T.O.S.C.A. Workstation
Contents
1. sad p eh oo b c d 2 PRINTER dsl 1 oe System components Connections 1 Isolating transformer with multi outlet a Computer power supply cable distribution unit 5 outlets b Power supply cable with power supply unit 2 Computer of the 15 TFT flat screen 3 15 TFT flat screen C 9 video monitor screen power supply cable 4 9 video monitor screen d TMS 3 AutoTopographer power supply cable 5 TMS 3 AutoTopographer e Isolating transformer mains power connection Page 20 Document No 310599001 T O S C A TMS 3 WORKSTATION Asclepien 6 4 Turning the system on off Turn the T O S C A TMS 3 Workstation on off at the isolating transformer It is also possible to turn the system components on or off at the mains switch of each component For details of the location of the mains power switch on each component please refer to the illustration below il Note Please turn the system on or off at the isolating transformer System components On off switch _ Isolating transformer TMS 3 AutoTopographer Isolating transformer on off switch TMS 3 AutoTopographer on off switch 9 video monitor screen 15 TFT flat screen Computer Video monitor screen on off push button TFT flat screen on off push button a RC nm o a O O 9 Computer on off push button Version 1 0 Closing date 01 2000 Page 21 Start up USER2. Phone 49 36 41 65 22 78 Facsimile 49 36 41 65 39 31 e mail AMJ EXCIMER HOTLINE 2compuserve com Version 1 0 Closing date 01 2000 Page 3 USER S MANUAL Page 4 Document No 310599001 ero T O S C A TMS 3 WORKSTATION Asclepien Contents 1 General information 7 1 1 Machine identification data esscr nean aa nn 7 1 2 Document data Ra 7 1 3 Purpose of this doc rnent cedi eden 7 1 4 Availability of the User s Manual ooocccccnnoccccnnonccccononcncnonanccnnnnoncncnnnnn cnc nan ener 7 1 5 Complete documentation enden aan 8 1 6 O eis its Heritage 8 2 Machine description 9 2 1 eL 9 2 2 GOnsIFUcti n ie T 10 2 3 FUNCION cr e dl di a 11 2 4 ITem 11 3 Safety instructions 13 3 1 Customer s safety obligations sse eene nnne 13 3 2 Safety alert Symbols S 13 3 3 Concrete safety Instructions tent eet rtr t e aa tal ea die 14 4 Transport 15 4 1 DEINO dl be da 15 4 2 Transter to CA teste ee el 15 5 Setting up 17 5 1 Requirements on the roOM unnsaanennannnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnannennnnnnnnnnnnnnnnnnnannennnnannnn 17 5 2 UNPAckINO escorial tata 17 5 3 Check for short deliver Y ooooonnicninnccnnninnnconnnccnonconorcn crac cnc cnn 17 5 4 Installation and layout of the system components ssseseeeeeem een 18 5 5 Initial instruction in the use of the system uernnenessnnn
3. 7 3 7 The bottom status line Fox Help press F1 zzz M 234 Legend 1 Displays messages according to the current conditions 2 Not assigned Indicates if the number field of the keyboard is turned on or off 4 Not assigned 7 3 8 The color scale The color scale displays all colors used together with their dpt values The color scale can change its appearance depending on the source of the invoked patient data record Version 1 0 Closing date 01 2000 Page 31 Operation USER S MANUAL 7 3 9 The power map Axial 7 3 10 Eye type and machine type OD 1 0D 2 ae STANDARD TMS 3 ORBSCANE TECHNOMED Legend Displays the curvature of the cornea as a color contour together with the assigned dpt values Temporal Angle matrix in 10 steps Nasal Legend Displays the eye type Displays the machine type Page 32 Document No 310599001 T O S C A TMS 3 WORKSTATION Asclepien 7 3 11 The elevation maps elevation maps la j devation maps 2a O Target elevation mags 3a 3b Legend The Elevation window displays the elevation contour of the cornea Elevation is indicated in units of um Before the Apply function is performed to obtain an elevation contour of the cornea the Target window is blank After performing the Apply function the current display of the cornea in the Elevation window remains displayed After performing
4. 98 operating system 7 2 The TMS 3 software The use of the TMS 3 software is described in the delivered operator manual of the supplier Fortune Technologies Version 1 0 Closing date 01 2000 Page 25 Operation USER S MANUAL 73 The T O S C A software 7 3 1 Starting the T O S C A software s To start the software double click the TOSCA icon gt The main menu of the software is displayed 7 3 2 The main menu A ee 2 Fie pkes Heb 3 on X Es oem amp em Po mn c postam j one avo evvation maps Target OD STANDARD T O S C A NUM Axial P duas 5 fe Heb ss F1 6 7 8 9 Legend Top status line Menu bar Icon bar Register cards Bottom status line Color scale Power map Eye type and machine type oO ON OO 2 W D Elevation maps Page 26 Document No 310599001 e T O S C A TMS 3 WORKSTATION Asclepien 7 3 3 The top status line e 1 2 34 5 1 2 3 4 5 7 3 4 The menu bar MT 1 2 3 14 1 1 1 24 Ben 1 2 1 123 1 2 2 2 1 23 1 4 1 3 1 4 24 Map options 2 1 2 24 v Tooker 2 2 2 Y Statue Bar 2 2 1 2 3 1 Data View 2 2 2 2 3 2 Palieni View 2 3 3 Belac viem 2 3 1 2 3 4 Extended View 2 3 2 2 3 3 2 3 4 31 Tape 3 1 3 2 About Tosca 3 2 Legend File name of the current file Software name Minimize window Maximize window Close the software Legend Opens the window to select a patient dat
5. Caution Computer A Caution Video monitor 9 A Caution For technical data and further specification details please refer to the operator manual of the supplier Fortune Technologies For technical data and further specification details of the computer please refer to the computer supplier s documentation in the supply For technical data and further specification details of the video monitor please refer to the video monitor supplier s documentation in the supply Version 1 0 Closing date 01 2000 Page 11 Machine description USER S MANUAL TFT flat screen 15 AN Caution Computer table Dimensions W x D x H Weight Material Carrying power For technical data and further specification details of the TFT flat screen please refer to the screen supplier s documentation in the supply 1 5m x 1 0m x 0 8 m 26 kg Metal frame with plastic coated table top panels 12 kg each panel Page 12 Document No 310599001 T O S C A TMS 3 WORKSTATION Asclepien 3 Safety instructions 3 1 Customer s safety obligations The T O S C A TMS 3 Workstation was designed and produced in accordance with the applicable harmonized norms and further technical specifications It is a state of the art product and warrants the highest measure of safety This level of safety can be maintained in practical use of the system only if all required measures are taken It is the obligation of the customer of
6. S C A TMS 3 Workstation please call our Excimer laser hotline or your nearest distributor Phone 49 36 41 65 22 78 Facsimile 49 36 41 65 39 31 e mail AMJ_EXCIMER_HOTLINE compuserve com Please note that supplier and distributor will only accept responsibility for the function reliability and safety of the system if the system was set up started maintained and repaired only by personnel authorized by it the electrical installation conforms to the legal requirements the system is used in accordance with the instructions Version 1 0 Closing date 01 2000 Page 47 Further informations USER S MANUAL 10 4 Conformity statement e Asclepien Asclepion Meditec AG Pr ssingstra e 41 07745 Jena Germany Kombination von Produkten mit CE Kennzeichnung Combination of CE compliant products TMS 3 Software Workstation Hiermit erkl rt die Asclepion Directive 93 42 EEC d in line with it s ea G Relevant information delivered documentation All these ditec AG Quality Management TMS 3 Art Nr 4640 mit io fh Art Nr 3104 TMS 3 Model No 4640 with TOSCA Workstation Model No 3107 and Software TOSCA Model No 3104 Diese Erkl rung ist nur in Verbindung mit den zu den Einzelkomponenten geh renden EG Konformit ts erkl rungen g ltig Bei nderungen an den Einzelkomponenten oder der Kombination mit nicht aufge f hrten Produkten die nicht von der Asclepion Meditec AG autorisiert wurden
7. date 01 2000 Page 13 Safety instructions USER S MANUAL 3 3 Concrete safety instructions A Danger A Danger The TOSCA program should not be solely relied on for determining pre operative or post operative procedures As there is potential for serious injury including patient discomfort pain disorientation loss of degrees of sight and blindness from improper use at all times the user of the software should be a trained ophthalmologist familiar with the use and operation of the software and theories behind TOSCA The user of the program should rely on his or her own skill knowledge expertise and judgment when making decisions as to operative procedures and should not rely solely on the suggested parameters provided by the software which is a calculating tool only dependent on data acquired by topography machines All work on the electrical equipment of the system must only be carried out by a trained electrician It is not allowed to connect several components of the system by portable multiple socket outlets sharing a common grounding cable Always use the isolating transformer with multi outlet distribution unit supplied with the machine Never clean or bring the electrical components of the system in contact with water or a similar liquid Lay the electrical cables and lines supplying the system in such a way that they do not constitute a tripping hazard Regularly inspect the safe standing of the system Do no
8. field If the number is correct the color of the input field changes to white If you want to proceed with the installation click the Accepted button once If you do not want to go ahead with the installation click the Not Accepted button once This completes the installation process Please remove the installation disk from the ZIP drive of your computer Closing date 01 2000 Page 23 Start up USER S MANUAL Page 24 Document No 310599001 e T O S C A TMS 3 WORKSTATION Asclepien 7 Operation 7 1 Qualification of the operator The T O S C A TMS 3 Workstation must only be used by qualified and instructed ophthalmologists Danaer The TOSCA program should not be solely relied on for determining pre operative ger or post operative procedures As there is potential for serious injury including patient discomfort pain disorientation loss of degrees of sight and blindness from improper use at all times the user of the software should be a trained ophthalmologist familiar with the use and operation of the software and theories behind TOSCA The user of the program should rely on his or her own skill knowledge expertise and judgment when making decisions as to operative procedures and should not rely solely on the suggested parameters provided by the software which is a calculating tool only dependent on data acquired by topography machines The operator of the system must have knowledge of the WIN
9. hotline or contact the nearest distributor Excimer hotline Phone 49 36 41 65 22 78 Facsimile 49 36 41 65 39 31 e mail AMJ_EXCIMER_HOTLINE compuserve com 8 1 Problems with the hardware The T O S C A TMS 3 Workstation contains no parts that can be maintained or Caution repaired by the user Only our customer service technicians and other specialists trained by us are authorized to carry out service work on the system Any repair attempt by unauthorized personnel can lead to forfeiture of all warranty claims Besides functions of the system may be disrupted 8 2 Fault messages when using the system The computer of the T O S C A TMS 3 Workstation displays fault messages in non coded text format The message display should help you set the problem right il Note This section only deals with fault messages of the T O S C A software To set right software faults of other programs or of the operating system refer to the appropriate system manual Version 1 0 Closing date 01 2000 Page 43 Troubleshooting USER S MANUAL Fault message Fie yz sx not found A Can riot wite the MELTO fie to ZIP dive ap dsk Please insert Cause The file you wanted was not found or is defective Remedy Install the required file Please very that the path and file correct The installation of TOSCA was not successfully completed The settings of the export options on the topogr
10. peripherals is described in the documentation of the respective suppliers The documentation is supplied with the machine The correct use of the 9 video monitor is described in the video monitor supplier s documentation The correct use of the 15 TFT flat screen is described in the screen supplier s documentation The system must only be used by trained ophthalmologists instructed by Asclepion Meditec in the construction operation handling safety instructions cleaning and maintenance of the machine The instruction shall be recorded and signed in a transfer certificate Additional requirements qualifications or know how are identified in the chapters of this User s Manual A Danger The TOSCA program should not be solely relied on for determining pre operative or post operative procedures As there is potential for serious injury including patient discomfort pain disorientation loss of degrees of sight and blindness from improper use at all times the user of the software should be a trained ophthalmologist familiar with the use and operation of the software and theories behind TOSCA The user of the program should rely on his or her own skill knowledge expertise and judgment when making decisions as to operative procedures and should not rely solely on the suggested parameters provided by the software which is a calculating tool only dependent on data acquired by topography machines Page 8 Document No
11. the Apply function the elevation contour of the Elevation window corrected for the entered refraction data is displayed in the Target window The elevation values are displayed in units of um After using the Shaping function the result of treating the cornea is displayed in a simulation capture in the Elevation Sim window After using the Shaping function the Target window changes to the Ablation window The Ablation window displays the elevation values of the ablation to be made The elevation values are displayed in units of um Version 1 0 Closing date 01 2000 Page 33 Operation USER S MANUAL 7 4 Making an examination 7 4 1 Instructing the patient Explain the patient what is going to happen during the examination Explain the further procedural steps to the patient AN Caution The set up of the patient place and the handling of the TMS 3 AutoTopographer are described in the operator manual of the supplier Fortune Technologies 7 4 2 Making a topographic image exposure The topographic image exposure is made and the appropriate patient data record generated with the TMS 3 AutoTopographer using the TMS 3 software A Caution The topographic image exposure is described in the operator manual of the supplier Fortune Technologies 7 4 3 Generating a data record for ablation The further processing of the topographic data runs under the T O S C A software 1 Start the T
12. the system to plan and supervise the performance of these measures The customer is responsible in particular to ensure the following to use the system only for the intended purpose tooperate the system only in perfect technical state with no function impaired to maintain the User s Manual and all OEM documentation material in good condition and complete and store them on or near the machine to allow only sufficiently qualified and authorized personnel to operate maintain and repair the machine to ensure regular instruction of such personnel in all matters pertaining to the machine and any of its components and make certain that all operators know the User s Manual and in particular the safety instructions to make certain that none of the hazard warning labels on the system is removed or made illegible 3 2 Safety alert symbols The following safety alert symbols indicate important safety messages in this User s Manual When you see this symbol carefully read the message that follows be alert to the possibility of personal injury or death A This symbol indicates a hazardous situation which if not avoided will result in Danger death or serious injury A This symbol indicates a hazardous situation which if not avoided will result in Caution damage to the machine material or the environment il Note This symbol indicates information for the better understanding of the machine Version 1 0 Closing
13. verliert diese Erkl rung ihre G ltigkeit This declaration is only valid with the declarations of conformity for each device Changes of the single devices or combinations with other devices not mentioned without approval by Asclepion Meditec AG will cause the loss of validity of this declaration Jena 17 02 2000 itec AG Asclepion Meditec AG iV Df Michael DettelbaChe Dirk Colditz orstand Directa 2 Qualit tsmanagement Quality Management 606 Ey Page 48 Document No 310599001 ye T O S C A TMS 3 WORKSTATION Asclepien 10 5 Trademarks WIN 98 is a registered trademark of Microsoft Corporation lomega ZIP is a registered trademark of lomega Corporation TMS 3 AutoTopographer is a registered trademark of Fortune Technologies 10 6 Copyright All rights in the text and illustrations of this publication and the T O S C A program reserved Reproduction translation reprinting or multiplication including of parts or in modified form only with the prior written approval of the supplier Version 1 0 Closing date 01 2000 Page 49 Further informations USER S MANUAL Page 50 Document No 310599001
14. 310599001 T O S C A TMS 3 WORKSTATION Asclepien 2 Machine description 2 1 Concept The T O S C A TMS 3 Workstation is an advanced system for the acquisition and diagnosis of the superficial conditions of the cornea The system supplies data for the planning design and later performance of refractive intervention with the Excimer laser MEL 70 G Scan With a CCD camera the TMS 3 AutoTopographer scans the patient s eye and generates the elevation contour of the cornea The required data record is generated by the TMS 3 software supplied with the TMS 3 AutoTopographer The TMS 3 data record is sent to the T O S C A software The user can verify the data string with the T O S C A software reference it to other diagnostic data edit data and finally generate a data record for an Excimer laser MEL 70 G Scan Now the OPASS software processes the data on the Excimer laser MEL 70 G Scan T O S C A TMS 3 Workstation Excimer laser MEL 70 G Scan S TMS 3 T O S C A AutoTopographer Workstation e MS 3 software OPASS software gt T O S C A software Version 1 0 Closing date 01 2000 Page 9 Machine description USER S MANUAL 2 2 Construction q EA Lege
15. Asclepien T O S C A Workstation with TMS 3 AutoTopographer t Sapa as SS 3 m USER S MANUAL Document No 310599001 Version 1 0 Closing date 01 2000 TMS 3 Software V 2 2 T O S C A Software V 2 2 OPASS Software V 2 2 Asclepion Meditec AG PR SSINGSTRASSE 41 07745 JENA GERMANY EXCIMER HOTLINE Phone 49 36 41 65 22 78 Facsimile 49 36 41 65 39 31 e mail AMJ_EXCIMER_HOTLINE compuserve com USER S MANUAL Page 2 Document No 310599001 T O S C A TMS 3 WORKSTATION Asclepien Dear customer you have decided to use the T O S C A TMS 3 Workstation We congratulate you on your decision You now own an advanced system for the topographic acquisition evaluation and subsequent correction of the cornea of the human eye This system enables you to generate data records for ablation specific to each individual patient with high precision and transfer the data to the Excimer laser MEL 70 G Scan for carrying out the treatment The video monitor supplying a permanent image of the TMS 3 AutoTopographer camera picture and the TFT flat screen monitor displaying the user surface in large size will facilitate your work If you have any questions or would like to make any comments please contact the following address Asclepion Meditec AG Pr ssingstrasse 41 07745 Jena Germany Phone 49 36 41 65 32 23 Facsimile 49 36 41 65 36 60 Excimer hotline
16. O S C A software TOSCA icon The main menu of the software is displayed s To start the software double click the 2 Invoke the patient database S ge Click Open in the icon bar of the main menu The patient database is displayed Page 34 Document No 310599001 T O S C A TMS 3 WORKSTATION Asclepien 3 Select a patient data record Open T opotile SERGE 0D ANGELES 0D ANGELES 10 08 99 17 11 18 2206 99 173021 111623 A ENGELHARDT MARGOT FEUCHTER WILMA DD ORBSCAN II FEUCHTER WILMA 0D ORBSCAN II GEBAUER REINHARD OS TMS3 GERHARDT RAINER OD TECHNOMED GERHARDT RAINER 0D ECHNOMED CEDUADAT DAMIEO nn TENA Click the required data record The selected data record is highlighted blue Confirm your selection by clicking lt Open gt Click Cancel to exit the selection window without enabling a data record 4 Verify the patient data fe Hit11501 dat Tosca lol Fie Options Help om x En Drum amp om Po meo c Postam u 2 moe Far Help press F1 To verify the patient data click the lt Patient gt register card Version 1 0 Closing date 01 2000 Page 35 Operation USER S MANUAL 5 Enter the refraction values IL Hin 1501 dat Tosca Ferm Fie Options Help wen X Em a Preven amp em Po mem ca postam MES Paos mans O Target sph 050 o 100 acd 160 00 ppal T O S C A F
17. ON Asclepien 8 Generate a data record for ablation E Hit1 1501 dat Tosca Piel aed Fie Options Help Som X En Green B m o mon cv roo MES oo ehevation maps dz ORE C T 0 S C A For Help press Fl a Click the lt Shaping gt button A data record for ablation is generated The generated data record is written directly on the ZIP disk in the ZIP drive of your computer b After using the lt Shaping gt function the result of treating the cornea is displayed in a simulation capture in the Elevation Sim window The Ablation window displays the elevation values of the ablation to be made Load a ZIP disk with sufficient free memory space in the ZIP drive of the computer before starting the Shaping function AN Caution Version 1 0 Closing date 01 2000 Page 39 Operation USER S MANUAL 9 Verify the result c Fie Opies Heb om X en Are Bon For Help pess F1 NUM a b a Open the lt Data gt register card b Place the mouse pointer above the Target window The current value is displayed in the display window below the mouse pointer Adjust the elevation value to the patient data 1 Noti The lowest point in units of um should approximately be equal to the refraction ote sph cyl in units of dpt multiplied by 13 um dpt plausibility check If you are in doubt select a new Z shift value c Click the lt Pre Sim gt b
18. S MANUAL 6 5 Installation of the software The complete software required by the system is already installed on the computer and ready for use when it is delivered If you want to re install the software follow the instructions on this and the following pages A Caution Store the installation disks at a safe place Do not expose the installation disks to strong magnetic field heat or cold direct sunlight moisture or dust 6 5 1 Installation of the TMS 3 software For a description of the installation of the TMS 3 software refer to the delivered operator manual of the supplier Fortune Technologies Page 22 Document No 310599001 T O S C A TMS 3 WORKSTATION Asclepien Installation of the T O S C A software Start Windows unless already running Load the T O S C A installation disk in the ZIP drive of the computer Wait for the installation window display The installation disk is self starting If the installation will start automatically start it manually by selecting the SETUP EXE file Please read the disclaimer notice carefully If you do not agree to the terms and conditions click Not Accepted If you agree to the terms and conditions you can proceed with the installation Record your license ID To know your serial number please dial the following number 49 36 41 65 22 78 You can also send us an e mail or a fax transmittal Enter your serial number in the red input
19. The power map ne ne 32 7 3 10 Eye type and machine type ooooccccinncccccnnnccccononeccnnnnnenonnnnocnnnnnnennn nano EAE TAKATA ET 32 TBAT E A NO 33 7 4 Making an examination niena eaaa a nano nc nr enne nnne EAA NE Er 34 7 4 1 Instructing the patient o ette ar pe diets 34 7 4 2 Making a topographic image exposure ooooccccnnocccccononccnnnonccnnnnnnccnnnnnncnnnnnanccnnnnncncnnns 34 7 4 8 Generating a data record for ablation sss eene 34 7 4 4 Printing out the data record overview nnensssnnnnnesnnnnnennnnennnnnnnnnnnnnnennennn nenn 41 75 Transferring the data record to the Excimer laser MEL 70 G Scan sess 42 8 Troubleshooting 43 8 1 Problems with the hardware ooooocccnnnoccccnnnoccconnnoncccnnnonncnnn non cnn nan nennen nn rra 43 8 2 Fault messages when using the system occcccnnnccccnnoncconononcccno noc cn nono corn nr 43 9 Cleaning and maintenance 45 9 1 eru pc c 45 9 2 Maintenance tii t eerte fo tta pet obe totae ad onde ea Ix eg 45 10 Further information 47 10 1 Accessories and replacement parts sssssssssssesseeeeeneeen eene nnne nnne 47 10 2 ECIAM 47 10 3 Customer Mal 47 10 4 Gonformity staterment 2 utet du side nr dp lead 48 10 5 Trademarks ont E emittenti e e tides 49 10 6 Gopyright rat onmi e BE ente a ee ce Pb pred oie bt dale 49 Page 6 Document No 310599001 T O S C A TMS 3 WORKSTATION Asclepien 1 1 1 2 1 3 1 4 Ge
20. a record Prints the current file Opens the file print preview window Opens the Printer Set up window of the currently selected printer Displays the two files opened last Quits the current program Opens the Map Options selection window Hides shows the icon bar Hides shows the bottom status bar Displays the content of the Data register card Displays the content of the Patient register card Displays the content of the Refract register card Displays the content of the TSA register card Displays help topics for using the T O S C A software Displays information on the T O S C A installation data Version 1 0 Closing date 01 2000 Page 27 Operation USER S MANUAL 7 3 5 The icon bar 1 2 3 4 5 6 9 7 3 6 The register cards 1 2 3 4 Lm 1 mien w 6 7 8 9 Legend Opens the window to select a patient data record Quits the current program Opens the print preview window of the file Prints the current file Displays the current file prior to simulation of treatment Displays the current file after simulation of treatment Opens the tutorial on T O S C A Displays help topics for using the T O S C A software Displays information on the T O S C A installation data T O S C A Po m De see m Tea Legend Displays the value under the mouse pointer Displays the available patient data Enables entry of the refraction data Enables ent
21. aphic unit were not correctly made The connected ZIP drive is not enabled Call the hotline Correct the settings of the export parameters Call the hotline Start the ZIP drive There is no ZIP disk in the drive Load a ZIP disk The ZIP medium is full Make sure that sufficient free storage space is available on the ZIP disk Load a new ZIP disk if necessary For other problems go to the ZIP drive help function Call the hotline Page 44 Document No 310599001 T O S C A TMS 3 WORKSTATION Asclepien 9 1 9 2 A Caution Cleaning and maintenance Cleaning Computer table housings and monitor screens Clean the computer table and the housings with a soft wet cloth Remove obstinate dirt with a mild cleaner Clean the screens with a soft dry cloth Use special screen cleaner if necessary Danger Do not use a dripping wet cloth There is risk of electric injury Caution Do not use aggressive or abrasive cleaner Optical components All optical parts must be of very high quality Protect all optical parts from damage and accumulation of dirt Caution Do not touch an optical surface Have customer service personnel clean the optical parts Maintenance For details of maintenance intervals of the TMS 3 AutoTopographer please refer to the operator manual of the supplier Fortune Technologies There are no prescribed maintenance intervals for all other syst
22. button on the icon bar The data record overview is printed out il Note Print out the data on a color printer Version 1 0 Closing date 01 2000 Page 41 Operation USER S MANUAL 7 5 Transferring the data record to the Excimer laser MEL 70 G Scan 1 Remove the ZIP disk from the computer s ZIP drive 2 Load the ZIP disk in the ZIP drive of the Excimer laser MEL 70 G Scan 3 Start the OPASS software unless already started 4 Select the required data record in drive E and open the data record il Note 5 Again verify the correctness of the selected patient data record A Danger 6 Now you can start the treatment in accordance with the operating instructions and the application manual of the Excimer laser MEL 70 G Scan All patient data records use the extender DAT If by chance you should select wrong patient data serious injury can be caused by the treatment i This User s Manual of the T O S C A TMS 3 Workstation is not an instruction to Danger carry out the treatment on the Excimer laser MEL 70 G Scan Always refer to the operating instructions and the application manual of the Excimer laser MEL 70 G Scan Page 42 Document No 310599001 e T O S C A TMS 3 WORKSTATION Asclepien 8 Troubleshooting If you require the assistance of our customer service department or if you have a question relating to the machine and how it is handled or the software please call the Excimer
23. e consignment note The carrier should immediately inspect the damage or determine the value of the items in short delivery Inform the competent insurance company of the damage or short delivery without delay Only the insurance company will pay for the supply of the lost or damaged items in the consignment If you fail to note any damage during a visual inspection of the consignment packages but on unpacking you find that a component of the system has been damaged and provided such damage has been caused in transit inform the carrier of the facts without delay and insist that an inspection of the system components is made Do not dispose of the original packaging unless all matters have been settled with the carrier and the insurance company 4 2 Transfer to new site If later you want to transfer the system to a new site observe the following points Make sure that no component can drop to the ground The floor over which the system is transported should be level and have sufficient carrying power for vibration free transport of the system A The system is a measuring instrument of high precision which must not be Caution exposed to strong vibration Non level ground can damage the system Version 1 0 Closing date 01 2000 Page 15 Transport USER S MANUAL Page 16 Document No 310599001 T O S C A TMS 3 WORKSTATION Asclepien 5 1 A Danger 5 2 5 3 Setting up Requirements on the room The r
24. em components Only Asclepion Meditec technicians or specialists authorized by Asclepion Meditec are permitted to carry out cleaning and maintenance of the system Version 1 0 Closing date 01 2000 Page 45 Cleaning and maintenance USER S MANUAL Page 46 Document No 310599001 T O S C A TMS 3 WORKSTATION Asclepien 10 10 1 10 2 10 3 Further information Accessories and replacement parts Please note that under the Medical Equipment Act you are required to use parts tested and released for use with this system For information on certificates confirming the safe use of the system please refer to the OEM documentation We urgently advise you not to use accessory components of other suppliers Asclepion Meditec cannot accept any liability for any such component Warranty The T O S C A TMS 3 Workstation is warranted for a period of 12 months after delivery ex works The warranty covers all parts manufactured by us and all parts from other manufacturers installed in this system We reserve the right to repair defects in the system by replacement of the defective part The replacement of any part is no reason to claim an extension of the warranty period The warranty prescribed by law is available for any part renewed by us Defects caused by improper handling of the machine are not covered by our warranty Customer service If you require customer service or if you have any question regarding the T O
25. llation and layout of the system components All system components are installed by a service technician of Asclepion Meditec The layout of the system components is largely determined by the shape of the computer table You can arrange the monitor screens to your most comfortable position A Danger A Caution Cable ends and components live with electric power can cause electric injury Lay the electrical cables and lines supplying the system in such a way that they do not constitute a tripping hazard Wrongly placed or improperly mounted parts can drop to the ground and cause personal injury Improperly installed cables and lines e g if laid with close bending radius can smoulder or catch fire Electronic assemblies can be damaged by electrostatic processes 5 5 Initial instruction in the use of the system The service technician from Asclepion Meditec installing the system carries out the function test and instructs the operators of the system in its use as required under MPG and EC directive The fact that the instruction was carried out shall be recorded in the delivery document of the system Page 18 Document No 310599001 T O S C A TMS 3 WORKSTATION Asclepien 6 Start up 6 1 Qualification of the start up operator The first start up of a new system is the job of an authorized representative of Asclepion Meditec who explains all involved steps to the customer s operators 6 2 Connection of all sy
26. nd TMS 3 AutoTopographer with power supply cable and parallel cable to the computer Video monitor 9 with power supply cable and connecting cable to the TMS 3 AutoTopographer TFT flat screen 15 with power supply unit and connecting cable to the computer Computer table a fF 0 N Computer with power supply cable mouse and keyboard Page 10 Document No 310599001 T O S C A TMS 3 WORKSTATION Asclepien 2 3 Function The CCD camera of the TMS 3 AutoTopographer produces the elevation contour of the examined patient s eye The image captured by the camera is displayed on the video monitor in real time mode The connected computer processes all data and allows user intervention with the software The TMS 3 software interprets the results of the camera and generates the data records These data records are sent to the T O S C A software for processing The user can verify the data contents reference data to other diagnostic data and edit data The revised data records can then be transferred to an Excimer laser MEL 70 G Scan for further processing by the OPASS software 2 4 Technical data T O S C A TMS 3 Workstation overall system Dimensions W x D x H 1 5mx 1 0m x 1 4m Weight 40 kg Power supply 220 230 V single phase 6 A 50 60 Hz Power consumption 150W Class of electric protection 1 type B continuous service License test CE label Ambient conditions 15 35 C 20 50 RH TMS 3 AutoTopographer AN
27. neral information Machine identification data Machine data Model designation T O S C A TMS 3 Workstation Serial number Order number Year of construction TMS 3 software License ID Serial number T O S C A software License ID Serial number WIN 98 operation system Serial number Distributor Firm name Address Phone no Document data Document type User s manual Document number 310599001 Version 1 0 Closing date 01 2000 Purpose of this document This User s Manual makes the user of the T O S C A TMS 3 Workstation familiar with the construction operation setting up handling safety instructions cleaning and maintenance of the system Availability of the User s Manual Always keep the User s Manual and the other documents available to the operator The User s Manual should always be readily available for consultation Version 1 0 Closing date 01 2000 Page 7 General information USER S MANUAL 1 5 Complete documentation The scope of delivery of T O S C A TMS 3 Workstation the system also comprises the product descriptions of the system components A Caution 1 6 Operators A Danger The correct use of the TMS 3 AutoTopographer and the handling of the TMS 3 software are described in the Operator Manual of the supplier Fortune Technologies which is supplied with the machine The correct use of the computer and the computer
28. nnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn anne 18 6 Start up 19 6 1 Qualification of the start up operator eene 19 6 2 Connection of all system components sse nentes 19 6 3 Mains power s pply 3 cmt tentent en ees a bna adn eade dr YR a bid et 20 6 4 Turning the system onol senenin a nnn nennen nennen 21 6 5 Installation of the software 200umnnnsannnnnnnannnnnnnnnnnnnnnnnnnnnnnnnnnnnnnannennnnannennnnannennnnannnnnnnannnn 22 6 5 1 Installation of the TMS 3 software uusensnssssesnnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nn 22 6 5 2 Installation of the T O S C A software nesessesnnsnennnnnnennnnnnnnnnnnnnnnnnnnnnnnnn nenn 23 Version 1 0 Closing date 01 2000 Page 5 Inhaltsverzeichnis USER S MANUAL 7 Operation 25 7 1 Qualification of the operator ursnnersnsnnsnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn manner 25 7 2 The TMS G Solwa E EE E 25 7 3 The T O S C A software uusnsrsssnnnnansnnnonnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnannnnnnnnnnnannnnnnnnnnn nennen 26 7 3 1 Starting the T O S C A software ueessnsenssnsnnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nennen 26 32 E er a eiaeia iea a ia aaae a Ni 26 7 33 The top status Me san tiara tee lec S either 27 3 44 A dpd ea rn Runen L oTa 27 Te o A N aE oT DAA tbe A E AA ETT 28 7310 Tneregister cards actas eb 28 73 7 The botom status ide pe 31 AC e The ColOrscale E E T 31 T39
29. oom in which the T O S C A TMS 3 Workstation is installed and operated should permit electrical supply in accordance to national requirements have a firm floor with a minimum carrying capacity of 500 kg m Use the system only in a room with electrical installation satisfying the national requirements Unpacking All supplied components will be unpacked by a service technician of Asclepion Meditec Check for short delivery Together with the Asclepion Meditec service technician inspect the consignment if all components needed to operate the system have actually been delivered The system consists of the following components TMS 3 AutoTopographer with power supply cable parallel cable to the computer and the operator manual of the supplier Fortune Technologies the computer with power supply cable mouse keyboard and instruction material the 15 TFT flat monitor screen with power supply unit connecting cable to the computer and instruction material the 9 video monitor with power supply cable connecting cable to the TMS 3 AutoTopographer and instruction material the isolating transformer with multi outlet distribution unit 5 outlets the computer table one ZIP installation disk with the T O S C A software one 3 installation disk with the TMS 3 software the user s manual of the supplier Asclepion Meditec Version 1 0 Closing date 01 2000 Page 17 Setting up USER S MANUAL 5 4 Insta
30. or Help press Fl NUM a c b a Open the lt Refract gt register card b Enter the patient s current refraction values in the input fields C Click the Apply button to obtain the display of the new calculation in the Target window Page 36 Document No 310599001 T O S C A TMS 3 WORKSTATION Asclepien 6 Determine the elevation values in the Target window Fle Options Help Som x Ext are ent Po res ca postam m amos elevation mans Axial For Help press F1 NUM f o a Open the Data register card b Place the mouse pointer over the Target window The current value is displayed in the display window below the mouse pointer Determine the highest elevation value along the second ring counting from the center point Version 1 0 Closing date 01 2000 Page 37 Operation USER S MANUAL 7 Set the depth of treatment Fie Opies Help Som x a A Preven pr Po mem ma sm lt REM Iii ea sphere cylinder ON For Help pest F1 E a Open the lt TSA gt register card b Enter the value of the shift of the reference area in the Z axis C Click the Apply button to obtain the display of the new calculation in the Target window If you change the depth by a shift of the reference area in the Z axis you also change the size of the treatment area A Danger Page 38 Document No 310599001 T O S C A TMS 3 WORKSTATI
31. rated data record is written directly on a ZIP disk A Load a ZIP disk with sufficient free memory space in the ZIP drive of the computer Caution before starting the lt Shaping gt function dus s retract Isa aj 40shal OFF anjio I E T O S C A 4 1 42 43 4 4 Legend 4 1 Enables entry of the correction values for the shift of the reference area in the Z axis 4 2 Status message 4 3 Status message 4 4 Starts the new calculation with the refraction data The newly calculated elevation contour is displayed in the Target window il Note The values for Z shifting are entered with the arrow keys beside the input fields The values are entered in steps of 1 um either as incrementing or decrementing value steps The maximum value for Z shifting is 100 um The refraction data are still enabled in TSA mode even if the value calculated by the software is disabled in TASA mode After completing the lt Apply gt function a new shift value can be defined by mouse clicking the Target window Page 30 Document No 310599001 T O S C A TMS 3 WORKSTATION Asclepien oats seo rem Isa Cr se El OO 4 Legend 4 5 Generates a data record for ablation on the Excimer laser MEL 70 G Scan The generated data record is written directly on a ZIP disk Load a ZIP disk with sufficient free memory space in the ZIP drive of the computer before starting the Shaping function N Caution
32. ry of the shift of the reference area in the Z axis om T O S C A 1 1 1 1 Legend Displays the value under the mouse pointer Page 28 Document No 310599001 T O S C A TMS 3 WORKSTATION Asclepiem Lan Name Schweblick 25 08 69 Mame Iris 06 07 99 21 22 2 3 1 2 1 2 2 2 3 2 4 3 1 3 2 3 3 3 1 3 2 3 3 3 4 il Note input fields T O S C A Legend Displays the patient s family name Displays the patient s first name Displays the patient s date of birth Displays the date of the topographic image exposure d x T O S C A C A Legend Enables the entry of the correction values for the sphere data Enables the entry of the correction values for the cylinder data Enables the entry of the correction values for the axis data Starts the new calculation with the refraction data The newly calculated elevation contour is displayed in the Target window The values for sphere cylinder and axis are entered with the arrow keys beside the The values are entered in steps of 0 25 dpt and 5 respectively either as incrementing or decrementing value steps The maximum values for sphere and cylinder are 12 5 dpt The maximum value for axis is 0 180 Version 1 0 Closing date 01 2000 Page 29 Operation USER S MANUAL T O S C A 3 5 Legend 3 5 Generates a data record for ablation on the Excimer laser MEL 70 G Scan The gene
33. stem components All connections are made on the rear of each component A Caution Make sure of the proper seating of all plugs v PRINTER System components Connections 1 Computer a Mouse cable 2 Mouse b Keyboard cable 3 Keyboard C Monitor screen connection 4 15 TFT flat screen d TMS 3 monitor screen 5 9 video monitor screen e TMS 3 computer 6 TMS 3 AutoTopographer Version 1 0 Closing date 01 2000 Page 19 Start up USER S MANUAL 6 3 Mains power supply The T O S C A TMS 3 Workstation is supplied with single phase power 220 230 V 50 Hz 6 A fused To connect the system to the power source proceed as follows 1 Make sure that all system components and the isolating transformer are turned off 2 Make sure that the voltage specified on the nameplate on the rear of each system component agrees with the voltage of your socket outlet Check to make sure that that the power supply cable can be used on your power source 3 Connect all system components to the multi outlet distribution unit using the delivered power supply cables 4 Plug the isolating transformer in a properly grounded socket outlet Use the system only in a room with electrical installation satisfying the national Danger requirements It is not allowed to use portable multiple socket outlets sharing a common grounding cable to connect several components of the system
34. t make any changes to any system of the component without the supplier s authority Use only original replacement parts original wearing parts original accessory items These parts and items are specially designed for the system The use of parts other than original does not ensure design and manufacture in accordance with the service and safety requirements of the machine Parts and optional accessories which are not supplied with your order are not released by us for use with your particular system Inspect the electrical equipment regularly for proper seating and connection damage to cables lines and housing Disconnect the power supply immediately in case of fire Extinguish fire only with CO2 or powder extinguisher Page 14 Document No 310599001 T O S C A TMS 3 WORKSTATION Asclepien 4 Transport 4 1 Delivery The consignment with the T O S C A TMS 3 Workstation was delivered to our carrier in undamaged condition and complete with all required papers The carrier delivering the system to your place is responsible for speedy and safe transport and delivery of the consignment to you without damage If on inspection of the consignment on receipt you find short delivery or damage in transit this is the responsibility of the carrier delivering the consignment If you find damage to the consignment in transit please observe the following points Insist that carrier make a note of the nature of the defect on th
35. utton to restore the status before the data record for ablation was generated 10 Correct the settings if necessary If you think that the depth should be corrected open the lt TSA gt register card once more Make the required change by entering a different value To obtain a new preview repeat the lt Apply gt and lt Shaping gt functions A Danger If you change the depth by a shift of the reference area in the Z axis you also change the size of the treatment area Page 40 Document No 310599001 e T O S C A TMS 3 WORKSTATION Asclepien 7 4 4 Printing out the data record overview 1 Print Set up EJ orion Click the lt Print Setup gt button in the lt File gt menu Select the printer that is connected to the system Complete the required settings 1c VoscaMomeyA Hi 1501 dar 2 cVoscaMomeyA Hit A01 dar 3 c Mosca Miomey A HIZ503 dar A c MosceNiomeg H T 401 det s 1 Note To confirm the entries click OK The data screen for the output of the data record overview uses a A4 landscape format as a default 2 Print Preview TL Click the lt Preview gt button on the icon bar The Print Preview window is displayed a It contains an overview of all relevant data b A print out can be obtained from the Print Preview window c The preview display can be zoomed in or out d Closes the Print Preview window 3 Print d m Click the lt Print gt
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