Dentsply Sirona Orthophos E User manual

New as of:
Installation Requirements
03.2019
Orthophos E /
Orthophos E Ceph
English
=
Title page

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Table of contents Dentsply Sirona
Installation Requirements Orthophos E
Table of contents
1General data............................................................................................................ 4
1.1 Notes on the installation requirements......................................................... 4
1.2 Structure of the document............................................................................ 5
1.2.1 Identification of the danger levels.................................................... 5
1.2.2 Formats and symbols used ............................................................. 5
2Safety instructions ................................................................................................... 6
2.1 Product safety .............................................................................................. 6
2.2 Combination with other units........................................................................ 6
2.3 On-site radiation protection .......................................................................... 6
2.4 Radiotelephones .......................................................................................... 6
2.5 Electromagnetic compatibility....................................................................... 6
2.6 Electrical installation..................................................................................... 7
3Checklist of installation prerequisites ...................................................................... 8
3.1 Purpose of the checklist ............................................................................... 8
3.2 Persons or companies performing inspection .............................................. 9
3.3 Construction requirements ........................................................................... 11
3.4 IT Hardware.................................................................................................. 14
3.4.1 Requirements for X-ray image PC Orthophos E ............................. 14
3.4.2 Additional IT hardware requirements .............................................. 15
3.5 Network ........................................................................................................ 17
3.6 Data processing ........................................................................................... 18
3.7 List of measures........................................................................................... 21
4Preparations ............................................................................................................ 22
4.1 Installation options........................................................................................ 22
4.2 Mounting options.......................................................................................... 24
4.3 On-site installation: Schematic diagram ....................................................... 25
4.4 Emergency stop switch (if legally required).................................................. 27
4.5 On-site installation for PC/networks ............................................................. 29
4.6 For USA and Canada................................................................................... 31
4.6.1 Emergency Stop for Canada........................................................... 32

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Dentsply Sirona Table of contents
Installation Requirements Orthophos E
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5Dimensions, technical data...................................................................................... 33
5.1 Dimensions 1:20 Orthophos E ..................................................................... 33
5.1.1 Top view.......................................................................................... 33
5.1.2 Front view........................................................................................ 34
5.1.3 Top view with floor stand................................................................. 35
5.1.4 Front view with floor stand............................................................... 36
5.1.5 Top view with Ceph left ................................................................... 37
5.1.6 Front view with Ceph left................................................................. 38
5.2 Technical data.............................................................................................. 39
5.2.1 Unit data.......................................................................................... 39
5.2.2 Transport, storage, and operating conditions.................................. 39
5.2.3 Weight and packaging..................................................................... 40
5.2.4 Certification and registration............................................................ 40
6Electromagnetic compatibility.................................................................................. 41
6.1 Accessories .................................................................................................. 41
6.2 Electromagnetic emission ............................................................................ 42
6.3 Immunity to interference............................................................................... 43
6.4 Working clearances...................................................................................... 46

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1General data Dentsply Sirona
1.1Notes on the installation requirements Installation Requirements Orthophos E
1General data
1.1 Notes on the installation requirements
This document describes the installation requirements for the X-ray units:
Orthophos E,
Orthophos E Ceph
Subsequent installation is described in the:
Orthophos E Installation Instructions REF 67 10 961

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Dentsply Sirona 1General data
Installation Requirements Orthophos E 1.2Structure of the document
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1.2 Structure of the document
1.2.1 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.
1.2.2 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.
NOTE
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
Requests you to do something.
See "Formats and symbols used
[→5]"
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Safety instructions Dentsply Sirona
2.1Product safety Installation Requirements Orthophos E
2Safety instructions
2.1 Product safety
2.2 Combination with other units
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.
2.3 On-site radiation protection
When using the Orthophos E X-ray unit, proper shielding of the room and
operator position is essential.
It is the installer's responsibility to ensure that all local radiation
regulations and safety measures are met.
2.4 Radiotelephones
Mobile RF communication equipment, including accessories, should not
be used at a low level to the unit. Non-compliance can lead to a reduction
in the performance features of the unit.
2.5 Electromagnetic compatibility
The device should not be operated immediately adjacent to other
devices. If this proves to be unavoidable, the unit should be monitored to
ensure that it is operating properly.
For details, see section Electromagnetic compatibility
CAUTION
Product safety hazard
For reasons of product safety, this product may be operated only with
original Dentsply Sirona accessories or third-party accessories
expressly approved by Dentsply Sirona.
The user is responsible for any damage resulting from the use of non-
approved accessories.
Recommendation! If any devices not approved by Dentsply Sirona are
connected, they shall comply with the applicable standards:
- IEC 60950 / IEC 62368-1 for information technology equipment
(e.g. PC)
- IEC 60601-1 for medical electrical equipment
In case of doubt, contact the manufacturer of the system components.

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Dentsply Sirona 2Safety instructions
Installation Requirements Orthophos E 2.6Electrical installation
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2.6 Electrical installation
The electrical installation must be made in compliance with DIN VDE
0100-710.

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3Checklist of installation prerequisites Dentsply Sirona
3.1Purpose of the checklist Installation Requirements Orthophos E
3Checklist of installation prerequisites
3.1 Purpose of the checklist
We recommend performing an inspection of the circumstances on location 4 weeks prior to installation.
This can help ensure a smooth procedure on the day that the Orthophos E device is actually installed. The checklist
of this document contains the most important items to take into consideration.
An installed and executable version of the Sidexis 4 X-ray software must be installed as a prerequisite to operating
the Orthophos E unit.

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Dentsply Sirona 3Checklist of installation prerequisites
Installation Requirements Orthophos E 3.2Persons or companies performing inspection
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3.2 Persons or companies performing inspection
List of the persons/companies performing inspection on location:
Specialized dealers:
Date of the inspection:
Present/company:
Present/company:
Present/company:
Installation site / practice / clinic:
Last name, first name:
Street:
Postal code / city:
Phone:
E-mail:
@
Special field of system owner:

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3Checklist of installation prerequisites Dentsply Sirona
3.2Persons or companies performing inspection Installation Requirements Orthophos E
List of contact persons on-site:
Function First name/Last
name:
Phone Cell phone Email
Service engineer
IT specialist
Specialist advisors
Administrator
Expert
Clinic engineer
Professor
Dentist
Day/date of planned installation:
Time:
Installation postponement to
day/date (if applicable):
Time

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Dentsply Sirona 3Checklist of installation prerequisites
Installation Requirements Orthophos E 3.3Construction requirements
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3.3 Construction requirements
Transport paths ☑
● Clarify and/or walk along unit transport path from delivery
location to installation site, measuring doorways and
passageways
(For dimensions/weight, see Weight and packaging [ → 40])
Transport path OK?
☐ Yes ☐ No
● Elevator available and large enough for transporting the unit?
☐ Yes ☐ No
● Are appropriate transport personnel provided?
☐ Yes ☐ No
● Person responsible:
● Remarks / tasks:

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3Checklist of installation prerequisites Dentsply Sirona
3.3Construction requirements Installation Requirements Orthophos E
Installation location ☑
● Installation location:
Unit location:
Building number:
Room name/number:
● Is the room large enough?
(see section Dimensions 1:20) ☐ Yes ☐ No
● Radiation protection plan available?
☐ Yes ☐ No
ATTENTION!
If the room height is less than 2.27 m (89 3/8") or 2.30 m (90 1/2") for
installation with the floor stand, the maximum travel height must be
limited.
● Room height measures at least 2100 mm (82 3/4")?
Maximum unit height without floor stand 2249 mm (88 1/2")
Maximum unit height with floor stand 2279 mm (89 1/4")
☐ Yes ☐ No
● Is there a floor heating system?
If yes, use 2nd wall bracket. ☐ Yes ☐ No
● Is there carpet at the unit's installation location?
If yes, remove carpet from under the unit. ☐ Yes ☐ No
● Information about the characteristics/material of the wall
available?
If possible perform test drilling! ☐ Yes ☐ No
● Required extraction forces ensured?
(for wall plugs, see Installation options) ☐ Yes ☐ No
ATTENTION!
If the condition of the wall is not sufficient, a floor stand can be used.
The upper wall fastening for immobilizing the unit is absolutely
essential when installing it on the floor stand!
● Installation on the wall with or without floor stand
(see Mounting options)? ☐ with ☐ without
● Temporary storage facilities for the styrofoam parts available?
The unit should be brought to the installation location with the
styrofoam parts; one of the installation aids should also be
available. These should be temporarily stored until collection. ☐ Yes ☐ No
● Remarks / tasks:

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Dentsply Sirona 3Checklist of installation prerequisites
Installation Requirements Orthophos E 3.3Construction requirements
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Electrical connection: ☑
● Fusing of the unit termination 3x2.5 mm2 (14 AWG) 230/ B25A,
for 3x1.5mm2 (16AWG) B16A/B20A only the Orthophos E may
be connected.
☐ Yes ☐ No
● Checked internal line resistance? (Max. 0.8 ohms)
☐ Yes ☐ No
● Connection option available for second protective ground wire?
If no connection option is available, one must be retrofitted! ☐ Yes ☐ No
● Other large electrical units (e.g. air conditioning systems, fan
motors) in the vicinity?
If yes, which (EMC influences)? ☐ Yes ☐ No
● Clearance of the large electrical units to Orthophos E?
__________________m
● Remarks / tasks:
Type of remote control installation: ☑
● Type of remote control required (see Installation options):
– In the room
– Outside without coiled cable
– Outside with coiled cable
☐ Yes
☐ Yes
☐ Yes
☐ No
☐ No
☐ No
● Ductwork available?
☐ Yes ☐ No
● Diameter of the ductwork?
(Min. diameter 10mm (3/8")) __________________mm
● Removal? (Length of the special control cable supplied 15 m
(590 1/2")) __________________m
● Remarks / tasks:

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3Checklist of installation prerequisites Dentsply Sirona
3.4IT Hardware Installation Requirements Orthophos E
3.4 IT Hardware
For the requirements for the Sidexis 4 workstations and the Sidexis 4
server station, please refer to the system requirements for Sidexis 4
3.4.1 Requirements for X-ray image PC Orthophos E
Requirements for 2D X-ray image PC Fulfilled
Operating system ● Windows 7 Pro SP1 (64 bit)
● Windows 8.1 Pro (64 bit)
● Windows 10 Pro (64 bit)
☐
Processor > 2 GHz DualCore
☐
Main memory > 4 GB
☐
Hard disk > 5 GB of free hard disk space
☐
Graphics card >DirectX 9.0c graphics card (512 MB RAM dedicated or Intel Onboard graphics
with the latest graphics card driver) ☐
Screen resolution Minimum 1280x1024 pixels
☐
Drive ● DVD ROM
● DVD RAM (to use Wrap & Go) ☐
Screen Suitable for diagnosis applications
☐
Software ● Acrobat Reader, contained on DVD
(required for the PDF test report function) ☐
IMPORTANT
An Internet connection is required from Windows 8.1. Also, the most up-
to-date patch level is a prerequisite for every operating system. For the
64-bit operating systems, installation under bootcamp is also approved.
IMPORTANT
The Intel on-board graphics card does not have its own graphics
memory and uses the RAM of the PC.

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Dentsply Sirona 3Checklist of installation prerequisites
Installation Requirements Orthophos E 3.4IT Hardware
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3.4.2 Additional IT hardware requirements
Workstations / X-ray image PC ☑
● Is a diagnostic monitor available?
At least one diagnostic monitor must be available in the practice. ☐ Yes ☐ No
● Number of planned Sidexis 4 workstations
It is advisable to position the X-ray image PC near the Orthophos
E.
__________________workstations
● Is a switch available? ☐ Yes ☐ No
● Remarks / tasks:
SQL/Fileserver ☑
● Are Sidexis databases already installed?
☐ Yes ☐ No
● If yes, which version of the Sidexis database?
(Patients.paf, Pdata.mdb, SQL-Express or SQL)
___________________________________
● Is migration necessary?
☐ Yes ☐ No
● SQL server available?
Microsoft SQL-Express is included in the scope of supply!
– SQL-Server version
– SQL-Server name
☐ Yes
________________
________________
☐ No

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3Checklist of installation prerequisites Dentsply Sirona
3.4IT Hardware Installation Requirements Orthophos E
● File server installed (separate server for image database only)?
– Windows release with full access
– Operating system/version
– Name of computer
– IP address
– Processor performance (clock frequency)
– Available RAM?
– Available hard disk storage?
☐ Yes
☐ Yes
☐ No
☐ No
________________
________________
_____ . _____ . _____ . _____
________________
________________ GB
________________ GB
ATTENTION!
Network Attached Storage (NAS) units
The use of LINUX based Network Attached Storage (NAS) units for
PDATA can cause problems.
● Remarks / tasks:
SQL/Fileserver ☑

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Dentsply Sirona 3Checklist of installation prerequisites
Installation Requirements Orthophos E 3.5Network
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3.5 Network
Network ☑
● Network connection for Orthophos E available?
☐ Yes ☐ No
● Network connection available at all workstations?
☐ Yes ☐ No
● Network connection for the X-ray image PC available?
☐ Yes ☐ No
IMPORTANT!
It is advisable to locate the X-ray image PC near the Orthophos.
● Network configuration plan available?
☐ Yes ☐ No
● Have the network sockets been certified?
☐ Yes ☐ No
● Network certificate present?
☐ Yes ☐ No
● Network installation company?
● Remarks / tasks:

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3Checklist of installation prerequisites Dentsply Sirona
3.6Data processing Installation Requirements Orthophos E
3.6 Data processing
IP addresses / firewall ☑
● TCP/IP address range
______ . ______ . ______ . ______ - ______ . ______ . ______ . ______
● Subnet mask
______ . ______ . ______ . ______
● Are addresses already defined/present?
☐ Yes ☐ No
● Is there a DCHP server (dynamic TCP/IP address assignment)?
☐ Yes ☐ No
ATTENTION!
A static address is required for the Orthophos and the X-ray image
PC! It must not lie in the dynamic address range!
● Orthophos E
______ . ______ . ______ . ______
● X-ray image PC:
______ . ______ . ______ . ______
● Sidexis 4 workstations:
______ . ______ . ______ . ______ - ______ . ______ . ______ . ______
● Standard gateway:
______ . ______ . ______ . ______
● Antivirus software available?
☐ Yes ☐ No
● Is a firewall installed?
– Software or hardware firewall?
☐ Yes
☐ SW
☐ HW
☐ No
● Remarks / tasks:

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Dentsply Sirona 3Checklist of installation prerequisites
Installation Requirements Orthophos E 3.6Data processing
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IP addresses / firewall ☑
● The following ports must be open for configuration and operation!
● Orthophos E 12835
12836
12837
12838
12839
443
● X-ray image PC 52837
● Sidexis 4 server 42916
42927
42928
● Remarks / tasks:
Practice administration programs ☑
● Are connections to the practice administration programs, etc.
installed? ☐ Yes ☐ No
● If yes, which system (manufacturer + name)?
● Remarks / tasks:

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3Checklist of installation prerequisites Dentsply Sirona
3.6Data processing Installation Requirements Orthophos E
DICOM ☑
● Is a DICOM installation already present?
– Which version?
– Configuration?
☐ Yes
________________
________________
☐ No
● Is a DICOM connection required?
☐ Yes ☐ No
● If yes, what is required?
– SIDICOM WLS or QR
Which functionalities should be supported?
In this case, the DICOM questionnaire must be completed!
– DICOM Removable Media (included in delivery)
☐ Yes
☐ Yes
☐ No
☐ No
● Remarks / tasks: