Huvitz HFC-1 Bedienungsanleitung

FUNDUS CAMERA

HFC-1

SERVICE MANUAL

■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. 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.

■Revision History

Revision Date Approval Description

A 2019.04.01 First issued

B 2020.06.25 Added stereo function

XXVSSM-19-00001, Rev.B

(2020/06/25)

38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 14055, Republic of Korea

Under copyright laws, this manual may not be copied, in whole or in part, without the prior written consent of

HUVITZ Co., Ltd.

CONTENT

1. SAFETY PRECAUTIONS.............................................................................................................................................5

1.1 Overview ............................................................................................................................................................... 5

2. Symbol Information ....................................................................................................................................................6

2.1 Usage Precautions ...............................................................................................................................................9

2.2 Environmental Considerations ........................................................................................................................... 12

2.3 Safety Precautions..............................................................................................................................................14

3. INTRODUCTION.........................................................................................................................................................16

3.1 System Outline................................................................................................................................................16

3.2 Intended Use...................................................................................................................................................16

3.3 Classification ................................................................................................................................................... 16

3.4 Contraindications ............................................................................................................................................16

3.5 Patient requirements....................................................................................................................................... 16

3.6 Operating Principles........................................................................................................................................17

3.7 Applied Standard List......................................................................................................................................17

4. System Overview.......................................................................................................................................................18

4.1 Configuration and Functions ..............................................................................................................................18

4.2 Optical System....................................................................................................................................................20

4.3 Electrical construction diagram ..........................................................................................................................23

5. Check and Testing..................................................................................................................................................... 30

5.1 Fundus checking.................................................................................................................................................30

5.2 Setup data checking ...........................................................................................................................................33

6. Installation Procedure ..............................................................................................................................................36

6.1 System installation..............................................................................................................................................36

6.2 Operation Software.............................................................................................................................................39

6.3 SETUP Mode ......................................................................................................................................................41

6.3 DICOM SETUP Mode.........................................................................................................................................44

7. Maintenance............................................................................................................................................................... 46

7.1 After operation..................................................................................................................................................... 46

7.2 Cleaning ..............................................................................................................................................................48

7.3 Replacement of consumables and fuse.............................................................................................................51

7.4 How to pack the device ......................................................................................................................................52

7.5 Self-diagnosis using Model eye ......................................................................................................................... 54

8. Exploded Diagram.....................................................................................................................................................57

8.1 COVER ASSY.....................................................................................................................................................57

8.2 UNCOVER ASSY ...............................................................................................................................................58

8.3 BASE ASSY........................................................................................................................................................59

8.4 PC BOX ASSY.................................................................................................................................................... 60

8.5 MOVING BASE ASSY ........................................................................................................................................61

8.6 HEAD REST ASSY.............................................................................................................................................62

8.7 LCD ASSY ..........................................................................................................................................................63

9. Troubleshooting ........................................................................................................................................................64

10. Replacement ............................................................................................................................................................67

10.1 SMPS ................................................................................................................................................................67

10.2 PC MOTHER BOARD ...................................................................................................................................... 70

10.3 LCD PANEL ......................................................................................................................................................75

10.4 Headrest............................................................................................................................................................80

11. Calibration ................................................................................................................................................................83

11.1 Device Calibrator ..............................................................................................................................................83

12. Specifications and Accessories............................................................................................................................85

12.1 Standard Accessories.......................................................................................................................................85

12.2 Specifications....................................................................................................................................................86

12.3 Drawings of System..........................................................................................................................................86

13. EMC Information......................................................................................................................................................87

14. Service Information.................................................................................................................................................89

1. SAFETY PRECAUTIONS

1.1 Overview

Safety is everyone’s responsibility. The safe use of this instrument is largely dependent upon the installers, users,

operators, and managers. It is prerequisite to read and understand these specifications before installing, using,

cleaning, fixing or revising. Fully understanding the whole instructions must be the first priority. For this reason, 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 signs of Warnings and Cautions.

“Warning” indicates the presence of a hazard that could result in severe personal injury, death or substantial

property damage if ignored.

“Warning” indique la présence d'un danger pouvant entraîner des blessures graves, la mort ou des dommages

matériels importants s'il est ignoré.

“Caution” indicates the presence of a hazard that could result in minor injury, or property damaged if ignored.

“Caution” indique la présence d'un danger pouvant entraîner des blessures légères ou des dommages matériels

en cas d'ignorance.

This is used to emphasize essential information.

Be sure to read this information to avoid operating the device incorrectly.

WARNING

CAUTION

NOTE

2. Symbol Information

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.

Symbol Indication

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.

(Ce symbole identifie une note de sécurité. Assurez-vous de comprendre la fonction de ce

contrôle avant de l'utiliser. La fonction de contrôle est décrite dans le manuel d'utilisation ou

d'entretien approprié.)

I and O on power switch represent ON and OFF respectively.

(O sur l'interrupteur d'alimentation représentent

respectivement ON et OFF.)

Temperature Limitation

(Limitation de température)

Atmospheric pressure limitation

(Limitation de pression atmosphérique)

Humidity limitation

(Limite d'humidité)

Stack direction

(Direction de la pile)

Keep DRY

(Garder au sec)

Fragile , handle with care

(Fragile, manipuler avec soin)

Keep away from sunlight

(Tenir àl'écart de la lumière du soleil)

Stack layer limit

(Limiter la couche de pile)

CE Mark

(Marque CE)

Use no hook

(N'utilisez aucun crochet)

WEEE Symbol – EU only

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.

(Symbole W EEE- EU seulement

Mise au rebut de votre ancien appareil

Lorsque ce symbole de poubelle barrée est joint àun 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 oules

autorités locales. L'élimination correcte de votre ancient

appareil aidera àprévenir les conséquences negatives

potentielles sur l'environnement et la santéhumaine.

Pour plus d'informations sur l'élimination de votre ancient

appareil, veuillez contacter votre mairie, le service

d'élimination des déchets ou le magasin oùvous avez acheté

le produit.)

Authorized representative in the European Community –EU

ONLY

(Représentant autorisédans la Communautéeuropéenne-

EU seulement)

Manufacturer

(Fabricant)

Date of manufacture

(Il indique l'année de fabrication et le fabricant.)

Refer to instruction manual/booklet

(Se reporter au manuel d’instructions / brochure)

Type B Isolated patient connection

(Type B Connexion patient isolée.)

Warning: Crushing or insert of hand

(Attention: écrasement ou insertion de la main)

QR code

(QR code)

Alternating Current

(Courant alternative)

Consult instructions for use

(Consulter les instructions d'utilisation)

The United States and Canada have mutual-recognition agreements.

Therefore, if certified using a Canadian specification (CSA) for UL, the

certification mark for the product will be a C-UL certification mark which

means CSA specification compliance as follows.

(Les États-Unis et le Canada ont conclu des accords de libre-échange. Par

conséquent, si l'on obtient une certification au moyen d'une spécification

canadienne (CSA) pour l'AMT, la marque de certification pour le produit sera

une marque de certification C-UL, ce qui signifie la conformitéde la

spécification CSA comme suit.)

CE for RoHS

RoHS Directive Compliance 2011/65/EU

(CE pour les RoHS Respect de la directive en matière de conformité

2011 / 65 / CE)

2.1 Usage Precautions

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.

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.

Pour l'utilisation d'équipements à une tension nominale inférieure à 125 Vca, minimum 6 A, type SJT ou SVT, 18

/ 3AWG, 10 A, max 3,0 m de long: une extrémité avec type hospitalier, NEMA 5-15P Autre extrémité avec

coupleur d'appareil.

Pour l'utilisation d'équipement à une tension nominale inférieure à 250 Vca, minimum 6 A, type SJT ou SVT, 18 /

3AWG, 10 A, max 3,0 m de long: une extrémité se termine par un bouchon de fixation de lame (HAR) de type

NEMA 6-15P.

Use instrument that comply with IEC60601

1 in the patient environment. [The figure below show]

Utilisez un instrument conforme à la norme IEC60601-1 dans l'environnement du patient. [La figure ci-dessous

montre]

If and instrument that does not comply with IEC 60601-1 is to be used, use an isolation transformer.

If a person handling a conductive part of the system comes into contact with a patient at the same time, hazard

may occur due to leakage current exceeding the value specified in the applicable standard. Be careful not to

touch patients when connecting or removing the power plug or cable connectors.

Si un instrument non conforme à la CEI 60601-1 doit être utilisé, utilisez un transformateur d'isolement.

Si une personne manipulant une partie conductrice du système entre en contact avec un patient en même

temps, un danger peut se produire en raison d'un courant de fuite dépassant la valeur spécifiée dans la norme

applicable. Veillez à ne pas toucher les patients lors de la connexion ou du retrait de la fiche d'alimentation ou

des connecteurs de câble.

WARNING

This instrument includes lithium battery. This hazardous material needs to be disposed of properly to limit

environmental pollution. Please contact to the professional waste disposal company.

Cet instrument comprend une pile au lithium. Cette matière dangereuse doit être éliminée correctement pour limiter

la pollution de l'environnement. Veuillez contacter la société professionnelle d'élimination des déchets.

Do not install any software on equipment without our consent.

The manufacturer is not responsible for any failure due to random installation.

N'installez aucun logiciel sur l'équipement sans notre accord.

Le fabricant n'est pas responsable de toute défaillance due à une installation aléatoire.

This equipment is a meets ISO 15004-2 Group1 specifications.

Cet équipement est conforme aux spécifications ISO 15004-2 Group1.

lThe longer the duration of exposure and the greater the number of pulses, the greater the risk of ocular

damage. Exposure to light from this instrument when operated at maximum output will exceed the safety

guideline after 9.9 x 107sec for Retina IR, 5.3 x 107sec for Working dot(Manual Focusing), 4.1 x 107sec for

Kerato ring(Auto / Manual Tracking), 9.5 x 107sec for Kerato focus(Auto/Manual Tracking), 1.0 x 108sec for

Split focus(Optimizing), 9.1 x 105sec for external fixation lamp, 1,936,114 pulses for the light source of

fundus image capture.

Note 1: The exposure time and number of pulses from all light sources is cumulative and additive.

Note 2: If the intensity of any of the light sources is reduced to 50% of the maximum intensity, the

exposure time or number of pulses for that light source to reach the exposure guideline is doubled. This

linear relationship can be used to determine the time to reach the exposure guideline for the

combination of light sources at various intensity settings.

Note 3: The weighted retinal radiant exposure guideline is 10 J/cm2

lPlus la durée d'exposition est longue et plus le nombre d'impulsions est élevé, plus le risque de lésions

oculaires est grand. L'exposition à la lumière de cet instrument lorsqu'il est utilisé à la sortie maximale

dépassera les directives de sécurité après 9,9 x 107 s pour la rétine IR, 5,3 x 107 s pour le point de travail

(mise au point manuelle), 4,1 x 107 s pour l'anneau Kerato (suivi automatique / manuel) , 9,5 x 107 s pour la

mise au point Kerato (suivi automatique / manuel), 1,0 x 108 s pour la mise au point divisée (optimisation),

9,1 x 105 s pour la lampe de fixation externe, 1 936 114 impulsions pour la source lumineuse de capture

d'image du fond d'œil.

CAUTION

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