ARK-560A Operators Manual Nov 2010

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

November 2010 30703-P902E 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 AUTO REF/KERATOMETER, ARK-560A. 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 Od = 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



Usage precautions

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

NIDEK will not be responsible for accidents or malfunction caused by misuse.

• Be sure to read the manual prior to operation of the device to understand the safety precautions and operating procedures thoroughly. Using the device for purposes other than specified in this manual may cause unexpected malfunctions and/or adverse events. • Never disassemble nor touch the inside of the device. This may result in electric shock or malfunction. • Install the device in an environment that meets the following conditions. The following conditions must be maintained during use. Use conditions Temperature: 10 to 35ºC (50 to 95ºF) Humidity: 30 to 90% (Non-condensing) Pressure: 800 to 1060 hPa A place with low dust A place with little external light A level and stable surface free from vibration and shock If the device is not installed and used under the above conditions, the reliability of measured results is impaired, and malfunction may result. In addition, there is a possibility of injury if the device receives shock and falls down. • 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-conditioning flow. Changes in temperature may result in condensation inside the device or adversely affect measurements. • Be sure to use a wall outlet which meets the power specification requirements. If the line voltage is too high or too low, the device may not give full performance. Malfunction or fire may occur. • Be sure to use an outlet equipped with a ground terminal. Electric shock or fire may occur in the event of device malfunction or power leakage. • Completely insert the power plug into the outlet as far as the prongs will go. Fire may occur if the device is used with a loose connection. • Never use a power strip or extension cable to supply the device with power. The electrical safety may be lowered.

II

CAUTION • Do not use a power cord other than the one provided. Also do not connect the provided power cord to any other device. Failure or fire may result. • Do not place heavy objects on the power cord. The damaged power cord may cause fire or electric shock. • Before connecting the cable, turn off the power switch and disconnect the power cord from the outlet. Malfunction of the device 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. • When the device is carried, two persons should hold it at positions (A) and (B) (both right and left sides). Avoid lifting by the forehead rest or main body instead hold it by the bottom of the base. If only one person carries the device, or areas other than the base are used for lifting and the device falls, there is a possibility of injury or malfunction.

(A)

(B)

• To transport the device, use the special packing materials to protect the device from impact of dropping. Excessive vibration or impact to the device may cause malfunction. • This device has been tested and found to comply with the limits for medical devices to the 60601-1-2: 2001/am1: 2004. 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.

III



CAUTION • The International Electrotechnical Commission sets the essential requirements for electrical and electronic equipment that may disturb, or be disturbed by, other equipment. The ARK-560A complies with these requirements as shown in the tables in “6 EMC (ELECTROMAGNETIC COMPATIBILITY) (page 127)”. Follow the guidance in the tables for use of the device in an electromagnetic environment.

During use CAUTION • Before use, perform visual and operation checks. If abnormal conditions are encountered, stop using the device.

If the device is used under abnormal conditions, intended results may not occur. Also unexpected malfunctions or health hazards may occur due to improper measurement. • Be sure to connect a communication cable, checking the symbols of input (IN: and output (OUT:

)

).

Data transmission may not be performed properly. • Before treating each patient, clean the patient’s contact area (chin rest and forehead rest) with rubbing alcohol. If chinrest paper is used, remove one piece for each patient. For severe stains, wipe the area not with a dry cloth but with gauze dampened with alcohol. • 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. After you are sure that the smoke has stopped, then contact NIDEK or your authorized distributor. Usage of the device under such abnormal conditions may cause fire or electric shock. In case of fire, use a dry chemical (ABC) extinguisher to extinguish the fire. • Immediately replace the power cord if the internal wires are exposed, the device turns on or off when the power cord is moved, or the cord and/or plug are too hot to hold. This may result in electric shock or fire. In the event of malfunction, disconnect the power cord from the wall outlet. Never touch the inside of the device and contact NIDEK or your authorized distributor. • Never press on the LCD with a hard object such as a ball-point pen. Keep magnetic objects away from the LCD. The device may be damaged. • Do not operate the LCD with wet hands. Water seeping into the device may result in failure of the device. • There may be a few dead or constantly-lit pixels in your LCD. This does not represent failure of the LCD; This is due to the structure of the LCD.

IV

CAUTION • 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 (HUB etc.), 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. • 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. • This device is classified as Group 1 set by ISO 15004-2:2007 Light Hazard and conforms to the standard.

V



{ 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.

Radius of 1.5 m

2.5 m

1.5 m

VI

1.5 m

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. If not, dust may affect the measurement accuracy. • Do not yank the power cord to disconnect it from a wall outlet. This can damage the metal core of the cord and may result in fire, short circuit or electric shock. • Occasionally clean the prongs of the main plug with a dry cloth. If dust settles between the prongs, the dust will collect moisture, and short circuit or fire may occur. • If the device will not be used for a long time, disconnect the power cord from the wall outlet. Fire may occur. • Maintain the surrounding temperature and humidity in the following ranges during transport and storage of the device. Environmental conditions Temperature: –10 to 55ºC (14 to 131ºF) Humidity: 10 to 95% (non-condensing) Atmospheric pressure: 700 to 1060 hPa A place with low dust A place not exposed to direct sunlight • When transporting, pack the main body in the original packing material with the fixing lever unlocked. Excessive vibration or impact may cause device malfunction.

VII



Maintenance and check CAUTION • Only service technicians properly trained by NIDEK can repair the device.

NIDEK will not be responsible for any accidents caused by improper servicing.

• When performing maintenance work, secure a sufficient maintenance space. Maintenance work in an insufficient space may result in injury. • 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-measured 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.

VIII

Table of Contents 1. BEFORE USE... 1 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8

Outline of the Device...1 Intended Use...2 Principles...2 Configuration...3 Measurement Screen Layout...8 Labels...14 Checking Contents...16 Before First Use...17

2. OPERATING PROCEDURE... 21 2.1 Operation Flow...21 2.2 Preparation for Measurement...22 2.2.1 2.2.2 2.2.3 2.2.4

Checking the measuring window cleanliness at device start-up...28 Switching to manual mode...29 Sleep mode...30 Finishing the measurement...30

2.3 AR (Refractive Error) and KM (Corneal Curvature Radius) Measurements: AR/KM Measurement Mode...31 2.3.1 2.3.2 2.3.3

2.4 2.5 2.6 2.7

Cataract measurement mode...39 Measurement ring image display...40 KM peripheral measurement...41

AR (Refractive Error) Measurement: AR Measurement Mode...42 KM (Corneal Curvature Radius) Measurement: KM Measurement Mode . .44 Uncorrected Visual Acuity Measurement...46 Corrected Visual Acuity Measurement (Subjective Measurement)...48 2.7.1 2.7.2

Distance vision measurement...48 Near vision measurement...52

2.8 CS (Corneal Size) Measurement...57 2.9 PS (Pupil Size) Measurement...59 2.10 PD (Pupillary Distance) Measurement...61 2.10.1 Auto PD measurement...61 2.10.2 Manual PD measurement...61

2.11 Sagittal Radius Measurement...63 2.12 Measuring Hard Contact Lenses...66 2.13 Printing...68 2.13.1 Printing measured data...68 2.13.2 Eyeprint...72 2.13.3 Printing parameter settings...73

2.14 Parameter Settings...74

IX

:

2.14.1 Parameter tables... 77 2.14.2 Setting and confirming the network communication function (LAN)... 90 2.14.3 Setting the date and time... 94 2.14.4 Entering comments... 96

3. OPERATION WHEN PERIPHERAL DEVICES ARE CONNECTED... 99 3.1 Connecting to the NIDEK Motorized Refractor (RT) or Computer... 99 3.1.1 3.1.2 3.1.3

Outline... 99 RS-232C connection... 100 Network connection (LAN)... 101

3.2 Connecting to the NIDEK Auto Lensmeter (LM)... 102 3.2.1 3.2.2 3.2.3

Outline... 102 Connecting procedure... 102 Operating procedure... 103

3.3 Reading Patient ID... 104 3.3.1 3.3.2 3.3.3

Connecting procedure of barcode scanner / magnetic card reader... 104 Operating procedure of barcode scanner... 105 Operating procedure of magnetic card reader... 106

4. MAINTENANCE... 107 4.1 4.2 4.3 4.4 4.5 4.6

Troubleshooting... 107 Error Messages and Countermeasures... 109 Replacing Printer Paper... 113 Fixing Chinrest Paper... 115 Checking AR/KM Measurement Accuracy... 116 Cleaning... 118 4.6.1 4.6.2

Cleaning the measuring window... 118 Cleaning the printer... 120

4.7 List of Replacement Parts... 120

5. SPECIFICATIONS AND ACCESSORIES... 121 5.1 Classifications... 121 5.2 Specifications... 122 5.3 Standard Configuration... 126 5.3.1 5.3.2

Standard accessories... 126 Optional accessories... 126

6. EMC (ELECTROMAGNETIC COMPATIBILITY)... 127

X

:

7. GLOSSARY... 131 8. INDEX... 133

XI

:

XII

1. BEFORE USE 1.1

Outline of the Device

1

The NIDEK ARK-560A is an auto ref/keratometer which functions as both a refractometer and keratometer in one unit. The refractometer objectively measures refractive errors of sphere, cylinder, and axis for lenses to correct the patient’s vision to emmetropia. In addition, subjective refraction is performed using the built-in charts and corrective lenses. The keratometer measures the corneal curvature radius (corneal refractive power), principal meridian direction, and corneal cylindrical power. Measurement of refractive errors is mainly performed as a reference for lens prescription to correct the visual acuity using glasses or contact lenses. The corneal curvature radius measurement is mainly performed for the following purposes: xLens prescription for correction of visual acuity using contact lenses or such xDetermination of the power of intraocular lenses to be implanted after cataract surgery xPostoperative follow-up of corneal shape This device is a single unit with the main body mounted on a base. The base is provided with a chinrest on the patient side and an Eye Care card reader/writer that saves measured results on the operator side. The measuring unit is provided with an LCD panel, operating buttons, joystick, and printer to facilitate alignment and other operations. The device offers the following features in addition to the above: xThe ARK-560A is provided with an auto tracking mechanism that automatically achieves alignment in the up-and-down, right-and-left directions and focusing. x An auto shot function is provided that allows measurements to be taken automatically when the device is best aligned and focused. x A motorized up-and-down chinrest allows the operator to easily adjust the height of the chinrest. xAn IC card (Eye Care card) reader/writer is equipped as standard to cordlessely exchange data with other devices. xA built-in RS-232C interface allows data export to computers and such. xEthernet LAN support allows measured data and ring image data to be output to a computer. xA recall function for vision comparison and a display function for measurement ring image are provided.

1

BEFORE USEIntended Use

1.2

Intended Use The auto ref/keratometer ARK-560A is a medical device which performs measurement of the objective and subjective refractive errors and corneal curvature radius of the eye.

1.3

Principles Objective measurement of refractive errors Fine measurement beams are projected on the fundus of the patient’s eye by a projecting optical system and then computation is performed by capturing the reflected beams as a ring image to measure the refractive errors (SPH, CYL, AXIS) of the patient’s eye. Subjective measurement of refractive errors When a patient views a chart optically adjusted for refraction distance through corrective lenses, subjective refractive errors and visual acuity are measured by patient’s response. Spherical powers are changed by adjusting the distance of the lens from the patient’s eye. Measurement of corneal curvature radius Calculation is also performed by capturing the mire ring projected on the patient’s cornea as an image to measure the corneal curvature radius (refractive power) and the principal meridian direction.

2

BEFORE USEConfiguration

1.4

Configuration

{ Front view

1

Function buttons

LCD

Memory indicator

Start button

Locking lever

Joystick

Power switch Eye Care card slot

Cover open button Printer cover

Function buttons Set the device and switch screens. Functions assigned to the function buttons are displayed by icons on the screen. Two buttons in the lower left corner of the screen have unique functions when the measurement screen is displayed. • Clear button (

)

Erases measured data. When the clear button is held for about a second, all the measured data is erased.

3

BEFORE USEConfiguration

• Print button (

)

Pressing this button when the memory indicator is lit, prints out the measured data. Pressing the button when the memory indicator is not lit, advances printer paper.

LCD 5.7-inch LCD. Pulling the bottom of the display panel provides an adjustable viewing angle. For measurement in a standing posture, set the panel at a suitable angle. The panel is held in its original position by magnet.

Memory indicator Indicates that measured data is being saved in memory. ON

Being saved

OFF

Not being saved

Blink

Sleep mode

Start button When the start button is pressed, measurement starts regardless of the alignment or focusing condition of the device. Joystick Used for alignment and focusing. Alignment in the side-to-side direction can be performed by moving the joystick to the right and left. Rotating the joystick is for alignment in the up-and-down direction. For focusing, move the joystick forward and backward.

Eye Care card slot An Eye Care card is inserted here. AR measured values (S, C, A) of both eyes, KM measured values, and PD value can be saved to the card. LM data used for the recall function can also be read from the Eye Care card. Eye Care card is inserted before measurement.

Data is saved to the card at printing.

Eye Care card is inserted after measurement.

Data is saved to the Eye Care card when the card is inserted.

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

Power switch Turns on or off the power to the device. Printer cover Protects a printer equipped with an auto cutter. Open the printer cover to replace printer paper by pressing the cover open button. Cover open button Opens the printer cover.

4

BEFORE USEConfiguration

{ Rear view Forehead rest Eye level marker

1

Measuring window

Chinrest up/down button

Chinrest

PD window

Forehead rest During measurement, the patient’s forehead should gently rest against the forehead rest. Clean the forehead rest after each patient.

Measuring window Check the window cleanliness before measurement. Chinrest Clean the chinrest after each patient. Eye level marker Used as a guide for the patient’s eye level during measurement. The height of the chinrest should be adjusted so that the center level of the patient’s eye roughly aligns with this line.

Chinrest up/down button (

,

)

Moves the chinrest up or down. PD window An LED is provided to detect the PD value. • Parts that come into contact with the patient during measurement are composed of the following materials. Forehead rest: Elastomer Chinrest, start button, chinrest up/down button, function buttons: ABS resin Measuring window, locking lever: Aluminum Joystick: ABS resin, synthetic rubber

5

BEFORE USEConfiguration

{ Underside view Power inlet

LAN port

USB-A port RS-232C ports

Power inlet A detachable power cord is connected here. LAN port*1 By connecting a LAN cable, the measured data can be exported to an external computer with a LAN connection. NIDEK service personnel sets the LAN connection with permission from the network administrator of the facility. When connecting a cable, be sure to turn off the power of each device.

*1.

6

Accessory equipment connected to the analog and digital interfaces must be certified according to the representative appropriate national standards (for example, UL 1950 for Data Processing Equipment, UL 60601-1 for Medical Equipment, and CSA C22.2 No. 601-1, EN 60601-1, and IEC 60601-1.) Furthermore, all configurations shall 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, and 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 or your local representative.