Right On Retinomax Screeen User manual

Hand Held Auto Refractometer
Instructions
November 2018
D054-E

1
CAUTION: Please read this instruction manual before using the instrument.
This instruction manual is intended for users of the Retinomax Screeen.
It includes instructions on how to use the instrument, safety handling precautions, and
specifications.
These instruments conform to the Japanese Industrial Standards (JIS) as well as the
standards of the International Electrotechnical Commission (IEC).
Before using the instrument be sure to read the instructions carefully, and fully
understand the operation procedures and safety instructions to ensure correct usage.
Also, please keep this manual near the main unit so that you can refer to it whenever
necessary.
If you have any questions or comments, please do not hesitate to contact the dealer
from whom you purchased the instrument.
• No part of this manual may be reproduced or transmitted without permission.
• The information in this manual is subject to change without prior notice.

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CONTENTS
■ Handling Precautions - Please first read for safety purposes ............................................ 5
■ EMC (Electromagnetic Compatibility) .............................................................................. 11
1. Overview ...................................................................................................................... 16
1-1 Instrument Overview, Components and Options .................................................. 16
1-2 Instrument Classification ....................................................................................... 17
1-3 Symbols on the Instrument ................................................................................... 18
1-4 Labels and Marks .................................................................................................. 20
2. Name of Parts .............................................................................................................. 24
2-1 Main Unit ............................................................................................................... 24
2-2 Operation Panel .................................................................................................... 25
2-3 Station ................................................................................................................... 27
2-4 Printer .................................................................................................................... 28
3. Setup ............................................................................................................................ 30
3-1 Attaching/Detaching the Strap .............................................................................. 30
3-2 Installing and Removing the Battery Pack ............................................................ 30
3-2-1 Main Unit ........................................................................................................ 30
3-2-2 Printer ............................................................................................................ 31
3-3 Setting Up the Instrument ..................................................................................... 31
3-4 Charging the Battery Pack .................................................................................... 32
3-4-1 Automatic Charging of the Main Unit ............................................................. 33
3-4-2 Automatic Charging of the Printer .................................................................. 34
3-4-3 Charging a Spare Battery Pack ..................................................................... 34
4. Measurement ............................................................................................................... 35
4-1 Power on ............................................................................................................... 36
4-1-1 Opening Screen ............................................................................................. 36
4-1-2 Measurement Screen ..................................................................................... 36
4-1-3 Setting Confirmation ...................................................................................... 38
4-1-4 Measuring the Model Eye .............................................................................. 41
4-2 Preparation for Patient .......................................................................................... 43
4-2-1 Prepare the Forehead Rest ........................................................................... 43
4-2-2 Positioning the Measurement Eye ................................................................. 43
4-2-3 Before the Measurement ............................................................................... 44
4-3 Measurement Modes and Start Measuring ........................................................... 45
4-3-1 Automatic Measurement Mode (AUTO, AUTO2) ........................................... 46
4-3-2 Continuous Measurement Mode (CONT) ...................................................... 50
4-3-3 CHILD/QUICK Mode ...................................................................................... 51

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4-4 Various Functions ................................................................................................. 54
4-4-1 Pupil Diameter Measurement Function .......................................................... 54
4-4-2 Alignment Direction Indication Function ......................................................... 56
4-4-3 Focus Assist Function .................................................................................... 57
4-4-4 Astigmatic Axis Correction Function .............................................................. 59
4-4-5 AUTO QUICK Mode ....................................................................................... 63
4-4-6 Retroillumination Mode .................................................................................. 65
4-4-7 Storing Data ................................................................................................... 66
4-5 Printing .................................................................................................................. 69
4-5-1 Printing Procedure ......................................................................................... 69
4-5-2 Printing Examples .......................................................................................... 71
4-5-3 Cutting off the Printer Paper .......................................................................... 72
4-5-4 Using Multiple Printers ................................................................................... 73
4-5-5 Change Setting by DIP Switch ....................................................................... 74
4-6 Power off ............................................................................................................... 74
4-7 The Other .............................................................................................................. 75
4-7-1 For Proper Measurement ............................................................................... 75
4-7-2 Auto Fogging .................................................................................................. 77
4-7-3 Representative Value ..................................................................................... 79
4-7-4 REF Confidence Value .................................................................................. 79
4-7-5 Standby Mode and Auto Power off ................................................................ 80
4-7-6 Measurement of IOL Eyes ............................................................................. 80
4-7-7 If Measured Values are not Obtained ............................................................ 80
5. Setting Up the Instrument ............................................................................................. 82
5-1 Measurement Setup [MEASURE] ......................................................................... 83
5-2 OUTPUT Screen [OUTPUT] ................................................................................. 84
5-2-1 Output Setting [OUTPUT SETTING] .............................................................. 85
5-2-2 Output Format [OUTPUT FORMAT] .............................................................. 86
5-2-3 Output Format of CONT Measurement [CONT FORMAT] ............................ 87
5-3 MEMORY Screen [MEMORY] .............................................................................. 88
5-4 CHILD Mode Screen [CHILD] ............................................................................... 90
5-5 OTHER Setting [OTHER] ...................................................................................... 91
5-6 CLOCK Screen [CLOCK] ...................................................................................... 92
5-7 POWER OPTION Screen [POWER OPTION] ...................................................... 93
5-8 Patient Number Setup [PATIENT No] ................................................................... 94
5-9 MESSAGE Screen [MESSAGE] ........................................................................... 95
5-10 INITIALIZING Screen [INITIAL] ............................................................................. 96

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5-11 VERSION Confirmation [VERSION] ..................................................................... 97
6. Connecting to External Instruments ............................................................................. 98
6-1 Wireless Transmission to the Remote Vision RV-II .............................................. 98
6-2 Connecting to Computer via USB ......................................................................... 98
7. Maintenance ................................................................................................................. 99
7-1 Checking the Measurement Accuracy .................................................................. 99
7-2 Replacing the Print Roll ......................................................................................... 99
7-3 Replacing the Fuses ........................................................................................... 100
7-4 Cleaning the Forehead Rest ............................................................................... 101
7-5 Cleaning the Measurement Window ................................................................... 101
7-6 Cleaning Model Eye ............................................................................................ 101
7-7 Cleaning Appearance .......................................................................................... 101
7-8 List of Consumable and Maintenance Parts ....................................................... 102
7-9 Lifetime of the Instrument .................................................................................... 102
8. Troubleshooting ......................................................................................................... 103
8-1 Main Unit ............................................................................................................. 103
8-2 Station ................................................................................................................. 105
8-3 Printer .................................................................................................................. 106
9. Main Specifications .................................................................................................... 108

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■Handling Precautions - Please first read for safety purposes
CAUTION 1. Intended product use
• Retinomax Screen is only intended to be used for measuring refractive power
and pupil diameter. Do not use it for any other purpose.
CAUTION 2. Do not disassemble
• Never attempt to disassemble the product as it could cause a serious electric
shock or equipment damage.
CAUTION 3. Measuring operation
• When moving the main unit toward the patient or laterally in front of the patient,
use care to avoid hitting the patient's face.
• Do not measure under environment if there are many people or strong lights
around the patient where disturbing measurement, it may cause failure of
measurement.
CAUTION: Indicates a potentially hazardous situation which, if not avoided,
could result in injury or damage to the surrounding equipment.
Meaning
Symbol
<Caution Symbols Used in This Manual>
Righton products are manufactured with full attention to safety. However, these instruments
can cause personal injury or equipment damage if used improperly or if the instructions are
ignored. For your own safety, read this instruction manual carefully and thoroughly before
using the instrument. Do not discard this manual, but keep it handy for easy reference.
This manual uses the following symbols to draw your attention to “important safety
instructions”. Be sure to follow the instructions marked with these symbols.

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CAUTION 4. Installation and transport
• Do not place the instrument and the peripheral equipment (PC, monitor) on an
unstable location, such as a shaky table or inclined surface. It could be
dropped or fall and cause injury.
• Hold the main unit using the grip. Do not hold it with the LCD or forehead rest.
• Install the unit at place where easy to plug and unplug the electric outlet.
• Place the station and the printer in a well-ventilated location. Do not place
thick cloth or paper under the station or the printer, as it may prevent the
release of heat during battery charging. Heat will accumulate internally,
leading to the danger of fire or failure.
• The operating environment: Temperature 10°C to 35°C, relative humidity 30%
to 85% (no condensation), atmospheric pressure 800-1060 hPa.
• This instrument does not meet the temperature requirements of ISO 15004-1
for using. Do not use this instrument in conditions where the temperature may
rise above 35°C or fall below 10°C.
• Although the instrument is designed with dust protection, it should not be used
in a dusty room.
• The best location for the instrument is a room equivalent to a semi-dark room.
Do not expose the instrument to a bright window or illumination light.
• Measurement space requirement is as follows. Follow requirement of
IEC60601-1 if other type of instruments will be used.
• The instrument conforms to the EMC standard (IEC60601-1-2:2014), but
discharges weak radio waves. If the instrument in operation interferes with
other equipment, such as a TV or radio, take appropriate action, such as
increasing the distance between the instruments or changing each direction.
Radius of 1.5m
2.5m
1.5m
1.5m

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• This instrument is not waterproof. It should not be used or placed in a place
where it can be exposed to liquid such as rainwater, beverages or chemicals.
• If dew condensation occurs, allow the dew to disappear before using the
instrument.
• When transporting the instrument, protect against vibration and shock,
preferably by placing the instrument in the optional carrying case or a packing
box.
CAUTION 5. Other handling precautions
• Make sure that the power cord is not damaged, broken, machined, exposed to
excessive force (bend, pull, or twist), or twisted with other cords. Do not put
heavy objects on, or apply heat to, the power cord, as the cord can be severed,
possibly leading to a fire or electric shock. If the power cord is damaged,
replace it.
• If dust accumulates on the metal part of the power plug, pull out the power
plug and remove the dust. Dust or dirt can cause contact failure of the power
plug, resulting in a fire.
• Connect the instrument to a grounding-type receptacle outlet in a manner that
meets the power supply specifications. Improper connections can affect the
performance, or even cause failure, leakage, shock, or fire.
• Fully insert the power plug. Insufficient insertion can cause a fire.
• When replacing the fuse in the station, be sure to turn off the power switch and
pull out the power cord. Be sure to use the designated fuse. Use of an
undesignated fuse can lead to electric shock or fire.
Designated fuse: Littelfuse's time-lag fuse, f5 x 20 mm
250 V, 1.6 AH (021501.6XP)
• Never short-circuit the battery charging contacts of the main unit, the station,
or the printer.
• Do not expose the connectors or battery charging contacts to your body or
metal objects. If a contact is dirty, turn the power off and wipe the contact off
with a dry, soft cloth.
• If contacts become dirty, wipe with a dry, soft cloth after turning off the power.
• This product is precision optical equipment, containing a large number of
electrical components. Handle with care, avoiding exposure to physical shock.
• Do not drop or bump the instrument. When handling the main unit, always use
the supplied strap. Do not swing the main unit holding only the strap.
• If the instrument ceases to function, pull the power cord from the receptacle
outlet, and without accessing the inside of the instrument, contact your dealer.
• Use the designated print roll. Use of an undesignated brand can lead to
failure.
• Although the printer cutter is located at not accessible place by finger, caution
when changing the paper roll.
• Use accessory cable enclosed with the unit. (See “1-1 Instrument Overview,
Components and Options”)

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• Do not put any objects around power switch of the station or the printer to not
disturbing emergency operation.
• Do not lean on the units.
• Please clean according to the specified method on the manual. If not follow, it
may cause deterioration or damage to the unit. (See “7-4 Cleaning the
Forehead Rest” to “7-7 Cleaning Appearance”)
• Clean the forehead rest for every patient, if not, it may cause cross infection.
• For repair or maintenance, wipe the outer cover with cloth with alcohol for
sterilization.
• When the device is return for maintenance or repair, clean the surface of the
device (especially, forehead rest) with a cloth dampened with rubbing alcohol
for disinfections.
• Accessory equipment connected to the analog and digital interfaces must be
certified according to the appropriate national standards. Furthermore, all
configurations shall comply with the IEC 60601-1. Anyone who connects
additional equipment to the signal input part or signal output part is
responsible for making sure that the system complies with the requirements of
the IEC 60601-1.
• The operator must not touch the external instrument connected with this
equipment and the patient simultaneously. Electrical shock can result.
• If in doubt, consult the technical service department or your local
representative.
CAUTION 6. Transportation / Storage
• The ambient conditions of transportation: Temperature -20°C to 60°C, relative
humidity 10% to 95% (no condensation), atmospheric pressure 500-1060
hPa.
• The ambient conditions of storage in a packaged condition: Temperature
-10°C to 45°C, relative humidity 10% to 85%(no condensation), atmospheric
pressure 700-1060 hPa.
• 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 45°C or fall below -10°C.
• Select a storage area exposed to limited amounts of dust, free of vibration and
shock.

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• After use, turn off the power switch of the station and put on the dust cover.
OFF
• If you plan to put the instrument out of service for a long time, pull the power
cord out from the receptacle outlet. Also, remove the batteries from the main
unit and keep them for later use. There is a danger of fire if the power cord is
left in the receptacle outlet for a long time or the battery is left unremoved for a
long time.
• Make sure that when the batteries are in storage, their contacts are not
touched by metals, etc. If they are short-circuited to a metal, heating or even a
fire can occur.
• When the measurement window stained by dust, nose oil, and fingerprint,
effect the results of the measurement. Therefore, please keep clean on the
surface of measurement window. (See “7-5 Cleaning the Measurement
Window”)
• To clean the measuring window, be careful not to make damage or broken of
the window screen.
• Internal Battery
For clock function, lithium battery is equipped, and if the battery is out, date
and time setting is not work properly. To change the battery, ask for your
distributor.
CAUTION 7. Battery pack
• You should use the RT-01XR battery pack, which uses our designated lithium
ion battery. Use of any other battery pack voids the operation warranty.
• Carefully read the instructions shipped with the battery pack before using the
battery pack.
• Never disassemble or modify the battery pack.
• To recharge the battery pack, always use the station or the printer.
• Never short-circuit the terminal of the battery pack. Otherwise, heating may
occur, leading to burn injury or a fire. Also, keep metals (coins, paper clips,
etc.) away from contact with the terminal area.
• Do not use the battery pack of this product with any other product.

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• When charging the battery pack, do not place any cover over the main unit,
the station, or the printer. If a cover is used, the heat generated in the main
unit, the station, or the printer during charging may cause fire. In addition, the
service life of the battery pack will be reduced by the additional load due to
such a cover.
• Do not expose the battery pack to an intense heat source or flames. Explosion,
electrolyte leakage, or fire can occur.
• Do not leave the battery pack in a sun-heated car with the windows closed, or
in any location that may be exposed to intense sunlight.
• Do not let the battery pack be exposed to strong impact or drop it.
• If the metal terminals of the battery pack are dirty, wipe them off with a dry, soft
cloth.
• If you plan to put the instrument out of service for a week or longer, take the
battery packs out of the main unit and the printer.
• The battery pack is a consumable item. It can be recharged, but eventually
wears out. When the battery pack is no longer usable, purchase a new one
from your local dealer of the instrument.
CAUTION 8. Disposal instructions
• Follow local regulations concerning disposal and recycling.
For lithium ion batteries and lithium primary battery, in particular,
observe the specific disposal methods stipulated by your local
government.
We recommend entrusting disposal to a designated industrial waste
disposal firm.
• When disposing packaging, sort them by material, and then follow the local
regulations and plans concerning disposal and recycling.
Symbol for separate collection in European countries
Products bearing this symbol must be collected separately.
The following rule is applicable only to users in European
countries.
This product is designated as an item to be collected
separately at an appropriate spot. Do not dispose of it as
household waste.
For further information, contact the retailer or the local
authorities responsible for waste management.

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CAUTION 9. Information of EMC (Electro Magnetic Compatibility)
1. Reorient or relocate the receiving device.
2. Increase the distance to the device.
3. Correct the device into an outlet on a circuit different from that to which the other
device(s) are connected.
4. Consult the manufacturer or field service technician for assistance.
・In installation and operation of the device, observe the following instructions about EMC
(electromagnetic compatibility):
1. Do not use the device simultaneously with other electronic equipment to avoid
electromagnetic interference with the operation of the device.
2. Do not use the device near, on, or under other electronic equipment to avoid
electromagnetic interference with the operation of the device.
3. Do not use the device in the same room with other equipment such as life-support
equipment, other equipment that has major affects on the life of the patient and
results of treatment, or other measurement or treatment equipment that involves
small electric current.
4. Do not use the device simultaneously with portable and mobile radio frequency
communication systems because it may have an adverse effect on operation of the
device.
5. Do not use cables and accessories that are not specified for the device because
that may increase the emission of electromagnetic waves from the device or the
system and decrease the immunity of the device to electromagnetic disturbance.
■ EMC (Electromagnetic Compatibility)
The Electromagnetic Compatibility Directive sets the essential requirements for electrical and electronic equipment that
may disturb or even be disturbed by other equipment. The Retinomax Screeen complies with these requirements as
tabled below. Follow the guidance on the tables for use of the device in the electromagnetic environment.
WARNING: The use of this equipment adjacent to or stacked with other equipment
should be avoided because it could result improper operation.
If such use is necessary, this equipment and the other equipment should
be observed to verify that they are operating normally.
WARNING: The use of accessories and cables other than those specified or
provided by the RIGHT MFG. CO., LTD. of Retinomax Screeen could
result in increased electromagnetic emissions or decreased
electromagnetic immunity of Retinomax Screeen and result in improper
operation.

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(A) ：Environments for Retinomax Screeen
This device is applied for use in professional healthcare facility environment and home
healthcare environment.
－Doctor's offices, clinics, medical facilities, hospital, optician's offices, etc.
(B) List of cables, Length of cables
Model name
Model No.
Length
Power cord 100V area
DDB20207
3.0m
Power cord 120V area (Hospital grade)
DDB20201-UL
3.0m
Power cord 120V area
DDB20202
3.0m
Power cord 240V area
DDB20203
3.0m
Power cord 240V area (China)
DDC20209
3.0m
(C)EMC (IEC60601-1-2:2014)
(1) Emission guidance
Retinomax Screeen is intended for use in the electromagnetic environment specified below. The customer or the
user of the Retinomax Screeen should assure that they are used in such an environment.
Emissions test
Basic EMC standard or test method*1
Conducted and radiated RF
EMISSION
CISPRE 11 Group 1 ClassB
Harmonic EMISSION
IEC61000-3-2*2
Voltage fluctuations and flicker
IEC61000-3-3*2
*1: See “(A) Environments for Retinomax Screeen” for information about the environments of INTENDED USE.
*2: This test is not applicable in this environment unless the ME EQUIPMENT and ME SYSTEMS used there will be connected to
the PUBLIC MAINS NETWORK and the power input is otherwise within the scope of the Basic EMC standard.
(2) Immunity guidance
Retinomax Screeen is intended for use in the electromagnetic environment specified below. The customer or the
user of the Retinomax Screeen should assure that they are used in such an environment.
・ Enclosure port
Phenomenon
Basic EMC
standard or test
method
IMMUNITY TEST LEVELS
Professional healthcare facility environment
Electrostatic discharge
IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
Radiated RF EM fields*1
IEC 61000-4-3
10V/m*6
80 MHz – 2,7 GHz*2
80% AM at 1 kHz*3
Proximity fields from RF
wireless communications
equipment
IEC 61000-4-3
See (C)-(3)
Test Specifications for ENCLOSURE PORT IMMUNITY
to RF wireless communications equipment
Rated power frequency
magnetic fields*4*5
IEC 61000-4-8
30 A/m*7
50 Hz or 60 Hz
*1: The interface between the PATIENT physiological signal simulation, if used, and the ME EQUIPMENT or ME
SYSTEM shall be located within 0,1 m of the vertical plane of the uniform field area in one orientation of the
ME EQUIPMENT or ME SYSTEM.
*2: ME EQUIPMENT and ME SYSTEMS that intentionally receive RF electromagnetic energy for the purpose of
their operation shall be tested at the frequency of reception. Testing may be performed at other modulation
frequencies identified by the RISK MANAGEMENT PROCESS. This test assesses the BASIC SAFETY and
ESSENTIAL PERFORMANCE of an intentional receiver when an ambient signal is in the passband. It is
understood that the receiver might not achieve normal reception during the test.
*3: Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS.
*4: Applies only to ME EQUIPMENT and ME SYSTEMS with magnetically sensitive components or circuitry.
*5: During the test, the ME EQUIPMENT or ME SYSTEM may be powered at any NOMINAL input voltage, but
with the same frequency as the test signal.

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・ Input a.c. power port
Phenomenon
Basic EMC
standard or test
method
IMMUNITY TEST LEVELS
Professional healthcare facility environment
Electrical fast transients /
bursts*1*12*15
IEC 61000-4-4
±2 kV
100 kHz repetition frequency
Surges *1*2*10*15
Line-to-line
IEC 61000-4-5
±0,5 kV, ±1 kV
Surges*1*2*10*11*15
Line-to-ground
IEC 61000-4-5
±0,5 kV, ±1 kV, ±2 kV
Conducted disturbances
induced by RF fields*3*4*15
IEC 61000-4-6
6 V *13
0,15 MHz – 80 MHz
6 V*13 in ISM bands between 0,15 MHz and 80 MHz*14
80% AM at 1 kHz*5
Voltage dips *6*16*18
IEC 61000-4-11
0% UT; 0,5 cycle*7
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°*17
0% UT; 1 cycle and 70% UT; 25/30 cycles*8
Single phase: at 0°
Voltage interruptions*6*9*15*18
IEC 61000-4-11
0% UT; 250/300 cycle*8
*1: The test may be performed at any one power input voltage within the ME EQUIPMENT or ME SYSTEM
RATED voltage range. If the ME EQUIPMENT or ME SYSTEM is tested at one power input voltage, it is not
necessary to re-test at additional voltages.
*2: All ME EQUIPMENT and ME SYSTEM cables are attached during the test.
*3: Calibration for current injection clamps shall be performed in a 150 Ω system.
*4: If the frequency stepping skips over an ISM or amateur band, as applicable, an additional test frequency shall
be used in the ISM or amateur radio band. This applies to each ISM and amateur radio band within the
specified frequency range.
*5: Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS.
*6: ME EQUIPMENT and ME SYSTEMS with a d.c. power input intended for use with a.c.-to-d.c. converters shall
be tested using a converter that meets the specifications of the MANUFACTURER of the ME EQUIPMENT
or ME SYSTEM. The IMMUNITY TEST LEVELS are applied to the a.c. power input of the converter.
*7: Applicable only to ME EQUIPMENT and ME SYSTEMS connected to single-phase a.c. mains.
*8: E.g. 10/12 means 10 periods at 50 Hz or 12 periods at 60 Hz.
*9: ME EQUIPMENT and ME SYSTEMS with RATED input current greater than 16 A / phase shall be interrupted
once for 250/300 cycles at any angle and at all phases at the same time (if applicable). ME EQUIPMENT and
ME SYSTEMS with battery backup shall resume line power operation after the test. For ME EQUIPMENT
and ME SYSTEMS with RATED input current not exceeding 16 A, all phases shall be interrupted
simultaneously.
*10: ME EQUIPMENT and ME SYSTEMS that do not have a surge protection device in the primary power circuit
may be tested only at ± 2 kV line(s) to earth and ± 1 kV line(s) to line(s).
*11: Not applicable to CLASS II ME EQUIPMENT and ME SYSTEMS.
*12: Direct coupling shall be used.
*13: r.m.s., before modulation is applied.
*14: The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795
MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur
radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4
MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz
to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
*6: Before modulation is applied.
*7: This test level assumes a minimum distance between the ME EQUIPMENT or ME SYSTEM and sources of
power frequency magnetic field of at least 15 cm. if the RISK ANALYSIS shows that the ME EQUIPMENT or
ME SYSTEM will be used closer than 15 cm to sources of power frequency magnetic field, the IMMUNITY
TEST LEVEL shall be adjusted as appropriate for the minimum expected distance.

14
・ Signal input/output parts port
Phenomenon
Basic EMC
standard or test
method
IMMUNITY TEST LEVELS
Professional healthcare facility environment
Electrostatic discharge*4
IEC61000-4-2
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Conducted disturbance by
RF field*1*3*5
IEC61000-4-6
6 V*6
0,15 MHz – 80 MHz
6 V*6 in ISM bands between 0,15 MHz and 80 MHz*7
80% AM at 1 kHz*2
*1: SIP/SOPS whose maximum cable length is less than 3 m in length are excluded.
*2: Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS.
*3: Calibration for current injection clamps shall be performed in a 150 Ω system.
*4: Connectors shall be tested per 8.3.2 and Table 4 of IEC 61000-4-2:2008. For insulated connector shells,
perform air discharge testing to the connector shell and the pins using the rounded tip finger of the ESD
generator, with the exception that the only connector pins that are tested are those that can be contacted or
touched, under conditions of INTENDED USE, by the standard test finger shown in Figure 6 of the general
standard, applied in a bent or straight position.
*5: If the frequency stepping skips over an ISM or amateur radio band, as applicable, an additional test frequency
shall be used in the ISM or amateur radio band. This applies to each ISM and amateur radio band within the
specified frequency range.
*6: r.m.s., before modulation is applied.
*7: The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz;
13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3
MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz,
21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
*15: Applicable to ME EQUIPMENT and ME SYSTEMS with RATED input current less than or equal to 16 A /
phase and ME EQUIPMENT and ME SYSTEMS with RATED input current greater than 16 A / phase.
*16: Applicable to ME EQUIPMENT and ME SYSTEMS with RATED input current less than or equal to 16 A /
phase.
*17: At some phase angles, applying this test to ME EQUIPMENT with transformer mains power input might
cause an overcurrent protection device to open. This can occur due to magnetic flux saturation of the
transformer core after the voltage dip. If this occurs, the ME EQUIPMENT or ME SYSTEM shall provide
BASIC SAFETY during and after the test.
*18: For ME EQUIPMENT and ME SYSTEMS that have multiple voltage settings or auto ranging voltage
capability, the test shall be performed at the minimum and maximum RATED input voltage. ME EQUIPMENT
and ME SYSTEMS with a RATED input voltage range of less than 25% of the highest RATED input voltage
shall be tested at one RATED input voltage within the rage.

15
(3) Test Specifications for ENCLOSURE PORT IMMUNITY to RF wireless
communications equipment
Test
Frequency
(MHz)
Band*1
(MHz)
Service*1
Modulation*2
Maximum
power
(W)
Distance
(m)
IMMUNITY
TEST LEVEL
(V/m)
385
380－390
TETRA400
Pulse
Modulation*2
18Hz
1.8
0,3
27
450
430－470
GMRS460
FRS460
FM*3
±5kHz deviation
1kHz sine
2
0,3
28
710
745
780
704－787
LTE Band 13,
17
Pulse
modulation*2
217Hz
0,2
0,3
9
810
870
930
800－960
GSM800/900,
TETRA800,
iDEN820,
CDMA850,
LTE Band 5
Pulse
modulation*2
18Hz
2
0,3
28
1720
1845
1970
1700－
1990
GSM1800;
CDMA1900;
GSM1900;
DECT;
LTE Band 1, 3,
4, 25;
UMTS
Pulse
modulation*2
217Hz
2
0,3
28
2450
2400-2570
Bluetooth,
WLAN,
802.11 b/g/n,
FRID 2450,
LTE Band 7
Pulse
modulation*2
217Hz
2
0,3
28
5240
5500
5785
5100－
5800
WLAN 802.11
a/n
Pulse
modulation*2
217Hz
0,2
0,3
9
NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and
the ME EQUIPMENT or ME SYSTEM may be reduced to 1m. The 1m test distance is permitted by IEC61000-4-3.
*1: For some services, only the uplink frequencies are included.
*2: The carrier shall be modulated using a 50% duty cycle square wave signal.
*3: As an alternative to FM modulation, 50% pulse modulation at 18Hz may be used because while it does not
represent actual modulation, it would be worst case.

16
1. Overview
1-1 Instrument Overview, Components and Options
Retinomax Screeen is an objective hand held refractometer, designed to measure refractive
power and pupil diameter.
This equipment is intended for use indoors by medical doctors, orthoptists, and
optometrists.
The refractive power measurement examines the refractive condition of the patient's eye to
measure the spherical diopter power, cylindrical power, and cylinder axis angle.
The pupil diameter measurement measures the pupil size in the horizontal and vertical
directions.
This instrument consists of a main unit (Retinomax Screeen), Station (Retinomax Station 5),
and Printer (Retinomax Printer 5).
Device and printer could be carried with ease, and contains battery, make it easier to
measure and print out in small spaces. The station has function to charge, and power supply,
makes it chargeable for the battery and supplies to the device and the printer.
It also has a function to transfer the measured data to PC.
■ Components
● Main unit (1) ● Station (1) ● Printer (1)
● Battery pack (1) ● Model eye (1) ● Print paper rolls (5)
(RT-01XR) (DXA30109)
● Strap (1) ● Blower (1)
(DDB30006)

17
● Fuses (2)
(φ5 x 20 mm250 V, T1.6 AH (021501.6XP))
● Power cord (1)
● Instruction manual (1)
● Dust cover (1)
■ Options
● Carrying case
● Battery pack
1-2 Instrument Classification
<Classification as per 93/42/EEC (MDD)>
Class IIa
<Protection type against electric shock>
Class I
This instrument is classified as equipment whose protection against electric shock
does not rely on basic insulation only, but which includes an additional safety
precaution, in that means are provided for the connection of the equipment to a
protective earth conductor in the fixed wiring of the installation in such a way that
accessible metal parts cannot become live in the event of a failure of the basic
insulation. Always use the power cord shipped with the instrument. It must be
connected to a receptacle outlet with a ground.
<Degree of protection against electric shock>
Type B Applied Part
The forehead rest of this instrument is a type B attachment.
Material: ABS resin
This instrument is equipped with a reliable safeguard against electric shock, as
verified through testing in accordance with the applicable standard for patient leakage
current.
<Protection against water and particle ingression>
IPX0
This instrument is not protected against the infiltration of water and other liquids. The
instrument should not be exposed to liquids.

18
<Degree of safety for use in a flammable environment>
Retinomax Screeen is not designed to be used in a flammable environment. Do not
use it in a flammable environment.
<Disinfection method approved by the manufacture>
If necessary, clean the forehead rest with soft cloth soaked with rubbing alcohol.
Cleaning conducted by a process other than the one described above may cause
deterioration or damage to the equipment.
<Operation mode>
Continuous operation
1-3 Symbols on the Instrument
：
This symbol on the instrument indicates the need for caution.
：
This symbol indicates the necessity if referring to the relevant part of the
instruction manual before use.
：
This symbol indicates that the type of protection against electric shock for
the applied part is type B.
：
This symbol indicates that has place where forehead rest has put and
pull.
：
Represent a print paper outlet.
：
Represent an output.
：
Represent an input
：
Represent an output and input.
：
This symbol indicates the main unit and the printer power switch.
：
This symbol on the station indicates the on position of power switch.
：
This symbol on the station indicates the off position of the power switch.
：
Represent a fuse.
：
Represent a connection suitable only for DC power.

19
：
The lamp indicated by this symbol on the station illuminates while the
battery is charged.
：
This symbol means that this equipment has been certified as NRTL
(National Recognized Testing Laboratories) by UL (Underwriters
Laboratories).
：
This symbol means this equipment conforms to Medical Device Directive
(93/42/EEC) in EU.
：
This symbol means the manufacturer.
：
This symbol means the manufacture date.
：
This symbol means this equipment conforms to China RoHS
(Management methods for Controlling pollution by Electronic Information
Products).
：
This symbol means this equipment conform to WEEE directive
(2012/19/EU) in EU.
：
This symbol is designed to promote the recycling of used lithium ion
battery in Japan.
：
This symbol is designed to promote the recycling of used batteries in
Taiwan.