Shin-Nippon Accuref-K 9001 Operation manual

AUTO REFKERATOMETER
ACCUREF-K
9001
Operations Manual
RB-400-B02Q
INTRODUCTION
NOTE
The information contained in this manual is subject to change without notice. While reasonable efforts have been made in the preparation of this document to ensure its accuracy,
you should contact your local distributor immediately, if any quarries arise due to editorial errors or omissions etc.
If you find any imperfect collating or missing pages, contact your local distributor for replacement.
SAFETY CONSIDERATION
ACCUREF-K 9001 is a Class I, Type B medical instrument as well as LED Class 2 product. This instrument complies with Medical Device Directive 93/42/EEC.
A great deal of consideration has gone into the design and manufacturing of this instrument with regard to its operational ease, the patient's safety and well-being as well as to the reliability of the product. For safer and more effective use, however, follow the points described in this manual.
This instrument is designed for professional use.
~ General Definitions of Safety Symbols ~
Personal injury or physical damage may occur when this warning
CAUTION
LED Class 2 Product
NOTE
is ignored. General warning. Caution. Risk of danger.
Denotes general ban or prohibition.
General mandatory action.
Caution of invisible LED radiation. Avoid exposure to beam. Indicated inside of the device.
This device is an LED class 2 product.
Additional information which is important to the text or is useful/convenient to know.
Symbol for “MANUFACTURER”.
EC
REP
Symbol for “AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY”.
RB-400-B02Q1
CAUTION
Always take great care when operating ACCUREF-K. Malfunction or damage to the instrument could
occur.
Cut the power immediately if malfunction occurs during operation. Damage to the equipment or
personal injury will result. Consult your dealer, if repair work needs to be carried out.
At no time attempt to remodel or disassemble ACCUREF-K. Damage to the instrument or personal
injury will result.
As ACCUREF-K is a precision optical instrument, operations must be carried out at all times by
experienced, authorized personnel. Damage to the equipment or personal injury will result.
Electromagnetic wave generated by TV, radio, mobile phone, radio transceiver, etc. may cause
malfunction of this instrument. This instrument may also generate noise in the TV, radio, mobile phone, radio transceiver, etc. Avoid introducing or installing instruments which may have adverse influence to the circumstance.
Avoid use this instrument adjacent to other instruments or stacked in plies. Failure or malfunction of
the instrument may occur.
Avoid installation near TV or radio. The reception can be disturbed by electrical noise. Follow the
manual for the proper installation.
Never remove the plug from the outlet if your hands are wet. Electric shock or personal injury could
result.
Make sure the power cord is not damaged. Fire or electric shock may occur. Do not touch the optical parts. Measurement accuracy will be adversely affected.
The power cord must be firmly connected to an electrical ground (safety ground) at the power outlet.
Personal injury may result from electric shock, etc.
If the instrument fails to work properly, you should not try to repair the fault. Consult your dealer
immediately.
The instruction in this manual ensures correct operations. Observe the following environmental conditions for used and storage. Avoid dew condensation at all
time.
Temperature Relative humidity Use +10°C to +40°C 30% to 85% Storage –10°C to +60°C below 70%
Avoid the following conditions for storage and use of the instrument.
Where noxious gases or air pollutants are present. Where dust and grit may occur. Where oil fumes or greasy substances are emitted. Where there are atmospheric concentrations of salt. Near gas generation areas and places where dust accumulates. Keep in a secure, stable situation. Do not expose to strong vibrations (areas of seismic activity) and
sudden shocks (this includes transportation) etc.
Where there is an inclination of more than 10 degrees. Where voltage from the power sources rises or falls sharply during loading. Where fluctuations in the voltage of the power source occurs. Direct contact with sunlight.
If the instructions above are not followed, damage to the equipment or personal injury will ensue.
RB-400-B02Q2
Guidance and manufacturer’s declaration – electromagnetic emissions
ACCUREF-K9001 is intended for use in the electromagnetic environment specified below. The customer or the user of ACCUREF-K9001 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions CISPR 11
RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3
Group 1 ACCUREF-K9001 uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Class A
Class A
Complies
ACCUREF-K9001 is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Guidance and manufacturer’s declaration – electromagnetic immunity
ACCUREF-K9001 Image Intensifier is intended for use in the electromagnetic environment specified below. The customer or the user of ACCUREF-K9001 Image Intensifier should assure that it is used in such an environment.
Immunity test IEC 60601
test level Electrostatic discharge (ESD) IEC 61000-4-2
Electrical fast transient/burst IEC 61000-4-4
Surge IEC 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
6 kV contact 8 kV air
2 kV for power
supply lines
1 kV for
input/output lines
1 kV differential
mode
2 kV common mode
<5 %
U
U
U
T
T
T
(>95 % dip in for 0.5 cycle
40 % (60 % dip in for 5 cycles
70 % (30 % dip in for 25 cycles
U )
U )
T
U )
T
T
Compliance level Electromagnetic environment –
guidance 6 kV contact 8 kV air
2 kV for power
supply lines
1 kV for
input/output lines
1 kV differential
mode
2 kV common mode
<5 %
U
U
U
T
U )
T
U )
T
U )
(>95 % dip in for 0.5 cycle
40 % (60 % dip in for 5 cycles
70 % (30 % dip in for 25 cycles
T
T
T
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of ACCUREF-K9001 Image Intensifier requires continued operation during power mains interruptions, it is recommended that ACCUREF-K9001 Image Intensifier be powered from an uninterruptible power supply or a battery.
<5 %
U
(>95 % dip in
for 5 s Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 NOTE
U is the a.c. mains voltage prior to application of the test level.
T
3 A/m 3 A/m Power frequency magnetic fields
T
U )
T
<5 %
U
(>95 % dip in for 5 s
T
U )
T
should be at levels characteristic of a typical location in a typical commercial or hospital environment.
RB-400-B02Q3
Guidance and manufacturer’s declaration – electromagnetic immunity
P
ACCUREF-K9001 is intended for use in the electromagnetic environment specified below. The customer or the user of ACCUREF-K9001 should assure that it is used in such an environment.
Immunity test IEC 60601
test level
Compliance
level
Electromagnetic environment – guidance
Portable and mobile RF communications equipment should be used no closer to any part of ACCUREF-K9001, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
Conducted RF IEC 61000-4-6
3 Vrms 150 kHz to 80 MHz
3 Vrms
Pd 2.1
Radiated RF IEC 61000-4-3
3 V/m 80 MHz to 2.5 GHz
3 V/m
Pd 2.1 80 MHz to 800 MHz
Pd 3.2 800 MHz to 2.5 GHz
where
is the maximum output power rating of
the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
a
b
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which ACCUREF-K9001 is used exceeds the applicable RF compliance level above, ACCUREF-K9001 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating ACCUREF-K9001.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
RB-400-B02Q4
Recommended distance between portable/mobile RF communication equipment and ACCUREF-K9001
P
ACCUREF-K9001 intends to be used in the radiated RF contolled environment. Customers or users of ACCUREF-K9001 shall maintain the minimum safe distance between portable/mobile RF communication equipment(transmitter) and ACCUREF-K9001 to prevent electromagnetic interference. The minimum distance shall be accordance with the maximum output of the communication equipment as recommended below.
Separation distance according to frequency of transmitter
mRated maximum output
power of transmitter
150kHz to 80MHz
80MHz to 800MHz
800MHz to 2.5GHz
W
Pd 2.1
Pd 2.1
Pd 3.2
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73 1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
is the
RB-400-B02Q5
CONTENTS
Introduction......................................................................................................................... 1
Safety Consideration ..........................................................................................................1
Accessories......................................................................................................................... 7
1. Parts Identification.......................................................................................................8
2. Conveyance and Handling Procedure........................................................................ 9
3. Installation Environment ............................................................................................. 9
4. Safeguard Summary .................................................................................................. 10
5. Preparation................................................................................................................. 11
5.1 Setting ......................................................................................................................................11
5.2 Applying Power ........................................................................................................................12
5.3 Standby ....................................................................................................................................13
5.4 Switch Function........................................................................................................................14
6. Measurement.............................................................................................................. 15
6.1 Measurement Flow...................................................................................................................15
6.2 Alignment .................................................................................................................................16
6.3 Measurement Results ..............................................................................................................17
6.4 Print Out ...................................................................................................................................18
6.5 Kerato-Peripheral Measurement..............................................................................................19
6.6 IOL Measurement Function......................................................................................................21
6.7 Menu Screen Setting................................................................................................................22
6.7.1 Each Item Description....................................................................................................23
6.7.2 Optional Functions .........................................................................................................26
6.8 Auto Start Function...................................................................................................................30
6.9 Data Screen Function...............................................................................................................31
6.10 Power Saving Function ............................................................................................................32
6.11 Output Terminal........................................................................................................................32
7. Tips for Effective Measurement ................................................................................ 33
8. Error Messages.......................................................................................................... 34
9. Troubleshooting.........................................................................................................35
10. Contact Lens: Base Curve Measurement................................................................. 36
11. Storage and Maintenance.......................................................................................... 37
11.1 Reloading Printer Paper...........................................................................................................37
11.2 Fuse Replacement ...................................................................................................................38
11.3 Storage.....................................................................................................................................38
11.4 Confirmation of Measurement Accuracy..................................................................................39
11.5 Periodical Inspection and Maintenance ...................................................................................39
12. Specification............................................................................................................... 40
RB-400-B02Q6
Accessories
Model Eye: 1
with a contact lens holder
A sticker indicating the
diopter value is affixed.
Fuse: 2
(T2A 250V)
Power Cord: 1
(2.5m)
Pack of Chin Rest Liners: 1
(1,000 sheets)
Printer Paper: 3
(width 57mm)
Two packed and one installed
into the body
Chin Rest Liner Pin: 2
Dustproof Cover: 1 Operations Manual: 1 Filing Soft: 1
Cable to be used
Power cord KP4819YKS31A 2.5m
Use accessories specified by us to avoid any malfunction or failure.
Use of accessory (power cord) other than specified below may adversely affect
Extra care should be taken for storage of a model eye. Avoid where the lens of the
model eye may be damaged as well as any dusty or humid/steamy environments.
Avoid direct sunlight, humidity and high temperature when storing printer paper
which is a thermal paper.
Name Model No. Length
other instruments and/or cause malfunction of the instrument. Always use the accessory specified by us.
RB-400-B02Q7
1. Parts Identification
ACCUREF
K
90
Fuse Holder
LCD Monitor
Power Indicator
IOL Switch
Measurement Mode
Selection Switch
Menu Switch
Print Switch
Anti-sliding lock
AUTO REFKERATOMETER
SHIN-NIPPON
Printer
Body
Base
Head Rest
Eye Mark
Measurement
Start Switch
Power Switch
Power Plug Connector
View Window
Chin Rest
Joystick
Nameplate
External Interface Connector
Output Terminal for External Monitor
RB-400-B02Q8
2. Conveyance and Handling Procedure
be carried out.
When transporting the instrument, make sure that the body has been securely locked.
Center the body onto the base so that their edges are aligned. Push up the lock while turning right until both body and base are firmly fixed to each other.
3. Installation Environment
1) Do not expose the instrument's view window directly to the sunlight or bright lighting from other sources.
Great care should be taken and avoid that the examinee is exposed to strong light or glare. The pupil will contract too much for measurement to
2) Do not operate in places where either dust or rubbish accumulates. Environment with extremes in heat and humidity should also be avoided. Always follow the environmental requirements below for installation.
Temperature +10 °C ~ + 40°C Relative Humidity 30 % ~ 85 %
3) Keep away from inflammable or explosive gases as well as storage areas housing medical supplies and chemicals.
4) Avoid installing where dew condensation may accumulate. Also, avoid where the radical temperature changes may occur.
5) Keep away from sites that may experience strong vibrations or sudden shocks.
6) Malfunction is likely to occur if the instrument is improperly stabilized or accidentally overturns. To prevent internal/external damage caused by sudden impact, set the instrument on a solid and secure surface. Do not store in high, 'out of reach' places.
Du s t
Gases
RB-400-B02Q9
4. Safeguard Summary
1. ACCUREF-K is a precision optical instrument. Always handle with care and avoid dropping it accidentally.
2. Ensure that the instrument is properly grounded when connected to the power source.
3. Do not touch the optical parts with fingers and be sure to avoid dust, as their measuring accuracy could be adversely affected and incorrect values may result.
When dust or fingerprints appear on the optical part, use a soft cloth to wipe off the build-up. In case that the build-up is hard to remove, absolute alcohol is recommended. Take great care when cleaning these parts as they are particularly sensitive and fragile.
4. If the surfaces of the measuring unit and main unit including the control panel are dirty, gently wipe with a dry cloth. For hard to
Thinner
remove stains, a damp cloth or neutral cleanser is recommended.
Avoid using organic solvents that will damage the water based paint finish of the instrument.
Benzene
5. Clean the chin rest and head rest with the neutral cleanser. For disinfecting them, especially where the examinee may contact, hydrogen peroxide (Oxydol) is recommended.
6. If the instrument is not used for any length of time, remove the power cord from the outlet.
7. When not in use, protect the instrument with a supplied dustproof cover.
8. When the instrument fails to function properly, never attempt to perform internal service or adjustment. Contact your nearest registered agent, distributor or retail outlet.
RB-400-B02Q10
5. Preparation
5.1 Setting
(1) Set a roll of printer paper in the printer. Refer to '11.1 Reloading Printer Paper' for the procedure.
(2) Set and fix the chin rest liners with the chin rest
liner pins on the chin rest. Refer to the figure on the right.
For sanitary consideration, disposing
NOTE
a sheet of the used chin rest liners after every measurement is recommended.
Always use the chin rest liners following above. For sanitary consideration, disinfecting the chin rest with Oxydol is
recommended.
Chin Rest Liners
Chin Rest Liner Pins
Chin Rest
RB-400-B02Q11
5.2 Applying Power
(1) Confirm that the power is 'OFF' (○).
O
POWER
I
T 2A 250V
(2) Insert the power cord into the instrument's power plug
connector. Then insert the plug into a general purpose outlet.
Always make sure that the cable is grounded.
(3) Turn the power switch 'ON'(|).
O
POWER
I
T 2A 250V
RB-400-B02Q12
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