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.
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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)>
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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