Eli Ezer ERK-5400A User manual

AUTO REF / KERATOMETER ERK-5400A
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Operation Manual

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Table of Contents
1. IMPORTANT NOTICE................................................................................................................................... 1
1.1 Intended Use........................................................................................................................................................................... 1
1.2 Contraindications .................................................................................................................................................................. 1
1.3 Classifications.......................................................................................................................................................................... 1
1.4 Caution....................................................................................................................................................................................... 2
2. SAFETY........................................................................................................................................................... 3
2.1 SAFETY INFORMATION ...................................................................................................................................................... 3
2.2 Symbol Information ............................................................................................................................................................. 4
2.3 General Safety Information .............................................................................................................................................. 6
2.4 Cautions in Installation , Storage and Transportion............................................................................................. 7
2.5 Patient environment ............................................................................................................................................................ 8
2.6 Labels.......................................................................................................................................................................................... 9
3. Features .......................................................................................................................................................10
4. Notes for Using the Instrument .............................................................................................................11
5. Prerequisites for safety ............................................................................................................................13
5.1 Preparation before use.....................................................................................................................................................13
5.2 Preparation when you use..............................................................................................................................................13
5.3 Instruction and operation sequence..........................................................................................................................13
5.4 Storage after use.................................................................................................................................................................13
6. Introduction................................................................................................................................................14
6.1 Front side of body..............................................................................................................................................................14
6.2 Back side of body ...............................................................................................................................................................15
6.3 Bottom side of body .........................................................................................................................................................16
6.4 Plugging ..................................................................................................................................................................................17
6.5 Release stage fixing ...........................................................................................................................................................17
6.6 Engage printing papers ...................................................................................................................................................17
7. GUI(User Interface) ...................................................................................................................................18
7.1 Main Dialog ...........................................................................................................................................................................18
7.2 Size mode...............................................................................................................................................................................20
7.3 Display Dialog.......................................................................................................................................................................22
7.4 Setting Dialog.......................................................................................................................................................................23
7.5 Update .....................................................................................................................................................................................30
7.6 Log View .................................................................................................................................................................................32
7.7 Image Dialog.........................................................................................................................................................................33
8. Print Mode..................................................................................................................................................37
9. Self Inspection and Maintenance ...........................................................................................................38
9.1 Before Calling a Service Person ...................................................................................................................................38
9.2 Fuse Replacement...............................................................................................................................................................40

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9.3 Service Information............................................................................................................................................................41
10. Specifications ...........................................................................................................................................42
11. ACCESSORY...............................................................................................................................................43
12. Packing ......................................................................................................................................................44
12.1 Packing Foam Design.....................................................................................................................................................44
12.2 Packaging step ..................................................................................................................................................................45
13. EMC (ELECTROMAGNETIC COMPATIBILITY).......................................................................................46
14. Disposal of waste products...................................................................................................................49

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1. IMPORTANT NOTICE
1.1 Intended Use
The Auto Refractor/Keratometer ERK-5400A is used to determine the initial objective
refractive values for a patient’s eye in the workflow of refraction to determine the optical
prescriptions for myopia, hyperopia and astigmatism.
1.2 Contraindications
People with eye disease, glaucoma patients and children under the age of 12 months shall
be prohibited because it is difficult to precise measurement.
1.3 Classifications
Classification under the provision of 21 CFR)] ClassI
The ERK-5400A is classified as Class Idevice
[Form of protection against electric shock] ClassⅠ
The ERK-5400A is classified as Class I.
This product is always protected when you connect the power supply must be connected to
ground included. Class I is a product in which the protection against electric shock does not
rely on basic insulation only, but which includes an additional safety precaution in such a
way that means are provided for the connection of the product to the protective (ground)
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 in the basic insulation. Use a power outlet which
is equipped with a grounding terminal.
[Degree of protection against electric shock] Type B Applied Part
The ERK-5400A is classified as a device with a Type B Applied Part
[Degree of protection against ingress of liquids] IPX0
The ERK-5400A is classified as IPX0
[Degree of protection against flammability]
The ERK-5400A is classified as a device not suitable to be used in a potentially flammable
environment. Do not use near flammable materials
[Method(s) of sterilization or disinfection recommended by the manufacturer]
The forehead rest and chinrest should be wiped using a cloth dampened with soapy water
as necessary
[Mode of operation]
Classification of ERK-5400A : continuous operation

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1.4 Caution
This product may malfunction due to electromagnetic waves caused by portable personal
telephones, transceivers, radio-controlled toys, etc.
Be sure to avoid having objects such as, which affect this product, brought near the product.
It should be used under the supervision of medical staff of hospital
The information in this publication has been carefully checked and is believed to be entirely
accurate at the time of publication. ERK-5400A assumes no responsibility, however, for
possible errors or omissions, or for any consequences resulting from the No use of the
information contained herein.
ERK-5400A reserves the right to make changes in its products or product specifications at
any time and without prior notice, and is not required to update this documentation to reflect
such changes.
“Do not modify this equipment without authorization of the manufacturer.”
“If this equipment is modified, appropriate inspection and testing must be
conducted to ensure continued safe use of equipment”
Under copyright laws, this manual may not be copied, in whole or in part, without the prior written
consent of USO

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2. SAFETY
2.1 SAFETY INFORMATION
Accessory equipment connected to the analog and digital interfaces must be certificated according
to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing equipment and IEC/EN
60601-1 for medical equipment).
Furthermore all configurations shall comply with the system standard IEC 60601-1-2:2014.
Everybody who connects additional equipment to the signal input part or signal output part
configures a medical system, and is therefore responsible that the system complies with the
requirements of the system standard IEC 60601-1:2005(Thrid Edition)+
CORR.1:2006+CORR.2:2007+A1:2012
If in doubt, consult the technical service department or your local representative.
.
ISO 15004
This report provides information about the hazard to the examinee’s eyed in compliance with
ISO 15004-1:2006, ISO 15004-2:2007 Ophthalmic instruments –Fundamental requirements
and test methods Part2–Light hazard protection. This condition is satisfied even when the
instrument is operating at maximum light intensity and maximum aperture! (Maximum intensity is
the highest brightness the instrument is capable of delivering, including the highest brightness
achievable if overvoltage is provided) detailed radiation information at normal usage of this
instrument is like bellows.
Radiation output: below 117.1 μW/cm2 Limit by ISO15004: 100 mW/cm2
Number
Radiation output [μW/cm2]
1
107.0
2
117.1
3
115.5
4
115.7
5
103.6
6
103.7
7
108.8
8
109.0
9
105.6
10
105.8
average
109.1
.

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2.2 Symbol Information
Symbol
Descriptions
TYPE B EQUIPMENT
Protective earth (ground)
Alternating current
Off (power: disconnect to the mains)
On (power: connection to the mains)
Do not throw away the waste to inappropriate place
Crushing hazard sign
Hand hazard sign
Risk of electric shock
Instruction for user manual
Operating instructions
CAUTION
Keep dry symbol
DO NOT Hand Hooks symbol
Fragile symbol
This way up symbol
Handle with care symbol
Do not build up more than 2 boxes
Manufacture

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Only one unit in the box
Temperature between - 40˚C ~ 70˚C
Humidity between 10%RH ~ 95%RH
Air pressure between 500hPa ~ 1060hPa
.

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2.3 General Safety Information
If you see any warnings or cautions printed on the warning labels, follow the safety
instructions in this manual. Ignoring such cautions or warnings while handling the product
may result in injury or accident. Be sure to read and fully understand the manual before
using this product.
Keep this manual in easy-to-access place.
Safety Symbols and sign
This indicates hazardous situations which may result in crush your hand.
This indicates hazardous situations which may result insert your hand.
NOTE
This is used to emphasize essential information. Be sure to read this information to avoid
incorrect operation.

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2.4 Cautions in Installation , Storage and Transportion
● Exposure to the direct sunlight or too bright indoor lights may influence on the result of accurate
measurement. Use the appropriate Optometry room.
●Keep the objective glass of the examinee side clean. If it was stained, it may cause on ERROR or
inaccurate measurements.
●In case you leave ERK-5400A without using for certain period, disconnect the power supply and
protect the unit with dust cover.
●In case moving this ERK-5400A, fix the stage by using clamping bolt and stage holding knob,
always keep power off, and then lift the bottom of the unit with both hands.
●In case moving this ERK-5400A, do not hold forehead.
●In case moving and connect other device this ERK-5400A, keep in touch with qualified technician
or service agent and place the equipment plain.
●Get worked, store and move under the following environment conditions for proper operation.
●Operation environment :
- Temperature : +10℃~ +40℃
- Humidity : 30% ~ 90% RH
- Atmospheric pressure range : 700 hPa ~ 1060 hPa
●Storage and Transportion environment :
- Temperature : -40℃~ +70℃
- Humidity : 10% ~ 95% RH
- Atmospheric pressure range : 500 hPa ~ 1060 hPa

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2.5 Patient environment
The patient environment represents a space where there is a possibility of direct contact between
the patient or the operator and third person.
When another type of device is used in the patient environment, use a device that complies with
IEC 60601-1. If the devices that do not comply with IEC 60601-1 are used, it is necessary to use an
isolating transformer to power the device or to connect the devices to additional protective
grounding.
①Patient environment (represented by dotted line, extending exactly 1.5 meters)
②ERK-5400A equipment ③④ Peripheral equipment(EN XXXXX and IEC XXXXX)
⑥Power cord(⑤included protective earth)

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2.6 Labels
The following labels and indications are affixed to draw the operator’s attention

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3. Features
Various Measurements Supported
Not only the usual refractometry and keratometry, but also corneal diameter and
base curve of contact lens can be measured with this one instrument. Thus,
measurements of eye and prescriptions for glasses and contact lenses can be made
more efficiently.
Wide Dioptric Measurement Range
Because the ERK-5400A covers a wide measurement range, from -25D to +22D,
even an examinee with strong myopia can be measured.
More accurate Measurement
The fogging method of the eye fixation target makes examinee’s eye comfortable
and enables to get more accurate measurement data
Simple and convenient user’s environment
Deliver more convenient user environment with wide viewed 7.0" TFT COLOR LCD
screen and with simple and intimate design.
Easy Connection with other Equipment
This instrument is designed to connect other Equipment such as LCD monitor.

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4. Notes for Using the Instrument
1. To avoid the risk of electric shock, this equipment as power protective earth
connection must be connected
2. Ensure that the examinee has not placed his/her hand or fingers under the
chin rest. Otherwise, hand or fingers may be hurt.
3. Do not hit or drop the instrument. The impact may cause damage to the
function of this instrument. Please handle with care.
4. Only operate the instrument with the power supply indicated on the rating
plate. Otherwise, it may result in fire or electric shock.
5. Never disassemble or modify. This can cause fire or electric shock.
6. In case there is smoke, strange odor or noise during operation, disconnect the
power supply and consult the distributor.
7. For replacement parts (battery, fuse, or other parts), please contact the
distributor from whom you purchased the product.
8. The external connection device is used UL certificate device and the specified
power code, paper and fuse are used.
1. A sudden heating of the room in cold areas will cause condensation on the
protective glass in the monitor screen and on optical parts inside the
instrument. In this case, just wait until condensation disappears before
performing measurement.
2. Keep the objective glass of the examinee side clean. If it was stained, it may
cause on ERROR or inaccurate measurements.
3. If you leave ERK-5400A without using for certain period, disconnect the power
supply and protect the unit with dust cover.
4. When moving this ERK-5400A, fix the stage by using clamping bolt and stage
holding knob, always keep power off, and then lift the bottom of the unit with
both hands.
5. When moving this ERK-5400A, do not hold forehead.
6. When moving and connect other device this ERK-5400A, keep in touch with
qualified technician or service agent and place the equipment plain. .
7. The patient should raise your hands in your lap when measuring
8. When S/W version up, check the label on the main board.

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1. Don’t use organic solvents such as alcohol, thinner, benzene, etc. to clean the
surface of this instrument. It may damage the instrument.
2. Do not store alcohol, thinner and other flammable vapors and liquids in the vicinity
of this equipment.
3. Do not turn off the instrument before finishing initialization. It may cause motor
movement error.
4. Do not use outdoors. The instrument is designed to be used only indoors.
5. Do not use Humidity or dusty environment
6. Never disassemble or modify this instrument because it may result in fire or electric
shock. Also, since this instrument incorporates high-voltage parts and other
hazardous parts, touching them may cause death or serious injury.
7. Keep it away from other persons but qualified technician.
8. Be sure to turn OFF the power switch before connecting or disconnecting the
cables. Also, do not handle them with wet hands. Otherwise, you may get an
electric shock that may result in death or serious injury.
9. If you leave this instrument without using for certain period, disconnect the power
supply
10. This equipment may be able to be operated improper by micro waves from cellular
phones, walkie-talkie, remote controlled electric toys. Keep it away.
At the time of publishing the information in this book carefully identified and has been judged to be
correct. However, there are mistakes and omissions that the USO, the use of the information
contained in this book is not responsible for the results that occurred.

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5. Prerequisites for safety
5.1 Preparation before use
-. Do not operate under direct sunlight or too strong lights
-. Do not store alcohol, thinner and other flammable vapors and liquids in the vicinity
of this equipment.
-. Check the voltage.
-. Check chin rest is working properly
-. Remove dusts, especially on the lens.
5.2 Preparation when you use
-. Place this equipment plain
-. Do not put others on this equipment
-. Do not disassemble or modify on your own
-. Stand 40 minutes and get it worked if it is stored at extended temperate place
-. Keep it away from other persons but qualified technician.
-. Be sure to unplug if do not use long.
-. Do not turn off the instrument before finishing initialization.
(Don’t power off during loading)
5.3 Instruction and operation sequence
-. Please connect the power plug.
-. Press “ON”
-. Put the chin on chin rest and make forehead stuck on to forehead rest
-. Release stage by turning stage knob
-. Press buttons what you want
-. Try to get it worked as per the instructions of 7 and 9
5.4 Storage after use
-. Cover it up and unplug if do not use long
-. Clean with soft cloth, soaped and rinse, wipe dry
-. Wipe lens and glass’ dusts out with wind blower and with soft cloth.
-. Fix by turning the fixation knob and keep it plain when you are about to move or lift up
-. Do store at the following place
①Not humid place
②Not in the vicinity of water
③Not dusty and not in the vicinity of filthy place with salt or sulphur
④Plain place
⑤Not in the vicinity of vibration or shock
⑥Not in the vicinity of other flammables vapors or liquids
⑦Not in the vicinity of direct sunlight
-. Store the accessories and cords for next operation.

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6. Introduction
6.1 Front side of body
[ Drawing 1] Front Side
Name
Functions
①Touch screen Monitor
Monitor that displays Measurement
②Measurement Button
Press this button for measurement.
③Joystick
Control lever for lining up and focusing
④Printer
Print the measured result
⑤Stage Holding Knob
Holds the movement of stage
[ Chart 1 ] Front side