3021 Mammography Hologic Dimensions Site Planning Guide

Artwork and Signature File for:
MAN-01120, MNL, SEL DIMENSIONS, SITE PLANNING GUIDE
Artwork consists of:
Thirty-Six (36) 8 inch x 11 inch sheet(s) attached.
REV AUTHORED BY DATE

A.TAMBASCIO 01/20/10
REV DRAFTED BY DATE
J. SHARP 01/20/10
PROPRIETARY INFORMATION: TITLE DOCUMENT NUMBER REV
The content of this document is the
exclusive property of Hologic and may MNL, SEL DIMENSIONS, SITE
not, without prior written permission of
AW-02832 002
Hologic, be reproduced, copied or used
PLANNING GUIDE
for any purpose whatsoever. ARTWORK SIZE A SHEET 1 OF 1
ENG-0034-T33, Rev. 002
Site Planning and Pre-Installation Guide
for Selenia Dimensions System
Part Number MAN-01120
Revision 002
January 2010
This manual is for permanent Selenia Dimensions installations.
For Mobile Selenia Dimensions installations, refer to MAN-01411.
Service Support:
USA: +1.877.371.4372
Europe: +32.2.711.4690
All Other: +1.781.999.7750
Corporate Headquarters Europe

(EU Representative)
35 Crosby Drive,
Bedford, MA 01730-1401 USA Hologic NV
Tel: +1.781.999.7300 Leuvensesteenweg 250A
Sales: +1.781.999.7453 1800 Vilvoorde, Belgium
Fax: +1.781.280.0668 Tel: +32.2.711.4680
www.hologic.com Fax: +32.2.725.2087
Refer to the corporate website for more facilities worldwide.
Copyright Hologic 2010. All rights reserved. Printed in USA. This manual was originally written
in English. Hologic and the Hologic Logo are trademarks or registered trademarks of Hologic, Inc. Other trademarks registered or used by Hologic and its divisions and
subsidiaries in the United States and other countries include: Dimensions, DSM, FAST Paddle, HTC, Lorad, MIMS plus, M-IV, MultiCare, ScoutMarc, SecurView, Selenia, Smart
Paddle, SmartWindow, StereoLoc, and TechMate. Microsoft and Windows are trademarks or registered trademarks of Microsoft Corporation in the United States and other
countries. Any other product and company names mentioned herein are the trademarks or registered trademarks of their respective owners.
Table of Contents
Table of Contents
Chapter 1Introduction and General Information 1

1.0 Introduction .......................................................................................................................................... 1
2.0 System Description ............................................................................................................................... 1
3.0 Room Layout Considerations ................................................................................................................ 2
4.0 Safety ................................................................................................................................................... 3
4.1 Isolation Integrity ........................................................................................................................... 3
4.2 Shielding ........................................................................................................................................ 3
4.3 Remote X-ray On/Power On Indicators .......................................................................................... 3
5.0 Compliance .......................................................................................................................................... 4
5.1 Compliance Requirements .............................................................................................................4
5.2 Compliance Statement ................................................................................................................... 4
Chapter 2Specifications and Reference Information 5

1.0 Unit Measurements .............................................................................................................................. 5
2.0 Electrical Input ..................................................................................................................................... 7
3.0 Environmental ...................................................................................................................................... 7
4.0 Center-of-Gravity Reference ................................................................................................................. 8
Chapter 3Site Planning Checklist 11

Room Requirements ................................................................................................................................... 11
Clearance Requirements ............................................................................................................................. 13
Power Requirements ................................................................................................................................... 15
Environmental Requirements ...................................................................................................................... 17
Cable Requirements ................................................................................................................................... 19
Wireway and Threshold Requirements ....................................................................................................... 21
X-Ray Shielding Requirements .................................................................................................................... 23
Mounting Requirements ............................................................................................................................. 25
Room Planning Templates 27
P/N MAN-01120 v
Table of Contents
vi P/N MAN-01120
Chapter 1Introduction and General Information
1.0 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-01411 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 services.
2.0 System Description
Figure 1-1: The Selenia Dimensions System
Legend for Figure 1-1
1. The Gantry
2. The C-Arm
3. The Acquisition Workstation
P/N MAN-01120 1
3.0 Room Layout Considerations

Chapter 3Site Planning Checklist is setup 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 clearanceAllocate space for patient and technologist movement. Avoid
obstructions in the room that may hinder access to the unit controls or the patient.
StorageProvide 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, etc.)
Service access
5. Networking requirements (DICOM, PACS, etc.)
6. Physical and environmental requirements
7. Shielding requirements
8. Cabling and wireways
2 P/N MAN-01120
4.0 Safety
4.1 Isolation Integrity
WARNING! To keep the isolation quality for the system, attach only
approved accessories or options to the system. Only the
authorized personnel can make changes to the connections.
WARNING! Keep a 1.5 meter safe distance between the patient and any
non-patient devices.
Non-patient system components (like the Workflow Manager,
the diagnostic review workstation, or the hard copy printer)
must not be installed in the Patient Area.
1.5m
4.2 Shielding
4.2.1 Structural Shielding
A Medical Physicist should review the room walls in which this system is used to
ensure the room meets local guidelines for radiation shielding.
4.2.2 The Operator Radiation Shield
The operator radiation shield, attached to the Acquisition Workstation, provides a
minimum of 0.5 mm of lead equivalent attenuation.
4.3 Remote X-ray On/Power On Indicators

Selenia Dimensions gives the user the ability to operate remote lights which indicate when
the system is On and when X-rays are being taken. These lights are normally installed outside
the exam room, above the door. Installation should be done by a certified electrician. The
relay contacts are rated:
10 A, 250 VAC (normally open)
10 A, 30 VDC (normally open)
P/N MAN-01120 3
5.0 Compliance
The following section details the mammography system compliance requirements and the
manufacturers responsibilities.
5.1 Compliance Requirements

The manufacturer is responsible for the effects of safety, reliability and performance of this
equipment with the following provisions:
The electrical installation of the room complies with the appropriate requirements.
The equipment is used in accordance with instructions for use.
Assembly operations, extensions, re-adjustments, modifications, or repairs are
performed by Hologic authorized personnel only.
The installed network and communications equipment must comply with an IEC
Standard and the complete installed system (network and communications equipment
and the Selenia Dimensions System) must comply with IEC 60601-1 and IEC 60601-1-1.
5.2 Compliance Statement

The manufacturer states that this device is manufactured/conforms to:
CAN/CSA ISO 13485:2003
EN 60601-1:1990 +A1+A11+A12+A2+A13 Medical Electrical EquipmentGeneral
Requirements for Basic Safety and Essential Performance
FDA, 21 CFR [Parts 820, 900 and 1020]
IEC 60601-1:1988 +A1+A2:1995 +A13:1996 Medical Electrical EquipmentGeneral
Requirements for Safety
IEC 60601-1-1:2000-12 Medical Electrical EquipmentCollateral Standard: Safety
Requirements for Medical Electrical Systems
IEC 60601-1-2:2001 Medical Electrical EquipmentCollateral Standard:
Electromagnetic Compatibility for Medical Electric Systems
IEC 60601-1-3:1994 Medical Electrical EquipmentCollateral Standard: Requirements
for Radiation Protection in Diagnostic X-ray Equipment
IEC 60601-1-4:1996 +A1:1999 Medical Electrical EquipmentCollateral Standard:
Programmable Electrical Medical Systems
IEC 60601-2-7:1998 Medical Electrical EquipmentParticular Requirements for the
Safety of High-Voltage Generators of Diagnostic X-ray Equipment
IEC 60601-2-28:1993-03 Medical Electrical EquipmentParticular Requirements for the
Safety of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis
Safety of Associated Equipment of X-ray Equipment
Safety of Mammographic X-ray Equipment and Mammographic Stereotactic Devices
UL 60601-1: Medical Electrical Equipment, Part 1General Requirements for Safety
CAN/CSA: Medical Electrical Equipment Part 1: C22.2 No. 601.1M90General
Requirements for Safety
4 P/N MAN-01120
Chapter 2Specifications and Reference Information
1.0 Unit Measurements
Figure 2-1: Tubestand Dimensions
Height 223 cm (87.8 in.) at highest C-arm travel

Width 66 cm (26 in.)
Depth 138 cm (54.25 in.)
Weight Maximum of 400 kg (882 lb)
P/N MAN-01120 5
207 cm
(81.5 in.)
92.7 cm
(36.5 in.)
58.5 cm
(23 in.)
Figure 2-2: Acquisition Workstation Dimensions

Height 207 cm (81.5 in.)
Width 92.7 cm (36.5 in.)
Depth 58.5 cm (23 in.)
Weight 154 kg (340 Ib)
6 P/N MAN-01120
2.0 Electrical Input

Tubestand
Mains Voltage 200/208/220/230/240 VAC 10%
Mains Impedance Maximum line impedance not to exceed
0.20 ohms for 208/220/230/240 VAC,
0.16 ohms for 200 VAC
Mains Frequency 50/60 Hz 5%
Average Current over 24 Hours <5A
Peak Line Current 65 A for 2 seconds
Acquisition Workstation
Mains Voltage 200/208/220/230/240 VAC 10%
Mains Frequency 50/60 Hz 5%
Power Consumption < 1000 watts
3.0 Environmental
General Conditions for Operation
Temperature Range 20 C to 30 C
Relative Humidity Range 10% to 80% Without condensing moisture
Storage Environment
Gantry
(Put in a package for storage in a building)
X-ray Detector
Temperature Range 10 C to 30 C indefinitely
10 C to 35 C for a maximum of 12 hours
Max. rate of temperature change Less than 10 C per hour
Acquisition Workstation
P/N MAN-01120 7
4.0 Center-of-Gravity Reference
Figure 2-3: Gantry Center-of-Gravity Reference
8 P/N MAN-01120
Figure 2-4: Acquisition Workstation Center-of-Gravity Reference
P/N MAN-01120 9
10 P/N MAN-01120
Chapter 3Site Planning Checklist

Room Requirements
Done
Item Requirements Actual Corrective Action
(Init/Date)
Room Size
Length 3.65 m (12 ft.)
Width 2.75 m (9 ft.)
Ceiling 2.44 m (8 ft.)
Door 203 x 76 cm (6.6 ft. x 2.5 ft.)
Notes: The exam room layout should be pre-planned before the arrival of the system. Refer to Room Layout Work Sheet, pg. 29. A typical room layout is shown
here. Check specific local or hospital requirements for additional data.
Legend
1. Phone Line
2. Wall Outlet for CAT 5 cable
3. 120 VAC Outlet
4. Wireway
5. Circuit Breaker
P/N MAN-01120 11
Additional Notes
Note # Topic Notes
P/N MAN-01120 12
Clearance Requirements
Minimum Done
Item Actual Corrective Action
Requirements (Init/Date)
Access Clearance
Acquisition 61 cm (2.0 ft.) on 3 sides
Workstation
Gantry Rear 30 cm (1 ft.)
Gantry Front 76 cm (2.5 ft.)
Work Area 76 x 76 cm diameter
(2.5 ft. x 2.5 ft.)
Working Clearance
Gantry with C-Arm 76.2 cm (30 in.) each side
of C-arm (for complete
C-arm rotation)
Work and Patient 76.2 cm (30 in.) diameter
Area (min) between Tubestand
and Acquisition Workstation
P/N MAN-01120 13
Additional Notes
Note # Topic Notes
P/N MAN-01120 14
Power Requirements
Done
(Init/Date)
Power Requirements
Dedicated Power Dedicated disconnect box
Line with lockout capability, circuit
breaker or fuse (per local
codes), and remote
emergency OFF trip switch if
required (the location is
determined by local codes).
Acquisition Refer to Chapter 2, Section

Workstation 2.0, page 7.
Light Indicator Relay 10 A, 250 VAC (N.O.)
Contact Ratings1 10 A, 30 VDC (N.O.)
Notes:
Refer to NEC Article 660X-ray Equipment
1 There are provisions in the system to accommodate local regulations that require an X-ray System Power-On, and X-ray On Indicators at the door. These
lights are normally installed above the door to the exam room.
P/N MAN-01120 15
Additional Notes
Note # Topic Notes
P/N MAN-01120 16
Environmental Requirements
Done
(Init/Date)
Environmental Requirements: Operating
Temperature Range 20 C to 30 C (68 F to 86F)
Relative Humidity 10% to 80% non condensing
Range
Notes:
P/N MAN-01120 17
Additional Notes
Note # Topic Notes
P/N MAN-01120 18
Cable Requirements
Done
(Init/Date)
Cables (Length)
Gantry Power Cable 7.5 m (25 ft.)
If Mains box is over 15 m
(50 ft.) away, custom
lengths should drop 2
gauges when length is
doubled.
Workstation to Gantry 12.2 m (40 ft.)
Interconnect Cable
Ground Wire 12.2 m (40 ft.)
Workstation to Gantry 13 m (42.65 ft.)
Interconnect (Fiber
Optic Cable)
Acquisition Workstation 3.05 m (10 ft.)
Power cord
Notes:
Strain relief for Mains cable: Cable should not flex, move, etc. Considered permanently connected per its safety classification.
Hologic does not provide the Gantry power cable for some countries. If the power cable is not provided, the installed cable must meet the following requirements
and all local codes that apply: 3 conductor, 8 AWG (10 mm2) copper not more than 25 feet (7.62 meters) in length.
P/N MAN-01120 19
Additional Notes
Note # Topic Notes
P/N MAN-01120 20
Wireway and Threshold Requirements

Done
(Init/Date)
Interconnects
Wireways Horizontal surface wireway,
1-3/4 in. x 5-1/4 in. divided
with removable covers.
Vertical surface flush-
mounted wireway, 1-3/4 in. x
5-3/4 in. divided with
removable covers.
Horizontal surface mounted
floor duct wireway, 1-3/4 in. x
5-1/4 in. divided with
removable covers,
grommeted on open end.
Thresholds Length depends on cable run.
(if required)
Notes:
P/N MAN-01120 21
Additional Notes
Note # Topic Notes
P/N MAN-01120 22
X-Ray Shielding Requirements

Done
(Init/Date)
X-ray Shielding
Room Per state and local codes
based on Medical
Physicists test results.
Notes:
P/N MAN-01120 23
Additional Notes
Note # Topic Notes
P/N MAN-01120 24
Mounting Requirements
Done
(Init/Date)
Mounting Requirements
Gantry Anchors embedded 2-1/2 in.
minimum and appropriate
bolts/hardware1
Acquisition Anchors embedded 2-1/2 in.
Workstation minimum and appropriate
bolts/hardware2
Seismic Strongly recommended that
the customer consults with a
professional structural
engineer familiar with
seismic requirements3
Notes:
The mounting diagrams provided in this document are recommendations only; the final responsibility for proper installation belongs to the site field engineer.
Ensure all installations meet local regulations.
1The Gantry base has four 11/16 inch mounting holes.
2The Acquisition Workstation base has four (two additional holes are available, if needed) 5/8 inch mounting holes.
3Seismic installations are dependant on local regulations.
P/N MAN-01120 25
Additional Notes
Note # Topic Notes
P/N MAN-01120 26
Room Planning Templates
P/N MAN-01120 27
P/N MAN-01120 28
Room Layout Work Sheet

These templates can be used to establish a functional room layout.
1. Make copies of the grid and the system component cutouts. Each grid square is equal to 930 square cm (1 square foot).
2. Outline the designated room size (to scale) on the grid.
3. Cut out the system components from the copy.
4. Position the component cutouts on the grid to layout the desired work space.
Allow sufficient and convenient storage for accessories. Be sure to include access clearances for service personnel. Avoid areas that may hinder
access to the equipment and patient. Also avoid equipment positioning near heat ducts or air-conditioning vents.
To protect from radiation exposure, locate the Acquisition Workstation so the radiation shield provides complete protection for the operator. If
possible, include extra space and power outlets for future expansion of clinical services.
When completed, use this final floor plan layout as a guide during the final installation phase.
P/N MAN-01120 29
P/N MAN-01120 30

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Artwork and Signature File for:

MAN-01120, MNL, SEL DIMENSIONS, SITE PLANNING GUIDE

Artwork consists of:

Thirty-Six (36) 8 inch x 11 inch sheet(s) attached.

REV AUTHORED BY DATE

Corporate Headquarters Europe

Chapter 1Introduction and General Information 1

Chapter 2Specifications and Reference Information 5

Chapter 3Site Planning Checklist 11

Room Planning Templates 27

Chapter 1Introduction and General Information

Note Refer to MAN-01411 for Mobile applications.

2.0 System Description

Figure 1-1: The Selenia Dimensions System

Legend for Figure 1-1

3.0 Room Layout Considerations

4.3 Remote X-ray On/Power On Indicators

5.1 Compliance Requirements

5.2 Compliance Statement

Chapter 2Specifications and Reference Information

1.0 Unit Measurements

Figure 2-1: Tubestand Dimensions

Height 223 cm (87.8 in.) at highest C-arm travel

Figure 2-2: Acquisition Workstation Dimensions

2.0 Electrical Input

4.0 Center-of-Gravity Reference

Figure 2-3: Gantry Center-of-Gravity Reference

Figure 2-4: Acquisition Workstation Center-of-Gravity Reference

Chapter 3Site Planning Checklist

Acquisition Refer to Chapter 2, Section

Refer to NEC Article 660X-ray Equipment

Wireway and Threshold Requirements

X-Ray Shielding Requirements

Room Planning Templates

Room Layout Work Sheet

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