KM-500 Operators Manual Jan 2005

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. In this manual, IEC 60601-1 and UL standards are applied. 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.

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 ... 2-3 2.3 In Installation ... 2-3 2.4 In Wirings ... 2-4 2.5 After Use ... 2-4 2.6 In Maintenance ... 2-5 2.7 Disposal ... 2-5 2.8 Others ... 2-5 2.9 Labels ... 2-6

§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

Page 7.4 Time Setting ... 7-6 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 [Classification under the provision of 93/42/EEC (MDD)] Class The KM-500 is classified into Class a system.

a

[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 protection against flammability] 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

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 • This device has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2: 2001, EN 60601-1-2: 2001, 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 separation between the device. - 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 help. • 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.

2-4

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 • 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 KM500 complies with these requirements as tabled on pages 11-1 to 11-3. Follow the guidance in the tables for use of the device in an electromagnetic environment.

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.

2-5

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.

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.

2-6

2.8 Labels In order to draw the operator’s attention, the appropriate warning labels are attached to the specified locations. {Main Body (For 230V areas)

or

[Connecter Part side]

{AC Adapter

or

[Bottom View]

2-7 {Battery Pack (Only for Hand Held Type)

or

(For 230V areas)

{Battery Charger (Only for Hand Held Type)

or

[Top View]

[Bottom View]

2-8 {SL Arm (Only for Slit Lamp Joint Type)

or

/$

{Slide Base (Only for Slide Base Type)

or

[Top View]

2-9

(Both Sides)

[Side View] {Printer (Option)

or

[Bottom View]

§3 CONFIGURATION {Main Body

Mire Part Observation Window

Display Panel Print Button Setting Button Measuring Light Source Part OFF Button Measuring Window L (left) Button R (right) Button

Connection Part

3-2 Observation Window The operator looks through this window to measure the patient’s eye. Display Panel This panel displays measured data and other information. Print Button This button is used to transmit data to the printer. Setting Button This button is used to set various parameters. OFF Button This button is used to turn the power OFF. L (left) Button This button has two functions which are to put the power ON and to start the left eye measuring mode. R (right) Button This button has two functions which are to put the power ON and to start the right eye measuring mode. Mire Part This part is a light source which works as a substitute for the mire chart. It is also used to illuminate the anterior part of the eye. Measuring Light Source Part This is used as a light source for measurement. Measuring Window The patient looks at the red fixation light through this window.

Connection Part This part is connected to battery pack, SL arm, or mounting bracket of slide base.

3-3 {Display Panel R1 Sign

R2 Sign AVE Sign

CYL Sign

AX Sign R, L Sign

SAGIT K Sign

Battery Sign Meridian Display

Target Ring

N,T Sign

Mire Ring

Fixation Light

[Patient’s View] [Operator’s View]

{AC Adapter Pilot Lamp

Power Switch

Power Inlet

Jack

3-4 R1 Sign This shows the data of minor meridian. R2 Sign This shows the data of major meridian. R, L Sign This shows the measuring eye either R (right) or L (left). Battery Sign This shows the remaining power of battery (Only for Hand Held Type). If sign is ON or the display is too light to read, recharge the battery. N,T Sign This shows N (Nasal) side and T (Temporal) side of measuring eye. Meridian Display This shows the abbreviated figure of corneal shape with the lines based on the measured data. The long line shows the minor meridian, and the short line shows the corneal astigmatism value as follows. CYL 0D 0D CYL 3D 3D CYL 6D 6D CYL SAGIT K Sign This shows that Sagittal Radius is being measured. AX Sign This shows the axis of minor meridian. CYL Sign This shows the cylindrical value.

AVE Sign This shows the average value of R1 and R2. Target Ring This ring is used to make a focusing. It lights in the condition when the keratometer is out of focus and when the focusing point approaches, it starts blinking. The blinking speed becomes faster as it comes closer to the focusing point. Mire Ring This is used to observe the shape of the corneal surface. Fixation Light This light is used to fix the patient's eye.