Dentsply Sirona Propex IQ Manual

EN
Propex IQ®Apex Locator
Directions for Use

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Table of contents
Table of contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
4 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
5 Adverse Reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
6 Step by Step Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
6.1 Document Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
6.2 Device Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
6.3 Package Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
6.3.1 Assembling the charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
6.4 Modes of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
6.5 Description of the Propex IQ®Apex Locator . . . . . . . . . . . . . . . . . . . . . 21
6.5.1 General overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
6.6 Description of the LED Colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
6.7 Description of the Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
6.8 Plugging in the Propex IQ®Measurement Cable . . . . . . . . . . . . . . . . . 25
6.8.1 Plugging in the Propex IQ®Measurement Cable in uncombined
mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
6.8.2 Plugging in the X-Smart IQ®Measurement Cable in combined
mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
6.9 Testing Propex IQ®Apex Locator Functionality . . . . . . . . . . . . . . . . . . 27
6.9.1 Closed-loop test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
6.9.2 Device test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
6.10 Determining the Working Length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
6.10.1 Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
6.10.2 Start working length determination . . . . . . . . . . . . . . . . . . . . . . . . . . 31
6.10.3 Working length determination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
6.10.4 Uncombined mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Table of contents
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6.10.5 Combined mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
6.10.6 Interruption of file progression indication . . . . . . . . . . . . . . . . . . . . . .38
6.10.7 Tips for successful file progression indication . . . . . . . . . . . . . . . . . .38
6.10.8 Comparison of electronic length determination versus radiography . .39
6.11 Stand-by Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
6.12 Battery Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
6.12.1 Battery Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
7 Cleaning, Disinfection and Sterilization . . . . . . . . . . . . . . . . . . . . 43
7.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
7.2 Cleaning Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
7.3 Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46
7.4 Sterilization of the File Clip and Lip Clip . . . . . . . . . . . . . . . . . . . . . . . . . .47
8 Technical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
9 Propex IQ®Apex Locator Error Codes . . . . . . . . . . . . . . . . . . . . . 51
10 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
11 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
12 Disposal of the Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
13 Identification of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
13.1 Normative Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61
Appendix A: Electromagnetic Emissions and Immunity . . . . . . 63

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FOR DENTAL USE ONLY
Introduction
Dear Customer,
Congratulations on your purchase of Propex IQ®Apex Locator.
Propex IQ®Apex Locator is an electronic device for support in working length
determination using endodontic instruments.
It can be used in:
• Uncombined mode (Propex IQ®Apex Locator only);
• Combined mode with X-Smart IQ®Handpiece;
• Connected mode (Propex IQ®Apex Locator in wireless communication with
Endo IQ®App available for iPad®).
These Directions for Use (DFU) are kept up-to-date by Dentsply Sirona. The most current
version canbeaccessedatdentsplysirona.com and is also available from Endo IQ®App.
We strongly recommend that you periodically check this website for updates of this DFU.
The DFU is available in other languages upon request. If a printed version in your
language is not enclosed, Dentsply Sirona will send a free copy to any address in Europe.
To order a free copy of the DFU, send a request to [email protected].
Some images in the DFU may vary slightly from the actual device. We would appreciate
your feedback. If any errors are noted, please contact Dentsply Sirona Endodontics
Customer Service.
Maillefer Instruments Holding Sàrl
Chemin du Verger 3
CH-1338 Ballaigues
Switzerland
Telephone [phone]
Fax [phone]
[email protected]
dentsplysirona.com

Indications for Use
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1 INDICATIONS FOR USE
Propex IQ®Apex Locator supports the dentist in the determination of the working length
during the endodontic treatment. The use of this product is destined exclusively to duly
qualified dental practitioners.
The use of this product by unqualified, or untrained personnel can result in patient injury,
personal injury and / or material damage.
Disposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for
dental instruments and equipment. Propex IQ®Disposable Barrier Sleeve is non-sterile
and intended for single patient use only.
To guarantee the safety, intended functionalities and good maintenance of Propex IQ®
Apex Locator, follow the indications given in the present Directions for Use (DFU). Keep
the DFU updated as per described in the Introduction section. Dentsply Sirona will not
accept any liability if Propex IQ®Apex Locator is used, stored or manipulated outside of
the indications given in the DFU.
2 CONTRAINDICATIONS
Read the following contraindications before use.
• Do not use Propex IQ®Apex Locator on patients wearing active implantable devices
such as a heart pacemaker or defibrillator.
• The use of Propex IQ®Apex Locator is not recommended in patients allergic to
metals. Check Section 8 Technical Characteristics for a list of materials used.
• Do not use Propex IQ®Apex Locator for implants or any other dental procedure
outside endodontics.
• Safety and effectiveness of use have not been established in pregnant or
breastfeeding women or in children.
• The end user of the device should use clinical judgment for its proper use.
• Color-blind users must ensure that they always operate the device with the sound
ON, and that they are familiar with the various sound signals before using the device
for the first time. Check section 6.7 Description of the Sounds before using the
device.
• Hearing-impaired users must ensure familiarity with the various visual signals before
using the device for the first time. Check section 6.6 Description of the LED Colors
before using the device.
• The device is not indicated for users both color-blind and hearing-impaired unless
they have these difficulties balanced out.

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Warnings
3 WARNINGS
Read the following warnings before use.
Dental Practitioner
• Read the full DFU before using Propex IQ®Apex Locator on a patient. Operate
Propex IQ®Apex Locator only in accordance with this DFU to ensure safe and
effective use.
• Ensure that you have a suitable working distance to see the display from your
working position.
•Propex IQ®Apex Locator and the Endo IQ®App are intended for:
- Endodontic treatment.
- Use by trained and qualified professionals only, such as:
- dentists in dental practice, and
- dental assistants for cleaning and preparation of the device only, and in
accordance with this DFU.
Environmental conditions
• Do not use Propex IQ®Apex Locator in the presence of free oxygen, anesthetics,
flammable substances / gases or in a potentially explosive environment.
•Propex IQ®Apex Locator must be operated and stored in a safe, dry and clean
environment.
•PlacePropex IQ®Apex Locator on a flat and stable surface (if used without the
clamp) or firmly attached to the lab coat (when used with the clamp).
•Propex IQ®Apex Locator must not be placed on damp surfaces, in damp locations
or near liquids.
• Do not expose Propex IQ®Apex Locator to direct or indirect heat sources.
• Avoid collisions and falls. After a fall, please check that Propex IQ®Apex Locator
works properly (refer to section 6.9 Testing Propex IQ®Apex Locator
Functionality).
Some sections / texts of this DFU are dedicated uniquely to readers from a specific
territory. When this happens the section / text will be clearly identified with a sentence
similar to: For US / EU readers. If nothing is indicated, the text is applicable to all of the
intended territories.
Dentsply Sirona accepts no liability in the event that any of these warnings are
disregarded.
Check the outer packaging seal on reception. Do not use the device if the packaging
seal has been broken. Contact customer service.
Report discrepancies between labeling and packaging, or issues with either, to
customer service.

Warnings
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•Propex IQ®Apex Locator contains a Bluetooth®module and may cause radio
interference or disrupt the operation of equipment in its vicinity. If this happens, the
interference should be reduced by reorienting or repositioning Propex IQ®Apex
Locator or by screening off its immediate environment. For further information refer
to Appendix A: Electromagnetic Emissions and Immunity.
•Propex IQ®Apex Locator requires special precautions with regard to
electromagnetic compatibility (EMC) and must be installed and operated in strict
compliance with the EMC Directive. In particular, Propex IQ®Apex Locator must not
be used in the vicinity of fluorescent lamps, radio transmitters, remote controls or
portable / mobile RF communication devices, even if they meet CISPR 11
requirements. See Appendix A: Electromagnetic Emissions and Immunity.
• Make sure cables do not limit mobility during a procedure.
• Do not kink the cables or the charger.
• Do not pull directly on the cables when plugging in or unplugging components. Make
sure the cables are not obstructed or have limited mobility.
• Refer also to section 8 Technical Characteristics for general Environmental
Conditions specifications.
•UseofPropex IQ®Apex Locator adjacent to, or stacked with other equipment
should be avoided because it could result in improper operation. If such use is
necessary, Propex IQ®Apex Locator and the other equipment should be observed
to verify that they are operating normally.
• Do not expose Propex IQ®Apex Locator to infrasound or ultrasound sources.
During treatment
• Ensure that contact point between file and file clip are kept dry to avoid inaccurate
readings.
• Make sure that the Propex IQ®Lip Clip and the Propex IQ®File Clip do not come
into contact with an electric power source such as an electrical socket. This could
result in severe electrical shock.
• The cable functionality must be checked with a closed-loop test before each use.
See 6.9.1 Closed-loop test.
• If the Propex IQ®File Clip is not properly connected to the endodontic instrument,
Propex IQ®Apex Locator will not provide correct information and the file clip could
be damaged.
• Use of gloves and of a rubber dam are mandatory during treatment.
• Do not pour water or any other liquid over Propex IQ®Apex Locator.

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Warnings
• The use of Dentsply Sirona Propex IQ®Disposable Barrier Sleeves is required (see
section 7 Cleaning, Disinfection and Sterilization). Use only custom barriers
provided by Dentsply Sirona made specifically for Propex IQ®Apex Locator.
• Always perform an X-ray and set the stopper to the determined working length
before using Propex IQ®Apex Locator.
• Before starting the reading, dry the access cavity with a cotton pellet and ensure that
there is no excess of liquid inside the root canal targeted for the treatment. An
excess of liquid can hinder the reading process. Take into account that the canal
should not be completely dry otherwise no reading will occur. Moisten an extremely
dry canal with Glyde™ file prep to help provide a stable reading.
• Before starting the treatment, make sure that the device is in a stable position (over a
flat surface or firmly attached to the lab coat if using the clamp) to ensure that the
treatment can be done comfortably and that any visual / auditory signals emitted by
Propex IQ®Apex Locator can be received.
• If any irregularities with Propex IQ®Apex Locator should occur during treatment,
switch it off, consult Section 10 Troubleshooting or Contact Dentsply Sirona
Endodontics Customer Service.
• The scale indication on Propex IQ®Apex Locator and on Endo IQ®App does not
represent a distinct length or distance in [mm] or other linear units. It only indicates
an estimated proximity of the file tip to a reference point for working length
determination.
• Make sure to use only fully metallic endodontic files whether in combined mode or in
uncombined mode.
• Only use undamaged endodontic instruments, meaning the instruments shall be in
good condition and within their useful life (as defined by the manufacturer). Please,
refer to the information provided by the manufacturer of the instrument.
• An accurate working length determination cannot be made using a damaged
Propex IQ®File Clip.
• Only use original cables and adaptors.
• The following patient-related factors may prevent accurate readings:
- Blocked root canal.
- Teeth with large apices.
- Root fracture or perforation.
- Metal crowns or bridges.
- Endodonic file not matching canal size (canal size much larger than
endodontic file size).

Warnings
10/74 BENPPIQDFUWEB / Rev.04 / 08-2018
• If there is no audible sound or no visible flash of the LEDs when Propex IQ®Apex
Locator is switched on, do not use it.
• Always switch off Propex IQ®Apex Locator before cleaning it.
• Dentsply Sirona cannot be held liable if Propex IQ®Apex Locator is not installed,
operated and maintained in accordance with the instructions in this DFU. No
modifications to Propex IQ®Apex Locator are allowed, except battery changes (see
following Section).
• Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the Propex IQ®Apex Locator (IEC 60601-1), including cables specified
by Dentsply Sirona. Failure to observe this could result in a degradation of the
performance of this equipment. For further information, refer to Appendix A:
Electromagnetic Emissions and Immunity.
After Treatment
• Never leave Propex IQ®Lip Clip or Propex IQ®File Clip in contact with a patient if
either of them is not plugged into the measurement cable. This could result in severe
electrical shock if they come into contact with an electrical source.
• Follow instructions given in section 7 Cleaning, Disinfection and Sterilization.
Battery
• Always use the original charger with the charging cable to charge Propex IQ®Apex
Locator. Use of non-original chargers may result in serious risk for the safety of the
user.
• Regularly check for signs of battery leakage.
• If fluid leaks from Propex IQ®Apex Locator, the battery may be damaged. Stop
using the device immediately. If the leakage occurs while charging, disconnect the
charger immediately. Avoid skin contact with the leaking fluid and contact the
Dentsply Sirona Endodontics Customer Service as soon as possible.
• Do not recharge the battery in case of suspected faulty/ leaking battery.
• Do not use batteries past the expiry date (when provided).
• Never use a battery that is deformed, discolored or otherwise abnormal.
• If the batteries do not charge fully after 6 hours, they should be replaced.
• To charge the device, connect the charger to electrical mains compliant with the
regulations in each country.
• Be sure to purchase and use only the original battery (part reference: for
EU B00PPIQ2ACBAT, for US T00PPIQ2ACBAT).
• Only charge Propex IQ®Apex Locator out of patients reach.