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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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23
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
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134°C
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