Dimensions Site Planning Guide MAN-03169 EN Rev_005 12-2017.pdf

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.

Hologic, 3Dimensions, Dimensions, Selenia, Affirm, FAST Paddle, SecurView, SecurXchange, and associated logos are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries. All other trademarks, registered trademarks, and product names are the property of their respective owners.

This product may be protected by one or more U.S. or foreign patents as identified at www.Hologic.com/patents

Technical Support

USA: +1.877.371.4372

Europe: +32 2 711 4690 Asia: +852 37487700 Australia: +1 800 264 073 All Other: +1 781 999 7750

Selenia Dimensions System Site Planning and Pre-Installation Guide Table of Contents

MAN-03169 Revision 005 v

List of Figures ________________________________________________________________ vii

List of Tables __________________________________________________________________ ix

1: Introduction and General Information ___________________________________________1

1.1 Introduction

1.2 System Description

1.2.1 Tubestand Overview

1.2.2 Acquisition Workstation Overview

1.3 System Location Considerations

1.4 Safety

1.4.1 Isolation Integrity

1.4.2 Shielding

1.4.3 Remote X-ray On/Power On Indicators

1.4.4 The X-ray Interlock

1.5 Compliance

1.5.1 Compliance Requirements

1.5.2 Compliance Statements

1.5.3 Electromagnetic Compatibility

2: Specifications and Reference Information ______________________________________15

2.1 Product Measurements

2.1.1 Tubestand (Gantry with C-Arm)

2.1.2 Universal Acquisition Workstation

2.1.3 Premium Acquisition Workstation

2.1.4 Standard Acquisition Workstation

2.2 Electrical Input

2.2.1 Tubestand

2.2.2 Acquisition Workstation

2.3 Operation and Storage Environment

2.3.1 General Conditions for Operation

2.3.2 Storage Environment

2.4 Center of Gravity Reference

3: Site Planning Checklist _______________________________________________________25

4: Room Layout Worksheet ______________________________________________________44

MAN-03169 Revision 005 vii

List of Figures

Figure 1: Tubestand for Selenia® Dimensions® System Figure 2: Acquisition Workstations Figure 3: Tubestand (Gantry with C-arm) Measurements Figure 4: Universal Acquisition Workstation Measurements Figure 5: Premium Acquisition Workstation Measurements Figure 6: Standard Acquisition Workstation Measurements Figure 7: Gantry Center-of-Gravity Reference Figure 8: Premium Acquisition Workstation Center-of-Gravity Reference Figure 9: Standard Acquisition Workstation Center-of-Gravity Reference Figure 10: Universal Acquisition Workstation Center-of-Gravity Reference

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List of Tables

Table 1: Electronic Emissions Table 2: Electromagnetic Immunity Part 1 Table 3: Electromagnetic Immunity Part 2 Table 4: Separation Distances for RF Equipment Table 5: Room Requirements Table 6: Clearance Requirements Table 7: Power Requirements Table 8: Environmental Requirements Table 9: Cable Requirements Table 10: Wireway and Threshold Requirements Table 11: X-Ray Shielding Requirements Table 12: Mounting Requirements

Chapter 1: Introduction and General Information

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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.

The mounting diagrams provided in this manual are recommendations only; the final responsibility for proper installation belongs to the Installation Coordinator.

Ensure all installations meet local regulations. A licensed electrician must perform the necessary electrical service.

Chapter 1

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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

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1.2.2 Acquisition Workstation Overview

Figure 2: Acquisition Workstations

1. Universal Acquisition Workstation

2. Premium Acquisition Workstation

3. Mobile Acquisition Workstation

4. Standard Acquisition Workstation

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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

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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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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.

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.

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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.

Portable and mobile RF communications can affect medical electrical equipment.

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.

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.

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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Changes or modifications not expressly approved by Hologic could void your authority to operate the equipment.

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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• 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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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.

MAN-03169 Revision 005 Page 11

Table 2: Electromagnetic Immunity Part 1 Electromagnetic Immunity – Part 1

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

<5% Ut (>95 % dip in Ut) for 0,5 cycle

40% Ut (60 % dip in Ut) for 5 cycles

70% Ut (30 % dip in Ut) for 25 cycles

<5% Ut (>95 % dip in Ut) for 5 s

<5% Ut (>95 % dip in Ut) for 0,5 cycle

40% Ut (60 % dip in Ut) for 5 cycles

70% Ut (30 % dip in Ut) for 25 cycles

<5% Ut (>95 % dip in Ut) for 5 s

Mains power quality should be that of a typical commercial or hospital environment. If the user of the system requires continued operation during power mains interruptions, it is recommended that the system be powered from an uninterruptible power supply or battery.

Power Frequency (50/60Hz) Magnetic Field

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at l4evels characteristic of a typical location in a typical commercial or hospital environment.

NOTE Ut is the a.c. mains voltage prior to application of the test level.

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Table 3: Electromagnetic Immunity Part 2

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 EN/IEC 60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms 150 kHz to 80MHz

3 V/m 80 MHz to 2.5 GHz

[V1] = 3 V

[E1] = 3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

where P is the maximum output power rating of the transmitter in watts (W) and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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Table 3: Electromagnetic Immunity Part 2

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 EN/IEC 60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the system is used exceeds the applicable RF compliance level above, the system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the system.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Table 4: Separation Distances for RF Equipment

Recommended Separation Distances for Portable and Mobile RF Communications Equipment and the system

The system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the system as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter m

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.7 3.7 7.38

100 11.7 11.7 23.3

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Chapter 2: Specifications and Reference Information

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2: Specifications and Reference Information

2.1 Product Measurements

2.1.1 Tubestand (Gantry with C-Arm)

Figure 3: Tubestand (Gantry with C-arm) Measurements

A. Height 223 cm (87.8 inches)

B. Width 66 cm (26 inches)

C. Width 173 cm (68.0 inches)

D. Depth 138 cm (54.3 inches)

Weight Maximum of 400 kg (882 pounds)

Chapter 2

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2.1.2 Universal Acquisition Workstation

Figure 4: Universal Acquisition Workstation Measurements

A. Width (maximum) with optional articulated display arm extended

136 cm (53.4 inches) - series I UAWS

128 cm (50.3 inches) - series II UAWS

Width (maximum) with standard display arm

94.0 cm (36.9 inches) - series I UAWS

107 cm (42.0 inches) - series II UAWS

B. Depth (maximum) with keyboard tray extended and optional articulated display monitor arm

122 cm (48.4 inches) - series I UAWS, rotated to the side

115 cm (45.1 inches) - series II UAWS, rotated to the side

Depth (maximum) with keyboard tray extended and standard display arm

83.6 cm (32.9 inches) - series I and II UAWS

C. Height (nominal) 219 cm (86.1 inches) after August 2017

204 cm (80.3 inches) before September 2017

Weight (maximum) 209 kg (460 pounds)

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2.1.3 Premium Acquisition Workstation

Figure 5: Premium Acquisition Workstation Measurements

A. Height 202 cm (79.8 inches)

B. Width 92.7 cm (36.5 inches)

C. Depth 58.5 cm (23.0 inches)

Weight 154 kg (340 pounds)

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2.1.4 Standard Acquisition Workstation

Figure 6: Standard Acquisition Workstation Measurements

A. Height 192 cm (75.3 inches)

B. Width 107 cm (42.1 inches)

C. Depth 76.2 cm (30.0 inches)

Weight 219 kg (462 pounds)

2.2 Electrical Input

2.2.1 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 < 5 A

Peak Line Current 4 A (65 A maximum for < 5 seconds)

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2.2.2 Acquisition Workstation

Mains Voltage 100/120/200/208/220/230/240 VAC ±10%

Mains Frequency 50/60 Hz ±5%

Power Consumption < 1000 watts

Duty Cycle (Standard Acquisition Workstation)

10% ~ 6 minutes per hour or 2 minutes on, 18 minutes off

Overcurrent Protection 8A

2.3 Operation and Storage Environment

2.3.1 General Conditions for Operation

Temperature Range 20 °C (68 °F) to 30 °C (86 °F)

Relative Humidity Range 20% to 80% without condensing moisture

2.3.2 Storage Environment

Gantry Temperature Range –10 °C (14 °F) to 40 °C (104 °F)

Relative Humidity Range 0% to 95% without condensing moisture

(Put in a package for storage in a building.)

X-ray Detector Temperature Range 10 °C (50 °F)to 30 °C (86°F) indefinitely

10 °C (50 °F) to 35°C (95 °F) for a maximum of 12 hours

Maximum rate of temperature change Less than 10 °C (50 °F) per hour

Relative Humidity Range 10% to 80% without condensing moisture

Acquisition Workstation Temperature Range –10 °C (14 °F) to 40 °C (104 °F)

Relative Humidity Range 0% to 95% without condensing moisture

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2.4 Center of Gravity Reference

Figure 7: Gantry Center-of-Gravity Reference

A. 31.8 cm (12.5 inches)

B. 95.5 cm (37.6 inches)

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Figure 8: Premium Acquisition Workstation Center-of-Gravity

Reference

A. 62.9 cm (24.8 inches)

B. 10.5 cm (4.13 inches)

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Figure 9: Standard Acquisition Workstation Center-of-Gravity Reference

A. 64.3 cm (25.3 inches)

B. 11.4 cm (4.5 inches)

C. 18.8 cm (7.4 inches)

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Figure 10: Universal Acquisition Workstation Center-of-Gravity Reference

A. 61.7 cm (24.3 inches)

B. 29.0 cm (11.4 inches)

C. 14.2 cm (5.6 inches)

Chapter 3: Site Planning Checklist

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3: Site Planning Checklist

Chapter 3

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Table 5: Room Requirements

Item Requirements Actual Corrective Action Done

(Init/Date)

Room Size

Length 365 cm (12 feet)

Width 275 cm (9 feet)

Ceiling 244 cm (8 feet)

Door 214 cm x 92 cm (84 in. x 36 in.)

Notes:

The exam room layout should be pre-planned before the arrival of the system. Refer to Room Layout Worksheet on page

44. A typical room layout is shown here. Check specific local or hospital requirements for additional data. Check the route from the loading dock to the room.

Maintain a clearance of 50 cm between the tube head at any position of rotation and any stationary object (excluding the floor). If this clearance cannot be maintained due to space constraints, provide as much clearance as possible. The standard operation of the controls for C-arm rotation should not be altered at installations that do not meet the 50 cm clearance.

1. Universal Acquisition Workstation

2. Tubestand/Gantry

3. Minimum clearance of 50 cm (20 in.)

4. Consult local regulations for minimum clearance

5. Minimum doorway opening of 92 cm (36 in.)

6. Patient Area

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Additional Notes

Note # Topic Notes

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Table 6: Clearance Requirements

Item Minimum Requirements Actual Corrective Action Done (Init/Date)

Access Clearance

Acquisition Workstation

61 cm (2.0 feet) on 3 sides

Gantry Rear 30 cm (1 feet)

Gantry Front 76 cm (2.5 feet)

Work Area 76 x 76 cm diameter (2.5 feet x 2.5 feet)

Working Clearance

Gantry with C- Arm

50 cm (20 inches) each side of C-Arm (for complete C-Arm rotation)

Work and Patient Area

76.2 cm (30 inches) diameter (minimum) between Tubestand and Acquisition

Note: Refer to the specifications.

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Table 7: Power Requirements

Done

(Init/Date)

Power Requirements

Dedicated Power Line

Dedicated disconnect box 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 Electrical Input on page 18.

Light Indicator Relay Contact Ratings*

10 A, 250 VAC (N.O.)

10 A, 30 VDC (N.O.)

*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.

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Table 8: Environmental Requirements

Done

(Init/Date)

Environmental Requirements: Operating

Temperature Range

20° C to 30° C (68° F to 86°F)

Relative Humidity Range

20% to 80% non condensing

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Table 9: Cable Requirements

Item Recommendations Actual Corrective Action Done

(Init/Date)

Cables (Length)

Gantry Power Conduit

7.5 m (25 feet) If Mains box is over 15 m (50 feet) away, custom lengths must drop 2 gauges when length is doubled.

Optional, purchased separately

(Optional)

Workstation to Gantry Interconnect Cable

12.2 m (40 feet)

Ground Wire 12.2 m (40 feet)

Workstation to Gantry Interconnect (Fiber Optic Cable)

13 m (42.65 feet)

Power Cord

3.05 m (10 feet)

If flex cable is used, do not permanently affix to wall, floor, or place in wireway that is permanently attached to the structure. Conduit is recommended with use of NEC wiring.

Power cables must not be enclosed in wireways or permanently affixed to the building structure.

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.

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Table 10: Wireway and Threshold Requirements

Done

(Init/Date)

Interconnects

Wireways

Horizontal surface wireway, 1-3/4 inches x 5-1/4 inches divided with removable covers.

Vertical surface flush-mounted wireway, 1-3/4 inches x 5-3/4 inches divided with removable covers.

Horizontal surface mounted floor duct wireway, 1-3/4 inches x 5-1/4 inches divided with removable covers, grommeted on open end.

Thresholds (if required)

Length depends on cable run.

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Table 11: X-Ray Shielding Requirements

Done

(Init/Date)

X-ray Shielding

Room Per state and local codes based on Medical Physicist’s test results.

Shielding refers to the protection from leakage radiation that usually occurs during mammography exams.

Leakage Radiation All related x ray safety features meet 21 CFR, Chapter I, 1020.31, IEC 60601-1-3, and IEC 60601-2-45.

Typical values of x ray leakage shown are at a distance of 1 meter from the tube focal spot, at maximum kVp, and adjusted for a maximum in use duty cycle of 0.027.

Duty cycle is derived from a maximum throughput of 12 patients per hour x 4 exposures, or 48 exposures per hour with a maximum exposure time of 2 seconds.

Therefore; 48x2 = 96 exposure seconds per hour, or 96 exposure seconds/3600 seconds per hour = 0.027.

The meter measures x ray leakage in units of mR/Hour.

The meter indication is multiplied by the duty cycle to get the correct leakage value (N x 0.027) and this is compared with the maximum allowed criteria 90 mR/Hour.

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Table 12: Mounting Requirements

Done

(Init/Date) Mounting Requirements

Gantry (The Gantry base has four 11/16 inch mounting holes.)

Anchors embedded 2- 1/2 inches minimum and appropriate bolts/hardware. The floor must be able to support a minimum of 210 lb./ft2.

(The AWS base has four (two additional holes are available, if needed) 5/8 inch mounting holes.)

Anchors embedded 2- 1/2 inches minimum and appropriate bolts/hardware. The floor must be able to support a minimum of 210 lb./ft2.

Seismic (Refer to 'Center-of- Gravity' section in Chapter 2.)

(Seismic installations are dependent on local regulations.)

Strongly recommended that the customer consults with a professional structural engineer familiar with seismic requirements.

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.

MAN-03169 Revision 005 Page 41

Page 42 MAN-03169 Revision 005

MAN-03169 Revision 005 Page 43

Room Planning Templates

Chapter 3: Room Layout Worksheet

Page 44 MAN-03169 Revision 005

4: Room Layout Worksheet These templates can be used to establish a functional room layout.

Instructions: Make copies of the grid and the system component cutouts. Outline the designated room size (to scale) on the grid, and then cut out the system components from the copy. 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.

Chapter 3: Room Layout Worksheet

MAN-03169 Revision 005 Page 45

2.4 Center of Gravity Reference

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/HRV (Za stvaranje Adobe PDF dokumenata najpogodnijih za visokokvalitetni ispis prije tiskanja koristite ove postavke. Stvoreni PDF dokumenti mogu se otvoriti Acrobat i Adobe Reader 5.0 i kasnijim verzijama.)

/HUN /ITA /JPN /KOR /LTH /LVI /NLD (Gebruik deze instellingen om Adobe PDF-documenten te maken die zijn geoptimaliseerd voor prepress-afdrukken van hoge kwaliteit. De gemaakte PDF-documenten kunnen worden geopend met Acrobat en Adobe Reader 5.0 en…