Nidek Medical AR-600 Operator's Manual
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Nidek Medical AR-600 Operator's Manual

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Заказывайте у нас на сайте
www.euromed.in.ua
NIDEK
AUTO REFRACTOMETER
Model AR-600
OPERATOR'S
MANUAL

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  • Page 1 Заказывайте у нас на сайте www.euromed.in.ua NIDEK AUTO REFRACTOMETER Model AR-600 OPERATOR’S MANUAL...
  • Page 2 NIDEK CO., LTD. : 34-14, Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan (Manufacturer) Telephone: (0533) 67-6611 Facsimile: (0533) 67-6610 NIDEK CO., LTD : 6th Floor, Takahashi Bldg., No.2, 3-chome, Kanda-jinboucho (Tokyo Office) Chiyoda-ku, Tokyo 101-0051, Japan Telephone: (03) 3288-0571 Facsimile: (03) 3288-0570 Telex: 2226647 NIDEK J NIDEK INCORPORATED : 47651 Westinghouse Drive, Fremont, California 94539, U.
  • Page 3 BEFORE USE OR MAINTENANCE, READ THIS MANUAL. This Operator’s Manual contains information necessary for the operation of the NIDEK AUTO REFRACTOMETER Model AR-600. 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.

  • Page 4: Table Of Contents

    Table of Contents Page § 1 INTRODUCTION ......................1-1 1.1Outline of the Product ....................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 Operation ........................2-1 2.2 Storage ........................2-2 2.3 Transportation......................
  • Page 5 Page § 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 §...
  • Page 6 [This page is intentionally left blank.]...

  • Page 7: Introduction

    1.2 Indications for Use The Model AR-600 Auto Refractometer is a diagnostic device that is indicated for use in the automated measurement of refractive errors of the eye. 1.3 Classifications [Form of protection against electric shock] Class I The AR-600 is classified as a Class I device.

  • Page 8: Symbol Information

    1 - 2 [Degree of protection against flammability] The AR-600 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.

  • Page 9: Safety

    If dust settles between the prongs, the dust easily takes up moisture, and it may cause short circuit and fire. • The measured values of objective refractive power obtained by the AR-600 are intended to be used as a reference for lens prescription for the correction of visual acuity with spectacle or contact lenses.

  • Page 10: Storage

    2 - 2 CAUTION • In advance of measurement of each patient, wipe the forehead rest and chinrest with a clean cloth. Moreover, remove one piece of chinrest paper for each patient if a stack of the chinrest paper is fixed to the chinrest. If necessary, wipe the forehead rest and chinrest using a cloth dampened with rubbing alcohol.

  • Page 11: Transportation

    2 - 3 2.3 Transportation 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.
  • Page 12 2 - 4 CAUTION • 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 and Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.

  • Page 13: Wiring

    2 - 5 2.5 Wiring CAUTION • Be sure to use a power outlet which meets the power specification requirements. If the line voltage is too high or too low, the device may not give full performance. Malfunction or fire may also occur. •...
  • Page 14 The following page shows the graph of spectrum output for the AR-600. Patients will be at low risk of acute optical radiation with the AR-600. 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.
  • Page 15 2 - 7 CAUTION Spectrum output of all light source during AR measurement (maximum light intensity) AR-630A 1000 波長：(nm) Wavelength: Spectrum irradiance (µW/cm /sr) 380 - 700 nm 1.158 (µW/cm /sr) 305 - 700 nm 0.106 : Spectrally weighted photochemical aphakic source radiance : Spectrally weighted photochemical phakic source radiance...
  • Page 16 2 - 8 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.

  • Page 17: Maintenance And Checks

    2 - 9 2.7 Maintenance and Checks CAUTION • Replace the fuses with the specified fuses only. A fire may result. • If disassembling is necessary to repair the device, be sure to ask your authorized distributor for servicing. • Never use an organic solvent such as paint thinner to wipe the exterior. This may ruin the surface.

  • Page 18: Labels

    2 - 10 2.9 Labels The following labels provide safety information about each part. (Only marketed for NIDEK INCORPORATED)
  • Page 19 2 - 11 Заказывайте у нас на сайте www.euromed.in.ua...

  • Page 20: Configuration

    CONFIGURATION § 3 Заказывайте у нас на If optionally ordered: сайте www.euromed.in.ua IC Card System Measuring Unit Knob TV Monitor Start Button Joystick Display Panel Memory Indicator Print Button Cover for Switches Changing Button Locking knob IOL Button Printer Power Switch...
  • Page 21 3 - 2 IC Card System (Optional) IOL Button If the optional IC card system was ordered, Should be pressed to turn on the IOL mode the IC card Reader/Writer should be factory- when measuring an IOL-implanted eye or an built into this part.
  • Page 22 3 - 3 Заказывайте у нас на сайте www.euromed.in.ua Min. Pupil Marker Cylinder Mode Indication Target Measurement count indication Alignment Light Indications on the TV monitor during measurement Contrast Control Brightness Control Setting Switch Eyeprint Switch CYL Mode Changing Switch Auxiliary Switches...
  • Page 23 3 - 4 Min. Pupil Marker CYL Mode Changing Switch Indicates the minimum pupil size measurable. Changes the cylinder mode, the reading di- The device may not perform measurement when rection of cylinder data. the pupil is smaller than this marker or eye- + mode ..
  • Page 24 3 - 5 Заказывайте у нас на сайте www.euromed.in.ua Forehead Rest Measuring Window Eye Level Marker LED for Corneal Illumination Chinrest PD Window Chinrest Knob From-the-top view V Control of TV Monitor Underside view H Control of TV Monitor Fuses Power Inlet Interface Connectors Заказывайте...
  • Page 25 A guide for the patient’s eye level for mea- lensmeter to import measured results from the surement. The height of the chinrest should lensmeter. If the AR-600 is equipped with an be adjusted so that the center of the patient’s IC card system, the connector on the side eye almost aligns with this line.

  • Page 26: Operating Procedures

    OPERATING PROCEDURES § 4 4.1 Operation Flow Power ON 4.2 Preparation for Measurement (p. 4-1) Measurements → 4.3 AR (refractive error) Measurement (p. 4-6) → 4.4 PD (Pupillary Distance) Measurement (p. 4-8) 5. PRINTOUT (p. 5-1) Power OFF (Determine the final prescription by subjective refraction.) 4.2 Preparation for Measurement 1.
  • Page 27 4 - 2 NOTE • If “< PD ERR >” is on the left side of the TV monitor, the device may not recognize left and right (measurement may not be performed binocularly), and also PD (pupillary distance) may not be measured. Check the PD window.
  • Page 28 4 - 3 3. If you are measuring an IOL-implanted eye or an eye with a Contact Lens (CL), turn on the IOL mode by pressing The IOL ON mark appears in the top left of the TV monitor. IOL ON Mark NOTE •...
  • Page 29 4 - 4 4. Prepare the patient. 1) Clean the forehead rest and chinrest with clean gauze. If a stack of chinrest paper is fixed to the chinrest, remove one piece of paper. 2) Instruct the patient to take off his/her glasses or contact lenses and to have a seat.
  • Page 30 4 - 5 2) Manipulate the joystick to place the patient’s eye onto the TV monitor. By moving the joystick laterally, the main body moves right, left , back and forth. By turning the measuring unit knob, the measuring unit moves up and down. Align the eye position to the measuring point with right, left, up and down movements.

  • Page 31: Ar (Refractive Error) Measurement

    4 - 6 4.3 AR (refractive error) Measurement 1. Perform measurement. Press the start button. NOTE • Instruct the patient not to blink during measurement. You will hear a short beep, and the alignment light will stop blinking. The patient’s view will be fogged. AR measurement will take place.
  • Page 32 Заказывайте у нас на сайте www.euromed.in.ua 4 - 7 NOTE • The device can memorize up to 10 measurements each for the right and left eyes. If the measurements exceed 10, older data will be cleared in turn. • If the AI Mode parameter is set to “NO”, take about three shots for AR measurement. If the measurement result is not stable, take some additional shots.

  • Page 33: Pd (Pupillary Distance) Measurement

    4 - 8 4.4 PD (Pupillary Distance) Measurement A. Auto-PD measurement (When the Auto-PD parameter is set to “YES”) The PD measurement will have been completed when AR measurement is finished. NOTE • The PD measurement will not be on the display but will be printed out together with AR results.
  • Page 34 4 - 9 NOTE • If the patient’s head is tilted, straighten it before starting measurement. • To measure monocular PD at the same time as the normal binocular PD measurement, press the start button each time for the right eye, the center, and the left eye, after careful alignment of each.

  • Page 35: Printout

    PRINTOUT § 5 5.1 Printing Measurement Results Measured data will be printed out as soon as the AR measurement is completed. NOTE • When the Print parameter is set to “Manu.”, must be manually pressed to print data. • Do not touch the printer paper while printing out. This may cause a loss of text or lightly printed text.
  • Page 36 5 - 2 < Sample Printout 2 > Description of printing contents Patient number ’ ) Space for name and sex Measuring date and time Vertex distance * Near working distance* AR measurement ’ ), Confidence index* ’ ) S = Sphere, C = Cylinder, A = Axis Median value* SE value* ’...
  • Page 37 5 - 3 *1 < Vertex distance > The distance between the corneal vertex to the posterior surface of a spectacle lens. *2 < Near working distance > Used for near PD calculation. Selectable between 35 - 70 cm in the system parameters. *3 <...

  • Page 38: Eyeprint

    5 - 4 *7 < Measurable range over error > Err +o ..The spherical power is over the measurable limit of the + side. Err -o ..The spherical power is over the measurable limit of the - side. Err co ..

  • Page 39: Other Functions

    OTHER FUNCTIONS § 6 6.1 System Setup The AR-600 is equipped with a function to change parameters of several system conditions according to the operator’s needs. The way of changing and confirming each parameter is described as follows. 1. Press the button.
  • Page 40 6 - 2 3. In the selected mode, press The contents will be printed as follows: Заказывайте у нас на сайте Parameter name Setting www.euromed.in.ua...
  • Page 41 6 - 3 4. Make the desired item number appear on the display panel. For each pressing of the start button, the item number increases. NOTE • Pressing the start button on the condition that the last number of the mode is shown makes the first item number of that mode appear again.
  • Page 42 Заказывайте у нас на сайте www.euromed.in.ua 6 - 4 Parameter Table < Setting Mode 1 > * The underlined items indicate factory-settings. Parameter name Setting option Step 0.01D / 0.12D / 0.25D Vertex D. 0mm / 10.5mm / 12mm / 13.75mm / 15mm / 16.5mm Axis Step 1°...
  • Page 43 6 - 5 < Setting Mode 2 > * The underlined items indicate factory-settings. Item Contents Patient No. YES / NO Patient No. 0001 / 9999 Name Print YES / NO Date Format Y.M.D / M.D.Y / D.M.Y / NO AR Print All / Short SE Print...
  • Page 44 6 - 6 < Setting Mode 3 > * The underlined items indicate factory-settings. Parameter name Setting option Conf. Index YES / NO Near PD YES / NO Working D. 35-70 cm / 14-28 inch Auto PD YES / NO Chart Scene I/F Mode...
  • Page 45 6 - 7 < Setting Mode 4 > * The underlined items indicate factory-settings. Parameter name Setting option TV Auto-OFF YES / NO Error Print YES / NO Error Code YES / NO Error Data YES / NO IN port (LM) NIDEK LM Data Prt.

  • Page 46: Setting Date And Time

    6 - 8 6.2 Setting Date and Time 1. Press 2. Press four times so that the date and time setting mode is established. The TV monitor shows “CLOCK SET” while the display panel shows the data with “year” blinking. The blinking indicates that the number is changeable. Year Month Hour...

  • Page 47: Entering Comments

    6 - 9 6.3 Entering Comments 1. Turn off the power switch. 2. While pressing down , turn on the power. The following will be printed out. < Sample Printout > P a r a m e t e r s for servicing Parameters Date &...
  • Page 48 6 - 10 3. Press five times to establish the mode for entering comments. The following appears on the TV monitor. Character code Line No. Column No. NOTE • It is possible to input up to 24×2 characters. Column No. 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Line No.
  • Page 49 6 - 11 Character Code Table The following characters (marks) are available to input. First digit of character code “ & Second digit of ‘ character code ∗ < ¥ > < Example > 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 •...

  • Page 50: Troubleshooting

    TROUBLESHOOTING § 7 In the event that the device does not work correctly, correct the problem according to the following table before contacting NIDEK or your authorized distributor. Symptom Suggestion • The power cord may not be correctly connected. Reconnect it securely. The TV monitor and disdplay panel do •...
  • Page 51 7 - 2 Symptom Suggestion The printer does operate, however, • The printer paper may be set with the wrong side up. printed results cannot be obtained. Set it with the correct side up. • The patient may have blinked during measurement. Instruct the patient not to blink, and try again.

  • Page 52: Maintenance

    MAINTENANCE § 8 8.1 Replacing the Printer Paper When a red line appears on the side of the printer paper, it means that the paper is running short. In such a case, stop using the printer and replace the paper with a new one. NOTE •...
  • Page 53 8 - 2 4. Insert the shaft into the new roll of printer paper. 5. Set the roll into the printer housing. NOTE • If the paper is set in such a way that the paper becomes upside down, it is not possible to print data on the paper.

  • Page 54: Setting A Stack Of Chinrest Paper

    8 - 3 8.2 Setting a Stack of Chinrest Paper 1. Remove the two fixing pins from the chinrest. 2. Take out a proper number of chinrest papers from a pack of the paper. It is impossible to set a whole stack of chinrest paper. Be sure to set a stack with a thickness of 6 mm or less.

  • Page 55: Replacing Fuses

    8 - 4 8.3 Replacing Fuses If the device does not work even though the power switch is on, the fuses may be burnt out. In such a case, replace them. CAUTION • Perform replacement work in a stable and open space. If the device falls, it may malfunction or cause injury.
  • Page 56 8 - 5 5. Remove the used fuses from the fuse holders. 6. Insert new fuses into the fuse holders. 7. Turn the fuse holders clockwise while pressing them down with the screwdriver and set them into the main body. CAUTION •...

  • Page 57: Cleaning The Measuring Window

    8 - 6 8.4 Cleaning the Measuring Window When the measuring window gets fingerprints or dust on it, the reliability of the measured value will be lowered substantially. Check the measuring window before use, and then clean it if it is soiled.

  • Page 58: Cleaning The Exterior

    8 - 7 8.5 Cleaning the Exterior When covers or panels become dirty, wipe with a dry and soft cloth. For stubborn dirt, immerse the cloth in a neutral detergent, wring well, and wipe. Finally, wipe with a dry and soft cloth. NOTE •...

  • Page 59: Ic Card System (Optional)

    Data will be printed out and at the same time written onto the card. The card will then come out automatically. NOTE • In this case, data in the AR-600 will not be cleared. *1 When the AR-600 is equipped with an IC card system, the interface connector on the side can not be used.

  • Page 60: Specifications

    SPECIFICATIONS § 10 Measurement of refractive error (AR measurement) (VD=12 mm) • Spherical power (S) Measurable range: –18.00D - +23.00D (When VD = 12 mm) Indication steps: 0.01D/0.12D/0.25D • Cylindrical power (C) Measurable range: 0D - ±8.00D Indication steps: 0.01D/0.12D/0.25D [Accuracy* Deviation from Criterion...
  • Page 61 10 - 2 Printout Date and time of measurement, and Patient number AR measurements Maximum 10 stored measurements for both the right and left eyes Median value (when there are three or more measurements) Latest value (When there are two or less measurements) PD measurements Measured value of Distance PD Calculated value of Near PD...
  • Page 62 10 - 3 Power source* A. 100/120 Vac ±10% 50/60 Hz B. 200 - 220/230 - 240 Vac ±10% 50/60 Hz Dimensions 260 (W) × 485 (D) × 451 (H) mm 19.5 kg Environmental conditions (In transport and storage) Temperature -40 - 70ºC Humidity 10 - 100% (Non-condensing)

  • Page 63: Accessories

    § 11 ACCESSORIES 11.1 Standard Accessories 4 fuses (Two of them are located in the body.) 4 rolls of printer paper (One of them is set in the printer.) 1 power cord 1 dust cover 1 pack of chinrest paper 11.2 Optional Accessories IC card system (Factory-built option) Video output (Factory-built option)

  • Page 64: Emc (Electromagnetic Compatibility)

    EMC (IEC 60601.1.2:2001) Guidance and manufacturer's declaration - electromagnetic emissions The AR-600 is intended for use in the electromagnetic environment specified below. The customer or the user of the AR-600 should assure that it is used in such an environment.
  • Page 65 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the AR-600 is used exceeds the applicable RF compliance level above, the AR-600 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the AR-600.
  • Page 66 The AR-600 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the AR-600 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AR-600 as recommended below, according to the maximum output power of the communications equipment.

  • Page 67: Appendix Aglossary

    GLOSSARY APPENDIX A · AI Mode The mode where the device completes AR measurement as soon as the median value is obtained. But if “Error Data” of the parameter is set to “YES” and there are not any variations in the three measurements, measurement ends.
  • Page 68 A - 2 · Trial Lens Data Based on the AR median value, the cylinder reading direction is automatically converted so that a spherical trial lens will have lower power as reference data. · Vertex Distance The distance between the corneal vertex to the posterior surface of a spectacle lens.

  • Page 69: Index

    INDEX AI mode ............4-6 Forehead Rest ..........3-5 Alignment Light........3-3, 4-5 Fuses ............3-5 Alignment observation ......10-2 AR Measurements ........4-6 H Control of TV Monitor ......3-5 Auto IOL ............. 4-3 Highspeed mode ......... 4-6 Auto-PD measurement ....... 4-8 Auxiliary Switches ........
  • Page 70 Index - 2 Operation Flow ........... 4-1 Parameter Table .......... 6-4 PD ERR............4-2 PD Measurements....... 4-8, 10-1 PD Window ..........3-5 Power Inlet ..........3-5 Power source ..........10-2 Power Switch ..........3-1 Preparation for Measurement ...... 4-1 Print Button ..........3-1 Printer ............

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