iTero Element User manual
EXHIBIT G
FILED
2019 Jan-09 PM 03:24
U.S. DISTRICT COURT
N.D. OF ALABAMA
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OPERATION MANUAL •
•
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COPYRIGHT
Copyright©
by Align Technology Inc. 2016. All rights reserved.
The information contained
in
this manual
is
subject
to
change
without notice.
The hardware
and
software
described
in
this manual are supplied under a Sales
and
Services
Agreement
and
may
be
used only
in
accordance with
the
terms
of
that
agreement.
No
part of this manual may
be
reproduced, photocopied, stored
in
a retrieval system, or transmitted
in
any
manner (electronic
or
mechanical)
for
any purpose
other
than
the
customer's normal usage,
without
the
prior
written permission
of
Align Technology Inc.
This manual describes the
iTero®
Element'" Optical Impression Device.
English language version.
TRADEMARKS
The following
are
trademarks and/or service marks
of
Align Technology, Inc. or one
of
its subsidiaries
or
affiliated companies and may be registered
in
the
U.S.
and/or
other
countries: Align Technology Inc.,
iTero®
Any
other
trademarks
or
registered trademarks
appearing
in
this manual
are
the
property oftheir respective
owners.
USA
OFFICE
Corporate
Headquarters
Align Technology, Inc.
2560 Orchard Parkway
San
Jose, California 95131
www.aligntech.com
Tel:
+1
(408) 470-1000
Fax:
+1
(408) 470-1010
CUSTOMER
SUPPORT
Tel:
+1
(800) 577-8767
E-mail:
E-mail:
ISRAEL
OFFICE
Align Technology Ltd.
3 Ariel Sharon Blvd.
OrYehuda 6037606
Tel:
+972
(3)
634-0020
Fax:
+972(3)634-1440
NETHERLANDS OFFICE
International Headquarters
Align Technology
B.V.
Arlandaweg
161
1043
HS
Amsterdam
Tel:
+31
(0)
20-586-3600
Fax:
+31
(0)
20-586-3751
EUROPEAN
AUTHORIZED
REPRESENTATIVE
Obelis
s.a.
Boulevard General Wahis
53
B - 1030 Brussels, Belgium
www.obelis.net
Tel:
+32.2.732.59.54
Fax:
+322.732.60.03
E-mail: [email protected]
CLASS
1
LASER
COMPLIANCE
~I
Class 1 laser'Product
Thi.s
device complies with: "21
CFR
1040.1
O"
and
"EN
60825-1
".
EMC COMPLIANCE
~
C
US
FCC
COMPLIANCE
FCC Warning
This device complies
with
the
following
CSA
standard for Canada and
the
USA:
"UL
Std No. 60601-1 Second Edition -Medical Electrical Equipment Part
1:
General Requirements for Safety"
This device complies with Part
15
of
FCC
Rules and its operation
is
subject
to
the
following two conditions:
1)
This device may
not
cause harmful interference.
2)
This device must accept any interference received, Including interference
that
may cause undesired operation.
Modifications
to
the
device
that
are
not
expressly approved
by
the
manufacturer may void your
authority
to
operate
the device under
FCC
Rules.
EMC COMPLIANCE
This device complies
with
the
following
EMC
standard:
"/EC 60601-1-2 Medical electrical
equipment
-Part
1-2:
General requirements
for
basic safety
and
essential
petformance -Collateral standard: Electrom·agnetic
phenomena
-Requirements
and
tests".
SAFETY
COMPLIANCE
This device complies with
the
following safety standard:
"/EC 60601-1 Medical electrical
equipment
-Part
1:
General requirements
for
basic safety and essential
performance.
CE
COMPLIANCE
This
device complies with Council Directive 93/42/EEC for Medical Devices.
CE
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CONFORMITE
DU LASER CLASSE 1
.£}Prodult
l.a$4!rde
Classe
1jcet
appareil
est
conforme aux normes:
"21
CFR
1040.10"
et
"EN
60825-1 ".
CONFORMITE CSA
~us
CONFORMITE FCC
Avertissement FCC
Ce dispositif
est
conforme a
la
norme
CSA
pour le Canada
et
les ~tats-Unis «
UL
Std
No. 60601-1 Second Edition -Medical Electrical Equipment Part
1:
General Require-
ments for Safety »
Ce dispositif
est
conforme a!'Article
15
des R9glementations
FCC
et
son fonctionne-
ment est soumis aux conditions suivantes :
1)
Ce dispositif ne doit pas causer d'interf9rences nuisibles.
2)
Ce dispositif doit accepter
toute
interference
re<;ue,
y compris
des
interferences
pouvant causer
un
dysfonctionnement.
Toute modification
apportee
au dispositif n'ayant pas
ete
expressement approuvee par
le
fabricant
peut
annuler
votre droit autiliser ce dispositif d'apres les RE!glementations
FCC.
CONFORMITE CEM
Cet appareil est conforme aux normes
de
sE!curite
CEM
suivantes :
"IEC
60601-1-2 Dispositifs electromedicaux- Partie 1-2: Exigences generales pour
la
securite
de
base
et
les
performances essentielles -Norme collatera1e: Ph€nom€nes E!lectromagn€tiques -Prescriptions
et
essais"
SECURITE
DU
DISPOSITIF
Cet apparelI
est
conforme aux normes
de
securite suivantes :
"IEC
60601-1 Dispositifs €1ectrom€!dicaux -Article 1 : Exigences generales pour
la
securite
de
baseet
les perfor-
mances essentielles".
CONFORMITE
CE
CE
Ce dispositif est conforme a
la
directive 93/42/CEE relative aux dispositifs m€dicaux.
SYMBOLS
The
following symbols may
appear
on iTero Element hardware components, and
may
also
appear
within this
manual and other iTero Element literature.
-
"Rx only"
Wherever
this symbol appears on the device,
it
is
recommended
to
refer
to
this manual
for information on
proper
usage
of
the device.
Applied part type
B.
Any
component
on which this symbol
appears
is
electric isolation
type
B.
Separate collection
of
electrical waste and electronic
equipment
is
required.
Attention: This symbol
is
used
to
highlight
the
fact that
there
are specific warnings
or precautions associated with
the
device. Wherever this symbol appears on
the
device,
it
is
mandatory to refer
to
safety-related information within this manual.
Parts
or
accessories
on
which
this
symbol
occurs
should
not be
reused.
CAUTION:
US
Federal
Law
restricts this device
to
sale by
or
on
the
order of a licensed
Dentist, Orthodontist or Dental Professional.
The
system serves
as
a prescription medi~
cal
device and should
be
operated
by qualified health-care providers
only.
Medical device manufacturer.
l'ubl·,~~v;,n
SG02.:.1-?2-D
iTt:.~ro~
Elemenf"
OpNal1on
Mc111ual
EN(LISH
SYMBOLES
Les
symboles suivants
peuvent
appar·a't'lre sur des con1posants mater1els
do
1'1
lero Clement Loul
corrnne
dans ce
rnarwel
et
d'autres
publicat1011s
relatives
al'iTero Elerne11t.
-
"Rx
only"
Lorsque ce symbole apparait sur
le
dispositif,
ii
est recommande
de
vous reporter
ace
manuel pour
des
informations sur !'utilisation appropriee
de
ce dispositif.
Piece appliquee
de
type
B.
Tout composant sur lequel ce symbole apparait
est
une
isolation electrique
de
type
B.
II
est
necessaire
de
collecter separement !es
dechets
d'equipements
E!lectriques
et
elec-
troniques.
Attention : Ce symbole
est
utilise pour souligner
le
fait qu'il existe
des
avertissements
ou precautions specifiques
assodes
ace
dispositif. Lorsque
ce
symbole apparait sur
le
dispositif,
ii
est obligatoire
de
vous reporter aux informations concernant
la
securite
dans ce manuel.
Les
pieces ou accessoires sur lesquels ce symbole apparait ne doivent pas
etre
rE!util-
ises.
ATIENTION :
La
Loi
federale
des
~tats-Un
is
restreint
la
vente
de
ce dispositif
par
ou
pour
le
compte
d'un dentiste, d'un orthodontiste ou d'un professionnel dentaire agree.
Le
systeme sert
de
dispositif
de
prescription m0dicale
et
devrait etre utilise uniquement
par
des
prestataires
de
soins
de
sante qualifies.
Fabricant du dispositif medical
1::\J(JLISrl
1Tero""
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Operc1l1011
Manual
SAFETY
INSTRUCTIONS
Before beginning
to
work with the system,
all
users are required
to
read
these
safety instructions.
Power Supply
Electric
Warning
Wireless
LAN
Safetr,
Classifications
Prescription
Health Device
Scanner
Warnings
Cleaning &
Disinfection
Unpacking &
Installing
Work
Environment
Electro
Magnetic
Interference
General
• Power
is
supplied
to
the system
via
an internal medical grade power supply.
•
Electric
shock
hazard!!
Only authorized Align Technology technicians can remove
external panels
and
covers. There are no user-serviceable parts inside.
•
To
avoid
risk
of electric shock,
iTero
Element must only be connected
to
a supply
mains
with
protective grounding.
• Only Align Technology approved
Web
Camera
or
DOK
should be
connected
to
the
USB
socket
on
the back side
of
the
System.
• The system comes equipped with a Wireless
LAN
unit.
• Type of protection against electrical shock: Class
1.
•
Degree
of protection against electrical shock: Type
B.
• Degree of protection against harmful ingress of water: Ordinary.
• Equipment not suitable for use
in
presence of flammable anesthetic mixtures.
• Mode of operation: Continuous.
• The system serves as a prescription medical device and should
be
operated
by
qualified health-care providers only.
• The scanner emits red laser light (680nm Class
1)
as
well
as white
LED
emissions. Normal
usage of the scanner
does
not present any
danger
to
the human eye. However, doctors
should refrain from shining the scanner directly into the patient's eyes.
• Avoid twisting cable, knotting cable, pulling on cable, stepping on cable.
• When
the
system
is
not
in
use,
the
scanning unit should
be
placed inside the holder with
the
probe facing
to
the rear side ofthe touchscreen so there
will
be
no eye contact with
the
laser beam
in
any case.
•
To
avoid cross contamination,
it
is
mandatory that after each patient session the
disposable plastic sleeve
be
replaced and
the
scanning unit
be
disinfected.
• Dispose of scanner sleeves according
to
standard operating procedures or local
regulations for
the
disposal of contaminated medical waste.
• The system should
be
unpacked and installed following Align Technology's instructions.
• The system should
be
moved between rooms
with
utmost care to avoid damage.
• Do
not
block
the
air vents on
the
Scanning
Unit
and
Base
Unit.
• System
is
intended for indoor use only.
It
should
not
be
exposed
to
direct sunlight,
excessive heat or humidity.
•
WARNING:
This device has
been
tested
and found
to
comply with
the
requirements for
medical devices according to standard EN60601-1-2. This standard
is
designed
to
provide reasonable protection against harmful interference
in
a typical medical
installation. However, because of the proliferation of radio-frequency transmitting
equipment and other sources of electrical noise
in
the healthcare environments
(e.g., cellular phones, mobile two-way radios, electrical appliances),
it
is
possible that
high levels of such interference
due
to
close proximity or strength
of
source, may result
in
disruption of performance of this device.
•
WARNING:
No modification of this equipment
is
allowed.
•
WARNING:
The touchscreen always
needs
to be
in
a stand while
in
operation!
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1
CONSIGNES
DE
SECURITE
Avant
de
commencer a travailler avec le systeme, taus les utilisateurs
doivent
lire les consignes
de
sE!curitE!.
Alimentation
Avertissement
electrique
Reseau
Local
Sans
Fil
Classifications
de Securite
Dispositif de
Prescription
Medicale
Avertissements
concernant
le
scanner
Nettoyage
et
Desinfection
Deballa~e
et
Installation
Environnement
de Travail
Interference
General
• L'alimentation electrique est
fournie
au systeme via
une
alimentation
interne
pour
le milieu
medical.
• Danger d'8lectrocution
!!
Seuls les techniciens
Align
autorises
peuvent
retirer les
panneaux
et
couvercles externes.
II
ne
contient
aucune
piE!ce
reparable
par
l'utilisateur.
• Afin d'E!viter les risques d'E!lectrocution, I' iTero® Element™
doit
uniquement
etre connect€!
au secteur par une mise a
la
terre
de
protection.
• Uniquement
la
webcam (approuvee par Align Technology) ou des
des
USB
peuvent etre
connectE!es
au
port
USB
al'arriE!re
du
dispositif.
• l'.appareil est livre equipe d'une unite locale
sans
Iii.
• Type
de
protection centre !'electrocution : Classe
1.
• Degre
de
protection centre l'electrocution :
Type
B.
• Degre
de
protection contre
la
penetration d'eau nuisible : Normal.
• Dispositif ne convenant pas aune utilisation en presence
de
melanges d'anesthesiques
inflammables.
• Mode
de
fonctionnement: Continu.
•
Le
systeme sert
de
dispositif de prescription medicale
et
devrait
E!tre
utilise uniquement
par
des
prestataires
de
soins
de
sante qualifies.
•
Le
scanner €met une lumiere laser rouge (680
nm
Classe
1)
ainsi que
de
la
lumiere blanche
via
des
DEL.
Une
utilisation normale du scanner ne presente aucun
danger
pour
l'ceil
humain. Cependant, les praticiens devraient s'abstenir d'eclairer
les
yeux du patient
directement avec le scanner.
• Evitez
de
tordre le cable,
de
faire
des
nceuds,
de
tirer dessus ou bien
de
marcher dessus.
• Lorsque le systeme n'est pas utilise, l'unite
de
balayage devrait
E!tre
placee dans
le
support
prevu acet effet avec
la
sonde
tournee
du
cote
de
la
face arriere du moniteur
afin
d'E!viter
tout contact entre le faisceau laser
et
les yeux.
• Pour eviter toute contamination croisee,
ii
est obligatoire
de
remplacer
le
manchon jetable
en
plastique apres chaque session avec
un
patient
et
de
destnfecter l'unite
de
balayage.
• Jetez les manchons en plastique du scanner selon les procedures normalisees ou
les
rE!glementations locales concernant les dechets medicaux contamines.
•
Le
dispositifdevrait etre deballe
et
installe selon les instructions d'Align.
•
Le
dispositif doit
E!tre
deplace
d'une
piece al'autre avec
la
plus grande precaution
afin
d'E!viter
de
l'endommageren faisant preuve du plus grand soin.
•
Ne
bloquez pas les ouvertures d'aeration sur les unites
de
balayage
et
de
base.
•
Le
systeme est destine! a
E!tre
utilise
en
interieur uniquement.
II
ne doit
pas
E!tre
expose
directement a
la
lumiE!re
du soleil,
ni
aune chaleur excessive ou al'humidite.
• AVERTISSEMENT:
Ce
dispositif a ete teste
et
est conforme aux exigences concernant
les
dispositifs medicaux d'apres
la
norme EN60601-1-2. Cette norme est destinee aapporter
une protection raisonnable contre
des
interferences nuislbles dans une installation medicale
typique. Cependant, en raison
de
la
proliferation d'equipements transmettant
des
rdio-
frequences et d'autres sources
de
bruit electrique dans les environnements lies a
la
sante
(telephones portables, radios mobiles bidirectionnelles, appareils electriques),
ii
est possible
que
des
niveaux
Elleves
d'interferences
dues
a
la
proximite ou a
la
puissance
de
la
source
entrainent une perturbation
de
la
performance
de
ce
dispositif.
• AVERTISSEMENT: Aucune modification
de
ce
dispositif n'est autorisee.
• AVERTISSEMENT:
NE
PAS
UTILISER
le moniteur
en
position horizontale !
1Tero~
Elemenf"' Operation
~/hrnual
E:r\JGLISH
TABLE
OF
CONTENTS
CHAPTER
1:
Introduction
......................................................
2
About
this Operation Manual
................................................
2
Intended
Use
.............................................................
2
Benefits
of
the iTero Element
System
........................................
2
The
iTero
Element
User
Interface
............................................
3
CHAPTER 2: Basic
Hardware
Features
..................................
4
FrontView
of
System
......................................................
4
Back View
of
System
...................................................
5
Counter Stand Option
..................................................
6
Scanning Unit (Wand)
.......................................................
7
CHAPTER
3:
Operating
Instructions
......................................
8
Initial Power-Up and Boot
...............................................
8
End-of-Day Shut Down
.................................................
8
Moving
System
within Office
.................................................
8
CHAPTER
4:
AC
Power
Problems-Troubleshooting
.........................
9
Checking & Replacing Main
Fuses
............................................
9
CHAPTER
5:
Scanner
Handling,
Cleaning, and
Disinfection
Instructions
............
10
Handling the Scanning Unit (Wand)
...........................................
10
Handling
of
the Scanner Unit Cable
............................................
10
Cleaning and Disinfectant Materials for Scanning Unit and
Base
Unit
..........
10
Recommended best practices for cleaning and disinfecting
....................
11
CHAPTER 6:
Changing
Sleeves
between
Patients
...........................
12
Cleaning the Scanning Unit
.............................................
12
Replacing Disposable Sleeves
...........................................
12
Scanner Sleeves
.......................................................
13
APPENDIX
A: EMC
Declaration
...............................................
14
APPENDIX
B:
Hardware
Specifications
..........................................
17
0
..
'
............................
'
...
.
CHAPTER
1:
Introduction
About this Operation Manual
The iTero Element system
is
delivered
as
a proprietary, PC-based workstation
for
performing
intra oral
scans
in
the
doctor's office. This Operation Manual describes
how
to
boot
and shut
down the system,
how
to correctly handle
the
Scanning Unit/Wand and cable, and how
to
clean the Scanning Unit and replace its sleeves between patients.
Intended Use
iTero Element
is
an
optical impression system (CAD/CAM) used
to
record the topographical
images
of
teeth and oral tissue. Data generated from iTero may
be
used
in
conjunction with
the production
of
dental devices (e.g., aligners, braces, appliances, etc.) and accessories.
iTero Element software
is
used with the iTero Element scanner
in
capturing 3D digital
impressions
of
teeth, oral soft tissue and structures, and bite relationship. The software
controls the processing
of
the
data, facilitating the integration
of
data, and exporting
of
the
data
for
CAD/CAM
fabrication
of
dental restorations,
Orthodontic
devices, abutments, and
accessories.
In
addition
to
scan data, various patient and case information can be
imported/
exported
or
used
for
simulation purposes.
Other
functions are available
for
verification and
service
of
the system and
to
serve
as
an
order
management tool.
Benefits
of
the iTero Element System
The iTero Element system provides important advantages over existing crown-production
methods, Including powder-free scanning, greater crown-production accuracy, and
immediate feedback during
the
scanning process.
Refer
to
our website http://www.itero.com
to
learn how the iTero Service can enhance your
business
by
Increasing patient satisfaction, improving clinical outcomes, and enhancing office
efficiency.
0
1Tcro®
Elernent"~
Operation
Mc111ua!
CNGLISH
The iTero Element User Interface
The
iTero
Element
system
provides
an
intuitive user interface
for
performing
digital
scans
for
Restorative
or
Orthodontic
use. The
doctor
is
guided
through
the
scanning sequence
by
means
of
visual
and
text
assistance. The touchscreen
and
wand
buttons
are used
to
respond
to
screen instructions
during
the
scanning process.
One
tap
on
the
question
mark will
enable
a transparent
Help
overlay
that
will
provide
a
brief
overview. Please
note
that
the
Headset
image
appears instead
of
the
question
mark while
in
this view. Tap anywhere
to
close
the
help
screen
and
return
to
the
relevant screen.
Tap
to
sot
_your
profcu_;nces
fop
lo
lock the
desktop
Taµ
to
enter
the Learnin9 CenLer 01 start t,·aining
••
New
Scan
Patients
Double
tap
to
connect
to
a support
agent
for
remote
troub/eshoot1n9
(please call suppor1
frrstJ
:Tap
to
start
a ne\'1 case)
(Tap
to
see/search
patient
/,st)
Tap
::o
cneck
th::-,
status
cii yod,-
(,1r(/e1s
,'
·1:_1
~r~;.-'•,vr,ere
on
SC(een
t·o
ciose
th;::,
heip
overlay
Tan
in
viev1 nor:rf1r.at1011,;,
u,rxlates
c.uid
ul.lle!' 1nessoges
frorTJ
A,.1S_."t
1Tcchnoiogy
0
ENGLISH
1Tero.;i
Eleri1e11r_·v
Opcrc1L1crn
Manucil
CHAPTER
2:
Basic
Hardware
Features
CUSTOM
WHEEL
STAND
HARDWARE
FEATURES:
Front View of System
...
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---l'-lf-ll!-~--<11
Wheel
Base
0 Publication SD08492-D Align Technology,
Inc.
Updated
Jcdy
2016
\
Scanning
Unit (Wand)
~--
Scanning
Unit
(Cradle)
Power
LEO
Power
Switch
CUSTOM
WHEEL
STAND
HARDWARE
FEATURES:
Back
View
of
System
Arr
Vents
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(Do
not
block
~:,:-;~:
•:•:•:•.•.•:•:,:
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back
of
system)
USB
Socket
for
Optional
Camera/DOK
Scanning Unit
Connector
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icat:c~, SD08,1?2 D
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Power
Inlet
and
Fuse Holder
Power
Cord
0
l:::\J~~iLISH
iTero®
Elemenf"
Operation
Manual
CUSTOM COUNTER STAND: Front
and
Back View
of
System
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iTnrog Elemenf~
Operation
Manual
ENCiLISH
SCANNING UNIT (WAND)
Touchpad
Disposable
Sleeve
Side
Buttons.·
Scan,
On/OH,
Touchpad Activation
...
Detachable
Scanning
Unit Cable
with
USB
connector
0
t,\JC~LISH
1Tcr"o®
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v Opcr·c1lio:•
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CHAPTER
3:
0 perat
in
g In
st
ructions
INITIAL POWER-UP
AND
BOOT
Plug main cable into the
Base
Unit socket and other end into wall
outlet;
Plug free end
of
Wheel Stand main cable into wall socket.
E)
Press
and release the
power
switch on
the
bottom
of
the
screen frame, on
the right side. The
power
LED
will turn on.
It
is
recommended
to
keep the system
in
operation during office hours to allow background
file transfers between the doctor's office, the doctor's partnered labs, and
the
Align
Technology Center. It
is
recommended
to
shut
down
the system at the end
of
the day,
and
to
reboot
in
the morning.
END-OF-DAY SHUT
DOWN
0 Close all files and applications.
8
Press
and release the Power Switch on the
bottom
of
the screen
to
shut down the system.
MOVING
SYSTEM
WITHIN OFFICE
To
ensure maximum system protection, it
is
recommended
to
have two people move
the system. Follow these instructions
for
relocating the system:
1 Verify
the
Scanning Unit (Wand) sits well inside the Scanning Unit Cradle (holder).
2
Press
and release the Power Switch on the bottom
of
the
screen to shut down the system.
3 Unplug system from the wall outlet.
4 Move the system carefully using two people.
5 Place the system at its new location and
it
plug into a wall outlet.
6
Press
and release the
power
switch
to
power
ON
the system.
0
PulJ·:aMn
SD08•192 D
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CHAPTER
4:
AC
Power Problems-Troubleshooting
CHECKING &
REPLACING
MAIN
FUSES
r,1_
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a;,
IJ'.1
0 Unplug Cord from Wall
Unplug the power cord from the
wall
socket.
••
'----~
E) Disconnect Cord from Base Unit
Unplug the power cord
from
the back of the system.
0
Open
Fuse Tray
Push down on the small plastic part on the fuse
tray
to
release
it,
then
pull
the fuse tray out.
0 Replace Fuse
If
either fuse
is
blown or suspect, replace both fuses
(See "FuseType" specs at the end of
the
manual.)
I
,,
:-:·:·:·:·:-:·:·
,l
I
8 System Access
Move
system
away
from
any
wall
to
allow
easy
access
to
the power cord and fuse tray.
0
View
Fuse Tray
The fuse tray
is
located below the power socket.
0 Remove & Check Fuses
Carefully remove each fuse
from
the
tray.
Check fuses visually (and
with
tester
if
available).
0 Close Fuse Tray
Close the fuse tray and insert cord
firmly.
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0
CHAPTER
5:
Scanner
Handling,
Cleaning,
and
Disinfection
Instructions
HANDLING THE SCANNING
UNIT
(WAND)
• The Scanning Unit contains delicate components and should
be
handled with care.
HANDLING OF THE SCANNER UNIT CABLE
• The scanner cable should be treated with care
to
avoid possible damage.
• Avoid twisting, knotting, pulling
or
stepping on cable, etc.
• Between patient sessions,
it
is
recommended
to
undo
any twists and knots
in
order
to
relieve all tension from the scanner cable
RECOMENDED
BEST
PRACTICES
FOR
CLEANING
AND
DISINFECTING
the Scanning Unit,
Base
Unit, Wheel Stand
and/or
Counter Stand
in
between patients.
• Do
not
spray disinfectant directly on scanner system surfaces.
• Spray the disinfectant
on
a towel,
or
use disinfectant wipes
for
the Scanning Unit,
and
Base
Unit.
• Warning: over saturation
of
disinfectant product on the scanner system surfaces may
cause damage, including internal components.
• Follow the disinfectant manufacturers' instructions for appropriate contact time.
Remove residual liquid disinfectant with a lint-free, clean cloth.
• Note: follow standard precautions for personal protection,
as
appropriate.
• Warning:
DO
NOT
touch the optical surface
of
the Scanning Unit (Wand).
iTero®
Element-"
Opcral1011
Manual
ENGLIS:--1
CLEANING
AND
DISINFECTANT MATERIALS
for
Scanning
Unit
and Base
Unit
The
following
cleaning
and
disinfectant
materials are
recommended
for
use
for
Scanning
Unit
and Base Unit.
b,ii!itli6tioi1
i>H
M11nufacturer
PIN
. .
.
Manl!f~i:t\l):i)f.
·.•
...
.,_,.,..
Birex®
Ouat Wioes 7.6
BP240
Biotrol Intl.
CaviCide AF 12.7 13-8000 Metrex
CaviCide 12.5 13-1000 Metrex
CaviWioe 13-1100
CaviCide 1 12.5 13-5000 Metrex
CaviWioe 1 13-5100
Clorox Healthcare® 2-3 30828,30829 Clorox® Healthcare™
Hydrogen Peroxide
Cleaner Disinfecting
Liauid
Clorox Healthcare® 2-3 30824,30825 Clorox® Healthcare™
Hydrogen Peroxide
Cleaner Disinfectant
Wioes
Opti-Cide
3®
Liquid 7.6 DOCS12-024, Biotrol Intl.
DOCP04-128
Ooti
Cide
3®
Wipes 7.6 DOCW06-100 Biotrol Intl.
OPTIM 33TB Liquid 2.5-3.5 OPT33-1 GAL,
OPT-
SciCan
Inc.
33-1QT
OPTIM 33TB Wipes 2.5-3.5 OPT33-W1OX10,
OPT-
SciCan
Inc.
33-W12
ProSpray 10
PSC240
Certol
ProSoray wioes
PSW-1
Webcol® Alcohol Prep 7 5110 Medtronic
Pads
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