Vatech EzSensor Guide

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This manual covers the installation and operating procedures of the EzSensor.
Unless otherwise specified, all the information contained in this manual is applicable equally to
all EzSensor types.
Notice to users
For the improvement of product performance, supplementation, and the follow-up of information,
the contents of this manual are subject to change without prior notice.
Please note that our company bears no responsibility for accidental damage nor will be
obligated to perform warranty service for any damage to equipment due to user error. Please
follow the instructions in this manual closely. Become familiar with the safety precautions and
usage procedures for this product. Note that the product may differ slightly from the contents of
this manual, depending on individual product specifications.
The following symbols are used throughout this manual to provide instructions on the effective
use of this product.
Indicates useful information and tips on how to use our software and
products.
Indicates important instructions. If not observed, malfunction or damage to
the system or other property may occur.
Indicates warnings and instructions for safety. If not adhered to, there is a
serious risk of injury to the patient and/or the operator.
United States federal law restricts this device to use by or on the order of a
physician.

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The device must be installed and used in accordance with the safety regulations and
instructions supplied in this user manual only for the purposes and applications for which it is
intended.
Indications for Use
EzSensor, an Intra-oral Imaging System, is intended to collect dental x-ray photons and
convert them into electronic impulses that may be stored, viewed, and manipulated for
diagnostic use by dentists.
Before each usage, check the outer surface of the EzSensor for any signs of physical damage
or defect. The surface of the EzSensor should have a smooth finish, with no evidence of
chipping or damage. Otherwise, contact your local VATECH product distributor for further
instructions on how to proceed.
To ensure the correct usage of the EzSensor device in a clinical environment, for which the
intended purposes correspond to its design and application, only dentists or their designated
operators are authorized to operate this system.
Modifications and/or additions to the device must be conducted exclusively by VATECH
personnel or by parties expressly authorized to do so by VATECH. Any modifications or
additions must always comply with the standards and generally recognized rules of good
workmanship.
It is the user‟s responsibility to ensure compliance with all local safety regulations in effect in the
jurisdiction of installation.
Electrical safety
The covers of the device may be removed only by qualified and authorized technical personnel.
This device can only be used in rooms or areas which comply with all laws and regulations
applicable to electrical safety on medical premises, such as CEI standards for the use of an
additional ground terminal for equipotential connections. This device must always be
disconnected from the power supply before cleaning or disinfecting.

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This device should be connected with the product which is complied with IEC 60601-1.
Water and other liquids must not be permitted to penetrate the device. Liquids may cause
corrosion or the device to short circuit. No protection is offered against liquid penetration.
Explosion safety
This device is not recommended for use in the presence of flammable gases or vapours. Some
disinfectants evaporate and form explosive or flammable mixtures. If disinfectants of this kind
are used, it is important to let the vapours disperse before using the device again.
For the improvement of product performance, supplementation, and follow-up of information,
the contents of this manual are subject to change without prior notice.
X-ray protection
The rules of dental radiography apply to digital X-ray systems. Please continue to use protection
for your patients. As a clinician, clear the immediate area when exposing the sensor.
Symbols Descriptions
Item
Symbol
Description
1
Type B applied part
2
Indicates to the user to check the accompanying documents (this
User Guide) for more information about EzSensor
3
Conforms to CE MDD 93/42/EEC (European Communities)
concerning medical devices
4
Waste Electrical and Electronic Equipment
5
Handle with care
6
Fragile, handle with care
7
This way up
8
Intended for a single use.

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WEEE information according to directive 2002/96/EC
(Waste Electrical and Electronic Equipment)
The crossed-out wheeled bin symbol, that is present on the device, means that
within the European Union the product must be taken to separate collection at the
product end-of life. Therefore, at the end of the life-cycle of the device, the user
should deliver the device to the proper collection facilities of the Electric and
Electronic Equipments. Alternatively, the user can return the device to the seller, on a one-to-
one basis, as long as he or she is buying a new one of equivalent type and that fulfills the same
functions as the old one.
Disposing of the device separately avoids possible negative consequences for the environment
and health deriving from inappropriate disposal and enables the constituent materials to be
recovered to obtain significant savings in energy and resources.
Who disposes any Electric and Electronic Equipment, reporting the above symbol, as unsorted
municipal waste, instead of collecting it separately, incurs the administrative sanctions in
accordance with law.
Label Location
The VATECH logo and the following label can be found on the EzSensor device.

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Contents
CHAPTER 1 INTRODUCTION ...................................................................6
1.1 System Description ...........................................................................................6
1.2 System Components.........................................................................................8
1.3 Sensor positioning aid accessories (optional) .............................................11
CHAPTER 2 HARDWARE INSTALLATION .............................................12
2.1 What you should do before use .....................................................................12
2.2 Specifications ..................................................................................................12
2.2.1 PC Specifications....................................................................................................................12
2.2.2 EzSensor Driver Setup ...........................................................................................................13
2.3 Cable Connection & Driver Installation..........................................................15
2.4 Installation of the EzSensor Holder ...............................................................18
CHAPTER 3 INSTALLING THE SOFTWARE...........................................19
3.1 Installation of EasyDent..................................................................................19
3.2 Preparing for Image Acquisition with the EzSensor.....................................24
3.3 Running the EasyDent.....................................................................................25
3.3.1 Patient Registration and Device Selection...........................................................................25
3.3.2 Single Shot ..............................................................................................................................27
3.3.3 Multi Shot.................................................................................................................................31
3.3.4 Sequence Shot........................................................................................................................35
CHAPTER 4 MAINTENANCE ..................................................................38
4.1 Visual Inspection .............................................................................................38
4.2 Periodic Maintenance......................................................................................38
4.3 Care and Cleaning ...........................................................................................38
4.4 Precautions......................................................................................................39
4.5 Product complaint ...........................................................................................39
CHAPTER 5 WARRANTY........................................................................41
APPENDIX .............................................................................................43
A.1 LED Indicators .................................................................................................43
A.2 X-ray Exposure Guide .....................................................................................44
A.3 Error Message..................................................................................................46
A.4 Troubleshooting ..............................................................................................48
A.5 How to use the sensor positioning system...................................................49
A.6 Electromagnetic field information according to IEC601-1-2........................52

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Chapter 1 Introduction
1.1 System Description
EzSensor is a modern digital imaging solution for intraoral dental radiography. Its advanced
CMOS technology provides excellent image quality. For patient comfort, the ergonomic design
is based on human intraoral anatomy.
EzSensor is a digital X-ray imaging system designed specifically for dental radiography within
the oral cavity. The system captures X-ray images and makes them available for display and
storage across your computer network.
EzSensor is connected by a „USB A-A‟ cable (supplied separately) to a compatible Windows XP
or Windows Vista or Windows 7 PC. EzSensor is provided the power from PC. Support for the
EzSensor is provided by compatible software programs such as EasyDent.
For other custom applications, a programmer‟s guide is available.
The EzSensor includes a detachable holder that can be mounted on the wall or other stable
surface.
The EzSensor comes with the following features:
●Excellent image quality based on advanced CMOS technology
●More comfortable sensor ergonomic shape for the human oral structure
●Lower dose exposure
●Enhanced durability
●Easy-to-use USB interface

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<Table 1. Specifications >
Parameter
Description
Detector Structure
Low Noise Hybrid CMOS
Dimensions (W x L x T)
Size 1.0: 1.03 x 1.45 x 0.19 inch (26.1 x 36.8 x 4.95 mm)
Size 1.5: 1.14 x 1.52 x 0.19 inch (29.2 x 38.7 x 4.95 mm)
Size 2.0: 1.24 x 1.69 x 0.19 inch (31.5 x 42.8 x 4.95 mm)
Pixel Pitch
0.035 mm
Active Pixel Array
Size 1.0: 572 x 858 pixels (20.02 x 30.03 mm)
Size 1.5: 686 x 944 pixels (24.01 x 33.04 mm)
Size 2.0: 744 x 1030 pixels (26.04 x 36.05 mm)
Grayscale
4096 gray levels
Resolution
14.2 lp/mm (theoretical)
USB Cable length
between Controller and PC
3m
Electrical rating
DC 5V, 500mA
Operation mode
Continuous
Ambient Temperature
10℃to 30℃(Usage)
-20℃to 60℃(Transportation and Storage)
Relative Humidity
30% to 95% (Usage)
10% to 95% (Transportation and Storage)
Air Pressure
700 to 1060 hPa
EU classification
Medical Devices 93/42/EEC as a class IIa
Protection against shock
Type B applied part
Protection against water/matter
IPX0
The sensor has to install and transportation and storage in the permissible environmental
conditions. And sensor is not suitable to be operated in explosive environments. Use the
provided protective package for transporting or storage.
Also sensor should not operate in oxygen rich or explosive environments.

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1.2 System Components
The EzSensor device installer should check the following items listed in the table below before
system installation. If the serial numbers of the individual parts do not match, do not install the
system. Contact your local distributor or agent for support.
This device should be connected with the product which is complied with IEC 60601-1.
<Table 2. EzSensor system components>
No
Components
Remarks
1.
Sensor Module*
2.
Control Board Box
3.
USB PC Interface Cable (3M)
4.
Holder for Sensor
5.
Silicon cover*
6.
Wrap* (Hygienic Sleeves)
7.
S/W Installation CD
EasyDent + EzSensor Driver
8.
EzSensor Manual
Document
* Patient applied part (Inside Patient environment)
1. Sensor Module:
Consists of a special CMOS sensor specifically designed for use in radiography and
enclosed in a hermetically sealed ergonomic capsule. The sensitive surface of the
sensor is covered with a thin layer of scintillating phosphorous, through which X-ray
radiation is converted into light and then into an electric charge.

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2. Control Board Box:
Provides power to the sensor, timing and synchronization of sensor signals, signal pre-
amplification, analogue/digital signal conversion, USB port interface and optical
insulation of all connections.
3. USB PC Interface Cable:
Used to transmit the output signal from the control board box to the computer.
4. Holder for Sensor:
Used to stow the sensor when not in use
5. Silicon cover:
Used to protect from external shock.
6. Wrap (Hygienic Sleeves):
The sensor is supplied in a non sterile state. Single-use wrap must cover the
sensor before placing it in the patient‟s mouth. The once used wrap shall be

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disposed. These wrap are conform to the ISO 10993-1.
7. S/W Installation CD

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1.3 Sensor positioning aid accessories (optional)
The positioning system is an intraoral positioning device specifically designed to support and
align the sensor with the X-ray source when positioned along the upper or lower jaw.
Please refer to the Appendix for more information (pages 49~51).

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Chapter 2 Hardware Installation
2.1 What you should do before use
To operate the intraoral sensor, you need to install the EzSensor driver. This device should be
connected with the product which is complied with IEC 60601-1.
2.2 Specifications
2.2.1 PC Specifications
①Operating System
● Microsoft Windows XP 32bit
● Microsoft Windows Vista 32bit
● Microsoft Windows 7 32bit
②Hardware requirements
● Main CPU: Intel Pentium IV 3.0 GHz
● Main Memory: 1GB of RAM (DDR2)
● Video Memory: 64 MB
● HDD: 80 GB (or better)
● CD-ROM (prefer CD-RW)
● USB Port
● Network Card: 1 EA
● Monitor: Min. resolution: 1024*768
● Keyboard/Mouse
We cannot guarantee that EasyDent will work properly with an unregistered
copy of Microsoft Windows. Therefore, you should use registered, genuine
version of Microsoft Windows .
Turn off the Windows Firewall service for proper communication across the
network for the installed database and file servers.
If you need to install additional software on your computer, please install
only those that are internationally authorized. Take extra precaution when
installing any Active-X controls.

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2.2.2 EzSensor Driver Setup
This step is necessary for the installation of EzSensor. Capturing software and Calibration data
for the EzSensor will be installed along with the Windows device driver. A Twain driver is also
installed during this step.
Step 1
Insert the S/W Installation CD
in the CD-ROM. Setup should
start automatically.
If it does not, click Start > Run
and type
D:\Console\setup.exe or
D:\EzSensor\setup.exe.
Step 2
The install program for
„EzSensor Acquisition
Software Version 6‟will
appear. Click the „Next‟ button.

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Step 3
Check the EzSensor
installation directory and then
click the „Next‟ button.
Step 4
The Installshield Wizard will
start configuring the
installation parameters.
Step 5
The InstallShield wizard will
copy the EzSensor calibration
files to your workstation(PC).

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2.3 Cable Connection & Driver Installation
Step 1
Connect the EzSensor Module
to the Control Board box.
Step 2
Connect the USB PC Interface
Cable to the Control Board
box.
Do not connect the EzSensor and USB PC Interface cable to your computer
until you have successfully installed the setup program.
Be sure to connect the EzSensor module to the control board box before
connecting the USB PC Interface cable to your computer.
Connect only item that has been specified as part of the Medical Equipment
System.

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Step 3
Connect the USB PC Interface
cable connector to the USB
port on the PC.
Be sure to connect the USB
port on backside for
accurate operation.
Step 4
Confirmation of Driver installation at the Device Manager.
Method of Confirmation:
Windows 7 : Control Panel System and Security System Device Manager
Windows XP : Settings Control Panel SystemHardware Device manager
Select „VH EzSensor-N x.x‟, located under Imaging Devices. You should see the message,
“This device is working properly”.

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EzSensor is supplied the power and transported data via USB port of PC.
Do not disconnect during usage.

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2.4 Installation of the EzSensor Holder
The EzSensor holder is used for mounting the EzSensor to the wall when not in use.
When choosing where to install the EzSensor, locate an area that offers easy access and
visibility during patient examinations.
①Position the holder on a stable, flat surface. Using the holes at the back of the holder as
guides, fasten the holder securely to the wall using two dry wall screws (included).