DEXIS DEXcam4 HD User manual

Intra-oral Camera
User Manual
English

1
DEXcam4 HD Intra-oral
Camera Features
The DEXIS DEXcam4 HD intra-oral camera provides live high definition
video display, as well as freeze and capture capabilities, for dental
imaging. The camera is not meant to be used for diagnostic purposes.
There are no contraindications for use of the camera.
•Proprietary, seven-element glass optical lens produce exceptional
image quality
•Uses an HD Sony CMOS sensor with resolution of 1.3 Mega-pixels
•Two button capture control capability directly on the handpiece
•One-touch focus adjustment
•Detachable cable for easy sharing
•Robust aluminum construction.
Intended Use
This intra-oral camera system and accessories are indicated for use
to provide the dentist and the patient with a view of the mouth
before and after the dental procedure, which assists the dentist in
describing the dental procedure being performed as well as
showing the results.
•This camera is designed to be operated by healthcare
professionals who are educated and competent in the
techniques described in this manual.
•Visual impairment is permissible so long as the user can
resolve the necessary details of the accompanying
documentation, user interface and image data. Use of
corrective measures such as glasses or contact lenses is
permissible.
•Audio impairment is permissible as there are no sounds
emitted from the device.
•General physical impairments involving the arms, legs and/or
motor skills are permissible so long as the user can perform
all of the tasks required for proper operation of the device as
described in this Manual.
Conventions Used in the Manual
The following conventions are used to bring the operator’s attention
to important information:
Alerts the operator that failure to follow the
procedure could cause serious bodily injury or
death.
Alerts the operator that failure to follow in-
structions may result in minor or moderate
bodily injury or damage to the device.
Please Note: Highlights important or unusual points.
WARNING
CAUTION
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DEXcam4 HD
Camera Holster
User Manual
Sheaths (100 count)
Intra-oral Camera
User Manual
Manuel de l’utilisateur
Intra-oral Camera
2
Proficiency with your New Device
Please become acquainted with your new DEXcam4 HD intra-oral
camera, it is your tool. As with all new clinical tools, it is necessary
to invest a certain amount of time for practice in order to become
proficient. Learn to use it well and it will become an effective aid.
Please note that this manual assumes that new users possess
basic computer skills and an understanding of the Windows®
operating system. Absent this experience, we highly recommend
that you obtain these skills through a computer course, video, or
textbook. Your DEXIS representative may be able to suggest
(although not endorse) one or more of these computer learning
resources.
DEXcam4 HD Intra-oral Camera
Specifications
Package Contents
Name DEXcam4 HD
Power DC 5V, 500mA
Image Sensor 1/4" SXGA EDR 1.3 Mega-pixels
Resolution 1280 (H) x 720 (V)
AGC/ White balance Auto
Lamp High luminance white chip LED:
4EA
Cable Length: 8.9 ft. (2.7 m)
Connector: USB
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3
Names and Functions of the Camera Parts
This device is an intra-oral camera system that provides the dentist
and the patient with intra-oral and extra-oral images. This assists
the dentist in describing the dental procedure being performed, as
well as allowing the dentist to show the results to the patient.
Viewing Head
Seven-element glass optical lenses
One-touch Focus
Adjustment
5 position zoom stepper switch offers a
focus mechanism to view intra-oral and
extra-oral images without a lens
change. The face icon captures smile,
arch, and portrait images. The tooth
icon captures up to three teeth. The
magnifying glass captures a single
tooth, detailed image,
Dual Capture
Buttons
Freeze live images with a click of the two
capture buttons.
- Single-touch: Freeze image
Light Source
Four bright white LEDs
Quick-disconnect
Cable
Easy sharing using multiple operatories.
2
1 4
5
3
Both
Sides
1
2
3
4
5
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4
DEXcam4 HD Installation
Minimum system requirements:
•Microsoft Windows 7 or higher
•DirectX 9.0b or higher
•Pentium 4 at 2 GHz or higher
•1 GB RAM
•Monitor with minimum 1024 x 768 resolution capability
•Graphics / display card capable of minimum 1024 x 768 resolution
at 24-bit color and 32 MB video RAM
•CD-ROM drive
•USB 2.0 port
The installation procedure has two parts:
First - install DEXcapture software (refer to the DEXcapture Software
manual for the software installation).
Second - install the intra-oral camera.
Important! Be sure to follow the instructions to install the software
before connecting the camera. Otherwise the camera will not function
properly.
Install the Intra-oral Camera
WARNING
No modification of this device is allowed.
WARNING
Loading incompatible software or viruses may result in loss of
patient data.
WARNING
Do not connect multiple cameras to the same acquisition
computer as this may lead to unexpected behavior by the
software.
1. After installing DEXcapture, connect the USB cable of the
camera to an available USB port on your computer.
NOTE: Remove the protective film covering the glass of the viewing
head before using the camera.
2. Launch DEXcapture module from DEXIS software by clicking
on the DEXcam icon.
3. Click the Display Settings slider button to display Appli-
cation and Device settings.
4. Click the DEXcam4 HD device icon to connect the camera.
5. Refer to the DEXcapture Software Manual for all other
software related settings.
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5
6. Install the camera holster in a place that is convenient and
does not exceed the maximum length of the USB cable,
which is 8.9 ft. (2.7 m). The camera holster should also be
positioned so that the cable from the camera does not create
a tripping hazard. To install the holster, clean the mounting
surface, remove the backing from the double sided-tape on
the holster, then firmly press the holster against the
mounting surface. After approximately two hours, the
holster can be used to store the camera.
Intra-oral Camera Sheath
Refer to the intra-oral camera sheath instructions on the sheath box
for installation and replacement procedures.
To order more sheaths, please contact your local sales
representative.
WARNING
To help prevent cross-contamination between patients, place a
new hygienic sheath on the camera for each new patient.
CAUTION
The sheath must be removed after each patient. The intra-oral
camera must be cleaned and disinfected after each patient. After
cleaning the camera and handpiece, install a new camera
sheath.
Intra-oral camera sheaths are applied parts. After each
replacement, check the camera sheath for any tears or rips. Replace
any damaged sheaths before use.
Avoid contact between the camera sheath and any sharp objects,
such as the patient’s teeth, orthodontia, etc. If there is any form of
contact made, inspect the sheath for any tears or rips and replace it
if necessary.
The camera sheath is disposable and should be replaced before
each use of the camera. Dispose of sheaths following the normal
dental office procedure for biomedical waste.
The camera sheath is designed only for intra-oral use. If you use it
for taking extra-oral images, the images will not be clear as
compared to intra-oral use because the transparent film reflects
light and changes the focus.
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1
3
4
6
DEXcam4 HD Operation
To use the camera, remove it from the holster. It turns on and begins to
send video images.
1. Preset the camera to view either an intra-oral or extra-oral image.
CAUTION
Be sure to use a new sheath when capturing intra-oral images.
2. Position the camera.
3. Adjust the camera focus.
•Press+to zoom in, which moves the LED indicator to the right.
•Press-to zoom out, which moves the LED indicator to the left.
4. Press and release the two Capture buttons to freeze the image on
your viewing screen.
CAUTION
Ensure that the camera is properly placed into the holster with
the cord end facing down. The camera will fail to turn OFF if
placed in the holster with the cord end facing up.
5. Place the camera in the camera holster to turn the camera off.
Handling
After extensive use, the camera focusing motor may need to be
reset (only as needed).
1. Press the -button to move the LED indicator to the leftmost
position.
2. Then press the +and -buttons simultaneously until five LED
indicator lamps are lit then turned off.
3. Using the +and -buttons, focus on an object more than 10
feet away.
•Press +to zoom in.
•Press -to zoom out.
4. Once the image is focused and clear, press the +and -
buttons simultaneously until the five LED lamps blink again.
5. The Camera focus is now reset.
CAUTION
Failure to follow instructions may result in damage to the
product.
• Do not drop or strike the camera since the internal precision
optics could be damaged.
• When the camera is not in use, place the camera in the camera
holster, which will turn it off.
• The intra-oral camera system should only be used for dental
purposes.
5
4
2
3
1
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7
• The camera is not waterproof. Do not immerse in water and
avoid situations where water or other foreign matter could get
on or inside the product. Failure to do so may damage the
product.
• If the camera is wet, or if your hands are wet, do not use the
product.
• Avoid subjecting the camera to vibrations or shocks. When the
product is not in use, make sure it is placed in the camera
holster.
• Examine the camera housing for visible damage. Be careful not
to use the camera if it is damaged. Doing so may cause injury.
• Avoid using the camera in a dusty environment.
• Remove the protective film covering the glass of viewing head.
Important Safety Precautions
CAUTION
Failure to follow instructions may result in damage to the
product.
• If the camera gets wet, disconnect it, wipe it down, then allow it
to air dry. Do not attempt to dry with a heater or microwave.
• During severe thunderstorms, stop using the camera. Failure to
do so may cause damage to the product.
• Do not disassemble, drop, or otherwise subject the camera to
hard shocks. It may cause electric shock, short circuit, or fire.
The warranty is null and void in such cases.
Attention: US federal law restricts the sale of this device to licensed
dental practitioners only.
Cleaning and Disinfecting
Important:
Before applying cleaning or disinfecting solution:
•disconnect the camera from power, and
•disconnect the USB cable from the USB port.
Do not soak the camera.
Always dry completely after cleaning or disinfecting.
To clean: Use a lint-free cloth to apply a solution of mild soap and
water.
To disinfect: Use a lint-free cloth to apply disinfectant and rub for at
least on minute, using one of the following disinfectants:
•Isopropyl alcohol (70%)
•CaviCide
•CaviCide1
•CaviWipes
•CaviWipes1
NOTE: After applying the disinfectant to the cotton cloth, excess
solution must be squeezed out before wiping the camera.
When using the wipes, excess solution must also be squeezed
out before wiping the camera.
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Label Location
The following label is located on the USB cable of the camera.
Product Symbols
Indicates the product should be used only once. The symbol is
found on the packaging for the sheaths.
This symbol on the product and/or accompanying documents
means that used electrical and electronic products should not be
mixed with general household waste.
Please refer to the written instructions of this manual.
Direct Current (DC)
The ETL listed mark indicates that Intertek has certified the product
described herein under control number 4005847 to be in
compliance with the applicable regulations. Intertek is:
• a Nationally Recognized Testing Laboratory by the Occupational
Safety and Health Administration (OSHA) in the United States.
• a Certifying Body in Canada by the Standards Council of Canada.
The CE symbol represents that the product herein specified meets
the provisions of European Council Directive 93/42 EEC concerning
medical devices and Directive 2011/65/EU of the European
Parliament and of the Council on the restriction of the use of certain
hazardous substances in electrical and electronic equipment
(RoHS).
Date of Manufacture
Manufactured for
Authorized Representative in Europe
4005847
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Service and Proper Disposal
The service life of the camera is five years. There are no serviceable
parts or maintenance on the device. Consult the device warranty for
additional information.
Properly dispose of the camera at the end of its useful life. Do not
mix with general household waste.
Specifications
USB Compatibility
USB 2.0 or later
Electrical Ratings
5VDC, 500mA
Requirements for safety approvals
This device must be connected to a personal computer that meets
the standard specified in IEC 60950, revision 2003.
Ambient conditions:
Transportation and storage temperature: -40°C to +70°C (-40°F to
+158°F)
Operating temperature: +10°C to +40°C (+50°F to +104°F)
Relative humidity: 30% to 75%, non-condensing
Air Pressure: 700 to 1060 hPa
Maximum surface temperature of camera at maximum ambient:
59°C (138°F)
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Manufacturer’s Declaration
The intraoral camera emits electromagnetic energy at levels compliant
to international standards; however, interference between the camera
and other devices is possible if located in close proximity. The customer
or the user of the camera can help prevent electromagnetic interference
by locating sensitive devices away from the camera.
This camera, classified as Medical Electrical Equipment, requires spe-
cial precautions regarding EMC and must be installed and put into ser-
vice according to the EMC information provided in the accompanying
product documentation. Portable and mobile RF communications
equipment can effect Medical Electrical Equipment. This camera com-
plies with EMC requirements when used with the cables and accesso-
ries supplied with the product. The use of accessories and cables other
than those sold by DEXIS, LLC and specified as replacement parts for
internal components, may result in increased emissions or decreased
immunity of this camera. This camera should not be used adjacent to or
stacked with other equipment. If adjacent or stacked use is necessary,
this camera should be observed to verify normal operation in the con-
figuration in which it will be used.
Guidance and manufacturer’s declaration - electromagnetic emissions
for all
EQUIPMENT and SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic emissions
This camera is intended for use in the electromagnetic environment specified
below. The customer or the user of this camera should assure that it is used in such
an environment.
Emissions test Compliance Electromagnetic environment -
guidance
RF emissions
CISPR 11
Group 1 This camera uses RF energy only for its
internal function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
RF emissions
CISPR 11
Class B The camera is suitable for use in all
establishments other than domestic,
and may be used in domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes,
provided the following warning is
heeded:
Warning:
This camera is intended for use by
healthcare professionals only. This
camera may cause radio interference or
may disrupt the operation of nearby
equipment. It may be necessary to take
mitigation measures, such as re-
orienting or relocating the camera or
shielding the location.
Harmonic
emissions
IEC 61000-3-2
Class A
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Complies
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11
Guidance and manufacturer’s declaration - electromagnetic immunity for all EQUIPMENT
and SYSTEMS
Guidance and manufacturer’s declaration - electromagnetic immunity
This camera is intended for use in the electromagnetic environment specified below. The
customer or the user of this camera should assure that it is used in such an environment.
Immunity test IEC 60601
test level
Compliance level Electromagnetic
environment – guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±2, 4 & 6 kV
contact
±2, 4 & 8 kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should
be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output lines
±2 kV for power
supply lines
±1 kV for input/
output lines
Mains power quality
should be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
±0.5 & 1 kV
differential mode
±0.5, 1 & 2 kV
common mode
Mains power quality
should be that of a typical
commercial or hospital
environment.
Voltage dips,
short
interruptions and
voltagevariations
on power supply
input lines
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
Mains power quality
should be that of a typical
commercial or hospital
environment. If the user of
this camera requires
continued operation
during power mains
interruptions, it is
recommended that this
camera be powered from
an uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3A/m 3A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE UTis the a.c. mains voltage prior to application of the test level.
DEXcam4 HD EN.book Page 11 Monday, January 16, 2017 2:12 PM

12
Guidance and manufacturer’s declaration - electromagnetic immunity for EQUIPMENT and
SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity
This camera is intended for use in the electromagnetic environment specified below. The
customer or the user of this camera should assure that it is used in such an environment.
Immunity test IEC 60601
test level
Compliance
level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
3 V
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of this camera, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
80 MHz-800 MHz
800 MHz-2.5 GHz
where Pis the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and dis the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey,ashould be less than the
compliance level in each frequency range. b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which this camera is used exceeds the appli-
cable RF compliance level above, this camera should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating this camera.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
d1.2 P=
d1.2 P=
d2.3 P=
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13
Recommended separation distances between portable and mobile RF communications
equipment and the EQUIPMENT or SYSTEM for EQUIPMENT and SYSTEMS that are not
LIFE-SUPPORTING
Accessories
Recommended separation distances between portable and mobile RF
communications equipment and this camera
This camera is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of this camera can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and this camera as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter m
150 kHz to 80 MHz 80 MHz to 800 MH 800 MHz to 2,5 GHz
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
Part Description Part Number
Camera Holster PLU7611H
USB Quick-disconnect Cable PLU7631C
Intra-oral Camera Sheaths
Case (5 boxes - 500 count) PLU7611S
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14
Additional Help and Support
DEXIS on the Internet
www.dexis.com
The DEXIS device described herein does not contain parts which can be serviced.
DEXIS Customer Care Center (United States and Canada)
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
Outside North America
Kaltenbach & Voigt GmbH
Bismarckring 39
D-88400 Biberach, Germany
+49 (0) 73 51 / 56-0
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Caméra intra-orale
Manuel d’utilisation
Français

1
Caractéristiques de la caméra intra-
orale DEXcam4 HD
La caméra intra-orale DEXIS DEXcam4 HD offre des possibilités
d’affichage vidéo en haute définition et en direct, d’arrêt sur image et
de capture, pour l’imagerie dentaire. La caméra ne doit pas servir à des
fins de diagnostic. Il n’existe aucune contre-indication à l’utilisation de
la caméra.
•Lentilles optiques brevetées de verre à sept composants procurant
une qualité d’image exceptionnelle
•Utilise un capteur HD Sony CMOS avec une résolution de
1,3 Mega-pixels
•Deux boutons de commande de saisie positionnés directement sur
la pièce à main
•Mise au point en une touche
•Câble amovible pour faciliter le partage
•Bâti robuste en aluminium
Utilisation prévue
Ce système de caméra intra-orale avec accessoires sert à fournir au
dentiste et au patient un panorama de la bouche avant et après une
procédure dentaire. Cet outil aide le dentiste à décrire la procédure
dentaire avant de l’effectuer, ainsi qu’à montrer les résultats à la
fin.
•La caméra a été conçue pour être utilisée par des
professionnels de la santé compétents ayant suivi une
formation sur les techniques décrites dans ce manuel.
•Une déficience visuelle de l’utilisateur est acceptable dans la
mesure où l’opérateur peut percevoir les détails nécessaires
de la documentation d’accompagnement, de l’interface
utilisateur et des données d’image. L’utilisation de verres
correcteurs ou de lentilles cornéennes est acceptable.
•Une déficience auditive est admissible, car le système n’émet
aucun son.
•Une déficience physique générale qui touche les bras, les
jambes ou la motricité est acceptable dans la mesure où
l’opérateur peut effectuer toutes les tâches nécessaires à
l’utilisation appropriée du système tel que cela est décrit
dans ce manuel.
Symboles utilisés dans le manuel
Les symboles suivants sont utilisés pour attirer l’attention de
l’opérateur sur des renseignements importants :
Alerte l’utilisateur que le non-respect de la
procédure peut entraîner des blessures graves
voire mortelles.
Alerte l’utilisateur que le non-respect des
instructions peut entraîner des blessures
légères à modérées ou encore endommager le
système.
Remarque : Souligne des points importants ou inhabituels.
AVERTISSEMENT
MISE EN GARDE
DEXcam4 HD FR.backup.book Page 1 Monday, January 16, 2017 3:53 PM

Caméra intra-orale
Étui pour caméra
Manuel de l’utilisateur
Gaines (100 unités)
Intra-oral Camera
User Manual
Manuel de l’utilisateur
DEXcam4 HD
2
Maîtrise de l’utilisation de la caméra
Veuillez vous familiariser avec la caméra intra-orale DEXcam4 HD,
votre nouvel outil de travail. L’apprentissage d’un nouvel outil
clinique requiert du temps pour se pratiquer et bien maîtriser son
utilisation, et la caméra DEXcam4 ne fait pas exception. Apprenez à
bien l’utiliser et elle deviendra une aide efficace.
Le présent guide suppose que les nouveaux utilisateurs possèdent
des connaissances de base en informatique et une compréhension
du système d’exploitation Windows®. Sans cette expérience, nous
vous recommandons fortement d’acquérir ces compétences par un
cours, un manuel ou le visionnement d’une vidéo sur
l’informatique.Votre représentant DEXIS pourrait être en mesure de
vous suggérer (sans toutefois endosser) une ou plusieurs de ces
ressources d’apprentissage informatique.
Caractéristiques de la caméra intra-orale
DEXcam4 HD
Contenu de la trousse
Nom DEXcam4 HD
Alimentation 5 V CC, 500 mA
Capteur d’image 1/4 po SXGA EDR 1.3 Mega-pixels
Résolution 1280 (H) x 720 (V)
CGA/balance des blancs Automatique
Lampe DEL blanche de luminance élevée à
microprocesseur : 4 UNITÉS
Câble Longueur : 2,7 m (8,9 pi)
Connecteur : USB
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