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
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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
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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.