ARK-30 Operators Manual Type R 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 32725-P902G Printed in JAPAN

BEFORE USE OR MAINTENANCE, READ THIS MANUAL. The Operator’s Manual contains information necessary for the operation of the NIDEK AUTO REF/KERATOMETER Model ARK-30. This manual includes operating procedures, cautions for safety, and specifications. The device complies with ISO 10342 (Ophthalmic instruments - Eye refractometers). IEC and UL standards are applied in this manual. The dioptric powers are indicated with reference wavelength λd = 587.56 nm. For correct use, this manual is needed. Especially, the cautions for safety and operating procedures must be thoroughly understood before using the device. Keep this manual handy to verify use whenever necessary. There are no user-serviceable parts inside the device except the printer paper, fuse, and battery. If you encounter any problems or have questions about the device, contact your authorized distributor.

(This applies only to the equipments whose power source is 100/120Vac.)

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 ... 1-2

§2 SAFETY ... 2-1 2.1 Cautions during Use ... 2-1 2.2 Storage ... 2-6 2.3 Transport... 2-6 2.4 Installation ... 2-7 2.5 Wiring ... 2-8 2.6 After Use ... 2-8 2.7 Maintenance and Checks ... 2-9 2.8 Disposal ... 2-9 2.9 Labels ... 2-10

§3 CONFIGURATION ... 3-1 §4 OPERATING PROCEDURES ... 4-1 4.1 Operation Flow ... 4-1 4.2 Before First Use ... 4-1 4.3 Measuring Procedures ... 4-4 4.4 AR (refractive error) & KM (corneal curvature radius) Measurements (R/K mode) ... ... 4-18 4.5 AR (refractive error) Measurement (R mode) ... 4-20 4.6 KM (corneal curvature radius) Measurement (K mode) ... 4-22 4.7 90º Angle Correction Function ... 4-24 4.8 Measurement Using Cable ... 4-26 4.9 Storing and Printing Measured Results ... 4-28 4.9.1 Storing measured results ... 4-28 4.9.2 Printing stored data ... 4-30 4.9.3 Clearing measured results in memory ... 4-32 4.9.4 Confirming measured results in memory ... 4-33 4.10 Connection with External Devices ... 4-34 4.10.1 Output to the RT or computer ... 4-34 4.10.2 Input from the LM ... 4-36 4.10.3 Output to the IC card Reader/Writer ... 4-38

Page 4.10.4 Output to the IC card Reader/Writer (EyeCa-RW) ... 4-40 4.11 Sagittal Radius Measurement ... 4-42

§5 PRINTOUT ... 5-1 5.1 Printing Measured Values ... 5-1 5.2 Other Prints ... 5-5 5.2.1 Printout sample of stored data ... 5-5 5.2.2 Printout sample of parameter ... 5-6

§6 OTHER FUNCTIONS ... 6-1 6.1 Parameter Settings ... 6-1 6.2 Setting Date and Time ... 6-9 6.3 Entering Comments ... 6-11

§7 TROUBLESHOOTING GUIDE ... 7-1 §8 MAINTENANCE ... 8-1 8.1 Replacing Printer Roll ... 8-1 8.2 Installing/Removing Battery ... 8-3 8.3 Charging Battery ... 8-4 8.4 Attaching/Detaching the Strap... 8-6 8.5 Attaching the Eye Mask ... 8-8 8.6 Replacing Fuses... 8-9 8.7 Cleaning the Measuring Window ... 8-10 8.8 Cleaning Exterior ... 8-11 8.9 Lists of Replacement Parts ... 8-11

§9 SPECIFICATIONS ... 9-1 §10ACCESSORIES ... 10-1 10.1 Standard Accessories ... 10-1 10.2 Optional Accessories ... 10-1

§11EMC (ELECTROMAGNETIC COMPATIBILITY) ... 11-1 APPENDIX. A GLOSSARY ... A-1 INDEX ...End of this manual

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§1 INTRODUCTION 1.1 Outline of the Device The NIDEK Auto Ref/Keratometer ARK-30 is an objective refraction measurement device that contains the functions for measuring refractive errors such as spherical power, cylindrical power, and cylinder axis and the functions for measuring corneal shapes such as the corneal curvature radius (corneal refractive power), angle of meridian, and corneal cylindrical power. The measured value of refractive errors are mainly used as the reference of the lens prescription for correction of visual acuity in spectacle and contact lenses. The measured value of the corneal curvature is used for the prescription of visual acuity corrective lenses such as contact lenses. It is also used to observe the corneal curvature radius necessary for setting the refractive power of intraocular lens that will be implanted after cataract surgery and the change process of the postoperative corneal shape after corneal surgery. This device is a hand-held type that allows children who cannot fix their head on the stationary chinrest and lying patients to be measured. As well as the compact station, the device can be easily moved, which makes the measurement possible in a sick room or operating room where the measurement is not possible with the stationary type. The device consists of a measuring unit and a station. The station is provided with a power supply, a charger, and a printer to print the measured results. The measuring unit is provided with a color LCD monitor and a control panel, etc. to perform alignment and operation. To make the measurements easier, an auto-shot function is available, which will start the measurement automatically when the patient’s eye is aligned and focused. The built-in RS-232C interface allows you to output data to a personal computer.

1.2 Indications for Use The Model ARK-30 Auto Ref/Keratometer is a diagnostic device that is indicated for use in the automated measurement of refractive errors of the eye, and in the measurement of the corneal curvature of the eye.

1.3 Classifications [Classification under the provision of 93/42EEC (MDD)] Class IIa The ARK-30 is classified as a Class IIa device. [Form of protection against electrical shock] Class I The ARK-30 is classified as a Class I device. The Class I device is a device in which protection against electric shock does not rely solely on basic insulation. The Class I device includes additional safety precaution that provides for a connection of accessible conductive parts to a protective (earth) grounding conductor in the fixed wiring of the installation. Use a power outlet which is equipped with a ground terminal.

1-2 [Degree of protection against electrical shock] Type B applied part The ARK-30 is provided with a Type B applied part. The Type B applied part provides an adequate degree of protection against electrical shock, particularly regarding the following: - allowable leakage currents - reliability of the protective earth ground connection (if applicable) [Degree of protection against liquid entry] IP20*1 The ARK-30 is classified as a normal device, as such provides only minimal protection against liquid intrusion. Avoid splashing water or another liquid on or in the device. [Degree of protection against flammability] The ARK-30 is classified as a device not suitable to be used in a potentially flammable environment. Do not operate the device near flammable type materials. [Method (s) of sterilization or disinfection recommended by the manufacturer] The forehead rest can be cleaned with a cloth dampened with rubbing alcohol as necessary. [Mode of operation] Classification of the ARK-30: Continuous operation

1.4 Symbol Information This symbol on the device indicates that caution must be taken. Refer to the operator’s manual before use. This symbol indicates that the degree of protection against electrical shock of the applied part is classified as a Type B applied part. This symbol on the control panel indicates the start button for placing the device in the measurement mode. This symbol on the control panel indicates the power button for turning the measuring unit on and off. Pressing the button turns the measuring unit on and off.

*1 In accordance with IEC 60529

1-3 This symbol on the station indicates that the power is on. This symbol on the station indicates that the power is off. This symbol on the control panel indicates the print button for transmitting the measured results to the station for printing out. On the station, this symbol indicates the feed button for feeding the printer paper. This symbol on the control panel indicates the parameter button for displaying the menu to change the settings on the screen. This symbol on the control panel indicates the memory button to store the median values of the measured results. On the station, the illuminated lamp for this symbol indicates that AR and KM data that will be outputted externally are being stored in memory. This symbol on the control panel indicates the angle correction button for rotating the measuring optical axis 90°. This is the symbol on the control panel and station. The lamp with this symbol flashes while the battery is being charged. This symbol indicates the fuse rating. This symbol indicates that the device must be supplied only with alternating current. This symbol indicates the connection part that is suitable for direct current only. This indicates the input part. This indicates the output part. This symbol on the station indicates that power is supplied to the station and the power switch is turned on when the lamp with this symbol is illuminated.

§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 Cautions during Use CAUTION • Do not modify or touch the inside of the device. This may result in an electric shock or a malfunction. • Do not dismantle or modify the battery. Heat generation, explosion, or combustion may result. • Never remove the power cord from the wall outlet by holding on to the cord. This may damage the cord and cause a short circuit or an electric shock. Grasp the plug then pull. • Do not place heavy objects on the power cord to prevent damage to the power cord, and a fire or an electric shock. • Immediately replace the power cord if the internal wires are exposed, the device power turns on or off when the power cord is moved, or the cord and/or plug becomes extremely hot. This may result in an electric shock or a fire. • Do not use the device for other than the intended purpose. NIDEK will not be responsible for accidents or a malfunction caused by carelessness. • Wipe between the prongs of the main plug with a dry cloth every once in a while. If dust settles between the prongs, the dust will collect moisture, and a short circuit or a fire may occur. • Before measuring a patient, wipe the forehead rest with a clean cloth. If necessary, wipe the forehead rest with a cloth dampened with rubbing alcohol.

2-2

CAUTION • In the event of a malfunction, do not touch the inside of the device, but disconnect the power cord from the wall outlet and contact your authorized distributor. • There may be cases where a measuring eye (R/L) is not detected correctly, depending on the shape of the patient’s face. Change the setting by pressing the R/L selection button if the indication of the measuring eye side is not correct. • When moving the device with your hand, use the hand strap or neck strap (option). To move the device, be sure to hold the grip. Do not hold the hand strap only. Accidentally dropping the device may cause an injury or a malfunction. For a malfunction caused by dropping the device, the warranty is not valid. You must pay to repair the device. • Bring the device to the patient’s face after drawing out the forehead rest. The device may contact the patient’s face. • Keep the measuring window free of fingerprints and dust to prevent the measurement accuracy from decreasing. • The date and time may deviate if the battery is removed from the measuring unit for more than 12 hours. In this situation, reset the date and time. • The measured values of objective refractive power obtained by the ARK-30 are intended to be used as a reference of lens prescription for the correcton of visual acuity with spectacle or contact lenses. Manifest refraction must be used as the basis for the spectacle or contact lens prescription.

2-3

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-30 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 0.5 mW/(cm2•sr), 480 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 0.05 mW/(cm2•sr), ten times that time (i.e. 4800 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-30. Patients will be at low risk of acute optical radiation with the ARK-30. 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.

2-4

CAUTION Spectrum output of all light source during AR measurement (maximum light intensity) AR-20/ARK-30 ARK-30

10 8 7 6 5 4

ance:

Irradi放射照度：(μW/c㎡)

9

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

0.527 0.056

Spectrum output of all light source during KM measurement (maximum light intensity) AR-20/ARK-30 ARK-30

7

5 4 3 ance:

Irradi放射照度：(μW/c㎡)

6

2 1 0

300

400

500

600

700

800

900

Wavelength: 波長：(nm)

Spectrum irradiance *1 LA (µW/cm2/sr) 380 - 700 nm B

2

* L (µW/cm /sr) 305 - 700 nm 2

*1 *2

0.002 0.030

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

1000

2-5 { 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

2-6

2.2 Storage CAUTION • Store the device in a place that is dry and free from poisonous gas. • The device must be maintained under the following conditions during transport and storage (packed condition). Environmental conditions Temperature: –20ºC to 60ºC Humidity: 10% to 95% (No condensation) A place with low dust A place not exposed to direct sunlight

2.3 Transport CAUTION • Do not drag the cord or cables when moving the device to prevent an injury or a malfunction. • Place the device in the shipping carton or optional carrying case when moving to another location. Do not use the carrying case if you ask the moving company to take care of the device. Excessive vibration or impact may cause a device malfunction.

2.4 Installation CAUTION • Do not install the device near water. Keep water away from the device to prevent an electric shock or a malfunction. • Install the device on a stable and level surface free from vibration and impact to prevent a malfunction or an injury caused by knocking over the device. • For printing, wireless communication is performed using infrared beams from the measuring unit to the station. Install the device where the light-receiver window of the station is not exposed to intense light such as sunlight and illumination that contains infrared rays. If the intense external light comes into the light-receiver window, printing may not be performed correctly. Cut off sunlight with a curtain and turn off nearby illumination.

2-7

CAUTION • Install the device in an environment that meets the following conditions. Conditions in use Temperature: 10ºC to 40ºC Humidity: 30% to 75% (No condensation) Pressure: 700 hPa to 1060 hPa A place with little dust A place with little external light A place free of vibration and impact • This device complies with the limits for medical devices in IEC60601-1-2: 2001, EN606011-2: 2001, and Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a standard medical installation. This device generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this device does cause harmful interference to other devices, which can be determined by turning the device off and on, the user is encouraged to try to correct the interference by one or more of the following measures: - Reorient or relocate the receiving device. - Increase the distance to the device. - Correct 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 assistance. • 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 ARK30 complies with these requirements as tabled on pages 11-1 to 11-3. Follow the guidance in the tables for use of the device in an electromagnetic environment.

2-8

2.5 Wiring CAUTION • Be sure to use a wall outlet which meets the requirements of the power specification. If the line voltage is too high or too low, the device may not give full performance. A malfunction or a fire may occur. • Do not put many loads on one electrical outlet. A fire may occur. • Insert the mains plug into a grounded wall outlet. An electric shock or a fire may occur in case of a device malfunction or power leakage. • Securely connect the main plug into a wall outlet. A loose connection may cause a fire. • Be sure to connect the interface cable, checking the symbols of input (IN: (OUT: ). Correct communications will not be possible.

) and output

2.6 After Use CAUTION • If the device will not be used for a long time, disconnect the power cord from the wall outlet to prevent a fire. • If the device will not be used for a long time, remove the battery from the device to prevent rust and deterioration of the battery. • Store the battery with the contact away from metal. The contact is recessed to prevent easy contact. However, if the battery is stored with a metal necklace, etc., it may result in a short circuit, which may generate heat or a malfunction. • When the device is not in use, turn off the power and put the dust cover on the device to prevent dust from affecting the measurement accuracy.

2-9

2.7 Maintenance and Checks CAUTION • Use the specified fuses to replace the old ones to prevent a fire. • Disassembly is not permitted except at NIDEK or your authorized distributor. • Never use organic solvents such as paint thinner to wipe the exterior. This may ruin the surface. • When charging and replacing the battery, use the specified battery and charger (station or measuring unit) only. In addition, do not put foreign matters such as metal into the battery slot to prevent a malfunction or a fire. • Do not discharge the battery in other devices. Do not connect the positive and negative terminals with metal such as wire to prevent damage, deterioration, and shortened lifespan of the battery. • Do not dismantle or modify the battery to prevent heat generation, explosion, or combustion. • Replace the printer paper with the specified paper only to prevent damage to the head. • Before sending the device back to NIDEK for repair or maintenance, wipe the surface (especially the area that contacts the patient’s skin) 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 the 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. Especially the disposal method of lithium-ion batteries varies according to the government. A rechargeable lithium battery is used in the device. Follow the local governing ordinances and recycling plans when disposing of a board with lithium batteries. • When disposing of packing materials, sort them by material and follow the local ordinances and recycling regulations.

2 - 10

2.9 Labels To catch the attention of the user, some labels and indications are provided on the device. [Measuring unit]

2 - 11 [Station]

200-240 V range

100-120 V range