Download User Manual - Ashtel Dental

IN
NSTALLLATIO
ON AND
U
USER MANUA
M
AL
Versio
on 03 • Juuly 18, 2012
EN
Index
1 INTRO
ODUCTION ....................
.
................................................................................................................... 3
1.1 1.2 1.3 1.4 1.5 1.6 COM
MPLIANCE WIT
TH STANDARDS ............................................................................ .................................. 3
POW
WER SUPPLY ....................
.
............................................................................... .................................. 3
INSTTALLATION PR
RECAUTIONS................................................................................. .................................. 4
LIAB
BILITY AND OP
PERATORS.................................................................................... .................................. 4
PAC
CKAGING AND ENVIRONMEN
NT ............................................................................ .................................. 5
MAR
RKING AND LA
ABELLING SYMBOLS ....................................................................... .................................. 5
2 CONT
TENTS ................................................................................................................................................ 6
3 INSTA
ALLATION ......................................................................................................................................... 7
3.1 3.2 3.3 3.4 3.5 PRE
ECAUTIONS ....................................................................................................... .................................. 7
EQU
UIPMENT INST
TALLATION .................................................................................... .................................. 8
SOFFTWARE INSTA
ALLATION ..................................................................................... .................................. 9
CON
NFIGURATION IN THE OWAN
NDY IMAGING S
SOFTWARE .......................................... ................................ 11
SHA
ARING THE SENSOR AND BO
OX BETWEEN D
DIFFERENT WO
ORKSTATIONS
S .................. ................................ 12
4 USE........................................................................................................................................................... 13
4.1 4.2 4.3 4.4 4.5 PRE
ECAUTIONS ....................................................................................................... ................................ 13
SEN
NSOR PRINCIP
PLES ............................................................................................ ................................ 13
USE
E OF THE OWA
ANDY XIO STA
ANDALONE SO
OFTWARE ............................................ ................................ 14
ACQ
QUISITION OF AN
A IMAGE .................................................................................... ................................ 16
EXP
POSURE TIMES
S ................................................................................................. ................................ 17
5 HYGIE
ENE AND MAINTENANC
M
CE ............................................................................................................ 18
5.1 5.2 5.3 HYG
GIENE AND DIS
SINFECTION ................................................................................. ................................ 18
REC
COMMENDED CLEANING
C
AND DECONTAM INATION PROC
CEDURE ........................... ................................ 19
MAINTENANCE ...................................................................................................... ................................ 19
6 TROU
UBLESHOOT
TING ............................................................................................................................ 20
6.1 6.2 GEN
NERAL .............................................................................................................. ................................ 20
IMAG
GE QUALITY ..................................................................................................... ................................ 21
7 SPEC
CIFICATIONS
S................................................................................................................................... 22
7.1 7.2 GEN
NERAL SPECIF
FICATIONS .................................................................................... ................................ 22
REG
GULATORY DECLARATIONS
E
............................................................................... ................................ 23
8 ACCE
ESSORIES ........................................................................................................................................ 26
The manufaccturer, OWAND
DY, reserves the
e right to make modifications to
t its products or
o to their speciifications in ord
der to improve
the performa
ance, quality, orr ease of produc
ction. Specificatitions of products
s or accessories
s may be modifified without priorr notice.
his manual may be reproduced without the prio
or consent of the
e manufacturer, Owandy.
No part of th
Language off original docum
ment: French.
Year CE marking assigne
ed: 2012
nd
OPTEO 2 g
generation – Usser manual
OWANDY
Le
e Coruscant - 2, rue des Vie
eilles Vignes
777183 Croissy
y-Beaubourg
FRANCE
Telepphone : +33 1.64.11.18.18
Fax : +33 1.64.11.18.10
Page 2/26
EN
1 Intrroductio
on
You have jjust received your Opteo new
n
generatio
on digital intra
a-oral radiolog
gy kit, with dirrect USB conn
nection. We
thank you ffor the confide
ence you have
e in us and hop
pe that this pro
oduct will give
e you entire saatisfaction.
mend you to read this man
nual thorough
hly before insttallation; follow
wing the guideelines for insttallation and
We recomm
usage desccribed in it willl exclude risk
ks to the patie
ent and the ca
are team. Plea
ase keep it cloose to your eq
quipment so
you can reffer to it at a latter date.
Your senso
or uses an X-ray sensitive electronic dettector (the flatt part at the bottom
b
of the ssensor) that replaces
r
the
conventional film used fo
or the acquisittion of radiolo
ogical intra-ora
al images. The
e X-rays are aautomatically detected by
the sensor which triggerss image acquisition. The acq
quired image is displayed almost
a
instantaaneously on th
he screen of
the computter to which th
he sensor is connected.
c
Th
hese digital im
mages can the
en be manipulaated, analyse
ed, saved as
files or printed.
The develo
opment processs of conventional films is thus complete
ely eliminated as well as thhe possible in
nfluences on
image quallity; such as the type and age
a of the che
emical produc
ct, the temperrature of the bbaths or the development
d
time.
on the kit you
u have ordere
ed you
The sensor is available in two sizes;; depending o
received a size 1, a size 2 sensor or both:

Th
he size 1 sen
nsor allows yo
ou to acquire the majority of intra-oral im
mages
(peri-apical and retro-coronarry) both vertica
ally and horizo
ontally.

Th
he size 2 se
ensor furtherm
more allows yyou to easily
y acquire horizontal
“bitewing” image
es.
The instrucctions and infformation in th
his manual re
efer to both sensor
s
sizes, unless
specifically stated. The size
s
of the sensor is marked
d on the senso
or itself.
1.1 Co
ompliance with standards
The Opteo
o kit is class IIA equipmen
nt within the meaning of the
t
European
n Directive 933/42/CEE con
ncerning CE
markings. T
The Opteo kit complies with
h the EN/IEC6
60601-1 medic
cal standard.
ain conditionss (see chap. 1.3
1 “Installatio
on precautions
s”) it is necessary that the other compon
nents of the
Under certa
system tha
at are possibly connected (computer an
nd optional pe
eripherals) arre also complliant to standard IEC950
(EN60950) and that the installation
i
com
mplies with th e EN/IEC6060
01-1 standard.
The intra-oral sensor is contained
c
with
hin a hermetic and sealed ca
ase (resistant to immersion)).
There is no
o physical or electrical
e
conne
ection betwee
en the Opteo kit
k and the X-rray generator.
1.2 Pow
wer supplly
The power to the Opteo box is provide
ed directly by tthe power sup
pply of the USB cable conneecting it to the
e computer.
nd
OPTEO 2 g
generation – Usser manual
Page 3/26
EN
1.3 Ins
stallation precaution
p
ns
A
As the intra-oral sensor is situated
s
inside
e the patient environment
e
(less than 1,5m
m / 4.9ft from the patient),
yyour compute
er must neces
ssarily complyy with standarrd EN/IEC60601-1, or yourr installation in
ncluding the
ccomputer must have been
n rendered co
ompliant with standard EN
N/IEC60601-1--1. You can connect
c
the
ssensor to you
ur computer without
w
additio nal precaution
ns once your complete insttallation is compliant with
standard EN/IEC60601-1
1.
puter is not siituated in the patient enviro
onment and is not complia
ant with standdard EN/IEC60
0601-1, it is
If the comp
necessary tto place the se
ensor in non-c
conductive pa ckaging.
T
The Opteo se
ensor is an ele
ectrical mediccal device requ
uiring special precautions re
regarding elec
ctromagnetic
ccompatibility. Please observ
ve the recom mendations in
n this manual during the coommissioning and use of
tthe equipmentt.
T
The use of ca
ables or acces
ssories other tthan those sp
pecified in this
s manual can cause an increase in the
e
emissions or a reduction in the immunity of the Opteo sensor.
1.4 Lia
ability and
d operators
s
Installer: tthe installation
n of the kit re
equires comp
puter skills relating to both
h equipment aand software. Follow the
recommend
dations and gu
uidelines of th
he installation cchapter to install the equipm
ment and softw
ware.
User: the kkit must be use
ed by a dental practitioner.
T
The sensor sh
hould never be opened by the user. Only the manufacturer is authoorised to open and make
rrepairs to the
e sensor. Re
eturn the equ
uipment to the distributor in case of m
malfunction and/or if the
d
documentation
n you possess
s does not co
ontain the necessary information for the ((authorised) maintenance
m
o
of the malfuncctioning equipm
ment.
A
Any modification of the Op
pteo device is forbidden. All repairs of this same devicce can only be
e performed
b
by OWANDY personnel.
The manufa
acturer will no
ot be liable if:

Intterventions or repairs hav
ve been made
e by persons
s without the authorizationn of the manufacturer or
disstributor and are
a not part off accepted inte
erventions.

Th
he equipment is used with an
a installation that is not co
ompliant with the
t applicablee standards an
nd decrees in particular when not compliant with the E
EN/IEC60601--1-1 standard relating to thee security rules for electro
ms. Make sure the installation
n of the equip
pment is compliant with the aapplicable reg
gulations.
medical system
o
than those mentioned
d specifically in
n this manual (use of the kkit in normal conditions
c
of

Ussed in ways other
usse and in compliance with its intended pu rpose).
nd
OPTEO 2 g
generation – Usser manual
Page 4/26
EN
1.5 Pac
ckaging and
a
enviro
onment
Transport,, storage and environme
ent: the kit iss supplied in protective packaging (prootection again
nst physical
impacts and antistatic pa
ackaging). It must
m
be stored under the folllowing conditio
ons:
Ambient tem
mperature: -10
0°C to +70°C / 14°F to 158°°F
Relative humidity: <9
95% without co
ondensation
Atmospheric pressure: 500hPa to 1060
0hPa
ernational saffety standard EN/IEC601-1 (section 2), thhe kit has bee
en designed
Operation:: in compliancce with the inte
for normal u
use under the
e following con
nditions:
Ambient tem
mperature: +10°C to +40°C / 50°F to 104
4°F
Relative humidity: 30% to 75%
0hPa
Atmospheric pressure: 700hPa to 1060
o distributor:: should a retturn to the diistributor be nnecessary, make sure to
Equipmentt packaging for return to
package the sensor and box kit in its original
o
packag
ging after having cleaned it thoroughly.
documentation. Please con
pped with its d
ntact your disttributor for a replacement
r
Documenttation loss: all kits are ship
manual if th
his documenta
ation is lost.
1.6 Ma
arking and
d labelling symbols
These symbols are used
d on the product labels and inform you ab
bout the compliance with staandards and the technical
specificatio
ons of the com
mponent.
Direct current.
Type B equippment, EN/IEC
C 60-601-1,
annexes I annd II.
The CE
C marking certifies that
this prroduct complie
es with
European directive 93/42 CEE.
Important infformation: follow the
instructions printed in this
s
manual.
Senso
or waterproo
ofness stand
dard,
EN/CE
EI 60529 regulation.
Only the
t
part of th
he sensor puttted
in month,
m
comp
plies with this
standard.
Storag
ge condition: relative
r
humid ity
limitations
Storage conndition: temperature
limitations.
Storage conndition: Atmos
spheric
pressure lim
mitations.
Equipment subject to a selective co
ollection in acccordance witth Directive 2002/96/EC
2
oon waste elec
ctrical and
electronic e
equipment (W
WEEE) and with
w
Decree 2
2005-829 of the
t
20th July 2005 regardding the comp
position of
electrical an
nd electronic equipment
e
and the eliminatiion of waste coming
c
from th
his equipment..
nd
OPTEO 2 g
generation – Usser manual
Page 5/26
EN
2 Contents
Your Opteo
o kit consists of
o the following elements (il lustrations ma
ay vary from items supplied)):
1 self-adhe
esive sensor w
wall support
An Opteo se
ensor - size 1 or size 2
(cable of 3m / 9.9foo
ot)
Meta
al positioner kit
((available for size
s
1 sensor as
a default)
A bag o
of disposable single-use hy
ygienic protecttive
sleevves (compatiblle with size 1 and
a 2 sensorss)
An introductory pack of plasstic positionerrs
or size 2 sensoor as default)
(available fo
An O.S.P. installation CD-ROM
ers/diagnosticc tools)
(drive
C
with the
t installationn files of the se
ensor
A CD-ROM
A manual
A packkaging checklist
nd
OPTEO 2 g
generation – Usser manual
Page 6/26
EN
stallation
n
3 Ins
3.1 Pre
ecautions
T
The kit must be
b handled with care, minim
mise the twisting, pulling and bending of tthe attachmen
nt cable. Do
n
not step or roll on the cable
e. Do not pulll on the cable
e itself but on the connectioon plug to dis
sconnect the
U
USB cable.
T
To avoid interrferences in the
t
image, do
o not use the system close
e to strong m
magnetic fields
s and avoid
p
proximity to electrostatic em
mission source
es.
R
Read paragraph “0 Installation precaution
ns” to ensure the
t installation
n complies witth the standard
ds.
IInstall your im
maging software before th
he installation
n of the kit, its drivers annd O.S.P. too
ols and the
ensor.
installation files of the se
3.1.1
Recomme
ended minim
mal configu ration
A
Any computer configuratio
on that does not comply with the minimal recommeended configuration can
p
prevent the sttarting or proper functionin
ng of the sens
sor kit. Verify
y the specificaations of the computer(s)
b
before the insttallation.
Operating ssystem
Windows XP
P SP2, Vista or
o Seven (32 and
a 64 bits)
Computer
Motherboarrd
USB port
Compliant C
CE-IEC950
Intel 1.4GHzz chipset and processor
USB 2.0 Hig
gh-Speed
Graphics ca
ard
Monitor
64MB
High resoluttion 1024x768
8 (15inch)
RAM memo
ory
Hard disk
256MB
10GB
CD-ROM d
drive
Backup sysstem
24x
movable disk, Zip or Jaz sys
stem, CD-ROM
M/DVD…
External/rem
Printer
Keyboard a
and mouse
Laser, inkjett, thermal
At acquisitio
on workstation
n
Opteo kit w
with appropriate
e drivers
Imaging soft
ftware
X-ray generrator with electtronic timer
If your com
mputer does not
n possess USB 2.0 portts, these can be added as
s PCI/PCI exppress cards (for
(
desktop
computers)) or PCMCIA cards (for lap
ptops). If the U
USB ports do not provide enough
e
currennt, please use
e a powered
hub (with itts own power supply). The PCMCIA card
ds need to be powered by an
a external poower supply or connected
to a powere
ed hub if they do not provide
e enough currrent. Please co
ontact your IT
T specialist for further inform
mation.
3.1.2
Setup guidelines
The compu
uter and the sccreen with wh
hich the senso
or and the box
x are used sho
ould preferablyy be situated close to the
chair, within
n the field of vision
v
of the practitioner,
p
to
o allow for imm
mediate use. Provide
P
visuall access for th
he patient to
be able to sshare the radio
ological inform
mation with him
m/her.
The screen
n must be placced so as to avoid any refle ctions or direc
ct overhead illuminations thaat could be de
etrimental to
the visualizzation of the ra
adiological ima
ages. It must b
be set up (con
ntrast and brig
ghtness) to dissplay as many
y grey levels
as possible
e in the image..
nd
OPTEO 2 g
generation – Usser manual
Page 7/26
EN
The X-ray g
generator has a great influe
ence on the qu
uality of the ac
cquired images
s. The kit is coompatible with
h any kind of
generator, be it high-freq
quency or conv
ventional. The
e generator mu
ust be equippe
ed with an eleectronic timer (allowing for
very short exposure time
es) and must emit a dose sufficient for the acquisitio
on of a good iimage (with enough
e
grey
ake sure that your generato
or is not worn
n as the dose
e emitted will be insufficientt and could in
nfluence the
levels). Ma
quality of the acquired image. The en
nergy emitted
d by a genera
ator diminishes
s over time; w
when in doub
bt have your
o the generato
or is stable, anny movement of the head
generator cchecked by a qualified technician. Make ssure he had of
will induce movement blu
ur in the acquired image.
3.2 Equipment installation
n
3.2.1
Connectio
on
o sensor is fitte
ed directly to a cable equipp
ped with a US
SB connector linking it direcctly to the com
mputer. If the
The Opteo
distance be
etween the se
ensor and the computer is g
greater than th
he 3m / 9.8ft of
o USB cable, it is possible to add USB
cables by u
using a USB distributor (“hub”) connected
d to an externa
al mains powe
er supply, betw
ween each cab
ble.
Connection
n without hub
Connection with power ssupplied hub
M
Make sure the
e USB port of the computerr is preferably a USB 2.0 po
ort. Only use U
USB 2.0 cable
es and hubs
w
with a USB 2.0
2 port and make
m
sure tha
at the hub ha
as its own ex
xternal power supply (do not
n use selfp
powered hubss, drawing the
e power from tthe USB cable). Each USB
B cable shouldd not be longe
er than 3m /
9
9.8ft. The kit iss compatible with
w USB 1.1 p
ports but with reduced imag
ge transmissioon speed.
The USB cable can be co
onnected / dis
sconnected wiithout the need
d to power down the compuuter.
Check thatt the sensor iss correctly co
onnected: if th
he sensor toolbar turns gre
een after remooving the sen
nsor from its
support, it is powered correctly.
3.2.2
Sensor su
upport
The sensorr can be place
ed on its self--adhesive sup
pport supplied
d with the kit. The support iis
compatible with sensorss of size 1 or size 2. This support can be fixed on any
a type of flaat
orktop or a pa
art of the chaiir. The sensorr will then be inserted into the fork of thhe
surface: wo
support takking care not to
o impede the cable.
D
Do not mount the wall support upside-dow
wn or horizonttally, the sensor could fall oon
tthe ground and be damaged
d.
nd
OPTEO 2 g
generation – Usser manual
Page 8/26
EN
3.3 Software ins
stallation
Install the O
Owandy QuickkVision (or third party) imag
ging software and check its proper functiooning before installing the
equipment and its driverss. Refer to the
e software man
nual for the installation instrructions.
Y
You need adm
ministrator righ
hts for the insstallation and use of the so
oftware and eqquipment. Ple
ease contact
yyour IT specialist to create a suitable userr account.
3.3.1
Installatio
on of the driivers
T
The Opteo drivvers are only compatible wiith the Window
ws XP (service
e pack 2 or higgher), Window
ws Vista and
W
Windows Seve
en operating systems
s
– 32 a
and 64 bits.
Automatic
c installation: insert the O.S
S.P. CD-ROM
M in the CD-RO
OM-drive. The
e interface will launch autom
matically and
will guide yyou through the
t
different in
nstallation ste
eps. Refer to the Windows help if the C
CD-Rom does
s not launch
automatically.
1.
2.
3.
4.
5.
6.
7.
8.
Se
elect the desirred language in the main sccreen. The tab
bs at the top of the page linkk to different pages
p
of the
Ow
wandy website
e and provide more informa
ation regarding
g Owandy.
Se
elect “USB” in the menu tha
at appears.
Co
onnect the USB
U
cable to the connectiion box and the USB 2.0 port of the computer. Windows
W
will
au
utomatically de
etect your box
x.
d” that appea
Ca
ancel the win
ndow “Add ha
ardware wizard
ars then click on “Click heere” in the win
ndow of the
O.S.P. installer..
In the new wind
dow, confirm the
t location off the drivers th
hat is displaye
ed by clicking on “Install”. This
T
location
must correspon
nd to the direc
ctory of the drrivers on the O.S.P.
O
CD-RO
OM. The driveer files are the
en copied to
yo
our hard disk.
Cllick on “Contin
nue” in the me
essage window
w “Equipment installation” th
hat appears.
A confirmation window is displayed afterr the files hav
ve been copie
ed, it confirm
ms the drivers have been
ng “Opteo V2 USB: Installed
d”. Click on “O
OK” to close thhis window.
insstalled correcttly by displayin
Th
hen continue the
t installation
n of the O.S.P . with referenc
ce to paragrap
ph “3.3.2 Instaallation of the O.S.P.”.
O
stallation: it iss also possible
e to install the
e drivers manu
ually by using the “New harddware detecte
ed assistant”
Manual ins
of Windowss. Follow these
e steps:
1.
2.
3.
4.
5.
6.
Co
onnect the co
onnection box to the USB 2
2.0 port of the
e computer. Windows
W
will aautomatically detect your
eq
quipment and will display the “Found New
w Hardware Wizard”
W
window
w.
If the wizard re
equests the au
uthorization to
o connect to the Windows Update site, sselect “No, no
ot this time”,
nding on your version of Wiindows.
then click on “Next”. This window does not appear depen
Th
he wizard will inform you itt has detecte d your “Opteo
o V2 USB” kitt. Select “Insttall from a listt or specific
loccation” then click on “Next” after making ssure the O.S.P
P. CD-ROM is
s inserted in thhe CD-ROM drive.
Se
elect “Don’t se
earch. I will choose the drive
er to install” an
nd click on “Ne
ext”.
Cllick on “Have Disk” under th
he list that is d
displayed. If the window co
ontaining this llist does not appear,
a
click
on
n “Show All De
evices” then click on the “Ha
ave Disk” button.
Th
he next window
w will allow yo
ou to navigate to the directo
ory that contain
ns the requiredd files; click on “Browse”.
nd
OPTEO 2 g
generation – Usser manual
Page 9/26
EN
avigate to the “\drivers
s\WIN_2000_X
XP\OWandy USB”
Na
dirrectory on the
e O.S.P. CD-ROM; this dirrectory contains the
file
e “ow_usb.inf””. Click on “OK
K” to select thiis directory.
8. Th
he previous window
w
now diisplays the loccation of the files
f
to
be
e installed: “E:\drivers\WIN
“
N_2000_XP\O
OWandy USB
B” (E :
representing th
he letter of yo
our CD-ROM drive, this can
c
be
ding on your computer con
nfiguration). Click on
diffferent depend
“O
OK” to start the
e installation.
9. Th
he “Opteo V2
2 USB” driverrs are displayyed in the lis
st (see
op
pposite); click on “Next”.
10. Cllick on “Contin
nue” in the warning window “Device installation”
that appears.
“
in the la
ast window of tthe wizard.
11. Finally click on “Exit”
7.
Optteo V2 USB
eo V2 USB”” is installed
d under “Un iversal Seria
al Bus
The “Opte
controllers”” in the “Devicce manager”. To reach this window click on the Works
station icon wiith the right mouse button
and select “Manage” in th
he drop-down menu. In the window that appears
a
select “Device mannager”.
3.3.2
Installatio
on of the O.S
S.P.
c installation:: the installation of the O.S
S.P. tools is automatically proposed aftter the installation of the
Automatic
drivers. Reffer to the proccedure below.
1.
2.
3.
4.
5.
6.
7.
8.
Se
elect the desirred language in
i the window that appears and click on “Next”.
In the welcome screen click on
o “Next”.
Se
here the softw
elect the targe
et directory (th
he directory wh
ware will be installed) by cliccking on “Brow
wse” and by
na
avigating to th
he desired dire
ectory. If you use the QuickVision imaging software sselect the dire
ectory where
yo
ou installed Qu
uickVision (pro
oposed by deffault). After ha
aving selected the target direectory click on
n “Next”.
Cllick on “Install”” to start the copying
c
the file
es.
Affter the files ha
ave been copied, select “Op
pteo V2 USB” in the list thatt appears and click on “OK”.
A window will in
nform you of th
he successful installation, close it by click
king on “Exit”.
Th
he last window
w displays the
e location of th
he O.S.P. tools; close this window
w
by cli cking on the red cross of
the window (top
p right).
Cllose the main O.S.P. installa
ation window if it is still disp
played on-scre
een.
Manual ins
stallation: if you
y have follow
wed the manu
ual installation of the drivers
s, you must staart the manua
al installation
of the O.S.P
P. tools:
1.
2.
3.
4.
Inssert the O.S.P
P. CD-ROM in the CD-ROM
M drive.
Na
avigate to the “\setups\CMO
OS_XRAYS_B
BOX_W2000_
_WXP” directorry on the O.S..P. CD-ROM.
La
aunch “setup.e
exe”.
Re
efer to the auttomatic installa
ation of the O..S.P. mentione
ed above.
nd
OPTEO 2 g
generation – Usser manual
Page 10/26
EN
3.3.3
Sensor in
nstallation fiiles
E
Each kit is prrovided with a sensor insta
allation CD-R
ROM of its ow
wn; the serial number of th
he sensor is
w
written on the CD-ROM and
d on the conne
ection box. Yo
ou can therefore not use thee same CD-RO
OM to install
sseveral sensors; each sensor requires itss own CD-ROM
M.
alling the senssor installatio
on files, make
e sure that:
Before insta

Th
he drivers of th
he kit are insta
alled.

Th
he imaging software is not started.
s
OM, a window
w appears an
nd the files arre copied to tthe hard disk
k. Close the
Insert the ssensor installlation CD-RO
window afte
er the files havve been copie
ed by pushing any key of the
e keyboard wh
hen asked for..
3.3.4
O.S.P. up
pdate
If you need
d to update you
ur O.S.P.:
1.
2.
3.
4.
Inssert the O.S.P
P. CD-ROM.
Na
avigate to the “\setups\CMO
OS_XRAYS_B
BOX_W2000_
_WXP” directorry on the CD-R
ROM.
La
aunch “setup.e
exe”.
Cllick on “Install or Reinstall” and
a follow the
e instructions on-screen.
o
3.4 Co
onfiguratio
on in the Owandy
O
im
maging software
To be able to use your kiit with the Owa
andy QuickVission imaging software
s
you must
m
configuree your equipm
ment.
1.
Sttart the imag
ging software (double-clickk on the des
sktop icon or use the linkk in Start / Programs /
Qu
uickVision).
sion version 3
Configurattion QuickVis
2.
3.
Cllick on the “Co
onfiguration” button
b
in the m
main screen.
Se
elect “OWAND
DY DSX & Kry
ystal-X” under the “Intra-Ora
al sensor” optio
on in the winddow that appea
ars.
4.
Cllick on “Config
gure” at the rig
ght of the men
nu.
Configurattion QuickVis
sion version 4
2.
3.
4.
Se
elect the “Setttings” menu in the menu barr, then click on
n “Preferences
s”, then selectt the “Equipme
ent” tab.
Se
elect the manu
ufacturer “OW
WANDY” underr the “Intra-ora
al sensors”.
Cllick on the con
nfiguration buttton at the righ
ht of the menu
u.
nd
OPTEO 2 g
generation – Usser manual
Page 11/26
EN
In the co
onfiguration w
window:
◄ Check the “USB” ttype.
2
◄ Selec
ct the “Opteo 2” kit.
◄ Set th
he activation time of the box
b
(default 5min).
5
◄ Set th
he inlay and ssize of the date &
time and
d exposure pparameters in
n the
acquired
d image.
◄ Selec
ct the image ttreatment (*)).
◄ Config
gure the Owa
wandy software (**).
(*) When th
he “Film alike”” option is activ
vated, the con
ntrast depends
s on the expos
sure time. Adjjust the X-ray dose on the
generator tto obtain a goo
od image.
(*) When yyou select the option “Auto contrast” the ccontrast is constant. Expos
sure errors aree corrected au
utomatically,
which revea
als noise in ba
adly exposed images.
In both casses, the expossure bar (blue//green/red) he
elps to find the correct expos
sure of the imaages.
(**) This op
ption appears only when the
e sensor is ussed from certa
ain Owandy so
oftware prograams; it allows the change
of the sharp
pness setting or the high resolution for ea
ach acquired image.
i
5.
Cllick on “OK” to
o confirm yourr choice.
6.
Th
hen click on th
he “Save”
the settings.
button (Qu
uickVision 3) or
o on the “Valid
date” button (Q
QuickVision 4)
4 to validate
The use of the kit is identical to the use
e of the Owan
ndy XIO Stand
dAlone softwarre described bbelow.
3.5 Sharing the sensor an
nd box bettween diffferent worrkstations
Sharing the sensor allo
ows you to use
u
one or m
more sensors
s in turn in a practice w
with multiple chairs.
c
It is
ded to link th
he different workstations
w
in
n a network to allow for th
he central stoorage and sha
aring of the
recommend
images.
A USB port must be plugged
p
into each
e
workstattion to allow for an easy connection oof the box. Windows
W
will
automatically recognise the
t equipmentt when it is co
onnected and iti will be availa
able immediattely for image acquisition.
To enable the sharing of a kit betwee
en different wo
orkstations, it is necessary to first install the imaging software for
the acquisition of the images, the driv
vers, O.S.P. to
sor installation
n files on all tthe computers
s with which
ools and sens
o will be used.
your Opteo
nd
OPTEO 2 g
generation – Usser manual
Page 12/26
EN
4 Use
e
4.1 Pre
ecautions
M
Make sure the
e sensitive su
urface (the flatt surface) of the
t sensor is directed towaards the X-ray
y generator.
T
The active surrface of the se
ensor is marke
ed by a frame. The back of the sensor (roounded) does not react to
X
X-rays and do
oes not produc
ce an image o n-screen.
T
The kit must be manipulatted with care,, minimising the
t
twisting, pulling
p
and beending of the attachment
ccable. Do nott step or roll on
o the cable. Be careful no
ot to pull on the
t cable wheen removing the
t hygienic
p
protective she
eaths.
he plug to discconnect the USB
U
cable.
Do not pull on the cable itself, but on th
E
Even though the
t sensor is resistant
r
to im
mpacts, it is strrongly recomm
mended to nott let it fall on the floor. If a
p
physical impact should exce
eptionally hap
ppen, contact your
y
distributo
or and do not ttry to intervene
e yourself.
D
Do not ask the
e patient to bitte on the senssor or cable.
Use of a mobile phone or an RF commun
nications devic
ce near the Op
pteo sensor m
may affect the sensor.
4.2 Sensor princ
ciples
4.2.1
Sensor
The sensorr’s sensitive area is delimite
ed by a horizo
ontal line; the area below th
his line is not ssensitive to X--rays. When
the sensor is placed in the
t mouth it is
s necessary to
o check that this
t
area is turned towards the radiation source and
a
is irradiatted.
that the whole sensitive area
e surface
Active
4.2.2
Sensorr’s rear shell:: inactive surrface
Sensor ac
ctivation
The sensorr automaticallyy puts itself on
n standby afte
er a period which can be
4 Configuration in the
configured in the configuration wind
dow (see “3.4
maging softwarre” - the defau
ult period is 5 minutes). The sensor’s
Owandy im
toolbar is th
hen in its red state.
s
e your sensor physically, ju
ust remove it from its supp
port and/or
To activate
give it a slig
ght jerk. The Opteo is equiipped with a g
gravity sensor which will
detect this movement an
nd will so activate the emb
bedded electro
onics. The
ensitivity to gravity
g
is prog
grammed so as not to ac
ctivate the
sensor’s se
Opteo intra
a-oral sensor inopportunely by an involun
ntary movemen
nt.
W
When activating the senso
or physically, take care to
o hold the
ssensor by both sides of its shells
s
and nott by the cable in order to
a
avoid any riskk of the cable
e connections breaking or the
t sensor
ffalling and bre
eaking.
nd
OPTEO 2 g
generation – Usser manual
Page 13/26
EN
4.3 Use of the Owandy
O
XIO StandA
Alone softw
ware
4.3.1
Modes off operation
The sensorr kit can function in two way
ys:

Th
hrough the Tw
wain protoco
ol (for scannerrs): to use thiis mode selec
ct “Owandy Inntra Oral X-rays…” in the
TW
WAIN acquisittion option of your
y
imaging software. Sub
bsequently sta
art the TWAIN
N acquisition; the
t interface
is identical to that of the indep
pendent mode
e described be
elow.

nt mode: the independent software pro
ogram can be
e started withh the
ic
con (on the
In independen
W
Windows deskttop) or by sta
arting an Owa
andy software program. This memory reesident softwa
are package
oftware progra
alllows the use of
o the sensor outside any so
am. If an imag
ge is acquiredd without a pro
ogram ready
to receive it, th
he resident pro
ogram will dissplay the image on-screen for a few seeconds and sa
ave it in the
“C
C:\Program Filles\OWANDY\\OSP - XRAY
YS BOX STA
ANDALONE\SttandAlone\Datta” directory on
o the hard
dissk. A sensor icon
i
appears in the Window
ws taskbar, ne
ext to the cloc
ck. The colourr of the icon in
ndicates the
sta
ate of the sensor:
Red: sensor inactivve
Yellow: sensor initiialising
Green: sensor read
dy for acquisittion
4.3.2
Sensor to
oolbar
It is possible to display the
t sensor too
olbar by clickin
ng with the rig
ght mouse button on the seensor icon in the taskbar.
The colour of the sensor toolbar indica
ates the state o
of the sensor:
Red: sensor inactivve
Yellow: sensor initiialising
Green: sensor read
dy for acquisittion
Options of tthe sensor too
olbar:
◄ Orientatio
on of the sen
nsor (vertical or horizonta
al), double-cliick the icon tto change
the orientatio
on of the sen
nsor.
◄ Activate/d
deactivate the sensor.
◄ Iconize th
he toolbar in the taskbar.
T
The sensor automatically switches
s
to sttandby mode after a few minutes
m
of nott being used; the sensor
ttoolbar turns red.
r
C
Check that the
e sensor toolbar is displayed
d in green beffore each acqu
uisition.
nd
OPTEO 2 g
generation – Usser manual
Page 14/26
EN
4.3.3
Configura
ation menu
A right-clickk on the senso
or icon in the taskbar
t
or on tthe sensor too
olbar displays the configurattion menu:
X-ray sensor
Displays th
he sensor toolbar.
Start when Windows sta
arts
Once checcked, the Stan
ndAlone progra
am will be launnched each time
your comp
puter is started
d.
Configura
ation
Displays tthe configuration menu (se
ee “3.4 Conffiguration in the
t
Owandy im
maging softwa
are”).
Display ne
ew images forr
Adjusts the
e display time of the image.
Allows you
u to browse th
hrough the ima
ages waiting too be transferred.
If no image
e is acquired this
t
option is not
n displayed.
Closes the
e resident softw
ware program. Warning: thhe acquisition will
w
no longer b
be available until
u
the resident program is restarted.
Remaining
g images
Exit
4.3.4
Image tra
ansfer interfa
ace
Options of tthe image tran
nsfer interface
e:
Image dissplay
Wh
hen an image is selected, it is displayed on
o a blue backkground.
“Load” button
Tra
ansfers the se
elected image to the softwarre program.
“Cancel” b
button
Ca
ancels the ima
age selection and
a starts the toolbar for a nnew acquisitio
on
(on
nly when in a ssoftware progrram).
“Preview” button
Dis
splays the sele
ected image fu
ull-screen.
“Email” bu
utton
Op
pens a blank e
email and attac
ches the image in a zip file.
“Delete” b
button
De
eletes the sele cted image.
“Delete on
n load” option
De
eletes the sele
ected image frrom the list aftter it has beenn transferred to
t
a software
s
progrram.
nd
OPTEO 2 g
generation – Usser manual
Page 15/26
EN
4.4 Acquisition of an imag
ge
4.4.1
Acquisitio
on procedure
The image acquisition go
oes through se
everal steps:
1.
efore being able
a
to acquirre an image w
with the sens
sor, you need
d to start the computer to which it is
Be
co
onnected and start the imag
ging software. Check that th
he sensor toolb
bar or the sennsor icon in the
e task bar is
grreen.
2.
Prrogram the diffferent parame
eters (exposurre time, etc.) on
o the X-ray generator
g
(seee “4.5 Exposure times” for
mo
ore informatio
on).
3.
Co
over the senso
or with a hygie
enic protective
e sheath making sure to cov
ver a sufficientt length of cab
ble.
4.
A set of position
ners is provide
ed with the kit to place the sensor
s
in the different
d
parts of the mouth;; their use is
t ensure the sensor is posiitioned perpen
ndicularly to th
he X-ray beam
m.
recommended to
Th
he sensor can
n also be posiitioned manua
ally, maintaine
ed by the patie
ent as with coonventional film. This can
be
e necessary fo
or children with
h a small oral cavity. Positio
on the sensor in the mouth, behind the tooth of which
yo
ou want to accquire an imag
ge. If you do not use a po
ositioner, a cotton roll can bbe helpful to position the
se
ensor parallel to
t the tooth.
Tu
urn the sensitive surface of the senso
or (the flat surface) towards the geneerator; if it is
s facing the
otther way, the sensor will not
n be able to
o acquire ima
ages.
5.
osition the generator so as
s to cover the whole sensitive area of th
he sensor. Thee paralleling technique
t
is
Po
strrongly recomm
mended and the
t use of possitioners allow
ws you to corre
ectly place thee generator th
hanks to the
aim
ming ring.
6.
enerator. The sensor toolba
ar turns yellow
w to indicate the treatmentt and transmis
ssion of the
Acctivate the ge
accquired image
e. Once the im
mage treated, it appears in the imaging software and the sensor to
oolbar turns
grreen allowing a new acquisittion.
4.4.2
Imaging software
s
fun
nctions
An exposurre percentage
e is displayed in
i the acquired
d image:

0 tto 80% - unde
er-exposed image, the X-rayy dose is too low; increase the
t X-ray dosee on the generator.

80
0 to 120% - co
orrectly expose
ed image
image, the X--ray dose is too high; reduce

12
20 to 200% - over-exposed
o
e the X-ray doose on the gen
nerator.
When the image is displa
ayed in the Owandy QuickV
Vision imaging
g software, a coloured bar aappears in the
e top part of
posure bar. Th
his function is available only
y to users of th
he Owandy im
maging softwarre.
the image, this is the exp
ed in this bar indicates the e
exposure leve
el of the image
e:
The white ccursor displaye

If tthe cursor is in the green, th
he image is co
orrectly expos
sed.

If tthe cursor is in the red, the image is overr-exposed; red
duce the exposure time on tthe generator.

If tthe cursor is in the blue, the
e image is und
der-exposed; increase
i
the exposure
e
time on the genera
ator.
nd
OPTEO 2 g
generation – Usser manual
Page 16/26
EN
4.5 Exposure tim
mes
Recommen
nded exposure
e times in seco
onds for the O
Owandy X-ray generators:
Des
scription
Owan
ndy Owandy-R
RX
Owandy Ellios AC
Current / Voltage
7
7mA / 65KV
8mA / 700KV
Lower incisor / canine
0
0.06 – 0.09
0.04 – 00.08
Lower premolar
0
0.06 – 0.10
0.06 – 00.10
Low
wer molar
0
0.07 – 0.11
0.07 – 00.12
Upper incisor / canine
0
0.08 – 0.10
0.06 – 00.10
Upper premolar
0
0.08 – 0.11
0.08 – 00.12
Upp
per molar
0
0.11 – 0.16
0.10 – 00.14
Refere
ence condition
ns:

Adult patien
nt, young man
n or woman off average size
e

Distance fo
ocal spot to se
ensor
250mm / 9.8
8inch

Total (inherrent) filtration
equivalent to
t 2mm / 0.08iinch Al
The valuess indicated in the table abov
ve can vary fro
om one genera
ator to another. It is the respponsibility of each
e
user to
calibrate hiss/her doses before use.
If an image
e is over or un
nder-exposed, it can be corrrected afterwa
ards with the imaging softw
ware (contrast,, brightness,
etc.) to imp
prove its visualisation.
The table b
below allows you
y to note the
e exposure tim
mes specific to
o your generato
or:
Des
scription
Adult
d
Child
Lower incisor / canine
Lower premolar
Low
wer molar
Upper incisor / canine
Upper premolar
Upp
per molar
nd
OPTEO 2 g
generation – Usser manual
Page 17/26
EN
5 Hyg
giene and main
ntenanc
ce
5.1 Hygiene and
d disinfecttion
5.1.1
USB Connector
The connecctor does not require any particular ma
aintenance, it should be cle
eaned using a cloth and non-abrasive
n
detergents..
5.1.2
Sensor
To avoid crross-contamin
nation between
n patients durring use, it is necessary
n
to protect
p
the se nsor with hygienic singleuse protecttive sheaths (FDA cleared for
f the USA, C
CE marked fo
or Europe). So
ome hygienic protective she
eaths suited
for your reg
gion are provid
ded with each system.
p
the used sheath sho
ould be throw
wn away and the
t sensor dissinfected applying a high
Before eacch use on a patient,
level disinfe
ection procedure (see “5.2 Recommende
ed cleaning and decontamiination proceddureErreur ! Aucun
A
nom
n'a été don
nné au signet.Erreur ! Auc
cun nom n'a été donné au
u signet.”). A new protectivve sheath is ap
pplied to the
sensor for each new pa
atient. We rec
commend the disposal of the hygienic protective
p
sheeaths with the biologically
hazardous waste of yourr practice.
TA HEALTHC
Validated protections for North Am
merica: BANT
CARE or TID
DI PRODUCTS
S X-ray sens
sor sheaths,
CTS RS barrie
ers.
STERI-SHIIELD PRODUC
D
Do not pull on the cable whe
en removing tthe used prote
ective sheath.
5.1.3
Cables
The cable can be cleaned with cautio
on by using a disinfecting wipe. Hold the sensor withh one hand and, with the
e of the sensor along the first
f
20cm / 88inch of the ca
able without
other hand, apply a disinfecting wipe from the side
pulling on tthe cable; sub
bsequently cle
ean the remain
nder of the ca
able in segments of 20-30ccm / 8-12inch with as little
pinching off the cable as possible, the wipe
w
should sllide without ap
pplying force.
5.1.4
Positione
ers
The positio
oners provided
d with the sy
ystem should be covered by
b the hygienic protective sheath togeth
her with the
sensor.
D
Do not pull on the cable whe
en removing tthe sensor from
m the position
ner.
They should be cleaned and disinfecte
ed according tto the same procedure
p
as for the sensor (see “5.2 Rec
commended
nd decontamin
nation procedu
ureErreur ! Au
ucun nom n'a
a été donné au
a signet.Erreeur ! Aucun nom
n
n'a été
cleaning an
donné au signet.”). The
ey can be ste
erilised, eitherr in an autocla
ave (classic steam-sterilizerr, distilled water, 134°C /
273°F, 3ba
ar, 4min) or using cold sterrilisation (see product instrructions). They
y withstand a maximal tem
mperature of
145°C / 293
3°F.
e positioner ca
an be thrown away
a
with the rregular waste.
A defective
nd
OPTEO 2 g
generation – Usser manual
Page 18/26
EN
5.2 Recommend
ded cleaning and de
econtamin
nation procedure
Remove the hygienic pro
otective sheath
h (dispose of iit appropriately with the con
ntaminated
gorously wipe down the sensor to removve any visible
e residues. If necessary
waste). Vig
rinse with ccopious amoun
nts of water. Then
T
place the
e sensor in the
e disinfecting agent.
a
O
Only immerse
e the sensor and the head o
of the positioner or sensor connection
c
ccable in the disinfectant
d
forr 15min, neve
er immerse the connector on
o the box
sside of the possitioner or sen
nsor connectio
on cable in the
e liquid.
During the
e immersion, brush the submerged pa
arts with a soft
s
brush. Then
T
rinse
thoroughly the sensor and
a
the positio
oner or the se
ensor connec
ction cable witth copious
amounts off fresh water.
D
Do not put the
e sensor in a sterilizer
s
or an
n autoclave, th
he high temperature and
e
excessive high pressure will seriously d amage the ellectronics of the sensor
a
and connectorrs.
D
Do not clean the
t sensor with inappropriatte instruments
s (knife…).
or, positioner or sensor con
nnection cable
e are not bein
ng used imme
ediately upon rinsing, as in the case of
If the senso
allowing the
em to air-dry overnight
o
at th
he end of a wo
orking day, the
ey should be rinsed with steerile water.
When the ssensor, positio
m from any damage, it is
oner or senso
or connection cable are not being used, to
t protect them
recommend
ded to store th
hem in their bo
ox or to hang tthem in the se
ensor wall sup
pport.
n using prote
ective sheaths
s, the sensorr should be disinfected re
egularly. Imm
merse the sen
nsor in cold
Even when
sterilisation
n fluid in acco
ordance with the
t
instruction
ns of the man
nufacturer afte
er having cleaaned it from all
a residues.
Never leave
e the sensor immersed for longer than ne
ecessary.
5.2.1
Recomme
ended deco
ontaminating
g product fo
or North-America
The sensorr being sealed
d watertight an
nd to minimize
e the potential for device-associated infecctions, the sen
nsor and the
part of the positioner or sensor
s
connection cable insserted in the mouth
m
shall be
e disinfected w
with an FDA-c
cleared high
level disinfe
ection agent fo
ollowing the in
nstructions of tthe manufactu
urer for use, sttorage, handli ng and warnin
ng.
The follow
wing disinfecta
ant agent ha
as been valid
dated with the sensor: CIDEX
C
OPA solution (0.5
55% Orthophthalaldeh
hyde solution). The maximum soaking pe
eriod is 24 hou
urs.
5.2.2
Recomme
ended deco
ontaminating
g products outside
o
North-America
The following disinfectan
nts are compa
atible with the sensor and the part of the positioner orr sensor conne
ection cable
outh:
that is inserrted in the mo

2%
% Sodium Hyp
pochlorite (ma
aximum immerrsion time of 24
2 hours)

Etthyl alcohol (m
maximum immersion time off 24 hours)

Qu
uaternary amm
monium
5.3 Ma
aintenance
e
5.3.1
Computer data-prote
ection
Your patien
nt and image database must be backed--up regularly to be able to recuperate thhem if needed
d (in case of
hard disk o
or computer problems). Ask
k the advice o
of your IT specialist with reg
gard to the baackup system that is best
suited to yo
our computer configuration (external or rremovable hard disk, Zip or Jaz system, CD-ROM or DVD writer,
etc.). Test a
and store the copies in a sa
afe place.
nd
OPTEO 2 g
generation – Usser manual
Page 19/26
EN
6 Tro
oubleshooting
occurs during operation, ch
heck the differe
ent items in th
his troublesho
ooting guide. Iff you cannot resolve
r
your
If an error o
problem ple
ease contact your
y
distributo
or.
6.1 Ge
eneral
Symptom
Cause / Solution
es not power up
u or it does no
ot
The kit doe
acquire ima
ages.

heck that the active surface
e of the senssor is directed
d
Ch
tow
wards the X-ra
ay generator and is positiooned correctly
y
in tthe field of the
e X-ray beam.

Ch
heck that the kit
k is correctly
y configured inn the imaging
g
sofftware and tha
at the drivers are
a correctly innstalled.

Ch
heck the conn
nection betwee
en the sensorr and the PC,,
and
d ensure that the PC is pow
wered externallly.

Ch
heck that the generator
g
is em
mitting X-rayss (with anotherr
sen
nsor or with co
onventional film).

An
n error has occ
curred during acquisition, ddisconnect the
e
cab
ble and wait a few seconds before reconnnecting it.

Ch
heck that the outer
o
sheath of the cable coonnection from
m
the
e sensor does not show any
y signs of teariing.
No image a
appears on the
e screen.
The sensorr is slightly wa
arm.
This is normal. The temperature of the sensoor can exceed
d
12°C (5
54°F) when th
he kit is activa
ated for a prollonged period
d
(e.g. w
when taking many
m
consecu
utive images)) and has no
o
bearing
g on the functio
oning of the kit.

nd
OPTEO 2 g
generation – Usser manual
Re
educe the stan
ndby time in the configuratioon screen.
Page 20/26
EN
6.2 Ima
age qualitty
Symptom
Cause / Solution
e
The imagess are cut off, e.g.:
The se
ensor is badly positioned with regard to the X-ray
y
beam.
The imagess are too light or contain noise,
e.g.:

eposition the sensor,
s
makin
ng sure it is w
well within the
e
Re
fielld of the X-ray
y beam.

Usse the position
ners provided with the senssor for optimal
possitioning.

The
e image is un
nder-exposed, the X-ray doose is too low;;
inccrease the X-ray
X
dose on the ge nerator. The
e
perrcentage that is displayed in the imagee indicate the
e
exp
posure level:
o 0 to 80%
% - under-exp
posed image
o 80 to 12
20% - correctly exposed im age
o 120 to 200%
2
- over-e
exposed imagee

Ch
heck the dose
e emitted by th
he X-ray geneerator, due to
o
age
e the dose can
c
be insufficient. Have tthe generatorr
che
ecked by a tec
chnician when
n in doubt.

Th e generator is
s positioned to
oo far from thhe patient with
h
gard to the sellected dose.
reg

Ch
heck the para
ameters of yo
our monitor ((contrast and
d
brig
ghtness) and avoid reflectio
ons on the scre
reen.

The
e image is ov
ver-exposed, the
t X-ray dosse is too high;;
red
duce the X-ray
y dose on the generator. Thhe percentage
e
tha
at is displaye
ed in the ima
age indicate tthe exposure
e
levvel:
% - under-exp
posed image
o 0 to 80%
o 80 to 12
20% - correctly exposed im age
o 120 to 200%
2
- over-e
exposed imagee

Ch
heck the para
ameters of yo
our monitor ((contrast and
d
brig
ghtness) and avoid reflectio
ons on the scre
reen.

Ch
heck the qualitty and parame
eters of the moonitor.

Ch
heck the conn
nection of the cable of the screen at the
e
sid
de of the graph
hics card and the monitor.

Ch
heck the scree
en configuratio
on under Winndows (screen
n
con
nfiguration pa
anel, it must display colouurs in at leastt
24b
bits.
211 1
Film alike m
mode
Au
uto contrast mo
ode
The imagess are too darkk, e.g.:
Grey levelss seem to be missing
m
in the
image (flat areas of grey appear).
The image is blurred.
nd
OPTEO 2 g
generation – Usser manual
Re-acq uire the image
e:

Th e patient has moved during the exposuree.

s
and has moved.
Th e generator head was not stabilised
Page 21/26
EN
7 Spe
ecifications
7.1 Ge
eneral specifications
s
Opteo Sen
nsor - Size 1
External dim
mensions size
e 1 sensor
CMOS mattrix size 1 senssor (cut corne
ers)

Sensitiive area in sizze


Sensitiive area in pixxels
Pixel d
dimensions
38.6 x 24.7 x 5.2mm
/ 1.6 x 1.0
0 x 0.2inch
30 x 20mm (600mm2)
/ 1.2 x 0.8
8inch (1.0inch22)
1500 x 1000
0pixels
20 x 20µm
Opteo Sen
nsor - Size 2
External dim
mensions size
e 2 sensor
CMOS mattrix size 2 senssor (cut corne
ers)

Sensitiive area in sizze


Sensitiive area in pixxels
Pixel d
dimensions
43.2 x 30.8 x 5.2mm
/ 1.7 x 1.2
2 x 0.2inch
34 x 26mm (900mm2)
/ 1.3 x 1.0
0inch (1.3inch22)
1700 x 1300
0pixels
20 x 20µm
Technical specification
ns (size 1 and
d 2 sensors)
nsor cable)
Length sen
3m / 9.9ft
Grey levelss
14bits (1638
84 grey levelss)
Connection
n
USB standa
ard:
USB 2.0 Hig
gh-Speed (4800Mbit/s) and
USB 3.0
Consumptio
on kit
0.5VA unde
er 5V (USB poort)
Input voltag
ge sensor
Input curren
nt sensor
0.15A Max
Operating ttemperature
+10°C to +4
40°C / 50°F too 104°F
Lifespan CM
MOS
Min. 100,00
00 cycles
Standards
Conformity to standards
nd
OPTEO 2 g
generation – Usser manual
NF EN/IEC6
60601-1
NF EN/IEC6
60601-1-2
Page 22/26
EN
7.2 Regulatory Declaratio
D
ons
Table 1
Man
nufacturerr’s instruc
ctions and declaratio
on – electtromagnettic emissio
ons
The OPTEO model is de
esigned for us
se in the electtromagnetic en
nvironment sp
pecified below
w. The OPTEO
O customer
or user musst ensure that it is used in such
s
an enviro
onment.
Emis
ssions test
Compliiance
E
Electromagne
etic environm
ment - instrucctions
RF emissio
ons
Gro
oup 1
T
The OPTEO model
m
only use
es RF energy for its internal functions.
CISPR 11
C
Consequently,, its RF emissions are very low and are not
n capable
o
of causing inte
erference in ne
earby electronnic equipment.
RF emissio
ons
Cla
ass B
T
The OPTEO model
m
is suita
able for use inn all premises
s, including
CISPR 11
d
domestic prem
mises and th
hose directly connected to the low
Harmonic e
emissions
Not ap
pplicable
vvoltage public electricity su
upply networkk supplying bu
uildings for
IEC 61000--3-2
d
domestic use.
Voltage flucctuations/
Not ap
pplicable
flicker
IEC 61000--3-3
Table 2
Man
nufacturerr’s instruc
ctions and
d declaratiion – electtromagneetic immun
nity
The OPTEO model is de
esigned for us
se in the electtromagnetic en
nvironment sp
pecified below
w. The OPTEO
O customer
or user musst ensure that it is used in such
s
an enviro
onment.
Immunity ttest
I
IEC
60601
Co mpliance
Electrom
magnetic envirronment - ins
structions
T
Test
level
vel
lev
Electrostatiic
± 6 kV at conta
act
± 6 kV at contactt
Floors mu
ust be of woood, concrete or
o ceramic
discharge
tiles.
± 8 kV in the air
a
± 8 kV in the air
a covered w
with synthetic materials,
(ESD)
If floors are
IEC 61000--4-2
the relativ
ve humidity muust be at leastt 30%.
Rapid tran
nsients in ± 2 kV for electricity Nott applicable
The quality of the eleectricity supply network
must be that of a typical comm
bursts
s
supply
lines
mercial or
hospital environment.
e
IEC 61000--4-4
±
1
kV
V
for
input/output lin
nes
Transient
± 1 kV between
b
Nott applicable
The quality of the eleectricity supply network
overvoltage
must be that of a typical comm
e
p
phases
mercial or
IEC 61000--4-5
hospital environment.
e
± 2 kV between
b
p
phase
and earrth
Nott applicable
Voltage d
dips, brief <5
< % UT
The quality of the eleectricity supply network
(
% dip in UT)
mercial or
power
cuts
and (>95
must be that of a typical comm
variations in voltage for
hospital environment.
f 0.5 cycle
e
on electriccity supply
userr requires continuous
If the OPTEO
O
c
input lines
4 % UT
40
operation during poweer cuts in the
e electricity
( % dip in UT)
(60
IEC 61000--4-11
etwork, it is re
recommended to supply
supply ne
f 5 cycles
for
OPTEO from
f
an uninteerruptible ene
ergy supply
or a batte
ery.
7 % UT
70
( % dip in UT)
(30
f 25 cycles
for
<5 % UT
<
(
(>95
% dip in UT)
f 5s
for
3 A/m
Magnetic fiield at the
3A
A/m
Magnetic fields at tthe frequenc
cy of the
electricity network m
frequency of the
must have the
t
same
network
characterristic levels ass a representa
ative place
electricity
(50/60 Hz)
located in a typical ccommercial or
o hospital
IEC 61000--4-8
environment.
NOTE: UT is the voltage of the alternattive network b
before applicattion of the testt level.
nd
OPTEO 2 g
generation – Usser manual
Page 23/26
EN
Table 3
Man
nufacturerr’s instruc
ctions and
d declaratiion – electtromagneetic immun
nity
The OPTEO model is de
esigned for us
se in the electtromagnetic en
nvironment sp
pecified below
w. The OPTEO
O customer
or user musst ensure that it is used in such
s
an enviro
onment.
Immunity ttest
IE
EC 60601
Compliiance
Ele
ectromagnetic
c environmen
nt - instructio
ons
T
Test
level
Level
3V
Conducted
RF 3 Veff
Porrtable and mo
obile RF com
mmunications equipment
e
frrom 150 kHz
z to
interference
must not be us
sed nearer too any part of
o OPTEO,
IEC 61000--4-6
8 MHz
80
inclluding the cables, thaan the reco
ommended
sep
paration distance, calculateed on the ba
asis of the
equ
uation applic
cable to thhe frequency
y of the
tran
nsmitter.
Radiated
RF 3 V/m
e
frrom 80 MHz
z to 3 V/m
interference
commended separation
s
disttance
Rec
IEC 61000--4-3
2 GHz
2.5
1.16√P
d=1
1.16√P from 80 MHz to 8000 MHz
d=1
2.33√P from 800MHz to 2.55 GHz
d=2
ere P is the transmitter’s m
maximum outtput power
whe
rating in watts (W), accordinng to the tra
ansmitter’s
manufacturer and d is the reecommended separation
es (m).
disttance in metre
The
e field inten
nsities of fifixed RF tra
ansmitters,
determined
by
y
an
onn-site
electrromagnetic
inve
estigationa, must be below the complianc
ce level, in
b
eac
ch frequency range
r
.
erference can occur near a device marke
ed with the
Inte
follo
owing symbol:
NOTE 1: Att 80 MHz and 800 MHz, the
e higher freque
ency range ap
pplies.
hese directive
es may not apply in all situa
ations. Electrom
magnetic prop
pagation is affe
fected by abso
orption and
NOTE 2: Th
reflection by structures, objects
o
and pe
eople.
a: The field
d intensities off fixed transmitters, like base
e stations for radiotelephones (cellular/coordless) and mobile
m
land
radios, ama
ateur radio, AM
A and FM ra
adio broadcastting and TV broadcasting,
b
cannot be theeoretically fore
eseen with
exactitude. In order to assess the electromagnet
e
ic environmen
nt produced by fixed RF transmitters, an on-site
electronic investigation must
m
be consiidered. If the field intensity, measured att the location where OPTE
EO is used,
exceeds the applicable RF
R compliance
e level below, OPTEO mus
st be observed
d to check that
at its operation
n is normal.
If abnormall performance
e is observed, additional step
ps may be necessary, like reorienting
r
or repositioning OPTEO.
ge from 150 kHz to 80 MHzz, field intensities must be be
elow 3 V/m.
b: For the ffrequency rang
nd
OPTEO 2 g
generation – Usser manual
Page 24/26
EN
Table 4
Re
ecommended separration disttances between porrtable and
d mobile RF
R
communication s equipme
ent and OPTEO
OPTEO is designed for use in the ele
ectromagneticc environment where radiated RF interferrence is contrrolled. The
OPTEO customer or use
er can help to prevent electrromagnetic intterference by keeping
k
a minnimum distanc
ce between
the portable
e and mobile RF communic
cations (transm
mission) devic
ce and OPTEO
O, as recomm
mended below, based on
the maximu
um transmissio
on power of th
he communica
ations device.
Assigned
d maximum
Sepa
aration distan
nce by transm
mitter frequen
ncy
output power of
From 150 kHz
k to 80 MH
Hz
From 80
8 MHz to 800
0 MHz
Fro
om 800 MHz to
t 2.5 GHz
smitter
trans
W
D=1.16√P
√P
D=1.16√P
D=2.33√
0.01
0.12
0
0.12
0.23
0
0.1
0.37
0
0.37
0.74
1
1.16
1.16
2.33
1
10
3.67
3
3.67
7.37
100
11.60
1
11.60
23.3
For transm
mitters whose assigned max
ximum transm
mission power is not given above, the reecommended separation
distance d in metres (m) can be estima
ated using the
e equation app
plicable to the transmitter fre
requency, whe
ere P is the
transmitter’’s maximum trransmission power rating in watts (W), ac
ccording to its manufacturerr.
NOTE 1: att 80 MHz and 800 MHz, the
e separation diistance for the
e higher freque
ency range appplies.
NOTE 2: th
hese directivess may not app
ply in all situattions. Electrom
magnetic prop
pagation is affeected by abso
orption and
reflection by structures, objects
o
and pe
eople.
nce of the OP
PTEO intra-orral sensor (in
n terms of image transfer) remains com
mplete in an
The essential performan
gnetic environm
ment that resp
pects the regu latory limits.
electromag
nd
OPTEO 2 g
generation – Usser manual
Page 25/26
EN
8 Acc
cessories
Refill packs of 10 positioners:
p
D0RT
T1ANGUBW
D0RT
T1ANGUZE
D0RT
T1ANGUZP
D0RT
T1ANGUZPA
D0RT
T2ANGUBW
D0RT
T2ANGUZE
D0RT
T2ANGUZP
D0RT
T2ANGUZPA
Size 1 bitewing
Size 1 endo
Size 1 posterior
Size 1 peri-apical
Size 2 bitewing
Size 2 endo
Size 2 posterior
Size 2 peri-apical
Meta
al positioner kitt
DA20
07
Size 1 only
enic single-us
se disposable protection sleeves
Hygie
(for size
s
1 and 2 se
ensors)
ROTECCAPXL20
D0PR
Bag oof 20 pieces
Hygie
enic single-us
se disposable protection sleeves
(for size
s
1 and 2 se
ensors)
D0PR
ROTECAPL50
00
Bag oof 500 pieces
Moun
nting accessories
D0SU
UPCAP730
nd
OPTEO 2 g
generation – Usser manual
Self-aadhesive
wall s upport
Page 26/26