Sirona Orthophos SL Installation requirements

kÉï=~ë=çÑW=
MPKOMNS
loqelmelp=pi=Oa=L=loqelmelp=pi=Oa=`ÉéÜ= loqelmelp=pi=Pa=L=loqelmelp=pi=Pa=`ÉéÜ
fелн~дд~нбзе=oЙимбкЙгЙенл
bеЦдблЬ
bеЦдблЬ
Title page
=
Sirona Dental Systems GmbH Table of contents
Installation Requirements ORTHOPHOS SL 2D / 3D

Table of contents

1
2
3
General data............................................................................................................. 5
1.1 Notes on the installation prerequisites .......................................................... 5
1.2 Structure of the document............................................................................. 6
1.2.1 Identification of the danger levels..................................................... 6
1.2.2 Formats and symbols used .............................................................. 6
Safety instructions .................................................................................................... 7
2.1 Product safety ............................................................................................... 7
2.2 Combination with other units......................................................................... 7
2.3 Shielding of room .......................................................................................... 7
2.4 Radiotelephones ........................................................................................... 7
2.5 Electromagnetic compatibility........................................................................ 7
2.6 Electrical installation...................................................................................... 7
Checklist of installation prerequisites ....................................................................... 8
3.1 Purpose of the checklist ................................................................................ 8
3.2 Persons or companies performing inspection ............................................... 9
3.3 Construction requirements ............................................................................ 11
bеЦдблЬ
3.4 IT Hardware .................................................................................................. 14
3.5 Network ......................................................................................................... 18
3.6 Data processing ............................................................................................ 19
3.7 List of measures............................................................................................ 22
4
Preparations ............................................................................................................. 23
4.1 Installation options ........................................................................................ 23
4.2 Mounting options........................................................................................... 25
4.3 On-site installation: Schematic diagram........................................................ 26
4.4 Emergency stop switch (if legally required)................................................... 28
4.5 On-site installation for PC/networks .............................................................. 30
4.6 For USA and Canada.................................................................................... 32
4.6.1 Emergency Stop for Canada............................................................ 33
3
Table of contents Sirona Dental Systems GmbH
Installation Requirements ORTHOPHOS SL 2D / 3D
5
Dimensions, technical data ...................................................................................... 34
5.1 Dimensions 1:20 ORTHOPHOS SL.............................................................. 34
5.1.1 Top view........................................................................................... 34
5.1.2 Front view......................................................................................... 35
5.1.3 Top view with floor stand.................................................................. 36
5.1.4 Front view with floor stand ............................................................... 37
5.1.5 Top view with Ceph left .................................................................... 38
5.1.6 Front view with Ceph left.................................................................. 39
5.1.7 Top view with Ceph right.................................................................. 40
5.1.8 Front view with Ceph right................................................................ 41
5.2 Technical data............................................................................................... 42
5.2.1 Unit data........................................................................................... 42
5.2.2 Operating and transport conditions .................................................. 42
5.2.3 Weight and packaging...................................................................... 42
5.2.4 Certification and registration ............................................................ 43
6
Electromagnetic compatibility................................................................................... 44
6.1 Accessories................................................................................................... 44
6.2 Electromagnetic emission ............................................................................. 44
6.3 Interference immunity.................................................................................... 45
6.4 Working clearances....................................................................................... 47
4 D3632.021.01.03.02 03.2016
64 95 183 D3632
Sirona Dental Systems GmbH 1General data
Installation Requirements ORTHOPHOS SL 2D / 3D 1.1Notes on the installation prerequisites

General data

1
1.1

Notes on the installation prerequisites

This document describes the installation conditions for the X-ray units ORTHOPHOS SL 2D, ORTHOPHOS SL 2D Ceph, ORTHOPHOS SL 3D, ORTHOPHOS SL 3D Ceph
Subsequent installation is described in the ORTHOPHOS SL Installation Instructions (REF 64 95 142).
bеЦдблЬ
5
1General data Sirona Dental Systems GmbH
1.2Structure of the document Installation Requirements ORTHOPHOS SL 2D / 3D
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 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.
IMPORTANT
Application instructions and other important information.
Tip: Information on making work easier.

1.2.2 Formats 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 [ → 6]"
● List Designates 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.
6 D3632.021.01.03.02 03.2016
64 95 183 D3632
Sirona Dental Systems GmbH 2Safety instructions
Installation Requirements ORTHOPHOS SL 2D / 3D 2.1Product safety

Safety instructions

2
2.1
2.2

Product safety

Product safety
CAUTION
Risk to product safety
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 assumes the risk of using non-approved accessories.
Recommendation If any equipment not approved by Sirona is connected, it should comply with the applicable standards:
- IEC 60950 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.

Combination with other units

Combination with other un its in accordance with IEC 60601-1 -1
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.
bеЦдблЬ
2.3
2.4
2.5
2.6

Shielding of room

Panoramic X-ray
When using the ORTHOPHOS SL 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.

Radiotelephones

Mobile RF communications equipment can affect electro-medical equipment. Therefore, the use of mobile wireless phones in medical office or hospital environments must be 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 operating properly.

Electrical installation

The electrical installation must be made in compliance with DIN VDE 0100-710.
7
3Checklist of installation prerequisites Sirona Dental Systems GmbH
3.1Purpose of the checklist Installation Requirements ORTHOPHOS SL 2D / 3D

Checklist of installation prerequisites

3
3.1
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 SL 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 SL unit.
DANGER! It cannot be used with the SIDEXIS XG version.

Purpose of the checklist

8 D3632.021.01.03.02 03.2016
64 95 183 D3632
Sirona Dental Systems GmbH 3Checklist of installation prerequisites
Installation Requirements ORTHOPHOS SL 2D / 3D 3.2Persons or companies performing inspection
3.2
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:

Persons or companies performing inspection

bеЦдблЬ
Street:
Postal code / city:
Phone:
E-mail:
Special field of system owner:
@
9
3Checklist of installation prerequisites Sirona Dental Systems GmbH
3.2Persons or companies performing inspection Installation Requirements ORTHOPHOS SL 2D / 3D
List of contact persons on-site:
Function First name/Last
Phone Cell phone E-mail
name:
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
10 D3632.021.01.03.02 03.2016
64 95 183 D3632
Sirona Dental Systems GmbH 3Checklist of installation prerequisites
Installation Requirements ORTHOPHOS SL 2D / 3D 3.3Construction requirements
3.3
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 [ → 42]) Transport path OK?
● Elevator available and large enough for transporting the unit?
● Appropriate transport personnel provided.
● Person responsible:
● Remarks/Tasks:

Construction requirements

☐ Yes ☐ No
☐ Yes ☐ No
☐ Yes ☐ No
bеЦдблЬ
11
3Checklist of installation prerequisites Sirona Dental Systems GmbH
3.3Construction requirements Installation Requirements ORTHOPHOS SL 2D / 3D
Installation site
● Installation location:
Unit location:
Building number:
Room name/number:
● Is the room large enough? (see Dimensions 1:20 ORTHOPHOS SL [ → 34] )
☐ 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 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
● Underfloor heating available? If yes, use 2 wall brackets.
☐ Yes ☐ No
● Is there carpet at the unit's installation location? If yes, remove carpet from under the unit.
● Information about the characteristics/material of the wall available? If possible perform test drilling!
● Required extraction forces ensured? (for wall plugs, see Installation options [ → 23])
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 [ → 25])?
● 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.
● Remarks/Tasks:
☐ Yes ☐ No
☐ Yes ☐ No
☐ Yes ☐ No
☐ with ☐ without
☐ Yes ☐ No
12 D3632.021.01.03.02 03.2016
64 95 183 D3632
Sirona Dental Systems GmbH 3Checklist of installation prerequisites
Installation Requirements ORTHOPHOS SL 2D / 3D 3.3Construction requirements
Electrical connection:
● Fusing of the unit termination 3x2.5mm2 (14 AWG) 230/ B25A,
2
for 3x1.5mm may be connected.
● Checked internal line resistance? (Max. 0.8 ohms)
● Connection option available for second protective ground wire? If no connection option is available, one must be retrofitted!
● Other large electrical units (e.g. air conditioning systems, fan motors) in the vicinity? If yes, which (EMC influences)?
● Clearance of the large electrical units to ORTHOPHOS SL?
● Remarks/Tasks:
(16AWG) B16A/B20A only the ORTHOPHOS SL
☐ Yes ☐ No
☐ Yes ☐ No
☐ Yes ☐ No
☐ Yes ☐ No
__________________m
Type of remote control installation:
● Type of remote control required (see Installation options [ → 23]):
– In the room
– Outside without coiled cable
– Outside with coiled cable
● Ductwork available?
● Diameter of the ductwork? (Min. diameter 10mm (3/8"))
● Removal? (Length of the special control cable supplied 15m (590 1/2"))
● Remarks/Tasks:
☐ Yes
☐ Yes
☐ Yes
☐ Yes ☐ No
__________________mm
__________________m
☐ No
☐ No
☐ No
bеЦдблЬ
13
3Checklist of installation prerequisites Sirona Dental Systems GmbH
3.4IT Hardware Installation Requirements ORTHOPHOS SL 2D / 3D
3.4

IT Hardware

Requirements for workstation PCs, service engineer
Requirements on workstation PCs when using a separate RCU
Requirements for 2D workstation
Operating system: ● Windows 7 Professional/Ultimate (64 bit)
● Windows 8.1 Professional (64 bit)
● Windows 10
IMPORTANT: An Internet connection is required from Windows 8.
Processor ≥ 2.3 GHz DualCore
with SSE3 support
Main memory ≥ 4 GB ≥ 8 GB ≥ 8 GB
Hard disk ≥ 500 GB free hard disk space
Graphics card DirectX 9.0c graphics card
(512 MB RAM dedicated or Intel Onboard graphics)
Graphics settings Minimum 1280x1024 pixels
Recommended 1600x1200 pixels
Drive ● DVD ROM
● DVD RAM (to use Wrap & Go)
Screen Suitable for diagnosis applications
Software ● Acrobat Reader 8.0, contained on DVD
(required for the PDF test report function)
Requirements for 3D workstation
≥ 2.3 GHz QuadCore
with SSE3 support
DirectX 10 graphics card (1GB RAM dedicated or Intel Onboard graphics) with WDDM driver 1.0 or higher
Requirements for 2D/3D workstation with panorama editor
≥ 2.3 GHz QuadCore
with SSE3 support
(16 GB recommended)
DirectX 10 graphics card (1GB RAM dedicated or Intel Onboard graphics) with WDDM driver 1.0 or higher
Fulfilled
14 D3632.021.01.03.02 03.2016
64 95 183 D3632
Sirona Dental Systems GmbH 3Checklist of installation prerequisites
Installation Requirements ORTHOPHOS SL 2D / 3D 3.4IT Hardware
Requirements on RCU hardware, service engineer
Requirements on RCU hardware
Requirements Fulfilled
Operating system: ● Windows 7 Professional/Ultimate (64 bit)
● Windows 8.1 Professional (64 bit)
● Windows 10
IMPORTANT: An Internet connection is required from Windows 8.
Processor ≥ 2.3 GHz QuadCore with SSE3 support, only intel ≥ i73xx
Main memory ≥ 16 GB
Hard disk ≥ 2 TB of free hard disk space
Graphics card Only for combined use as workstation on one PC, see above.
Drive ● DVD ROM
● DVD RAM (to use Wrap & Go)
bеЦдблЬ
Workstations/RCU
● Is a diagnostic monitor available? At least one diagnostic monitor must be available in the practice.
● Number of planned workstations It is advisable to locate a workstation PC near the ORTHOPHOS SL for the purpose of readying the unit for exposure.
● Plan/determine location of RCU (room)
● Is a switch available? ☐ Yes
● Remarks/Tasks:
☐ Yes ☐ No
__________________workstations
☐ 1 GBit
☐ No
15
Loading...
+ 35 hidden pages