MUKOMNN
uflp
mäìë
=pЙелзкл
kÉï=~ë=çÑW==
bеЦдблЬ
lйЙк~нбеЦ=fелнкмЕнбзел
Cover page
61 97 102 D3495
2 D3495.201.03.07.02 08.2011
Sirona Dental Systems GmbH
Operating Instructions XIOS
Plus
Sensors
Table of contents
1
Dear Customer, ........................................................................................................ 4
1.1 Contents of this document ............................................................................ 4
1.2 General conventions ..................................................................................... 4
1.3 Structure of the document ............................................................................. 4
1.3.1 Identification of danger levels............................................................. 4
1.3.2 Formats and symbols used................................................................ 5
1.4 Other valid documents .................................................................................. 5
2
Warning and safety information................................................................................ 6
2.1 ESD protective measures ............................................................................. 9
2.2 About the physics of electrostatic charges.................................................... 10
3
Technical description................................................................................................ 12
3.1 General data ................................................................................................. 12
3.2 Sensors ......................................................................................................... 12
3.3 Ambient conditions........................................................................................ 12
3.4 Requirements for intraoral X-ray tube assemblies ........................................ 13
4
Accessories and spare parts .................................................................................... 14
4.1 Accessories................................................................................................... 14
5
Use of the X-ray Sensor ........................................................................................... 17
5.1 Preparation.................................................................................................... 17
5.2 Hygienic protection........................................................................................ 18
5.2.1 General information............................................................................ 18
5.2.2 Sliding the hygienic protective sleeve over the sensor ...................... 19
5.2.3 Removing the hygienic protective sleeve from the sensor................. 19
5.3 Parallel technique with radiation limiter!........................................................ 21
5.3.1 Anterior tooth exposure ...................................................................... 21
5.3.2 Posterior tooth exposures .................................................................. 22
5.3.3 Bite wing exposures ........................................................................... 23
5.3.4 Endodontics ....................................................................................... 24
5.4 Half-angle technique without radiation limiter ............................................... 25
5.4.1 Endodontic Exposures ....................................................................... 25
61 97 102 D3495
D3495.201.03.07.02 08.2011
3
Sirona Dental Systems GmbH
Operating Instructions XIOS
Plus
Sensors
bеЦдблЬ
6
Exposure times........................................................................................................ 27
6.1 HELIODENT DS........................................................................................... 28
6.1.1 HELIODENT DS Serial Nos. 15864 and higher (wall model) and
4416 and higher (ceiling model)
28
6.1.2 HELIODENT DS up to Serial No. 15863 (wall model) and 4415
(ceiling model)
30
7
Care of outer surface............................................................................................... 32
7.1 Care and cleaning agents ............................................................................ 32
7.2 Disinfecting................................................................................................... 32
7.3 Sterilizing ...................................................................................................... 33
8
Configuration ........................................................................................................... 36
61 97 102 D3495
4 D3495.201.03.07.02 08.2011
1 Dear Customer, Sirona Dental Systems GmbH
1.1 Contents of this document Operating Instructions XIOS
Plus
Sensors
1
Dear Customer,
Dear Customer,
XIOS Plus Sensors
Thank you for purchasing the XIOS
Plus
X-ray sensor.
In combination with a XIOS
Plus
wall module or a XIOS
Plus
USB module,
the XIOS
Plus
X-ray sensor facilitates the digital acquisition of intraoral X-
ray images.
General
Your XIOS Team
1.1
Contents of this document
Contents of this document
Table of contents This operator manual describes the handling of the sensor.
1.2
General conventions
General conventions
General conventions You should familiarize yourself with the unit by reading through the
operating instructions before taking patient exposures. Please always
observe the valid radiation protection directives and the safety
information in these instructions.
These operating instructions are based on the assumption that you are
familiar with the SIDEXIS XG software.
In case you get stuck despite having thoroughly studied the operating
instructions, please contact your dental depot.
To prevent any personal injury or material damage, pay special attention
to any notes printed in bold type or highlighted with signal words such as
NOTICE, CAUTION or WARNING:
1.3
Structure of the document
Structure of the document
1.3.1 Identification of danger levels
Identification of danger level s
To prevent personal injury and material damage, please observe the
warning and safety information provided in this document. Such
information is highlighted as follows:
DANGER
An imminent danger that could result in serious bodily injury or death.
WARNING
A possibly dangerous situation that could result in serious bodily injury
or death.
CAUTION
A possibly dangerous situation that could result in slight bodily injury.
NOTICE
A possibly harmful situation which could lead to damage of the product
or an object in its environment.
61 97 102 D3495
D3495.201.03.07.02 08.2011
5
Sirona Dental Systems GmbH 1 Dear Customer,
Operating Instructions XIOS
Plus
Sensors 1.4 Other valid documents
bеЦдблЬ
Tip: Information on making work easier.
1.3.2 Formats and symbols used
Formats a nd sy mbol s used
The symbols and character formats used in this manual have the
following meaning:
1.4
Other valid documents
Other valid documents
Documents for XIOS Plus Sensors
For the operation of XIOS
Plus
sensors the following documents are
required:
● Operating instructions:
XIOS
Plus
wall module
or
XIOS
Plus
USB module
● SIDEXIS XG Installation Instructions (included in delivery SIDEXIS
XG)
● SIDEXIS XG Operator's Manual (for working with SIDEXIS XG
software, included in delivery SIDEXIS XG).
X-ray system book
Keep these documents handy at all times (file them in the X-ray System
Logbook in 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.
IMPORTANT
Application instructions and other important information.
✔ Prerequisite
1. First action step
2. Second action step
or
➢ Alternative action
ª Result
Requests you to do something.
See "Formats and symbols
used [ → 5]“
Identifies a reference to another
text passage and specifies its page
number.
●List Identifies a list item.
"Command/menu item" Identifies commands, menu items
or quotations.
61 97 102 D3495
6 D3495.201.03.07.02 08.2011
2 Warning and safety information Sirona Dental Systems GmbH
Operating Instructions XIOS
Plus
Sensors
2
Warning and safety information
Warning and safety information
Symbols used Symbols used
Observe accompanying documents (on rating plate)
Intended use Intraoral
Intended use This product has been designed for the digital acquisition of intraoral X-
ray images.
This product must not be used in areas subject to explosion hazards.
Indications in the areas:
Intraoral indication
● Conservative dentistry
● Caries diagnosis, especially of proximal lesions
● Endodontics
● Periodontology
● Prosthodontics
● Functional diagnosis and therapy of craniomandibular dysfunctions
● Surgical dentistry
● Implantology
● Oral and maxillofacial surgery
● Orthodontics
Contraindications:
Intraoral contraindication
● Display of cartilage structures
● Display of soft tissue
Restriction of customers (USA)
USA only: Caution! According to US Federal Law, this product may be sold only to or by
instruction of physicians, dentists, or licensed professionals.
Maintenance and service recommendations
Maintenance and service
recommendations
Inspection and maintenance must be performed at scheduled intervals to
ensure the operational and functional reliability of your product and to
protect the safety and health of patients, users and other persons. In
accordance with IEC 60601-1.
The system owner must ensure that all inspections and maintenance
events take place.
If the system owner fails to fulfill the obligation to have inspections and
maintenance work performed or ignores error messages, Sirona Dental
Systems GmbH and its authorized dealers cannot assume any liability for
resulting damage.
As manufacturers of medical electrical equipment, we can assume
responsibility for the safety properties of the system only if maintenance
and repair work on the system is performed by ourselves or by agencies
expressly authorized by us, and if components affecting safe operation of
the system are replaced by original spare parts in case of failure.
61 97 102 D3495
D3495.201.03.07.02 08.2011
7
Sirona Dental Systems GmbH 2 Warning and safety information
Operating Instructions XIOS
Plus
Sensors
bеЦдблЬ
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.
Modifications to the unit
Modifications to the unit 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 assumes the risk of using non-approved accessories.
CAUTION! PC extensions can lead to impairment of the system's
functional reliability (e.g. patient safety and electromagnetic
compatibility). The guarantee of the system's functional reliability will
automatically be transferred to anyone who implements a system
extension which has not been expressly approved by Sirona.
Changes to unit / X-raying of patients - XIOS Plus Sens or Operating Instructions
Use the XIOS
Plus
sensor only as described in these Operating
Instructions.
Combination with other equipment
Combination with other equipment Permissible combinations are specified in the Declaration of Conformity
by the system integrator.
61 97 102 D3495
8 D3495.201.03.07.02 08.2011
2 Warning and safety information Sirona Dental Systems GmbH
Operating Instructions XIOS
Plus
Sensors
Patient environment
Patient environment
Within the patient environment (A), direct contact is only permissible with
devices or system parts that are approved for use in the patient
environment (A).
This applies to all possible patient positions (B) during the examination or
treatment.
X-raying of patients
X-raying of patients X-rays of patients must be taken only when the system works without
errors.
The system may only be operated by skilled or properly trained
personnel.
Do not leave the patient at the unit unattended.
Changes to unit / X-raying of patients - XIOS Plus Sensor Operating Instructions
Use the XIOS
Plus
sensor only as described in these Operating
Instructions.
1500mm
59”
1500mm
59”
1500mm
59”
1500mm
59”
1500mm
59”
1500mm
59”
1500mm
59”
1500mm
59”
1500mm
59”
1500mm
59”
1500mm
59”
61 97 102 D3495
D3495.201.03.07.02 08.2011
9
Sirona Dental Systems GmbH 2 Warning and safety information
Operating Instructions XIOS
Plus
Sensors 2.1 ESD protective measures
bеЦдблЬ
Electromagnetic compatibility (EMC) of the XIOS Plus Sensor
Electromagnetic compatibility (EMC)
The XIOS
Plus
sensor complies with the requirements of IEC 60601-1-2.
Medical electrical devices are subject to special precautionary measures
regarding EMC. It must be installed and operated as specified in the
document “Installation Requirements”.
Portable and mobile RF communications equipment may interfere with
medical electrical equipment. Therefore, the use of mobile wireless
phones in medical office or hospital environments must be prohibited.
Allocation of acquisition system to patient
Allocation of acquisition system to
patient
Within the scope of practice operations, unambiguous allocation of the
acquisition system to the examinee must be ensured to guarantee
reliable allocation of X-ray exposures to the patient data saved by
SIDEXIS!
XIOS Plus hygiene inf ormation
Hygiene information
The XIOS
Plus
protective sleeves and the XIOS
Plus
sensor holder tabs are
single use devices and must be renewed for each patient. The sterilizable
exposure accessories should be resterilized for each new patient to
prevent any possible transmission of infective agents which might under
certain circumstances cause serious illnesses.
Suitable hygienic measures must be taken to prevent cross
contamination between patients, users and other persons.
The sensors and the cable must be wiped disinfected before each patient!
Disturbance of electronic devices worn on th e patient's body
Disturbance of electronic devices worn
on the patient's body
To prevent the malfunctioning of electronic devices and data memories,
e.g. radio-controlled watches, telephone cards etc., these objects must
be removed prior to the X-ray exposure.
Environmentally sound disposal
Your product is marked with the adjacent symbol. Within the European
Economic Area, this product is subject to Directive 2002/96/EC as well as
the corresponding national laws. This directive requires environmentally
sound recycling/disposal of the product. The product must not be
disposed of as domestic refuse!
Please observe the disposal regulations applicable in your country.
2.1
ESD protective measures
ESD protective measures
ESD ESD stands for ElectroStatic Discharge.
ESD protective measures ESD protective measures include:
● Procedures for preventing electrostatic charge build-up (e.g. air
conditioning, air moistening, conductive floor coverings and nonsynthetic clothing)
● Discharging the electrostatic charges of your own body on the frame
of the UNIT, the protective ground wire or large metallic objects
● Connecting yourself to ground using a wrist band.
Training We therefore recommend that all persons working with this system be
instructed on the significance of this warning label. Furthermore, they also
should receive training in the physics of electrostatic discharges which
can occur in the practice and the destruction of electronic components
which may result if such components are touched by electrostatically
charged USERS.
61 97 102 D3495
10 D3495.201.03.07.02 08.2011
2 Warning and safety information Sirona Dental Systems GmbH
2.2 About the physics of electrostatic charges Operating Instructions XIOS
Plus
Sensors
The content of this training is explained in the Chapter "About the physics
of electrostatic charges" [ → 10].
2.2
About the physics of electrostatic charges
About the physics of electrostatic charges
What is an electrostatic charge? An electrostatic charge is a voltage field on and in an object (e.g. a human
body) which is protected against conductance to ground potential by a
nonconductive layer (e.g. a shoe sole).
Formation of an electrostatic charge
Electrostatic charges generally build up whenever two bodies are rubbed
against each other, e.g. when walking (shoe soles against the floor) or
driving a vehicle (tires against the street pavement).
Amount of charge The amount of charge depends on several factors:
Thus the charge is higher in an environment with low air humidity than in
one with high air humidity; it is also higher with synthetic materials than
with natural materials (clothing, floor coverings).
The following rule of thumb can be applied to assess the transient
voltages resulting from an electrostatic discharge.
An electrostatic discharge is:
● perceptible at 3,000 V or higher
● audible at 5,000 V or higher (cracking, crackling)
● visible at 10,000 V or higher (arc-over)
The transient currents resulting from these discharges have a magnitude
of 10 amperes. They are not hazardous for humans because they last for
only several nanoseconds.
Background Integrated circuits (logical circuits and microprocessors) are used to
implement a wide variety of functions in dental/X-ray/CAD/CAM systems.
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.
It is obvious that integrated circuits which are connected to plugs leading
outside of the unit via cables are sensitive to electrostatic discharge.
Even voltages which are imperceptible to the user can cause breakdown
of the structures, thus leading to a discharge current which melts the chip
in the affected areas. Damage to individual integrated circuits may cause
malfunction or failure of the system.
NOTICE
Electrostatic discharge must be preceded by electrostatic charging.
61 97 102 D3495
D3495.201.03.07.02 08.2011
11
Sirona Dental Systems GmbH 2 Warning and safety information
Operating Instructions XIOS
Plus
Sensors 2.2 About the physics of electrostatic charges
bеЦдблЬ
To prevent this from happening, the ESD warning label next to the plug
warns of this hazard. ESD stands for ElectroStatic Discharge.
61 97 102 D3495
12 D3495.201.03.07.02 08.2011
3 Technical description Sirona Dental Systems GmbH
3.1 General data Operating Instructions XIOS
Plus
Sensors
3
Technical description
Technical descript ion
3.1
General data
General data
XIOS Plus sensors
The XIOS
Plus
sensors, type D3495, were tested in combination with the
XIOS
Plus
wall module or the XIOS
Plus
USB module in accordance with
IEC 60 601–1.
They comply with the requirements of these regulations.
3.2
Sensors
Sensors
NEW
3.3
Ambient conditions
Ambient conditions
Original language of the
present document:
German
Patents US 5,912,942
US 5,434,418
US 6,811,312
US 6,069,935
US 6,134,298
US 5,841,126;
US 6,549,235;
US 6,570,617
US 5,513,252
Additional patents pending.
Technology: CMOS-APS (Active Pixel Sensor)
Physical pixel size: 15 µm
Active surface: Size 1 - sensor = 20 x 30 mm
Size 2 - sensor = 25.6 x 36 mm
The active surface of the sensor is identified
by dots and labeling.
External dimensions: Size 1 - sensor = 24,8 x 38,5 x 6.7 mm
Size 2 - sensor = 31.3 x 44.5 x 6.7 mm
Cable length: 2,85 m
Degree of protection
against electrical shock:
Type BF
Ambient temperature: 10° (50°F) – 40°C (104°F)
Storage temperature: -40°C (-40°F) – 70°C (158°F)
Relative humidity
(storage and transport)
10% – 95%
Loading...