EM-3000 Instruction Manual

i Important Safety Information

„ Do not install this instrument in a location where explosives or inflammable substances are used or stored. Otherwise, fires or explosion may occur.

„ Do not remove the cover of the instrument. Otherwise, you may be directly exposed to high voltage sections.

„ Do not disassemble or modify the instrument. Otherwise, you may be directly exposed to high voltage sections.

„ Do not look straight at any alignment laser light emitted from the measuring section.

„ Disconnect the power cord from the instrument before servicing the instrument. Otherwise, you may get an electric shock.

„ Do not place water or chemicals on the instrument. Any water or chemicals entering the instrument may cause an electric shock or failure.

„ Only use the specified terminal for connection of the instrument. Using another type of terminal may result in failure of the instrument.

„ This instrument is a diagnostic/measuring device specially designed for ophthalmology. Never use the instrument for other purposes.

„ The external output terminal is not isolated from the internal circuit. Inappropriate wiring may damage the internal circuit. If you wish to connect this instrument to other devices, contact our local distributor or the Tomey Corporation.

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„ Never damage or cause caution labels provided for the instrument to become illegible. A caution label is provided on the back side of the instrument.

„ If a label is damaged or becomes illegible, please contact Tomey Corporation or our local distributor.

Caution label

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ii How to Read This Manual

Outline This manual is structured as follows. 1. PRIOR TO USE Describes safety precautions and important information to be understood before installing and using the instrument. 2 . N A M E S A N D F U N C T I O N S O F PA R T S A N D COMPONENTS Describes names and functions of each section of the instrument. 3. PERATION PROCEDURES Describes information required for installing and using the instrument. 4. TECHNICAL INFORMATION Describes useful technical information about the instrument. 5. INSPECTION AND MAINTENANCE Describes procedures for replacing consumable parts, etc. that the user of the instrument should normally conduct. 6. TROUBLESHOOTING Describes how to solve problems. 7. CONSUMABLES AND OPTIONAL EQUIPMENT Describes consumable parts and optional equipment. 8. SPECIFICATIONS Describes the specifications of the instrument. 9. INDEX Refer to the index when needed.

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SYMBOLS USED IN THIS MANUAL The symbols below indicate the following:

„ This is a precaution that, if unheeded, will result in a hazardous situation where there is an imminent danger of serious injury or death.

„ This is a precaution that, if unheeded, could result in a hazardous situation where there is a possibility of serious injury or death.

„ This is a precaution that, if unheeded, may result in a situation where there is a possibility of minor or moderate injury or damage to property.

„ This is an additional instruction which may contain a special precaution on company policy related, either directly or indirectly, to the safety of personnel or to the protection of property.

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iii Contents i Important Safety Information ...i-1 ii How to Read This Manual... ii-1 Outline ii-1 SYMBOLS USED IN THIS MANUAL ii-2 iii Contents ... iii-1 1. PRIOR TO USE ...1-1 1.1 Precautions for operation ...1-1 1.2 Checking contents of package ...1-5 1.3 Glossary ...1-6 1.4 Outline of operation ...1-8 2. NAMES AND FUNCTIONS OF PARTS AND COMPONENTS ...2-1 2.1 Physician's side ...2-1 2.2 Patient's side ...2-4 2.3 Screen ...2-5 2.4 Operation of the joystick ...2-13 2.5 Touch Alignment ...2-14 3. OPERATION PROCEDURES...3-1 3.1 Installation ...3-1 3.1.1 Precautions for installing the instrument ...3-1 3.1.2 Precautions for connecting the power cord ...3-2 3.2 Preparation before use ...3-3 3.2.1 Connecting the power cord ...3-3 3.2.2 Connecting an external digital printer ...3-3 3.2.3 Connecting external ID input device...3-4 3.2.4 Connecting TOMEY Link/DATA Transfer ...3-4 3.2.5 Starting ...3-5 3.2.6 Setting ...3-5 3.3 Capturing Images ...3-6 3.3.1 Precautions ...3-6 3.3.2 Entering patient information ...3-6 3.3.3 Patient's eye height adjustment ...3-9 3.3.4 Changing sight-fixing lamp position...3-10 3.3.5 Alignment ... 3-11 3.3.6 Capturing endothelial images ...3-13 3.3.7 Captured Image Selection ...3-16 3.3.8 Analysis result screen ...3-18 3.3.9 Editing the extracted edges ...3-22 3.4 Recalling data in the memory ...3-24

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3.5 Data communication ...3-25 3.5.1 Querying for patient information ...3-25 3.5.2 Sending examination data ...3-26 3.6 Setting ...3-28 3.6.1 Common ...3-29 3.6.2 Function...3-30 3.6.3 Printer ...3-31 3.6.4 Export ...3-32 3.6.5 LAN ...3-34 3.6.6 Information ...3-35 4. TECHNICAL INFORMATION ...4-1 5. INSPECTION AND MAINTENANCE ...5-1 5.1 Warranty ...5-1 5.2 Durable years ...5-2 5.3 Inspection ...5-2 5.4 Routine maintenance ...5-3 5.4.1 Forehead pad/Chin rest...5-3 5.4.2 Outer surface...5-3 5.5 Replacing consumables ...5-4 5.5.1 Fuses...5-4 5.5.2 Chin rest paper ...5-4 5.6 Storing ...5-5 5.7 Disposal ...5-6 6. TROUBLESHOOTING ...6-1 7. Consumables ...7-1 8. SPECIFICATIONS ...8-1 8.1 Specifications ...8-1 8.1.1 Capturing scope ...8-1 8.1.2 Corneal thickness measurement accuracy ...8-1 8.1.3 Main unit ...8-1 8.1.4 Power source ...8-1 8.2 Noise ...8-2 8.3 Operating environment ...8-2 8.4 Conforming standards ...8-2 8.5 Declaration of conformity with EMC ...8-3 9. INDEX ...9-1

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1. PRIOR TO USE „ Read this manual thoroughly before using the instrument to ensure proper and safe operation. „ Always follow the operation procedures described in this manual. „ Check that there is no device that generates strong magnetic fields near the instrument. Strong magnetic fields may cause noise and affect the measurement.

1.1 Precautions for operation „ Only allow adequately skilled operators to use the instrument. „ Precautions for installing the instrument ­ Install the instrument in a location free of water or chemicals. Any water or chemicals entering the instrument may cause an electric shock or failure. ­ Do not install the instrument in a place where chemicals are stored or gases may occur. Spilt chemicals or vapor may enter the instrument and ignite. ­ Check the frequency, voltage, and allowable current (or power consumption) of the power source. Operating the instrument connected to an inappropriate power source may cause fire or an electric shock. ­ Connect the power plug to a grounded 3P-outlet. Otherwise, a short circuit due to failure of the instrument may result in an electric shock. ­ Do not place any heavy object on the power cord or squash the power cord. Connecting such a device may cause fire or an electric shock. ­ Completely insert the power plug into the outlet. Faulty contact, allowing any metal to contact exposed plug terminals, or dust accumulated on exposed plug terminals may result in fire or an electric shock. ­ Do not connect any device with data transmission specifications that are not compatible with the instrument. Connecting such a device may cause a fire or an electric shock. If you wish to connect this instrument to other devices, contact our local distributor or the Tomey Corporation. ­ Ground the instrument appropriately. Otherwise you may get an electric shock.

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­ Do not hold the head unit, chin rest, forehead pad, or joystick when lifting the instrument. These components are detachable and the instrument may drop, resulting in injuries. ­ Install the instrument in a location not subject to direct sunlight, high temperature and humidity, or air with significant dust, salt, and/or sulfur content. These may cause failure or malfunction of the instrument. ­ Install the instrument in a level and stable location free of vibration and mechanical impacts to ensure correct capturing, and prevent the instrument from falling or being dropped, which can result in fire or fatal accidents. ­ Install the instrument between the patient and physician so that they can face with each other. ­ Install the instrument in a location that it is sufficiently clear of any other equipment that may interfere with the examination when using the instrument.

„ Precautions before using the instrument ­ Check that all cables are connected correctly and completely. ­ 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. ­ Check that the instrument is correctly grounded. ­ Check that the date set in the instrument conforms to the actual operation date and time. ­ When the room temperature lowers to 10°C or below in winter, turn the instrument on and warm it up before starting operation. Low temperature may affect the image quality.

„ Precautions during operation ­ Do not place any container with liquid in it on the instrument. Any liquid entering the instrument may cause an electric shock or failure. ­ Do not operate the joy stick, touch panel, and membrane switch during initial operation until the capture screen appears after turning the power switch on. If the initial operation is not complete properly, malfunction may occur during capturing. ­ If any smoke, offensive odor, or abnormal sound occurs, turn off the instrument immediately, disconnect the power plug from the outlet, and contact our local distributor or Tomey Corporation. ­ When moving the head unit and/or chin rest of the instrument, pay attention to the position of the patient's face, hands, and fingers. The patient may be injured by the moving section of the instrument.

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­ Do not allow any person to place their hands or fingers in the clearance under the head unit or the section under the chin rest. Their hands or fingers may be crushed and injured. ­ Do not place any finger or object through the capturing window. These may cause malfunction or failure of the instrument and/or an inaccurate analysis result. ­ Do not lean on the instrument or press on the instrument from the top. The instrument may fall, resulting in mechanical failure or injuries. ­ Complete the capturing within the prescribed time and number of repetitions. ­ Observe both the instrument and patient to ensure there are no problems. ­ If a problem with the instrument or the patient occurs, take appropriate action such as stopping the machine to ensure the safety of the patient. ­ Halt the operation immediately if the patient shows any sign of photosensitive epilepsy while capturing images. ­ Poor fixation, blepharoptosis, trichiasis, or corneal disease may cause inaccurate analysis results or corneal thickness measurements. ­ If the captured image is not clear, analyze another image or capture a new image. ­ When using the photographing and analysis results by this instrument for diagnosis, also conduct other examinations and carefully consider the results of those examinations to make final judgment. Capturing conditions may affect the precision of captured images or analysis results. ­ Do not allow the patient to touch the instrument. ­ Peel off the top sheet of chin rest paper and clean the forehead pad with a cloth dampened with alcohol before the next patient.

„ Precautions after operation ­ Do not place any container with liquid in it on the instrument. Any liquid entering the instrument may cause an electric shock or failure. ­ Do not use organic solvents such as thinner, benzene, or acetone to clean the instrument. This may cause fire or an electric shock. (These can also corrode the resin or coating of the instrument cover.) ­ Hold the plug when disconnecting the power plug from the outlet to avoid applying excessive force on the cord. Pulling the cord may damage inner core wires, resulting in electric shock or fire. ­ Disconnect the power plug when the instrument is not operated for a long period of time. ­ Refer to "5.6 Storing" for instructions on storing the instrument.

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­ Clean the instrument appropriately at the end of operation to get ready for the next operation. ­ Clean and neatly arrange the accessories and cables. ­ If any smoke, offensive odor, or abnormal sound occurs, turn off the instrument immediately, disconnect the power plug from the outlet, and contact our local distributor or Tomey Corporation.

„ If any instrument failure occurs, stop operation immediately, indicate the failure, and contact our local distributor to request repair. ­ Never modify the instrument. Doing so may cause electric shock or failure of the instrument. The instrument contains high-voltage sections. Touching these sections will result in death or serious injuries. ­ Disconnect the power plug from the outlet when replacing fuses. Otherwise you may get an electric shock, 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 other equipment. ­ When any instrument failure occurs, indicate the failure, and contact our local distributor to request inspection and repair. Do not attempt to repair the instrument yourself. ­ Conduct regular inspections of the instrument and components. ­ When the instrument is not used for 1 month or longer, refer to "5.3 Inspection" in this manual and check that the instrument is operating correctly and safely before starting operation.

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1.2 Checking contents of package Open the package and check that the specified amount of the following items are included in the package and are not damaged. If any item is missing or damaged, contact our local distributor as soon as possible.

„ Keep the box and packing materials for use when moving or transporting the instrument. „ When taking the instrument out of the box, pull the outer box upward and then remove the packing materials. Be careful not to lift the instrument by directly holding the head unit, chin rest, forehead pad, or joystick. Otherwise, the instrument could be damaged.

● Main unit ● Power code... 1 ● Fuse... 4 (2 fuses are installed in the main unit.)) ● Chin rest paper ... 1 ● Chin rest paper pins ... 2 ● Dust cover ... 1 ● INSTRUCTION MANUAL ... 1 ● DATA Transfer Installation CD ... 1 ● DATA Transfer Start Guide ... 1

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1.3 Glossary [AVG]

: Indicates the average dimension of the analyzed endothelial cells.

[CD]

: Indicates the density of the analyzed endothelial cells as the number of cells per 1 mm.

[CV]

: Indicates the coefficient of variation of the analyzed endothelial cells, derived by dividing standard deviation by the average dimension.

[DATA Transfer]

: System to output the examination data from Tomey products to digital files

[Max]

: Indicates the dimension of the largest analyzed endothelial cell.

[Min]

: Indicates the dimension of the smallest analyzed endothelial cell.

[Number]

: Indicates the number of analyzed endothelial cells.

[Polymegathism]

: Represents the difference in sizes and shows the distribution of endothelial cell dimensions in a histogram.

[Plemorphism]

: Represents plemorphism and shows the distribution of endothelial shapes in a histogram.

[Quick mode]

: Stores captured images of a right eye and left eye in the memory, and allows you to display, print, and/or send the image data of both eyes.

[SD]

: Indicates the standard deviation of the analyzed endothelial cell dimensions.

[Standard mode]

: Temporarily stores captured images of ten eyes (regardless of right or left eye) in the memory.

[TOMEY Link]

: Digital medical record system to control the data inspected with Tomey products

[Auto Mode]

: Mode to automatically conduct alignment and capturing

[Auto Alignment]

: Function to automatically align the sight in up/down/right/left focus directions

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[Auto Power Off]

: Function to automatically turn the LCD off, with only the power lamp flashing, when the instrument is not operated for the specified time (Auto Power Off mode). Touch any button to return to Normal mode.

[Touch Alignment]

: Allows you to move the head unit by touching the screen. This is used for rough alignment.

[Touch Panel]

: Allows you to make various settings and execute the touch alignment function by directly touching the screen.

[Manual Mode]

: Mode to manually conduct alignment, switching to an enlarged screen, and image importing

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1.4 Outline of operation The EM-3000 is a Corneal Endothelium Analyzer, which captures images of the corneal endothelial cells of a patient's eye, automatically analyzes captured images, and calculates the cell density. It is also equipped with a corneal thickness measurement function. The patient places her chin on the chin rest and looks into the sight-fixing lamp in the capturing window. After the physician observes the patient's eye on the monitor screen and roughly aligns the capturing position, fine alignment and capturing are automatically conducted. When the endothelial cells cannot be captured automatically, align the capturing position with the joystick and press the joystick button to start capturing. Once the capturing process begins, a green LED will shine on the patient's eye and a corneal endothelial image will be captured. By pushing the ANALYSIS switch after the image has been captured, various parameters for cell dimensions and cell shapes will be automatically calculated.

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2. NAMES AND FUNCTIONS OF PARTS AND COMPONENTS 2.1 Physician's side (1)

(2)

(7)

(13) (12) (17) (15) (8) (9) (10)

(4)

(11) (14)

(16)

(21)

(3) (6) (5)

(18) (19)

(20)

(1) Head unit Section that conducts image capture. (2) Monitor / touch panel Displays the capturing screen and various setting screens. Touch the touch panel buttons shown on the monitor to make various settings and operate the instrument. (3) Joystick Tilting the joystick to the right, left, back, and forth moves the head unit to the right, left, forward, and backward for fine positioning. (4) Joystick button Starts capturing images.

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(5) Up/down ring Moves the head unit up and down. Moving the ring up and down moves the head unit for rough positioning. Turning the ring moves the head for fine positioning. (6) Hand rest Place your hand on the rest to operate the joystick. Sliding the rest forward, backward, to the right, and left moves the head unit in the corresponding direction for rough positioning. (7) Eye level mark Reference mark when aligning the height of the patient's eye (8) Membrane switch Used to make various settings and operations. (9) "CLEAR" switch Deletes all the examination data. (10) "MODE" switch Switches the alignment mode between automatic and manual. (11) "PRINT" switch Prints the captured result on a connected external printer. (12) "SIZE" switch Used to select a cell size before performing automatic analysis. (13) "ANALYSIS" switch Analyzes the captured endothelial image automatically. (14) "TOMEY" Link switch Connects to the external devices to send data. (15) "PACKING" switch Pressing this button for 3 seconds moves the head unit to the lowest position for packing (lower dead center). (16) "CHIN REST" switch Touching the UP and DOWN buttons moves the chin rest up and down respectively. (17) Power lamp Stays lit while the instrument is turned on.

(18) USB-D connectors Connect the PC and printer here. There are two ports.

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(19) USB-H connector Connects the barcode reader, card reader, and supported digital printers. There are two ports. (20) LAN connector Connect the LAN cable here. (21) Maintenance switch This switch is reserved for use by servicemen performing maintenance work. Do not operate this switch.

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2.2 Patient's side (2)

(4)

(1)

(3)

(6)

(5)

(7)

(1) Capturing window The patient's endothelium is illuminated and captured through the capturing window. (2) Peripheral sight-fixing lamp When an image of the cornea periphery is being captured, the patient is prompted to stare at the peripheral sight-fixing lamp. (3) Chin rest The patient places their chin on this rest. (4) Forehead pad The patient presses their forehead against this pad. (5) Power switch Press the [I] or [O] side to turn the instrument on or off respectively. (6) Power socket Connect the power cord here. (7) Fuse holder Insert the fuses here.

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2.3 Screen <Capturing Screen> (1) (2)

4

(3) 㪥㪸㫄㪼

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.

1&

15

(14)

(15)

(13)

(4)

(5)

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㪤㫆㪻㪼

(6)

(7)

㪣㫆㫎

(8)

(9)

㪛㪸㫋㪸

㪱㫆㫆㫄 㪠㫅

㪚㪸㫇㫋㫌㫉㪼

(10)

(11)

(12)

#WVQ 㪘㫌㫋㫆

(1) Eye display button [R]/[L] Displays the right or left eye on which the head unit is positioned, using the corresponding color. Touch this icon to move the head unit when changing the eye to be examined. (2) ID number [ID] Displays the ID number. (3) Patient's name [Name] Indicates the patient's name. (4) Chin rest height Displays the current chin rest height according to the preset 6 levels. (5) Head unit height Displays the current head unit height according to the preset 11 levels. (6) "Setup" button Sets operation conditions for each function. (7) "Mode" button Switches the alignment mode between automatic and manual.

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