Sirona Sidexis User Manual
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Sirona Dental Systems GmbH
Operating Instructions SIDEXIS – Intraoral
Dear Customer Thank you for purchasing your new Intraoral X-ray prod-
uct from the SIDEXIS family.
This product enables the digital image acquisition of
intraoral X-rays.
For this unit we have also provided the technical docu-
mentation.
Keep this documentation nearby for quick and easy reference (in the Federal Republic of Germany in the
X-ray System book).
In order to protect your warranty rights, please fill out the
Installation Report / Warranty Passport provided,
together with the technician, immediately after installation of the system.
These Operating Instructions cover the operation of the
Wall Model X-ray Box, X-ray box on the dental treatment
center, the Universal sensor and the Full Size sensor.
Read the Operating Instructions to familiarize yourself
with the product before taking X-rays on the patient. Be
sure to observe the currently valid Radiation Protection
Guidelines and the Safety Notes in these Operating
Instructions.
These Operating Instructions assume a thorough familiarity with the SIDEXIS software.
In the Federal Republic of Germany, the system integrator is required to fill out the enclosed declaration of conformity in accordance with the Medical Device Directive.
Your SIDEXIS Team
Maintenance To ensure the safety of the patient, the operators and
third parties, equipment inspections and maintenance
work must be carried out at specified intervals in order to
guarantee the operational safety and functional reliability
of your product.
It is the responsibility of the operator to ensure that the
inspections and maintenance work are carried out.
In the event that the operator fails to fulfil the obligation
to carry out inspections and maintenance work or
ignores error messages, Sirona Dental Systems GmbH
or their contracted dealer cannot assume liability for any
damage attributable to this.
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Sirona Dental Systems GmbH
Operating Instructions SIDEXIS – Intraoral
List of Contents
1 Warning and safety information ................................................................................ 5
1.1 General safety information................................................................................................................ 5
1.2 ESD protective measures ................................................................................................................. 8
1.3 Concerning the physics of electrostatic charges .............................................................................. 8
2 Technical data ............................................................................................................. 10
3 Operating and display elements ................................................................................ 12
3.1 Wall model X-ray box........................................................................................................................ 12
3.2 X-ray box on the dental treatment center ......................................................................................... 13
4 Accessories ................................................................................................................. 14
5 Collimation................................................................................................................... 15
6 Hygiene protection...................................................................................................... 16
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7 Use of the X-ray sensor .............................................................................................. 17
8 Preparations for the exposure ................................................................................... 18
8.1 The X-ray sensor .............................................................................................................................. 18
8.2 Switching the unit on......................................................................................................................... 18
9 System statuses .......................................................................................................... 19
10 Making the system ready for exposure..................................................................... 21
11 Exposure control, adapting exposure data .............................................................. 23
11.1 Exposure control............................................................................................................................... 23
11.2 Adapting exposure data.................................................................................................................... 23
12 Care .............................................................................................................................. 25
12.1 Cleaning............................................................................................................................................ 25
12.2 Disinfecting ....................................................................................................................................... 25
13 Exposure values.......................................................................................................... 27
13.1 HELIODENT DS as from Serial No. 15864 (wall model) and 4416 (ceiling model).......................... 27
13.2 HELIODENT DS up to Serial No. 15863 (wall model) and 4415 (ceiling model).............................. 28
13.3 HELIODENT Vario............................................................................................................................ 31
13.4 HELIODENT MD............................................................................................................................... 32
13.5 HELIODENT 70 (not USA version!).................................................................................................. 33
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Sirona Dental Systems GmbH
Operating Instructions SIDEXIS – Intraoral
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Sirona Dental Systems GmbH 1 Warning and safety information
Operating Instructions SIDEXIS – Intraoral 1.1 General safety information
1 Warning and safety information
1.1 General safety information
Intended use This unit is not to be operated in areas where an explo-
sion hazard exists.
Symbols used Observe accompanying documents
(on name plate)
Maintenance and repair As manufacturers of electromedical equipment we can
assume responsibility for the safety properties of the
system in particular only if maintenance and repairs on
the system are performed by us or by agencies we have
expressly authorized to perform these and if components affecting safe operation of the system are
replaced by original spare parts in case of failure.
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.
For product safety reasons this product may be operated
only with original Sirona accessories or accessories of
third parties expressly approved by Sirona. The user
assumes the risk for the use of nonapproved accessories.
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ATTENTION! If extensions are made to the PC, this can
impair the functional reliability of the system (e.g. patient
safety and EMC compatibility). The person who makes
the extension which is not expressly approved by Sirona
undertakes the warranty for the functional reliability of
the system.
Combination with other equipment Permissible combinations are defined by the system
administrator in the declaration of conformity.
The declaration of conformity is included with the technical documents.
Electromagnetic compatibility (EMC) The SIDEXIS – Intraoral complies with the requirements
of IEC 60601-1-2:2001.
Medical electrical devices are subject to special precautionary measures regarding EMC. They must be
installed and operated as specified in the document
"Installation Requirements".
Portable and mobile HF communication devices can
influence medical electrical equipment. The use of
mobile telephones in the practice or hospital area therefore must be prohibited.
Please also observe the ESD protective measures in
Chapter 1.2.
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1 Warning and safety information Sirona Dental Systems GmbH
Example
1.1 General safety information Operating Instructions SIDEXIS – Intraoral
Allocation of acquisition system to patient In the course of the dental practice procedure, in order
to guarantee reliable assignment of the X-ray exposures
to the patient data stored by SIDEXIS it must be guaranteed that the unequivocal assignment of the acquisition
system to the examined patient is assured!
Hygiene information The protective covers must be exchanged for each new
patient and the sterilizable accessories must be sterilized to prevent any transmission of infective agents
which might cause serious illnesses.
Suitable hygienic measures must be taken to prevent
cross contamination among patients, users and other
persons.
Identification of warning and safety information To avoid personal injury and material damage, also
observe the warning and safety instructions given in
these Operating Instructions. These are specially identified with ATTENTION.
Interference with electronic devices worn on the body
of the patient
To avoid failures of electronic devices and data memories, such as radio-controlled clocks and telephone
cards, these must be removed before the X-ray exposure.
Maintenance performed by the operator If a second protective ground wire connection is speci-
fied in the installation instructions to be used, the operator must ensure that no changes are made to the second
protective ground wire connection, as shown in the picture.
No further maintenance measures are required on the
part of the operator.
The operator must ensure that all components are in
undamaged condition (cables, sensors, housing parts).
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Sirona Dental Systems GmbH 1 Warning and safety information
Operating Instructions SIDEXIS – Intraoral 1.1 General safety information
Disposal It generally applies that any disposal of this product must
comply with the relevant national regulations. Please
observe the regulations applicable in your country.
Within the European Economic Community, Council
Directive 2002/96/EU (WEEE) requires environmentally
sound recycling/disposal of electrical and electronic
devices.
Your product is marked with the adjacent symbol. Disposal of your product with domestic
refuse is not compatible with the objectives of environmentally sound recycling/disposal.
The black bar underneath the "garbage can" symbol
means that it was put into circulation after Aug. 13, 2005.
(see EN 50419:2005)
Please note that this product is subject to Council Directive 2002/96/EU (WEEE) and the applicable national law
of your country and must be recycled or disposed of in
an environmentally sound manner.
The X-ray tube assembly of this product contains a
tube with a potential implosion hazard, a small amount
of beryllium, a lead lining and mineral oil.
Please contact your dealer if final disposal of your product is required.
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1 Warning and safety information Sirona Dental Systems GmbH
CAUTION
1 nanosecond = 1 / 1,000,000,000 second =
1 billionth of a second
1.2 ESD protective measures Operating Instructions SIDEXIS – Intraoral
1.2 ESD protective measures
ESD is the abbreviation for ElectroStatic Discharge.
Connector pins or sockets bearing ESD warning labels
must not be contacted or interconnected without ESD
protective measures.
ESD protective measures include:
• Procedures for preventing electrostatic charges
(e.g. via air conditioning, air moistening, conductive
floor coverings and nonsynthetic clothing)
• Discharging the electrostatic charges of your own
body on the frame of the U
wire or large metallic objects
• Connecting yourself to ground using a wrist band.
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 contacted by electrostatically charged USERS.
The content of this training is specified in Chapter 1.3.
NIT, the protective ground
1.3 Concerning the physics of electrostatic charges
ESD is the abbreviation for ElectroStatic Discharge.
Electrostatic discharge must be preceded by electrostatic charging.
Static electric charges generally occur whenever two
bodies are rubbed against each other, e.g. when walking
(shoe soles against the floor) or driving a car (tires
against the street pavement). The amount of the charge
depends on several factors:
I.e. the charge is higher with a low air humidity than with
a high air humidity and higher with synthetic materials
than with natural materials (clothing, floor coverings).
The following rule of thumb can be applied to gain an
overview of the compensating voltages resulting from an
electrostatic discharge.
An electrostatic discharge is:
• perceptible at 3000V or higher
• audible at 5000V or higher (cracking, crackling)
• visible at 10,000V or higher (arc-over)
The compensating currents resulting from these discharges have a magnitude of 10 amperes. They are not
hazardous for humans because they last for only several
nanoseconds.
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Sirona Dental Systems GmbH 1 Warning and safety information
Operating Instructions SIDEXIS – Intraoral 1.3 Concerning the physics of electrostatic charges
Voltage differences exceeding 30,000 volts per centimenter may lead to a charge compensation (electrostatic discharge, lightning, arc-over).
Integrated circuits (logical circuits and microprocessors)
are used in order to enable a wide variety of functions in
a dental/X-ray/CEREC system. 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
layer thicknesses with a magnitude of several 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
layers, 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.
To prevent this from happening, the ESD warning label
next to the plug warns of this hazard.
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2 Technical data Sirona Dental Systems GmbH
1.3 Concerning the physics of electrostatic charges Operating Instructions SIDEXIS – Intraoral
2 Technical data
1. General
The Digital Intraoral X-ray system, type D 3334,
was tested by the VDE test and certification institute according to EN 60 601–1:1996 in conjunction
with EN 60 601–1–1: 9-1994; A1: 1996. It fulfils the
requirements specified therein.
Patent
This product is covered by US Patent Numbers US
5,513,252. Additional patents are pending.
Original language of the present document: German
Reg. No.: China
Product Standard No.:
SFDA (I) 20052302655
YZB / GEM 1866 - 2005
This product bears a CE marking, documenting its
compliance with the provisions of
Council Directive 93/42/EEC of June 14, 1993 concerning medical devices.
2. Sensors
Cable length: 3 m
Degree of protection against electrical shock: : Type BF
Physical pixel size: 19.5 µm (pixel binning to 39 µm)
Active area: 26 x 34 mm Full Size
20 x 30 mm Universal Size
Outer dimensions: 30,93 x 40,96 x 7,0 mm – Full Size
25,6 x 36,9 x 6,8 mm – Universal
Ambient temperature: 0 – 40°C
Storage temperature: –10°C to +70°C;
on dispatch in original packaging
–40°C to +70°C for max. 48 h
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Sirona Dental Systems GmbH 2 Technical data
Operating Instructions SIDEXIS – Intraoral 1.3 Concerning the physics of electrostatic charges
3. Image acquisition
a) Wall model X-ray box:
US-version:
Worldwide version:
Type of protection against electrical shock: unit of Protection Class I
b)X-ray box on dental treatment centers: 100 – 240V, 50 / 60Hz max. 40W
Fuses: 2 x 800 mA slow-blow
Type of protection against electrical shock: unit of Protection Class I
for a) and b):
Degree of protection against penetration of
water:
Operating mode: continuous operation
120 V, 50 / 60 Hz max. 40 W
100 – 240V, 50 / 60 Hz max. 40 W
normal unit
(without protection against penetration of water)
4. Minimum requirements for the PC systems
Hard disk: > 2 GByte / database
> 50 MByte / SIDEXIS installation
RAM: at least 64 MB
Drives: CD-ROM
3.5" diskette (one per system / network)
MOD drive min. 640 MByte (one per system / network)
Operating system: Windows 98
Windows NT 4.0 / Service Pack >
Graphics system: Resolution at least 1024 x 768 pixels,
color depth at least 8 bits
Network: 10 / 100 MBit Ethernet
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5. Requirement for the intraoral X-ray tube assembly:
Multipulse units, mAs product: 0.14 – 1.4 mAs, at 60 – 70 kV and 8" Tube
These data apply correspondingly for single-pulse units or other cone lengths.
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