Huvitz CDC-1 Manuel utilisateur
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USER MANUAL
Automatic Visual Acuity Tester
CDC-1
2 CDC-1 -----------------------------------------------------------------------------------------------------------------------------------
IMPORTANT NOTICE
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.
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.
V1.0 (9000ENG0113)
SHANGHAI HUVITZ Co., Ltd.
Building 1, No. 150, Renjie Road, Fengxian, Shanghai, 201401, China
EU Representative
LGMed Trades OY
Mikkolantie 19D, 00640 Helsinki,
Finland
Tel: +358 400 588 555
Fax: +358 400 588 555
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.
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CONTENTS
1. INTRODUCTION ......................................................................................................................6
1.1. OUTLINE OF PRODUCT ............................................................................................................................6
1.2. INTENDED USE ..........................................................................................................................................6
1.3. CLASSIFICATION.........................................................................................................................................6
1.4. PATIENT RESTRICTION .............................................................................................................................6
1.5. PATIENT REQUIREMENT...........................................................................................................................6
1.6. APPLIED STANDARD..................................................................................................................................7
2. INFORMATION REGARDING SAFETY.................................................................................8
2.1. INTRODUCTION ..........................................................................................................................................8
2.2. SAFETY SYMBOLS.....................................................................................................................................9
2.3. ENVIRONMENTA RELATED MATTERS.................................................................................................. 11
2.4. SAFETY PRECAUTIONS......................................................................................................................... 13
2.5. FCC WARNNING .................................................................................................................................... 14
3. CHARACTERISTICS.............................................................................................................15
4. USING THE DEVICE .............................................................................................................15
4.1. PREPERATION BEFORE USE ................................................................................................................ 15
4.2. USING THE DEVICE................................................................................................................................ 17
4.3. AFTER USING THE DEVICE .................................................................................................................. 17
5. PRECAUTIONS......................................................................................................................18
5.1. PRECAUTIONS FOR USE....................................................................................................................... 18
5.2. PRECAUTIONS FOR INSTALLATION...................................................................................................... 18
5.3. PRECAUTIONS FOR STROAGE............................................................................................................. 20
6. CONFIGRATION ....................................................................................................................21
6.1. MAIN BODY.............................................................................................................................................. 21
6.2. REMOTE CONTROLLER......................................................................................................................... 23
7. INSTALLIATION.....................................................................................................................28
7.1. PREPARATION ......................................................................................................................................... 28
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7.2. INSTALLING THE MAIN BODY ............................................................................................................... 28
7.3. CONFIGURATION..................................................................................................................................... 29
7.4. CONNECTION WITH DIGITAL REFRACTOR......................................................................................... 29
8. USING MENU MODE AND FUNCTIONS ............................................................................29
8.1. EXECUTING AND OPERATING THE MENU MODE ............................................................................. 29
8.2. FUNCTIONS IN THE MEUN MODE........................................................................................................ 30
8.2.1. Vision Test
.................................................................................................................................... 31
8.2.2. Movie/Photo
................................................................................................................................. 34
8.2.3. Setting
............................................................................................................................................ 35
8.3. OTHER FUNCTIONS................................................................................................................................ 38
8.3.1. Adjusting Contrast Sensitivity
................................................................................................ 38
8.3.2. Edit User Program
..................................................................................................................... 38
8.3.3. Set Remote Controller IR Channel
...................................................................................... 39
9. OPTOMETRIC TEST USING THE ACUITY TESTER.........................................................40
9.1. CYLINDER AXIS TEST............................................................................................................................ 40
9.2. CYLINDER POWER TEST ...................................................................................................................... 40
9.3. BINOCULAR CYLINDER AXIS TEST ..................................................................................................... 41
9.4. BINOCULAR CYLINDER POWER TEST................................................................................................ 41
9.5. RED/GREEN TEST ................................................................................................................................. 42
9.6. CROSS CYLINDER TEST FOR AXIS..................................................................................................... 42
9.7. CROSS CYLINDER TEST FOR POWER ............................................................................................... 43
9.8. BINOCULAR BALANCE TEST ................................................................................................................ 43
9.9. DOMINANT EYE TEST FOR PATIENTS WITH PHORIA....................................................................... 43
9.10. WORTH 4 DOT TEST......................................................................................................................... 44
9.11. POLARIZED CROSS TEST ................................................................................................................ 44
9.12. FIXATION DISPARITY TEST............................................................................................................... 44
9.13. COINCIDENCE TEST .......................................................................................................................... 45
9.14. SCHOBER TEST .................................................................................................................................. 45
9.15. VON GRAEFE TEST........................................................................................................................... 45
9.16. MADDOX ROD TEST & THORINGTON TEST ................................................................................. 46
9.17. ZEIGER TEST...................................................................................................................................... 47
9.18. STEREO TEST .................................................................................................................................... 47
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9.19. MINUTE STEREO TEST..................................................................................................................... 48
10. MAINTENANCE .................................................................................................................49
10.1. REPLACEMENT BATTERY.................................................................................................................. 49
10.2. CLEANING............................................................................................................................................ 49
10.3. DISPOSAL............................................................................................................................................ 49
11. TROUBLE SHOOTING......................................................................................................50
11.1. PRESSED POWER SWITCH BUT THE SCREEN DOESN’T WORK.................................................. 50
11.2. CHART DISPLAYED AS BROKEN IMAGE .......................................................................................... 50
11.3. MAIN BODY DOESN’T RESPONSE TO REMOTE CONTROLLER.................................................... 50
11.4. THE SCREEN IS TOO BRIGHT OR TOO DARK ................................................................................. 50
11.5. VISUAL ACUITY TEST RESULTS IN OVERCORRECTION OR UNDERCORRECTION ................... 51
11.6. RED/GREEN TEST IS OVERCORRECTION OR UNDERCORRECTION ......................................... 51
11.7. RED/GREEN FILTER IS NOT FILTERING COMPLETELY ................................................................. 51
11.8. POLARIZER TEST IS NOT WORKING ................................................................................................ 51
12. ACCESSORIES..................................................................................................................52
13. PRODUCT SPECIFICATION.............................................................................................53
14.SERVICE INFORMATION .................................................................................................55
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1.1. Outline of Product
The Shanghai Huvitz Automatic Visual Acuity Tester (CDC-1) is a computerized chart presenting device that provides
charts for refractive correction test and various functional tests such as cross cylinder, red/green, binocular balance,
fusion and suppression, heterophoria, associated phoria, aniseikonia, stereopsis, and dominant eye test for
heterophoria. Since the Digital Chart implements charts on the LCD panel by adopting the cutting edge digital
technology, it’s not only faster and quieter but also equipped with multifarious convenient functions. The contrast
sensitivity and the background luminance of the chart are adjustable for environmental needs. Also the image gallery
contains a dozen of image clips that the examiner could utilize during the examination. Various masking and random
functions would be helpful for a punctual vision test.
The examiner may execute all the charts and functions by using the remote controller and when it is connected to
Shanghai Huvitz Digital Refractor, the Operation Panel can also control this product.
1.2. Intended Use
Shanghai Huvitz Automatic Visual Acuity Tester displays optotypes or symbols on LCD for eyesight test within visible
distance using electronic power.
1.3. Classification
•Classfication of Product::
- EU –Class I according to Annex VIII (Rule 13) of the Medical Device Regulation MDR
•Resistance against electric shock: Class I
•Protection against harmful ingress of water: Ordinary, IPX0
•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
•Mode of Operation: Continuous
1.4. Patient Restriction
• Patient who cannot keep a comfortable position.
1.5. Patient Requirement
Patient tested with this device should keep concentration for several minutes and follow below items.
-Keep eyes wide open.
1. Introduction
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-During the test, understand and follow instructions.
When patient comply above conditions, would get a correct test result.
1.6. Applied Standard
•IEC/EN 60601-1: MEDICAL ELECTRICAL EQUIPMENT
–Part 1: General requirements for safety
•IEC/EN 60601-1-2: Medical electrical equipment Part1: General requirements for safety
- Collateral Standard: Electromagnetic Compatibility-Requirements and tests
ETSI EN 301 489-17: ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part
17: Specific conditions for Broadband Data Transmission Systems; Harmonised Standard for
ElectroMagnetic Compatibility
•ISO15004-1: Ophthalmic instruments
–Fundamental requirements and test methods
General Requirements applicable to all Ophthalmic instrument
8 CDC-1 -----------------------------------------------------------------------------------------------------------------------------------
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, 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“ indicates the presence of a hazard that could result in severe personal injury, death or substantial
property damage if ignored.
“Caution” indicates the presence for a hazard that could result in minor injury, or property damaged if ignored.
“Note” describes information for the installation, operation, or maintenance of which is important but hazard
related if ignored.
2. Information regarding Safety
!
WARNING
!
CAUTION
NOTE
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2.2. Safety Symbols
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.
It indicates the year of manufacture and the manufacturer.
(Il indique l'année de fabrication et le fabricant.)
Manufacturer
(Fabricant)
CE Mark
(Marque CE)
Temperature Limitation
(Limitation de température)
Keep DRY
(Garder au sec)
WEEE mark
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.
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.
(Mise au rebut de votre ancien appareil
Lorsque ce symbole de poubelle barrée est joint à un produit, cela signifie que
le produit est couvert par la directive européenne 2002/96 / CE.
Tous les produits électriques et électroniques doivent être éliminés séparément
du flux des déchets municipaux via des installations de collecte désignées par
le gouvernement ou les autorités locales.
L'élimination correcte de votre ancien appareil aidera à prévenir les
conséquences négatives potentielles sur l'environnement et la santé humaine.
Pour plus d'informations sur l'élimination de votre ancien appareil, veuillez
contacter votre mairie, le service d'élimination des déchets ou le magasin où
vous avez acheté le produit.)
Atmospheric pressure limitation
(Limitation de pression atmosphérique)
Humidity limitation
(Limite d'humidité)
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Stack direction
(Direction de la pile)
Fragile , handle with care
(Fragile, manipuler avec soin)
Stack layer limitation
(Limiter la couche de pile)
Use no hooks
(N'utilisez aucun crochet)
Alternating Current
(Courant alternative)
Direct Current
(Courant continu)
Consult instructions for use
(Consulter les instructions d'utilisation)
Serial Number Symbol
(Symbole du numéro de série)
Authorised Representative in the European Community
(Représentant autorisé dans la Communauté européenne)
Medical Device
Model Name
Unique Device Identifier
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