Huvitz HFC-1 User manual

FUNDUS CAMERA
HFC-1
SERVICE MANUAL

2
■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)
©2019 HUVITZ Co., Ltd.
38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 14055, Republic of Korea
All rights reserved.
Under copyright laws, this manual may not be copied, in whole or in part, without the prior written consent of
HUVITZ Co., Ltd.

3
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

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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

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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

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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

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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)

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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)

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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
WARNING

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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
!
CAUTION
!
CAUTION

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Remarque 1: Le temps d'exposition et le nombre d'impulsions de toutes les sources lumineuses sont
cumulatifs et additifs.
Remarque 2: Si l'intensité de l'une des sources de lumière est réduite à 50% de l'intensité maximale, le
temps d'exposition ou le nombre d'impulsions pour que cette source de lumière atteigne la ligne
directrice d'exposition est doublé. Cette relation linéaire peut être utilisée pour déterminer le temps
nécessaire pour atteindre la ligne directrice d'exposition pour la combinaison de sources lumineuses à
divers réglages d'intensité.
Remarque 3: La ligne directrice pondérée d'exposition au rayonnement rétinien est de 10 J/cm2
<Spectrum output of all light source during measurement (maximum light intensity)>
<Sortie spectrale de toutes les sources lumineuses pendant la mesure (intensité lumineuse maximale)>
<Relationship between fundus flash level and maximum light intensity>
<Relation entre le niveau de flash du fond d'œil et l'intensité lumineuse maximale>

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2.2 Environmental Considerations
Avoid the following environments for operation or storage:
Where the instrument is exposed to water vapor.
Don’t operate the instrument with wet hands Indoor use only.
Where the instrument is exposed to direct sunlight.
A place where the equipment can be exposed to direct ultraviolet.
Where there are big changes in temperature.
Optimal temperature range for normal operation is from 10°C to 35°C (Humidity : 30 ~
90%).
Where there is hot equipment nearby.
Where the humidity is extremely high or there is a ventilation problem.
Where the instrument is exposed to excessive shocks or vibrations.
Where the instrument is exposed to chemical material or explosive gas.
Be cautious so that things like dust and metal do not fall inside the instrument.
Don’t disassemble or open the product. HUVITZ does not take responsibility for the
possible problems
Be careful not to block the fan of the instrument.

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Don’t plug the AC power cable into the outlet unless all parts of the instrument are
completely connected. Otherwise, it will cause severe damage on the instrument.
Pull out the power cable with holding the plug, not the cord.
To avoid risk of electric shock, this equipment must only be connected to a supply mains
with protective earth.
For the normal operation of the instrument, please keep the ambient temperature is 10℃~ 35℃, humidity is 30% ~
90% (with non-condensing) and atmospheric pressure is 800 ~ 1060hpa. For the Transportation of the instrument,
please keep the ambient temperature is -40℃~ 70℃, humidity is 10% ~ 95% and atmospheric pressure is 500 ~
1060hpa. For the Storage of the instrument, please keep the ambient temperature is -10℃~ 55℃, humidity is 10% ~
95% (with non-condensing) and atmospheric pressure is 700 ~ 1060hpa. Avoid environments where the
equipment is exposed to excessive shocks or vibrations.

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2.3 Safety Precautions
1. This is an electric medical device. Use is limited to doctors or persons qualified by the law of each country.
2. Do not make a diagnosis base on a single captured image. Doctors are responsible for making the final diagnosis
based on the present and past medical records of the patient such as captured images. Without sufficient
information, proper diagnosis may not be made.
3. This equipment must not be used in an area that is in danger of explosions and in the presence of flammable,
explosive, or volatile solvent such as alcohol, benzene or similar chemicals.
4. Do not place or store this instrument in humid area. Do not expose the device to water splashes, dripping water,
or sprayed water. Do not place containers with fluids, liquids, or gases on top of this instrument.
5. The device must be operated by a trained and qualified person or under his or her supervision.
6. Repair of this instrument must be conducted by HUVITZ’s service technicians or other authorized persons.
7. Maintenance by users must observe the User’s Manual and Service Manual. Any additional maintenance may
only be performed by HUVITZ’s service technicians or other authorized persons.
8. Manufacturers are not responsible for the damages caused by unauthorized alterations. Such tampering will
forfeit any rights to receive services during the term of guarantee.
9. This instrument must be connected with the accessories supplied by HUVITZ. If you are to use other accessories,
their safety or usability must be checked and proved by their manufacturers or HUVITZ.
10. Only those who have undergone proper training and instructions are authorized to install, use, operate, and
maintain this instrument.
11. Do not apply excessive force to cable connections. If the cable does not connect easily, make sure that the
connector (plug) is appropriate for the receptacle (socket). If you caused 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 grab the plug when disconnecting cables.
13. Do not block any ventilation outlet necessary for proper heat dissipation.
14. If smoke, sparks or any abnormal noise or smell is noticed coming from the instrument, please switch the power
off immediately and pull out the plug.
15. To avoid the risk of electric shock, this instrument must only be connected to protective earth.
16. Do not place the instrument where it is difficult to operate the disconnecting device. (disconnecting device: power
cable)

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17. External equipment intended for connection to signal input, signal output or other connectors of this instrument,
shall comply with relevant IEC Standard (e.g., 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
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. When you carry this product, please hold on left(A) and right(B) bottom of the product.
19. Do not touch directley if an operator has a hand injury or a significant allergic reaction to the material used in the
operaton contact part.
Part Name Material
LCD Touch pannel Glass
Joystick / button
ABS + Silicon,
Aluminum(A6061 T6) + Anodizing
Power switch PC + PA66
Cover ABS
Chin Rest ABS
20. Do not measure to patients who are sensitive to light. (ex> photophobia)
21. When instrument is send back to A/S center for repair or maintenance, or before authorized service man is
arrived at the place for repair or maintenance, wipe the surfaces of the instrument (especially, the parts that come
into contact with the patient) with a clean cloth dampened with rubbing alcohol.
22. In the event of a serious incident involving the device, the user shall report it to the manufacturer and the
competent authority of the Member State in which the user and/or patient are established.
23. If a user uses power save supported by Windows 10 except for the power save in User setting, it causes some
trouble in HFC-1. The manufacturer isn't responsible for the problem.
24. User must not change the setting supported by the manufacturer, This change might make some trouble in HFC-1.
The manufacturer isn't responsible for the problem.

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3. INTRODUCTION
3.1 System Outline
The Huvitz Fundus camera HFC-1 is a non-contact, high-resolution bio-microscopic imaging device. It is indicated for in-vivo viewing,
color fundus imaging.
3.2 Intended Use
A device that illuminates the fundus by entering light into the pupil and photographs the fundus state according to the reflected light.
3.3 Classification
•Classification of product : Class II according to Annex IX (Rule 10) of the Medical Device Directive 93/42/EEC as amended by
2007/47/EC
•Resistance against electric shock : Class I (earthed)
•Protection class against electric : Type B(Head rest, chinrest paper)
•Classification Light hazard : Group I (EN/ISO15004-2 Standard)
3.4 Contraindications
This device should not be used for:
- Patients who are hypersensitive to light.
- Patients who recently underwent photodynamic therapy
- Patients taking medication that causes photosensitivity
3.5 Patient requirements
The patient who undergoes and examination by this instrument must maintain concentration for a few minutes and adhere to the
following instructions;
- After his/her face to the chinrest, forehead rest.
- Keep the eye open
- Understand and follow instructions when undergoing an examination.
If the patient does not conform to these conditions, it is not possible to take a picture correctly

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3.6 Operating Principles
The anterior of an eye is illuminated by IR light, the retina of an eye is illuminated by a white LED, of which lightings are emitted by the
fundus illumination optical system. The fundus observation/photography optical system forms and makes an image with image sensors,
which images are observed and manipulated with the display panel.
3.7 Applied Standard List
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
ISO15004-1: Ophthalmic instruments
- Fundamental requirements and test methods
General Requirements applicable to all Ophthalmic instrument
ISO15004-2: Ophthalmic instruments -Fundamental requirements and test methods
- Part 2: Light hazard protection
ISO 10940: 2009 Ophthalmic instruments - Fundus Cameras

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4. System Overview
4.1 Configuration and Functions
■Front View
No Part Name Description
1 Display LCD Monitor for displaying captured image and user interface icon.
2
Body
Chinrest button Button for moving chinrest up and down.
3 Joystick
Joystick for aligning body to patient’s eye.
Button for capturing image.
4 User Lock Lock for fixing body to base frame.
5 OPT button Button for optimizing signal
6-1
6-2
Align index mark Mark for indicating center of body and base.
7
Base
Power button
Button for turning power of internal PC on/off.
When the power is on, white light is lit.
9-1 Power switch Switch for power on/off.
9-2 Power inlet Inlet for connecting power cable.
10 Headrest Eye level mark Mark for indicating base height of patient’s eye.
11 Body Heat vent Window for emitting internal heat.
①
④
③⑤
⑥-1
⑨
②
⑥-2
⑦
⑨-1 ⑨-2
⑩
⑪

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■Rear View
No Part Name Description
1
Headrest
Headrest Rubber for fix patient’s head.
2 External LED External LED for fixing patient’s eyes.
3 Chinrest For fixing patient’s chin.
4-1
Body
Objective lens
Lens for passing illumination light from body and reflected light
from patient’s eye.
4-2 Mirering Focus LED LEDs for checking working distance.
5 Headrest Objective lens cap Cap for protecting objective lens.
8
Base
External port Port for communicating internal or external device.
8-1 RS-232 port Port for communicating internal PC board and main board.
8-2 RGB port Port for external display device.
8-3 DP port Port for communicating external DP device.
8-4 LAN port Port for external network (2 ports)
8-5 USB port Port for internal or external USB device (4 ports)

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■Bottom View
No Part Name Description
1 Base Packing lock Lock for fixing body and base during transportation. (2 points)
4.2 Optical System
①
②
③
○
24
○
19
⑩
⑨
⑥
⑤
⑧
⑦
⑮
⑬
○
17
⑪
④
○
18
○
16
⑭
○
25
○
23
○
22
○
21
○
20
⑫
①