Sirona XIOS XG Select Operating instructions

New as of: 11.2017
XIOS XG WiFi System and Sensors
Operating Instructions and Installation
English
XIOS XG Select
XIOS XG Supreme

Table of contents Sirona Dental Systems GmbH
Gebrauchsanweisung und Installation
264 08 137 D3610
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Table of contents
1General information ................................................................................................ 6
1.1 Dear Customer,............................................................................................ 6
1.2 Contact information...................................................................................... 7
1.3 General information about this operating manual ........................................ 8
1.4 Other valid documents ................................................................................. 8
1.5 Intended use ................................................................................................ 9
1.6 Indications and contraindications................................................................. 9
1.7 Structure of the document............................................................................ 10
1.7.1 Identification of the danger levels .................................................. 10
1.7.2 Formats and symbols used............................................................ 10
2Safety Instructions .................................................................................................. 11
2.1 Qualifications of operating personnel........................................................... 11
2.2 Hygiene........................................................................................................ 11
2.3 Radiation protection ..................................................................................... 11
2.4 PC system and software .............................................................................. 11
2.5 Allocation of acquisition system to patient ................................................... 12
2.6 Storage battery ............................................................................................ 12
2.7 Trouble-free operation ................................................................................. 13
2.8 Maintenance ................................................................................................ 13
2.9 Changes and extensions to the device ........................................................ 14
2.10 Combination with other units........................................................................ 14
2.11 Wireless technology..................................................................................... 14
2.12 Radiotelephones .......................................................................................... 14
2.13 Electrostatic discharge................................................................................. 15
3System description ................................................................................................. 17
3.1 System structure .......................................................................................... 17
3.2 WiFi Interface............................................................................................... 19
3.3 Charger ........................................................................................................ 19
3.4 Power supply unit......................................................................................... 20
3.5 USB cable .................................................................................................... 20
3.6 Sensors........................................................................................................ 21
3.7 Sensor holder systems ................................................................................ 21
3.7.1 Single-use sensor holder system................................................... 21
3.7.2 Aimright reusable sensor holder system........................................ 22
3.8 Intraoral X-ray tube assembly ...................................................................... 23
3.9 Wireless Access Point ................................................................................. 24

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3.10 PC system.................................................................................................... 25
3.11 RFID Reader................................................................................................ 26
3.12 Technical data.............................................................................................. 27
3.13 Certification, registration and standards ...................................................... 29
3.14 Symbols ....................................................................................................... 29
3.15 Position of the Labels................................................................................... 30
4Installation............................................................................................................... 32
4.1 Position the PC ............................................................................................ 32
4.2 Install the PC software ................................................................................. 32
4.3 Check Firewall Settings ............................................................................... 34
4.4 Connect the charger .................................................................................... 36
4.5 Setting channels at the Wireless Access Point............................................ 37
4.6 Configure the WiFi interface for the practice network .................................. 37
4.7 Find an error in the system configuration..................................................... 43
4.7.1 Execute a diagnostics test ............................................................. 43
4.7.2 Diagram for fault rectification ......................................................... 45
4.8 Enabling the WiFi interface in SiXABCon .................................................... 47
4.9 Pair WiFi interface with the PC .................................................................... 48
4.9.1 Pairing via a selection list using the serial number ........................ 49
4.9.2 Pairing using RFID Technology ..................................................... 50
4.9.3 Remove pairing.............................................................................. 52
4.10 Connecting the sensor ................................................................................. 53
4.11 Complete test exposures/acceptance tests ................................................. 53
4.12 Web Server and Upgrade Utility page ......................................................... 54
4.12.1 Flash Upgrade ............................................................................... 55
4.12.2 FPGA Upgrade .............................................................................. 57
4.12.3 Sensor Upgrade............................................................................. 59
4.12.4 Set the WiFi Interface .................................................................... 62
4.13 Install holders and a patient clip................................................................... 63
4.13.1 Wall holder for sensors .................................................................. 63
4.13.2 Wall holder for the charger............................................................. 64
4.13.3 Patient clip for the WiFi interface ................................................... 64
5Operation ................................................................................................................ 65
5.1 Switch WiFi interface on/off ......................................................................... 65
5.2 Determine unit status ................................................................................... 66
5.2.1 LED displays on the WiFi interface ................................................ 66
5.2.2 LED displays on the charger.......................................................... 68
5.3 Charge the WiFi interface storage battery ................................................... 69

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5.4 Enabling exposure readiness....................................................................... 70
5.5 Sliding the hygienic protective sleeve over the sensor ................................ 73
5.6 Position the sensor ...................................................................................... 74
5.6.1 Position sensor with single-use sensor holder system .................. 75
5.6.1.1 Notes on the sensor holder tabs................................... 75
5.6.1.2 Anterior tooth exposure ................................................ 75
5.6.1.3 Posterior tooth exposures............................................. 77
5.6.1.4 Bite wing exposures ..................................................... 78
5.6.1.5 Endodontics exposures with the half-angle technique . 79
5.6.1.6 Measurement exposure for endodontics ...................... 80
5.6.2 Position sensor with Aimright reusable sensor holder system....... 81
5.6.2.1 Anterior tooth exposure ................................................ 81
5.6.2.2 Posterior tooth exposures............................................. 85
5.6.2.3 Horizontal bite wing exposures..................................... 88
5.7 Select the exposure parameters for the X-ray tube assembly ..................... 91
5.7.1 X-ray doses and image quality....................................................... 91
5.7.2 Recommended dose for XIOS XG sensors ................................... 91
5.7.3 HELIODENT Plus exposure times ................................................. 92
5.7.3.1 Pre-programmed exposure times for XIOS XG
sensors with 200 mm (8") FHA cone............................ 92
5.7.3.2 Pre-programmed exposure times for XIOS XG
sensors with 300 mm (12") FHA cone (round or
square cone)................................................................. 93
5.8 Releasing the exposure ............................................................................... 94
5.9 Removing the hygienic protective sleeve from the sensor........................... 95
5.9.1 With single-use sensor holder system ........................................... 95
5.9.2 With Aimright reusable sensor holder system................................ 97
5.10 Alignment of the X-ray image....................................................................... 98
5.11 Resend non-transmitted WiFi exposures to SIDEXISXG / SIDEXIS 4 ....... 99
6Maintenance and inspection ................................................................................... 101
6.1 Hygiene........................................................................................................ 101
6.1.1 Care, cleaning agents, and disinfectants....................................... 101
6.1.2 WiFi interface, charger and sensors .............................................. 101
6.1.3 Sensor holders............................................................................... 102
6.2 Regular inspections ..................................................................................... 103
6.3 Replace the sensor cable ............................................................................ 104
6.4 Replace the WiFi interface storage battery.................................................. 106
7Consumables and spare parts................................................................................ 108

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8Electromagnetic compatibility ................................................................................. 113
8.1 Accessories.................................................................................................. 113
8.2 Electromagnetic emission ............................................................................ 114
8.3 Interference immunity .................................................................................. 115
8.4 Working clearances ..................................................................................... 116
9Disposal .................................................................................................................. 118

1 General information Sirona Dental Systems GmbH
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1General information
1.1 Dear Customer,
We are pleased that you have equipped your practice with the wireless
digital Intraoral X-ray system XIOS XG from Sirona.
The WiFi interface transfers the X-ray images to a PC via your wireless
practice network (WLAN). The WiFi interface contains a storage battery
that is recharged via the charger. The system provides you with
outstanding image quality and high reliability on a day-to-day basis with
maximum flexibility.
XIOS XG can be operated with two types of sensor – the XIOS XG
Select and XIOS XG Supremesensors. Both types of sensor are
available in three sizes (0, 1 and 2). By using XIOS XG Supreme
sensors enhanced image processing functions are available to you in
SIDEXIS XG / SIDEXIS 4 through special filters. Depending on the
indication you can apply the corresponding filter to the X-ray image in
order to amplify the relevant structures. XIOS XG Supreme sensors
offer higher resolution compared with XIOS XG Select sensors.
In addition to SIDEXIS XG / SIDEXIS 4 (SIDEXIS XG version 2.5.6 and
above) the SIDEXIS plug-in must be installed for XIOS XG. Information
on the PC software can be found in the "SIDEXIS Plug-in for XIOS
XGOperator's Manual".
This operating manual should be of good help to you before use as well
as serve anytime later as a reference material.
We wish you a great deal of success and pleasure with XIOS XG.
Your XIOS XG Team

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1.2 Contact information
Customer service center In the event of technical queries, please use our online contact form at
www.sirona.com. In the navigation bar, go to the menu commands
"CONTACT" / "Customer Service Center" and then click the "CONTACT
FORM FOR TECHNICAL QUESTIONS"
button.
Authorized agent in the EU Sirona Dental Systems GmbH
Fabrikstrasse 31
64625 Bensheim
Germany
Tel.: +49(0) 6251/16-0
Fax: +49(0) 6251/16-2591
e-mail: [email protected]
www.sirona.com
Manufacturer's address Sirona Dental, Inc
30-30 47th Ave
Long Island City
New York, 11101
U.S.A.

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1.3 General information about this operating manual
Observe the Operating Instructions Please familiarize yourself with the unit by reading through these
Operating Instructions before putting it into operation. It is essential that
you comply with the specified warning and safety information.
Always keep the operating instructions handy in case you or another
user require(s) information at a later point in time. Save the operating
instructions on the PC or print them out.
If you sell the unit, make sure that the operating instructions are
included with it either as a hard copy or on an electronic storage device
so that the new owner can familiarize himself with its functions and the
specified warning and safety information.
Online portal for technical documents We have set up an online portal for the Technical Documents at http://
www.dentsplysirona.com/manuals. There, you can download these
operating instructions and further documents. Please complete the
online form if you would like a hard copy of a particular document. We
will then be happy to send you a printed copy free of charge.
Help If you require additional help despite having thoroughly studied the
Operating Instructions, please contact your dental depot.
1.4 Other valid documents
The X-ray system includes other components, such as PC software,
which are detailed in other documents. Instructions and warning and
safety information provided in the following documents must be taken
into account:
● SIDEXIS 4 Installation Instructions
● SIDEXIS 4 User Manual
● SIDEXIS XG Installation Instructions
● SIDEXIS XG Operator's Manual
● SIDEXIS Plug-in for XIOS XG Operator's Manual
Keep these documents handy at all times (file them in the X-ray System
Logbook in the FR of Germany).
The system integrator must complete the enclosed declaration of
conformity.
To safeguard your warranty claims, please complete the attached
"Installation Report / Warranty Passport" together with the service
engineer immediately after the installation of your unit.

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1.5 Intended use
The XIOS XG X-ray system is designed for digital acquisition of intraoral
X-ray images for diagnostic purposes. The system is used on patients
by dental professionals. The digital images produced are transferred to
a PC and displayed on a monitor. The images can be edited, saved and
printed on the PC.
The product must not be operated in hazardous areas.
1.6 Indications and contraindications
Indications in the areas:
● Conservative dentistry
● Caries diagnosis, especially of proximal lesions
● Endodontics
● Periodontology
● Prosthodontics
● Functional diagnosis and treatment of craniomandibular
dysfunctions
● Surgical dentistry
● Implantology
● Oral and maxillofacial surgery
● Orthodontics
Contraindications:
● Display of cartilage structures
● Display of soft tissue

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1.7 Structure of the document
1.7.1 Identification of the danger levels
To prevent personal injury and material damage, please observe the
warning and safety information provided in these operating instructions.
Such information is highlighted as follows:
DANGER
An imminent danger that could result in serious bodily injury or death.
WARNING
A possibly dangerous situation that could result in serious bodily
injury or death.
CAUTION
A possibly dangerous situation that could result in slight bodily injury.
NOTICE
A possibly harmful situation which could lead to damage of the
product or an object in its environment.
IMPORTANT
Application instructions and other important information.
Tip: Information for simplifying work.
1.7.2 Formats and symbols used
The formats and symbols used in this document have the following
meaning:
Prerequisite
1. First action step
2. Second action step
or
➢ Alternative action
Result
➢ Individual action step
Prompts you to do something.
See “Formats and symbols
used [→10]”
Identifies a reference to another text
passage and specifies its page num-
ber.
● List Designates a list.
“Command / menu item” Indicates commands, menu items or
quotations.

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2Safety Instructions
2.1 Qualifications of operating personnel
The system may only be operated by skilled or properly trained
personnel.
Personnel undergoing education or training, or who are using the unit
as part of general training may only operate the unit under the constant
supervision of an experienced person.
2.2 Hygiene
Suitable hygienic measures must be taken to prevent cross
contamination between patients, users and other persons.
The hygienic protective sleeves and sensor holder tabs are single use
devices which must be renewed for each patient. Do not use single use
devices more than once.
The sterilizable exposure accessories such as the rods and rings of the
XIOS XG sensor holder must be sterilized to prevent any possible
transmission of infective agents which might under certain
circumstances cause serious illnesses.
The sensors and the cable must be disinfected before each patient.
Refer to Hygiene [→101].
2.3 Radiation protection
The valid radiation protection regulations and measures must be
observed. The statutory radiation protection equipment must be used.
Please follow the manual for your X-ray tube assembly.
2.4 PC system and software
During the exposure, the data connection and power supply must be
ensured via the USB port. Under Power Options on the control panel
set the PC so that it never switches to stand-by operation or goes to
sleep.
SIDEXIS XG / SIDEXIS 4 may not be terminated until the end of the
exposure. Before image acquisition, close all programs that are not
required for the operation of SIDEXIS XG / SIDEXIS 4. Any programs
running in the background, such as media players, print managers,
backup software, etc., may cause SIDEXIS XG / SIDEXIS 4 to crash
during the exposure. In cases of doubt, consult your system
administrator.
These operating instructions presuppose that you are familiar with the
use of the SIDEXIS XG / SIDEXIS 4software.

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2.5 Allocation of acquisition system to patient
During routine practice, the clear allocation of the acquisition system to
the patient to be examined is ensured. This also applies to the
allocation of the X-rays to the patient data stored by SIDEXIS XG /
SIDEXIS 4.
2.6 Storage battery
General guidelines and warnings Hazards may be caused by lithium-ion storage batteries. Incorrect
charging or improper use may result in fire as well as personal injury
and damage to property.
If the WiFi interface with the installed storage battery becomes
unusually warm or deformed, switch the unit off immediately and consult
your specialist dealer.
No liability can be accepted for the storage battery for damage resulting
from misuse, incorrect charging or improper use.
Charging the storage battery Only use the charger and power supply unit supplied to charge the WiFi
interface storage battery. Otherwise the storage battery may overheat
and ignite.
The charging temperature should be between 0°C (32°F) and 45°C
(113°F) for an optimum charge.
Ensure that no flammable materials are nearby during charging. If the
WiFi interface with the storage battery is warm to the touch, let it cool
down first of all before charging it.
The storage battery is only half charged upon delivery.
Storage battery lifetime The battery should be recharged in the charger between patients with
regular use of the WiFi interface. This prolongs the battery lifetime.
Where the WiFi interface is not in use for longer than one week (on
account of a vacation for example), it should be removed from the
charging device. However, please note that it still uses a low amount of
power even when switched off on account of internal switching
operations, and a fully-charged storage battery will be dead in approx. 5
weeks. The WiFi interface must be recharged at this point at the latest
in order to prevent an exhaustive discharge of the storage battery which
shortens the battery lifetime.
If the storage battery has been charged for several hours and shows an
"orange" charge state after just one exposure (see "Determine unit
status" [→66]), the storage battery must be taken out of service and
disposed of.
Storage and transport Store storage batteries at room temperature between 4°C (40°F) and
21°C (70°F). Do not expose the storage battery to direct sunlight for
long periods of time. Do not store the storage battery at locations where
the temperature may exceed 49°C (120°F).
For temporary storage and transportation of the storage battery the
temperature should not fall below -7°C (20°F) or exceed 66°C (150°F).
Temperatures of 66°C (150°F) and above may damage the storage
battery where stored for a longer period (more than 2hours) and may
cause fire.

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Do not expose the storage battery to heavy impacts or vibrations.
2.7 Trouble-free operation
Use of this unit is permissible only if it works properly without
malfunctions. If trouble-free operation cannot be ensured, the unit must
be taken out of service, checked by authorized technicians for
malfunctions and, if necessary, repaired or replaced.
2.8 Maintenance
In the interest of safety and health of patients, users or third parties, it is
necessary that inspections are carried out at fixed time intervals to
ensure operational and functional safety of your product (IEC 60601-1 /
DIN EN 60601-1, etc.), see "Regular checks" [→103].
The owner is responsible for making sure that all inspections are
performed.
In the event that the system owner fails to fulfill the obligation to perform
scheduled inspection activities or ignores error messages, Sirona
Dental Systems GmbH and its authorized dealers cannot assume any
liability for damages.
As manufacturers of medical electrical equipment we can assume
responsibility for the safety-related features of the equipment only if
maintenance and repair are carried out only by ourselves or agencies
expressly authorized by us, and if components affecting safe operation
of the system are replaced with original spare parts upon failure.
We suggest that you request a certificate showing the nature and extent
of the work performed from those who carry out such work; it must
contain any changes in rated parameters or working ranges (if
applicable), as well as the date, the name of the company and a
signature.

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2.9 Changes and extensions to the device
Modifications to this system which might affect the safety of the system
owner, patients or other persons are prohibited by law!
For reasons of product safety, this product may be operated only with
original Sirona accessories or third-party accessories expressly
approved by Sirona. The user is responsible for any damage resulting
from the use of non-approved accessories.
If devices that are not approved by Sirona are connected, they must
comply with the applicable standards, e.g.:
● IEC60950-1 or IEC62368-1 for IT equipment (e.g. PC) and
● IEC 60601-1 for medical devices.
In case of doubt, contact the manufacturer of the system components.
2.10 Combination with other units
Permissible combinations are specified in the Declaration of Conformity
by the system integrator.
2.11 Wireless technology
Operation in Europe The XIOS XG WiFi system may be operated in all European countries.
Operation in the USA in accordance with
the Federal Communications
Commission (FCC)
This device fulfills part 15 of the FCC stipulations. The following two
conditions apply to operation: (1) This device may not cause any
harmful radio interference, and (2) this device must withstand any radio
interference received, including interference that may lead to
unintended operation.
Any changes or modifications which have not been expressly approved
by the party responsible for providing approval may revoke the user's
right to operate the device.
Transmission rate and range of the
wireless signal
The maximum wireless transmission rate for the system is established
in accordance with the specifications of the IEEE standard 802.11a/b/g.
The actual data transfer rate varies. Network and environmental
conditions, such as data traffic in the network and network overhead
along with the construction materials and design, may result in a lower
actual data transfer rate. The environmental conditions may have a
negative impact on the range of the radio signal.
2.12 Radiotelephones
Mobile RF communications equipment can affect electro-medical
equipment. Therefore, the use of mobile wireless phones in medical
office or hospital environments must be prohibited.

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2.13 Electrostatic discharge
Protective measures
Electrostatic discharge (abbreviated: ESD – ElectroStatic Discharge)
Electrostatic discharge from people can damage electronic components
when the components are touched. Damaged components usually have
to be replaced. Repairs must be performed by qualified personnel.
Measures to protect against ESD include:
● Procedures to avoid electrostatic charging via
– air conditioning
– air humidification
– conductive floor coverings
– non-synthetic clothing
● discharging the electrostatic charges from your own body through
contact with
– a metallic unit casing
– a larger metallic object
– any other metal part grounded with the protective earth
Endangered regions are indicated on the unit by the ESD warning label:
We recommend that all persons working with this system are made
aware of the significance of the ESD warning label. A training course
should also be held to inform users about the physics of electrostatic
charges.
Physics of electrostatic charges
An electrostatic discharge requires prior electrostatic charging.
There is a danger of electrostatic charges building up whenever two
bodies rub against each other, e.g. when:
● walking (soles of shoes against the floor) or
● moving (chair casters against floor).
The amount of charge depends on several factors: The charge is:
● higher at low air humidity than at high air humidity, and
● higher with synthetic materials than with natural materials (clothing,
floor coverings).
The following rule of thumb can be applied to assess the transient
voltages resulting from an electrostatic discharge.
An electrostatic discharge is:
● perceptible at 3,000 V or higher
● audible at 5,000 V or higher (cracking, crackling)
● visible at 10,000 V or higher (arc-over)
The transient currents resulting from these discharges have a
magnitude of over 10 amps. They are not hazardous for humans
because they last for only several nanoseconds.
Tip: 1 nanosecond = 1/1,000,000,000 second = 1 billionth of a second
Voltage differentials exceeding 30,000 volts per centimeter may lead to
a charge transfer (electrostatic discharge, lightning, arc-over).

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Integrated circuits (logical circuits and microprocessors) are used in
order to implement a wide variety of functions in a device. The circuits
must be miniaturized to a very high degree in order to include as many
functions as possible on these chips. This leads to structure thicknesses
as low as a few ten thousandths of a millimeter. Integrated circuits that
are connected to wires leading externally are therefore particularly at
risk from electrostatic discharge.
Even voltages that are imperceptible to the user can cause breakdown
of the structures, thus leading to a discharge current that melts the chip
in the affected areas. Damage to individual integrated circuits may
cause malfunction or failure of the unit.

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3System description
3.1 System structure
A WiFi interface [→19] with RFID transponder
B Charger [→19]
C USB cable [→20]
D Sensor (size 0, 1 or 2) [→21]
E Single-use sensor holder system with localizer rings, guide
rods, sensor holder tabs, [→21] and hygienic protective
sleeves [→73]
F Wireless access point to the practice network [→24]

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G Optional RFID reader with USB interface [→26]
H SIDEXIS PC [→25] with
● Access to the practice's wireless network
● SIDEXIS XG / SIDEXIS 4 (SIDEXIS XG version 2.56 or
higher)
● SIDEXIS plug-in for XIOS XG
I Power supply unit [→20]
J Aimright reusable sensor holder system with localizer ring,
sensor holders, [→21] and hygienic protective
sleeves [→73]

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3.2 WiFi Interface
The WiFi interface transfers the X-ray images to a SIDEXIS PC via a
wireless practice network (WLAN). The WiFi interface contains a
rechargeable storage battery. Further information can be found in the
"Operation" [→65]section.
3.3 Charger
The charger is used as the storage location for the WiFi interface when
it is not in use, and it allows the user to configure the wireless network
connection via the USB interface upon initial commissioning.

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3.4 Power supply unit
The power supply unit is connected to the charger and it charges the
WiFi interface storage battery.
NOTICE
Please only use the power supply unit supplied with REF 6404425 for
the external power supply for the charger. Ensure that the power
supply unit and the plug contacts are suitable for use in your country.
3.5 USB cable
A USB cable is supplied by Sirona with the delivery. It meets the USB
2.0 standard and is designed especially for use on XIOS XG.
CAUTION
Standard commercial USB cables do not offer adequate protection
from electromagnetic interference.
➢ Only use the special USB cable supplied by Sirona with the
delivery.