ARK-30 Type R Operators Manual Nov 2010

Original instructions

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

NIDEK INCORPORATED (United States Agent) NIDEK S.A. (EU Authorized Representative)

: 34-14, Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan Telephone: +81-533-67-6611 Facsimile: +81-533-67-6610 : 3F Sumitomo Fudosan Hongo Bldg., 3-22-5, Hongo, Bunkyo-Ku, Tokyo 113-0033, Japan Telephone: +81-3-5844-2641 Facsimile: +81-3-5844-2642 : 47651 Westinghouse Drive, Fremont, California 94539, U. S. A. Telephone: +1-510-226-5700 Facsimile: +1-510-226-5750 : Europarc 13, rue Auguste Perret, 94042 Créteil, France Telephone: +33-1-49 80 97 97 Facsimile: +33-1-49 80 32 08

November 2010 32725-P912B 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 REF/KERATOMETER Model ARK-30. This manual includes operating procedures, cautions for safety, and specifications. The device complies with ISO 10342 subclause 4:2010 (Eye Refractometers) and ISO 10343 sub-clause 4: 2009 (Ophthalmometers). The dioptric powers are indicated with a reference wavelength of Od = 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.

CAUTION • United States Federal law restricts this device to sale by or on the order of a properly licensed practitioner.

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. The following conditions must be maintained during use. Conditions in useTemperature: 10 to 40ºC (50 to 104ºF) Humidity: 30 to 75% (No condensation) Pressure: 700 to 1060 hPa A place with little dust A place with little external light A place free of vibration and impact • 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. • Never use a power strip or extension cable to supply the device with power. The electrical safety may be lowered. • Do not use a power cord other than the one provided. Also do not connect the provided power cord to any other device. Failure or fire may result.

II

CAUTION • In installation and operation of the device, observe the following instructions about EMC (electromagnetic compatibility):

- Do not use the device simultaneously with other electronic equipment to avoid electromagnetic interference with the operation of the device. - Do not use the device near, on, or under other electronic equipment to avoid electromagnetic interference with the operation of the device. - Do not use the device in the same room with other equipment such as life-support equipment, other equipment that has major affects on the life of the patient and results of treatment, or other measurement or treatment equipment that involves small electric current. - Do not use the device simultaneously with portable and mobile radio frequency communication systems because it may have an adverse effect on operation of the device. - Do not use cables and accessories that are not specified for the device because that may increase the emission of electromagnetic waves from the device or the system and decrease the immunity of the device to electromagnetic disturbance. • 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. • If the instrument is connected to a PC that does not comply with IEC60601-1 (except one that uses an AC adapter that meets the Class II requirements of IEC60950-1), supply power to the instrument and PC through isolation transformers. Contact NIDEK or your authorized distributor for installing isolation transformers.

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 14). 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. • 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 to be measured is not correct.

if the indication of the eye

• The measured values of objective refractive power obtained by the ARK-30 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.

IV

CAUTION • This device is classified as Group 1 set by ISO 15004-2: 2007 Light Hazard and conforms to the standard.

• 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

V



After Use CAUTION • This device uses a heat-sensitive printer paper. To keep the printed data for a long period of time, make copies of the printouts.

The paper degrades over time and the printed data may become illegible. • 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:–20 to 60ºC (-4 to 140ºF) Humidity: 10 to 95% (No condensation) Pressure: 700 to 1060 hPa 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.

VI

Maintenance CAUTION • Disassembly is not permitted except by NIDEK or an authorized distributor.

NIDEK is not responsible for any accidents resulted from improper servicing.

• When performing maintenance work, secure sufficient maintenance space. Maintenance work in an insufficient space may result in injury. • 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. • 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.

VII



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. Inappropriate disposal may contaminate the environment.

• When disposing of packing materials, sort them by material and follow local ordinances and recycling regulations. Inappropriate disposal may contaminate the environment.

VIII

Table of Contents 1. BEFORE USE... 1 1.1 Outline of the Device...1 1.2 Intended Use...1 1.3 Configuration...2 1.4 Labels and Indications on the Device...10 1.5 Checking the Contents...13 1.6 Attaching/ Detaching the Strap...14 1.6.1 1.6.2

Attaching the strap...14 Detaching the strap...14

1.7 Adjusting the Strap...15 1.7.1 1.7.2

Adjusting the hand strap...15 Adjusting the neck strap (option)...16

1.8 Charging the Battery...17 1.9 Installing/Removing the Battery...19 1.9.1 1.9.2

Installing the battery...19 Removing the battery...20

1.10 Before Initial Use...21 1.11 Describing the LCD Screen...24

2. OPERATING PROCEDURES... 27 2.1 Operation Flow...27 2.2 Measuring Procedure...27 2.3 Getting Started and Exiting...28 2.3.1 2.3.2 2.3.3 2.3.4 2.3.5 2.3.6 2.3.7 2.3.8

Measurement of one patient...31 Measurement of two or more patients...39 AR (refractive error) Measurement (R mode)...41 KM (corneal curvature radius) Measurement (K mode)...43 Measurement of the lying patient...45 QUICK measurement mode...47 IOL measurement mode...48 Sagittal Radius Measurement...49

2.4 Using Measured Results (stored data)...53 2.4.1 2.4.2 2.4.3

Storing measured results...53 Displaying stored data...55 Clearing stored measured results...56

2.5 Printout...57 2.5.1 2.5.2

Printing measured values...57 Printing measured results (all stored data)...61

IX

:

2.5.3 2.5.4

Printing measured results (a set of stored data)... 63 Printing parameter settings... 64

2.6 Replacing the Printer Paper... 65 2.7 Measurement when the Battery is Low... 67 2.8 Parameter Settings... 69 2.8.1 2.8.2 2.8.3

Parameter setting table... 71 Setting the date and time... 77 Entering comments... 79

3. OPERATION WHEN PHERIPHERAL DEVICES ARE CONNECTED... 81 3.1 Connecting to the NIDEK Motorized Refractor (RT) or Computer... 81 3.1.1 3.1.2

Connecting procedure... 82 Operating procedure... 82

3.2 Connecting to the NIDEK Auto Lensmeter (LM)... 83 3.2.1 3.2.2

Connecting procedure... 83 Operating procedure... 84

3.3 Connecting to the IC Card Reader/Writer... 85 3.3.1 3.3.2 3.3.3

Connecting procedure... 85 Operating procedure of the ICS-100... 86 Operating procedure of the EyeCa-RW... 87

4. MAINTENANCE... 89 4.1 Troubleshooting... 89 4.2 Attaching the Eye Mask... 90 4.3 Replacing Fuses... 91 4.4 Cleaning... 92 4.4.1 4.4.2

Cleaning the device... 92 Cleaning the measuring window... 92

4.5 List of Replacement Parts... 94

5. SPECIFICATIONS AND ACCESSORIES... 95 5.1 Classifications... 95 5.2 Specifications... 96 5.3 Accessories... 100 5.3.1 5.3.2

X

Standard accessories... 100 Optional accessories... 100

:

6. GLOSSORY... 101 7. INDEX... 103

XI

:

XII

1. BEFORE USE 1.1

Outline of the Device

1

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

Intended 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

BEFORE USEConfiguration

1.3

Configuration

{ Measuring unit

LCD screen

R/L selection button

R/L selection button

Start button

Memory button

Print button

CYL mode selection button

Parameter setting button Power button

Angle correction button Grip

Charge indicator

LCD screen Displays the patient’s eye, target, focusing indicator, measured values, and measurement count, etc. (see page 24). The color of the characters and the background on the LCD screen can be selected from a combination of 28 kinds. See “2.8 Parameter Settings” (page 69) for details.

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

>o<

>o

(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 53). The memory function stores the measured results of 30 patients (60 eyes).

2

) o

) o… (see page 32).

When alignment is performed in the AUTO mode, <

(or

BEFORE USEConfiguration

CYL mode selection button Establishes the CYL mode of the AR measured results. Pressing this button changes the mode in the order of “CYL–” o “CYL+” o “CYL±” o “CYL–” o…(see page 23). •CYL– (Minus reading) Cylinder data is displayed by the – reading.

1

•CYL+ (Plus reading) Cylinder data is displayed by the + reading. •CYL± (Mix reading) In the AR measurement, 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. In the KM measurement, 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 45). This is used to measure a patient who is lying down.

Start button Places the device in the measurement mode from standby (see page 22). Print button Prints measured results, etc. (see page 57). Parameter setting button Used to change the settings of the device (see page 69). Power button Turns the measuring unit on and off. Pressing this button turns on the power and vice-versa (see page 22). Turning on the power places the device in standby (see page 22). 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 19). Charge indicator (

)

Flashes while the battery in the measuring unit is being charged (see page 68). R/K selection button Changes the measurement mode. The mode changes in the order of R/K mode (Serial AR & KM measurements)o R mode (AR measurement)o K mode (KM measurement)o R/K modeo࡮࡮࡮(see page 31).

3

BEFORE USEConfiguration

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 hooks

mounting

Neck strap mounting hooks

Stand mounting screw

Connecting cable connector

BEFORE USEConfiguration

Eye mask Open this mask to shield the patient’s eye which is not being measured (see page 32). This allows the patient to fixate his/her eye easier. To avoid damage from impact, the eye mask is easily detached. See page 90 for attaching the eye mask.

Eye level marker 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 32). 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 32). Keep this window clean. The measuring window checker allows automatic confirmation of cleanliness (see page 29).

Forehead rest Place it against the patient’s forehead (top of eyebrow) to stabilize the position of the measuring unit (see page 32). 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 19). Hand strap mounting hooks The hand strap is to be attached to prevent accidental dropping (see page 14). Neck strap mounting hooks The neck strap (option) is to be attached (see page 14). 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 67). 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.

• Parts that come into contact with the patient during measurement are composed of the following materials. Forehead rest: ABS resin

5

1

BEFORE USEConfiguration

{ Station

Feed button

Memory lamp

Charge lamp

Pilot lamp

Measuring unit stage

Printer Light-receiver windows for printing

Connecting cable connector

6