Dentsply Sirona X-Smart IQ Manual

NA
Directions for Use
X-Smart IQ™

2/88 T US XSIQ DFU WEB / Rev.00 (based from T US XSIQ DFU WEB / Rev.05 / 07-2017) / 09-2018
PAGE INTENTIONALLY LEFT BLANK

T US XSIQ DFU WEB / Rev.00 (based from T US XSIQ DFU WEB / Rev.05 / 07-2017) / 09-2018 3/88
Table of contents
Table of contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
1 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
4 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5 Adverse Reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
6 Step by Step Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
6.1 Document Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
6.2 DENTSPLY ENDO IQ™ Application Compatibility . . . . . . . . . . . 19
6.3 Package Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
6.4 Components not included . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
6.5 System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
6.5.1 Turning on the iPad®and setting the Volume . . . . . . . . . . . . . . . . . . . . .21
6.5.2 Activating the AssistiveTouch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
6.5.3 Activating the WiFi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
6.5.4 Activating the Bluetooth® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
6.5.5 Installing and Updating the DENTSPLY ENDO IQ™ Application . . . . 25
6.5.5.1 Firmware update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
6.5.6 Setting up the Complete System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
6.6 Motor Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
6.6.1 Description of the Motor Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
6.6.1.1 Description of the LED Colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
6.6.1.2 The Auto Reverse (AutoRev) Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
6.6.1.3 Description of the Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
6.6.1.4 Stand-by Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
6.6.1.5 Battery Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
6.6.2 Inserting and removing the File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
6.6.2.1 Inserting the File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
6.6.2.2 Removing the File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
6.6.3 Stand-alone Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Table of contents
4/88 T US XSIQ DFU WEB / Rev.00 (based from T US XSIQ DFU WEB / Rev.05 / 07-2017) / 09-2018
6.7 DENTSPLY ENDO IQ™Application . . . . . . . . . . . . . . . . . . . . . . . . 36
6.7.1 Starting the Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
6.7.2 Editing or creating a User Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
6.7.3 Connecting the Motor Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
6.7.3.1 Connecting a Second Motor Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
6.7.3.2 Disconnecting the Motor Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
6.7.4 Interface Presentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
6.7.5 Three Modes of Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
6.7.5.1 Motor Handpiece Information and Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
6.7.5.2 Start Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
6.7.5.3 Start and Record Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
6.7.6 Treatment Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
6.7.6.1 Treatment Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
6.7.6.2 Treatment Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
6.7.7 Customize File Sequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
6.7.7.1 Create new File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
6.7.7.2 Create File Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
6.8 Storing and charging the Motor Handpiece . . . . . . . . . . . . . . . . 56
7 Cleaning, Disinfection and Sterilization . . . . . . . . . . . . . . . . 57
7.1 Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
7.2 Single Use of Custom Polyethylene Barrier . . . . . . . . . . . . . . . . 57
7.3 Disinfection of Motor Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . 58
7.4 Lubrication of the Contra-Angle . . . . . . . . . . . . . . . . . . . . . . . . . . 61
7.5 Cleaning, Disinfection and Sterilization of the Contra-Angle . 62
7.5.1 Pre-Treatment of the Contra-Angle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
7.5.2 Machine-based Reprocessing of the Contra-Angle (Thermal-
Disinfection) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
7.5.3 Sterilization of the Contra-Angle (Autoclaving) . . . . . . . . . . . . . . . . . . . 66
7.5.3.1 Sterilization Procedure of the Contra-Angle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

T US XSIQ DFU WEB / Rev.00 (based from T US XSIQ DFU WEB / Rev.05 / 07-2017) / 09-2018 5/88
Table of contents
8 Technical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68
9 Motor Handpiece Error Code . . . . . . . . . . . . . . . . . . . . . . . . . 70
10 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
11 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74
11.1 Exclusion of Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
12 Disposal of the Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
13 Identification of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77
13.1 Normative Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
14 Electromagnetic Emissions and Immunity . . . . . . . . . . . . . . .79
14.1 Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
14.2 Compliant Cables and Accessories . . . . . . . . . . . . . . . . . . . . . . . .79
14.3 Instructions for Maintaining BASIC Safety and Essential
Performance for the Expected Service Life . . . . . . . . . . . . . . . .79
14.4 Compliance with Emission and Immunity standard . . . . . . . . 80

6/88 T US XSIQ DFU WEB / Rev.00 (based from T US XSIQ DFU WEB / Rev.05 / 07-2017) / 09-2018
FOR DENTAL USE ONLY
Introduction
Congratulations on your purchase of the X-SMART IQ™ endo
motor.
These Directions for Use are always kept up to date by
DENTSPLY Tulsa Dental Specialty Systems (hereafter Dentsply
Sirona) to bring them in line with the latest developments. You
will find the current version on www.dentsplysirona.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 Directions
for Use, 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 seven calendar days to any address
in North America). To order, simply send your request to
[email protected].
The Directions for Use are available in other languages on
request. These Directions for Use have 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.
We would 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 Directions for Use without prior
notice.
Manufactured For:
Dentsply Tulsa Dental Specialties
Johnson City, TN 37604
USA

Phone: [phone]
Fax: [phone]
[email protected]
www.dentsplysirona.com

T US XSIQ DFU WEB / Rev.00 (based from T US XSIQ DFU WEB / Rev.05 / 07-2017) / 09-2018 7/88
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.
The device must only be used in hospital environments, clinics
or dental offices, by qualified practitioners.

Contraindications
8/88 T US XSIQ DFU WEB / Rev.00 (based from T US XSIQ DFU WEB / Rev.05 / 07-2017) / 09-2018
2 Contraindications
Read the following contraindications before use.
•X-SMART IQ™ must not be used 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.)

T US XSIQ DFU WEB / Rev.00 (based from T US XSIQ DFU WEB / Rev.05 / 07-2017) / 09-2018 9/88
Warnings
3Warnings
Read the following warnings before use.
• The motor handpiece is intended for endodontic treatment
and may only be used by trained and qualified dentists.
• Do not use X-SMART IQ™ for implants or any other dental
procedure outside endodontics.
Environmental conditions
• The device is intended for use in professional healthcare
facility environments: physician offices, dental offices, clinics
and hospitals (except near HF SURGICAL EQUIPMENT,
outside of RF shield room of an ME SYSTEM for magnetic
resonance imaging).
• The device must not be used neither in home healthcare
environment nor in special environment. For more details,
please refer to IEC 60601-1-2:2014, EN 60601-1-2:2015.
• 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 2,000m (~ 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 (IEC 60601-1-2:2014, EN 60601-1-2:2015).

Warnings
10/88 T US XSIQ DFU WEB / Rev.00 (based from T US XSIQ DFU WEB / Rev.05 / 07-2017) / 09-2018
• Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in
improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that
they are operating normally.
• 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
11 requirements.
• The use of accessories, transducers and cables other than
those specified or provided by the manufacturer of this
equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this
equipment and result in improper operation. (Refer to the
chapter 14.2 Compliant Cables and Accessories)
• 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 X-SMART IQ™ motor handpiece, including cables
specified by the manufacturer. Otherwise, degradation of
the performance of this equipment could result.
• The iPad Mini™ generates, uses and can radiate radio-
frequency energy. The use of the iPad Mini™ 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 Mini™’s electromagnetic compatibility.
• The iPad Mini™ protective case and the motor handpiece
cover contain permanent magnets. Magnets could affect 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.
• An FDA cleared barrier sleeve must be used to cover the
iPad in its protective case with the recommended
dimensions of 14.5” x 18".