Huvitz HRK-1 User manual

Auto Ref/Keratometer
HRK-1
USER MANUAL

2
Precautions
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.
9000ENG0032-A
Ver 0.0 (2017.08)
©2017 HUVITZ Co., Ltd.
38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 14055, Republic of Korea
All rights reserved.
Under copyright laws, this manual may not be copied, in whole or in part, without the prior written
consent of HUVITZ Co., Ltd
.

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HRK-1
Provision of information on the avoidance of light hazard from the optical device is required in
ISO 15004-2:2007
“Ophthalmic instruments-Fundamental requirements and test methods”
1. The manufacturer shall, on request, provide the user with a graph showing the relative spectral
output of the instrument between 305 nm and 1 100 nm when the instrument is operating at
maximum light intensity and maximum aperture. The spectral output shall be shown for the beam
after it exits the instrument.
< Spectrum output of all light source during measurement (maximum light intensity) >
2. “CAUTION – The light emitted from this instrument is potentially hazardous. The longer the
duration of exposure, the greater the risk of ocular damage. Exposure to light from this instrument
when operated at maximum intensity will exceed the safety guideline after 1.72 minutes.”
!
CAUTION

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CONTENT
1. Introduction..................................................................................................................................6
1.1. Intended Use ....................................................................................................................................................... 6
1.2. Equipment overview............................................................................................................................................ 6
1.3. Grade classification and mentioned items ......................................................................................................... 6
2. Information regarding safety .......................................................................................................7
2.1. Introduction.......................................................................................................................................................... 7
2.2. Safety indication .................................................................................................................................................. 8
2.3. Environment related matters............................................................................................................................... 9
2.4. Safety Precautions .............................................................................................................................................11
3. Characteristics...........................................................................................................................14
4. Precautions during use..............................................................................................................15
5. Name and function of each part ................................................................................................16
5.1. Key part ............................................................................................................................................................. 16
5.2. Main measurement screen button explanation ................................................................................................ 19
6. Equipment installation and preparation for measurement........................................................21
7. Measurement Method ................................................................................................................24
8. Measurement .............................................................................................................................29
8.1. Refractive power measurement mode (REF mode) ........................................................................................... 29
8.1.1. Manual measurement mode.................................................................................................................................................... 29
8.1.2. Automatic measurement mode.............................................................................................................................................. 33
8.1.3. Message List..................................................................................................................................................................................... 34
8.2. Corneal curvature measurement mode (KER mode).......................................................................................... 35
8.2.1. Manual measurement mode.................................................................................................................................................... 35
8.2.2. Automatic measurement mode.............................................................................................................................................. 36
8.2.3. Message List..................................................................................................................................................................................... 37
8.3. Continuous corneal curvature / refractive power measurement mode (K&R mode) ......................................... 38
8.3.1. Manual measurement mode.................................................................................................................................................... 38
8.3.2. Automatic measurement mode.............................................................................................................................................. 40
9. Other mode ................................................................................................................................41
9.1. COLOR VIEW mode ............................................................................................................................................ 41
9.1.1. Yellow Filter ....................................................................................................................................................................................... 42
9.1.2. White LED .......................................................................................................................................................................................... 43
9.1.3. Blue LED.............................................................................................................................................................................................. 44
9.1.4 Returning to the measurement mode ................................................................................................................................. 44
9.1.5. Capture screen ................................................................................................................................................................................ 44
9.1.6. Capture image viewing screen ............................................................................................................................................... 45
9.2. SIZE mode (pupil diameter measurement) ..................................................................................................... 48
9.3. RETRO-ILLUMINATION mode ............................................................................................................................ 50
9.3.1. Arrangement and focusing....................................................................................................................................................... 50
9.3.2. Retro-Illumination observation ............................................................................................................................................... 51
9.3.3. Saving................................................................................................................................................................................................... 52
9.3.4. Test for other eye........................................................................................................................................................................... 52
9.3.5. Importing saved image .............................................................................................................................................................. 52
9.3.6. Returning to the main measurement mode .................................................................................................................... 53

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HRK-1
9.4. DISPLAY mode..................................................................................................................................................... 54
9.5. User SETUP mode ............................................................................................................................................... 56
9.5.1. List of setup items & Initial ...................................................................................................................................................... 56
9.5.2. Initial setting..................................................................................................................................................................................... 56
9.5.3. Detailed description of setting ............................................................................................................................................... 58
9.6. Input method......................................................................................................................................................... 63
10. Self-diagnosis and maintenance/repair ...................................................................................65
10.1. REF / KER Accuracy check ............................................................................................................................... 65
10.2. Replacing............................................................................................................................................................ 66
10.2.1. Printer paper.................................................................................................................................................................................. 66
10.2.2. Chin rest paper............................................................................................................................................................................. 66
10.3. Cleaning Equipment ........................................................................................................................................... 67
10.4. Cleaning.............................................................................................................................................................. 68
10.4.1. Cleaning the measuring window ........................................................................................................................................ 68
10.4.2. Cleaning the mire ring ............................................................................................................................................................. 68
10.4.3. Cleaning the forehead rest and chin rest ...................................................................................................................... 68
10.5. Prior to contact with prefered distributor............................................................................................................ 69
10.6. When moving equipment installation place ....................................................................................................... 70
11. Information needed for servicing.............................................................................................71
12. Key specs.................................................................................................................................73
13. Accuracy ..................................................................................................................................75
14. Accessories..............................................................................................................................76
15. EMC Information ......................................................................................................................77

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Introduction
1.1. Intended Use
The Auto Ref/Keratometer HRK-1 is intended to be used to measure the refractive power of the eye.
1.2. Equipment overview
Automatic eye examination refractive power measurement device, HRK-1 is the equipment that measures
refractive power of patient’s eyeball to show Sphere (SPH), Cylinder (CYL) and Axis (AXS) information.
Moreover, it can measure test subject’s corneal curvature and PD (Pupillary 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.
•Color image observation
•Light observation with Retro-Illumination
Automatic eye examination refractive power measurement device, HRK-1 carries out automatic
arrangement to the Y axes (up and down) direction according to pupil to the location optimized for filming
including pupil’s automatic tracking function.
1.3. Grade classification and mentioned items
1. Classification of product :
-. EU - Class I with a measuring function according to Annex IX (Rule 12) of the Medical Device
Directive 93/42/EEC
-. KFDA – Class II
2. Resistance against electric shock : Class I (earthed)
3. Protection class against electric : Type B
4. Protection against harmful ingress of water : Ordinary, IPX0
5. 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.
6. Mode of operation : Continuous
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HRK-1
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 patient or users. For this reason, thefollowing 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.
“Caution” informs of the matters related to calamity that can cause minor injury or property
loss in case of negligence.
“Note” explains important information related to installation, operation and management, and
failure to comply may lead to calamity in case of negligence.
2
!
WARNING
!
CAUTION
!
NOTE

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2.2. Safety indication
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.
Symbols I and O regarding power switch signify power
connection and blocking, respectively.
Indicates Type B segregated patient connection.
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.
Temperature Limitation
Humidity Limitation

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HRK-1
Atmospheric Pressure Limitation
This side up
Fragile , handle with care
Do not use hand hooks
Keep DRY
Stacking Limit by Number
Keep away from sunlight
2.3. Environment related matters
The following environment for operation and storage:
Place where device comes directly into contact with moisture
(do not operate the device with wet hand)
Place where device is exposed directly to sunlight.
A place where the equipment can be exposed to direct
ultraviolet.

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Place with severe temperature change (temperature for
normal operation ranges from 10 C to 40 C while humidity
level ranges from 30% to 75%).
Where there is a hot equipment nearby.
Where the humidity is extremely high or there is a ventilation
problem.
Where the machine is exposed to excessive shocks or
vibrations.
Where the machine is exposed to chemical material or
explosive gas.
Be cautious so that things like dust and metal do not fall inside
the machine.
Don’t disassemble or open the product. HUVITZ does not take
responsibility for the possible problems
Be careful not to block the fan of the machine.
Don’t plug the AC power cord into the outlet unless all parts of
the machine are completely connected. Otherwise, it will cause
severe damage on the machine.
Pull out the power cord with holding the plug, not the cord.
To avoid risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
This instrument must be followed by these following conditions:

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HRK-1
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.
2.4. Safety Precautions
The safety precautions and operating procedures must be thoroughly understood prior to
operation of the device.
The device complies with ISO 10342 subclause 4: 2010 (Ophthalmic instruments – Eye
Refractometers) and ISO 10343 subclause 4: 2009 (Ophthalmic instruments -
Ophthalmometers). The dioptric powers are indicated with reference wavelength λd = 546.07
nm or λd = 587.56 nm
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.
!
BEFORE USE, READ THIS MANUAL

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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 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.
17. IEC standard needs to be satisfied withinorder to connect anoutside 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 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.
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.

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HRK-1
-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.
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 terminated 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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Characteristics
1. It is possible to carry out both refractive power and corneal curvaturemeasurement with onemachine.
2. It is possible tomeasure even themyopia since the refractive power measurement range isvery broad
ranging from –30 D to +25 D.
3. When measuring refractive power, it is possibleto measure upto aminimum pupil diameter Ø 2.0 mm.
4. Fog and mist technique that is applied to the internal fixation Target enables increasingly accurate
measurement by ensuring natural and comforting feel for the patient’s eyes.
5. Cornea measurement’s marking form and cornea equivalence curve rate can be selected.
6. Distance between pupils (PD) measurement is enabled.
7. It is possible to observe the state of cataract patient’s eyes or scratch on the contact lens surface
throughlight observationwith Retro-Illumination. Itis possibletostoreup totwoimages of theleft/right
eyes in the memory. Stored image can be output on the monitor screen again to show to the patient.
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HRK-1
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 thereis 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
thesemay damage the equipment.
8. When moving the HRK-1, 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-1 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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Name and function of each part
5.1. Key part
[Front part]
1. Eye height mark: indicates the height that patient’s eyes should be placed
2. Stage fixation lever: for fixating stage
3. Movement indicator lamp: indicates whether the device power is turned on
4. Display monitor: indicates measurement screen and movement state
5. Printer: printer for printing out measurement results
6. Measurement button: button pressed on to measure
7. Joystick (Operation lever): lever for moving object lens to the front and back, left and right and up
and down
5
2
3
4
5
6
7
1

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HRK-1
[Back part]
1. Forehead rest: location for placing the forehead to prevent test subject from moving the face (Type B
attachment part)
2. Measuring window: object lens for measuring the image that is formed in the eye retina
3. Chin rest: location for placing the chin to prevent test subject from moving the face
(Chin rest paper: Type B attachment part)
4. Power switch: switch for turning the power on or off
5. Chin rest control knob: the chin rest’s height adjustment knob
6. Measuring head: Optical head of mearing.
7. Eye height mark of measuring window: indicates the position of the measuring window.
2
3
4
5
6
1
7

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[Lower part]
1. Power supply socket (Fuse holder): Socket that connects with the outside power plug
(250V T3.15AL)
2. Serial interface connector: Connector for connecting outside device connector
3. RGB connector: Connector for connecting with the outside monitor of the RGB method
4. Clamping bolt: Fixate system stage
Noise may appear on the screen when connecting with outside monitor due to the length and
type of the cable, and monitor quality.
Use signal amplifier if the distance with the outside monitor is significant.
1
2
3
4
!
NOTE

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HRK-1
5.2. Main measurement screen button explanation
[Front part’s switch]
1. (MODE) button: Main measurement mode Button for modifying (REF, KER, K&R,).
2. (MANUAL) button: Button for selecting whether to carry out automatic measurement
(Number is frequency) (MANUAL, AUTO-3, AUTO-5, AUTO-A)
3. (AT) button: Button for selecting whether to use automatic tracking function
(MT: manual /AT: automatic tracking for up & down)
4. (COLOR) Button: Button for viewing to color observation mode
5. (Retro-ILL) button: Button for viewing to retro-illumination mode
6. (SIZE) button: button for measuring to pupil diameter
7. (CYLINDER) Button: Button that reverses cylinder value’s sign (+ => -, - => +)
1
2
3
4
5
6
7
8
9
10
11
12
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8. (DATA CLEAR) Button: Button that deletes measurement result.
9. (PRINT) Button: Button that prints measurement result.
10. (SETUP) button: Button for converting to the user SETUP screen.
11. (MEASURE) Button: Button that measures DATA.
12. (CYLINDER) Display: Show current cylinder selected in “7. Cylinder button”
(Displayed only in REF, K&R mode).
13. (VD) button: Button for converting VD to one of the following set up value
(Default value: 12.0)