1.6 Data processing ..................................................................................................................... 17
1.7 Action list ............................................................................................................................... 19
êÉ~Çó
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5
1 Installation requirements checklist Sirona Dental Systems GmbH
Installation Requirements ORTHOPHOS XG 3D/3D
ready
1.1 Purpose of this checklist
We recommend checking the local conditions 4 weeks prior to the date of installation.
This will help ensure a smooth workflow when the ORTHOPHOS XG 3D/3D
ready
unit is actually ins-
talled. The most important points to be observed are specified in the checklist contained in this
document.
• Clarify and/or walk along unit transport path from delivery location to
installation site, measuring doorways and passageways (Dimensions/
weight, see 3.5)
Transport path OK?
• Elevator available?
• Provide appropriate transport personnel!
• Person responsible:
• Remarks/Tasks:
yes no
yes no
yes no
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1 Installation requirements checklistSirona Dental Systems GmbH
ATTENTION
Installation Requirements ORTHOPHOS XG 3D/3D
,
ready
1.3 Structural prerequisites
Transpor t path :
• Transport path:
Unit location:
Building number:
Room name/number:
• Is the room large enough? (see 3.1)
• Is a radiation protection plan available?
• Measured room height 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
yes no
yes no
• Floor heating installed?
• If so, use 2nd wall bracket
• Carpeting at system site?
If so, remove carpeting underneath system.
• Info available on wall material?
Perform test drilling if necessary!!
• Required extraction forces (wall plugs see 2.2) ensured?
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 2.3)?
• Intermediate storage possibilities available for styrofoam parts?
The unit should be brought to the installation site with the styrofoam parts,
one of the installation aids should also be present. They must be temporarily
stored until they are shipped.
• Is a diagnostic monitor available?
At least one diagnostic monitor must be available in the practice.
• Number of treatment centers planned (viewing PCs)
It is advisable to locate a treatment center PC (viewing PC) near the
ORTHOPHOS XG 3D/3D
exposure.
ready
for the purpose of readying the unit for
_________piece
• Plan/determine location of RCU (room)
• Is a switch installed?
1GBit
• Remarks/Tasks:
yes no
yes
100MBit
no
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1 Installation requirements checklistSirona Dental Systems GmbH
ATTENTION
Installation Requirements ORTHOPHOS XG 3D/3D
ready
1.4 IT hardware
SQL/Fileserver
• Are SIDEXIS databases already installed?
• f so, which version of the SIDEXIS database?
(Patients.paf, Pdata.mdb, SQL-Express or SQL)
• Is migration necessary?
• SQL Server installed?
Microsoft SQL Express is included in the scope of supply!
yes no
yes no
yes
no
– SQL Server version
– SQL Server name
• File server installed (separate server for image database only)?
– Windows release with full access
– Operating system/version
– Name of computer
– IP adress
– Processor speed (clock frequency)
– Available RAM?
– Available hard disk storage?
_________
_________
yes
yes
_________
_________
____ . ____ . ____ . ____
_________
________GB
________GB
• Estimated number of exposures (approx.) /
Approx. 500 MB per volume are currently stored in the database!_________
– Per month?
– Month x 12 = per year
– Approx. required storage space
– Depending on this, is a backup system available?
_________
_________
_______GB
yes
no
no
no
Network Attached Storage (NAS) units .
The use of LINUX based Network Attached Storage (NAS) units for PDATA
can cause problems. Adjustment problems with these units have
occurred in the past.
• Remarks/Tasks:
14D3352.021.03.04.02
– Is a backup system planned?
yes
no
63 03 551 D3352
Sirona Dental Systems GmbH1 Installation requirements checklist
NOTE
i
Installation Requirements ORTHOPHOS XG 3D/3D
ready
1.5 Network
Network
• The entire network should be configured with 1GBit Ethernet!
yes
–Cat 5 100Mbit/sec
no
– Cat 5e/Cat 6 1 Gbit/sec
• Network connection installed for ORTHOPHOS XG 3D/3D
• "Network connection installed on all treatment centers?
• "Network connection installed for RCU?
It is advisable to locate a treatment center PC near the
ready
ORTHOPHOS XG 3D/3D
for the purpose of readying the unit for
exposure.
• Network configuration plan available?
• "Have the network jacks been certified?
• "Network certificate available?
• "Network installation company?
• Remarks/Tasks:
ready
yes
?
yes no
yes no
yes no
yes no
yes no
yes no
no
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1 Installation requirements checklistSirona Dental Systems GmbH
2.4 Principle of On-site Installation .............................................................................................. 23
2.5 Emergency Stop (if required by law) ..................................................................................... 24
2.6 On-site Installation for PC/Networks ...................................................................................... 25
2.7 For USA and Canada ............................................................................................................ 26
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2 PreparationsSirona Dental Systems GmbH
DANGER
WARNING
CAUTION
NOTICE
NOTE
WARNING
CAUTION
WARNING
CAUTION
CAUTION
CAUTION
Installation Requirements ORTHOPHOS XG
2.1 Safety
Warning and safety information
To prevent personal injury and material damage, please
observe the warning and safety information provided in the
present operating instructions.
The content, appearance and use of warning and safety
information in Sirona documents are based on the ANSI
Z535 standard.
The following warnings may be used in this document:
An imminent danger that could result in serious bodily
injury or death.
A possibly dangerous situation that could result in serious bodily injury or death.
A possibly dangerous situation that could result in slight
bodily injury.
A possibly harmful situation which could lead to damage of
the product or an object in its environment.
Instructions for use
The following application information may be used in this
document:
For reasons of product safety, only original Sirona accessories approved for this product, or accessories
from third parties approved by Sirona, may be used.
The user is responsible for dangers resulting from the
use of non-approved accessories.
If any devices not approved by Sirona are connected,
they must comply with the applicable standards, e.g.:
• IEC 60950 for information technology equipment and
• IEC IEC 60601-1 for medical electrical equipment
In case of doubt, contact the manufacturer of the system components.
Any person who assembles or modifies a medical electrical
system complying with the standard IEC 60 601-1-1 (safety
requirements for medical electrical equipment) by combining it with other equipment (e.g. when connecting a PC) is
responsible for ensuring that the requirements of this regulation are met to their full extent for the safety of the patients,
the operators and the environment.
Proper shielding of room and operator position is essential.
Since these requirements vary from state to state it is
the assembler's / installer's responsibility that all local
radiation safety requirements are met.
Störung elektromedizinischer Geräte durch Funktelefone:
Application instructions and other important information.
Tip: Information on making work easier.
Zur Gewährleistung der Betriebsbereitschaft elektromedizinischer Geräte ist der Betrieb mobiler Funktelefone im
Praxis- oder Klinikbereich zu untersagen.Interference of
electromedical devices caused by radio telephones:
To ensure the operational readiness of electromedical devices, the use of mobile radio telephones in the practice or
hospital area is prohibited.
Electromagnetic compatibility: The unit should not be operated in the immediate vicinity of other devices. If this
proves to be unavoidable, the unit should be monitored to
ensure that it is used properly.
The electrical installation must comply with local code requirements for electromedical systems, IEC 364-7-710.
63 03 551 D3352
20D3352.021.03.04.02
Sirona Dental Systems GmbH2 Preparations
CAUTION
3.
1.2.
Installation Requirements ORTHOPHOS XG
,
2.2 Possibilities of Installation
aЙмнлЕЬ
ready
1. ORTHOPHOS XG 3D/3D
control with release button on coiled cable in the
treatment room.
2. ORTHOPHOS XG 3D/3D
utside of X-ray room, without release button on coiled
cable.
Length of special control cable supplied: approx. 15m
(590 1/2“).
3. ORTHOPHOS XG 3D/3D
outside of X-ray room, with release button on coiled
cable.
® without remote
ready
with remote control1
ready
with remote control1
Wall plugs!
Every wall anchor for fixing the unit must be able to resist a
withdrawal force of 700N.
•Depending on the construction of the wall, suitable
special wall plugs must be obtained or an anchor plate
made.
1 With use of a door contact: run shielded 2-core cable
(24 AWG / 0.22 mm
When an X-ray warning lamp is used: run a 3-wire cable
2
1.5mm
CAUTION
A maximum load of 50 W is permissible and no additional
circuit may be connected.
(16 AWG),to the warning lamp.
2
) to the remote control.
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2 PreparationsSirona Dental Systems GmbH
1.3.2.
Standard versionOption 1Option 2
Installation Requirements ORTHOPHOS XG
,
2.3 Mounting options
Standard version
1. Wall-mounted installation with 1 wall holder and
floor fastening if both wall and floor installation are
possible on-site.
Option 1: with second wall holder
2. Wall-mounted installation with 2 wall holders (and
no floor fastening) if only wall installation is possible
on-site.
Option 2: with floor stand and wall holder
3. Installation using a floor stand and 1 wall holder, if it is
possible to mount the unit on the wall.
22D3352.021.03.04.02
63 03 551 D3352
Sirona Dental Systems GmbH2 Preparations
NOTICE
DANGER
WARNING
300
11 3/4”
Minimum height of
room 82 5/8”
(2100mm)
145
5 3/4”
40
1 1/2”
2.
1.
Remote Control
Cable opening
300
11 3/4”
1545
61”
1950
76 3/4”
Wall bracket
USA /
CANADA:
Wooden studs
410
16 1/2”
Center of
unit's column
3.
230
9”
150
6”
4.
600
23 5/8”
Minimum distance,
Ceph left
600
23 5/8”
Minimum distance,
Ceph right
Installation Requirements ORTHOPHOS XG
2.4 Principle of On-site Installation
aЙмнлЕЬ
1. Conduit for remote control
For concealed installation of the shielded control cable
(included in delivery), a conduit must be used.
∅ int. min. 10mm (1/2”), max. length admissible 13 m
(512”/43 feet)!
Only the provided control cable may be used. This cable will
be installed during installation of the unit. No other cable is
permissible.
2. Distributor box for remote control
A distributor box with strain relief capability must be
provided next/behind to the unit column.
Fixed connection!
The installation of a power plug instead of the prescribed fixed (hard-wired) connection violates international medical regulations and is prohibited.
In case of a fault, you would thus endanger the life and
limb of the patient, the operator or other persons.
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3. Distributor box with power cable and terminal strip
Recommendation: A separate three wire (N, L, PE, at
least 3 x 2,5 mm
power cable connected directly to the central
distribution panel with an overcurrent circuit breaker B
rated for 25 A should be used.
•For an on-site installation with 3 x 1,5 mm
3 x 2,5 mm
circuit breaker B rated for 16 A/20 A), it is permissible to
connect only the ORTHOPHOS XG 3D/3D
such units that cause no danger to the patients or to the
computer systems in case the automatic circuit breaker
is activated.
4. Install the installation socket for the second protective
ground wire.
Install the connection possibility for the second protective ground wire. Second protective ground wire is preassembled with a 5 - 2.5 DIN 46234 cable lug. For connection to a terminal the cable lug can be removed.
2
or 3 x 4 mm
2
(16 AWG / 14 AWG) and an overcurrent
2
(14 AWG or 12 AWG))
2
/
ready
or other
23
2 PreparationsSirona Dental Systems GmbH
CAUTION
3.
1.
Remote Control
Center of
unit's column
2.+4.
2.
LNPE
Emergency stop switch
Powe r cable
ORTHOPHOS XG 3D
second
protectiv ground wire
1.
1200 - 1500
47 - 59”
400 - 800
16 - 31”
300 - 400
12 - 16”
1000 - 1200
39 - 47”
Installation Requirements ORTHOPHOS XG
2.5 Emergency Stop (if required by law)
1. Install the emergency stop switches in the power cable.
Mount the switches so that they are easy to reach but
cannot be activated by mistake.
2. Distributor box with power cable and terminal strip
Recommendation: A separate three wire (N, L, PE, at
least 3 x 2,5 mm
power cable connected directly to the central
distribution panel with an overcurrent circuit breaker B
rated for 25 A should be used.
The cables to the emergency stop switches must
3.
have at least the same diameter as the power cable
24D3352.021.03.04.02
2
or 3 x 4 mm2 (14 AWG or 12 AWG))
•For an on-site installation with 3 x 1,5 mm
3 x 2,5 mm
circuit breaker B rated for 16 A/20 A), it is permissible to
connect only the ORTHOPHOS XG 3D/3D
such units that cause no danger to the patients or to the
computer systems in case the automatic circuit breaker
is activated.
4. Install the installation socket for the second protective
ground wire.
2
(16 AWG / 14 AWG) and an overcurrent
2
/
ready
or other
Install the connection possibility for the second protective
ground wire. Second protective ground wire is preassem-
.
bled with a 5 - 2.5 DIN 46234 cable lug. For connection to a
terminal the cable lug can be removed.
63 03 551 D3352
Sirona Dental Systems GmbH2 Preparations
ORTHOPHOS
3.1.
3.2.
4.
PE
4.
L25
5.
RCU
3.2.
RCU
NetworkNetwork
* The media converter is necessary if no fiber optic network with SC connectors is present.
Media converter *
SC Fiber optic cable SC → RJ45 Ethernet cable
Installation Requirements ORTHOPHOS XG
2.6 On-site Installation for PC/Networks
aЙмнлЕЬ
1. Length of patch cable supplied with media converter:
5 m (197“).
Reserve room for the media converter either behind the
column or near the PC. An electric outlet is required
for the media converter.
2. For concealed installation of the Ethernet cable, an
installation conduit must be used, internal diameter:
min. 21 mm (7/8“) (provide a sufficient bending radius
for a 4 cm (1 1/2“) long plug).
Provide for strain relief!
•Recommendation: To rule out interference, do not run
the cable together with other cables.
3. For RCU-Server, visualization PC, Monitors, switch etc.
(not included in the scope of supply) at least five wall
installed safety outlets are required.
4. Network: 1 Gbit Ethernet recommended.
Communication interface: RJ45 for LAN cable.
5. For PCs connected to an x-ray unit and standing in the
same room an additional protective ground wire
is required at IEC 60601-1-1 (4 mm
6 DIN 46234 CU).
2
with cable lug 4 –
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25
2 Preparations Sirona Dental Systems GmbH
Minimum
wire size
No.12 AWG
No.10 AWG
No.8 AWG
Wire run distance in feet
255075 100 125
Ground
3x AWG see chart
Distribution panel with an
overcurrent circuit breaker
rated for 25 A
Distributor box
Installation Requirements ORTHOPHOS XG
2.7 For USA and Canada
Wire Size for Power Line
•The unit is designed to operate on a nominal 200 240 VAC line.
Permitted line voltage variation ±10% .
On request, the local Electrical Utility Company will
perform a voltage regulation test to verify the line
quality.
•The distributor box should be installed in the position as
shown on page 23.
•To assure proper line quality, a separate three-core
grounded power cable connected directly to the
central distribution panel with an overcurrent circuit
breaker rated for 25 A must be used.
For an on-site installation with 14 AWG (3 x 2,5 mm
and an overcurrent circuit breaker rated for 20 A, it is
permissible to connect only the ORTHOPHOS XG 3D/
ready
or other such units that cause no danger to the
3D
patients or to the computer systems in case the
automatic circuit breaker is activated.
•The line voltage drop in the power supply circuit from
the central distribution panel to the distributor box
depends on length and size of wire.
Measure the distance from the central distribution
panel to the distributor box and select the correct wire
size, see chart.
2
)
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63 03 551 D3352
loqelmelp=ud=PaLPa
3 Dimensions, technical data
êÉ~Çó
3.1 Dimensions of the ORTHOPHOS XG 3D / 3D
3.2 Dimensions of the ORTHOPHOS XG 3D / 3D
3.3 Dimensions of the ORTHOPHOS XG 3D / 3D
3.4 Dimensions of the ORTHOPHOS XG 3D / 3D
3.5 Technical data ....................................................................................................................... 36
Voltage dips, short interruptions and variations
of the power supply
according to IEC
61000-4-11
± 8 kV air discharge
± 1kV for input and output lines
± 2kV power cables
± 1kV push-pull voltage
± 2kV push-pull voltage
<5% U
(>95% dip of U
for ½ period
T
)
T
40% UT for 5 periods
(60% dip of U
)
T
70% UT for 25 periods
(30% dip of U
)
T
<5% UT for 5sec.
(>95% dip of U
)
T
± 8kV air discharge
± 1kV for input and output lines
± 2kV power cables
± 1kV push-pull voltage
± 2kV push-pull voltage
<5% UT for ½ period
(>95% dip of U
40% UT for 5 periods
(60% dip of U
70% UT for 25 periods
(30% dip of U
<5% UT for 5sec.
(>95% dip of U
The customer or user of the UNIT should make sure that it
is used in such an environment.
lines
Floors should be made of wood or concrete or covered with ceramic tiling. If
the floor surface consists of synethetic
material, the relative humidity must be at
least 30%.
The quality of the supply voltage should
conform to the typical business or hospital environment.
The quality of the supply voltage should
conform to the typical business or hospital environment.
The quality of the supply voltage should
)
T
)
T
)
T
correspond to the typical business or
hospital environment.
If the user of the UNIT requires it to continue functioning following interruptions
of the power supply, it is recommended
to have the UNIT powered by an uninterruptible power supply or a battery.
)
T
bеЦдблЬ
Magnetic field of power
frequencies (50/60 Hz)
according to IEC
61000-4-8
Remarks: U
is the AC supply voltage prior to application of the test level.
T
3 A/m3 A/mThe power frequency magnetic fields
should correspond to the typical values
found in the relevant business and hospital environment.
40D3352.021.03.04.02
63 03 551 D3352
Sirona Dental Systems GmbH4 Electromagnetic compatibility
Portable and mobile radio equipment
must not be used within the recommended working clearance from the
UNIT and its cables, which is calculated
based on the equation suitable for the
relevant transmission frequency.
Recommended working clearance:
3V
3V
3V
eff
eff
eff
where P is the nominal transmitter output in watts (W) specified by the transmitter manufacturer and d is the
recommended working clearance in
meters (m).
The field strength of stationary radio
transmitters is based on a local investigation for all frequenciesb less than the
conformance level for all frequencies
Interference is possible in the vicinity of
equipment bearing the following graphic
symbol.
a
a
a
bеЦдблЬ
c
.
a. The higher frequency range applies at 80MHz and 800MHz.
b. The field strength of stationary transmitters such as the base stations of radio telephones and land mobile services,
amateur radio stations as well as AM and FM radio and television broadcasting stations cannot be accurately predetermined. An investigation of the location is recommended to determine the electromagnetic environment resulting from
stationary HF transmitters. If the field strength measured at the UNIT location exceeds the conformance level specified
above, the UNIT must be observed with respect to its normal operation at each application site. If unusual performance
characteristics are observed, it may be necessary to take additional measures such as reorientation or repositioning of
the UNIT.
c.A frequency range of 150kHz to 80MHz results in a field strength of less than 3V/m.
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41
4 Electromagnetic compatibilitySirona Dental Systems GmbH
d12,[]P=
d12,[]P=
d23,[]P=
Installation Requirements ORTHOPHOS XG 3D/3D
ready
4.4 Working clearances
Recommended working clearances between portable and mobile HF communication devices and
the UNIT
The UNIT is intended for operation in an electromagnetic
environment, where radiated HF interference is checked.
The customer or the user of the UNIT can help prevent
electromagnetic interference by duly observing the minimum distances between portable and/or mobile HF communication devices (transmitters) and the
values may vary according to the output power of the relevant communication device as specified above.
UNIT. These
Nominal transmitter output
[W]
0,010,120,120,23
0,10,380,380,73
11,21,22,3
103,83,87,3
100121223
For transmitters whose maximum nominal output is not
specified in the above table, the recommended working
clearance d in meters (m) can be determined using the
equation in the corresponding column, where P is the maximum nominal output of the transmitter in watts (W) specified by the transmitter manufacturer.
Annotation 1
The higher frequency range applies at 80 MHz and 800
MHz.
Annotation 2
These guidelines may not be applicable in all cases. The
propagation of electromagnetic waves is influenced by
their absorption and reflection by buildings, objects and
persons.
150kHz to 80MHz80MHz to 800MHz800 MHz to 2.5GHz
Working clearance according to transmission frequency [m]