OPD-Scan III Operators Manual Feb 2011

Original instructions

NIDEK CO., LTD. (Manufacturer) NIDEK CO., LTD. (Tokyo Office)

NIDEK INCORPORATED (United States Agent) NIDEK S.A. (EU Authorized Representative)

: 34-14, Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan Telephone: +81-533-67-6611 Facsimile: +81-533-67-6610 : 3F Sumitomo Fudosan Hongo Bldg., 3-22-5, Hongo, Bunkyo-Ku, Tokyo 113-0033, Japan Telephone: +81-3-5844-2641 Facsimile: +81-3-5844-2642 : 47651 Westinghouse Drive, Fremont, California 94539, U. S. A. Telephone: +1-510-226-5700 Facsimile: +1-510-226-5750 : Europarc 13, rue Auguste Perret, 94042 Créteil, France Telephone: +33-1-49 80 97 97 Facsimile: +33-1-49 80 32 08

February 2011 32186-P922A Printed in Japan

:

Use this device properly and safely.

BEFORE USE, READ THIS MANUAL. This operator’s manual includes operating procedures, safety precautions, and specifications for the NIDEK REFRACTIVE POWER / CORNEAL ANALYZER, OPD-Scan III. Cautions for safety and operating procedures must be thoroughly understood before using this device. Keep this manual handy for reference. The device complies with ISO 10342 subclause 4: 2010 (Ophthalmic instruments - Eye Refractometers) and ISO 10343 subclause 4: 2009 (Ophthalmic instruments Ophthalmometers). The dioptric powers are indicated with reference wavelength λd = 587.56 nm. There are no parts within the device that requires servicing by the user other than printer paper. If you encounter any problems or have questions about the device, please contact NIDEK or your authorized distributor.

CAUTION • United States Federal law restricts this device to sale by or on the order of a licensed practitioner.

Safety precautions In this manual, a signal word is used to designate the degree or level of safety alerting. The definition is as follows.

CAUTION • Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury or property damage accident.

Even situations indicated by “ CAUTION” may result in serious injury under certain conditions. Safety precautions must be strictly followed at all times.

I

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Usage precautions

Before use CAUTION • Do not use the device for other than the intended purpose.

NIDEK will not assume responsibility for accidents or malfunction caused by misuse.

• The safety precautions and operating procedures must be thoroughly understood prior to operation of the device. Use of the device outside the scope of this manual may cause adverse events. • Never modify or touch the internal structure of the device. Electric shock or malfunction may result. • Install the device in an environment that meets the conditions listed below. The following conditions must be maintained during use. Ambient temperature: 10 to 35ºC (50 to 95ºF) Humidity: 30 to 90% (Non-condensing) Atmospheric pressure: 800 to 1060 hPa A well ventilated place free from hazardous particles, smoke or fumes Level and stable surface free from vibration and bumping If the device is not installed and used under the above conditions, the reliability of image capture results is lowered, and malfunction may result. In addition, injury may result if the device is bumped or topples over. • Do not store the device in an area that is exposed to rain or water, or contains poisonous gas or liquid. Corrosion or malfunction of the device may occur. • Avoid installing the device where it is exposed to direct air flow from an air conditioner. Changes in temperature may result in condensation inside the device or adversely affect measurement results. • Be sure to use a power outlet which meets the specified power requirements. If the supplied voltage is too high or low, the device may not perform up to specifications, and malfunction or fire may result. • Be sure to use a grounded power outlet. Electric shock or fire may result in the event of malfunction or power leakage. • Insert the power plug fully into the power outlet. Imperfect connection may result in fire. • Never use power strips or extension cables for the power supply of the device. Overloading the electric outlet may cause overheating and fire.

II

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CAUTION • Do not use any power cord other than the one provided. Do not use the provided power cord for any other instrument. Malfunction or fire may result. • Install the device in area where the outlet that the mains plug is inserted into is easily accessible during use. In addition, ensure that the power cord can be disconnected without the use of a tool. Otherwise, it may interfere with disconnecting of the power from the input power source in case of abnormality. • Never crush or pinch the power cord with heavy objects. Damage may result in electric shock or fire. • Before connecting any cables to the device, be sure to turn off power to the {device} and unplug the power cord. Malfunction may result. • When carrying the {device} to another location, its base should be held by two hands from both sides by two persons as indicated by (A) and (B) in the figure shown to the right. Never hold any parts other than the base such as the forehead rest, chinrest, joystick, or main unit. If any parts other than the base are held, the device may fall and injury or failure may result. In particular, never hold the forehead rest or chinrest.

(A)

(B)

• Keep the touch screen panel away from direct sunlight or excessive ultraviolet rays. They will damage the touch-screen panel.

III

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During use CAUTION • Perform visual and operational checks before using the device. Do not use the device if any error is found.

Use of a malfunctioning {device} will not produce the expected results and may cause troubles or lead to inappropriate diagnoses that may induce health hazards. • Be sure not to touch the patient’s face during alignment or when switching the right and left of the patient's eye. • Before and after use, and before every patient, clean the forehead rest and chinrest with clean gauze or cloth dampened with rubbing alcohol. For severe stains, wipe with a clean cloth dampened with rubbing alcohol instead of wiping them repeatedly with a dry cloth. If the chinrest paper is used, remove a sheet after each patient. • Take care not to catch hands or fingers in moving parts (such as the measuring unit or chinrest). Be sure to also give this caution to patients. Hands or fingers may be pinched and result in injury. • Keep the measuring window free of fingerprints and dust. The measurement accuracy may decrease substantially. • In the event of smoke or strange odors, immediately turn off the device and disconnect the power plug from the outlet. Once it is determined that the smoke will not become more serious, contact NIDEK or your authorized distributor. Continued use may result in electric shock or fire. In case of fire, use a dry chemical (ABC) extinguisher. • Before measurement, explain the measurement purpose or method sufficiently to patients. • Instruct the patient to fix on the fixation light with their eyes wide open. Start the measurement after confirming that the instruction is properly followed by the patient. Proper measurement may not be performed. • Immediately replace the power cord if the internal wires are exposed, the power turns on or off when the power cord is moved, or the cord or plug is too hot. Immediately remove the plug from the power outlet and contact NIDEK or your authorized distributor for replacement. Failure to do so may result in electric shock or fire. • Never touch the LCD monitor with any hard pointed object such as a ball-point pen. Never touch the LCD monitor with wet hands. Keep magnetic objects away from the LCD monitor. The monitor may be damaged. • There may be a few “constantly-lit”, “missing” or “dead” pixels in your LCD monitor which are a characteristic of the LCD monitor manufacturing process. This does not represent a failure of the LCD monitor, and the monitor can be used with no problem.

IV

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CAUTION • When turning off the instrument, be sure to follow the instructions in “2.2.3 Shut down (page 46)” instead of turning OFF the power switch.

Turning off the power switch before Windows is shut down may result in a loss of data or a malfunction. • While the pointer (

) is changed into the hourglass (

), do not perform any

operation through the touch-screen panel. A malfunction may result or the system may lock up. • Operators are responsible for managing their data. NIDEK assumes no responsibility for a loss of data. • Be sure to back up measured data on removal storage drives such as a removal hard disk drive or USB flash drive. In case of the corruption of the built-in SSD (Flash Solid State Drive), saved data will never be usable again. • Never press two or more points on the touch-screen panel at the same time. A malfunction may result. • Do not install Windows application software other than the OPD-Scan III software. Installing any other Windows application software may lead to abnormal operation of the OPD-Scan III and loss of stored data. In addition, the warranty may not cover the OPD-Scan III if Windows application software other than the OPD-Scan III software is installed. • This device has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2: 2007. These limits are designed to provide reasonable protection against harmful interference in a standard medical installation. This device generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this device does cause harmful interference to other devices, which can be determined by turning the device off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Failure or fire may result. - Reorient or relocate the receiving device. - Increase the separation between the devices. - Connect the device to an outlet on a circuit different from that to which the other device(s) are connected. - Consult the manufacturer or field service technician for help.

V

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CAUTION • The International Electrotechnical Commission sets the essential requirements for electrical and electronic equipment that may disturb, or be disturbed by, other equipment. The OPD-Scan III complies with these requirements as shown in the tables in “6.3 EMC (ELECTROMAGNETIC COMPATIBILITY) (page 314)”. Follow the guidance in the tables for use of the device in an electromagnetic environment. • During installation and operation of the device, observe the following instructions about EMC (electromagnetic compatibility): - Do not use the device simultaneously with other electronic equipment to avoid electromagnetic interference with the operation of the device. - Do not use the device near, on, or under other electronic equipment to avoid electromagnetic interference with the operation of the device. - Do not use the device in the same room as other electronic equipment such as lifesupport equipment, equipment that has major effects on the life of the patient and results of treatment, or any other measurement or treatment equipment that involves small electric current. - Do not use the device with portable and mobile radio frequency communication devices because that may have an adverse effect on operation of the device. - Do not use cables or accessories that are not specified for the device because that may increase the emission of electromagnetic waves from the device and decrease the immunity of the device to electromagnetic disturbance. • If the device fails, disconnect the power cord from the power outlet, then contact NIDEK or your authorized distributor without touching the interior of the device. • If the instrument is connected to a PC that does not comply with IEC60601-1 (except one that uses an AC adapter that meets the Class II requirements of IEC60950-1), supply power to the instrument and PC through isolation transformers. Contact NIDEK or your authorized distributor for installing isolation transformers. • When connecting to peripheral equipment such as a PC with LAN port via a medical facility network, insert or connect an isolation transformer between the medical electrical equipment and network devices (such as HUB), or the network devices and other electrical equipment. Depending on the types or numbers of other electrical equipment connected to the network, electric shock or malfunction/failure of the electrical equipment may occur. For installation of the network isolation transformer, consult NIDEK or your authorized distributor.

VI

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CAUTION • Provision of information on the avoidance of light hazard from the optical device is required in ISO 15004-2 (2007) “Ophthalmic instruments - Fundamental requirements and test methods -”. The light emitted from this device is potentially hazardous. The greater the number of times, the greater the risk of ocular damage. Exposure to light from this device when operated at maximum intensity will exceed the guideline in 18 seconds. However, because exposure to light lasts only about 0.45 second in a single CT measurement, 18 seconds of exposure is not reached until the measurement is executed about 40 times.

Spectrum output of all light source during measurement (maximum light intensity) OPD-Scan III Relative Spectral Distribution   

Relative power

        

















Wavelength (nm)

* The values in the graph were obtained using separate measurement devices.

VII

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{ Patient environment The patient environment is the volume of space in which contact can occur between the patient and any part of the device (including connected devices) or between the patient and any other person(s) touching the device (including connected devices). Use devices that comply with IEC60601-1 in the patient environment. If any device that does not comply with IEC 60601-1 is to be used, use an isolating transformer or common protective grounding.

VIII

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After use CAUTION • This device uses a heat-sensitive printer paper. To keep the printed data for a long period of time, make copies of the printouts.

The paper degrades over time and the printed data may become illegible. • When the device is not in use, turn off the power switch and put the dust cover over the device. Dust may affect the accuracy of image capture. • Always hold the power plug, not the cord, when removing it from the power outlet. The metal core of the cord may be damaged and electric shock, malfunction, or fire may result. • Occasionally clean the prongs of the power plug with a dry cloth. If dust settles between the prongs, the dust could collect moisture, and short circuit or fire may occur. • If the device will not be used for an extended period of time, disconnect the power cord from the power outlet. Failure to do so may leave the device vulnerable to electric disturbances which may result in fire. • During transport or storage, maintain an environment that meets the following conditions: Ambient temperature: –10 to 55ºC (14 to 131ºF) Humidity: 10 to 95% (non-condensing) Atmospheric pressure: 700 to 1060 hPa No large amount of dust content in the air A place not exposed to direct sunlight • When transporting, set the mode to Packing mode and pack the main body in the original packing material with the locking lever unlocked. It may result in failure when excessive vibration and shock are applied.

IX

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Maintenance and check CAUTION • Only service personnel trained by NIDEK are allowed to repair and service the device. NIDEK assumes no responsibility for any adverse events resulting from improper servicing.

• When performing maintenance work, secure a sufficient maintenance space. Maintenance work in an insufficient space may result in injury. • Never use organic solvents such as a thinner, or detergents with abrasives to clean the covers, touch-screen panel, and placido rings. The covers or touch-screen panel may be corroded or scratched. Especially, cleaning of the placido rings with organic solvents or detergents with abrasives will disturb concentric ring shapes, which may lower measurement accuracy. • Blow the dust off the placido rings with a blower. Careless wiping may disturb concentric ring shapes, and may lower the measurement accuracy. • When the device is sent back to NIDEK for repair or maintenance, wipe the surfaces (especially, the area where patients contact) of the device with a clean cloth dampened with ethyl alcohol for disinfection. • Contact NIDEK or your authorized distributor to check whether the device needs measurement accuracy calibration if the AR measurement results are substantially different from subjectively measured results. • The manager of this device must perform maintenance and check every six months. For details of the maintenance and check, contact NIDEK. When the maintenance check cannot be performed oneself, NIDEK can accept the maintenance check.

Disposal CAUTION • Follow local governing ordinances and recycling plans regarding disposal or recycling of device components. The device contains a circuit board with a lithium

battery mounted. Because the disposal method of lithium batteries varies according to the local government, follow the local governing ordinances and recycling plans when disposing of the circuit board with the lithium battery. It is recommended to entrust the disposal to a designated industrial waste disposal contractor. Inappropriate disposal may contaminate the environment. • When disposing of packing materials, sort them by material and follow local ordinances and recycling regulations. Inappropriate disposal may contaminate the environment.

X

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Connection to Network CAUTION • To share the database with PCs installed with OPD Software for External PC, do not connect them to the network that can connect to the Internet.

Configure a local network only with the device, PCs installed with OPD Software for External PC, and other related instruments or software such as Final Fit. NIDEK will not assume responsibility or compensate for damages caused by any virus infection and development due to connection of the device to a network that can connect to the Internet. The device is a medical equipment. If the user changes the setting of the device by installing other software such as antivirus software, NIDEK will not guarantee proper operation of the device.

XI

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XII

Table of Contents 1. BEFORE USE... 1 1.1 Device Outline...1 1.2 Intended Use...2 1.3 Principles...2 1.4 Device Configuration...3 1.5 Screen Configuration...9 1.5.1 Main Menu screen...9 1.5.2 Patient List Screen (before measurement)...11 1.5.3 Create Patient window...15 1.5.4 Patient List Screen (before displaying summary)...17 1.5.5 Measurement screen...18 1.5.6 Verify Examination Quality screen...21 1.5.7 Verify Multi Measurement screen...24 1.5.8 Exam List screen...27 1.5.9 Summary screen...30 1.5.10 Maintenance screen...33 1.5.11 Utility screen...34 1.5.12 Settings screen...35 1.5.13 OPD Database Manager screen...36

1.6 Labels...38 1.7 Checking Contents...40 1.8 Before First Use...41

2. OPERATING PROCEDURE... 43 2.1 Operation Flow...43 2.2 Start Up and Shut Down...44 2.2.1 2.2.2 2.2.3

Start up...44 Recovery from power saving mode...45 Shut down...46

2.3 Patient List Screen Operation...47 2.3.1 2.3.2 2.3.3 2.3.4 2.3.5

Patient List Screen Operation...47 Registering new patient...48 Editing patient data...53 Deleting patient data...53 Patient search...55

2.4 Measurement...57 2.4.1

Measurement procedure...59

2.5 Measurement in OPD/CT measurement mode...63 2.5.1

OPD/CT single measurement...63

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2.5.2

OPD/CT multi measurement (Multi measurement mode)... 72

2.6 OPD Measurement... 77 2.6.1 2.6.2

OPD single measurement... 77 OPD multi measurement (Multi measurement mode)... 81

2.7 CT Measurement... 84 2.7.1 2.7.2

CT single measurement... 84 CT multi measurement (Multi measurement mode)... 88

2.8 Viewing Maps... 91 2.8.1 2.8.2 2.8.3 2.8.4 2.8.5

Displaying summary from Measurement screen... 91 Displaying summary from Patient List screen... 93 Operation in summary screen... 95 Tool button functions... 104 Changing analysis conditions (Zone)... 105

2.9 Selecting Examination Data... 106 2.9.1 2.9.2

Selecting examination data for summary... 106 Operation in Exam List screen... 108

2.10 Difference Analysis Display... 112 2.10.1 Selecting data for difference analysis... 112 2.10.2 Operation in Difference screen... 114

2.11 Comparison Analysis Display... 117 2.11.1 Selecting data for comparison analysis... 117 2.11.2 Operation in Comparison screen... 119

2.12 Printing... 121 2.12.1 Printing measurement data (Internal printer)... 121 2.12.2 Printing summary (Color map) (External printer)... 123

3. ADVANCED OPERATION... 127 3.1 Color Maps... 128 3.1.1 Common items in maps... 129 3.1.2 Axial map (Corneal curvature radius / Corneal refractive power)... 137 3.1.3 Instantaneous map (Corneal curvature radius / Corneal refractive power)... 140 3.1.4 Gradient map (slope of cornea)... 141 3.1.5 “Refractive” map (corneal surface refractive power)... 142 3.1.6 Elevation map... 143 3.1.7 Eye Image... 147 3.1.8 OPD map (Distribution of refractive error)... 149 3.1.9 Internal OPD map (internal eye aberration, refractive power)... 151 3.1.10 Wavefront Map... 154 3.1.11 Zernike graph... 161 3.1.12 PSF map... 168 3.1.13 MTF graph (Contrast analysis graph)... 171 3.1.14 Visual Acuity chart... 174 3.1.15 Zonal Refraction map... 177

XI

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3.2 Explanation of Summaries... 179 3.2.1 3.2.2 3.2.3 3.2.4 3.2.5 3.2.6 3.2.7 3.2.8

Overview... 179 Cataract... 182 Diagnostic Marco... 183 Toric IOL... 184 Wavefront... 185 Optical Quality... 186 Other summaries... 186 Calculating corneal diameter (White to White)... 189

3.3 Setting of Summaries (Map Layout)... 190 3.3.1 3.3.2 3.3.3 3.3.4

Registering new summaries... 191 Editing existing summary... 203 Deleting existing summaries... 203 Other operations in summary list... 204

3.4 OPD Database Manager... 205 3.4.1 3.4.2 3.4.3 3.4.4 3.4.5 3.4.6 3.4.7 3.4.8 3.4.9

Creating database... 205 Switching database (Local database)... 209 Using database in another PC on network... 211 Database backup... 213 Rebuilding database... 216 Setting destination of data backup, import, and export... 219 Setting data deletion condition... 222 List of connected computers... 224 List of computers that have been connected before... 225

3.5 Outputting Map Data... 227 3.5.1

Outputting summary image data (Saving maps)... 227

3.6 Editing Placido Ring Edges... 231 3.6.1 3.6.2 3.6.3 3.6.4

Entering the edge edit mode (Tools)... 232 Selecting Edges... 233 Editing Edges... 235 Saving data after edge editing... 237

3.7 Editing Detected Pupil Edge... 238 3.7.1 3.7.2 3.7.3 3.7.4

Entering pupil edge edit mode... 238 Erasing pupil edges (Erase)... 240 Moving pupil edges (Move)... 241 Saving edited data... 242

3.8 Editing OPD analysis area... 243 3.8.1 3.8.2

Entering OPD analysis area edit mode... 243 Erasing analysis area (Erase)... 245

4. MAINTENANCE... 247 4.1 Troubleshooting... 247 4.2 Error Messages and Remedy... 249

XII

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4.3 Replacing Printer Paper... 252 4.4 Attaching a Stack of Chinrest Paper... 254 4.5 Checking Measurement Accuracy... 255 4.6 Utility Screen Operation... 257 4.6.1 4.6.2 4.6.3 4.6.4

Importing/exporting measured data... 257 Setting barcode reader and magnetic card reader... 263 Copying temporary data (OPD-Scan III)... 265 Using on-screen keyboard (OPD-Scan III)... 266

4.7 Maintenance Screen Operation... 267 4.7.1 4.7.2 4.7.3 4.7.4 4.7.5 4.7.6 4.7.7

Database maintenance... 267 Backup/Restoration of device parameters... 268 LAN setting... 269 Setting date and time... 271 Reading license file... 272 Touch screen calibration... 273 Packing mode... 274

4.8 Changing Device Parameters... 275 4.8.1 Changing settings... 275 4.8.2 Measurement tab... 277 4.8.3 Print tab... 280 4.8.4 Communication tab... 283 4.8.5 Data Output tab... 285 4.8.6 Summary tab... 287 4.8.7 Parameter tab... 289 4.8.8 Map Scale tab... 292 4.8.9 Lists tab... 296 4.8.10 Other tab... 298

4.9 Cleaning... 301 4.9.1 4.9.2

Cleaning the measuring window... 301 Cleaning the printer... 302

4.10 List of Replacement Parts... 303

5. SPECIFICATIONS AND ACCESSORIES... 305 5.1 Classifications... 305 5.2 Specifications... 306 5.3 Standard Configuration... 309 5.3.1 5.3.2

Standard accessories... 309 Optional accessories... 309

6. APPENDIX... 311 6.1 Glossary... 311

XIII

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6.2 List of Abbreviations... 313 6.3 EMC (ELECTROMAGNETIC COMPATIBILITY)... 314

7. INDEX... 319

XIV

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XV

1. BEFORE USE 1.1

Device Outline

1

The NIDEK refractive power / corneal analyzer OPD-Scan III (hereafter referred to as “the device”) measures objective refraction, corneal curvature, shape of the anterior segment (topography), and pupil size of the patient’s eye, and analyzes wavefront aberration. The measured refractive error can be used for reference when prescribing corrective lenses such as glasses and contact lenses. The measured corneal curvature and shape of the anterior segment can be used for reference when selecting the base curve of contact lenses or determining refractive power of intraocular lenses. The measured pupil diameter and pupil center can be used for reference when selecting multifocal intraocular lenses. The result of the wavefront aberration analysis can be used when obtaining informed consent from patients, for example, by quantifying components of irregular astigmatism or presenting simulated views of how visual acuity charts appear to the patient with vision correction. The analysis result is also useful for planning of refractive or cataract surgery. In addition, the database function facilitates postoperative followup. The device offers three measurement modes: OPD mode for refraction measurement, CT mode for corneal curvature measurement, and OPD/CT mode for both refraction and corneal curvature measurements. Each measurement mode offers different measurements as shown below. OPD measurement mode

AR values, OPD map, anterior segment image in mesopic vision, retroillumination image

CT measurement mode

KM values, placido ring image, anterior segment image in photopic vision

OPD/CT measurement mode

AR values, KM values, OPD map, anterior segment image in mesopic vision, retroillumination image, placido ring image, anterior segment image in photopic vision

AR values:

Refraction of the central area of the eye as obtained with an auto-refractometer

KM values:

Keratometry data simulated based on analysis of the captured placido ring image

When an external PC installed with OPD Software for External PC is connected to the OPD-Scan III, operations such as viewing or export of measurement data can be performed with the PC.

1

BEFORE USE: Intended Use

1.2

Intended Use The OPD-Scan III is a diagnostic instrument that is indicated for use: Mapping of refractive power distribution of the eye, by measurement and analysis of spherical power, cylindrical power, and cylinder axis. The measurement and analysis of corneal curvature (corneal refractive power), cylindrical power, and cylinder axis of the cornea. Mapping and display of the corneal shape, and screen out possibility of having corneal diseases or conditions.

1.3

Principles

{ Refraction measurement Measurement light emitted in a grid-like pattern is scanned on the retina, and the light reflected from the retina is received by multiple pairs of photodetectors. Refraction of the eye causes time (phase) difference in the signals issued by the pairs of photodetectors. The device calculates the refraction (spherical and cylindrical refractive errors, and cylinder axis angle) of the patient using these phase differences.

{ Corneal topography Placido ring images are projected onto the cornea and the reflected light is captured with a CCD camera. The device measures the distances between the captured placido rings and calculates the shape (curvature radius and refraction) of the cornea.

2

BEFORE USE: Device Configuration

1.4

Device Configuration

{ Front view

1

1. Touch screen

2. Start button

5. Locking lever

3. Joystick

4. Power switch

Connector panel

7. Cover open button 6. Printer

1. Touch screen Displays various operation screens, examination data, and maps. The device can be operated by touching the buttons on the screen.

3

BEFORE USE: Device Configuration

The touch screen is a 10.4-inch color LCD. It can be tilted by pulling its bottom and fixed at various angles. If the operator uses the device in a standing posture, tilt the screen at a suitable angle. To return the screen to the original position, raise it to the horizontal position, then slowly lower it. The screen is fastened to the original position by magnet.

2. Start button Used to start measurement. 3. Joystick Used for alignment and focusing. For horizontal alignment, move the joystick to the right and left. For vertical alignment, rotate the joystick. For focus adjustment, move the joystick forward and back.

4. Power switch Flip the power switch to the On side to turn on power to the device. Do not use the power switch to turn off the device power. Be sure to use the Exit button on the touch screen to turn off the device power.

5. Locking lever Used to lock the main body to the base. To lock the main body, press down the locking lever.

6. Printer This internal printer is used to print AR and KM values (equivalent to values measured with a keratometer). 7. Cover open button Used to open the printer cover for replacement of the printer paper.

4

BEFORE USE: Device Configuration

{ Connector panel Provides the connectors for the keyboard, mouse, and external devices.

CAUTION • Equipment connected to the analog or digital interfaces must be certified according to the representative appropriate national standards (such as EN 60601-1 and IEC

60601-1). Furthermore, all configurations must comply with the system standard IEC 60601-1-1. Anyone who connects additional equipment to the signal input part or signal output part configures a medical system is therefore responsible that the system complies with the requirements of the system standard IEC 60601-1-1. If in doubt, consult the technical service department of your local representative.

10. COM connector 11. Ethernet connector

8. Mouse connector

9. Keyboard connector

12. USB connector 13. VGA connector

8. Mouse connector Used to connect a PS/2 mouse. To connect a USB mouse, connect it to the USB connector.

9. Keyboard connector Used to connect a PS/2 keyboard. To connect a USB keyboard, connect it to the USB connector.

CAUTION • The PS/2 connector is not designed for hot plug. Be sure to connect or remove the PS/2 mouse or PS/2 keyboard when the device power is off.

• When connecting devices to the PS/2 connector, be sure to check the orientation of the connector and insert the plug straight into the connector.

10. COM connector This COM conductor is a 9-pin, D-sub serial port to which the RS-232C cable is connected to transfer data to the NIDEK RT-2100, RT-5100, or Eye Care card system, or to an external PC. Be sure to connect or remove the connector with the device power turned off.

5

1

BEFORE USE: Device Configuration

11. Ethernet connector Used to connect the device to an Ethernet network. Setting up of a LAN is required for connection to an Ethernet network. Set up a LAN in the LAN Settings window that appears by pressing the LAN button in the Maintenance screen.

12. USB connector Used to connect USB devices. There are four ports of them. (USB 2.0 ports) They can be used to connect an external color printer, barcode reader, magnetic card reader, and external storage device. The USB connector is designed for hot plug. The USB plugs can be connected or removed with the device power on.

13. VGA connector The VGA connector is a 15-pin, D-sub display port for devices such as an external monitor. When an external monitor is connected to the VGA connector, the Measurement screen is not displayed on the external monitor while the touch screen displays it. While the touch screen displays the Measurement screen, do not operate the device referring to the external monitor.

6

BEFORE USE: Device Configuration

{ Rear view 14. Forehead rest 17.Eye level marker

1

15. Measuring window 18. Chinrest up/down button

16. Chinrest

19. PD window

14. Forehead rest Used to rest the patient’s forehead to restrict head movement during measurement. Clean it for each patient.

15. Measuring window Check the window cleanliness before measurement. 16. Chinrest Clean the chinrest for each patient. 17. Eye level marker Used as a guide to adjust the patient’s eye level. Adjust the height of the chinrest so that the patient’s eyes are roughly aligned with this line.

18. Chinrest up/down button (

,

)

Used to move the chinrest up and down. 19. PD window An LED is provided to detect the PD value. • Parts that come into contact with the patient or the operator during measurement are composed of the following materials: Forehead rest - Fluorocarbon resin Forehead rest frame, locking lever - Aluminum Chinrest, start button, chinrest up/down button - ABS resin Joystick- ABS resin, synthetic rubber, polycarbonate Touch screen - Polyester Power switch - Nylon Power switch cover - Steel

7

BEFORE USE: Device Configuration

{ Bottom view 20. Sockets for AR tray pins

Cooling fan vent

21. Power inlet

22. Bottom cover (for servicing)

20. Sockets for AR tray pins When placing the device on the AR tray of the NIDEK system table, place it so that the pins on the AR tray are inserted into these sockets. 21. Power inlet A detachable power cord is connected here. 22. Bottom cover (for servicing) This cover is opened when a service person accesses the interior of the device. Only service persons are allowed to open this cover.

8

BEFORE USE: Screen Configuration

1.5

Screen Configuration

1.5.1

Main Menu screen

1

The Main Menu screen is displayed when the OPD-Scan III is activated and allows selection of the screen to proceed to.

±

² ³

´ µ

¶ ·

1

VERSION button

2

Measurement button

3

Patient Files button

4

Maintenance button

5

Utility button

6

Settings button

7

Exit button

1. VERSION button Used to display the software version of the device.

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BEFORE USE: Screen Configuration

2. Measurement button Used to move to the Patient List screen (before measurement). If this software is used on an external computer, this button is disabled. This software can be installed on an external computer and used as standalone viewer software. (A USB license key is needed.)

3. Patient Files button Used to move to the Patient List screen (before displaying summary). 4. Maintenance button Used to move to the Maintenance screen. The Maintenance screen allows maintenance of the database, backup and restoration of the device parameters, LAN setting, date and time setting, reading of the license file, touch screen calibration, and setting of the device to Packing mode.

5. Utility button Used to move to the Utility screen. The Utility screen allows import and export of the measurement data, setting of bar-code or magnetic card readers, copying of temporary data, and setting of the on-screen keyboard.

6. Settings button Used to move to the Settings screen. The Settings screen allows setting of the measurement conditions, summary parameters, and color scale parameters.

7. Exit button Used to close the OPD-Scan III software and turn off power to the device. Be sure to use this button, not the power switch, to turn off power to the device. Turning off power to the device using the power switch may cause failure of the device. In the case of OPD Software for External PC, pressing this button closes the OPD-Scan III software.

10

BEFORE USE: Screen Configuration

1.5.2

Patient List Screen (before measurement) The Patient List screen (before measurement) allows selection of the patient for whom the measurement is going to be performed. ±

²

³

´

µ

1

¶

· ¸ ¹ ±°

±± 1

New Patient button

2

Measurement button

3

Patient data brief information box

4

Easy search boxes

5

Edit button

6

Main Menu button

7

Delete button

8

Clear button

9

Option button

10

Number of listed data sets

11

Patient List

1. New Patient button Used to create new patient data. The New Patient window is displayed. Input new patient data.

2. Measurement button Used to display the Measurement screen and start measurement for the patient selected in the patient list. The measurement is performed for the patient being selected in the patient list.

3. Patient data brief information box Displays the ID, name, number of examination data sets, and physician name for the patient selected in the patient list. 4. Easy search boxes Used to search the desired patient data by entering search conditions in the ID, Name, and Group boxes. If a hardware keyboard is used, characters can be directly input in the box. The result of the search is cleared when the Patient List screen is closed.

11

BEFORE USE: Screen Configuration

ID button

Used to display the on-screen keyboard for inputting the ID.

ID box

Used to enter the ID of the patient to search for the patients whose ID begins with the entered ID.

Name button

Used to display the on-screen keyboard for inputting the name.

Name box

Used to enter the patient name to search for the patients whose names begin with the entered name.

Group button

Used to display the on-screen keyboard for inputting the group.

Group box

Used to enter the group of the desired patient. Clicking the V button displays the existing groups that can be selected. The patients who belong to the group the name of which begins with the entered characters are displayed.

If multiple search conditions are entered, the AND search is executed. • The button for displaying the on-screen keyboard is effective only when the software runs on the OPD-Scan III device. In case of the OPD Software for External PC, only the names of the boxes are displayed instead of the buttons for displaying the on-screen keyboard.

5. Edit button Displays details of the selected patient data in the Edit Patient Information window that allows editing of the information as well. In the Edit Patient Information window, patient information such as diagnosis, phone number, and address 1 to 3, email, and referrer can be input in addition to the existing patient information.

6. Main Menu button Used to return to the Main Menu screen. 7. Delete button Used to delete the selected patient and their examination data. When a patient is deleted, all examination data sets for the patient are deleted. To delete only examination data, move to the Exam List screen.

8. Clear button Used to clear the current search condition. The search condition is not cleared when a search has been executed using “Sex” or “Last Exam Date” in the Search Option screen. To clear the search condition set with “Sex” or “Last Exam Date”, press the Clear button in the Search Option window.

9. Option button Used to display the Search Option window. The desired patient can be searched by date or the last examination date. The search conditions specified in this window are maintained even when the Patient List screen is closed or the device power is turned off.

10. Number of displayed data sets Shows the total number of data sets (A) and the number of data sets being displayed in the list (B). Search conditions specified in the Search Option window are shown as well. Number of data sets being displayed in the list (B) / Total number of data sets (A) If search is not executed, (B) equals (A).

12

BEFORE USE: Screen Configuration

11. Patient List Shows the existing patients. Select the row of the patient for whom the measurement is going to be performed. Pressing an item name (ID, Name, Sex, Group, or Last exam date) on top of the patient list sorts the data in ascending order. Pressing the item name once again sorts the data in descending order. The sort order is indicated by

(ascending order) or

(descending order) on the side of the item name.

1

When extracted data is shown, the background of the patient list changes from white to yellow. If the extracted data sets cannot be displayed in a single screen, the list can be scrolled using a scroll bar.

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