GNATUS In Cam LX Camera User manual

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PRESENTATION OF MANUAL
EQUIPMENT:
Technical Name: Camera Image Recorder
Brand Name: In Cam LX - Camera
Model: In Cam LX - Camera
Brand: GNATUS
Manufacturer/ Distribuitor:
GNATUS - EQUIPAMENTOS MÉDICO-ODONTOLÓGICOS LTDA.
Rod. Abrão Assed , Km 53+450m - Cx. Postal 782 CEP 14097-500
Ribeirão Preto - S.P. - Brasil
Fone [phone] - Fax [phone]
C.N.P.J. 48.015.119/0001-64 - Insc. Est. 582.329.957.115
www.gnatus.com.br - [email protected]
Technical Duties: Gilberto Henrique Canesin Nomelini
CREA-SP: 0600891412
INSTRUCTIONS FOR USE
ATTENTION
For greater safety:
Read and understand all the instructions contained in these
Instructions for Use before installing or operating this Equipment.
Note: These Instructions for Use must be read by all the operators
of this Equipment.

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INDEX
PRESENTATION OF MANUAL ........................................................................02
IDENTIFICATION OF EQUIPMENT .................................................................04
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION .....06
TECHNICAL SPECIFICATIONS .......................................................................08
- Dimension....................................................................................................09
- Eletromagnetic emissions ...............................................................................10
- Norms employed...........................................................................................13
- Symbologies of packaging ..............................................................................14
- Contents of the accessible and inaccessible markings .........................................14
- Installation of equipment................................................................................14
- Operation.....................................................................................................25
PRECAUTIONS, RESTRICTIONS AND WARNINGS .........................................35
- Conditions of transport and storage .................................................................35
- Environmental conditions of operation..............................................................35
- Sensitiveness to environmental conditions foreseeable in normal situations of use .35
- Recommendations for preserving the equipment................................................35
- Precautions and warnings “during the installation” of equipment .........................36
- Precautions and warnings “during the use” of equipment ...................................36
- Precautions and warnings “after” the use of equipment ......................................37
- Precautions and warnings during the “cleaning and disinfection” of equipment ......37
- Precautions in case of alteration in the functioning of equipment..........................37
- Precautions to be adopted against foreseeable or uncommon risks,
related to the deactivation and abandoning of equipment .....................................37
CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION............37
- Additional procedures for reuse .......................................................................37
- Cleaning, disinfection and sterilization..............................................................38
- Preventive maintenance .................................................................................38
- Corrective maintenance..................................................................................38
UNFORESEEN EVENTS – SOLUTION OF PROBLEMS ........................................39
WARRANTY OF EQUIPMENT ..........................................................................40
FINAL CONSIDERATIONS..............................................................................40

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Dear Customer
Congratulations. You have made a good choice when you decided to buy a GNATUS
QUALITY product comparable to the best products available in the World. This manual is a
general presentation of your product and it will give you important details to help you to
solve possible problems.
Please, read it and keep this with you..
Identication
Technical Name: Camera Image Recorder
Brand Name: In Cam LX - Camera
Model: In Cam LX - Camera
Brand: GNATUS
DESCRIPTION OF THE EQUIPMENT

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• Allows installation on Television set / Monitor with video / VGA Monitor input;
• Freezing of images performed through key available on the handpiece; allows the
operator greater freedom in usage;
• Installation on Computer through USB device; allows storage and management of
images through specic software;
• Image selection made through Remote Control; allows selection one by one, or four
simultaneous images directly on the television set or monitor;
• Lighting system through white LEDs with cold light, providing an image with a maximum
degree of reality;
• Built in protective lens, protects the optic components against small accidents, scratches
and dust;
• Handpiece with anatomical format; allows capturing images with quality of the mouth
and allows the use of devices for prevention of cross contamination;
• Comes together with handpiece holder with automatic electromagnetic switch; allows
positioning in the most diverse locations, such as: LCD Monitors, sides of delivery unit, water
unit, cabinets, etc. Provides practicality, time and electrical power savings, turning on/off
automatically upon being removed / placed in a different position in the holder.
• Light table module, compact and functional with interfaces for diverse applications;
allows connections in VGA monitors, TV and Computer.
• Remote control with programming and image selection functions; allows greater mobility
in control and storage of captured images;
• Handpiece communication cable in highly exible material; allows exibility and does
not have the fragility found in ber optic cables;
• On/off switch placed on the handpiece, providing ease in activation;
• Switching power supply; allows use of the equipment at any supply voltage from 100V
to 240V – 50/60Hz.
Indication of Equipment
This equipment It must be operated and utilized by specialized professional (certied
professional, according to the legislation of the country) and following the instructions of
the manual.
The operation of the equipment required, for the professional, the utilization of
correct instruments and it should to be in perfect conditions of the use, and to protect the
professional, the patients and others, in the eventual danger situation.
Purpose of the equipment
The camera has the purpose of capturing images with quality of the mouth, allowing
visualization of images with the maximum degree of reality (including blown-up images)
through the monitor or television set, allowing perfect diagnosis.
DESCRIPTION OF THE EQUIPMENT
Description of Equipment

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MODULES, ACCESSORIES, OPTIONS AND MATERIALS
OF CONSUMPTION
A - Handpiece In Cam LX Camera
B - Module
A
B

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MODULES, ACCESSORIES, OPTIONS AND MATERIALS
OF CONSUMPTION
Accessories and cables which come with the product:
01- Power supply source 100-240V~ (camera)
02- Video VGA cable
03 - Protective cover
04 - Camera cable
05 - Video RCA cable
06 - USB cable
07 – Sensor IR Cable
08 – Supplemental cable
09 – Camera holder
10 – Camera holder fastening screw
11 – Software installation CD for
capturing and storage of images.
12 – Remote IR control

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TECHNICAL SPECIFICATIONS
General
Classication of Equipment
According to the norm NBR IEC 60601-1
Electric shock protection type
Class II Equipment
Degree of protection against electric shock
B type
Protection against harmful water penetration
IPX 0
Mode of Operation
Continuous
Model
In Cam LX Camera
Capture element
1/4” Color CCD
Gain control
Automatic
Power
14VA (100V~) / 17VA (240V~)
Video output
1.0Vp-p Composite/75ohm
Resolution
480 TV Line
Electronic shutter
Automatic,1/60(1/50)~ 1/100,000seg
Power supply
Ve - 100-240V~ - 50/60 Hz
Vs - 5V~/2A
Focal Distance
2mm - 40mm
Freezing
On the handpiece button. 60 blown-up frozen images total or on the “Grids” mode, 240
images.

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Dimensions (mm)
TECHNICAL SPECIFICATIONS
Input/Output
Digital 16bits
Signal
52Db
Power supply of the module
DC 5V
Digital resolution
8 Bit 256 Grad, 512x1024 pixels
Lighting
6 LEDs
Handpiece weight
89g
Net weight
900 g
Gross weight
1.030 Kg
The video monitor used combined with the In Cam Lx Camera must present the
following minimum conguration:
Power: 100~ 240VAC (50/60Hz) - Internal source in the monitor
Vídeo signal: RGB Analogical / USB / VGA
Contrast: 30.000 :1 DFC
Response time: 8ms
Angle of vision: H=176º / V=170º

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TECHNICAL SPECIFICATIONS
Eletromagnetic emissions

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TECHNICAL SPECIFICATIONS

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TECHNICAL SPECIFICATIONS

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TECHNICAL SPECIFICATIONS
NBR 60601-1:1997 - Equipamento Eletromédico- Parte 1: Prescrições gerais para
segurança;
NBR ISO 14971:2009- Dispositivos médicos - Gestão de aplicação de dispositivos
médicos de riscos.
EN ISO 13485-2003 - Quality systems - medical devices;
IEC 60601-1-2:2007 - Collateral Standard - Eletromagnetic Compatibility.
ISO 9001:2008 - Quality Management System - Requirements
RDC 59/2000 - Boas práticas de fabricação de produtos médicos - ANVISA
Norms employed:
The materials used to produce the equipment are Biocompatible.
The video monitor and In Cam Lx Camera set is appropriated for use inside the
patient’s environment.

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It determines the maximum
quantity of boxes which can be
stacked during transportation
and storage “as per packaging”.
Packing to be transported and / or
stored with the harrows up.
Packing to be transported and /
or stored with care (should not
suffer drop and neither receive
impact).
Packing to be transported and
/ or stored avoiding humidity,
rains and wet oor.
The packing must be stored and
transported away from direct
sun light exposure.
Temperature limit for the
packing to be stored or
transported.
Packing symbols
TECHNICAL SPECIFICATIONS
Contentofaccessibleandnon-
accessible demarcations
- Gnatus bears no responsibility for damages or accidents caused by poor installation
executed by a technician not authorized by Gnatus.
- Only after the equipment has been installed and duly tested by the authorized technician
representing Gnatus, will it be ready to start work operations.
OBS: These information also make part of the Manual of Installation and
Maintenance of the equipment that can be found with the authorized
Gnatus technician.
INSTALLATION OF EQUIPMENT
Important: It indicates an
instruction of safety for operation
of the product. Not following it,
can lead to serious danger to
the patient.
Note: It indicates useful
information for operation of the
product.
Warning - see the manual

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INSTALLATION
B) Then connect the cables to the back of the module.
1) POWER: On/Off button
2) USB: USB cable
3) VGA OUT: Video cable
4) DC 5V: Camera Power
supply cable
5) VIDEO OUT: Video component
output cable
Before starting the installation, read the manual carefully, and if you have any queries,
please contact the Gnatus technical assistance.
Note: The camera can be installed directly in the monitor or the computer using the
software of capturing and storing images.
The video monitor used combined with the In Cam Lx Camera must be according with
the guidelines:
IEC 60.950 / IEC 801.3
Installation of the camera in the“Monitor”
A) Connect one of the sides of the camera cable (1) to the module (2) and the other end
to the camera (3). To disconnect the camera cable or module, press button (04).
3
1
2
4

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INSTALLATION
Installation of the camera in the“Monitor”
C) Connect the end of the VGA video cable (4) to the module (5) and the other end (6)
to the monitor.
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4
D) Connect the camera Power supply source (7) to the electrical network and the other
end to the module (8).
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7
In order to install the camera on the column of the light, it is necessary to use the cables
below. The installation should only be executed by Gnatus authorized technicians.
Complementary cable

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INSTALLATION
Installation of the camera in the“Computer”
In order to install the camera in the computer, connect the power supply source of
the camera (01) to the electrical network and the other end to the module (02). Connect
the USB cable (03) to the back of the module and the other end to the USB input of the
computer (4) and turns on the module.
1
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4
We recommend that you use the “2.0” USB device input located in
the back of the computer.
Fixation of the camera holder in the ruler of the holder monitor.
To install the holder of the camera (A) in the ruler of the holder monitor (B), use a
Phillips screwdriver and release the 2 screws (C) that match the piece (A) and (D). Discard
pieces (C) and (D), because they will no longer be used, attach the piece (A) in the ruler
(B) using the 2 screws (E). Remembering that it is extremely important the utilization of
the magnet, because it has the automatic disconnection function of the camera.
This procedure must be applied in case of purchasing the “Holder Monitor set”.

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INSTALLATION

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Installation of the camera“Driver”
INSTALLATION
A) Insert the camera installation CD, enter into the “D:” CD driver and click on setup for
installation of the driver.
B) Wait for installation of the driver.

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Installation of the camera“Driver”
INSTALLATION
C) Click on forward.
D) Click on nish.