Essilor AKR 550 User manual

www.essilor-instruments.com
User manual

CONTENTS
I. INTRODUCTION 5
II. SAFETY CONSIDERATION 9
1. General cautions 10
2. Precautions regarding IT network 10
3. Electromagnetic compatibility 11
III. ACCESSORIES 15
IV. DEVICE 17
1. General description of product 18
2. Intended use defined 18
3. Classification defined, rule given 18
4. Classification of device 18
5. Usage of product 19
6. Mode of operation 19
7. Parts identification 20
V. INSTRUCTIONS FOR USE 21
1. Conveyance 22
2. Installation 22
3. Connection / Wiring 23
4. Maintenance / Inspection 23
5. Disposal 24
VI. HOW TO USE 25
1. Operation procedure 26
2. Measurement flow 27
3. Measurement 28
a. Preparation for measurement 28
b. Power distribution 28
c. Standby 29
d. Preparation of examinee 30
e. Alignment 30
f. Measurement 34
g. Print-out of measurement result 35
4. Setting of setup screen 37
a. Number 40
b. Language 41
c. Customize 41
d. Date form 42
e. Message 43
f. Default setting 43
5. Scotopic Pupil Size (SPS) - measurement function 44
6. IOL measurement function 45
USER MANUAL> CONTENTS

7. Low reliability mark display function 47
8. Output 47
9. Data screen function 48
10. Power saving function 50
11. Contact lens: measurement of base curve 50
VII. STORAGE AND MAINTENANCE 51
1. Reload of printer paper 52
2. Fuse replacement 53
3. Setting of chinrest liner 53
4. Storage of device 54
5. Confirmation of measurement accuracy 54
6. Periodical inspection and maintenance 55
VIII. TIPS FOR EFFECTIVE MEASUREMENT 57
IX. ERROR DISPLAY 59
X. MAIN TROUBLE AND TROUBLESHOOTING 61
XI. SPECIFICATIONS 63
USER MANUAL> CONTENTS

I. INTRODUCTION

The complete user manual is available on a web space.To access, please scan the QR code below
using a dedicated application.
Le manuel utilisateur complet est disponible sur un espace web. Pour y accéder veuillez scanner
le QR code ci-dessous à l'aide d'une application dédiée.
Die vollständige Bedienungsanleitung ist auf einem Speicherplatz verfügbar: Für den Zugriff
darauf scannen Sie bitte untenstehenden QR-Code mittels einer dafür vorgesehenen Anwendung.
El manual de uso completo está disponible en la web. Para acceder, escanee el código QR que se
encuentra a continuación con la ayuda de una aplicación.
Il manuale utente completo è disponibile su uno spazio Web. Per accedervi, scansionare il codice
QR seguente mediante un'applicazione dedicata.
Please read this manual thoroughly so that effective operation is ensured.
1. The information contained in this manual is subject to change without notice.
2. 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.
3. If you find any imperfect collating or missing pages, contact your local distributor for replacement.
This manual includes important contents to prevent users or the others from harms and to use this device
safely. This device (AKR550) can objectively measure the refractive power of the eye.
Read this manual after understanding the symbols below and follow the instructions in use.
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USER MANUAL> I. INTRODUCTION

This symbol indicates that mishandling as a result of failure to comply with the indications can
result in “personal death or serious injury”
Denotes general ban or prohibition
General mandatory action
Additional information which is important to the text or useful/ convenient to know
Refer to operation manual
Do not reuse
Serial No.
Catalog number
Number on the left is the lower limit and the one on the right is the upper limit of the
temperature
Number on the left is the lower limit and the one on the right is the upper limit of the humidity
The number on the left is the lower limit and the one on the right is the upper limit of the
atmospheric pressure
EU Battery Directive
WEEE symbol
Avoid direct sunlight
This is the type B equipment
Symbol for “MANUFACTURER”
Symbol for Compliant with CE marking i.e. with applicable European directives
This way up
Manufacturing date (year)
This manual includes the information about basic operation, inspection and maintenance etc. of
AKR550.
This device and the contents of this manual comply with IEC60601-1.
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II. SAFETY CONSIDERATION

1. GENERAL CAUTIONS
•It affects its measurement accuracy if fingerprints or dust etc. are on the optical parts, such as the
lens of the view window. Do not touch them with hands and avoid dust
•If fingerprints or dust are adhered on the optical parts, such as lens, wipe it gently with a soft cloth.
•Observe the following environmental conditions for use and storage.
Temperature Humidity Atmospheric pressure
Use
Storage /
Transportation /
•Avoid installation near TV or radio. The reception can be disturbed by electrical noise.
•If liquid is spilled on this device or a foreign substance is entered in it, unplug the power cord and
contact your local distributor.
Cut the power immediately and contact your local distributor if malfunction (noise, smoke etc.)
occurs. It can result in fire or injury if you keep using it.
•Do not attempt to disassemble it. It can result in malfunction or fire.
•If malfunction occurs, do not touch the inside of this device. Unplug the power cord and contact your
local distributor.
2. PRECAUTIONS REGARDING IT NETWORK
•This device can output the data to PC and so on through RS-232C interface.
•Connection of this device to an IT-network that includes other equipment could result in previously
unidentified risks to patients, operators or third parties.
•The responsible organization should identify, analyze, evaluate and control these risks.
•Subsequent changes to the IT-network could introduce new risks and require additional analysis.
•Changes to the IT-network include:
◦Changes in the IT network configuration
◦Connection of additional items to the IT-network
◦Disconnecting items from the IT-network
◦Update of equipment connected to the IT-network, and
◦Upgrade of equipment connected to the IT-network
•Please contact your distributor about the detail of this device.
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3. ELECTROMAGNETIC COMPATIBILITY
This product conforms to the EMC Standard (IEC 60601-1-2 Ed. 3.0: 2007).
1. This product needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in this manual.
2. Portable and mobile RF communications equipment can affect medical electrical equipment.
3. The use of accessories, transducers and cables other than those specified, with the exception of
transducers and cables sold by the manufacturer of the equipment or system as replacement parts for
internal components, may result in increased emissions or decreased immunity of the equipment or
system.
4. The equipment or system should not be used adjacent to or stacked with other equipment. If adjacent
or stacked use is necessary, the equipment or system should be observed to verify normal operation
in the configuration in which it will be used.
5. The use of the accessory, transducer or cable with equipment and systems other than those specified
may result in increased emission or decreased immunity of the equipment or system.
Guidance and manufacturer's declaration – electromagnetic emissions
AKR550 is intended for use in the electromagnetic environment specified below.
The customer or the user of AKR550 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions CISPR 11 Group 1
AKR550 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.
RF emissions CISPR 11 Class A
AKR550 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.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/flicker
emissions
IEC 61000-3-3 Complies
RF emissions CISPR 14-1
RF emissions CISPR 15
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Guidance and manufacturer's declaration – electromagnetic immunity
AKR550 Image Intensifier is intended for use in the electromagnetic environment specified below.
The customer or the user of AKR550 Image Intensifier should assure that it is used in such an environment.
mmunity test EC 60601 test level Compliance level Electromagnetic environment –
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
6 kV contact
8 kV air
6 kV contact
8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
2 kV for power
supply lines
1 kV for input/output
lines
2 kV for power
supply lines
1 kV for
input/output lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
1 kV differential
mode
2 kV common mode
1 kV differential
mode
2 kV common mode
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11
<5 % UT
(>95 % dip in UT) for 0.5
cycle
40 % UT
(60 % dip in UT) for 5
cycles
70 % UT
(30 % dip in UT) for 25
cycles
<5 % UT
(>95 % dip in UT) for 5 s
<5 % UT
(>95 % dip in UT) for
0.5 cycle
40 % UT
(60 % dip in UT) for 5
cycles
70 % UT
(30 % dip in UT ) for 25
cycles
<5 % UT
(>95 % dip in UT) for 5
s
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of AKR550
image intensifier requires continued
operation during power mains
interruptions, it is recommended
that AKR550 image intensifier be
powered from an uninterruptible
power supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m
If image distortion occurs, it may be
necessary to position AKR550
further from sources of power
frequency magnetic fields or to
install magnetic shielding. The
power frequency magnetic field
should be measured in the intended
installation location to assure that it
is sufficiently low.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
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Guidance and manufacturer's declaration – electromagnetic immunity
AKR550 is intended for use in the electromagnetic environment specified below.
The customer or the user of AKR550 should assure that it is used in such an environment.
mmunity test EC 60601
test level Compliance level Electromagnetic environment – guidance
Conducted RF IEC
61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of AKR550,
including cables, than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
d= 1.2 √P
d= 1.2 √P 80 MHz to 800 MHz
d= 2.3 √P 800 MHz to 2.5 GHz
where P 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 meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site surveya, should
be less than the compliance level in each frequency
range b.
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.
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
AKR550 is used exceeds the applicable RF compliance level above, AKR550 should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating AKR550.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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Recommended separation distance between portable and mobile RF communication equipment
and AKR550
AKR550 is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of AKR550 can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communication equipment (transmitters) and AKR550
are recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of
transmitter (W)
Separation distance according to frequency of transmitter
(m)
150kHz to 80MHz
d= 1.2 √P
80MHz to 800MHz
d= 1.2 √P
800MHz to 2.5GHz
d= 2.3 √P
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 meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where
(P) is the 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.
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III. ACCESSORIES

Model Eye: 1
With a contact lens holder
Diopter value is indicated on the sticker.
Power cord: 1
(2.5m)
Printer paper: 3
(Width: 58mm)
[2 included and 1 installed in the unit]
Fuse: 2
(T2A L 250V)
Chinrest liner: 1
(1,000 sheets)
Chinrest liner pin: 2
Dust cover: 1
Operation manual: 1
Name Model No. Length
Power cord KP4819YKS31A or equivalent 2.5m
Use only the accessories specified by us.
Use of the accessory (power cord) other than specified below may adversely affect other
instruments and/or cause malfunction of this device.
Extra care should be taken for storage of a model eye.
Do not store it at where it is dusty or high-temperature and humidity.
Avoid direct sunlight, high-temperature and humidity when storing the printer paper because it is
a thermal paper.
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USER MANUAL> III. ACCESSORIES

IV. DEVICE

1. GENERAL DESCRIPTION OF PRODUCT
This product (AKR550) aims to objectively measure the refractive power of the eye by using the light that is
projected to and reflected from the eyeground. It also aims to measure the radius of corneal curvature by
using the light that is projected to and reflected from the cornea.
As the feature of this device, the LCD is tilted to the vertical direction and horizontal direction so that the
angle can be adjusted.
As for safety consideration, see “5. Instructions for use” of this manual.
2. INTENDED USE DEFINED
This product (AKR550) aims to objectively measure the refractive power of the eye by using the light that is
projected to and reflected from the eyeground. It also aims to measure the radius of corneal curvature by
using the light that is projected to and reflected from the cornea.
Moreover, it can measure the pupil diameter by taking the image of the anterior eye of the examinee.
3. CLASSIFICATION DEFINED, RULE GIVEN
This product is the active device which does not belong to the category of the invasive/ non-invasive device
and does not intend the performances below.
Supply of energy / observation of physiological process/ irradiation of ionization radiation/ medication of
medicines etc.
Therefore, this is a class I medical device with a measuring function based on the rule 12 of MDD Annex IX.
4. CLASSIFICATION OF DEVICE
According to European directive on medical device, the AKR550 is a class I medical device.
It is marked 0459. Date of first marking is February 2016. The expected lifetime is 7 years.
Type of protection against electrical shock: Class I Equipment
Class 1 equipment is equipment in which 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 which a way which
accessible metal parts cannot become live in the event of a failure of the basic insulation.
Degree of protection against electrical shock: Type B Equipment
Type B equipment provides an adequate degree of protection against electrical shock, particularly
regarding allowable leakage currents and reliability of the protective earth connection.
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Degree of protection against harmful intrusion of water (IEC 60529): IPX0
This product does not provide protection against intrusion of water.
(The degree of protection against harmful ingress of water defined in IEC 60529 is IPX0).
Classification by safety of use in air/ flammable anesthetic gas, oxygen or nitrous oxide/ flammable
anesthetic gas atmosphere:
•Equipment not suited for use in air/flammable anesthetic gas, oxygen or nitrous oxide/flammable
anesthetic gas atmosphere.
•This product should be used in an environment free of flammable anesthetic gas and other flammable
gases.
Classification by operation mode: Continuous operation with short-time loading.
5. USAGE OF PRODUCT
This product is for medical use which must be used under instructions of a doctor.
6. MODE OF OPERATION
This product is for continuous operation. It takes approx. 2 sec. for each measurement.
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7. PARTS IDENTIFICATION
1. LCD monitor
2. Power indicator
3. Printer unit
4. Base unit
5. Slide lock
6. Operation switch
1. Headrest
2. Eye mark
3. Chinrest
4. Rating plate
5. Power inlet
6. Fuse holder
7. RS-232C terminal
8. Power switch
9. Measurement start switch
Applied parts are headrest and chinrest.
There is the parts list separated from this manual.
Also there is another parts list related to the safety.
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V. INSTRUCTIONS FOR USE

1. CONVEYANCE
1. Before conveyance, move the main unit undermost, set it in the center of the base unit and secure it by
tightening the slide lock.
Side of examiner Side of examinee
1. Main unit
2. Base unit
3. Slide lock
4. Chinrest
5. Handle
2. The slide lock can be tightened by pushing it up and rotating it in counterclockwise direction.
3. At the time of conveyance, hold the back and front of the base unit (the cutout of the front side and the
handle under the chinrest) with both hands securely. Do not hold the headrest, chinrest or LCD monitor
because it can result in deformation or malfunction of them.
4. Do not drag the power cord with being attached to the main unit. It can result in malfunction of the device
caused by fall or drop, or personal injury if the cord is stuck or stepped on.
2. INSTALLATION
1. Do not expose the view window of the device directly to the sunlight or bright lighting from other sources.
Great care should be taken because the measurement cannot be carried out if the examinee is
exposed to strong light or glare during the measurement and his/her pupil contracts too small.
2. Do not operate it at the place where it is either dusty or grubby.
Environment with extremes in heat and humidity should also be avoided. In case of using the device, fulfill
the environmental conditions at the time of unpacking and use.
3. Keep away from the place which stores chemicals or which emits gas.
4. Keep away from the sites which may experience strong vibrations or sudden shocks.
5. It can result in malfunction if the device is accidentally overturns. Also, it is very dangerous if it is dropped
on your foot etc. Do not store it at the unstable or high place.
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