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Topcon SP-1P User Manual
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Topcon SP-1P User Manual

Topcon SP-1P User Manual

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USER MANUAL
SPECULAR MICROSCOPE
SP-1P

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Summary of Contents for Topcon SP-1P

  • Page 1 USER MANUAL SPECULAR MICROSCOPE SP-1P...

  • Page 3: Introduction

    • The manual image alignment function allows the operator to utilize the internal function of the SP-1P to focus on the cornea and obtain the image. The manual image alignment can be utilized in difficult lighting or cases where the subject has a difficult time fixating. See page 60 for details.
  • Page 4 1. No part of this manual may be copied or reprinted, in whole or in part, without prior written permission. 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 original instructions. ©2014 TOPCON CORPORATION ALL RIGHTS RESERVED...

  • Page 5: Table Of Contents

    CONTENTS INTRODUCTION ........................1 DISPLAYS AND SYMBOLS FOR SAFE USE .................6 DISPLAY.........................6 SYMBOL ..........................6 GENERAL SAFETY INFORMATION..................8 HOW TO READ THIS MANUAL ....................11 GENERAL MAINTENANCE INFORMATION ................11 USER MAINTENANCE......................11 CLEANING OF PHOTOGRAPHING WINDOW............11 DISCLAIMERS........................11 POSITIONS OF WARNING AND CAUTION INDICATIONS ..........12 STANDARD ACCESSORIES .....................13 COMPONENTS...
  • Page 6 PRINT-OUT OF PHOTOGRAPHING DATA................52 DATA OUTPUT........................53 OPERATION OF AFTER USE....................53 OPTIONAL OPERATIONS ......................54 FREE STYLE COURSE PHOTOGRAPHY................54 PANORAMA PHOTOGRAPHY .....................56 PHOTOGRAPHING WITHOUT AUTO ANALYSIS..............59 PHOTOGRAPHING IN FIXED FOCUS MODE ..............60 DISPLAYING THE PATIENT ID (PATIENT No.) OR OPERATOR ID ........61 FOR DICOM WORK LIST ....................61 FOR ID INPUT......................61 SPECIFYING THE AREA OF CELL ANALYSIS..............62...
  • Page 7 SUPPLYING THE CHINREST TISSUE................97 MAINTENANCE........................98 CLEANING THE INSTRUMENT...................98 CLEANING THE PHOTOGRAPHING WINDOW GLASS ..........98 CLEANING THE COVER .....................99 CLEANING THE CONTROL PANEL................99 CLEANING THE FOREHEAD REST AND CHIN REST..........99 CLEANING OF EXTERNAL INPUT / OUTPUT DEVICE ..........99 SP-1P SOFTWARE LICENSE TERMS ..................100...

  • Page 8: Displays And Symbols For Safe Use

    DISPLAYS AND SYMBOLS FOR SAFE USE In order to encourage the safe use of the instrument and to avoid danger to the operator and others as well as dam- age to properties, warnings are described in this manual and marked on the instrument body. We suggest you thoroughly understand the meaning of the following displays/icons and Safety Cautions, as well as read the manual, and strictly observe the instructions.
  • Page 9 Symbol Meaning Signification 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 Nombre maximum d’emballages identiques which may be stacked on one another.

  • Page 10: General Safety Information

    GENERAL SAFETY INFORMATION WARNING Ensuring the Safety of Patients and Operators Be careful not to hit the patient's eyes or nose with the instrument during operation. The patient may be injured. Preventing Electric Shocks and Fires To avoid injury caused by electric shock, do not open the cover. Ask your dealer for service. To avoid fire and electric shock, install the instrument in a dry place free of water and other liquids.
  • Page 11 CAUTION Ensuring the Safety of Patients and Operators The following patients should be carefully applied: The patient with a history of epilepsy and the patient who is suspected of epilepsy. If a symptom of photosensitive epilepsy appears in a patient during photography, please stop photography and measurement immediately.
  • Page 12 Precaution: The software-generated values for CV may demonstrate lower readings at the high end of the scale. In addition, for % Hexagonality, may demonstrate lower readings at the low end of the scale. In both cases, this indicates that results associated with stressed corneas may be unreliable. Therefore, these results should be interpreted with caution.

  • Page 13: How To Read This Manual

    For details, See “CLEANING THE PHOTOGRAPHING WINDOW GLASS” on page 98. 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 14: Positions Of Warning And Caution Indications

    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 Meaning...

  • Page 15: Standard Accessories

    STANDARD ACCESSORIES The following are standard accessories. Make sure that all these items are included (quantity). User manual, Instruction manual Power cable (1) Unpacking and Assembling (1 each) Dust cover (1) Printer paper (2) Monitor cleaner (1) Chinrest tissue (1) Chinrest tissue pin (2) Stylus pen (1) Accessory case (1)

  • Page 16: Components

    COMPONENTS COMPONENT NAMES Main body unit Photographing head Control panel Up and down position check seal Power unit The up and down posi- Printer cover open switch tion of the measuring head can be checkd. The central position of the up and down trian- Printer cover gle shows the central position of the up and...

  • Page 17: Operation Method Of Control Panel

    OPERATION METHOD OF CONTROL PANEL The control panel is designed as a touch panel for performing various operations and settings. It displays images and shows information, including set conditions and photographing results. • The control panel is a touch panel. Do not use any sharp tools; e.g. ball NOTE point pen.

  • Page 18: Control Panel Components

    CONTROL PANEL COMPONENTS PATIENT SCREEN (DICOM WORK LIST) Patient ID input change button Operator ID Settings button Patient ID MPPS cancel button Last name First name MPPS finish button Scheduled Date Scroll bar Work list Next button List update button Patient ID input change button.....A patient screen is switched to ID input.

  • Page 19: Dicom Mpps Start Screen

    • The expected query results of wild card collation may not be obtained according to the specification of DICOM SCP (Service Class Provider). Keyboard List update button DICOM MPPS START SCREEN You can input with a software keyboard by tapping “Code Value”, “Code Meaning” or “Code Scheme Designer”...

  • Page 20: Patient Screen (Id Input)

    PATIENT SCREEN (ID INPUT) Operator ID Settings button Patient list button Caps Lock button Data call button Ten key changeover button Next button Query patient button Patient list button........Displays the Patient screen (DICOM work list). This button appears when “Use LAN” of “NETWORK SETTINGS” (P.76) in the setup screen is ON, and when the “Use DICOM”...
  • Page 21 List of query result Returns without setting up Reloads by query condition Sets up selected patient data patient data Data call button ........Calls selected data which is stored in USB flash memory or shared holder. Data call screen Select a USB flash memory Select data destination It is enabled to remove the Plugged USB flash memory...

  • Page 22: How To Input A Patient Id

    HOW TO INPUT A PATIENT ID Tap the on the control panel. Patient ID input change button Patient ID input screen is selected. Tap the input window of patient ID to change the frame color to orange. Input window Enter the Patient ID tapping the Input button Input button If you need to input numeral by ten-key, ten-key input screen appears by tapping the...
  • Page 23 Tap the to return to the capture screen, check that patient ID is updated. Next button COMPONENTS...

  • Page 24: Photography Setting Screen

    PHOTOGRAPHY SETTING SCREEN Photography point setting button CENTER button Panorama button Multi points button Button to select patient's OS(L) button OU(R/L) button OD(R) button CENTER button ......Centering photography is set. Panorama button......Panorama photography that is to photograph 3 points around the center is set.

  • Page 25: Photographing Position (Showing Position Of Fixation Target) Selecting Screen

    PHOTOGRAPHING POSITION (SHOWING POSITION OF FIXATION TARGET) SELECTING SCREEN When Multi point button is selected in photography point, photographing position selecting screen is shown. Photographing position is determined here. Settings button Selecting position display Return button Next button Selecting position display........The position to be photographed is selected. Settings button ........Displays Setup screen.

  • Page 26: Caputer Screen

    CAPUTER SCREEN The image to be observed is displayed operating the instrument to tell the state of setting or the result of photography. UNDER PHOTOGRAPHING Device ID number Display Patient No./Patient ID Operator ID Settings button ID button OD button OS button Photographing position display Photographing position display...

  • Page 27: Photographing Result Screen

    Focus mode button .....Focus mode in auto alignment is switched to AUTO FOCUS and FIXED FOCUS. (Refer to P.60) Photographing skip button ....The present photography is skipped and changes to the next photography point. The following message window is displayed by tapping the photographing skip button.
  • Page 28 Rephotographing button ....Photographing the same position. (Move to the capture screen.) Print/output reservation button ....This is shown only when more than 2 times photographed on the same position. Data contemporarily displayed is set to print/output. Print/output button......Printing/output carried out according to the settings. Overlay button ........Classifies the image to analyze in color according to the number of cell's angle or cell area.

  • Page 29: Manual Editing Screen

    MANUAL EDITING SCREEN Screen for editing the result of automatic cell analysis. Scroll bar Thumb nail display Excluding button Selected area delete button Manual edit button Undo button The display of the number of manual edit cells Return button Zoom out button Zoom in button Overlay button Thumb nail display ..........When the image is enlarged the enlarged area is shown.

  • Page 30: The Checking Screen In The Middle Of Panorama Photography

    THE CHECKING SCREEN IN THE MIDDLE OF PANORAMA PHOTOGRAPHY This screen appears when panorama photography is carried out, where 3 images are combined and photographing result of each position is checked. Center Left side Right side OD button/OS button Photographing point display Photographing result Rephotographing button Next button...

  • Page 31: Result Screen For Panorama Photography

    RESULT SCREEN FOR PANORAMA PHOTOGRAPHY Result screen after photographing 3 images in Panorama photography. Button layout is same as that of normal photography result screen. SETUP SCREEN COMPONENTS...

  • Page 32: List Of Printing Items Screen

    LIST OF PRINTING ITEMS SCREEN When more than 2 positions is photographed list of printing items is shown during print/output is car- ried. After print/output is complete, the screen returns to patient screen automatically waiting next patient. If the reliability is low, the character is displayed in yellow. COMPONENTS...

  • Page 33: Printer Output

    Average cell area TOKO HOSPITAL Standard deviation of cell area TOPCON logo mark Input message • Even if Patient ID is selected in the “Patient ID” of “INTERNAL PRINTER”, “Patient No.” is printed when Patient ID is not entered. (Patient No: starts from 0001, automatically added +1 upon com- pletion of photographing).
  • Page 34 Maximum cell area Average cell area Standard deviation of cell area Corneal endothelium image TOPCON logo mark TOPCON Input message TOKO HOSPITAL • When a patient name has been inputted, the name is printed at the name entry column automati- cally.

  • Page 35: Installation

    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 well as damage to the instrument.

  • Page 36: Connecting External I/O Terminals

    Connect the power cable to the Power inlet. Insert the power cable plug into the commercial power (the 3-pin AC grounding receptacle.) 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 IEC 62368-1.

  • Page 37: Imagenet

    • Do not insert or remove the LAN cable while the power of the instrument is • Sometimes the connection is not done properly because of the character- istics of the hardware. Use the LAN cable specified by TOPCON. DATA INPUT •...

  • Page 38: External Printer

    If any printing paper other than specified is used, the printer might break, NOTE which could cause the product to be unusable. • If you insert the printer paper backwards, printing will not start. • For printing paper, use the following paper specified by TOPCON. Item Name Item Code Printing Paper 448004001 Product No.: TP-50K-J-R (manufactured by Nippon Paper Industries Co., Ltd.)
  • Page 39 Press the switch to open the printer cover. Printer cover open Printer cover Printer cover open switch 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.
  • Page 40 Bring the paper into the center, then close the printer cover. • If the printer cover is closed when the power is ON, the paper cut opera- NOTE tion is carried out automatically. • In case the printer cover is not firmly closed, printing will not start. PREPARATIONS...

  • Page 41: Region Selection Of The Initial Startup

    REGION SELECTION OF THE INITIAL STARTUP Please select a region in the initial startup of this instrument. • This operation is done only at initial startup. • An area besides America, China, Europe and Japan, please choose the NOTE “General”. •...

  • Page 42: Recovery From Power Save Status

    RECOVERY FROM POWER SAVE STATUS This instrument adopts the power save system for saving electric power. When the machine is not operated for a set time, the control panel becomes a screensaver. Tap the control panel or operate the control lever. In a few seconds, the measurement screen is displayed and photography is enabled.

  • Page 43: Basic Operations

    BASIC OPERATIONS OPERATION FLOW CHART Two different operation flows are available sequence course and free style course. Before ship- ment, default setting is sequence course. • Sequence course ....Setting Patient ID, photography point and patient's eye is required before photographing. (In current chapter) •...

  • Page 44: Preparation Before Photographing (Sequence Course)

    PREPARATION BEFORE PHOTOGRAPHING (SEQUENCE COURSE) • Do not put the patient's chin on the chinrest until the power is on. • If room temperature becomes low at 10°C or less in the winter, after turned NOTE the power switch on, warming up is necessary before use. Image quality may be influenced for low temperature.

  • Page 45: Select Photography Point And Patient's Eye

    SELECT PHOTOGRAPHY POINT AND PATIENT'S EYE Tap the photography point setting button. Photography point setting button Button to select patient's eye CENTER button ..Centering photography is carried out. Panorama button..Panorama photography that is to photograph 3 points around the center is set.

  • Page 46: Preparation Of Patient

    PREPARATION OF PATIENT • 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 CAUTION catch the patient's finger.
  • Page 47 Place the patient's chin on the chinrest and check that his/her forehead is touching to the fore- head rest. Press the to adjust the chinrest height until the eye height mark of the UP/DOWN button chinrest reaches the same height as the patient's eye. At this moment, confirm that the height mark of the photographing window is at the height of the patient's visual line.

  • Page 48: Photography And Analysis Result Display

    PHOTOGRAPHY AND ANALYSIS RESULT DISPLAY • Photographing may not be possible, in case the eyelid and the eyelashes cover the pupil. If this occurs, the operator should tell the patient to open their eyes as wide as possible, or lift the eyelid to allow for measurement. •...
  • Page 49 • When the photographing head has reached the limit of movement (verti- cal/lateral directions), a yellow-colored limit mark appears on the control panel’s top, showing it is the movement limit in that direction. Tap the dis- play, move the photographing head to the position where aligning is possi- ble.
  • Page 50 Results of Photography and analysis. Hexagon scale Anterior image (The size of the cell corre- Corneal endothelium image Analyzing image sponding to the CD value) (basis image) Date of photographing OD button/OS button Photographing position display Photographing position tab Pleomorphic histogram Print/Output reservation mark Corneal thickness...
  • Page 51 classified in color according to number of angle of cell”. If calculating cell area, it is calculated including the cell.) Under “Panorama photography” is set, the procedure is follows; “photographing” - “check the photographing result” - “photographing” - “check the photographing result”, then repeat same procedure.

  • Page 52: In Manual Alignment

    IN MANUAL ALIGNMENT To keep pressing on the screen, the instrument moves to the direc- tion from center of screen to the pressed point. It is possible to change the direction by dragging on the screen, too. The instrument does not move even if you press around cen- ter of screen without the bar.
  • Page 53 Patient ID TOPCON_TAROU NOTE Under Back/forth movement mode, it is possible to move like the arrow of the screen. Patient ID TOPCON_TAROU BASIC OPERATIONS...

  • Page 54: Print-Out Of Photographing Data

    PRINT-OUT OF PHOTOGRAPHING DATA • To avoid a paper jam in the printer, do not feed the paper if it is partly cut or wrinkled. • To avoid discoloring of the printer paper (particularly the recording area) during storage, use a polypropylene bag and not one containing plasti- NOTE cizer (PVC, etc.).

  • Page 55: Data Output

    • 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” on page 36. 58mm wide printer paper is NOTE recommended.

  • Page 56: Optional Operations

    OPTIONAL OPERATIONS FREE STYLE COURSE PHOTOGRAPHY In the free style course, it is possible to capture an eye as soon as the power turns on; selecting the patient's ID, photography point or patient's eye is not required. • To change to free style course form the sequence course the setup screen is used.
  • Page 57 Start Preparation of patient (Refer to P.44 “PREPARATION OF PATIENT”) Carry out Photographing. (Refer to P.46 “ALIGNMENT AND PHOTOGRAPHY”) Results of Photography and analysis are displayed. If photographing of the required position is complete, select the result for printing position. Photographing position tab Print/Output reservation mark...

  • Page 58: Panorama Photography

    PANORAMA PHOTOGRAPHY Photograph 3 points-center, ear side and nose side. Those images are combined automatically and observation of large area can be performed. • In the case of sequence course, preparation and photography are carried out as the follow- ing procedure. •...
  • Page 59 Check the result of photography. If photography is required again, tap the Rephotographing button. Left side Center Right side OD button/OS button Photographing point display Result of photography Rephotographing button Next button Tap the to photograph next position. Next button The capture screen is shown.
  • Page 60 Drag your finger up or down on the image of result of photographing. Display of image transmissivity Rephotographing button The desired transmissivity can be applied to the centered image. Check the combined area of the image overlaps correctly by changing transmissivity of center image.

  • Page 61: Photographing Without Auto Analysis

    Tap the , “Do you want analyzed using the combined image?” is displayed. Analyze button If tapping “Combined image”, the analyzing image is displayed in combined image. • The analyzing of using combined image is available after photographing 2 points. •...

  • Page 62: Photographing In Fixed Focus Mode

    PHOTOGRAPHING IN FIXED FOCUS MODE Under FIXED FOCUS mode, photographing is forcibly performed in fixed distance from a corneal surface, even if auto alignment cannot be performed for reasons for weak reflected light on the cor- neal back surface etc. Tap the in the bottom left corner of screen.

  • Page 63: Displaying The Patient Id (Patient No.) Or Operator Id

    After the focus setting, by touching the pupil which you can see outside of the graphic chart, align to the focus position that has been set up and perform photography. In fixed focus mode photography corneal thickness measurement is not performed, so that CCT value is displayed as N/A.

  • Page 64: Specifying The Area Of Cell Analysis

    SPECIFYING THE AREA OF CELL ANALYSIS It is possible to analyze by specifying the part of the area in the photographed image. This function is only available for single eye photographing. It cannot be NOTE used for panorama photography. On endothelium image display (basis image), drag your finger to draw a rectangle in the area you want to select.

  • Page 65: Cell Analysis In Editing Mode

    CELL ANALYSIS IN EDITING MODE Use of a stylus pen is recommended to edit. Make sure that Photographing result screen is displayed. Various data Icon Tap the manual editing button Manual editing screen is displayed. Scroll bar Thumb nail display Excluding button Selected area delete button...
  • Page 66 Selected area delete button ....You can delete the cell within selected area and the dot of manual editing by dragging corneal endothelium image. Manual edit button........Specifies a cell which you need to analyze manually by tap- ping the center of the cell. Undo button ..........You can undo one operation of “Exclude”, “Selected area delete”, and “manual edit”.
  • Page 67 Zoom in button/Zoom out button ..Enlargement and reduction of image are done. Analyze button Manual edit check button Overlay button........Classifies the image to analyze in color according to the number of cell's angle or cell area. Return button........Return to Analysis result screen. (The changes are dis- carded.) Tap the to display a corneal endothelium image of manual analyzing...

  • Page 68: Output To Imagenet System

    OUTPUT TO IMAGEnet SYSTEM • Set LAN output to ON. Check the connection of IMAGEnet system. For connection, refer to “CONNECTING EXTERNAL I/O TERMINALS” on page 34. Photographing is performed at all position. Tap the on the screen to display the List of printing items Print/Output button screen.

  • Page 69: Input Using Usb

    INPUT USING USB This instrument can input ID numbers from a bar code reader, etc. via the USB. Check the connection of USB IN. For connection, refer to “CONNECTING EXTERNAL I/O TERMINALS” on page 34. Input ID numbers from the external device. The inputted ID numbers are displayed on the screen.

  • Page 70: Setting Functions On Setup Screen

    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 cable is connected. For connection, refer to “CONNECTING POWER CABLE” on page 33. Turn ON the switch.

  • Page 71: Outline Of Setup Screen Operations

    OUTLINE OF SETUP SCREEN OPERATIONS and select the subject of setting. INDEX Initial Capture mode Settings Internal Free style start Printer screen External Buzzer Printer Network Stand by mode Settings Operator Patient ID reset Settings DICOM Settings Exit Operate the button or button, as necessary, and display the page NEXT PAGE...

  • Page 72: Pull-Down Menu

    PULL-DOWN MENU: Tap the options button to show a pull-down menu. Select a figure and value etc. to be changed in menu items. Initial Show device ID Settings number Internal Device ID number Printer External Pupil distance 64(mm) Printer Pull-down menu Network Auto power save Settings...

  • Page 73: Returning To The Measurement Screen

    NOTE The set value is updated when an options button is tapped. RETURNING TO THE MEASUREMENT SCREEN Tap the button. Exit Operator Patient ID reset Settings DICOM Settings Exit The capture screen is displayed. Patient ID TOPCON_TAROU SETTING FUNCTIONS ON SETUP SCREEN...

  • Page 74: List Of Setup Items

    LIST OF SETUP ITEMS Setup items are categorized into 6 large indexes. “Initial Settings”......items related to the initial status after power on “Internal Printer” ......items related to output from the internal print “External Printer” .......items related to output from the external print “Network Settings”.....items related to output using the LAN “Operator Settings”....items related to Operator ID INITIAL SETTINGS...
  • Page 75 Patient ID is not required.  SP-1P data is exported to USB flash memory. Export SP-1P Data(USB) SP-1P data is not exported to USB flash memory.  60(%) 70(%) If the capacity of a USB memory is over the preset value,...

  • Page 76: Internal Printer

    Endothelium image is not printed. Message is printed. Print message Message is not printed.  Message Input String of up to 72 characters. None TOPCON logo is printed.  TOPCON logo TOPCON logo is not printed. SETTING FUNCTIONS ON SETUP SCREEN...

  • Page 77: External Printer

    EXTERNAL PRINTER Print contains settings related to output from the external printer. Initial None Printer Settings Internal Paper size Printer External Layout Landscape Printer Network Photo plus Print templates Settings report Preview of the Operator Header Settings set up details DICOM Settings Exit...

  • Page 78: Network Settings

    Report image format Report image is output in JPG. SP-1P data is output to shared folder. Export SP-1P Data SP-1P data is not output to shared folder.  DCM file is output to shared folder. Export DCM file DCM file is not output to shared folder.

  • Page 79: Operator Settings

    OPERATOR SETTINGS OPERATOR contains settings related to Operator ID. Initial value (Region) Descriptions Options Details Operator ID will be displayed on the control panel and output. Use of operator ID Operator ID will not be displayed  on the control panel and output. ASCIIZ string up to Prefix of Ope.
  • Page 80 DCM file of completed storage is not stored. 0-65535 Port number of using to transmission between SP-1P port 64001 Set by ten-key display. SP-1P and DICOM server. Character string AE (Application Entity) name of DICOM transmission. SP-1P AE Title TP_AM_SP1P_001 Set by keyboard display...

  • Page 81: Troubleshooting

    Packing mode was finished. Please Indicates the packing operation is completed. Switch off the machine. turn off the SP-1P. Cannot get the disk space information! It was not possible to check the capacity of the USB storage. Please check USB storage is correctly inserted.
  • Page 82 This data has been analyzed by the Display for confirmation of when you call the data of previous version. older version. Do you want to reana- lyze by the current version? Do you want to analyze by using the Display for review when the analysis is performed by combining the combined image? images taken by the central panoramic.
  • Page 83 Shared folder cannot access. Displayed when access to the shared folder could not be in the data out- put, set the shared folder, are connected, please check the connected Capture mode setting has been Displayed for confirmation when the setting screen with remained data changed.

  • Page 84: Trouble-Shooting Operations

    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 85: Specifications And Performance

    SPECIFICATIONS AND PERFORMANCE Item Specifications Corneal endothelium photography Photography magnification 254x (on the control panel: within ±8%) Photography range 0.25x0.55mm (within ±8%) Resolving power More than 125 line/mm Fixation target Central and peripheral Corneal thickness measurement Measurement range 0.400-0.750mm Display unit: 0.001mm step display Allowance: Less than 0.600mm within ±0.010mm Over 0.600mm within ±0.025mm •...

  • Page 86: General Information On Usage And Maintenance

    • To keep the eye open. • To understand and follow instructions when undergoing an examination. INTENDED USER PROFILE Since the SPECULAR MICROSCOPE SP-1P is a medical device, the operation should be supervised by a physician. ENVIRONMENTAL CONDITIONS OF USE Temperature : 10°C to 40°C...

  • Page 87: Environmental Conditions For Packaging In Transportation

    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...

  • Page 88: Operation Principle

    OPERATION PRINCIPLE Photography of the corneal endothelium: Slit light is projected from oblique direction to a patient's eye, and corneal endothelial cells are photo- graphed with the CCD camera optically installed in a diagonal. Image processing of the photographed corneal endothelial cells is carried out, the boundary of a cell is detected, and the area (Cell density (CD), Minimum cell area (MIN), Maximum cell area (MAX), Average cell area (AVG), Standard devia- tion of cell area (SD), Coefficient of variation (CV) and cell area histogram) and the form (Frequency of hexagon cells (HEX) and form histogram (angle of cell)) are computed.

  • Page 89: Checkpoints For Maintenance

    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. NOTE EU Battery Directive This symbol is applicable for EU members states only.

  • Page 90: Electromagnetic Compatibility

    Guidance and manufacturer's declaration - electromagnetic emissions The SP-1P is intended for use in the electromagnetic environment specified below. The customer or the user of the SP-1P should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance The SP-1P uses RF energy only for its internal function.
  • Page 91 Guidance and manufacturer's declaration - electromagnetic immunity The SP-1P is intended for use in the electromagnetic environment specified below. The customer or the user of the SP-1P should assure that it is used in such an environment. Compliance Electromagnetic environment -...
  • Page 92 Guidance and manufacturer's declaration - electromagnetic immunity The SP-1P is intended for use in the electromagnetic environment specified below. The customer or the user of the SP-1P should assure that it is used in such an environment. Immunity test Test level...

  • Page 93: Requirements For The External Device

    • When connected with an IT network with which a device other than SP-1P is connected, the patient, the operator or the third party may suffer unexpected and unacceptable risks. Before using SP-1P, it is rec- ommended to identify, analyze, evaluate and manage these risks.

  • Page 94: Patient's Environment

    PATIENT'S ENVIRONMENT When the patient or inspector comes into contact with the devices (including the connecting devices) or when the patient or inspector is in contact with the person that touches the devices (including the connecting devices), the patient's environment is shown below. In the patient's environment, use devices conforming to IEC 60601-1.

  • Page 95: Reference

    REFERENCE TYPE OF PLUG Country Voltage/frequency Type 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 96: Maintenance

    NOTE measuring head to their initial positions. 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 Product name...

  • Page 97: User Maintenance Item

    USER MAINTENANCE ITEM Item Inspection time Contents • The instrument works properly. Inspection Before using • The photographing window must be free of stain or flaw. • Photographing window Cleaning When the part is stained • External cover, control panel, etc. Replacement As required •...

  • Page 98: Printer Paper Jam

    PRINTER PAPER JAM • To avoid failure or potential injury, do not open the printer cover while the printer is in operation. • To avoid potential injury in case of malfunction, including a paper CAUTION jam, be sure to shut off the power before attempting to repair it. •...

  • Page 99: Supplying The Chinrest Tissue

    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 100: Maintenance

    MAINTENANCE To avoid electric shocks, make sure the power is off and the power CAUTION cable is unplugged before maintenance. • To avoid damage to the instrument or electric shock, turn the power switch OFF and unplug the power cord before maintenance. •...

  • Page 101: Cleaning The Cover

    • Replace new applicator and repeat cleaning. It is complete when stains can be wiped off finely. If the stains are still hard to remove, contact your dealer or the TOPCON sales department. CLEANING THE COVER Do not clean plastic parts with solvents. Benzine, thinner, ether and gasoline NOTE may cause discoloring and decomposition.

  • Page 102: Sp-1P Software License Terms

    Digia Plc and its licenser posses the copyright and the intellectual property right of the “Qt” soft- ware installed in SP-1P. TOPCON CORPORATION grants to you the right to use this SP-1P Software under the terms and condi- tions outlined below.

  • Page 103: Limited Warranty

    LICENSE TERMS. 7. LIMITED WARRANTY 7.1 In the event that a hidden material defect is found by USER, USER shall notify TOPCON in writing of such defect directly or through its subsidiary, affiliate, distributor or agent within ninety (90) days after USER has received the SOFTWARE.
  • Page 104 THE ENTIRE RISK ARISING OUT OF, RESULTING FROM OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THE SOFTWARE REMAINS WITH THE USER. IN NO EVENT SHALL TOPCON OR ITS SUBSIDIARIES, AFFILIATES, DISTRIBUTORS OR AGENTS BE LIABLE FOR ANY CONSEQUENTIAL, INCIDENTAL, DIRECT, INDIRECT, SPECIAL, PUNITIVE, OR OTHER...

  • Page 105: Governing Law

    TERMS shall be governed by and under the laws of Japan. 11. ENTIRE AGREEMENT These LICENSE TERMS constitute the entire agreement between USER and TOPCON with respect to the subject matter hereof, and shall supersede and cancel any and all prior written or oral agreements, undertakings, negotiations, communications, commitments, representations, publications and adver- tisement, etc.
  • Page 107 ● Period of use: Please inform us of the date of purchase. ● Defective condition: Please provide us with as much detail as possible. SPECULAR MICROSCOPE SP-1P USER MANUAL Revision 12 Date of issue 2023-11-1 Published by TOPCON CORPORATION 75-1 Hasunuma-cho, Itabashi-ku, Tokyo, 174-8580 Japan.
  • Page 108 SPECULAR MICROSCOPE SP-1P Parts management code Printed in Japan 2311-100LW...