Sirona Orthophos XG 5, Orthophos XG 5 DS Operating Instructions Manual
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Operating Instructions
This product is covered by one or
more of the following US patents:
• US8,152,373
• US6351519
• US6570953
• US6926442
• US7322746
• US6731717
• US6891921
• D502543
• D497994
• D503804
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Sirona Dental Systems GmbH Table of contents
Operating Instructions ORTHOPHOS XG 5 / Ceph
Table of contents
1
General data............................................................................................................ 7
1.1 Dear Customer, ............................................................................................ 7
1.2 General information about this operating manual ........................................ 8
1.3 Contact information ...................................................................................... 8
1.4 Other valid documents ................................................................................. 8
1.5 Warranty and liability .................................................................................... 9
1.6 Obligation of system owner and personnel .................................................. 9
1.7 Intended use................................................................................................. 10
1.8 Indication and contraindication..................................................................... 10
1.9 Structure of the document ............................................................................ 11
1.9.1 Identification of the danger levels.................................................... 11
1.9.2 Formats and symbols used ............................................................. 11
2
Safety information.................................................................................................... 12
2.1 Information on the unit.................................................................................. 12
2.2 Ventilation slots ............................................................................................ 12
2.3 Condensation ............................................................................................... 12
2.4 Qualifications of operating personnel ........................................................... 13
2.5 Switch on the unit ......................................................................................... 13
2.6 Radiation protection ..................................................................................... 13
2.7 Emergency Stop........................................................................................... 13
2.8 Laser light localizer....................................................................................... 14
2.9 Hygiene ........................................................................................................ 14
2.10 Trouble-free operation.................................................................................. 14
2.11 Interference with electronic devices ............................................................. 14
2.12 Risks of electromagnetic fields..................................................................... 15
2.13 Combination with other equipment............................................................... 15
2.14 Changes to the unit ...................................................................................... 15
2.15 Structural alterations .................................................................................... 15
2.16 Electromagnetic compatibility....................................................................... 16
2.17 Electrostatic discharge ................................................................................. 16
3
Unit description........................................................................................................ 18
3.1 Certification and registration......................................................................... 18
3.2 Technical data .............................................................................................. 19
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Operating Instructions ORTHOPHOS XG 5 / Ceph
3.3 Main components of the product................................................................... 24
3.3.1 Basic unit.......................................................................................... 24
3.3.2 Cephalometer................................................................................... 25
3.3.3 Multipad............................................................................................ 26
3.3.4 Remote control................................................................................. 28
3.4 Spare parts and consumables ...................................................................... 29
3.4.1 Accessory parts................................................................................ 29
3.4.1.1 Bite blocks and contact segments..................................... 29
3.4.1.2 Temple supports, forehead support, and
temporomandibular joint supports
30
3.4.2 Hygienic protective sleeves.............................................................. 31
3.4.2.1 Protective sleeves for basic unit........................................ 31
3.4.2.2 Protective sleeves for cephalometer ................................. 32
4
Installation and start-up............................................................................................ 33
4.1 Replacing accessories on the basic unit ....................................................... 33
4.1.1 Replacing the bite block, contact segment, or chin rest................... 33
4.1.2 Changing the temple supports and temporomandibular joint
supports
34
4.2 Adjusting/inserting accessory parts on the cephalometer............................. 35
4.3 Moving the sensor......................................................................................... 36
5
Operation.................................................................................................................. 38
5.1 Switching the unit on ..................................................................................... 38
5.2 Readings on the digital display ..................................................................... 39
5.3 Switching SIDEXIS to ready for exposure state............................................ 39
5.4 Panoramic and bite wing exposure ............................................................... 40
5.4.1 Program descriptions ....................................................................... 40
5.4.1.1 P1 – Panoramic exposure ................................................. 40
5.4.1.2 P1 L – Panoramic exposure, half-side left......................... 40
5.4.1.3 P1 R – Panoramic exposure, half-side right ...................... 40
5.4.1.4 P1 A – Panoramic exposure, artifact-reduced................... 41
5.4.1.5 P1 C – Panoramic exposure, constant 1.25x magnification 41
5.4.1.6 P10 – Panoramic exposure for children ............................ 42
5.4.1.7 P12 – Thick slice, anterior tooth region ............................. 42
5.4.1.8 BW1 – Bitewing exposure in the posterior tooth region..... 43
5.4.2 Preparing the exposure.................................................................... 44
5.4.3 Selecting an exposure program ....................................................... 44
5.4.4 Setting the temple width................................................................... 44
5.4.5 Setting the kV/mA values ................................................................. 45
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Operating Instructions ORTHOPHOS XG 5 / Ceph
5.4.6 Positioning the patient ..................................................................... 46
5.4.6.1 Positioning with chin rest and rod for bite block ............... 47
5.4.6.2 Positioning with chin rest and bar..................................... 50
5.4.6.3 Positioning with bite block ................................................ 50
5.4.6.4 Positioning with contact segment ..................................... 50
5.5 Temporomandibular joint exposure.............................................................. 51
5.5.1 TM1.1 / TM1.2 – Lateral view of temporomandibular joints with
mouth open and closed
51
5.5.2 Preparing the exposure ................................................................... 52
5.5.3 Selecting an exposure program ...................................................... 52
5.5.4 Setting the kV/mA values ................................................................ 53
5.5.5 Positioning the patient ..................................................................... 54
5.6 Sinus view .................................................................................................... 57
5.6.1 S1 – Paranasal sinuses................................................................... 57
5.6.2 Preparing the exposure ................................................................... 57
5.6.3 Selecting an exposure program ...................................................... 57
5.6.4 Setting the kV/mA values ................................................................ 58
5.6.5 Positioning the patient ..................................................................... 59
5.7 Transversal multi-slice posterior teeth.......................................................... 61
5.7.1 MS1 – Program description ............................................................. 61
5.7.2 Preparing the exposure ................................................................... 61
5.7.3 Selecting an exposure program ...................................................... 61
5.7.4 Setting the kV/mA values ................................................................ 62
5.7.5 Positioning the patient ..................................................................... 63
5.7.5.1 Positioning with bite block ................................................ 64
5.7.5.2 Positioning with contact segment ..................................... 65
5.8 Cephalometric exposures............................................................................. 66
5.8.1 Program description ........................................................................ 66
5.8.1.1 C1 – Posterior-anterior exposure, symmetrical ................ 66
5.8.1.2 C2 – Anterior - posterior exposure, symmetrical .............. 66
5.8.1.3 C3 – Lateral exposure ...................................................... 67
5.8.1.4 C4 – Carpus view, symmetrical ........................................ 68
5.8.2 Preparing the exposure ................................................................... 69
5.8.3 Selecting an exposure program ...................................................... 70
5.8.4 Setting the kV/mA values ................................................................ 71
5.8.5 Positioning the patient ..................................................................... 72
5.8.5.1 Positioning for symmetrical exposures C1, C2................. 73
5.8.5.2 Positioning for C3 lateral exposures................................. 74
5.8.5.3 Positioning for carpal exposures C4................................. 76
5.9 Starting the test cycle ................................................................................... 77
5.10 Releasing the exposure................................................................................ 77
5.11 Using the remote control .............................................................................. 81
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Operating Instructions ORTHOPHOS XG 5 / Ceph
5.12 Canceling an exposure ................................................................................. 82
5.13 Reprogramming the kV/mA values ............................................................... 83
5.14 Activating the Info menu................................................................................ 84
5.15 Activating the service menu .......................................................................... 84
6
Maintenance............................................................................................................. 85
6.1 Cleaning and care ......................................................................................... 85
6.1.1 Cleaning ........................................................................................... 85
6.1.2 Disinfecting....................................................................................... 85
6.1.3 Sterilization....................................................................................... 87
6.2 Inspection and maintenance ......................................................................... 88
7
Malfunctions ............................................................................................................. 89
7.1 Help messages ............................................................................................. 89
7.2 Error message structure................................................................................ 90
7.3 Error description............................................................................................ 91
7.3.1 Ex – Error type ................................................................................. 91
7.3.2 yy – Locality...................................................................................... 92
8
Program values ........................................................................................................ 93
8.1 Panoramic exposure ..................................................................................... 93
8.2 Cephalometric exposures ............................................................................. 96
8.3 Dose information ........................................................................................... 97
8.3.1 Dose area product parameters for Panorama images ..................... 97
8.3.2 Dose area product parameters for Ceph-images............................. 100
8.3.3 Calculate dosage ............................................................................. 101
9
Dismantling and disposal ......................................................................................... 103
9.1 Dismantling and reinstallation ....................................................................... 103
9.2 Disposal ........................................................................................................ 103
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Sirona Dental Systems GmbH 1General data
Operating Instructions ORTHOPHOS XG 5 / Ceph
1
General data
1.1
Dear Customer,
We are pleased that you have equipped your practice with the
ORTHOPHOS XG X-ray system from Sirona.
Sirona was one of the first inventors of film-based panoramic X-ray
systems, and since 1996 has been a pioneer of digital X-ray technology.
You benefit from the vast experience we have gained through the
thousands of digital panoramic X-ray systems with CCD sensors installed
worldwide. This device is characterized by many features including
outstanding image quality, simple operation, and a high day-to-day
reliability.
This device enables you to take the following digital images:
● Standard exposures (jaw area)
● Bite wing exposures (upper and lower jaws)
● Sinus views (maxillary sinuses)
● Temporomandibular joint exposures
● Multislice (posterior tooth region)
If the unit is equipped with a cephalometer, you can also take
cephalometric images.
These Operating Instructions are designed to assist you prior to initial use
and whenever you require information later on.
We wish you every success with using your ORTHOPHOS XG system.
Your ORTHOPHOS XG Team
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1General data Sirona Dental Systems GmbH
1.2General information about this operating manual Operating Instructions ORTHOPHOS XG 5 / Ceph
1.2
General information about this operating manual
Observe the Operating Instructions Please familiarize yourself with the unit by reading through these
Operating Instructions before putting it into operation. It is essential that
you comply with the specified warning and safety information.
Always keep the operating instructions handy in case you or another user
require(s) information at a later point in time. Save the operating
instructions on the PC or print them out.
If you sell the unit, make sure that the operating instructions are included
with it either as a hard copy or on an electronic storage device so that the
new owner can familiarize himself with its functions and the specified
warning and safety information.
Online portal for technical documents We have set up an online portal for the Technical Documents at http://
www.dentsplysirona.com/manuals. There, you can download these
operating instructions and further documents. Please complete the online
form if you would like a hard copy of a particular document. We will then
be happy to send you a printed copy free of charge.
Help If you require additional help despite having thoroughly studied the
Operating Instructions, please contact your dental depot.
1.3
Contact information
Customer service center For technical questions, use the contact form on the internet at the
following address:
http://srvcontact.sirona.com
Manufacturer's address
Sirona Dental Systems GmbH
Fabrikstrasse 31
64625 Bensheim
Germany
Tel.: +49 (0) 6251/16-0
Fax: +49 (0) 6251/16-2591
e-Mail: contact@dentsplysirona.com
www.dentsplysirona.com
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 Operator's Manual
● Software Components Operating Instructions
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Operating Instructions ORTHOPHOS XG 5 / Ceph
1.5
Warranty and liability
Maintenance
In the interest of the safety and health of patients, users and other
persons, inspection and preventive maintenance 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.).
The system owner is responsible for making sure that all scheduled
inspections and preventive maintenance activities are performed.
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.
Exclusion of liability In the event that the system owner fails to fulfill the obligation to perform
scheduled inspections and preventive maintenance activities or ignores
error messages, Sirona Dental Systems GmbH and its authorized dealers
cannot assume any liability for damages.
Certificate of work We suggest that you request a certificate, showing the nature and extent
of the work performed, from those who carry out such work, and specify
that the certificate show any changes in rated parameters or working
ranges, as well as the date, the name of the firm and a signature.
1.6
Obligation of system owner and personnel
These operating instructions presuppose that you are familiar with the
use of Sidexis software.
Prior to the exposure, please ask women of a childbearing age as to
whether they are pregnant or not. If the patient is pregnant, a risk/benefit
analysis must be performed.
According to the X-ray Ordinance of Germany, owners of X-ray
equipment must perform constancy tests at regular intervals in order to
ensure the safety of operating staff and patients. Sirona recommends
monthly testing.
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1.7Intended use Operating Instructions ORTHOPHOS XG 5 / Ceph
1.7
Intended use
The ORTHOPHOS XG 5 / XG 5 DS / Ceph generates digital X-ray images
of maxillofacial regions and subregions for dentistry. With the
cephalometric arm projections of the skull are also possible and carpus
views for orthodontics.
This unit must not be operated in areas subject to explosion hazards.
The operating and maintenance instructions must be observed.
1.8
Indication and contraindication
Indications in dentistry areas:
● Conservative dentistry
● Endodontics
● Periodontology
● Prosthodontics
● Functional diagnosis and therapy of craniomandibular dysfunctions
● Surgical dentistry
● Implantology
● Oral and maxillofacial surgery
● Orthodontics
Contraindications:
● Display of cartilage structures
● Display of soft tissue
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Operating Instructions ORTHOPHOS XG 5 / Ceph
1.9
Structure of the document
1.9.1 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 for simplifying work.
1.9.2 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 [ → 11]”
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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2.1Information on the unit Operating Instructions ORTHOPHOS XG 5 / Ceph
2
Safety information
2.1
Information on the unit
The following symbols are applied to the unit:
Accompanying documents
This symbol can be found next to the rating plate on the unit.
Meaning: Observe the Operating Instructions when operating the unit.
This symbol can be found on the rating plate on the unit.
Meaning: The accompanying documents are available on the
manufacturer's homepage.
Electrostatic discharge (ESD)
Connector pins or sockets bearing ESD warning labels must not be
touched or interconnected without ESD protective measures. See also
"Electrostatic Discharge" and "Electromagnetic Compatibility".
Identification of single use devices
Prior to each exposure, the hygienic protective sleeves (single use
devices) must be fitted.
Single use devices are identified with the symbol shown on the left. They
must be disposed of immediately after use. Do not use single use devices
more than once.
2.2
Ventilation slots
Under no circumstances may the ventilation slots on the unit be covered,
since otherwise the air circulation will be obstructed. This can cause the
unit to overheat.
Do not spray into the ventilation slots
Do not spray liquids such as disinfectants into the ventilation slots. This
may lead to malfunctions. Use wipe disinfection only in the vicinity of the
ventilation slots.
2.3
Condensation
Extreme temperature fluctuations may cause condensation inside the
unit. Do not switch the unit on before it has reached normal room
temperature. See also the chapter Technical data.
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Operating Instructions ORTHOPHOS XG 5 / Ceph
2.4
Qualifications of operating personnel
The unit may only be operated by skilled or properly trained personnel.
Personnel, who are to be trained, taught, instructed or are taking part in
a general training, may operate the device only under the supervision of
an experienced person.
To operate the unit, the operating personnel must:
● have read and understood the Operating Instructions
● be familiar with the fundamental structure and functions of the unit
● be able to recognize irregularities in the functioning of the unit and
implement the appropriate measures where necessary
2.5
Switch on the unit
Safety information for switching on the un it: Customer
No patient may be positioned in the unit while it is booting up. The patient
could be injured in case of malfunction.
In case of an error that requires switching the unit off and back on again,
the patient must be removed from the unit, at the latest before the unit is
switched back on.
2.6
Radiation protection
The valid radiation protection regulations and measures must be
observed. The statutory radiation protection equipment must be used. In
order to reduce radiation exposure, Sirona recommends using bismuth or
lead shields or aprons, especially for pediatric patients.
During an exposure, the operator should move as far away from the X-ray
tube assembly as the coiled cable of the release button permits.
With the exception of the patient, no other persons without radiation
protection are allowed to stay in the room during an exposure. In
exceptional cases, a third person may provide assistance, but not the
practice staff. Visual contact with the patient and the unit must be
maintained throughout the entire exposure.
In case of malfunctions, cancel the exposure immediately by letting go of
the exposure release button.
2.7
Emergency Stop
If any parts of the unit touch the patient during the rotary movement, let
go of the exposure release button (X-Ray) immediately or stop the unit at
once by actuating the unit main switch or an Emergency Stop switch (not
included in the scope of supply)!
CAUTION
CAUTION!
Not for use on patients less than approximately 5 years old [~21 kg (46
lb) and 113 cm (44.5 in) standing height]
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2.8Laser light localizer Operating Instructions ORTHOPHOS XG 5 / Ceph
2.8
Laser light localizer
The system incorporates Class 1 laser products.
The light localizers are intended for correct patient positioning. They must
not be used for any other purposes.
A minimum distance of 10 cm (4") is required between the eye and the
laser. Do not stare into the beam.
The light localizers may be switched on only when functioning perfectly.
Repair work must be carried out by authorized staff only.
Do not use the system with any other lasers, and do not make any
changes to settings or processes that are not described in these
operating instructions. This may lead to a dangerous exposure to
radiation.
For the USA only:
Caution: Federal Law (USA) restricts the sale of this device to or on the
order of a physician, dentist, or licensed practitioner.
2.9
Hygiene
The protective sleeves must be reapplied for each patient, all auxiliary
exposure tools must also be disinfected to avoid potential transmission of
pathogens that may cause serious illnesses.
Suitable hygienic measures must be taken to prevent cross
contamination between patients, users, and other persons.
The following chapters contain more information about sterilization and
hygienic protective sleeves: “Hygienic protective sleeves [ → 31]“,
“Preparing the exposure“, “Sterilization [ → 87]“.
2.10
Trouble-free operation
Use of this system 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.
X-rays of patients may be taken only when the system is working troublefree.
The movements of the unit must not be obstructed by physical
constitution, clothing, dressings, wheelchairs, or hospital beds.
The travel range of the unit must be kept free from foreign matter.
Do not leave the patient at the unit unattended.
The device may only be operated with a complete cover and protective
hood.
2.11
Interference with electronic devices
To prevent the malfunctioning of electronic devices and data memories,
these objects must be removed prior to the X-ray exposure.
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Operating Instructions ORTHOPHOS XG 5 / Ceph
2.12
Risks of electromagnetic fields
The function of implanted systems (cardiac pacemakers or cochlear
implants, for example) can be affected by electromagnetic fields. Before
commencing treatment, ask if the patient has a cardiac pacemaker or any
other implanted system.
Any prevailing risks are listed in the documentation provided by the
implant manufacturer.
2.13
Combination with other equipment
Putting together or altering a medical electrical system by combining with
other devices in accordance with IEC 60601-1 (safety requirements for
medical electrical systems) is subject to the obligation to ensure
compliance with the requirements of this provision for patient safety, the
operator, and the environment.
If any devices not approved by Sirona are connected, they must comply
with the applicable standards:
● IEC 60950-1 or IEC 62368-1 for information technology equipment
and
● IEC 60601-1 for medical electrical equipment
To this end, refer to the ‘Installation requirements’ and compatibility list/
declaration of conformity by the system integrator.
If in doubt, contact the manufacturer of the system components.
2.14
Changes to the unit
Modifications to this unit 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.
2.15
Structural alterations
If structural changes are made in the vicinity of the X-ray unit which result
in the device being exposed to very high levels of vibration or even
impact, the device must be inspected by a service engineer and readjusted and re-calibrated if necessary.
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2.16Electromagnetic compatibility Operating Instructions ORTHOPHOS XG 5 / Ceph
2.16
Electromagnetic compatibility
The acquisition unit complies with the requirements of the standard IEC
60601-1-2.
Medical electrical devices are subject to special precautionary measures
with regard to electromagnetic compatibility (EMC). It must be installed
and operated as specified in the “Installation Requirements” document.
Portable and mobile RF communications equipment may affect medical
electrical equipment.
If the installation requirements and the following recommendations are
not observed, there is a risk that the X-ray images will not have the correct
exposure.
The correctness of the radiation parameters and the repeatability of the
dose values in particular may be affected.
Only operate units approved by Sirona at a distance of < 30 cm from the
X-ray unit. The Sirona intraoral sensors are approved for this.
In the case of repairs, only use replacement parts approved by Sirona.
Only use disinfectants approved by Sirona so as not to damage electrical
insulation.
Portable HF equipment must not be placed within a 30 cm radius of the
X-ray unit.
HF surgery units and X-ray units must not be operated at the same time.
2.17
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
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Sirona Dental Systems GmbH 2Safety information
Operating Instructions ORTHOPHOS XG 5 / Ceph
Endangered regions are indicated on the unit by the ESD warning label:
We recommend that all persons working with this system are made aware
of the significance of the ESD warning label. A training course should also
be held to inform users about the physics of electrostatic charges.
Physics of electrostatic charges
An electrostatic discharge requires prior electrostatic charging.
There is a danger of electrostatic charges building up whenever two
bodies rub against each other, e.g. when:
● walking (soles of shoes against the floor) or
● moving (chair casters against floor).
The amount of charge depends on several factors: The charge is:
● higher at low air humidity than at high air humidity, and
● higher with synthetic materials than with natural materials (clothing,
floor coverings).
The following rule of thumb can be applied to assess the transient
voltages resulting from an electrostatic discharge.
An electrostatic discharge is:
● perceptible at 3,000 V or higher
● audible at 5,000 V or higher (cracking, crackling)
● visible at 10,000 V or higher (arc-over)
The transient currents resulting from these discharges have a magnitude
of over 10 amps. They are not hazardous for humans because they last
for only several nanoseconds.
Tip: 1 nanosecond = 1/1,000,000,000 second = 1 billionth of a second
Voltage differentials exceeding 30,000 volts per centimeter may lead to a
charge transfer (electrostatic discharge, lightning, arc-over).
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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3Unit description Sirona Dental Systems GmbH
3.1Certification and registration Operating Instructions ORTHOPHOS XG 5 / Ceph
3
Unit description
3.1
Certification and registration
The ORTHOPHOS XG 5 / XG 5 DS / Ceph X-ray unit complies with
IEC 60601-1:2005 + A1:2012
The ORTHOPHOS XG 5 / XG 5 DS / Ceph X-ray unit complies with
IEC 60601-1-3:2008 + A1:2013
The ORTHOPHOS XG 5 / XG 5 DS / Ceph X-ray unit complies with
IEC 60601-2-63:2012
ORTHOPHOS XG 5 / XG 5 DS / Ceph complies with:
● AS/NZS 3200.1.0
Original language: German
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 (MDD).
0123
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Sirona Dental Systems GmbH 3Unit description
Operating Instructions ORTHOPHOS XG 5 / Ceph
3.2
Technical data
Unit data
Model designation: ORTHOPHOS XG 5 / XG 5 DS / Ceph
Nominal voltage: 200 – 240 V
Permissible fluctuation: ± 10%
Permissible drop under load: 10%
Rated current: 12 A
Rated power: 2 kW at 90 kV/12 mA with any radiation
time
Nominal frequency: 50 Hz / 60 Hz
Mains resistance: max. 0.8 ohms
Main building fuse: 25 A slow-blow (16 A for single line)
Power consumption: 2 kVA
Power output of tube
assembly:
90 kV/12 mA = 1080 W with any radiation
time
Tube voltage: 60 – 90 kV (at 90 kV max. 12 mA)
Tube current: 3 – 16 mA (at 16 mA max. 66 kV)
Maximum setting range: 60 kV / 3 mA to 90 kV / 12 mA
High-voltage waveform: High-frequency multipulse
Residual ripple ≤ 4 kV
High voltage generation
frequency:
40 – 120 kHz
Program duration: See "Program values" [ → 93].
Exposure time: See "Program values" [ → 93].
Image acquisition scale: For P1, normal dental arch (slice center)
approx. 1:1.19, i.e. the acquired image is
magnified by approx. 19% on average
compared to reality.
Exposure time for a
cephalometric image:
14.9 s max.
Image acquisition scale for a
cephalometric image:
approx. 1:1.1, i.e. the acquired image is
magnified by approx. 10% on average
compared to reality.
Total filtration of X-ray tube
assembly:
> 2.5 AI / 90 IEC 60522
Focal spot size as specified
in IEC 60336, measured in
the central X-ray beam:
0.5 mm
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3Unit description Sirona Dental Systems GmbH
3.2Technical data Operating Instructions ORTHOPHOS XG 5 / Ceph
X-ray tube
Siemens SR 90/15 FN or
CEI OCX 100
Marking of focal spot:
Source-skin distance > 200 mm (8“)
Automatic exposure
blocking:
The duration of automatic exposure
blocking (cooling period) depends on the
set kV/mA level and the actual exposure
time. Depending on the tube load,
interval times of 8 s to 300 s are
automatically set by the system.
Example: For program P1 with exposure
data of 80 kV/14 mA and a radiation time
of 14.1 s, the pause duration is 150 s.
Equipment class: IPX0
Class I device
Degree of protection against
electric shock:
Type B device
Degree of protection against
ingress of water:
Ordinary equipment (without protection
against ingress of water)
Year of manufacture:
(on the rating plate)
Operating mode: Continuous operation
Long-term power output: 100 W
Anode material: Tungsten
Exposure parameters for
determining leakage
radiation:
2mA / 90 kV
Transport and storage
temperature:
-10°C – +70°C (14°F – 158°F)
Air humidity: 10% – 95%
Admissible operating
temperature:
Acc. to IEC 60601-1 between +10°C and
+40°C (50°F – 104°F)
Operating altitude: ≤ 3000 m
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Sirona Dental Systems GmbH 3Unit description
Operating Instructions ORTHOPHOS XG 5 / Ceph
PAN Sensor
Digital CCD line sensor, repluggable for panoramic exposure technique
Ceph sensor
Digital CCD line sensor, repluggable for panoramic or ceph exposure
technique
Active sensor area, Pan type: 138 mm x 6.48 mm
Detail resolution: 0.027 mm pixel size
Focus-sensor distance: 497 mm
Active sensor area, Ceph
type:
230 mm x 6.48 mm
Detail resolution: 0.027 mm pixel size
Focus-sensor distance: 1714 mm
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3Unit description Sirona Dental Systems GmbH
3.2Technical data Operating Instructions ORTHOPHOS XG 5 / Ceph
Cooling curve for tube housing
Cooling curve of X-ray tube
Heating curve of tube housing
Central X-ray beam and anode angle
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Sirona Dental Systems GmbH 3Unit description
Operating Instructions ORTHOPHOS XG 5 / Ceph
Minimum PC system requirements for SIDEXIS
Processor: DualCore 1.6 GHz
RAM 2 GB
Free hard disk
storage:
5 GB for SIDEXIS installation and database
Removable
medium:
CD/DVD writer
Operating system: Windows XP Professional, 32-bit, SP3
Windows 7 Professional, 32-bit or 64-bit (64-bit
version not tested)
Windows 7 Ultimate, 32-bit or 64-bit
Graphics card: > 512 MB, minimum resolution 1280 x 1024 pixels,
16.7 million colors (TrueColor)
Screen: suitable for diagnostic applications
Network card: Network RJ45, 100 MBit/s
USB port: For Version 1.1 and higher, required for USB
components only
Software: Internet Explorer 6.0, SP1
Acrobat Reader 8.0, contained on CD, required for
the PDF test report function
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3Unit description Sirona Dental Systems GmbH
3.3Main components of the product Operating Instructions ORTHOPHOS XG 5 / Ceph
3.3
Main components of the product
3.3.1 Basic unit
A Main switch
B Light localizer with height adjustment of the laser line (Frankfurt
plane)
C Light localizer central laser line for face center
D Control mirror for patient positioning
E Tray for jewelry, etc.
F Forehead support
G Temple supports
H Pushbutton for sensor removal
I Sensor
J Primary diaphragm field on the X-ray tube assembly
K Bite block, contact segment or chin rest
S Holder for chin rest, bite blocks, or contact segments etc.
M Handle for patient
N Drawer for accessories
O Multipad (swiveling control panel)
I
H
G
F
E
D
C
B
A
Q
P
O
N
M
L
K
J
T
R
CEPH
PAN
TS
ORTHOPHOSist aufnahmebereitORTHOPHOSist aufnahmebereit
1260
64
64kV
8mA
?
P1
14,2s14,2s
AEC
TS
T
R
Prog.
S
kV
mA
P1 14.1 64 8
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Sirona Dental Systems GmbH 3Unit description
Operating Instructions ORTHOPHOS XG 5 / Ceph
3.3.2 Cephalometer
P Touch bar for swiveling the control mirror in and out
Q Release button
A Projection scale
B Scale for vertical nose support adjustment
C Nose support
D Locking knob for nose support
F Pushbutton for sensor removal
G Rotating element for rotary movement of head supports
H Secondary diaphragm with light localizer of laser line (Frankfurt
horizontal plane)
I Sensor
J Carpus support plate
K Ear plugs with holders
A
F
I
K K
J
C
B
A
H
GF
D
20
30
40
50
20
30
40
50
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3Unit description Sirona Dental Systems GmbH
3.3Main components of the product Operating Instructions ORTHOPHOS XG 5 / Ceph
3.3.3 Multipad
In addition to the program numbers, help messages, kV/mA combinations
and the expected and actual radiation time, the height adjustment setting,
forehead support position, info texts and values as well as the help and
error messages are also shown on the digital display.
A "Move forehead support away from forehead" key
B Light localizers ON/OFF key with LED
C "Move forehead support towards forehead" key
D "Unit up" arrow key
E "Unit down" key
F Program number/Help message digital display
G Forward/backward program selection keys
H Optical radiation indicator
I Forward/backward keys, without function
J Digital display of expected radiation time (after completion:
actual radiation time)
K LED display "Unit ON"
S Keys for manually setting kV/mA combinations forward/
backward
M Digital display of kV/mA combinations
N Memory key for saving kV/mA values and digital display of info
text with LED
O Key for service menu display with LED
P Row of patient symbol keys with LEDs, programmed kV/mA
values
T
S
R
Q
P
O
N
M
L
K
J
I
H
G
F
E
D
C
B
A
T
R
Prog.
S
kV
mA
P1 14.1 64 8
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Sirona Dental Systems GmbH 3Unit description
Operating Instructions ORTHOPHOS XG 5 / Ceph
Q "R" key for unit return with Ready LED (flashes if the unit is not
ready for an exposure).
R "T" key for test cycle without radiation with LED display
S "Close temple supports" key
T "Open temple supports" key
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3Unit description Sirona Dental Systems GmbH
3.3Main components of the product Operating Instructions ORTHOPHOS XG 5 / Ceph
3.3.4 Remote control
A Radiation indicator
B "Unit ON" LED display
C Display field
D Exposure release button
E "R" key for return of unit
F Exposure release button with coiled cable
F
E
D
C
B
A
A
B
R
s
k
V
m
A
R
P1
14.1
64
8
P1
14.1
64
8
Prog.
s
k
V
m
A
Prog.
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Sirona Dental Systems GmbH 3Unit description
Operating Instructions ORTHOPHOS XG 5 / Ceph
3.4
Spare parts and consumables
3.4.1 Accessory parts
3.4.1.1
Bite blocks and contact segments
The drawer between the handles is provided for the storage of accessory
parts and hygienic protective sleeves.
A Bite block (10 pieces)
REF 18 88 887
B Bite block rod (5 pieces)
REF 18 88 895
C Bar for chin rest
REF 59 61 461
DRest
REF 14 49 227
E Chin rest assembly, including A (5 pieces), B (1 piece), C, D,
protective sleeves for bite block (500 pieces), protective sleeves
for chin rest and bar (100 pieces), see "Hygiene protective
sleeves" [ → 31]
REF 59 81 472
F Contact segment yellow for subnasale (5 pieces)
REF 89 31 545
G Bite block yellow (5 pieces)
REF 89 21 843
H Contact segment blue for subnasale (5 pieces)
REF 89 31 552
I Bite block blue (5 pieces)
REF 89 21 850
E
D
I
H
G
F
C
B
A
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3Unit description Sirona Dental Systems GmbH
3.4Spare parts and consumables Operating Instructions ORTHOPHOS XG 5 / Ceph
3.4.1.2
Temple supports, forehead support, and temporomandibular joint
supports
A Forehead support and temple supports (1 piece)
REF 59 80 383
B Contact pads for forehead and temple supports (1 set)
REF 59 80 391
C Temporomandibular joint support 1 for temporomandibular joint
exposures
REF 59 80 607
D Temporomandibular joint support 2 for temporomandibular joint
exposures
REF 59 80 599
E Contact pads for temporomandibular joint supports (10 pieces)
REF 59 90 648
F Ear holders for temporomandibular joint supports (10 pieces)
REF 18 88 838
1
2
F
E
D
C
B
A
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