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Operating instructions and installation, XIOS XG USB module and sensors
XIOS XG Select
XIOS XG Supreme
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Sirona Dental Systems GmbH Table of contents
Operating Instructions and Installation XIOS XG USB module and sensors
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Table of contents
1
General information................................................................................................. 6
1.1 Dear Customer, ............................................................................................ 6
1.2 Contact information ...................................................................................... 6
1.3 General information about this operating manual ........................................ 7
1.4 Other valid documents ................................................................................. 7
1.5 Intended use................................................................................................. 7
1.6 Indications and contraindications ................................................................. 8
1.7 Structure of the document ............................................................................ 9
1.7.1 Identification of the danger levels.................................................... 9
1.7.2 Formats and symbols used ............................................................. 9
2
Safety instructions ................................................................................................... 10
2.1 Qualifications of operating personnel........................................................... 10
2.2 Hygiene ........................................................................................................ 10
2.3 Radiation protection ..................................................................................... 10
2.4 PC system and software .............................................................................. 10
2.5 Allocation of acquisition system to patient.................................................... 10
2.6 Trouble-free operation.................................................................................. 11
2.7 Maintenance................................................................................................. 11
2.8 Changes and extensions to the device ........................................................ 11
2.9 Combination with other units........................................................................ 11
2.10 Radiotelephones .......................................................................................... 12
2.11 Electrostatic discharge ................................................................................. 12
3
System description .................................................................................................. 14
3.1 System structure .......................................................................................... 14
3.2 USB module ................................................................................................. 16
3.3 USB cable .................................................................................................... 16
3.4 Sensors ........................................................................................................ 17
3.5 Sensor holder systems................................................................................. 17
3.5.1 Single-use sensor holder system .................................................... 17
3.5.2 Aimright reusable sensor holder system ......................................... 18
3.6 Intraoral X-ray tube assembly ...................................................................... 19
3.7 PC system .................................................................................................... 20
3.8 USB hub (optional)....................................................................................... 21
3.9 Technical data .............................................................................................. 22
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Table of contents Sirona Dental Systems GmbH
Operating Instructions and Installation XIOS XG USB module and sensors
3.10 Certification, registration and standards........................................................ 23
3.11 Symbols ........................................................................................................ 24
3.12 Position of the labels ..................................................................................... 25
4
Installation ................................................................................................................ 26
4.1 Fitting a second protective ground conductor on the PC .............................. 26
4.2 Install the PC software .................................................................................. 28
4.3 Connect USB module and hub...................................................................... 29
4.4 Install holder for the USB module ................................................................. 31
4.5 Connect sensor ............................................................................................. 32
4.6 Complete test exposures/acceptance tests .................................................. 32
5
Operation.................................................................................................................. 33
5.1 Enable exposure readiness........................................................................... 33
5.2 Determine unit status .................................................................................... 36
5.3 Sliding the hygienic protective sleeve over the sensor ................................. 37
5.4 Position the sensor........................................................................................ 38
5.4.1 Position sensor with single-use sensor holder system..................... 39
5.4.1.1 Anterior tooth exposure ..................................................... 39
5.4.1.2 Posterior tooth exposures ................................................. 40
5.4.1.3 Bite wing exposures .......................................................... 41
5.4.1.4 Endodontics exposures with the half-angle technique ......42
5.4.1.5 Measurement exposure for endodontics........................... 43
5.4.2 Position sensor with Aimright reusable sensor holder system ......... 44
5.4.2.1 Anterior tooth exposure ..................................................... 44
5.4.2.2 Posterior tooth exposures ................................................. 48
5.4.2.3 Horizontal bite wing exposures ......................................... 51
5.5 Select the exposure parameters for the X-ray tube assembly ...................... 53
5.5.1 X-ray doses and image quality......................................................... 53
5.5.2 Recommended dose for XIOS XG sensors ..................................... 53
5.5.3 HELIODENT Plus exposure times ................................................... 54
5.5.3.1 Pre-programmed exposure times for XIOS XG sensors
with 200 mm (8") FHA cone
54
5.5.3.2 Pre-programmed exposure times for XIOS XG sensors
with 300 mm (12") FHA cone (round or square cone)
55
5.6 Releasing the exposure ................................................................................ 56
5.7 Removing the hygienic protective sleeve from the sensor............................ 57
5.7.1 With single-use sensor holder system ............................................. 57
5.7.2 With Aimright reusable sensor holder system.................................. 59
5.8 Alignment of the X-ray image........................................................................ 60
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Sirona Dental Systems GmbH Table of contents
Operating Instructions and Installation XIOS XG USB module and sensors
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6
Maintenance and inspection.................................................................................... 61
6.1 Hygiene ........................................................................................................ 61
6.1.1 Care, cleaning agents, and disinfectants ........................................ 61
6.1.2 USB module and sensors................................................................ 62
6.1.3 Sensor holders ................................................................................ 63
6.2 Regular inspections...................................................................................... 64
6.3 Replace the sensor cable............................................................................. 66
7
Consumables and spare parts................................................................................. 69
8
Electromagnetic compatibility.................................................................................. 73
8.1 Accessories .................................................................................................. 73
8.2 Electromagnetic emission ............................................................................ 73
8.3 Interference immunity................................................................................... 74
8.4 Working clearances...................................................................................... 76
9
Disposal................................................................................................................... 77
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1General information Sirona Dental Systems GmbH
1.1Dear Customer, Operating Instructions and Installation XIOS XG USB module and sensors
1
General information
1.1
Dear Customer,
We are pleased that you have equipped your practice with the digital
Intraoral X-ray system XIOS XG from Sirona. The system is characterized
by many features including outstanding image quality and a high day-today reliability.
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
1.2
Contact information
Worldwide customer service
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: contact@sirona.com
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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Sirona Dental Systems GmbH 1General information
Operating Instructions and Installation XIOS XG USB module and sensors 1.3General information about this operating manual
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1.3
General information about this operating manual
Observe the Operating Instructions
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.
Keep documents safe 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.sirona.com/manuals. From here, you can download these
Operating Instructions along with other 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 continue to have difficulties 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.
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.
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1General information Sirona Dental Systems GmbH
1.6Indications and contraindications Operating Instructions and Installation XIOS XG USB module and sensors
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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Sirona Dental Systems GmbH 1General information
Operating Instructions and Installation XIOS XG USB module and sensors 1.7Structure of the document
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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:
Tip: Information on making work easier.
1.7.2 Formats and symbols used
The formats and symbols used in this document have the following
meaning:
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.
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 [ → 9]"
Identifies a reference to another text
passage and specifies its page
number.
● List Designates a list.
"Command / menu item" Indicates commands, menu items or
quotations.
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2Safety instructions Sirona Dental Systems GmbH
2.1Qualifications of operating personnel Operating Instructions and Installation XIOS XG USB module and sensors
2
Safety 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.
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.
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.
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Sirona Dental Systems GmbH 2Safety instructions
Operating Instructions and Installation XIOS XG USB module and sensors 2.6Trouble-free operation
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2.6
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.
2.7
Maintenance
Reference to Regular Inspections , US B Mo du le
In the interest of the safety and health of patients, users and other
persons, inspections must be performed at scheduled intervals to ensure
the operational reliability and functional safety of your product (IEC
60601-1 / DIN EN 60601-1 etc.), see "Regular Inspections" [ → 64].
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.
2.8
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.
2.9
Combination with other units
Permissible combinations are specified in the Declaration of Conformity
by the system integrator.
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2Safety instructions Sirona Dental Systems GmbH
2.10Radiotelephones Operating Instructions and Installation XIOS XG USB module and sensors
2.10
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.
2.11
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
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Sirona Dental Systems GmbH 2Safety instructions
Operating Instructions and Installation XIOS XG USB module and sensors 2.11Electrostatic discharge
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● 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).
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 Sirona Dental Systems GmbH
3.1System structure Operating Instructions and Installation XIOS XG USB module and sensors
3
System description
3.1
System structure
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Sirona Dental Systems GmbH 3System description
Operating Instructions and Installation XIOS XG USB module and sensors 3.1System structure
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A USB module [ → 16]
B USB cable [ → 16]
C Sensor (size 0, 1 or 2) with cable and plug [ → 17]
D Single-use sensor holder system with localizer rings, guide
rods, sensor holder tabs, [ → 17] and hygienic protective
sleeves [ → 37]
E SIDEXIS PC [ → 20] with
● USB interface
● SIDEXIS XG / SIDEXIS 4 (SIDEXIS XG version 2.56 or
higher)
● SIDEXIS plug-in for XIOS XG
F USB hub (optional) [ → 21]
G Aimright reusable sensor holder system [ → 18] with localizer
ring, sensor holders, and hygienic protective sleeves [ → 37]
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3System description Sirona Dental Systems GmbH
3.2USB module Operating Instructions and Installation XIOS XG USB module and sensors
3.2
USB module
The USB module is connected between the sensor and the PC. Image
data is transferred to a PC via the USB module and USB cable. Further
information can be found in the "Operation" [ → 33]section.
3.3
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.
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Sirona Dental Systems GmbH 3System description
Operating Instructions and Installation XIOS XG USB module and sensors 3.4Sensors
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3.4
Sensors
XIOS XG can be operated with two types of sensor – the XIOS XG Select
and XIOS XG Supreme sensors. Both types of sensor are available in
three sizes (0, 1 and 2).
By using XIOS XG Supreme sensors enhanced image processing
fu nctions ar e a vailable to y ou in SIDEXIS XG / SIDEXI S 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. Information
on the PC software can be found in the "SIDEXIS Plug-in for XIOS XG
Operator's Manual".
3.5
Sensor holder systems
3.5.1 Single-use sensor holder system
There are different sensor holders available depending on the type of
exposure. The localizer rings and sensor holder tabs are color-coded.
XIOS XG Select
XIOS XG Supreme
A Blue for anterior tooth exposure
B Yellow for posterior tooth exposures
C Red for bite wing exposures
D Green for endodontics exposures with the half-angle
technique
E Grey for endodontics (measurement exposure)
E
D
C
B
A
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3.5Sensor holder systems Operating Instructions and Installation XIOS XG USB module and sensors
3.5.2 Aimright reusable sensor holder system
There are different sensor holders available depending on the type of
exposure. The sensor holders are color-coded.
The same localizer ring is used for all sensor holders.
The sensor holders are available for sensor sizes 1 and 2.
A Localizer ring
B Sensor holder for posterior tooth exposures right upper jaw /
left lower jaw, yellow
C Sensor holder for bite wing exposures, red
D Blue for anterior tooth exposures, blue
E Sensor holder for posterior tooth exposures left upper jaw /
right lower jaw, yellow
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Sirona Dental Systems GmbH 3System description
Operating Instructions and Installation XIOS XG USB module and sensors 3.6Intraoral X-ray tube assembly
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3.6
Intraoral X-ray tube assembly
The following requirements apply to the intraoral X-ray tube assembly:
Intraoral X-ray tube assembly with multipulse technology (direct current)
0.14 – 1.4 mAs at 60 – 70 kV and 8" cone
This information must be modified accordingly for other tube lengths or
single-pulse X-ray tube assemblies.
For optimal image quality we recommend using a multipulse X-ray tube
assembly with a 12"cone.
IMPORTANT
The intraoral X-ray tube assembly must be installed in accordance with
the manufacturer's instructions and requirements. Please follow the
manual for your X-ray tube assembly.
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3System description Sirona Dental Systems GmbH
3.7PC system Operating Instructions and Installation XIOS XG USB module and sensors
3.7
PC system
The digital X-ray exposures are transferred to a PC via a USB port.
In addition to SIDEXIS XG / SIDEXIS 4 (SIDEXIS XG version 2.56 and
above) the SIDEXIS plug-in for XIOS XG must be installed. Information
on the PC software can be found in the "SIDEXIS Plug-in for XIOS XG
Operator's Manual".
Hardware requirements for SIDEXIS 4
Minimum PC requirements for SIDEXIS 4:
Hardware requirements for SIDEXIS XG
Minimum PC requirements for SIDEXIS XG:
The following operating systems are supported:
XIOS XG Plug-in system r equirements
● Windows 7 Professional SP 1 32 and 64-bit
● Windows 7 Ultimate SP 1 32 und 64-bit
● Windows 8.1 Professional (32-bit and 64-bit)
● Windows 10 Professional (64-bit)
Processor: > 2 GHz DualCore
RAM: > 4 GB
Free hard disk storage: > 5 GB for SIDEXIS 4 installation and
database
Removable medium: CD/DVD drive
Graphics card: > 512 MB
Screen: suitable for diagnostics applications, e.g. in
accordance with DIN 6868-57
Resolution: 1280 x 1024 pixels
Network card: Network RJ45, 100 MBit/s
USB port: in accordance with USB 2.0 standard
Processor: 32-bit (x86), 1 GHz
RAM 2 GB
Free hard disk storage: 5 GB for SIDEXIS XG installation and
database
Removable medium: CD/DVD drive
Graphics card: > 128 MB, minimum resolution 1024 x 768
pixels, 16.7 million colors (TrueColor)
Screen: suitable for diagnostics applications, e.g. in
accordance with DIN 6868-57
Network card: Network RJ45, 100 MBit/s
USB port: in accordance with USB 2.0 standard
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Sirona Dental Systems GmbH 3System description
Operating Instructions and Installation XIOS XG USB module and sensors 3.8USB hub (optional)
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3.8
USB hub (optional)
A USB module can be connected to the USB port of a PC either directly
or via an active USB hub. An active USB hub is only required if there is
inadequate power supply via the USB port of the PC.
The USB hub is not included in the scope of supply. It must meet the
following requirements:
Type of protection against
electric shock:
Protection class II
USB standard: 2.0
Power supply: Separate power supply (not bus-powered!)
Safety: The USB hub must comply with standard
IEC 60950-1 or be certified by a testing
laboratory which requires compliance with
this standard (e.g. VDE, UL, CSA)
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3.9Technical data Operating Instructions and Installation XIOS XG USB module and sensors
3.9
Technical data
USB module
XIOS XG Select Sensors
XIOS XG Supreme Sensors
Electric class:
Protection class II
Type of protection against
electric shock:
Applied part type BF
Degree of protection
against ingress of water:
Usual device (without protection against
ingress of water), corresponds to protection
class IPX0
USB port: Version 2.0
Operating voltage: 5 V DC
Device is supplied with power via the USB
connection of the PC.
Supply current: 250 mA
Power consumption: 1.25 W
Maximum USB cable
length:
5 m
Dimensions L x W x H: 107 x 62 x 28 mm
approx. 50 g
Technology: CMOS-APS (Active Pixel Sensor)
Physical pixel size: 15 µm, image acquisition in 30 µm
Line pairs: 16.7 lp at 30 µm
Measured resolution: 16 Lp/mm
Theoretical resolution: 16.7 Lp/mm
Active sensor area: Size 0 - sensor = 18 x 24 mm
Size 1 - sensor = 20 x 30 mm
Size 2 - sensor = 25.6 x 36 mm
External dimensions: Size 0 - sensor = 23.5 x 32 x 6.3 mm
Size 1 - sensor = 25.3 x 38.4 x 6.3 mm
Size 2 - sensor = 31.2 x 43.9 x 6.3 mm
Cable length: max. 2.70 m
Technology: CMOS-APS (Active Pixel Sensor)
Physical pixel size: 15 µm, image acquisition in 15 µm
Line pairs: 33.3 lp at 15 µm
Measured resolution: 28 Lp/mm
Theoretical resolution: 33.3 Lp/mm
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Sirona Dental Systems GmbH 3System description
Operating Instructions and Installation XIOS XG USB module and sensors 3.10Certification, registration and standards
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Operating and transport conditions
3.10
Certification, registration and standards
Certification
The XIOS XG USB system complies with the following standards, among
others. It complies with the requirements of these regulations:
EMC / safety
● IEC 60601-1 (Standard for Safety Medical Electrical Equipment Part 1: General Requirements for Safety)
● IEC 60601-1-1 (Medical electrical equipment - Part 1-1: General
requirements for safety; 1. Collateral standard: Safety requirements
for medical electrical systems)
● IEC 60601-1-2 (Medical electrical equipment - Part 1: General
requirements for safety; 2. Collateral standard: Electromagnetic
compatibility - Requirements and tests)
Quality
● AAMI TIR12:2004 (Designing, testing and labeling reusable medical
devices for reprocessing in health care facilities: A guide for device
manufacturers)
● CAN/CSA C22.2 No.601.1-M90 (Medical Electrical Equipment Part 1: General Requirements for Safety)
Active sensor area: Size 0 - sensor = 18 x 24 mm
Size 1 - sensor = 20 x 30 mm
Size 2 - sensor = 25.6 x 36 mm
External dimensions: Size 0 - sensor = 23.6 x 32 x 7.5 mm
Size 1 - sensor = 25.4 x 38.3 x 7.5 mm
Size 2 - sensor = 31.2 x 43 x 7.5 mm
Cable length: max. 2.70 m
Mode of operation: Continuous operation
Additional information: The unit must not be used near flammable
anesthesia gas mixtures containing air,
oxygen or nitrogen oxide.
Transport and storage
conditions:
Temperature: -40 °C (-40 °F) to 70 °C (158
°F)
Relative humidity: 20 % to 85 %
Air pressure: 500 to 1060 hPa
Operating conditions: Temperature: 10 °C (50 °F) to 40 °C (104 °F)
Relative humidity: 20 % to 85 %
Air pressure: 700 to 1060 hPa
Operating altitude: ≤ 2000 m
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3System description Sirona Dental Systems GmbH
3.11Symbols Operating Instructions and Installation XIOS XG USB module and sensors
This product bears the CE mark in accordance with the provisions of the
Council Directive 93/42/EEC of June 14, 1993 concerning medical
devices.
Original language of the present document: English
3.11
Symbols
Unit with protection class II in accordance with IEC 60601-1
Type BF applied part according to IEC 60601-1
This symbol indicates that the user must read the operating manual
before use.
CE mark in accordance with Council Directive 93/42/EEC, stating the
manufacturer’s Notified Body.
This identification signifies fulfillment of the requirements of the national
standards of the USA and Canada.
This identification signifies fulfillment of the requirements of the national
standards of the Brazilian market.
Year of manufacture
Denotes sterilizable accessories.
Item is only approved for one-off use.
USB connection socket
Refers to Directive 2002/96/EC and EN 50419
Do not dispose of device with domestic waste
0413
0413
YYYY
134°C
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Sirona Dental Systems GmbH 3System description
Operating Instructions and Installation XIOS XG USB module and sensors 3.12Position of the labels
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3.12
Position of the labels
The following labels are attached to components of the XIOS XG USB
system:
USB module
sensors
Sensor cable
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4Installation Sirona Dental Systems GmbH
4.1Fitting a second protective ground conductor on the PC Operating Instructions and Installation XIOS XG USB module and sensors
4
Installation
4.1
Fitting a second protective ground conductor on
the PC
Depending on whether the PC is operated inside or outside of the patient
environment (up to 1.5 m around the patient), an additional protective
ground conductor must be provided on the PC housing.
Power transmission to the X-ray system
Definition of the patient environment in accordance with IEC 60601-1
Within the patient environment (A), direct contact is only permissible with
devices or system parts that are approved for use in the patient
CAUTION
Leakage currents from the PC are transmitted to the X-ray system.
If a PC is not sufficiently grounded, there is a risk of electric shock for
both the patient and the user.
➢ The PC must be connected to a grounded electric outlet when in
operation.
➢ If the PC is operated in the patient environment (up to 1.5 m around
the patient), it must also be fitted with an additional protective
ground conductor.
1500mm
59”
1500mm
59”
1500mm
59”
1500mm
59”
1500mm
59”
1500mm
59”
1500mm
59”
1500mm
59”
1500mm
59”
1500mm
59”
1500mm
59”
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Sirona Dental Systems GmbH 4Installation
Operating Instructions and Installation XIOS XG USB module and sensors 4.1Fitting a second protective ground conductor on the PC
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environment (A). This applies to all possible patient positions (B) during
the examination or treatment.
Variant: PC located outside the patient environment
Variant: PC located inside the patient environment
If the PC is operated inside the patient environment, the system integrator
must fit a second protective ground conductor on the PC housing. To do
this, proceed as follows:
✔ The PC is switched off and the mains cable removed.
1. Put on an ESD wrist band or discharge your body by touching an
equipotential bonding conductor.
2. Loosen the PC housing screws and remove a PC cover. Refer to the
manual for the PC.
3. Find a location to connect the protective ground conductor on the rear
side of the metal PC housing that is readily accessible from the inside
and from the outside.
4. Drill a suitable hole for an M4 screw at this location.
CAUTION
The PC must not then be moved closer to the patient. A distance of 1.5
m should be maintained at all times.
NOTICE
Drilling may damage the PC.
➢ When drilling, ensure that no part of the PC is damaged and no
swarf gets inside the PC.
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4Installation Sirona Dental Systems GmbH
4.2Install the PC software Operating Instructions and Installation XIOS XG USB module and sensors
5. Remove any paint around the drill hole to achieve a good metal
contact.
6. Fasten the M4 connecting screw to the PC casing firmly with a
toothed lock washer and nut.
7. Screw down the protective ground conductor as shown.
8. Affix the "Grounding point" label provided next to the protective
ground conductor connection.
9. Connect the protective ground conductor to a suitable equipotential
bonding conductor.
4.2
Install the PC software
The PC must be in a state of operational readiness before the installation
of the XIOS XG Intraoral System. Make sure that the hardware and the
operating system are properly installed. Refer to the manuals for your PC
and operating system.
The installation of SIDEXIS XG / SIDEXIS 4 is described in the installation
instructions for SIDEXIS XG / SIDEXIS 4.
The SIDEXIS XG / SIDEXIS 4 plug-in for the XIOS XG USB module must
be installed in addition to SIDEXIS XG. To do this, proceed as follows:
✔ SIDEXIS XG / SIDEXIS 4 (SIDEXIS XG 2.5.6 or higher) is installed
on the PC.
1. Log onto your PC with an administrator account.
2. Insert the
"Sirona XIOS XG Select/Supreme 1.0 - Installation"
CD
into your PC's CD/DVD drive.
3. The setup normally starts automatically. If the setup does not start,
double-click on the "Autorun.exe" file in the main directory of the
installation CD.
The setup window opens.
NOTICE
The USB module must not be connected to the PC during installation of
the SIDEXIS plug-in for XIOS XG.
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Sirona Dental Systems GmbH 4Installation
Operating Instructions and Installation XIOS XG USB module and sensors 4.3Connect USB module and hub
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4. Click on
"Installing the device connection with USB support"
in the
setup window.
5. Follow the additional instructions.
6. Restart the PC if you are required to do so.
The SIDEXIS plugin for XIOS XG USB system is installed.
4.3
Connect USB module and hub
A USB module can be connected to the USB port of a PC either directly
or via an active USB hub. An active USB hub is only required if there is
inadequate power supply via the USB port of the PC.
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4Installation Sirona Dental Systems GmbH
4.3Connect USB module and hub Operating Instructions and Installation XIOS XG USB module and sensors
✔ SIDEXIS XG / SIDEXIS 4 and the SIDEXIS plug-in for XIOS XG has
been successfully installed on the PC, see "Install PC software"
[ → 28].
1. If an active USB hub is required, install it according to the
manufacturer's instructions.
2. Connect the USB module directly with the PC or with the hub. Use the
USB cable supplied by Sirona.
The operating system detects the USB module. A message appears
in the info area of the Windows taskbar (Systray).
CAUTION
Leakage currents from the USB hub are transmitted to the X-ray
system.
There is a risk of electric shock for both the patient and the user.
➢ The USB hub should only be operated outside the patient
environment (up to 1.5 m around the patient).
➢ Please also refer to the technical requirements for the USB hub, see
"USB hub (optional)" [ → 21].
IMPORTANT
Only one XIOS XG USB module may be connected to this PC.
NOTICE
Ensure safe cable installation
When installing the USB cable and the individual components, make
sure that the connections cannot be accidentally loosened,
disconnected or damaged, e.g. due to tripping over or pulling them, etc.
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Sirona Dental Systems GmbH 4Installation
Operating Instructions and Installation XIOS XG USB module and sensors 4.4Install holder for the USB module
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4.4
Install holder for the USB module
A holder is supplied with the USB module. It can be screwed to a wall
using the drywall screws provided or any other mounting material.
Alternatively, the holder can be glued to an even surface, for example
using a self-adhesive Velcro strip or double-sided adhesive tape.
Position the holder so that the USB module can be accessed easily
during the treatment and the LED displays are clearly visible.
NOTICE
There may be cables in the wall.
Drilling can damage these cables.
➢ Make sure that drilling does not accidentally damage any cables.
1.
2.
3.
4.
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4.5Connect sensor Operating Instructions and Installation XIOS XG USB module and sensors
4.5
Connect sensor
A calibration file is saved on the XIOS XG Select and XIOS XG Supreme
sensors which is transferred to the PC the first time that the sensor is
used.
✔ The USB module can be connected to the USB port of a PC either
directly or via a USB hub. The orange LED on the USB module lights
up, see also "Determine unit status" [ → 36].
1. Start SIDEXIS XG / SIDEXIS 4.
2. Plug the connector of the sensor into the front socket of the USB
module.
3. Register a patient in SIDEXIS XG / SIDEXIS 4 and establish
readiness for intraoral exposures.
A sensor calibration file is installed automatically if you are using
the XIOS XG Select or XIOS XG Supreme sensor on this PC for
the first time. If this does not occur and no exposure readiness is
established, disconnect the sensor from the USB module and
plug the cable in again.
4.6
Complete test exposures/acceptance tests
A test exposure must be completed after installing a XIOS XG USB
module or a new sensor.
An acceptance test must be completed by a service engineer from a
specialist retailer in Germany (Austria and Switzerland).
For completing test exposures, use a test phantom, see Consumables
and spare parts [ → 69]. Do not complete test exposures on a patient.
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Sirona Dental Systems GmbH 5Operation
Operating Instructions and Installation XIOS XG USB module and sensors 5.1Enable exposure readiness
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5
Operation
5.1
Enable exposure readiness
✔ The USB module and the sensor are installed in accordance with the
instructions in the "Installation" [ → 26] section.
1. Connect a sensor to the USB module.
2. Register the patient in SIDEXIS XG / SIDEXIS 4. Detailed information
can be found in the SIDEXIS XG / SIDEXIS 4 operator's manual.
3. Establish exposure readiness for intraoral exposures. Click on the
"[I]ntraoral X-ray"
button.
The
"Set tooth or program before exposure"
window opens. The
intraoral exposure is selected as the image type.
4. Click on the tooth for which the intraoral exposure is being produced.
Information on the tooth displays can be found in the SIDEXIS XG /
SIDEXIS 4 operator's manual. Confirm your selection with the
"OK"
button.
The
"Select X-ray device"
window appears where multiple
intraoral X-ray system are registered in SIDEXIS XG / SIDEXIS 4.
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5Operation Sirona Dental Systems GmbH
5.1Enable exposure readiness Operating Instructions and Installation XIOS XG USB module and sensors
5. Select the XIOS XG USB module.
The
"Exposure readiness "
window is displayed. SIDEXIS XG /
SIDEXIS 4 Is ready for exposures when the green display is
flashing here.
"Exposure readiness " window when using a XIOS XG Select sensor
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Sirona Dental Systems GmbH 5Operation
Operating Instructions and Installation XIOS XG USB module and sensors 5.1Enable exposure readiness
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"Exposure readiness " window when using a XIOS XG Supreme sensor
6. When using a XIOS XG Supreme sensor: Select the desired filter to
be applied to the x-ray image produced depending on the indication.
The selection can also be changed after the exposure.
The button for the selected image filter is shown inside a red
frame. The
"Universal"
image filter is pre-selected by default.
The orange LED on the USB module flashes, the adjacent LED lights
up green, see "Determine unit status" [ → 36]. The USB module is
now also ready for exposures. The exposure can be released now.
WARNING
Connecting / replacing a sensor on the USB module
You can connect or replace the sensor on the USB module until the
radiation is released. The sensor can also be exchanged when the
exposure readiness is already created.
When you separate the sensor from the USB module, after the radiation
is released, and the image has not yet been transferred, the image data
will be lost.
➢ Do not disconnect the sensor from the USB module before the
image data has been transferred to SIDEXIS XG / SIDEXIS 4.
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5.2Determine unit status Operating Instructions and Installation XIOS XG USB module and sensors
5.2
Determine unit status
The XIOS XG USB module features three LED displays. They indicate
the unit status.
Sensor SIDEXIS
XG /
SIDEXIS 4
Sensor status
LED, green
Exposure
readiness LED,
orange
Sensor
connection LED,
green
Status / bug fixing
Connected Running at Flashes every
half to one and
a half seconds
at Ready for exposure
Connected Running on off on Exposure in progress
Connected Not running off off on Start SIDEXIS XG / SIDEXIS 4 to
establish unit exposure readiness
Connected Running or
not running
off on off Short circuit or overcurrent condition.
Replace the sensor cable. If the
problem persists, replace the sensor.
Connected Running or
not running
off on flashing Undercurrent condition. Replace the
sensor cable. If the problem persists,
replace the sensor.
Not
connected
Not running off on off Connect the sensor and start
SIDEXIS XG / SIDEXIS 4.
Connected
or not
connected
Running or
not running
On or off flashing off USB voltage supply too low. Use
another original USB cable, another
USB port on the PC or use a hub.
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Sirona Dental Systems GmbH 5Operation
Operating Instructions and Installation XIOS XG USB module and sensors 5.3Sliding the hygienic protective sleeve over the sensor
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5.3
Sliding the hygienic protective sleeve over the
sensor
Hygienic protective sleeves are available depending on the size of the
sensor (0, 1 or 2). They fit both XIOS XG Select and XIOS XG Supreme
sensors.
To reorder the hygienic protective sleeves, see"Consumables and spare
parts" [ → 69].
1. Please select a hygienic protective sleeve with a size that matches
the sensor.
2. Slide the Sensor into the Sheath
The hygienic protective sleeve is slightly undersized, so that it
surrounds the sensor tightly and prevents the sensor from
slipping out of place.
WARNING
Sensors and sensor cables must be disinfected prior to initial use.
Patients may become sick due to components that have not been
disinfected.
➢ Remove the sensor connector from the unit.
➢ Clean the sensor and the sensor cable thoroughly with disinfectant
at least twice. Refer to Hygiene.
WARNING
The hygienic protective sleeves and sensor holder tabs are single use
devices.
Patients may become sick due to unsterilized accessories.
➢ Replace the hygienic protective sleeves and sensor holder tabs
after each patient. However, they can be used multiple times on the
same patient. The adhesive on the sensor holder tabs is suitable for
gluing and detaching them from the hygienic protective sleeve
repeatedly.
➢ Under no circumstances should you slide a hygienic protective
sleeve over a sensor where a sensor holder tab is already glued on
it.
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5.4Position the sensor Operating Instructions and Installation XIOS XG USB module and sensors
5.4
Position the sensor
Since the positioning of the sensors in the beam path of the cone strongly
influences the image quality, using the parallel technique with the XIOS
XG sensor holder system or with the #AimRight# sensor holder system is
recommended for optimal positioning of the sensors.
With the XIOS XG sensor holder system the sensor is affixed to the
sensor holder with a sensor holder tab. Sensor holder tabs may be
detached and reaffixed several times during an exposure series on the
same patient. The sensor holder tabs must be glued to the active sensor
surface (A) in all cases.
The #AimRight# sensor holder system is a plug-in system. No sensor
holder tabs are required.
NOTICE
The sensor cable is sensitive to mechanical influences.
The cable may become damaged or may wear out prematurely.
➢ Avoid bending, creasing or rotating the cable or exposing it to other
strains. Do not ride over the sensor cable, e.g., in a chair. Do not
swirl the sensor about by its cable.
➢ When removing the plug pull on the plug and not on the cable.
➢ Make sure that the sensor cable is run out of the patient's mouth in
such a way that the patient cannot bite it.
➢ Inspect the sensor cable visually for damage every day.
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Operating Instructions and Installation XIOS XG USB module and sensors 5.4Position the sensor
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5.4.1 Position sensor with single-use sensor holder system
5.4.1.1
Anterior tooth exposure
For anterior tooth exposures use the blue sensor holder.
1. Place the blue localizer ring (B) onto the triple-angled guide rod (C).
2. Place the blue sensor holder tab (A) onto the guide rod (C).
3. Slide the sensor into the hygienic protective sleeve, see section
"Slide the hygienic protective sleeve over the sensor".
4. Glue the sensor holder tab onto the sensor's hygienic protective
sleeve. Place the tab in the center of the sensor as shown in the
diagram.
5. Position the sensor in the patient's mouth.
6. Bring the X-ray tube assembly into the correct position and take an
X-ray exposure.
7. Remove the sensor from the hygienic protective sleeve. For this
follow the instructions in section "Remove the hygienic protective
sleeve from the sensor" [ → 57]. The used sensor holder tab and
hygienic protective sleeve must be disposed of after the examination.
8. Clean and sterilize the guide rod and localizer ring.
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5.4Position the sensor Operating Instructions and Installation XIOS XG USB module and sensors
5.4.1.2
Posterior tooth exposures
For posterior tooth exposures use the yellow sensor holder.
1. Place the yellow localizer ring (B) onto the double-angled guide rod
(C).
2. Place the yellow sensor holder tab (A) onto the guide rod (C).
3. Slide the sensor into the hygienic protective sleeve, see section
"Slide the hygienic protective sleeve over the sensor".
4. For the left upper jaw and right lower jaw: Glue the sensor holder tab
onto the sensor's hygienic protective sleeve. Place the tab in the
center on the sensor. The edge of the tab must lock with the edge of
the sensor, as shown in the diagram.
5. For the right upper jaw and left lower jaw the sensor holder tab must
be placed in the mirrored position. See the adjacent drawing.
6. Position sensor in patient's mouth.
7. Bring the X-ray tube assembly into the correct position and take an Xray exposure.
8. Remove the sensor from the hygienic protective sleeve. For this
follow the instructions in section "Remove the hygienic protective
sleeve from the sensor" [ → 57]. The used sensor holder tab and
hygienic protective sleeve must be disposed of after the examination.
9. Clean and sterilize the guide rod and localizer ring.
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Operating Instructions and Installation XIOS XG USB module and sensors 5.4Position the sensor
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5.4.1.3
Bite wing exposures
For bite wing exposures use the red sensor holder.
1. Place the red localizer ring (B) onto the straight guide rod (C).
2. Place the red sensor holder tab (A) onto the guide rod (C).
3. Slide the sensor into the hygienic protective sleeve, see section
"Slide the hygienic protective sleeve over the sensor".
4. For vertical bite wing exposures: Glue the sensor holder tab onto the
sensor's hygienic protective sleeve. Align the tab vertically to the
sensor and place it in the center on the active sensor surface, as
shown in the diagram.
5. For horizontal bite wing exposures the tab must be placed aligned
horizontally to the sensor. See the adjacent drawing.
6. Position the sensor in the patient's mouth.
7. Bring the X-ray tube assembly into the correct position and take an Xray exposure.
8. Remove the sensor from the hygienic protective sleeve. For this
follow the instructions in section "Remove the hygienic protective
sleeve from the sensor" [ → 57]. The used sensor holder tab and
hygienic protective sleeve must be disposed of after the examination.
9. Clean and sterilize the guide rod and localizer ring.
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5.4Position the sensor Operating Instructions and Installation XIOS XG USB module and sensors
5.4.1.4
Endodontics exposures with the half-angle technique
For endodontics exposures with the half-angle technique use the green
universal sensor holder tab.
1. Slide the sensor into the hygienic protective sleeve, see section
"Slide the hygienic protective sleeve over the sensor".
2. Glue the green universal sensor holder tab onto the sensor's hygienic
protective sleeve. Place the tab in the center of the sensor as shown
in the diagram.
3. For anterior tooth exposures: Glue the sensor holder tab onto the
sensor's hygienic protective sleeve. Align the tab to the sensor edge
of the cable and place it in the center on the sensor, as shown in the
diagram.
4. For posterior tooth exposures the tab must be aligned vertically to th e
sensor and placed in the center on the sensor. See the adjacent
drawing.
5. Position sensor in patient's mouth.
6. Bring the X-ray tube assembly into the correct position and take an Xray exposure.
7. Remove the sensor from the hygienic protective sleeve. For this
follow the instructions in section "Remove the hygienic protective
sleeve from the sensor" [ → 57]. The used sensor holder tab and
hygienic protective sleeve must be disposed of after the examination.
8. Clean and sterilize the tab.
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Operating Instructions and Installation XIOS XG USB module and sensors 5.4Position the sensor
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5.4.1.5
Measurement exposure for endodontics
Endodontic needles and files can remain in the root canal for the
measurement exposure.
For endodontics exposures use the grey sensor holder.
1. Place the grey localizer ring (B) onto the plastic guide rod (C).
2. Place the grey sensor holder tab (A) onto the guide rod (C).
3. Slide the sensor into the hygienic protective sleeve, see section
"Slide the hygienic protective sleeve over the sensor".
4. Glue the sensor holder tab onto the sensor's hygienic protective
sleeve. Place the tab in the center of the sensor as shown in the
diagram.
5. Position the sensor in the patient's mouth.
6. Bring the X-ray tube assembly into the correct position and take an Xray exposure.
7. Remove the sensor from the hygienic protective sleeve. For this
follow the instructions in section "Remove the hygienic protective
sleeve from the sensor" [ → 57]. The used sensor holder tab and
hygienic protective sleeve must be disposed of after the examination.
8. Clean and sterilize the guide rod and localizer ring.
C
B
A
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5.4Position the sensor Operating Instructions and Installation XIOS XG USB module and sensors
5.4.2 Position sensor with Aimright reusable sensor holder
system
5.4.2.1
Anterior tooth exposure
Preparing the sensor holder
For anterior tooth exposures use the blue sensor holder.
1. Fasten the guide rod for the sensor holder (C) in the perforation (B)
of the localizer ring (A).
2. Slide the sensor into the hygienic protective sleeve;
see "Slide the hygienic protective sleeve over the sensor".
3. To do this, place the sensor on the palm of your hand and clip the
sensor holder onto the sensor.
4. Push the sensor into the sensor holder up to the stop.
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Operating Instructions and Installation XIOS XG USB module and sensors 5.4Position the sensor
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Positioning the sensor for exposures of the lower jaw
1. Look through the localizer ring to check the alignment of the sensor.
The sensor must be located centrally in front of the opening in the
localizer ring.
2. Position the sensor in the patient's mouth.
3. Use light pressure to align the sensor so that it lies parallel with the
lower front teeth.
4. Ask the patient to close their mouth slowly and bite down on the
sensor holder.
5. Slide the localizer ring onto the patient’s lips.
6. Align the cone of the X-ray tube assembly parallel to the sensor
directly on the localizer ring.
7. Release an X-ray exposure. Refer to sections Select the exposure
parameters for the X-ray tube assembly [ → 53] and Releasing the
exposure. Also observe the operating instructions for the X-ray tube
assembly.
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5.4Position the sensor Operating Instructions and Installation XIOS XG USB module and sensors
Positioning the sensor for exposures of the upper jaw
1. Look through the localizer ring to check the alignment of the sensor.
The sensor must be located centrally in front of the opening in the
localizer ring.
2. Position the sensor centrally in the oral cavity without it touching the
roof of the mouth.
3. Ask the patient to close their mouth slowly and fix the sensor holder
to the cutting edge.
Tip: A cotton roll on the lower cutting edge stabilizes the sensor
holder support and supports parallelism with the bite block on the
sensor holder.
The sensor is parallel with the upper front teeth.
4. Slide the localizer ring to the patient's face.
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Operating Instructions and Installation XIOS XG USB module and sensors 5.4Position the sensor
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5. Align the cone of the X-ray tube assembly parallel to the sensor
directly on the localizer ring.
6. Release an X-ray exposure. Refer to sections Select the exposure
parameters for the X-ray tube assembly [ → 53] and Releasing the
exposure. Also observe the operating instructions for the X-ray tube
assembly.
After the exposure
After the exposure
1. Ask the patient to open their mouth.
2. Remove the sensor from the patient’s mouth.
3. Remove the sensor from the hygienic protective sleeve. Follow the
instructions in the section Removing the hygienic protective sleeve
from the sensor [ → 57]. The hygienic protective sleeves must be
disposed of after the examination.
4. Clean and sterilize the sensor holder and localizer ring.
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5.4Position the sensor Operating Instructions and Installation XIOS XG USB module and sensors
5.4.2.2
Posterior tooth exposures
Preparing the sensor holder
For posterior tooth exposures use the yellow sensor holders.
1. For the right upper jaw and left lower jaw: Fasten the guide rod for the
sensor holder (C) in the perforation (B) of the localizer ring (A).
2. For the left upper jaw and right lower jaw: Fasten the guide rod for the
sensor holder (E) in the perforation (D) in the localizer ring (A).
3. Slide the sensor into the hygienic protective sleeve, see section
"Slide the hygienic protective sleeve over the sensor".
4. Place the sensor on the palm of your hand and clip the sensor holder
onto the sensor.
5. Push the sensor into the sensor holder up to the stop.
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Operating Instructions and Installation XIOS XG USB module and sensors 5.4Position the sensor
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Position the sensor
1. Look through the localizer ring to check the alignment of the sensor.
The sensor must be located centrally in front of the opening in the
localizer ring.
2. Position the sensor in the patient's mouth and align it so that it is
parallel with the posterior teeth.
Example: Positioning on the lower jaw
Example: Positioning on the upper jaw
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5.4Position the sensor Operating Instructions and Installation XIOS XG USB module and sensors
3. Align the cone of the X-ray tube assembly parallel to the sensor
directly on the localizer ring.
4. Release an X-ray exposure. Refer to sections Select the exposure
parameters for the X-ray tube assembly [ → 53] and Releasing the
exposure. Also observe the operating instructions for the X-ray tube
assembly.
After the exposure
After the exposure
1. Ask the patient to open their mouth.
2. Remove the sensor from the patient’s mouth.
3. Remove the sensor from the hygienic protective sleeve. Follow the
instructions in the section Removing the hygienic protective sleeve
from the sensor [ → 57]. The hygienic protective sleeves must be
disposed of after the examination.
4. Clean and sterilize the sensor holder and localizer ring.
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Operating Instructions and Installation XIOS XG USB module and sensors 5.4Position the sensor
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5.4.2.3
Horizontal bite wing exposures
Preparing the sensor holder
For bite wing exposures use the red sensor holder.
1. Fasten the guide rod for the sensor (C) in the perforation (B) of the
localizer ring (A).
2. Slide the sensor into the hygienic protective sleeve, see section
"Slide the hygienic protective sleeve over the sensor".
3. Place the sensor on the palm of your hand and clip the sensor holder
onto the sensor.
4. Slide the sensor into the center of the sensor holder.
Position the sensor
1. Look through the localizer ring to check the alignment of the sensor.
The sensor must be located centrally in front of the opening in the
localizer ring.
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5.4Position the sensor Operating Instructions and Installation XIOS XG USB module and sensors
2. Position the sensor directly on the dental arch.
The bite block of the sensor holder must be located between the
upper molars, parallel to the occlusal plane.
In order to avoid superimpositions, the sensor must be positioned
parallel to the dental arch line.
3. Slide the localizer ring to the patient's face.
4. Align the cone of the X-ray tube assembly parallel to the sensor
directly on the localizer ring.
5. Release an X-ray exposure. Refer to sections Select the exposure
parameters for the X-ray tube assembly [ → 53] and Releasing the
exposure. Also observe the operating instructions for the X-ray tube
assembly.
After the exposure
After the exposure
1. Ask the patient to open their mouth.
2. Remove the sensor from the patient’s mouth.
3. Remove the sensor from the hygienic protective sleeve. Follow the
instructions in the section Removing the hygienic protective sleeve
from the sensor [ → 57]. The hygienic protective sleeves must be
disposed of after the examination.
4. Clean and sterilize the sensor holder and localizer ring.
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Operating Instructions and Installation XIOS XG USB module and sensors 5.5Select the exposure parameters for the X-ray tube
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5.5
Select the exposure parameters for the X-ray
tube assembly
5.5.1 X-ray doses and image quality
Factors for determining the X-ray doses
The dose to be set for X-ray exposure depends primarily on the following:
● Type of X-ray tube assembly (manufacturer, AC/DC, etc.)
● Distance between focal spot and sensor
● Morphology of patient
● Object, which tooth is to be X-rayed
The dose is adjusted through tube voltage and tube current (specified by
kV/mA) as well as exposure time.
Please refer to the operating instructions for the X-ray unit.
Effects of too low or too high a dose
For physical reasons the digital X-ray sensors behave in the same wa y as
with X-ray film. The lower the dosage value the higher the image noise,
which in turn generally leads to a poorer detail resolution.
Default setting for brightness and contrast
Default settings for brightness and contrast can always be optimally
adjusted through the image preprocessing function, independent of dose.
5.5.2 Recommended dose for XIOS XG sensors
XIOS XG sensors have a very wide effective dose area, so that,
depending on the object and diagnostic question at hand, the selection of
an optimal parameter adjustment is always possible.
Corresponding values apply to X-ray tube assemblies from other
manufacturers and to AC tube units. However, for optimal image quality
DC tube units should be used.
Please follow the manual for your intraoral X-ray tube assembly.
CAUTION
Image degradations caused by overexposure of the sensor cannot be
compensated using subsequent image processing!
IMPORTANT
Since the exposure time depends on the diagnostic problem as well as
the respective clinical situation, the selection of an optimal adjustment is
the responsibility of the treating physician.
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5.5Select the exposure parameters for the X-ray tube assembly Operating Instructions and Installation XIOS XG USB module and
5.5.3 HELIODENT Plus exposure times
5.5.3.1
Pre-programmed exposure times for XIOS XG sensors with
200 mm (8") FHA cone
Exposure times by dental region XIOS XG sensors cone 8" WW
0.01 0.02 0.03 0.04 0.05 0.06 0.08 0.10 0.12 0.16 0.20 0.25 0.32 0.40
Upper jaw
Lower jaw
Upper jaw
Lower jaw
Exposure time in seconds
with:
60kV 0.060.080.100.120.16
70kV 0.030.040.050.060.08
Freely programmed values
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Operating Instructions and Installation XIOS XG USB module and sensors 5.5Select the exposure parameters for the X-ray tube
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5.5.3.2
Pre-programmed exposure times for XIOS XG sensors with
300 mm (12") FHA cone (round or square cone)
Exposure times XIOS X G sensors cone 12" WW
Exposure times by dental region XIOS XG sensors cone 12" WW
0.03 0.04 0.05 0.06 0.08 0.10 0.12 0.16 0.20 0.25 0.32 0.40 0.50 0.64 0.80
Upper jaw
Lower jaw
Upper jaw
Lower jaw
Exposure time in seconds
with:
60kV 0.12 0.16 0.20 0.25 0.32
70kV 0.06 0.08 0.10 0.12 0.16
Freely programmed values
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5.6Releasing the exposure Operating Instructions and Installation XIOS XG USB module and sensors
5.6
Releasing the exposure
✔ The exposure parameters for the X-ray tube assembly are set, see
"Select the exposure parameters for the X-ray tube assembly" [ → 53].
✔ The sensor is positioned in the patient's mouth with the
corresponding auxiliary exposure equipment, see "Position the
sensor" [ → 38].
1. Ensure that the USB module is ready for exposures. The orange LED
on the USB module must flash, the adjacent LED must light up green,
see "Determine unit status" [ → 36].
2. Ensure that SIDEXIS XG / SIDEXIS 4 is ready for exposures. The
green display must be flashing in the Exposure readiness window.
3. Check that the X-ray tube assembly is in the correct position and take
the X-ray exposure.
4. Remove the sensor from the hygienic protective sleeve. For this
follow the instructions in section "Remove the hygienic protective
sleeve from the sensor" [ → 57]. The used sensor holder tab and
hygienic protective sleeve must be disposed of after the examination.
The guide rod and localizer ring must be cleaned and sterilized. The
sensor must be wiped with disinfectant before it is used for another
patient.
5. Following the X-ray exposure, carefully remove the sensor to prevent
it from falling down.
6. Continue with image processing in SIDEXIS XG / SIDEXIS 4.
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Operating Instructions and Installation XIOS XG USB module and sensors 5.7Removing the hygienic protective sleeve from the sensor
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5.7
Removing the hygienic protective sleeve from the
sensor
5.7.1 With single-use sensor holder system
Have the sensor holder tab and the sensor holder glued onto the hygienic
protective sleeve. This makes it easier to remove the hygienic protective
sleeve.
1. Grasp the guide rod in one hand so that you can touch the side of the
sensor facing away from the sensor cable with your thumb.
2. Carefully push the sensor out of the part of the hygienic protective
sleeve that is glued to the sensor holder tab with your thumb.
NOTICE
The sensor cable is sensitive to mechanical influences.
The cable may become damaged or may wear out prematurely.
➢ Do not pull on the sensor cable when pulling the sensor out of the
hygienic protective sleeve. Slide the sensor further out of the
hygienic protective sleeve with your thumb as described below.
➢ Avoid bending, creasing or rotating the cable or exposing it to other
strains.
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5.7Removing the hygienic protective sleeve from the sensor Operating Instructions and Installation XIOS XG USB module and sensors
3. Slide the sensor further out of the hygienic protective sleeve with your
thumb.
4. Hold the sensor cable firmly to prevent the sensor from falling out of
the hygienic protective sleeve.
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Operating Instructions and Installation XIOS XG USB module and sensors 5.7Removing the hygienic protective sleeve from the sensor
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5.7.2 With Aimright reusable sensor holder system
1. Remove the sensor with the hygienic protective sleeve from the
sensor holder. To do this, open up the sensor holder by pressing
gently on one side as shown in the figure.
2. Carefully push the sensor out of the narrow part of the hygienic
protective sleeve with two fingers.
3. Slide the sensor further out of the hygienic protective sleeve.
4. Hold on to the sensor and remove it from the hygienic protective
sleeve.
NOTICE
The sensor cable is sensitive to mechanical influences.
The cable may become damaged or may wear out prematurely.
➢ Do not pull on the sensor cable when pulling the sensor out of the
hygienic protective sleeve. Slide the sensor further out of the
hygienic protective sleeve with your thumb as described below.
➢ Avoid bending, creasing or rotating the cable or exposing it to other
strains.
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5.8Alignment of the X-ray image Operating Instructions and Installation XIOS XG USB module and sensors
5.8
Alignment of the X-ray image
The sensor alignment is shown on the X-ray image by a small rectangle
of inverted pixels.
Positioning the sensor Sensor alignment Inverted pixels (encircled) and image
alignment
Patient's right side
Right bite wing
Patient's left side
Left bite wing
Upper jaw
Upper jaw anterior teeth
Lower jaw
Lower jaw anterior teeth
XIOS XG Supreme
XIOS XG Select
XIOS XG Supreme
XIOS XG Select
XIOS XG Supreme
XIOS XG Select
XIOS XG Supreme
XIOS XG Select
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Sirona Dental Systems GmbH 6Maintenance and inspection
Operating Instructions and Installation XIOS XG USB module and sensors 6.1Hygiene
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6
Maintenance and inspection
6.1
Hygiene
Disinfect and sterilize accessories prior to initial use and after each
patient.
6.1.1 Care, cleaning agents, and disinfectants
Approved care, cleaning, and disinfecting agents
Care, cleaning, and disinfecting agents, with REF number
For a continuously updated list of approved agents, please visit
"www.sirona.com"
. To access the online portal for technical
documentation, follow the
"SERVICE"
/
"Technical Documentation"
menu items in the navigation bar. The portal can also be accessed
directly via the following address http://www.sirona.com/manuals. Click
on the menu item
"General documents"
and then open the
"Care,
cleaning and disinfection agents"
document.
If you do not have any access to the Internet, please contact your dental
depot to order the list (REF 59 70 905).
NOTICE
Approved care, cleaning, and disinfecting agents
Use only care, cleaning and disinfecting agents approved by Sirona!
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6.1Hygiene Operating Instructions and Installation XIOS XG USB module and sensors
6.1.2 USB module and sensors
Surfaces, medication
✔ All plug connections are disconnected.
1. Clean the sensor, the sensor cable and the USB module with a cloth
soaked in soapy water. After this, dry the components with a lint-free
cloth.
2. The sensor and the sensor cable must be wiped clean with
disinfectant completely and thoroughly at least twice. Then wipe the
USB module clean with disinfectant.
3. Remove any chemical residues by wiping the components clean with
a sterile cloth. The surfaces should then be dry.
4. Store the sensor and the USB module in a clean place for the next
treatment.
134°C 273,2°F
93°C 197°F
NOTICE
Liquids can get into the USB module or the sensor during cleaning and
disinfection. The plug contacts may become wet.
The USB module, sensor and PC can be damaged or destroyed by a
short circuit.
➢ Before cleaning and disinfection, remove the USB plug on the PC or
USB hub. The system must be disconnected from the mains. Also
remove the sensor plug from the USB module.
➢ The USB module and the sensor must not be thermal disinfected,
sterilized or immersed in disinfectant. They must not be disinfected
or sterilized with radiation. Apply wipe disinfectant only.
➢ Never spray plug connections with disinfectants or cleaning
solutions. Make sure that the plug contacts do not become wet.
NOTICE
Drugs have a chemical reaction with the surface of the unit.
Due to their high concentrations and the substances they contain, many
drugs can dissolve, etch, bleach, or stain surfaces.
➢ Wipe any drug residues off the unit immediately with a moist, white
cloth!
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Sirona Dental Systems GmbH 6Maintenance and inspection
Operating Instructions and Installation XIOS XG USB module and sensors 6.1Hygiene
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6.1.3 Sensor holders
The rods and rings of the XIOS XG single-use sensor holder system and
all parts of the reusable sensor holder system can be sterilized.
The rods and rings or sensor holder and rings must be sterilized before
initial use and once a treatment has ended. All parts must be cleaned
before each sterilization.
1. Separate the rods and rings or the sensor holder and rings.
2. Remove any residues with hot soapy water or mild dishwashing
liquid.
3. Put the components, metal parts separated from plastic parts, into
individual sterilization pouches.
4. Put the sterilization pouches into the middle tray of the steam
sterilizer, ensuring sufficient distance to the walls of the steam
sterilizer and the heating element.
5. Sterilize in a steam sterilizer at 134°C (273.2°F) for at least 3 min.
holding time and 2.1 bar (30.5 psi) overpressure.
NOTICE
The plastic parts of the sensor holder must not be exposed to high
sterilization temperatures.
The plastics may melt, warp or become brittle as a result of improper
sterilization.
➢ Sterilize metallic and plastic parts in separate sterilization pouches.
➢ Ensure that the temperature in the steam sterilizer does not exceed
134°C (273°F) during the sterilization process. Operate the steam
sterilizer according to the manufacturer's instructions.
➢ Do not use phenol-based glutaraldehyde, ultrasonic cleaners,
chemiclaves or hot-air sterilizers for sterilization. Do not use cold
sterilization.
IMPORTANT
Plastic parts have a limited lifetime. This is reduced with each
sterilization cycle. As a result replace the plastic parts of the sensor
holder on a regular basis.
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6.2Regular inspections Operating Instructions and Installation XIOS XG USB module and sensors
6.2
Regular inspections
Inspections must be performed at scheduled intervals to protect the
health and safety of patients, users and other persons.
Before and during operation
The system owner or an appointed person must ensure that:
● there are no changes to the additional second protective ground
conductor connection of the PC
● the PC used is outside the patient environment (up to 1.5 m around
the patient) if it is installed without a second protective ground
conductor
● the USB hub is outside the patient environment if the USB module is
not connected directly to the PC
● all components, such as cables, sensors and housing parts, are in
sound condition
Monthly
Once a month the system owner or an appointed person must:
● check the sensor cable thoroughly for wear and tear
● make sure the connector housing is fastened securely at the sensor
cable
Annually
The image quality must be assessed by the system owner or an
appointed person at regular intervals, at least once a year.
On digital sensors, the degree of postprocessing (brightness or contrast
adjustment) that is required in the image processing software (e.g.
SIDEXIS XG / SIDEXIS 4) to produce satisfactory results is used as an
assessment criterion.
If these assessment criteria are regarded as given irrespective of the
patient’s anatomy and/or possible sources of error such as patient
positioning, a service engineer should be called in immediately to rectify
any possible system faults.
Observe any possible additional country-specific requirements.
Please also check that all labels on the underside of the USB module are
undamaged and legible.
CAUTION
Should you identify faulty components on your XIOS XG product, please
inform your appointed service engineer. In this case, the device should
no longer be used for patient exposures.
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Sirona Dental Systems GmbH 6Maintenance and inspection
Operating Instructions and Installation XIOS XG USB module and sensors 6.2Regular inspections
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CAUTION
The USB module must not be opened or repaired by the user.
All parts of the device are maintenance-free. In case of malfunctioning,
please always contact your specialized dealer.
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6.3Replace the sensor cable Operating Instructions and Installation XIOS XG USB module and sensors
6.3
Replace the sensor cable
The sensor cable can be replaced with a new one in the event of damage.
A "sensor cable" replacement set is required for this, see Consumables
and spare parts"Consumables and spare parts". This contains the
required spare parts and tool:
● Sensor cable
● Screwdriver
● 2 protective screw caps
● 2 Elastomer strips
● 4 flathead screws
NOTICE
The electric plug contacts of the sensor are exposed during installation.
The sensor may be destroyed by the electrostatic discharge at the
contacts.
➢ Before installation discharge at a conductive grounded item, e.g., a
water faucet or a bare heating pipe.
NOTICE
No dirt or moisture must be allowed to get into the exposed plug
contacts.
Dirt causes contacts faults, moisture may lead to a short circuit.
➢ Wash and dry your hands. Do not wear powdered gloves. The
powder could become deposited in the plug contacts of the sensor.
➢ Place the sensor on a clean, dry and stable surface.
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Sirona Dental Systems GmbH 6Maintenance and inspection
Operating Instructions and Installation XIOS XG USB module and sensors 6.3Replace the sensor cable
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Unscrew a damaged cable from the sensor
1. Disconnect the sensor from the XIOS XG system.
2. With e.g. a dental instrument remove the protective screw cap from
the rear side of the sensor.
3. Using the screwdriver supplied with the set remove the 2 screws
which fasten the cable to the sensor.
Replace the Elastomer strip
1. Remove the existing Elastomer strip from the sensor with tweezers.
2. Insert a new Elastomer strip in the slot. Check that it is positioned
correctly by pressing lightly with the finger.
The Elastomer strip must be placed exactly in the slot so that the
sensor works.
IMPORTANT
Use the new parts supplied with the cable for the assembly!
IMPORTANT
The spare parts for XIOS XG Select sensors are blue while those of the
XIOS XG Supreme sensors are red. Always replace the existing
Elastomer strip with one of the same color.
The Elastomer strip must be placed exactly in the slot so that the sensor
works.
XIOS XG Supreme
XIOS XG Select
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6.3Replace the sensor cable Operating Instructions and Installation XIOS XG USB module and sensors
Attach a replacement cable
1. Place the plug for the sensor cable properly on the sensor. Both parts
must interlock.
2. Screw the sensor cable to the sensor using the screws supplied.
Initially only tighten the screws until a light resistance can be felt. After
this tighten both screws carefully.
3. Cover the screw heads with a new protective screw cap. Press the
cap into the plug of the sensor cable until it locks in place.
The cable replacement is now completed. The sensor can be used
again.
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Sirona Dental Systems GmbH 7Consumables and spare parts
Operating Instructions and Installation XIOS XG USB module and sensors
bеЦдблЬ
7
Consumables and spare parts
Hygienic protective sleeves for sensors
Hygienic protective sleeves for sensor size 0 and 1, quantity 300
REF 64 09 960
Hygienic protective sleeve for sensor size 2, quantity 300
REF 64 09 952
Sensor holder tabs for single-use sensor holder system
Blue sensor holder tab for front tooth exposure (anterior), quantity 100
REF 61 76 510
Yellow sensor holder tab for side tooth exposures (posterior), quantity
100
REF 61 76 528
Red sensor holder tab for bite wing exposures, quantity 100
REF 61 76 536
Green sensor holder tab for endodontic exposures using half-angle
technique, quantity 100
REF 61 76 544
Gray sensor holder tab for endodontics (measurement exposure),
quantity 50
REF 61 76 551
Starter kits for single-use sensor holder system
Starter kits include the localizer ring and the guide rod along with 15
sensor holder tabs each for the blue, yellow, red, green and gray sensor
holder. The kit also includes 50 hygienic protective sleeves for one sensor
size.
Sensor holder starter kit for sensor size 0 and 1
REF 64 11 289
Sensor holder starter kit for sensor size 2
REF 64 11 297
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Operating Instructions and Installation XIOS XG USB module and sensors
Aimright spare parts
Aimright reusable sensor holder system
Localizer ring (red), quantity 1
REF 65 45 599
Sensor holder for bite wing exposures (red), for sensor size 1, quantity 2
REF 65 45 557
Sensor holder for bite wing exposures (red), for sensor size 2, quantity 2
REF 65 45 565
Sensor holder for anterior tooth exposures (blue), for sensor size 1,
quantity 2
REF 65 45 573
Sensor holder for anterior tooth exposures (blue), for sensor size 2,
quantity 2
REF 65 45 581
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Sirona Dental Systems GmbH 7Consumables and spare parts
Operating Instructions and Installation XIOS XG USB module and sensors
bеЦдблЬ
Sensor holder for posterior tooth exposures (yellow), for sensor size 1,
quantity 4
(2 for right lower jaw / left upper jaw and 2 for left lower jaw / right upper
jaw)
REF 65 45 532
Sensor holder for posterior tooth exposures (yellow), for sensor size 2,
quantity 4
(2 for right lower jaw / left upper jaw and 2 for left lower jaw / right upper
jaw)
REF 65 45 540
Starter kits for Aimright reusable sensor holder system
The starter kits are available for sensor sizes 1 and 2. Starter kits include
the following:
● 2 localizer rings
● 2 sensor holders for horizontal bite wing exposures (red)
● 2 sensor holders for posterior tooth exposures left upper jaw / right
lower jaw (yellow)
● 2 sensor holders for posterior tooth exposures right upper jaw / left
lower jaw (yellow)
● 2 sensor holders for anterior tooth exposures (blue)
● 100 hygienic protective sleeves
● 1 poster showing sensor positioning
Aimright sensor holder starter kit for sensor size 1
REF 65 45 607
Aimright sensor holder starter kit for sensor size 2
REF 65 45 615
Test phantom
Test phantom for sensor size 0, 1 and 2 for consistency test
REF 64 00 449
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7Consumables and spare parts Sirona Dental Systems GmbH
Operating Instructions and Installation XIOS XG USB module and sensors
Sensors with cable for USB port
XIOS XG Select USB size 0, 270 cm
REF 64 83 478
XIOS XG Select USB size 1, 270 cm
REF 64 83 486
XIOS XG Select USB size 2, 270 cm
REF 64 83 494
XIOS XG Supreme USB size 0, 270 cm
REF 64 83 502
XIOS XG Supreme USB size 1, 270 cm
REF 64 83 510
XIOS XG Supreme USB size 2, 270 cm
REF 64 83 528
Sensor cable for USB module
XIOS XG USB cable kit 90 cm
REF 64 04 169
XIOS XG USB cable kit 180 cm
REF 64 04 177
XIOS XG USB cable kit 270 cm
REF 64 04 185
Radiated field limitation for HELIODENT
PLUS
Radiation field limitation for sensor size 0, white
REF 64 00 142
Radiation field limitation for sensor size 1, black
REF 62 42 007
Radiation field limitation for sensor size 2, blue
REF 62 41 991
Turning handle with locking hook
REF 63 52 319
Locking hook
REF 51 67 965
USB module and USB cable
XIOS XG USB module
REF 64 04 656
USB cable A/B 2 m with ferrite
REF 64 04 235
Holders
XIOS XG wall-mounted sensor holder
REF 64 04 151
XIOS XG USB box wall fastening
REF 64 04 326
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Sirona Dental Systems GmbH 8Electromagnetic compatibility
Operating Instructions and Installation XIOS XG USB module and sensors 8.1Accessories
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8
Electromagnetic compatibility
XIOS XG complies with the requirements for electromagnetic
compatibility (EMC) according to IEC 60601-1-2.
XIOS XG is hereinafter referred to as "UNIT". Observance of the following
information is necessary to ensure safe operation regarding EMC
aspects.
8.1
Accessories
Designation of the interface cable:
USB cable A/B 2 m with ferrite, REF 64 04 235
The UNIT may only be operated with accessories and spare parts
approved by Sirona. Unapproved accessories and spare parts may lead
to an increased emission or to a reduced immunity to interference.
The UNIT should not be operated in the immediate vicinity of other
devices. If this proves to be unavoidable, the UNIT should be monitored
to check and make sure that it is used properly.
8.2
Electromagnetic emission
The UNIT is intended for operation in the electromagnetic environment
specified below.
The customer or user of the UNIT should make sure that it is used in such
an environment.
System components Manufacturer Order No. Serial No.
CDR Remote SIRONA USA Not
applicable
10171017
CDR Elite Intraoral
Sensor & Cable
Assembly
SIRONA USA Not
applicable
20000102
Emission measurement Conformity Electromagnetic environment - guidelines
RF emissions according to CISPR 11 Group 1 The UNIT uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in
nearby electronic equipment.
RF emissions according to CISPR 11 Class B The UNIT is intended for use in all facilities,
including residential areas and in any facilities
connected directly to a public power supply
providing electricity to buildings used for residential
purposes.
Harmonics
according to IEC 61000-3-2
Class A
Voltage fluctuations / flicker according
to IEC 61000-3-3
coincides
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8Electromagnetic compatibility Sirona Dental Systems GmbH
8.3Interference immunity Operating Instructions and Installation XIOS XG USB module and sensors
8.3
Interference immunity
XGPF-38231; limit valu es for magnetic fields
The UNIT is intended for operation in the electromagnetic environment
specified below.
The customer or user of the UNIT should make sure that it is used in such
an environment.
Interference immunity
tests
IEC 60601-1-2 test
level
Compliance level Electromagnetic environment -
guidelines
Electrostatic discharge
(ESD) according to
IEC 61000-4-2
± 6 KV contact
discharge
± 8 KV air discharge
± 6 KV contact
discharge
± 8 KV air discharge
Floors should be made of wood or
concrete or finished with ceramic
tiling. If the floor is covered with
synthetic material, the relative
humidity should be at least 30%.
Electrical fast transient/
burst
according to
IEC 61000-4-4
± 1kV for input and
output lines
± 2 kV for power supply
lines
± 1kV for input and
output lines
± 2 kV for power supply
lines
The quality of the line power supply
should be that of a typical
commercial or hospital environment.
Surge voltages according
to
IEC 61000-4-5
± 1 kV differential mode
voltage
± 2 kV common mode
voltage
± 1 kV differential mode
voltage
± 2 kV common mode
voltage
The quality of the line power supply
should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and
variations of the power
supply according to
IEC 61000-4-11
<5% U
T
for ½ period
(>95% dip of U
T
)
40% U
T
for 5 periods
(60% dip of U
T
)
70% U
T
for 25 periods
(30% dip of U
T
)
<5% U
T
for 5 sec.
(>95% dip of U
T
)
<5% U
T
for ½ period
(>95% dip of U
T
)
40% U
T
for 5 periods
(60% dip of U
T
)
70% U
T
for 25 periods
(30% dip of U
T
)
<5% U
T
for 5 sec.
(>95% dip of U
T
)
The quality of the line power supply
should be that of a typical
commercial or hospital environment.
If the user of the UNIT requires it to
continue functioning following
interruptions of the power supply, it is
recommended to have the UNIT
powered by an uninterruptible power
supply or a battery.
Magnetic field of power
frequencies (50/60 Hz)
according to
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
Note: U
T
is the AC supply voltage prior to application of the test level.
Portable and mobile radio equipment
must not be used within the
recommended working clearance
from the UNIT and its cables, which
is calculated based on the equation
suitable for the relevant transmission
frequency.
Recommended working clearance:
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Sirona Dental Systems GmbH 8Electromagnetic compatibility
Operating Instructions and Installation XIOS XG USB module and sensors 8.3Interference immunity
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1. The higher frequency range applies at 80 MHz and 800 MHz.
2. The field strengths of fixed transmitters, such as base stations of
radiotelephones and mobile agricultural radio broadcast services,
amateur radio stations, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. A site
survey is recommended to assess the electromagnetic environment
due to fixed RF transmitters. If the measured field strength in the
location in which the UNIT is used exceeds the applicable RF
compliance level above, the UNIT should be observed to verify
normal operation. If unusual performance characteristics are
observed, it may be necessary to take additional measures such as
reorientation or repositioning of the UNIT.
3. Over the frequency range 150kHz to 80 MHz, field strengths should
be less than 3 V/m.
Conducted RF
interference
IEC 61000-4-6
3 V
eff
150 kHz to 80 MHz
1
3 V
eff
d= [1.2] √P
Radiated RF interference
IEC 61000-4-3
3 V/m
80 MHz to 800 MHz
1
3 V/m
800 MHz to 2.5 GHz
1
3 V
eff
3 V
eff
d= [1.2] √P
at 80 MHz to 800 MHz
d= [2.3] √P
at 800 MHz to 2.5 GHz
with P as the power rating of the
transmitter in watts (W) according to
the transmitter manufacturer's
specifications and d as
recommended safety distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey
2
should
be less than the compliance level
3
in
each frequency range.
Interference is possible in the vicinity
of equipment bearing the following
graphic symbol.
Interference immunity
tests
IEC 60601-1-2 test
level
Compliance level Electromagnetic environment -
guidelines
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8Electromagnetic compatibility Sirona Dental Systems GmbH
8.4Working clearances Operating Instructions and Installation XIOS XG USB module and sensors
8.4
Working clearances
Recommended working clearances
between portable and mobile RF
communication devices and the UNIT
The UNIT is intended for operation in an electromagnetic environment,
where radiated RF interference is checked. The customer or the user of
the UNIT can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications
equipment (transmitters) and the UNIT - depending on the maximum
output power of the communication device, as shown below.
The recommended safety distance d in meters (m) can be determined for
transmitters, whose maximum power rating is not specified in the above
table, using the equation that belongs to the corresponding column,
wherein P is the maximum power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
Note 1
The higher frequency range applies at 80 MHz and 800 MHz.
Note 2
These guidelines may not apply in all cases. The propagation of
electromagnetic waves is influenced by their absorption and reflection by
buildings, objects and persons.
Power rating of the transmitter
[W]
Working clearance according to transmission frequency [m]
150 kHz - 80 MHz 80 MHz - 800 MHz 800 MHz - 2.5 GHz
d= [1.2] √P d= [1.2] √P d= [2.3] √P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
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Sirona Dental Systems GmbH 9Disposal
Operating Instructions and Installation XIOS XG USB module and sensors
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9
Disposal
In accordance with Directive 2012/19/EU and national disposal
regulations regarding old electrical and electronic devices, please be
advised that such items must be disposed of in a special way within the
European Union (EU). These regulations require environmental friendly
usage/disposal of old electrical and electronic devices. Such items must
not be disposed of as domestic refuse. This has been expressed using
the icon of the “crossed out trash can” since March 24, 2006, amongst
other methods.
Disposal procedure
We feel responsible for our products from the first idea to their disposal.
For this reason, we give you an option to return our old electronic and
electrical devices.
If you wish to dispose of your devices, please proceed as follows:
In Germany
To initiate return of the electrical device, please send a disposal request
to enretec GmbH. You have the following options here:
● Use the “Returning an electrical device” button under the “eom” menu
item on the enretec GmbH homepage (www.enretec.de).
● Alternatively, you can also contact enretec GmbH directly.
enretec GmbH
Kanalstraße 17
16727 Velten
Tel.: +49 3304 3919-500
E-Mail: eom@enretec.de
In accordance with the national disposal regulations regarding old
electrical and electronic devices (ElektroG), as the manufacturer, we
assume the costs for disposing of the electrical and electronic devices in
question. Disassembly, transport and packaging costs shall be borne by
the owner/ operator.
Prior to disassembly / disposal of the product, it must be fully prepared
(cleaned / disinfected / sterilized).
If your unit is not permanently installed, it will be collected from the
practice. If it is permanently installed, it will be picked up curbside at your
address by appointment.
Other countries
For country-specific information on disposal, contact your local dental
dealers.
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