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Topcon RM-800 User Manual
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Topcon RM-800 User Manual

Topcon RM-800 User Manual

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USER MANUAL
AUTO REFRACTOMETER
RM-800
AUTO KERATO-REFRACTOMETER
KR-800

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Summary of Contents for Topcon RM-800

  • Page 1 USER MANUAL AUTO REFRACTOMETER RM-800 AUTO KERATO-REFRACTOMETER KR-800...
  • Page 3 INTRODUCTION Thank you for purchasing the TOPCON AUTO REFRACTOMETER RM-800, AUTO KER- ATO-REFRACTOMETER KR-800. INTENDED USE / INDICATIONS FOR USE This instrument is used to measure the spherical refractive-power, cylindrical refractive power, the direction of astigmatic axis, the radius of curvature, to compute the corneal refractory power, corneal astigmatic power and the corneal astigmatic axis angle.
  • Page 4 2. The contents of this manual are correct to the best of our knowledge. Please inform us of any ambiguous or erroneous descriptions, missing information, etc. 3. This manual is translation of the original instructions.This manual was originally written in English. ©2013 TOPCON CORPORATION ALL RIGHTS RESERVED...
  • Page 5 COMPOSITION OF PARTS WHICH CONTACT THE HUMAN BODY .........12 OPERATION METHOD OF CONTROL PANEL..............13 CONTROL PANEL COMPONENTS..................13 FUNCTION BUTTON ....................14 MONITOR SCREEN ......................15 MEASUREMENT SCREEN..................15 RM-800 .........................15 KR-800..........................15 SETTINGS SCREEN....................16 CORNEA DIAMETER MEASUREMENT SCREEN (ONLY IN KR-800).......16 PRINTER OUTPUT .......................17 RM-800 .........................17 KR-800..........................18...
  • Page 6 TROUBLESHOOTING TROUBLE-SHOOTING OPERATIONS .................59 MESSAGE LIST ......................59 TROUBLE-SHOOTING OPERATIONS................60 SPECIFICATIONS AND PERFORMANCE SPECIFICATIONS AND PERFORMANCE ................61 RM-800 .........................61 KR-800..........................61 GENERAL INFORMATION ON USAGE AND MAINTENANCE INTENDED PATIENT POPULATION ..................62 INTENDED USER PROFILE ....................62 ENVIRONMENTAL CONDITIONS OF USE ................62 STORAGE, USAGE PERIOD ....................62 ENVIRONMENTAL CONDITIONS FOR PACKAGING IN STORAGE ........62...
  • Page 7 ELECTRIC RATING.......................63 SAFETY DESIGNATIONS PER IEC 60601-1 STANDARD ..........63 DIMENSIONS AND WEIGHT ....................63 OPERATION PRINCIPLE.....................64 DISPOSAL ..........................64 ELECTROMAGNETIC COMPATIBILITY................65 REQUIREMENTS FOR THE EXTERNAL DEVICE...............68 IT NETWORK ENVIRONMENT.....................68 PATIENT'S ENVIRONMENT ....................69 REFERENCE SHAPE OF PLUG ........................70 IPA FONT LICENSE AGREEMENT v1.0 .................71...
  • Page 8 DISPLAYS AND SYMBOLS FOR SAFE USE To encourage safe and proper use and to prevent injury to the operator and others or potential damage to property, important messages are put on the instrument body and inserted in the manual. We suggest that everyone understand the meaning of the following displays, icons and text before reading the "GENERAL SAFETY INFORMATION"...
  • Page 9 Humidity limitation Limite d'humidité Atmospheric pressure limitation Limite de pression atmosphérique Temperature limit Limite de température Fragile, handle with care Fragile manipuler avec soin Keep dry Garder au sec This way up Vers le haut Maximum number of identical packages which Nombre maximum d’emballages identiques pouvant may be stacked on one another.
  • Page 10 GENERAL SAFETY INFORMATION WARNING Ensuring the Safety of Patients and Operators When operating the instrument, do not touch the patient's eye or nose. Preventing Electric Shocks and Fires To avoid fire and electric shock, install the instrument in a dry place free of water and other liquids. To avoid fire and electric shock, do not put cups or other containers with liquids near the instrument.
  • Page 11 For details, See "CLEANING THE INSTRUMENT" on page 54. DISCLAIMERS • TOPCON is not responsible for damage due to fire, earthquakes, actions or inactions of third persons or other accidents, or damage due to negligence and misuse by the user and any use under unusual conditions.
  • Page 12 To secure safety, this equipment provides warnings. Correctly use the equipment following these warning instructions. If any of the following marking labels are missing, please contact your dealer or TOPCON at the address stated on the back cover. Label Label...
  • Page 13 STANDARD ACCESSORIES The following are standard accessories. Make sure that all these items are included (quantity). Chinrest tissue pin (2) Power cord (1)* Printer paper (2) Monitor cleaner (1) Chinrest tissue (1) Dust cover (1) Accessory case (1) User manual, Instruction manual* Unpacking and Assembling (1 each) Rubber cap (1) Model eye (1)
  • Page 14 COMPONENTS COMPONENT NAMES Main body Section Measuring head Control panel Printer cover open switch Chinrest up/down knob Printer cover Measurement switch Control lever Base stopper Power unit Section External I/O terminal Chinrest Section Forehead rest* Measuring window Eye height mark Eye height mark of measuring window Chinrest tissue pin...
  • Page 15 OPERATION METHOD OF CONTROL PANEL • The control panel is a touch panel. Do not use any sharp tools; e.g. ball NOTE point pen. • Do not touch two points on a control panel simultaneously. To select any relevant item. 0000100001000 0000100001000 0000100001000...
  • Page 16 Auto Shoot button ........Selects Auto Shoot/Manual mode. When selected, "Auto Shoot" is displayed on the control panel, and this button is framed in orange. (Only in KR-800) Settings button ..........Displays the Settings screen. FUNCTION BUTTON ALL CLEAR button Cataract button Cornea diameter button Fixation target button Print out button...
  • Page 17 MONITOR SCREEN MEASUREMENT SCREEN RM-800 Cataract mode display * Barcode reader display Alignment mark Patient No. (Patient ID Smallest measurable pupil diameter mark when patient ID is input) Operator ID Number of reading (R, REF) Number of reading (L, REF)
  • Page 18 SETTINGS SCREEN CORNEA DIAMETER MEASUREMENT SCREEN (ONLY IN KR-800) R:9.50 R :9 .5 0 L:0.00 L:0 .0 0 COMPONENTS...
  • Page 19 -0.75 +0.25 S.E. -0.75 during a measurement. ADD : 2.25 NPD :61 PD : 65.0 TOPCON logo mark TOPCON Near vision PD value ADD (standard additional power) Pupil distance (PD value) (mm) Refractive power measurement result (L) Refractive power measurement result (R) • The reliability factor is defined with integers 1 to 9 in increasing order of reliability.
  • Page 20 Left eye corneal curvature Pupil distance (PD value) (mm) measurement Refractive power measurement result (L) TOPCON logo mark Refractive power measurement result (R) • The reliability factor is defined with integers 1 to 9 in increasing order of reliability. Additionally, if the reliability is high enough, the reliability factor is not shown on the printout.
  • Page 21 KRT typical value style and KRT print data are R1R2 Barcode Work ID No. Reliability factor Operator ID OID : C mark appears when Patient No./Patient ID the mode is changed Device ID number to the cataract mode manually during a Serial number measurement.
  • Page 22 Date style DMY* DMY* DMY* DMY* Patient No./Patient ID Device ID Common Serial number Include error data TOPCON logo Message print Input message NULL NULL NULL NULL Graphic print Normal Printer Normal Printer Normal Printer Normal Printer Line space Auto Cut...
  • Page 23 PREPARATIONS INSTALLATION • When moving the instrument, two people should lift from the bot- tom of the device. One person lifting the device may cause harm to his back or injury by falling parts. Also, holding areas other than the bottom and holding the External I/O terminal cover may cause injury, as CAUTION well as damage to the instrument.
  • Page 24 CONNECTING EXTERNAL I/O TERMINALS To avoid electric shock, do not touch the external connection CAUTION terminal and the patient at the same time. When connecting this product with a commercial personal computer, use NOTE one conforming to IEC62368-1, with a separation unit. DATA OUTPUT This product can be connected to a personal computer (PC) and other external devices via the RS- 232C or LAN.
  • Page 25 Connect the other end of the connection cable to the external device. NOTE For questions about connections, contact your TOPCON dealer. USB input terminal PRINTER PAPER SETTING • When setting a printer paper, keep a patient's face away from the instrument.
  • Page 26 Open the printer cover to the limit. Insert the printer paper in the direction shown below and pull out the paper end to your side by 7 to 8cm. Roll direction Bring the paper into the center, then close the printer cover. •...
  • Page 27 BASIC OPERATIONS PREPARATION BEFORE MEASUREMENT TURNING ON THE INSTRUMENT Make sure the power cord is connected properly. For the details of connection, refer to "CONNECTING POWER CORD" on page 21. Press on the switch. POWER Make sure that the title screen is displayed and then the MEASUREMENT screen is displayed in a few seconds.
  • Page 28 PATIENT POSITIONING • To avoid electric shock, do not touch the external connection ter- minal and the patient at the same time. • To avoid injury, do not insert fingers under the chinrest. To avoid injury when moving the chinrest down, be careful not to catch the patient's finger.
  • Page 29 AUTO SHOOT MODE MEASUREMENT (ONLY IN KR-800) When operating the instrument (for measurement and control panel operation), be careful that the instrument does not touch the CAUTION patient's lip or nose. If touched, clean the instrument as specified in "CLEANING THE INSTRUMENT" on page 54. •...
  • Page 30 ALIGNMENT AND MEASUREMENT To avoid injury when operating the machine (for measurement and control panel operation), be careful not to approach the finger to space of movable part. CAUTION Alignment operations are done with the control lever. • The main body position can be fine-adjusted laterally by inclining the control level to each direction.
  • Page 31 If Auto Shoot mode measurement does not work, select manual mode. NOTE Auto Shoot mode measurement may not work depending on the cornea condition. Use the base stopper to release the main body. Hold the control lever and move the main body to the operator side. Operate the control lever laterally and vertically to obtain the target eye in the center of control panel screen.
  • Page 32 Keeping the alignment dot within the alignment area, slowly move the main body toward the patient. When the main body approaches the target eye, alignment arrows appear to the control panel screen. 0000100001000 0000100001000 0000100001000 0000100001000 0000100001000 0000100001000 0000100001000 0000100001000 AutoShoot AutoShoot AutoShoot...
  • Page 33 0000100001000 0000100001000 0000100001000 0000100001000 AutoShoot AutoShoot mm mm 13.75 13.75 01 0 1 Too close 0000100001000 0000100001000 0000100001000 0000100001000 AutoShoot AutoShoot 13.75 13.75 01 0 1 mm mm Too far 0000100001000 0000100001000 0000100001000 0000100001000 AutoShoot AutoShoot 13.75 13.75 0 1 0 1 mm mm Positioning is incorrect at all.
  • Page 34 After the alignment arrows appear, please push and pull main body slightly. When the alignment arrows disappear, Auto shoot function is performed automatically at speci- fied number of times of measurement. The latest measurement value is displayed on the control panel. 0000100001000 0000100001000 0000100001000...
  • Page 35 MANUAL MODE MEASUREMENT SETTING THE MANUAL MODE (ONLY IN KR-800) Check the measurement screen. If button is not framed in orange, it is in Manual Auto Shoot mode. button is framed in orange, it is in Auto Shoot mode. Tap the button Auto Shoot Auto Shoot...
  • Page 36 When the measuring head has reached the limit of movement (vertical/ lateral directions), a yellow-colored limit mark appears on the control panel’s top, showing it is the movement limit in that direction. Move the measuring head or chinrest to a position that aligning is possible. Limit mark 0000100001000 0000100001000...
  • Page 37 DISPLAYING MEASUREMENT VALUES Data of the latest measurement are displayed on the control panel screen. Figures only: Measurement was done correctly. ERROR: Measurement was not done correctly. For explanation of the messages on the control panel screen, refer to NOTE "MESSAGE LIST"...
  • Page 38 • When the cylindrical refractive power is "0," the direction of astigmatic axis and measurement values are not displayed/printed. • When a red line is printed at the end of the printer paper, replace it with a new one. For details about the replacement of printer paper, see "PRINTER PAPER SETTING"...
  • Page 39 DISPLAYING ALL MEASUREMENT DATA Normally the latest measurement is displayed, but it is possible to display and confirm all measure- ment data. Measurement data chooses and displays "REF data" and "KRT data (Only in KR-800)." Tap the button of the control panel. TARGET IMAGE 0000100001000 0000100001000...
  • Page 40 NOTE When no data is memorized, the data table shows blank. To change "REF data" and "KRT data (Only in KR-800)," tap the button. REF/KRT RIGHT LEFT 7.80 7.75 7.80 7.75 7.80 7.75 7.80 7.75 7.80 7.75 7.80 7.75 7.80 7.75 7.80 7.75...
  • Page 41 OPTIONAL OPERATIONS DISPLAYING THE PATIENT ID (PATIENT No.) OR OPERATOR ID A patient ID or operator ID of up to 13 characters can be input and displayed on the control panel and printout. However, if no patient ID is input, the patient No. is allocated automatically by the device. button.
  • Page 42 MEASUREMENT OF CORNEA DIAMETER (ONLY IN KR-800) MEASUREMENT ON THE ACTUAL IMAGE Tap the button. CORNEA DIAMETER 0000100001000 0000100001000 0000100001000 0000100001000 AutoShoot AutoShoot mm mm 13.75 13.75 0 1 0 1 The Cornea Diameter Measurement screen is displayed, and the positioning bar is displayed. R : 0 .
  • Page 43 Using the button (R), move the right positioning bar to the right POSITIONING BAR CONTROL end of the iris from the control panel side. R:0.00 R:0.00 L:0.00 L:0.0 0 By tapping the positioning bar R/L balance display, positioning bar can be NOTE moved.
  • Page 44 MEASUREMENT ON THE STILL IMAGE When KRT measurement values are available, the still image of the measurement is displayed. Follow steps 1 to 3 of "MEASUREMENT ON THE ACTUAL IMAGE" and display the cornea image at the screen center. Press the to display the saved image.
  • Page 45 OUTPUT USING RS-232C This instrument can output data to a PC, etc. via the RS-232C interface. Connect the interface cable to RS-232C OUT. Refer to "CONNECTING EXTERNAL I/O TERMINALS" on page 22. Set up of data communication settings. For details, refer to "DATA COMMUNICATION (COMM)" on page 52. Perform measurements.
  • Page 46 SETTING FUNCTIONS ON SETUP SCREEN OPERATING THE SETUP SCREEN Various functions can be set on the SETUP screen. PREPARATONS FOR SETTING Make sure that the power cord is connected. For connection, refer to "CONNECTING POWER CORD" on page 21. Turn ON the switch.
  • Page 47 OUTLINE OF SETUP SCREEN OPERATIONS and select the subject of setting. INDEX Operate the button or button, as necessary, and display the page NEXT PAGE BACK PAGE to confirm/change. Tap the button of the item to be changed and find the but- CURRENT CONDITION OPTIONS...
  • Page 48 TEN-KEY: Tap ten-key on the screen and enter the figure. If there are several windows to enter, tap the window to enter the figure by ten-key. Tap and fix the input value. Enter window KEYBOARD: Tap keyboard on the screen and enter characters. If there are several windows to enter, tap the window to enter the figure by keyboard.
  • Page 49 RETURNING TO THE MEASUREMENT SCREEN Tap the button. RETURN The Measurement screen is displayed. 0000100001000 0000100001000 0000100001 0000100001 AutoShoot AutoShoot - 1 . -1 .25 25 - 0 . -0 .25 25 - 0 . -0 .50 50 - 0 . -0 .50 50 1 8 0 1 8 0...
  • Page 50 LIST OF SETUP ITEMS Setup items are categorized into 6 large indexes. "Initial" ........items related to the initial status after power on "Print" ........items related to output from the internal printer "Comm" ........items related to data output with the external device "LAN".........items related to output using the LAN "Operator ID"...
  • Page 51 Descriptions Options Details Initial value 40-44 45-49 50-54 The typical additional power for the age can be selected. 55-59 60-64 65-69 70-74 D (diopter) of corneal refractive power D or mm(KRT)* mm of corneal curvature Corneal curvature radius measurement result on screen is displayed by HV HV or R1R2* R1R2...
  • Page 52 Serial No. is not printed. Serial number Serial No. is printed. "Error" data is not printed. Include error data "Error" data is printed. TOPCON logo is not printed. TOPCON logo TOPCON logo is printed. Message is not printed. Message print Message is printed.
  • Page 53 Description Options Details Initial value DATA Measurement values are printed in terms of REF or KRT. Print Layout DATA Measurement values are printed in terms of Right or Left. VD value (Vertex distance) is not printed. VD value (Vertex distance) is printed. Cylinder sign is not printed.
  • Page 54 Description Options Details Initial value Only REF data are output. Output data format* Only KRT data are output. All data are output. OLD TOPCON format NEW TOPCON format STD1 TOPCON STD1 format Communication Format STD2 TOPCON STD2 format STD4 TOPCON STD4 format...
  • Page 55 XML file is not output. XML File Output XML file is output. Data is not output. Data format STD2 REF/KRT data are output in TOPCON STD2 format STD4 REF/KRT data are output in TOPCON STD4 format Shared Folder (up to 32 characters) User Name...
  • Page 56 If the measurement result is widely different from the value shown on the model eye, call your dealer or TOPCON at the address on back cover. CLEANING THE INSTRUMENT • Dust on measuring window ... Blow off dust with a blower.
  • Page 57 • When not in use, turn off the POWER switch. ORDERING CONSUMABLE ITEMS • When ordering consumable items, tell the product name, product code and quantity to your dealer or TOPCON at the address of back cover. Product name Product code...
  • Page 58 BRIGHTNESS ADJUSTMENT OF CONTROL PANEL • The control panel is optimally adjusted when shipped. • For control panel brightness adjustment, see "INITIAL (INITIAL SETTING)," "Control panel bright- ness" (page 49). PRINTER PAPER JAM • To avoid failure or potential injury, do not open the printer cover while the printer is in operation.
  • Page 59 SUPPLYING THE CHINREST TISSUE • When the chinrest tissue has run out, pull off chinrest tissue pins and place new tissue. Chinrest tissue pins Chinrest tissue MAINTENANCE...
  • Page 60 MAINTENANCE CLEANING THE KERATO RING AND THE COVER Do not clean plastic parts with solvents. Benzine, thinner, ether and gasoline NOTE may cause discoloring and decomposition. If the kerato ring and the cover get soiled, wipe the surface with dry cloth. If the kerato ring and the cover are noticeably stained, wipe the surface with a damp cloth which is moistened in a tepid water solution of neutral detergent.
  • Page 61 TROUBLESHOOTING TROUBLE-SHOOTING OPERATIONS MESSAGE LIST "OVER-SPH" Displayed when spherical power exceeds +22D or -25D. Measurement cannot be performed for out of measuring range. "OVER-CYL" Displayed when cylindrical power exceeds ±10D. Measurement cannot be performed for out of measuring range. "OVER-R" * Displayed when corneal curvature exceeds 5.00-10.00mm.
  • Page 62 If a problem is suspected, use the following check list. If following instructions does not improve the condition, or if your problem is not included in the list, con- tact your dealer or TOPCON at the address on the back cover. CHECK LIST...
  • Page 63 SPECIFICATIONS AND PERFORMANCE SPECIFICATIONS AND PERFORMANCE RM-800 Range of Refractometry Measurement Spherical refractive power: -25 to +22D (0.12D/0.25D steps) Cylindrical refractive power: 0D to 10D (0.12D/0.25D steps) Direction of astigmatic axis: 0° to 180° (1°/5° steps) (where, spherical refractive power + cylindrical refractive power...
  • Page 64 (4) Do not store the instrument where chemicals are stored or gas is generated. 3. Normal life span of the instrument: 8 years from delivery providing regular maintenance is performed [TOPCON data] ENVIRONMENTAL CONDITIONS FOR PACKAGING IN STORAGE (Product in its normal transport and storage container as provided by manufacturer) Temperature: -20°C to 50°C...
  • Page 65 ENVIRONMENTAL CONDITIONS FOR PACKAGING IN TRANSPORTATION (Product in its normal transport and storage container as provided by manufacturer) Temperature: -40°C to 70°C Humidity: 10% to 95% Pressure: 700hPa to 1060hPa ELECTRIC RATING Source voltage: 100-240V AC Frequency: 50-60Hz Power input: 30-70VA SAFETY DESIGNATIONS PER IEC 60601-1 STANDARD •...
  • Page 66 This Product Contains a coin cell. You cannot replace batteries by yourself. When you need to replace and/or dispose batteries, con- tact your dealer or TOPCON listed on the back cover. EU Battery Directive NOTE This symbol is applicable for EU members states only.
  • Page 67 ELECTROMAGNETIC COMPATIBILITY This product conforms to the EMC standard IEC 60601-1-2:2014(Ed.4.0). The expected electromagnetic environment for the whole life cycle is home medical treatment envi- ronment. a) MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS.
  • Page 68 Guidance and manufacturer's declaration - electromagnetic emissions The RM-800/KR-800 is intended for use in the electromagnetic environment specified below. The customer or the user of the RM-800/KR-800 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance The RM-800/KR-800 uses RF energy only for its internal function.
  • Page 69 Guidance and manufacturer's declaration - electromagnetic immunity The RM-800/KR-800 is intended for use in the electromagnetic environment specified below. The customer or the user of the RM-800/KR-800 should assure that it is used in such an environment. IEC 60601-1-2:2014 Immunity test...
  • Page 70 • When connected with an IT network with which a device other than RM-800/KR-800 is connected, the patient, the operator or the third party may suffer unexpected and unacceptable risks. Before using RM-800/KR-800, it is rec- ommended to identify, analyze, evaluate and manage these risks.
  • Page 71 PATIENT'S ENVIRONMENT When the patient or inspector may touch the devices (including the connecting devices) or when the patient or inspector may touch the person that comes into contact with the devices (including the connecting devices), the patient's environment is shown below. In the patient's environment, use the device conforming to IEC60601-1.
  • Page 72 REFERENCE SHAPE OF PLUG Country Voltage/frequency Shape of plug Mexico 110V/50Hz Type C&E Argentina 220V/60Hz Type A Peru 220V/60Hz Type A Venezuela 110V/50Hz Type C&E Type A (Most common) Bolivia & Paraguay 220V/60Hz Type H (Infrequently) Chile 220V/60Hz Type A Colombia 110V/50Hz Type C...
  • Page 73 IPA FONT LICENSE AGREEMENT v1.0 The Licensor provides the Licensed Program (as defined in Article 1 below) under the terms of this license agreement (“Agreement”). Any use, reproduction or distribution of the Licensed Program, or any exercise of rights under this Agreement by a Recipient (as defined in Article 1 below) constitutes the Recipient’s acceptance of this Agreement.
  • Page 75 Marked on the rating nameplate.  Period of use: Please inform us of the date of purchase.  Defective condition: Please provide us with as much detail as possible. AUTO REFRACTOMETER RM-800 AUTO KERATO-REFRACTOMETER KR-800 USER MANUAL Revision 6 Date of issue 2023-2-14 Published by TOPCON CORPORATION 75-1 Hasunuma-cho, Itabashi-ku, Tokyo, 174-8580 Japan.
  • Page 76 AUTO REFRACTOMETER RM-800 AUTO KERATO-REFRACTOMETER KR-800 4184697056...

This manual is also suitable for:

Kr-800