Dentsply Sirona X-Smart IQ User manual

User Manual
EN
X-Smart IQ™

2/74 B EN XSIQ DFU MAS / Rev.10 / 01-2017
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Table of contents
Table of contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
5 Adverse Reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
6 Step by Step Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
6.1 Document Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
6.2 DENTSPLY ENDO IQ™ Application Compatibility . . . . . . . . . . . . . 16
6.3 Package Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
6.4 Components not included . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
6.5 System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
6.5.1 Turning on the iPad®and setting the Volume . . . . . . . . . . . . . . . . . . . . . . . 18
6.5.2 Activating the AssistiveTouch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
6.5.3 Activating the WiFi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
6.5.4 Activating the Bluetooth® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
6.5.5 Installing and Updating the DENTSPLY ENDO IQ™ Application . . . . . . . . . 22
6.5.5.1 Firmware update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
6.5.6 Setting up the Complete System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Table of contents
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6.6 Motor Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
6.6.1 Description of the Motor Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
6.6.1.1 Description of the LED Colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
6.6.1.2 The Auto Reverse (AutoRev) Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
6.6.1.3 Description of the Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
6.6.1.4 Stand-by Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
6.6.1.5 Battery Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
6.6.2 Inserting and removing the File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
6.6.2.1 Inserting the File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
6.6.2.2 Removing the File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
6.6.3 Stand-alone mode: operation without the DENTSPLY ENDO IQ™
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
6.7 DENTSPLY ENDO IQ™Application . . . . . . . . . . . . . . . . . . . . . . . . . 32
6.7.1 Starting the Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
6.7.2 Editing or creating a User Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
6.7.3 Connecting the Motor Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
6.7.3.1 Connecting a Second Motor Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
6.7.3.2 Disconnecting the Motor Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
6.7.4 Interface Presentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
6.7.5 Three Modes of Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
6.7.5.1 Motor Handpiece Information and Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
6.7.5.2 Start Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
6.7.5.3 Start and Record Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
6.7.6 Treatment Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45
6.7.6.1 Treatment Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
6.7.6.2 Treatment Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
6.7.7 Customize File Sequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
6.7.7.1 Create new File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
6.7.7.2 Create File Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
6.8 Storing and charging the Motor Handpiece . . . . . . . . . . . . . . . . . . . 52

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Table of contents
7 Cleaning, Disinfection and Sterilization . . . . . . . . . . . . . . . . . . . 53
7.1 Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
7.2 Single Use of Custom Barrier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
7.3 Disinfection of Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
7.4 Lubrication of the Contra-Angle . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
7.5 Cleaning, Disinfection and Sterilization of the Contra-Angle . . . . . . 57
7.5.1 Pre-Treatment of the Contra-Angle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
7.5.2 Machine-based Reprocessing of the Contra-Angle (Thermal-Disinfection) . 59
7.5.3 Sterilization of the Contra-Angle (Autoclaving) . . . . . . . . . . . . . . . . . . . . . . . 60
7.5.3.1 Approved Sterilization Procedure of the Contra-Angle . . . . . . . . . . . . . . . . . . . . . . . . . 61
8 Technical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
9 Motor Handpiece Error Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
10 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
11 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
11.1 Exclusion of Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
12 Disposal of the Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
13 Identification of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
13.1 Normative Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

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FOR DENTAL USE ONLY
Introduction
Congratulations on your purchase of the X-SMART IQ™ endo motor.
The User Manual is always kept up to date by Maillefer Instruments
Holding Sàrl (hereafter Dentsply Sirona) to bring it in line with the latest
developments. You will find the current version on
www.dentsplymaillefer.com and integrated into the DENTSPLY ENDO
IQ™ application.
In countries where the legal situation enables us to do so, we have
decided not to produce a printed version of the User Manual, for
environmental reasons.
If no printed version is enclosed in your national language and you wish
to have a printed one, we will be happy to send you a copy (free of
charge within 7 calendar days to any address in the EU). To order,
simply send your request to [email protected].
The User Manual is available in other languages on request.
This User Manual has been compiled with the utmost care.
Nevertheless, it is not always possible to completely rule out the risk of
error, despite all efforts to do so. Wewould appreciate your feedback in
this area. If any errors are noted, please contact Dentsply Sirona.
Dentsply Sirona reserves the right to change the information and data
contained in the User Manual without prior notice.
Maillefer Instruments Holding Sàrl
Chemin du Verger 3
CH-1338 Ballaigues
Switzerland
Telephone [phone]
Fax [phone]
[e-mail]
www.dentsplymaillefer.com

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Indications for Use
1 Indications for Use
X-SMART IQ™ is a cordless motor handpiece with torque control used
for driving files in both reciprocating and continuous rotation mode
during an endodontic procedure.

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Contraindications
2 Contraindications
Read the following contraindications before use.
• In cases where a patient has been fitted with an implanted heart
pacemaker (or other electrical equipment) and has been cautioned
against the use of small electrical appliances (such as electric
shavers, hair dryers, etc.), X-SMART IQ™ must not be used.
• Do not use X-SMART IQ™ for implants or any other dental
procedure outside endodontics.
• Safety and effectiveness have not been established in pregnant
women and children.
• Clinical judgment needs to be applied by the end user of the device.

B EN XSIQ DFU MAS / Rev.10 / 01-2017 9/74
Warnings
3 Warnings
Read the following warnings before use.
Dentist
• The motor handpiece is intended for endodontic treatment and may
only be used by trained and qualified professionals such as
dentists.
Ambient conditions
• The device must not be placed in humid surroundings or where it
can come into contact with liquids.
• Do not expose the device to direct or indirect heat sources. The
device must be operated and stored in a safe environment.
• The device can be operated up to a maximum temperature of 35°C
(95°F) and up to an altitude of 2 000 m (~ 6561ft 8in) above sea
level.
• Do not use the device in the presence of free oxygen, anesthetics
or flammable substances. The device must be operated and stored
in a safe environment.
• The device can cause radio interference or disrupt the operation of
equipment in the vicinity. If this happens, the interference should be
reduced by reorienting or repositioning the device or by screening
off the immediate environment. The electromagnetic radiations
emitted by the X-SMART IQ™ motor handpiece are below the
recommended limits specified by the applicable relevant provisions
(DIN EN 60601-1-2:2007).
• The device requires special precautions with regard to
electromagnetic compatibility (EMC) and must be installed and
operated in strict compliance with the EMC Directive. In particular,
do not use the device in the vicinity of fluorescent lamps, radio
transmitters, remote controls or portable or mobile RF
communication devices, even if they meet CISPR 8 requirements.
•TheiPad
®generates, uses and can radiate radio-frequency energy.
The use of the iPad®in a medical environment requires particular
care in regards to electromagnetic interference with other devices.
Please refer to the Apple User Manual for more information about
the iPad®’s electromagnetic compatibility.

Warnings
10/74 B EN XSIQ DFU MAS / Rev.10 / 01-2017
•TheiPad
®protective case and the motor handpiece cover contain
permanent magnets. Magnets couldaffect the normal functioning of
pacemakers, implanted heart defibrillators and hearing aid devices.
Do not place the accessories near these devices or any other object
sensitive to static magnetic fields.
• Do not charge, operate or store at high temperatures. Comply with
the specified operating and storage conditions.
During treatment
• Gloves and a rubber dam are absolutely essential during treatment.
• If any irregularities with the device should occur during treatment,
switch it off. Contact Dentsply Sirona or your Dentsply Sirona
authorized service partner.
Battery
• Always use the original charger with the charging cable to charge
the device. Use of non-original chargers jeopardizes the safety of
the patient and user.
• If liquid should emerge from the motor handpiece, the batteries may
be leaking. In this event, stop using the device immediately and
contact Dentsply Sirona or your Dentsply Sirona authorized service
partner.
• Never open the device yourself. Opening the device voids the
warranty. Contact Dentsply Sirona or your Dentsply Sirona
authorized service partner.
• A device with a faulty battery must not be sent by air freight.
• Always check to ensure that both the motor handpiece and the
iPad®have a sufficient battery charge before starting treatment.
Contra-angle
• Never press the contra-angle pushbutton when the motor
handpiece is running or if it is coming to a stop. This will lead to
detachment of the instrument or cause the pushbutton to overheat.
• Never remove the contra-angle from the motor handpiece during
operation.
• Only use undamaged root canal instruments. Please refer to the
information provided by the manufacturer.