km-500 autokeratometer manual

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    NIDEK

    AUTO KERATOMETER

    Model KM-500

    OPERATORS MANUAL

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    * Specifications are subject to change without notice for improvement.

    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. S. A.

    (United States Agent) Telephone: (510) 226-5700Facsimile: (510) 226-5750

    NIDEK SOCIETE ANONYME : Europarc 13, rue Auguste Perret, 94042 CRETEIL, France

    (Authorized Representative) Telephone: (01) 49 80 97 97

    Facsimile: (01) 49 80 32 082004. 2

    31511-P902I

    Printed in JAPAN

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    BEFORE USE OR MAINTENANCE, READ THIS MANUAL.

    This Operators 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 instrument. Also, have the manual always

    near the instrument so that you can read it whenever it is necessary.

    There are no user-serviceable parts inside the instrument except a printer paper.

    Therefore, if you find any problems or have questions about the instrument during

    operation, please contact your authorized distributor.

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    Table of Contents

    1 INTRODUCTION........................................................................................................ 1-11.1 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 ........................................................................................................................ 2-12.1 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 ................................................................................ 4-14.1 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.................................................................................... 5-15.1 Preparation ............................................................................................................... 5-1

    5.2 Standard Measurement ............................................................................................. 5-3

    5.3 Sagittal Radius Measurement ................................................................................... 5-5

    6 CHARGING THE BATTERY PACK ........................................................................ 6-17 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 ................................................................................................. 7-17.3.2 Parameter setting list ....................................................................................... 7-2

    Page

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    7.4 Time Setting ............................................................................................................. 7-6

    7.5 Comment Setting ...................................................................................................... 7-7

    8 MAINTENANCE .........................................................................................................8-18.1 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.......................................................................................................... 10-110.1 Standard Accessories ............................................................................................ 10-1

    10.2 Optional Accessories ............................................................................................ 10-1

    Page

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    [This page is intentionally left blank.]

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    1.1 Outline of Product

    This device is a keratometer which consists of main body and other various options, such asHand 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 corneas 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 a

    The KM-500 is classified into Class a system.

    [Protection method against electric shock] Class I

    The KM-500 is classified into Class I instrument.Class I instrument 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 instrument (enclosed instrument without protection against ingress

    of liquids). Be careful not to splash water on the instrument.

    [Degree of protection against flammability]

    The KM-500 is classified as an instrument not suitable to be used in a potentially flammable

    environment.

    Do not use near flammable materials.

    1 INTRODUCTION

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    [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

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    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 CAUTIONmay 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 instrument.

    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 instrument 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 instrument 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 thecable, 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 instrument 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 instrument, but remove the

    power cable and contact your authorized distributor.

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    CAUTION

    Never touch the device with wet hand.

    You may get an electric shock or the system may malfunction.

    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 instrument 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.

    NOTE

    Charge the battery pack before use for the first time since the electricity has been self-

    discharged. 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.

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    NOTE

    Use the specified cables for connecting each unit of the device.

    Never disassemble the device.

    Never use the battery pack for any other purpose.

    2.2 In Storage

    NOTE

    Do not store the instrument in a place where it may get wet or where poisonous gas or

    liquid is stored.

    Avoid storing the instrument in an area with excessive heat, humidity, or dust.

    To preserve the appearance or internal parts of the instrument, avoid direct exposure to

    sunlight.

    2.3 In Installation

    CAUTION

    This instrument has been tested and found to comply with the limits for medical devices

    to the IEC 60601-1-2: 1993, EN 60601-1-2: 1994, Medical Device Directive 93/42/EEC.

    These limits are designed to provide reasonable protection against harmful interference

    in a typical medical installation. This instrument 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 instrument does cause

    harmful interference to other devices, which can be determined by turning the instrumentoff 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 instrument.

    - Connect the instrument 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.

    Never use the instrument with cable or accessories other than the designated ones.

    Malfunction caused by deteriorated electromagnetic compatibility (EMC) characteristics

    may result.

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    2 - 4

    CAUTION

    Never use portable and mobile radio frequency (RF) devices in the vicinity of this

    instrument.

    These devices may adversely affect medical electrical equipment and malfunction may

    result.

    Do not install the instrument near water.

    If water gets into the internal structure, there is a possibility of an electric shock or

    instrument malfunction.

    Install the instrument in a stable and level place where vibration or shock does not occur.

    The instrument may not perform measurement correctly or may malfunction.

    Also, if the instrument is tripped over because of any accidental shock, it may result in

    possible injury.

    NOTE

    Use the instrument in following conditions.

    Temperature : 10 - 40 C (50 - 104 F)

    Humidity : 30 - 75% (Non-condensing)

    A dust free environment

    A light interference free environmentA vibration and shock free 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 instrument is tripped over, it may injury or instrument malfunction.

    2.5 After Use

    CAUTION

    If the instrument is not to be used for a long time, disconnect the power cable from the

    wall outlet.

    This may cause a fire.

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    2.6 In Maintenance

    CAUTION If disassembling is necessary to repair the instrument, 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.

    2.7 Disposal

    NOTE

    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.

    2.8 Others

    CAUTION

    When the instrument is sent back to NIDEK for repair or maintenance, wipe the surface

    (especially, the area where the patients skin contacts) of the instrument with a clean cloth

    immersed in ethyl alcohol for disinfection.

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    2 - 6

    2.9 Labels

    In order to draw the operators attention, the appropriate warning labels are attached to thespecified locations.

    Main Body

    AC Adapter

    or

    [Bottom View]

    [Connecter Part side]

    (For 230V areas)

    or

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    Battery Pack (Only for Hand Held Type)

    or

    Battery Charger (Only for Hand Held Type)

    [Top View] [Bottom View]

    or

    (For 230V areas)

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    SL Arm (Only for Slit Lamp Joint Type)

    or

    Slide Base (Only for Slide Base Type)

    or

    [Top View]

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    [Side View]

    (Both Sides)

    Printer (Option)

    or

    [Bottom View]

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    3 CONFIGURATION

    Main Body

    Observation Window

    Display Panel

    Print Button

    Setting Button

    OFF Button

    L (left) Button

    R (right) Button

    Mire Part

    Measuring Light

    Source Part

    Measuring

    Window

    Connection Part

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    3 - 2

    Observation Window

    The operator looks through this window

    to measure the patients eye.

    Display Panel

    This panel displays measured data and

    other information.

    Print Button

    This button is used to transmit data to the

    printer.

    Setting ButtonThis button is used to set various param-

    eters.

    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 alsoused to illuminate the anterior part of the

    eye.

    Measuring Light Source Part

    This is used as a light source for measure-

    ment.

    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.

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    Display Panel

    R1 Sign

    R2 Sign

    AVE Sign

    CYL Sign

    AX Sign

    R, L Sign

    Battery Sign

    N,T Sign

    SAGIT K Sign

    Meridian Display

    Target Ring Mire Ring Fixation Light

    [Operators View][Patients View]

    AC Adapter

    Pilot Lamp Power Switch Power Inlet Jack

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    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 bat-

    tery (Only for Hand Held Type). If signis ON or the display is too light to read,

    recharge the battery.

    N,T Sign

    This shows N (Nasal) side and T (Tempo-

    ral) side of measuring eye.

    Meridian Display

    This shows the abbreviated figure of cor-

    neal shape with the lines based on the

    measured data.

    The long line shows the minor merid-

    ian, and the short line shows the cor-

    neal 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.

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    Power Cable

    (230V)

    (110V)

    Specified Cable

    Battery Pack (Only for Hand Held Type)

    Main Body Connection Part

    Data Transmission Window

    Trickle Charge Terminal

    Battery Charger (Only for Hand Held Type)

    [Top View] [Side View][Bottom View]

    Charging Indicator

    Power Indicator

    Trickle Charge Terminal

    Jack (Both Sides)

    Fast Charge Connector

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    3 - 6

    Main Body Connection Part

    This part is used to connect to the main

    body to supply the power or to charge fast

    the internal battery.

    Data Transmission Window

    Through this window, measured data is

    wireless-transmitted to the printer (Op-

    tion).

    Trickle Charge Terminal

    These terminal is used to charge tricklingly

    the internal battery.

    Trickle Charge Terminal

    This is used to charge tricklingly the bat-

    tery pack.

    Charging Indicator

    This indicator will light while battery is

    being fast-charged. When it is on trickle

    charge, it does not light.

    Power Indicator

    This indicator will light while power is

    supplied to the battery charger.

    Jack

    This is used to input/output the data and

    to supply the power.

    Fast Charge ConnectorThis is used to connect the battery pack

    and to charge fast. During this charge, the

    charging indicator lights.

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    3 - 7

    SL Arm (Only for Slit Lamp Joint Type)

    Main Body Connection Part

    JackSlit Lamp Connecting Shaft

    Slide Base (Only for Slide Base Type)

    Jack

    (Both Sides)

    Joystick

    Start Button

    Mounting Bracket

    Forehead rest

    Chin rest

    Chin rest elevation

    knob

    Head Rest (Option)

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    Main Body Connection Part

    The main body is mounted on this part.

    From this part, the power is supplied and

    the data is output.

    Mounting Bracket

    The main body is mounted on this part.

    From this part, the power is supplied and

    the data is output.

    Start Button

    This button is used to measure the same

    eye again, to start the sagittal radius mea-surement, or to change the parameter item

    No..

    Joystick

    This joystick offers one handed operation

    for lateral and vertical movements.

    Manipulate this joystick to move the

    main body laterally for focusing, and

    also turning of this joystick controls

    vertical movement to raise or lower themain body.

    Jack

    This is used to input/output the data and

    to supply the power.

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    3 - 9

    Printer (Option)

    Memory IndicatorPaper Feed ButtonData Receiving WindowPower Indicator

    Printer Paper Holder

    External Jack (RS-232C)

    Jack (Both Sides)

    Printer Paper Inlet Slot

    Printer Paper Outlet Slot

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    3 - 10

    Memory Indicator

    This indicator will light while the mea-

    sured data are stored in the printer.

    Paper Feed Button

    It works as a paper feed button when

    Memory indicator is not ON and it also

    works to re-print the memorized data when

    Memory indicator is ON.

    Data Receiving Window

    This receives the data from the Data Trans-

    mission Window of the Battery Pack.

    Power Indicator

    This indicator will light while power is

    supplied to the printer.

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    4.1 Setting of the Main Body and the Battery Pack

    Setting:Put the marks of the main body and the

    battery pack together. Then slide the battery

    pack to the right to assemble them.

    Removing:

    Slide the battery pack to the left to separate

    them.

    4.2 Connection of Battery Charger

    The battery charger and the printer have two power jacks for each. Connect appropriately

    according to the setting place.

    Use only the cables of our supply.

    4SETTING AND CONNECTION

    Main body

    Grooves

    Battery pack

    Top view of Battery pack Bottom view of Main body

    Battery charger

    Specified cable (2m)

    AC adapter

    Power cable

    Specified cable (0.4m)

    Specified cable (2m)

    PrinterAC adapter

    Power cable

    Battery charger

    marks

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    4 - 2

    4.3 Mounting the Main Body on a Slit Lamp

    1. Mount the SL arm on a slit lamp.The SL arm can be mounted on the slit lamp

    which can hold the focusing rod, such as the

    NIDEK slit lamp, or Haag type slit lamp, etc.

    2. To join the main body to the SL arm,

    put the marks of the main body and the

    SL arm together. Then slide the main body

    to the left to assemble them.

    3. Connect the cables as shown below.

    SL arm

    Focusing rod setting hole

    Main body

    Slit lamp

    SL arm

    Main body

    Slit lamp

    SL arm

    Main body

    Specified cable

    (2m)

    Specified cable

    (0.4m)

    AC adapter

    Power cable

    AC adapter

    Power cable

    Printer

    Specified cable

    (2m)

    SL arm

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    4.4 Mounting the Main Body on the Slide Base

    1. To join the main body to the slide base, putthe marks of the main body and the slide

    base together. Then slide the main body to

    the left to assemble them.

    2. Connect the cables as shown below.

    Main body

    Main body

    Slide base

    Specified cable (0.4m)

    Printer

    Specified cable (2m)

    AC adapter

    Power cable

    Slide base

    AC adapter

    Main body

    Specified cable (2m) Power cable

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    4.5 Interfacing with External Instruments

    When connecting this device to external instruments [such as NIDEK US (Ultrasonicinstruments) series or external computer]*1, make sure to use external jack (RS-232C) of

    the printer and connect the instrument with external connection cable.

    External instrument (personal computer etc.)

    External Connection Cable

    Printer

    *1 Accessory equipment connected to the analog and digital interfaces must be certified

    according to the representative appropriate national standards (for example, UL 1950 for Data

    Processing Equipment UL 2601-1 for Medical Equipment, and CSA C22.2 No. 601-1, EN

    60601-1 and IEC 60601-1.)

    Further more all configurations shall comply with the system standard IEC 60601-1-1.

    Everybody who connects additional equipment to the signal input part or signal output part

    configured a medical system, and is therefore responsible that the system complies with the

    requirements of the system standard IEC 60601-1-1. If in doubt, consult the technical service

    department or your local representative.

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    5.1 Preparation

    [For Hand Held Type]

    1. Have the patient remove glasses or contact

    lenses.

    2. Turn the power switch of the AC adapter ON

    (|) to supply the power to the whole system.

    3. Have the hand strap on the wrist and hold

    the main body.

    4. Put the other hand on the main body to make

    it stable.

    [For Slit Lamp Joint Type]

    1. Ask the patient to take off glasses or contact

    lenses.

    2. Turn the power switch of the AC adapter ON

    (|) to supply the power to the whole system.

    3. Clean the forehead rest and chin rest with a

    clean gauze. If a bunch of chin rest papers is

    fixed on the chin rest, remove one paper.

    4. Put the patients head on the head rest of

    the slit lamp steadily.

    5. Turn both the illuminating arm and the

    microscope arm of the Slit Lamp to the same

    direction so that they do not obstruct the

    keratometer measurement.

    6. Slide and turn the SL arm to face the main

    body to the patient.

    5OPERATING PROCEDURES

    Main body

    Battery pack

    Hand strap

    Illumination part

    Main body

    SL arm

    Microscope arm

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    [For Slide Base Type]

    1. If the joystick is locked, move the cross slide

    base forward to release the lock.

    NOTE

    To lock the cross slide base, position the

    joystick to the center and pull it backward.

    2. Ask the patient to take a seat and to take off

    glasses or contact lenses.

    3. Turn the power switch of the AC adapter ON

    (|) to supply the power to the whole system.

    4. Clean the forehead rest and chin rest with a

    clean gauze. If a bunch of chin rest papers is

    fixed on the chin rest, remove one paper.

    5. Ask the patient to put his/her chin on the

    chin rest and his/her forehead on the pads

    on the forehead rest.

    6. Align the patients eye with the observation

    window position by turning the chin rest

    elevation knob or manipulating the joystick.

    Forehead rest

    Observation

    window

    Chin rest

    Chin rest

    elevation knob

    Cross slide base

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    5.2 Standard Measurement

    1. Press R or L button which corresponds tothe patients eye.

    The power will automatically be turned ON.

    When using the slide base type, and if it is

    not the first operation after the power supply,

    the power can be turned ON by pressing the

    start button or moving the cross slide base

    laterally. The measuring-eye side is detected

    by the slide base automatically.

    2. Ask the patient to watch the fixation light

    (red light) inside the measuring window.

    3. While looking into the observation window,

    move the main body until the size of target

    ring almost coincides with the outer circles

    of iris and the target ring become concentric

    circle with the mire ring.

    4. When this measuring window is brought

    around the focusing point (about 40mm in

    front of patients eye), the target ring may

    start blinking, and its blinking speed

    becomes higher as the focusing point gets

    closer.

    When it is exactly focused, a beep sounds and

    the target ring disappears so as to notify that

    the measurement is now completed.

    When seen with both eyes and the main body

    is at around the focusing position, the mire ring

    and the target ring looks at the same position.

    If you see the mire ring farther than the target

    ring, move the main body closer to the patients

    eye. If you see it closer, move the main body

    apart from the patients eye.

    R bouton

    Mire ring

    Target ring

    Focusing point

    About 40 mm

    light

    fast blinkblink

    light

    [Target Ring]

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    NOTE

    If the eyelashes obstructs the outer target ring, correct measurement may not be

    performed. In this case, ask the patient to open eyes widely. If opening is still notenough, make them open with your finger.

    Ask the patient not to blink eyes while measuring.

    5. Repeat the process of 1. - 4. to measure the other eye.

    It can memorize 5 measured data for each eye. When data is inputted more than 5 for one eye,

    the old data will be deleted.

    When there are more than 3 measured data in the memory, the selected data will be obtained on

    the printout.

    When parameter item No. 21 Auto-print is set to YES, the measured data will be

    automatically printed out as soon as the measurement of both eyes are finished (except when

    using the Hand Held type). The auto-print will not be activated at sagittal radius measurement.

    6. Press the Print button on the main body

    to print out the measured data whenever it

    is necessary.When using Hand Held Type, aim the data

    transmission window at the data receiving

    window of the printer, then press the Print

    button. The data wil l be transmitted to the

    printer and be printed out.

    Check if the memory indicator of the printer

    goes OFF once and ON again when

    transmitting. If not, press the Print button

    again.

    7. Press the OFF button to turn the power

    OFF.

    The Auto-OFF function turns OFF the power

    automatically when no button operation is done

    more than 3 minutes.Printer

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    5.3 Sagittal Radius Measurement

    This measurement is not appropriate for Hand Held Type since the holding hand shakes to disturbthe measurement. Use something to fix the patients head such as the head rest of Slit Lamp or

    Slide Base.

    Change the parameter settings of 10, , for sagittal radius measurement. (See 7.3 Parameter

    Setting)

    1. Put the patients chin on the chin rest. Then ask him/her to put the forehead on the

    forehead rest.

    The patients head should be fixed to make this measurement.

    2. Press R (or L) button to select the patient eye.

    3. Make the regular measurement.

    4. Press Setting button to change the display to Sagittal Radius measurement condition.

    The SAGIT K sign appears on the display panel.

    5. The patient will see a red spot on the left of measuring light source part. Ask the patient

    to watch it.

    6. The circle and the dotted line on the N (or T) side of meridian display will blink.

    Press R (or L) button or start button of the slide base to start measuring.

    7. Bring the main body to the position that the mire ring and the target ring on the eye

    become concentric circle, then move it back and forth to adjust the focus.

    The sagittal radius will be measured.

    8. The patient will see a red spot on the right of measuring light source part. Ask the patient

    to watch it.

    9. The circle and the dotted line on the T (or N) side of meridian display will blink.

    Make the measurement in the same manner as step 6. and 7.

    10. The patient will see a red spot at the bottom of measuring light source part. Ask the

    patient to watch it.

    11. The circle and the dotted line at the bottom of meridian display will blink. Make the

    measurement in the same manner as step 6. and 7.

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    1. Check if the power indicator for battery charger is ON.

    2. Connect the battery pack with the battery charger according to the following use.

    As trickle charge is just a supplement for the natural discharge, it is necessary to make the fastcharge when the battery sign appears.

    [Trickle charge]

    As shown on the right, put the main body which

    is connected with the battery pack on the battery

    charger.

    When the main body is set on the battery

    charger, the power indicator brightens to give

    a notice that it is properly set.

    NOTE

    To maximize battery charge, turn the main body off before placing in this charger.

    [Fast charge]

    1) Disconnect the battery pack from the main

    body.

    2) Pull out the fast charge connector from the

    battery charger.

    3) Connect the battery pack to the fast charge

    connector.

    The power supply terminals on the battery

    charger is contacted with the charging

    terminal on the battery pack and the charging

    will be started. While charging, the charge

    indicator will light and it turns off whencharging is completed.

    Fast charge takes about one and a half hour.

    NOTE

    Do not turn the power switch of AC adapter (OFF) until the charging is completed.

    The instrument battery should only be recharged when the letters/numbers on the displaypanel have begun to fade. Premature charging will reduce lifetime memory permanently.

    6CHARGING THE BATTERY PACK

    Main body Battery pack

    Battery charger

    Battery charger

    Battery packFast charge connector

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    Battery Charger Instruction

    Charge the battery pack when the letters/numbers on the display panel fades.

    Do

    In order to charge the battery pack to full capacity, do not charge it before the letters/numbers on

    the display panel has faded.

    Dont

    Do not stop charging before it is charged to full capacity and the charge indicator goes out.

    Otherwise, the specified time of battery use will be shortened.

    NOTE The battery may not perform sufficiently as long-term storage causes a self-discharge

    or an inactivation of reaction substance.

    Store the battery pack under the following conditions.

    - A place that is not exposed to direct sunlight

    - A narrow temperature variation environment

    - 10C to 30C (recommended temperature)

    To avoid performance degradation and leakage due to self-discharge, full charge the

    battery pack at least once half a year and use it until the battery is exhausted.

    The battery may not be charged properly at the first charge after long-term storage.

    In such a case, the battery will be recovered after charging and discharging (use until

    the battery is exhausted) several times.

    Charged to full capacity Letters/numbers on the display

    panel has faded.

    Charge to full capacity

    Charged to full capacity Letters/numbers on the display

    panel has not faded.

    Do not charge because it can not

    be charged to full capacity.

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    7.1 Illumination of Display Panel

    The display panel will be illuminated when R (or L) button is pressed more than 2 seconds. Toturn OFF the light, press OFF button and finish measuring.

    This description is only for the case that parameter item No.23 Back-light is set to NO.

    7.2 Change of Corneal Curvature Display

    If you press Setting button after the measurement, the corneal curvature display changes to

    other way (D or mm).

    The regular display unit can be set in parameter setting mode by selecting either D or

    mm.When Sagittal radius mode is set and the parameter is set to yes, this button is used to

    change the measuring directions and functions of sagittal radius.

    7.3 Parameter Setting

    KM-500 is equipped with the functions to set the various parameter of the device according to

    the operators way of use.

    For the item numbers, setting items, and setting contents, see the parameter setting list on the

    next page.

    7.3.1 Setting change

    1. Press R (or L) button to turn ON the power.

    2. Press Setting button more than 2 seconds to change the display to parameter setting

    condition.

    3. By every press of OFF button, the item No. increases.Referring to the parameter setting list on the next page, indicate the desired item No. on

    the display panel.

    Item No. is displayed on the left top of the display panel.

    When the Slide Base type is used, the start button can also be used for this operation.

    4. Press R (or L) button to change the setting contents.

    Setting contents are manifested with numbers or abbreviations, and it is displayed on the right

    top part of the display.

    5. Repeat the process in 3. - 4. to set other parameters.

    6. Press Setting button to finish the setting.

    7OTHER FUNCTIONS

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    7.3.2 Parameter setting list

    * The underline shows the factory setting.

    * To use the functions of circled number, optional printer is required.

    * For item No. - , external connecting cable is required as well as the printer. These

    items are used for communication with NIDEK US series and other external computer.

    No. Items Contents1 Display change of R1, R2 / AVE, CYL R1, R2 / AVE, CYL

    2 Display Unit of Corneal curvature mm / D

    3 Step of Refractive power display 0.01D / 0.12D / 0.25D

    4 Corneal Refractive index 1.3375 / 1.336 / 1.332

    5 Mire ring brightness 1:(Dark) 5:(Bright) (3)

    6 Display contrast 1:(Low) 5:(High) (3)

    7 Beeping sound High / Low / NO

    8 Auto-OFF YES / NO

    9 Fixation Light YES / NO

    10 Measurement of Sagittal radius YES / NO

    Axis for Sagittal radius data Fix / Axis

    Sagittal radius data print format All / Short

    Data format Y.M.D / M.D.Y

    Print format All / Short / NO

    Time setting See 7.4 Time Setting

    Comment Setting See 7.5 Comment Setting

    Baud-rate 1200 / 2400 / 4800 / 9600

    Bit length 7 / 8

    Interface carriage return code YES / NO

    Interface format All / Short

    21 Auto-Print YES / NO

    22 Continuous Measurement 1 5 times (1)

    23 Back-Light YES / NO

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    The followings are an explanation of the items.

    [Item No.1] Serves to choose R1, R2, or AVE, CYL of the display.

    [Item No.2] Serves to set the data display of corneal curvature value either corneal radius

    (mm) or corneal refractive power (D).[Item No.3] Serves to select the diopter step of corneal refractive power (which is converted

    to diopter from the corneal radius.)

    [Item No.4] Serves to select the desired corneal refractive index to convert the corneal radius

    to corneal refractive power.

    [Item No.5] Serves to control the brightness of Mire ring.

    [Item No.6] Serves to control the contrast of display.

    [Item No.7] Serves to decide whether the beep sounds when any button is pressed.

    [Item No.8] Serves to select the Auto-off function. At the condition that power is ON, the

    power of the main body becomes OFF after passing a certain time without pressing

    any button.

    [Item No.9] Serves to choose ON or OFF of the Fixation light.

    [Item No.10] Serves to decide whether to measure the Sagittal radius.

    [Item No.11] Serves to decide whether to convert the Sagittal radius data for the principal

    meridian angle. To obtain the converted data, choose AXIS.

    [Item No.12] Serves to choose the printout format of Sagittal radius data.

    All ............ All data are printed out.

    Short ........Only Sagittal radius value and the total eccentricity are printed out.

    The followings are the sample printings for left eye and explanations of Sagittal

    radius data.

    = Sagittal radius on each side

    SUP. = Superior side

    INF. = Inferior side

    TEM.= Temporal side

    NAS. = Nasal side

    A = Principal Meridian Angle(F = Fixation Angle)

    E = Total Eccentricity

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    S = Sagittal data which the dRo value is added to

    or reduced from Sagittal radius values

    e = Eccentricity values of each Sagittal radius

    eh = Eccentricity on horizontal meridian

    ev = Eccentricity on vertical meridian

    ASTc = Corneal astigmatism of central part

    ASTp = Corneal astigmatism of peripheral part

    Rh = Average of Corneal curvature on horizontal

    meridian

    Rv = Average of Corneal curvature on vertical

    meridian

    Ro = Average of Corneal curvature on central part

    dRo = Difference of Corneal curvature between R1

    and R2

    dAST= Difference of Corneal astigmatism between

    central part and peripheral part

    [Item No.13] Serves to choose the date format.

    Y.M.D. = Year, Month, Day.

    M.D.Y. = Month, Day, Year.

    [Item No.14] Serves to choose the print out format of the measured data.All ............ All measured data and selected values are printed out.

    Short .........Only the selected value is printed out.

    NO ............Nothing is printed out.

    (This setting is for transmitting the data to some external

    instruments.)

    When there are only two data or less, the latest value will be printed out.

    The following is the sample printing of measured data.

    Name and Sex

    Date and Time

    Selected value of Corneal curvature

    Comment

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    [Item No.15] Serves to set the time.

    [Item No.16] Serves to input the comment.

    [Item No.17] Serves to choose the transmission speed of the bit (baud rate) in communication.

    [Item No.18] Serves to choose the bit number of a single character in communication.

    [Item No.19] Serves to decide whether CR code should be added at the end of the transmitting

    data, or not.

    [Item No.20] Serves to choose the All(all data) or Short(shortened data) format of transmitting

    data.

    [Item No.21] Serves to decide whether to print the data out automatically after the measurement

    of both eyes are completed.

    (This function does not effect when the device is used as Hand Held Type.)

    [Item No.22] Serves to set the times of continuous measurement.

    Measurements are taken several times in a row for each eyes according to the set

    number.

    [Item No.23] Serves to leave the back-light of the display panel ON. The back light can also be

    ON by pressing R or L button for a while at the beginning of the measurement

    (See 7.1 Illumination of Display Panel).

    Name and Sex

    Date and Time

    Corneal curvature

    = Right eye

    = Left eye

    R1 = Minor meridian

    R2 = Major meridian

    AVE = Average of R1 and R2

    CYL = Corneal astigmatism

    deg = Corneal axis

    Comment

    Selected value

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    7.4 Time Setting

    (Only for when connecting the optional printer)

    1. Press R (or L) button to put the power ON.

    2. Press Setting button more than two seconds to shift the display to the parameter

    setting condition.

    3. Press OFF button to set the Item No. to 15.

    4. Press R (or L) button to set to the time setting mode.

    The date and time parameter appears on the left column and the go sign appears on the rightcolumn of the display. There are two dots below the Year position to show the changing

    position.

    5. Each time you press OFF button, the position of the dots change in order as follows.

    Bring the dots to the desired place.

    6. By pressing R or L button, change the setting number as desired.

    L button ..... Increases the number

    R button ..... Decreases the number

    7. Repeat the process of 5., 6. to set other time units.

    8. After the setting is completed, press the OFF button to bring the dots to go.

    9. Press R (or L) button to finish the setting.

    If you press R or L button, the time will be transmitted to the printer and the clock starts from 0

    second of the set time. Then the set time will be printed out from the printer. (When using the

    Hand Held Type, do this operation with the data transmission window aimed at the data receiving

    window of the printer.)

    If you press setting button, the setting mode will be canceled.

    Year Month Day Hour Minute go Year ......

    (Top line) (Middle line) (Middle line) (Bottom line) (Bottom line) (Top line)

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    7.5 Comment Setting

    (Only for when connecting the optional printer)

    1. Press R (or L) button to put the power ON.

    2. Press Setting button more than two seconds to shift the display to the parameter

    setting condition.

    3. Press OFF button to change the Item No. to 16.

    4. Press R (or L) button to change to comment setting mode.

    The comment setting parameter appears on the middle line of the display panel. The number onthe left shows the indication place and the numbers on the right show the character code.

    5. Each time you press OFF button, the number on the left changes from 1. to 48. Select

    the number of the desired place.

    The number of the indication place is shown below. The No.1 indicates the place on the left top

    and the No.48 indicates the place on the right bottom.

    6. By pressing R or L button, select the desired character code.

    L button ..... Increases the character code number.

    R button.....Decreases the character code number.

    For the character code, refer to the Table of Character codes on the next page.

    7. Press Setting button after the selection.

    If you press Setting button, the setting will be over.

    If you press the Print button while setting comments, the present set comment will be

    printed out.

    1 24

    25 48

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    7 - 8

    Table of Character Codes

    Following characters (marks) are available to input.

    < Example >

    To input the character N, which is at the column 4, line E of the table above, to the

    7th column in the first line, display 7 4E on the display panel.

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    8.1 Cleaning

    8.1.1 Cleaning the plastic body

    1. Blow dusts by blower brush.

    2. Wipe the part with dry soft cloth.

    To remove stubborn dirt, you should immerse a cloth in a neutral detergent and wring it well to

    remove the dirt. After that, wipe it out with a dry soft cloth.

    NOTE

    Never use the organic solvent such as paint thinner. Such thing could dissolve the

    surface of the instrument.

    8.1.2 Cleaning of Measuring Window, Observation Window,

    and Measuring Light Source Part

    1. Blow dusts by blower brush.

    2. For the adherent dust, wet an absorbent cotton with a little alcohol and wipe it out softly.

    8.2 Replacement of Printer Paper (Option)

    1. Turn the power switch of AC adapter | (ON).

    8 MAINTENANCE

    Power switch

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    8 - 2

    2. Pull the printer paper holder to the both sides

    and remove the printer paper shaft.

    3. Cut the printer paper at the paper inlet.

    4. Discharge the remained paper by pressing

    Paper Feed button.

    5. Put the new printer paper into the paper inlet

    slot with its outer side down.

    6. Press Paper Feed button until the end of

    paper comes out from the paper outlet slot.

    Printer paper holder

    Printer paper shaft

    Cut

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    8 - 3

    7. Set the paper to the printer paper holder.

    8. To remove the slack of the paper, turn the

    paper with your hand.

    9. Cut off the extra paper at the paper outlet.

    8.3 List of Parts for Replacement

    Article Order Number

    Printer roll 80620-00001

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    9 SPECIFICATIONS

    (1) Measurable area (on the cornea)

    Center Part 3.3 mm in diameter

    (Corneal curvature : 7.7 mm)

    (2) Size of Mire Ring (on the cornea)

    4.7 mm in diameter

    (Corneal curvature : 7.7 mm)

    (3) Measurable range

    Corneal radius (R1, R2, AVE)

    Measurable range 5.00 to 10.00 mm

    Indication step 0.01 mm

    Measurement accuracy 0.05mm

    Corneal refractive power (R1, R2, AVE)

    Measurable range 33.75 to 67.50 D

    (Corneal refractive index : n=1.3375)

    Indication step 0.01 D / 0.12 D / 0.25 D

    (Corneal refractive index : n=1.3375 Changeable to

    n=1.336, n=1.332)

    Corneal astigmatism (CYL)

    Measurable range 0 to -10.00 D

    Indication step 0.01 D / 0.12 D / 0.25 D

    Corneal cylindrical axis (AXIS)

    Measurable range 0 to 180

    Indication step 1

    (4) Sagittal Radius measurement

    Measurable angle 25 from the center (superior, inferior, nasal, temporal)

    Eccentricity (E)

    Measurable range 4.10 to +2.05

    (5) Display contents

    Corneal radius (R1, R2, AVE)

    Corneal refractive power (R1, R2, AVE)

    Corneal astigmatism (CYL)

    Corneal axis (AX)

    Eccentricity [E] (for Sagittal Radius measurement)

    (6) Time of measurementWithin 0.1 second.

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    (7) Print out contents (When using printer)

    Measured date and time

    Corneal radius measured valueCorneal refractive power measured value

    Sagittal Radius (for Sagittal Radius measurement)

    Eccentricity [E] (for Sagittal Radius measurement)

    (8) Power Source

    AC Adapter*1 : A. 110 V~, 50/60 Hz, 30 VA *2

    B. 230 V~, 50/60 Hz, 30 VA *2

    Main Body : 6-25 V , 5 VA

    Battery charger : 6-25 V , (Battery Pack : 6 V 1100 mAh)

    Printer : 6-25 V , 8.5 VA (option)

    (9) Dimensions and weight

    Main Body : 97.5(W) 87.5(D) 201(H) mm 570 g

    AC Adapter : 96(W) 155(D) 62(H) mm 1.1 kg

    Battery Pack : 65.5(W) 68.5(D) 45(H) mm 200 g

    Battery charger : 90(W) 244(D) 50(H) mm 370 g

    SL Arm : 60(W) 238-371.5(D) 44.5(H) mm 490 g

    Slide Base : 235.5(W) 239.5(D) 210.5-243.5(H) mm 4 kg

    Printer : 133(W) 141.5(D) 49.5(H) mm 360 g (option)

    Head Rest : 187(W) 88.5(D) 432(H) mm 1.1 kg (option)

    (10) Environmental condition

    Temperature : 10 - 40 C (In usage)

    20 - 60 C (In storage/ Transference)

    Humidity : 30 - 75 % (Non-condensing)(In usage)

    10 - 95 % (In storage/ Transference)

    Atmospheric pressure : 700 - 1060 hpa (In usage)

    *Specifications are subject to change without notice for improvement.

    *1 The electrical rating , A or B for the instrument is factory-configured.

    *2 Main supply voltage fluctuation not to exceed 10% of the nominal voltage.

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