Vatech EzSensor Classic Installation & User Manual

Installation & User Manual
(IOS-U20VB, IOS-U15VB, IOS-U10VB,
IOS-U20IB, IOS-U15IB, IOS-U10IB)
Contents
CHAPTER 1 INTRODUCTION ................................................................... 1
1.1 Notice .................................................................................................................. 1
1.2 Conventions and Symbols ................................................................................ 1
1.3 Safety Instructions ............................................................................................ 3
1.4 Disposing of the Product .................................................................................. 5
CHAPTER 2 SYSTEM OVERVIEW ............................................................ 6
2.1 System Description ........................................................................................... 6
2.2 Product Components ........................................................................................ 8
CHAPTER 3 INSTALLATION ..................................................................... 9
3.1 PC Specifications .............................................................................................. 9
3.2 Installation of Software Driver ........................................................................ 10
3.2.1 EzSensor Classic(IOS-U20VB, IOS-U15VB, IOS-U10VB)Driver Setup .............................. 10
3.2.2 Cable connection & Driver Installation ................................................................................. 12
3.3 Installation of the EzSensor Classic Holder .................................................. 14
CHAPTER 4 IMAGE ACQUISITION BY USING EASYDENT ................... 15
4.1 Installation of EasyDent .................................................................................. 15
4.2 Image Acquisition Overview ........................................................................... 20
4.3 Running the EasyDent ..................................................................................... 21
4.3.1 Patient Registration and Device Selection ........................................................................... 21
4.3.2 Single Shot .............................................................................................................................. 23
4.3.3 Multi Shot ................................................................................................................................. 27
4.3.4 Sequence Shot ........................................................................................................................ 31
CHAPTER 5 IMAGE ACQUISITION BY USING EZDENT-I ...................... 34
5.1 Installation EzDent-i ........................................................................................ 34
5.2 License Activation. .......................................................................................... 40
5.3 Consult DB License Activation ....................................................................... 43
5.4 Preparing for Image Acquisition .................................................................... 46
5.5 Running the EzDent- i...................................................................................... 47
5.5.1 Patient Registration ................................................................................................................ 47
5.5.2 Acquiring Image ...................................................................................................................... 48
5.5.3 Image View............................................................................................................................... 51
CHAPTER 6 MAINTENANCE .................................................................. 52
6.1 Visual Inspection ............................................................................................. 52
6.2 Periodic Maintenance ...................................................................................... 52
6.2.1 Test List ................................................................................................................................... 53
6.2.2 Connection .............................................................................................................................. 53
6.2.3 Cable ........................................................................................................................................ 54
6.2.4 Resolution................................................................................................................................ 54
6.3 Care and Cleaning ........................................................................................... 55
6.4 Precautions ...................................................................................................... 55
6.5 Product complaint ........................................................................................... 56
APPENDIX .............................................................................................. 57
A.1 X-ray Exposure Guide ..................................................................................... 57
A.2 Error Message .................................................................................................. 59
A.3 Troubleshooting .............................................................................................. 61
A.4 Electromagnetic Compatibility Information ................................................... 62
1
Chapter 1 Introduction
1.1 Notice
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 we be obligated to provide 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.
1.2 Conventions and Symbols
1. Convention 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 Product or other property may occur.
Indicates warnings and safety instructions. If not adhered to, there is a serious risk of injury to the patient and/or the operator.
For U.S.A. users: United State federal law restricts this device to use by or on the order of physician. For other countries users: This device to use by or on the order of a licensed person under the related laws in each country.
2
2. Symbols Descriptions
Item
Symbol Description
1
Type B applied part
2
Refer to instruction manual/ booklet
3
Conforms to CE MDD 93/42/EEC (European Communities) concerning medical devices
4
Waste Electrical and Electronic Equipment
5
Manufacturer
6
Date of manufacture
7
Serial number
8
Authorized representative in the European Community
9
Handling procedures for Electro-Static Discharge (ESD).
9
Handle with care
10
Fragile, handle with care
11
This way up
3
1.3 Safety Instructions Indications for Use
EzSensor Classic, an Intra-oral Imaging device, 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 Classic for any signs of physical damage or defect. The surface of the EzSensor Classic should have a smooth finish, with no evidence of chipping or damage. Otherwise, contact your local Product distributor for further instructions on how to proceed.
To ensure the correct usage of the EzSensor Classic 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 Product
Modifications and/or additions to the device must be conducted exclusively by MANUFACTURER or by parties expressly authorized to do so by MANUFACTURER. 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.
4
Electrical safety
The covers of the Product may be removed only by qualified and authorized technical personnel.
This Product can only be used in rooms or areas that comply with all laws and regulations applicable to electrical safety on medical premises, such as IEC standards for the use of an additional ground terminal for equipotential connections. This Product must always be disconnected from the power supply before cleaning or disinfecting. This Product should be connected with a device which is complied with IEC 60601-1. Water and other liquids must be kept at a distance to avoid penetration of the Product. Liquids may cause corrosion or the Product to short circuit. No protection is offered against liquid penetration.
Explosion safety
This Product 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 Product 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.
5
1.4 Disposing of the Product
1. WEEE information according to directive 2002/96/EC
(Waste Electrical and Electronic Equipment)
The crossed-out wheeled bin symbol, that is present on the Product, 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 Product, the user
should deliver the device to the proper collection facilities of the Electric and Electronic Equipments. Alternatively, the user can return the Product to the seller, on a one­to-one basis, as long as he or she is buying a new one of equivalent type and that fulfils the same functions as the old one. Disposing of the Product 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.
2. Label Location
The label can be found on the EzSensor Classic device.
6
Chapter 2 SYSTEM OVERVIEW
2.1 System Description
This manual covers the installation and operating procedures of the EzSensor Classic(
IOS-
U20VB, IOS-U15VB, IOS-U10VB, IOS-U20IB, IOS-U15IB, IOS-U10IB)
“collectively or individually
referred to as EzSensor or Product”.
Unless otherwise specified, all the information contained in this manual is applicable equally to all EzSensor Classic types.
<Table 1. Specifications >
Parameter Description
Detector Structure CMOS Photodiode Array
Dimensions (W x L x T)
Size 1.0: 1.44 x 1.00 x 0.19 inch(36.8 x 25.4 x 4.8 mm)
Size 1.5: 1.55 x 1.15 x 0.19 inch (39.5 x 29.2 x 4.8mm)
Size 2.0: 1.69 x 1.28 x 0.19 inch(42.9 x 31.3 x 4.8 mm)
Pixel Pitch 0.0296 mm
Active Pixel Array
Size 1.0: 1014 x 676 pixels (30.01 x 20.01 mm)
Size 1.5: 1115 x 810 pixels (33.00 x 23.98 mm)
Size 2.0: 1216 x 878 pixels (35.99 x 25.99 mm)
Grayscale 4096 gray levels
Resolution Normal Resolution Mode : 16.89 lp/mm (theoretical)
USB Cable length
between Controller and PC
2.7 m
Electrical rating DC 5V, 500mA
7
Operation mode Global shutter
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 matter/water
IP 68
The Product has to be installed, transported and stored in the permissible environmental conditions. Use the provided protective package for transporting or storage. Also, the Product should not operate in oxygen rich or explosive environments.
8
2.2 Product Components
The EzSensor Classic device installer should check the following items listed in the table below before Productinstallation. If the serial numbers of the individual parts do not match, do not install the Product. Contact your local distributor or agent for support. This Product should be connected with a device or product which is complied with IEC 60601-1.
<Table 2. EzSensor Classic Product components>
No Components Remarks
1 Sensor Module* 2.7m USB cable is all in one 2 Wrap* (Hygienic Sleeves) 3 Holder for Sensor 4 Silicon cover* 5 S/W Installation CD(or USB)
EasyDent (or EzDent-i) 6 Driver Installation CD USB Device Driver 7
EzSensor Classic Manual
Document
* Patient applied part (Inside Patient environment)
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.
9
Chapter 3 INSTALLATION
3.1 PC Specifications
1. Recommended Server PC Specifications
Workstation
Operating System: Window 2000 server or higher
RAM: 4GB or Higher
HDD: 1TB or higher
2. Recommended Client PC Specifications
CPU: Core DUO CPU 1.8GHz or Higher
Main Memory: 2GB of Higher
Graphic Card : 512MB or Higher
HDD: 2GB free space
Display: 1280x1024x32bpp
3. Operating System
Window 34&64bit: XP(SP1), Vista, 7, 8, 8.1
We cannot guarantee that EasyDent (EzDent-i) will work properly with an unregistered copy of Microsoft Windows. Therefore, you should use a 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.
3.2
Installation of Software Driver
3.2.1
EzSensor Classic
This step is necessary
for the
Calibration data for the
EzSensor Classic
Windows device driver
. A Twain driver is also installed
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
Homedirctory:\Console\
setup.exe
Step 2
The install program for ‘
IntraOral
USB-Sensor Acquisition Software’
will appear. Click the
‘Next’ button.
To operate the intraoral sensor, you need to install the
Driver. This Product
should be connected with the product
complied with IEC60601
10
(
IOS-U20VB, IOS-U15VB, IOS-U10VB)
Driver Setup
installation of EzSensor Classic.
Capturing software and
will be installed
and downloaded
during this step.
EzSensor Classic
or the device
-1
along with the
EzSensor Classic
which is
Step 3
Check the EzSensor Classic installation directory and
then
click the ‘Next’ button.
Step 4
The Install shield Wizard will start configuring the installation parameters.
The Install-shield wizard will Copy the calibration files To your work-station (PC).
Step 5
The Install-shield wizard will be done.
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12
3.2.2 Cable connection & Driver Installation
Step 1
Connect the EzSensor Classic USB Connector to the
USB port on the PC directly.
Be sure to connect the USB port on backside for accurate operation.
Do not connect the EzSensor Classic and USB PC Interface cable to your computer until you have successfully installed the setup program.
Only connect the item that has been specified as part of the Medical Equipment System.
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Step 2
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”.
EzSensor Classic is supplied to the power and transports data via the USB port of the PC. Do not disconnect during usage.
14
3.3 Installation of the EzSensor Classic Holder
The EzSensor Classic holder is used for mounting the EzSensor Classic to the wall when not in use. When choosing where to install the EzSensor Classic, locate an area that offers easy access and visibility during patient examinations.
Position 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).
15
Chapter 4 Image Acquisition by using EasyDent
4.1 Installation of EasyDent
In this step, EasyDent will be installed. Alternatively, software which supports the Twain interface can be used instead of EasyDent.
Step 1
Insert the S/W installation CD in the CD-ROM drive.
Homedirectory:\EasyDent\setup.exe
. Press ‘Enter’.
Step 2
Select the language you want to install and then click ‘Next’.
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Step 3
The ‘EasyDentV4 Install Shield Wizard’ will appear. Click the ‘Next’ button.
Step 4
Select the setup type that best suits your needs. Click the ‘Next’ button.
Basic : Installs the basic version of EasyDent V4 CD-Publishing : Installs the basic version of EasyDent V4 along with CD-Publishing capabilities (optional)
For the EasyDent server, select all items. For PC being used for viewer: Select only the items except for DB & File servers. For the detailed installation, refer to the EasyDent installation manual.
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Step 5
Select the features that you want to install. Click the ‘Next’ button.
EasyDent Viewer is the minimum requirement for EzSensor Classic use.
Step 6
Now you are ready to install. If you would like to review any of your installation settings, click ‘Back’. To proceed with the installation, click ‘Install’. Click ‘Cancel’ to exit the wizard.
18
Step 7
Installing EasyDentV4
Step 8
The program compatibility and Windows Firewall alarm messages are shown.
Click 'Run program' button on the program compatibility message.
And click 'Allow access' button on the windows security message.
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