RM-800 and KR-800 Instruction Manual ver Jan 2013

INTRODUCTION Thank you for purchasing the TOPCON Auto Refractometer RM-800, Auto Kerato-Refractometer KR-800.

INTENDED USE / INDICATIONS FOR USE This instrument is used to measure the spherical refractive-power, cylindrical refractive power,the direction of astigmatic axis, the radius of curvature, the corneal astigmatic axis angle and the corneal refractory power. (Function to measure the radius of curvature, the corneal astigmatic axis angle and the corneal refractory power is possible only with KR-800.)

FEATURES This instrument features the following:

• The auto shoot function facilitates quick measurements under the optimal condition. (Only in KR-800) • This instrument is simple to operate and measures the refraction and corneal curvature of the eye. (Function to measure the corneal refraction is possible only with KR-800.).

PURPOSE OF THIS MANUAL To get the best use of the instrument, read GENERAL SAFETY INFORMATION and DISPLAYS AND SYMBOLS FOR SAFE USE. Keep this Manual at hand for future reference.

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

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1. No part of this manual may be copied or reprinted, in whole or in part, without prior written permission. 2. The contents of this manual are subject to change without prior notice and without legal obligation. 3. The contents of this manual are correct to the best of our knowledge. Please inform us of any ambiguous or erroneous descriptions, missing information, etc. ©2013 TOPCON CORPORATION ALL RIGHTS RESERVED

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GENERAL SAFETY INFORMATION WARNINGS Ensuring the Safety of Patients and Operators When operating this instrument, ensure that it does not hit the patient's eye or nose. Handling the cord on this product or cords associated with accessories sold with this product, will expose you to lead, a chemical known to the State of California to cause birth detects or other reproductive harm. Wash hands after handling.

Preventing Electric Shocks and Fires To avoid fire and electric shock, install the instrument in a dry place free of water and other liquids. To avoid fire and electric shock, do not put cups or other containers with liquids near the instrument. To avoid electric shocks, do not insert metal objects into the instrument body through the vent holes or gaps. To avoid fire in the event of an instrument malfunction, immediately turn OFF the power switch " " and disconnect the power cord from the outlet if you see smoke coming from the instrument, etc. Don't install the instrument where it is difficult to disconnect the power cord from the instrument. Ask your dealer for service.

CAUTIONS Ensuring the Safety of Patients and Operators To avoid injury when operating the instrument, do not touch the main body to the patient's eye or nose.

Preventing Electric Shocks and burn. To avoid injury by electric shock, do not open the cover. For repair, call your service engineer.

Electromagnetic Compatibility (EMC) This instrument has been tested (with 100/120/230V) and found to comply with IEC60601-1-2:Ed.3.0:2007. This instrument radiates radio frequency energy within standard and may affect other devices in the vicinity. If you have discovered that turning on/off the instrument affects other devices, we recommend you change its position, keep a proper distance from other devices, or plug it into a different outlet. Please consult your authorized dealer if you have any additional questions.

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DISPLAYS AND SYMBOLS FOR SAFE USE In order to encourage the safe use of the instrument and to avoid danger to the operator and others as well as damage to properties, warnings are described in the User Manual and marked on the instrument body. We suggest you thoroughly understand the meaning of the following displays/icons and Safety Cautions, as well as read the Manual, and strictly observe the instructions.

DISPLAYS Display

Meaning

WARNINGS

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

CAUTIONS

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

SYMBOLS Symbol

IEC/ISO Publication

Description

Description (French)

IEC 60417-5032

Alternating Current

Courant alternatif

IEC 60417-5008

Off (power: disconnection from the main power supply)

Éteint (courant: coupure avec le secteur)

IEC 60417-5007

On (power: connection to the main power supply)

Allumé (courant: raccordement sur le secteur)

IEC 60878-02-02

Type B applied part

Partie appliquée du Type B

ISO 7010-W001

General warning sign

Symbole d'avertissement général

ISO 7010-M002

Refer to instruction manual/booklet

Voir le manuel/la brochure

ISO 7000-2497

Date of manufacture

Date de fabrication

ISO 7000-2498

Serial number

Numéro de série

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POSITIONS OF WARNING AND CAUTION INDICATIONS To ensure safety, this machine provides warning displays. Use the instrument correctly by observing the display instructions. If any of the following display labels are missing, contact your TOPCON dealer at the address listed on the back cover.

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1

No.

Label

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3

Meaning WARNING

1

To avoid injury caused by electric shock, do not open the cover. Ask your dealer for service.

2

Be careful not to hit the patient's eyes or nose with the instrument during operation.

3

Pay much attention not to touch the internal printer's body when the cover is open. If touched, it may result in trouble due to electrostatic discharge.

4

Degree of protection against electric shock : TYPE B APPLIED PART

CAUTION CAUTION

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MAINTENANCE User maintenance items Item

Inspection time

Contents

Inspection

Before using

• The instrument works properly. • The objective lens must be free of stain or flaw.

Cleaning

When the part is stained

• Objective lens • External cover, control panel, etc.

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SPECIFICATIONS & PERFORMANCE SPECIFICATIONS RM-800 Range of Refractometry Measurement

Spherical refractive power: -25D to +22D (0.12D/0.25D steps) Cylindrical refractive power: 0D to ±10D (0.12D/0.25D steps) Direction of astigmatic axis: 0° to 180° (1°/5° steps) (where, spherical refractive power + cylindrical refractive power +22D, or spherical refractive power + cylindrical refractive power -25D) Measured minimum pupil diameter: φ2mm

PD measurement

20-85mm (0.5mm display unit)

External I/O terminal

USB(for Import), RS232C(for Export), LAN(for Export)

KR-800 Range of Refractometry Measurement

Spherical refractive power: -25D to +22D (0.12D/0.25D steps) Cylindrical refractive power: 0D to ±10D (0.12D/0.25D steps) Direction of astigmatic axis: 0° to 180° (1°/5° steps) (where, spherical refractive power + cylindrical refractive power +22D, or spherical refractive power + cylindrical refractive power -25D) Measured minimum pupil diameter: φ2mm

Range of Cornea Curvature Measurement Cornea curvature radius: 5.00mm to 10.00mm (0.01mm step display) Corneal refractive power: 67.50D to 33.75D(0.12D/0.25D steps) (where, corneal refractive power =1.3375) Corneal astigmatic power: 0D to ±10D (0.12D/0.25D steps) Direction of corneal astigmatic axis: 0° to 180° (1°/5° steps)

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PD measurement

20-85mm (0.5mm display unit)

External I/O terminal

USB(for Import), RS232C(for Export), LAN(for Export)

GENERAL INFORMATION ON USAGE AND MAINTENANCE INTENDED PATIENT POPULATION The patient who undergoes an examination by this instrument must maintain concentration for a few minutes and keep to the following instructions: • To fix the face to the chinrest, forehead rest. • To keep the eye open. • To understand and follow instructions when undergoing an examination.

INTENDED USER PROFILE Since the Auto Refractometer RM-800, Auto Kerato-Refractometer KR-800 are medical devices, the operation should be supervised by a physician.

ENVIRONMENTAL CONDITIONS FOR USE Temperature : 10°C to 40°C Humidity : 30% to 90% RH(without condensation) Atmospheric pressure: 700hPa to 1060hPa

STORAGE, USAGE PERIOD 1. Environmental conditions (without package) *Temperature : 10°C to 40°C Humidity : 10% to 95% (without condensation) Air pressure : 700hPa to 1060hPa * THIS INSTRUMENT DOES NOT MEET THE TEMPERATURE REQUIREMENTS OF ISO 15004-1 FOR STORAGE. DO NOT STORE THIS INSTRUMENT IN CONDITIONS WHERE THE TEMPERATURE MAY RISE ABOVE 40°C OR FALL BELOW 10°C. 2. When storing the instrument, ensure that the following conditions are met: (1) The instrument must not be splashed with water. (2) Store the instrument away from environments where air pressure, temperature, humidity, ventilation, sunlight, dust, salty/sulfurous air, etc. could cause damage. (3) Do not store or transport the instrument on a slanted or uneven surface or in an area where it is subject to vibrations or instability. (4) Do not store the instrument where chemicals are stored or gas is generated. 3. Normal life span of the instrument: 8 years from delivery providing regular maintenance is performed [TOPCON data]

ENVIRONMENTAL CONDITIONS FOR PACKAGING IN STORAGE Temperature : -20°C to 50°C Humidity : 10% to 95%

ENVIRONMENTAL CONDITIONS FOR PACKAGING IN TRANSPORTATION Temperature : -40°C to 70°C Humidity : 10% to 95%

ELECTRIC RATING Source voltage:100 - 240V AC, 50 - 60Hz Power input:30-70VA

DIMENSIONS AND WEIGHT Dimensions Weight

: 317~341mm(W) x 521~538mm(D) x 447~477mm(H) : 15kg

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OPERATION PRINCIPLE Refraction (REF) The instrument projects a near infra red ring of light onto the retina and the reflection of the ring is captured by a CCD camera. An internal computer analyzes the image and calculates the spherical, cylindrical and axial values. Keratometry (KRT) The instrument projects a near infra red ring of light onto the cornea and the reflection of the ring is captured by a CCD camera. An internal computer analyzes the image and calculates the curvature radius, corneal astigmatic axis and the corneal refractive values.

DISPOSAL • When disposing of the instrument and/or parts, follow local regulations for disposal and recycling.

This symbol is applicable for EU member countries only. To avoid potential damage to the environment and possibly human health, this instrument should be disposed of (i) for EU member countries - in accordance with WEEE (Directive on Waste Electrical and Electronic Equipment), or (ii) for all other countries, in accordance with local disposal and recycling laws.

NOTES

This Product Contains Mercury in the backlighting of the LCD display. Prior to disposal remove or otherwise ensure that this is disposed of in accordance with Local, State and Federal Laws. This information is applicable in U.S.A only.

This product contains a CRL Lithium Battery which contains Perchlorate Material-special handling may apply. See http://www.dtsc.ca.gov/hazardouswaste/perchlorate/ Note;This is applicable to California,U.S.A.only

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USAGE PURPOSE, FUNCTION AND EFFECTS To perform measurements of the spherical refractive power, cylindrical refractive power and direction of astigmatic axis, as well as the radius of curvature of the corneal surface, direction of corneal astigmatic axis and corneal refractive power. (Function to measure the radius of curvature of the corneal surface, direction of corneal astigmatic axis and corneal refractive power is possible only with KR-800.)

OPERATING AND USAGE METHOD Usage method 1. Connect the power cord to a commercial power source. 2. Turn ON the power switch. 3. Use the base stopper, and release the main unit attachments. 4. Rest the patient's chin on the chinrest, align his/her forehead against the forehead rest and adjust the height of the chinrest by rotating the chinrest up/down handle to adjust the height of the patient's eye. 5. Operate the control lever to move the main unit left/right, or up/down so that the patient's eye is displayed within the centre of the control panel screen. 6. Adjust the focus of the of the patient's eye by moving the main unit forward/back. 7. Measurements will start automatically when operating the control lever so that the alignment bright spot enters the alignment area on the control panel and the spot becomes smallest in size (when auto shoot mode is set. When manual measurement has been set, press the measurement switch to perform measurements). 8. Repeat operations 4 through 6 again to perform measurements if required. 9. The results are printed out automatically after completing the measurements.(The instrument can be set to manually print out the results manually after completing the measurements on the left and right eyes by tapping the print button on the control panel. As well as printing out the data, the instrument can also transfer the data to a PC). 10. Use the base stopper to fix the main unit. 11. Turn OFF the power switch of the power supply unit. 12. Remove the power plug from the power outlet.

See "PREPARATIONS", "BASIC OPERATIONS", "OPTIONAL OPERATIONS" and "MAINTENANCE" in the "User Manual" for more information.

Please refer to the User Manual.

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When calling please have ready the following information about your unit: • Machine type:

RM-800, KR-800

• Manufacturing No.

Shown on the rating plate on the right side of the base.

• Period of usage:

Please give us the date of purchase.

• Description of Problem :Please provide us with as much detail as possible on the problem.

AUTO REFRACTOMETER RM-800 AUTO KERATO-REFRACTOMETER KR-800 INSTRUCTION MANUAL 2013 version (2013 1-100TH 0 ) Date of issue: January 23, 2013 Published by TOPCON CORPORATION 75-1 Hasunuma-cho, Itabashi-ku, Tokyo, 174-8580 Japan.

©2013 TOPCON CORPORATION ALL RIGHTS RESERVED

AUTO REFRACTOMETER

RM-800 AUTO KERATO-REFRACTOMETER

KR-800

41846 97040 Printed in Japan 1301-100TH 0