Sirona XIOS Plus User manual

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Sirona Dental Systems GmbH
Operating Instructions XIOSPlus Sensors
Table of contents
1Dear 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
2Warning and safety information................................................................................ 6
2.1 ESD protective measures ............................................................................. 9
2.2 About the physics of electrostatic charges.................................................... 10
3Technical 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
4Accessories and spare parts .................................................................................... 14
4.1 Accessories................................................................................................... 14
5Use 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

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Sirona Dental Systems GmbH
Operating Instructions XIOSPlus Sensors
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6Exposure 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
7Care of outer surface............................................................................................... 32
7.1 Care and cleaning agents ............................................................................ 32
7.2 Disinfecting................................................................................................... 32
7.3 Sterilizing...................................................................................................... 33
8Configuration ........................................................................................................... 36

61 97 102 D3495
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1 Dear Customer, Sirona Dental Systems GmbH
1.1 Contents of this document Operating Instructions XIOSPlus Sensors
1Dear Customer,
Dear Cus tomer,
XIOS Plus Sensors
Thank you for purchasing the XIOSPlus X-ray sensor.
In combination with a XIOSPlus wall module or a XIOSPlus USB module,
the XIOSPlus X-ray sensor facilitates the digital acquisition of intraoral X-
ray images.
General
Your XIOS Team
1.1 Contents of this document
Content s of this docum ent
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
Structur e of the docum ent
1.3.1 Identification of danger levels
Identificat ion of danger levels
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.

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Sirona Dental Systems GmbH 1Dear Customer,
Operating Instructions XIOSPlus Sensors 1.4 Other valid documents
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Tip: Information on making work easier.
1.3.2 Formats and symbols used
For mats a nd sy mbols used
The symbols and character formats used in this manual have the
following meaning:
1.4 Other valid documents
Other valid doc uments
Documents for XIOS Plus Sensors
For the operation of XIOSPlus sensors the following documents are
required:
● Operating instructions:
XIOSPlus wall module
or
XIOSPlus 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 syst em 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
ªResult
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.

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2 Warning and safety information Sirona Dental Systems GmbH
Operating Instructions XIOSPlus Sensors
2Warning and safety information
Warning and safety informatio n
Symbols used Symbols used
Observe accompanying documents (on rating plate)
Intended us e 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 i ndication
● 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
Restricti on of custom ers (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.

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Sirona Dental Systems GmbH 2Warning and safety information
Operating Instructions XIOSPlus Sensors
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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.
Modification s 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 t o unit / X-rayi ng of patients - X IOS Plus S ensor Operati ng Instructions
Use the XIOSPlus sensor only as described in these Operating
Instructions.
Combination w ith other equipme nt
Combination with other equipment Permissible combinations are specified in the Declaration of Conformity
by the system integrator.

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2 Warning and safety information Sirona Dental Systems GmbH
Operating Instructions XIOSPlus Sensors
Patient env ironment
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 pat ients
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.
Chang es to unit / X- raying of pati ents - XIOS Pl us Senso r Operating Ins tructions
Use the XIOSPlus 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”

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Sirona Dental Systems GmbH 2Warning and safety information
Operating Instructions XIOSPlus Sensors 2.1 ESD protective measures
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Electromagnetic compatibility (EMC) of the XIOS Plus Sensor
Electromagnetic compatibility (EMC) The XIOSPlus 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 acqui sition 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 hygi ene information
Hygiene information The XIOSPlus protective sleeves and the XIOSPlus 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 dev ices worn on the patien t'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.
Environmen tally sound dispos al
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 prote ctive 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 non-
synthetic 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.

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2 Warning and safety information Sirona Dental Systems GmbH
2.2 About the physics of electrostatic charges Operating Instructions XIOSPlus 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.

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Sirona Dental Systems GmbH 2Warning and safety information
Operating Instructions XIOSPlus Sensors 2.2 About the physics of electrostatic charges
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To prevent this from happening, the ESD warning label next to the plug
warns of this hazard. ESD stands for ElectroStatic Discharge.

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3 Technical description Sirona Dental Systems GmbH
3.1 General data Operating Instructions XIOSPlus Sensors
3Technical description
Techn ical desc ription
3.1 General data
General data
XIOS Plus sensors
The XIOSPlus sensors, type D3495, were tested in combination with the
XIOSPlus wall module or the XIOSPlus 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%

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Sirona Dental Systems GmbH 3Technical description
Operating Instructions XIOSPlus Sensors 3.4 Requirements for intraoral X-ray tube assemblies
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3.4 Requirements for intraoral X-ray tube assemblies
Requirement s for intraora l X-ray tube a ssemblies
Relative humidity in
operation
10% – 75%
Air pressure (storage
and transport)
500 – 1060 hPa
Air pressure (operation) 700 – 1060 hPa
Operating altitude: ≤ 3000 m
Multipulse units (DC),
mAs product:
0.14 – 1.4 mAs, at 60 – 70 kV and 8" cone
This information must be modified
accordingly for single-pulse units or other
cone lengths.
NOTICE
The intraoral X-ray tube assembly must be installed in accordance with
the manufacturer's instructions and requirements. Please refer to the
manuals supplied with your intraoral X-ray unit for more information.
NOTICE
For optimal image quality we recommend using a multipulse unit as well
as a 12" cone.

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4 Accessories and spare parts Sirona Dental Systems GmbH
4.1 Accessories Operating Instructions XIOSPlus Sensors
4Accessories and spare parts
Accessor ies and spar e parts
General
Sensors
Identification of single use devices
Single use devices are identified with the symbol shown at left.
4.1 Accessories
Acces sories
XIOS Plus sensor holder starter kit, size 2
Order No.: 61 73 624
Contents:
● 15x sensor holder tab, anterior (blue), including localizer ring and
guide rod
● 15x sensor holder tab, posterior (yellow), including localizer ring and
guide rod
● 15x sensor holder tab, bite wing (red), including localizer ring and
guide rod
● 15x sensor holder tab, endo (gray), including localizer ring and guide
rod
● 15x sensor holder tab, universal (green)
● 50x hygienic protective sleeves, size 2
XIOS Plus sensor holder starter kit, size 1
Order No.: 61 73 632
Contents:
● 15x sensor holder tab, anterior (blue), including localizer ring and
guide rod
● 15x sensor holder tab, posterior (yellow), including localizer ring and
guide rod
● 15x sensor holder tab, bite wing (red), including localizer ring and
guide rod
NOTICE
Not all of the accessories listed here are included in the scope of supply.
NOTICE
Sensor holder tabs and hygienic protective sleeves are single use
devices!
They can, however, be used repeatedly on the same patient. The
adhesive on the sensor holder tabs is suitable for gluing and detaching
them from the protective sleeve repeatedly.

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Sirona Dental Systems GmbH 4Accessories and spare parts
Operating Instructions XIOSPlus Sensors 4.1 Accessories
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● 15x sensor holder tab, endo (gray), including localizer ring and guide
rod
● 15x sensor holder tab, universal (green)
● 50x hygienic protective sleeves, size 1
XIOSPlus Hygienic protective sleeves, size 1 (single use device, 300
pcs)
● Size 1: Order No.: 61 48 998
● Size 2: Order No.: 61 49 004
Wall holder for XIOS X-ray sensors
Order No.: 61 74 879
Phantom XIOSPlus sensor sizes 1 and 2 for constancy test (only for
Germany)
Order No.: 62 09 634
XIOS sensor holder tab, anterior, blue (single use device, 100 pcs)
Order No.: 61 76 510
XIOS sensor holder tab, posterior, yellow (single use device, 100 pcs)
Order No.: 61 76 528
XIOS sensor holder tab, bite wing, red (single use device, 100 pcs)
Order No.: 61 76 536

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4 Accessories and spare parts Sirona Dental Systems GmbH
4.1 Accessories Operating Instructions XIOSPlus Sensors
XIOS sensor holder tab, endo, gray (single use device, 50 pcs)
Order No.: 61 76 551
XIOS sensor holder tab, universal, green (single use device, 100 pcs)
Order No.: 61 76 544
Radiation field limiter 3x4 for HELIODENT DS, replacement
Order No.: 46 81 974
Radiation field limiter 2x3 for HELIODENT DS, replacement
Order No.: 60 00 579

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Sirona Dental Systems GmbH 5Use of the X-ray Sensor
Operating Instructions XIOSPlus Sensors General information
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5Use of the X-ray Sensor
Use of the X- ray Sensor
General information
General in formation
Placement
The X-ray sensor should be placed according to the well-known parallel
or half-angle technique.
Risk of damage to sens or
XIOS Plus s ensor operational re liability
5.1 Preparation
Preparatio n
Checklist
CAUTION
Illustrations without hygienic sleeves
For the sake of clarity, no hygienic sleeves are shown in some of the
illustrations. However, a hygienic sleeve always must be slipped over
the sensor before using it on a patient.
NOTICE
Risk of damage
- Handle the sensor carefully.
- Do not drop the sensor!
- Do not swirl the sensor about by its cable.
- Do not bend the sensor cables or run over them (e.g. with a chair)!
- Avoid laying sensor cables on the floor if possible.
- Make sure that the patient does not bite on the sensor or the sensor
cable.
NOTICE
Operational reliability
- The sensor must be checked to ensure that it is plugged in correctly
before releasing an exposure!
- The user must check exposure readiness prior to radiation release.
See Operating Instructions for the XIOSPlus wall module or the XIOSPlus
USB module.
- Never place two sensors in the beam path at the same time!
NOTICE
Check the sensor cable and sensor for damage, e.g. cracks or splinters,
prior to each exposure. In case of visible damage to the sensor, please
contact your dealer.

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5 Use of the X-ray Sensor Sirona Dental Systems GmbH
5.2 Hygienic protection Operating Instructions XIOSPlus Sensors
● No other programs should be running on the PC during an exposure.
5.2 Hygienic protection
Hygienic protection
5.2.1 General information
General information
Hygienic protection
Please use Sirona hygienic protective sleeves for hygienic protection.
● Prior to each application on a new patient, the sensor must be
covered with a new hygienic protective sleeve.
● Do not bend the sensor cable when slipping the hygienic protective
sleeve over it!
● Please use the hygienic protective sleeve which correctly matches
the sensor.
Hygienic protective sleeves
●XIOS
Plus hygienic protective sleeve for sensor size 1
300 pcs, Order-No: 62 01 839
●XIOS
Plus hygienic protective sleeve for sensor size 2
300 pcs, Order-No: 62 01 847
Sensor
NOTICE
Check all adhesive labels at regular intervals, and at least once a month,
to make sure that they are intact, legible and properly affixed.
Also check the acquisition unit (i.e. XIOSPlus USB module or XIOSPlus
wall module) and the cables connected to it for damage.
In case of visible damage to the acquisition unit, cables or adhesive
labels, please contact your dealer.
CAUTION
Use only the XIOSPlus hygienic protective sleeves offered by Sirona,
especially in connection with the XIOSPlus sensor holders.
CAUTION
Hygienic protective sleeves and sensor holder tabs are single use
devices. Do not use hygienic protective sleeves more than once!
NOTICE
Make sure that the cable connecting the sensor is run out of the patient's
mouth in such a way that the patient cannot bite it.

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Sirona Dental Systems GmbH 5Use of the X-ray Sensor
Operating Instructions XIOSPlus Sensors 5.2 Hygienic protection
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5.2.2 Sliding the hygienic protective sleeve over the sensor
Sliding the hy gienic protective sleev e over the senso r
Handling
1. Please select a hygienic protective sleeve with a size that matches
the sensor.
2. Slide the sensor into the hygienic protective sleeve.
3. Position the sensor holder tab on the hygienic protective sleeve.
Handling information for the parallel technique
If the supplied XIOS sensor holder tab set is used, the hygienic protection
sleeve must be placed between the sensor and the holder. The sensor
holder tab must not be glued onto the unprotected sensor.
5.2.3 Removing the hygienic protective sleeve from the sensor
Removing the hygienic pr otective sleeve from the sensor
NOTICE
Size of the hygienic protective sleeve
The hygienic protective sleeve is slightly undersized, so that it surrounds
the sensor tightly and prevents the sensor from slipping out of place.
NOTICE
The exact position depends on the sensor holder tab used and the X-ray
exposure area. The following sections contain specific information on
how to position different sensor holder tabs.
NOTICE
Never slide the hygienic protective sleeve over the sensor with glued on
sensor holder!
NOTICE
Leave the sensor holder tab attached to the sensor and slide the sensor
out of the hygienic protective sleeve using your thumb.
NOTICE
Please do not pull on the sensor cable while pushing the sensor out of
the hygienic protective sleeve!
NOTICE
Always handle the cable with care when removing the hygienic
protective sleeve.

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5 Use of the X-ray Sensor Sirona Dental Systems GmbH
5.2 Hygienic protection Operating Instructions XIOSPlus Sensors
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.
3. Slide the sensor further out of the hygienic protective sleeve with your
thumb.