AR-20 Type R 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 32700-P902H Printed in JAPAN

FOR SAFE AND CORRECT USE BEFORE USE OR MAINTENANCE, READ THIS MANUAL. The Operator’s Manual contains information necessary for the operation of the NIDEK AUTO REFRACTOMETER Model AR-20. 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 a reference wavelength of 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, fuses, and battery. If you encounter any problems or have questions about the device, please contact your authorized distributor.

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

CAUTIONS FOR SAFETY In this manual, Signal Words are used to designate the degree or level of safety alert. The definitions are as follows.

CAUTION: Indicates a potentially hazardous situation which may result in bodily injury or damage to equipment.

Even situations that are labeled “ CAUTION” may result in serious injury under certain conditions. Safety must be followed strictly at all times.

I

CAUTIONS FOR USE

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

NIDEK will not be responsible for accidents or a malfunction caused by such carelessness.

• Do not modify or touch the inside of the device. This may result in an electric shock or a malfunction. • Install the device in an environment that meets the following conditions. following conditions must be maintained during use. 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

The

• 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 intense external light comes into the light-receiver window, printing may not be performed correctly. Block sunlight with a curtain and turn off nearby illumination. • Be sure to use a wall outlet which meets the power specification requirements. If the line voltage is too high or too low, the device may not give full performance. A malfunction or a fire may occur. • Insert the mains plug into a grounded wall outlet. An electric shock or a fire may occur in the event of a device malfunction or power leakage. Do not crush or squeeze the power cord with heavy objects. The damaged power cord may cause a fire or an electric shock. • 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.

II

CAUTION • This device has been tested and found to comply with the limits for medical devices

to the IEC 60601-1-2: 2001, and 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 distance between 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 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 AR-20 complies with these requirements as tabled on pages 91 to 94. Follow the guidance in the tables for use of the device in an electromagnetic environment. •Do not put many loads on one electrical outlet. A fire may occur. • Securely connect the mains plug into a wall outlet. A loose connection may cause a fire.

III

During Use CAUTION • Be sure to connect the interface cable, checking the symbols of input (IN: output (OUT:

) and

).

Correct transmission will not be possible. • When moving the device with your hand, use the hand strap or neck strap (option) (See page 15.) To move the device, be sure to hold the grip. Do not hold the hand strap only. Accidental dropping of the device may cause an injury or a malfunction. For a malfunction caused by dropping of the device, the warranty is not valid. You must pay to repair the device. • Before measuring the patient, wipe the forehead rest with a clean cloth. If necessary, wipe the forehead rest using a cloth dampened with rubbing alcohol. • 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. The measurement accuracy may decrease substantially. • 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. In the event of a malfunction, disconnect the power cord from the wall outlet. Never touch the inside of the device and contact your authorized distributor. • Do not dismantle or modify the battery. Heat generation, an explosion, or combustion may result. • Never remove the mains plug from the wall outlet by holding its cord. Be sure to grasp the plug. This may damage the cord and cause a short circuit or an electric shock. • Do not place heavy objects on the power cord to prevent damage to the power cord and a fire or an electric shock. • 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.

IV

CAUTION • There may be cases where the eye to be measured (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 eye to be measured is not correct.

if the indication of the

• The measured values of objective refractive power obtained by the AR-20 are intended to be used as a reference for lens prescription for the correction of visual acuity with spectacle or contact lenses. Manifest refraction must be used as the basis for the spectacle or contact lens prescription. • 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 AR-20 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).

V

CAUTION • Spectrum output of all light source during AR measurement (maximum light intensity)

AR-20 AR-20/ARK-30

10

Irradiance 放射照度：(μW/c㎡)

9 8 7 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

0.527

*2 LB (µW/cm2/sr) 305 - 700 nm

0.056

*1LA: Spectrally weighted photochemical aphakic source radiance *2LB: Spectrally weighted photochemical phakic source radiance

VI

1000

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 606011 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

VII

After Use CAUTION • When the device is not in use, turn off the power switch and put the dust cover over the device. If not, dust may affect the measurement accuracy.

• 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. • If the device will not be used for a long time, disconnect the power cord from the wall outlet. A fire may occur. • If the device will not be used for a long time, remove the battery from the device. It may form rust and deteriorate the battery performance. • The date and time may deviate when the battery is removed from the measuring unit for more than 12 hours. In this case, reset the date and time. • 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

• Place the device in the shipping carton or carrying case (option) when moving it to another location. Do not use the carrying case only when you ask a moving company for transport. Excessive vibration or impact may cause a device malfunction. • 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.

VIII

Maintenance CAUTION • Store the device in a place that is dry and free from poisonous gas.

Especially the disposal method of lithium-ion batteries varies according to the government.

• Do not drag the cord or cables when moving the device to prevent an injury or a malfunction. • Use the specified fuses to replace the old ones to prevent a fire. • Disassembly is not permitted except by NIDEK or an authorized distributor. • Never use organic solvents such as paint thinner to wipe the exterior. This may ruin the surface. • When charging or replacing the battery, use the specified battery and charger (station or measuring unit) only. In addition, do not put foreign matter 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 a shortened lifespan of the battery. • Do not dismantle or modify the battery to prevent heat generation, an 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 measurement accuracy calibration if the AR measured results are largely different from the subjective measurements.

IX

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. Follow the local governing ordinances 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 ordinances and recycling regulations.

X

Table of Contents 1. BEFORE USE... 1 1.1 Outline of the Device...1 1.2 1.3 1.4 1.5

Configuration...2 Labels and Indications on the Device...10 Checking the Contents...14 Attaching/ Detaching the Strap...15 1.5.1 1.5.2

Attaching the strap...15 Detaching the strap...15

1.6 Adjusting the Strap...16 1.6.1 1.6.2

Adjusting the hand strap...16 Adjusting the neck strap (option)...17

1.7 Charging the Battery...18 1.8 Installing/Removing the Battery...20 1.8.1 1.8.2

Installing the battery...20 Removing the battery...21

1.9 Before Initial Use...22 1.10 Describing the LCD Screen...25

2. OPERATING PROCEDURES... 27 2.1 Operation Flow...27 2.2 Measuring Procedure...27 2.2.1 2.2.2 2.2.3 2.2.4 2.2.5

Measurement of one patient...29 Measurement of two or more patients...35 Measurement of the lying patient...37 QUICK measurement mode...39 IOL measurement mode...40

2.3 Using Measured Results (stored data)...41 2.3.1 2.3.2 2.3.3

Storing measured results...41 Displaying stored data...43 Clearing stored measured results...44

2.4 Printout...46 2.4.1 2.4.2 2.4.3 2.4.4

Printing measured values...46 Printing measured results (all stored data)...50 Printing measured results (a set of stored data)...52 Printing parameter settings...53

2.5 Replacing the Printer Paper...54 2.6 Measurment when the Battery is Low...56 2.7 Parameter Settings...59 2.7.1 2.7.2

Parameter setting table...61 Setting the date and time...66

XI

:

2.7.3

Entering comments... 68

3. OPERATION WHEN PHERIPHERAL DEVICES ARE CONNECTED . . 71 3.1 Connecting to the NIDEK Motorized Refractor (RT) or Computer... 71 3.1.1 3.1.2 3.1.3

Outline... 71 Connecting procedure... 72 Operating procedure... 72

3.2 Connecting to the NIDEK Auto Lensmeter (LM)... 73 3.2.1 3.2.2 3.2.3

Outline... 73 Connecting procedure... 73 Operating procedure... 74

3.3 Connecting to the IC Card Reader/Writer... 75 3.3.1 3.3.2 3.3.3 3.3.4

Outline... 75 Connecting procedure... 75 Operating procedure of the ICS-100... 76 Operating procedure of the EyeCa-RW... 77

4. MAINTENANCE... 79 4.1 4.2 4.3 4.4

Troubleshooting... 79 Attaching the Eye Mask... 80 Replacing Fuses... 81 Cleaning... 82 4.4.1 4.4.2

Cleaning the device... 82 Cleaning the measuring window... 82

4.5 List of Replacement Parts... 84

5. SPECIFICATIONS AND ACCESSORIES... 85 5.1 Classifications... 85 5.2 Specifications... 86 5.3 Accessories... 89 5.3.1 5.3.2

Standard accessories... 89 Optional accessories... 89

6. EMC (ELECTROMAGNETIC COMPATIBILITY)... 91 7. GLOSSORY... 95 8. INDEX... 97

XII

1. BEFORE USE 1.1

Outline of the Device

1

The NIDEK Auto Refractometer AR-20 is an objective refraction measuring device that contains the functions for measuring the spherical power, cylindrical power, and cylinder axis. The measured values of refractive errors are mainly used as a reference for the lens prescription for correction of visual acuity in spectacle and contact lenses. This device is a hand-held type that allows children who cannot fix their head on the stationary chinrest and patients lying down to be measured. As well as the compact station, the device can be easily moved, which makes measurement possible in a hospital room or operating room where measurement is not feasible 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 measuring easier, an auto-shot function is available, which will start 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. Indications for use The Model AR-20 Auto Refractometer is a diagnostic device that is indicated for use in the automated measurement of refractive errors of the eye.

1

BEFORE USE: Configuration

1.2

Configuration

Measuring unit

LCD screen

Start button R/L selection button

Print button

Memory button

Parameter setting button

CYL mode selection button

Power button Grip

Angle correction button Charge indicator

LCD screen Displays the patient’s eye, target, focusing indicator, measured values, and measurement count, etc. (see page 25). The color of the characters and the background on the LCD screen can be selected from a combination of 28 kinds. See “2.7 Parameter Settings (page 59)” for details.

R/L selection button Sets the eye to be measured. Pressing this button changes the screen in the order of <

>→<

>→

(or

(right eye) or

> indicates that the right eye has been manually set and <

(left eye) will be identified automatically. > indicates the left eye.

Memory button Stores the measured results (see page 41). The memory function stores the measured results of 30 patients (60 eyes).

2

)→

) →… (see page 30).

When alignment is performed in the AUTO mode, <

(or

BEFORE USE: Configuration

CYL selection button Establishes the CYL mode of the AR measured results. Pressing this button changes the mode in the order of “CYL–” → “CYL+” → “CYL±” → “CYL–” →…(see page 24). •CYL– (Minus reading) Cylinder data is displayed by the – reading.

1

•CYL+ (Plus reading) Cylinder data is displayed by the + reading. •CYL± (Mix reading) Cylinder data is displayed by the + reading when the refractive power is positive for any axis angle. In other cases, cylinder data is displayed by the – reading. The CYL mode can be changed even after measurement. All stored data will be printed out in the CYL mode selected when the print button

is pressed.

Angle correction button Used to rotate the measuring unit 90º when the patient is measured from the side (see page 37). This is used to measure a patient who is lying down.

Start button Places the device in the measurement mode from standby (see page 23). Print button Prints measured results, etc. (see page 46). Parameter setting button Used to change the settings of the device (see page 53). Power button Turns the measuring unit on and off. Pressing this button turns on the power and vice-versa (see page 23). Turning on the power places the device in standby (see page 23). The position of the chart is initialized and the LCD screen and chart lamp light up.

Grip Use to hold the measuring unit. The battery holder is mounted inside. Open the cover to replace the battery (see page 20). Charge indicator (

)

Flashes while the battery in the measuring unit is being charged (see page 58).

3

BEFORE USE: Configuration

Eye mask

Eye level marker

Measuring window

Forehead rest

Target detector window Focus detector window Window for optical communication and detection of eye (R/L) to be measured

Lock switch

4

Hand strap mounting hooks

Neck strap mounting hooks

Stand mounting screw

Connecting cable connector

BEFORE USE: Configuration

Eye mask Open this mask to shield the patient’s eye which is not being measured (see page 29). This allows the patient to fixate his/her eye easier. To avoid damage from impact, the eye mask is easily detached. See page 80 for attaching the eye mask.

Eye level marker

1

A guide for the patient’s eye level for measurement. It is located at both the front and back sides of the eye mask (see page 30). Adjust the measuring unit so that the center of the patient’s eye is aligned with this line.

Measuring window Patient looks at the chart through this window (see page 29). Keep this window clean. The measuring window checker allows automatic confirmation of cleanliness (see page 28).

Forehead rest Place it against the patient’s forehead (top of eyebrow) to stabilize the position of the measuring unit (see page 29). The push-type lock forehead rest can be drawn out once it is pushed lightly. Use the forehead rest so that the measuring unit will not contact the patient’s face.

Lock switch Slide this switch downward to remove the grip cover (see page 20). Hand strap mounting hooks The hand strap is to be attached to prevent accidental dropping (see page 16). Neck strap mounting hooks The neck strap (option) is to be attached (see page 17). Stand mounting screw This screw secures the measuring unit to the portable stand (option). Connecting cable connector Connector for the cable when the measuring unit is connected to the station (see page 56). When the measuring unit is connected to the station using the connecting cable, the measuring unit can be used without the battery. When the measuring unit is connected to the station using the connecting cable, printing is possible through the connecting cable.

5

BEFORE USE: Configuration

Station

Feed button

Memory lamp

Charge lamp

Pilot lamp

Measuring unit stage

Printer

Light-receiver windows for printing

Connecting cable connector

6