HandyRef-K Operators Manual March 2015

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

March 2015 30721-P902-B0 Printed in Japan C 2015 NIDEK CO., LTD.

Before Use This operator’s manual includes operating procedures, safety precautions, maintenance, and specifications for the NIDEK HANDHELD REF/KERATOMETER, HandyRef-K. The cautions for safety and operating procedures must be thoroughly understood before using the device. Keep this manual handy for reference. For any problems or questions about the device, please contact NIDEK or your authorized distributor.

30721-P902-B0

I

Table of Contents 1

SAFETY PRECAUTIONS - - - 1 1.1 1.2 1.3 1.4

2

For Safe Use - - - 1 Signal Words for Safety - - - 1 Usage Precautions - - - 2 Labels and Symbols - - - 9

INTRODUCTION - - - 13 2.1

Outline - - - 13 2.1.1 Device outline - - - 13 2.1.2 Intended use - - - 13 2.1.3 Principles - - - 13

2.2 2.3 2.4

Configuration - - - 14 Packed Contents - - - 26 Before First Use - - - 27 2.4.1 2.4.2 2.4.3 2.4.4 2.4.5 2.4.6 2.4.7 2.4.8

2.5

Connecting the Main Body and Station - - - 38 2.5.1 2.5.2 2.5.3 2.5.4

3

Removing and installing the battery pack - - - 27 Power cord connection - - - 28 Charging the battery pack - - - 29 Attaching neck strap - - - 31 Setting the printer paper - - - 33 Other preparations - - - 35 Startup of main body - - - 36 Powering the station by battery pack - - - 37 Connection by cable - - - 38 Connection by infrared (printer-equipped model only) - - - 39 Connection by wireless LAN (printer-equipped model only) - - - 40 Functionality depending on communication method - - - 41

OPERATING PROCEDURE - - - 43 3.1 3.2 3.3

Operation Flow - - - 43 Screen List - - - 44 Startup and Shutdown - - - 45 3.3.1 Device startup - - - 45 3.3.2 Device shutdown - - - 49

3.4 3.5

Operating Procedure and Measurement Method - - - 50 AR (refractive error) and KM (corneal curvature radius) Measurements - - - 56 3.5.1 AR/KM measurement mode - - - 56 3.5.2 AR measurement mode - - - 59 3.5.3 KM measurement mode - - - 60

3.6 3.7

Supine Position Mode (measurement for patients lying down) - - - 61 Other Measurements - - - 64 3.7.1 Quick measurement mode - - - 64

II

3.7.2 3.7.3 3.7.4 3.7.5 3.7.6 3.7.7

Cataract measurement mode - - - 65 Ring observation - - - 66 Retroillumination image observation - - - 67 Pupil size measurement (PS measurement mode) - - - 68 Contact lens measurement - - - 70 Sagittal measurement - - - 71

3.8 Printing Measured Values - - - 73 3.9 Measured Value List on Summary Screen - - - 78 3.10 Memory Data Management - - - 79 3.10.1 Saving memory data - - - 79 3.10.2 Printing all saved data - - - 80 3.10.3 Printing selected data - - - 81 3.10.4 Deleting memory data - - - 83

3.11 Connection and Handling of Peripheral Devices - - - 84 3.11.1 Connecting peripheral devices - - - 84 3.11.2 Connection with computer - - - 86 3.11.3 Handling of barcode scanner and magnetic card reader - - - 88

4

PARAMETER SETTINGS AND MAINTENANCE - - - 89 4.1

Parameter Settings - - - 89 4.1.1 4.1.2 4.1.3 4.1.4 4.1.5

4.2

Maintenance - - - 107 4.2.1 4.2.2 4.2.3 4.2.4 4.2.5

5

Setting procedure - - - 89 Parameter settings - - - 91 Setting station parameters - - - 104 Setting the date and time - - - 105 Entering comments - - - 106 Troubleshooting - - - 107 Error messages and remedies - - - 108 Measurement accuracy check - - - 110 Cleaning - - - 112 Consumable list - - - 113

SPECIFICATIONS AND TECHNICAL INFORMATION - - - 115 5.1 5.2 5.3

Specifications - - - 115 Glossary and Abbreviations - - - 118 EMC (Electromagnetic Compatibility) - - - 119

III

IV

1 1.1

SAFETY PRECAUTIONS

For Safe Use BEFORE USE, READ THIS MANUAL. The cautions for safety and operating procedures must be thoroughly understood before using the device. The device complies with ISO 10342 subclause 4: 2010 (Ophthalmic instruments - Eye Refractometers) and ISO 10343 subclause 4: 2009 (Ophthalmic instruments - Ophthalmometers). The dioptric powers are indicated with reference wavelength λd = 587.56 nm.

CAUTION: The U.S. Federal Law restricts this device to sale, distribution, and use by or on the order of a licensed eye care practitioner.

1.2

Signal Words for Safety In this manual, signal words are used to designate the degree or level of safety alert. The definitions are as follows.

WARNING Indicates a potentially hazardous situation which, if not avoided, may result in death or serious injury.

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 tions.

CAUTION may result in serious injury under certain condi-

Safety precautions must be strictly followed at all times.

1

SAFETY PRECAUTIONS: Usage Precautions

1.3

Usage Precautions Safety of LED CAUTION • The device is a Class 1 LED product. The LED used for the device is safe under expected use conditions including situations such as looking into the LED using an optical system. However, it is recommended to observe the following precautions when using the device: • Do not aim LED beams to human eyes unnecessarily. • Do not look into the measuring window (LED light-emitting section) for a prolonged time.

Before use WARNING • Connect the power plug to a grounded outlet. Electric shock or fire may occur in the event of malfunction or power leakage.

CAUTION • Do not use the device for any purposes other than the intended purpose. NIDEK is not responsible for accidents or malfunctions caused by misuse. For the intended purpose of the device, “2.1.2 Intended use” (page 13) • Be sure to read the operator’s manual prior to operation of the device to understand the safety precautions and operating procedures thoroughly. Use of the device outside the scope of this manual may cause adverse events. Use the accessories specified by NIDEK only.

• Do not modify the device. Never touch the internal structure of the device. There are no parts within the device that requires servicing by the user other than printer paper and battery pack. Electric shock or malfunction may result.

• Install the device in an environment that meets the specified conditions. For use conditions,“ Environment and others” (page 117)

• For the installation location and environment of the device, always follow the cautions below. Malfunction, electric shock, or fire may occur. • A location that is not exposed to water • A location that is level, stable surface free from vibration and bumping. • A location that is not exposed to direct air flow from an air conditioner. • A location that is not exposed to strong electromagnetic wave. • A location that is not exposed to contaminant such as corrosive gas, acid, or salt.

2

SAFETY PRECAUTIONS: Usage Precautions

CAUTION • For the power specification requirements, always follow the instructions below. Malfunction, electric shock, or fire may occur. • Be sure to use a power outlet which meets the specified power requirements. • Insert the power plug fully into the power outlet. • Install the device in an area where the outlet that the mains plug is inserted into is easily accessible during use. In addition, ensure that the power cord can be disconnected without the use of a tool.

• Do not place heavy objects on the power cord. • Never use power strips or extension cables for the power supply of the device. • Do not use the power cord other than the one that is provided. Also do not use the supplied cord for any other devices.

• Before connecting the cable, turn off the power switch and disconnect the power plug from the power outlet.

• When measuring a patient lying down, do not use the occluders. • The occluders may fall on the patient resulting in injury.

3

SAFETY PRECAUTIONS: Usage Precautions

During use CAUTION • Before use, perform visual and operation checks. If abnormal conditions are encountered, stop using the device. If the device is used under abnormal conditions, intended results may not be obtained. Also, unanticipated malfunctions or health hazards may occur due to inappropriate diagnoses.

• In the event of smoke or strange odors, immediately turn off the device and disconnect the power plug from the power outlet. Once it is confirmed that the smoke has stopped, contact NIDEK or your authorized distributor. Use of the device under such abnormal conditions may cause fire or electric shock. In case of fire, use a dry chemical (ABC) extinguisher to extinguish the fire.

• Immediately replace the power cord if the internal wires are exposed, power is intermittent when the power cord is moved, or the cord and/or plug are hot to the touch. Electric shock or fire may occur.

• Should the device fail, disconnect the power cord from the power outlet and contact NIDEK or your authorized distributor without touching the interior of the device. Electric shock may result.

• When the device is being held for measurement, be sure to use the neck strap. Accidental dropping of the device may result in injury or malfunction. Malfunction due to the device dropping or impacting with something is not covered by the warranty. A repair fee will be charged for resulting malfunctions despite the device still being under warranty.

• Before measurement, explain the measurement purpose and method sufficiently to patients. • Before placing the device over the patient’s face, release the forehead rest. Otherwise, parts other than the forehead rest may come into contact to the patient’s face.

• Before and after use of the device, and before measuring each patient, clean the forehead rest with clean gauze or absorbent cotton. As necessary, dampen a cloth with rubbing alcohol and gently wipe them off. • Keep the measuring window free of fingerprints and dust. Measurement accuracy may be adversely affected.

• The forehead rest is made of resin and therefore cannot be sterilized. When using the device in an operating room, do not use the forehead rest. • Do not pull the power cord to disconnect it from the power outlet. Always hold it by the plug. The metal core of the cord may be damaged and electric shock, malfunction, or fire may result.

• Before measurement, confirm that the eye detected is correctly indicated as the one to be measured (R/L). There may be cases where the eye to be measured (R/L) is not detected correctly due to the patient's face shape or such. If the R/L indication is incorrect, press the R/L button to select the correct eye to be measured (R/L).

• The measured values of objective refractive error obtained by the HandyRef-K are intended to be used as a reference for lens prescription for the correction of visual acuity with spectacles or contact lenses. Manifest refraction must be performed as the basis for the spectacle or contact lens prescription. • Instruct the patient to look at the picture of a balloon with their eyes wide open. Start measurement after confirming that the instruction is properly followed by the patient. Be careful not to perform measurement while the device is misaligned to the patient’s eye. Proper measurement may not be performed.

4

SAFETY PRECAUTIONS: Usage Precautions

CAUTION • Never press on the LCD with a hard object such as a ball-point pen. • There may be a few defective or constantly-lit pixels on the LCD. This does not represent failure of the LCD; it is due to the structure of the LCD. • Patient environment The patient environment is the volume of space in which contact can occur between the patient and any part of the device or between the patient and any other person(s) touching the device. Use devices that comply with IEC 60601-1 in the patient environment. If any device that does not comply with IEC 60601-1 is to be used, use an isolation transformer or common protective grounding. If the device is connected to the EyeCa-RW2 whose power is supplied though an AC adapter for 200 V or a computer that does not comply with IEC 60601-1 (except one that uses an AC adapter that meets the Class II requirements of IEC 60950-1), supply power to the device and computer through isolation transformers.

Radius of 1.5 m

2.5 m 1.5 m

1.5 m

5

SAFETY PRECAUTIONS: Usage Precautions

After use CAUTION • This device uses a heat-sensitive printer paper. The paper degrades over time and the printed characters may become illegible. If glue containing organic solvents or adhesives such as on adhesive tape comes in contact with the printer paper, the printed characters may become illegible. To keep the printed data for a long period of time, make copies of the printouts or write down the measured results by hand.

• When the device is not in use, turn off the power switch and place the dust cover over the device. Dust may affect the measurement accuracy.

• Make sure that the power switch is turned off before connecting or disconnecting the power cord to or from the power outlet. If the power cord is connected or disconnected with the power switch on, device malfunction may occur.

• If the device is not to be used for a long time, disconnect the power cord from the power outlet. • Maintain the surrounding temperature and humidity in the specified ranges during transport and storage of the device. For the environmental conditions,“ Environment and others” (page 117)

• When moving the device to another location, put it in its shipping carton or optional carrying case. Do not use the carrying case alone when transporting the device by a shipping company. Excessive vibration or impact to the device may cause malfunction. • Do not carry or store the battery pack with any metal objects. The battery pack is designed so that it is unlikely that the terminals will come into contact with each other. However, if contact with metallic objects such as a necklace or key occurs, a short circuit may result, causing overheating, fire, battery leakage, or malfunction.

6

SAFETY PRECAUTIONS: Usage Precautions

Maintenance CAUTION • Maintenance of the device must be performed every 6 months. If maintenance cannot be performed by the user, request assistance from NIDEK or your distributor. For maintenance details, contact NIDEK or your distributor.

• Only personnel authorized by NIDEK or a NIDEK distributor are allowed to disassemble or touch the interior of the device. NIDEK will not be responsible for accidents caused by improper servicing.

• Before servicing or inspecting the device, wipe the surfaces of the device (especially the areas that come into contact with patients) with a clean cloth dampened with rubbing alcohol. • When performing maintenance work, secure sufficient maintenance space. Maintenance work in an insufficient space may result in injury.

• For the handling and replacement of the battery pack, follow the instructions below. Failure to do so may cause malfunction, electric shock, fire, or battery deterioration. • Do not use a battery pack other than that specified. Do not use the specified battery pack with any other devices.

• Do not remove the battery pack while it is charging in the main body. • Do not immerse or soak the battery pack in liquid such as water. • Do not use or leave the battery pack near fire or a stove (60ºC or higher). • Do not expose the battery pack to excessive shocks such as by throwing it. • Do not contact the battery pack terminals or the terminals of the battery slot with fingers or patient during replacement.

• When recharging the battery, follow the procedures described in this Operator’s Manual. For the recharging procedure,“2.4.3 Charging the battery pack” (page 29)

• Do not insert foreign items such as metallic objects into the battery slot. • Do not disassemble or modify the battery pack. • Be sure to use only the printer paper (80620-00001) specified by NIDEK. If printer paper other than that specified is used, the printer head may be damaged due to printing failure or paper jam, or printed contents may easily become illegible.

• Before returning the device to NIDEK for repair, wipe the surfaces of the device (especially the areas that come into contact with patients) with a clean cloth dampened with rubbing alcohol. • If the AR-measured results differ substantially from subjectively measured results, perform the procedure described in “4.2.3 Measurement accuracy check” (page 110). If the results of the “Measurement accuracy check” differ substantially from the values indicated on the model eye, contact NIDEK or your authorized distributor to check whether the device needs measurement accuracy calibration. • Do not use the device beyond its service life. Even with proper maintenance and check, after time, the device reliability or safety may become degraded and fail to achieve the target values.

7

SAFETY PRECAUTIONS: Usage Precautions

Disposal CAUTION • Follow the local ordinances and recycling regulations regarding disposal or recycling of the device or its components, particularly when disposing of the battery pack (lithium ion battery), lithium battery used on the board, circuit board, plastic parts that contain brominated flame retardant, LCD, or power cord. It is recommended to commission the disposal to a designated industrial waste disposal contractor. 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.

8

SAFETY PRECAUTIONS: Labels and Symbols

1.4

Labels and Symbols  To call attention to users, labels and indications are provided on the device. If labels are peeling off, characters are fading, or otherwise becoming illegible, contact NIDEK or your authorized distributor. Indicates that caution must be taken. Refer to the operator’s manual before use. Indicates that the degree of protection against electric shock is of a Type B Applied Part. Indicates that the operator is advised to refer to the related instructions in the operator’s manual. Indicates the power button of the main body and station. Pressing this button switches the device status between ON and power-saving. While the device is in power-saving, the following conditions are in effect. • Main body: The LCD and memory indicator are turned off. • Station: The pilot lamp is turned off even if the station is powered by the battery pack.

Indicates the state of the power switch of the station. When this symbol side of the switch is pressed down, power is supplied to the device. Indicates the state of the power switch of the station. When this symbol side of the switch is pressed down, power is not supplied to the device. Indicates that the device must be supplied only with alternating current. Indicates that the connection port is suitable for direct current only. Indicates an input terminal. Indicates an output terminal. Indicates that this product is to be disposed of in a separate collection of electrical and electronic equipment in EU. Indicates the year of manufacture. Indicates the manufacturer. Indicates that this medical device incorporates a wireless communication module. Indicates that interference may occur in the vicinity of equipment marked with this symbol. The wireless LAN module incorporated in this device conforms to the regional regulations of Japan, the USA, Canada, and other countries that implement the R&TTE Directive. The wireless LAN module is not equipped with products shipped for countries other than the above. CE marking Indicates that the product conforms fully to the requirements of the Machinery Directive (2006/42/EC). The CE marking is placed only on the product for EU regions. This device is classified as a Class IIa product according to the Medical Device Directive.

9

SAFETY PRECAUTIONS: Labels and Symbols

O Labeling <Top view>

<Bottom view>

1

5

0$

&RQWDLQV)&&,';)561 &RQWDLQV,&,'$

5()5$&7248(5$7•0(7523257ƒ7,/

5‹)5$&72.‹5$720Š75(3257$%/(

+$1'5().(5$720(7(5

0$ 0$

5()5$7720(752&+(5$720(7520$18$/(

30721-M503-A1

2

4 3

No.

Labels and symbols

Relevant section

1

“ During use” (page 4) “3.4 Operating Procedure and Measurement Method” (page 50)

2

“5.1 Specifications” (page 115) 30721-M503-A1

5‹)5$&72.‹5$720Š75(3257$%/(

3

5()5$7720(752&+(5$720(7520$18$/( +$1'5().(5$720(7(5 5()5$&7248(5$7•0(7523257ƒ7,/ 0$ 0$

4

&RQWDLQV)&&,';)561 &RQWDLQV,&,'$ 0$

5

10

“5.3 EMC (Electromagnetic Compatibility)” (page 119) * For the USA, Canada, and other countries that implement the R&TTE Directive only.

“2.5.1 Connection by cable” (page 38) “3.11.1 Connecting peripheral devices” (page 84)

SAFETY PRECAUTIONS: Labels and Symbols

For the USA only

<Rear view of the station>

8

HandyRef STATION C O N N  100-240V〜 F R E Q . 50/60Hz POWER 60VA OUTPUT 9V

2A

XXXX SER.NO. Rx only

MADE IN JAPAN 34-14 MAEHAMA HIROISHI-CHO GAMAGORI AICHI 443-0038 JAPAN 30621-M513-A2

&RQWDLQV)&&,';)561 &RQWDLQV,&,'$ 0$

6

No.

Labels and symbols

6

&RQWDLQV)&&,';)561 &RQWDLQV,&,'$ 0$

7

Relevant section “5.3 EMC (Electromagnetic Compatibility)” (page 119) * For the USA, Canada, and other countries that implement the R&TTE Directive only.

HandyRef STATION C O N N  100-240V〜

7

F R E Q . 50/60Hz POWER 60VA OUTPUT 9V

2A

“5.1 Specifications” (page 115) XXXX SER.NO. Rx only

MADE IN JAPAN 34-14 MAEHAMA HIROISHI-CHO GAMAGORI AICHI 443-0038 JAPAN 30621-M513-A2

8

“2.5.1 Connection by cable” (page 38) “3.11.1 Connecting peripheral devices” (page 84)

11

SAFETY PRECAUTIONS: Labels and Symbols

<Rear side of battery pack> 9

10

No.

12

Labels and symbols

Relevant section

9

“2.4.1 Removing and installing the battery pack” (page 27) “2.4.3 Charging the battery pack” (page 29)

10

“2.4.1 Removing and installing the battery pack” (page 27) “2.4.3 Charging the battery pack” (page 29)

2

INTRODUCTION

2.1

Outline

2.1.1

Device outline The NIDEK HANDHELD REF/KERATOMETER, HandyRef-K, measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye. The keratometer measures the corneal curvature radius (corneal refractive power) in the steepest and flattest meridian directions, cylinder axis, and corneal cylindrical power. This device is a hand-held model that allows measurement of children who cannot hold their head on the stationary chinrest, bed-ridden patients or patients in an operating room.

2.1.2

Intended use The HANDHELD REF/KERATOMETER, HandyRef-K, is a medical device which measures objective refractive errors and corneal curvature radius of the patient’s eye.

2.1.3

Principles Objective refractive error measurement Fine measurement beams are projected on the fundus of the patient’s eye by a projecting optical system and then the ring image obtained from the reflected beams is used for computation to determine the refractive errors (SPH, CYL, AXIS) of the patient’s eye. Corneal curvature radius measurement The image of the mire ring projected on the patient’s cornea is captured and used for computation to determine the corneal curvature radius (refractive power) in the steepest and flattest meridian directions, cylinder axis, and corneal cylindrical power.

13

INTRODUCTION: Configuration

2.2

Configuration ● Main body [Patient’s side]

[Operator’s side]

1 7 2 3

7

8

4

6

9

5

11

12

8

10

1 LCD Displays the patient’s eye, target, focusing indicator, measurement values, number of measurement and such.

2 Memory indicator Indicates that measured data is saved in memory. The indicator illuminates when data is being saved in memory. It blinks during initialization and in sleep mode.

3

Print button Prints or outputs the measured results.

4

Function buttons Buttons to select the five operation icons shown on the screen. The corresponding icons change depending on function. Select the corresponding button under each icon to change the device settings, measurement modes, and such.

5 Handle The grip for the main body. In addition, it stores the battery pack. Open the handle cover to replace the battery pack.

“2.4.1 Removing and installing the battery pack” (page 27)

14