Sirona Dental Systems GmbH 1About these Installation Instructions
Installation Manual ORTHOPHOS SL1.1Structure of the document
About these Installation Instructions
1
1.1
Structure of the document
1.1.1Identification of the danger levels
To prevent personal injury and material damage, please observe the
warning and safety information provided in the present operating
instructions. 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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IMPORTANT
Application instructions and other important information.
Tip: Information on making work easier.
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1About these Installation InstructionsSirona Dental Systems GmbH
1.1Structure of the documentInstallation Manual ORTHOPHOS SL
1.1.2Formats and symbols used
The formats and symbols used in this document have the following
meaning:
Prerequisite
1. First action step
2. Second action step
or
➢ Alternative action
Result
➢ Individual action step
See "Formats and symbols
used [ → 10]"
● ListDesignates a list.
"Command / menu item"Indicates commands, menu items or
Requests you to do something.
Identifies a reference to another text
passage and specifies its page
number.
quotations.
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Sirona Dental Systems GmbH 1About these Installation Instructions
Installation Manual ORTHOPHOS SL1.2Scope
1.2
1.3
Scope
These installation instructions describe the installation of the
ORTHOPHOS SL digital X-ray unit/digital volume tomograph. They are
intended for use exclusively by trained and authorized distributors and
service technicians.
Other relevant documents
In addition to these installation instructions you will require the following
documentation:
Current Service Documentation, such as the Service Manual, can be
downloaded from the Sirona dealer website.
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2Safety instructionsSirona Dental Systems GmbH
2.1Information on the unitInstallation Manual ORTHOPHOS SL
Safety instructions
2
Accompanying documents
Electrostatic discharge (ESD)
Identification of single use devices
2.1
Information on the unit
The following symbols are applied to the unit:
Accompanying documents
This symbol is affixed next to the unit rating plate.
Meaning: When operating the unit, observe the operating instructions.
This symbol is affixed on the unit rating plate.
Meaning: The accompanying documents are available on the homepage
of Sirona.
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" [ → 14].
Single use hygienic protective sleeves
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
Fixed connection
DANGER
Potentially lethal shock hazard!
Fixed connection!
Installing a mains plug instead of the specified fixed connection infringes
international medical regulatory actions and is prohibited. In case of
error, this puts patients, users, and other parties seriously at risk.
2.3
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Ventilation slots
Ventilation slots
Never cover the ventilation slots on the unit under any circumstances,
since this may obstruct air circulation. This can cause the unit to overheat.
SL sensor ventilation sl ots
Under no circumstances may the ventilation slots on the sensor unit be
covered, since otherwise the air circulation in the sensor unit will be
obstructed. This can cause the sensor unit to overheat.
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Sirona Dental Systems GmbH 2Safety instructions
Installation Manual ORTHOPHOS SL2.4Condensation
2.4
2.5
2.6
2.7
Condensation
Safety information for co ndensation: Service engi neer
Extreme fluctuations of temperature may cause condensation inside the
unit. Do not switch the unit on before it has reached normal room
temperature. See also Technical Data.
Qualifications of service personnel
Installation and startup may be carried out only by personnel specifically
authorized by Sirona.
Switching the unit on
Safety information for switching on the unit: Service engineer
Due to the risk of injury caused by malfunction, no person may be
positioned in the unit when it is switched on.
Radiation protection
Safety information for rad iation protection: Service engineer
The valid radiation protection regulations and measures must be
observed. The statutory radiation protection equipment must be used.
During an exposure, the service engineer should move as far away from
the X-ray tube assembly as the coiled cable of the manual release
permits.
With the exception of the service engineer, no other persons are allowed
to stay in the room during an exposure.
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2.8
In case of malfunctions, cancel the exposure immediately by letting go of
the exposure release button.
Information about radiation protection for Canada
NOTICE
3D imaging should not be used for screening examinations. 3D imaging
examinations must be clinically warranted and each exam must be
justified by demonstrating that the benefits outweigh the risks.
NOTICE
Where it is likely that evaluation of soft tissues will be required as part of
the patient's radiological assessment, the appropriate imaging should
be conventional medical CT or MR, rather than 3D imaging using Cone
Beam technology.
Laser light localizer
Safety information for light localizer: Service engineer
The system incorporates Class 1 laser products.
A minimum distance of 10 cm (4") is required between the eye and the
laser. Do not stare into the beam.
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.
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2Safety instructionsSirona Dental Systems GmbH
2.9Modifications to the unitInstallation Manual ORTHOPHOS SL
2.9
2.10
2.11
Modifications 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.
Transport safety devices
Transport safetydevices
IMPORTANT
The transport safety devices (marked in red) attached to the unit must
be removed prior to initial startup.
Electromagnetic compatibility
The unit complies with the requirements of standard IEC 60601-1-2.
Medical electrical equipment is subject to special EMC-related
precautions. It must be installed and operated as specified in the
document "Installation Requirements".
If high-voltage systems, radio link systems or MRI systems are located
within 5 m of the unit, please observe the specifications stated in the
installation requirements.
2.12
Portable and mobile RF communications equipment may affect medical
electrical equipment. Therefore, the use of mobile wireless phones in
medical office or hospital environments must be prohibited.
Pan sensor: Digital CdTe sensor
with direct converter technology for
panoramic exposure technology
ORTHOPHOS SL 3D
Digital X-ray unit with digital Flat
Panel Detector and DCS sensor
Flat Panel Detector: Digital Flat
Panel Detector with a-Si
technology (amorphous silicon)
Pan sensor: Digital CdTe sensor
with direct converter technology for
panoramic exposure technology
BORTHOPHOS SL 2D/3D
Ceph, left-arm version
Digital X-ray unit ORTHOPHOS SL
(all variants A) with cephalometer,
left-arm version
CORTHOPHOS SL 2D/3D
Ceph, right-arm version
Digital X-ray unit ORTHOPHOS SL
(all variants A) with cephalometer,
right-arm version
fastening if both wall and floor installation are possible on-site
(see section “Wall mounting (standard and option 1) [ → 49]”).
BOption 1
Wall-mounted installation with 2 wall holders
fastening) if only wall installation is possible on-site (see section
“Wall mounting (standard and option 1) [ → 49]”).
COption 2
Installation using a floor stand and 1 wall holder
possible to mount the unit on the wall and on the floor on-site and
x-rays are often taken while the patient is seated on a chair →
better positioning of seated patient (see section “Installing the
floor stand (option 2) [ → 55]”).
without remote control with release button on the coiled cable
in the treatment room.
BInstallation version 1
Unit
with remote control
button on the coiled cable.
Without coiled cable [ → 76]”).
CInstallation version 2
Unit
with remote control
button on the coiled cable.
With spiral cable [ → 77]”).
outside the X-ray room
(see section “Installation version 1:
outside the X-ray room
(see section “Installation version 2:
without release
with release
27
4Delivery and transportSirona Dental Systems GmbH
A
B
A
4.1Operating and transport conditionsInstallation Manual ORTHOPHOS SL
Delivery and transport
4
4.1
4.2
Operating and transport conditions
Transport and storage
temperature:
Air humidity:10 % – 95 %
Admissible operating
temperature:
Operating altitude:≤ 3,000 m above sea level
-10°C – +70°C (14°F – 158°F)
+18 °C - +31 °C (64 °F – 88 °F)
Delivery
Damage following delivery
NOTICE
Possible transport damage
If the shipment was damaged during transport, document all damage
carefully and contact the responsible carrying agent immediately.
Indicators
Two shock indicators (A) are attached to the side of the X-ray unit
packaging to indicate whether the unit was exposed to a shock during
transport.
● White indicator: No shock
● Red indicator: Shock
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Sirona Dental Systems GmbH 4Delivery and transport
Installation Manual ORTHOPHOS SL4.2Delivery
Tilt indicators (B) are attached to the X-ray unit and cephalometer
packaging to indicate whether the units were improperly transported.
● Red indicator: Improper transport
The display of improper transport doesn't necessarily mean that the unit
is damaged.
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Make a note on the delivery slip that the indicator is activated. Ensure that
the driver from the transport company confirms this on the delivery slip.
Fax the delivery slip to the Sirona Customer Service Center (CSC).
Enter the state of the indicators in the startup report in the case of
warranty claims.
Disposal of packaging materials
Disposal of packaging materials
Return the packaging materials to Sirona or dispose of them in
compliance with the legal regulations applicable in your country.
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4Delivery and transportSirona Dental Systems GmbH
A
A
G
F
C
B
D
E
4.2DeliveryInstallation Manual ORTHOPHOS SL
4.2.1ORTHOPHOS SL
Dimensions and weight
DimensionsLengthWidthHeight
in cm19969122
in inches78 3/427 1/848
Weightin kg186
in lbs410
Scope of supply
The packaging of the X-ray unit is designed both for protection during
transport and as an installation aid. Therefore, please remove only the
surrounding packaging prior to installation. Please leave the Styrofoam
packaging and transport pallet attached to the unit. Save the two lateral
styrofoam packaging parts for later use as an installation aid (A).
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