ARK-760A Operators Manual Jan 2005

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

NIDEK INCORPORATED (United States Agent) NIDEK SOCIETE ANONYME (Authorized Representative)

: 34-14, Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan Telephone: (0533) 67-6611 Facsimile: (0533) 67-6610 : 6th Floor, Takahashi Bldg., No.2, 3-chome, Kanda-jinboucho Chiyoda-ku, Tokyo 101-0051, Japan Telephone: (03) 3288-0571 Facsimile: (03) 3288-0570 Telex: 2226647 NIDEK J : 47651 Westinghouse Drive, Fremont, California 94539, U. S. A. Telephone: (510) 226-5700 Facsimile: (510) 226-5750 : Europarc 13, rue Auguste Perret, 94042 CRETEIL, France Telephone: (01) 49 80 97 97 Facsimile: (01) 49 80 32 08 2005. 1 32160-P902K Printed in JAPAN

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-760A. 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 only to products whose power source is 100/120Vac.)

Table of Contents

§1 INTRODUCTION ...Page 1-1 1.1 Outline of the Product ... 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 Operation ... 2-1 2.2 Storage ... 2-5 2.3 Placement ... 2-5 2.4 Installation ... 2-5 2.5 Wiring ... 2-7 2.6 After Use ... 2-7 2.7 Maintenance and Checks ... 2-8 2.8 Disposal ... 2-8 2.9 Labels ... 2-9

§3 CONFIGURATION ... 3-1 §4 OPERATING PROCEDURES ... 4-1 4.1 Operation Flow ... 4-1 4.2 Preparation for Measurement ... 4-2 4.3 Objective (AR) and Corneal Curvature (KM) Measurements ... 4-6 4.3.1 When using the auto-tracking function ... 4-6 4.3.2 When not using the auto-tracking function ... 4-13 4.4 Unaided Visual Acuity Test ... 4-19 4.5 Subjective Refinement ... 4-22 4.6 Red/Green (RG) Test ... 4-32 4.7 Cylinder Test ... 4-33 4.8 Near Vision Test ... 4-34 4.9 Corneal Size (CS) Measurement ... 4-38 4.10 Pupil Size (PS) Measurement ... 4-40 4.11 Pupillary Distance (PD) Measurement ... 4-42 4.12 Measuring Sagittal Radius ... 4-44

§5 PRINTOUT ... 5-1 5.1 Printing Measurement Results ... 5-1 5.2 Eyeprint ... 5-7

§6 OTHER FUNCTIONS ...Page 6-1 6.1 System Setup ... 6-1 6.2 Setting Date and Time ... 6-11 6.3 Entering Comments ... 6-12 6.4 Measuring Hard Contact Lenses ... 6-15

§7 TROUBLESHOOTING GUIDE ... 7-1 §8 MAINTENANCE ... 8-1 8.1 Replacing the Printer Paper ... 8-1 8.2 Setting a Stack of Chinrest Paper ... 8-3 8.3 Replacing Fuses ... 8-4 8.4 Cleaning the Measuring Window ... 8-6 8.5 Cleaning the Exterior ... 8-7 8.6 List of Replacement Parts ... 8-7

§9 IC CARD SYSTEM (OPTIONAL)... 9-1 §10 SPECIFICATIONS ... 10-1 §11 ACCESSORIES ... 11-1 11.1 Standard Accessories ... 11-1 11.2 Optional Accessories ... 11-1

§12 EMC (ELECTROMAGNETIC COMPATIBILITY) ... 12-1 APPENDIX A. GLOSSARY ... A-1 APPENDIX B. Conversion table for representation of VA ... B-1 INDEX ... End of this manual

[This page is intentionally left blank.]

§1 INTRODUCTION 1.1 Outline of the Product The ARK-760A is an auto ref/keratometer which is used to measure the refractive errors of sphere, cylinder, and axis for the lens that corrects the patient’s vision into emmetropia. The device objectively measures the refraction of the patient’s eye with infrared rays and it subjectively measures the refraction by using the built-in charts and corrective lenses. 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 and down 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-760A 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-760A is classified as Class IIa. [Form of protection against electric shock] Class I The ARK-760A 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-760A 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-760A is classified as IP20*1. The ARK-760A 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-760A 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-760A: 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 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 Operation CAUTION • Never disassemble nor touch the inside of the device. This may result in electric shock or device malfunction. • Be sure to use the wall outlet which meets the specfied power requirements. If the line voltage is too high or too low, the device may not give full performance. Malfunction or fire also may occur. • Never yank the power cord to disconnect it from a wall outlet but hold the plug while disconnecting. This can weaken the metal core of the cord and may result in short circuit or electric shock. • Do not place the device on the power cord. The sheath of the cord becomes ragged and may cause electric shock or short circuit. • If the metal core of the power cord is exposed, power turns on and off by shaking the cord, or the cord/plug gets so heated that one cannot hold it, it means that the cord is damaged. Immediately replace the cord. This may cause electric shock or fire. • Do not use the device for other than the intended purposes. NIDEK will not be responsible for accidents or malfunction caused by carelessness. • In the event of malfunction, do not touch the inside of the device but remove the power cord and contact NIDEK or your authorized distributor. • The measured values of objective refractive power obtained by the ARK-760A are intended to be used as a reference of lens prescription for the correction of visual acuity with spectacle or contact lenses. Manifest refraction must be used as the basis for spectacle or contact lens prescription. • In advance of measurement of each patient, wipe the forehead rest and chinrest with a clean cloth. Moreover, remove one pirce of chinrest paper for each patient if a stack of the chinrest papers is fixed to the chinrest. If necessary, wipe the forehead rest and chinrest using a cloth dampened with rubbing alcohol.

2-2

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-760A 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-760A. Patients will be at low risk of acute optical radiation with the ARK-760A. 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.

2-3

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

Irradiance: 放射照度：(μW/c㎡)

6 5 4 3 2 1 0 300

400

500

600

700

800

900

1000

Wavelength: 波長：(nm)

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 波長：(nm) Wavelength:

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

800

900

0.008 0.001

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

1000

2-4 { 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

2-5

2.2 Storage CAUTION • Do not store the device in a place where it may get wet or where poisonous gas or liquid is stored. • Avoid storing the device in an area with excessive heat, humidity, or dust. To preserve the appearance and internal parts of the device, avoid direct exposure to sunlight.

2.3 Placement CAUTION • Do not drag the device by its cord or cable. This may cause injury or device damage. • To carry the device, hold it from the side with both your hands on its base. (Do not ever hold the forehead rest to lift up the device.) This may result in injury or device damage.

2.4 Installation CAUTION • Before connecting the power cord or interface cable, provide a stable, level, and open space. Since receptacles are under the base unit, the device may fall and may cause injury or device malfunction. • Do not install the device near water. If water gets into the internal structure, there is the possibility of electric shock or device malfunction. • Install the device in a stable and level place where vibration or shock does not occur. The device may not perform measurement correctly or may malfunction. Also, if the device is tipped over because of any accidental shock, it may result in injury.

2-6

CAUTION • Install the device in the following conditions. A low dust environment A low light interference environment A vibration and shock free environment • Install the device in an environment that can be maintained under the following conditions. Operation environment Temperature: 10 - 40ºC Humidity: 30 - 85% (non-condensing) • This device has been tested and found to comply with the limits for medical devices to the IEC-60601-1-2: 1993, EN60601-1-2: 1994, Medical Device Directive 93/42/EEC. 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 device. - 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. • 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.

2-7

CAUTION • The Electromagnetic Compatibility Directive sets the essential requirements for electrical and electronic equipment that may disturb, or be disturbed by, other equipment. The ARK-760A 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.

2.5 Wiring 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 leakage.

2.6 After Use CAUTION • If the device is not be used for a long time, disconnect the power cord from the wall outlet. This may cause fire. • When the device is not in use, turn off the power switch and place the cover over the machine. If the device is not covered, dust may affect the measurement accuracy.

2-8

2.7 Maintenance and Checks CAUTION • Disassembling for service is not permitted except by NIDEK or your authorized distributor. • Be careful not to leave fingerprints or dust on the measuring window. This will substantially lower the reliability of the measurement results. • Never use an organic solvent such as paint thinner to wipe the exterior. This may ruin the surface. • 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.

2.8 Disposal CAUTION • 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.

2-9

2.9 Labels The following labels provide safety information about each part.

or

or

MADE IN JAPAN

32160-M535-D

(Only marketed for NIDEK INCORPORATED)

or

or

2 - 10

§3 CONFIGURATION If optionally ordered:

IC Card System

TV Monitor

Changing Button Print Button

R/K Button

Display Panel Cover for Switches

Locking Knob

IOL Button Printer Power Switch Auto-shot Button

UP Button Auto-tracking Button

DOWN Button

IC Card System (Optional) If the optional IC card system has been ordered, the IC card Reader/Writer should have been factory-built in this part. TV Monitor Displays the patient’s eye, Target, Focusing indicator, KM (corneal curvature) measurements, measurement count, and Mire ring projected on the patient’s eye.

Display Panel Displays refractive errors, CS (corneal size), PS (pupil size), and PD (pupillary distance) measurements. The R (right) or L (left) indicator shows the eye to be measured as well as the eye of the measurement result on the display. Cover for Switches Inside, there are two switches for setting measurement conditions, a switch for printing “Eyeprint”, and also knobs for adjusting the contrast and brightness of the TV monitor display.

3-2 Locking Knob Used to fix the main body to the base unit. To lock the main body, bring the main body to the center of the base unit, and turn the knob counterclockwise while pressing 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 transport. Otherwise, breakdown of the device may result.

Used during CS and PS measurements to move the guide lines on the TV monitor. Also used to change the VA value when testing visual acuity.

Changes between on/off of the auto-tracking function. When the auto-tracking function is on, the device automatically controls the up, down, right, and left movement of the measuring part to adjust the alignment.

Used during CS and PS measurements to move the guide lines on the TV monitor. Also used to change the VA value when testing visual acuity.

Changes between on/off of the auto-shot function. It is available only when the autotracking function is on. When the auto-shot function is on, the device automatically starts serial measurement as soon as the device is best aligned and in ideal focus (AR and KM measurements). Also used to activate the recall function during the subjective refinement and near vision test.

Should be pressed to turn on the IOL mode when measuring an IOL-implanted eye or an eye with a Contact Lens (CL). If such an eye is measured without turning on the IOL mode, an error may appear and measurement may not be completed. During the subjective refinement and the near vision test, it is used to proceed to the next step of the programmed sequences.

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

Prints the measurement results if pressed after measurement.

Used to change from AR/KM measurements to CS/PS/PD measurements. By pressing this button measurement mode changes in the order of CS→ PS→ Manual PD→ CS... . (To return to AR/KM measurements from CS/ PS/PD measurements, press .) During the visual acuity test for distance vision or the cylinder test, used to switch among SPH, AXIS and CYL. When testing near vision, used to switch between ADD and WD.

3-3

Chart Buttons

Start Button

Memory Indicator

Joystick

Dial

Chart buttons The following six chart buttons are used to present the chart in front of the patient. Scenery Chart Button Cross-grid Chart Button

R/G Chart Button

Dot Chart Button VA Chart Button

Astigmatism Clock dial Chart Button

3-4 • Cross-grid Chart Button Used to present the cross-grid chart and place the device in the addition power measurement mode. • R/G Chart Button Used to present the Red/Green chart and place the device in the Red/Green test (RG test

) mode.

• Scenery Chart Button Used to present the scenery chart and place the device in the objective measurement mode. The switch is also used to switch between the scenery chart and astigmatism clock dial chart during the objective measurement. • VA Chart Button Used to switch to the mode for testing visual acuity. When pressed during the Objective measurement mode Unaided visual acuity test is enabled. When pressed during the addition power measurement Near vision test is enabled. When pressed during the subjective refinement Aided visual acuity test is enabled. Also used to switch between the whole VA chart and single-line chart during visual acuity test. • Dot Chart Button Used to present the dot chart to place the device in the cross cylinder (XC) test mode. When pressed during the XC test The XC test for axis refinement and that for cylinder power refinement can be switched.

• Astigmatism Clock Dial Chart Button used to present the astigmatism clock dial chart and place the device in the cylinder test mode. Also used to switch between CYL and AXIS during the cylinder test.

Start Button Used to start the AR/KM or PD measurement. Also used to change the item number of system parameters. When pressed during the XC test Switching between the Chart 1 and the Chart 2 is done. When pressed during the cylinder test The device is put into the XC test mode. When pressed while testing aided visual acuity or checking objective correction The device is put into the R/G test mode.

Joystick Used to move the main body right, left, back and forth. By turning this, the measuring unit can be moved up and down. Dial Use to change the sphere (SPH), cylinder (CYL), axis (AXIS), addition (ADD), and working distance (WD). Memory Indicator The lamp is illuminated while measurements are being stored in the memory. The lamp will go out as soon as the measurements have printed out and the device has begun the next measurement.

3-5 Screen indications during objective measurement Auto-tracking ON Mark Auto-shot ON Mark Mire Ring

Cylinder Mode Indication

Focusing Indicator Measurement Count Indication

Target

Min. Pupil Marker

Screen indications during subjective refinement

Base Values Mire Ring Min. Pupil Marker

Cylinder Mode Indication Focusing Indicator Target Operational Message

Auto-tracking ON Mark Shows that auto-tracking function is active. (During objective AR and KM measurements)

Auto-shot ON Mark Shows that the auto-shot function is active. (During objective AR and KM measurements)

3-6 Mire Ring Should be in focus at measurement. With this ring projected on the cornea, it is possible to observe the corneal shape. When the autotracking function is on, you may move this ring close to the target so that the device automatically begins alignment (controls the up, down, right, and left movement of the main body to make the ring concentric with the target). When the function is off, you should manually place the ring concentric with the target.

Operational Message The message shows the current mode (see the following table) and the next procedural step.

Current mode

Message

Objective measurement

≪OBJ. MEAS.≫ ≪R/K≫ ≪K≫

Unaided VA test

≪VA TEST≫ UNAIDED

Checking objective

≪VA AR≫

correction

≪VA SUBJ≫

Recalling the data when

≪RECALL≫

checking objective

LM

correction

≪RECALL≫ UNAIDED

Cylinder Mode Indication Indicates the current cylinder mode. Focusing Indicator When the auto-shot function is on, indicates the focusing condition (distance between the measuring unit and the patient’s eye). (During objective AR and KM measurements) When the auto tracking function is on, indicates the focusing condition (distance between the measuring unit and the patient’s eye) (During subjective refinement)

≪RECALL≫ AR RG test

≪RG TEST≫

TG test ①

≪RG TEST≫

TG test ②

≪RG TEST≫

XC test

≪AXIS XC TEST≫ ≪CYL XC TEST≫

Cylinder test

≪CYL TEST≫

Aided visual acuity test

≪VA TEST≫

Recalling the data when

≪RECALL≫

checking aided VA

LM ≪RECALL≫ UNAIDED ≪RECALL≫ AR

Target Used during measurements as a guide to place the patient’s eye in the center of the TV monitor. Min. Pupil Marker Indicates the minimum pupil size measurable. The device may not perform measurement when the pupil is smaller than this marker or eyelashes are within this marker. Base Values The values will be the initial values for subjective refinement. The AR median value or existing LM data will be used as the data.

Addition power

≪NEAR TEST≫

measurement Near vision test

≪NEAR VA≫

Recalling the data when

≪RECALL≫

checking near VA

ADD=0

Final display

≪END OF LEFT EYE≫ ≪END OF RIGHT EYE≫

The icons which appear on the operational message show the buttons as follows. → → ,

→

,

→

→ Start Button

, →

,

,

,

,

→ Dial

3-7 Contrast Control Brightness Control

Setting Switch

Eyeprint Switch

CYL Mode switch

Auxiliary Switches

3-8 Contrast Control Used to adjust the contrast of the TV monitor. Brightness Control Used to adjust the brightness of the TV monitor.

Used when setting system parameters, setting date and time, and writing comments.

Prints only the basic result and an eyeprint, which graphically tells the refractive status of the eye by pressing it after measurement. The eyeprint will be printed out regardless of the settings in the system parameters. Also, used to select one of the parameter setting modes or date & time setting mode.

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, cylinder 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 printout.

3-9

Forehead Rest

Measuring Window

Eye Level Marker

LED for Corneal Illumination

Chinrest PD Window Chinrest Knob

From-the-top view

V Control of TV Monitor Underside View H Control of TV Monitor Fuses Power Inlet

Interface Connectors

3 - 10 Measuring Window A patient looks at the chart through this window. Eye Level Marker A guide for the patient’s eye level for measurement. The height of the chinrest should be so adjusted that the center level of the patient’s eye almost aligns with this line. Chinrest Knob Used to moves the chinrest up and down. You can use the eye level marker as a guide to adjust the patient’s eye level to a comfortable height for measurement. Fuses Be sure to use the specified ones. Power Inlet The attached power cord is to be connected here.

Interface Connectors*1 side: Connect the interface cable to transfer measured results to an external computer. side: Connect the interface cable from the lensmeter to import measured results from the lensmeter. If the ARK-760A is equipped with an IC card system, the connector on the side can not be used. By connecting the Lensmeter to the side of the interface connectors and the refractor RT-2100/RT-1200 to the side, the LM (Lensmeter) data can be transmitted to the refractor via the ARK.*2 By pressing the print button on the Lensmeter, data transmission will be started.

H Control of TV Monitor Adjusted with a screwdriver when the display does not lock horizontally. Can be found under the main body. V Control of TV Monitor Adjusted with a screwdriver when the display does not lock vertically. Can be found under the main body.

*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. 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. If in doubt, consult the technical service department or your local representative. *2 When communicating with the Lensmeter, set communication parameters for each device as follows. For the setting procedure, see the Operator’s Manual of each device. • ARK-760A • NIDEK Lensmeter 53: Baud Rate = 9600 RS-232C = NIDEK 54: Bit Length = 8 Baud Rate = 9600 Parity = Odd Data Bits = 8 Stop Bits = 1

§4 OPERATING PROCEDURES 4.1 Operation Flow Power ON  4.2 Preparation for Measurement

(p. 4-2)

 Measurements → 4.3 Objective (AR) and Corneal curvature (KM) measurements (p. 4-6) → 4.3.1 When using the auto-tracking function (p. 4-6) → 4.3.2 When not using the auto-tracking function (p. 4-13) → 4.4 Unaided Visual Acuity Test (p. 4-19) → 4.5 Subjective Refinement (p. 4-22) Checking objective corrections Red/Green test

(RG test

)

Cross cylinder test (XC test) XC test for axis refinement XC test for cylinder power refinement Red/Green test

(RG test

)

Aided visual acuity test → 4.6 Red/Green (RG) Test (p. 4-32) → 4.7 Cylinder Test (p. 4-33) → 4.8 Near Vision Test (p. 4-34) Addition power measurement Near vision test → 4.9 Corneal Size (CS) Measurement (p. 4-38) → 4.10 Pupil Size (PS) Measurement (p. 4-40) → 4.11 Pupillary Distance (PD) Measurement (p. 4-42) → 4.12 Measuring Sagittal Radius (p. 4-44)  5. PRINTOUT

(p. 5-1)

 Power OFF

 (Determine the final prescription by subjective refraction.)

4-2

4.2 Preparation for Measurement 1. Turn on the power switch. The display panel indicates as shown below. On the TV monitor, you will see the target, focusing indicator and Min. Pupil Marker in the center, the Auto-tracking ON mark, and Autoshot ON mark above the center, the Cylinder mode indication in the top right, and the Measuring mode, Measurement count, and KM measurements in the bottom left. Auto-tracking ON Mark

Min. Pupil Marker Target

Auto-shot ON Mark

Focusing Indicator

Just after power-up, the main body makes slight movements to the left and right. The movement is for determining the initial position for tracking, and is not faulty.

NOTE • If “< PD ERR >” is on the left side of the TV monitor, the device may not recognize the left and right (measurement may not be performed binocularly), and also 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 indicated 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 the light interference.

4-3

NOTE • “Err” appears on the TV monitor if the power switch is turned ON on condition that the printer paper is not set. To correct the condition, turn ON the power switch again after setting the printer paper roll into the printer housing (see “8.1 Replacing the Printer Paper”).

2. Open the cover for switches and set measurement conditions. The cover can be opened by sliding it to the left. a. Using : Perform system setup. As to the procedure, see “6. OTHER FUNCTIONS”. b. Using : Set the cylinder mode, the indication of cylinder reading direction. CYL + ... Indicates cylinder power by a + reading. CYL – ... Indicates cylinder power by a - reading. CYL ± ... Indicates the cylinder power by a + reading when the refractive error is positive for any meridian. Indicates the cylindrical power by a - reading in other cases. (MIX) * The cylinder mode can be changed even after measurement. * Data will be printed out with the mode status at the time of printout. * When the cylinder mode is set to CYL+, the AXIS value in the KM measurement indicates the angle of the steepest meridian. In other cases (CYL – or CYL ±), the AXIS value indicates the angle of the flattest meridian. 3. Press the R/K button to select the measuring mode. The mode changes in the order of R/K, → R → K, → R/K... . R/K mode ...AR/KM measurements in succession R mode ...AR measurement K mode ...KM measurement

4-4 4. If you are AR-measuring an IOL-implanted eye or an eye with a Contact Lens (CL), turn on the IOL mode by pressing . The IOL ON mark appears in the top left of the monitor.

NOTE • When AR-measuring an IOL-implanted eye or an eye with a Contact Lens (CL), the IOL mode should be turned on. If such an eye is measured without turning on the IOL mode, an error message may appear and measurement may not be completed.

IOL ON Mark

• The IOL mode automatically turns off by sliding the main body or after printout. • The IOL mode automatically turns on when an error occurs for AR measurement three times in a row. (Auto IOL*1) 5. Prepare the patient. 1) Clean the forehead rest and chinrest with clean gauze. If a stack of chinrest papers is fixed to the chinrest, remove one piece of paper. 2) Instruct the patient to take off his/her glasses or contact lenses and to have a seat. 3) Instruct the patient to place his/her chin on the chinrest and to rest his or her forehead on the forehead rest. 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 the following before measurement. “This device measures your eye with an infrared ray to find which kind of lens fits you. The infrared ray does not harm to your eyes.” *1 < Auto IOL > The on/off of the Auto IOL function can be changed in the system parameters. As to the changing procedure, see “6.1 System Setup”.