TOPCON
RM-8900 and KR-8900 Instruction Manual ver June 2006
Instruction Manual
92 Pages
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INSTRUCTION MANUAL
AUTO REFRACTOMETER
RM-8900 AUTO KERATO-REFRACTOMETER
KR-8900
INTRODUCTION Thank you for purchasing the Auto Refractometer RM-8900, Auto Kerato-Refractometer KR-8900.
This instrument is used to measure the spherical refractive-power,cylindrical refractive power, the direction of astigmatic axis, the radius of curvature, the direction of principal meridian and the corneal refractory power. This instrument features the following: • Measures the refractory power of eye and the corneal curvature with simple operations. • The minimum measurable pupil diameter is now smaller and thus the measuring range is extended. • The auto start function facilitates quick measurements under the optimal condition. This Instruction Manual covers an overview of the basic operation, toroubleshooting, checking, maintenance and cleaning of the Auto Refractometer RM-8900 and Auto Kerato-Refractometer KR-8900. To get the best use of the instrument, read Safety Displays and Safety Cautions. Keep this Manual at hand for future reference.
PRECAUTIONS • Since this product is a precision instrument, always use and keep it in a normally controlled living environment, within a temperature range of 10-40°C, humidity levels between 30-90% and an atmospheric pressure range of 700hPa-1,060hPa. The instrument should also be placed away from direct sunlight. • To ensure smooth operation, install the instrument on a level floor free of vibrations. Also, do not put things on the instrument. • Connect all cables properly before using. • Use the power at a rated voltage. • When not in use, switch off the power source and apply the measuring lens cap and dust cover. • For accurate measurement results, take care to keep the examination window clean and free of fingerprints, spots and dust.
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.
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PRECAUTIONS BASIC INSTRUCTIONS • To avoid electrical shock, do not open the instrument. Refer all servicing to only qualified personnel. • Electrical shock may cause burns or possible fire. Turn the main power switch OFF and UNPLUG the power cord before replacing fuses. Replace only with fuses of the correct rating. • To avoid potential injury during operation, do not touch the patient’s eyes or nose with the instrument.
WORKING ENVIRONMENT Temperature: Humidity: Atmospheric Pressure:
10°C-40°C 30-90% (without dew) 700hPa-1,060hPa
STORAGE, USAGE PERIOD AND OTHERS 1. ENVIRONMENTAL CONDITIONS FOR INSTALLATION (WITHOUT PACKAGE) Temperature: 10 °C-40 °C Humidity: 10%~95% (without dew) Air Pressure: 700hPa-1,060hPa 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 STRING THE INSTRUMENTS, ENSURE THAT THE FOLLOWING CONDITIONS ARE MET: (1) The instrument should not be splashed with water. (2) Store the instrument where air pressure, temperature, humidity, ventilation, sunlight,dust, salty/sulfurous air, etc. do not give any negative side water. (3) Do not store or transport the instrument on a slope 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.USAGE PERIOD 8 years from delivery providing regular maintenance is performed (according to the self-certification [Topcon data])
ENVIRONMENTAL CONDITIONS FOR PACKING IN TRANSPORTATION Temperature: Humidity:
-40°C~70°C 10%-95%
MAINTENANCE AND CHECKS 1.Regularly maintain and check all equipment and parts. 2.Before using equipment that has not been used in a while, be sure to confirm normal and safe operation beforehand attempting any patient measurements. 3.Keep the examination window free from finger prints and dust. 4.When the instrument is not in use, protect the instrument by covering it with the dust cover. 5.When the examination window becomes dirty or soiled, clean it according to the instructions listed in “CLEANING THE INSTRUMENT” on page 83 of the Instruction Manual.
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SAFETY DISPLAYS 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 Instruction 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
WARNING
Improper handling or ignoring this display may lead to the danger of death or serious injury.
CAUTION
Improper handling or ignoring this display may cause personal injury or physical damage.
• Injury means hurt, burn, electric shock, etc. • Physical damage means extensive damage that may involve building, peripheral equipment and furniture.
ICON ICON
MEANING This icon indicates an action to be avoided. Specific contents are shown with words or illustration close to the icon.
This icon indicates Mandatory Action. Specific contents are shown with words or illustration close to the icon.
This icon indicates Hazard Alerting (Warning). Specific content are shown with words or illustration close to the icon.
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SAFETY CAUTIONS WARNINGS Icon
Meaning
Page
To avoid electric shocks, do not attempt overhauling, rebuilding or repairs. Ask your dealer for repair.
74
To avoid electric shocks, do not remove covers from bottom and top surfaces, monitor, measuring unit, etc.
74
To prevent shock hazard, do not allow water or other foreign matter to enter the instrument.
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To avoid fire and electric shocks in case of tumbling, do not place a cup or vessel containing water/fluid on the instrument.
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To avoid electric shocks, do not insert objects metals through vent holes or gaps or contain them inside the machine body.
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To avoid electric shocks during fuse change, be sure to unplug the power cable before removing the fuse lid. Also, do not plug the power cable leaving the fuse box open.
86
Always use the attached fuse (3A 250V). Using any other type may cause troubles and fire.
86
Should any anomaly, such as smoke, occur, immediately switch OFF the power source and unplug the powr cable. Continued use ignoring the condition may cause fire. Ask your dealer for repair.
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. WARNING : 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 This Product Contains Mercury in the backlighting of the LCD display. Prior to disposal remove of 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 CR 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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SAFETY CAUTIONS CAUTIONS Icon
Meaning Before moving the instrument, fasten the clamping knob at the bottom surface to stop movements. Negligence of this may cause injury by falling parts. When moving the instrument, be sure to hold it at the bottom surface with two persons. Carrying by one person may cause a backache or injury by falling parts. Also, holding ares other than the bottom surface may cause pinching fingers between parts and injury by falling parts as well as damage to the instrument.
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To prevent injury due to tumbling of the instrument body and falling parts, avoid a slope and unstable floor for installation.
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To avoid electric shocks, do not handle the power plug with wet fingers.
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To avoid injury, do not insert fingers under the chinrest. *Be sure to instruct the patient about this.
55
This instrument has been tested (with 100/120/230V) and found to comply with IEC60601-1-2:Ed.2.1:2004. 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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USAGE AND MAINTENANCE Usage: • Since the Auto Refractometer is an electric equipment for medical purposes, the operation should be supervised by a well-experienced doctor.
USER MAINTENANCE To maintain the safety and performance of the equipment, never attempt to do maintenance and except for the items specified here. For details, follow the instructions.
FUSE CHANGE: For details, See “FUSE CHANGE” on page 86. CLEANING OF EXAMINATION WINDOW: For details, See “CLEANING THE INSTRUMENT” on page 83.
ESCAPE CLAUSES • TOPCON shall not take any responsibility for damage due to fire, earthquakes, actions by third persons and other accidents, or the negligence and misuse of the user and use under unusual conditions. • TOPCON shall not take any responsibility for damage derived from the use or unavailability of this equipment, such as a loss of business profit and suspension of business. • TOPCON shall not take any responsibility for damage caused by usage other than that described in this Instruction Manual. • TOPCON shall not take any responsibility for the result of diagnosis using this equipment.
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WARNING INDICATIONS AND POSITIONS To secure safety, this equipment provides warnings. Correctly use the equipment following these warning instructions. If any of the following marking labels are missing, please contact your dealer or TOPCON to the address stated on the back cover. CAUTION • To avoid potential injury during operation, do not touch the patient’s eyes or nose with the instrument.
WARNING • To avoid electrical shock, do not open the instrument. Refer all servicing to only qualified personnel.
WARNING • Electrical shock may cause burns or possible fire. Turn the main power switch OFF and UNPLUG the power cord before replacing fuses. Replace only with fuses of the correct rating.
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CONTENTS INTRODUCTION ...1 PRECAUTIONS ...2 WORKING ENVIRONMENT ...2 STORAGE, USAGE PERIOD AND OTHERS ...2 ENVIRONMENTAL CONDITIONS FOR PACKING IN TRANSPORTATION ... 2 SAFETY DISPLAYS ... 3 SAFETY CAUTIONS ...4 USAGE AND MAINTENANCE ...6 USER MAINTENANCE ...6 ESCAPE CLAUSES ...6 WARNING INDICATIONS AND POSITIONS ...7
COMPONENT NAMES MAIN BODY COMPONENTS ...10 CONTROL PANEL COMPONENTS ...11 MONITOR SCREEN ...13 PRINTER OUTPUT ...15 STANDARD ACCESSORIES ...20
PREPARATIONS INSTALLATION ...21 CONNECTING POWER CABLE ...22 CONNECTING EXTERNAL I/O TERMINALS ...22 INITIAL SETTINGS ...23 INITIAL SET SCREEN ...24 NO. SETTING ...29 PRINTOUT ...33 CUSTOM-PRINT SETTINGS ...38 ON-LINE (DATA COMMUNICATION) ...44 MENU SETTING ...47 PRINTER PAPER SETTING ...53 RESETTING FROM POWER SAVE STATUS ...54
BASIC OPERATIONS PREPARATION BEFORE MEASUREMENT ...55 MEASUREMENT UNDER AUTO START MODE (ONLY IN KR-8900) ...57 MEASUREMENT UNDER MANUAL MODE ...62 ERASING MEASUREMENT VALUES ...64
INDIVIDUAL OPERATIONS PRINT-OUT OF MEASUREMENT VALUES ...65 MEASUREMENT OF CORNEA DIAMETER (ONLY IN KR-8900) ...67 MEASUREMENT OF HARD CONTACT LENS ...71 INPUT/OUTPUT USING RS232C ...72 OUTPUT USING USB ...72
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TROUBLESHOOTING TROUBLE-SHOOTING OPERATIONS ...73
SPECIFICATIONS AND PERFORMANCE ELECTROMAGNETIC COMPATIBILITY ...77 ELECTRIC RATING ...81 SYSTEM CLASSIFICATION ...81 DIMENSIONS AND WEIGHT ...81 PURPOSES OF USE ... 81
REFERENCE OPTIONAL ACCESSORIES ...82 SHAPE OF PLUG ...82
MAINTENANCE DAILY CHECKUPS ...83 MAINTENANCE ...87
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COMPONENT NAMES MAIN BODY COMPONENTS Measuring Head Unit
Measuring Head
monitor
Measurement switch Contorol lever Clamping knob Base Unit
Control panel
Power lamp Clamping knob (for movement)
External I/O terminal
Chinrest Unit Forehead rest
Examination window Eye height mark
Brightness volume Printer cover open switch
Chinrest tissue pin Chinrest
Power switch
Cap (for examination window)
10 COMPONENT NAMES
CONTROL PANEL COMPONENTS RM-8900 Print switch
Menu switch
IOL switch
Graphic print switch
Target image observation switch Fixation target brightness switch CYL (cylinder) display selection switch
Print switch... Prints out the measurement result. When there is no measurement value, press the switch to feed paper. Menu switch ... Displays the menu screen. IOL switch ... Press the switch to try measurement when errors are likely, for example, eyes with IOL. Graphic print switch... Prints out graphically the state of refraction. Target image switch ... Allows the operator to observe the stored target image on the monitor screen. Fixation target brightness switch... Changes the brightness of fixation target.
CYL CYL display selection switch... Changes the CYL display.
11 COMPONENT NAMES
KR-8900 Print switch
Graphic print switch Menu switch
Auto start switch
Target image observation switch
IOL switch
Fixation target brightness switch CYL (cylinder) display selection switch Measurement mode switch
Cornea diameter switch
Print switch... Prints out the measurement result. When there is no measurement value, press the switch to feed paper. Menu switch ... Displays the menu screen. IOL switch ... Press the switch to try measurement when errors are likely, for example, eyes with IOL. Graphic print switch... Prints out graphically the state of refraction. Target image switch ... Allows the operator to observe the stored target image on the monitor screen. Fixation target brightness switch ... Changes the brightness of fixation target.
CYL CYL display selection switch ... Changes the CYL display. R
K Measurement mode switch ... Changes the measurement mode.
Auto start switch... Switch between auto start and manual mode. Cornea diameter switch ... Measures the cornea diameter.
12 COMPONENT NAMES
MONITOR SCREEN RM-8900 MEASURING SCREEN (LAYOUT 1)
IOL Mode
S + 0.00 C +0.50 A 100
Fixation target brightness
R L 03 / 03
CYL power symbol Vertical distance Instrument No. Patient No. Target eye
CYL VD
(-) 12.00 01 0001
R L
S + 0.00 C +0.50 A 100
Result of refractory power measurement Frequency of measurement Alignment mark Smallest measurable pupil diameter mark Typical value
MEASURING SCREEN (LAYOUT 2)
Result of refractory power measurement (Right eye)
Instrument No. Patient No. CYL power symbol IOL Mode Vertical distance
S + 0.00 C + 0.50 100 A
CYL
0001 (-)
+ 0.00 S + 0.50 C 100 A
VD
01 12.00
R L 01 / 01 R L
Result of refractory power measurement (Left eye)
Alignment mark Smallest measurable pupil diameter mark Frequency of measurement Target eye Fixation target brightness
INITIAL SETTING SCREEN
INITIAL MENU INITIAL SET NUMBER SET PRINT OUT ON-LINE EXIT
MENU SETTING SCREEN
SETTING MENU STEP AXIS STEP VD CONT. MEAS ON LINE ADD DATE/TIME D/MM EXIT MEASURE SWITCH PRINT SWITCH
0.12 0.25
ITEM SELECT
13 COMPONENT NAMES
KR-8900 MEASURING SCREEN(LAYOUT 1)
Mode IOL Mode D/MM mark
R K
Fixation target brightness
S + 0.00 C + 0.50 A 100 H 44.00 V 44.00 A 100 R L R 03 / 03 K 03 / 03
mD
CYL power symbol Vertical distance Instrument No. Patient No. Alignment bar Target eye
CYL VD
(-)
12.00 01 0001
R L
S + 0.00 C + 0.50 A 100
Vertical distance Result of refractory power measuremen Cornea measurement result Frequency of measurement (REF) Frequency of measurement (KRT) Alignment mark Smallest measurable pupil diameter mark Typical value
MEASURING SCREEN(LAYOUT 2)
Result of refractory power measurement (Right eye) Cornea measurement result(Right eye) Instrument No. Patient No. CYL power symbol
CYL
Mode IOL Mode Vertical distance
+ 0.00 + 0.50 100 43.00 44.00 180
S + 0.00 C + 0.50 100 A H 43.00 V 44.00 180 A
0001
(-)
R K
8&
01 12.00
S C A H V A
R L R 01 / 01 K 01 / 01
O &
R L
Result of refractory power measurement (Left eye) Cornea measurement result(Left eye) Alignment mark Smallest measurable pupil diameter mark Frequency of measurement Target eye Fixation target brightness D/MM mark
INITIAL SETTING SCREEN
INITIAL MENU INITIAL SET NUMBER SET PRINT OUT ON-LINE EXIT
MENU SETTING SCREEN
SETTING MENU STEP AXIS STEP VD CONT. MEAS ON LINE ADD DATE/TIME D/MM EXIT MEASURE SWITCH PRINT SWITCH
0.12 0.25
ITEM SELECT
CORNEA DIAMETER MEASUREMENT SCREEN
CORNEA DIAMETER
R L
14 COMPONENT NAMES
R
L
PRINTER OUTPUT RM-8900
Bar code Work ID No.
4/ 0#/'
AA#/ 0Q 8& %;. % # ޛ4 ޜ5
ޛ.ޜ
5'
5
%
#
Patient No. Instrument No. VD (vertical distance) Cylindrical power mark Results of 5 refractory power measurements of right eye (recordable up to 10 measurements) Typical value of right eye Equivalent spherical power of right eye Results of 5 refractory power measurements of left eye (recordable up to 10 measurements)
5' 2& #&& 02&
612%10
The ( ) mark is added when measurement values are not fully reliable. The Ι mark is displayed at IOL mode. If the reliablity is low and values of C and A cannot be determined, ∗∗ marks are given to pertaining columns. Typical value of left eye PD (pupil distance)
Reliability mark (displayed when reliability is low)
When measurement is done under the IOL mode, a reliability factor is printed out following the Ι mark. The reliability factor is formed with integers 1 to 9 in increasing order of reliability. Additionally, if the reliability is high enough, the reliability factor is not shown in the printout.
15 COMPONENT NAMES
KR-8900 When "KRT PRINT TYPE" is set to "NORMAL" <R/K> mode
Bar code Work ID No.
-4
Patient No.
0#/'
Instrument No. AA#/ 0Q 4'(# 8& %;. % # ޛ4 ޜ5 5'
VD (vertical distance) Cylindrical power mark Right eye measurements Measurement Results of 3 right eye measurements (recordable up to 10 measurements) Typical value of riht eye Equivalent spherical power of right eye
ޛ.ޜ
% # 5 5' 2& #&& 02&
-46# ޛ4ޜ & // * 8 #8' %;. %140'#&+# & & عع عع عع ޛ.ޜ * 8 #8'
The ( ) mark is added when measurement values are not fully reliable. Near vision PD value ADD (ordinary additional power) PD value
# #
Measured value of horizontal corneal curvature Measured value of vertical corneal curvature Average value Corneal astigmatic power Cornea diameter
&
//
#
%;. %140'#&+# & & # عع عع عع عع
612%10
D1:Refractory power of second principal meridian D2:Refractory power of first principal meridian A1:angle of second principal meridian Low reliability mark
ALL mode (example)
When measurement is done under the IOL mode, a reliability factor is printed out following the Ι mark. The reliability factor is formed with integers 1 to 9 in increasing order of reliability. Additionally, if the reliability is high enough, the reliability factor is not shown in the printout.
16 COMPONENT NAMES
<REF> mode
<KRT> mode
-4
-4
0#/'
0#/'
AA#/ 0Q 4'(# 8& %;. % # ޛ4 ޜ5
ޛ.ޜ
5'
5
%
#
Patient No. Instrument No. VD (vertical distance) Cylindrical power mark Results of 5 refractory power measurements of right eye (recordable up to 10 measurements) Typical value of right eye
Results of 5 refractory power measurements of left eye (recordable up to 10 measurements)
5' 2& #&& 02&
Typical value of left eye PD (pupil distance)
612%10
Reliability mark (displayed when reliability is low)
AA#/ 0Q -46# ޛ4ޜ & // # * 8 #8' %;. %140'#&+# // // # عع عع عع عع عع ޛ.ޜ & // # * 8 #8' %;. %140'#&+# // // # عع عع عع عع عع 612%10
Typical measured value of right eye corneal curvature Measured value of right eye cornea (mm) Results of 5 right eye corneal curvature measurements of right eye, average value and astigmatic power of cornea (recordable up to 10 measurements each for right / left eye)
Measured value of left eye MM1:Radius of curvature of second principal meridian MM2:Radius of curvature of first principal meridian A 1:Angle of second principal meridian
<R/K><KRT> mode The kerato data display in the case of setting the HV display as the R1R2 display.
-46# & ޛ4ޜ 4 4 #8'
//
#
STD 2 FORMAT, see “Setting communication format” on page 45.
17 COMPONENT NAMES
When "KRT PRINT TYPE" is set to "CLASSIC" <R/K> mode
Bar code Work ID No.
Instrument No.
Patient No. Instrument No. VD (vertical distance) Cylindrical power mark Right eye measurements Measurement Results of 5 right eye measurements (recordable up to 10 measurements) Typical value of riht eye (The * mark is displayed when 3 or more measurements are done.) Equivalent spherical power of right eye The ( ) mark is added when measurement values are not fully reliable. The I mark is displayed at IOL mpde. If the reliability is low and values of C and A cannot be detemined, ** marks are given to pertaining columns.
PD value
Measured value of horizontal corneal curvature Measured value of vertical corneal curvature Average value Cornea astigmatic power Cornea diameter
ALL mode (example)
When measurement is done under the IOL mode, a reliability factor is printed out following the Ι mark. The reliability factor is formed with integers 1 to 9 in increasing order of reliability. Additionally, if the reliability is high enough, the reliability factor is not shown in the printout.
18 COMPONENT NAMES
<REF> mode
<KRT> mode
Patient No. Instrument No. VD (vertical distance) Cylindrical power mark Results of 5 refractory power measurements of right eye (recordable up to 10 measurements) Typical value of right eye
Typical measured value of right eye corneal curvature
Measured value of right eye cornea (mm)
Results of 5 refractory power measurements of left eye (recordable up to 10 measurements) Typical value of left eye PD (pupil distance)
Results of 5 right eye corneal curvature measurements of right eye, average value and astigmatic power of cornea (recordable up to 10 measurements each for right / left eye)
Reliability mark (displayed when reliability is low)
Measured value of left eye
19 COMPONENT NAMES