MNL, SEL DIMENSIONS, SITE AW PLANNING GUIDE ARTWORK SIZE A SHEET 1 OF 1

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1 Artwork and Signature File for: MAN-01120, MNL, SEL DIMENSIONS, SITE PLANNING GUIDE Artwork consists of: Thirty-Six (36) 8 ½ 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: The content of this document is the exclusive property of Hologic and may not, without prior written permission of Hologic, be reproduced, copied or used for any purpose whatsoever. TITLE DOCUMENT NUMBER REV MNL, SEL DIMENSIONS, SITE AW PLANNING GUIDE ARTWORK SIZE A SHEET 1 OF 1 ENG-0034-T33, Rev. 002

5 for Selenia Dimensions System Part Number MAN Revision 002 January 2010 This manual is for permanent Selenia Dimensions installations. For Mobile Selenia Dimensions installations, refer to MAN Service Support: USA: Europe: All Other: Corporate Headquarters 35 Crosby Drive, Bedford, MA USA Tel: Sales: Fax: Europe (EU Representative) Hologic NV Leuvensesteenweg 250A 1800 Vilvoorde, Belgium Tel: Fax: Refer to the corporate website for more facilities worldwide. Copyright Hologic 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.

7 Table of Contents Table of Contents Chapter 1 Introduction and General Information Introduction System Description Room Layout Considerations Safety Isolation Integrity Shielding Remote X-ray On/Power On Indicators Compliance Compliance Requirements Compliance Statement...4 Chapter 2 Specifications and Reference Information Unit Measurements Electrical Input Environmental Center-of-Gravity Reference...8 Chapter 3 Site 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 v

8 Table of Contents vi P/N MAN-01120

9 Chapter 1 Introduction and General Information Chapter 1 Introduction 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 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 2.0 System Description Ensure all installations meet local regulations. A licensed electrician must perform the necessary electrical services. Figure 1-1: The Selenia Dimensions System Legend for Figure The Gantry 2. The C-Arm 3. The Acquisition Workstation P/N MAN

10 Chapter 1 Introduction and General Information 3.0 Room Layout Considerations Chapter 3 Site 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 clearance Allocate space for patient and technologist movement. Avoid obstructions in the room that may 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, 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

11 Chapter 1 Introduction and General Information 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 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 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

12 Chapter 1 Introduction and General Information 5.0 Compliance The following section details the mammography system compliance requirements and the manufacturer s 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 and IEC Compliance Statement The manufacturer states that this device is manufactured/conforms to: CAN/CSA ISO 13485:2003 EN :1990 +A1+A11+A12+A2+A13 Medical Electrical Equipment General Requirements for Basic Safety and Essential Performance FDA, 21 CFR [Parts 820, 900 and 1020] IEC :1988 +A1+A2:1995 +A13:1996 Medical Electrical Equipment General Requirements for Safety IEC : Medical Electrical Equipment Collateral Standard: Safety Requirements for Medical Electrical Systems IEC :2001 Medical Electrical Equipment Collateral Standard: Electromagnetic Compatibility for Medical Electric Systems IEC :1994 Medical Electrical Equipment Collateral Standard: Requirements for Radiation Protection in Diagnostic X-ray Equipment IEC :1996 +A1:1999 Medical Electrical Equipment Collateral Standard: Programmable Electrical Medical Systems IEC :1998 Medical Electrical Equipment Particular Requirements for the Safety of High-Voltage Generators of Diagnostic X-ray Equipment IEC : Medical Electrical Equipment Particular Requirements for the Safety of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis IEC :1994 Medical Electrical Equipment Particular Requirements for the Safety of Associated Equipment of X-ray Equipment IEC :2001 Medical Electrical Equipment Particular Requirements for the Safety of Mammographic X-ray Equipment and Mammographic Stereotactic Devices UL : Medical Electrical Equipment, Part 1 General Requirements for Safety CAN/CSA: Medical Electrical Equipment Part 1: C22.2 No M90 General Requirements for Safety 4 P/N MAN-01120

13 Chapter 2 Specifications and Reference Information Chapter 2 Specifications and Reference Information 1.0 Unit Measurements Figure 2-1: Tubestand Dimensions Height Width Depth Weight 223 cm (87.8 in.) at highest C-arm travel 66 cm (26 in.) 138 cm (54.25 in.) Maximum of 400 kg (882 lb) P/N MAN

14 Chapter 2 Specifications and Reference Information 207 cm (81.5 in.) 92.7 cm (36.5 in.) 58.5 cm (23 in.) Figure 2-2: Acquisition Workstation Dimensions Height Width Depth Weight 207 cm (81.5 in.) 92.7 cm (36.5 in.) 58.5 cm (23 in.) 154 kg (340 Ib) 6 P/N MAN-01120

15 Chapter 2 Specifications and Reference Information 2.0 Electrical Input Tubestand Mains Voltage 200/208/220/230/240 VAC ±10% Mains Impedance Mains Frequency 50/60 Hz ±5% Average Current over 24 Hours Peak Line Current Acquisition Workstation Maximum line impedance not to exceed 0.20 ohms for 208/220/230/240 VAC, 0.16 ohms for 200 VAC < 5 A 65 A for 2 seconds Mains Voltage 200/208/220/230/240 VAC ±10% Mains Frequency 50/60 Hz ±5% Power Consumption 3.0 Environmental General Conditions for Operation < 1000 watts Temperature Range 20 C to 30 C Relative Humidity Range Storage Environment Gantry Temperature Range 10 C to 40 C Relative Humidity Range X-ray Detector Temperature Range Max. rate of temperature change Relative Humidity Range Acquisition Workstation 10% to 80% Without condensing moisture 0% to 95% Without condensing moisture (Put in a package for storage in a building) 10 C to 30 C indefinitely 10 C to 35 C for a maximum of 12 hours Less than 10 C per hour Temperature Range 10 C to 40 C Relative Humidity Range 10% to 80% Without condensing moisture (Put in a package for storage in a building) 0% to 95% Without condensing moisture (Put in a package for storage in a building) P/N MAN

16 Chapter 2 Specifications and Reference Information 4.0 Center-of-Gravity Reference Figure 2-3: Gantry Center-of-Gravity Reference 8 P/N MAN-01120

17 Chapter 2 Specifications and Reference Information Figure 2-4: Acquisition Workstation Center-of-Gravity Reference P/N MAN

18 Chapter 2 Specifications and Reference Information 10 P/N MAN-01120

19 Chapter 3 Site Planning Checklist Room Requirements Item Requirements Actual Corrective Action Done (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 VAC Outlet 4. Wireway 5. Circuit Breaker P/N MAN

20 Additional Notes Note # Topic Notes P/N MAN

21 Clearance Requirements Item Access Clearance Acquisition Workstation Gantry Rear Gantry Front Work Area Working Clearance Gantry with C-Arm Work and Patient Area Minimum Requirements 61 cm (2.0 ft.) on 3 sides 30 cm (1 ft.) 76 cm (2.5 ft.) 76 x 76 cm diameter (2.5 ft. x 2.5 ft.) 76.2 cm (30 in.) each side of C-arm (for complete C-arm rotation) 76.2 cm (30 in.) diameter (min) between Tubestand and Acquisition Workstation Actual Corrective Action Done (Init/Date) P/N MAN

22 Additional Notes Note # Topic Notes P/N MAN

23 Power Requirements Item Requirements Actual Corrective Action 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). Done (Init/Date) Acquisition Workstation Light Indicator Relay Contact Ratings 1 Notes: Refer to Chapter 2, Section 2.0, page A, 250 VAC (N.O.) 10 A, 30 VDC (N.O.) Refer to NEC Article 660 X-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

24 Additional Notes Note # Topic Notes P/N MAN

25 Environmental Requirements Item Requirements Actual Corrective Action Environmental Requirements: Operating Temperature Range 20 C to 30 C (68 F to 86 F) Relative Humidity 10% to 80% non condensing Range Notes: Done (Init/Date) P/N MAN

26 Additional Notes Note # Topic Notes P/N MAN

27 Cable Requirements Item Requirements Actual Corrective Action 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 m (40 ft.) Workstation to Gantry 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. Done (Init/Date) 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 mm 2) copper not more than 25 feet (7.62 meters) in length. P/N MAN

28 Additional Notes Note # Topic Notes P/N MAN

29 Wireway and Threshold Requirements Interconnects Wireways Thresholds (if required) Notes: Item Requirements Actual Corrective Action Horizontal surface wireway, 1-3/4 in. x 5-1/4 in. divided with removable covers. Vertical surface flushmounted 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. Length depends on cable run. Done (Init/Date) P/N MAN

30 Additional Notes Note # Topic Notes P/N MAN

31 X-Ray Shielding Requirements X-ray Shielding Room Notes: Item Requirements Actual Corrective Action Per state and local codes based on Medical Physicist s test results. Done (Init/Date) P/N MAN

32 Additional Notes Note # Topic Notes P/N MAN

33 Mounting Requirements Item Requirements Actual Corrective Action Mounting Requirements Gantry Anchors embedded 2-1/2 in. minimum and appropriate bolts/hardware 1 Acquisition Anchors embedded 2-1/2 in. Workstation minimum and appropriate bolts/hardware 2 Seismic Strongly recommended that the customer consults with a professional structural engineer familiar with seismic requirements 3 Notes: Done (Init/Date) 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. 1 The Gantry base has four 11/16 inch mounting holes. 2 The Acquisition Workstation base has four (two additional holes are available, if needed) 5/8 inch mounting holes. 3 Seismic installations are dependant on local regulations. P/N MAN

34 Additional Notes Note # Topic Notes P/N MAN

35 Room Planning Templates P/N MAN

36 P/N MAN

37 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

38 P/N MAN

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