Dentsply Sirona ProPex II Manual

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CONTENTS
English ....................................................... 2
Français ..................................................... 16
Deutsch ...................................................... 30
Español ...................................................... 44
Italiano ...................................................... 58
Português. Este manual de utilização está também disponível, quando
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Table of contents
Introduction…………………………………………………….. 3
1. Indications for use …….…………………………………………3
2. Contraindications …………………………………………….... 3
3. Warnings ……………………………………..……………….... 3
4. Precautions .……………………………..…………………….. 4
5. Adverse Reactions …………………………………………….. 4
6. Step by step instructions …….……………………………….. 5
A. Contents ……………………….………………………. 5
B. Recharging the Battery ..……………………….…….. 5
C. Replacement of the rechargeable battery ………….. 6
D. Getting Started ……………………………………….... 7
E. Search for the Apex …………………………………… 8
F. Sound Adjustment …………………………………….. 10
G. Demo mode ..………………………………………….. 10
H. Automatic Shutdown ..………………………………... 11
I. Maintenance of your ProPex®II ….……….………... 11
J. Guarantee ………..……………………………………. 11
K. Technical Specifications …………………….……….. 12
L. Standard symbols …..……………………….………... 12
Disinfection, cleaning and sterilization ………..…………..….…… 13

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FOR DENTAL USE ONLY
DIRECTIONS FOR USE
Introduction
Congratulations on the purchase of ProPex®II.
1. Indications for use
ProPex®II is an electronic device used for apex location determination and working
length determination. This product must only be used in hospital environments, clinics or
dental offices by qualified dental personnel.
2. Contraindications
The ProPex®II is not recommended for use in patients that have a pacemaker or other
implanted electrical devices.
3. Warnings
See above.
•Only use the original charger

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4. Precautions
The ProPex®II device must be used with the manufacturer's original accessories only.
In order to prevent infectious agent transmission it is highly recommended to use a rubber
dam system during the endodontic procedure.
To ensure that short circuits do not impair the measurements, be particularly careful with
patients fitted with metal crowns or bridges (avoid any metallic contact with the file or the
lip clip)
•High concentrations of sodium hypochlorite may result in a lower accuracy. For
working length determination, we recommend to use sodium hypochlorite solution at
maximum 3% concentration.
•Make sure that the canal is wet enough to ensure reliability of the measurement
•Ensure that the file does not touch another instrument.
•Do not expose ProPex®II to any liquid.
•Avoid excessive liquids inside the tooth cavity to prevent overflow and incorrect
measurements.
•ProPex®II must be stored in normal temperature (< 60 °C) and humidity conditions.
•Do not use in the presence of flammable products.
•Teeth with open apices will give imprecise results.
•If the bar graph suddenly makes a large movement in the upper part of the canal –
continue slightly towards the apex so the signal returns normal.
•An apex locator may not be able to measure in all conditions. In any case, it is
recommended to take an X-Ray prior to use of the unit and compare the information
given by both means.
•For your own safety, please wear personal protective equipments (gloves, glasses,
mask).
5. Adverse Reactions :
None known.

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6. Step-by-Step Instructions
A. Content
Check the content of the equipment before use:
-one ProPex®II apex locator
-one charger
-one measurement cable
-two lip clips
-two connection hooks
-two connection forks
-one user manual
B. Recharging the Battery
The ProPex®II is delivered with a rechargeable battery.
On ProPex®II a screen indicator shows the level of the battery charge. When this is
flashing, the battery requires recharging. However, it is still functional for several
treatments before the battery shuts down.
Procedure for recharging the battery:
1. Disconnect the measurement cable
2. Connect the charger cable to the ProPex®II
3. Connect the charger to the mains
Charging screen will appear during battery charging. When the battery image on the
screen stops blinking and turns green, the charging is complete.
Low Mid Full
Duration of charging: About 12 hours (24 hours after long periods without use).
Note: ProPex®II cannot be used while charging.

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C. Replacement of the rechargeable battery
The battery compartment is located at the bottom of ProPex®II and its cover is secured
by a screw.
1. Release the screw and remove the battery compartment cover
2. Remove the battery and disconnect the battery cable from the jack connector
3. Insert the new battery cable into the jack connector
4. Insert the battery into the battery compartment.
5. Close the battery compartment and secure it with the screw
Warning: Use only original battery pack from your supplier !

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D. Getting Started
1. Disconnect the charger from the device if connected
2. Connect the measurement cable and switch the device On – after a short logo
presentation, the main screen is displayed and the cursor on the tooth image will
start blinking.
(While turning the device On without the measurement cable – the main screen
will be displayed without cursor on the tooth image)
3. Attach the lip clip to the patient
4. Insert the file into the canal – (to ensure precise measurements the file size
should be adjusted to the canal diameter)
5. Connect the hook to the file
The cursor on the tooth will stop blinking (accompanied by a double beep signal).
A blinking cursor and no sound signal indicates a faulty connection. Check your
connections, clean your hook connection, moisten the canal, if necessary, and start
again.
No other adjustments are necessary before starting measurement.
Note: Connection test feature is included in ProPex®II
in order to check the cables:
●Connect metal part of the connection hook
to the lip clip
●“Connection test” icon should
appear in the bottom left corner of the
display, indicating proper connection
●If no icon appears, the connection hook or
the measurement cable should be replaced

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E. Searching for the Apex
1) Coronal and Medial Zone
Slowly introduce the file into the canal.
The cursor on the tooth icon indicates the progression of the file inside the canal.
Further progression of the file in the canal is shown both by the cursor on the tooth icon
and by numerical value on the graphical scale (which does not represent length in
millimeters). ProPex®II emits audible information of file progression via a series of
progressive rate beeps.

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2) Apical Zone
The apical zone is divided into 10 segments graduated from 0.9 to 0.0 (apex) as visual
information of file progression.
When the apex is reached, the cursor shows “APEX” and a solid tone is emitted.
Beginning of Apical
Zone
Middle of Apical Zone Apical position
Once apex is reached, it is recommended to subtract 0.5 mm to determine the working
length for shaping
3) Over-instrumentation
A red segment and a warning signal indicate that the file has passed the Apex. The
cursor on the tooth icon shows “OVER”.

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F. Sound Adjustment
ProPex®II is equipped with a sonic indicator which enables monitoring of the progression
of the file within the canal.
This function, in conjunction with the display of progression, enables working "blind" while
still monitoring the progression of the file.
The volume can be adjusted to one of four levels: mute, low, normal and high, by
successive presses on the volume key.
G. Demo mode
The built-in Demo mode is available to become acquainted with the device and to
demonstrate it’s operation.
1. Disconnect the measuring cable or the charger from the device if connected and
turn Off the device
2. To start Demo Mode, press and hold the (On/Off) button for about 2 sec. until
the second beep sounds and “Demo” indication appears in the bottom left corner
of the display
3. During Demo cycle device operating sequence is shown on the screen. Press
button to pause the simulation; press button again to resume
4. When Demo cycle is completed, it is repeated automatically until interrupted by
the operator
5. To exit Demo mode press button and hold it for about 2 sec. until a beep
sounds
Note: If measurement cable is connected to ProPex® II during Demo cycle, the
device switches automatically to normal operation mode

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H. Automatic Shutdown
ProPex®II automatically shuts down after 5 minutes without use. It is advisable,
however, to manually switch off equipment after measurement by simply pressing the
key (On/Off).
I. Maintenance of your ProPex®II
The device does not contain user serviceable parts. The service and repair should be
provided by factory trained service personnel only.
After each use, all the objects that were in contact with infectious agents should be
cleaned using towels impregnated with a disinfecting and detergent solution (a
bactericidal, fungicidal and aldehyde free solution). Use of chemical agents may cause
damage to the equipment.
Reprocessing procedure :
-the lip clip, the hook and the fork must be sterilized between treatments by
autoclaving at 134°C
See after for detailed procedure
The measuring cable can not be autoclaved.
J. Warranty
ProPex®II is warranted for 24 months from the date of purchase. The accessories
(cables, battery etc.) are warranted for 6 months from the date of purchase.
The warranty is valid for normal usage conditions. Any modification or accidental damage
will render the warranty void.

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K. Technical Specifications
ProPex®II complies to IEC60601-1 safety standard and the requirement of CE Marking
of Conformity.
ProPex®II electronic apex locator belongs to the following category of medical devices:
-Internally powered equipment (2.4V NiMH rechargeable battery)
-Type BF applied parts
-Not suitable for use in the presence of flammable anesthetic mixtures with air,
oxygen or nitrous oxide
-Continuous operation
-Ingress of liquids – not protected
-Environmental conditions during transportation: temperature: –20ºC to +60ºC
(0 to 140ºF); relative humidity: 10% to 90%, non-condensing
Technical specifications
Dimensions: 130 x 80 x 63 mm
Weight: 360 gr.
Type of screen: Color Graphic TFT
Screen dimensions: 3.5 “
Supply: 2.4V NiMH rechargeable battery
External charger: Input: 120 V / 50-60 Hz or 230V / 50-60 Hz
Output: 6V DC
L. Standard symbols
On the device label appear standard symbols as follows:
Recycling : PLEASE DO NOT THROW AWAY! This product and all its
components must be recycled through your supplier.
Type BF applied partClass II equipment
Attention, consult accompanying documents
Direct current

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Disinfection, cleaning and sterilization procedure
for the ProPex®II accessories
Foreword
The lip clip, the hook and the fork must be cleaned, disinfected and sterilized before each
use to prevent any contamination according to ISO 17664. This concerns the first use as
well as the subsequent uses.
General recommendation
●The user is responsible for the sterility of the product for the first cycle and each further
usage as well as for the usage of damaged or dirty instruments.
●For your own safety, please wear personal protective equipment (gloves, glasses,
mask).
●Use only disinfecting solution which is approved for their efficacy (DGHM-listing, CE
marking, FDA approval)

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Procedure for lip clip, hook and fork
Operation Operating mode Warning
1. Pre-Disinfection or
Decontamination
- Soak immediately just after
usage all instruments in a
disinfectant solution
combined with proteolytic
enzyme if possible.
- Follow instructions and observe
concentrations and immersion time
given by the manufacturer (an
excessive concentration may cause
corrosion or others defects on
instruments).
- The disinfectant solution should be
aldehyde free (to avoid blood
impurities fixation).
- Do not use disinfectant solution
containing Phenol or any products
which are not compatible with the
instruments (See general
recommendation).
- For visible impurities that are
observed on instruments, a pre-
cleaning is recommended by
brushing them manually with soft
material.
X
2. Rinsing - Rinse manually and
abundantly the accessories
with current water
X
3. Manual Cleaning - clean manually the
accessories with an adequate
brush, preliminary soaked in
a clean pre-disinfectant
solution
- the hook mechanism has to be
activated during the cleaning
process (press several times the
push button)
- no visible impurities should be
observed on the accessories
X
4. Rinsing See point # 2 X
5. Disinfection - Immerse the accessories in a
disinfectant solution
(bactericidal, virucidal,
fungicidal, tuberculocidal and
aldehyde free) according to
the manufacturer
recommendations
- Follow instructions and observe
concentrations and time given by
the manufacturer
X
6. Final rinsing - See point # 2
- After rinsing, the accessories
have to be dried.
X
7. Inspection - Inspect devices and sort out
those with defects.
- Dirty instruments must be cleaned
and disinfected again. X
8. Packaging - Pack the devices in
“Sterilization pouches”.
- Check the validity period of the
pouch given by the manufacturer to X

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determine the shelf life.
- Use packaging which are resistant
up to a temperature of 141°C
(286°F) and in accordance with EN
ISO 11607.
9. Sterilization - Steam sterilization at:
134°C (237°F) during 18 min
- The accessories (lip clip, hook and
fork) must be sterilized according to
the packaging labeling.
- Use fractionated vacuum or gravity
(less preferred) autoclaves
(according to EN 13060, EN 285).
- Use validated sterilization
procedure according to ISO 17665-
1
- Respect maintenance procedure of
the autoclave device given by the
manufacturer.
- Use only the listed sterilization
procedures.
X
10. Storage - Keep devices in sterilization
packaging in a dry and clean
environment
- Sterility cannot be guaranteed if
packaging is open, damaged or wet
(check the packaging before using
the instruments).
X

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Table des matières
Introduction……………………………………………………………. 17
1. Indications concernant l’utilisation……………………………. 17
2. Contre-indications……………………………………………….17
3. Mises en garde…………………………………………………. 17
4. Précautions d’utilisation……………………………………….. 18
5. Effets secondaires……………………………………………… 18
6. Instructions d’utilisation, étape par étape……………………. 19
A. Contenu de l’emballage……………………………….. 19
B. Rechargement de la batterie…………………………. 19
C. Remplacement de la batterie…………………………. 20
D. Mise en route…………………………………………… 21
E. Localisation de l’apex…………………………………. 22
F. Réglage du son………………………………………… 24
G. Mode « démo »………………………………………… 24
H. Arrêt automatique de l’appareil………………………. 25
I. Maintenance et entretien de votre ProPex®II……… 25
J. Garantie…………………………………………………. 25
K. Caractéristiques techniques………………………….. 26
L. Pictogrammes…………………………………………. 26
Désinfection,nettoyage et stérilisation…………………………….. 27

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POUR USAGE DENTAIRE UNIQUEMENT
MODE D’EMPLOI
Introduction
Félicitations pour votre nouvelle acquisition, le ProPex®II !
1. Indications concernant l’utilisation
ProPex®II est un appareil électronique servant à localiser l’apex. Il est destiné
uniquement aux hôpitaux, aux cliniques et aux cabinets dentaires. Seuls les
professionnels du dentaire qualifiés sont habilités à l’utiliser.
2. Contre-indications
Il est recommandé de ne pas utiliser ProPex®II chez les patients porteurs d’un
pacemaker (ou de tout autre type d’appareil électrique implanté).
3. Mises en garde
Voir ci-dessus.
•Toujours utiliser le chargeur d’origine.

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4. Précautions d’utilisation
Toujours utiliser le ProPex® II avec ses accessoires d’origine, c'est-à-dire ceux du
fabricant de l’appareil.
Afin de prévenir tout risque de transmission d’agents infectieux, il est vivement
recommandé de poser une digue avant de pratiquer l’intervention d’endodontie.
Etre particulièrement vigilant si le patient est porteur de couronnes ou de bridges
métalliques : en pareil cas, tout contact entre ces couronnes/bridges avec la lime ou le
clip labial doit en effet être évité car cela provoquerait un court-circuit qui perturberait le
mesurage.
•Parce que les fortes concentrations en hypochlorure de sodium peuvent nuire à la
précision du mesurage, veuillez, pour déterminer la longueur de travail, utiliser une
solution d’hypochlorure de sodium présentant un taux de concentration qui ne
dépasse pas les 3 %.
•Afin que le mesurage puisse s’effectuer correctement, toujours s’assurer que le canal
est suffisamment humide.
•La lime utilisée pour le mesurage ne devra toucher aucun autre instrument.
•N’exposer le ProPex®II à aucun liquide.
•A cause des risques de débordement et d’erreurs de mesure qui en résulteraient,
faire en sorte qu’il n’y ait pas, dans la cavité, trop de liquide.
•Le ProPex®II devra être rangé dans un endroit présentant des conditions normales
de température (< 60°C) et d’humidité.
•Ne pas utiliser cet appareil en présence de produits inflammables.
•Dans le cas d’un apex ouvert, la précision du mesurage sera moins bonne.
•Si au niveau de la représentation graphique (barres) vous constatez un mouvement
important au niveau de la partie supérieure du canal : continuez de progresser
doucement vers l’apex pour faire revenir le signal à la normale.
•Tout localisateur d’apex peut, dans certains cas, être dans l’incapacité d’effectuer le
mesurage. C’est pourquoi il est recommandé de toujours faire une radiographie
avant de l’utiliser. Ensuite, on compare les résultas obtenus avec les deux
techniques (radiographie et localisateur d’apex).
•Pour votre propre sécurité, veuillez porter les équipements de protection individuelle
requis (gants, protection oculaire, masque).
5. Effets secondaires
Aucun à notre connaissance.

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6. Instructions d’utilisation, étape par étape
A. Contenu de l’emballage
Avant d’utiliser l’appareil, vérifier que rien ne manque dans l’emballage. Il doit contenir
ceci:
- 1 localisateur d’apex ProPex®II
- 1 chargeur
- 1 câble de mesure
- 2 clips labiaux
- 2 crochets de connexion
- 2 fourchettes de connexion
- 1 mode d’emploi
B. Rechargement de la batterie
Le ProPex®II est fourni avec une batterie rechargeable.
Sur l’écran du ProPex®II un témoin vous indique le niveau de charge de la batterie.
Quand ce témoin clignote, cela veut dire que vous pourrez encore utiliser l’appareil pour
quelques interventions mais que vous devrez recharger la batterie sans tarder.
Pour la recharger, veuillez procéder comme suit :
1) Déconnectez le câble de mesure
2) Branchez le câble du chargeur sur le ProPex®II
3) Branchez le chargeur sur votre prise de courant (courant de secteur)
Pendant que la batterie se recharge, l’indicateur de charge affiché à l’écran de l’appareil
vous indique la progression du rechargement. Quand cet indicateur s’arrête de clignoter
et devient vert, cela signifie que le rechargement est terminé.
Faible charge Mi-charge Pleine charge
Temps de rechargement de la batterie : 12 heures (24 heures si, pendant une période
prolongée, l’appareil n’a pas été utilisé).
Note: pendant toute la durée de rechargement de la batterie on ne peut pas utiliser
ProPex®II.

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C. Remplacement de la batterie
La batterie se trouve dans le compartiment situé en bas de l’appareil ProPex®II et muni
d’un couvercle fixé par une vis. Pour remplacer la batterie :
1. Dévissez la vis du couvercle puis ôtez ce dernier.
2. Sortez la batterie puis débranchez son câble de la prise jack
3. Branchez le câble de la nouvelle batterie sur la prise jack.
4. Introduisez cette nouvelle batterie dans le compartiment.
5. Remettez le couvercle du compartiment puis refixez-le avec sa vis.
Attention ! : Utilisez uniquement des batteries d’origine, c’est à dire celles fournies par
votre revendeur !