Huvitz HRK-9000A User manual

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User Manual
Auto Ref/Keratometer HRK-9000A
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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.
9000ENG0023-A
Ver 1.0 (2015.06)
© 2014 - 2015 Huvitz Co., Ltd.
(HQs) 298-29, Gongdan-ro, Gunpo-si, Gyeonggi-do, 435-862, Korea
Manufacturer : Huvitz
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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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”
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 33 minutes.
< Spectrum output of all light source during measurement (maximum light intensity) >
!
CAUTION
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Table of Contents
1. Introduction ................................................................................................................... 7
1.1. Intended Use ............................................................................................................ 7
1.2. Equipment overview ................................................................................................. 7
1.3. Grade classification and mentioned items ............................................................... 8
2. Information regarding safety ...................................................................................... 9
2.1. Introduction ............................................................................................................... 9
2.2. Safety indication ..................................................................................................... 10
2.3. Environment related matters .................................................................................. 12
2.4. Prerequisites for safety .......................................................................................... 14
3. Characteristics ............................................................................................................ 19
4. Precautions during use ............................................................................................. 20
5. Name and function of each part ............................................................................... 22
5.1. Key part ................................................................................................................... 22
5.2. Main measurement screen button explanation ..................................................... 25
6. Equipment installation and preparation for measurement ................................... 27
7. Practical training via Model Eye ............................................................................... 29
8. Measurement ............................................................................................................... 33
8.1. Refractive power measurement mode (REF mode) ............................................. 34
8.1.1. Manual measurement mode........................................................................ 34
8.1.2. Automatic measurement mode ................................................................... 40
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8.2. Corneal curvature measurement mode (KER mode) ............................................ 43
8.2.1. Manual measurement mode ........................................................................ 43
8.2.2. Automatic measurement mode .................................................................... 46
8.3. Continuous corneal curvature / refractive powermeasurement mode (K&R mode)
.......................................................................................................................... 47
8.3.1. Manual measurement mode ........................................................................ 47
8.3.2. Automatic measurement mode .................................................................... 50
8.3.3. All kinds of markings .................................................................................... 51
8.4. Peripheral Corneal measurement (KER-P mode) ................................................. 52
9. Other mode .................................................................................................................. 57
9.1. Visual Acuity Test Mode .......................................................................................... 57
9.1.1. Uncorrected Vision Measurement ............................................................... 59
9.1.2. Corrected Vision Measurement ................................................................... 60
9.1.3. Other Examinations (Near Distance Refraction, Glare and Low Contrast
Environment) .......................................................................................................... 63
9.2. Other menu mode ................................................................................................... 65
9.2.1. COLOR VIEW mode .................................................................................... 65
9.2.2. SIZE mode (pupil diameter measurement) ................................................. 75
9.2.3. ZERNIKE mode ............................................................................................ 77
9.2.4. RETRO-ILLUMINATION mode .................................................................... 84
9.2.5 TFBUT measurement mode (Tear film break-up time) ................................ 90
9.2.6. Meibography mode ...................................................................................... 92
9.2.7. DISPLAY mode............................................................................................. 97
9.3. User SETUP mode ................................................................................................. 99
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9.4. Measurement Data Transmission using WiFi ...................................................... 109
9.4.1. WiFi Environment Setting .......................................................................... 109
9.4.2. Check WiFi Network Status ....................................................................... 113
9.4.3. Measurement Data Transmission ............................................................. 116
9.5. Input method ......................................................................................................... 119
9.6. Power saving function .......................................................................................... 120
10. Self-diagnosis and maintenance/repair ................................................................. 121
10.1. Prior to calling a serviceman .............................................................................. 121
10.2. Replacing ............................................................................................................ 123
10.2.1. Printer page.............................................................................................. 123
10.2.2. Chin rest paper ........................................................................................ 124
10.3. Cleaning Equipment ........................................................................................... 125
10.4. When moving equipment installation place ....................................................... 127
11. Information needed for servicing ............................................................................. 128
12. Key specs .................................................................................................................... 130
13. Accessories ................................................................................................................. 134
14 EMC Informations ..................................................................................................... 135
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1. Introduction
1.1. Intended Use
The Auto Ref/Keratometer HRK-9000A 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-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
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▪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 provided to
facilitate adjustment of the chin rest’s height, up and down.
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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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 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
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Direct Current.
Serial Number
Humidity Limitation
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
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Huvitz Symbol
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)
Place where device is exposed directly to sunlight.
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 related에
problem
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Place where device is exposed to severe shock or vibration
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.
Do not block the heat radiation located at the device’s upper part.
Do not connect the AC power code while the device’s
parts are not connected completely. T his d amag es
th e d evi c e.
Do not pull out the power code while holding just the code.
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.
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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. Prerequisites for safety
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.
!
BEFORE USE, READ THIS MANUAL
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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
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
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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 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
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19. When this equipment is connected to the Wireless Network AP, set the wireless
security type to WPA2-PSK.
-Access with applicable AP is not possible when other securities such as
OPEN / WEP are set. (FDA recommended matter)
-The Company is not responsible for the problem that may result when
accessing with the wireless network that is not secured.
20. Secure open space within 10m when it comes to the location of the wireless AP
(HUB) where this equipment is to be connected.
-When the distance between this equipment and AP is over that of a
specific distance, remove obstacle if there is obstacle, use Wireless
Repeater or install additional AP (Wireless Hub) at nearby place.
-If there is a wireless connection, contact local technician or distributor to
receive help.
21. Refractive power measurement result and VA Test result may be different.
-Refractive power measurement result and VA Test result may be different
due to reasons such as the state of subject’s eyeball and adjustment
ability intervention.
22. To avoid electrocution, this device must be connected to the supply power
along with protective grounding.
23. Do not place at a difficult location when separating cable when it comes to the
device’s placement.
24. 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 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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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 Ø2.0 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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