Rodenstock REM 4000, Instruction Manual

Page 1: ...d safe operation Contact Tomey Corporation or your local distributor if you have any questions or encounter any issues during operation Always follow the operation procedures described in this manual...

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Page 3: ...he instrument Any water or chemicals entering the instrument may cause electric shock or failure Use only the specified data terminal for connection of the instrument Using another type of terminal ma...

Page 4: ...MENT Describes consumable parts and optional equipment 7 SPECIFICATIONS Describes the specifications of the instrument Symbols used in this manual Sentences accompanied by the symbols below indicate t...

Page 5: ...ls used for marking 2 11 3 OPERATION PROCEDURES 3 1 3 1 Safety precautions 3 1 3 2 Preparation before use 3 1 3 2 1 Connections 3 1 3 2 2 Starting shutting down the instrument 3 3 3 2 3 Clearing last...

Page 6: ...Inspection 4 2 4 4 Routine maintenance 4 3 4 5 Replacing consumables 4 4 4 5 1 Fuses 4 4 4 5 2 Built in printer paper 4 4 4 6 Storing 4 6 4 7 Disposal 4 6 5 TROUBLESHOOTING 5 1 5 1 Common items 5 1 6...

Page 7: ...ic shock Do not place any heavy object on the power cord or compress the power cord Fire or electric shock may occur Fully insert the power plug into the outlet Faulty contact allowing any metal to co...

Page 8: ...ctly Check the sections that the patient will directly touch Peel off the top sheet of chin rest paper and clean the forehead pad with a cloth dampened with alcohol before capturing images Check that...

Page 9: ...rm another inspection When using captured images or analysis results obtained with this instrument for diagnosis also refer to the results of other examinations Capturing conditions may affect the pre...

Page 10: ...resulting in death or serious injuries Use the power cord and fuses provided with the instrument or specified by Tomey to ensure safety Also do not use the accessories provided with the instrument for...

Page 11: ...d Open the package and check that the required quantity of the following items is included and they are not damaged If any item is missing or damaged contact your local distributor as soon as possible...

Page 12: ...the physician CV Coefficient of variation A value calculated by dividing the standard deviation of cell areas with the average area of the cells D A AVG Average size of Dark Area The average area of...

Page 13: ...em for electronic medical records that controls the examination data obtained with Tomey products Auto Alignment Function to automatically align the camera in up down right left focus directions Auto...

Page 14: ...t also measures the central corneal thickness while capturing an image of corneal endothelium The patient places their chin on the chin rest and looks into the Fixation Light in the capture window The...

Page 15: ...can be adjusted 2 Power lamp The lamp stays lit while the power is turned ON 3 Chin rest up down button Press the button to move the chin rest up and down 4 Joystick Used for alignment Use the capture...

Page 16: ...side of the monitor 2 Forehead rest and pad Have the patient lightly press their forehead to this pad to stabilize their head while capturing an image 3 Capture window Radiates light for capturing ima...

Page 17: ...An SD card used to save the examination data is inserted here 5 USB H connector Connect the video printer and external ID input device here 6 USB D connector PICT Connect the Pict Bridge printer here...

Page 18: ...the ID and name of the patient 3 Version Displays the version of the system 4 Database button Displays the Patient List screen 5 Retake button Touch and hold this button to delete the examination data...

Page 19: ...gnment Auto Shot AA MS Auto Alignment Manual Shot MA MS Manual Alignment Manual Shot 4 Light Power setting Displays the setting for the light strength for capturing an image of the endothelium Auto Br...

Page 20: ...Fixation screen 10 Setup button Moves to the Setup screen 11 Analyze button Performs automatic analysis and moves to the R L eye analysis screen 12 Head retract button The head retracts while this but...

Page 21: ...ays the captured image of the anterior segment 5 Fixation light position Displays the fixation light position when the image was captured 6 Central corneal thickness Displays the thickness in the cent...

Page 22: ...2 8 2 4 4 Analysis screen a R L eye analysis screen b Single eye analysis screen 3 5 6 8 10 11 1 2 14 15 16 17 18 12 13 4 1 7 9 3 10 11 1 2 14 15 16 17 18 21 20 12 13 4 1 7 5 6 9 11 22 19...

Page 23: ...segment 6 Fixation light position Displays the fixation light position when the image was captured 7 Analysis method Displays the analysis method used for the displayed analysis results 8 Edit mark S...

Page 24: ...Trace Edit screen 17 Cell Select button Opens the Cell Selection screen 18 Print Export Save buttons Two buttons can be selected from Print Export and Save using the system setup function Refer to 3 7...

Page 25: ...2 11 2 5 Symbols used for marking Refer to instruction manual ON power OFF power Type B attached part Grounding earth...

Page 26: ...2 12 This page is intentionally left blank...

Page 27: ...3 2 1 Connections a Power code Insert the connector of the power cord into the power socket on the side of the main unit in correct alignment Connect all three pins of the plug side Fig 1 b External...

Page 28: ...on data receiving software DATA Transfer included in the package is required for data communication with the instrument Refer to the corresponding operation manual for installation settings and operat...

Page 29: ...rs b Shutdown 1 Turn OFF O the power switch of the REM 4000 To pack the instrument move the head to the specific storage position with the packing button and then turn the power off Refer to 2 3 Sides...

Page 30: ...er electronic medical records Only the first 14 digits of the ID number are displayed in the patient information field Check that the ID number is correct on the patient information entry screen The n...

Page 31: ...ch the Patient Search button 2 on the Patient Information screen Fig 2 to open the Patient List screen Fig 4 Touch the required patient name in the list 8 and then the Select button 9 Entry method 3 I...

Page 32: ...the patient s face hands and fingers Otherwise injury to the hands and fingers may result from the movement of the head and chin rest The chin rest paper is provided to keep the chin rest clean For p...

Page 33: ...3 7 Fig 1 Fig 2 2 1 3 4...

Page 34: ...Fig 2 2 Touch the appropriate button 2 to select the lighting position Descriptions on each button represent the direction viewed from the patient C Center U Upper R U Upper right R L Lower right L L...

Page 35: ...ot active Use the capture button on the monitor or joystick button to capture an image c Light Power Auto The power of the light for capturing an image of the endothelium is adjusted automatically Hig...

Page 36: ...tly Auto Alignment is set as the standard setting to capture better images In some rare cases auto alignment cannot be performed because of a shortage of reflection light due to deformation and or inf...

Page 37: ...ad is too close to the eye When Auto Alignment is active focusing in the forward and backward directions starts automatically when the cornea approaches the optimum alignment position 5 When the optim...

Page 38: ...far from the eye A vertical focus indicator means that the head is too close to the eye When Auto Alignment is set focusing in the forward backward directions starts automatically when the cornea app...

Page 39: ...ired Image is captured automatically when alignment has been completed 2 The following screen appears when capturing has been completed In Quick mode The capture screen refer to 2 4 2 appears when an...

Page 40: ...other eye The R L eye analysis screen refer to 2 4 4 appears when images of both eyes have been captured In Basic mode The image selection screen refer to 2 4 3 appears when capturing has been complet...

Page 41: ...Fig 2 appears every time an image of an eye is captured Fig 1 Fig 2 1 Touch one of the thumbnails 2 of captured images to select the image to be used for analysis The selected image is displayed in t...

Page 42: ...Editing outlines for how to edit the outlines Selecting cells Exclude cells with outlines extracted incorrectly from the target of analysis Refer to 3 4 1 c Selecting cells for how to select cells Ch...

Page 43: ...endothelium CD Cell density mm2 The number of the analyzed endothelial cells in 1 mm2 AVG Average area m2 The average area of the analyzed endothelial cells SD Standard deviation m2 Standard deviatio...

Page 44: ...matically analyzing the displayed image of endothelium is displayed using a histogram on the single eye analysis screen The class width of distribution according to cell sizes can be set on the System...

Page 45: ...L L R L R U Checking reliability The displayed endothelial image is automatically analyzed and resultant reliability is displayed on the R L eye analysis screen and single eye analysis screen The rel...

Page 46: ...2 L count method and 3 4 3 Core method for the application of the L count method and Core method The reliability mark does not appear when the following analytical calculations are conducted When an o...

Page 47: ...Density Dark Area density mm2 The number of Dark Areas in 1 mm2 of the analyzed endothelium D A AVG Average size of Dark Area m2 Average area of sizes of the analyzed Dark Areas D A SD Standard deviat...

Page 48: ...7 3 Application for setting method b Editing outlines Outlines of endothelial cells extracted by automatic analysis can be edited Edit marks appear on the analysis screen when the outlines are edited...

Page 49: ...button deletes all outlines of endothelial cells and Dark Areas currently displayed and then displays outlines of automatically extracted endothelial cells and Dark Areas 8 Undo Redo button Returns o...

Page 50: ...and cells not selected are displayed without color or in gray Touch a cell on the image of the endothelium to select it Fig 1 Fig 2 1 All selection button Selects all cells automatically extracted 2...

Page 51: ...g 2 Fig 1 Fig 2 2 Touch the L count button 2 and then the OK button to open the Point Edit L count screen Fig 3 b Editing range and point The L count assist function is designed to help users operate...

Page 52: ...uch pen An orange dot appears at the touched point The number of current dots appears in the Count field 3 To delete a dot touch the eraser button 7 to activate it and then touch the dot to be deleted...

Page 53: ...Fig 5 A hyphen is shown for analysis values other than NUM CD and AVG The analyzed image Area Apex is not output Touch the Point Edit button and open the Point Edit screen to edit points again When an...

Page 54: ...ng dots in the Core method Otherwise incorrect results may be displayed The number of points should be 50 or more The recommended number of points is 100 or more Place a dot as close to the center of...

Page 55: ...displayed Touch the undo redo buttons 7 to undo and or redo the operation to specify dots 2 Touch the Calc calculation button 8 to close the Point Edit screen The result of calculation is displayed on...

Page 56: ...The analyzed image Trace Area and Apex is not output Touch the Point Edit button and open the Point Edit screen to edit points again When analyzing another eye by the Core method touch the image of th...

Page 57: ...n settings on the Setup screen must be completed in advance to connect with TOMEY Link and DATA Transfer Refer to 3 7 4 Connection Print for the setting method Data cannot be sent using some settings...

Page 58: ...tion screen Fig 2 Fig 1 Fig 2 2 The transfer confirmation screen Fig 2 displays patient ID name sex and date of birth Touch the Export button 2 to start sending data Touching the Cancel button 3 retur...

Page 59: ...nt for the setting of the printer a Example of printout from built in printer The printing format for the built in printer can be selected in the system setup Refer to 3 7 4 Connection Print for the s...

Page 60: ...s provided at the bottom of the screen are not printed 13 Central corneal thickness 14 Ultrasonic correction for central corneal thickness 15 Dark area analysis value 16 Dark area analysis setting D D...

Page 61: ...ged due to SD card corruption or instrument failure Backup the data as necessary Touch the Save button 1 on the analysis screen to save the examination data of both eyes to the database SD card insert...

Page 62: ...nts are found from the patient IDs and names in the database and listed in the patient list window Touch any of the titles at the top of the patient list window ID Name and Date of birth to sort patie...

Page 63: ...the R L eye analysis screen Refer to 2 4 4 Analysis screen for operation of the buttons on the R L eye analysis screen Edit the analysis result and touch the Save button 10 to overwrite the existing...

Page 64: ...ted Fig 1 3 6 3 Changing ID Examination data are saved or deleted when changing ID Do not turn off the power when ID is being changed Otherwise the data may be corrupted The data saved in the SD card...

Page 65: ...3 39 2 Enter the ID number and press the save button 2 to change the current examination data ID number Fig 2 2...

Page 66: ...rmation etc Measurement Capture of images and operation Application Analysis and correction Connection Print Connection and printing Touch the menu tab 2 to open the corresponding setup screen The set...

Page 67: ...n is performed for a specified time Touch the monitor screen to return to normal status Set the time until the auto power off function is activated 5 mins 10 mins OFF 6 Brightness monitor Sets the bri...

Page 68: ...he patient information input screen before capturing images when starting to capture images for a new patient When 2 ID Necessity SAVING EXPORT setting is No this setting is automatically set to No an...

Page 69: ...on is not active Use the Touch Alignment function or joystick to conduct alignment 2 Shot Select the shot mode Auto or Manual Auto The Auto Shot function is active An image is captured automatically w...

Page 70: ...completed This mode is for users that do not need to look at all 16 images of the endothelium Basic Capture mode in which the image selection screen appears when capturing is completed This mode is fo...

Page 71: ...ixation light position display of the analysis screen a CCT Touch the Setting button 1 of CCT to display the System Setup screen Fig 2 Fig 1 Fig 2 2 CCT US Display Sets whether to display the ultrasou...

Page 72: ...f 1 m2 5 Dark Area Analysis Turns the Dark Area detection function on and off Dark Areas are not detected when set to OFF 6 Dark Area as Cell Sets whether to regard detected Dark Areas as endothelial...

Page 73: ...o 100 m2 regarding a point specified on the image of endothelium as the center 3 L count Assist Turns the L count assist function on and off Cells are automatically selected after the range is specifi...

Page 74: ...n the Select Function screen Fig 2 Fig 1 Fig 2 2 Select Function Select functions of two buttons at the bottom center of the analysis screen Fig 3 Fig 3 b My IP Setting Touch the Setting button 1 of P...

Page 75: ...cord the IP address and subnet mask of the computer with DATA Transfer installed Refer to the DATA Transfer operation manual for details 2 Initiate settings on the Instrument The settings shown in the...

Page 76: ...nected This item is displayed only when LAN is selected Touch the DNS button to specify the personal computer name A DNS server must be running in the LAN environment to enable connection using the DN...

Page 77: ...ompliant server SCP As DICOM communication is generally carried out in combination with IP address port number and AE title make sure to set these names Check the DICOM Conformity Statement regarding...

Page 78: ...Setting button Open the setting screen related to the built in printer 4 External Printer Setting button Open the setting screen related to the external printer Built in Fig 1 1 Header Footer Set the...

Page 79: ...printer is selected printer specific setting items appear P93D Mitsubishi P93D monochrome P95D Mitsubishi P95D monochrome 2 Print Size Set the printing size Video Color Printer Fig 1 1 Printer Select...

Page 80: ...centered B5 Form 2 When the paper feed tray is left aligned Data Transfer Fig 1 1 Connection admission and Cable type 2 Login to TOMEY Link 3 Host IP Address 4 Port Number 5 IP Check button 6 Paper S...

Page 81: ...Delete button All patient and examination data are deleted 2 SD card Format button Format the SD card inserted in the main unit All examination data is deleted 3 Exam List View Normal Displays thumbna...

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Page 83: ...n for proper installation use and maintenance of product This warranty is only applicable to the new product and DOES NOT cover any damage resulting from or caused by accident or negligence abuse misu...

Page 84: ...n operating life of 8 years when operated in the appropriate environment and it is adequately inspected and serviced 4 3 Inspection When there is a problem measurement may not be performed correctly C...

Page 85: ...rub sections that patients touch directly such as the forehead pad and chin rest with cotton dampened with alcohol Do not leave any water chemicals etc remaining on the touch panel as the surface of...

Page 86: ...ocket of the instrument Insert a flat screwdriver or coin into the slot on the fuse case located at the bottom of the main unit Turn the screw counterclockwise to remove it 3 Replace the blown fuse wi...

Page 87: ...roll and install a new roll If the roll is installed in the wrong direction nothing will be printed 3 Close the printer cover with the end of the paper protruding 2cm from the outlet Press the cover f...

Page 88: ...or fall resulting in fire or a fatal accident Place the dust cover over the main unit when not being used High quality images may not be captured if the optical section in the instrument becomes dirty...

Page 89: ...here are no flaws in the power cord such as cracks or tears Problem with the power outlet Check that power is supplied to the outlet to which the power cord is connected Faulty fuse Check that fuses a...

Page 90: ...g the output printer Set Video for the output destination when the Print button is touched Refer to 3 7 4 Connection Print for the correct setting The brightness and color of printouts from the video...

Page 91: ...able Verify that the USB cable of the external ID input instrument is correctly connected to the main unit Refer to 3 2 1 Connections for correct connection A screen which does not receive an ID input...

Page 92: ...SB is running correctly Refer to the instruction manual of TOMEY Link or DATA Transfer for details TOMEY Link or DATA Transfer is in an error state Check that no error is current in TOMEY Link or DATA...

Page 93: ...TIONAL EQUIPMENT The following spare parts and accessories are available from your local distributor of this instrument Contact your local distributor to order them Built in printer paper Chin rest pa...

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Page 95: ...r the following environmental conditions Installation Indoors not in direct sunlight Temperature 10 C 40 C Humidity 30 75 Atmospheric pressure 800 1060hPa Power fluctuation less than 10 of normal volt...

Page 96: ...nerate RF energy intentionally in the form of electromagnetic irradiation inductive coupling and or capacitive coupling for processing of materials or inspection analysis and that it is suitable for u...

Page 97: ...alculated analysis of captured image is Indicated properly Measurement data of corneal thickness is indicated properly Name Specification Length Note AC Power Cord Unshielded 2 5m Accessories LAN Cabl...

Page 98: ...Class A Voltage fluctuations and flicker IEC 61000 3 3 Complies Test Standard IMMUNITY TEST LEVELS HOME HEALTHCARE ENVIRONMENT ELECTROSTATIC DISCHARGE IEC 61000 4 2 8 kV contact 2 kV 4 kV 8 kV 15 kV...

Page 99: ...iation 1kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modulation 217Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation 18Hz 2 0 3 28 870 930 1 72...

Page 100: ...V 0 15MHz 80MHz 6V in ISM and amateur radio bands between 0 15MHz and 80MHz 80 AM at 1kHz Voltage dips IEC 61000 4 11 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 cycles...

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Page 102: ...33 Noritakeshinmachi Nishi ku Nagoya 451 0051 JAPAN Tel 81 52 581 5327 Fax 81 52 561 4735 EC Representative Tomey GmbH Wiesbadener Stra e 21 90427 N rnberg Germany Tel 49 911 9385462 0 Fax 49 911 938...