KM-500 Operators Manual June 2008

BEFORE USE OR MAINTENANCE, READ THIS MANUAL. This Operator’s Manual contains information necessary for the operation of the NIDEK AUTO KERATOMETER Model KM-500. This manual provides a detailed description of the device, as well as cautions, specifications, accessories, procedure for operation, and maintenance. The dioptric powers are indicated with refernce wavelengh of 546.07nm. For correct use, it is necessary that this manual, in particular the operating procedures, be thoroughly understood before using this device. Also, have the manual always near the device so that you can read it whenever it is necessary. There are no user-serviceable parts inside the device except a printer paper. Therefore, if you find any problems or have questions about the device during operation, please contact your authorized distributor.

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

Table of Contents

§1 INTRODUCTION ...Page 1-1 1.1 Outline of 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 In Storage ... 2-5 2.3 In Installation ... 2-5 2.4 In Wirings ... 2-7 2.5 After Use ... 2-7 2.6 In Maintenance ... 2-8 2.7 Disposal ... 2-8 2.8 Labels ... 2-9

§3 CONFIGURATION ... 3-1 §4 SETTING AND CONNECTION ... 4-1 4.1 Setting of the Main Body and the Battery Pack ... 4-1 4.2 Connection of Battery Charger ... 4-1 4.3 Mounting the Main Body on a Slit Lamp ... 4-2 4.4 Mounting the Main Body on the Slide Base ... 4-3 4.5 Interfacing with External Instruments ... 4-4

§5 OPERATING PROCEDURES ... 5-1

5.1 Preparation ... 5-1 5.2 Standard Measurement ... 5-3 5.3 Sagittal Radius Measurement ... 5-5

§6 CHARGING THE BATTERY PACK ... 6-1 §7 OTHER FUNCTIONS ... 7-1

7.1 Illumination of Display Panel ... 7-1 7.2 Change of Corneal Curvature Display ... 7-1 7.3 Parameter Setting ... 7-1 7.3.1 Setting change ... 7-1 7.3.2 Parameter setting list ... 7-2 7.4 Time Setting ... 7-6

Page 7.5 Comment Setting ... 7-7

§8 MAINTENANCE ... 8-1 8.1 Cleaning ... 8-1 8.1.1 Cleaning the plastic body ... 8-1 8.1.2 Cleaning of Measuring Window, Observation Window, and Measuring Light Source Part ... 8-1 8.2 Replacement of Printer Paper (Option) ... 8-1 8.3 List of Parts for Replacement ... 8-3

§9 SPECIFICATIONS ... 9-1 §10 ACCESSORIES... 10-1

10.1 Standard Accessories ... 10-1 10.2 Optional Accessories ... 10-1

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§1 INTRODUCTION 1.1 Outline of Product This device is a keratometer which consists of main body and other various options, such as Hand Held type, Slit Lamp Joint type, and Slide Base type. By using a specified printer, it can also output data to NIDEK US (Ultrasonic instrument) series, or external computers.

1.2 Indications for Use This device is designed to measure and indicate the radii of curvature and principal meridians of the human cornea’s central area and peripheral areas. The measured value of the corneal curvature is used for the prescription of visual acuity corrective lenses such as contact lenses.

1.3 Classifications [Protection method against electric shock] Class I The KM-500 is classified into Class I device. Class I device in which protection against electric shock does not rely on basic insulation only, but which includes an additional safety precaution in such a way that means are provided for the connection of accessible conductive parts to the protective (earth) conductor in the fixed wiring of the installation in such a way that accessible conductive parts cannot become live in the event of a failure of the basic insulation. [Degree of protection against electrical shock] Type B applied part The KM-500 is provided with a Type B applied part. The Type B applied part provides an adequate degree of protection against electrical shock, particularly regarding the following: - allowable leakage currents - reliability of the protective earth ground connection (If applicable). [Degree of protection against ingress of liquids] IP20 The KM-500 is the ordinary device (enclosed device without protection against ingress of liquids). Be careful not to splash water on the device. [Degree of safety of application in the presence of flammable anesthetics and/or flammable cleaning agents] The KM-500 is classified as a device not suitable to be used in a potentially flammable environment. Do not use near flammable materials.

1-2 [Method(s) of sterilization or disinfection recommended by manufacturer] It is possible to wipe the forehead rest and chin rest with a cloth dampened with alcohol as necessary. [Mode of operation] Continuous operation

1.4 Symbol Information Caution : See explanation in manual Direct Current Alternating Current Input Output Write data into memory device Power ON OFF (power) OFF (main body) Type B applied part Charging Indoor use For recycling

§2 SAFETY In this manual, a Signal Word is used to designate a degree or level of safety alerting, whose definitions are as follows. CAUTION:

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury or property damage.

Even the cases mentioned in CAUTION may result in serious injury under a certain situation. Be sure to observe the instructions of CAUTION. When using this system, be sure to follow all the instructions below in order to avoid damage to the personnel and the system.

2.1 Operation CAUTION • Do not modify or touch inside of the device. You may get an electric shock or the system may malfunction. • Be sure to use the specified electrical current. If the supplied voltage is too high or too low, the device may not work sufficiently, may malfunction or cause an electric shock. • Never yank the power cable to disconnect from receptacles but hold the plug. This can weaken the metal core of the cable and may result in a fire from short circuit, or an electric shock. • Do not place the device on top of the cable. The cover of the cable becomes ragged and may cause a fire or an electric shock from short circuit. • If the metal core of the power cable is exposed, power turns on and off by shaking the cable, or cable/plug gets so heated that one cannot hold it, it means that the cable is damaged. Immediately replace the cable. This may cause an electric shock or a fire. • Do not use the device for other than the intended purpose. NIDEK will not be responsible for accidents or malfunction caused by carelessness. • In the event of a malfunction, do not touch the inside of the device, but remove the power cable and contact your authorized distributor. • Never touch the device with wet hand. You may get an electric shock or the system may malfunction.

2-2

CAUTION • Never make the short circuit for each connectors on the Battery Pack and the Battery Charger. It may cause overheat and the damage of the device or the operator may get burned. • Never throw the battery pack into the fire. It may explode. • Never drop the battery pack into the water. Charging function will be damaged. • Never charge the battery pack with unspecified battery charger or remodeled one. It may cause the battery explosion. • Indoor use only. • If this device should for any reason malfunction, do not touch the inner structures, but contact your authorized distributor. • In advance of a measurement of each patient, wipe the forehead rest and chin rest with a clean cloth. Moreover, remove one chin rest paper for each patient if a bunch of the chin rest papers is fixed on the chin rest. If necessary, wipe the forehead rest and chin rest using a cloth dampened with rubbing alcohol. • Charge the battery pack before use for the first time since the electricity has been selfdischarged. Make sure to charge in a correct way. • Keep the measuring window and observation window away from direct sun light or bright illumination. • Never use or store the device where the wind from air conditioner comes directly. • When using the optional printer, never place any obstacle between the data transmitting window of the battery pack and the data receiving window of the printer. • Never touch the inner optical part of the measuring window to keep away from fingerprints and dusts; such things may affect the result of measurement. • Use the specified cables for connecting each unit of the device. • Never disassemble the device. • Never use the battery pack for any other purpose.

2-3

CAUTION • Information on the avoidance of overexposure to potentially hazardous optical radiation (ISO 15004: 1997) Spectrally weighted photochemical radiances LB and LA give a measure of the potential that exists for a beam of light to cause photochemical hazard to the retina. LB gives the measure for eyes in which the crystalline lens is in place. LA gives this measure either for eyes in which the crystalline lens has been removed (aphakes) and has not been replaced by a UV-blocking lens or for the eyes of very young children. The value stated for this ophthalmic device gives a measure of hazard potential when the device is operated at maximum intensity and maximum aperture. The values of LA or LB for the KM-500 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/(cm 2•sr), ten times that time (i.e. 4800 min) would be needed to reach the recommended limit. The recommended exposure dose is based on calculations arising from the American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Values for Chemical Substances and Physical Agents (1995 - 1996 edition). The following page shows the graph of spectrum output for the KM-500. Patients will be at low risk of acute optical radiation with the KM-500. However, it is recommended that the intensity of light directed into the patient’s eye be limited to the minimum level which is necessary for diagnosis. The total of the retinal exposure dose must be carefully watched for infants, aphakes and persons with diseased eyes who are at greater risk when other ophthalmic devices with a high level of radiance are used in conjunction.

2-4 㩷 ᷹ቯ⚿ᨐ

CAUTION

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

㪇㪅㪈 㪇㪅㪇㪐

㪠㫉㫉㪸㪻㫀㪸㫅㪺㪼㪑䋨㱘㪮㪆㪺㫄 㪉㪀

㪇㪅㪇㪏 㪇㪅㪇㪎 㪇㪅㪇㪍 㪇㪅㪇㪌 㪇㪅㪇㪋 㪇㪅㪇㪊 㪇㪅㪇㪉 㪇㪅㪇㪈 㪇 㪊㪇㪇

㪋㪇㪇

㪌㪇㪇

㪍㪇㪇

㪎㪇㪇 㪮㪸㫍㪼㫃㪼㫅㪾㫋㪿㪑㩿㫅㫄㪀

㪏㪇㪇

㪐㪇㪇

㪈㪇㪇㪇

㪈㪈㪇㪇

* The wavelength 1000 to 1100 is calculated and plotted according to the wavelength characteristic data of the infrared LED used. 㶎ᵈ

Spectrum irradiance

LA (mW/cm2・sr) 305 - 700 nm LB (mW/cm2・sr) 380 - 700 nm

0.5259 0.0481

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

2-5

2.2 In Storage CAUTION • Do not store the device in a place where it may get wet or where poisonous gas or liquid is stored. • Avoid storing the device in an area with excessive heat, humidity, or dust. To preserve the appearance or internal parts of the device, avoid direct exposure to sunlight.

2.3 In Installation CAUTION • Do not install the device near water. If water gets into the internal structure, there is a possibility of an electric shock or device malfunction. • Install the device in a stable and level place where vibration or shock does not occur. The device may not perform measurement correctly or may malfunction. Also, if the device is tripped over because of any accidental shock, it may result in possible injury. • 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.

2-6

CAUTION • Use the device in following conditions. Temperature : 10 to 40 ºC (50 to 104 ºF) Humidity : 30 to 75% (Non-condensing) A dust free environment A light interference free environment A vibration and shock free environment

{ Patient environment The patient environment represents a space where there is a possibility of direct contact between the patient or the operator and third person. When another type of device is used in the patient environment, use a device that complies with IEC 60601-1. If the devices that do not comply with IEC 60601-1 are used, it is necessary to use an isolating transformer to power the device or to connect the devices to additional protective grounding.

Radius of 1.5 m

2.5 m

1.5 m

1.5 m

2-7

2.4 In Wirings CAUTION • Be sure to use the grounding-type wall-outlet for power source. In the event of electric leak, your may get and electric shock. • Before connecting the cables, provide a stable and level place. If the device is tripped over, it may injury or device malfunction. • 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.

2.5 After Use CAUTION • If the device is not to be used for a long time, disconnect the power cable from the wall outlet. This may cause a fire. • 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.

2-8

2.6 In Maintenance CAUTION • If disassembling is necessary to repair the device, be sure to ask your authorized distributor for servicing. • Be careful not to leave fingerprints or dust on the measuring window. This will substantially lower the reliability of the measurement results. • Never use an organic solvent such as paint thinner to wipe the exterior. This may ruin the surface. • When the device is sent back to NIDEK for repair or maintenance, wipe the surface (especially, the area where the patient’s skin contacts) of the device with a clean cloth immersed in ethyl alcohol for disinfection.

2.7 Disposal CAUTION • Follow local governing ordinances and recycling plans regarding disposal or recycling of device components. Especially the battery pack is provided with a nickel-cadmium battery, and the printer has a lithium battery on the board. The nickel-cadmium batteries are reusable resources. In the interest of recycling raw materials, please do not dispose of the battery pack in the household waste at the end of its useful life. The disposing method of lithium batteries varies according to the government. Follow the local governing ordinates and recycling plans when disposing a board with lithium batteries. • When disposing packing, sort them by the materials and follow local governing ordinances and recycling plans.

2-9

2.8 Labels In order to draw the operator’s attention, the appropriate warning labels are attached to the specified locations. {Main Body

[Connecter Part side]

{AC Adapter

[Bottom View]

2 - 10 {Battery Pack (Only for Hand Held Type)

{Battery Charger (Only for Hand Held Type)

[Top View]

[Bottom View]

2 - 11 {SL Arm (Only for Slit Lamp Joint Type)

{Slide Base (Only for Slide Base Type)

[Top View]

2 - 12

(Both Sides)

[Side View] {Printer (Option)

[Bottom View]

2 - 13

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