Post on 16-Mar-2022
PRESE
GMDN
Model
Brand
Techn
CREA-
ANVIS
AlliaRodRibe
Tele CNP
770
ENTATIO
N: 44905 - D
: New IDA
: Dabi Atla
ical Respo
-SP: 50607
SA Registe
age S/A Indovia Abrão
eirão Pretoephone: +5PJ: 55.979.
CINTEInternRua F 2900
Portug
000000592
ON OF MA
Dental digi
A
ante
onsible: R
714523
er: 101011
dustrias Méo Assed, Ko - SP - Bra55 (16) 351.736/0001-
ERQUAL –nacional, LdFran Pache0-374 Setúbgal
2 - Rev.: 13
Do
ANUAL
ital imaging
Ricardo Jos
139025
édico OdonKm 53 - CEazil 2-1212
-45
– Soluçõesda. eco N°220 bal
3 – June/2
ocument or
g sensor, i
sé Ravane
ntológico EP 14097-5
s de Comé
2° And
2019
riginally wr
intraoral
eli
500
ércio
ritten in Portuguese.
22
3
TRADEMARKS
All terms stated in this manual that are from known trademarks, commercial trademarks or service marks were properly labeled as such. Other products, services or terms that are mentioned in this manual can be trademarks, commercial trademarks or service marks of their respective owners. The Alliage S/A makes no claim in relation to these trademarks. The use of a term in this manual must not be considered as influential over any trademark, commercial trademark or service mark. New IDA is a commercial trademark from Alliage S/A. Microsoft, Windows and .NET Framework are commercial trademarks of Microsoft Corporation in the United States and other countries. GNU LESSER is a trademark from Free Software Foundation, Inc. Copyright © 2017 Alliage S/A. All Rights Reserved. The performance characteristics presented in this manual are only for reference and mustn't be considered as secured specifications.
4
TABLE OF CONTENTS
DEAR CUSTOMER ............................................................................................................................................... 6
USE INDICATION ................................................................................................................................................ 6
CONTRAINDICATIONS ........................................................................................................................................ 6
SYMBOLOGY ...................................................................................................................................................... 7
WARNINGS, CAUTIONS, AND RECOMMENDATIONS ........................................................................................... 8
DURING TRANSPORTATION AND STORAGE ............................................................................................................. 8
BEFORE USING THE EQUIPMENT ............................................................................................................................. 9
DURING THE INSTALLATION OF THE EQUIPMENT ................................................................................................... 9
DURING THE EQUIPMENT USE ................................................................................................................................. 9 Prevention against cross contamination ........................................................................................................... 10
AFTER USE / OPERATION OF THE EQUIPMENT ...................................................................................................... 10
PRECAUTIONS IN CASE OF CHANGE IN THE PERFORMANCE OF THE EQUIPMENT ................................................ 10
PRECAUTIONS FOR THE REDUCTION OF ENVIRONMENTAL IMPACT ..................................................................... 11
PRECAUTIONS IN CASE OF DESTRUCTION OF THE EQUIPMENT ............................................................................ 11
SYSTEM DESCRIPTION ...................................................................................................................................... 12
SYSTEM STRUCTURE .............................................................................................................................................. 12
INTRAORAL SENSOR ............................................................................................................................................... 13
INTRAORAL SENSOR HOLDER ................................................................................................................................. 13
COMPUTER SYSTEM ............................................................................................................................................... 13 Software requirements ...................................................................................................................................... 13 Hardware requirements .................................................................................................................................... 14 Electrical requirements ..................................................................................................................................... 14 Installation site .................................................................................................................................................. 14
SOFTWARE ............................................................................................................................................................. 15 Software installation ......................................................................................................................................... 15 Main screen ....................................................................................................................................................... 20 Setting screen .................................................................................................................................................... 24 Odontogram ...................................................................................................................................................... 26
CONSUMABLES ...................................................................................................................................................... 31
LABELS .................................................................................................................................................................... 32 Identification ..................................................................................................................................................... 32 Safety ................................................................................................................................................................ 32 Refer to instruction manual .............................................................................................................................. 32
INTRAORAL RADIOGRAPHY EQUIPMENT ............................................................................................................... 33
SPECIFICATIONS AND TECHNICAL CHARACTERISTICS ............................................................................................ 34 General information .......................................................................................................................................... 34 Characteristics of the sensor ............................................................................................................................. 34 Environmental conditions for transportation and storage ................................................................................ 35 Conditions for installation and operation of the equipment ............................................................................. 35
CERTIFICATIONS AND STANDARDS ................................................................................................................... 36
5
EMC / Security ................................................................................................................................................... 36 Usability ............................................................................................................................................................ 36 Software ............................................................................................................................................................ 36 Quality ............................................................................................................................................................... 36
SYSTEM OPERATION ........................................................................................................................................ 37
PREPARATION FOR USE.......................................................................................................................................... 37
ACQUISITION OF RADIOGRAPHIC IMAGES ............................................................................................................. 38 Create a new registration of patient ................................................................................................................. 39 Opening a patient registration .......................................................................................................................... 40 Changing a patient registration ........................................................................................................................ 40 Sensor status ..................................................................................................................................................... 40 Process of image capturing ............................................................................................................................... 41 Images of the patient's registration .................................................................................................................. 42 Metric Calibration ............................................................................................................................................. 44 Precision of the measurement .......................................................................................................................... 47
RECOMMENDATION FOR EXAMS ..................................................................................................................... 48
CLEANING AND DISINFECTION .......................................................................................................................... 51
MAINTENANCE ................................................................................................................................................ 52
PERIODIC INSPECTION ............................................................................................................................................ 52
PREVENTIVE MAINTENANCE .................................................................................................................................. 52
CORRECTIVE MAINTENANCE .................................................................................................................................. 52
ERROR DIAGNOSIS ................................................................................................................................................. 54
CABLE REPLACEMENT ............................................................................................................................................ 55
AUTHORIZED SERVICE NETWORK .......................................................................................................................... 58
WARRANTY TERM .................................................................................................................................................. 58 Warranty period ................................................................................................................................................ 59
ELECTROMAGNETIC COMPATIBILITY ................................................................................................................ 60
GUIDANCE AND DECLARATION FOR ELECTROMAGNETIC IMMUNITY ................................................................... 61
6
EQUIPMENT IDENTIFICATION
DEAR CUSTOMER Congratulations for your excellent choice. When buying equipment with the "DABI ATLANTE" quality, you can be sure you purchased products with technology that is compatible with the best in the world from its class. This manual offers you a general presentation of your equipment, describing important details that can guide you in its correct use, as well as in the solution of small issues that can eventually occur. There is no need of any additional training besides its own reading.
This manual must be read on the whole and preserved to future consultations.
USE INDICATION The Intraoral dental digital imaging sensor New IDA is aimed at the acquisition of intra-oral medical images from teeth, jaw and oral structure, only for exclusive dental use and must be handled by trained and qualified health professionals, observing the instructions included in this manual. CONTRAINDICATIONS
The intraoral dental digital imaging sensor New IDA is contraindicated to patients with temporomandibular dysfunction that limited mouth opening and who have anatomical characteristics that prevent their use as a low palate.
The protective plastic covers contain polyvinyl chloride (PVC) and should not be use by people with allergies to polyvinyl chloride (PVC) or substances used in the manufacturing process of the same such as bisphenol A, adipic polyester, propylene glycol compound and ethylhexyl maleate
SYMBO
IP
OLOGY Use the ic
Insplifa
00 Tw
Inevdeoth
InDcee
Intha
cons above
Fragil
Keep a
Ma
Te
H
D
ndicates that thpecial waste cfespan. Applieccessories.
his product iswater infiltrations
ndicates that valuation, andeveloped for tbserved in its d
he market.
ndicates that theDirective 2011/6ertain hazardolectronic equipm
ndicates that thehe Guideline 9bout Medical De
e to identify
e, handle w
Keep dry
This side u
away from s
ximum stac
emperature l
Humidity lim
Recyclable
Do not re-us
he product mucollection site es to the dev
s not protecteds and particulate
the product that standard
he product catdesign / manufa
e equipment is 5 / EU on restrus substances ment.
e equipment is 3/42 / CEE ofevices (MDD)
y the symb
with care
up
sunlight
cking
limit
mit
e
se
ust be taken tat the end ofvice and to
d against harme matter.
has passed ds or regulatitegory have bacture / placing
in compliance wriction of the uss in electrical
in compliance wf European Un
bology of yo
o a f its the
mful
an ons een
g on
with e of and
with nion
our equipm
ment.
Applied
Equipm
A
Gene
Mand
Follow thfor
USB
Catal
Seri
Par
Authorizedin the
Co
Manuf
Man
7
parts BF ty
ment Class
ttention
eral warning
atory action
he instructiooperation
connection
log number
al number
rt Number
d represente European
ommunity
facture date
nufacturer
7
ype
II
n
ons
ative
e
WARN
DURIN
NINGS, CA
Read afor use
The opunlessPerson
Use thpatien
This eto the and se
The Neare: IdentifSecuriidentif- Imagthe se
This (Restrand ththat texclus
Non-auinvalid
G TRANSP
The equip
Handle The arr Don't s Protect Observ
AUTIONS, A
and undee before in
peration os safe expnal protec
he equipmts and thi
quipmentnecessar
econdary
ew IDA se
fication laity symbofication; ge acquisnsor is co
equipmenriction of he Directivhe comp
sive respo
uthorized date the C
PORTATION
ment must
e with care rows on th
stack itemst against sve the limit
AND REC
erstand thnstall or o
of this devposure facctive equip
ment only rd parties
t must be ry precauradiation.
ensor has
bel: Placeology: Pla
ition softwonnected.
nt meetsCertain H
ve of Mediliance wi
onsibility o
modificaE marking
N AND STO
t be shall b
to avoid fae package
s above theunlight, hut of temper
COMMEND
e instructoperate thi
vice may bctors and pment mu
if in perfs against p
installed tions to a
three diff
ed in the loaced in t
ware: Fou
the reqHazardousical Devicith the dof the man
ation of tg
ORAGE
be carried a
alls and ime must be pe quantity iumidity, warature, pres
DATIONS
tions contis equipm
be dangeroperatingst be used
fect condpossible d
and operaavoid exc
ferent inte
ower part he upper
und instal
quirements Substances (Directdirectives nufacturer
the produ
and stored
mpacts. pointing upindicated o
ater and dussure and
tained in ent.
ous for pag instructid with this
itions anddangers.
ated by peessive ex
eractions w
of the propart of
lled with
s of thences) (Diretive 93/42/RoHS is
r.
uct or of
d according
pwards. on the packust. relative hu
these ins
atient andions are os device.
d protect
ersonal acxposure to
with the u
oduct packthe senso
a comput
e directivrective 202/EEC). Ples ensured
the conf
g to the fol
kaging
umidity
8
structions
d operator observed.
yourself,
cquainted o primary
ser. They
kage; or on its
ter where
ve RoHS 11/65/UE) ease note d by the
figuration
lowing:
8
r
BEFOR
before instruct
DURIN
DURIN
RE USING T
To help anfirst use,
tions enclo
G THE INS
Put wate
Instatemp
The (incl
Thisflam
The Comperfo
G THE EQU
Properamong
The inclu
The oper
X-Rarecounlemus
Opeare the a
The cominterothehigh
THE EQUIP
nd ensure the equip
osed in this
STALLATIO
the equipmer. all the unperature, h
equipmenuding duri
s equipmemmable ane
recommenmmunicatioormance o
UIPMENT U
r hygienicg the patie
equipmenuding safeg
equipmenration; theray expos
ommendedess the const be propeerators shopregnant oabdomen a
equipmempatibility srference wer devices h electroma
PMENT
a proper hpment mus manual.
ON OF THE
ment in a p
ity in a phumidity, dnt must nong transpont was noesthetics mndations o
on equipmeof the equip
USE
c measureent, users
nt must beguard knownt was marefore, folloure can
d that no ontainment oerly protectould follow or suspectand thyroident was standards,
with other that are se
agnetic dis
hygiene anust be cle
EQUIPMEN
place whe
place wheirect sunligot be sub
ortation andot designe
mixtures or of this manuent and sopment.
es must band othe
e operatedwledge agaanufactureow the cyc
cause done staysof the patieted againstall radiatio
ted of pregd.
projected but in vequipmenensitive toturbances
nd to proteaned and
NT
re it won't
ere it wonght, dust, sbjected to d handle).ed for use
nitrous oxual must bources tha
e taken tor people.
d only by qainst exces
ed to resiscles describamage to
s in the raent is necet ray emisson protectignancy, inc
d accordivery extret. Don't u
o interferen.
ect against disinfecte
be in cont
't be damsalt or corro
excessive
e in presexide. e followed
at generate
o avoid cr
qualified hssive expost continuobed in the Oo human adiographicssary. In th
sions. on guidelincluding the
ng to thme conditse this eq
nce or with
infectioused accordi
tact with h
maged by osive prod
e vibration
nce of va
d regardinge RF can
ross conta
healthy proosure to radous and inOwner's M
body cec examinahis case, t
nes for pae use of s
he electrtions, it cquipment ah devices t
9
diseases,ing to the
humidity or
pressure,ucts. or shock
apors from
g the EMC.affect the
amination
ofessionalsdiation. ntermittent
Manual. ells. It isation roomhis person
tients whohielding of
omagneticcan causealong withthat create
9
, e
r
,
k
m
. e
s
t
s m n
o f
c e h e
Preven
AFTER
PRECA
If th
item listhe pro
The m • If thewhat it • For result in comequipm • For in
ntion agai
To man
The The
the U Don
R USE / OPE
Turn The
avoicond
Perfcont
Don
AUTIONS IN
he equipmsted in the oblem, turn
In the an Aut
anufactur
e equipmet was orig
damages of incorre
mpliance ment.
nappropri
inst cross
help to pndatory thee covers me protectiveUSB cablen't ever use
ERATION O
n off the eqprotective
d the traditions. form the tained in th't modify a
N CASE OF
ment presetopic: "Err
n off the eq
event of dthorized S
rer assum
ent is useginally des
caused tect installawith the
ate opera
contamin
prevent thee use of dismust be pro
e plastic ce. e damaged
OF THE EQ
quipment we plastic cansmission
cleaning his manualany part of
F CHANGE
nts any abor Diagnosuipment, d
damage oService All
es NO liab
ed for othesigned.
to the eqation and
operatio
ation of the
nation
e cross csposable poperly dispocover must
d protectiv
QUIPMENT
when it is ncovers musn of infec
and disin. the equipm
E IN THE PE
bnormalitysis" of this disconnect
or defect dliage.
bility:
er purpos
quipment, maintenan instruc
e equipme
contaminatiprotective posed of fort cover the
ve plastic c
not being ust be disp
ctious age
nfection a
ment.
ERFORMAN
, verify id user manu
t the cables
do not use
es that ar
operator ance procetions tha
ent.
ion amongplastic cover each newe sensor an
overs.
sed for an osed for e
ents that
according
NCE OF TH
the probleual. If it is ns.
e the equi
re not the
and/or pedures tha
at comes
g the patiers.
w patient. nd at least
extended each new can caus
to the in
HE EQUIPM
em is relatnot possib
pment an
10
e ones for
patient as at are not with the
ents, it is
t 10 cm of
period. patient to
se serious
nstructions
MENT
ted to anyble to solve
d contact
0
r
s
f
o s
s
y e
PRECA
medicaenvironhealth. recomm
1 DIMENS
PRECA
it is deappropenviron
2012/1the proApplies
AUTIONS F
Alliage S/Aal and dennmental im To keep mendation
Afte Duri To p
plasproc The disein astoreand
The paplastic
SIONS: 185 x 1
AUTIONS IN
To avoid eestroyed, tpriate placnment. To the Eu9/EU, ass
oduct musts to the deContact th
FOR THE RE
A aims tontal producmpact and
a minims:
r installationg the life prevent entic covers
cedure of th
biomedicaases or su
a yellow bed in a coincineratio
ackaging1
c, which a
160 x 71.5 mm
N CASE OF
environmenthey must ce, since
uropean Ecwell as to
t be takenvice and to
he retailer if
This equi
EDUCTION
o reach ancts environthat are m
um impac
on, forwardcycle of th
nvironmenand othe
he dental o
al waste cuspect for hag proper
ontainer reon.
of the Nere 100% re
/WEIGHT: Ap
F DESTRUC
ntal contambe disposthe exis
conomic A the corres to a speco the accesf the final d
pment mu
N OF ENVIR
n environmnmental co
more friend
ct on the
d the recyche equipmetal contam
er consumaoffice for b
compriseshousing parly labeledesistant to
ew IDA seecyclable
pproximately: 1
CTION OF
mination orsed of (acstent mate
Area (EEA)spondent ncial waste ssories disposition
ust not be
RONMENTA
mental polionscious tdly to the e
e environm
clable mateent, turn it mination, tables musiomedical
nonhigh mathogenic d with the
perforatio
ensor is cmaterials
00g
THE EQUIP
r inapproprccording toerials insi
), this prodnational lawcollection
n of the pro
disposed
AL IMPACT
tics to prohat continu
environmen
ment, obs
erials for thoff when ithe dispos
st be accowaste.
materials sorganismssymbol o
on, tight an
composeds.
PMENT
riate use oo the curreide it ca
duct is subws. This dsite at the
oduct is nec
d of as dom
T
omote the uously minnt and to t
serve the
he recyclingt is not bei
sal of the ording to t
susceptibles that mustof biologicand even re
d of cardb
of the New ent legislatn contam
bject to theirective reqe end of it
cessary.
mestic wa
11
supply ofnimize thethe human
following
g process.ng used. protective
he normal
e to causet be storedal hazard,ecollection
board and
IDA whention) in an
minate the
e Directivequires thats lifespan.
aste.
f e n
g
e l
e d ,
n
n n e
e t .
SYSTE
SYSTE
1 – Intr2 – Co3 – Ins4 – Intr5 – Co 1Don't
EM DESCR
EM STRUCT
raoral senomputer systallation fraoral sen
onsumable
accompan
RIPTION
TURE
nsor ystem1 (USflash drivensor holdees (Plastic
ny the prod
SB interfae (Softwarer c Protectiv
duct
ace) re, Drivers
ve Covers
s & Manua
1)
als)
12
2
13
INTRAORAL SENSOR
The Intraoral dental digital imaging sensor New IDA uses a sensor that employs
the associated technologies from CMOS (Complementary Metal-Oxide-Semiconductor), protective optical fiber and scintillator. This sensor was developed to obtain a high-quality x-ray image from the human arch and its structures. The acquisition process is made by positioning the sensor inside the mouth, behind the structure you want to perform the exam. The structure must be exposed to an x-ray dose using an external source. Once exposed, the sensor performs a conversion of the x-ray photons into a digital sign and transfers it to a computer through USB 2.0 connection (Universal Serial Bus).
INTRAORAL SENSOR HOLDER
The intraoral sensor holder consists of a base where the sensor can be placed
when it is not in use. The intraoral sensor holder can be screwed close to the computer system using
the two supplied screws or other mounting material. Alternatively, it may be glued to a uniform surface using the supplied double-
sided adhesive tape.
COMPUTER SYSTEM
Software requirements
For the correct performance of the New IDA software, some basic software described below is necessary: .Net Framework 4.5.1: The NET Framework is essential to run several programs that
were developed through the use of this technology from Microsoft. This framework offers a series of resources for the agile and robust development of applications. The 4.5.1 version requires the Windows Vista SP2 or superior and it's included in Windows 8.1 and in Windows Server 2012 R2.
wkhtmltopdf 0.12.3.2: It's an open-source command line tool (LGPLv3) to render
HTML to PDF using the rendering mechanism from Qt WebKit. It works completely "headless" and it doesn't require an exhibition service or exhibition. The required software for the performance of the New IDA software will be
automatically installed, in shape of prerequisites, during the installation of the application, offering more speed and convenience to the user.
Hardw
Electri supplieconsum
Installa
there's
avoid d
the com
ware requir
The comp
OpSys
CPHDRAMoUS
The cothe staVoltag Besidinstallwon't a
It is rpatiensystem
ical requir
The New ed throughmption of 3
Don't uof thesuffici
ation site
To melike pearea, iit's use
Place you enough spPreferably
direct light Place the mputer. On
rements
uter system
perational stem
PU DD AM onitor SB connecto
omputer mandard EC
ge 2014/35
des, to heled prograaffect the
ecomment data to
m.
rements
IDA sensoh the US300mA.
use USB p computeent power
eet the saersonal ct's accepted compu
ur computepace for pr
y, use the or reflexessensor ne
nly the sen
m must me
Windo WindoWindoWindoIntel i3500 G2GB D1024x
or 2 x US
must be apC 60950-1
5/EU and t
lp ensure ams are fre
image acq
nded the avoid rec
or doesn't rSB connec
ports avaier. These r for the p
afety regucomputerstable the puter equipm
er and videroper ventimonitor in s that can mext to the pnsor and m
eet the follo
ows 7 (x86 eows 8 (x86 e
ows 8.1 (x86 ows 10 (x86 e3 3.0 Ghz or B
DDR2 SDRAx768 SB 2.0 – 500
pproved b1:2005 + Ahe EMC 2
the idealee from vquisition s
executioncord loss
require an ction of th
lable in keconnectio
proper ope
ulations, ds inside tpresence ment appr
eo monitorilation. 4:3, with f
make difficpatient, wit
medical equ
owing requ
e x64) - Home x64) - Pro
e x64) - Pro e x64) - Homsuperior
M
mA
by CE andAMD1:200014/30/EU
l performairus and wsoftware a
n of regul in case
external phe compu
eyboards ons are feration of
don't operhe patienof non-meroved and
r outside t
full HD feacult the visuh a minim
uipment ca
uirements.
e, Starter, Pr
me, Pro
d must be 09+AMD2:U Directive
ance, makwere propafter its in
lar backuof failure
power supputer and
or in the ffrequentlythe senso
rate non-mnt area. Oedical equ
d certified
he patient
atures andualization oum distancn be inside
ro
in confor2013 and
es.
ke sure thperly testenstallation
up in the of the co
ply since itit has ap
front or lay unable tor.
medical eOutside thuipment a
t area, ens
place theof the imagce of 1.5 me the patie
14
rmity with the Low
hat all the d so they .
files and omputing
s power ispproximate
ateral side to deliver
quipmenthe patient as long as
suring that
e screen toges. meter fromnt area.
4
s e
r
t
o
m
SOFTW
dental improv
Softwa
Cdevice
Select
on I ac
WARE
The dentadigital im
vement, sto
are install
Insert the
Connect theand click o
the desire
Read and ccept the t
al image mmaging seorage, send
lation
sensor in t
e flash drivon the file
d language
understanterms of th
anagemennsor Newding, printi
the USB po
ve that accsetup_Ne
e and click
nd the Endhe Contra
nt softwarew IDA anding among
ort of the c
companiesew_IDA_2_
k on OK
d User Licect. Click N
e performs d the use other func
computer
s the New _0_0_X
ense AgreeNext.
the interfaer, allowinctions.
IDA in the
ement and
ace with thg the vis
e USB port
d, if you ac
15
e Intraoralsualization,
t, open the
ccept, click
5
l
e
k
Select the
Click Insta
dialog box
all to begin
x if you wa
n the instal
ant to creat
lation proc
te an icon o
cess.
on Desktop
p and click
16
k Next
6
accept
Setup will
Setup willthe terms
Click "Inst
install .NE
install thof the soft
tall"
ET 4.5.1
e necessatware
ary tools t
to generate reports.
Click "I A
17
Agree" to
7
o
Wait for th
Setup will
Click Finis
he end of in
install the
sh to end i
nstallation
USB drive
nstallation
and click "
er. Press In
.
"Close"
nstall to beegin the ins
stallation p
18
process.
8
Main s
01 - La
02 - Ac
03 - Pa
04 - Se
05 - H
06 - Fi
07 - Ex
08 - N
09 - To
10 - Sh
11 - Od
12 - He
13 - Se
14 - Co
15 - Fu
16 - Sa
17 - De
18 - Ex
19 - Pr
20 - Sh
21 - Br
screen
anguage s
ccess to t
atient fol
ensor stat
istogram
ixed Zoom
xit
umber tag
ooth selec
how / Hid
dontogram
elp
etting
ompare im
ull Screen
ave
elete
xport ima
rint
harpen
rightness
selection
the manuf
lder
tus
window
m 1x or 2x
gging and
ction
de toolbar
m
mages in f
n
ge
setting
facturer s
d diagnosi
r
full screen
ite
is
n
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
- Invert c
- Contras
4 - Histogr
- Gamma
- Insert T
- Insert A
8 - Insert c
- Insert d
– Select
– Croppin
- Angula
– Calibra
4 - Multipl
- Single M
– Rotate
– Undo
8 - Open im
- Openin
- Histogr
- Gamma
- Histogr
colors
st setting
ram
a setting
Text
Arrow
circle
drawing
ng
r measure
ate
le measur
Measurem
mages
g the Pat
ram Adjus
a Adjustme
ram Adjus
g
ement
rement
ment
ient's Fol
stment – m
ent
stment -
20
lder
minimum
0
INTERFFACE ICON
Icon
NS
Exit To exit the
MaximizeMaximize aMinimizeMinimize a
Create a nAllows to c
Open a paAllows the patients.
Open the Allows the the interfacBrowse upAllows slid Browse doAllows to slibrary. SequentiaDefines thedone. Zoom x1. To show th
Zoom x2 To expand
Compare Compare i
Full ScreeChange the
Save Save imag
ma
F
application
application
application
new patientcreate a new
atient access to t
patient recaccess to t
ce and openp. ing images
own slide images
al capture.e number o
he whole cli
d the image
images mages in fu
en e viewing m
ge in patient
aximum
Features
n
t folder w folder (ne
the databas
cord the folder ren previously
showed in
s showed in
f sequentia
ché in the v
ull screen
mode to full
t's record
ew patient)
se of saved
ecord showey saved files
the vertical
n the vertica
l captures t
viewing wind
screen
ed on s.
l library.
al
to be
dow.
21
Dele imagPermanent
Export Allows savname in sePrint Print the im
The settingSetting meEdge highImprove deAvailable in Obs: Availamarking. Itthe image
BrightnesAllows sett
Inversion Invert the c
Contrast SAllows adju
HistogramAllows the
Gamma SeAllows the
Insert textInsert a tex The definitSettings mInsert ArroInsert an a The definitSettings m
ge tly delete th
ving a copy everal imag
mage in DIC Print in s Print in s
g of the maienu hlight efinition of tn 4 levels o
able only fot is recommcapturing.
s setting ting the brig
of colors color of the
Setting usting the c
m setting of t
etting setting of t
t xt on the im
tion of colormenu
ow arrow in the
tion of colormenu
he display im
of the images standard
COM or Con
standard pri
secondary p
in printer is
the edge of of density.
or TIFF imagended to ap
ghtness of th
image.
contrast of th
he image h
he image g
mage.
r and width
image.
r and width
mage
e with anotds.
nventional.
nter
printer
made in the
the image.
ges without pply it right
he image.
he image.
istogram
amma
is made in t
is made in t
ther
e
t after
the
the
222
Insert CircInsert a cir The definitSettings mInsert FreeInsert a fre The definitSettings m
SelectionSelect an a
Cut Cut a selec
Simple mePerform a the image
Multiple mPerform a on the ima
Angular mPerform an
CalibratioPerform th
Image rotaAllows 90 d
Undo
Show/hideShow/hideresources/
OdontograAccess to O
cle rcle in the im
tion of colormenu
ehand draweehand draw
tion of colormenu
area of the
cted area of
easuremendistance m
measuremedistance mge
measuremen angular m
n e calibratio
ation. degrees rot
Undo all Partial un
e toolbar toolbar wit/association
am Odontogram
mage.
r and width
wing wing in the i
r and width
image
f the image
nt easuremen
ent easuremen
ent measuremen
n of the dis
tation of the
ndo
h marking n of the imag
m mode
is made in t
image
is made in t
t of two poi
t of multiple
nt on the im
tance of the
e image.
ge
the
the
nts on
e points
age
e image
233
Setting
To set
g screen
the applica
ation, pres
HistogramAutomaticaimage (con
Tooth cheUsed to chimage. AccompanSetting. Allows the computer (images, doHelp Shows tuto
ss the icon
m window ally opens wnfigurable in
eckbox heck the too
ny "delete" b
access to t(format andownloads)
orial on how
. The
when loadinn the option
oth (teeth) s
button to un
the paramet file path of
w to perform
e following
ng or capturs menu)
howed in th
do checking
ters of yourf database o
m an acquisi
g screen wi
ring an
he
g.
r of
ition
ill appear.
244
25
01 - Path of Database
02 - DICOM address
03 - Definition of the main printer
04 - Software version
05 - EULA
06 - Color and size of the text*
07 - Color and width of the arrow*
08 - Color and width of free-hand
drawing*
09 - Color, width, and filling of the
circle.*
10 - Distance measurement: Color and
size of the text font.*
11 - Angular measurement: Color and
size of font.*
12 - Cancel changes
13 - Confirm changes
14 - Preprocessing of image
15 - Histogram
16 - Background color
17 - Monitor test.
*Measurement unit in pixels.
Odont
building clicking
appear
togram
The Odong image re
It's possibg the right
To accessr
ntogram reecord to ea
ble to viewbutton of t
s the odo
esource aach tooth a
w the imagehe mouse
ntogram, c
llows orgaand genera
e records on the des
click on th
anizing imating report
or start thsired tooth
he icon
ages accots of the tre
he capture .
. The f
ording to eatments.
of a new
following s
26
the tooth,
image by
screen will
6
,
y
l
a) insert d
Associate
Perform aSelect numdiagnosis i
Click on
The tooth
e image to
n image cambering of nformation
to ass
whose ima
o the odon
apturing the tooth y
n in the tex
sociate the
age is asso
ntogram
you want txt field.
e image wit
ociated wil
to associat
th the patie
l be pointe
te with the
ent record.
ed in YELL
image. If y
LOW
27
you want,
7
b) capture
Capture th
To start a e.
through od
capture, c
dontogram
lick the rig
m
ht button o
of the mousse and afteer that, on
28
start
8
c)
mouse
d)
tools o
Opening i
Click on a e. Select th
Click with
Help odon
The iconn the Odon
image thro
tooth thate day and
right butto
ntogram
opensntogram.
ough odo
has an imtime of the
n to open
s a window
ntogram
mage on thee image yo
an image.
w with an
e odontogrou want to
illustrated
ram with thopen.
guide to
he right bu
help with t
29
utton of the
the use of
9
e
f
e)
display
a - Prin
b - Senc - Savd - Dele - Pre
* In cas
Generatin
With the oyed.
nt report
nd by emave report olete reporteview repo
se of more
ng report t
odontogram
ail. on pdf t ort
e than an im
through o
m open, cl
f -witg -h -i - j -
mage asso
dontogram
ick on the
Selectionthout imag- Select th- Add logoPreview loClinic dat
ociated with
m
icon
of report ges) e image to
o ogo ta
h the tooth
. The follo
model (w
o be inser
h
owing scre
with image
rted in the
30
een will be
s or
e report*
0
e
CONSU
contam
with int
for eac
UMABLES
Protective mination beThis equiptraoral denProtective
ch new pat
The pr
When approv
plastic etween patpment shontal sensor
plastic coient.
rotective p
buying ved, alway Always ucytotoxicaccordan Always us
Always us
covers artients, userould be usrs. overs are s
plastic cov
a protectys follow t
use protec, non-irritce with IS
se produc
se single
re used rs and otheed with pl
single use
vers don't
tive plastthe items
ctive plastant and
SO 10993-1
cts for exc
use produ
as an aers. lastic prote
consuma
t accompa
tic cover,listed belo
stic covernon-sens1.
clusive de
ucts.
additional
ective cove
bles that s
any the pro
, make sow:
rs manufaitizing po
ntal use.
measure
ers, specif
should be
roduct.
sure they
factured wolyethylene
31
to avoid
fic for use
discarded
y are CE
with non-e film, in
d
e
d
LABEL
Identif
*DEMON
Safety
* DEMON
Refer t
*DEMON
LS
fication
NSTRATIVE PI
y
NSTRATIVE P
to instruc
NSTRATIVE PI
ICTURE REAL
PICTURE REA
tion manu
ICTURE REAL
L DIMENSION
AL DIMENSION
ual
L DIMENSION
NS 100 x 63 mm
NS 50 x 23 mm
NS DIAM. 10 m
m
m
mm
322
INTRAO
equipm60601-
ORAL RAD
The Intraoment with e-1-2, EN 60
The intraoand an anThe intraoinstruction
Don't u
DIOGRAPH
oral Dentaelectronic t0601-1-3 a
oral X-ray gode curren
oral X-ray gns and requ
use gener
HY EQUIPM
al Digital Itimer that and IEC 60
generator nt of 7mA.generator uirements.
rators with
MENT
Imaging Scomplies
0601-2 -65
must oper
must be in
h power o
Sensor is with curre and meet
rate at a v
nstalled ac
f less than
compatiblent standars the follow
voltage bet
ccording to
n 60KV.
e with intrards EN 60wing requir
tween 60 a
o the man
33
aoral x-ray601-1, ENrements:
and 70 kV
ufacturer's
3
y N
V
s
SPECIF
Genera
Name Model EquipmClassificClassificClassificClassificProtectiProtecti
Degree flammaboxygen OperatioInput VoInput CuPower CCable le
CharacSize* Sensor (pl/mm) ExternaActive s(mm) Matrix dPixels nTechnolGray levImage r
Image fo
Optical Weight
Connec
Cable le* Order
FICATIONS
ral informa
Alliage TelephAddressRibeirã
ent Classification classcation classcation of thecation of theon Against on Against
of applicatible anestheor nitrous oon Mode oltage urrent Consumptioength
cteristics
resolution
l dimensionsurface dime
dimension number (Melogy vel resolution
ormat
Fiber
ction
enght on request
S AND TEC
ation
S/A Industone: +55 (s: Rodoviao Preto – S
cation s according s according e Equipmene product foElectrical SHarmful Wa
on securityetic mixture oxide
on
of the sen
ns (mm) ensions
egaPixels)
CHNICAL C
trias Médic(16) 3512-a Abrão AsSP - Brasil
to ANVISAto CE
nt accordingor applied pShock ater Infiltrat
in presencwith the air
nsor
2
21.7
17
850 x0
CM40
12
TIFF, JPGDIC
6
USB2 - H
3 m
CHARACTE
co Odonto-1212 ssed, Km 5l CEP 1409
InN
A CC
g to the NBRarts A
Ction IP
hm
ce of one r,
In
C+313
0
25
x 30.3
x 22
x 1100 0.93 MOS 096
2 bits
G, PNG, BMCOM
1 60 g
High speed
meters
ERISTICS
lógica
53 - Recrei97-500 ntraoral Den
New IDA
Class I Class IIa R IEC 6060
Applied partClass II P00 - This p
harmful watematter. nappropriat
Continuous +5 Vdc 300 mA
.5 W 3 m
24
10
P TIFF, JP
USB2
3
o Anhangü
ntal Digital
01-1 regulats BF type
product is ner infiltration
e equipmen
operation
1
25
4.7 x 38.3
20 x 30
00 x 1500 1.50
CMOS 4096
12 bits
PG, PNG, BDICOM
1 65 g
- High spee
3 meters
üera
Imaging Se
tion
not protectedns and part
nt
30
2
130
C
1
BMP TIFPN
D
ed USB
s3
34
ensor
d against iculate
2
25
.6 x 44.2
26 x 36
00 x 1800 2.34
CMOS 4096
12 bits FF, JPG, NG, BMP DICOM
1 70 g
B2 - High speed meters
4
35
Environmental conditions for transportation and storage
Room temperature range for transportation and storage
+4ºC to +40ºC
Relative humidity range for transportation and storage
< 85% RH
Atmospheric pressure band 797 hPa to 1013 hPa (598 mmHg to 760 mmHg)
Conditions for installation and operation of the equipment
Operating room temperature band +10ºC to +30ºC Operating relative humidity range (non-condensing)
< 75% RH
Atmospheric pressure band 797 hPa to 1013 hPa (598 mmHg to 760 mmHg)
Operating altitude ≤ 2000 m
36
CERTIFICATIONS AND STANDARDS
This product bears CE mark in accordance with the provisions of Council Directive 93/42/ EC of June 14, 1993 on medical devices as amended by Directive 2007/47/EC of September 5, 2007.
The Intraoral Dental Digital Imaging Sensor, along with the components of his system, have been evaluated and are conformed to the international EMC, safety and quality standards listed below, among others:
EMC / Security
EN 60601-1: 2006 / A1: 2013 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
EN 60601-1-2: 2015 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
Usability
EN 60601-1-6: 2010 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
EN 62366: 2008 - Medical devices - Application of usability engineering to medical devices.
Software
EN 62304: 2006 / AC: 2008 - Medical device software - Software life-cycle processes.
Quality
EN ISO 13485: 2016 - Medical devices - Quality management systems - Requirements for regulatory purposes
EN ISO 14971: 2012 - Medical devices - Application of risk management to medical devices.
SYSTE
PREPA
ensure
TheIn t
deeperThe
EM OPERA
Never
ARATION F
The eqnew pa
To predisposdamag
Cover thee that it will
e sensor mhe case ofr possible pe active su
By insthe pobstrusenso
ATION
let the pa
FOR USE
quipment atient, obs
event crosed of foged.
e sensor w not be in c
must be posf manual ppart. rface of th
serting thepatient frouction of tr from the
Active
tient unat
must be serving th
oss-contamr each ne
with the discontact wit
sitioned malacing, intr
e sensor m
e sensor om suckthe airwaye patient's
ttended du
cleaned he instruct
mination, ew patien
sposable pth the patie
anually. roduce the
must be pla
into the p
king in tys. In cas mouth.
uring the a
and disintions inclu
use hygnt, always
plastic covent.
e sensor in
aced towar
patient's mthe protee of naus
acquisitio
nfected beuded in th
ienic covs observin
er, also co
the mouth
rds the sou
mouth be ective plaea, immed
on process
efore the his manua
vers that ng if they
overing th
h of the pat
urce of X-R
careful toastic caudiately re
37
s.
use by a l.
must be y are not
e cable to
tient in the
Rays.
o prevent sing the move the
7
o
e
ACQUI
To verify if
Sta
Start The
Duringpatien
ISITION OF
use the Inf it's on.
art the softw All progra
e home scr
g the examt from biti
F RADIOGR
ntraoral de
ware of imaams New
reen of the
mination, ting the se
RAPHIC IMA
ntal digital
age capturw IDA
e applicatio
take the nensor cabl
AGES
imaging s
ring clickin
on will appe
ecessary e.
sensor New
ng on the s
ear
precautio
w IDA, sta
hortcut ico
ons to prev
art the com
on on the D
38
vent the
mputer and
Desktop or
8
d
r
Create
Clic
NexFill
obligat
The
this fold
e a new reg
ck on icon
xt, click onthe fields ory fields).
Select the
e name of der.
gistration
the n
icon to do the
. Next, clic
file that yothe folder
of patien
next screen
e registratiok "OK"
ou createdappears in
t
n will be sh
on of the
d and click n the captu
hown
new patie
OK. ure window
nt (Name
w. The ima
and Last
ages will be
39
name are
e stored in
9
e
n
Openin
ClicSel
Clic
Chang
ClicSelClic
Clic
Clic
Senso Symbo
ng a patie
ck on the icect the pat
ck on
ging a pati
ck on the icect the pat
ck on the in
ck on t
ck on
or status
ol
ent registra
con tient direct
to confirm
ient regist
con tient directnformation
to save the
to confirm
Color
ation
tory that yo
m or click o
tration
tory that yo tab and fil
e changes.
m or click o
Sen
ou want to
on to
ou want to ll the fields
on to
nsor statu
open.
o go back t
open. s you want
o go back t
us
o the initia
to change
o the initia
al interface
e.
al interface
40
.
.
0
Proces
Ver Sel
On
Thethe X-Rshows
At tstandb
TheCANCE
ss of imag
rify if the se
ect the nec
Select The sepatiensenso As a rean 85%
the applica
e icon of thRay exposthe counte
the end ofby mode. Jue activatioEL CAPTU
Beforemake messa
Blue icon
Green icon
Red icon
ge capturi
ensor statu
cessary ex
ting the X-
etting dept anatomyr in the or
eference, % dose les
ation interf
he sensor sure, beinger.
f this perioust click ST
on of the URE.
e the shotsure that
age "Waiti
TherecoWasen
n TheRay
Theacqsen
ing
us has the
xposition tim
-Ray expo
pends on y, distancral cavity.
it must bess that the
face, click
turns GREg kept activ
od, if thereTART CAPsensor ca
t, to avoidt the sensng to exp
e sensor isognized byiting for St
nsor.
e sensor isys.
e sensor isquisition, pansor error.
BLUE ligh
me on the
osition set
multiple ce betwee
e considee movie "T
on INITIAT
EEN. The ve during 1
e`s no X-RPTURE to an be inte
d unnecessor statusose" in it.
connectedy the applictart comma
active and
not conneatient folde
ht.
timer of th
ting, verif
variables,n the sen
ered that tTipo-D".
TE CAPTU
sensor wi120 secon
Ray emissioreactivate
errupt at a
ssary X-Rs shows a
d and was cation. and to activ
d able to re
ected, cancer not selec
he periapic
y if they a
, such assor-font a
he New ID
URE
ill be activds. An ind
on, the seit.
any mome
Ray exposa GREEN
vate the
eceive X-
celed cted or
cal X-Ray.
are all app
s... the X-Rand locati
DA sensor
vated and wdicative pro
ensor will b
ent, just b
sure to theicon and
41
propriate
Ray tube, on of the
r requires
waiting forogress bar
be back to
by clicking
e patient, d has the
r r
o
g
Per Afte
If th
patientexposu
At
dispose
Images
To
icon
rform the e
er the expo
he capture
t folder, oture.
the end oe the plast
Keep t
s of the pa
access the
the follo
exposure w
osure, the
ed image is
herwise, d
of the exatic protectio
the senso
atient's re
e registere
owing scree
with the X-R
image will
s suitable
delete the i
m, removeon followin
r in its bo
egistration
d images o
en will app
Rays gene
appear on
for diagno
image clic
e the senng the reco
x when it'
n
of a patien
pear
rator to ca
n the scree
osis, click t
king on th
sor from tommendati
's not in u
t, open the
pture the i
en of the ap
the icon
e icon
the mouthons includ
se.
e register o
mage.
pplication.
to sav
and pe
h of the ped in this m
of him click
42
ve it in the
rform new
atient andmanual.
king on the
2
e
w
d
e
followin
Select theng screen
All images
patient folwill be disp
s with date
lder and afplayed.
informatio
fter, click o
on and time
on the icon
e of the capture will b
. Th
be exhibite
43
he
ed.
3
a) Add
window b) Dele
perman c) Open
click on
Metric
The
techniqTechni
a) R
Par In t
and theof the s
a new ima
To add a w will be op
Select the
ete an imag
To delete nently.
n an image
To open a
n the icon.
Calibratio
The prafter in
The mThe mchang
e intraoral que used. que and P
Radiograph
rallelism Tec
his techniqe focal poinsensor.
age to the r
new imagpened.
image you
ge from the
an image
e from the r
an image fr
on
rocess of nstallation
etric calibetric teched.
calibrationThere are
Parallelism
hic techniq
chnique or L
que, the dint of the x-
register
e to the p
u want to a
e register
e, select th
register
rom the re
metric caln.
bration denique mus
n is unique e two basicTechnique
ques
Long cone
igital senso-ray genera
patient reg
add to the
he image
egister, sele
libration m
pends on st be perf
for any dec periapicae
or is placeator must
ister, click
register an
you want
ect the ima
must be pe
the radiogformed eve
evice and al radiogra
ed in parallbe position
on the ico
nd click "Op
and click
age that yo
erformed
graphic teery time th
it dependsaphic tech
el to the aned at a dis
on .
pen".
k to
ou want to
at least on
echnique uhe techniq
s on the raniques: th
axis plan ostance aro
44
. A search
o delete it
o open and
ne time
used. que is
diographice Bisector
f the toothound 40cm
4
h
t
d
c r
h m
Thisare bei
Bise In t
Ray mangle accordgenera
Thisand prcomfor
b) M To
that cathe sen
s techniquing x-rayed
ector Techn
his techniqust fall upoformed being to the
ator must b
s techniqurecision of rtable posit
Metric calib
perform than be physinsor.
ue produced in their tr
nique or Sho
que, the digon in a peretween the
isometric be placed a
ue producethe opera
tioning to t
bration pro
he metric cically meas
es radiograrue anatom
ort Cone
gital sensorpendiculae long axlaw from
at a distanc
es radiograted. Howethe patient
cedure
calibration,sured, usin
aph with mmic relation
or is placedr way over
xis of the Cieszinsk
ce of appro
raphs withever, it als.
first perfong the radi
minimum dn and size.
d in a way r an imagintooth and
ki. For thisoximately 2
distortionso provide
orm the caographic te
istortion, s
that the benary plan o the sens, the focal20cm of th
, regardles a relativ
pture of anechnique t
showing ob
eam of theof the bisesor capturel point of e sensor.
ss of the
vely simple
n image ofthat will be
45
bjects that
central X-ector of thee surface,the X-Ray
techniquee, fast and
f an objecte used with
5
t
-e , y
e d
t h
AfteDra
The
er this phasaw a line be
e system w
se, click onetween the
will show a
n Calibratioe two point
standard d
on icon. ts that will
distance in
be measu
n pixel and
red later.
mm.
46
6
Per
Typ
Afte
Precis
rform the p
pe the dista
er entering
sion of the
ParameDistanc
Angle
physical me
ance meas
the distan
e measure
ter ce e
easuremen
sured in mm
nce, click o
ment
0
nt of the x-
m.
on .
Range0 to 99,9 m
0,00 to 179
-rayed obje
e mm 9,99°
ect.
Precisio0,1mm 0,01°
47
n
7
48
RECOMMENDATION FOR EXAMS
The radiographs must be performed only when there's a diagnosis expectation that will affect the treatment of the patient. The dentist shall consider the benefits of getting radiographs against the risk of exposing the patient to radiation.
Due to the effects of radiation accumulation over time, all efforts must be done to minimize the patient exposure.
Use lead apron and thyroid collar, Use pediatric profile or low usage and select the lowest permissible time of
exposure. There may be clinical circumstances for which a radiography is indicated, but a
diagnosis image can't be obtained. For example, the patient may not be able to cooperate with the dentist.
TYPE OF CONSULTATION
PATIENT AGE AND STAGE OF DENTAL DEVELOPMENT1 Children with primary dentition (before the eruption of the first permanent tooth)
Children with transitory dentition (after the eruption of the first permanent tooth)
Teenager with permanent dentition (before the eruption of the third molars)
Adult toothed or partially edentulous
Adult, Edentulous
New Patient * being evaluated for oral
diseases
Individualized radiographic exam which consists of periapical / Occlusal view and/or posterior bitewings if the proximal surface can't be viewed or probed. Patients with no indication of the disease and with open proximal contacts may not require a radiography
Individualized radiographic exam which consists of posterior bitewings with panoramical exam or posterior bitewings and selected periapical images.
Individualized radiographic exam which consists of posterior bitewings with panoramical exam or posterior bitewings and selected periapical images. A complete intraoral radiography exam from the mouth is preferable when the patient has clinical evidence of generalized oral disease or an extensive record of dental treatment.
Individualizes radiography exam, based on signs and clinical symptoms.
Patient follow-up* with decay or increased
risk of decay**
Posterior bitewing exam in intervals of 6-12 months if the proximal surfaces can't be visually examined or with a probe
Posterior bitewing exam in intervals of 6-18 months
Non-applicable
Patient follow-up* without decay or
increased risk of decay**
Posterior bitewing exam in intervals of 12-24 months if the proximal surfaces can't be visually examined or with a probe
Posterior bitewing exam in intervals of 18-36 months
Posterior bitewing exam in intervals of 24-36 months
Non-applicable
Patient follow-up* with periodontal disease
Clinical judgment related to the need and type of radiographic images for the evaluation of the periodontal disease. The image can consist, but not be limited to, bitewing and/or periapical images from areas where the periodontal disease (except non-specific gingivitis) can be clinically demonstrated.
Non-applicable
Patient (New and Return) A clinical judgment about the need A clinical It is usually not indicated for
for
de
den
Pcircu
bpr
implcranrest
cperio
rem
r growth moand dentof
evelopment,evaluation otal/skeletal
Patient with umstances ibut not limitroposed or eant, other d
niofacial pattoration / encare, treatmeodontal disemineralizatio
decay
* Clinicnot lim A. Hist1. Prev2. Histo3. Fam4. Post5. Rem6. Implimplant B. Clin 1. Cli
onitoring facial , and/or of the relations
other including, ted to, existent dental and thologies, ndodontic ent for eases and on of the y
This reapplic It is threason
cal situatimited to:
tory of povious perioory of pain
mily history t-surgery e
mineralizatiant present placemen
nical posit
nical evid
and type ofevaluation growth aevaluation dentofacial
Clinical judcontrol of th
ecommenable to ev
he dentist nably poss
ons in wh
sitive discodontal or or traumaof dental a
evaluation fon monitornce, patholnt
tive - Sign
dence of
f radiographand/or mon
and develof dental relations.
gment abouhese conditio
ndation isvery patien
responsisible) to m
hich the ra
coveries endodontic
a abnormalitifor healingring logy relate
s and Sym
periodon
ic images foitoring of thlopment oand skeleta
ut the need ons
subjectednt.
bility to fominimize t
adiograph
c treatmen
ies g
ed to previo
mptoms
ntal 14. P
or he or al
judgmenthe netype radiograimages evaluatioand/or monitoringrowth dentofacdevelopmevaluatiodental skeletal relationsPanoramperiapicato evaludevelopmthe third
and type of
d to the c
ollow the he exposu
is indicat
nt
ous implan
Pain or ATM
nt about ed and
of phic
for on
ng of the and
cial ment or on of
and
s. mic or al exam uate the ment of molars
gmaraere
f radiograph
clinical jud
ALARA pure of the
ed include
ts or evalu
M dysfunct
growth amonitoring. about the radiographic evaluation ofrelations.
hic images f
dgment a
principle (apatient.
es, but it's
uation for
tion
49
and deveA clinical jneed and
imagesf dental and
for evaluatio
and is not
as low as
s
9
elopment judgment type of
s for d skeletal
on and/or
50
disease 2. Big or deep restoration 3. Injury from deep cavity 4. Crooked or broken teeth 5. Swelling 6. Evidence of dental or facial trauma 7. Teeth mobility 8. Fistula 9. Clinical suspect of sinus pathology 10. Growth anomalies 11. Oral involvement in the known or suspicious systemic disease 12. Neurological positive findings in the head or neck 13. Evidence of strange objects
15. Facial asymmetry 16. Pillar for prosthesis partially removable or fix 17. Unexplained bleeding 18. Inexplicable teeth sensibility 19. Unusual eruption, spacing or teeth migration 20. Morphology of the unusual tooth, calcification or color 21. Inexplicable absence of teeth 22. Clinical Acid Erosion 23. Peri-implanting
The factors that increase the risk for caries can be available using the ADA forms for caries risk assessment (0 - 6 years old and older than 6 years old).
1U.S. Department of Health and Human Services. Dental Radiographic Examinations: Recommendations for Patient Selection and Limiting Radiation Exposure. Available in http://www.ada.org/~/media/ADA/Member%20Center/FIles/Dental_Radiographic_Examinations_2012.ashx. Accessed on November 2, 2015. 2The American Academy of Pediatric Dentistry. Guideline on Prescribing Dental Radiographs for Infants, Children, Adolescents, and Persons with Special Health Care Needs. Available in http://www.aapd.org/media/policies_guidelines/e_radiographs.pdf. Accessed on November 2, 2015. 3U.S. Department of Health and Human Services. Pediatric X-ray Imaging Available at: http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/ucm298899.htm. Accessed on November 2, 2015.
CLEAN
The
and be Wh
saliva. Cle For
perform For
have acontact
The
can tolthis ma
NING AND
Beforesensoequipm
For yomandaglasse
e cleaning efore the st
en starting
an careful
r the cleanm the dryin
r the disinfactive comt time indic
ere's no cylerate durianual.
Don't u
Don't d
The Ne
D DISINFE
e starting r from thment.
our protecatory the es.
and disintorage of th
g the proc
ly the New
ning, use ng with a cl
fection promponents bcated by th
ycle limits ng the cle
use saniti
dip the Ne
ew IDA se
CTION
the cleane USB po
ction, duriuse of I
fection prohe product
cess, chec
w IDA sens
a clean alean and s
ocess of thbased on Dhe manufac
or time of eaning and
zing or cle
ew IDA sen
ensor cann
ing and dort of the
ing the clIPEs suc
ocess must.
ck the exis
or and the
and soft coft cloth or
he New IDDidecyldimcturer.
applicatiod disinfectio
eaning ag
nsor in liq
not be ste
isinfection compute
eaning anh as disp
st be perfo
stence of
first 30cm
cloth dampr with a pa
DA sensor,methylamm
n that the on proces
gents as a
quid saniti
erilized.
n proceduer to avoi
nd disinfeposable g
ormed at e
visible dir
m of the US
p with neuper towel.
, use disinonium chlo
New IDA s, followin
spray.
izing.
ure, discod damage
ection progloves an
each patie
rt, such as
SB cable.
utral soap
nfectants toloride resp
sensor ang the instr
51
nnect the e to your
ocess, it´s nd safety
nt change
s blood or
and then
owels thatpecting the
nd its partsructions of
r
e
r
n
t e
s f
MAINT
PERIOD
It is
safety The
month)subject
The
don't p Insp The The
recomm
In c
Service
PREVE
Bes
your eqmost th
Conpreven
CORRE
All
manuadiagno
TENANCE
The Nassista
DIC INSPE
s mandatorand functio
e periodica) to ensuret to the nor
e manufacerform the
pection an
e inspectio
e followingmended fre
ItemUSB ca
Intraoral s
Accesso
case are de Departm
ENTIVE MA
sides the pquipment, hree (3) yentact the Antive mainte
ECTIVE MA
instructional. If a probosis section
ew IDA sance durin
ECTION
ry that thisonal reliab
al inspectioe that the prmal wear
cturer is exe maintena
d service a
ns perform
g table sequency.
ble
ensor
ories
detected pent.
AINTENANC
periodical init's import
ears. Alliage Seenance.
AINTENANC
s about thblem is detn, contact A
ensor or ng its use
s equipmenility.
on must bproduct is must be ve
xempt fromnce recom
are not par
med must b
shows a
Com
roblems d
CE
nspection, tant to per
rvice Depa
CE
e use of thected and Alliage Ser
any of itse with a pa
nt be inspe
be performpermanenerified and
m liability fmmended b
rt of the wa
be docume
description
Communicati
Gene
uring the
to ensure rform a pr
artment fo
he equipmcan't be c
rvice Depa
s parts caatient.
ected regu
med at regutly safe an
d, if necess
for uncomby him.
arranty of t
ented and k
n of the
Controlonnection /on / Opera
Deral damag
inspection
a long dureventive m
or our peri
ent as intecorrected wartment.
an't receiv
ularly to en
ular intervand operatiosary, replac
mon resul
the equipm
kept with th
main ins
l descripti/ Physical dation / Oveamage e that can
s, contact
rability andmaintenanc
odical rev
ended are with the ins
ve mainte
nsure the o
als (at leaonal. All coced.
ts, in case
ment.
he equipm
spection i
ion damage
erheating /
cause risk
us, with t
d good funce for a pe
iew and p
provided instructions i
52
enance or
operational
ast once aomponents
e the user
ent.
tems and
Physical
k
the Alliage
ctioning oferiod of at
program of
n this usern the error
2
l
a s
r
d
e
f t
f
r r
Alliainformapreviou
The
technic
age statesation that usly agreed
e warrant cians from
The cdentalreplac
s that the provides
d between
will be non autho
orrective digital
cement of
supply oftechnical
him and A
annulled orized servi
maintenaimaging the USB c
f circuit di assistanc
Alliage Ent
if the orices.
ance that sensor
cable.
agrams, cce for theerprise.
iginal par
can be New IDA
componente user ca
ts are re
performedA user i
ts lists or an be req
emoved/rep
d by the is limited
53
any otherquested if
placed by
Intraoral d to the
3
r f
y
54
ERROR DIAGNOSIS In the case of problems with the functioning of your sensor, verify the following:
Symptoms Diagnosis and solutions
Red status of the sensor, indicating that it is not connected
The sensor was not recognized by the computer or it is off. - Verify if the USB cable is properly connected to the computer - Restart the computer - Verify if the drivers of the sensor are correctly installed.
Red status of the sensor, indicating that it is not connected And start capture button doesn't appear
Patient folder was not selected
Blue status of the sensor and there's no image.
- Make sure the sensor is activated (button "Start capture" before the X-Ray shots. - Verify the correct performance of the generator. - Make sure the sensor surface is oriented to the x-rays source and that is correctly aligned.
Green status of the sensor and there's no image.
- Verify the correct performance of the X-Ray generator. - Make sure the active sensor surface is oriented to the x-rays source and that is correctly aligned.
Error "TransfersThread() - pre-capture(0) SafeHandle was closed"
Fail in USB communication during the capture of the sensor. - Verify if the USB cable shows any damage indicative - Verify USB connection with the computer - Verify if the USB port of the computer has the capacity to supply enough power for the proper operation of the sensor.
Error "New IDA has stopped working A problem made the program stop working correctly. Windows will close the program and will notify if there's an available solution"
Fail in USB communication during the setting of the sensor. - Verify if the USB cable shows any damage indicative - Verify USB connection with the computer - Verify if the USB port of the computer has the capacity to supply enough power for the proper operation of the sensor.
Fail in RAM memory - Verify the RAM memory of the computer
WarningbetweenNew calibratifiles bplease i
Error "TnecessafollowingFramew
Very cle
Very da
Image c
Image w
Image fa
CABLE
g "There'sn the serialIDA sension files. If elongs to ignore this m
To run this aary to instg version
work v4.0"
ear image
ark image
completely d
with artifacts
ailure
In the case
E REPLACE
Beforefrom th
s a differel number ofsor and
the calibrathis sen
message
application,tall one of ns of .
dark
s or lines
e of pendin
EMENT
e starting he USB po
ence f the
the ation nsor,
Calib - Co
Calibwith- Ign
, it is f the NET
Fail - Ins
-
-
(<60-
- TheRays- Ins Calib - CoUSB- Ve- Ve- Vesuppsens
Fail - Co
ng issues,
the cable ort of the
bration file d
ontact the te
bration file a wrong se
nore warning
to install.NE
stall Microso
Very - A (bright
Insu - The
0kV). Adjust
(bright
e active ares
sufficient X-
bration file d
ontact the teB cable failurify if the USrify USB corify if the Uply enoughsor.
in the sensontact the te
contact Al
replacemcomputer
doesn't belo
echnical ser
belongs toerial numbeg
ET 4.5.1.
oft.NET 4.5.
longAdjustment ness and co
ufficient tension of
ment ness and co
ea of the se
Ray dose
doesn't belo
echnical supure SB cable sh
onnection wSB port of t
h power fo
or due to phechnical ser
liage autho
ent procer to avoid
ong to the s
vice
the sensor,r.
.1 or reinsta
g exof
ontrast)
expothe gene
of ontrast)
ensor was n
ong to the s
pport
hows any daith the comthe compute
or the prop
hysical damvice
orized tech
dure, discdamage to
sensor
, but it was
all software
xposure your
osure erator is i
your
not exposed
sensor
amage indiputer er has the cper operati
mage (impac
hnical serv
connect tho your eq
55
generated
time. monitor.
time. insufficient
monitor.
d to the X-
cative
capacity to on of the
ct)
vice.
he sensor uipment.
5
cover o
cable.
The esuscepreplacpossib
With the hof the screw
With the s
Remove th
Attach the
lectronic ptible to
cement, mble damag
elp of a scw.
crewdriver
he USB ca
e screws ag
circuits oelectrost
measures ge by ESD
crewdriver w
r with the ti
able and pe
gain.
of Intraoratatic discmust be .
with the tip
ip of 3 x 0,
erform the
al dental charge (Etaken to
p of 3 x 0,8
8mm, rem
replaceme
digital imESD).
protect t
8mm, remo
ove the sc
ent.
maging seDuring t
the device
ove the fini
crews that
56
ensor are he cable e against
shing
attach the
6
the plu
It is re
Make sure
Place the g.
commend
e there's no
cover of th
ded the us
o space be
he screws a
se of a torq
etween the
available in
quemeter
e plastic pa
n the kit an
adjusted
arts.
nd press th
for 10 N.c
hem until th
57
cm
hey fit in
7
58
AUTHORIZED SERVICE NETWORK
All services performed in the Alliage equipment must be done by an Authorized
Technical Assistant, because, otherwise, they won't be covered by the warrant. If you need to request electrical schemes and/or components specifications that are
not declared in the user manual, use the Alliage Customer Attendance Service to make the request.
Telephone: +55 (16) 3512-1212 E-mail: imagem.eagle@alliage-global.com Address: Rodovia Abraão Assed, Km 53 - Recreio Anhangüera - Ribeirão Preto-SP/ Brasil CEP 14097-500
WARRANTY TERM
The Warranty Term, in three copies, must the properly filled by the Alliage
Authorized Technical Assistant. One of the copies, already marked, will be delivered to
the owner for confirmation of the equipment under warranty. One of the remaining
copies will stay with the distributor and the other one will be sent to the manufacturer.
The warranty is limited to the repair or replacement of manufacturing defect parts
and it doesn't include the repair of defects caused by:
- Damage or loss caused by improper use or abuse;
- Damage or loss caused by non-compliance of use and maintenance
instructions.
- Damage or loss caused by acts of nature or catastrophes like fire,
earthquakes, floods, lightning, etc.
- Damage or loss caused by a failure in compliance of the specified conditions
for the system, such as improper installation, improper environment
conditions, etc.
- Damage or loss caused by the use outside the territory where the system was
originally sold;
- Damage or loss caused by Malware (malicious software such as virus, worm,
among others that can damage computers);
- Fall or crash;
59
- inappropriate storage;
- Technical service performed by nonauthorized people by Alliage.
Warranty period
The manufacturer offers a warranty of 12 (twelve) months starting from the
installation date, against parts defects, raw materials, and manufacturing of its
hardware products. In the case of defects occurred and notified during the warranty
period, replacement parts and labor force will be supplied for the replacement or the
items covered by the warranty.
THE MANUFACTURER IS NOT RESPONSIBLE FOR ANY OTHER
WARRANTY, EXPRESS OR IMPLIED, INCLUSIVE BUT NOT ONLY THE
WARRANTIES IMPLIED FOR COMMERCIALIZATION OR SUITABILITY TO A
PARTICULAR PURPOSE AND THE ONES RESULTING OF A TRANSACTION OR
COMMERCIAL USE.
The express warranty is not applicable to the following items: disposable parts,
defect or damage caused by negligence, improper use, operator mistake, inappropriate
installation, changings or non-specified operations of the product from the manufacturer
hardware.
PERFORMING THE CONDITIONS STATED ABOVE, THE MANUFACTURER
WON'T BE RESPONSIBLE BY ANY DAMAGE, DIRECT OR INDIRECT,
IRRELEVANT OR SIGNIFICANT, THAT CAN OCCUR AND REGARDLESS THE
LEGAL THESIS PROPOSED, INCLUDING RESPONSIBILITY STRICT AND
NEGLIGENCE.
At no time the manufacturer will be responsible by any of the following
circumstances:
- Performance, failure or interference from any net used by the Client;
- Performance, failure or interference caused by any equipment or third-party
software;
60
ELECTROMAGNETIC COMPATIBILITY
The Intraoral Dental Digital Imaging Sensor is intended for use in the electromagnetic environment specified below. Buyer or user should ensure that it is used in such an environment.
The Intraoral Dental Digital Imaging Sensor is suitable for use in a
professional health care environment, not including areas where there are sensitive equipment or sources of intense electromagnetic disturbances, such as the RF shielded room of an imaging system magnetic resonance imaging, in operating rooms near active AF surgical equipment, electrophysiology laboratories, armored rooms or areas where short wave therapy equipment is used. The following tables provide information on compliance of the equipment according to the standard EN 60601-1-2:2015. GUIDANCE AND DECLARATION FOR ELECTROMAGNETIC EMISSIONS Emission Essays Conformity Electromagnetic environments -
guidelines
RF emissions CISPR 11 Group 1
The Intraoral Dental Digital Imaging
Sensor uses RF energy only for its
internal functions. Therefore, your RF
emissions are very low and probably
will not cause any interference in
nearby electronic equipment.
RF emissions CISPR 11 Class B The Intraoral Dental Digital Imaging
Sensor is suitable for use in all
establishments other than domestic and
those directly connected to the public
low-voltage power supply network that
supplies buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2 Not applicable
Voltage fluctuation/
Scintillation Emissions
IEC 61000-3-3
Not applicable
61
GUIDANCE AND DECLARATION FOR ELECTROMAGNETIC IMMUNITY
Phenomenon Basic standard of
EMC
Immunity test level Level of conformity
Electrostatic discharge IEC 61000-4-2
±8 KV contact
± 2 KV, ± 4 KV, ± 8 KV,
± 15 KV air
±8 KV contact
± 2 KV, ± 4 KV, ± 8 KV,
± 15 KV air
Radiated RF EM fields IEC 61000-4-3
3 V/m
80 MHz – 2.7 GHz
80 % AM at 1 kHz
3 V/m
80 MHz – 2.7 GHz
80 % AM at 1 kHz
Proximity fields from RF
wireless communications
equipment
IEC 61000-4-3 See table See table
Electrical Fast / Transients
bursts IEC 61000-4-4
± 1 kV
100 kHz repetition
frequency
± 1 kV
100 kHz repetition
frequency
Conducted disturbances
induced by RF fields IEC 61000-4-6
3 V
0.15 MHz – 80 MHz
6 V m in ISM bands between 0.15MHz e 80MHz
80 % AM at 1 kHz
3 V
0.15 MHz – 80 MHz
6 V m in ISM bands between 0.15MHz e 80MHz
80 % AM at 1 kHz
Rated power frequency
magnetic fields IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz or 60 Hz
Tes
freque
(MH
385
450
710
745
780
810
870
930
172
184
197
245
524
550
578
P
st
ency
z)
Ban
(MH
5 380
390
0 430
470
0
704
7875
0
0
800
9600
0
20
1700
19945
70
50 240
257
40
5100
58000
85
The Inof intrafor excexperie
Proximity fie
nd
Hz) S
0-
0 TE
0-
0 GMRS
4-
7 LTE 1
0-
0
GSM
TETRA
820, C
LTE
0 -
90
GSM 1
1900;
DECT;
25 Ba
0-
70
Blueto
802.11
2450,
0 -
00 WLAN
traoral Dea-oral medclusive denence loss o
elds from w
ervice
TRA 400
460,FRS 460
13, 17 Band
M 800/900,
A 800, iDEN
CDMA 850,
E 5 Band
1800; CDMA
GSM 1900;
; LTE 1, 3, 4,
and, UMTS
ooth, WLAN
b/g/n, RFID
LTE 7 Band
N 802.11 a/n
ental Digitical image
ntal use onof commun
ireless RF c
Modu
Pulse mo
18
0
F
± 5 kHz d
1kHz
Pulse mo
217
Pulse mo
18
A
,
Pulse mo
217
D
Pulse mo
217
Pulse mo
217
tal Imagines of teethnly. In casenication be
communicat
lation
M
odulation
Hz
M
deviation
z sine
odulation
7 Hz
odulation
Hz
odulation
7 Hz
odulation
7 Hz
odulation
7 Hz
g Sensor, mandiblee of EM d
etween the
tions equipm
Maximum
power
(W)
1.8
2
0.2
2
2
2
0.2
is intendee and oral isturbancedevice an
ment
Distance
(m)
0.3
0.3
0.3
0.3
0.3
0.3
0.3
ed for the astructures
es, the oped the com
62
Immunity
Test Level
(V/m)
27
28
9
28
28
28
9
acquisition s, and it is erator may puter.
2
The cothe ussame s
This eequipm
Don't other cThis mimmun
Portabantenn30 cmincludof the
To maduringspecifrecom
ompliancese of modstandards
equipmenment. The
use accescables othmay resulnity and re
ble RF comna cables
m to any ing cablesperforma
aintain bag the expfied electr
mmendatio
e with EMdified cabs under wh
t must nrecomme
ssories, trher than tht in increesult in im
mmunicatand extepart of
s specifience of this
asic safetypected seromagnetns descri
C and EMbles or thhat the eq
not be usendations
ransducerhose preveased emimproper op
tions equirnal antenthe Intrao
ed by the ms equipme
y in relatervice lifeic envirobed in this
MI regulatihose whicquipment w
sed adjaceof this ma
rs, internaviously spission or peration.
pment (innnas) shooral Dentmanufactuent could
tion to ele, always nment ans manual.
ions can'tch doesn'was valida
ent or suanual mus
al parts oecified bydecrease
cluding pould be ustal Digitalurer. Otheresult.
ectromagnuse the
nd follow
t be guara't comply ated.
upported st be follo
of compony the manued electro
peripheralssed no clol Imaging
erwise, deg
netic distequipmen
w the mai
63
anteed by with the
by other owed.
nents and ufacturer.
omagnetic
s such as oser than
g Sensor, gradation
turbances nt in the intenance
3