HDI 1000

Manual de instalacin &

Uso
Este manual cubre la instalacin y funcionamiento de la HDI 1000. A menos que se
especifique lo contrario, toda la informacin contenida en este manual es aplicable
igualmente a todos los tipos de HDI 1000.

Aviso a los usuarios

Para la mejora del rendimiento del producto, la suplementacin y el seguimiento de la
informacin, el contenido de este manual est sujetas a cambios sin previo aviso.

Tenga en cuenta que nuestra empresa no lleva ninguna responsabilidad por daos
accidentales, ni estar obligada a realizar el servicio de garanta por daos al equipo
debido a un error de usuario. Siga de cerca las instrucciones de este manual.
Familiarizarse con los procedimientos de uso de este producto y las precauciones de
seguridad. Tenga en cuenta que el producto puede diferir ligeramente de los contenidos
de este manual, segn las especificaciones del producto individual.

Se utilizan los siguientes smbolos en este manual para proporcionar instrucciones en

el uso efectivo de este producto.

Indica informacin til y consejos sobre cmo utilizar nuestros productos

y software.
NOTE

Indica instrucciones importantes. Si no, pueden ocurrir un mal

funcionamiento o daos en el sistema u otras propiedades.
CAUTIONI

Indica las advertencias e instrucciones de seguridad. Si no, hay un riesgo

grave de lesin para el paciente y el operador.

WARNING En Estados Unidos la ley federal restringe este dispositivo a utilizar o por
prescripcin facultativa de un mdico..

CAUTIONI
 El dispositivo debe instalarse y utilizarse de acuerdo con las normas de seguridad y las
instrucciones provistas en este manual del usuario slo para los fines y usos que est destinado.

Indicaciones para el uso

HDI 1000, un sistema de proyeccin de imagen Intra-oral, pretende recoger fotones de rayos x
dental y convertirlos en impulsos electrnicos que pueden ser almacenados, han consultado y
manipulados para uso diagnstico por los dentistas.

Antes de cada uso, Compruebe la superficie externa de la 1000 del IDH para detectar cualquier
signo de dao fsico o defecto. La superficie del IDH 1000 debe tener un acabado liso, sin evidencia
de daos o saltar. De lo contrario, pngase en contacto con su distribuidor local de productos
RAYENCE para ms instrucciones sobre cmo proceder.

To ensure the correct usage of the HDI 1000 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 RAYENCE

personnel or by parties expressly authorized to do so by RAYENCE. Any modifications or additions
must always comply with the standards and generally recognized rules of good workmanship.

It is the users 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.

2
2
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

2 *cm Type B applied part

Indicates to the user to check the accompanying documents (this

User Guide) for more information about HDI 1000

3 CE
O 1 2 O
Conforms to CE MDD 93/42/EEC (European Communities)
concerning medical devices

5
~

- Waste Electrical and Electronic Equipment

Handle with care

6 Fragile, handle with care

7 This way up

8 Intended for a single use.

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 RAYENCE logo and the following label can be found on the HDI 1000 device.

Rayence Co., Ltd.

,., lF, 2F, 3F, #402, 14, Samsung lro 1-gil,
Ravence Hwaseong-si, Gyeonggi-do, 445-170, Korea

Product Name : Medical Image Processing Unit

Model Name : HD! 1000
~ XXXXXXXXXXXXXXXX *[EJCE
I 1r 0120 -
Associated equipment complywith the Radiation Control
I for Health and Safety Act of 1968 or 21 CFR 1020.30 d XXXX. XX. XX
!REF! RUSM-703

I ec I I REP
Vatech Dental Manufacturing Ltd.
Axlom House, The Centre Fettham, Mlddlesex.
1W13 4AU, United Kingdom IP Class : IPXO
Tel : +44-20-8831-1660 Fax: +44-20-8831-1679
4
Contents
CHAPTER 1 INTRODUCTION ...................................................................6
1.1 System Description ...........................................................................................6
1.2 System Components .........................................................................................8

CHAPTER 2 HARDWARE INSTALLATION .............................................10

2.1 What you should do before use .....................................................................10
2.2 Specifications ..................................................................................................10
2.2.1 PC Specifications.................................................................................................................... 10
2.2.2 HDI 1000 Driver Setup ............................................................................................................ 11
2.3 Cable Connection & Driver Installation..........................................................13
2.4 Installation of the HDI 1000 Holder.................................................................16

CHAPTER 3 INSTALLING THE SOFTWARE...........................................17

3.1 Installation of EasyDent ..................................................................................17
3.2 Preparing for Image Acquisition with the HDI 1000 ......................................22
3.3 Running the EasyDent.....................................................................................23
3.3.1 Patient Registration and Device Selection ........................................................................... 23
3.3.2 Single Shot .............................................................................................................................. 25
3.3.3 Multi Shot ................................................................................................................................. 29
3.3.4 Sequence Shot ........................................................................................................................ 33

CHAPTER 4 MAINTENANCE ..................................................................36

4.1 Visual Inspection .............................................................................................36
4.2 Periodic Maintenance ......................................................................................36
4.3 Cleaning............................................................................................................36
4.4 Precautions ......................................................................................................37

CHAPTER 5 WARRANTY ........................................................................38

APPENDIX ..............................................................................................40
A.1 LED Indicators .................................................................................................40
A.2 X-ray Exposure Guide .....................................................................................41
A.3 Error Message ..................................................................................................43
A.4 Troubleshooting ..............................................................................................45
A.5 Electromagnetic field information according to IEC601-1-2 ........................46

5
 Chapter 1 Introduction

1.1 System Description

HDI 1000 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.

HDI 1000 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.

HDI 1000 is connected by a USB A-A cable (supplied separately) to a compatible Windows XP
or Windows Vista or Windows 7 PC. HDI 1000 is provided the power from PC. Support for the
HDI 1000 is provided by compatible software programs such as EasyDent.
For other custom applications, a programmers guide is available.

The HDI 1000 comes with the following features:

Excellent image quality based on advanced CMOS technology

More comfortable sensor ergonomic shape for human oral structure
Lower dose exposure
Enhanced durability
Easy-to-use USB interface

6
6
< Table 1. Specifications >

Parameter Description

Detector Structure Low Noise Hybrid CMOS

Size 1.5: 1.14 x 1.52 x 0.19 inch (29.2 x 38.7 x 4.95 mm)
Dimensions (W x L x T)
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

Size 1.5: 686 x 944 pixels (24.01 x 33.04 mm)
Active Pixel Array
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

3m
between Controller and PC

Electrical rating DC 5V, 500mA

Operation mode Continuous

10 to 30 (Usage)
Ambient Temperature
-20 to 60 (Transportation and Storage)

30% to 95% (Usage)

Relative Humidity
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.

7
 1.2 System Components

The HDI 1000 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. HDI 1000 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) Sensor cover

7. S/W Installation CD EasyDent (Image S/W) + HDI 1000 Driver

8. HDI 1000 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.

8
8
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.

00

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 (disposable sensor
cover) must cover the sensor before placing it in the patients mouth. The once
used wrap shall be disposed. These wrap are conform to the ISO
10993-1.

7. S/W Installation CD
Include EasyDent V4 (Image S/W) Installation & Sensor Driver CD.
Chapter 2 Hardware Installation

2.1 What you should do before use

To operate the intraoral sensor, you need to install the HDI 1000 driver. This device should be
connected with the product which is complied with IEC 60601-1.

2.2 Specifications
We cannot guarantee that EasyDent will work properly with an unregistered
copy of Microsoft Windows. Therefore, you should use registered, genuine
WARNING version of Microsoft Windows.

2.2.1 PC Specifications

Operating System
Microsoft Windows XP 32bit
Microsoft Windows Vista 32bit
Microsoft Windows 7 32bit
Hardware 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

ti NOTE
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

ti NOTE
only those that are internationally authorized. Take extra precaution when
installing any Active-X controls.
-
10
2.2.2 HDI 1000 Instalacion del controlador

Este paso es necesario para la instalacin de 1000 de IDH. Captura de datos de calibracin
y software para el HDI 1000 se instalar junto con el controlador de dispositivo de Windows.
Tambin est instalado un controlador Twain durante este paso.

Paso 1

Inserte el CD de instalacin
"
en la unidad de CD-ROM se Acrobat EasyDentV4 EzSensor Manual autorun.inf
iniciar automticamente.
Si no lo hace, haga clic en
Inicio > Ejecutar y escriba
D:\EzSensor\setup.exe.
CAL setup.exe
J
layout.bin

r1"
0x0409.ini EZSENSOR.i setup.ini
J
datal.hdr
ni

Paso 2
El programa de instalacin
Welcome to the l nst allShield Wizard for
para 'EzSensor adquisicin EzSensor Acquisition Software Version 6
Software versin 6'
aparecer. Haga clic en el T he I nstallS hield W izard will install E zSensor Acquisition
Soltware Version 6 on your computer. To continue, click
botn 'Siguiente. Next.

<!l.ack Next > 1 1 Cancel

 Paso 3
E.zSensor Acquisition Software Version 6 - InstallShield Wizard
Home direclory C:\EzSentor
Compruebe el directorio de
instalacin del EzSensor
lnstal rnandatory modules and the next featu,ed application components
y haga clic en el botn 'Siguiente'.
Calitwalion Data for EzSensor 1.5, Serial ID CR10EOH81234-5678
C:\E zSensor\MultiSensor\CR 1 OEDHB 1234-5678

Legyl!R)lications supporl palchlor EzSensor 1.5

C:\E zSensorl 50 (compatible ~h Ez0ent4)

64-bi ivefs
C:\EzSensor\DRV

lnstallShreld ---------------------------

< -ck ff Next > j I c.r.:e1

Paso 4
EzSensor Acquisition Software Version 6 - lnstallShield Wizard
Setup Status
El asistente Installshield
empezar a configurar los
The lnstallShield V\Azard is installing EzSensor Acquisttion Software Version 6
parmetros de la instalacin.

lnstalling
C:\WI NDOWS\TWAI N_ 32\VATWAI N\E zTWAI N.ds

lnstallShield ---------------------------
Cancel

Paso 5
Jpyng cdbillhan les
Su workstation(PC) copia los C\ \CRlOEOHB 1Z3H78\d~ raw
archivos de calibracin 1000 HDI el
Asistente de InstallShield.

-
12
2.3 Cable Connection & Driver Installation

No conecte el cable HDI 1000 y USB PC interfaz al ordenador hasta que haya
instalado con xito el programa de instalacin.
CAUTIONI

Asegrese de conectar el mdulo de HDI 1000 a la caja del tablero de control

antes de conectar el cable de interfaz de PC USB a su ordenador.
CAUTION

Conectar el nico elemento que se ha especificado como parte del sistema de equipo
mdico.
WARNING

o:

Step 1

Connect the HDI 1000 Module

to the Control Board box. 00

Step 2

Connect the USB PC Interface

Cable to the Control Board
box.
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.

VU (1~ ~ Control Panel ~ System and Security ~ System . . l t J ( Seottb ControlPaoel pi

file f:dit l[iew Iools !::!elp

Control Panel Home

View basic information about your computer
Device Manager Windows edition
Remole settings Windows 7 Ultimate
System protection Copyright 2009 Microsoft Corporation. AII rights
Advanced system settings reserved.
Service Packl

System
Manufacturer. Hewlett-Packard
See also

Rating: :.;.! Windows Experience Jndex

Action Center
Windows Update Processor. Intel(R) Core(TM) o CPU Q 720
@ 1.60GHz 1.60 GHz
Performance Information and
Tools Installed memory (RAM): 8.00 GB
System type: 64-bit Operating System
-
14
 :a Device Manager VH EzSensor-N 1.5 Preperties
~
file ~ction ~ew .tfelp General I Driver I Detals I
1

- '"' . ~
VH EzSensor-N 1.5

Device type: lmagilg devices

" lmaging devices Manacttxer: VaTech

~ HP ENVY HD Webcam l.ocaton: l.ocaton o

-. VH EzSensor-N 15
Device status
Keyboards ,.
,o l!hs device is working properly.
u M1.ce and other pointing devices
L Monitors
~ Network adapters
Portable Devices
Q Processors .
Sound, video and game controllers
1> ., System devices
Universal Serial Bus controllers

1 OK
11 Cancel 1

HDI 1000 is supplied the power and transported data via USB port of PC.
Do not disconnect during usage.
CAUTIONI
 2.4 Installation of the HDI 1000 Holder

The HDI 1000 holder is used for mounting the HDI 1000 to the wall when not in use.
When choosing where to install the HDI 1000, 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).

16

16
Chapter 3 Installing the software

3.1 Installation of EasyDent

In this step, EasyDent(viewer) 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. Acrobat EasyOentV4 EzSensor Manual autorun.inf
D:\EasyDentV4\setup.exe.
Press Enter.

setup.exe

Step 2
EasyDent V4 (Multi-Language) - InstallShield Wizard
Select the language you want Choose Setup Language
Select the language for the installation lrom the choices below.
to install and then click Next.

Chinese (Simplified)
Chinese (T raditional)
Czech
Enolish
French (Standard)
Hungarian
ltalian
Japanese
Polish
Portuguese (Brazilian)
Russian
Spanish
Turkish

nstallShl Id

<ack ):!ext > ! 1 Cancel

 Step 3
The EasyDent V4 InstallShield
\llelcome lo the lnstallShield \llizard lor
EasyDent V4 (Mult i-Language)
Wizard will appear. Click the
Next button. The lns t allShiel d Wizard will install EasyDent V4
Multi
( -Language )on your computer. To continue. click
Next.

<!!ack Next > ] 1 Cancel

Step 4
EasyDent V4 (Multi-Language) - InstallShield Wizard
Setup Type
Select the setup type that best Select the setup type that best suitsyour needs.

suits your needs.

Please select installationmode of EasyDent4
Click the Next button.
@:~.~.s.itj
e_1 For CD -Publishing
Basic : Installs the basic
version of EasyDent V4
CD-Publishing: Installs the
basic version of EasyDent V4
along with CD-Publishing
nstallSh.ld
capabilities. (optional)

'---<-=!!:....a_ck_...,. >_.N.,_! e1_x_Ctancel

For the EasyDent server, select all items.

For PC being used for viewer: Select only the items except for DB & File
servers.
NOTE

For the detailed installation, refer to the EasyDent installation manual.

-
18
Step 5
EasyOent V4 (Multi-language) InstallShield Wizard
S ele et Feature:1
Select the features that you Selecl lhe leaiur .. selup wll inslII.

want to install. Click the Next

Selecl lhe lealut .. l'O'I wonl lo n,loll, ond do,olocl lho loolu10, you do nol wonl lo in,1011.
button.
De,c,iplion

iti'htfflmtAt~iMli
Eo,y()ent4.0Viowe, EooyDenl Vowe,. Ez><. EzCom
EzP..X V,ewe,
EasyDent Viewer is the G1I EzCom V,ewe,
G1I FileS OIVOI
minimum requirement for HDI G2I D8Se1ve1

1000 use.

518.81 MB o/ spece 1equi1ed on the C drive

458666. 75 MB o/ spece available on the C drive
aS1 eld~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

-
< ack ![ ti ext > J I Cancel

Step 6
EasyOentV4 (Multi-language) - InstallShield Wizard
A eady lo I nstall lhe Progr am
Now you are ready to install. The wi.zard is ready to begininstallation.

If you would like to review any

Cick Instan to begn the installation.
of your installation settings, U you want to review or change anyof yourinstallationsettings,click Back. Click Cancel to exit
lhe wiza,d
click Back, To proceed with
the installation, click Install.
Click Cancel to exit the
wizard.

< l!ck IIC'.in,1011 JI ! Concol

 Step 7
EasyDent V4 (Multi-Language) - lnstallShield Wizard
Setup Status
Installing EasyDent V4.

The lnstallShieldWizardis installingEasyDentV4 (MultiLanguage)

lnstaning

C:\EasyDent4\EdpV4\Language\ESP\EzXESP.dll

ln~allSh,eld ----------------------------

Cancel

Step 8
Progr,m Comp1tibility Assistlnt

This program has known compatibility issues

The program compatibility and
Check on1ine to see if selutiens are available from the Microsoftweesite, Jf solutions are found, Windows
Windows Firewall alarm will 1utom1tically displ1y website th1t lists steps you con tske.

messages are shown. Progr,m: Microsoft SQL Server MSDE

Publisher. Microsoft
tccatien: Not Av1il1ble

Microsoft SQL Server MSDE is inccmpatible with this version of Windows. For more informotion, contact
Click 'Run program' button on Microsoft.

the program compatibility (") Hide let1ils Check forsolutions online ll Bun progr,m ll Cincel
~ Dn't show this mesuge 19,in
message.

,i Wndows Socurity Alert

And click 'Allow access' button
~ Windows Firewall has blocked sorne features of this program

message. Windows Firewallhas blocked sorne featisesof FileServer on al public and private networks.

~ame: ~
eublisher: vaiu. AddedTehnologiesCo.,Ltd

Pato: C:Weasydent4\/t'fie serverWfileserver.exe

Allow FileServer to comnunicate on these netwon<s:

~ Pjvate networl<s, sud, as my home or work network

l!:J Piblic netWO<ks, sud, as those in airports and coffee shops (not recommended
because these networks ofteri have lttle orno seaxity)
What are the risks of alowng a program IIYough a fi"ewal?

~ow access J I Cancel

20
Step 9

MSDE(Microsoft SQL server

Desktop Engine) is installed
automatically.
IE80725 ...:]
Close the SQL Server Service 1 ' ...:]
=
Manager. Refresh serllices...
J
~ lita,VC01 tinue
,
....!!..J P.ause
....!_J S QD
t
r e,u 0-start serllice when OS starts
1
Stirtig-=-WWEll072~S-SQIServe
r

Step 10
Seleccione 'No, reiniciar lnstallShield 'w'izard
mi equipo ms tarde' y haga Complete
Se up has inished nstall
clic en 'Finalizar'. yout compute,.
f i ingEasyOentV4 [MultiLanguage)on r

e> Yes,1 want to restar! my compute,now.

@ No , .1..wiUresta rtm: c ompute,.lated

Remove any d isks from their drives. and lhen click Finish lo
complete setup.

Finish Cancel
3.2 Preparing for Image Acquisition with the HDI 1000

Turn on the computer.

Run the EasyDent. (refer to P23)

Configure the required X-ray parameters (exposure time, etc.) for the X-ray generator.

Put a new sensor cover on the HDI 1000 and connect this to the sensor positioning

system.

Position the HDI 1000 at the appropriate area in the mouth. The flat receptor side of the

sensor must face the X-ray source. Note that the receptor side is marked with a label for
ease of recognition.
The use of the sensor positioning aid is recommended to guarantee that the sensor is
parallel to the tooth and at the appropriate angle for exposure.

The use of the parallel technique with a positioning system, if possible, is highly

recommended.

After preparing the sensor for exposure in EasyDent, acquire an image by pressing the
exposure button for your X-ray source.

Using the HDI 1000 with

Using the HDI 1000 with intraoral X-ray
a Sensor positioning system(optional)
22
22
3.3 Running the EasyDent

Shot functions are available after patient registration and device selection. Single shot, multi
shot, sequence shot are used frequently. You must be fully aware of the explanations before
capturing image.

3.3.1 Patient Registration and Device Selection

Step 1

Turn on the PC.

Run EasyDent4 Viewer. Click the Patient ( ) button to register a new patient.
v,~e.1
{[] bsyDt:nt V4
f,lt: fd,t ~it:w 01t1,b:ut: .Qr1w M,Hsurt: i!Tilgt: !ool Jmpl1nt :i{indow tjdp
---------=--
Gl !Al

~ ''"' 1 ! 1..... ~ 1 ZtQ ..,... ~, 1 .:-

!fl)TSFD la>w
TCIT ALSOtUT!OllfORotlfTAl
fageUst
P1tit:ntN1mt: ChartNo.
lgt:Typt: C1pturt:dDete
Chart No.
Fi'stName
Last Name
Social ID
Age/Gender
Treatment
Mobie

Tel

Sech(Date)

c"'~"'--:;t""J

l
P1ti1:nt Neme ChartNo. Cha,tNo.

~---L

EasyOentV4 runn1no DServer Connected ~ FServer ConneGted itl )1

Step 2

The new patient registration window will appear. You are asked to register the new patient
and click Add.
Add Patient
Chart No.: I Recently 1 [] Auto No.

Fi"st Name:

Last Name:

Social ID :

Bithday :. !2_01_2 ~1_-

1 -~l_1 ~I

Gender :~!M_a_le ~J Treatment: ~T' _r_e_ant_

mte ~J
Addressl :

Address2:

E-mai:
Tel: Mobfle:

Doctor:. ! -------~!
Add Cancel

Step 3

Click Help > Intra-Oral Sensor Setting > Select Device on the menu bar.
Select your capture device. At this time, you are asked to select the device and image
quality.
The sensor model and image processing setting information is stored internally. Change
these settings when using another sensor or changing the image processing option.

Setect Intra-OralSensor

lntra-Oral Sensor Model

High Contrast (Default)
e HDS-150 ~ HDS-1505 e HDS-lOOL
_ AnySensor 1.0 AnySensor 1.5 6 AnySensor 1.0N ~ AnySensor 1.5N Middle Contrast
EzSensor 1.0
Low Contrast
EzSensor 1.5 e.') EzSensor 2. O @i=.zSensor Multi
Hyman EzSensor P

High Contrast New

lmage Processing Option
<> High Contrast Middle Contrast ; Low Contrast High Contrast New Middle Contrast New

Middle Contrast New Low Contrast New Normal Image

Low Contrast New
Ok 11 Cancel
Normal Image
-
24
3.3.2 Single Shot

Capture a single image.

Step 1

Start EasyDent by clicking the EasyDent V4 Viewer on the desktop.

f,~ fdit
Oata.t!u<I' Q,- MtISUl'<I'

- !oo< Jmplant W,ndow

- . . fil 'ii

~""' -
[)EH)'Dffl:V.fV!r 'Mf
tit,._ .... ~ .... """'"' - ,...
-<
.....,_.. ...... .... -- ....
ltllo. IOHIIIIIII, .., sam ..,.,,,
t;;;:t,~

~
.....[... W CllEII [fNUlO 1

...

~ =~ 1: 11 I
.....
P Patient Ust
-- ........ c...,...,

-~ ... '
lmage Ust

. ..
Bir thcby Cptured0.t<I'
im.gt'l)'p<I'
Pi'tientN.111<1' CtwortNo.

JoM '"
""""""
LastName Jung
SOCiallD

-
Age/Gendef12 / M'* '
Treatment Treatment

r A
.
.._...,,,
1 1

Tc:ultwges):0

:--- r- .
1
1
CtwortNo. Birthd.y CtwortNo. .......,.

lI
EasyOent V4 rurrino 10-S<l'rver Connedediial f server Connected 'i: S, ~
 Step 2

Click the Layouts tab. Select your favorite layout from the Layout template list.
The Layout Template can be customized. Please refer to the EasyDent manual.

Seled i..,.,.. T..,..,i.te Seled Sm Type

Old Easy[)ert 's Periopcal Sr,gle

DD[Il]DD
DO DD
0000000
..........."""'"""
""
"""'"
-
~ 12/M*
Tr r.atmffll Treatmffll:

DD re

1 -

DDDD
4Elle,w,os

Step 3

Select the Single from the Shoot Type list.

DO

DD

DO
ooDDloo
DD 1'22

Multiple

~ [2]19~~[61[sl
AA 0L18l
l7 [s]E~3 41L3l
Basic SeQUenee

-
26
Step 4

Select the tooth position to capture. The tooth box is selected in blue.

00[1[1[100 13,12 11,21 22,23

oo onRM RI LI lM

nnDDDnn
46. 47, 46 45, 44 43, 42 41. 31 32, 33 34, 35 36, 37. 38

Step 5
Click the SENSOR ( ) button or Capture ( [ . ....................
Capture.l ) button.

Step 6

Position the sensor correctly.

 Step 7

After checking the sensor is in the correct position, expose the X-ray after the Please
expose X-ray message appears.
The message, Optimizing Image Please wait appears while the image is being
optimized. The image will appear after optimization is complete.

~erbyDale .

-~I"-"""' I
Chart No. 1000

10 0
Fnt Name John
L.ast:Name Jung
SOOO!D
Age/Gender12 / Hale
""""
Tel
Treatment Treatment
1a.11.,a 15,14 Press tbe X-ra~ (sbotJ bucton 24.~ 2e.27,28

00
Seadl(Oate)

Total{hlages):0

RM RI

ooD 411,47.46 45.4 4

'eisyoet V4 runmno 0.ServerConnected-~I F-ServerConnected jes"I

[')EasyOentV4Vi- ~~
file Idit ;iliew Data.b:He Qraw MeHu1e lmjge !ool Jmplant rfindow t:felp

~"" 1111 :! ~I 8IIGil CCIITIIISI GIIMI ~ ~ 1

ZlXll ..:iltftit REPUIT 1 t9mfG ll6ISlff ...utll (1(9f 1
IHIElfii SCIEOOIIIT llM !ESEI.EO Hlfl.12E
1

~~~00
PP11l&plc,,.-
~
.
-- -
2012/07/03PM06: 02:..52
,,,....----
,.... ........ a.-...c-1
- "' -

~ FMXwithlhtfflOllhs
. . I"-"' .. I
(})artNo. 1000 . Seled!.a,uJ;Tffl'Clble: SeledShootT)'Pe ~erbyDale:

~
Fnt Name John

oo~oooc
last Name
5ocel ID
'""9 2012J07/03
e
Age/Gender 12 / Male
Treatment Treatment

""""
Te l
.-J = .
s..oh(Dot,) 13.(121 11.21 22.23

00 DD
1 1
Total(lnaget):1

RM
., u lM

ooDD Doc
-1
411,47,46 45,44 43,42 41,31 32,33 3 4,35 36,37.38

Eas'f[)ent V4runnim; 1 1 10-Server Connected iml F-Server Connected iijr.--4

28
3.3.3 Multi Shot

You can capture multiple images continuously until you click stop. Click and drag the image to
its appropriate position after stopping capture.

Step 1

Select the Multiple from the Shoot Type list.

Sele Shoot T)'pe: Fllerby Dote:

Single G ! Cai,t\ft ! !c.i,tured Dote ~ 1

i DO 0000080
DD r-------

Single

DO DD -
21

C11Cil8E3L6l[s)
Muk,ple

AA L17JA
L7J[s]EJ53L4JL3J
Basic Sequence
Step 2
Select the tooth position to capture. A blue rectangle will be drawn on the tooth box.

oomoooo
201mMl4

nn
(131, 12 11, 21 22. 23

RM RI
noLI LM

nBDDDoo
48,47. 46 45,44 43, 42 41, 31 32. 33 34. 35 36, 37.38

Step 3

Click the SENSOR ( ) button or Capture ( ) button.

Step 4

Position the sensor correctly.

30

Step 2
Step 5

Expose the X-ray after the Please expose X-ray message appears.
The message, Optimizing Image Please wait appears while the image is being
optimized.

Qr1w M,uure lm1ge lool Jmplan t Window t:felp

-< .il\. 1 . ..
EAiHl (()l lflASI liFm1 ZOOI lf,Nftil , AEPOJt l ORAINi IIIEA5(ft

Selec:tl..ayot.tT""1)1ate
. ~eo-byOe I
FMXwthJHf.eitotthoh ~ c..-,o.,
Chart No. 1000
R'St Name .John

-
Last.Name Jung
/

DD
5ocel ID
r t
Age/Gender 12 Male
T eatment Treatmen
Td 11!1.17.16 15.14

,._,, 13.1121

Tatal(maget):1

DD -
DD u ~

ooDDD oo 48.47.46 45,44 '3.42 '1.31 32.33 34,35 36,37,38

EasyOent V4 runnirnJ 1 0-Server Conned:ed W;j I F-St!!rverConnected ~ !si

Step 6

If you want to acquire more images, continue to expose the x-ray when the Press the X-ray
(shot) button message appears.
To finish, double click on the Press the X-ray (shot) button message box. And then the
image will appear after optimization is complete.

1000

John

DD
ft'StName
l.astName Jung

'""ID
Age/Gender 12 / Male

Treatmeot Treatmffit

Te re. 17, 16 15, 14

00 DO
1l.[121

T<Ul~J-,

D DDDoo .,.u.,, u.2 1.31 n.33 34.:ss :,e.37.38

0-ServerConnected'11:! FServerConned:ed CI ,

Step 7

Click and drag the image to its appropriate position.

[]Et~v,v_.er
ftlt: fdit Y-

p_. -.~
Selec:tl.aratlTerrce
FMXwth3kr.eitorn:ib

ChartNo. 1000
ft'St Name John
Las( Name Jung

D
S<m!D

-
Age/Gender 12 / Mate
Treatment Treatmeflt

Te 111,17,16

.......,.,, 13.1121

Total(hages)'
00
EaSV[)ffltV4 runnino 32
IDServerConneaed IIC! FSuverConneaed -ic ,

Step 7
3.3.4 Sequence Shot

You can capture multiple images according to a pre-saved order. Capturing according to the
order will ensure the images appear automatically in the correct positions.

Step 1

Select your favorite sequence from the Shoot Type list. Red numbers are represented the
capture order.
The Sequence shot can be customized. Please refer to the EasyDent manual.

DO 00

0000000
DO 00

Mutlple

GL2lf";-'':'3L6lL5l
r-r-: [1i][1a)
L710~~3L4JL3l

Step 2

Click the SENSOR ( ~ ) button or Capture ( ~Capture] ) button.

-----
~

Step 3

Position the sensor correctly.

Step 4

Capturing according to the order, the images appear automatically in the correct positions.
Expose the X-ray after the Please expose X-ray message appears.
The message, Optimizing Image Please wait appears while the image is being
optimized.

IE)Easy()fflt\J4Virwt'r

File Ed,t V.f!W Oatabase Or- Mewi.ure Jm.ge Tool lmplant W~dow Help

~lll11 ~
~ren ! SfD INXtl ..-,;
IIMitll
lOll!MSI ~ ZOOI '"'l .Jk..I llGHffA REPOIH rffllNi

I Fhrt,,-0.e I
Olart No.
R'st Name
1000
John
~ """"'""'
LaSt Name Jung 2012/07/03
Sodo ID
Age/Geflder 12 / Male
Treatment Treatment
Mollle GJ=
2
Tel 18,17,HI 15,[14)

13,(121 11,21 22,23

Total\1,naoes)I

Dllle2012/07/03PM06:07:10
@]~
K..,,AnA.:63.0/0.0
RM RO

0 -~- 1EJBEJ00
43,42 '1,(31) 3 2 ,33 34,35 36,37,3&

48,47,46 [45),4-4

EasyOent V4 runnino DServer COnned:ed IICI fServer COnned.ed ~[si"

34
Step 5
Step 6

If you want to finish, double click the Press the X-ray (shot) button message box. And then
according to the capturing order, the images appear automatically in the correct positions.

[)EnyO~V4VlfWtJ -e, -- ~

.
file (dit ~- D1t1.b:ne .D:raw Musure lmtge lool jmplant Window l::!elp

!flHI CONI.SI ~ Z'OOI MiJ,,ftll IIEKIII ~

FlerbyOete

~l"'"""'I
~- 1000
IFirst Name John L.aSt
Name Jung SOdal ID 2012J07I03
Age/Gender12/Maje
Treatment Treatment

,. f

DD
Moble

13,1121 11,21 22.23

Totill~)9

DD RM R! U LM

D~Dgm
0.,2 ,1.(311 32.33 (34).35 [38].37.38

easyOent V4 ruonino D-~rverCOnneded ~ F-ServerCOnr.ected -~"

All images are saved in the Database server automatically.

With double click on the image, the image is shown as large size at any
NOTE functions table.
 Chapter 4 Maintenance

4.1 Visual Inspection

Like all electrical systems, HDI 1000 requires not only correct usage, but also visual inspection
prior to operation, as well as routine checks at regular intervals. These precautions will help ensure
that the system operates accurately, safely, and efficiently.
Before use, the operator should check the system for any signs of physical damage or defect. If
something out of order is suspected, contact your local RAYENCE product distributor for further
instructions on how to proceed.

4.2 Periodic Maintenance

Periodic maintenance should be performed as necessary, and at least once a month. Maintenance
should consist of various checks performed by the operator or by a qualified service
technician.
Check that all cables connected to the HDI 1000 are undamaged.
Check for external damage to the HDI 1000 that may compromise its ability to be safely
operated.

4.3 Cleaning

To clean the HDI 1000, use either of the following solutions listed below and observe the
precautions noted.
Mild soap and water
Isopropyl alcohol (70%)
Do not soak or immerse the system and be sure to dry it completely after cleaning.
Clean the surface of the system by moistening it with a soft cotton swab dipped in either of the
cleaning solutions listed above. Gently wipe the surface from end-to-end in straight lines,
without applying any pressure. Make sure that liquid does not penetrate the system through the
USB cable or the sensor cable connectors.
After cleaning the surface of the HDI 1000, use a clean lint-free cloth to dry the system, as
required, until the surface is clean.
Clean the silicone cover using the same method.

36
36
4.4 Precautions

Do not soak the sensor in the water or alcohol.

Authorized service personnel can repair about calibration.
Service personnel cannot handle the problem which is not mentioned in this manual. So,
in this case please request the repair to manufacturer through RAYENCE dealer.

Do not modify this equipment without authorization of the manufacturer.

WARNING
 Chapter 5 Warranty

RAYENCE hereby warrants HDI 1000TM (Product) against defects in material and
workmanship under normal usage and service for a period of 12 months from the date of
installation or 15 months from shipment date, whichever comes earlier.
If Buyer promptly notifies RAYENCE or Seller regarding any parts that fail to perform as
specified under normal usage during the Warranty Period and RAYENCE determines that such
failure resulted from a defect in materials or workmanship during the Warranty Period, then
RAYENCE, at its option, shall repair, rebuild or adjust the affected parts.

RAYENCE shall have no obligation for any defects to the extent that such defect arises out of
(i) normal and fair wear and tear or Product which has been modified without RAYENCE's
approval, (ii) Product which has not been installed in strict conformity to the RAYENCE's
directions or which have been subjected to electrical or other abuse, or damaged by improper
handling, storage or use by Buyer or a third party, (iii) use of Product in combination with
devices or products not purchased from RAYENCE; (iv) use or application of Product in a field
or in an environment for which such Product was not designed or contemplated; (v) use of any
parts or material not provided by RAYENCE for warranty service; or (vi) the third partys
maintenance not certified by RAYENCE; or (vii) force majeure such as natural disaster.

Repaired, rebuilt or adjusted component parts are warranted for 90 days or the remainder of the
Warranty Period, whichever is longer. This Warranty extends solely to Buyer and shall not
extend to any person that purchases the Products from Buyer or any other person, whether an
entity or a natural person, in the chain of the use or distribution of the Products.

The warranty period for Product shall including replacement of Non-Consumable parts and the
labor to correct warranty issues.

Buyer will make all reasonable efforts to advise RAYENCE of the use of any non-RAYENCE
authorized Items, components, or parts in Product. If, after troubleshooting, it is determined that
repairs (including replacement of any Items, components, or parts) to Product under warranty
are a result of a non-RAYENCE authorized Item, component, or part, RAYENCE will be paid for
all costs associated with the repair service rendered.

38
38
This expresses all of RAYENCEs responsibilities regarding the Product, including the sale of
the Product, the events giving rise to the sale of the Product, defects in the Product, and the failure
of the Product to meet or perform in accordance with specifications or as intended. The remedies
contained in this warranty are Buyers exclusive remedies. RAYENCE shall not, in any event or
under any circumstances, be responsible for damages or other sums in excess of the total
purchase price actually paid by Buyer to Seller i.e., RAYENCE or RAYENCEs dealer. Without
limiting the generality of the foregoing under no circumstance shall RAYENCE be responsible
or liable in any regard with respect to damages from loss of use, loss of time, loss of data,
inconvenience, commercial loss, lost profits or savings, or other incidental, special or
consequential damages claimed by Buyer to arise out of the use or inability to use the Product,
even if Buyer has been advised of the possibility of such damages.

If the Buyer fails to pay any amounts due to the Seller, whether related to the Products or
otherwise, RAYENCE shall have the right to refuse to provide any services to the Buyer under this
Warranty until such payment has been received by the Seller.

In the event that the product is returned to RAYENCE after the warranty has expired, RAYENCE
reserves the right to invoice a reasonable fee for the repair services provided to Buyer.

RAYENCE shall make the sole final determination about whether the fail to perform occurred in
normal usage (under warranty) or not (excluded from warranty). If the dealer or the Buyer
doesnt accept the result of RAYENCEs investigation, the burden of proof is on them.

Warranty Procedure
If Buyer needs to make a claim based on this Warranty, Buyer should advise Seller in writing
immediately at the following address:

RAYENCE Co., Ltd.

1F, 2F, 3F, #402, 14, Samsung 1ro 1-gil, Hwaseong-si, Gyeonggi-do, 445-170, Korea

39
 Appendix

A.1 LED Indicators

The HDI 1000 Hardware Controller has two LED indicators that show its functional status.
The location of the LED lights is as shown in the following illustration and described in Table 3.

LED 1

LED 2

<Table 3. Description of LED Indicators>

LED State Functional Status

Operational State
LED 1 LED 2 Confirmation
Initial State Green Off USB Connection

Standby Green Green Capture standby

Trigger (X-ray On) Orange Green X-ray On and Sensor Trigger On

Data Transmission Confirm data transmission

Green Orange
with the USB PC interface cable with the sensor board

Image acquisition Completion of data transmission

Green Off
(Return initial state)

40

40
A.2 X-ray Exposure Guide

The required X-ray dose for the best image is dependent on the following:
- X-ray source (tube assembly, manufacturer, AC/DC, etc.)
- Distance between beam focus and sensor
- Tooth (object) to be X-rayed
- Bone density and age of patient
- Miscellaneous circumstances, etc.

The X-ray dose influences image quality. Based on fundamental laws of physics, an insufficient
dose generally means higher image noise, which leads to poorer detail discrimination. On the
other hand, an excessively high dose can cause the sensor to be overexposed. This is also
perceptible by a decrease in detail discrimination, specifically in darker areas.

The effect of image processing reduces the difference between image qualities of different
doses. Users can adjust brightness and contrast in the option menu.

The recommended exposure dose is from 300Gy to 600Gy when measuring without an
object. Exposure time corresponding to the dose may vary depending on the X-ray equipment
used. Recommended exposure times according to positions are as shown in the Recommendation
on Exposure Time Table.

The X-ray dose is maintained through tube voltage (kVp) and current (mA), as well as exposure
time according to the signal level.

Since the exposure time depends on the diagnostic problem as well as the

ti NOTE
clinical situation, the selection of an adjustment is the responsibility of the
treating physician.

Image degradations caused by overexposure of the sensor cannot be

compensated but by insufficient dose can be partially compensated
CAUTION' through image processing.
 < Table 4. Recommendation on Exposure Time >
Exposure Dose 60kvp 60kVp 65kVp
condition (Gy) 6mA 2mA 5mA

Patient Adult Adult Adult

SID 28cm 18cm 28cm

Intra Oral X-ray Unit No VX 70 AnyRay ESX

(Model name) Filter Approximate Exposure Time (sec)
Incisor
& 300 ~ 500 0.12 ~ 0.2 0.1 ~ 0.2 0.18 ~ 0.28
Canine

Molar 400 ~ 600 0.16 ~ 0.25 0.15 ~ 0.25 0.24 ~ 0.34

* SID : Source to imaging receptor Distance

For larger body types : increase the source current by 25%

tiNOTE
For children : reduce the source current (or Exposure time) by 20%
For edentulous patients : reduce the source current by 20%.

The X-ray dose required for image acquisition can vary depending on the X-
ray source and environmental circumstances. You must maintain the
exposure time and change the kVp and mA values according to the signal
level. In addition, if the X-ray source and the distance to the sensor were
changed during the initial installation, the distance (from cone to detector)
CAUTION

must be changed to the 80mm setting.

The exposure time may vary depending on the age, gender and bone
density of the patient.

-
42
A.3 Error Message

1. USB device driver is not installed.

Solution: Please install the device driver again.

2. Control box cannot be initialized.

Solution: Check and re-connect the USB PC interface cable.

3. USB device driver is not working properly.

Solution: Re-install the driver.

4. Capture program is already running.

Solution: Please close any other programs.

5. Detector response time-out.

Check and re-connect the USB PC interface cable. Please try again.
If the same message is displayed again, contact Customer Service.

6. Data communication error.

Solution: Re-connect the USB PC interface cable.

7. Canceled image capturing.

This means that the user canceled image capture. Please try again.

8. Cannot find dark frame.

Solution: Restore the HDI 1000s calibration data from the S/W installation CD or re-
calibrate the sensor. If the same message is displayed again, contact Customer Service.

9. Cannot find bright frames for calibration.

Solution: Reinstall the HDI 1000 driver.

10. Bad Pixel Map correction error.

Solution: Restore the HDI 1000s calibration data from the S/W installation CD or re-
calibrate the sensor. If the same message is displayed again, contact Customer Service.

11. Wrong image processing parameters.

Solution: Check the X-ray source. If the problem persists, call for technical assistance.

43
 12. Cannot load 'EzSensor.dll'.
Solution: Please re-install the acquisition software.

13. Require EzSensor.dll' was damaged.

Solution: Please re-install the acquisition software.

44
44
A.4 Troubleshooting

If you experience any problems regarding the HDI 1000 system during operation, please refer to
the troubleshooting table below for corrective measures. If the problem persists, please contact
your local RAYENCE product distributor.

< Table 5. Troubleshooting Table>

Item Description Corrective Measure

LED 1 on the control board box does Check that the USB PC interface cable is
1 not illuminate after installing the device. plugged in correctly at the control board box
and on the console PC.
LED 1 on the control board box Check that the Sensor is properly connected.
2 continuously illuminates an ORANGE Unplug the USB PC interface cable from the
light during image acquisition. control board box and then reconnect it.
LED 2 on the control board box Unplug the USB PC interface cable from the
continuously illuminates a RED light control board box and then reconnect it.
during image acquisition. Open the Windows Device Manager and
3
check that the device is installed correctly.
Alternatively, try another USB port on your
computer.
A PID 2XXX NO; interface #0 (Check Unplug the USB PC interface cable from the
Connection) error message is control board box and then reconnect it.
displayed. Open the Windows Device Manager and
4
check that the device is installed correctly.
Alternatively, try another USB port on your
computer.

45
 A.5 Electromagnetic field information according to IEC601-1-2

Guidance and manufacturers declaration electromagnetic emissions

The Model HDI 1000 is intended for use in an electromagnetic environment as specified below. The
customer or the user of the Model HDI 1000 should ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions Group 1 The model HDI 1000 uses RF energy only for its internal
CISPR 11 functions. Therefore, its RF emissions are very low and are not
likely to cause any interference to nearby electronic equipment.
RF emissions Class A The model HDI 1000 is suitable for use in all establishments,
CISPR 11 including domestic establishments, and those directly
connected to a personal computer USB port used for domestic
purposes.

Guidance and manufacturers declaration electromagnetic emissions

The model HDI 1000 is intended for use in an electromagnetic environment as specified below. The
customer or the user of the model HDI 1000 should ensure that it is used in such an environment.
Immunity test IEC 60601 Compliance Electromagnetic environment
test level level guidance
Electrostatic 6 kV contact 6 kV contact Floors should be wood, concrete or
discharge (ESD) 8 kV air 8 kV air ceramic tiles. If floors are covered with
IEC 61000-4-2 synthetic material, relative humidity
should be at least 30%.
Electrical fast 2 kV for power 2 kV for power Mains power quality should be that of a
transient/burst supply lines supply lines typical commercial or hospital
IEC 61000-4-4 1 kV for environment.
input/output lines
Surge 1 kV differential 1 kV differential Mains power quality should be that of a
IEC 61000-4-5 mode mode typical commercial or hospital
2 kV common 2 kV common environment.
mode mode
Voltage dips, < 5 % UT < 5 % UT Mains power quality should be that of a
short interruption, (> 95 % dip in UT) (> 95 % dip in UT) typical commercial or hospital
and voltage for 0.5 cycles for 0.5 cycles environment. If the user of the model HDI
variations on 1000 requires continued operation during
power supply 40 % UT 40 % UT power mains interruptions, it is
input lines (60 % dip in UT) (60 % dip in UT) recommended that the model HDI 1000
IEC 60601-4-11 for 6 cycles for 6 cycles be powered from an uninterruptible
power source or battery.
70 % UT 70 % UT
(30 % dip in UT) (30 % dip in UT)
for 30 cycles for 30 cycles

< 5 % UT < 5 % UT
(> 95 % dip in UT) (> 95 % dip in UT)
for 5 s for 5 s
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should
(50/60 Hz) be at levels characteristic of a typical
IEC 61000-4-8 location in a typical commercial or
hospital environment.
Note : U is the A.C. mains voltage prior to the application of the test level.

46
46
Guidance and manufacturers declaration electromagnetic immunity
The model HDI 1000 is intended for use in an electromagnetic environment as specified below. The
customer or the user of model HDI 1000 should ensure that it is used in such an environment.
Immunity test IEC 60601 test Compliance Electromagnetic environment
level level guidance
Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications
IEC61000-4-6 150 kHz to 150 kHz to equipment should be used no closer to any
80MHz 80MHz part of the model HDI 1000, including cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Radiated RF 3 V/m 3 V/m Recommended separation distance
IEC61000-4-3 80 MHz to 80 MHz to d=[3.5/V1]P
2.5GHz 2.5GHz
d=[3.5/E1]P 80MHz to 800MHz

d=[7/E1]P 800MHz to 2.5GHz

where P is the maximum output power rating

of the transmitter in watts(W) according to
the transmitter manufacturer, and d is the
recommended separation distance in
meters(m).

Field strengths from fixed RF transmitters, as

determined by an electromagnetic site
a
survey, should be less than the compliance
b
level in each frequency range.

Interference may occur in the vicinity of

equipment marked with the following symbol:

Note 1 : At 80MHz and 800MHz, 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.
a
Field 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 the model HDI 1000 is used
exceeds the applicable RF compliance level above, normal operation of the model HDI 1000
must be verified. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the model HDI 1000.

b
Over the frequency range of 150kHz to 80MHz, field strengths should be less than [V1] V/m.

47
 Copyright by 2012 Rayence

The information in this document is subject to change without notice and

does not represent a commitment on the part of the vendor.

This document contains materials protected under International Copyright

Laws. All rights reserved. No part of this manual may be reproduced,
transmitted, or transcribed without the expressed written permission of the
manufacturer and authors of this manual.

If you do not properly set the device setting, causing the device to
malfunction or fail, we cannot guarantee any responsibility.

Ravence"'
Rayence Co., Ltd.
Web Sitewww.rayence.com
Head Office & Factory1F, 2F, 3F, #402, 14, Samsung 1ro 1-gil,
Hwaseong-si, Gyeonggi-do, 445-170, Korea

CE
O 1 2 O
CE symbol grants the product compliance to the European
Directive for Medical Devices 93/42/EEC as a class IIB
device. Authorized by SGS United Kingdom Ltd

EC Representative; VATECH Dental Manufacturing Ltd.

Axiom House, The Centre Feltham, Middlesex,
TW13 4AU, United Kingdom
Tel: +44 (0)208-831-1660, Fax: +44 (0)208-831-1679

48
 Document No. R-USM-703
Release Version 2.4
Dated Oct. 26th. 2012

~
Ravence"'

~
Ravence"'
1F, 2F, 3F, #402, 14, Samsung 1ro 1-gil, Hwaseong-si, Gyeonggi-do, 445-170, Korea www.rayence.com