Sirona Orthophos XG5 Installation manual

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ORTHOPHOS XG 5 / Ceph
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English
Sirona Dental Systems GmbH Installation Instructions ORTHOPHOS XG 5 / Ceph
General information
About this document
This document describes the installation of the ORTHOPHOS XG 5 panoramic X-ray unit in the following versions:
ORTHOPHOS XG 5 Digital unit
ORTHOPHOS XG 5 Ceph Digital unit with cephalometer
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For installation, please refer also to the following documents:
Installation drawings
"Installation Requirements" (separate document)
Operating Instructions
•Service Manual
Installation Report and Warranty Passport
SIDEXIS XG, Digital Radiography: Installation instructions
Our Customer Service Center can provide the technical documentation in paper form free of charge on request provided that the respective order numbers are specified correctly.
In addition, the latest documentation can always be down­loaded from the Sirona homepage:
www.sirona.com/HOME/Service/Technical Documentation
Changes since the last version 07.2013:
Chapter or section page
7.2 Checking the device leakage current .................... 79
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Contents
1 Before you begin ............................................................................................................... 5
1.1 Identification of warnings ......................................................................... 6
1.2 Safety....................................................................................................... 7
1.3 System versions ...................................................................................... 8
1.4 Sensor versions....................................................................................... 9
1.5 Dimensions/Space requirements........................................................... 10
1.6 Mounting options ................................................................................... 12
1.7 Installation versions ............................................................................... 13
2 Delivery and transport .................................................................................................... 15
2.1 Delivery.................................................................................................. 16
2.2 Transport to the installation site............................................................. 22
3 Installation: Panoramic X-ray unit ................................................................................. 25
3.1 Installation material................................................................................ 26
3.2 Required tools........................................................................................ 28
3.3 Wall mounting (standard/option 1)......................................................... 29
3.4 Installing the floor stand (option 2)......................................................... 36
3.5 Removing the transport safety device ................................................... 46
3.6 Installing the release button holder........................................................ 47
3.7 Attaching the covers .............................................................................. 48
4 Electrical connection ...................................................................................................... 51
4.1 Connecting the control cables (PAN)..................................................... 52
4.2 Connecting the line voltage ................................................................... 53
5 Installation: CEPH arm.................................................................................................... 55
5.1 Installation material/tools ....................................................................... 56
5.2 CEPH installation................................................................................... 57
5.3 Installing the secondary diaphragm ....................................................... 60
5.4 Connecting the control cables (CEPH) .................................................. 61
5.5 Final installation work ............................................................................ 63
6 Installation: Remote control........................................................................................... 65
6.1 Installation material/tools ....................................................................... 66
6.2 Mechanical installation........................................................................... 67
6.3 Connecting the control cables (REMOTE)............................................. 69
6.4 Connecting the door contact switch....................................................... 72
6.5 Connecting the X-ray warning lamp....................................................... 73
6.6 Final work .............................................................................................. 74
7 Safety checks................................................................................................................... 75
7.1 Checking the protective ground wires.................................................... 76
7.2 Checking the device leakage current..................................................... 79
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8 Initial startup.................................................................................................................... 81
8.1 Inserting the forehead and temple supports........................................... 82
8.2 Plugging in the sensor(s) ....................................................................... 83
8.3 Switching the units ON........................................................................... 84
8.4 Checking the data paths ........................................................................ 86
9 Startup for USA/Canada only ......................................................................................... 89
9.1 Startup, measurements and controls ..................................................... 90
9.2 Power supply adequacy ......................................................................... 91
9.3 Tube Current Verification ....................................................................... 92
9.4 kV – verification / Exposure Time Verification........................................ 95
9.5 Checking the laser for USA/Canada only............................................... 97
10 Checking and adjusting the unit.................................................................................... 99
10.1 Panoramic unit: Checking the adjustment............................................ 100
10.2 Adjusting the cephalometer.................................................................. 107
10.3 Checking and adjusting the alignment of the ear plugs ....................... 129
10.4 Resetting the adjustment ..................................................................... 135
11 Final work....................................................................................................................... 137
11.1 Attaching the profile covers.................................................................. 138
11.2 Selecting More details.......................................................................... 139
11.3 Declaration of Conformity..................................................................... 140
11.4 Unit handover....................................................................................... 141
12 Appendix ........................................................................................................................ 143
12.1 Service routines (for installation).......................................................... 144
12.2 Adjusting the panoramic X-ray unit ...................................................... 156
12.3 Demo mode.......................................................................................... 187
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ORTHOPHOS XG 5 / Ceph

1 Before you begin

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1 Before you begin Sirona Dental Systems GmbH
DANGER
WARNING
CAUTION
NOTICE
IMPORTANT

1.1 Identification of warnings Installation Instructions ORTHOPHOS XG 5 / Ceph

1.1 Identification of warnings
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 structure, 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 can result in serious bodily injury or death.
A possibly dangerous situation that can result in slight bodily injury.
A possibly harmful situation which can 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:
Application instructions and other important information.
Tip: Information on making work easier.
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Sirona Dental Systems GmbH 1 Before you begin
DANGER
WARNING
WARNING
WARNING
WARNING
CAUTION
NOTICE
NOTICE
NOTICE
Installation Instructions ORTHOPHOS XG 5 / Ceph 1.2 Safety
1.2 Safety
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.
Installation and startup must be carried out in accordance with the requirements stated in our Installation Instructions.
Installation and startup may be carried out only by personnel specifically authorized by SIRONA.
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 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.
If any equipment not approved by SIRONA is connected, it must comply with the applicable standards:
The unit contains class 1 lasers. A distance of at least 4" (10 cm) between eye and laser must be observed. 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.
Use an ESD wrist band during installation. Connect it to the protective ground wire.
When opening the unit: Please observe the usual precautionary measures for handling PCBs (ESD). Touch a ground point to discharge static electricity before handling any components.
Extreme fluctuations of temperature may cause condensation inside the unit. Do not switch the unit on before it has reached normal room temperature.
English
- IEC 60950-1 for information technology equipment and
- IEC 60 601-1 for medical electrical equipment.
See also “On-site installation, dimensions, technical data” and the “Compatibility list/Declaration of conformity” issued by the system integrator.
In case of doubt, contact the manufacturer of the system components.
Wireless phone interference with medical electrical equipment: To ensure safe operation of medical electrical equipment, the use of mobile wireless phones in practice or hospital environments is prohibited.
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1.
2.

1.3 System versions Installation Instructions ORTHOPHOS XG 5 / Ceph

1.3 System versions
1. ORTHOPHOS XG 5
Digital unit
2. ORTHOPHOS XG 5 Ceph
Digital unit with cephalometer
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Sirona Dental Systems GmbH 1 Before you begin Installation Instructions ORTHOPHOS XG 5 / Ceph 1.4 Sensor versions
1.4 Sensor versions
1. XG PAN sensor
Sensor for panoramic exposures (PAN)
2. XG CEPH sensor
Sensor for panoramic and cephalometric (ceph) exposures
English
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NOTICE
1.
NOTICE
These dimensions apply to installation of the X-ray unit without the floor stand. Installation with the floor stand results in an additional 30 mm (1 3/16") increase of all height dimensions.
1 Before you begin Sirona Dental Systems GmbH

1.5 Dimensions/Space requirements Installation Instructions ORTHOPHOS XG 5 / Ceph

1.5 Dimensions/Space requirements
1. ORTHOPHOS XG 5
The minimum ceiling height for an installation should be
2.10 m (82 11/16"). If the ceiling height is lower than 2.27 m (89 3/8") (max. travel height of 2.25 m (88 1/2")), the travel height of the unit must be adjusted or limited prior to startup of the unit (see section 12.1.8).
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2.
NOTICE
The dimensions specified here apply to installation of the X-ray unit without the floor stand. Installation with the floor stand results in an additional 30 mm (1 3/16") increase of all height dimensions.
Sirona Dental Systems GmbH 1 Before you begin Installation Instructions ORTHOPHOS XG 5 / Ceph 1.5 Dimensions/Space requirements
English
2. ORTHOPHOS XG 5 Ceph
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1 Before you begin Sirona Dental Systems GmbH
IMPORTANT
IMPORTANT
1. 3.2.
Standard version Option 1 Option 2

1.6 Mounting options Installation Instructions ORTHOPHOS XG 5 / Ceph

1.6 Mounting options
Standard version
(see section 3.3)
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
(see Section 3.3)
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
(see section 3.4)
3. Installation with floor stand for free installation anywhere in the room or if wall-mounted installation is not possible on-site (e.g. with lightweight walls).
If the unit is installed freely with a floor stand, the quality of the resulting X-ray exposures may be impaired, depending on the floor or surface conditions. Sirona therefore recommends additional fastening of the unit with an upper wall holder also when installing it with a floor stand.
If the unit is installed freely with a floor stand, CEPH installation is not permissible. When operating the unit with a floor stand and a cephalometer, an additional fastening with the upper wall holder is absolutely essential.
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Sirona Dental Systems GmbH 1 Before you begin
1. 2.
3.

Installation Instructions ORTHOPHOS XG 5 / Ceph 1.7 Installation versions

1.7 Installation versions
1. Standard installation:
ORTHOPHOS XG 5/Ceph without remote control with release button on the coiled cable in the
treatment room.
English
2. Installation version 1 (see section 6.3.1): ORTHOPHOS XG 5 / Ceph with remote control outside the X-ray room without release button on the
coiled cable.
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3. Installation version 2 (see section 6.3.2): ORTHOPHOS XG XG5/Ceph with remote control outside the X-ray room without release button on the
coiled cable.
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1.7 Installation versions Installation Instructions ORTHOPHOS XG 5 / Ceph
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ORTHOPHOS XG 5 / Ceph

2 Delivery and transport

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2 Delivery and transport Sirona Dental Systems GmbH
NOTICE
IMPORTANT
IMPORTANT
Dimensions (cm): 199 x 69 x 122
Weight: 177 kg (390 lbs)
(inches): 78 3/8 x 30 3/4 x 28 3/4

2.1 Delivery Installation Instructions ORTHOPHOS XG 5 / Ceph

2.1 Delivery
Possible transport damage! If the shipment was damaged during transport, document all damage carefully and contact the responsible carrying agent immediately.
All SIRONA equipment is carefully checked and packed prior to shipment. Please carry out an incoming inspection of the equipment in order to make sure that it was not damaged during transport.
2.1.1 ORTHOPHOS XG 5 panoramic X-ray unit
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 one of the lateral styrofoam packaging parts for later use as an installation aid A.
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Check the packaging and the equipment for visible signs of damage.
Check the shipment for completeness based on the attached “scope of supply” checklist.
Disposal: Return the packaging materials to SIRONA or dispose of them in compliance with the legal regulations applicable in your country.
Scope of supply
Panoramic X-ray unit
Profile cover (D)
•Sensor (B)
Accessories and hygienic protective covers (see pp. 18 ff.) (B)
Installation material (see section 3.1) (B)
Safety strap (B)
Remote control (optional) (C)
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A
A
B
Installation Instructions ORTHOPHOS XG 5 / Ceph 2.1 Delivery
Tw o shock indicators A are attached to the side of the packaging to indicate whether the unit was exposed to a shock during transport.
White indicator: No shock
Red indicator: Shock
A tilt indicator B that enables you to recognize whether the unit was transported improperly is also attached to the packaging.
Red indicator: Improper transport
The display of improper transport doesn't necessarily mean that the unit is damaged.
Make a note on the delivery slip that the indicator is activated. Have this confirmed on the delivery note by the driver of the transport company.
English
Fax the delivery note to the Sirona Customer Service Center (CSC).
Enter the state of the indicators in the startup report in the case of warranty claims.
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2 Delivery and transport Sirona Dental Systems GmbH
8.
13.
12.
10.
11.
14.
15.
7.
9.
Bar
Bite block
Bite block fixation
16.
Chin rest
Chin pad
2.1 Delivery Installation Instructions ORTHOPHOS XG 5 / Ceph
Accessories: Panoramic X-ray unit
1. Forehead (1x) and temple supports (2x)
2. Buttons (2x)
3. Temporomandibular joint supports 1 (1x) and 2 (1x)
4. Ear holders (4x)
5. Buttons TMJ (2x)
6. Chin rest accessories (1x)
– Bite block (5x) – Bite block fixation (1x) –Bar (1x) – Chin pad (1x) – Chin rest (1x)
7. Contact segment blue (1x)
8. Bite block blue (1x)
9. Contact segment standard yellow (1x)
10. Bite block standard yellow (1x)
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19.
18.
17.
20.
21.
22.
23.
Top sideBottom side
Installation Instructions ORTHOPHOS XG 5 / Ceph 2.1 Delivery
Hygienic protection: Panoramic X-ray unit
Hygienic protective sleeves for...
11. Forehead and temple supports (500x)
12. Bite block (500x)
13. Chin rest and bar (100x)
14. Bite blocks and contact segments (500x)
15. XG hygienic handle (100x)
English
Adjustment set: Panoramic X-ray unit
16. Panoramic needle phantom
17. Set of Torx offset screwdrivers
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2 Delivery and transport Sirona Dental Systems GmbH
IMPORTANT
IMPORTANT
Tilt indicator
2.+3. 1.
B
Dimensions (cm): 175x78x73
Weight: 40 kg (88 lbs)
(inches): 68 7/8 x 30 3/4 x 28 3/4
2.1 Delivery Installation Instructions ORTHOPHOS XG 5 / Ceph
2.1.2 CEPH arm
The cephalometer is a sensitive instrument. Please remove the styrofoam packaging B only following installation.
A tilt indicator that responds to improper transport is also attached to the packaging. Indicator red: Improper transport
However, an indication of improper transport does not
necessarily mean that the unit has been damaged. Make an entry on the delivery note stating that the indicator
is activated and have this confirmed on the delivery note by the driver of the transport company. Please also fax the delivery note to our Customer Service Center. The condition of the indicator must be recorded in the startup report for warranty claims.
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Scope of supply
1. Cephalometer with support arm
2. Accessories and hygienic protective covers
(see pp. 21 ff.)
3. Installation material (see section 5.1)
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20
30
40
50
4.
5.
7.
8. 6.
10.
9.
11.
Installation Instructions ORTHOPHOS XG 5 / Ceph 2.1 Delivery
Accessories: Cephalometer
4. Nose support (1x)
5. Ear plug holders with ear plug fastening (2x)
Adjustment set: Cephalometer
9. CEPH test phantom
10. Adjusting caps (1x black, 1x transparent)
English
6. Carpus support plate (1x)
Hygienic protection: Cephalometer
7. Hygienic protective sleeves for nose support (100x)
8. Hygienic caps for ear plugs (4x), sterilizable
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11. Torx offset screwdriver
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2 Delivery and transport Sirona Dental Systems GmbH
NOTICE
WARNING
IMPORTANT
NOTICE
IMPORTANT
1. 2.
A
B
short
long
C
D
D
E

2.2 Transport to the installation site Installation Instructions ORTHOPHOS XG 5 / Ceph

2.2 Transport to the installation site
2.2.1 Panoramic X-ray unit
If possible leave the packaging attached to the unit during transport in order to protect it against damage.
1. Transport with packaging attached (normal case)
– Open the surrounding packaging at the tabs
provided for that purpose (A), pull out the carrying handles (B), and transport the unit to the installation site.
When in transport position, the unit has a very high center of gravity. Take care that the unit does not tip over during transport.
2. Transport without pallet (exception)
If the pallet is too wide for transport to the installation site, you may unscrew the pallet from wooden support C and transport the unit by means of the wooden supports without the pallet.
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To do this, proceed as follows: – Remove the surrounding packaging, the two card-
board boxes, as well as the two lateral styrofoam parts.
– Loosen the four screws D.
The center styrofoam part should remain attached to the unit for protection. If this is not possible, SIRONA recommends securing the tube assembly in its position with the supplied strap prior to any further transport (see the label on the styrofoam packaging)!
Tighten the strap only loosely. Do not stretch!
– Pull the carrying handles B out of their holders and
insert them through the drillings of the wooden support C from the back.
– Insert screws D through the drillings E into the
drillings of the carrying handles to attach them firmly. Long or short.
The carrying handles have rims which prevent them from slipping out of the holes.
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IMPORTANT
IMPORTANT
1.
A
B
Installation Instructions ORTHOPHOS XG 5 / Ceph 2.2 Transport to the installation site
2.2.2 Cephalometer
1. Open the cardboard case and remove the styrofoam part (A).
The cephalometer is a sensitive instrument. Remove the styrofoam packaging B only following installation.
Lift the CEPH arm out of the cardboard case and transport it to the installation site.
Disposal: Return the packaging materials to SIRONA or dispose of them in compliance with the legal regulations applicable in your country.
English
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2.2 Transport to the installation site Installation Instructions ORTHOPHOS XG 5 / Ceph
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3 Installation: Panoramic X-ray unit

ORTHOPHOS XG 5 / Ceph
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3 Installation: Panoramic X-ray unit Sirona Dental Systems GmbH
1. 2.
for installation on wooden stud frame structures
for installation on wooden stud frame structures

3.1 Installation material Installation Instructions ORTHOPHOS XG 5 / Ceph

3.1 Installation material
Standard version
(see Section 3.3)
Option 1: with second wall holder
(see Section 3.3)
1. Wall/floor mounting – Hexagon wood screws 8x80 (5/16x3"): 4 pc. – Plastic wall plug S10: 2 pc. – Screw M8x30: 2 pc. –Washer 8.4: 6 pc. – Nut M8: 2 pc. – Screw M4x10: 3 pc. –Washer 4.3: 2 pc. – Mounting kit 10 SXR: 2 pc. – Torx offset screwdrivers TX10, TX20, TX25:
resp. 1 pc. – Offset Allen key (size 6): 1 pc. – Wall holder: 1 pc. – Cover for wall holder: 2 pc. – Intermediate piece: 1 pc. – Release button holder: 1 pc. – Handle: 1 pc. – Screw (for handle) M6x25: 1 pc.
2. Additional wall holder (for bottom wall mounting) – Wall holder: 1 pc. – Wood screws 8x80 (5/16x3"): 2 pc. –Washer 8.4: 3 pc. – Hexagon head screw M8x50: 1 pc. – Nut M8: 1 pc. – Mounting kit 10 SXR: 2 pc. – Profile clamp: 1 pc. – Cover for wall holder: 2 pc.
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3.
Option 2
Mounting hardware
Floor stand
Covers Floor stand
Cover Slide
Installation Instructions ORTHOPHOS XG 5 / Ceph 3.1 Installation material
Option 2: Floor stand installation
(see Section 3.4)
3. Floor stand installation – Floor stand – Floor stand covers – Wood screws 10x160 (3/8x6"): 5 pc. – Plastic wall plug S12: 5 pc. – Screw EM8x60: 2 pc. – Screw M8x80: 2 pc. – Washer 8.4: 2 pc.
– Nut M8: 2 pc. – Screw M10x50: 1 pc. – Profile clamp: 1 pc. – Screw M5x12: 1 pc. – Washer 10.5: 13 pc. – Nut M10: 4 pc. – Spring steel clamp: 8 pc. – Screw M10x25: 4 pc. – Wood screw M10x80 (3/8x3): 5 pc. – Mounting kit 10 SXR: 2 pc.
English
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3 Installation: Panoramic X-ray unit Sirona Dental Systems GmbH
1.
2.
3.
7.4.
5.
6.
8.
9.

3.2 Required tools Installation Instructions ORTHOPHOS XG 5 / Ceph

3.2 Required tools
1. Masonry drill
10mm (3/8")
2. Impact drill or percussion drill
3. Torx offset screwdriver*
–TX10 –TX20 –TX25
4. Open-end wrench – 13 mm A/F
5. Socket wrench – Wrench insert 13
6. Hammer
7. Center punch
8. Spirit level
9. Additional requirements for installation with floor stand:
– Masonry drill 12mm (1/2") – Allen key 6 mm – Socket wrench and extension
Wrench insert 17
Required measuring instruments
Multimeter or ammeter (battery-operated)
Test unit for device leakage current measurement, e.g. Bender tester or line-frequency, high-resistance measurement voltage source (isolation transformer) and measuring circuit (MD) that meets the requirements of IEC 60 601-1.
Power source for protective ground wire test Technical data:
– No-load voltage at least 4V - max. 24V – Short-circuit current at least 0.2A
* included in the scope of supply
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1.
2.
Sirona Dental Systems GmbH 3 Installation: Panoramic X-ray unit Installation Instructions ORTHOPHOS XG 5 / Ceph 3.3 Wall mounting (standard/option 1)
3.3 Wall mounting (standard/option 1)
English
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IMPORTANT
CAUTION
IMPORTANT
3.
B
C
D
3.3 Wall mounting (standard/option 1) Installation Instructions ORTHOPHOS XG 5 / Ceph
Remove profile cover A.
1. Position the two installation aids B at the foot C of the device and secure their position with adhesive tape.
CAUTION! The installation aids must be placed on top of each other in such a way that their openings lie on top of each other.
2. Set up the unit. To do this, tilt the transport pallet
upright.
If you have transported the unit on the wooden support without a pallet, set the unit upright with the wooden support. You can also use the lateral styrofoam packaging as a support with this variation.
3. Loosen the nuts B (with washers) on both sides of the
Remove the lower bolts first, followed by the upper bolts.
The nuts D on the unit may remain inside the unit when the threaded rods are removed. Remove the upper nuts. The lower nuts may remain in the unit.
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pallet (or the wooden support). Take off the pallet (or the wooden support). Remove the threaded bolt C.
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