Dentsply Sirona ProPex II User manual

ProPex® II
apex locator
User Manual
For dental use only

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Contents
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Appendix 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
Appendix 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176
Electronic instructions for use
For additional languages, visit our website: dentsplysirona.com
Technical modifications on our product are not subject to notification. Photos on our
devices are not contractual.
Des modifications techniques peuvent être apportées à nos produits sans préavis. Les
photos de nos dispositifs sont non contractuelles.
Technische Änderungen an unseren Produkten können ohne Vorankündigung erfolgen.
Fotos unserer Produkte sind unverbindlich.
Las modificaciones técnicas de nuestros productos no son objeto de notificación. Las
fotos de nuestros dispositivos no son contractuales.
Modifiche tecniche dei prodotti non soggette a notifica. Le foto dei dispositivi sono solo
indicativel.
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Table of contents
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Table of contents
1 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5 Adverse Reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
6 Step-by-Step Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
6.1 Content . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
6.2 Connecting the AC Plug Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
6.3 Recharging the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
6.4 Replacement of the Rechargeable Battery . . . . . . . . . . . . . . . . . . . . 15
6.5 Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
6.6 Searching for the Apex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
6.6.1 Coronal and Medial Zone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
6.6.2 Apical Zone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
6.6.3 Over-Instrumentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
6.6.4 Completion of the Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
6.7 Sound Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
6.8 Demo Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
6.9 Automatic Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
6.10 Maintenance of your ProPex ®II . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
7 Cleaning, Disinfection and sterilization . . . . . . . . . . . . . . . . . . . . 24
7.1 General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
7.2 General Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
7.3 Procedure for Lip Clip, Hook and Fork . . . . . . . . . . . . . . . . . . . . . . . 26

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Table of contents
8 Technical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
9 ProPex ®II Apex Locator Error Code . . . . . . . . . . . . . . . . . . . . . . 32
10 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
11 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
12 Disposal of the Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
13 Identification of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

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Introduction
Congratulations on the purchase of ProPex ®II.
ProPex ®II is a device aimed at detecting the minor apical foramen
based on analysis of electrical properties of different tissues inside the
root canal system. For optimal safety and performance, read this user
manual carefully before use. Make sure you have understood and
followed the clinical precautions - as well as the general warnings,
precautions and contraindications - before proceeding to determining a
working length.
Keep this user manual for future reference.

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Indications for Use
1 INDICATIONS FOR USE
ProPex ®II is an electronic device used to indicate the location of the
apex and the working length. This product must only be used in hospital
environments, clinics or dental offices, by qualified practitioners.
2 CONTRAINDICATIONS
The ProPex ®II is not recommended for use:
• in patients who have a pacemaker or other implanted electrical
devices, or have been cautioned by their physicians against the use
of small electric appliances such as shavers, hair dryers, etc;
• in patients allergic to metals;
• in children.

Warnings
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3 WARNINGS
• The scale indication on the ProPex ®II screen does not represent a
distinct length or distance in mm or other linear units. It simply
indicates the file progression towards the apex.
• The following patient's related factors may prevent accurate
readings:
- blocked root canals;
- teeth with large apices;
- root fracture or perforation;
- metal crowns or bridges, if they come into contact with the file or
the lip clip.
• Inaccurate or incorrect readings due to the environment are likely to
occur in the following cases:
- presence of portable or movable radio frequency transmitters in
the surroundings;
- film viewers or other Illumination devices which use an inverter
may cause abnormal operation of the apex locator. Such devices
should be turned off during use of the ProPex ®II.
• Electromagnetic interference could cause improper operation of the
device. In such cases the device behavior may become abnormal
or random. Usage of any devices emitting electromagnetic
radiation, such as cellular phones, remote controls, transceivers,
etc., should be prohibited in the vicinity of ProPex ®II.
• General safety warnings:
- in order to prevent infectious agent transfer it is highly
recommended to use a rubber dam system during the endodontic
procedure;
- make sure that the lip clip, hook or fork does not come into contact
with an electric power source such as an electrical socket. This
could result in a severe electrical shock;
- do not use ProPex ®II in the presence of flammable substances.
• Only use the original battery pack from your supplier.
• Only use the original charger.

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Precautions
4 PRECAUTIONS
Important notice
• Inaccurate or incorrect readings are likely to occur in the following
cases, all procedure related:
- partially blocked canal;
- size of the measuring file differing significantly from the canal
diameter. Ideally, the selected file should be the thickest one
capable of reaching the apex;
- presence of liquids and/or tissue debris in the access cavity. Prior
to the use of the device, the access cavity must be dried with a
cotton pellet in order to prevent leaking current;
- contact of the file or the lip clip with metallic dental structures. Be
particularly careful with patients fitted with metal crowns or
bridges;
- contact of the file with another instrument;
- very dry canal, for instance in the presence of restoration. In this
case the canal must be moistened with an irrigation solution, or
with Glyde™ file prep;
- contact between the file and the gums (this may cause a false
reading indicating that the apex has been reached);
- use of an ultrasonic scaler with the counter electrode attached to
the patient (electrical noise from the scaler could interfere with the
apex localization);
- use of the apex locator in conjunction with an electric scalpel;
- use of a damaged lip clip, hook or fork.
The use of apex locators alone without a preoperative and
postoperative radiograph is not a recommended practice, since apex
locators may not be able to work properly in all conditions.
It is mandatory to confirm radiographically the working length
established using the apex locator.
It is important to follow the precautions below and pay close attention
to any condition or situation that may influence the electrical
conductivity during the procedure.

Precautions
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• For apex localization, concentrations of NaOCl higher than 5% may
result in reduced accuracy.
• As a safety precaution in order to avoid over-instrumentation, it is
recommended to proceed as follows: place the file onto an
endodontic ruler at the point where the ProPex ®II indicates
‘APEX’. Subtract a minimum of 0.5 mm from the measured file
length.
• Please also respect the following precautions:
- for your own safety, be aware of wearing personal protective
equipment (gloves, glasses, mask);
- if the bar graph makes sudden large movements in the coronal
part of the canal, slowly continue advancing the file toward the
apex until the signal returns to normal;
- this ProPex ®II unit must not be connected to or used in
combination with any other apparatus or system. It must not be
used as an integral component of any other apparatus or system.
Using replacement parts or accessories not supplied by the
original manufacturer or vender could adversely affect the EMC
performance of the ProPex ®II;
- the device must be used with the manufacturer's original
accessories only;
- unplug the device before replacing the battery;
- never use batteries that are leaky, deformed, discolored or
otherwise abnormal;
- in case of battery leakage, carefully dry the battery terminals and
remove all of the leaked liquid. Then replace the battery with a
new one;
- if you do not use the device for a long period of time, it is
recommended to remove the battery from the device to prevent
possible fluid leakage;
- dispose of old batteries according to local codes and regulations;
- accessories including lip clips, hooks or forks should be clean and
without residue of chemical disinfectants or other medicinal
solutions such as sodium hypochlorite or formalin;
- do not expose ProPex ®II to any liquid;
- ProPex ®II must be stored in normal temperature (< 60°C) and
humidity conditions.

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Adverse Reactions
5 ADVERSE REACTIONS
If the apex locator provides incorrect reading and there is no
radiographic data (see "Important notice" in the “Precautions” section in
chapter 4), the following adverse reactions may occur:
• incomplete root canal treatment;
• apex perforation.
6 STEP-BY-STEP INSTRUCTIONS
6.1 Content
Check the content of the equipment before use:
• one ProPex ®II apex locator;
• one switching charger with EU, UK, USA, AUS exchangeable
plugs;
• one measurement cable;
• two lip clips;
• two connection hooks;
• two connection forks;
• one user manual.

Step-by-Step Instructions
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6.2 Connecting the AC Plug Adapter
Select the plug adapter that matches your electric power outlet.
Align and insert the plug adapter at the rounded edge and then snap it
into place by inserting the opposite end. To remove, pull the locking
button (A) and pull out the plug adapter.

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Step-by-Step Instructions
6.3 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) Complete the measurements and disconnect the
measurement cable from the patient.
(2) Unplug the measurement cable from the device.
(3) Connect the charger cable to the ProPex ®II.
(4) Connect the charger to the mains. While charging, the charger
and the device should be outside patient environment (at least
1.5 m from the patient).

Step-by-Step Instructions
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Charging screen will appear during battery charging. When the battery
image on the screen stops blinking and turns green, the charging is
complete.
Duration of charging:
About 12 hours (24 hours after long periods without use).
Low Mid Full
ProPex ®II cannot be used while charging.

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Step-by-Step Instructions
6.4 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
connector.
(3) Insert the new battery cable into the connector.
(4) Insert the battery into the battery compartment.
(5) Close the battery compartment and secure it with the screw.
Use only original battery pack from your supplier!

Step-by-Step Instructions
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6.5 Getting Started
The cursor on the tooth will stop blinking (accompanied by a double
beep signal).
(1) Disconnect the charger from the device if connected.
(2) Before connecting the measurement cable with attached lip
clip and connection hook to the patient, plug measurement
cable into the device receptacle 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) Gently 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.

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Step-by-Step Instructions
A blinking cursor and no sound signal indicates a faulty connection.
Disconnect the measurement cable from the patient and check your
connections, clean your hook connection, moisten the canal, if
necessary, and start again.
No other adjustments are necessary before starting measurement.
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.
Measurement cable with attached lip clip and connection hook
constitute Applied Parts of the device.

Step-by-Step Instructions
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6.6 Searching for the Apex
6.6.1 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.
ProPex ®II emits audible information of file progression via a series of
progressive rate beeps. If the bar graph makes sudden large
movements in the upper part of the canal, continue slightly towards the
apex so the signal returns to normal.
The scale indication on the ProPex ®II screen does not represent a
distinct length or distance in mm or other linear units. It simply
indicates the file progression towards the apex.

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Step-by-Step Instructions
6.6.2 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

Step-by-Step Instructions
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6.6.3 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”.
6.6.4 Completion of the Measurements
Before unplugging the Measurement cable from the device receptacle,
disconnect the lip clip and the connection hook from the patient.
Move the file stopper to the selected reference point on the tooth.
Gently remove the file from the canal and measure the apical length
between the stopper and the file tip.
As a safety precaution in order to avoid over-instrumentation, it is
recommended to proceed as follows:
- stop file progression in the canal at the point where the ProPex ®II
indicates ‘APEX’;
- place the file onto an endodontic ruler and measure the apical
length;
- subtract a minimum of 0.5 mm from the measured file length.