Huvitz HRK-8000A User manual

--------------------------------------------------------------- Auto Ref/Keratometer HRK-8000A 1
User’s Manual
Auto Ref/Keratometer HRK-8000A

2Auto Ref/Keratometer HRK-8000A ---------------------------------------------------------------
IMPORTANT NOTICE
Potential electromagnetic or other interference between medical
equipments and other devices being operated together in the same
environmental may expert an adverse influence on functioning of the
medical equipment. Non-medical equipments not in compliance with
the requirements of EN 60601-1 and EN 60601-1-2 should not be
used together in the same environmental as the medical equipments.
This equipment has been tested and found to comply with the limits for
medical devices in IEC 60601-1-2:2001. These limits are designed to provide
reasonable protection against harmful interference in a typical medical
installation.
Power Cord
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 product may malfunction due to electromagnetic waves caused by
portable personal telephones, transceivers, radio-controlled toys, etc. Be sure
to avoid having objects such as, which affect this product, brought near the
product.
The information in this publication has been carefully checked and is believed
!
WARNING

--------------------------------------------------------------- Auto Ref/Keratometer HRK-8000A 3
to be entirely accurate at the time of publication. HUVITZ assumes no
responsibility, however, for possible errors or omissions, or for any
consequences resulting from the use of the information contained herein.
HUVITZ reserves the right to make changes in its products or product
specifications at any time and without prior notice, and is not required to
update this documentation to reflect such changes.
Ver 1.0
©2010 - 2011 - Huvitz Co., Ltd.
-689-3, Gumjeong-dong, Gunpoci, Gyeonggi-do,
435-862, Republic of Korea
All rights are reserved. Under copyright laws, this manual may not be copied, in
whole or in part, without the prior written consent of HUVITZ Co., Ltd.

4Auto Ref/Keratometer HRK-8000A ---------------------------------------------------------------
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 88 minutes.
< Spectrum output of all light source during measurement (maximum light intensity)>
!
CAUTION

--------------------------------------------------------------- Auto Ref/Keratometer HRK-8000A 5
Contents
1. Introduction .............................................................................................................9
1.1. Overview .......................................................................................................9
1.2. Classificaiton ..............................................................................................10
2. Safety Information.................................................................................................11
2.1. Overview .....................................................................................................11
2.2. Safety Symbol ............................................................................................12
2.3. Environmental Considerations ...................................................................15
2.4. Safety Precaution .......................................................................................17
3. Characteristics ......................................................................................................20
4. Note for Use...........................................................................................................21
5. Names and functions of each part........................................................................22
5.1. Main parts...................................................................................................22
5.2. Explanation on Switches in Front ..............................................................25
6. Installation of Equipment & Preparation of Measurement..................................26
7. Exercise through Model Eye.................................................................................28
8. Measurement.........................................................................................................33
8.1. Refractometry (REF Mode) ........................................................................34
8.1.1. Manual Measurement Mode........................................................................35
8.1.2. Auto Measurement Mode.............................................................................40

6Auto Ref/Keratometer HRK-8000A ---------------------------------------------------------------
8.2. Keratometry (KER Mode)............................................................................43
8.2.1. Manual Measurement Mode ........................................................................43
8.2.2. Auto Measurement Mode.............................................................................46
8.3. Corneal Curvature / Refractive Power Measurement Mode (K&R Mode).47
8.3.1. Manual Measurement Mode ........................................................................47
8.3.2. Auto Measurement Mode.............................................................................50
8.3.3. Diverse Indications ......................................................................................51
8.4. Keratometry Peripheral Measurement (KER-P Mode)...............................52
8.5. Measurement of Contact Lens Base Curve(CLBC Mode) ........................56
9. Other Modes...........................................................................................................59
9.1. ILLUMINATION Measurement Mode (ILLUM Mode)...................................59
9.1.1. Adjustment of Array and Focus....................................................................59
9.1.2. Observation on Illumination..........................................................................62
9.1.3. Storage........................................................................................................63
9.1.4. Examination on the other eye ......................................................................63
9.1.5. Call for Stored Image...................................................................................63
9.1.6. Return to measurement mode .....................................................................65
9.2. ZERNIKE Mode ...........................................................................................66
9.2.1. Composition of Window...............................................................................66
9.2.2. Change of Window ......................................................................................71
9.3. Measurement of Corneal Radius(SIZE Mode) ...........................................72
9.4. VIRTUAL COMPARISON Mode ...................................................................76
9.5. COLOR VIEW MODE...................................................................................78
9.5.1. White LED ...................................................................................................80

--------------------------------------------------------------- Auto Ref/Keratometer HRK-8000A 7
9.5.2. Blue LED.....................................................................................................81
9.5.3. Yellow Filter.................................................................................................82
9.5.4. Capture Screen ...........................................................................................83
9.5.5. Selected Capture Screen.............................................................................83
9.5.6. Return to measure mode.............................................................................87
9.6. DISPLAY Mode ...........................................................................................88
9.7. User SETUP Mode......................................................................................90
9.8. Power saving Function.............................................................................101
10. Self diagnosis & Maintenance ............................................................................102
10.1. Before calling for serviceman..................................................................102
10.2. Replacement.............................................................................................105
10.2.1. Printer paper..............................................................................................105
10.2.2. Chin rest paper..........................................................................................105
10.2.3. Replacing Fuse..........................................................................................106
10.3. Cleaning Equipment .................................................................................107
10.4. As changing the installation place of the equipment .............................107
10.5. Disposal....................................................................................................107
11. Service Information.............................................................................................108
12. Main Specifications.............................................................................................109
13. Accessories.........................................................................................................111
14. EMC Information..................................................................................................112
14.1 Guidance and manufacturer’s declaration – electromagnetic emissions ....112

8Auto Ref/Keratometer HRK-8000A ---------------------------------------------------------------
14.2 Guidance and manufacturer’s declaration – electromagnetic immunity......113
14.3 Guidance and manufacturer’s declaration – electromagnetic immunity......115
14.4 Recommended separation distances between portable and mobile RF
communications equipment and the EUT................................................................117
14.5 Immunity and Compliance Level................................................................118
14.6 Guidance and manufacturer’s declaration – electromagnetic immunity....119
15. Service Information.............................................................................................121

--------------------------------------------------------------- Auto Ref/Keratometer HRK-8000A 9
1. Introduction
1.1. Overview
Auto Ref/Keratometer HRK-8000A is the equipment to provide the information of
Spherical, Cylindrical and Axis while measuring the refraction of examinee’s eyes.
Auto Ref/Keratometer HRK-8000A is the equipment that can measure the corneal
curvature of examinee. In addition, it can measure PD (=distance in between
pupils) and pupil size. Especially, as its peripheral (=corneal peripheral curvature)
measurement is possible as measuring the corneal curvature of examinee, it is
possible to know the information on the corneal peripheral curvature as well as the
corneal core curvature, which enables the exact prescription for the examinee.
This equipment shall provide the optimal optometry information with Illumination
(=observing illumination) to obtain an optimal figure of the eyes’state of examinee.
CLBC (Contact Lens Base Curve) measurement is also a basic function of this
product.
The HRK-8000A is provided with an Auto-tracking function and a motorized
chinrest function.
Auto-tracking mechanism that automatically achieves alignment in the up/down,
right/left direction and focusing.
A motorized up/down chinrest allows the operator to easily adjust the height of the
chinrest.

10 Auto Ref/Keratometer HRK-8000A ---------------------------------------------------------------
1.2. Classificaiton
1) Classification of product :
-. EU - Class IIa according to Annex IX (Rule 10) of the Medical Device
Directive 93/42/EEC as amended by 2007/47/EC
-. 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

--------------------------------------------------------------- Auto Ref/Keratometer HRK-8000A 11
2. Safety Information
2.1. Overview
Safety is everyone’s responsibility. The safe use of this equipment is largely
dependent upon the installer, user, operator, and maintainer. It is imperative that
personnel study and become familiar with this entire manual before attempting to
install use, clean, service or adjust this equipment and any associated
accessories. It is paramount that the instructions contained in this manual are
fully understood and followed to enhance safety to the patient and the
user/operator. It is for this reason that the following safety notices have been
placed appropriately within the text of this manual to highlight safety related
information or information requiring special emphasis. All users, operators, and
maintainers must be familiar with and pay particular attention to all Warnings and
Cautions incorporated herein.
"Warning” indicates the presence of a hazard that could result in severe
personal injury, death or substantial property damage if ignored.
NOTE
"Note” describes information for the installation, operation, or
maintenance of which is important but hazard related if ignored.
“Caution” indicates the presence of a hazard that could result in minor
injury, or property damaged if ignored.
!
WARNING
!
CAUTION

12 Auto Ref/Keratometer HRK-8000A ---------------------------------------------------------------
2.2. Safety Symbol
The International Electrotechnical Commission (IEC) has established a set of
symbols for medical electronic equipment which classify a connection or warn of
any potential hazards. The classifications and symbols are shown below.
I and O on power switch represent ON and OFF
respectively.
Type B Isolated patient connection.
It indicates the connection of signal input/output.
This symbol identifies a safety note. Ensure you
understand the function of this control before using
it. Control function is described in the appropriate
User’s or Service Manual.
It indicates the year of manufacture and the
manufacturer.
Manufacturer
Authorised Representative in the European
Community

--------------------------------------------------------------- Auto Ref/Keratometer HRK-8000A 13
Identifies the point where the system safety ground
is fastened to the chassis. Protective earth
connected to conductive parts of Class I equipment
for safety purposes.
Hot surface.
Temperature Limitation
Keep DRY
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 60601-1, AND
CAN/CSA C22.2 NO.601.1
Disposal of your old appliance
When this crossed-out wheeled bin symbol is
attached to a product it means the product is
covered by the European Directive 2002/96/EC.
All electrical and electronic products should be
disposed of separately from the municipal waste
stream via designated collection facilities appointed
by the government or the local authorities.
The correct disposal of your old appliance will help
prevent potential negative consequences for the
environment and human health.
4. For more detailed information about disposal of
your old appliance, please contact your city office,
waste disposal service or the shop where you
purchased the product.

14 Auto Ref/Keratometer HRK-8000A ---------------------------------------------------------------
Alternating Current

--------------------------------------------------------------- Auto Ref/Keratometer HRK-8000A 15
2.3. Environmental Considerations
Please avoid the environment below for the operation and storage of the equipment.
Where the equipment is exposed to water vapor.
Don’t operate the equipment with wet hands.
Where the machine is exposed directly to the
sunlight.
Where the temperature changes frequently (Normal
temperature for operation of the machine is at the
range of 10C ~ 40C, and the humidity is at the
range of 30%~75%.
Where any heaters are at the close distance to the
machine.
Where the humidity is high and there are problems to
the heat dissipation and/or ventilation.
Where the equipment is subject to excessive shocks
or
Vibrations.

16 Auto Ref/Keratometer HRK-8000A ---------------------------------------------------------------
Where the machine can be exposed to the
chemical or flammable substances.
Please keep the equipment out of dust and do not
let inserted any metal parts such as coins, clips,
etc.
Do not disassemble or open the machine. The
manufacture shall have no responsibility for any
problems caused by these.
Do not close the thermal ventilation outlet.
Do not connect the AC power plug into the outlet
while not putting the parts of machine together
completely. It can harm the equipment.
Do not pull the plug out of outlet while holding the
cord.
For the normal operation of the machine, please keep the ambient temperature is
10℃~ 40℃, humidity is 30% ~ 75% and atmospheric pressure is 800 ~
1060hpa. For the Transfortation of the machine, please keep the ambient
temperature is -40℃~ 70℃, humidity is 10% ~ 95% and atmospheric pressure
is 500 ~ 1060hpa. For the Storage of the machine, please keep the ambient
temperature is -10℃~ 55℃, humidity is 30% ~ 75% and and atmospheric
pressure is 700 ~ 1060hpa. Avoid environments where the equipment is exposed
to excessive shocks or vibrations.

--------------------------------------------------------------- Auto Ref/Keratometer HRK-8000A 17
2.4. Safety Precaution
This equipment has been developed and tested in conformity with domestic &
international safety standards and regulations, which guarantees the high stability
of this product. This guarantees a very high degree of safety for this device. The
legislator expects us to inform the user expressively about the safety aspects in
dealing with the device. The correct handling of this equipment is imperative for
its safe operation. Therefore, please read carefully all instructions before
switching on this device. For more detailed information, please contact our
Customer Service Department or one of our authorized representatives.
1. This equipment must not be used (a) in an area that is in danger of
explosions and (b) in the presence of flammable, explosive, or volatile
solvent such as alcohol, benzene or similar chemicals.
2. The device should neither be kept nor installed in the place with high
humidity. For the optimal operation, the humidity should be at the range of
30%~75%. The machine should not be exposed to the place where water
splashes, drips or sprays. Do not place containers containing fluids,
liquids, or gases on top of any electrical equipment or devices
3. The equipment must be operated only by, or under direct supervision of
properly trained and qualified person/s.
4. Modifications of this equipment may only be carried out by Huvitz’s
service technicians or other authorized persons.
5. Customer maintenance of this equipment may only be performed as
stated in the User’s Manual and Service Manual. Any additional
maintenance may only be performed by Huvitz’s service technicians or
other authorized persons.
6. The manufacturer is only responsible for effects on safety, reliability, and
performance of this equipment when the following requirements are
fulfilled: (1) The electrical installation in the respective room corresponds
to the specifications stated in this manual and (2) This equipment is used,
operated and maintained according to this manual and Service Manual.

18 Auto Ref/Keratometer HRK-8000A ---------------------------------------------------------------
7. The manufacturer is not liable for damage caused by unauthorized
tampering with the device(s). Such tampering will forfeit any rights to
claim under warranty.
8. The equipment may only be used together with accessories supplied by
Huvitz’s. If the customer makes use of other accessories, use them only if
there are usability under technical safety aspects has been proved and
confirmed by Huvitz or the manufacturer of the accessory.
9. Only persons who have undergone proper training and instructions are
authorized to install, use, operate, and maintain this equipment.
10. User’s manual or service manual should be kept in the place where the
persons in chare of operation and maintenance can access easily any
time.
11. Do not force cable connections. If a cable does not connect easily, be
sure that the connector (plug) is appropriate for the receptacle (socket). If
you cause any damage to a cable connector(s) or receptacle(s), let the
damage(s) be repaired by an authorized service technician.
12. Please do not pull on any cable. Always hold on to the plug when
disconnecting cables.
13. This equipment may be used for the international application related to
Refractometry and Keratometry according to this manual.
14. Before every operation, proceed with visual inspection on the equipment
exterior to seek any mechanical damage(s) to ensure the proper
functioning.
15. Do not obstruct any ventilation outlet for proper heat dissipation.
16. In case of any presence of smoke, spark or abnormal noise/smell from
the machine, please power off immediately and pull out the plug.
17. External equipment intended for connection to signal input, signal output
or other connectors, shall comply with relevant IEC Standard (e.g.,

--------------------------------------------------------------- Auto Ref/Keratometer HRK-8000A 19
IEC60950 for IT equipment and IEC60601-1 series for medical electrical
equipment). In addition, all such combination-system-shall comply with
the standard IEC60601-1 and/or IEC60601-1-1 harmonized national
standard or the combination. If, in doubt, contact qualified technician or
your local representative the operator should not touch the patient and
accessible male parts of the SIP/SOP connectors simultaneously.
18. For 120 Volt applications, use only UL listed detachable power cord with
NEMA configuration 5-15P type (parallel blades) plug cap. For 240 Volt
applications use only UL listed detachable power supply cord with NEMA
configuration 6-15Ptype (tandem blades) plug cap.