Hologic selenia dimensions Technical manual

Selenia
®
Dimensions
®
Digital Mammography System
Digital Tomosynthesis System
Site Planning and Pre-Installation Guide
Part Number MAN-03169
Revision 005
December 2017

© 2012–2017 Hologic, Inc. Printed in the USA. This manual was originally written in English.
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Selenia Dimensions System Site Planning and Pre-Installation Guide
Table of Contents
MAN-03169 Revision 005 v
Table of Contents
List of Figures ________________________________________________________________ vii
List of Tables __________________________________________________________________ ix
1: Introduction and General Information___________________________________________1
1.1 Introduction.............................................................................................................................................................1
1.2 System Description.................................................................................................................................................2
1.2.1 Tubestand Overview................................................................................................................................2
1.2.2 Acquisition Workstation Overview .......................................................................................................3
1.3 System Location Considerations...........................................................................................................................4
1.4 Safety ........................................................................................................................................................................5
1.4.1 Isolation Integrity ..................................................................................................................................... 5
1.4.2 Shielding ....................................................................................................................................................5
1.4.3 Remote X-ray On/Power On Indicators.................................................................................................5
1.4.4 The X-ray Interlock...................................................................................................................................6
1.5 Compliance..............................................................................................................................................................7
1.5.1 Compliance Requirements ......................................................................................................................7
1.5.2 Compliance Statements ........................................................................................................................... 8
1.5.3 Electromagnetic Compatibility............................................................................................................. 10
2: Specifications and Reference Information ______________________________________15
2.1 Product Measurements ........................................................................................................................................ 15
2.1.1 Tubestand (Gantry with C-Arm)..........................................................................................................15
2.1.2 Universal Acquisition Workstation......................................................................................................16
2.1.3 Premium Acquisition Workstation ......................................................................................................17
2.1.4 Standard Acquisition Workstation.......................................................................................................18
2.2 Electrical Input ......................................................................................................................................................18
2.2.1 Tubestand ................................................................................................................................................ 18
2.2.2 Acquisition Workstation........................................................................................................................19
2.3 Operation and Storage Environment ................................................................................................................. 19
2.3.1 General Conditions for Operation........................................................................................................ 19
2.3.2 Storage Environment .............................................................................................................................19
2.4 Center of Gravity Reference ................................................................................................................................20
3: Site Planning Checklist _______________________________________________________25
4: Room Layout Worksheet ______________________________________________________44

Selenia Dimensions System Site Planning and Pre-Installation Guide
Table of Contents
MAN-03169 Revision 005 vii
List of Figures
Figure 1: Tubestand for Selenia®Dimensions®System ................................................................................................ 2
Figure 2: Acquisition Workstations................................................................................................................................. 3
Figure 3: Tubestand (Gantry with C-arm) Measurements......................................................................................... 15
Figure 4: Universal Acquisition Workstation Measurements ...................................................................................16
Figure 5: Premium Acquisition Workstation Measurements ....................................................................................17
Figure 6: Standard Acquisition Workstation Measurements ....................................................................................18
Figure 7: Gantry Center-of-Gravity Reference............................................................................................................. 20
Figure 8: Premium Acquisition Workstation Center-of-Gravity Reference ............................................................21
Figure 9: Standard Acquisition Workstation Center-of-Gravity Reference............................................................. 22
Figure 10: Universal Acquisition Workstation Center-of-Gravity Reference.......................................................... 23

Selenia Dimensions System Site Planning and Pre-Installation Guide
Table of Contents
MAN-03169 Revision 005 ix
List of Tables
Table 1: Electronic Emissions .........................................................................................................................................10
Table 2: Electromagnetic Immunity Part 1 ................................................................................................................... 10
Table 3: Electromagnetic Immunity Part 2...................................................................................................................12
Table 4: Separation Distances for RF Equipment ........................................................................................................13
Table 5: Room Requirements .........................................................................................................................................26
Table 6: Clearance Requirements ..................................................................................................................................28
Table 7: Power Requirements ........................................................................................................................................30
Table 8: Environmental Requirements..........................................................................................................................32
Table 9: Cable Requirements.......................................................................................................................................... 34
Table 10: Wireway and Threshold Requirements ....................................................................................................... 36
Table 11: X-Ray Shielding Requirements .....................................................................................................................38
Table 12: Mounting Requirements ................................................................................................................................ 40

Selenia Dimensions System Site Planning and Pre-Installation Guide
Chapter 1: Introduction and General Information
MAN-03169 Revision 005 Page 1
1: Introduction and General Information
1.1 Introduction
This guide, an aid for the Installation Coordinator responsible for site planning and
preparation, contains all product information, specifications, and directions necessary for
determining the installation requirements. All information in this guide is important and
relevant to the planning process.
Note
Refer to MAN-03170 for Mobile applications.
Note
The mounting diagrams provided in this manual are recommendations only; the final
responsibility for proper installation belongs to the Installation Coordinator.
Note
Ensure all installations meet local regulations. A licensed electrician must perform the
necessary electrical service.
Chapter 1

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Chapter 1: Introduction and General Information
Page 2 MAN-03169 Revision 005
1.2 System Description
1.2.1 Tubestand Overview
Figure 1: Tubestand for Selenia®Dimensions®System
Figure Legend
1. Tubestand (Gantry and C-arm)
2. Gantry
3. C-arm (Tube Arm and Compression Arm)
4. Tube Arm
5. Compression Arm

Selenia Dimensions System Site Planning and Pre-Installation Guide
Chapter 1: Introduction and General Information
MAN-03169 Revision 005 Page 3
1.2.2 Acquisition Workstation Overview
Figure 2: Acquisition Workstations
Figure Legend
1. Universal Acquisition Workstation
2. Premium Acquisition Workstation
3. Mobile Acquisition Workstation
4. Standard Acquisition Workstation

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Chapter 1: Introduction and General Information
Page 4 MAN-03169 Revision 005
1.3 System Location Considerations
The Site Planning Checklist on page 25 is set up to assist you with the following topics
when selecting a location for the system:
1. System component sizes and weight
•Flooring type for mounting and weight considerations
•Doorway clearance
•Installation space
•Relocation of equipment
2. Room size
•Movement clearance—Allocate space for patient and technologist movement.
Avoid obstructions in the room that hinder access to the unit controls or the
patient.
•Storage—Provide convenient storage for system accessories. If it is not possible
to store accessories within the exam room, arrange for safe storage close by.
3. Location for patient throughput
4. Power source requirements
•Interlocks (room, door, lights, and so on)
•Service access
5. Networking requirements (DICOM, PACS, and so on)
6. Physical and environmental requirements
7. Shielding requirements
8. Cabling and wireways

Selenia Dimensions System Site Planning and Pre-Installation Guide
Chapter 1: Introduction and General Information
MAN-03169 Revision 005 Page 5
1.4 Safety
1.4.1 Isolation Integrity
WARNING!
To correctly isolate the system, attach only approved accessories or
options to the system. Only approved personnel can change the
connections.
WARNING!
Keep a 1.5 meter safe distance between the patient and any non-patient
devices.
Do not install non-patient system components (like the Workflow
Manager, a diagnostic review workstation, or a hard copy printer) in
the Patient Area.
1.4.2 Shielding
Structural Shielding
A Medical Physicist should review the room walls in which this system is used to ensure
that the room meets local guidelines for radiation shielding. Refer to the table X-ray
Shielding Requirements in Chapter 3 of this document.
The Acquisition Workstation (AWS) Shield
The operator radiation shield attached to the Acquisition Workstation, provides a
minimum of 0.5 mm of lead equivalent attenuation.
1.4.3 Remote X-ray On/Power On Indicators
The system has provisions for remote lights which indicate when the system is On and
when x rays are being taken. These lights are usually installed outside the exam room,
above the door. Have a certified electrician install these lights.
The relay contacts are rated:
•10 A, 250 VAC (normally open)
•10 A, 30 VDC (normally open)

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Chapter 1: Introduction and General Information
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1.4.4 The X-ray Interlock
The X-ray Interlock connector at the rear of the Gantry provides a normally closed (NC)
contact (5V 10mA) for the Acquisition Workstation. When an external interlock is used
(for example a door or shield switch), a contact opens and an exposure cannot take place.
A switch closure on the contact must occur for an exposure to occur.
Note
If the X-ray Interlock is utilized, the state of the interlock contacts should be displayed
by visual means to the operator per IEC 60601-2-45:2011 (3rd Edition), Clause
203.6.2.1.101.

Selenia Dimensions System Site Planning and Pre-Installation Guide
Chapter 1: Introduction and General Information
MAN-03169 Revision 005 Page 7
1.5 Compliance
This section describes the mammography system compliance requirements and the
responsibilities of the manufacturer.
1.5.1 Compliance Requirements
The manufacturer has the responsibility for the safety, reliability, and performance of this
equipment with the following provisions:
•The electrical installation of the room meets all requirements.
•The equipment is used according to the User Guide.
•The assembly operations, extensions, adjustments, changes, or repairs are performed
only by authorized persons.
•The network and communication equipment is installed to meet IEC Standards. The
complete system (network and communications equipment and the mammography
system) must be in compliance with IEC 60601-1 and IEC 60601-1-1.
Caution:
Medical Electrical Equipment needs special precautions about EMC and must be
installed, put into service and used according to the EMC information provided.
Caution:
Portable and mobile RF communications can affect medical electrical equipment.
Caution:
The use of unauthorized accessories and cables can result in increased emissions or
decreased immunity. To keep the isolation quality for the system, attach only
approved Hologic accessories or options to the system.
Caution:
The Medical Electrical (ME) Equipment or ME System should not be used adjacent to
or stacked with other equipment. If adjacent or stacked use is necessary, make sure
that the ME Equipment or ME System operates correctly in this configuration.
Caution:
This system is intended for use by healthcare professionals only. This system may
cause radio interference or may disrupt the operation of nearby equipment. It may be
necessary to take mitigation measures, such as re-orienting or relocating the
equipment or shielding the location.

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Chapter 1: Introduction and General Information
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Caution:
Changes or modifications not expressly approved by Hologic could void your
authority to operate the equipment.
Caution:
This equipment has been tested and found to comply with the limits for a Class A
digital device, pursuant to part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference when the equipment is
operated in a commercial environment. This equipment generates, uses, and can
radiate radio frequency energy and, if not installed and used in accordance with the
instruction manual, may cause harmful interference to radio communications.
Operation of this equipment in a residential area is likely to cause harmful
interference in which case the user will be required to correct the interference at his
own expense.
1.5.2 Compliance Statements
The manufacturer states this device is made to meet the following requirements:
•CAN/CSA - ISO 13485-03 Medical Devices – Quality Management Systems –
Requirements for Regulatory Purposes (Adopted ISO 13485:2003 second edition,
2003-07-15)
•CAN/CSA C22.2 NO. 60601-1-08 Medical Electrical Equipment – Part 1: General
Requirements for Basic Safety and Essential Performance (Adopted IEC 60601-1:2005,
third edition, 2005-12), includes Corrigendum 1:2011; also CAN/CSA C22.2 NO.
601.1-M90 (R2005) Medical Electrical Equipment Part 1: General Requirements for
Safety
•EN 60601-1:2006 Medical Electrical Equipment. General Requirements for Basic
Safety and Essential Performance; also EN 60601-1:1990 +A1+A11+A12+A2+A13
Medical Electrical Equipment—General Requirements for Safety
•ETSI EN 300 330-1: V1.3.1, and ETSI EN 300 330-2: V1.5.1: 2006—Electromagnetic
compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Radio
equipment in the frequency range 9 kHz to 25 MHz and inductive loop systems in
the frequency range 9 kHz to 30 MHz
•ETSI EN 301 489-1: V1.6.1, and ETSI EN 301 489-3: V1.8.1: 2008—Electromagnetic
compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility
(EMC) standard for radio equipment and services
•FCC, 47 CFR Part 15, Subpart C, Section 15.225: 2009
•FDA, 21 CFR [Parts 820, 900 and 1020]
•IEC 60601-1 Ed. 3.0:2005 Medical Electrical Equipment – Part 1: General
Requirements for Basic Safety and Essential Performance; also IEC 60601-1 Ed.
2.0:1988 +A1+A2:1995 Medical Electrical Equipment—General Requirements for
Safety

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Chapter 1: Introduction and General Information
MAN-03169 Revision 005 Page 9
•IEC 60601-1-1Ed. 2.0:2000 Medical Electrical Equipment - Part 1-1: General
Requirements for Safety - Collateral Standard: Safety Requirements for Medical
Electrical Systems
•IEC 60601-1-2 Ed. 3.0:2007 Medical Electrical Equipment – Part 1-2: General
Requirements for Basic Safety and Essential Performance - Collateral Standard:
Electromagnetic Compatibility – Requirements and Tests
•IEC 60601-1-3 Ed. 2.0:2008 Medical Electrical Equipment – Part 1-3: General
Requirements for Basic Safety and Essential Performance –Collateral Standard:
Radiation Protection in Diagnostic X-Ray Equipment; also IEC 60601-1-3 Ed. 1.0:1994
Medical Electrical Equipment – Part 1: General Requirement for Safety -3. Collateral
Standard: Requirements for Radiation Protection in Diagnostic X-ray Equipment
•IEC 60601-1-4 Ed. 1.1:2000 Medical Electrical Equipment – Part 1-4: General
Requirements for Safety - Collateral Standard: Programmable Electrical Medical
Systems
•IEC 60601-2-28 Ed. 2.0:2010 Medical Electrical Equipment - Part 2-28: Particular
Requirements for the Basic Safety and Essential Performance of X-ray Tube
Assemblies for Medical Devices; also IEC 60601-2-28 Ed. 1.0:1993 Medical Electrical
Equipment – Part 2: Particular Requirements for the Safety of X-Ray Source
Assemblies and X-ray Tube Assemblies for Medical Diagnosis
•IEC 60601-2-32 Ed. 1.0:1994 Medical Electrical Equipment – Part 2: Particular
Requirements for the Safety of Associated Equipment of X-ray Equipment
•IEC 60601-2-45 Ed. 3.0:2011 Medical Electrical Equipment – Part 2-45: Particular
Requirements for Basic Safety and Essential Performance of Mammographic X-Ray
Equipment and Mammographic Stereotactic Devices; also IEC 60601-2-45 Ed.
2.0:2001 Medical Electrical Equipment Part 2-45: Particular Requirements for the
Safety of Mammographic X-ray Equipment and Mammographic Stereotactic Devices
•RSS-210: Issue 7, 2007 Radio Standards Specification Low-power License-exempt
Radiocommunication Devices: Category I Equipment
•ANSI/AAMI ES60601-1:2005 (IEC 60601-1:2005, MOD) Medical Electrical Equipment,
Part 1: General Requirements for Basic Safety and Essential Performance, includes
amendment (2010); also UL 60601-1 1st Edition: Medical Electrical Equipment, Part
1—General Requirements for Safety

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Chapter 1: Introduction and General Information
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1.5.3 Electromagnetic Compatibility
This section provides information about the electromagnetic compatibility of system per
IEC 60601-1-2.
Table 1: Electronic Emissions
Electromagnetic Emissions
The system is intended for use in the electromagnetic environment specified below. The customer or the
user of the system should assure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1 The system uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class A Meets Class A Compliance.
The system is suitable for use in all establishments other
than domestic, and those directly connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Table 2: Electromagnetic Immunity Part 1
Electromagnetic Immunity – Part 1
The system is intended for use in the electromagnetic environment specified below. The customer or the
user of the system should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment -
Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV Contact
±8 kV Air
±6 kV Contact
±8 kV Air
Floors should be wood, concrete,
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
Electrical fast
transient/ burst
IEC 61000-4-4
±2 kV for power supply
lines
±1 kV for input/output
lines
±2 kV for power supply
lines
±1 kV for input/output
lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1 kV line(s) to line(s)
±2 kV line(s) to earth
±1 kV line(s) to line(s)
±2 kV line(s) to earth
Mains power quality should be
that of a typical commercial or
hospital environment.