of The Eyetracker FUNCTION ceeeeeeeeeees 5 17 3 Eyetracker Test And Calibration Procedure 5 17 4 Test Of Eyetracker Centering cccceeeeeeeeeeeeeeeees 5 17 5 Fluence Test And Calibration Procedure 000 5 17 6 Ablation Depth Normal Glass Standard 008 DAV Scanner 1 OSl sioccsctcirnenherncsenmnceresnwornoseraanuatas 5 17 8 Scanner Test Procedure eecceceecceeeeeeeeeeeeeeeeeeees 5 18 TEMG Off cee cagesies seendtvevedesinecegdeeucieedtecetaedianusendieectacsis gt ae 62 63 he amp Soa een ei ee eee eee ence Dene ea eee men 6 1 Patient Bedsits noain noactvesbiutnaattantonets 6 2 Video Adapter veesincctcscteive rey Gendeeulccleeeytealbeubutvtvay eavbveyiue 6 3 Ne 010 0 Cee 7 CARE OF DEVICE AND ACCESSORIEG cccccsssseeeesseseeeeenes 8 ERRORS AND HOW TO PIM wiseicscssssnticssssndasssititnensanstassstastecesannes 9 LIST OF MESSAGES AND WARNINGS cssssseeeeseesteeeenes ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 TT gt Page 9 of 232 F WaveLight Contents sad cs ioc ei cs ns wine erase vin leo enn ti tales vin E A T Page 10 TECHNICAL ASSISTANCE scssissessssiissnssciceissscissnessveversssniceesisnivavenevsvensseuesnees 210 10 1 Service HONE Se secila ee tet tony dene ces iarere kaninn katni serka
80. ZA WaveLight ALLEGRETTO WAVE EYE Q User Manual This User Manual ALLEGRETTO WAVE EYE Q is valid as from Firmware Version PR V4 1 02 see chapter 5 3 Turning On The System from page 37 and Notebook Portal Software Version 2 020 see chapter 5 6 19 Notebook Software Info on page 127 Page 2 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 1 i Typographical Conventions S WaveLig ht Eee TTT TTT ETE C LTTE EL ETC LE LLCE TTT ELC LeTLTererreeriieerrrrlererrerrerreere reer err ie reer gt TYPOGRAPHICAL CONVENTIONS The following conventions and symbols are used in this manual A WARNING A Warning alerts the user to potential serious outcomes to the patient or user in case of non observance of this warning A CAUTION Precautions alert the reader to exercise special care necessary for the safe and effective use of the device Notes provide helpful or supplementary information to the user Further Typographical Conventions In addition to the aforementioned the following conventions are used in this User Manual SS KEYBOARD Here you have to enter or edit items in the menu EG MOUSE Move mouse or click mouse button ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 3 of 232 ZA WaveLight General Warnings And Precautions GENERAL WARNINGS AND PRECAUTIONS A WARNING This laser workstation and its accessories can caus
81. a Electromagnetic Immunity Guidelines and manufacturer s declaration Electromagnetic immunity FA WaveLight The ALLEGRETTO WAVE EYE Q system has been designed for use in an environment as specified below The customer or user of the ALLEGRETTO WAVE EYE Q system has to ensure that the system is used in such an environment Immunity test Electrostatic discharge ESD according to DIN EN 61000 4 2 Electrical fast transients bursts according to DIN EN 61000 4 4 Surges according to DIN EN 61000 4 5 Voltage dips short interruptions and voltage variations according to DIN EN 61000 4 11 Magnetic field Power frequency 50 60 Hz according to DIN EN 61000 4 8 DIN EN 60601 test level 6 kV Contact discharge 8kV Air discharge 2kV For mains power lines 1kV For in and output lines 1kV Normal mode voltage 2kV Common mode voltage lt 5 Ur gt 95 dip of Ur for Yea cycle 40 Ur 60 dip of Ur for 5 cycles 70 Ut 30 dip of Ur for 25 cycles lt 5 Ur gt 95 dip of Ur for 5s 3 A m Compliance level 6kV Contact discharge 8kV Air discharge 2kV For mains power lines 1kV For in and output lines 1kV Normal mode voltage 2kV Common mode voltage lt 5 Ur gt 95 dip of Ur for Yea cycle 40 Ur 60 dip of Ur for 5 cycles 70 Ur 30 dip of Ur for 25 cycles lt 5 Ur gt 95 dip of Ur for 5s 3 A m NOTE Ur
82. a virus free USB stick into the USB port and press the Save Data button to confirm In case the transfer process has been successfully completed a message window appears on the notebook screen To confirm the message press OK For further information please also refer to chapter 5 6 10 Setting Menu from page 118 With the Save Logfiles function two files are stored File name Contents File 1 lasercfg log Configuration of the laser console File 2 laseropm log Treatment data and list of messages occurred as well as status software version Page 40 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description A WaveLight ETT eT C LTTE EP ETE CLE LLCETTTPLCLerrTererrieeriiieererrrererriererreererreer irr ier ere gt 5 3 2 Self Test The Self Test is an internal procedure that does not require user participation The following items are inspected during the Self Test e the central processor e the memory in regard to the procedure program e the memory in regard to the treatment lists e the communication with the excimer laser head After successfully completing the Self Test the system continues with the System Check ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 41 of 232 A j SA WaveLight Functional Description 5 4 System Check The System Check tests function elements of the ALLEGRETTO WAVE EYE Q that
83. ademark of WaveLight AG Right From the Start is a registered trademark of WaveLight AG Zeiss and OPMI are registered trademarks of Carl Zeiss Microsoft Windows 2000 is a registered trademark of Microsoft Corporation Copyright by WaveLight AG Germany All Rights reserved Page 4 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Contents FA WaveLight CONTENTS 1 INTRODUC TION yisvcssvsssssssnsssvsacnnsesntancsssannvencevesneiswosnvsienniswetsvnannas 2 GENERAL NOTICES TO USERS sscvissiccvsccsscccscssvecssesscenseansvecssens 3 SAFETY INSTRUCTIONS ssscctissccscstsssinestucndsnsieeriasiereenetanaiwendinnd 3 1 Eye Protection seriinin AR 3 2 Safety Against Fluorine and OZone6 cccccceeeeeeees 3 3 Patient Safety sccsesececahedinnuntn5coecxtediowssdndcacceaedivensaedizccseeoes 3 4 Use Restrictions scsi ccntaceie cic iatertatindalsadebedelpedetsalilundsbadsiendal 3 5 Safety DO SION ersectuantenescutdewzesetaacboeetinesvastbeveneutieennestiauss 4 SYSTEM DESCRIPTION wisseiesccisosscccssasasenssnsseccnecnvousessneadveceseness 4 1 System Overview 2 0 0 2 eee eeeeeeeeeeeeee eee eeeeeeeeeaeeeeeeeeeeeeeeees 4 2 Ligning eea T 4 3 Switching Elements And Interfaces cccccecee 5 FUNCTIONAL DESCRIPTION ccccessseeeeeeessseeeeeeeneeeeeeeees 5 1 Important Steps Before Turning On The System 5 2 Structure Of The ALLEGRETTO WAVE EYE Q Firmware 5 3 Tu
84. age 89 after the treatment to enter a note Auto Print Enable this check box to get the printout of the treatment report automatically see chapter 5 6 5 Printout on page 94 Auto ARS The function ALLEGRETTO REMOTE SERVICE provides a data transfer to the service center Please ask your WaveLight AG authorized service representative to activate this function Enable this check box to get an automatically pop up window after each program start Page 122 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description ZA WaveLight T TTT gt 5 6 14 Treatment Counter e Enter the Setting Menu and click on Treatment Counter The following window opens where the remaining treatments are shown OP Counter Total Topo guided Figure 87 Treatment Counter Remaining Treatments This function is used for setting a defined limited number of treatments in for the respective treatment type 1 means that the counter is inactive i e an infinite number of treatments of this type can be realized When the treatment counter shows a number of x treatments x treatments can be performed Please refer to the following description ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 123 of 232 ZA WaveLight Functional Description Please always check the remaining treatments after each treatment
85. ains calm and relaxed during the treatment and that the patient is able to concentrate on the fixation light otherwise the treatment result could be unsatisfactory Ask your WaveLight AG service center to check the ALLEGRETTO WAVE EYE Q if the system was exposed to any type of shock that could have caused a misalignment of the optical pathway A safety check is necessary after any type of shock before any further treatments are performed Misalignment after a shock exposure could result in non satisfactory treatments ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 21 of 232 A z j A Wave Lig ht Safety Instructions 3 5 Safety Design General specifications and standards relevant to design and manufacturing practices and procedures such as those delineated in DIN EN 60601 and DIN EN 60825 were adhered to in the design and manufacture of the ALLEGRETTO WAVE EYE Q laser system Additional protective measures designed into the system offer a high degree of safety and operating comfort e The microprocessor unit conducts a Self Test after the laser is switched on If the test indicates an error the device shuts off automatically after a time span of 10 minutes e After successfully completing the internal Self Test the System Check is carried out e The user is actively involved into the System Check and should protocol the test results e Ifthe tests indicate no errors the laser switches to
86. aintained and the deteriorated ArF Premix gas fill of the laser head must be exchanged If the V value reaches a value gt 98 a new fill of the laser head is necessary This can be carried out by selecting this item in the Setup Menu An automatic ArF Premix gas Change is carried out once a day when starting the system in the morning Each additional gas change during a day can then be selected manually Make sure to open the ArF Premix gas valve according to the instructions on the LCD screen and close the cylinder after completing the new fill procedure The Gas Change ArF routine will step the operator through the process of changing the ArF Premix gas in the laser head 5 16 5 Scanner Test The Scanner Test verifies range and accuracy of the laser console scanning capability The test is performed monthly and documents the performance of the laser scanner with a Scanner Test Slide No operator adjustments can be made in this function 5 16 6 Micrometer Test The Micrometer Test verifies the accuracy of the Ablation Depth Micrometer The test is performed monthly and documented in the Archive Folder No operator adjustments can be made in this function 5 16 7 External Energy Check The External Energy Check is performed when the laser console is started after Warming up of the laser console and before each treatment The Energy Check ensures that the laser is capable of achieving the Target Energy during the F
87. al devices may be installed operated and used only in accordance with the purpose for which they were designed and only in accordance with the stipulations of the Medical Device Law including any associated legal codes accepted technological regulations worker safety regulations and accident prevention regulations Medical devices may not be operated and used if they exhibit any defects through which the health and safety of patients employees or other persons could be endangered The devices may be operated and used only by persons who due to their training or to their knowledge and practical skills can offer assurance of proper device operation Page 14 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A Safety Instructions WaveLig ht 3 1 Eye Protection Due to the high energy density levels Fluence involved the eye is especially at risk of injury from laser beams The eye can incur injury even at low levels of irradiation Protection from laser irradiation has two components 1 Protection of the patient through the proper operation of the laser device by the physician and 2 Protection of all involved persons including the physician from unintended beam emissions A CAUTION Protective goggles must be worn while in the laser area Not observance can lead to irreversible eye injury Make sure that the laser protection goggles are in perfect condition before use The pro
88. al zone Figure 53 Summary Window Calculation In Progress ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Treatment method Mustermann Peter 100003 18 08 1973 0B 1 WE optimized 22 10 2007 2 50 D 150D 10 12 00 mm 6 50 mm 9 00 mm 60 um 60 um 550 um 370 um Data to ALLEGRETTO Patient F3 Examination F4 Treatment F5 Lager IFT Print F8 ALLEGRETTO Page 81 of 232 A j SA WaveLight Functional Description and panga are After finishing the calculation the buttons F2 enabled and the treatment is registered in the Patient Treatment Field Patient Data Planned F2 ID 000 us New ID 7 Patient New Patient Measurements Pravissoftware F3 Mustermann Max 25 08 1962 os LastName Mustermann Examination 01 WFoptimized 25 10 2007 F4 First Name Date of Birth Summary F8 K 25 10 2007 ptimized Initiated Figure 54 Patient Data Window Registered Treatment In the Treatment Information Field the treatment status is displayed Treatment No fi z 25 10 2007 Page 82 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description ZA WaveLight TTT eee TET TC LET EL ELEC LE LLCE TTT PTCLerrererreeriieerereeererriererrrere reer err ie ree eeee gt Planned e Click the lea button to see the calcula
89. ance e g from an USB stick See chapter 5 6 9 Import Data on page 110 In addition wavefront topography or Q value based custom ablation treatments A CAT Topo guided F CAT can be selected when this feature was enabled Please refer to the appropriate User Manuals The Portal Software user interface offers more information regarding the treatment than the LCD screen at the laser console does e g ablation diameter or ablation depth Mustermann Eye h ee Patient Data 3 00 2 00 LASIK aad ean Version Of Used Nomogram New treatm Data op Flat K Reading D Vertex Distance mm Nomogram s001 D 0 00 i ae Dec y 0 00 mm Decentration in x amp y Direction Mustermann Eye h er i Treatment e g A CAT 3 00 2 00 EOS o s b Version Of Used Nomogram New treatm Data o Flat K Reading D Vertex Distance mm Nomogram S201 Dec x 0 00 mm Dec y 0 00 mm Decentration in x amp y Direction Figure 46 LCD Screen A CAT Treatment Option ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 69 of 232 ZA WaveLight p Functional Description A CAUTION Only a notebook authorized by WaveLight AG must be used with the ALLEGRETTO WAVE EYE Q see chapter 6 Accessories from page 186 All standard Microsoft Windows 2000 control operations exist on the notebook computer The u
90. anual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description A WaveLight ETT TTT Lee TCE PETE CETTE EL ELEC LE LLCLTTTPTeLerrTererrieeriiieererrrererriererriere ieee err ier eee gt Finish Treatment Once the treatment has been completed gt S e enter a COMMENT if desired The option is selected in the Setting Menu Enter Default Settings chapter 5 6 13 on page 121 The treatment has been successfully finished Figure 59 Popup Window Final Comments e and press the button Once this window is closed the notebook portal software automatically returns to the Summary Window see figure 52 Summary Window on page 80 Entry boxes and most of the buttons will be disabled In the patient data window the treatment status is 0 displayed see figure 54 Patient Data Window on page 82 Treatment No 2006 10 24 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 89 of 232 A j SA WaveLight Functional Description Interrupt Treatment If a running treatment is interrupted for more than 10 seconds by leaving the LASER pedal a message will pop up The message will automatically close when you proceed with the treatment by pressing the LASER pedal again The Laser did not answer during the last 10 seconds This could indicate a disconnection Do you want to wait 10 seconds more Ced e Figur
91. are important for its proper operation There are tests that require feedback from the user as well as tests that are performed automatically The laser unit carries out the following tests during the System Check e Nitrogen gas pressure for flushing of the optical path e ArF Premix gas pressure e Laser head pressure e Internal laser energy e Pulse energy at beam aperture e Eyetracker function The System Checks are described in the following sections of this User Manual 5 4 1 General Information About The System Check Completing the System Check can take up to 12 minutes if a gas change is carried out The control panel is partially inoperative during the System Check so that you cannot use the Setup Menu A manual gas change does not need to be carried out if you are sure that the laser energy is still sufficient but it is strongly recommended to perform a gas change at the beginning of each treatment day After a successful System Check the laser system shifts automatically into Standby Mode When using the laser panel the Treatment Selection Menu can be started at this point by pressing the OK Key Alternatively the notebook program can be used to activate the ALLEGRETTO WAVE EYE Q s remote control option Page 42 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description A WaveLight godicuua E A A E T gt 5 4 2 Check Of Nitroge
92. ata transmission is not successful the message Laser Not Ready will appear The calculated data are sent to the ALLEGRETTO WAVE EYE Q laser A progress bar shows this process Page 104 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description ZA WaveLight TTT TT eee LEE ETELC CETL EP ETEC LE LLCETTTPLeLerrTeererrieriieerrrerererriererriere reer erie eerie gt Carry Out The PTK Treatment After the data transfer a Popup Window prompts the user to select between the Test or Treatment Mode For detailed information please refer to section Carry Out The Wavefront Optimized Or The Test Treatment on page 85 Figure 71 Popup Window Select Mode Q e Press the MEA button to start the TREATMENT MODUS The following figure 72 ALLEGRETTO WAVE EYE Q PTK Treatment Window on page 106 is shown ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 105 of 232 ZA WaveLight Functional Description A CAUTION To carry out a treatment on a patient please refer to the following chapters in the sequence listed below e chapter 5 7 Positioning The Patient on page 129 e chapter 5 8 Checking The Eyetracker Function on page 130 e chapter 5 9 Hints For Keratectomy on page 132 e chapter 5 10 Ready Mode on page 133 e chapter 5 11 Patients Eye Alignment Fixation And Centering on pag
93. ate Time Format Setting The following formats can be selected Date Format Time Format Day Month Year DMY Hour Minute Seconds HMS Month Day Year MDY or or Hour Minute HM Year Month Day YMD Choose the language date and time desired p 9 e press the OK button to confirm the settings and a restart the program Or e press the button to abort ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 119 of 232 ZA WaveLight 5 6 12 How to Set The Timer Patient Data Language Timer Settings Save Logfiles Treatment Counter Treatments Search Recreate Datafiles e E IU Filter all Musterfrau Paula 24 02 1974 oD p1 PTK 15 05 2006 Mustermann Peter 18 08 1973 Treatment No Treatment method Treatment status Figure 85 Timer Setting I6 LDG A H546 OO i G LDB A 0 6018 00 00 See also the timer default Smoren page 121 Page 120 of 232 Functional Description 15 05 056 A uuu 3 0943 Planned F2 15 05 2006 Pati ent F3 Examination F4 Treatment F5 Summary F6 e Pressing Timer in the Setting Menu displays the clock in the upper right corner of the screen To set the timer press the arrow up down keys The Go button starts the countdown When reaching 0 00 a signal tone can be heard in figure 86 Default Setting
94. ative laser head energy and V relative laser head high voltage values The V value should not exceed 98 If so the system requires another gas change Finish the Energy Check and perform another gas change The Energy Calibration Check can be repeated by pressing and holding the LASER pedal at least until the LCD screen prompts you to leave the LASER pedal If all values are within tolerances press the OK Key to confirm the energy value A CAUTION Do not attempt to change the Target Energy with the joystick during or after External Energy Check unless the later Fluence Test findings require this ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 59 of 232 A j SA WaveLight Functional Description If the LASER pedal is released before the LCD screen prompts you to do so and the OK Key is pressed the system will show Measurement lt 15 sec In this case the message has to be confirmed and the whole External Energy Check procedure has to be repeated Measuring Time lt 15s Continue With OK KEY Figure 39 LCD Screen Measurement Time Too Short The laser system will perform a final Internal Nitrogen Pressure Check Once the final Pressure Check has been completed the laser is ready to start a treatment and will ask for treatment data Page 60 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description A
95. chnical information please refer to the Site Preparation Instructions in your Product Folder Page 224 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Technical Data FA WaveLight TTT TTT CETTE ETE ECE eTECEE TLE EPeTETe Li TLCETrTTTeLerreererrieeriiieerererererriererrieere reer rrr ieee eee gt 12 2 Electromagnetic Compatibility 4 note Portable and mobile HF communications equipment may have an influence on electrical medical devices NOTE Electrical medical devices are subject to special precautionary measures with respect to EMC For the ALLEGRETTO WAVE EYE Q laser system no special measures have to be taken into account The following cable types have to be employed to ensure compliance with and observance of the interference emission and immunity criteria Overview Cables A CAUTION The use of other cables and accessories than specified in this document may result in a higher emission of interferences or in a reduced immunity to interferences Cable Length Mains power line 2 5 mM 98 inches Foot pedal unit with supply cable 3 0 m 118 inches Table 26 Overview Cables ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 225 of 232 F WaveLight Technical Data Electromagnetic Emissions A CAUTION The ALLEGRETTO WAVE EYE Q system must not be arranged directly adjacent to or stacked with other devices If
96. d Erase flash code CRC cfg Fluence out of range System error code Shutter 2 defective Time out remote control Scanner answer defective Invalid card or reader defective Table 15 Errors Laser Console Page 194 of 232 Reasons Defective sec energy sensor or laser head Incorrect pressure regulator settings Scanner reaction time too long Gas change duration too long Internal error Error during Flash Test Error during Flash Test External energy cannot be adjusted Table management error Errors And How To Fix Solution Contact service Contact service Contact service Contact service e Close ArF cylinder e Contact service Contact service Contact service Contact service e Change ArF gas e Contact service Contact service Contact service Contact service Contact service Contact service ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Errors And How To Fix b Notebook Errors In the case of a fault a message is displayed on your computer screen Please follow the instructions in the table 16 below to correct the problem Please also refer to the error messages of the AALEGRETTO WAVE EYE Q laser console page 190 If no message appears but there is a problem or if a fault cannot be corrected by means of this summary call your authorized ALLEGRETTO WAVE EYE Q service representative see chapter 10 1 Service Hotl
97. d of disease Accessories may not be powered by the use of multiple purpose or non fixed outlets To ensure safe operation of the ALLEGRETTO WAVE EYE Q and associated accessories a single fixed outlet is required Please also refer to the User Manuals of the accessories and equipment that are used in conjunction with the ALLEGRETTO WAVE EYE Q The Medical Device Law requires the operator of laser devices to use only those accessories that have been tested and approved for use with this laser You are required to use only tested accessories for the ALLEGRETTO WAVE EYE Q laser system WaveLight AG undertakes no liability for operating the ALLEGRETTO WAVE EYE Q laser system with products that have not been tested and approved for use with this ALLEGRETTO WAVE EYE Q You are required to use only tested accessories for the ALLEGRETTO WAVE EYE Q laser system A current list of accessories from our AALEGRETTO WAVE EYE Q product range is available from WaveLight AG at any time see chapter 14 List Of Accessory Products on page 231 Not released USB devices such as USB Hub or USB devices with external power supply must not be used Please refer to table 22 Data Communication on page 223 Our product range is constantly being updated and expanded Please refer to the supplied User Manual for references to test certificates concerning the capability of using accessories safely with the ALLEGRETTO WAVE EYE Q Please also see chapter 7
98. e The ALLEGRETTO WAVE EYE Q is a scanning spot excimer laser system used in refractive surgery for LASIK Laser In Situ Keratomileusis treatments The uniqueness of the system consists in a combination of technologically refined features including a compact excimer laser with leading edge high pulse frequency a galvanometer scanner for positioning the laser spot and a fast eyetracker for determining eye position and laser beam direction The Gaussian shaped beam profile of the individual pulses and an ablation diameter of approximately 1 mm assure the desired contour and minimize surface irregularities during ablation In addition to the photorefractive Wavefront Optimized applications myopia with or without astigmatism hyperopia with or without astigmatism this attribute in combination with the open system concept enables also the usage of patient related individual corrections These corrections could e g be based on topography or wavefront data A further advantage of the small spot diameter is that the ALLEGRETTO WAVE EYE Q requires the use of only minimal pulse energy The result is a compact excimer laser beam source with minimal gas volume and minimal gas consumption As the excimer laser is operated at a high repetition frequency short treatment times are assured The integrated eyetracker offers unique automatic centering of the ablation and tracking of even rapid eye movements With the ALLEGRETTO WAVE EYE Q the user is provided
99. e 134 e chapter 5 12 Starting Laser Treatment on page 136 Laser Planned F2 Mustermann Peter 18 08 1973 x Treatment Data Patient 10um F3 Examination F4 Treatment Stroma Treatment time A Summary Print F8 Exit Esc Figure 72 ALLEGRETTO WAVE EYE Q PTK Treatment Window Page 106 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description A WaveLight TTT TT gt e Align the patient such that he is positioned correctly e Check the eyetracker e The laser can now be switched to the Ready Mode by moving the cursor to the laser warning symbol A and clicking on the left mouse button Instead of this itis also possible to press the SPACEBAR on the keyboard of the notebook e The ALLEGRETTO WAVE EYE Q will now conduct internal tests e If tests are successful the ALLEGRETTO WAVE EYE Q laser console and the notebook portal software will indicate the Ready Mode The treatment time anda green Ready Mode indicator will be shown in the ALLEGRETTO WAVE EYE Q Treatment Window e Follow the orders on the notebook screen and the LCD display of the laser console and execute the treatment e Press the CENTER pedal to check the eyetracker function e Treatment can now be started pressing the LASER pedal The progress bar in the laser status field shows the progress of the treatment All text that appears on the
100. e 60 Question Window qQ e Press the Yes button to continue the treatment or e press the LASER pedal again e To abort press the button A second window asking for confirmation of abortion will pop up see figure 61 Warning Window on page 91 Page 90 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description ZA WaveLight ETT eee LETT ETC LE TL EC ELEC Le LLCETTTPCLeTTererrieririeerrreeererrrererrrere reer rrr ier eee gt Abort Treatment A WARNING Incomplete Treatment If you press the button to abort the treatment the following window is displayed Are you sure to leave the Laser Window You MUST transfer the Treatment Data again before Treatment Please press the OK Key on Laser Panel to abort ene oT Figure 61 Warning Window e Press the button to transfer the treatment data e press the Cancel button to continue the treatment or e press the OK Key on the control panel to abort the treatment ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 91 of 232 A j SA WaveLight Functional Description 5 6 3 Examination Data Range Wavefront Optimized Planneel Mustermann Peter 18 08 1973 F2 Patient Treatment F5 Applied drugs Test Drug B achymeter SP 3000 g Surnay F Figure 62 Examination Data Window WFoptimized Mi
101. e aiming beam function allows the user to increase or decrease the intensity of the aiming beam Select the Aiming Beam Menu item by moving the joystick upward or downward Move the joystick to the left to decrease brightness and to the right to increase brightness Moving the joystick will immediately engage the brightness of the aiming beam This setting is then used as default setting e The aiming beam is switched off at the beginning of and at the end of the test routines Scanner Test Fluence Test e Within a test routine the brightness of the aiming beam can be adjusted by means of the Aiming Beam Key situated at the control panel Exception In Def Center the aiming beam is not adjustable via the keyboard e The aiming beam is adjustable with the CENTER pedal in the functions menu item Calibration Eyetracker e In Def Center and in Center Test the aiming beam is switched on when the CENTER pedal is pressed next page FLUENCE TEST ET TEST GAS CHANGE AFF SCANNER TEST ENERGY CHECK DEF CENTER CONTRAST LCD CTT DISTANCE DIODES MT AIMING BEAM TILT VD mm 14 FLAT K D 43 SETUP Return Press OK KEY Figure 110 LCD Screen Aiming Beam Intensity Bar Page 150 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description WaveLight 5 16 12 Vertex Distance A CAUTI
102. e flammable materials to ignite or explode A CAUTION Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure This manual is copyrighted with all rights reserved Under copyright laws this manual may not be reproduced or transmitted in whole or in part in any form or by any means electronic or mechanical including photocopying recording or any information storage and retrieval system without permission in writing from WaveLight AG Permitted copies must carry the same proprietary and copyright notices as were affixed to the original Under the law copying includes also translation into other languages Please note that while every effort has been made to ensure that the data given in this manual are accurate the information figures illustration tables specifications and schematics contained herein are subject to change without notice All images are representative The numbers shown in the images are just examples and may not represent typical values Some sections of this manual may not apply for all devices Such sections will be marked accordingly Other manuals may apply as well for use of the device described herein ALLEGRETTO WAVE EYE Q is a registered trademark of WaveLight AG Wavefront Optimized is a registered trademark of WaveLight AG Custom Q is a registered trademark of WaveLight AG PerfectPulse Technology is a registered tr
103. e powered with the use of a multiple or non fixed outlet The ALLEGRETTO WAVE EYE Q may not be operated in explosion endangered rooms and areas The ALLEGRETTO WAVE EYE Q may only be used in designated medical rooms in accordance to the international standards Do not connect the ALLEGRETTO WAVE EYE Q with non medical electrical equipment e g data processing devices for purposes of creating an electro medical system if this will result in a safety level for the patient which is below that specified by DIN EN 60601 1 standard If permissible levels for leakage currents are exceeded due to such connections appropriate safety measures including a disconnecting device must be present Any auxiliary equipment connected to the analog or digital interfaces of this unit must be certified as meeting applicable EN and or IEC specifications In addition all configurations must fulfill DIN EN 60601 1 and DIN EN 60601 1 1 standard for electro medical systems The USB stick must only be used for WaveLight AG units and must meet the criteria listed in table 22 Data Communication on page 223 The USB stick must not be removed during treatment Always disconnect the electric plugs of the ALLEGRETTO WAVE EYE Q and all units connected to it e g plume evacuator from their power sources before carrying out maintenance or cleaning work ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 19 of 232 A z j
104. e value is either too high or too low so the laser head cannot function properly The system allows only two gas changes during the energy level adjusting routine If there is still insufficient energy then there might be a defect within the laser gas or optical system Treatment data could not be found Energy and high voltage values do not match Critical laser head error ArF valve defective ArF pipe in the laser head has a leakage Errors And How To Fix Solution Contact service Adjust the standard energy level Examine the external energy meter for possible damage Contact service Change the ArF gas if the V Value is less than 73 e Contact service Contact service e Check the entered treatment data e Contact service If the problem is not solved by changing the gas in the laser head than contact service Contact service Immediately close the ArF cylinder e Open the windows and contact service e Immediately close the ArF cylinder e Open the windows and contact service ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Errors And How To Fix No 19 20 21 22 23 24 25 26 27 28 29 30 Display Sensor defect or cylinder closed LCD screen ArF or N2 cylinder Secondary energy too high Sec energy out of range E too low V out of range not used Operation memory full Flash error Check
105. ed Drugs and Pachymetry Test Pachy Test Drug can be entered as default settings Please see chapter 5 6 13 Enter Default Settings on page 121 e Click the button or the AN button to confirm the entries Or e click the button to switch to the patient data ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 77 of 232 Wave Lig ht Functional Description Entering Wavefront Optimized Treatment Data or the Eeu button the gt oo e Pressing the F5 Treatment Data Window is The ablation profile is visualized in the Treatment Data Window shown The Treatment Data Window is divided in four fields 1 Patient Data 3 Visualization of the treatment 2 Treatment Data 4 Menu Bar Table 5 Sections Of Treatment Data Window Nomogram info see chapter 5 5 1 Nomogram on page 64 Treatment Plan WFoptimized O D Planned Mustermann Peter 18 08 1973 1 ma Examination Correction Type F4 Ablation Depth dyn Optical zone Ablation zone Treatment 59 9 57 4 54 9 52 4 49 9 Flap thickness ilaa NaN aion Corneal thickness F7 ae o a max 59 93m LEKIT N 92D M Grid Figure 51 Treatment Data Window Radius of displayed Ablation depth in um circle in mm Pupil diameter and position during the measurement Page 78 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A
106. efer to the User Manual Sterile Set in your Product Folder for notes and information regarding operation cleaning and sterilization Page 188 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 SA i Errors And How To Fix ZA WaveLight eT TPCT eT eT T TEE TeT ECCT TL EP ETEe LE LLCETTTTLeLeriTererrieriiieerrrerererriererriere reer Tree eee gt 8 ERRORS AND HOW TO FIX A WARNING If a problem occurs which you cannot solve with the following directions please label the unit Out of Order and get in touch with our service department or an authorized dealer A CAUTION Never connect or disconnect a cable while the notebook or the ALLEGRETTO WAVE EYE Q laser system are turned on It is not necessary to exchange fuses as the unit is operated through a power supply unit with integrated automatic overcurrent circuit breaker ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 189 of 232 A j IA WaveLight Errors And How To Fix a LCD Screen Laser Console In the case of a fault a message is displayed on the LCD screen Please follow the instructions in the table 15 below to correct the problem If no message appears on the LCD screen but there is a problem or if a fault cannot be corrected by means of this summary call your authorized ALLEGRETTO WAVE EYE Q service representative see chapter 10 1 Service Hotline on page 210 In principle
107. em Description Remote Interlock Connector An external contact can be plugged into the remote interlock connector to interrupt the laser treatment if the laser room door is opened during treatment If no external contact is used the remote interlock plug that is delivered with the laser device should be plugged into the remote interlock connector outlet Aa NOTE If neither an external contact nor a remote interlock plug is plugged in the laser device will not operate The following message will appear on the display Door Contact Foot Pedal Unit The foot pedal unit consists of two pedals Laser Foot Pedal The left pedal the LASER foot pedal LASER pedal controls the emission of the laser during treatment It is fitted with a bow guard to prevent activating the laser unintentionally Pressing this pedal starts the treatment To interrupt the treatment lift your foot off the pedal The treatment can be continued by activating the LASER foot pedal again Center Test Foot Pedal The right pedal is the CENTER Test foot pedal CENTER pedal This pedal serves to check the centering of the ablation LASER Pedal CENTER Pedal Figure 6 LASER Foot Pedal And CENTER Test Foot Pedal Page 28 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 System Description WaveLight PET TLE ETE TTT ET eT ET CEeTLTEPeTETe rei LCerrTrieeerreererreeririeererreererrrererreere reer rrr ie reece
108. environment Immunity test DIN EN 60601 Compliance Electromagnetic environment guidelines test level level Portable and mobile RF devices shall not be used or operated in a smaller distance to the ALLEGRETTO WAVE EYE Q system including cables than the recommended safety distance that is calculated based on the formula suitable for the emission frequency Recommended safety distance Conducted HF interferences 3 Ver 150 kHz upto 3 Ver d 3 5 V VP according to 80 MHz DIN EN 61000 4 6 noes Wiin 80 MHz up to 3 V m d 3 5 E VP for 80 MHz to 800 MHz according to 25 GHz DIN EN 61000 4 3 d 7 E VP for 800 MHz to 2 5 GHz where P is the rated output of the sender in Watt W according to the specification of the manufacturer of the sender and dis the safety distance recommended in meters m According to an on site test the field intensity of stationary RF senders at all frequencies is lower than the compliance level Interferences are possible in the surroundings of devices being marked with the following symbol D NOTE 1 At 80 MHz and 800 MHz the higher value shall apply NOTE 2 It is possible that these guidelines are not applicable to all situations and cases The propagation of electromagnetic waves is influenced by absorptions and reflections of buildings objects and persons Theoretically the field intensities of stationary senders such as e g base stations of cellular phones or mobile
109. eployed for medical purposes the user is responsible for making sure that accompanying optical devices for observation or adjustment are outfitted with appropriate protective filters of the adequate protection class During operation the so called laser area must be delineated and identified according to DIN EN 60825 1 The gas cylinders must be transported separately from the laser Perform a visual inspection of the ALLEGRETTO WAVE EYE Q laser system housing before every use The laser device must not be operated if the LCD screen of the laser console is defective The menu structure is interactive Do not proceed when the LCD screen is dark or when visibility contrast is inadequate for clear visualization ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 13 of 232 A z j A Wave Lig ht Safety Instructions The operator has to ensure that protective measures against fire and explosion risks are taken in the medical application of laser radiation in the region of organs body cavities and tubes which can contain combustible gases or vapors In the event of fire or strong development of smoke in the treatment room the emergency stop button of the laser system has to be actuated and treatment has to be interrupted immediately All persons in the treatment room are asked to leave the room without delay and fire extinguishing measures have to be taken According to the German Medical Device Law medic
110. examination data The Summary Window shows all important data required to start the calculation of the ablation pattern needed for the treatment The Summary Window is divided in four fields 1 Patient Data 3 Treatment Calculation 2 Treatment Data 4 Menu Bar Table 6 Sections Of Summary Window Summary WFoptimized Planned Mustermann Peter 18 08 1973 F3 Treatment Data Patient Treatment F5 Test Doctor Confirmed by Laser F7 Treatment Calculation ALLEGRETTO RE Figure 52 Summary Window Remaining Stroma Ablation depth Treatment method Page 80 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Functional Description FA WaveLight Check all treatment data Enter the name of the surgeon in the field marked by SURGEON The name of the surgeon can also be entered as default setting Please see chapter 5 6 13 Enter Default Settings on page 121 gt e Enter the name of the examiner in the field CONFIRMED BY re check all treatment data by your assistant for more safety e Then press the e Click the Calculate button to start the ablation pattern calculation of the treatment A progress bar shows the progress of the calculation Mustermann Peter 18 08 1973 Planing F2 Last Name First Name ID Date of Birth Eye Treatment No Date Correction VD Optic
111. f the eyetracker does not display crosshairs and the edge of the pupil on the eyetracker monitor because of the Eyetracker not being able to detect the pupil then modify the brightness of the operation microscope illumination and or the eyetracker illumination until the pupil is found and consistently keep this setting N NOTE The diameter of the eyetracker s visual field is approximately 12 mm When the pupil is located outside of this field or is near the border the message Pupil Not Detected is displayed The permissible area of the pupil around the beam axis during treatment is only 2 5 mm If the pupil is outside of this permissible area the message Pupil Out Of Range is displayed The permissible pupil diameter is 1 5 8 mm In case of pupils outside of this range the message Pupil Not Detected is displayed ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 131 of 232 ZA WaveLight Functional Description 5 9 Hints For Keratectomy A WARNING Before performing the Keratectomy first switch to Ready Mode Make sure before the LASIK treatment that the pachymetry data are sufficient e To provide maximum working space for the Keratectomy shift the eyetracker illumination out of position so that it does not inadvertently interfere with the microkeratome e Move the lever to above the patient s throat e Make the LASIK flap as described in the instr
112. function is only applicable for use with the ALLEGRO Analyzer the ALLEGRO Topolyzer and the ALLEGRO Oculyzer system with optional custom ablation treatments A CAT Topo guided F CAT based on topography or wavefront guided LASIK treatments Please call your WaveLight AG authorized service representative for further information To import data please also refer to the A CAT or the Topo guided User Manual Page 110 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Functional Description A Wave lig nt Import Data Via USB stick The patient data have not to be entered in the Patient Data Window because they will be imported from the ALLEGRO Analyzer the ALLEGRO Topolyzer or from the ALLEGRO Oculyzer To import a new measurement Planing F2 New Patient Last Nam Exarninatior F4 First Name Date of Birth Traatrnert F5 Surnay F Treatment No Treatment method Treatment status New Exit Esc Figure 75 Patient Data Window e click onthe J Measurements button in the Patient Data Window The Measurement Data Window is shown See following figure 76 on page 112 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 111 of 232 A j SA WaveLight Functional Description Patient Data Planned F2 Patient ip 900000008 LastName Evarnination F4 Filter First Name
113. ge 16 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A o Safety Instructions WaveLig ht 3 3 Patient Safety In case of evident signs of erroneous data or system malfunction no treatments must be carried out to avoid irreversible injuries to the patient The ALLEGRETTO WAVE EYE Q laser system and accessories may only be operated by persons who have been trained in its use and are capable of ensuring proper operation Precautionary measures are to be taken in the handling and use of all accessories disposable articles and agents that come into contact with the patient so that exposure to pathogens can be avoided see chapter 7 Care Of Device And Accessories from page 188 After turning on the AALEGRETTO WAVE EYE Q carefully go through the System Check procedure and note the results in the Archive Folder see chapter 5 4 System Check from page 42 and chapter 5 17 Routine Test Procedures With The Control Systems from page 152 Consult your nearest authorized WaveLight AG dealer or the ALLEGRETTO WAVE EYE Q service center in case you have any questions regarding this matter Follow carefully the system comments displayed on the LCD and notebook screen Pay careful attention especially to messages informing you about laser pulse energy settings and the amount of gas in the cylinders Consult your nearest authorized WaveLight AG dealer or the ALLEGRETTO WAVE EYE Q service center
114. he glass surfaces with anything but optical paper This tool is used to check the function of the Ablation Depth Micrometer as the system will display the correct ablation depth of the Fluence Test Disk It is a glass disk with a flat side and a side with a recess of about 40 to 50 microns quan T Figure 142 Ablation Depth Normal Glass Standard The recess was measured and marked by WaveLight AG and the comparison of this marked value with the measured value provides information about the functionality of the Ablation Depth Micrometer The surface with the recess is identified by an arrow mark on the mounting of the Glass Standard The base of the arrow indicates the plain surface the tip of the arrow indicates the side with the recess Avoid touching the surface If debris cannot be wiped away use a soft optical paper or a fiber free tissue to clean the surface The procedure is very similar to the Fluence Test except ablation and calibration No user adjustments can be made in this function see chapter 5 17 5 Fluence Test And Calibration Procedure on page 165 The Ablation Depth Micrometer Test is performed once a month and if the Micrometer seems to measure strange unexpected values The result must be recorded in the Test Report which you will find in your Archive Folder ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 177 of 232 A SA WaveLight Functional Descripti
115. he patient already exists the system will create a new ID Please verify the patient data NOTE A For detailed information please refer to chapter 5 6 Navigation And Data Entry With The Notebook Portal Software section Entering Patient Data on page 73 gt Page 115 of 232 ZA WaveLight Functional Description Dependent on which diagnostic system has generated the data the imported data are divided into PRE OP Ocu or Topo shown in the Patient Treatment Measurement Field of the Patient Data Window PRE OP data result from an import from the ALLEGRO Analyzer Ocu data result from an import from the ALLEGRO Oculyzer and Topo data result from an import from the ALLEGRO Topolyzer The measurement data set is shown in the Patient Measurement Field of the Measurement Data Window The normal state is that a large number of measurement data are stored To select one special patient the Load procedure button must be activated imports new data from USB stick to the hard disk of the notebook put saved hard disk data to program handler process may take a few seconds qQ e Select a measurement and click the button This The load process will be indicated by a progress bar SVD Approximation Figure 80 Popup Window Processing Height Data After loading the measurement data the Mean Value Calculation Window or the
116. ient Data Planriecl F2 Search NewPaiem Patient Measurements Measurements E Filter all l jai ID Hew ID Last Name Mu ann Examination F4 Date of Birth Treatment F5 Gender Surnay F6 Treatment No Treatment method Treatment status New Print F2 selected 2 of 2 Exit Esc Figure 48 Patient Data Window Here you can search for available patient names use capital letters To support the search function the filter function can Filter be used ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 73 of 232 A gt j SA WaveLight Functional Description e Either select a patient from the treatment list or create a new one For creating a new patient click the New Patient button If the patient already exists a Popup Window asks to create a new ID The Necaicucicme button is needed to switch to the Measurement Data Window for A CAT and Topo guided treatments optional See chapter 5 6 9 Import Data figure 76 on page 112 ES e Now enter the patient s personal data Boxes have different meanings based on the color of the box Light Blue Entry is mandatory Dark Blue Entry is optional Grey No Entry possible automatically displayed values Table 2 Color Codes Entry Boxes Pac e A Here the patient data are shown Last Name First Nare To select your preferred date format see Date
117. in case you have any questions regarding this matter Make sure that the entered patient and treatment data coincide with the correct eye of the patient Also be sure that the correct Vertex Distance is entered in the Setup Menu of the ALLEGRETTO WAVE EYE Q The user is responsible for validating and cross checking of the data during the steps between measurement and treatment Please perform and note carefully all diagnostic and other clinical findings of the patient s eye prior to the laser treatment Especially crosscheck the subjective refraction data with the data displayed on the ALLEGRO Analyzer ALLEGRO Topolyzer ALLEGRO Oculyzer as well as on the F CAT System software This data must not differ significantly Also check differences between maximum ablation depths between Wavefront Optimized PTK A CAT Topo guided and F CAT treatments The ALLEGRETTO WAVE EYE Q light sources especially the illumination for the operation microscope are designed to enable optimal treatment by the user In order to avoid unnecessary discomfort for the patient the lighting should be switched on for as short a time as possible The laser treatment should take place in a quiet and relaxed atmosphere in order not to distract the attention of the patient The patient should lie in the middle of the bed the head should rest comfortably on the headrest Make sure that nobody bumps against the bed during the procedure of the laser treatment ALLEGRE
118. ine on page 210 No Error Message Solution No ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 FA WaveLight These numbers serve only for the internal organization Here you will find the display messages Here you will find suggestions to take remedial measures and to be able to continue the treatment If a message or warning does not disappear then please contact your authorized ALLEGRETTO WAVE EYE Q service representative Error Message An error occurred during the calculation or the process was canceled before finishing The file was manipulated manually so it is no longer valid and will be removed There are 5 different ALLEGRETTO WAVE EYE Q units already in use You are not allowed to use more than 5 There are 5 different ALLEGRO Analyzer ALLEGRO Topolyzer or ALLEGRO Oculyzer devices already in use You are not allowed to use more than 5 Unable to create this dialog ALLEGRO Analyzer ALLEGRO Topolyzer or ALLEGRO Oculyzer ID incorrect Solution Contact service Contact service Contact service Contact service Please reset system Contact service Page 195 of 232 WaveLight Errors And How To Fix No Error Message Solution 6 Module ID incorrect Contact service 7 You are not allowed to treat data from Contact service this ALLEGRO Analyzer ALLEGRO Topolyzer or ALLEGRO Oculyzer 8 The laser did not respond during the Contact
119. ing the unit with a damp cloth that no liquid gets into the unit Please refer to chapter 7 Care Of Device And Accessories on page 188 Do not cover the air vents The ALLEGRETTO WAVE EYE Q laser system may only be operated in rooms which can be adequately ventilated 100 m h 2 3500 feet h respectively The volume of the room must be 2 75 m3 2 2650 feet respectively However room ventilation must be switched off during treatments The ALLEGRETTO WAVE EYE Q laser system may not be operated above an altitude of 2000 m 6560 feet above sea level below room temperature of 18 C 64 4 F and above room temperature of 30 C 86 F The humidity values must be 20 to 70 at 25 C 77 F not condensing Avoid the vicinity of heating units and humidity both during use of the instrument and when it is stored The optic components in the unit may become covered by condensation if you store the unit in a cold room or in a vehicle during the cold part of the year or if there are wide changes from cold to warm in the ambient temperature Please give the unit time to acclimatize to its new surroundings before using it for the first time Please refer to chapter 12 Technical Data on page 222 Please use the designated on off switch for turning off the device Page 20 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 FA WaveLight Safety Instructions Make sure that the patient rem
120. is interrupted the progress of treatment is indicated on the display see also section Interrupt Treatment on page 90 Each time the treatment is interrupted it remains possible to resume the treatment exactly where it was stopped Page 138 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description A WaveLight ETT eee LEE ET ELC LET LEL ELEC LE TLCETTTPTeLerrererrieeriieerrrrrererriererriere reer TT gt 5 14 Aborting Treatment A WARNING Incomplete Treatment Each treatment can be aborted To do this first press the Ready Key A then press the OK Key and hold this key down for at least 2 seconds before releasing it again The laser system then returns to the Standby Mode 5 15 Finishing Treatment After completing the treatment the system automatically performs a Pressure Check During this check no entry is possible Subsequently the system will return to the Standby Mode Press OK KEY or start Notebook Program Figure 98 LCD Screen Standby e Close the flap after completing the laser treatment and swing back the eyetracker illumination out of working position for patient convenience e After the treatment has been completed move the patient away from underneath the laser by pushing the function button for preset positioning on the patient bed to facilitate the patient to leave the patient bed Pay attention to the patient s head
121. is the AC mains voltage before applying the test levels ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Electromagnetic environment guidelines Floor should be made of wood or concrete or covered with ceramic tiles In case the floor is covered with synthetic material the relative humidity must amount at least to 30 Quality of the supply voltage should correspond to the supply voltage of a typical business or hospital environment Quality of the supply voltage should correspond to the supply voltage of a typical business or hospital environment Quality of the supply voltage should correspond to the supply voltage of a typical business or hospital environment In case the user requires the ALLEGRETTO WAVE EYE Q system to ensure a continued operation even with interruptions of the supply voltage it is recommended to supply the ALLEGRETTO WAVE EYE Q system by an uninterruptible power supply or a battery Magnetic fields at mains frequency should correspond to the typical values as they can be encountered in a business and hospital environment gt Page 227 of 232 F WaveLight Technical Data Guidelines and manufacturer s declaration Electromagnetic immunity The ALLEGRETTO WAVE EYE Q system has been designed for use in an environment as specified below The customer or user of the ALLEGRETTO WAVE EYE Q system has to ensure that the system is used in such an
122. l It is however not necessary to use the notebook Data can be entered directly into the ALLEGRETTO WAVE EYE Q The possibility to document the treatment is not given ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 63 of 232 A j SA WaveLight Functional Description 5 5 1 _Nomogram A nomogram is integrated in the laser console which is based on long term results of clinical studies If you want to enable or disable the nomogram or if you have special questions please contact your ALLEGRETTO WAVE EYE Q service representative The nomogram version is displayed on the LCD screen of the laser console during the selection of treatment lists and must be absolutely considered A CAUTION Convention Nomogram Display Wavefront Optimized Nomogram Nomogram S001 Personal Nomogram Nomogram P001 A CAT Nomogram Nomogram S201 No Nomogram Nomogram NO Topo guided Nomogram Nomogram S101 F CAT Nomogram Nomogram S301 PTK lt p PTK aes DEPTH DIA Yy Beso l ors m aell A ow pam sr a DEPTH DIA 1 Select data with JOYSTICK 1 Select data with JOYSTICK 2 Press OK KEY for 2 sec 2 Press OK KEY for 2 sec Nomogram NO Nomogram S001 VD 13 0 mm VD 13 0 mm FLAT K 43 0 D Figure 40 Display Without Nomogram Figure 41 Display With Nomogram S001 Page 64 of 232 ALLEGRETTO WAVE
123. l en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description A WaveLight 5 16 10 Brightness Setting Distance Diodes The distance diodes function allows the user to increase or decrease the intensity of the distance diodes while focusing Select the Distance Diodes Menu item by moving the joystick upward or downward Move the joystick to the left to decrease brightness and to the right to increase brightness Moving the joystick will immediately engage the brightness of the distance diodes This setting is then used as default value e The distance diodes are switched on at the beginning of and at the final state in the test routines Scanner Test Fluence Test e Within a test routine you may toggle between on off of the distance diodes by means of actuating the Distance Diodes Key at the control panel e Inthe Def Center option and with the Center Test the distance diodes are switched off when the CENTER Pedal is pressed next page FLUENCE TEST ET TEST GAS CHANGE AFF SCANNER TEST ENERGY CHECK DEF CENTER CONTRAST LCD AT AIMING BEAM TTT VD mm 14 FLAT K D 43 SETUP Return Press OK KEY Figure 109 LCD Screen Distance Diodes Intensity Bar ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 149 of 232 ZA WaveLight Functional Description 5 16 11 Brightness Setting Aiming Beam Th
124. lie down Pay attention to the patient s head and move the patient bed into the treatment position Assist the patient with neck support and knee cushion Align the patient s eyes 0 axis parallel to the optics arm see figure 1 ALLEGRETTO WAVE EYE Q Laser System on page 23 Then move the patient bed so that the image of the pupil of the eye can be seen sharply in the center of the microscope To adjust the brightness of the microscope illumination turn the Microscope Illumination Brightness knob accordingly see figure 8 Control Panel With Joystick on page 30 Adjust the height of the patient bed so that the crossing point of the two distance diodes is on the vertex of the corneal surface Adjustment Of The Orientation Of The Patient s Head Mark the 0 axis on the sclera at the LED Slit Illumination System with a gentaviolet marker Position the patient s head roughly under the microscope Adjust the focus with the distance diodes Switch on the cross line projector and adjust the brightness to your personal needs Adjust the patient s head in such a way that the horizontal line of the cross line projector correlates with the marks at the sclera The vertical line must be in the center of the pupil ma i os Figure 92 Marked Sclera e Switch off the cross line projector ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 129 of 232 A j SA WaveLight
125. luence Calibration Test An External Energy Sensor measures the energy as the laser beam exits the laser beam aperture If the Target Energy cannot be achieved laser treatment will not be possible until a new gas change is performed Page 144 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description A WaveLight 5 16 8 Definition Center Of Ablation A WARNING Always use the Define Center function with great care Inaccurate centering may cause serious damages to the patients eye Settings performed in this menu will only be saved for the treatment during which this adjustment is performed After the treatment the default values are automatically set again Not available for A CAT and Topo guided This function permits the definition of the center of ablation with respect to the geometric center of the patient s pupil On the cornea the geometric center of the pupil optical axis is not always concentric with the center of the visual axis The deviation between both is known as Angle Kappa This routine can be used for two different purposes The pupil center is always considered as the origin of the coordinate systems If the surgeon wants to compensate for a large angle Kappa the automatic centering cannot be applied The laser ablation has to be centered on the visual axis rather than the geometric center of the pupil It will be necessary to offset the auto
126. matic centering of the eyetracker with the Define Center function 1 Defined offset Offsetting the treatment center to account for displacement of the visual axis from the geometric center of the pupil This should be used if the distance from the optical center to the pupil center is known The adjustment increments in this menu are 10 um The values are displayed in cartesian as well as polar coordinates Precise measurement of the visual axis location is required for setting the offset ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 145 of 232 ZA WaveLight Functional Description 2 Intentional decentration of the ablation on some point other than the pupil center A CAUTION The coordinate system that is used is a Cartesian System seen from the perspective of the user as seen through the microscope Example Positive x values will decenter nasally on the patient s left eye but laterally on his right eye The coordinate system that is used is a cartesian one seen from the perspective of the user as seen through the operation microscope In addition the decentration value is displayed in cylindrical coordinate systems coordinate systems centered ablation decentered ablation decentered ablation centered ablation cartesian x y cylindrical r phi dx 0 dy 0 e g dx gt 0 dy 0 e g dx lt 0 dy 0 dx gt 0 dy 0 coordinate center pupil center e g positive dx values
127. mmunication devices senders and the ALLEGRETTO WAVE EYE Q system as recommended and stated below according to the maximum output capacity of the communication equipment in question Rated capacity of the Safety distance according to transmitter frequency sender w m 150 kHz 80 MHz 80 MHz 800 MHz 800 MHz 2 5 GHz d 1 2 VP d 1 2 VP d 2 3 VP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For senders the rated capacity of which is not stated in the above table the distance can be determined using the equation belonging to the respective column where P is the rated capacity of the sender in Watt W according to the specifications made by the manufacturer of the sender NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 It is possible that these guidelines are not applicable to all situations and cases The propagation of electromagnetic waves is influenced by absorptions and reflections of buildings objects and persons Table 29 Recommended Safety Distances ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 229 of 232 ZA WaveLight Warranty 13 WARRANTY Warranty provisions are outlined in your purchase order confirmation Please contact WaveLight AG or authorized distributor for information about maintenance agreement Page 230 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001
128. must be 5 17 5 dated signed and stored in the Archive Folder from page 165 Scanner Test Once a month Used targets must be 5 17 7 dated signed and stored in the Archive Folder from page 180 Table 13 Routine Test Procedures Page 152 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description A WaveLight The Control Systems Consist Of Ablation Depth Micrometer Item No 10081402 fig 113 on page 156 Test Adapter Item No 10081401 fig 114 on page 156 Eyetracker Test Target Item No 10073401 fig 115 on page 157 Scanner Test Reticle Item No 10031422 fig 147 on page 182 Fluence Test Disk for Fluence Test Item No 10033432 fig 130 on page 168 Ablation Depth Normal Glass Standard Item No 10033947 fig 142 on page 177 Ablation Target for Scanner Test Item No 10031420 fig 145 on page 180 Table 14 Contents Of Control Systems The Control Systems serve the purpose of checking the function of the ALLEGRETTO WAVE EYE Q laser system The purpose of the Ablation Depth Micrometer is to determine the quantitative ablation depth The Fluence Test checks the energy setting of the laser system A Fluence Test Disk is used as the ablation target Only the use of the Ablation Depth Micrometer in combination with the Test Adapter guarantees the correct implementation of the Fluence Test routine The Test Adapter ensures that the various test targets available fo
129. n Data Window ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 75 of 232 A j SA WaveLight Functional Description A wrong Vertex Distance leads to wrong corrections please check this value carefully AN CAUTION For the s1 and 2 values only use the ALLEGRO Topolyzer Please refer to the Topo guided User Manual Examination Data Mustermann Peter 18 08 1973 Pupil r z mm Patient F3 Central thickness 52 um Examination F4 Clinical Refraction Sph eee Jo Cyl E Axis vb ae B iain Treatment F5 y Suy 43 00 D 2 eo D y Test Doctor Back Next Exit Esc Figure 50 Examination Data Window Example With Data Page 76 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description A WaveLight e Fill out all light blue textboxes in the Examination Data Window and check the entries for their correctness The dark blue textboxes are optional Pupil Diameter mm Pachymetry Central thickness um Clinical Refraction SPH D CYL D Axis VD mm Keratometry K1 D K2 D Doctor Table 4 Enter Examination Data If no treatment data is imported or no s and Q value is entered only Wavefront Optimized and PTK treatments can be selected Vertex Distance and resid Drags Flap Thickness as well as ut aerau Appli
130. n Gas Pressure And Beam Path Flushing Purpose Inspection of the quantity and pressure in the Nitrogen gas cylinder User Assistance Opening of the Nitrogen gas cylinder N Feedback Request for opening of the cylinder by the user warning in case of low Nitrogen gas pressure error message in case of defect Follow the system instructions i e open the Nitrogen gas cylinder and confirm by pressing the Gas Key SYSTEM CHECK Open Gas Cylinder and confirm with GAS KEY Figure 16 LCD Screen Open Gas Cylinder N2 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 43 of 232 A j SA WaveLight Functional Description The system will then start flushing the optical pathway with Nitrogen gas This is necessary to ensure that the pulse energy remains constant throughout the operation SYSTEM CHECK Purging beam path Please wait 300 sec Below a certain pressure the system displays the pressure to remind the user to order a new Nitrogen gas cylinder N If the pressure descends below a certain level no further treatments will be allowed The Nitrogen gas cylinder must not be closed before all treatments have been done Page 44 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description A WaveLight TTT TTT eee TET CLE TL EPETEe LE LLCETTTPTCLerrTererrreeririeererrrererriererreere rier err ie ee eeeee gt 5 4 3
131. n Max Step Pupil diameter mm 1 00 9 00 0 01 Pachymetry corneal um 200 700 1 thickness SPH D 14 00 6 00 0 01 CYL D 10 00 6 00 0 01 AXIS S 0 180 1 VD mm 0 30 0 1 K1 D 30 60 0 01 K2 D 2K1 60 0 01 is 0 180 1 el 1 00 1 00 0 01 2 1 00 1 00 0 01 If data are transferred from the ALLEGRO Analyzer the step values can vary The treatment range depends also from the used treatment list Only the released treatment lists can be selected Table 9 Examination Data Range WFoptimized Page 92 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description A WaveLight ELLE eee gt 5 6 4 Treatment Data Range Wavefront Optimized The table below shows the variable fields and ranges which can be adjusted between the minimum and maximum values Treatment Plan WFoptimized Planned Mustermann Peter 18 08 1973 F2 WFoptimized Patient F3 Examination Correction Type ic Astigmatism 4 AIEEE Optical zone SSOMIR mm Ablation zone Treatment i mm F5 Flap thickness um Corneal thickness vot ym Summary F6 i f i Stroma 370 urn SE le l o 20 10 00 4 0 2 0 Warnings ands max 59 93m 62D MGrid Figure 63 Visualization Window WFoptimized Min Max Step SPH target D 3 3 0 25 CYL target D 3 3 0 25 Optical zone mm 4 50 8 00 0 50 Flap thickness um 0 200 1 Starting from the entered clinical
132. n in case of an emergency so that any injuries to persons or damages to the device can be avoided through reaction of the user Pressing the Emergency Laser Emission Stop Switch does not disconnect the device from the mains supply Pressing the red button activates the switch The button must be released before the laser can be turned on again by turning the red knob clockwise Page 26 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 System Description ArF Gas Valve Handle N Gas Valve Handle Figure 5 Elements On The Rear Side Of The Device Main Power Cable Outlet S WaveLight Main Power Cable Outlet Main Power Switch Removable Cover To Gas Cylinder Compartment Interface Opt Video System Interface ET Monitor Interface Notebook Remote Interlock Connector Foot Pedal Unit Outlet Patient Bed Outlet The power cord is firmly attached to the laser device and comes fitted with a plug Main Power Switch The Main Power Switch is used for turning on the laser device After switching ON position the Main Power Switch the device is operational and can be activated via the Key Switch Notebook Interface Via this standard interface and with the use of a special program provided by WaveLight AG the ALLEGRETTO WAVE EYE Q can be operated via notebook ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 27 of 232 F WaveLight Syst
133. n will also appear on the display below the WaveLight logo ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 37 of 232 A j SA WaveLight Functional Description 5 3 1 Logfile Option The System Check involves checking the state of the ALLEGRETTO WAVE EYE Q and recording the relevant data The operational parameters of the ALLEGRETTO WAVE EYE Q are permanently traced and stored in the internal logfile After the start of the ALLEGRETTO WAVE EYE Q laser using the notebook data are automatically sent to the notebook fee ib n Data transfer is running Figure 13 Display Notebook Logfile Operation Figure 14 LCD Screen Logfile Operation With no notebook being connected the system waits 5 min This waiting time may be interrupted by pressing the OK Key See figure 15 LCD Screen At The Laser Unit on page 39 This data transfer should be performed for each working day Page 38 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description A WaveLight Saving Laser Data With The Save Logfiles Function With this function you can store laser data on a USB stick and send them to your ALLEGRETTO WAVE EYE Q service representative This function allows a distant diagnostic of the system to prevent problems or to remedy them In the logfile the following data are tran
134. nce diode reflex and aiming beam light reflex The distance diode reflex won t move with the eye The aiming beam blinks three times to indicate that the Center Test has been activated When the eyetracker illumination is not in the correct position the system will display an error message Lift foot off the CENTER pedal position the eyetracker illumination and repeat the Center Test The error message No Pupil Detected is displayed when the pupil is not detected Check the estimated threshold value Make sure that the diameter of the pupil is in the range of 1 5 8 mm Make sure that the eyetracker illumination is in place The error message Pupil Out Of Range is displayed when the pupil is out of the tracking area Let the patient position correctly make sure that he looks into the fixation light and continue with the treatment ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 135 of 232 ZA WaveLight Functional Description 5 12 Starting Laser Treatment A CAUTION The patient must be looking at the green fixation light before and during laser emission to minimize treatment inaccuracies The USB stick must not be removed during treatment e Check the focus and the eyetracker data contrast pupil correctly recognized e Open the flap e To emit laser pulses please press the LASER pedal PTK lt gt DEPTH DIA Whe 6 25 1 25 50 6 5 D SPH D CYL AXIS o
135. nergy measurement Page 203 of 232 ZA WaveLight No MES 85 MES 112 MES 17 MES 18 MES 23 MES 29 MES 32 Page 204 of 232 Menu Gas Menu Gas Menu General General General General General Display NOTE External N supply Check this pressure Continue with OK Key Sensor defective or cylinder closed Continue with GAS Laser Pedal pressed or error Count of lists exceeds Go on with ANY Key Table empty Press OK Key NOTE Door open Continue with OK Key Error flash Address List Of Messages And Warnings Reasons e The external N2 pressure is incorrect The gas cylinder is closed e The pressure sensor is defective e The valve of the gas cylinder is closed e The gas is empty e Error of the magnetic valve electric The LASER pedal has been activated during the System Check e Error of the system e Empty table in the Special Mode e The remote interlock connector is not connected e The external switch contact door is open A part of the memory in which the treatment data are stored is defective Solution e Open the gas cylinder e Contact service if this message does not disappear Open the gas valve and perform a gas change Release the LASER pedal and start the laser again Contact service Contact service e Insert the remote interlock connector plug e Close the door e It i
136. ngth always represents 100 of the treatment Once the treatment has been completed the laser turns off automatically even if the LASER pedal remains engaged Upon completion of the treatment the system returns to Standby Mode see figure 42 LCD Screen Standby on page 65 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 137 of 232 A j SA WaveLight Functional Description 5 13 Interrupting Treatment Interruption Caused By LASER Pedal Release e Release the LASER pedal reengage the pedal to continue treatment A ai DEPTH DIA S WANS 6 25 1 25 50 6 5 D SPH D CYL AXIS MM oz LASER PEDAL Continue at 35 CENTER PEDAL Test a READY e Figure 97 LCD Screen Continue Treatment A new Center Test is not required once the treatment has been started Interruption Caused By The Eyetracker Loss Of Pupil Detection e Ifthe pupil is no longer discerned or is located outside of the allowable treatment area treatment is automatically interrupted until the eye has been re positioned If the interruption lasts for longer than 3 seconds a message appears on the LCD screen of the laser console The eye should be re aligned Once the eye has been re aligned recheck centering and continue with the treatment Interruption Caused By The Ready Key e Pressing the Ready Key a second time can also interrupt the treatment Each time treatment
137. of Birth II Age chapter 5 6 11 How To Change The Language And Gender The Date Time Format on page 119 ES e Select the eye you wish to treat The treatment no will be selected automatically by the system Eye Here the treatment information is shown Treatment No Treatment method Treatment status q e Click the Page 74 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Examination button or the 2i button A e Functional Description WaveLight ETT TTT eee CEPT ELC LTTE EL ELEC LE LLCETTTPTeLerieererrieriieererreererriererrrere reer Tree eee gt Entering Wavefront Optimized Examination Data or the Examination button the o e Pressing the e a Examination Data Window is In the Examination Data Window the following data can be entered or edited shown This window is divided in seven fields 1 Patient Data 4 Clinical Refraction Data 2 Pupil Data 5 Keratometry Data Pre OP Eccentricity 3 Pachymetry Data 6 Memo 7 Menu Bar Table 3 Sections Of Examination Data Window Examination Data Patient Test 1977 11 14 Pachymetry Central thickness Applied drugs Test Drug z Examination Pachymeter Pachymeter test z F4 Clinical Refraction z Suramar Keratometry i i i i BA K1 D 9 Lasar Fy Entry made by RRAlphiest Zi Print F5 Figure 49 Examinatio
138. of the excimer laser however since the shutter is closed the beam cannot exit the aperture If the recommended energy level cannot be internally achieved the ALLEGRETTO WAVE EYE Q automatically performs a gas change The user will be prompted to open the ArF Premix gas cylinder and confirm by pressing the Gas Key If the recommended energy level still cannot be internally achieved after this second gas change the system will issue an error message Treatment will not be possible Contact your WaveLight AG authorized service representatives ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 51 of 232 A j SA WaveLight Functional Description Calibration Of The Laser Energy At The Beam Aperture This request pops up after the gas change has been performed The external Energy Calibration is used to verify the internal energy setting after certain periods of time Purpose Measurement of the pulse energy at the laser beam aperture with the use of the integrated measuring head User Assistance Swing the eyetracker illumination assembly in place shift the external energy sensor below the beam aperture confirm with the OK Key press the LASER pedal for at least 15 seconds and compare the measured energy with the recommended energy Feedback Status reports possible request for pressing the LASER pedal error message should the laser energy be too low or too high SYSTEM CHECK EXTERNAL
139. of the patient s eye The ALLEGRETTO WAVE EYE Q needs this information for selecting the optimum treatment After each treatment the Flat K Value K Reading is set to the default value of 43 D If an A CAT treatment is performed the Flat K value is taken over from the measurement and again set to its default value after treatment ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 151 of 232 A j WaveLight Functional Description 5 17 Routine Test Procedures With The Control Systems A CAUTION Please also refer to the User Manuals for accessories and equipment that are used in conjunction with the test procedures The following test procedures have to be routinely carried out by the user See also lt Calibration Test Schedule gt in your Archive Folder The user must store the used test targets and fill out the appropriate Test Reports To be able to guarantee a stable scanner temperature system performance the ALLEGRETTO WAVE EYE Q laser has to be in Standby Mode for at least 15 minutes before performing the Eyetracker Test Test Procedure Interval Note See Chapter Energy During Startup and 5 4 5 Calibration between patients within 30 minutes from page 50 before treatment Eyetracker Test Daily before surgeries Used targets must be 5 17 2 ET Test dated signed and stored in the Archive Folder from page 155 Fluence Test Daily before surgeries Used targets
140. on 1 First turn on the vacuum pump with the Vacuum Pump ON OFF Key 2 Insert the Glass Standard in the Ablation Depth Micrometer with the arrow facing down to determine the ablation depth 3 Wait until these readings have stabilized Figure 143 Insert Plain Side Arrow Down 4 Then press the ZERO Key 5 Place the holder again under the Micrometer aperture and turn the vacuum off 6 Repeat the procedure until the reading is within 0 0002 mm before pressing the ZERO Key 7 Press the ZERO Key again and turn off the vacuum 8 Catch the Glass Standard and flip it around carefully The arrow must show up The side with the recess is now up 9 Clean the surface of the side with the recess using the felt wiper see figure 129 Cleaning The Test Disk on page 167 10 Turn the vacuum on again and insert the Glass Standard with the arrow up into the Micrometer aperture Wait until the reading has stabilized and note the reading on the Test Report in the Archive Folder 11 Place the Test Target Holder under the Ablation Depth Micrometer aperture and turn the vacuum off Catch Glass Standard and repeat the measurement procedure three times Always note readings on the Test Report in the Archive Folder Page 178 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 FA WaveLight Da OO aia eter gt 12 Compare the readings with the marked depth value on the mounting of
141. on Page 142 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Functional Description 5 16 2 Fluence Test Please refer to chapter 5 4 7 Fluence Test on page 62 next page FLUENCE TEST ET TEST GAS CHANGE AFF SCANNER TEST ENERGY CHECK DEF CENTER CONTRAST LCD TUTTI DISTANCE DIODES III AIMING BEAM TT VD mm 14 FLAT K D 43 SETUP Return Press OK KEY Figure 105 LCD Screen Fluence Test Program 5 16 3 ET Test Please refer to chapter 5 4 6 Eyetracker Test on page 61 next page FLUENCE TEST ET TEST GAS CHANGE ATF SCANNER TEST ENERGY CHECK DEF CENTER CONTRAST LCD HITT DISTANCE DIODES MANALA AIMING BEAM IIMA VD mm 14 FLAT K D 43 SETUP Return Press OK KEY Figure 106 LCD Screen ET Test Program FA WaveLight OPTTT TET eTE eri TTee rir rrererrrerer eee ri ieeer irre retiree gt ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 143 of 232 A j SA WaveLight Functional Description 5 16 4 Gas Change ArF Gas change allows the operator to change the ArF Premix gas in the laser head The ArF Premix gas deteriorates over time even if the laser is not used The output energy may be maintained but laser efficiency will decrease Below a certain level of efficiency the output energy cannot be m
142. one mm Examination mm ra ym um Treatment um FS Stroma S U um Treatment time Laserstatus 4 Figure 57 ALLEGRETTO WAVE EYE Q WFoptimized Treatment Window Ns Ready Key on Laser Panel Laser lf all treatment data are calculated and transferred the activated Page 86 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description A WaveLight TTT TT gt A CAUTION To carry out a treatment on a patient please refer to the following chapters in the sequence listed below e chapter 5 7 Positioning The Patient on page 129 e chapter 5 8 Checking The Eyetracker Function on page 130 e chapter 5 9 Hints For Keratectomy on page 132 e chapter 5 10 Ready Mode on page 133 e chapter 5 11 Patient s Eye Alignment Fixation And Centering on page 134 e chapter 5 12 Starting Laser Treatment on page 136 All text that appears on the ALLEGRETTO WAVE EYE QLCD screen also appears on the notebook display The LCD screen of the ALLEGRETTO WAVE EYE Q is the master In the case of a defective connection between the notebook and the ALLEGRETTO WAVE EYE Q the error message Laser Not Ready appears In the case of incomplete parameter selection the error message Entry Incomplete appears In the case of unavailable treatment parameters the error message Selected Treatment Not Released appears on the LCD
143. or test or demonstration purpose 24 Are you sure to leave the laser You MUST transfer the treatment data dialogue again before treatment Please press also the OK Key on LASER panel to abort 25 Congratulations Happy Birthday Happy Birthday Table 18 Messages And Warnings Notebook ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 209 of 232 ZA WaveLight Technical Assistance 10 TECHNICAL ASSISTANCE 10 1 Service Hotline WaveLight AG offers a comprehensive warranty and support program Included in this service package is our AALEGRETTO WAVE EYE Q service hotline Highly qualified service representatives are available to help you resolve any operational problems By calling the hotline you will receive information about how best to avail yourself of our repair service Our customers outside of Germany should first use the service hotline provided by their local distributor or WaveLight AG authorized service representative If you have any questions please call SA Wave Light Am Wolfsmantel 5 91058 Erlangen Germany D Hotline Tel 49 1805 52 62 62 Fax 49 9131 6186 221 E Mail Service ophtha service wavelight com E Mail Application ophtha applications wavelight com Page 210 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A Technical Assistance o WaveLig ht 10 2 Maintenance All repairs and service work a
144. patibility with USB standard 1 1 or 2 0 e Only Windows 2000 standard driver is to be used Special Additional Options e The USB stick must not have special additional options e g Hard Disk Drive SD Card Hub WLAN Bluetooth MP3 Card Reader U3 etc Recommended Memory Capacity e lt 1GB gt Page 223 of 232 F WaveLight Technical Data Operating conditions Temperature recommended 18 C 64 4 F to 30 C 86 F above dew point Humidity recommended 20 to 70 at 25 C 77 F not condensing Air conditioning recommended 1 5 kW thermal dissipation Room temperature 22 C 71 6 F Ventilation 2 100 m h 3500 feet h Space utilization gt 75 mi 2 2650 feet Air pressure recommended 700 hPa to 1060 hPa Table 23 Operating Conditions Transport and storage conditions Ambient temperature 0 C 32 F to 50 C 122 F above dew point Relative humidity 0 to 90 at 50 C 122 F not condensing Air pressure 500 hPa to 1060 hPa Table 24 Transport And Storage Conditions Classification according to DIN EN 60601 1 standard Type of protection against Safety class electric shock Degree of protection against Type B according DIN EN 60601 1 electric shock Degree of waterproofing IP 20 Applicable standards and DIN EN 60601 DIN EN 60825 directives CE 1275 mark Medical device Class Ilb according to MDD 93 42 EEC Table 25 Classification For further te
145. r External Energy Check unless the later Fluence Test energy density measurement findings require this A CAUTION e Make sure that the measurement head is properly snapped into position e Only experienced personnel that have been trained in the use of the system may calibrate the system e Slip the measurement head back into position after finishing the procedure Page 56 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description A WaveLight TTT TTT TLE T ELC EE TLE EL ELEC LETC LTTTPTCLerrererreeriieererrrererreererrierereer err ie reece gt Example SYSTEM CHECK EXTERNAL ENERGY CHECK Test 15 s With LASER PEDAL 1 87 0 02 mJ Target Energy Factory setting 1 89 mJ Figure 34 LCD Screen Target Energy Check In this example the target energy range for the External Energy Check is 1 87 mJ 0 02 mJ 1 85 mJ 1 89 mJ Depending on when the laser was last operated the laser beam path may have to be purged with nitrogen gas prior to firing This process is initiated when the LASER pedal is depressed and will take about one minute to complete prior to the laser firing The countdown is displayed in the Energy Check screen as a decreasing number It is not possible to continue the energy check until the countdown has completed and disappeared Purging beam path Please wait 42 1 87 0 02 mJ Target Energy Factory setting 1 89 mJ Fig
146. r Test Reticle e The Scanner Test Reticle has to be placed on the ablation target for the Scanner Test and manually aligned by the view through the operating microscope When doing this evaluate if all 8 ablated spot areas are inside the outer ablation limit and outside the inner ablation limit of the Scanner Test Reticle The milky white spot of each spot should be inside the inner ablation limit Outer Ablation Limit Ablated Area Milky white Spot Inner Ablation Limit Figure 149 Ablation Limit Of the Spots On The Scanner Test Reticle b In exactly the same way the position of the ablated lines must be checked after the ablation Outer Ablation Limit Milky white Spot Ablated Area a Inner Ablation Limit Figure 150 Ablation Limit Of The Lines On The Scanner Test Reticle e The Scanner Test Slide must be dated signed and stored The performance of the test must be recorded in the Scanner Test Report Both are kept in the Archive Folder ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 183 of 232 A gt SA WaveLight Functional Description 5 18 Turning Off First quit the Portal Software with the ESC Key and confirm with OK then turn off the laser system by turning the Key Switch counter clockwise gt the indicator on the LCD screen vanishes The device Main Power Switch and the System Main Switch have to be turned off as well A CAUTION Never leave the la
147. r illumination into treatment position 6 Check if eyetracker has tracked the target 7 Start menu ET Test in the Setup Menu 8 Start the laser ablation Hold the LASER pedal pressed until the laser stops Follow the ablation through the microscope Repeat the laser action if it is necessary SYSTEM CHECK 1 Mount ET Test Target 2 Stay on LASER PEDAL Exit with OK KEY Figure 119 LCD Screen ET Test Page 160 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description A WaveLight Pressing the LASER pedal the following sequence appears on the LCD screen of the laser console SYSTEM CHECK Performing EYETRACKER TEST lt gt Figure 120 LCD Screen Performing Eyetracker Test SYSTEM CHECK EYETRACKER TEST finished leave LASER PEDAL Figure 121 LCD Screen Eyetracker Test Finished ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 161 of 232 A f SA WaveLight Functional Description 9 Check the position of the ablated ring around the pupil Central Eyetracker Target Fi _7 Outer Ablation Limit Inner Ablation Limit Milky Ablation Ring 150um ES Figure 122 Eyetracker Target Before Ablation Figure 123 Eyetracker Target After Ablation 10 Determine the amount of decentration in X and Y direction separately by using the grid marks Recommended usef
148. r the function tests can be positioned correctly Beyond that the Test Adapter is necessary to guarantee a specific and reproducible environment during the test routines For example a ventilation system provides for a constant airflow directly above the test targets This is necessary to remove gaseous ablation products Furthermore the Test Adapter enables ergonomic work with the test targets For example it provides glare less illumination of the test targets when white light is used Because of this the user can individually adjust the contrast of the test targets In addition the required aperture of the Eyetracker Test is provided in the Test Adapter Using this aperture provides a constant test environment during the Eyetracker Test The Ablation Depth Micrometer allows for convenient control and regulation of the device parameters Please ask your WaveLight AG Distributor for detailed information The Eyetracker Test checks the eyetracker for alignment A test slide Eyetracker Test Target is used for the Eyetracker Test The Scanner Test checks the beam aligning elements of the laser system Another test slide Ablation Target for Scanner Test is used for the Scanner Test ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 153 of 232 A SA WaveLight Functional Description 5 17 1 The Calibration Tool Kit The Calibration Tool Kit contains different tools in a small case These accesso
149. re 94 LCD Screen Center Test Qa NOTE Before the laser is in the Ready Mode laser pulses are emitted briefly with the shutter closed Energy Check No radiation is emitted If Treatment data are entered via notebook the system must be switched READY from the notebook the first time It cannot be switched to READY for the first time at the control panel but subsequently this will be possible ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 133 of 232 A j SA WaveLight Functional Description 5 11 Patient s Eye Alignment Fixation And Centering The patient must look up towards the operation microscope into the green blinking fixation light Adjust the patient s head using the cross line projector The patient s eye to be treated must be able to see the blinking green fixation light and fixate on it during the complete treatment The patient will see it if the pupil is centered and the surgeon can see the Purkinje image of the fixation light The fixation light is always on It cannot be permanently switched off However for the purpose of testing the patient s reaction the fixation light can be temporarily blocked out by pressing the corresponding button see figure 9 Switches Located Below The LCD screen on page 33 e Incase they are off switch on the distance diodes The brightness of the distance diodes can be adjusted in the Setup Menu
150. rgeon and staff members in the use of the ALLEGRETTO WAVE EYE Q laser Important Steps Before Turning On The System The user is responsible for determining that the laser system is functioning correctly and that the system is in good working condition before using it To accomplish this the following points must be considered e The laser device accessories and connecting cables are to be inspected for visible damage e The gas supply must not show any leaks e The Emergency Laser Emission Stop Switch is to be released if it has been activated see figure 4 Key Switch And Emergency Laser Emission Stop Switch On The Front Of The Device on page 26 e Local regulations must be taken into consideration Things to do before initial use e Please pay attention to the appropriate User Manuals e Plug the power cable into a separate grounded outlet Multiple purpose and non fixed outlets may not be used see chapter 12 Technical Data from page 222 e Attach the foot pedal unit to the rear side of the device e Attach the remote interlock connector plug e Connect the patient bed and the laser with the electrical cable ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 35 of 232 A j SA WaveLight Functional Description 5 2 Structure Of The ALLEGRETTO WAVE EYE Q Firmware Turn the Key Switch Self Test of the Controller System Check Internal Test
151. ries considerably facilitate the test procedures and routines The Tool Kit consists of e Ablation Depth Normal Glass Standard used to evaluate Ablation Depth Micrometer e Scanner Test Reticle used to evaluate Scanner Test Pattern e Test Target Holder used to mount Test Target in the Test Adapter e Square Ring Weight metal weight to fix the ET Test slide Figure 111 Calibration Tool Kit Ablation Depth Normal Glass Standard Circular Ring Weight not used Scanner Test Reticle Test Target Holder Square Ring Weight Figure 112 Calibration Tool Kit Content Page 154 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description A WaveLight ETT TTT eee TEEPE EC LE TL EPET EC LE LCE TTT PTeLerrTererrreeriiieererreererriererrieererreer irre ee eeeee gt 5 17 2 Check Of The Eyetracker Function Purpose Inspection of the eyetracker s function and dynamic range User Assistance Insert the Test Adapter into the headrest of the bed Place an Eyetracker Test Slide onto the test rest shift the eyetracker illumination into position inspect the dynamic range Fixate the test foil with the Square Ring Weight Feedback Request for the placement of the foil error message if the lighting was not shifted into position correctly e Confirm the position of the test object by pressing the OK Key on the control panel The Eyetracker Test And Calibration P
152. rightness Setup Key Distance Diodes ON OFF i Ready Key Figure 8 Control Panel With Joystick The control panel consists of a foil keypad with integrated LED s control knobs anda joystick positions up down left right The joystick serves the purpose of confirming routines as well as selecting parameters during the System Check Setup Menu and furthermore during Treatment Mode By pressing a foil key general functions will be carried out or continued Page 30 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 System Description WaveLight Eyetracker Adjustment The operating principle of the eyetracker is that the patient s pupil reflects the emitted infrared light less strongly than the iris The reflected infrared light is recorded by the eyetracker camera and converted into a black and white image that is used for the rapid image processing The computational algorithm changes the grey scale value brightness at which the transition between pupil and iris is optimal The manual adjustment is made by turning the knob on the control panel The tracker pupil is marked with a green cross and the border of the pupil with white dashes as soon as the pupil is detected from the eyetracker Adjusting The Brightness Of The Microscope Illumination The brightness of the microscope illumination can be adjusted by turning the knob Gas Key This key is used as a confirma
153. rk indicates that the device complies with the requirements of the Medical Device Directive 93 42 EEC The symbol according WEEE 2002 96 EC indicates that the device rae has to be disposed of in accordance with the manufacturer s a requirements see chapter 10 4 Disposal on page 213 Table 19 Symbol Description Identification Label Not for use in the United States Not licensed under U S patents Art Nr 10079008 Figure 154 U S Patent Labeling Position 2 WAVELIGHT ALLEGRETTO SYSTEM AND ITS USE MAY BE COVERED BY ONE OR MORE OF THE FOLLOWING PATENTS EP 1069 877 EP 1182997 EP 1 280 484 US 6 530 917 US 6 755 817 US 6 887 231 Figure 155 WaveLight AG ALLEGRETTO WAVE Patent Labeling Position 3 Please also refer to chapter 4 3 Switching Elements And Interfaces on page 25 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 215 of 232 A WaveLight Labeling Laser Warning Signs The laser warning signs are attached at the left side of the laser console see figure 160 on page 218 VISIBLE AND INVISIBLE LASER RADIATION AVOID EYE AND SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION CLASS 4 LASER PRODUCT ACCORDING TO DIN EN 60825 1 A2 01 ArF Excimer LASER CLASS 4 PILOT LASER LASER CLASS 2 DISTANCE DIODES LASER LASER CLASS 2 CROSS LINE PROJECTOR LASER KLASSE 2 Figure 156 Laser Warning Signs Position 4 Page 216 of 232 ALLEGRETTO WAVE EYE Q 101
154. rning On The System cccceeeeeeeeeeeeeeeeeenneeeeeeeees 53d Logtle OPWON ssnin noaa aaien 53 2 Self TST re oc aiaia a we eee ey ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 TT gt Page 5 of 232 F WaveLight Contents E e E E E E A Page 5 4 System Check oi siceias esc eces ccs eoesests uses note seus ectsuyes side soeeneteesanesacgennsteeoeeage 42 5 4 1 General Information About The System Check ceeeeeeeeeeeeee 42 5 4 2 Check Of Nitrogen Gas Pressure And Beam Path Flushing 43 5 4 3 ArF Premix GaS Pressure ccccceeeessseeeceeeeeeeeeesseseeeeeeeeeeeeneeeeees 45 5 4 4 Laser Head Pressure icjecc desscescheviseeiesesesslendicusdevinessdeviieusdevegev evans 47 5 4 5 Check And Calibration Of The Internal Laser Energy e 50 5 4 6 Eyetracker Test ag cccaeticiscrstrcicei cic uiaenaiedineedneedicaemundineastnenductcrnidmeaidnediue 61 D2 FIUCNCE TS esicrcscicrnosiasnanncsnonnondansectneronemmancmasmmnanne 62 5 5 Treatment Direct Entry Without Notebook ccceeeeeeeeeeeeeeeeeees 63 551 NomograM senintenee EaD 64 5 5 2 Entering Treatment Data cccccceeeeeecceeeeceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 65 5 6 Navigation And Data Entry With The Notebook Portal Software 69 5 6 1 Starting The Notebook Program a ccccicccicccscendaceteesdesxteosiverauneduesbeaytenvece 71 5 6 2 How To Perform A
155. rocedure as well as the Test Of Eyetracker Centering is described in the following chapter 5 17 3 and chapter 5 17 4 on page 156 and page 164 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 155 of 232 A f SA WaveLight Functional Description 5 17 3 Eyetracker Test And Calibration Procedure Aa NOTE Do not touch the surface of the ablation target for the Eyetracker Test with your hand so as to avoid finger oil contamination Only touch the frame of the ablation target for the Eyetracker Test Before performing the Eyetracker Test the following steps have to be done 1 The ALLEGRETTO WAVE EYE Q should be in Standby Mode Go to Setup Menu see chapter 5 16 Setup Menu on page 140 and choose ET Test see chapter 5 16 3 ET Test on page 143 2 Place the Test Adapter in the space provided on the patient bed head support so that the green LED is directed toward you 3 Adapt the voltage supply 3 pin connector of the Test Adapter on the right side of the Ablation Depth Micrometer The correct function can be tested with the integrated green LED Power OK LED glows green Power Supply Test Adapter 3 pin Connector Figure 113 Ablation Depth Micrometer Figure 114 Test Adapter Page 156 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description A WaveLight ETT TT LECT ECE LEEPE
156. rsely The current field is also inverted The joystick can be used to select the treatment type and to enter or change Page 66 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description A WaveLight TTT TTT TET EEE TET ELC EET EPETEC LE TLCETTTPTCLerrTererreerieieerrrrrererreererrieere ieee err re reece gt Joystick Functions For Parameter Selection Shifting the joystick i LEFT RIGTH The cursor moves from field to field UPWARD DOWNWARD Increasing decreasing the treatment values in the selected field Always enter the clinical refraction values Enter the Vertex Distance VD of the Refractor Phoropter in the Setup Menu The selected parameters are stored after the OK Key has been pressed for at least 2 seconds The treatment parameters are saved and the Compass Rose for parameter entry vanishes from the LCD screen The joystick cannot be used for changes now In the case that wrong parameters have been set abort treatment by pressing the OK Key for at least 2 seconds By pressing the Setup Key you can enter the Setup Menu ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 67 of 232 A j SA WaveLight Functional Description In Ready state some of the Setup Options are locked for safety reasons PTK lt p DEPTH DIA PSRS 6 25 1 25 50 D SPH D_ CYL AXIS
157. rst time after approx 15 seconds The relative laser head energy value has to be adjusted in relation to the depth of the Fluence Test Disk see chapter 5 17 Routine Test Procedures With The Control Systems from page 152 To set a new energy value via the joystick the LASER pedal has to be released After entering a new energy value the external energy measurement has to be performed again For saving the energy value the OK Key has to be pressed Always press the LASER pedal for at least 15 seconds Press the OK Key after comparing the measured and the recommended target energy ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 55 of 232 A j SA WaveLight Functional Description Problem Solution Problem Solution The required target energy cannot be achieved i e the measured value is out of tolerance or can only be achieved with V value of more than 98 A gas change is necessary This is initiated by entering the Setup Menu with the Setup Key and activating New Fill ArF After the gas change the external calibration must be performed again The required target energy cannot be achieved i e the measured value is higher or can only be achieved with V value of less than 52 No further treatments can be performed Call your ALLEGRETTO WAVE EYE Q service representative A WARNING Do not attempt to change the Target Energy with the cursor during or afte
158. s on ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Functional Description FA WaveLight gt Pachymetry Applied Drugs Ee default defaut default a a Te Vert ance Flap Thickness ult default Te eatment 12 0 150 Figure 86 Default Settings E Auto ARS eeeore o ii i e Enter the Setting Menu and click on Settings The Default Settings Window opens where default values can be entered The default values and entries are standard settings in the program see section Entering Wavefront Optimized Examination Data on page 75 e Use the Use the Use the program Add button to add new entries Remove button to remove the selected entries Default button to set the value as default value in the In the Surgeons field the default value is not being used by the program ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 121 of 232 A j SA WaveLight Functional Description Options PMMA Test Treatment Enable this check box to show the Popup Window Select Mode see figure 56 after sending the data to the ALLEGRETTO WAVE EYE Q laser please refer to section Carry Out The Wavefront Optimized Or The Test Treatment on page 85 Final Comments Enable this check box to show the Popup Window Final Comments see figure 59 on p
159. s And Warnings No Menu MES 97 Energy MES 98 Energy MES 140 Energy OPM 19 Energy ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Display energy set Change energy JOYSTICK Test Laser Pedal External energy sensor energy too high Continue with OK Key Secondary energy out of range Change target energy Continue with OK Key Check E V Continue with ANY Key FA WaveLight Reasons Solution Follow the instructions on the display The external energy measuring system displays an energy value of mJ The energy laser head can be adjusted by the joystick By pressing the LASER pedal the energy measurement is continued The measured e Perform the energy secondary energy is measurement once too high and cannotbe more and follow the realigned inside the instructions on the allowed borders display e Contact the service immediately The variation of the Change target energy adjusted target energy and repeat the energy to the previous value is measurement more than 20 The measured energy e Perform a gas and the high voltage of change and repeat the laser head are the energy outside the given measurement borders ae e Contact service if this message does not disappear Page 201 of 232 ZA WaveLight No Menu Display OPM 30 Energy Energy Progress Continue OK Key OPM 35 Energy Calibration of energy
160. s possible to perform treatments but treatment data will not be stored Contact service ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 List Of Messages And Warnings No MES 100 Menu Display General Capacity Memory lt Continue with OK Key Call Service MES 101 General Send Logfile to Notebook Yes OK Key No Other Key MES 20 Selected treatment data not released Treatment Continue with OK Key MES 90 Treatment Remaining no of treatments Call service Continue with OK Key MES 96 Treatment Repeat measurement Laser Pedal mJ measured energy ae WA Reasons The operation memory in which the treatment data are stored is occupied with capacity of lt This message is displayed at remaining capacity of lt 10 The treatment data can be sent to the notebook and stored on a USB stick A treatment list is selected which is not released with your system The number of treatments Is limited The number of possible treatments is displayed After that no more treatments are possible In this message the actual measured energy is displayed ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 WaveLight Solution Please contact service in order to read out the memory If the memory is 100 percent occupied a treatment cannot be performed The operation memory
161. s well as the regular technical inspections are carried out exclusively by WaveLight AG authorized service representative or service technicians specifically authorized by WaveLight AG Carrying out of repairs and servicing by non authorized personnel results in the nullification of warranty and liability claims Furthermore servicing that is carried out improperly can result in the exposure of users and patients to potentially hazardous system malfunctioning A CAUTION Should the ALLEGRETTO WAVE EYE Q laser system or any accessory require service please do not attempt to perform service yourself Please call your WaveLight AG authorized service representatives Please bear in mind that the manufacturer and distributor are only responsible for the proper functioning reliability and safety of the device when e Transport installation start up modifications servicing and repair is performed only by WaveLight AG authorized service representatives e The electrical wiring of the room in which the ALLEGRETTO WAVE EYE Q laser system is operated conforms to applicable legal codes and WaveLight AG installation specifications e The device and accessories are used in accordance with the specifications contained in this User Manual and the User Manuals that are used in conjunction Maintenance Intervals e Inspection by the user prior to use Energy Test Fluence Test Eyetracker Function Scanner Function Center Test see chapter 5 17
162. ser Manual en Rev 9 09 06 08 Item No 6638 2001 FA WaveLight Funcional MER On ai E eset se eet ee gt 12 Place the Test Target Holder for the Fluence Test in the center of the Test Adapter 1 Mount Fluence Test Disk 2 Stay on LASER PEDAL Exit with OK KEY Figure 134 LCD Screen Mount Fluence Test Disk Qa NOTE Alignment of the Fluence Test Disk is mandatory The WaveLight AG lettering must point to the blower and the number to the left see figure 130 Orientation Of The Fluence Test Disk on page 168 Figure 135 Test Adapter With Test Target Holder And Fluence Test Disk ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 171 of 232 ZA WaveLight Functional Description 13 Adjust the focus with the distance diodes Focus on the black point above the number on the plate red points must join CORRECT Figure 136 Wrong Focus Figure 137 Correct Focus 14 Do not change the focus Center the 4 mm pupil see figure 132 Test Adapter With Test Target Holder And Test Disk on page 169 by moving the patient bed Adjust the eyetracker setting accordingly A CAUTION Do not change the position of the patient bed in Y direction because the Z direction and thereby the focus changes also Stay on LASER PEDAL Figure 138 LCD Screen Stay On Laser Pedal Page 172 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No
163. ser should be familiar with point click drag amp drop functions as well as startup and shutdown functions Only Windows 2000 is used as the operating system for the notebook Exclusive use of the Windows operating systems prevents possible communication difficulties that could arise between the notebook and the ALLEGRETTO WAVE EYE Q Currently the user can only use the notebook with the ALLEGRETTO WAVE EYE Q Other programs or files must not be stored or run on the notebook How To Use The Program With The Keyboard lt Use the Tab Stop key to jump with the cursor to the next textbox Use the Shift key and the Tab Stop key to jump with the cursor to the preceding textbox Use the Enter key to confirm the entries Use the ALT key and the Down key to drop down the boxes To save the current window as a screenshot press the CTRL key and the P key Be sure that an USB stick is inserted SC To quit the Portal Software press the ESC key Page 70 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description A WaveLight mA E E A E ve deudandbabedusieuatumsnewue secant gt 5 6 1 Starting The Notebook Program e Start the notebook by pressing the Main Power Switch e Follow the instructions of the login window on the screen e Enter the system as user LASIK and enter the password LASIK Both m
164. ser unattended when it is turned on Protect against unauthorized use by removing the key from the Key Switch Make sure that the gas bottles are closed Emergency Laser Emission Stop Switch Key Switch Figure 151 Key Switch And Emergency Laser Emission Stop Switch Front Side Page 184 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description A WaveLight ETT eT EET ECE TTPO EET EPET Ee LETLCETTTPTeLerreererrieeriiieerererererrrererrrere reer err Creer gt A CAUTION Emergency Laser Emission Stop Switch The Emergency Laser Emission Stop Switch is only for emergencies that arise during normal system operation Pressing the Emergency Laser Emission Stop Switch shuts down the device immediately and shuts the laser off in case of an emergency The routine switch off process of the device should be performed using the Key Switch and the Main Power Switch and not via the Emergency Laser Emission Stop Switch In case the Emergency Laser Emission Stop Switch has been engaged make sure that it is released by turning the red knob clockwise before attempting to restart the system ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 185 of 232 F WaveLight Accessories 6 ACCESSORIES A CAUTION Caution should be taken when handling all accessories or materials that have come into contact with the patient so as to prevent the sprea
165. service last 10 seconds Transmission terminated 9 You are not allowed to use this Contact service ALLEGRETTO WAVE EYE Q for treatment with this software license 10 You are not allowed to use this Contact service ALLEGRO Analyzer ALLEGRO Topolyzer or ALLEGRO Oculyzer for treatment with this software license 11 The last treatment has not been Contact service finished or the notebook had no connection to the ALLEGRETTO WAVE EYE Q 12 The nomogram data in the Contact service ALLEGRETTO WAVE EYE Q is different from that on the notebook 13 Transmission Error CRC Error Please retry Please retry 14 The selected treatment data is not Contact service released 15 The laser does not accept the Please insert USB stick and retry transferred data 16 Could not open file Please insert another USB stick and retry 17 No data in topography file Contact service 18 The process finished with a timeout Contact service Page 196 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Errors And How To Fix No 19 20 21 22 23 24 25 26 27 28 Error Message Undefined Error in measurement file This file contains invalid measurement data or the measurement was released manually This measurement file does not contain valid pupil data Incorrect path setting Measured asphericity Q value is not within the limits of O to 0 6 Treatment code incorrect
166. sferred from the ALLEGRETTO WAVE EYE Q to the notebook e Current configuration of the laser device e List of system parameters and settings during the last treatments e List of warnings and errors which have occurred during the last treatments First switch on the notebook connected to the ALLEGRETTO WAVE EYE Q and wait until the notebook has successfully completed the boot process Subsequently turn on the ALLEGRETTO WAVE EYE Q laser system System data are transferred automatically see figure 13 Display Notebook Logfile Operation on page 38 Upon successful completion of data transfer the laser system ALLEGRETTO WAVE EYE Q automatically goes on with the System Check In case the notebook has not booted the following user prompt is displayed for 5 min Remaining time 300 sec Start notebook program to complete system diagnostic or continue with OK KEY Figure 15 LCD Screen At The Laser Unit If the system detects a notebook within the 5 min waiting time the transfer starts If you do not want to transfer data or wish to work without notebook then press the OK Key on the control panel The system will then proceed with the System Check without transferring the logfile ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 39 of 232 ZA WaveLight Functional Description Save Data To save the data to a USB stick open the Setup Window on your notebook Insert
167. ssage Solution Here you will find suggestions to take remedial measures and to be able to continue the treatment If a message or warning does not disappear then please contact your authorized ALLEGRETTO WAVE EYE Q service representative No Menu Display Reasons Solution MES 50 Energy Primary The measured energy e Repeat the energy energy too of the laser head is measurement low below the given borders e Perform a gas Continue with change OK Key Contact service if this message does not disappear MES 51 Energy Primary The measured energy e Repeat the energy energy too of the laser head is measurement baal eee E eee e Contact service if Continue with this message does OK Key not disappear Page 198 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 List Of Messages And Warnings No MES 52 MES 53 MES 55 MES 56 MES 77 MES 81 Menu Energy Energy Energy Energy Energy Energy Display Out of HV range Continue with OK Key Primary energy too low and HV value out of range Continue with OK Key Secondary energy too high Continue with OK Key Secondary energy too low Continue with OK Key V exceeds maximum Select Setup Menu for NEW FILL External energy sensor misaligned or defective Continue with OK Key ae WA Reasons The system has reached the high voltage control borders The given energ
168. sum error laser Energy transmission Energy not monotonous Energy control impossible Scanner defective Valve does not close Reasons Defective sensor or cable The adjusted laser energy seems to be too high or the sec internal energy sensor is defective The relative laser head high voltage value is either too high or too low or the sec internal energy sensor is possibly defective Number of treatments has exceeded 2 000 Flash memory has bad areas Communications error with the laser head Error in the optical pathway Defective sec energy sensor Incorrect scanner reaction time Defective valve AA WA WaveLight Solution Contact service Adjust the standard energy level e Examine the external energy meter for possible damage Contact service Adjust the standard energy level e Examine the external energy meter for possible damage Contact service Contact service Contact service Contact service Contact service Contact service Contact service Contact service ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Close gas cylinders Contact service Page 193 of 232 ZA WaveLight No 31 32 33 34 35 36 37 38 39 40 41 42 43 44 Display Energy deviation too large Shutter 1 defective Low press ArF incorrect Time out scanner Time out gas exchange Error laser hea
169. t see figure 106 LCD Screen ET Test Program on page 143 The principle behind the test procedure is that a test pupil is to be discerned by the eyetracker and ablated with the laser Should the ablation not correspond to the middle point of the test pupil then centering must be corrected This Eyetracker Test is not an endless loop but 3 complete testing circles are executed total time 4 seconds If the circle is interrupted during the test it is restarted again After performing this test the offset values can be edited in the Calibration Eyetracker Menu Apart from the values dx and dy the current values are displayed Change in the display during the test CALIBRATE EYETRACKER dx dy 0 um 50 um current X current Y 0 um 30 um Start test CENTER PEDAL Change X and Y ARROW KEYS Return OK KEY for 2 sec Figure 125 LCD Screen Eyetracker Calibration dx dy is the change as compared with the current set value edited values current x y is the current set value This means in the example above If this data are confirmed with OK the calibration of the eyetracker in x direction is 0 um and in y direction 50 um The values of x and y are modified during this calibration around the following values in x direction 0 um and in y direction 30 um Page 164 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description A WaveLight
170. t Treatment see page 91 Printout see page 94 Screenshot see page 95 Page 108 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description SA WaveLight 5 6 8 Treatment Data Range PTK nunnunununnnnnnnnn gt The table below shows the variable fields and ranges which can be adjusted between the minimum and maximum values Musterfrau Paula 24 02 1974 Planned F2 Flap thickness Corneal thickness Stroma Figure 74 Treatment Data Window PTK Min Max Depth um 5 100 Flap thickness um 0 200 Data Range Optical zone mm 2100 4 09 P5059 260 965 P70 depends on the depth Table 12 Treatment Data Range PTK The treatment range depends also from the used treatment list Only the released treatment lists can be selected ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Patient F3 Examination F4 Summary 75 80 Page 109 of 232 ZA WaveLight Functional Description 5 6 9 Import Data A CAUTION Tampering with the imported data or use with other devices than the ALLEGRETTO WAVE EYE Q laser system is strictly prohibited Make sure that all measurements to be imported meet criteria for use in topography or wavefront guided LASIK Review each measurement in the Examination Data Window before transmitting the data to the ALLEGRETTO WAVE EYE Q laser The import
171. tective glasses must not show any signs of mechanical damage The below prescribed type has to be used The protective goggles for use with the ALLEGRETTO WAVE EYE Q laser system must meet the following minimum standards IR 193 nm L3 according to DIN EN 207 Type of Laser IR Impulse Laser Wavelength at which the Protective goggles offer Protection Protection Grade For the purpose of safety verification the protective goggles must be marked as indicated above A CAUTION Never look directly at the laser beam ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 15 of 232 A z Wave Lig ht Safety Instructions 3 2 Safety Against Fluorine and Ozone When contemplating the potential risk from toxic gases you have to consider Fluorine A WARNING The ALLEGRETTO WAVE EYE Q is outfitted with a filter system which prevents toxic gas from passing out In case gas odor fluorine is detected the following steps must be taken Fluorine e Close the ArF Premix gas cylinder valve e Open all windows in the vicinity of the laser in order to ensure adequate ventilation and if available switch on room ventilation given that the ventilation does not spread the gas in other rooms e Leave the room and lock the door so that nobody can enter the room e Call your WaveLight AG authorized service technician or local distributor The ALLEGRETTO WAVE EYE Q checks for system gas leaks
172. ted planned treatment patterns in the schedule list Calculated Treatments Since only one data set has been imported confirmed and calculated a Planned data set is displayed The Planned Treatment Window is divided in three fields 1 Calculated Treatments 3 Menu Bar 2 Transmitted Treatments Table 7 Sections Of Planned Treatment Window Planned Treatments Planned F2 Calculated Treatments Transmitted Treatments Mustermann Peter 0D 01 Examination F4 UE a Ias 3 Summary F6 Mustermann Peter OD 01 TOSE Print F8 WFoptimized 6 50 22 10 2007 Exit Esc Figure 55 Planned Treatment Window ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 83 of 232 ZA WaveLight p Functional Description e Press the button ieee in the Summary Window and follow the prompts on the screen Aa NOTE A data transfer is only possible if the notebook is physically connected with the ALLEGRETTO WAVE EYE Q laser and the ALLEGRETTO WAVE EYE Q laser device is in the Standby Mode If the data transmission is not successful the message Laser Not Ready will appear The calculated data are sent to the ALLEGRETTO WAVE EYE Q laser A progress bar shows this process Page 84 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description A WaveLight ETT TT TEEPE ETC
173. ter With Ablation Target For Scanner Test we NOTE Adjust the target for the Scanner Test with the height diodes to the correct working distance ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 181 of 232 A SA WaveLight Functional Description 7 To carry out the test select the menu option Scanner Test in the Setup Menu of the ALLEGRETTO WAVE EYE Q laser system 8 Perform the Scanner Test routine by ablating 8 spots and 3 lines by pressing the LASER pedal The spots should form a square The ablation spots are at each of the 4 corners and in the center of each side The diameter amounts to D 1 0 mm Due to the ablation the transparency of the target for the Eyetracker Test will change In the area of the ablation the target will now be milky white see figure 149 on page 183 9 Analyze the scanner ablation Ablation Limit Figure 147 Scanner Test Reticle Figure 148 Ablation Target For Scanner Test With Scanner Test Reticle Page 182 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A e Functional Description A WaveLight A CAUTION In case the ablated spots and lines are not within the required positions a treatment should not to be performed and your ALLEGRETTO WAVE EYE Q service representative must be informed a After the ablation is performed the positions of the ablated spots must be checked using the Scanne
174. th 32 bit color depth The system will be temporarily changed to these parameters The logfile is not active in this session The laser did not answer during the last 10 seconds This could indicate a disconnection Do you want to wait 10 seconds more Sorry It is not possible the change the axis in this release List Of Messages And Warnings Solution Please define transition zone Please define optical zone Please define PTK depth Please define flap thickness Un Check Higher orders off or agree by proceeding Un Check Tilt Off or agree by proceeding Contact service Choose approved sphere or consider other options Choose approved cylinder or consider other options Undo modification of sphere and or cylinder agree to modified values and proceed or consider other options Contact service Contact service This could indicate a disconnection Do you want to wait 10 seconds more Contact service ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 ee 5 S List Of Messages And Warnings SA WaveLight No Error Message Solution 21 Sorry It is not possible the change the Contact service cylinder in this release 22 This treatment was already finished Contact service Transmission of this treatment is only allowed for test or demonstration purpose 23 This treatment was aborted Contact service Transmission of this treatment is only allowed f
175. the format seen on the left side is used to display error messages The error message itself is marked by a number ERR x and an additional error text ERR x error text Further symbols ensure a quick allocation of the Call Service error displayed Figure 152 LCD Screen Error Text No These numbers serve only for the internal organization Display Here you will find the display messages Reasons In this column possible reasons are shown which lead to the message Solution Here you will find suggestions to take remedial measures and to be able to continue the treatment If a message or warning does not disappear then please contact your authorized ALLEGRETTO WAVE EYE Q service representative Page 190 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Errors And How To Fix ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Display Exchange gas cylinder LCD screen ArF or No cylinder Pressure regulator defect LCD screen ArF or No cylinder Leakage CLOSE ArF Valve Regulator CLOSE ArF Valve Primary energy too low Communication laser head Internal energy loss too high No pupil detected Scanner defective CRC Program Reasons A The Nitrogen gas cylinder is displayed The cylinder has not been opened B The cylinder is empty Sensor or cable defective Defective sensor or a leakage in the s
176. tically 21 Turn off the Ablation Depth Micrometer briefly press ON OFF and release Mark the Fluence Test Disk surface below the WaveLight AG lettering outside of the ablation zone and only after the measurement has been taken as erroneous measurements will otherwise result due to the ink thickness 22 Mark the probe number and the date on the appropriate side of the Fluence Test Disk Example Probe No 5 Side 1 Marking 5 1 Probe No 12 Side 2 Marking 12 2 23 Store the Fluence Test Disk in the sheath of the Archive Folder Page 174 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description A WaveLight ETT TTT eee EEE TET ELC EET EPETEC LE LLCETTTPTeLerrTererrieeriieererrrererriererriere reer irre reer gt A CAUTION If the depth is not correct repeat the Energy Check see section Calibration Of The Laser Energy At The Beam Aperture on page 52 and the Fluence Test 24 If the required depth was not reached the energy must be changed Use the function Calibrate Energy by pressing the Setup Key If the ablation is too deep the energy has to be reduced If the ablation is too shallow the energy has to be increased After correcting the energy the result must be checked by performing another Fluence Test MEASURE ABLATION DEPTH depth OK OK KEY wrong depth SETUP KEY Figure 140 LCD Screen Tolerance Check ALLEGRETTO WAVE EYE
177. tion key during all routines for which ArF Premix gas or Nitrogen gas is required OK Key The OK Key is the universal confirmation key The key s situation dependent functions are found in the corresponding texts appearing on the LCD screen Eyetracker Key The eyetracker is turned on and off via this key In the Treatment Window the status is indicated on the LCD screen of the laser console and the corresponding LED is switched on at the control panel To disable the eyetracker this key must be pressed for at least 2 seconds We strongly recommend to use the eyetracker during the treatment Cross Line Key This key is used to switch the cross line projector on and off After turning ON the cross line projector always is set to the maximum brightness The brightness of the cross line projector can be adjusted by turning the corresponding knob ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 31 of 232 F WaveLight System Description Aiming Beam The aiming beam is turned on and off via this key when the system is in Treatment Mode The brightness of the aiming beam can be set in the Setup Menu This setting is then saved as the default value Distance Diodes The distance diodes focus diodes are turned on and off via this key when the system is in Treatment Mode The brightness of these diode lasers can be set in the Setup Menu This setting is then saved
178. tional Description ZA WaveLight ETT TTT TEEPE ELC EET LEEL ELEC LETC ETTTPLCLeTiererreeriiieererreererrrererreere reer err rer eee gt 5 6 18 Service This menu point is only for use through the customer service 5 6 19 Notebook Software Info e To see which program version is installed on the notebook enter the Setting Menu and click on Info The following window is shown Planned Treatments Planned F2 Patient F3 ed Treatments Transmitted Treatments Mustermann Peter 0D 01 Examination F4 Info ber Allegretto Treatment 2 020 build 0146 F5 Summary F6 F7 Mustermann Peter OD 01 Print F8 WFoptimized 6 50 22 10 2007 Exit Esc Figure 90 Version Portal Software Notebook ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 127 of 232 A gt j SA WaveLight Functional Description 5 6 20 Shutdown The Program e To shutdown the program press the button with the mouse or the function key ESC Figure 91 Question Window ES e Click the yes button to exit the program e orthe No button to proceed Page 128 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Functional Description FA WaveLight TTT TTT eee TET TTT gt Positioning The Patient First shift the eyetracker illumination in Move the patient bed out to allow the patient to
179. tioning e inspection of the laser parameters e inspection of protective earth as per DIN EN 60601 1 e inspection of electrical grounding under normal conditions as per DIN EN 60601 1 e air tightness of gas supply elements A CAUTION If inadequacies are found during the technical inspection which could have a bearing on the safety of patients users or third parties the ALLEGRETTO WAVE EYE Q laser system may not be used until a WaveLight AG authorized service representative has corrected these inadequacies Page 212 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A Technical Assistance SA WaveLig ht SECC ELEC ELEC eee gt 10 4 Disposal The lifetime of this medical device is defined to 5 years After this time the adequacy of the technology used must be rechecked by a service technician who is specially authorized by WaveLight AG WaveLight AG accepts devices that have been taken out of service and disposes of them in accordance with national regulations Contact WaveLight AG service for assistance on returning devices ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 213 of 232 FA WaveLight Labeling 11 LABELING Basically laser devices of all classes must be labeled The following applies 1 The labels must be easily legible 2 The labels must be clearly visible during operation and service work 3 Laser warning signs must be
180. uctions provided by the microkeratome manufacturer e Shift the eyetracker illumination back to the treatment position A CAUTION When the eyetracker illumination does not lock into place an error message is displayed Therefore shift the eyetracker illumination carefully into place e Check again the position of the patients eye and re align if necessary Page 132 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A he Functional Description A Wavelight 5 10 Ready Mode If the device is in Ready Mode laser pulses may be emitted via inadvertent engagement of the LASER pedal e For safety reasons the laser should be switched from Ready Mode to Standby Mode during treatment pauses e Pressing the Ready Key A the system switches into the mode from which laser treatment may begin e The system once more again conducts a check of the laser pulse energy and again indicates the E V values If the V value lies outside of the tolerance range i e less than 52 or larger than 97 a warning is displayed E And V Values Not Compatible This has to be confirmed with the OK Key A gas change new fill is necessary This can be activated in the Setup Menu The laser system then prompts you to conduct the Center Test PTK DEPTH DIA POLS 6 25 1 25 D SPH D CYL AXIS Start Center Test with CENTER PEDAL a READY va Figu
181. ul magnification 2 4 x The distance edge to edge between two grid lines is 150 microns um 11 If the decentration is less than 100 microns eyetracker calibration is ok Press the Setup Key to get directly to the Calibrate Eyetracker Menu see figure 125 LCD Screen Eyetracker Calibration on page 164 If the value is gt 100 um read the displayed X and Y values and note them on the used test target Remove the target and store it in your Archive Folder Page 162 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description A WaveLight 12 Re calibration is necessary if the deviation in one or both axes is more than 100 microns Therefore press the LASER pedal again Please refer to chapter 5 17 4 Test Of Eyetracker Centering on page 164 SYSTEM CHECK Measure Decentration OK KEY ok LASER PEDAL again SETUP KEY calibration Figure 124 LCD Screen Define Eyetracker Centering 13 If the deviation is more than 600 microns call your ALLEGRETTO WAVE EYE Q service representative 14 Archive the target with dx dy date and name in your Archive Folder ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 163 of 232 gt A j SA WaveLight Functional Description 5 17 4 Test Of Eyetracker Centering This test enables you to determine whether the laser eyetracker adjustment is correct Setup Menu ET Tes
182. ure 35 LCD Screen Purging Beam Path ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 57 of 232 A j SA WaveLight Functional Description Start the External Energy Check by pressing and holding down the LASER pedal at least till LCD screen shows External Energy Check finished release LASER pedal This will take about 15 seconds SYSTEM CHECK Repeat measurement LASER PEDAL 1 89 mJ measured energy 1 87 0 02 mJ Target Energy Factory setting 1 89 mJ Figure 36 LCD Screen Energy Check Running ENERGY CHECK finished leave LASER PEDAL Repeat measurement LASER PEDAL 1 89 mJ measured energy 1 87 0 02 mJ Target Energy Factory setting 1 89 mJ Figure 37 LCD Screen Energy Check Finished Page 58 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Functional Description A WaveLight ETT eee CEPT ELCLE TEP ELEC LE TLCETTTPLeLerrererrieriiieererrrererriererrrere reer err e reer gt Save OK KEY Test LASER PEDAL Change Target Energy ARROW KEYS 1 89 mJ measured energy 1 87 0 02 mJ Target Energy Factory setting 1 89 mJ Figure 38 LCD Screen Save Target Energy Note that the External Energy 1 89 mJ in the pictured example is well within the 0 02 mJ tolerance of the Target Energy 1 87 mJ 1 89 mJ After every 1 200 laser pulses the measured energy is displayed along with the E rel
183. ust be typed with all capital letters ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 71 of 232 A j SA WaveLight Functional Description 5 6 2 How To Perform A Wavefront Optimized Treatment The ALLEGRETTO WAVE EYE Q Portal Software starts automatically If no planned treatments are existent the following Patient Data Window is shown Otherwise the Planned Treatment Window is shown see figure 55 Planned Treatment Window on page 83 The Patient Data Window is divided in five fields 1 Patient Data 3 Patient Data Field 5 Menu Bar 2 Patient Treatment Measurement Field 4 Treatment Measurement Information Table 1 Sections Of Patient Data Window Patient Data Planned F2 Pati ent F3 Last Name First Name Date of Birth J Geimimeyaar AC Examinations F4 Treatment FS Treatment No Treatment method Treatment status New Print F2 selected 0 of 0 Figure 47 Patient Data Window Now there is either the possibility to e prepare the measurements for Wavefront Optimized WFoptimized PTK treatments or to e import new data A CAT Topo guided Optional available Please see chapter 5 6 9 Import Data on page 110 and refer to the appropriate User Manual Page 72 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Functional Description A Wave lig nt Entering Pat
184. veLight 5 3 Turning On The System Switch on the system at the System Main Switch located between laser console and patient bed see chapter 4 3 Switching Elements And Interfaces figure 3 Mains Distribution Box With System Main Switch on page 25 Then switch on the unit at the Main Power Switch located at the rear side of the laser console see figure 5 Elements On The Rear Side Of The Device on page 27 Power up the system components Functioning of notebook computer eyetracker monitor patient bed and plume evacuator are mandatory for tests and treatments Turn the Key Switch in a clockwise direction see figure 4 Key Switch And Emergency Laser Emission Stop Switch On The Front Of The Device on page 26 after the portal software has prompted on the notebook Hold the key in this position 3 until the following appears on the LCD screen of the laser console ZA WaveLight PR XXXXXX Firmware Version Figure 12 LCD Screen Start Window When the laser is turned on it will conduct a Self Test and a System Check The Self Test will run automatically after the laser has been turned on however the user must actively participate in the System Check If the laser device does not turn on check to see if the System Main Switch and or the Emergency Laser Emission Stop Switch has been released The Emergency Laser Emission Stop Switch is released by turning the red knob clockwise The firmware versio
185. y on page 124 Send the copy of the completed Treatment License Form per Fax to WaveLight AG to request the new Treatment Code Fax 49 9131 6186 221 Tel 49 9131 6186 139 WaveLight AG will send you the new Treatment Code with the new number of treatments e Enter the Treatment Code and confirm with ok or press the button to abort The remaining treatments will be displayed Repeat the procedure for each treatment type ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 Page 125 of 232 A gt j SA WaveLight Functional Description 5 6 15 Connect To Service Center Currently not available 5 6 16 Browse Customer Info Currently not available 5 6 17 Recreate Data Files In case the program has not been correctly shut down as described in chapter 5 6 20 Shutdown The Program on page 128 it could be necessary to recreate the patient index file Choose this menu option if you wish to recreate the patient index file e Enter the Setting menu and click on Recreate Data Files The following popup window opens Recreate Index Files This could take some minutes Figure 89 Popup Window Recreating The Index Files ES e press the OK button to continue or e press the Cancel button to abort Page 126 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A F e Func
186. y set is still reached The measured energy and the high voltage of the laser head are outside the given borders The measured secondary energy is too high and cannot be adjusted within the given borders The measured secondary energy is too low and cannot be adjusted within the given borders The measured energy of the laser head is too low and cannot be adjusted within the given borders During the energy measurement the energy sensor was not able to measure energy Either the sensor is not correctly positioned or the sensor is defective ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 WaveLight Solution e CAUTION Under correction is possible e Complete the currently started treatment e Contact the service immediately e Repeat the energy measurement e Perform a gas change e Contact service if this message does not disappear e Repeat the energy measurement e Follow the instructions on the display e Perform a gas change and repeat the energy measurement e Follow the instructions on the display Perform a gas change and repeat the energy measurement e Position the energy measuring sensor below the beam exit and restart the energy measuring e Contact service if this message does not disappear Page 199 of 232 ZA WaveLight No Menu MES 83 Energy MES 84 Energy MES 86 Energy MES 95 Energy Page 200
187. ystem Defective pressure regulator Despite new gas fill up laser energy is too low Data cable relay or laser head defective Attenuation within the beam emission route is too high A Eyetracker illumination is partially covered B Incorrect threshold settings C Eyetracker is defective Room temperature below required temperature or scanner is defective Checksum program error FA WaveLight Solution A Reboot the system and open the Np cylinder when prompted B Contact service and order the required gas cylinder Contact service e Immediately close the ArF cylinder e Open the windows e Contact service e Close the ArF cylinder e Contact service Contact service Contact service Contact service A Remove the obstacle covering the illumination source B Adjust the eyetracker to the correct threshold value C Contact service e Increase room temperature e Contact service Contact service Page 191 of 232 ZA WaveLight No 10 11 12 13 14 15 16 17 18 Page 192 of 232 Display CRC Data Primary energy too high Out of V range No of new fills exceeded Data not found E V incompatible code Laser head Valve CLOSE ArF cylinder Laser head CLOSE ArF Reasons Checksum data error e The adjusted relative standard energy is too high e The internal energy sensor is defective The relative laser head high voltag
188. z LASER PEDAL Start Treatment CENTER PEDAL Test a E Figure 95 LCD Screen Before Treatment e You will hear test pulses being emitted against the shutter during the first half second of treatment This is normal for safety reasons e The eyetracker corrects and guides the laser beam automatically in case of small eye movements Should the eye move more than 2 5 mm or exceed a certain velocity the eyetracker will interrupt the ablation automatically for a moment even if the LASER pedal remains engaged Page 136 of 232 ALLEGRETTO WAVE EYE Q 1010 User Manual en Rev 9 09 06 08 Item No 6638 2001 A he Functional Description eee A Wavelight If the eye movement corrects itself within 3 seconds the system will continue the treatment automatically without losing any pulses When the disturbance lasts longer than 3 seconds the error message No Pupil Detected or Pupil Out Of Range appears PTK lt g gt DEPTH DIA Mh 6 25 1 25 50 6 5 D SPH D CYL AXIS MM 074 Pupil Position Out Of Range E Figure 96 LCD Screen Error Message Solution Lift foot off the LASER pedal re align the eye and continue the treatment During treatment the ALLEGRETTO WAVE EYE Q emits laser pulses for as long as the LASER pedal is engaged The progress of the treatment is indicated by a growing horizontal line in the LCD screen The full display le

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