Huvitz CR-9000 User manual

Operation Manual
CR-9000/CRK-9000/CRK-9000P Auto Ref/Keratometer

Auto Ref/Keratometer CRK-9000P 1
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 60601-1-2:2007. 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 to be
entirely accurate at the time of publication. SHANGHAI HUVITZ assumes no
responsibility, however, for possible errors or omissions, or for any consequences
resulting from the use of the information contained herein.
!
WARNING

2Auto Ref/Keratometer CRK-9000P
SHANGHAI 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 2.0(20150420)
SHANGHAI HUVITZ Co., Ltd.
Building 2, No. 58, Lane 450, Xiaonan Road, Fengxian, Shanghai, 201401, China
All rights are reserved. Under copyright laws, this manual may not be copied, in
whole or in part, without the prior written consent of SHANGHAI HUVITZ Co., Ltd.

Auto Ref/Keratometer CRK-9000P 3
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

4Auto Ref/Keratometer CRK-9000P
Contents
1. Introduction .............................................................................................................7
1.1. Overview........................................................................................................7
1.2. Classificaiton..................................................................................................8
2. Safety Information ..................................................................................................9
2.1. Overview........................................................................................................9
2.2. Safety Symbol .............................................................................................10
2.3. Environmental Considerations .....................................................................12
2.4. Safety Precaution ........................................................................................14
3. Characteristics.......................................................................................................17
4. Note for Use..........................................................................................................18
5. Names and functions of each part....................................................................19
5.1. Main parts...................................................................................................19
5.2. Explanation on Switches in Front...............................................................22
6. Installation of Equipment & Preparation of Measurement..............................23
7. Exercise through Model Eye...............................................................................25
8. Measurement .........................................................................................................29
8.1. Refractometry (REF Mode)..........................................................................30
8.1.1. Manual Measurement Mode.......................................................................31
8.1.2. Auto Measurement Mode...........................................................................36

Auto Ref/Keratometer CRK-9000P 5
8.2. Keratometry (KER Mode) ............................................................................39
8.2.1. Manual Measurement Mode.......................................................................39
8.2.2. Auto Measurement Mode...........................................................................42
8.3. Corneal Curvature / Refractive Power Measurement Mode (K&R Mode) 43
8.3.1. Manual Measurement Mode.......................................................................43
8.3.2. Auto Measurement Mode...........................................................................46
8.3.3. Diverse Indications......................................................................................47
8.4. Keratometry Peripheral Measurement (KER-P Mode).................................48
8.5. Measurement of Contact Lens Base Curve(CLBC Mode)...........................52
9. Other Modes..........................................................................................................54
9.1. ILLUMINATION Measurement Mode (ILLUM Mode) ..................................54
9.1.1. Adjustment of Array and Focus .................................................................55
9.1.2. Observation on Illumination .......................................................................57
9.1.3. Storage ........................................................................................................58
9.1.4. Examination on the other eye ...................................................................58
9.1.5. Call for Stored Image .................................................................................58
9.1.6. Return to measurement mode ...................................................................59
9.2. ZERNIKE Mode............................................................................................60
9.2.1. Composition of Window.............................................................................60
9.2.2. Change of Window.....................................................................................64
9.3. Measurement of Corneal Radius(SIZE Mode).............................................66
9.4. VIRTUAL COMPARISON Mode ....................................................................70
9.5. COLOR VIEW MODE ...................................................................................72
9.5.1. White LED ...................................................................................................74

6Auto Ref/Keratometer CRK-9000P
9.5.2. Blue LED......................................................................................................75
9.5.3. Yellow Filter.................................................................................................76
9.5.4. Capture Screen............................................................................................77
9.5.5. Selected Capture Screen.............................................................................77
9.5.6. Return to measure mode............................................................................81
9.6. DISPLAY Mode ............................................................................................82
9.7. User SETUP Mode.......................................................................................84
9.8. Power saving Function................................................................................94
10. Self diagnosis & Maintenance............................................................................95
10.1. Before calling for serviceman.....................................................................95
10.2. Replacement ................................................................................................97
10.2.1. Printer paper ...............................................................................................97
10.2.2. Chin rest paper...........................................................................................98
10.2.3. Replacing Fuse ............................................................................................98
10.3. Cleaning Equipment ..................................................................................100
10.4. As changing the installation place of the equipment.............................100
10.5. Disposal .....................................................................................................100
11. Service Information ............................................................................................101
12. Main Specifications.............................................................................................102
13. Accessories .........................................................................................................104
14. EMC Information.................................................................................................105
15. Service Information ............................................................................................109

Auto Ref/Keratometer CRK-9000P 7
1. Introduction
1.1. Overview
Auto Ref/Keratometer CRK-9000P is the equipment to provide the information of
Spherical, Cylindrical and Axis while measuring the refraction of examinee‟s eyes. Auto
Ref/Keratometer CRK-9000P 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 auto Ref/Keratometer is provided with an Auto-tracking function and a motorized
chinrest function.
Auto-tracking mechanism 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.

8Auto Ref/Keratometer CRK-9000P
1.2. Classificaiton
1) Classification of product :
-. EU - Class Im (with a measuring function) according to Annex IX (Rule 12) 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 CRK-9000P 9
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

10 Auto Ref/Keratometer CRK-9000P
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
Manufacturer
Authorised Representative in the European
Community

Auto Ref/Keratometer CRK-9000P 11
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
IEC 60601-1
EN 60601-1
Medical Equipment with respect to electric shock
Fire and Mechanical Hazards only in accordance
with IEC60601-1 and EN60601-1
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.
Alternating Current

12 Auto Ref/Keratometer CRK-9000P
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 ~ 35C, and the humidity is at the range of
30%~90%.
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.

Auto Ref/Keratometer CRK-9000P 13
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℃
~ 35℃, humidity is 30% ~ 90% 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 10% ~
95% and atmospheric pressure is 700 ~ 1060hpa. Avoid environments where the
equipment is exposed to excessive shocks or vibrations.

14 Auto Ref/Keratometer CRK-9000P
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%~90%.
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 SHANGHAI
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 SHANGHAI 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.

Auto Ref/Keratometer CRK-9000P 15
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
SHANGHAI 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 SHANGHAI 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., IEC60950 for IT
equipment and IEC60601-1 series for medical electrical equipment). In addition,

16 Auto Ref/Keratometer CRK-9000P
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.

Auto Ref/Keratometer CRK-9000P 17
3. Characteristics
1. It is possible to measure the refractive power and corneal curvature with one(1)
set of the machine: Refractometry and Keratometry
2. As the measurement range of refractive power is wide from-30D to +25D, it
can measure the severe myopia.
3. As measuring the curvature, the minimum measurable pupil diameter is Ø2.0
mm.
4. The equipment can measure the peripheral part of cornea so that user can see
the value of curvature and eccentricity of each point while consecutively
measuring the curvature of peripheral part around cornea to the direction of
90degree to the upper/below/right/left from the core of cornea.
5. The refractive error can be showed in the form of Zernike topographic map.
6. The fogging technique which is applied to the internal fixed target is to make
the more accurate measurement possible while letting the eyes of patient at
the natural and comfortable state.
7. It is possible to select the display type of Refractometry and Keratometry.
8. It is possible to measure the distance in between pupils (PD).
9. Through the illumination, the Auto Ref/Keratometer can observe the eyes‟
condition of cataract patients or the scratches on the surface of contact lenses.
It can store the two (2) images for each eye, and show the patients displaying
them on the monitor screen.

18 Auto Ref/Keratometer CRK-9000P
4. Note for Use
1. Do not hit or drop the instrument. The instrument may be damaged by the
strong impact. The impact may damage the function of this instrument. Handle
it with care.
2. The precision of measurement can be affected when the machine is exposed to
the direct sunlight or too bright indoor illumination. It is recommended to
perform the measurement in the dark optometry room.
3. If you want to use it as connecting the device to other equipment, please follow
the guidance of our local representative.
4. Sudden heating of the room in cold areas will cause condensation of vapor on
the protective glass in the measurement window and on optical parts inside the
instrument. In this case, wait until condensation disappears before performing
measurements.
5. Make sure to keep the lens in examinee side is clean at all times. In case that it
has become dirty by dusts or other substances, it can cause errors in the
machine or affect the precision of measurement.
6. In case of any presence of smoke, smell or noise during the use of machine,
please contact our local representative after plugging it off from the socket
(outlet).
7. If you clean the surface of the equipment with organic solvents such as alcohol,
thinner, benzene, etc, it can damage the machine. So, please do not use them.
8. In case of moving AUTO REK/KERATOMETER, carry it holding the lower part of
machine body with both hands as fixing the stage after switching the machine
off all the time.
9. In case of no use of the machine for a long time, please put the dust cover on
the device after powering and plugging off.

Auto Ref/Keratometer CRK-9000P 19
5. Names and functions of each part
5.1. Main parts
[ Figure 5-1. Front ]
1. Height Adjustment Mark: Adjusts the eyes‟ height of examinees
2. Display Monitor: Monitor for measurement
3. Print Button: Button for printing of measuring results.
4. Measurement Button: Performing the measurement by pressing it after focusing.
5. Joystick: Adjusting the focus by moving to the directions of forward/backward,
left/right, up and down.
6. Printer: Printing the measured results
7. Stage Fixing Lever: Fixing the stage
8. Chinrest up/down Button: Move up or down the chinrest.