Dentsply Sirona Propex Pixi User manual

Propex Pixi®
apex locator
User Manual
A1030 000 001 00
For dental use only

Contents
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Contents
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213
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.
Ürünlerimizle ilgili teknik modifikasyonlar bildirime tabi değildir.
Bizim cihazlarda Fotoğraflar sözleşme değildir.
EN
FR
DE
IT
ES
TR

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Table of contents
Table of contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1 Indication For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
4 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
5 Adverse Reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
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 . . . . . . . . . . . . . . . . . . . 14
6.5 Cable Connection Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
6.6 Apex Localization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
6.6.1 Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
6.6.2 Apex Localization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
6.6.3 Apical Zone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
6.6.4 Over-Instrumentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
6.6.5 Completion of the measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
6.7 Sound Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
6.8 Demo Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
6.9 Automatic Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

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7 Cleaning, Disinfection and Sterilization . . . . . . . . . . . . . . . . . . . . 23
7.1 General Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
7.2 Disinfection and Sterilization Procedure for Lip Clip, Connection
Hook and Fork . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
8 Technical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
9 Error Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
10 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
11 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
12 Disposal of the Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
13 Identification of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Appendix (English) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213

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Introduction
Congratulations on the purchase of Propex Pixi® apex locator.
Propex Pixi® 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.

Indication For Use
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1 Indication For Use
Propex Pixi® is an electronic device used for apex location during root
canal treatment.
Propex Pixi® must only be used in hospital environments, clinics or
dental offices, by qualified practitioners.
2 Contraindications
Propex Pixi® 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 metal;
• In children.
3 Warnings
• The scale indication on the Propex Pixi® 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 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.

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Warnings
• 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 Pixi®;
- Electromagnetic interference could cause improper operation of
the device. In such cases the device behaviour 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 Pixi®.
• 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 Pixi® in the presence of flammable
substances.
• Only use the original charger.
• Use AAA 1.2V 1000mAh NiMH rechargeable batteries only. Usage
of non rechargeable batteries may cause device damage.
Recommended battery type: Manufacturer – GP Batteries
Model No.: GP100AAAHC.

Precautions
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4 Precautions
Important notice:
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.
• 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.

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Precautions
- 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.
• 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, where the Propex Pixi® indicates ‘0.0’. 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 Pixi® 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 Pixi®.

Adverse Reactions
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- 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.
- 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 Pixi® to any liquid.
- Propex Pixi® must be stored in normal temperature (< 60°C) and
humidity conditions.
5 Adverse Reactions
If the apex locator provides an 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.

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Step-by-Step Instructions
6 Step-by-Step Instructions
6.1 Content
Check the content of the equipment before use:
1. Propex Pixi® apex locator;
2. Switching charger;
3. Measurement cable with clip;
4. Lip clip (2x);
5. Connection hook
- User manual;
- Product card.
Fig. 1
1
2
3
4
5

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.
Fig. 2 Plug adapters for power supply
Align and insert the plug adapter at the rounded edge and then snap it
into place by inserting the opposite end (see Fig. 2). To remove, pull the
locking button (1) and pull out the plug adapter.
1

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Step-by-Step Instructions
6.3 Recharging the Battery
Propex Pixi® is equipped with a rechargeable battery.
When the battery is low, blinking battery icon appears on the status bar
of the device indicating that the battery requires recharging.
When the battery icon is blinking, the battery requires recharging.
However, it is still functional for several treatments before the device
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 Propex Pixi®;
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).
During battery charging the battery symbol will first blink (see Fig. 3),
then will remain steady when charging is completed (see Fig. 4).
Duration of charging: Approximately 12 hours (24 hours after long
period of non-use).
Fig. 3 Charging Fig. 4 Full
Note
Propex Pixi® cannot be used while charging.

Step-by-Step Instructions
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6.4 Replacement of the Rechargeable Battery
Propex Pixi® is powered by one 1.2V AAA NiMH rechargeable battery.
If a fully charged battery is not sufficient for normal device operation
during at least one working day, the battery should be replaced by a
new one at your earliest convenience.
Please note that a new battery should be charged for 24 hours prior to
the first use of the device.
The battery compartment is located at the rear side of Propex Pixi®.
1. Carefully lift and tilt back the silicon cover to expose the screw.
Release the screw.
Fig. 5
Warning
Use GP100AAAHC or compatible NiMH rechargeable battery only.
Usage of non-rechargeable batteries may cause device damage.

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Step-by-Step Instructions
2. Remove the battery compartment cover and the old battery.
Fig. 6
3. Insert a new battery into the battery compartment according to
polarity marking.
4. Close the battery compartment, secure the cover with the screw
and adjust the silicon screw cover.
The new battery should be charged for 24 hours prior to the first use of
the device.

Step-by-Step Instructions
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6.5 Cable Connection Test
A connection test feature is included in Propex Pixi® in order to check
the cables:
1. Connect the measurement cable and turn on the device.
2. Connect the metal part of the connection hook to the lip clip. Make
sure that the accessories are cleaned properly before the test.
3. “Connection test” icon should appear on the status bar -
see Fig. 7.
4. If no icon appears, the connection hook or the measurement cable
should be replaced.
Fig. 7
Note
Measurement cable with attached lip clip and connection hook
constitute Applied Parts of the device.

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Step-by-Step Instructions
6.6 Apex Localization
6.6.1 Getting Started
Disconnect the charger from the device if connected.
1. Before connecting the measurement cable with attached lip clip and
connection hook to the patient, plug measurement cable into the
device and turn on the device by pressing the “ON / OFF” button
on the top of the device. The first bar will start blinking.
2. Attach the lip clip to the patient.
3. Gently insert the file into the canal.
4. Connect the connection hook to the metal shaft of the file.
The first bar will stop blinking accompanied by a double beep signal –
see Fig. 8.
Fig. 8
No other adjustments are required before starting apex localization.
Note
To ensure optimal performance the file size should be adjusted to the
canal diameter.
Note
A blinking bar indicates faulty connection. Disconnect the
measurement cable from the patient and check cable connections,
clean the connection hook and the lip clip, moisten the canal if
necessary and start again.

Step-by-Step Instructions
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6.6.2 Apex Localization
Advance the file with slow clockwise turns. In the pre-apical zone bar
2.0 turns on – see Fig. 9 and an audio signal sounds. As the file
progresses in the canal, subsequent bars turn on gradually (Fig. 10)
and the interval between the audio signals becomes shorter. 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 to normal.
Warning
The scale indication on the Propex Pixi® screen does not represent
a distinct length or distance in mm or other linear units. It simply
indicates the file progression towards the apex.
Fig. 9 Fig. 10

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Step-by-Step Instructions
6.6.3 Apical Zone
The apical zone is divided into 3 bars graduated from 1.0 to 0.0 (apex)
– see Fig. 11.
Fig. 11
When the apex is reached, a solid tone is emitted.
The indication 0.0 on the Propex Pixi® screen relates to the minor
apical foramen file position (the apical length).
6.6.4 Over-Instrumentation
A red “OVER” segment and an audio warning signal (rapid intermittent
signal) indicate that the file has passed the apex – Fig. 12.
Fig. 12
Beginning of apical zone Apical position Middle of apical zone

Step-by-Step Instructions
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6.6.5 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.
6.7 Sound Adjustment
Propex Pixi® is equipped with an audio indicator which enables
monitoring of the progression of the file within the canal in addition to
visual monitoring.
The volume can be adjusted to four different levels: mute, low, normal
and high, by successively pressing the “VOLUME” button.
When sound level is muted the icon is turned off. At other sound
levels the icon remains turned on.
Note
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 Pixi® indicates ‘0.0’.
Place the file onto an endodontic ruler and measure the apical length.
Subtract a minimum of 0.5 mm from the measured file length.