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Operation Manual

1. 37 Flow of Operations aene ener y Q kan s kek ee Eno cd ae Run 37 Connecting Cables 2 Ernie est e HR RR Er e ERES ER 38 Preparations Prior to an Examination lt i Ak l ll dakae disk Kk kalalal kk 40 Patient DN NNN DD DD rrreeerrEeKKeEeRRRHRHHH HH HH HHHH 41 M a SU 0 EM 43 Finishing an Examination ennt nn intern tennis 47 Power Saving Mode tete tma na iva aces Rea aa Ru iy 48 Recovering from the Power Saving Mode seen 48 5 Types of Meas uremienis uiieeeeicerceiaes ecc cenante ce bak a r k ka kay awka aa a 49 Measurement Screen wa a o idees doa deeded 49 Changing the Alignment Mode EuEE Erkek kk kk kk Ak A 49 Changing the Number of Measurements sesseeeeeeee 50 Changing the Eye Fixation Lamp sese 51 PATIENT ID S r GI xoc eec a saya edith 51 Input Patient ID in the PATIENT ID Screen seeeeeeeeeee 52 Input Patient ID from an External Device eeeeeeee 56 MENU S r Cites E G 57 MENU Screen Display and Functions of Buttons sssse 57 2013 07 18 13 10 07 L IE 5191C TX 20 indbo 4 Basic Operations on MENU Screen see 58 Common Settings in Measurement Modes eene 61 Settings
2. Warning Code Cause Remedy Auto alignment stopped because the limit of motion to 231 right of the measurement unit was detected during auto alignment Auto alignment stopped because the limit of motion to 232 left of the measurement unit was detected during auto alignment 233 Auto alignment stopped because the limit of motion up of 1 Record the message code contents including error the measurement unit was detected during auto alignment codes and then execute OK Auto alignment stopped because the limit of motion 2 Besure that the patient s forehead and chin are firmly 234 down of the measurement unit was detected during auto against the forehead rest and chin rest and then do alignment measurement again Auto alignment stopped because the limit of motion 235 forward of the measurement unit was detected during auto alignment Auto alignment stopped because the limit of motion 236 backward of the measurement unit was detected during auto alignment 1 Record the message code contents including error codes and then execute OK 7 2 Do the following and do the measurement again 237 Auto alignment stopped DeGaliSe the SEE stop position of Press the LIMITER button to reset the position where the the nozzle was detected during auto alignment nozzle stops Be sure that the patient s head and chin are firmly against the forehead rest Operation stopped because a button or the operation lever 3H Re
3. N 9 0I N Has 2 IOP mmHg 12 13 14 13 14 15 12 13 14 l Intraocular pressure Shows measurements from highest to lowest reliability in order 1 to 10 Measurement number Up to 10 Qo Shows measurements from newest to oldest in order 1 to 10 Measurement number Up to 10 o Eye being measured 10 R Right eye L Left eye Level of received light Indicates the amount of light received from light reflected from cornea when measuring intraocular pressure The number of lines increases as the amount of received light increases If there is little received light light reflected from the cornea may be obstructed by the eyelid or eyelashes However it is also affected by the corneal reflectivity of the patient Low reliability This mark appears when the analysis of the results or reliability of the measurement is considered low Measured values that have this mark are not included in the standard value calculation Intraocular pressure standard value Representative intraocular pressure value that was statistically derived from measured values Measured values with a low reliability mark are not used External device connection status Shows the status of external device connection e USB device is connected 9 Error has occurred in USB device connection zzz LAN is connected RS 232C device is connected No display No connection Press to switch to the PATIENT
4. Canon Full Auto Tonometer TX 20 100 240V 50 60Hz 0 8 0 4A R Ce LI A Bad CANON INC 30 2 SHIMOMARUKO 3 CHOME OHTA KU TOKYO JAPAN SN MADE IN JAPAN The following table describes the symbols and indications on the TX 20 USA and Canada Ny Alternating current Type B A Caution Check the documentation provided MSSIF ry o qe MEDICAL EQUIPMENT WITH RESPECT TO ELECRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601 1 AND CAN CSA C22 2 NO 601 1 41C4 Rx only Caution Federal law USA restricts this device to sale by or on the order of a physician MANUFACTURED Year and month of manufacture Example October 2010 NO Serial number in SIX digits Example 123456 L IE 5191C TX 20 indbo 17 17 2013 07 18 18 10 19 2 Safety 18 L IE 5191C TX 20 indbo 18 European Union Ny Alternating current Type B Caution Check the documentation provided A 2 Product that WEEE directive Directive on Waste Electrical and Electronic Equipment 2002 96 EC requires separate collection C Eo This symbol shows compliance of the equipment with Directive 93 42 EEC This symbol indicates that a User s Manual is supplied with this equipment Manufacturer s name and address Serial number in SIX digits Example 123456 i ul EJ E
5. ON Prints OFF Does not print Reduced Set whether to reduce distance between lines of print OFF ON Reduce the distance between lines OFF Do not reduce the distance between lines Density Set the print density 2 1 to 3 Print density higher numbers are more dense Data Set which measurements to print ALL STANDARD Only the standard ALL Measurements for each of the set measurements and the standard Up to 10 sets of measurements are printed Pressing and holding the PRINT button for two seconds or more prints ALL regardless of the setting e Title Set whether to print the names of the manufacturer and machine ON ON Prints OFF Does not print Patient No Set whether to print the Patient No ON ON Prints OFF Does not print Patient ID Set whether to print the Patient ID ON ON Prints OFF Does not print Message Set whether to print a message OFF ON Prints OFF Does not print Ext Set the extension character used in the message LATIN Character LATIN Latin Alphabet No 1 ISO 8859 1 standard JIS Katakana Input For this setting press the measurement button to go to the print message Message input screen You can enter print messages in this screen 63 L IE 5191C TX 20 indbo 63 e 2013 07 18 13 10 37 5 Types of Measurements Settings for Patient ID Input Interface In the patient ID input interface men
6. WM All operations are done manually 1 Press the alignment mode key Every time the key is pressed the alignment mode changes Measurement Screen R Cc Alignment mode key Alignment mode 49 L IE 5191C TX 20 indb 49 e 2013 07 18 18 10 39 5 Types of Measurements Changing the Number of Measurements You can set the number of measurements done in full auto alignment mode One measurement Y One automatic measurement is done Two measurements Two automatic measurements are done Three measurements Three automatic measurements are done 1 Press the measurement count key Every time the key is pressed the number of measurements changes Measurement Screen C RES C Measurement count key Measurement count mc CO CO CD CD To get a highly reliable measurement We recommend that the number of measurements be set to three in full auto alignment mode e We also recommend performing more than three measurements in the auto or manual alignment e mode to get a stable measured values 50 L IE 5191C TX 20 indb 50 e 2013 07 18 13 10 31 5 Types of Measurements Changing the Eye Fixation Lamp You can select either the internal or external eye fixation lamp Internal eye fixation lamp Ei Located inside the nozzle Have the patient stare to fix his her line of sight Normally the internal eye fixation lamp is used Ext
7. Do not enable IP Address Enter the IP address 192 168 000 001 XXX XXX XXX XXx IPv4 address Subnet Mask Enter the subnet mask XXX XXX XXX XXX Subnet mask 255 255 255 000 Default Gateway Enter the default gateway XXX XXX XXX XXX IPv4 address 000 000 000 000 DNS Server Input the DNS server XXX XXX XXX XXX IPv4 address 192 168 000 100 User Enter the user name of the computer that is connected For this setting press the measurement button to go to the user name input screen Supported character code ASCII Maximum number of characters 16 ftp Password Enter the user password of the computer that is connected For this setting press the measurement button to go to the password input screen If the password is input reeeeeeeeeees appears Supported character code ASCII Maximum number of characters 16 ftp Computer Name Enter the name or IP address of the computer that is connected For this setting press the measurement button to go to the computer name input screen Supported character code ASCII Maximum number of characters 64 192 168 000 010 Output Folder Enter the path to a shared folder on the computer that is connected for saving measurements Do not input to indicate the root directory For this setting press the measurement button to go to the output folder input screen Supported character code ASCII Maximum number
8. Improper handling of this type of waste could have a possible negative impact on the environment and human health due to potentially hazardous substances that are generally associated with EEE At the same time your cooperation in the correct disposal of this product will contribute to the effective usage of natural resources For more information about where you can drop off your waste equipment for recycling please contact your local city office waste authority approved WEEE scheme or your household waste disposal service For more information regarding return and recycling of WEEE products please visit WwWw canon europe com WEEE EEA Norway Iceland and Liechtenstein For California USA Only The battery in this device contains perchlorate material Special handling may apply See http www dtsc ca gov hazardouswaste perchlorate 2013 07 18 13 10 13 2 Safety Labels and Symbols The position and contents of the label attached on the TX 20 are shown below USA and Canada 100 240V 50 60Hz MEDICAL e SSIF SN EQUIPMENT ULG0601 1 t US CAN CSA C22 2 No 601 1 41C4 Canon Full Auto Tonometer TX 20 Grounding reliability can only be 0 8 0 4A AN achieved when the equipment is connected to an equivalent receptacle marked HOSPITAL GRADE Rx only CANON INC 30 2 SHIMOMARUKO 3 CHOME MANUFACTURED OHTA KU TOKYO JAPAN NO MADE IN JAPAN European Union M MANUFACTURED
9. Input is not required Numeric Set whether to display numbers in the character list on the PATIENT ID ON Screen ON Displays OFF Does not display Alphabet Set whether to display upper case letters of the alphabet in the character ON Upper list on the PATIENT ID screen ON Displays OFF Does not display Alphabet Set whether to display lower case letters of the alphabet in the character ON Lower list on the PATIENT ID screen ON Displays OFF Does not display Symbol Set whether to display symbols in the character list on the PATIENT ID ON screen ON Displays OFF Does not display 2013 07 18 13 10 39 5 Types of Measurements Setting the Time Date and Power Saving Mode You can set the date time and power saving mode in the Other Menu On the TX 20 you can set the data and time so that the dates of measurements are output as data Also you can set the monitor to turn off and enter power saving mode if no operations are done for a set period Press a button on the operation panel or a soft key to recover from the power saving mode How to Enter the Other Menu MENU screen gt Other tab Date amp Time Settings for the LCD L IE 5191C TX 20 indbo 69 Factory tting it D ipti Setting items escription SUE Date Set the date 2010 to 2099 Year 1 to 12 or JAN to DEC Month The Format setting is MDY if DMY is select
10. You can change the setting by setting Display to ON see page 67 Count up on Error on the patient No menu Reset No on the patient No menu Appears if you try to change one of the following settings while Update in the patient ID input interface menu is 255 ADD 1 You can change the setting by setting Update to i OVERWRITE see page 64 Position of byte at which to start reading Number of bytes in the data to read 1 Do one ofthe following remedies e Use the BackSpace key on the USB device to reduce 257 Appears if you try to input more than 64 characters while the number of characters that have been input Update in the patient ID input interface menu is ADD Press the CLS key to delete all the characters that have been input Press the OK key to end the connection test 258 Confirm whether to save settings when changing the LAN 1 Select YES to save the settings settings 2 Select NO to not save the settings 1 Select OK to clear 259 Confirmation about whether to clear all input data If you do not want to clear the study results select CANCEL 84 L IE 5191C TX 20 indb 84 e 2013 07 18 13 10 41 7 Troubleshooting Warning Code Cause Remedy 1 Select OK to reset 260 Confirmation for executing reset of patient No If you do not want to reset the study results select CANCEL 261 Appears if the format of the text input
11. cursor for a patient ID MEASURE key MENU key DATA key Moves to other screens Measurement screen MENU screen DATA screen 2013 07 18 13 10 32 5 Types of Measurements L IE 5191C TX 20 indb 53 Basic Operations on the PATIENT ID Screen This section explains the basic procedures for the patient ID settings Steps 2 to 4 Input text Steps 5 to 6 Delete text Steps 7 to 8 Add text to existing text Step 9 Delete the entire ID Display the PATIENT ID screen Press the ID key The ID cursor is at the end of the patient ID on the right The selection cursor is at the top of the list of characters PATIENT ID ID cursor oclection EIBCDEFGHI JKLMNOPQRSTUVWXYZ cursor abcdefghijkImnopqrstuvwxyz 0123456789 amp lt gt 7 _ I CHIN REST STICK ew Dew wis 3 Decide on the position to input text Move the ID cursor to the right of where you want to input a character The procedure in steps 2 to 4 is explained using an example of inputting a C at the end of patient ID 12 In this example the cursor is already to the right of the 2 so there is no operation PATIENT ID ElB C D E F G H JKLMNOPQRSTUVWXYZ a b c d e f g h i j k Il mn o p qr st u vwxyz 0123456789 amp 23 lt gt 7 4_ CHINREST STICK r3 ENS EJ MEASURE MENU DATA Nu n To add text to the front Move the ID cursor to
12. the entire pupil of the patient s eye in the monitor Perform the measurement again Instruct the patient to stare at the eye fixation lamp confirm the patient s eye has stopped moving and then perform the measurement If a nystagmus or another problem causes the patient s eye to move constantly during auto alignment press the measurement button when the corneal light is clearly visible You can perform measurements during auto alignment However the positioning alignment may not be accurate Note that the measurement may not be accurate when measuring this way If the eyelid or eyelashes are blocking the pupil instruct the patient to keep his her eyes wide open until the measurement is finished If the patient cannot open his her eyes the examiner should lightly hold the upper eyelid and do the measurement while helping to lift the patient s eyelid Be careful to not hurt the patient Adjust so the corneal light point appears Do the measurement again Adjust the measurement unit and the chin rest to position the corneal light point so it appears near the center Do the measurement again Do the measurement in manual alignment mode However an error may occur even in manual alignment mode depending on the severity Do not allow bright light or sunlight to shine on the patient s eye during measurement 82 L IE 5191C TX 20 indb 82 2013 07 18 13 10 40 7 Troubleshooting
13. 5191C TX 20 indbo 92 ns voltage prior to application of the test level 2013 07 18 13 10 42 Appendix Guidance and Manufacturer s Declaration for Electromagnetic Immunity The TX 20 is intended for use in the electromagnetic environment specified below The customer or the user of the TX 20 should assure that it is used in such an environment IEC 60601 Compliance Level Electromagnetic Environment Guidance Test Level Immunity Test Portable and mobile RF communications equipment should be used no closer to any part of the TX 20 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distances d 1 2 JP d 1 2 JP 80 MHz to 800 MHz d 2 3 JP 800 MHz to 2 5 GHz Conducted RF 3 Vrms 3 Vrms here P is the maxi tout ti EN IEC 61000 4 6 150 kHz to 80 MHz a RM MER of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Radiated RF 3 V m 3 V m EN IEC 61000 4 3 80 MHz to 2 5 GHz Field strengths from fixed RF transmitters as determined by an electromagnetic site I survey should be less than the compliance e level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Cp NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 Thes
14. DATA screen is also cleared 7 Repeat the process from Setup for Patient to continue measurements with a different patient Finishing an Examination 1 Turn off the power switch 2 Clean the nozzle 3 Disinfect the forehead rest and the chin rest If chin rest paper is being used change the paper 4 Put the cap on the nozzle and cover the equipment with the dust cover To pack and transport Turn on the power in packaging mode see page 76 let the measurement unit move to the packaging and transport position and then turn off the power Remove the power cable and remove the cable from any external devices 47 L IE 5191C TX 20 indb 47 e 2013 07 18 13 10 29 4 Basic Operation Power Saving Mode If no operations are performed for a set period the TX 20 Turns off the backlight of the LCD monitor Turns off all LED lamps except the power lamp Flashes the power lamp Recovering from the Power Saving Mode Press a button on the operation panel a soft key on the monitor panel or the measurement button or tilt the operation lever to recover from the power saving mode Either the Measurement screen or the PATIENT ID screen is displayed at recovery depending on the Redisplay In Scn setting in the Patient ID menu see page 68 The status of the TX 20 is the following when recovering from power saving mode Do the following operations if necessary Nozzle stop position The setting value
15. Electrical fast transient burst EN IEC 61000 4 4 x2 KV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge EN IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines EN IEC 61000 4 11 596 Ur gt 95 dip in U1 for 0 5 cycles 40 Ur 6096 dip in Ur for 5 cycles 70 Ut 3096 dip in Ur for 25 cycles 596 Ur gt 95 dip in Ur for 5 sec 596 Ur 29596 dip in Ur for 0 5 cycles 4096 Ur 6096 dip in Ur for 5 cycles 70 Ut 30 dip in Ur for 25 cycles 596 Ur gt 95 dip in Ur for 5 sec Mains power quality should be that of a typical commercial or hospital environment If the user of the TX 20 requires continued operation during power mains interruptions it is recommended that the TX 20 be powered from an uninterruptible power supply Power frequency 50 60Hz magnetic field EN IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Uris the AC mai 92 L IE
16. IE 5191C TX 20 indb 24 ID 000001 L IOP mmHg 13 ull B 14 wl B14 a B 13 ul STD 13 2 0 Q 0 1 Soft keys The purpose of soft keys varies according to the assigned function An icon on the monitor near the soft key indicates the purpose assigned to the soft key Pressing a soft key changes and sets functions and changes the screen In this manual these soft keys are indicated by the name of their functions gt Alignment IOP mmHg Hi 13 l 14 ull B14 wt 2013 07 18 13 10 19 3 Names of Parts Measurement Screen This screen appears when doing measurements You can set the measurement functions show the most recent measurement data and switch Screens 1 2 30 ID 000001 3 IOP mmHg 4 5 6 7 8 9 10 1 Patient ID Patient No 11 Left right eye indicator 2 Measurement range R Right eye 3 Display order of measurement value BB L Left eye From highest to lowest reliability 1 to 3 12 Alignment mode setting From newest to oldest measurement 1 to 3 Press the adjacent alignment mode key to switch 4 LIMITER OFF mark the alignment mode e Indicates the LIMITER function is disabled gt 5 Measurement results history 13 Most recent intraocular pressure Shows the results of measurements according to Shows the most recent measurement age or reliability 14 Measurement count setting 6 Low reliability ma
17. Measurements MENU Screen In the MENU screen you can set the measurements printing data input and output patient ID patient No date amp time messages and the brightness of the monitor MENU Screen Display and Functions of Buttons MENU Screen Settings tab JEER k e DB S YER ew Name of the Common Page 1 2 Selected tab Auto Output ON Cursor Alignment Mode ANONO Order BY TIME Default Side RIGHT Settings R L Distance 66mm Joystick Movement NORMAL Setting items Tonometer Range 30 Unit mmHg CHIN REST STICK E e e Settings tab The items to set are grouped according to their purpose Selected items are light in orange EH Measure tab Settings for intraocular pressure measurements EEE Print tab Settings for printing with the built in printer e Input tab Settings for inputting data from an external device e Output tab Settings for outputting data to an external device ES Patient tab Settings for patient ID and patient No Other tab Settings for time power saving mode the LCD brightness and shows information about the firmware e Setting items The setting items for each setting tab are displayed e Settings The settings for each setting item are displayed Cursor Shows the position of the selected setting value setting item and tab They light orange when selected CHIN REST button Moves the cursor up and down Measurement unit vertical movement ring 1 Moves the
18. Numeric CHIN REST STICK 3 Select an item Use the CHIN REST button to select Patient No gt No MENU lt d e ea e Patient Patient No Page 1 2 Display ON Count up on Error ON No 4000000 gt Reset No Patient ID Redisplay In Scn OFF Limit Data Length OFF Always Input OFF Numeric ON CHIN REST STICK aS 58 L IE 5191C TX 20 indb 58 e 2013 07 18 13 10 38 5 Types of Measurements L IE 5191C TX 20 indb 59 4 Select a digit Press the measurement button four times Move the cursor four digits to the right and select a digit to Set a number If you go too far press the alignment off button to move the cursor to the left MENU Be 8 a Patient Patient No Page 1 2 Display ON Count up on Error ON No 4000000 gt Reset No Patient ID Redisplay In Scn OFF Limit Data Length OFF Always Input OFF Numeric ON CHIN REST STICK DEKA 5 Input a value Rotate the measurement unit vertical movement ring left and right to set 1 as the selected digit MENU 4 X 4 25 Patient Patient No Page 1 2 Display ON Count up on Error ON No 400000 Reset No Patient ID Redisplay In Scn OFF Limit Data Length OFF Always Input OFF Numeric en b d CHIN REST STICK ID MEASURE DATA Si m G Select a digit Press the measurement button one time Move the cursor one digit to the right and select a digit to Set a number If you go too far p
19. and blow off the dust on the optical component 2 Wipe the optical component Slightly dampen a lens cleaning paper with lens cleaner and lightly wipe the optical component Wipe it again if it needs it 72 L IE 5191C TX 20 indbo 72 e 2013 07 18 13 10 38 6 Maintenance Use lens cleaning paper and lens cleaner designated by Canon Forehead Rest A CAUTION To prevent the risk of infection wipe the forehead rest with disinfectant ethanol for each patient The forehead rest may be corroded if a disinfectant other than ethanol is used For details on how to disinfect consult a specialist Use a sanitized gauze or wipe that includes disinfectant to clean the forehead rest for each patient Exterior and monitor screen of the TX 20 ZA WARNING Before cleaning the exterior of the TX 20 be sure to turn off the power of all the devices and unplug the power cord from the AC outlet Do not use any flammable solvent such as alcohol that is not for cleaning benzene or thinner Otherwise fire or electric shock may result Clean the exterior rollers and monitor screen as follows if they are dirty 1 Turn off the power Turn off the power switch and disconnect the power cable from AC receptacle 2 Wipe the exterior and rollers Wipe them with a soft cloth that has been soaked in diluted neutral detergent and firmly wrung out Then wipe the exterior and rollers again with a cloth that has been soaked in w
20. field 3 CLS key The data input from the USB device is shown Press to delete the data input from the USB device 2 OK key Press to close the USB connection check screen Print Message Input Screen This screen is for inputting print messages Operations and the functions of the icons are the same as for the PATIENT ID screen PRINT MESSAGE FIBCDEFGHI JKLMNOPQRSTUVWXYZ abcdefghijklmnopqrstuvwxyz 0123456789 amp r3 lt gt 7 4_ 1 7 1 MA gt 2 3 1 Input text switch command 2 OK key EXT Switch the list of characters to Latin Press to save the print message and switch to the characters other than English MENU screen Switch the list of characters to English 3 CANCEL key Press to not save the print message and switch to the MENU screen 32 L IE 5191C TX 20 indb 32 e 2013 07 18 13 10 23 3 Names of Parts User Name Input Screen Enter the user name associated with the computer that is connected via LAN in this screen Operations and the functions of the icons are the same as for the PATIENT ID screen r EIBCDEFGHI JKLMNOPQRSTUVWXYZ abcdefghijkIimnopqrstuvwxyz 0123456789 amp _ 7 ELM es es Password Input Screen Enter the password for the computer that is connected via LAN in this screen Operations and the functions of the icons are the same as for the PATIENT ID screen CE PASSWORD iBCcDEFGHIJKLMNOPQRST
21. for each setting item are displayed ID key Oo 99 Press to switch to the PATIENT ID screen MEASURE key Press to switch to the Measurement screen DATA key Press to switch to the DATA screen External device connection status Shows the status of external device connection e USB device is connected 9 Error has occurred in USB device connection zz LAN is connected RS 232C device is connected No display No connection 2013 07 18 13 10 22 29 3 Names of Parts Screen that Appears When Measurement Fails Anterior Segment Image Display Screen If a measurement error occurs while measuring intraocular pressure the anterior segment image from just prior to measuring is displayed The anterior segment image disappears after 5 seconds or if you press a soft key If OFF is set for Error Display in the intraocular pressure measurement menu the anterior segment image is not displayed see page 62 Eg NE mensum iL guva IOP mmHg MENU DATA CLS cS dis 7 1 Eyelid warning line 2 Cross mark Perform the measurement while the eyelid and Displays the intraocular pressure measurement eyelashes are above the warning line optical axis 30 L IE 5191C TX 20 indb 30 e 2013 07 18 13 10 22 3 Names of Parts Anterior Segment Image and Intraocular Pressure Measurement Waveform Display Screen If the values of intraocular pressure measurements are u
22. for the computer name is incorrect 262 Appears if the format of the text input for the user name is 1 input it again in the correct format see page 65 incorrect 264 Appears if the format of the text input for the path to the folder to store data is incorrect i 1 Select OK to save the settings 265 eonim whethero save seltings when changing Me LAN oec CANCEL tenet save the settingsandinotdothe settings and then doing a LAN connection test j connection test Operation stopped because a button was operated during 1 RECON AMES eee Gods Coments eluding rror 269 ll codes and then execute OK LAN transmission 2 Do the operation again 271 272 273 280 1 Record the message code contents including error Abnormality occurred in LAN transmission codes and then execute OK 231 2 Do the transmission again 282 283 284 1 Record the message code contents including error 285 Abnormality occurred in LAN transmission The user name codes and then execute OK is not correct 2 Check that the User in the LAN menu is set correctly see I page 65 1 Record the message code contents including error 286 Abnormality occurred in LAN transmission The password codes and then execute OK is not correct 2 Check that the Password in the LAN menu is set correctly see page 65 1 Record the message code contents including error codes and then execute OK Abnormality occurred in LAN transmission The file you
23. of characters 31 Empty Connection Check For this setting press the measurement button to do a connection test and display the results 2013 07 18 13 10 37 5 Types of Measurements Settings for Patient No You can set patient No patient No display patient No count up output at measurement error reset in the Patient No menu screen L IE 5191C TX 20 indbo 67 The patient No is a number to identify patients You can set any number from 000001 to 999999 and you can set the number to increase by one each time a measurement is done Patient No can be checked on the Measurement screen MENU screen printed data and data output to external devices How to Enter the Patient No Menu MENU screen gt Ill Patient tab gt Patient No Setting items Description Fado settings Display Set the display of the patient No on the Measurement screen and ON whether to increase the numbers in series Increase the number after measurement when the PRINT button or the CLS key is pressed ON Displays Numbers increase serially OFF Does not display Numbers do not increase serially Count up on Set whether to increase the patient number serially even if the ON Error measurement results are just an error ON The patient No increases serially OFF The patient No does not increase serially No Set the patient No 1 000001 to 999999 Six digit number Reset No Set the patient N
24. sales representative or local Canon dealer for a replacement A damaged cord may result in fire or electric shock Do not use a multiple power strip and an extension cable Connect the power cord directly to the AC outlet Do not use a multiple power strip and an extension cable with it Do not disassemble or modify A disassembled or modified instrument may result in fire or electric shock Because the TX 20 incorporates high voltage parts that may cause electric shocks touching them may cause death or serious injury Do not leave alcohol thinner or any flammable chemicals near the instrument Do not place near to a flammable solvent Fire may result if the solvent spills or evaporates and makes contact with the internal electric parts Some disinfectants are flammable Be sure to take precautions when using them Stop using immediately if there is an abnormality or problem If an abnormality occurs immediately unplug the power plug and turn off the power of all the devices e Smoke is emitted e An unusual smell An unusual noise Foreign matter gets inside e Damaged Fire or electric shock may result if you continue use in such conditions Immediately turn off the power of TX 20 unplug the power plug and turn off the power of all connected devices Then contact your sales representative or local Canon dealer Do not place anything on top of the device Fire or electric shock may result if water or any other liquid or
25. set or the CHIN REST button is pressed Do not touch the measurement unit or the chin rest while they are moving Keep the patient s chin away from the chin rest Prohibited CAUTION Use the product s packaging to transport it aD Use the TX 20 packing materials to protect it from vibration and shocks when it is transported on a cart in a vehicle or if shipped over long distances Vibration or shock may cause a breakdown or damage the TX 20 For details contact your sales representative or local Canon dealer Inspect daily and periodically aD For safety reasons before using the TX 20 be sure to perform the daily inspection Have a periodically inspection performed for the TX 20 at least once a year by a Canon designated representative to maintain its performance and reliability 13 L IE 5191C TX 20 indbo 13 e 2013 07 18 13 10 13 2 Safety Notes on Using TX 20 Before Use e Sudden heating of the room in cold areas will cause condensation to form on the optical component of the nozzle and on optical parts inside the instrument In this case wait until condensation disappears before performing a measurement During Measurement Describe to the patient what to expect during measurement so he she will not be surprised by the sudden air puff Demonstrate the intensity of the air puff by having the patient place a finger in front of the nozzle and then press the CHECK button e The measurement unit automatically move
26. the result will be provided for diagnosis L IE 5191C TX 20 indo 5 e 2013 07 18 18 10 09 1 Introduction Components L IE 5191C TX 20 indb 6 Full Auto Tonometer TX 20 Chin rest paper Main unit Ga 100 sheets provided e Power cord Printing paper Connects the TX 20 to an AC 2 rolls provided outlet 3m USA and Canada only Plug type VMO275 Hospital Grade Nozzle cap Dust cover Initially covers the nozzle Use it to cover the TX 20 when the instrument is not being used Ferrite core If a LAN cable is being used attach the ferrite core to it Operation manual for the TX 20 this document Describes the handling precautions and operating instructions for the TX 20 Warranty Card for USA model only WEEE Directive Leaflet for EU model only Installation Report Optional products Chin rest paper 500 sheets Printing paper 10 rolls 2013 07 18 13 10 09 1 Introduction Conventions Used in This Manual This manual uses the following symbols to indicate precautions that are important for using the TX 20 safely Always follow these safety precautions A warning that incorrect operation may result in death or serious injury Z NA WARNING g P y Jay A caution that incorrect operation may result in serious injury Z N CAUTION p y did CAUTION A caution that incorrect operation may break the TX 20 or damage other dev
27. the first character 53 2013 07 18 13 10 32 L IE 5191C TX 20 indb 54 e 5 Types of Measurements 3 Select a character to input Use the CHIN REST button and the measurement unit vertical movement ring to move the selection cursor to the position of the C in the character list PATIENT ID Select C AB JDEFGH JKLMNOPQRSTUVWXYZ abcdefghijkIimnopqrstuvwxyz 0123456789 amp HELLE LEE IN niu 4 Input the selected character While C is selected with the selection cursor press the measurement button one time The C appears to the right of the 2 PATIENT ID The C appears A B D E F G H I J K LMN 0 P QR S T U VWXYZ abcdefghijkIimnopqrstuvwxyz 0123456789 amp lt gt 7 _ I CLS CHINREST STICK r3 rp co MEASURE MENU DATA Z7 5 Select the place to the right of the character to delete Move the ID cursor to the right of the character to delete Use the CHIN REST button and the measurement unit vertical movement ring to move the selection cursor to the position of ID cursor movement command Press the measurement button one time to move the cursor one space to the left The procedure in steps 5 to 6 is explained using an example of deleting a 2 from the patient ID 120 In this example the cursor moves to the C to the right of the 2 PATIENT ID Select the C to the right of the 2 ABCDEFGHI JKLMNOPQRSTUVWXYZ abcdefg
28. then execute OK 2 Turn the power off and then on again Abnormality occurred in LAN transmission 136 137 138 139 140 141 142 143 144 80 L IE 5191C TX 20 indb 80 2013 07 18 13 10 40 7 Troubleshooting Warning Code Cause Remedy 201 The printer is overheating Record the message code contents including error codes and then execute OK Wait a while and then print agai n 202 The paper cover is open Record the message code contents including error codes and then execute OK Close the paper cover 208 There is no paper Record the message code contents including error codes and then execute OK Replace the paper 204 Printing stopped because a button was operated during printing Record the message code contents including error codes and then execute OK Print again 206 Operation stopped because a button was operated during printer initialization Record the message code contents including error codes and then execute OK No specific remedy is needed you can do the next operations 209 Operation stopped because a button was operated while sending data via RS 232C Record the message code contents including error codes and then execute OK Do the transmission again The RS 232C connection is abnormal Record the message code contents including error codes and then
29. to 240 V 50 60 Hz 0 8 A to 0 4 A Dimensions 260 W x 490 D x 500 H mm Weight 15 kg 87 L IE 5191C TX 20 indb 87 e 2013 07 18 3041 Appendix Stylesheet File Setting the stylesheet to be output when transmitting via a LAN allows you to view the measurements on a web browser such as Windows Internet Explorer The stylesheet file defines the layout of the display when measurement files are displayed on a web browser Set whether to output the stylesheet file with the Stylesheet Output setting on the LAN menu see page 65 Use a web browser that supports XML Ask your sales representative or local Canon dealer to connect the LAN cables and do the Settings and to explain the data transfer and operation methods How to View Measurements on a Web Browser 88 L IE 5191C TX 20 indb 88 1 Open the folder in which to store data Open the folder that was set on the Output Folder in the LAN menu for outputting data see page 65 A maximum of two types of files can be transmitted at one time The files that can be transmitted are shown below Measurement files Includes patient information and intraocular pressure values File name Patient information patient ID etc output date yyyymmad output time hhmmss CANON TX 20 xml Example 999999 20110204 174235 CANON T X 20 xml Stylesheet file File name TX Stylesheet xsl e 2013 07 18 13 10 41 Appendix L IE 5191C
30. types of buttons that can be operated appears in the patient ID input field in the PATIENT ID screen Refer to 5 Types of A maximum of 64 ASCII code characters can be Measurements for operating procedures input 8 MEASURE key 2 ID cursor Press to switch to the Measurement screen Shows the position where the patient ID can be 9 MENU key e edited Press to switch to the MENU screen e 3 List of characters 10 DATA key List of characters that can be input for a patient ID Press to switch to the DATA screen 4 Selection cursor Select characters to input for a patient ID 5 ID cursor movement commands The ID cursor moves in the direction of the selected arrow 6 ID delete command BS Deletes the character that is before the character specified by the ID cursor However if the ID cursor is specifying the first character it deletes that character CLS Deletes all the characters in the patient ID The confirmation screen is displayed select one of the following OK Deletes all text CANCEL Does not delete By doing the settings in advance if a patient ID has not been input when it is pressed a message indicating that the patient ID has not been input is displayed see page 68 27 L IE 5191C TX 20 indb 27 e 2013 07 18 13 10 20 3 Names of Parts DATA Screen 28 L IE 5191C TX 20 indb 28 This screen shows measurements 1 R IOP mmHg 12 13 14 13 14 15 12 13 g
31. used Eye fixation lamp Press the adjacent eye fixation lamp key to switch the internal and external eye fixation lamps ON Il KORZA External device connection status Shows the status of external device connection E 18 ma 22 19 ID key Press to switch to the PATIENT ID screen 20 MENU key Press to switch to the MENU screen 21 DATA key Press to switch to the DATA screen 22 CLS key Press to do the following Nozzle stop position Releases the setting e Selection of eye fixation lamp The internal eye fixation lamp is selected The external eye fixation lamp turns off and the internal eye fixation lamp flashes Patient ID The patient ID is cleared not entered state e Patient No Counts up the patient numbers however according to settings Display of measured value Measured values are cleared not measured state Measurement unit Returns to the initial position You can confirm the patient ID or measured value on the DATA screen until the measurement button is pressed 2013 07 18 13 10 20 3 Names of Parts PATIENT ID Screen This screen is used to input patient IDs PATIENT ID 4 EB C D E F G H J K LMN 0 P QR S TU VWXYZ a b c d e f g h i j k I mn o p qr st u vwxyz 0123456789 amp 23 lt gt 7 4 5 6 CHINREST STICK S T 1 Patient ID area 7 Operation reference guide The text selected from the list of characters Shows the
32. 0 49 T Troubleshooting If any of the symptoms listed below occur or if a message appears while using the TX 20 try the relevant remedy described below If these remedies do not eliminate the symptoms or the message turn off the power and contact your sales representative or local Canon dealer Be ready to provide a detailed description of the symptoms and message Symptom and Remedy Symptom Cause Remedy Measurements are not stable Eyelashes or eyelid are blocking the pupil Tell the patient to open his her eye wide Or carefully lift the upper eyelid and perform the measurement The patient s eye is not still Relax the patient and have him her look at the eye fixation lamp External light is getting in Do not allow bright light or sunlight to shine directly on the patient s eye Too few lines for the received light level mark Eyelashes or eyelid are blocking the pupil Tell the patient to open his her eye wide Or carefully lift the upper eyelid and perform the measurement Blinking is increasing Tell the patient to stop blinking or carefully lift the upper eyelid and perform the measurement Patient s eye has low corneal reflectivity In this case the received light level marks do not increase Nothing appears on Screen even though the power is on and I the POWER lamp is flashing Power saving mode Press a button on the operation panel a soft k
33. 0950 1 is used Otherwise electric shock may occur Ask your sales representative or local Canon dealer to connect it to a computer Use an isolation transformer for LAN connections If the LAN connector is being used to connect to a network connect an isolation transformer for networks between the TX 20 and network devices HUB etc and between network devices If this is not done there is a risk of short circuits or malfunctioning devices Ask your sales representative or local Canon dealer to connect it to a network Turn off the power and unplug the power cord before connecting cables Always turn off the power and unplug the power cord before connecting the cables of any external devices to the TX 20 If this is not done there is a risk of damage Always disinfect the nozzle after measuring an infected patient s eyes A patient s tears may get on the nozzle and cause a secondary infection Always use a cotton swab or other appropriate material that has been treated with disinfectant ethanol to wipe the nozzle e 2013 07 18 13 10 12 2 Safety ZA CAUTION Keep the forehead rest and chin rest clean Q To prevent the risk of infection wipe the forehead rest with disinfectant ethanol for each patient To ensure cleanliness replace the chin rest paper for each patient If the chin rest paper is not being used be sure to disinfect the chin rest for each patient For details on how to disinfect consult a specialist The f
34. Canon Full Auto Tonometer TX 20 Operation Manual Make sure you read this manual before using the instrument Keep this manual in a safe place so that you can use it in the future L IE 5191C TX 20 indb 1 e 2013 07 18 13 10 07 Important Disclaimers Installation Trademarks Copyright L IE 5191C TX 20 indbo 2 Thank you for purchasing the Canon Full Auto Tonometer TX 20 referred to as TX 20 in this manual Be sure to read this manual thoroughly before using the instrument and apply the information that you learn e The TX 20 must only be used by a doctor or a legally qualified person The user is responsible for managing the usage and maintenance of medical equipment We suggest that a dedicated individual is assigned responsibility for maintenance to ensure that the TX 20 is kept in good condition and can be used safely Rx Only USA Federal law restricts this device to sale by or on the order of a physician Canon takes no responsibility for damage that occurs due to fires earthquakes third party actions other accidents the user s deliberate misuse negligence experimentation or use under other abnormal conditions Canon takes no responsibility for direct or consequential damages resulting from the use or the inability to use the TX 20 Canon takes no responsibility for injuries or property damage that may occur if safety precautions are not followed or the instrume
35. Front Avenue 04 01 Keppel Bay Tower Singapore 098632 Telephone 65 6799 8888 CANON AUSTRALIA PTY LTD Optical Products Division 1 Thomas Holt Drive North Ryde Sydney N S W 2113 Australia Telephone 61 2 9805 2000 L IE 5191C O713P0 001 CANON INC 2011 Printed in Japan L IE 5191C_TX 20 indb 100 e 2013 07 18 13 10 43
36. ID screen MEASURE key Press to switch to the Measurement screen MENU key Press to switch to the MENU screen DELETE key Press to clear all the measurements The measurement values are deleted from the instrument s memory 2013 07 18 13 10 21 MENU Screen L IE 5191C TX 20 indb 29 MENU 1 EE ter amp c Common Alignment Mode 2 _ Order Default Side R L Distance Joystick Movement Tonometer Range Unit AUTO BY TIME RIGHT 66mm NORMAL 30 mmHg Settings tab The items to set are grouped according to their purpose Selected items are shown in orange ERE Measure tab Settings for intraocular pressure measurements FEW Print tab Settings for printing with the built in printer Input tab Settings for inputting data from an external device Output tab Settings for outputting data to an external device Bg Patient tab Settings for patient ID and patient No Other tab Settings for time power saving mode and the LCD and shows information about the firmware Setting items The setting items for each tab are displayed Name of the selected tab Cursor Shows the position of the selected setting value setting item and tab They light orange when selected O 3 Names of Parts Perform the settings for measurements printing and operating the measurement unit Auto Output 4ON 4 Measure 3 Page 1 2 5 CHIN REST STICK 9 Settings The settings
37. TX 20 indbo 89 2 Open the measurement file on a web browser The patient information measurements and other information are displayed on the web browser An example of a display is shown below on the following Company Name Model Name Serial No Firmware Version XML Version Date 2011 02 03 Time 19 36 28 Patient No Patient ID TX 20 Measurement Data Measurement files that are created when Stylesheet Output is set to OFF cannot be viewed on a web browser even if a style sheet file is output later 89 2013 07 18 13 10 42 Appendix EMC Electromagnetic Compatibility The TX 20 is designed and tested to comply with IEC 60601 1 2 EN 60601 1 2 which are applicable regulations regarding EMC for medical devices and need to be installed and put into service according to the EMC information stated as follows If this equipment causes 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 Reorient or relocate the receiving device ncrease the separation between the equipment Connect this device into an outlet on a circuit different from that to which the other devices are connected If the problem cannot be solved with the above measures stop using this equipment and consult your sales representative or local Canon dealer Precautions on EMC 1 Medical electrica
38. Therefore you need to set the clock each time you turn on the power We recommend replacing the battery For replacing the battery ask your sales representative or local Canon dealer 329 The USB device of full speed specifications was connected to this product 1 2 Record the message code contents including error codes and then execute OK Connection check is necessary Ask your sales representative or local Canon dealer to perform the connection check 86 L IE 5191C TX 20 indb 86 2013 07 18 13 10 41 Appendix Specifications Intraocular pressure measurement Measurement type Air puff type Operation distance 11 mm Range of intraocular 0 to 80 hPa 0 to 60 mmHg pressure measurement 30 mode O to 40 hPa 33 to 80 hPa changes automatically 0 to 30 mmHg 25 to 60 mmHg changes automatically 60 mode 33 to 80 hPa 25 to 60 mmHg Displayed unit of 1 hPa regular measurements 0 1 hPa intraocular pressure 1 mmHg regular measurements 0 1 mmHg 1 33 hPa 1 mmHg Observation range 13 2 x 10 mm or more Movement range Measurement unit Front back 40 mm Right left 90 mm Up down 30 mm Chin rest 60 mm Printer Thermal printer auto cutter paper width 58 mm Interface USB A 1 port RS 232C 1 port LAN 1 port only one selectable Display 14 5 cm 5 7 inch TFT color LCD Tiltable Power saving function 5 min 10 min 15 min OFF 4 levels Power supply rating AC 100 V
39. UVWXYZ abcdefghijkIimnopqrstuvwxyz 0123456789 amp Ee Ae CHIN REST STICK amp 33 L IE 5191C TX 20 indb 33 e 2013 07 18 13 10 24 3 Names of Parts Computer Name Input Screen name as text or an IPv4 format Enter the name associated with the computer that is connected via LAN in this screen Input the Operations and the functions of the icons are the same as for the PATIENT ID screen COMPUTER NAME FIBCDEFGHI JKLMNOPQRSTUVWXYZ a b c d e f g h i j k I mn o p qr s t u v wx yz 0123456789_ REST STICK El Output Folder Name Input Screen Enter the name of a folder on the computer that is connected via LAN in this screen The slash is used as a separator so the setting can be deep in the hierarchy Operations and the functions of the icons are the same as for the PATIENT ID screen OUTPUT FOLDER EIBCDEFGHI JKLMNOPQRSTUVWXYZ abcdefghijklmnopqrstuvwxyz 0123456789 amp 5 CH ieee ee DIUI CHIN REST STICK ee LS P FP 1 OK key 2 CANCEL key Press to save the output folder name and switch to Press to not save the output folder name and the MENU screen switch to the MENU screen 34 L IE 5191C TX 20 indb 34 2013 07 18 13 10 24 3 Names of Parts LCD Brightness Adjustment Screen L IE 5191C TX 20 indb 35 Adjust the LCD brightness in this screen r Brightness gauge Shows the current bright
40. Year and month of manufacture Example October 2010 2013 07 18 13 10 17 Names of Parts Main Unit From the Examiner s Side Measurement unit 5 Printer Measurement is done at this part Prints the measurement results Oo 2 Height adjustment mark Operation lever Align the patient s eye with this mark 7 Indentation for lifting 3 LCD monitor The patient s eye and various screens appear here 4 Operation panel Operations such as setting the nozzle position chin rest height and printing are done from here 19 L IE 5191C TX 20 indbo 19 e 2013 07 18 13 10 17 3 Names of Parts Main Unit From the Patient s Side 20 L IE 5191C TX 20 indb 20 Forehead rest Patient rests his her forehead here to prevent patient s eye from moving Nozzle Blows air for observing or measuring the patient s eye Head rest Power switch Turns on the power for the main unit 6 External eye fixation lamp Used if it is difficult to fix the patient s eye by using the internal eye fixation lamp Fix on the eye that is not being measured Chin rest The patient s chin is placed here Raise or lower the chin rest to set the appropriate height for the patient s eye s Indentation for lifting 2013 07 18 13 10 18 3 Names of Parts Bottom Side 1 RS 232C connector 3 AC power connector Transfers measurement data to an external device 4 LAN connector e Can be connected to a device that
41. a needle paper clip or any foreign matter gets inside the TX 20 e 2013 07 18 13 10 19 2 Safety Z NA WARNING Z N CAUTION L IE 5191C TX 20 indo 11 Q Prohibited Q Prohibited e 9 Prohibited NN Prohibited e 9 Prohibited Prohibited Do not use a power supply voltage other than the one specified on the rating label Do not use any power cord other than the one supplied Use the power voltage specified on the rating label Otherwise fire or electric shock may result The supplied power cord is designed exclusively for this product Do not use any other power cord Do not plug or unplug the power plug with wet hands Do not plug or unplug the power plug or handle any other parts with wet hands Otherwise fire or electric shock may result Unplug the plug periodically and remove any dust or dirt around the plug and the AC outlet If the cord is kept plugged in for a long time in a dusty humid or sooty environment dust around the plug will attract moisture resulting in possible insulation failure that may result in a fire Insert the power plug completely Insert the power plug completely into the AC outlet If a pin of the power plug makes contact with metal or any conductive object fire or electric shock may result Do not clean the TX 20 with flammable solvent For safety reasons before cleaning the TX 20 be sure to turn off the power of all the devices and unplug the pow
42. a paper jam If the paper jams open the paper cover and adjust the paper so it feeds correctly 75 L IE 5191C TX 20 indbo 75 e 2013 07 18 13 10 40 6 Maintenance 6 Cut the paper Paper that is automatically cut has 1 5 mm of uncut paper in the middle of the cut so it does not fall off Hold the tip of the paper and slowly pull it to cut it Always remove the automatically cut paper Printing again while the cut paper is still attached may cause paper jams Preparations for Packing and Transport 76 L IE 5191C TX 20 indb 76 Before packing and transporting the TX 20 move its measurement unit and chin rest to the optimal position for packing and moving The measurement unit moves to the central lowest position The chin rest moves all the way down While pressing the R L button turn on the power Continue pressing the R L button after turning on the power until the buzzer sounds The chin rest and the measurement unit automatically move to the packing and transport position The following message appears on the monitor Transportation Package Position Please power down and remove the printing paper After that the TX 20 cannot be operated To do measurements again the power must be turned off and on again Turn off the power Remove the paper from the printer after turning off the power Unplug the power cord from the electric outlet and remove the cables to any connected devices e 2013 07 18 13 1
43. and 1 measurement are done automatically This mode is used to do measurements one eye at a time while checking the condition of the eye such as for patients who cannot keep their eyes open continuously Manual All operations are done manually This mode is used when full auto or auto modes cannot be used such as when the patient s pupil is eccentric or cornea is deformed The flow of operations is shown in the flow chart bellow The items with gray backgrounds are performed automatically Preparations before measuring Setup for patient Alignment mode Auto alignment Right eye measurement processing Automated FULL AUTO MANUAL Manual alignment Right eye measurement Auto alignment Right eye measurement Do a set number of measurements Switch eyes Auto alignment Left eye measurement Do a set number of measurements Switch eyes Switch eyes Manual alignment Left eye measurement Switch eyes Auto alignment Left eye measurement Return to initial position Return to initial position Return to initial position 37 2013 07 18 13 10 29 4 Basic Operation Connecting Cables A WARNING Take the following precautions to avoid risk of fire or electric shock Do not handle the power plug with wet hands Use only the power cord provided with the instrument e Connect the cables carefully
44. and then on again 103 Failed to set time 1 Record the message code contents including error codes and then execute OK 104 Abnormality occurred during printer cutter operation 2 Open and close the paper cover and check if the error recurs 3 If the error occurs again turn the power off and then on 1 Record the message code contents including error 105 The voltage being supplied to the printer is low codes and then execute OK 2 Turn the power off and then on again 1 Record the message code contents including error codes and then execute OK 106 Abnormality occurred at printer cutter position 2 Open and close the paper cover and check if the error recurs 3 If the error occurs again turn the power off and then on 107 Printer operation was not done normally 1 Record the message code contents including error codes and then execute OK 108 Printer power was not turned on or off normally 2 Tum the power off and then on again 1 Record the message code contents including error 119 Abnormality occurred while charging driver for air blower codes and then execute OK when CHECK button was pressed 2 Press the CHECK button again and check if the error recurs 120 Abnormality occurred while measurement unit was detecting position during move to initial position Abnormality occurred in USB transmission 125 126 127 128 129 130 131 132 1 Record the message code contents including error 188 codes and
45. are 2 If a file in the folder already exists with the same name 297 4 trying to send already exists change the name of one of the files Or use a different folder 3 Do the transmission again 1 Record the message code contents including error 298 Abnormality occurred in LAN transmission codes and then execute OK 2 Dothe transmission again 1 Record the message code contents including error Pa codes and then execute OK 299 Abnormality occurred in LAN transmission The output a Check that the Output Folder In the LAN menu is set folder does not exist correctly See page 65 Or check that a folder exists where you are outputting the data L IE 5191C TX 20 indb 85 85 2013 07 18 13 10 41 7 Troubleshooting Warning Code Cause Remedy 320 Because of a dead battery for backup automatic updating of date stops Measurements can be done Select either one from the followings and use the TX 20 as it is e Select OK Reflect the clock on the measurement results Set the correct clock again on the displayed clock input screen However the clock you have set again is valid only when the power is turned on Select CANCEL The clock is not reflected correctly on the measurement results The clock input screen is not displayed and the TX 20 is reset at the initial value 2010 1 1 If this error occurs the clock function of the main unit is not kept
46. ater and firmly wrung out 3 Wipe the monitor screen Wipe it lightly with a soft cloth such as an absorbent cotton rag dampened with a small amount of ethanol 73 L IE 5191C_TX 20 indbo 73 e 2013 07 18 13 10 39 6 Maintenance Refilling Chin Rest Paper A CAUTION If the chin rest paper is not being used be sure to disinfect the chin rest whenever the patient is changed For details on how to disinfect see the Forehead Rest section 1 Pull out the right and left chin rest holding pins 2 Insert the holding pins into the holes on the right and left of the chin rest paper 3 Attach the chin rest paper to the chin rest with the pins pressing into the holes on the chin rest Insert the pins straight into the holes Chin rest paper is a consumable product sold separately To purchase chin rest paper contact your sales representative or local Canon dealer Replacing Printing Paper Replace the roll of printing paper as soon as possible after the red line appears on the paper Do not replace the paper unless the TX 20 is correctly installed in a flat location as specified Changing the paper while the TX 20 is not level may cause a paper jam 1 Open the paper cover Pressing the paper cover button releases the lock and raises the paper cover ZA CAUTION Do not touch the area around the printer or open the paper cover during or immediately after printing The printer s thermal head and the surroundin
47. atient ID in the PATIENT ID Screen 52 L IE 5191C TX 20 indb 52 PATIENT ID EIBCDEFGHI JKLMNOPQRSTUVWXYZ abcdefghijklmnopqrstuvwxyz 0123456789 amp HIILLI NEN MEE E le es CHINREST STICK Patient ID area 7 Displays the patient ID that was input ID cursor 8 Displays the position immediately after a character is input Also selects the targeted character when deleting a patient ID List of characters 9 List of characters that can be input as a patient ID Specify from upper and lower case letters numbers and symbols 10 Selection cursor Selects characters or commands to use ID cursor movement commands Moves the ID cursor up down left or right one space ID delete command Deletes the patient ID Deletes the character that is before the character specified by the ID cursor However if the ID cursor is specifying the first character it deletes that character Deletes all the characters in the patient ID This section explains how to input the patient ID in the PATIENT ID screen PATIENT ID Screen Display and Functions of Buttons LIMITER CHECK a Z C3 A a CHIN REST PRINT o MC 3 8 CHIN REST button Moves the selection cursor up and down Measurement unit vertical movement ring Moves the selection cursor left and right Clockwise Right Counterclockwise Left Measurement button Inputs the character specified by the selection
48. cord tiemessage and coments he lu nO erte 298 was operated during auto alignment codas arid Ihen excute et 2 Dothe measurement again Measurement stopped because an intraocular pressure 241 measurement error occurred during full auto alignment measurement 1 Record the message code contents including error 242 The measured intraocular pressure is over the value set for codes and then execute OK the Upper IOP Warning 2 Do the measurement again 243 The measured intraocular pressure is below the value set for the Lower IOP Warning 1 Record the message code contents including error 244 Auto alignment stopped because the measurement unit codes and then execute OK and the chin rest may be interfering with each other 2 Besure that the patient s head and chin are firmly against the forehead rest L IE 5191C TX 20 indb 83 2013 07 18 13 10 41 83 7 Troubleshooting Warning Code Cause Remedy 1 Record the message code contents including error codes and then execute OK 2 Dothe measurement again and check if there is a reason for the dispersion of the measured values The following may be some reasons why the measured 245 Intraocular pressure measurements are dispersed values are dispersed Eyelashes or eyebrow are blocking the pupil The patient s eye moved Interference from external light Operation stopped because a button or the operation lev
49. ctrical equipment Part 1 General requirements for safety Medical electrical equipment Part1 General requirements for basic safety and essential performance Medical electrical equipment Part 1 1 General requirements for safety Collateral standard Safety requirements for medical electrical systems Medical electrical equipment Part 1 2 Collateral standard Electromagnetic compatibility Requirements and tests Medical electrical equipment Part 1 4 Collateral standard Programmable electrical medical systems Medical device software Software life cycle processes Medical device Application of usability engineering to medical devices Ophthalmic instruments Part 1 General requirements applicable to all ophthalmic instruments Ophthalmic instruments Part 2 Light hazard protection 2013 07 18 18 10 19 2 Safety L IE 5191C TX 20 indb 9 ISO 10993 1 2009 ISO 10993 5 2009 ISO 10993 10 2010 ISO 8612 2001 ANSI Z80 10 2003 European Union 93 42 EEC EN 60601 1 2006 EN 60601 1 2 2007 EN 60601 1 6 2010 EN 62304 2006 EN 62366 2008 EN ISO 14971 2009 EN ISO 15004 1 2009 ISO 15004 2 2007 EN ISO 10993 1 2009 EN ISO 10993 5 2009 EN ISO 10993 10 2010 ISO 8612 2001 Biological evaluation of medical devices Evaluation and testing Ophthalmic instruments Tonometers Medical Device Directive Medical electrical equipment Part1 General requireme
50. cursor left and right Clockwise Right Counterclockwise Left 2 Changes the settings and their values 57 L IE 5191C TX 20 indb 57 e 2013 07 18 13 10 38 5 Types of Measurements Measurement button 1 Moves the cursor between digits in the patient No IP address subnet mask default gateway DNS server time and date settings The cursor moves to the right every time it is pressed 2 Execute the setting e Input Message Move to the print message input screen e Adjust Brightness Move to the LCD brightness adjustment screen e Reset Set the patient No to 1 Connection Check Check the connection with external devices Alignment off button Moves the cursor between digits in the patient No IP address subnet mask default gateway and DNS server settings The cursor moves to the left every time it is pressed Basic Operations on MENU Screen This section explains how to set a patient No You can set other items with the same operations This procedure shows how to change the patient No from 000000 to 000012 1 Display the MENU screen Press the MENU key in the screens 2 Select the JIJ Patient tab Use the CHIN REST button and the measurement unit vertical movement ring to select lE Patient tab MENU e lt oe Gm o Patient Patient No Page 1 2 Display ON Count up on Error ON No 000000 Reset No Patient ID Redisplay In Scn OFF Limit Data Length OFF Always Input
51. e 2013 07 18 13 10 29 4 Basic Operation 3 Connect an RS 232C cable or LAN cable to send measurement results to an external device You cannot use the RS 232C and LAN connections at the same time Use only one Use a cross cable for the RS 232C cable Ask your sales representative or local Canon dealer to set the connections for RS 232C and LAN connector Power cord 5 Insert the power plug all the way into an AC outlet Do not replace the paper unless the TX 20 is correctly installed in a flat location as specified Changing the paper while the TX 20 is not level may cause a paper jam 39 L IE 5191C TX 20 indb 39 e 2013 07 18 13 10 29 4 Basic Operation Preparations Prior to an Examination Z N CAUTION Z N CAUTION 40 L IE 5191C TX 20 indb 40 Disinfect the forehead rest and replace the chin rest paper for each patient To prevent the risk of infection wipe the forehead rest with disinfectant ethanol for each patient If the chin rest paper is not being used be sure to disinfect the chin rest also The forehead rest and chin rest may be corroded if a disinfectant other than those above is used For details on how to disinfect consult a specialist 1 Remove the dust cover and the nozzle cap and check the printing paper Do not let dust get on the nozzle cap Add more paper for printing if there is not enough see page 74 Turn on the power The measurement unit mov
52. e guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the TX 20 is used exceeds the applicable RF compliance level above the TX 20 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the TX 20 b Over the frequency range 150 kHz to 80 MHZ field strengths should be less than 3 V m 93 L IE 5191C TX 20 indbo 93 e 2013 07 18 13 10 42 94 Appendix Recommended Separation Distances between Portable and Mobile RF Communications Equipment and Devices or the TX 20 The TX 20 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the TX 20 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the TX 20 as recommended below according to the maximum output pow
53. e measurement button 1 The measurement unit moves automatically to align with the position of the patient s eye AS SSeS _30 58 Dd To stop measurement Press any button on the operation panel Press any soft key on the monitor panel Press the measurement button or the alignment off button e Tilt the operation lever e Rotate the measurement unit vertical movement ring To do a measurement before alignment is finished e Press the measurement button Press the measurement button when the corneal light point can be seen clearly You can do measurements even during auto alignment However the positioning alignment may not be accurate Note that the measurement may not be accurate when measuring this way 45 L IE 5191C TX 20 indb 45 e 2013 07 18 13 10 28 4 Basic Operation Pi LI To restart measurement Press the measurement button If you are doing a set number of measurements when the measurement button is pressed the eye to which the measurement unit is positioned is measured once If a message appears Check 7 Troubleshooting see page 77 and perform the remedy indicated in the message 2 Three consecutive measurements are performed When the position is aligned three measurements are done consecutively 3 The measurement unit moves to the other eye The set number of measurements is done and the measurement unit moves to the other eye automatically n Except for
54. ect any cables connected to other equipment e When moving the TX 20 perform the specified operation to move the measurement unit to the transport position see page 76 e Remove the paper from the printer before moving the TX 20 Carry the TX 20 by the indentations for lifting at its front and rear and keep it level Do not hold anything except the indentions for lifting when lifting the TX 20 e The TX 20 needs to be protected from vibration and shocks when it is transported on a cart in a vehicle or if shipped over long distances Always use the original packaging For details contact your sales representative or local Canon dealer e 2013 07 18 13 10 13 15 2 Safety Disposal 16 L IE 5191C TX 20 indb 16 Disposal of this product in an unlawful manner may have a negative impact on human health and on the environment Therefore when disposing of this product be absolutely certain to follow the procedure which is in conformity with the laws and regulations applicable to your area European Union and EEA only This symbol indicates that this product is not to be disposed of with your household waste according to the WEEE Directive 2002 96 EC and your national law This product should be handed over to a designated collection point e g on an authorized one for one basis when you buy a new similar product or to an authorized collection site for recycling waste electrical and electronic equipment EEE
55. ed then JAN to DEC 1 to 31 Date Time Set the time 00 to 23 Hour 00 to 59 Minute Format Select the format to display the date MDY YMD Year month date MDY Month date year DMY Date month year Sleep Time Set the time before entering power saving mode 5min OFF Does not enter power saving mode 5min Five minutes 10min Ten minutes 15min Fifteen minutes You can set the brightness of the LCD screen in the LCD menu How to Enter the LCD Menu MENU screen Other tab LCD Factory tting it D ipti Setting items escription TN Adjust Adjusts the brightness of the LCD 50 Brightness For this setting press the measurement button to go to the LCD brightness adjustment screen 1 to 100 LCD brightness 69 2013 07 18 13 10 38 70 L IE 5191C TX 20 indb 70 5 Types of Measurements Checking Firmware You can check the name and version of the firmware in the firmware menu How to Enter the Firmware Menu MENU screen Other tab Firmware Setting items Fact Description bs zd Settings Name Displays the name of the firmware TX 20 Version Displays the version of the firmware 2013 07 18 13 10 38 6 Maintenance This section outlines the maintenance instructions for the TX 20 daily inspection cleaning disinfecting and refilling chin rest paper A CAUTION For safety reason before using the TX 20 be sure to perform the daily inspect
56. ent button one time to add the in front of the C PATIENT ID The is added ABCDEFGHIJKLMNOPQRSTUVWXYZ abcdefghijkimnopqrstuvwxyz Select 0123456789 amp 229 1 O 55 e 2013 07 18 13 10 34 5 Types of Measurements 9 Delete the entire patient ID Use the CHIN REST button and the measurement unit vertical movement ring to move the selection cursor to the position of ID delete command Pressing the measurement button opens a message screen to confirm that you want to delete the entire patient ID Select OK to delete All of the 1 C patient ID is deleted Select CANCEL to not delete The 1 C patient ID is kept as is PATIENT ID Warning w259 Message screen Clear all input data Select OK or CANCEL Select EE MEASURE MENU DATA Input Patient ID from an External Device Before starting measurements input the patient ID according to the operating procedure for the input device n For information about the TX 20 and connections with a USB device settings and usage contact your sales representative or local Canon dealer n The keys on a USB device that can be input are shown below e Numbers e Letters upper and lower case e Symbols excluding 96 and backslash e Space BackSpace Delete and arrow keys e NumLock and Enter 56 L IE 5191C TX 20 indb 56 e 2013 07 18 13 10 34 5 Types of
57. er 1 Record the message code contents including error 248 was operated while the measurement unit was moving left codes and then execute OK or right 2 Do the operation again 1 Record the message code contents including error 249 Operation stopped because limit of motion was detected codes and then execute OK while the measurement unit was moving left or right 2 Move the measurement unit so the patient s eye appears in the monitor Operation stopped because a button or the operation lever Record the message code contents including error 250 was operated while the measurement unit was moving to codes and then execute OK the initial position 2 Dothe operation again 1 Select YES to input the patient ID and then input the patient ID 251 Patient ID has not been input 2 Select NO if you are not going to input the patient ID If the patient ID does not normally need to be input on the patient ID menu set the Always Input setting to OFF 252 Confirmation about whether to delete all measurement 1 Select OK to delete all the measurement data data 2 Select CANCEL to not delete all the measurement data I 253 Appears if you try to change the IP address while DHCP 1 Set the DHCP setting to OFF when setting the IP e in the LAN menu was ON address see page 65 Appears if you try to change one of the following settings while Display in the patient No menu is OFF 254 No on the patient No menu 1
58. er cord from the AC outlet Do not use alcohol that is not for cleaning benzene thinner or any other flammable solvent Otherwise fire or electric shock may result Turn off the power before inspection For safety reasons before inspecting the instrument or cables be sure to turn off the power of all the devices Otherwise electric shock may result Do not measure an eye whose cornea is frail due to corneal disease or surgery Otherwise complications may occur Be sure to turn off the power before moving the TX 20 When moving the TX 20 always move the measurement unit to the packing position see page 76 turn off the power unplug the power cord and disconnect any external equipment Otherwise the cable may be damaged which may result in fire or electric shock Use the indentations for lifting and moving the TX 20 When lifting the TX 20 hold it on the bottom and keep it level Do not hold it by the head rest nozzle or LCD monitor as they may come off and result in injury Do not touch conductive parts of non medical equipment and the patient simultaneously Otherwise electric shock may result Do not install in locations exposed to water steam moisture or dust Doing so may cause problems or malfunctions 11 e 2013 07 18 13 10 11 2 Safety Z N CAUTION 12 L IE 5191C TX 20 indbo 12 Q Prohibited Q Prohibited Q Prohibited Q Prohibited Q Prohibited Do not instal
59. er of the communications equipment Rated maximum output Separation distance according to frequency of transmitter power of transmitter i W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 JP d 1 2 JP d 22 3 JP 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 transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHZ the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people L IE 5191C TX 20 indb 94 2013 07 18 13 10 42 Appendix Warranty and Repair Service Service life The service life of this product is eight years if specified inspections and maintenance are performed About repairs If a problem cannot be solved even after taking the measures indicated in 7 Troubleshooting see page 77 contact your sales representative or local Canon dealer for repairs When requesting repair please provide the following information Name of the instrument TX 20 Serial number 6 digit numb
60. er on the rating label Description of malfunction Report as much detail as possible Time limit for supplying performance parts for repair Performance parts parts for repairs to maintain performance will be stocked for eight years after production of the TX 20 is discontinued Expendable parts replaced by service personnel The following parts cannot be replaced by the user If these parts are found to be worn out or to have deteriorated during daily or regular inspection contact your sales representative or local Canon dealer for repairs Backup battery for the clock type name CR1632 battery life approximately 8 years 95 L IE 5191C TX 20 indb 95 e 2013 07 18 13 10 42 96 L IE 5191C_TX 20 indb 96 e 2013 07 18 13 10 42 97 L IE 5191C_TX 20 indb 97 e 2013 07 18 13 10 42 98 L IE 5191C_TX 20 indb 98 e 2013 07 18 13 10 42 L IE 5191C TX 20 indb 99 e 2013 07 18 13 10 42 L IE 5191C Canon Manufacturer ud CANON INC Medical Equipment Group 30 2 Shimomaruko 3 chome Ohta ku Tokyo 146 8501 Japan Telephone 81 3 3758 2111 Distributed by CANON U S A INC Healthcare Solutions Division 15955 Alton Parkway Irvine CA 92618 U S A Telephone 1 949 753 4160 ec rer CANON EUROPA N V Medical Products Division Bovenkerkerweg 59 1185 XB Amstelveen The Netherlands Telephone 31 20 545 8926 CANON SINGAPORE PTE LTD Medical Equipment Products Division 1 Harbour
61. ernal eye fixation lamp Located outside the nozzle The external eye fixation lamp stabilizes the line of site for patients who cannot see the internal eye fixation lamp or whose line of site is not stabilized by the internal eye fixation lamp 1 Press the eye fixation lamp key Every time the key is pressed the eye fixation lamp changes Measurement Screen C 2 Eye fixation lamp key EN los CO 5 PATIENT ID Screen Set the patient ID in the PATIENT ID screen The patient ID is a code to identify patients you can set up to 64 alphanumeric characters and symbols The patient ID can be displayed to appear on the Measurement screen PATIENT ID screen printed data and data output to external devices You can input patient IDs from a bar code reader or magnetic card reader that is connected via the USB interface Human Interface Device HID class n Patient ID on the Measurement screen Six digits of the patient ID can be shown on the Measurement screen If a patient ID is longer than 6 digits appears at the end of the ID Confirm the entire patient ID in the PATIENT ID screen PATIENT ID Screen PATIENT ID E BCDEFGHI JKLMNOPQRSTUVWXYZ abcdefghijkIimnopqrstuvwxyz 0123456789 amp 27 lt gt 7 4 I CHINREST STICK r3 rm E MEASURE MENU DATA SS 51 L IE 5191C TX 20 indbo 51 e 2013 07 18 13 10 31 5 Types of Measurements Input P
62. es during initialization keep the patient s chin away from the chin rest and do not touch the measurement unit There is a risk of injuring the patient The instrument automatically performs an initialization sequence internal check and positioning of measurement unit After initialization the measurement unit moves to the right eye side initial position and stops Initial position of measurement unit You can set the initial position of the measurement unit to either the right or left eye see page 61 Adjust the tilt of the monitor Use both hands as shown in the illustration when adjusting the tilt of the monitor Disinfect the forehead rest and the chin rest If chin rest paper is being used change the paper e 2013 07 18 13 10 28 Patient Setup L IE 5191C TX 20 indo 41 1 2 4 Basic Operation Disinfect the forehead rest and the chin rest If chin rest paper is being used change the paper Have the patient sit down Instruct patients to remove their glasses or contact lenses if they are wearing them Explain to the patient that intraocular pressure is measured by blowing air against the cornea Have the patient place their hand in front of the nozzle and press the CHECK button so they can feel the puff of air Input the patient ID Input the patient ID using a magnetic card reader barcode reader numeric keypad or other USB device To input the patient ID on the TX 20 wi
63. eshooting Message and Remedy The message screen appears if a problem occurs or if there is a notification If this happens check the displayed message refer to the message codes and error codes on the following list and follow the instructions in the remedy If the message screen does not close or if a message not shown in the table is displayed contact your sales representative or local Canon dealer Message Screen Error 1 Printer Abnormal Cutter Action Open and close the paper cover E104 2 3 1 Message content 2 Message code Displays the content of the notification and the The message category is indicated by the first status of the problem that has occurred It may letter also display the error code which indicates the details of the error status Fxxx The customer cannot resolve this error Exxx The customer may be able to apply a remedy to resolve this error Wxxx Alerts the customer to be careful 3 Check icon Message Screen Operations 1 Check the message e 2 Select the check icon Rotate the measurement unit vertical movement ring to select the confirm icon and press the measurement button 3 Apply the remedy Apply the remedies as shown in the message 78 L IE 5191C TX 20 indb 78 e 2013 07 18 13 10 49 Fatal 7 Troubleshooting Code Cause Remedy Abnormality occurred in transmission between boards Abnormality occurred when CCD turned
64. execute OK Check that the RS 232C cable is connected correctly use a cross cable for the RS 232C cable Also check the RS 232C transmission settings on the connected computer Abnormality occurred during RS 232C data transmission 1 2 Record the message code contents including error codes and then execute OK Check the RS 232C transmission settings Check the RS 232C transmission settings in the software on the connected computer No USB device is connected 1 Record the message code contents including error codes and then execute OK Check that the USB device is connected correctly 224 225 226 227 An unsupported USB device is connected Record the message code contents including error codes and then execute OK Connect an HID class USB device For details contact your sales representative or local Canon dealer Record the message code contents including error codes and then execute OK Connect a USB device that is compatible with HID class version 1 1 For details contact your sales representative or local Canon dealer Record the message code contents including error codes and then execute OK Connect a USB device that has a keyboard protocol code For details contact your sales representative or local Canon dealer Record the message code contents including error codes and then execute OK Connect a USB device that has a l
65. external output LAN Uses LAN interface RS 232C Uses RS 232C interface Settings for RS 232C You can set the data format transmission speed transmission bits parity and stop bit in the RS 232C menu How to Enter the RS 232C Menu MENU screen gt Output tab RS 232C Factory settings Format Select the format to output measurement data TX 20 Setting items Description T 2 EACH T 2 format 1 data T 2 ALL T 2 format all data TX F TX F format JMOIA JMOIA format TX 20 TX 20 format Baud rate Select transmission speed 9600 300 600 1200 2400 4800 9600 19200 Transmission speeds Bit Select transmission bit 8 7 8 Transmission bit Parity Select parity NONE DDD EVEN NONE Parity Stop Bit Select stop bit 1 1 2 Stop bit Settings for LAN You can set the DHCP IP address subnet mask default gateway user name password and IP address of the connected computer DNS server and name of data folder You can also enable transmission of image data and do connection tests 65 e 2013 07 18 13 10 37 5 Types of Measurements 66 L IE 5191C TX 20 indb 66 How to Enter the LAN Menu MENU screen Output tab LAN Setting items Description Factory settings Stylesheet Set to output stylesheets to the connected PC ON Output ON Output OFF Not output DHCP Set to enable DHCP OFF ON Enable OFF
66. ey on the monitor panel or the measurement button or tilt the operation lever Paper jam occurs when printing The printing paper is fed through the printer incorrectly The printing paper is set incorrectly he printing paper from last use has not been removed A Remove printing paper if there is any left from the last use 2 Open the paper cover 3 Check if the printing paper is fed through the printer aslant 4 Take out the printing paper and remove the part of paper which is wrinkled or creased 5 Setthe printing paper correctly 6 Check if printing is done correctly The paper cutter stops midway in a cut The printing paper is set incorrectly e Serious paper jam occurred Abnormality occurred in printer 1 If the message is displayed in the screen record the message 2 Press the paper cover button to move the cutter to its initial position If pressing the button once does not move the cutter press it several times 3 Open the paper cover 4 Check if the printing paper is fed through the printer incorrectly 5 Take out the printing paper and remove the part of paper which is wrinkled or creased 6 Setthe printing paper correctly 7 Check if printing and cutting are done correctly 8 Ifthis symptom occurs again turn the power off and then on and check if printing is done correctly L IE 5191C TX 20 indb 77 T7 2013 07 18 13 10 40 7 Troubl
67. for Intraocular Pressure Measurements EU U 62 Settings for Printing cot etn errare iain 63 Settings for Patient ID Input Interface seeeeeeene 64 Settings for Interface of Output of Measurements 64 Settings for Patient No etri eth ta eset tee ha ERA 2kA 67 Settings for Patient ID rni tar nenas 68 Setting the Time Date and Power Saving Mode 69 Settings for the LOD s xis dla csl dale lak kan iiaii aaa sal k eka kk seke ka v k ERA 69 Checking FIFMWANE j x 3 i d443 4541145 415530554 yas atte k k n Fake n EMEN ER ER d n d 70 6 Maint nalC E 71 Daily INSPCCtONS m M 71 Cleaning and Disinfection xi ui ix W kira alk ikakan r keka alaya canan k k d d kan 72 Refilling Chin Rest Paper eroras anisan 74 Replacing Printing Paper ierit ener rin uan teneret iot rt inpr asiya day dez 74 Preparations for Packing and Transport l keke 76 7 Troubleshooting ecco enero xakan kak ka naa ka au awa anak reu aa x k Wa nena nas 77 Symptom and Remedy sssrinin ainssi rn ka Kaka add a da cu as a kak 77 Message and Remedy cicceiccsescerssseceaseceneccecacaeaecaaekeceanensesestedeastesazecneieteases 78 nec 87 ere me 87 Stylesheet File nint tre terr et
68. g area are very hot during and immediately after printing To prevent burns wait for the printer to cool before opening the paper cover to replace paper 74 L IE 5191C TX 20 indb 74 e 2013 07 18 13 10 39 6 Maintenance 2 Remove the remaining paper Remove the old roll of paper ZA CAUTION Do not touch the cutter for the printer Do not touch the cutter for the printer Similarly instruct the patient not to touch the cutter for the printer Otherwise it may result in injury 3 Put new paper into the printer Load the roll of paper into the printer as illustrated Be sure to check that the direction of roll is the same as shown in the illustration CAUTION Print quality thermal head service life cutting operations and auto cutter service life may not be guaranteed if thermal paper not specified by Canon is used Always use thermal paper specified by Canon 4 Set the printing paper Pull out about 5 cm of the leading edge of the paper through the paper slot while the paper cover is open Set the printing paper straight so it does not skew 5 Close the paper cover When the paper is set correctly close the paper cover until it is in the lock position The paper automatically feeds and is cut CAUTION After closing the paper cover do not pull the thermal paper out before the paper is cut automatically There is a risk of damaging the printer If the paper is fed through the printer incorrectly it may cause
69. h eyes in full auto alignment mode ON Results are printed automatically OFF Results are not printed automatically If the Dutput setting is OFF printing is not done even if this setting is ON see page 63 If the Interface setting is OFF data is not output even if this setting is ON see page 64 Alignment Select an alignment mode after initialization FULL Mode The main unit performs initialization in the following situations PETS The power is turned on The PRINT button is pressed The CLS key is pressed e The TX 20 recovers from power saving mode FULL AUTOJ Full auto mode AUTO Auto mode Order Select the order in which measurement results are shown BY TIME BY TIME Show in order of time BY RELIABILITY Show in order of reliability Default Side Set the right eye side or left eye side as the recovery position for the RIGHT measurement unit The measurement unit moves to the recovery position of the side set in the following situations Power on After pressing the PRINT button After pressing the CLS key RIGHT Right eye LEFT Left eye R L Distance Set the distance moved when switching between left and right eyes 62 58 to 66 Distance moved mm Joystick Set whether to put the operation lever into proximity limiter mode NORMAL Movement In the proximity limiter mode coarse adjustment motions are prevented when the measurement unit moves within 2 mm of the alignment end positio
70. he number of measurements is assumed to be set at three n To get a highly reliable measurement We recommend that the number of measurements be set to three in full auto alignment mode We also recommend to perform more than three measurements in the auto or manual alignment mode to get a stable measured values 43 2013 07 18 13 10 27 4 Basic Operation 44 L 1E 5191C_TX 20 indb 44 7 Use the operation lever and the measurement unit vertical movement ring to display the patient s pupil in the monitor During full auto auto alignment Show all of the pupil in the monitor CHIN REST PRINT Operation lever Measurement unit vertical movement ring During manual alignment Have the alignment circle overlap close to the center of the pupil Also align the corneal light point on the same straight line as the vertical alignment guide see page 45 How to use the operation lever Left tilt Right tilt Forward tilt Backward tilt Rotate right Rotate left The measurement unit moves to the left a little according to the left tilt The motion is greater and speed increases as the tilt surpasses the maximum tilt position the buzzer sounds briefly The measurement unit moves to the right a little according to the right tilt The motion is greater and speed increases as the tilt surpasses the maximum tilt position the buzzer sounds briefly The measurement unit moves toward
71. hijkIimnopqrstuvwxyz y Li E 0123456789 amp Select Ell 3 lt gt 7 A 54 2013 07 18 13 10 33 5 Types of Measurements L IE 5191C TX 20 indb 55 6 Delete a character Use the CHIN REST button and the measurement unit vertical movement ring to move the selection cursor to the position of ID delete command Press the measurement button one time to delete 2 and move C one space to the left PATIENT ID The 2 disappears ABCDEFGHIJKLMNOPQRSTUVWXYZ abcdefghijklmnopqrstuvwxyz i 2 0123456789 amp Select IESE 2 2320 V IH rir as CHINREST STICK ES mm m MEASURE MENU DATA NE 7 Decide on the position to add text Move the ID cursor to the character to the right of the place to add text The procedure in steps 7 to 8 is explained using an example of adding an between the 1 and C In this example the cursor is already at the position of the C so there is no operation PATIENT ID ABCDEFGHI JKLMNOPQRSTUVWXYZ abcdefghijkimnopqrstuvwxyz 0123456789 amp 1 22 20 V 1 EIE NEN CHIN REST STICK MEASURE MENU DATA B amp d U To add text to the front Move the ID cursor to the first character 8 Add a character Use the CHIN REST button and the measurement unit vertical movement ring to select 9 Press the measurem
72. iately leaving it for a long time may cause distortion or discoloration e f the surface is dirty use something soft such as an absorbent cotton cloth with a small amount of ethanol and lightly wipe it 14 L IE 5191C TX 20 indb 14 e 2013 07 18 13 10 13 2 Safety Environment of Use Use store and transport the TX 20 in an environment that is within the range of the following conditions Use the original packaging to store or ship it Temperature Humidity Atmospheric pressure Environment of use 10 to 40 C 30 to 90 RH no 600 to 1060 hPa condensation Storage and transportation 30 to 50 C 10 to 9596 RH no 600 to 1060 hPa environment condensation Installation Transportation L IE 5191C TX 20 indb 15 Do not install store or leave the TX 20 in a very hot or humid environment Also do not use the TX 20 outside Doing so may cause a malfunction or misoperation e After many years of usage airborne dust in the room may get on the nozzle as well as the optical parts in the main unit and prevent accurate measurement When the TX 20 is not being used attach the nozzle cap and place the dust cover over the TX 20 Request your sales representative or local Canon dealer to install the TX 20 A strong shock to the TX 20 may put it out of alignment Please handle the unit carefully Be sure to turn off the TX 20 s power switch remove the AC plug from the outlet and disconn
73. ices S This symbol indicates actions that must not be taken prohibited actions This symbol indicates actions that must be taken HW This symbol indicates important advice that we strongly recommend be followed while operating the TX 20 a This symbol indicates supplementary explanations or advice for operating the TX 20 References This manual uses the following style to indicate reference destination Example see page 15 L IE 5191C TX 20 indb 7 e 2013 07 18 13 10 09 Safety Regulatory Information The following sections list the classifications applicable to the TX 20 and the directives and standards that the TX 20 complies with Device Classification Type of protection against electric shock Degree of protection against electric shock Degree of protection against ingress of water Degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide Mode of operation Directives and Standards L IE 5191C TX 20 indb 8 USA and Canada UL 60601 1 2003 CAN CSA C22 2 No 601 1 M90 IEC 60601 1 1988 A1 1991 A2 1995 IEC 60601 1 2005 IEC 60601 1 1 2000 IEC 60601 1 2 2001 A1 2004 IEC 60601 1 2 2007 IEC 60601 1 4 1996 A1 1999 IEC 62304 2006 IEC 62366 2007 ISO 15004 1 2006 ISO 15004 2 2007 Class equipment Type B applied parts Chin rest forehead rest IPXO Not suitable Continuous operation Medical ele
74. ion Have a periodically inspection performed for the TX 20 at least once a year by a Canon designated representative to maintain its performance and reliability Daily Inspections Perform the following inspections before using the TX 20 to ensure that it is used safely and correctly If a problem is found during the inspection and you are unable to correct the problem please contact your sales representative or local Canon dealer Checks before turning on the power Check the following items before turning on the power Cables 1 The power cord and connection cable are not damaged and their insulation is not torn 2 The power cord is fully and securely inserted into the AC connector on the main unit and the AC outlet e Main unit e 1 There are no scratches or dirt on the nozzle and objective lens Clean the nozzle and objective lens if they are dirty see page 72 2 There is no dirt on the monitor Clean the monitor if it is dirty 3 The forehead rest is disinfected see page 73 4 The chin rest paper is loaded see page 74 If the chin rest paper is not being used disinfect the chin rest see page 73 5 The printing paper is loaded see page 74 6 The covers and other parts are neither damaged nor loose Checks after turning on the power Check the following items after turning on the power 1 The power lamp lights 2 The chin rest moves up and down smoothly as the CHIN REST button is pressed 3 The measurement unit
75. is released Follow the procedure and set the position again Eye fixation lamp The internal eye fixation lamp is selected If the external eye fixation lamp was selected reselect it e Patient No Counts up the patient numbers It depends on the settings Set the number again if required Measurement screen The displayed value is cleared Check the patient ID or measured value e on the DATA screen or perform the measurement again 48 L IE 5191C TX 20 indb 48 e 2013 07 18 13 10 29 5 Types of Measurements This chapter explains how to perform the settings on the Measurement screen PATIENT ID screen and MENU screen Measurement Screen You can set the alignment mode number of measurements and the eye fixation lamp in the measurement mode Measurement Screen Alignment mode E EPSE Measurement count oM E Eye fixation lamp Changing the Alignment Mode The TX 20 lets you choose between the full auto auto and manual alignment modes I Full auto alignment mode ESI e Press the measurement button to do alignment measurement 1 to 3 times switching eyes alignment measurement 1 to 3 times and output of measurement results automatically In the MENU screen you can set whether or not to automatically output the measurement results e Auto alignment mode MA Press the measurement button to do alignment and one measurement automatically e Manual alignment mode
76. it From the Examiner s Side sseeeeee 19 Main Unit From the Patient s Side ssseeeee 20 Bottom Sid6 iic User er eens Cre acte Eve ee 21 Operatioti P Ariel ciuis rens aha a p s n nefa tet att 22 OperatioriiEeVel iis iad e eicere e Ere reete Ure ye deva na 23 Monitor Panel eet erben erred Feng esegue Dn kina z fea dD Ea d dane SEWE a seras 24 Measurement S l h oii eee c ipee ree rere ee 25 PATIENT ID SCre i ss xi io fects corteo octets rng pectet esu es 27 DATA SONO GI E L eet 28 MENU S l E 29 Screen that Appears When Measurement FailS 30 Anterior Segment Image Display Screen sssessess 30 Anterior Segment Image and Intraocular Pressure Measurement Waveform Display SCre n cccesceeseeseseceeeeececeeeeeaeesseeeeaeesseeseeteneeteaes 31 Other Screen ce nae ei ee 32 USB Connection Check Screen seen 32 Print Message Input Screen sse 32 User Name Input Screen ssessssssseeseeeeenneennnne nennen 33 Password Inp t Screen cec eeepc Ere eene 33 Computer Name Input Screen sesseseseseeeeeeeenneennenns 34 Output Folder Name Input Screen sese 34 LCD Brightness Adjustment Screen sssssssseee 35 Description of PrintoUts potere EE cnra RR RR Rs 36 4 Basic O p ra ti0 i ilk xi xasi
77. l equipment requires special precautions regarding EMC and must be installed and put into service according to the EMC information provided in the manual 2 Portable and mobile RF communications equipment can affect medical electrical equipment 3 Information regarding the cable affecting EMC is as follows To maintain the optimum EMC performance use only the designated cables Name Type Length Remarks AC Power Cord Non Shielded 3 0m Supplied RS 232C cable Shielded 1 5m Not supplied USB Ten Key Board TK TCMOO3SV 0 5m Not supplied LAN cable Non Shielded 50m Not supplied 4 The use of accessories transducers and cables other than those specified with the exception of transducers and cables sold by Canon sales representative or local Canon dealer as replacement parts for internal components may result in increased emissions or decreased immunity of the TX 20 5 The TX 20 should not be used adjacent to or stacked with other equipment if adjacent or stacked use is necessary the TX 20 should be observed to verify normal operation in the configuration in which it will be used 90 L IE 5191C TX 20 indb 90 e 2013 07 18 13 10 42 Appendix Guidance and Manufacturer s Declaration for Electromagnetic Emission The TX 20 is intended for use in the electromagnetic environment specified below The customer or the user of the TX 20 should ensure that it is used in such an environment Emissi
78. l in locations exposed to salt sulfur or corrosive gas Doing so may result in corrosion of the instrument problems or malfunctions Do not install in locations that are unstable or exposed to vibration The vibration may knock over the instrument or the instrument may become unbalanced and fall resulting in a malfunction or injury Do not place anything near the power plug To make it easy to unplug the power plug at any time avoid putting any obstructions near the AC outlet Fire or electric shock may result if the power plug is not unplugged during an emergency Do not block the vent holes Doing so may cause the internal temperature to rise and result in fire Do not put your hands or fingers near the measurement unit Your hand or fingers may be pinched and injured Similarly instruct the patient not to place his her hands or fingers on the base Hold the TX 20 when connecting or disconnecting a cable For safety reasons when connecting or disconnecting the power cord or any cable be sure to hold the main unit Otherwise the main unit may fall over possibly causing injury Ensure that the entire system conforms to IEC 60601 1 1 Use the computer and other equipment that conform to the system standard IEC 60601 1 or IEC 60950 1 for the Full Auto Tonometer TX 20 Be sure that the entire system conforms to IEC 60601 1 1 Be sure to also use an isolation transformer conforming to IEC 60601 1 when a computer conforming to IEC 6
79. moves smoothly in all directions forward back left right up and down as the operation lever and the measurement unit vertical movement ring are operated 71 L IE 5191C TX 20 indo 71 e 2013 07 18 18 10 39 6 Maintenance Cleaning and Disinfection A CAUTION Always disinfect the nozzle after measuring an infected patient s eyes A patient s tears may get on the nozzle and cause a secondary infection Always use a cotton swab or other appropriate material that has been treated with disinfectant to wipe the nozzle Nozzle When dust or dirt is stuck on the tip of or inside the nozzle press the CHECK button to blow it off Optical Component of Nozzle Do not wipe or rub the optical component if there is dirt or dust on it Doing so could scratch the surface of the optical component Do not wipe the optical component with disinfectant ethanol eyeglass cleaner or silicone coated paper Doing so could corrode the surface of the optical component or leave streaks Also wiping with too much lens cleaner causes streaking e For information about lens cleaning paper and lens cleaner contact your sales representative or local Canon dealer Be sure to put the cap over the optical component of the nozzle when the TX 20 is not in use Clean the optical component of the nozzle as indicated below when dust is on it or if it is stained with e tears e 1 Blow away any dust or dirt Remove the brush from the blower brush
80. n Beyond that fine adjustment motion takes place until the unit reaches the position NORMAL Normal mode SAFETY Proximity limiter mode 61 2013 07 18 13 10 39 5 Types of Measurements Settings for Intraocular Pressure Measurements In the intraocular pressure settings menu you can configure the settings of the intraocular pressure measurement range switching units of intraocular pressure measurements display of received light level warning display threshold for intraocular pressure display of error screen and display of warning screen waveform 62 L IE 5191C TX 20 indbo 62 How to Enter the Intraocular Pressure Measurement Menu MENU screen gt Measure tab Tonometer Setting items Description Factory settings Range Switch the range of intraocular pressure that can be measured 30 Measures a range from 0 to 30 mmHg If the pressure is over 30 mmHg it switches to 60 mmHg 60 Measures a range from 25 to 60 mmHg If the pressure is under 25 mmHg it switches to 30 mmHg 30 Unit Set the units for intraocular pressure measurements mmHg Units of measurement are shown in mmHg hPa Units of measurement are shown in hPa mmHg Level Meter Set to enable showing the received light level ON Show the received light level OFF Do not show the received light level ON Upper IOP Warning Set the upper pressure limit at which measurement i
81. ness of the LCD The left side is 1 and the right side is 100 Brightness value Shows the current brightness Specify a value from 1 to 100 O OK key Switches to the MENU screen Brightness down key Reduce the brightness Brightness up key Increase the brightness 35 2013 07 18 13 10 24 3 Names of Parts Description of Printouts The following shows how measurement results are printed CANON TX 20 1 2011 10 01 10 23 2 No 012345 3 ID A1234567 4 NAME M F 5 lt BY_RELIABILITY gt IOP mmHg RIGHT LEFT 6 15 ull 10 al 14 ull 9 ull 18 ull 6 ull 7 14 5 9 5 8 CANON EYE CLINIC TEL 12345 789 1 Date and time of measurement 6 Intraocular pressure measurement 2 Patient number 7 Intraocular pressure standard value 3 Patient ID 8 Message 4 Patient information entry field A message that has been input is printed 5 Order of data lt BY RELIABILITY gt In order of reliability BY TIME gt In order of time STANDARD ONLY Only the standard 36 L IE 5191C TX 20 indb 36 e 2013 07 18 13 10 24 L IE 5191C TX 20 indb 37 4 Basic Operation This chapter explains the flow of operations and the basic measurement procedure Flow of Operations The TX 20 has three alignment modes full auto auto and manual Full auto Alignment measuring left and right eyes and printing the results of the measurement are all done automatically Auto Alignment
82. niformly dispersed the TX 20 displays the anterior segment images and the intraocular pressure waveforms that are captured just prior to each of the three latest measurements as below This screen display is available for the measurements performed over three times Press the soft key to hide the anterior segment image and intraocular pressure measurement waveform If OFF is set for Warning Display in the intraocular pressure measurement menu the anterior segment image and intraocular pressure measurement waveform are not displayed see page 62 1 2 3 4 5 15 mmHg vj 1 Measurement count display 4 Intraocular pressure measurement value 2 Eyelid warning line Intraocular pressure measurement value reliability Perform the measurement while the eyelid and mark received light level mark and unit of measure eyelashes are above the warning line are displayed 3 Cross mark 5 Intraocular pressure measurement Displays the intraocular pressure measurement waveform optical axis Waveform graph of pressure sensor signal and corneal distortion signal of measured values 31 L IE 5191C TX 20 indbo 31 e 2013 07 18 13 10 23 3 Names of Parts Other Screens USB Connection Check Screen Screen for confirming that data is being input correctly from the USB device CONNECTION CHECK Please scan the data or input using keyboard READ DATA 1234567890 1 2 3 1 Data display
83. nt is used for something other than its intended purpose Medical examinations are the responsibility of a doctor Canon takes no responsibility for diagnostic results The information in this manual may be changed without prior notice e Although we have made every effort to ensure the accuracy of the information in this manual if you have any questions regarding the contents please contact your sales representative or local Canon dealer Request your sales representative or local Canon dealer to install the TX 20 Canon and the Canon logo are trademarks of Canon Inc Other system names and product names that appear in this manual are trademarks of their respective companies The copyright of this manual belongs to Canon Inc Unauthorized reproduction duplication or reprinting of this manual in whole or in part is prohibited e 2013 07 18 13 10 07 Contents L IE 5191C TX 20 indbo 3 1 INGO CU GO ll TEILE 5 FOATUICS c RESAS 5 Indications for Use eicere iere reta dedo ewan k ex ced Ea end 5 eInefe pm MOT 6 Conventions Used in This Manual seen 7 LE 8 Regulatory INformations cs et i daaxan cin n xoc x Fo dakan ito Sa rir 8 Safety Precautions inii a edt tre ERE OLEI c KAREN Ds 10 Notes on Using TX 20 iiiter nesa a dope ous 14 Labels and Symbols att ieee 17 3 Names of Dal TS E 19 Main Un
84. nts for basic safety and essential performance Medical electrical equipment Part 1 2 Collateral standard Electromagnetic compatibility Requirements and tests Medical electrical equipment Part 1 6 Collateral standard Usability Medical device software Software life cycle processes Medical device Application of usability engineering to medical devices Medical device Application of risk management to medical devices Ophthalmic instruments Part 1 General requirements applicable to all ophthalmic instruments Ophthalmic instruments Part 2 Light hazard protection Biological evaluation of medical devices Ophthalmic instruments Tonometers 2013 07 18 13 10 19 2 Safety Safety Precautions Z NA WARNING 10 L IE 5191C TX 20 indb 10 o 9 Prohibited 9 Prohibited 9 Prohibited 9 Prohibited 9 Prohibited To prevent injuries and data loss operate the TX 20 correctly by following the safety precautions To avoid the risk of electric shock this instrument must only be connected into a supply mains with protective earth Do not damage the power cord Do not place anything heavy onto the power cord e Do not damage or modify the power cord Do not forcibly bend twist or pull the power cord Do not hold the power cord when removing it from the AC outlet Be sure to hold the plug Handle the power cord carefully If the cord is damaged contact your
85. o to 000001 For this setting press the measurement button to display the message screen and you can select reset OK Resets CANCEL Does not reset 67 2013 07 18 13 10 37 5 Types of Measurements Settings for Patient ID You can set the input screen display number of characters to input requirement to input and type of characters to input in the patient ID menu 68 L IE 5191C TX 20 indbo 68 The patient ID is a code to identify patients You can set up to 64 alphanumeric characters and symbols The set patient ID can be checked on the Measurement screen PATIENT ID screen printed data and data output to external devices How to Enter the Patient ID Menu MENU screen gt Ifl Patient tab gt Patient ID Setting items Description dd Settings Redisplay In Set whether to display the PATIENT ID screen after printing PRINT button OFF Scn is presseo or clearing data CLS key is pressed ON Displays OFF Does not display Limit Data Set whether to limit the number of characters in a patient ID OFF Length OFF No limit Maximum number of characters is 64 1 to 63 Limited It is not possible to input more characters than the number set Always Input Set whether to require that the patient ID be input OFF ON Input is required A message appears after the PATIENT ID screen is closed and before the first printout and before transmitting data OFF
86. on Abnormality occurred in light sensor for intraocular pressure measurement A Abnormality occurred in pressure sensor for intraocular pressure measurement Abnormality occurred while checking memory Abnormality occurred while writing to memory Abnormality exists in data being stored O Ol o 1 i n n L n i n n n 0 N olal A Q NT O NIN o Abnormality occurred while measurement unit was detecting position during move to initial position 22 Operation stopped because a button or the operation lever was operated while measurement unit was moving to initial position 23 Abnormality found on the charging function for air blower during the initial checking after power on 1 2 Record the message code and contents including error codes Turn the power off and then on again If it does not return to normal stop using the unit and contact your sales representative or local Canon dealer L IE 5191C TX 20 indb 79 2013 07 18 13 10 49 79 7 Troubleshooting Error Code Cause Remedy 100 Found abnormality in setting during initialization operation when power was turned on Return to factory settings 1 Record the message code contents including error 101 Abnormality occurred while checking clock codes and then execute OK 102 Failed to read time 2 Turn the power off
87. on Test Compliance Electromagnetic Environment Guidance ms The TX 20 uses RF energy only for its internal RF emissions a EN 55011 GROUP 1 function Therefore its RF PrniSSionS are very low CISPR11 and are not likely to cause any interference in nearby electromagnetic equipment RF emissions EN 55011 Class B The TX 20 is suitable for use in all establishments CISPR11 including domestic establishments and those directly Harmonic emissions Class A connected to the public low voltage power supply EN IEC 61000 3 2 network that supplies buildings used for domestic Voltage fluctuations flicker emissions purposes Complies EN IEC 61000 3 3 Not applicable to regions where the rated voltage is less than 220V L IE 5191C TX 20 indo 91 91 2013 07 18 13 10 42 Appendix Guidance and Manufacturer s Declaration for Electromagnetic Immunity The TX 20 is intended for use in the electromagnetic environment specified below The customer or the user of the TX 20 should assu re that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD EN IEC 61000 4 2 2 4 6 kV contact 2 4 8 kV air 2 4 6 kV contact 2 4 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 3096
88. orehead rest may be corroded if a disinfectant other than those above is used Be sure to turn off the power when not in use For safety reasons be sure to turn off the power of all the devices when the TX 20 is not being used Also remove the power plug from the AC outlet and put on the cover when the TX 20 is not going to be used for a long time Otherwise dust or any foreign matter may accumulate and result in fire Make sure to select the position where the nozzle stops for each patient Look from the side of the patient when setting the stop position to see that the patient s forehead and chin are firmly against the forehead rest and chin rest If the Stop position is not set correctly the nozzle may contact the patient s eye and result in injury Do not touch the cutter for the printer Q Do not touch the cutter for the printer Similarly instruct the patient not to touch the Prohibited Cutter for the printer Otherwise it may result in injury Do not touch the area around the printer or open the paper Q cover during or immediately after printing Prohibited The printer s thermal head and the surrounding area are very hot during and immediately after printing To prevent burns wait for the printer to cool before opening the paper cover to replace paper Do not touch the measurement unit and the chin rest while Q they are moving The measurement unit and the chin rest move when the power is turned on full auto is
89. ow transmission speed For details contact your sales representative or local Canon dealer 228 Two or more USB devices are connected Record the message code contents including error codes and then execute OK Reduce the number of connected USB devices to one For details contact your sales representative or local Canon dealer L IE 5191C TX 20 indbo 81 81 2013 07 18 13 10 40 7 Troubleshooting Warning Code Cause Remedy 229 Detected over current on the USB device connection Record the message code contents including error codes and then execute OK Check the connected USB device it may not be compatible with the USB standard Or connect a USB device that is compatible with the standard For details contact your sales representative or local Canon dealer 230 Could not do auto alignment because could not find eye within set time period The following problems may have occurred The patient s eye is outside the possible range for auto alignment The patient s eye moved Or the eye is nystagmic Eyelid or eyelashes are blocking the pupil The pupil may be dystrophic or deformed Or there is a possibility the patient has undergone iris surgery A corneal disorder or some other abnormality exists on the surface of the cornea External light is shining on the patient s eye Adjust the measurement unit and the chin rest to position
90. r rni dika dank dn kade cn Re Euer uas 88 EMC Electromagnetic Compoatibility seen 90 Warranty and Repair Service 95 2013 07 18 13 10 09 1 Introduction Features The Canon Full Auto Tonometer TX 20 has full auto alignment for intraocular pressure measurement The features of these products are shown below Three alignment modes e n full auto mode both eyes are measured and the results are printed automatically shortening the time used for measuring e n auto mode auto alignment and measurement are performed each time the measurement button is pressed The examiner can monitor the condition of the patient s eyes while measuring them n manual mode measurements can be performed manually such as when the patient s pupil is eccentric or cornea is deformed Compact with superior operability More compact and more lightweight than the previous model Upright operations patient care alignment operation have been greatly improved with a tiltable color LCD monitor and powered operation lever Enhanced external interface Measurement data can be exported via RS 232C connections or to a LAN Patient ID can be input from a USB device Indications for Use For USA The Canon Full Auto Tonometer TX 20 is intended to be used for the measurement of intraocular pressure of the human eye For European Union The TX 20 measures the intraocular pressure detecting the change of the cornea surface and
91. rding to settings Display of measured value Measured values are cleared not measured state Measurement unit Returns to the initial position ji LIMITER button Sets the stop position to prevent the measurement unit from touching the patient CHECK button Blows air from the nozzle Paper cover button You can confirm the patient ID or measured value on the DATA screen until the measurement button is pressed 22 L IE 5191C TX 20 indb 22 2013 07 18 13 10 18 3 Names of Parts Operation Lever L IE 5191C TX 20 indb 23 CHIN REST PRINT Operation lever Tilt the operation lever to move the measurement unit Tilt right or left Moves slightly to right or left Tilt front or back Moves slightly to the front or back Tilt past the maximum to the front back left or right Motion is great Alignment off button While the button is pressed the measurement unit does not move even if the operation lever is tilted Use to adjust the angle of the operation lever without moving the measurement unit For example it can be used if the operation lever is at an awkward and difficult to manipulate angle when aligning with the patient s eye Measurement button Starts the measurement Measurement unit s vertical movement ring Turn the ring right and left to move the measurement unit up and down 2013 07 18 13 10 18 23 3 Names of Parts Monitor Panel 24 L
92. ress the alignment off button to move the cursor to the left MENU 4 A 4 wale Patient Patient No Page 1 2 Display ON Count up on Error ON No 400001 Reset No Patient ID Redisplay In Scn OFF Limit Data Length OFF Always Input OFF Numeric ON CHIN REST STICK 59 e 2013 07 18 13 10 39 60 5 Types of Measurements 7 Input a value Rotate the measurement unit vertical movement ring left and right to set 2 as the selected digit MENU 4 X 4 wale Patient Patient No Page 1 2 Display ON Count up on Error en No 4 000018 gt Reset No Patient ID Redisplay In Scn OFF Limit Data Length OFF Always Input OFF Numeric ON CHIN REST STICK 8 Close the MENU screen Press the ID key MEASURE key or DATA key to open a different screen L IE 5191C TX 20 indb 60 e 2013 07 18 13 10 39 5 Types of Measurements Common Settings in Measurement Modes In the common settings menu you can set auto data output alignment mode initial settings measurement results display order measurement unit recovery position distance moved when Switching eyes and operation settings of the operation lever L IE 5191C TX 20 indo 61 How to Enter the Common Settings Menu MENU screen gt Measure tab Common Factory tting it D ipti Setting items escription esu Auto Output Select whether to print or output data results automatically after ON measuring bot
93. rk Press the adjacent measurement count key to This mark appears when reliability of the Switch the measurement count setting Only measurement is considered low as the result of the enabled in full alignment mode analysis of the measured value 3 lt x2 7 Alignment circle 15 Level of received light Mark for aligning vertical and horizontal position of Indicates the amount of light received from light patient s eye and measurement unit reflected from cornea when measuring intraocular 8 Corneal light point pressure The number of lines increases as the A point that appears optically indicating alignment amount of received light increases of the position to measure in the patient s eye and If there is little received light light reflected from the measurement unit the cornea may be obstructed by the eyelid or 9 Measurement unit motion limit mark ARIE aia te a S0 tere by the Indicates measurement unit has moved to the limit SERAIS Se ohne patent position 10 Alignment guide This guide is an index that shows the corneal light point It only appears in manual alignment mode 25 L IE 5191C TX 20 indb 25 e 2013 07 18 13 10 20 3 Names of Parts 26 L 1E 5191C_TX 20 indb 26 ID 000001 Pa M CLS Intraocular pressure standard value Representative intraocular pressure value that was statistically derived from measured values Measured values with a low reliability mark are not
94. s after the power is turned on Do not prevent movement of the measurement unit by holding it or placing something near it Do not let the patient place his her chin on the chin rest until the measurement unit stops e t is recommended that a hard copy of the printout be made if you wish to store it for a long time because printouts on thermal paper are apt to deteriorate After Use Turn off the power put the cap over the optical component of the nozzle in order to prevent dust from attaching to it and place the dust cover over the instrument During Cleaning and Disinfection e f the surface of the optical component of the nozzle is wiped when dust or dirt is on it it will be scratched Also do not wipe the optical component with alcohol including disinfectant ethanol or silicone coated paper Otherwise the surface will be corroded or stained Use neutral detergent for cleaning the outside of the TX 20 Do not use neutral detergent for cleaning the LCD monitor See below for LCD cleaning instructions LCD Monitor Approximately 99 9996 of the dots in high technology LCD monitors are functional About 0 0196 of the dots may be missing or might appear as a bright spot This is not a malfunction The polarization plate on the surface of the monitor is very fragile Be careful when handling it and do not press or rub any hard objects against it Wipe water or saliva from the polarization plate on the monitor s surface immed
95. s forehead and chin are in secure contact with the forehead rest and chin rest 3 Set the distance between the nozzle and the patient s eye to approximately 8 to 10 mm and press the LIMITER button The LIMITER OFF mark disappears and the nozzle stop position mark is displayed I SSSR SS Sa 9 Nozzle stop position mark Stop doing measurements if the LIMITER OFF mark does not disappear even if the LIMITER button is pressed Stop using the instrument and contact your sales representative or local Canon dealer 42 4 Basic Operation 4 Move the operation lever to check the following Pull the operation lever slightly backward so the nozzle stop position mark disappears Tilt the operation lever forward and the nozzle stop position mark appears The nozzle should not approach the eye being examined closer than the stop position SSS SSE Sy l MN R EN Pull backward Press forward 9 Have the patient stare at the eye fixation lamp Measuring L IE 5191C TX 20 indb 43 Have the patient stare at the green internal eye fixation lamp inside the nozzle n Press the eye fixation lamp key to switch to the external eye fixation lamp if the patient cannot see the internal eye fixation lamp if it is difficult to see or if the patient s line of sight is unsteady External eye fixation lamp This section explains the full auto alignment mode which is most often used for normal measuring T
96. s normal a message to check at USB connection check screen appears If the connection is not normal an error message appears YES Go to the USB connection check screen NO End the USB connection test Settings for Interface of Output of Measurements You can send measurement results to an external device via LAN or RS 232C A CAUTION Always turn off the power before connecting cables Use the computer and other equipment that conform to the system standard IEC 60601 1 or IEC 60950 1 for the Full Auto Tonometer TX 20 Be sure that the entire system conforms to IEC 60601 1 1 Be sure to also use an isolation transformer conforming to IEC 60601 1 when a computer conforming to IEC 60950 1 is used Otherwise electric shock may result Ask your sales representative or local Canon dealer to connect it to a computer Be sure to attach the provided ferrite core before connecting the LAN cable to the LAN connector 64 L IE 5191C TX 20 indb 64 e 2013 07 18 13 10 37 5 Types of Measurements L IE 5191C TX 20 indbo 65 Using the RS 232C or LAN connector Ask your sales representative or local Canon dealer to check the connectable computer connecting cables setting and operation methods of the TX 20 How to Enter the Output Settings Menu MENU screen gt Output tab gt Output Factor Setting items Description d y settings Interface Set the interface for external output OFF OFF Turns off
97. s stopped only enabled in full auto mode 17 to 25 mmHg Upper limit of intraocular pressure at which to stop measurement 23 to 33 hPa Upper limit of intraocular pressure at which to stop measurement OFF Do not show message or stop measurement 18 Lower IOP Warning Set the lower pressure limit at which measurement is stopped only enabled in full auto mode 1 to 9 mmHg Lower limit of intraocular pressure at which to stop measurement 1 to 12 hPa Lower limit of intraocular pressure at which to stop measurement OFF Do not show message or stop measurement OFF Error Display Set whether to show an anterior segment image when a measurement error occurs ON Shows image OFF Does not show image ON Warning Display Set whether to show three anterior segment images and waveform when measurements are inconsistent ON Shows images and waveform OFF Does not show image and waveform ON 2013 07 18 13 10 39 5 Types of Measurements Settings for Printing You can enable or disable printing and set the text size the density of print and the type of print data as well as whether to print a title Patient ID Patient No and a message in the print menu How to Enter the Print Menu MENU screen gt El Print tab gt Print Factory settings Output Set whether to print the measurement results with the built in printer ON Setting items Description
98. so there are no problems operating the instrument A CAUTION Always turn off the power and unplug the power cord before connecting the cables of any external devices to the TX 20 Use the computer and other equipment that conform to the system standard IEC 60601 1 or IEC 60950 1 for the Full Auto Tonometer TX 20 Be sure that the entire system conforms to IEC 60601 1 1 Be sure to also use an isolation transformer conforming to IEC 60601 1 when a computer conforming to IEC 60950 1 is used Otherwise electric shock may occur Ask your sales representative or local Canon dealer to connect it to a computer e f the LAN connector is being used to connect to a network connect an isolation transformer for networks between the TX 20 and network devices HUB etc and between network devices If this is not done there is a risk of short circuits or malfunctioning devices Ask your sales representative or local Canon dealer to connect it to a network 1 Make sure that the power switch is off 2 Connect a USB cable to input patient IDs with USB devices Remove the paper from the printer before turning the TX 20 on its side to attach cables Otherwise the paper may jam Always turn off the power and unplug the power cord before connecting the USB cable to the TX 20 e For details on USB devices for inputting patient ID contact your sales representative or local Canon dealer USB cable 38 L IE 5191C TX 20 indbo 38
99. supports the Transfers measurement data to an external device e RS 232C standard 2 USB connector Reads patient ID from an external device Using the RS 232C or LAN connector See Safety Precautions see page 12 and Settings for Interface of Output of Measurements see page 64 21 L IE 5191C TX 20 indbo 21 e 2013 07 18 13 10 18 3 Names of Parts Operation Panel POWER 1 O TER CH 2 R L CHIN REST PRINT U 5 POWER lamp 5 Lights when power is turned on R L button Switches between the patient s left and right eye 6 as the measurement unit moves automatically CHIN REST button if Moves the chin rest up and down to align the height of the patient s eye PRINT button e Prints the measurement results Sends the measurement results to an external device if one is connected and the settings have been done in advance Pressing the PRINT button for 2 seconds or more prints or transmits the measured value and standard value for the number of measurements see page 63 For the preparation for the next measurement the settings change as shown below Nozzle stop position Releases the setting Selection of eye fixation lamp The internal eye fixation lamp is selected The external eye fixation lamp turns off and the internal eye fixation lamp flashes Patient ID The patient ID is cleared not entered state Patient No Counts up the patient numbers however acco
100. the full auto alignment mode switching between the left and right eye is done manually 4 Alignment is done with the left eye three measurements are done consecutively 5 The measurement results are printed see page 36 e 46 e 2013 07 18 13 10 29 L IE 5191C TX 20 indb 46 4 Basic Operation Sending data to an external device If you have set the instrument to send measurements to an external device the measurement results are output at this point If all the measurements are erroneous The measurement values are neither printed out nor output via RS 232C However the erroneous data is output via LAN Stopping printing or data transfer in progress To stop printing or data transfer in progress press a button on the operation panel or a soft key on the monitor panel measurement button or alignment off button e f you stop printing the paper is not cut automatically f you stop transferring data the file after the file being transferred is not sent The thermally sensitive paper used for printing may degrade over time Make a copy of measurement results to store them for a long period 6 The measurement unit moves to the right eye The Measurement screen changes to the default state The measured value is cleared and the LIMITER OFF mark is displayed However you can check the measured value on the DATA screen When the measurement button is pressed for the next measurement the measured value on the
101. the patient a little according to the forward tilt The motion is greater as the tilt surpasses the maximum tilt position the buzzer sounds briefly The measurement unit moves toward the examiner a little according to the backward tilt The motion is greater as the tilt surpasses the maximum tilt position the buzzer sounds briefly Measurement unit moves up Measurement unit moves down e 2013 07 18 13 10 28 4 Basic Operation To adjust the angle of the operation lever without moving the measurement unit Press the alignment off button while adjusting the angle of the operation lever While the button is pressed the measurement unit does not move even if the operation lever is tilted 2 Have the patient stare at the eye fixation lamp Ask patients if the green internal eye fixation lamp can be seen and instruct them as follows Have them blink several times before measurement Have them open their eyes very wide during measurement Help them to keep their eyelid open if the movement is difficult for them Be careful not to apply pressure to the eyeball while holding the eyelid open It is not possible to do measurements if there is pressure on the eyeball Have them not blink during measurement Have them stare at the eye fixation lamp Switch to the external eye fixation lamp if it is difficult to see the internal eye fixation lamp or if the patient s line of sight is unsteady see page 43 3 Press th
102. thout using a USB device press the ID key and input it from the PATIENT ID screen Go to step 5 if you are not going to input the patient ID Press the R L button to decide which eye to measure The standard is to measure the right eye first To measure the left eye press the R L button to switch the position of the measurement unit Place the patient s chin on the chin rest and forehead against the forehead rest Adjust the heights of the optical bench and chair so the patient is comfortable Be careful that the patient s chin does not protrude from the chin rest Move the chin rest with the CHIN REST button so that the patient s eye is aligned with the height adjustment mark Height adjustment mark e 2013 07 18 13 10 28 41 L IE 5191C TX 20 indb 42 e 2013 07 18 13 10 27 4 Basic Operation 8 Press the LIMITER button to set the position where the nozzle stops A CAUTION Be sure to set the position where the nozzle stops for each patient Look from the side of the patient when setting the stop position to see that the patient s forehead and chin are firmly against the forehead rest and chin rest If the stop position is not set correctly the nozzle may contact the patient s eye and result in injury 1 Check that the LIMITER OFF mark is displayed OFF mark 2 Slowly move the operation lever so the nozzle approaches the eye being examined Look at the patient from the side to make sure that the patient
103. u you can perform settings related to the position of the start byte for reading data number of bytes for reading input data method for inputting data and connection tests for a USB device for inputting the patient ID How to Enter the Patient ID Input Interface Menu MENU screen Input tab gt Input Factory tting it D ipti Setting items escription E Update Set the input methods to handle a USB device for automatic input ADD magnetic card reader barcode reader etc and a USB device for manual input numeric keypad etc OVERWRITE Input data overwrites existing data Select when a USB device for automatic input is connected ADD Input data is added to existing data Select when a USB device for manual input is connected Start Position Set the position of the byte at which to start reading data that is input 0 from a USB device You can only do this setting if OVERWRITE is selected for Update O to 255 Position of byte at which to start reading Data Length Set the number of bytes to read of the data that is input from a USB 1 device The length of data number of bytes read from the reading start byte position set for Start Position You can only do this setting if OVERWRITE is selected for Update 1 to 64 Length of data to read Connection For this setting press the measurement button to do a connection test Check for the USB device and display the results If the connection i

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