YUJ-PCB00116RFID Tag

DRAFT DRAFT DRAFT DRAFT Part Number MAN-01964 v User Manual Table of Contents Table of Contents List of Figures xi List of Tables xiii Preface xv 1.0 Intended Use Statements ...................................................................................................................... xv 1.1 Intended Use .................................................................................................................................. xv 1.2 Intended Use (Tomosynthesis Option) ............................................................................................ xv 2.0 System Capabilities ............................................................................................................................... xv 3.0 Users .................................................................................................................................................... xv 4.0 Skills Needed for System Use .............................................................................................................. xvi 5.0 Training Requirements ......................................................................................................................... xvi 6.0 Quality Control Requirements ............................................................................................................. xvi 7.0 Product Complaints ............................................................................................................................. xvi 8.0 Hologic Cybersecurity Statement ......................................................................................................... xvi 9.0 Warnings, Cautions, and Notes .......................................................................................................... xvii 10.0 Terms and Definitions ..................................................................................................................... xviii 11.0 International Symbols ........................................................................................................................ xix 12.0 Document Standards ......................................................................................................................... xix Chapter 1—General Information 1 1.0 System Description ................................................................................................................................. 1 1.1 Tubestand ........................................................................................................................................ 1 1.2 Acquisition Workstation ................................................................................................................... 2 2.0 Safety Information .................................................................................................................................. 3 2.1 General Safety .................................................................................................................................. 3 2.2 Patient Safety ................................................................................................................................... 4 2.3 Radiation Safety ............................................................................................................................... 5 2.4 Data Loss ......................................................................................................................................... 6 2.5 Equipment Damage .......................................................................................................................... 6 2.6 Emergency Off Switches ................................................................................................................... 7 2.7 Interlocks ......................................................................................................................................... 7 3.0 Compliance ............................................................................................................................................ 8 3.1 Compliance Requirements ............................................................................................................... 8 3.2 Compliance Statements .................................................................................................................... 9 4.0 Label Locations .................................................................................................................................... 10 Chapter 2—System Controls and Indicators 11 1.0 System Power Controls ......................................................................................................................... 11 2.0 Acquisition Workstation Controls and Indicators .................................................................................. 12 2.1 Premium Acquisition Workstation Controls and Displays ............................................................... 12 2.2 Standard Acquisition Workstation Controls and Displays ............................................................... 13 2.3 Keyboard ....................................................................................................................................... 13 2.4 Bar Code Scanner .......................................................................................................................... 13 2.5 Premium Acquisition Workstation Touchscreen Display ................................................................ 13 2.6 Standard Acquisition Workstation Control Display ......................................................................... 13 2.7 Preview Display ............................................................................................................................. 13 DRAFT viPart Number MAN-01964 User Manual Table of Contents 3.0 Tubestand Controls and Indicators ........................................................................…

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This is a picture of the GANTRY host Actual picture of RFID tag mounted on host RFID tag location on host The different configuration on the GANTRY will be this display that may change everything else remains the same.

MODEL SN 50-60Hz 200V/208V/220V/230V/240V Hologic, Inc., Danbury, CT. 06810, U.S.A. LBL-01947 rev.001 ! UL 60601-1 TYPE B CSA 601.1 Selenia Dimensions Gantry FCC ID: YUJ-PCB00116 IC: 9218A-PCB00116 This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. COMPLIES WITH FDA RADIATION PERFORMANCE STANDARDS 21CFR SUB CHAPTER J APPLICABLE AT DATE OF MANUFACTURE. MADE IN U.S.A. 4A (65A max. for ≤ 5 sec.) MODEL COMPLIES WITH FDA RADIATION PERFORMANCE STANDARDS 21 CFR SUB CHAPTER J APPLICABLE AT DATE OF MANUFACTURE LBL-00723 rev. 001 MADE IN U.S.A. SN Hologic, Inc., Danbury, CT. 06810, U.S.A. MODEL COMPLIES WITH FDA RADIATION PERFORMANCE STANDARDS 21 CFR SUB CHAPTER J APPLICABLE AT DATE OF MANUFACTURE LBL-00723 rev. 001 MADE IN U.S.A. SN Hologic, Inc., Danbury, CT. 06810, U.S.A. This product is protected by one or more of the following U.S. patent numbers, and other United States patents applied for: 5,606,589, 5,627,869, 5,706,327, 5,729,585, 5,814,235, 5,930,327, 6,075,840, 7,123,684, 7,245,694, 7,319,735 LBL-00707 rev. 001 Selenia Dimensions System MODEL SN 50-60Hz 200V/208V/220V/230V/240V Hologic, Inc., Danbury, CT. 06810, U.S.A. LBL-01947 rev.001 ! UL 60601-1 TYPE B CSA 601.1 Selenia Dimensions Gantry FCC ID: YUJ-PCB00116 IC: 9218A-PCB00116 This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. COMPLIES WITH FDA RADIATION PERFORMANCE STANDARDS 21CFR SUB CHAPTER J APPLICABLE AT DATE OF MANUFACTURE. MADE IN U.S.A. 4A (65A max. for ≤ 5 sec.) PARTIAL REAR VIEW OF SDM GANTRY (some items not shown) 11/10/2010 Location of Selenia Dimensions Gantry Nameplate Label, LBL-01947 rev.001 (FCC & IC)

Underwriters Laboratories Inc. A not-for-profit organization dedicated 1285 Walt Whitman Rd. to public safety and committed to Melville, NY 11747 quality service for over 100 years Tel: (631) 271-6200 Fax: (631)439-6095 Underwriters Laboratories Inc. 1285 Walt Whitman Rd. Melville, NY 11747 www.ul.com/emc (631) 271-6200 Job Number: 2010119 Project Number: 10CA07446 File Number: MC15404 Revision Date: 2010- 11-17 Model: FCC ID: Industry Canada ID: SDM-Series YUJ-PCB00116 9218A-PCB00116 Electromagnetic Compatibility Test Report For Hologic Inc Copyright  2010 Underwriters Laboratories Inc. Underwriters Laboratories Inc. authorizes the above-named company to reproduce this Report provided it is reproduced in its entirety. Job Number: 2010119 File Number: MC15404 Page 2 of 48 Model Number: SDM-00001 and SDM-05000 Client Name: Hologic Inc FCC ID: YUJ-PCB00116 Industry Canada 9218A-PCB00116 Underwriters Laboratories Inc. 1285 Walt Whitman Rd. Melville, New York 11747 USA Tel.: 631 271-6200 Fax: 631 439-6095 Rev. No 1.0 EMC Report 2010-87-EM-F0042 Test Report Details Tests Performed By: Underwriters Laboratories Inc. 1285 Walt Whitman Rd. Melville, NY 11747 Tests Performed For: Hologic Inc 36 Appleridge Road Danbury, CT 06810 Applicant Contact: Alan Rego Title: Manager, Electrical Engineering Phone: 203-207-4582 Fax: 203-792-8220 E-mail: [email protected] Revision Test Report Date: 2010-11-17 Product Type: RFID Tag (installed only in a Selenia Dimensions System Gantry) Product standards FCC Part 15, Subpart C, 15.225, RSS-210, RSS-GEN Model Number: SDM-00001 and SDM-05000 Sample Part Number: ASY-01646 EUT Category: Low Power RFID 13.56MHz Testing Start Date: 2010-09-17 Date Testing Complete: 2010-11-05 Overall Results: Compliant Underwriters Laboratories Inc. reports apply only to the specific samples tested under stated test conditions. All samples tested were in good operating condition throughout the entire test program. It is the manufacturer's responsibility to assure that additional production units of this model are manufactured with identical electrical and mechanical components. Underwriters Laboratories Inc. shall have no liability for any deductions, inferences or generalizations drawn by the client or others from Underwriters Laboratories Inc. issued reports. This report shall not be used to claim, constitute or imply product certification, approval, or endorsement by NVLAP, NIST, A2LA, or any agency of the US government. This report may contain test results that are not covered by the NVLAP or A2LA accreditation. The scope of accreditation is limited to the specific tests that are listed on the NVLAP and/or A2LA websites referenced at the end of this report. Job Number: 2010119 File Number: MC15404 Page 3 of 48 Model Number: SDM-00001 and SDM-05000 Client Name: Hologic Inc FCC ID: YUJ-PCB00116 Industry Canada 9218A-PCB00116 Underwriters Laboratories Inc. 1285 Walt Whitman Rd. Melville, New York 11747 USA Tel.: 631 271-6200 Fax: 631 439-6095 Rev. No 1.0 EMC Report 2010-87-EM-F0042 Report Directory 1.0 G E N E R A L - Product Description ..................................................................................................................4 1.1 Equipment Description ...................................................................................................................................5 1.2 Equipment Marking Plate ...............................................................................................................................5 1.3 Device Configuration During Test ..................................................................................................................6 1.3.1 Equipment Used During Test: ....................................................................................................................6 1.3.2 Input/Output Ports: .....................................................................................................................................6 1.3.3 EUT Internal Operating Frequencies: ........................................................................................................7 1.3.4 Power Interface: .........................................................................................................................................7 1.4 Block Diagram: ...............................................................................................................................................7 1.5 EUT Configurations ........................................................................................................................................8 1.6 EUT Operation Modes ....................................................................................................................................8 2.0 Summary ............................................................................................................................................................8 2.1 Deviations from standard test methods ..........................................................................................................8 2.2 Device Modifications Necessary for Compliance ...........................................................................................9 2.3 Reference Standards ...................................................................................................................................10 2.4 Results Summary .........................................................................................................................................10 3.0 Calibration of Equipment Used for Measurement ............................................................................................11 4.0 EMISSIONS TEST RESULTS ..........................................................................................................................12 4.1 Test Conditions and Results – MAINS TERMINAL – CONDUCTED EMISSIONS .....................................13 4.2 Test Conditions a…

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Test Setup for Conducted Emissions Test Setup for Occupied Bandwidth Test Setup for Frequency Stability Test setup for Radiated Emissions 9KHz to 30 MHz Vertical Polarity Front View 9KHz to 30 MHz Vertical Polarity Rear View 9KHz to 30 MHz Horizontal Polarity Front View Figure 1: Test Setup for Radiated Emissions Front View 30-1000MHz Rear View 30-1000MHz