ARK-730A Operators Manual Jan 2005

NIDEK AUTO REF/KERATOMETER

Model ARK-730A OPERATOR’S MANUAL

BEFORE USE OR MAINTENANCE, READ THIS MANUAL. This Operator’s Manual contains information necessary for the operation of the NIDEK AUTO REF/KERATOMETER Model ARK-730A. This manual includes the operating procedures, safety precautions, specifications, and information about accessories and maintenance. The device complies with ISO 10342 (Ophthalmic devices—Eye Refractometers). IEC 60601-1 and UL 60601-1 standards are applied in this manual. The dioptric powers are indicated with a reference of wavelength λd = 587.56 nm. This manual is necessary for proper use. Especially, the safety precautions and operating procedures must be thoroughly understood prior to operation of the device. Keep this manual handy for reference. There are no user-serviceable parts inside the device except printer paper and fuses. Therefore, if you encounter any problems or have questions about the device, please contact NIDEK or your authorized distributor.

MEDICAL ELECTRICAL EQUIPMENT 34VK UL60601-1 CAN/CSA C22.2 NO. 601.1 WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL6060l-1 AND CAN/CSA C22.2 NO. 601.1 (This applies to products whose power source is 100/120 Vac.)

Table of Contents

§1 INTRODUCTION ...Page 1-1 1.1 Outline of the Device ... 1-1 1.2 Indications for Use ... 1-1 1.3 Classifications ... 1-1 1.4 Symbol Information ... 1-3

§2 SAFETY ... 2-1 2.1 Cautions in Storage, Transportation and Installation ... 2-1 2.2 Connecting the Device to a Wall Outlet and Handling the Power Cord ... 2-4 2.3 Cautions during Use ... 2-5 2.4 Maintenance ... 2-9 2.5 Disposal ... 2-9 2.6 Labels ... 2-10

§3 CONFIGURATION ... 3-1 §4 OPERATING PROCEDURES ... 4-1 4.1 Operation Flow ... 4-1 4.2 Auto-Off Mode ... 4-1 4.3 Preparation for Measurement ... 4-2 4.4 AR (refractive error), KM (corneal curvature radius) Measurements ... 4-6 4.4.1 When both auto-tracking and auto-shot are ON ... 4-6 4.4.2 When both auto-tracking and auto-shot are OFF ... 4-14 4.4.3 When auto-tracking is ON and auto-shot is OFF ... 4-16 4.5 CS (Corneal Size) Measurement ... 4-17 4.6 PS (Pupil Size) Measurement ... 4-19 4.7 PD (Pupillary Distance) Measurement ... 4-21 4.8 Measuring Sagittal Radius ... 4-23

§5 PRINTOUT ... 5-1 5.1 Printing Measured Data ... 5-1 5.2 Eyeprint ... 5-4

§6 DATA TRANSFER USING EYE CARE CARD SYSTEM ... 6-1 6.1 Writing Measured Data to the Eye Care Card ... 6-1 6.2 Importing LM Data to be Used for the View Comparison Function ... 6-3 6.3 Erasing Data on the Eye Care Card ... 6-4

§7 ENTERING PATIENT ID USING BARCODE SCANNER ... 7-1 7.1 Connecting the Barcode Scanner ... 7-1 7.2 Reading a Patient ID ... 7-2

§8 VARIOUS SETTINGS ...Page 8-1 8.1 Setting Parameters ... 8-1 8.2 Setting Date and Time ... 8-10 8.3 Entering Comments ... 8-11 8.4 Measuring Hard Contact Lenses ... 8-14

§9 TROUBLESHOOTING GUIDE ... 9-1 §10 MAINTENANCE ... 10-1 10.1 Replacing the Printer Paper ... 10-1 10.2 Setting a Stack of Chinrest Paper ... 10-3 10.3 Replacing Fuses ... 10-4 10.4 Cleaning the Measuring Window ... 10-6 10.5 Cleaning the Exterior ... 10-7 10.6 List of Replacement Parts ... 10-7

§11 SPECIFICATIONS ... 11-1 11.1 Specifications ... 11-1 11.2 Accessories ... 11-5 11.2.1 Standard accessories ... 11-5 11.2.2 Optional accessories ... 11-5

§12 EMC (ELECTROMAGNETIC COMPATIBILITY) ... 12-1 APPENDIX A. GLOSSARY ... A-1 INDEX ... End of this manual

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§1 INTRODUCTION 1.1 Outline of the Device The ARK-730A is an auto ref/keratometer which contains both a refractometer and a keratometer in one unit. The refractometer objectively measures the refractive errors of sphere, cylinder, and axis for the lens that corrects the patient’s vision into emmetropia. The keratometer measures the corneal curvature radius, corneal refractive power, corneal cylindrical power, and corneal cylinder axis. Weak infrared rays are used for these measurements. This device has a main body and a measuring unit integrated on one base. On the base are a chinrest on the patient’s side and a printer on the operator’s side which outputs measured results. On the main body are a TV monitor, a control panel, and a joystick, which are used to make alignment and perform operations. The measuring unit has a measuring window into which the patient looks and where the infrared ray radiates on the patient’s eye. Also, there is an autotracking mechanism, which automatically moves the measuring unit up, down, right, left, back and forth to follow the eye movement, and an auto-shot function, which automatically takes serial measurements when the device is in focus.

1.2 Indications for Use The Auto-Ref/Keratometer ARK-730A is used to measure the refractive errors such as sphere, cylinder and its axis as well as corneal radius of curvature of the eye. The measured values are mainly used for the prescription of refractive correction with spectacle lenses or contact lenses.

1.3 Classifications [Classification under the provision of 93/42/EEC (MDD)] Class IIa The ARK-730A is classified as Class IIa. [Form of protection against electric shock] Class I The ARK-730A is classified as Class I. A Class I is a device in which the protection against electric shock does not rely on basic insulation only, but which includes an additional safety precaution in such a way that means are provided for the connection of the device to the protective (ground) conductor in the fixed wiring of the installation in such a way that accessible metal parts cannot become live in the event of a failure in the basic insulation. Use a power outlet which is equipped with a grounding terminal. [Degree of protection against electric shock] Type B Applied Part The ARK-730A is classified as a device with a Type B Applied Part. A Type B Applied Part provides a particular degree of protection against electric shock, particularly regarding the following: - allowable leakage currents - reliability of the protective earth connection (if present)

1-2 [Degree of protection against ingress of liquids] IP 20 The ARK-730A is classified as IP20*1. The ARK-730A is an ordinary device, as such does not provide protection with respect to harmful effects due to the ingress of water although it is protected against access to hazardous parts with a solid matter such as a finger of 12.5 mm in diameter. Avoid exposing water to the device. [Degree of protection against flammability] The ARK-730A is classified as a device not suitable to be used in a potentially flammable environment. Do not use near flammable materials. [Method(s) of sterilization or disinfection recommended by the manufacturer] The forehead rest and chinrest should be wiped using a cloth dampened with alcohol as necessary. [Mode of operation] Classification of the ARK-730A: continuous operation

*1 In accordance with IEC 60529

1-3

1.4 Symbol Information This symbol indicates that important descriptions are contained in the operator’s manual and that the operator must refer to the operator’s manual prior to operation or maintenance. This symbol indicates that the degree of protection against electric shock is of a Type B Applied Part. This symbol of the power switch indicates that when the switch is pressed to this symbol side, power is supplied to the device. This symbol of the power switch indicates that when the switch is pressed to this symbol side, power is not supplied to the device. This symbol indicates the fuse rating. This symbol indicates the input port. This symbol indicates the output port. This indicates that the device must be supplied only with alternating current. This indicates the knob for adjusting the contrast. This indicates the knob for adjusting the brightness.

§2 SAFETY The following safety precautions should always be followed. 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.

2.1 Cautions in Storage, Transportation and Installation CAUTION • The following environmental conditions must be maintained in storage (on the condition that the device is packed). - Place that is not exposed to rain or water. - Place that is free from harmful gas or liquid. - Place that does not contain salt, sulfur content or thick dust. - Place that is not exposed to direct sunlight. - Temperature: –20 to 60ºC, Humidity: 10 to 95% (Non-condensing) • Do not drag the device by its cables. Injury or device damage may result. • The device must be carried by two persons with its base held with their both hands from both sides of the device. Never hold the forehead rest, main body or measuring unit. Injury or device damage may result if the device is carried by one person or areas other than the base are held. • To transport the device to another location, store it in a shipping carton. In such cases, never lock the main body with the locking knob. Breakdown of the device may result if it is subjected to excessive vibration or shock. • Connect the power cord and interface cable on a stable, level place with enough space since the power inlet and interface connectors are provided at the base of the device. • Install the device in a place that will never be exposed to water. If water gets into the internal structure of the device, electric shock or device malfunction may result.

2-2

CAUTION • The installation location must satisfy the following environmental conditions: - Place with low dust content - Place with less light interference - Stable, level place that is free from vibration or shock The device may not perform measurement properly or may malfunction. In addition, if the device falls because of any accidental shock, injury may result. • Install and use the device in an environment that can be maintained under the following conditions: Temperature: 10 to 35ºC Humidity: 30 to 75% (Non-condensing) Atmospheric pressure: 800 to 1060 hpa • This device has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2: 2001, EN55011: 2000, Class B, Group 1. These limits are designed to provide reasonable protection against harmful interference in a typical 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: - Reorient or relocate the receiving device - Increase the separation between the devices. - Connect the device into 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.

2-3

CAUTION • In 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 with other equipment such as life-support equipment, other equipment that has major affects on the life of the patient and results of treatment, or other measurement or treatment equipment that involves small electric current. - Do not use the device simultaneously with portable and mobile radio frequency communication systems because it may have an adverse effect on operation of the device. - Do not use cables and accessories that are not specified for the device because that may increase the emission of electromagnetic waves from the device or the system and decrease the immunity of the device to electromagnetic disturbance. • The Electromagnetic Compatibility Directive sets the essential requirements for electrical and electronic equipment that may disturb, or be disturbed by, other equipment. The ARK-730A complies with these requirements as tabled on pages 12-1 to 12-3. Follow the guidance in the tables for use of the device in an electromagnetic environment.

2-4

2.2 Connecting the Device to a Wall Outlet and Handling the Power Cord CAUTION • Be sure to use a (HOSPITAL GRADE) wall outlet equipped with a grounding terminal in order to avoid electric shock or fire in the event of power leak. • Be sure to use an outlet equipped with a grounding terminal which meets the specified power requirements. The device may not deliver full performance, or malfunction or fire may result. In addition, if the outlet is not equipped with a grounding terminal, there is a fear of electric shock in the event of power leak. • Securely connect the mains plug into an outlet. Insecure connection may result in fire. • To disconnect the mains plug, hold it. If the power cord is pulled, short circuit or electric shock may result in case of break in the wires inside the power cord. • Never put heavy objects on the power cord nor catch the cord between any objects. The cover of the power cord may become worn and fire or electric shock may result. • If the metal core of the power cord is exposed, the power turns on and off by shaking the power cord, or cord or plug gets so heated that one cannot hold it, it means that the cord is damaged. Replace the power cord immediately. Electric shock or fire may result. • Wipe between the prongs of the mains plug with a dry cloth occasionally. If dust settles between the prongs, the dust easily takes up moisture, and short circuit and fire may result. • If the device will not be used for a long time, disconnect the power cord from the wall outlet. Fire may result.

2-5

2.3 Cautions during Use CAUTION • Do not use the device for other than the intended purpose. NIDEK is not responsible for accidents or malfunction caused by misuse. • Never disassemble nor touch the inside of the device. Electric shock or device malfunction may result. • In advance of measurement of each patient, wipe the forehead rest and chinrest with a clean cloth such as gauze. If necessary, wipe the forehead rest and chinrest using a cloth dampened with rubbing alcohol. • Keep fingerprints and dust off of the measuring window. Reliability of the measured data may be lowered substantially. • When the device is not in use, turn it off and place the cover over the device. If the device is not covered, dust may accumulate and affect measurement accuracy. • In the event of failure in the device, do not touch the inside of the device, but disconnect the power cord from the outlet and contact NIDEK or your authorized distributor

2-6

CAUTION • Information on the avoidance of overexposure to potentially hazardous optical radiation (ISO 15004: 1997) Spectrally weighted photochemical radiances LB and LA give a measure of the potential that exists for a beam of light to cause photochemical hazard to the retina. LB gives the measure for eyes in which the crystalline lens is in place. LA gives this measure either for eyes in which the crystalline lens has been removed (aphakes) and has not been replaced by a UV-blocking lens or for the eyes of very young children. The value stated for this ophthalmic device gives a measure of hazard potential when the device is operated at maximum intensity and maximum aperture. The values of LA or LB for the ARK-730A are sufficiently low as shown on the following page. The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time. For instance, at a radiance level of 1 mW/(cm2•sr), 240 min irradiation of the dilated (8 mm diameter) pupil would cause the retinal exposure dose level to attain the recommended exposure limit. If the value of radiance were reduced to 0.1 mW/(cm 2•sr), ten times that time (i.e. 2400 min) would be needed to reach the recommended limit. The recommended exposure dose is based on calculations arising from the American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Values for Chemical Substances and Physical Agents (1995 - 1996 edition). The following page shows the graph of spectrum output for the ARK-730A. Patients will be at low risk of acute optical radiation with the ARK-730A. However, it is recommended that the intensity of light directed into the patient’s eye be limited to the minimum level which is necessary for diagnosis. The total of the retinal exposure dose must be carefully watched for infants, aphakes and persons with diseased eyes who are at greater risk when other ophthalmic devices with a high level of radiance are used in conjunction.

2-7

CAUTION Spectrum output of all light source during AR measurement (maximum light intensity) ARK-710A / 光放射ｴﾈﾙｷﾞｰ / AR測定時 7

放射照度：(μW/c㎡) Irradiance:

6 5 4 3 2 1 0 300

400

500

600 700 Wavelength: 波長：(nm)

800

900

1000

Spectrum irradiance *1 LA (µW/cm2/sr) 380 - 700 nm *2 LB (µW/cm2/sr) 305 - 700 nm

0.788 0.089

Spectrum output of all light source during KM measurement (maximum light intensity) ARK-710A / 光放射ｴﾈﾙｷﾞｰ / KM測定時 7

放射照度：(μW/c㎡) Irradiance:

6 5 4 3 2 1 0 300

400

500

600

700

800

900

Wavelength: 波長：(nm)

Spectrum irradiance *1 LA (µW/cm2/sr) 380 - 700 nm *2 LB (µW/cm2/sr) 305 - 700 nm *1 *2

0.008 0.001

LA: Spectrally weighted photochemical aphakic source radiance LB: Spectrally weighted photochemical phakic source radiance

1000

2-8 { Patient environment The patient environment represents a space where there is a possibility of direct contact between the patient or the operator and third person. When another type of device is used in the patient environment, use a device that complies with IEC 60601-1. If the devices that do not comply with IEC 60601-1 are used, it is necessary to use an isolating transformer to power the device or to connect the devices to additional protective grounding.

Radius of 1.5 m

2.5 m

1.5 m

1.5 m

2-9

2.4 Maintenance CAUTION • Before fuse replacement, turn the device off and disconnect the power cord from the wall outlet. Electric shock may result. • Replace the fuses with the specified fuses only. Fire may result. • Never use an organic solvent such as paint thinner to wipe off the exterior. This may ruin the surface. • Service work should be performed only by service persons authorized by NIDEK. NIDEK is not responsible for any accidents resulted from improper servicing. • When the device is not in use, turn off the power switch and place a cover over the device. If the device is not covered, dust may affect measurement accuracy. • When the device is sent back to NIDEK for repair or maintenance, wipe the surface (especially, the area where the patient’s skin contacts) of the device with a clean cloth immersed in 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 largely different from the subjective measurements. NIDEK is not responsible for any accidents resulted from improper servicing.

2.5 Disposal NOTE • Follow local governing ordinances and recycling plans regarding disposal or recycling of device components. The device contains the circuit board with the lithium battery. Because the disposal method of lithium batteries varies according to the government, follow the local governing ordinates and recycling plans when disposing of the circuit board with the lithium battery. • When disposing of packing materials, sort them by material and follow local governing ordinances and recycling plans.

2 - 10

2.6 Labels The following labels and indications are affixed to draw the operator’s attention.

or

or

(Only marketed for NIDEK INCORPORATED)

or

or

§3 CONFIGURATION Measuring unit

Main body

TV monitor Start button

Display panel

Joystick Memory indicator Print button (clear button) Change button R/K button

Auxiliary button cover Locking knob Base unit

IOL button Power switch Printer

3D auto button UP button View Comparison button DOWN button

TV monitor Displays the patient’s eye, target, focusing indicator, KM measured data (corneal curvature radius), measurement count, and mire ring projected on the patient’s eye.

Auxiliary button cover Used to cover the buttons that are seldom used. See page 3-5 for details of the buttons inside the cover.

Display panel Displays measured data of AR (refractive error), CS (Corneal Size), PS (Pupil Size), and PD (Pupillary Distance) measurements. SPH: Spherical power CYL: Cylindrical power AXIS: Cylinder axis The R (right) or L (left) indicator shows the eye to be measured as well as the eye of measured data on the display.

Locking knob Used to fix the main body to the base unit. To lock the main body, bring it to the center of the base unit and turn the knob counterclockwise while holding it down. To temporarily lock the body at any position, turn the knob clockwise. Do not lock the main body with this locking knob during transportation. Otherwise, breakdown of the device may result.

3-2 Used to move the guidelines on the TV monitor during CS and PS measurements. It is also used to change parameter settings, date & time settings and enter comments.

Used for the comparison function. Changes the current viewing condition (unaided eye or corrected with glasses that the patient uses) and the viewing condition corrected according to AR measurement.

Used to check the viewing condition for near vision. Pressing this button again returns the device to its original state. It is also used to move the guidelines on the TV monitor during CS and PS measurements, and change parameter settings, date & time settings and enter comments.

Changes between ON and OFF of the autotracking and auto-shot functions.

Used when an IOL-implanted eye or an eye with a contact lens is measured. If such eyes are measured without turning on the IOL mode, an error may appear and measurement may not be completed.

Used to change modes to select whether to perform AR measurement and KM measurement in succession or separately. The mode changes in the order of R/K mode (AR and KM in succession),→ R mode (AR measurement),→ K mode (KM measurement)→ R/K mode... .

Used to change from AR/KM measurement to CS/PS/PD measurement. By pressing this button, the mode changes in the order of CS,→ PS,→ Manual PD, → CS... . (To change back from CS/PS/ PD measurements to AR/KM measurements, press .)

Prints measured results. Holding down this button for 2 seconds does not print but clears measured data.

Memory indicator Indicates that measured data is being stored in the memory. Illuminated: Being stored Not illuminated: Not being stored Flashing: Auto-off mode Joystick Used to move the main body right, left, back and forth. Manipulating the lever moves the main body right, left, back and forth. Turning the upper part of the lever moves the measuring unit up and down. Start button Used to start AR, KM, and PD measurements. It is also used to change the item number of system parameters.

3-3

Auto-shot ON mark Auto-tracking ON mark Mire ring

Cylinder mode indication Focusing indicator Measurement mode Measurement count

Target

KM measurement (Latest values) R1: Flattest meridian R2: Steepest meridian AXIS: Corneal cylinder axis

Min. pupil marker

[Measurement Screen]

COMPARE indication

Data to be compared with AR-measured data

[Screen during View Comparison]

AR-measured data SPH: Spherical power CYL: Cylindrical power AXIS: Cylinder axis

3-4 Auto-shot ON mark Shows that the auto-shot function is active. Auto-tracking ON mark Shows that the auto-tracking function (up, down, left and right) and/or auto-focusing function are active. Mire ring Used as a reference ring for alignment. When the auto-tracking function is on, bring this ring close to the target so that the device automatically starts alignment. When the auto-tracking function is off, place the ring concentric with the target. The ring can also be used to observe the shape of the corneal surface. Cylinder mode indication Indicates the current cylinder mode. Focusing indicator Indicates the distance between the measuring unit and the patient’s eye when the auto-tracking function is on. Target Used as a guide to place the patient’s eye in the center of the TV monitor during AR and KM measurements. Min. pupil marker Indicates the minimum pupil size measurable. The device may not perform measurement when the pupil size is smaller than this marker or eyelashes are within this marker.

COMPARE indication Indicates that the View Comparison function is active. Data to be compared with AR-measured data “ ”⇒ Unaided eye “LM”⇒ Patient’s glasses When data of the patient’s glasses is transferred from a lensmeter, the dioptric powers of the glasses will be shown. When the patient looks at the chart with these dioptric powers, “ ” or “LM” on the left of the monitor will flash. AR-measured data Indicates median values or latest values. When the patient looks at the chart with these dioptric powers, “AR” on the left of the TV monitor will flash.

3-5

Contrast control Brightness control

Setting button

CYL mode change button

Eyeprint button

[Auxiliary Buttons]

3-6 Contrast control Used to adjust the contrast of the TV monitor. Brightness control Used to adjust the brightness of the TV monitor.

Used to set system parameters, date and time, and enter comments.

Prints the eyeprint view of measured data. The eyeprint is printed out regardless of its parameter setting. It is also used to change parameter settings, date & time settings and enter comments.

Changes the cylinder mode, the reading direction of cylinder data. + mode ... Cylinder data will be indicated by a + reading. – mode ... Cylinder data will be indicated by a – reading. MIX mode .. Cylinder data will be indicated by a + reading when the refractive error is positive for any meridian. In other cases, cyl. data will be indicated by a – reading. • The cylinder mode can be changed even after measurement. • Data will be printed out with the mode status at the time of printing.

3-7

Forehead rest

Measuring window Eye level marker

LED for corneal illumination

Chinrest

PD window

Chinrest knob

[Top view]

TV monitor H control [Underside view] TV monitor V control

Interface connectors

Fuses

Power inlet [Underside]

3-8 Measuring window Patient looks at the chart through this window. Eye level marker Used as a guide for the patient’s eye level for measurement. The height of the chinrest should be adjusted so that the center of the patient’s eye almost aligns with this line. Chinrest knob Turning the chinrest moves the chinrest up and down. Use the eye level marker as a guide to adjust the patient’s eye level to a comfortable height for measurement. TV monitor H control Adjusted with a screwdriver when the TV monitor does not lock horizontally. Can be found on the underside of the main body.

TV monitor V control Adjusted with a screwdriver when the TV monitor does not lock vertically. Can be found on the underside of the main body. Interface connectors*1 side: Connect the interface cable to transfer measured data to a NIDEK refractor. The optional Eye Care card system is connected to this side. side: Connect the interface cable from a NIDEK lensmeter to import measured data.*2 To read a patient ID using the optional barcode scanner, it is connected to this side.*3 By connecting the lensmeter to the side side, LM data and the refractor to the can be transferred to the refractor via the ARK. Pressing the print button on the lensmeter starts data transfer.

*1 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. *2 When communicating with a lensmeter, set communication parameters for each device as follows: For the setting procedure, see the Operator’s Manual of each device. • ARK-730A • NIDEK Lensmeter 53: Baud Rate = 9600 RS-232C = NIDEK Data Bits = 8 54: Bit Length = 8 Baud Rate = 9600 Stop Bits = 1 56: IN Port Sel. = LM Parity = Odd *3 When connecting the optional barcode scanner, set parameters as follows: See “8.1 Setting Parameters” (p. 8-1). 53: Baud Rate = 9600 54: Bit Length = 8 56: IN Port Sel. = Barcode

§4 OPERATING PROCEDURES 4.1 Operation Flow Power ON 4.3 Preparation for Measurement

(p. 4-2)

Measurements →4.4 AR (refractive error), KM (corneal curvature radius) Measurements →4.4.1 When both auto-tracking and auto-shot are ON (p. 4-6) →4.4.2 When both auto-tracking and auto-shot are OFF (p. 4-14) →4.4.3 When auto-tracking is ON and auto-shot is OFF (p. 4-16) →4.5 CS (Corneal Size) Measurement (p. 4-17) →4.6 PS (Pupil Size) Measurement (p. 4-19) →4.7 PD (Pupillary Distance) Measurement (p. 4-21) →4.8 Measuring Sagittal Radius (p. 4-23) 5. PRINT OUT

(p. 5-1)

Power OFF (Determine final prescription by subjective refraction.)

4.2 Auto-Off Mode The device will go into the auto-off mode automatically to save power if no operation is performed for five minutes*1. OFF The auto-off mode places the device into the following conditions: Time • The TV monitor goes off. Flashing • Time appears on the display panel. • The memory indicator flashes. The device recovers to the normal mode from the auto-off mode by the following methods: • Press any switch. • Manipulate the joystick to move the base R or L.

NOTE

• The device may not go into the auto-off mode depending on the condition of the screen. • When the device goes into the auto-off mode from the Comparison View function screen, it will recover to the normal mode. (Only when the “Compare SW” parameter is set to “Manu.”) • When the device goes into the auto-off mode from the screen of CS, PS or PD measurement, it will recover to the normal mode. *1 Time to activate the auto-off mode can be changed. The parameter setting can be set so that the auto-off mode will not activate. See “8.1 Setting Parameters” (p. 8-1).

4-2

4.3 Preparation for Measurement

Auto-shot ON mark Auto-tracking ON mark

1. Turn on the power switch. The display panel is indicated as shown on the right. On the TV monitor are the target, focusing indicator and min. pupil marker in the center, auto-tracking ON mark, and auto-shot ON mark in the upper center, cylinder mode on the upper right, and measurement count on the lower left.

Min. pupil marker

Focusing indicator Target

When the power is turned on, the main body makes small right/left movements in order to determine the initial setting position for autotracking. This does not mean that the device has been broken.

NOTE • If “<PD ERR>” is shown on the left side of the TV monitor, the device may not recognize the left eye or right eye (measurement may not be performed binocularly), and also the PD (pupillary distance) may not be measured. Check the PD window. If the PD window is covered by anything, remove it. If covered by dust, wipe lightly with a swab with a little alcohol to clean it. If “<PD ERR>” is still shown on the monitor even after performing the corrections described above, install the device in a low light interference environment since the error may have occurred due to light interference.

PD window

NOTE • “Err” will appear on the display panel if the power is turned on with no printer paper set. To correct the condition, turn on the power switch again after setting the printer paper.

4-3 2. Open the auxiliary button cover and set measurement conditions. The cover can be opened by sliding it to the left. a. : See “6. VARIOUS SETTINGS” for details of setting parameters. b. : Set the cylinder mode, indication of cylinder reading direction. CYL +... Indicates cylindrical power by a + reading. CYL – ... Indicates cylindrical power by a – reading. CYL ±... Indicates the cylindrical power by a + reading when the refractive error is positive (MIX) for any meridian. Indicates the cylindrical power by a – reading in other cases. * The cylinder mode can be changed even after measurement. * Data will be printed out with the mode status at the time of printing. * When the cylinder mode is set to CYL+, the AXIS value of KM measurement indicates the angle of the steepest meridian. In other cases (CYL–, CYL±), the AXIS value indicates the angle of the flattest meridian.

4-4 3. Press to select the measurement mode. The mode changes in the order of R/K→ R→ K→ R/K... . R/K mode ... AR/KM measurement in succession R mode ... AR measurement K mode ... KM measurement 4. If you are AR-measuring an IOL-implanted eye or an eye with a contact lens, turn on the IOL mode by pressing . The IOL ON mark will appear on the top left of the TV monitor.

NOTE • When an IOL-implanted eye or an eye with a contact lens is measured, the IOL mode must be turned on. If such eyes are measured without turning on the IOL mode, an error message may appear and measurement may not be completed.

IOL ON mark

• The IOL mode will automatically turn off by sliding the main body or after printout. • The IOL mode will automatically turn on when a measurement error has occurred three times in a row. (Auto IOL*2)

5. Prepare the patient. 1) Clean the forehead rest and chinrest with clean gauze. If a stack of chinrest paper is fixed to the chinrest, remove one sheet of paper. 2) Instruct the patient to take off his/her glasses or contact lenses and have a seat.

*2 <Auto IOL> See “8.1 Setting Parameters” for details of setting parameters.

4-5 3) Instruct the patient to place his/her chin on the chinrest and forehead on the forehead rest. Eye level marker Chinrest knob

4) Adjust the height of the chinrest by turning the chinrest knob until the center of the patient’s eye aligns with the eye level marker.

NOTE • To relax the patient, explain as follows before measurement. “This device measures your eye with an infrared ray to find which kind of lens fits you. The infrared ray does no harm to your eyes.”

4-6

4.4 AR (refractive error), KM (corneal curvature radius) Measurements 4.4.1 When both auto-tracking and auto-shot are ON Alignment and focusing are automatically performed and measurement starts when in the optimum position. When the auto-tracking function is ON, auto-focusing is also performed. 1. Make sure that (auto-shot ON mark) and (auto-tracking ON mark) are shown on the upper part of the TV monitor. When they are not shown, press to turn on the auto-tracking and auto-shot functions. 2. Perform rough alignment. 1) Instruct the patient to: “Look through the measuring window. As you will see a picture of a balloon, watch the center of it without straining. 2) Manipulate the joystick to place the patient’s eye onto the TV monitor. By moving the joystick laterally, the main body moves right, left, back and forth. By turning the upper part of the joystick, the main body moves up and down. Align the eye position to the measuring point with right, left, up and down movements. Adjust the focus with back and forth movements.

NOTE • If the mire ring is not in the center of the pupil and the min. pupil marker is on the iris, turn off the auto-tracking function and bring the min. pupil mark into the center of the pupil to perform measurement, ignoring the mire ring. • Auto-tracking or auto-shot may not work on keratoconus or postoperative cornea. In such a case, turn off the auto-tracking and auto-shot functions. See “4.4.2 When both auto-tracking and auto-shot are OFF” (p. 4-14).