Huvitz HRK-9000A User manual

User Manual
Auto Ref/Keratometer HRK-9000A

------------------------------------- HRK-9000A User Manual 1
Important Notice
This product may malfunction due to the electromagnetic wave that is generated
from mobile phone, two-way radio, machinery controlled wireless and others. Do not
place any device that may affect this product nearby.
We believe that the contents of this user manual are accurate in overall since they were
reviewed carefully. However, Huvitz does not assume any kind of responsibility for the
latent mistake or omission that results from the use of information included in this user
manual.
Huvitz has the right to make any kind of modification to this product or product specs
anytime without prior notice and modification may not be renewed on this document.
9000ENG0023-A
Ver 1.0
© 2014 - 2015 Huvitz Co., Ltd.
(HQs) 298-29, Gongdan-ro, Gunpo-si, Gyeonggi-do, 435-862, Korea
Manufacturer: Huvitz Hogye Branch
16-17(Hogye-dong), 91-beongil, LS-ro, Dongan-gu, Anyang-si, Gyeonggi-do, 431-848,
Korea
Huvitz has the copyright to this document.
Parts or all of this user manual cannot be duplicated without Huvitz’s permission in
accordance to the copyright law.

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Table of Contents
1. Introduction..............................................................................................................5
1.1. Outline of the instrument ...................................................................................5
1.2. Classification.......................................................................................................6
2. Information regarding safety ...................................................................................7
2.1. Introduction ........................................................................................................7
2.2. Safety symbols ....................................................................................................8
2.3. Environment related matters ............................................................................11
2.4. Safety Precaution..............................................................................................13
3. Characteristics........................................................................................................17
4. Precautions during use ..........................................................................................18
5. Name and function of each part............................................................................20
5.1. Key part ............................................................................................................20
5.2. Main measurement screen button explanation .................................................23
6. Equipment installation and preparation for measurement ..................................25
7. Practical training via Model Eye ............................................................................28
8. Measurement..........................................................................................................33
8.1. Refractive power measurement mode (REF mode) ...........................................34
8.1.1. Manual measurement mode ....................................................................35
8.1.2. Automatic measurement mode ...............................................................41
8.2. Corneal curvature measurement mode (KER mode)..........................................44

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8.2.1. Manual measurement mode....................................................................44
8.2.2. Automatic measurement mode ...............................................................47
8.3. Continuous corneal curvature / refractive power measurement mode (K&R
mode) 48
8.3.1. Manual measurement mode....................................................................48
8.3.2. Automatic measurement mode ...............................................................51
8.3.3. All kinds of markings...............................................................................52
8.4. Peripheral Corneal measurement (KER-P mode) ...............................................53
8.5. Contact lens’ base curve measurement (CLBC mode) .......................................57
9. Other mode ............................................................................................................60
9.1. Visual Acuity Test mode ....................................................................................60
9.2. Accommodation Test mode (accommodation force)..........................................62
9.3. Other menu mode .............................................................................................64
9.3.1. COLOR VIEW mode..................................................................................64
9.3.2. SIZE mode (pupil diameter measurement)..............................................75
9.3.3. ZERNIKE mode ........................................................................................77
9.3.4. RETRO-ILLUMINATION mode....................................................................84
9.3.5 TFBUT measurement mode (Tear film break-up time) .............................90
9.3.6. Meibography mode..................................................................................92
9.3.6.1. Filming result selection screen............................................................93
9.3.6.2. Meibomian gland emphasis and analysis result screen.........................94
9.3.7. DISPLAY mode .........................................................................................97
9.4. User SETUP mode............................................................................................100
9.6. Input method ..................................................................................................108

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9.5. Power saving function .....................................................................................110
10. Self-diagnosis and maintenance/repair ...............................................................111
10.1 Prior to calling a serviceman ..........................................................................111
10.2. Replacing.......................................................................................................114
10.2.1. Printer page ........................................................................................114
10.2.2. Slip page .............................................................................................115
10.3. Equipment cleansing .....................................................................................116
10.4. When moving equipment installation place...................................................116
11. Information needed for servicing .........................................................................118
12. Key specs ...............................................................................................................120
13. Accessories.............................................................................................................123
14. EMC Information.....................................................................................................124

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1. Introduction
1.1. Outline of the instrument
Automatic eye examination refractive power measurement device, HRK-9000A is the
equipment that measures refractive power of the test subject’s eyeball to show
Sphere (SPH), Cylinder (CYL) and Axis (AXS) information. Moreover, it can measure test
subject’s corneal curvature and PD (Purpillary Distance, distance between pupils) and
pupil’s size. In particular, it is possible to measure Peripheral Corneal Curvature
separately when measuring corneal curvature, and it enables accurate prescription
since it is possible to know the information of the cornea’s center and periphery
curvature individually.
Moreover, optimal eye examination information is provided depending on the state of
test subject’s eyes with the following other functions that are provided additionally.
▪VA (Visual Acuity) test
▪Color image observation
▪Light observation with Retro-Illumination
▪Abnormal curve state output via Zernike graph
▪Tear film destruction time measurement
▪Meibomian gland filming function
Automatic eye examination refractive power measurement device, HRK-9000A carries
out automatic arrangement to the X-Y-Z axes (left and right/up and down/front and
back) direction according to pupil to the location optimized for filming including pupil’s
automatic tracking function. Moreover, automatic chin rest adjustment function is

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provided to facilitate adjustment of the chin rest’s height, up and down.
1.2. Classification
Classification Under the Provision if 93/42/EEC (MDD): Class Im
Protection Against Electrical Shock: Class I
Applied Parts: Type B applied parts. (Chinrest Paper, Forehead rest)
Protection against harmful ingress of water: Ordinary, IPX0
Pollution Degree : II
Degree of safety in the presence of a flammable anesthetics mixture with
air or with oxygen or with nitrous oxide: Not suitable for use in the presence
of a flammable anesthetics mixture with air or with oxygen or with nitrous
oxide.
Mode of Operation: Continuous
※This product is a medical device

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2. Information regarding safety
2.1. Introduction
Safety is everyone’s obligation and responsibility. Safe use of this device is
important for everyone involved - installers, users, operators and device managers. It
is a must to study and to master this user manual individually prior to installing,
using, cleaning, repairing or controlling this device and its accessories. It does not
suffice to emphasize the importance of understanding the instructions found in this
manual repeatedly in order to increase safety of patients or users. For this reason,
the following safety warning chart is included at the adequate place on this manual
in order to highlight information that requires special precaution or safety related
information in particular. All the users or managers need to pay special attention in
addition to mastering “WARNING” or “CAUTION” in the manual.
“Warning” cautions against the existence of calamity that can cause severe
personal injury, death or property loss in case of negligence.
NOTE
“Note” explains important information related to installation, operation and
management, and failure to comply may lead to calamity in case of
negligence.
“Caution” informs of the matters related to calamity that can cause minor
injury or property loss in case of negligence.
!
WARNING
!
CAUTION

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2.2. Safety symbols
The International Electro technical Commission (IEC) announced the symbols that
warn when connecting electric medical device’s power or that warn against calamity
that may occur. Classification and symbol are as follows.
European Conformity
UL60601-1
CAN/CSA C22.2
NO.601.1
MEDICAL EUIPMENT
WITH RESPECT TO ELECTRIC SHOCK
FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH UL 2601-1, AND
CAN/CSAC22.2 NO.601.1
Manufactured by xxxx (year).
Manufacturer
Symbols I and O regarding power switch signify power
connection and blocking, respectively.
Indicates Type B segregated patient connection.

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Indicates signal input and output connection.
This symbol indicates safety precautions. Understand
the related precautions thoroughly after reading the
manual prior to using the device.
Consult instructions for use.
Indicates safety grounding point connected to the
device’s sash. Subject Class I device’s conductive
part to protective grounding for safety purpose.
Alternating Current
Direct Current.
Serial Number
Humidity Limitation
Atmospheric Pressure Limitation

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This side up
Fragile , handle with care
Do not use hand hooks
Keep DRY
Stacking Limit by Number
Keep away from sunlight
Huvitz Symbol

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2.3. Environment related matters
Avoid the following environment for operation and storage:
Place where device comes directly into contact with
moisture (do not operate the device with wet hand)
Placewheredeviceisexposeddirectlytosunlight.
Place with severe temperature change (temperature
for normal operation ranges from 10C to 40C while
humidity level ranges from 30% to 75%).
Place where hot device is close by.
Place where humidity level is high and there is a heat radiation related 에
problem
Placewhere deviceisexposedtosevereshockorvibration

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Avoid placing the device where it may come into
contact with chemical substance or place where
there is flammable gas
Be careful so that dust or metallic substance does
not go into the inside of this device.
Do not disassemble or open the device. The manufacturer is
not responsible for any problem that may result as such.
Donotblocktheheatradiationlocatedatthedevice’s upper part.
Do not connect the AC power code while the
device’s parts are not connected completely. Th i s
d am a g e s t h e d e v i ce .
Do not pullout the powercodewhileholding just thecode.
As for the environment when using the device, maintain temperature of 10 ~ 40 ℃,
humidity level of 30 ~ 75 % and atmospheric pressure of 800 ~ 1060 hpa.
As for the environment when transporting the device, maintain temperature of -40 ~
70 ℃, humidity level of 10 ~ 95 %, and atmospheric pressure of 500 ~ 1060 hpa.
As for the environment when storing the device, maintain temperature of –10 ~ 55 ℃,
humidity level of 30 ~ 75 %, and atmospheric pressure of 700 ~ 1060 hpa.
Take precaution so that the device won’t be subjected to excessive shock or vibration.

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2.4. Safety Precaution
This device was developed and proven according to the domestic and
international safety specs. This guarantees this device’s high safety level. By law, a
manufacturer is obligated to provide sufficient explanation of the matters
pertaining to the device safety to device users. Likewise, compliance with the
contents of this device’s manual is mandatory for safety sake. Thus, read the
instructions in the manual sufficiently and understand prior to turning on the power.
For many more information, inquire the distributor where you purchased the device.
1. Do not store or install this device at the following places; (a) place that runs
the risk of exploding, or (b) place that has volatile chemical substance such
as alcohol benzene or inflammable and explosive material.
2. Do not store or install at a humid place. To ensure normal operation,
humidity level should range between 30 and 75%. The device should not be
exposed to a place where water splashes significantly, water falls off, or gets
sprayed. Do not place the container with liquid or gas on top of the device.
3. This device should be operated by qualified personnel with sufficient training
or under such personnel’s supervision.
4. This device can be modified only by Huvitz’s service technician or a person
with comparable qualifications.
5. Device management by customer should be carried out as explained in the
user or service manual. Management that requires more sophisticated skill
set can be carried out only by Huvitz’s service technician or a person with
comparable qualifications.
6. Manufacturer assumes responsibility for this device’s safety, reliability and
performance only when the following conditions are satisfied: (1) When this

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device was installed at a viable space in accordance to this manual’s
regulations, and (2) when this device was used and maintained according to
the procedure regulated in this manual or service manual.
7. Manufacturer does not take responsibility for the damage resulting from this
device’s unlawful modification. However, device’s unlawful modification
becomes a factor for losing the right to get warranty during the warranty
period.
8. This device is utilized with the accessories provided by Huvitz. If consumer
wants to use other manufacturers’ accessories, safety of use must be proven
and confirmed by Huvitz or by the accessories’ manufacturer.
9. Only a person who completed adequate training or education program can
install, operate and maintain this device.
10. Store user or service manual at a place that is readily accessible by the
person who manages and uses this device.
11. Do not exert force on the cable connection. If cable does not get connected
easily, then check whether connector (plug) is suitable for the socket. When
connector or socket is damaged, qualified service technician needs to repair
it.
12. Do not pull on the device’s cable. Hold on the plug to take out to open up
the cable.
13. This device can be used according to this manual in relation to the refractive
power, corneal curvature measurement and their application.
14. Always test the state of the device’s external appearance and check whether
it is functioning well before using the device.
15. Do not block device’s hole for heat radiation.
16. Turn off the power immediately and take out the plug when there is smoke,
spark, abnormal noise or smell.

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17. IEC standard needs to be satisfied with in order to connect an outside device
with input/output signal or other connector. (IT equipment is IEC 60950, and
electric equipment for medical use is IEC 60601). Moreover, all the systems
need to satisfy the safety requirement, IEC 60601-1-1 when it comes to the
electric system for medical use. Person who connects outside device with
input/output signal or other connector has the obligation to take
responsibility in accordance to the IEC60601-1-1. Contact local technician or
distributor if you have doubts.
18. This equipment may cause edge which is hazardous for other devices at the
periphery. Wireless frequency may be generated or used, and energy may be
released when the device is not installed or used according to the guideline.
However, there is no guarantee that edge does not result when carrying out
specific installation. If this device leads to hazardous interception on other
device when the equipment is turned on/off, user needs to solve the
interception issue by using one of the following measures.
-Change direction or relocate the receiver
-Distance between equipment is increased
-Connect the equipment with the socket of the circuit connected with
other device and other circuit
-Ask manufacturing business or field service technician for help
19. To avoid electrocution, this device must be connected to the supply power
along with protective grounding.
20. Do not place at a difficult location when separating cable when it comes to
the device’s placement.
21. When you carry this product, please hold on left and right bottom of the
product. If you want the product to be installed on another place, please call
A/S center.

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For use of equipment in rated voltage less than 125Vac,minimum 6A,Type SJT or
SVT , 18/3AWG,10A, max 3.0m long : One end with Hospital Grade Type, NEMA
5-15P Other end with appliance coupler. For use of equipment in rated voltage less
than 250Vac,minimum 6A,Type SJT or SVT , 18/3AWG,10A, max 3.0m long :
One end terminatesd with blade attachment plug(HAR) Type, NEMA 6-15P.
This equipment must be installed and operated in accordance with provided
instructions and the antenna(s) used for this transmitter must be installed to
provide a separation distance of at least 20 cm from all persons and must not be
co-located or operating in conjunction with any other antenna or transmitter. End-
users and installers must be provide with antenna installation instructions and
transmitter operating conditions for satisfying RF exposure compliance.
!
CAUTION

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3. Characteristics
1. It is possible to carry out both refractive power and corneal curvature
measurement with one machine.
2. It is possible to measure even the myopia since the refractive power
measurement range is very broad ranging from –30 D to +25 D.
3. When measuring refractive power, it is possible to measure up to a minimum
pupil diameter Ø 2.0 mm.
4. Function for measuring Peripheral Corneal is provided to find out the
curvature value and eccentricity of each point by measuring periphery
curvature separately into the up/down/left/right direction from the cornea’s
center.
5. It is possible to check abnormal curve state with a graph of the Zernike map
format.
6. Fog and mist technique that is applied to the internal fixation Target enables
increasingly accurate measurement by ensuring natural and comforting feel
for the patients’ eyes.
7. Cornea measurement’s marking form and cornea equivalence curve rate can
be selected.
8. Distance between pupils (PD) measurement is enabled.
9. It is possible to observe the state of cataract patients’ eyes or scratch on the
contact lens surface through light observation with Retro-Illumination. It is
possible to store up to two images of the left/right eyes in the memory.
Stored image can be output on the monitor screen again to show to the
patients.

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4. Precautions during use
1. Handle with care since shock can damage the outside or the inside.
2. Precision measurement may be affected when the product is exposed to
direct sunlight or too bright indoor illumination. It is recommended to
measure at a dark eye examination room.
3. Get guidance at the place of purchase when using the device by connecting
with other equipment.
4. When heating up the inside at a cold area all of the sudden, vapor may result
on the object lens of the customer side and on the optical parts at the inside
of the device. In this case, measure after waiting for the vapor to disappear.
5. Main the object lens from the customer side that is subjected to the test
clean at all times. Error may result or precision measurement may be
affected if tainted with dust or alien substance.
6. Take out the power plug to separate the power when there is smoke, smell or
noise during use. Then, follow the instructions of the place of purchase.
7. Do not use alcohol, thinner, benzene and organic solvent to clean this
equipment’s surface since these may damage the equipment.
8. When moving the HRK-9000A, turn off the power switch always, and fixate
the stage. Then, move by lifting up with lower part of the body with both
hands.
9. When HRK-9000A is not used for a long time, separate the power and cover it
with the dust cover.
10. When using this equipment under normal state, then the proper location is as
shown below.

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