ARK-760A Operators Manual Jan 2005

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

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§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

§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