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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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

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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

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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

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

7. INDEX... 319

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