XSB2300AAcuson Freestyle Ultrasound System Wireless Probe

ACUSON Freestyle System Reference Manual Siemens Medical Solutions, USA, Inc. 11002125_03_2_04 US Product Version 3.0 © 2013 Siemens Medical Solutions USA, Inc. All Rights Reserved May 2014 Printed in the United States of America ACUSON is a trademark of Siemens Medical Solutions USA, Inc. Asepti-Wipe, Cidex, MetriCide, T-Spray, Wavicide-01, Metrizyme, Sterrad SealSure, and Tyvek are trademarks or registered trademarks of their respective owners. Siemens reserves the right to change system specifications at any time Global Business Unit and Legal Manufacturer Siemens Medical Solutions USA, Inc. Ultrasound 685 East Middlefield Road Mountain View, CA 94043 U.S.A. Phone: +1-888-826-9702 www.siemens.com/healthcare EU Authorized Representative Siemens AG Medical Solutions Henkestrasse 127 91052 Erlangen Germany Siemens Global Headquarters Siemens AG Wittelsbacherplatz 2 80333 Muenchen Germany Global Siemens Healthcare Headquarters Siemens AG Healthcare Sector Henkestrasse 127 91052 Erlangen Germany Phone: +49 9131 84-0 www.siemens.com/healthcare ACUSON Freestyle System Reference Manual iii Contents About the User and Reference Manuals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v Conventions ..............................................................v Intended Audience .......................................................vi Safety – Electromagnetic Compatibility .......................................1 Electromagnetic Interference ................................................1 Electrosurgical Devices ....................................................2 Electrostatic Discharge ....................................................2 Restrictions for Use .......................................................2 Immunity Level Test Results ...............................................2 Manufacturer’s EMC Declaration .............................................3 TABLE 1: Guidance and Manufacturer’s Declaration: Electromagnetic Emissions for the ACUSON Freestyle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 TABLE 2: Guidance and Manufacturer’s Declaration: Electromagnetic Immunity for the ACUSON Freestyle System, Independent of Transducer Type . . . . . . . . . . . . . . . .4 Electromagnetic Immunity ..................................................5 TABLE 4: Guidance and Manufacturer’s Declaration: Electromagnetic Immunity for ACUSON Freestyle System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 TABLE 5: Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the ACUSON Freestyle System . . . . . . . . . . . . . .6 Interference from Leaking Microwave Ovens ...................................7 Avoiding Interference from Leaking Microwave Ovens ..........................7 Steps for Avoiding Interference from Leaking Microwave Ovens ...............7 Interference from RFID Devices .............................................8 TABLE 6: RFID Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 Avoiding Interference from RFID Devices ....................................8 Steps for Avoiding Interference from RFID Devices .........................8 RFID References .......................................................9 Wireless Specifications ...................................................10 Safety – Wireless RF Transmission .........................................10 Safety – Wireless RF Transmission & Receive .................................11 ACUSON Freestyle Wireless Technologies ................................11 TABLE 5: RF and Wireless Technology Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 TABLE 6: RF and Wireless Technology: About, Use, Configuration, Setup . . . . . . . . . .12 Safety – Wireless Accessory Compatibility ....................................13 TABLE 7: IEEE 802.11 b/g Router Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Security ................................................................14 IEEE 802.11b/g Security ..................................................14 Ultra-Wideband (Wireless Probe) Security ....................................14 Bluetooth (Wireless Probe) Security .........................................14 Quality of Service ........................................................15 Quality of Service and IEEE 802.11 ..........................................15 IEEE 802.11b/g Quality of Service and ACUSON Freestyle IEEE 802.11b/g Operation .15 TABLE 8: Recommended IEEE 802 .11b/g Quality of Service Metrics for ACUSON Freestyle IEEE 802 .11b/g Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16 Wireless Network Traffic Slowdowns or Problems .............................16 Bluetooth and Ultra-Wideband ..............................................17 Quality of Service and ACUSON Freestyle Bluetooth ..........................17 Tips for Maintaining ACUSON Freestyle Bluetooth Quality ..................17 Quality of Service and ACUSON Freestyle Ultra-Wideband .....................18 Tips for Maintaining ACUSON Freestyle Ultra-wideband Quality ..............18 Labels ..................................................................18 Open Source Software ....................................................20 iv ACUSON Freestyle System Reference Manual ACUSON Freestyle System Reference Manual v About the User and Reference Manuals The user and reference manuals consist of the following publications. PublicationIncludes User Manual ■Intended Audience ■Technical description of the ultrasound system ■Safety and care information for the system and compatible transducers ■Descriptions of system controls ■Procedures for system setup and examination fundamentals ■Acoustic output data System Reference ■Electromagnetic Compliance Information ■ Wireless specif…

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1 | Page WLL SIEM13187 External Photos Siemens C5‐2 Bottom View End View 2 | Page WLL SIEM13187 End View Side View Side View 3 | Page WLL SIEM13187 Top View Bottom View 4 | Page WLL SIEM13187 L8‐3 Bottom View End View 5 | Page WLL SIEM13187 End View Side View Side View 6 | Page WLL SIEM13187 Top View Bottom View 7 | Page WLL SIEM13187 L13‐5 Bottom View End View 8 | Page WLL SIEM13187 End View Side View Side View 9 | Page WLL SIEM13187 Top View Bottom View

Freestyle Probe Label Artwork Page 1 of 1 6/18/2014

Freestyle Probe Board Photos The boards used in all three probe types are identical, so the board stack from only one model is shown here. 11002626 HDRR (UWB radio) Bluetooth Module part of 01312 Assembly HVPS Board 11002569 Assembly Front End Board 01314 Assembly Controller Board 01312 Assembly TX Upper Board (2) 01358 Assembly TX Lower Board (2) 01360 Assembly Assembled Probe Board Stack TOP view TX Upper, 01358(shields removed) BOTTOM view TOP view TX Lower 01360 BOTTOM view TOP view Front End 01314 (shields removed) BOTTOM view TOP view HVPS 11002569 BOTTOM view TOP view Controller 01312 BOTTOM view (NOTE: On the 01312 Assembly, traces from the UWB antenna connectors to the antennas are internal to the PCB) TOP view HDRR 11002626 (with shield) BOTTOM view UWB antenna H1 UWB antenna H2 UWB antenna F1 UWB antenna F2 Connector for UWB antenna C1 Connector for UWB antenna C2 Connector for UWB antenna C1 Connector for UWB antenna C2 UWB antenna C1 UWB antenna C2 HDRR Assembly 11002626 TOP view with shield removed

Certificates and reports shall not be reproduced except in full, without the written permission of Washington Labs, Limited. RF Exposure Evaluation for the Siemens Medical Solutions USA, Inc. ACUSON Freestyle Ultrasound System FCC ID: XSB2600A August 8, 2014 WLL Report: 13292-02 Prepared for: SIEMENS MEDICAL SOLUTIONS USA, INC. 5168 CAMPUS DRIVE PLYMOUTH MEETING, PA 19462 Prepared by: WASHINGTON LABORATORIES, LTD. 7560 LINDBERGH DRIVE G AITHERSBURG, MARYLAND 20879 Testing Certificate AT-1448 Siemens Medical Solutions USA, Inc. ACUSON Freestyle Ultrasound System RF Exposure Test Report August 8, 2014 WLL Report #13292-MPE - Page 1 of 5 - © 2014 Washington Laboratories, Ltd. RF Exposure Evaluation For the Siemens Medical Solutions USA, Inc. ACUSON Freestyle Ultrasound System August 8, 2014 WLL Report # 13292-02 Prepared by: Steven Dovell Compliance Engineer Reviewed by: Michael Violette, P.E. President Siemens Medical Solutions USA, Inc. ACUSON Freestyle Ultrasound System RF Exposure Test Report August 8, 2014 WLL Report #13292-MPE - Page 2 of 5 - © 2014 Washington Laboratories, Ltd. Abstract This report has been prepared on behalf of Siemens Medical Solutions USA, Inc. UWB Probes and Receiver to document the findings of the RF evaluation on the Siemens Medical Solutions USA, Inc. UWB Probes and Receiver. The purpose of this evaluation is to establish that this device qualifies for a SAR exclusion under CFR 47 2.1093 in accordance with the procedures of KDB 447498. This report documents the results of testing to the requirements of:  CFR Title 47 CFR Sections 1.1307, 2.1091, and 2.1093 References:  447498 D01 General RF Exposure Guidance v05r02 The Evaluation was performed by Washington Laboratories, Ltd, 7560 Lindbergh Drive, Gaithersburg, MD 20879. Washington Laboratories, Ltd. has been accepted as an EMC Conformity Assessment Body (CAB) under the United States/European Union Memorandum of Agreement. Washington Laboratories, Ltd. is accredited by ACLASS under Testing Certificate AT-1448. Revision History Reason Date Rev 0 Initial Release July 31, 2014 Siemens Medical Solutions USA, Inc. ACUSON Freestyle Ultrasound System RF Exposure Test Report August 8, 2014 WLL Report #13292-MPE - Page 3 of 5 - © 2014 Washington Laboratories, Ltd. Table of Contents Abstract .................................................................................................................................................................... ii 1 Introduction ................................................................................................................................................ 4 2 Device Details .............................................................................................................................................. 4 3 Conditions of Compliance .......................................................................................................................... 4 4 RF Evaluation ............................................................................................................................................. 4 4.1 SAR Exclusion ......................................................................................................................................... 4 4.2 SAR Exclusion Calculations .................................................................................................................... 5 5 RF Evaluation Summary ........................................................................................................................... 6 Siemens Medical Solutions USA, Inc. ACUSON Freestyle Ultrasound System RF Exposure Test Report August 8, 2014 WLL Report #13292-MPE - Page 4 of 5 - © 2014 Washington Laboratories, Ltd. 1 Introduction This report has been prepared on behalf of Siemens Medical Solutions USA, Inc. UWB Probes and Receiver to document the findings of the RF evaluation on the Siemens Medical Solutions USA, Inc. UWB Probes and Receiver. The purpose of this evaluation is to establish that this device qualifies for a SAR exclusion under CFR 47 2.1093 in accordance with the procedures of KDB 447498. This module will be used in a portable host. Testing supporting this evaluation was performed at Washington Laboratories, Ltd, 7560 Lindbergh Drive, Gaithersburg, MD 20879. Washington Laboratories, Ltd. has been accepted as an EMC Conformity Assessment Body (CAB) under the United States/European Union Memorandum of Agreement. Washington Laboratories, Ltd. is accredited with ACLASS under Testing Certificate AT-1448. 2 Device Details The ACUSON Freestyle Ultrasound System contains two low powered radios; The host device radio FCC ID: XSB2600A (UWB) and a certified module FCC ID: ED9LMX9838 (Bluetooth). The output power of the UWB transmitter is -20.8dBm/50MHz (9.33μW) and the Bluetooth grant lists the maximum power as 1.63mW. 3 Conditions of Compliance Platform: The radios are to be used in the ACUSON Freestyle Ultrasound System Handheld Wireless Probes as host. 4 RF Evaluation 4.1 SAR Exclusion According to KDB 447498 v05r01, Paragraph 4.3.1, Standalone SAR test exclusion consideration The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test separation distances ≤ 50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] · [√f (GHz)] ≤ 3.0 for 1-g SAR and ≤ 7.5 for 10-g extremity SAR Siemens Medical Solutions USA, Inc. ACUSON Freestyle Ultrasound System RF Exposure Test Report August 8, 2014 WLL Report #13292-MPE - Page 5 of 5 - © 2014 Washington Laboratories, Ltd. According to KDB 447498 v05r01, Paragraph 4.3.2, Simultaneous transmission SAR test exclusion considerations, section 2, the SAR exclusion formula for antennas located less than <50mm is as follows: When the standalone SAR test exclusion of section 4.3.1 is applied to an antenna that transmits simultaneously with other antennas, the standalone SAR must be estimated according to the fol…

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FCC Certification Test Report For the Siemens Medical Solutions USA, Inc. ACUSON Freestyle Ultrasound System FCC ID: XSB2300A WLL JOB# 13187 Rev 4 November 12, 2013 Re-issued April 1, 2014 Prepared for: Siemens Medical Solutions USA, Inc. 5168 Campus Drive Plymouth Meeting, PA 19462 Prepared By: Washington Laboratories, Ltd. 7560 Lindbergh Drive Gaithersburg, Maryland 20879 Testing Certificate AT-1448 Certificates and reports shall not be reproduced except in full, without the written permission of Washington Laboratories, Limited. Siemens Medical Solutions USA, Inc. ACUSON Freestyle Ultrasound System FCC Certification Test Report April, 2014 FCC Certification Test Report For the Siemens Medical Solutions USA, Inc. ACUSON Freestyle Ultrasound System FCC ID: XSB2300A WLL JOB# 13187 Rev 4 November 12, 2013 Re-issued April 1, 2014 Prepared by: ___________________________ Steven Dovell Compliance Engineer Reviewed by: ____________________________ Steven D. Koster Vice President WLL Report #13187-01_Rev 4 - i - Washington Laboratories, Ltd. Siemens Medical Solutions USA, Inc. ACUSON Freestyle Ultrasound System FCC Certification Test Report April, 2014 Abstract This report has been prepared on behalf of Siemens Medical Solutions USA, Inc. to support the attached Application for Equipment Authorization. The test report and application are submitted for a UWB pulse-modulated BPSK Transmitter under Part 15.519 (10/2013) of the FCC Rules and Regulations. This Certification Test Report documents the test configuration and test results for the Siemens Medical Solutions USA, Inc. ACUSON Freestyle Ultrasound System . Testing was performed on an Open Area Test Site (OATS) of Washington Laboratories, Ltd, 7560 Lindbergh Drive, Gaithersburg, MD 20879. Site description and site attenuation data have been placed on file with the FCC's Sampling and Measurements Branch at the FCC laboratory in Columbia, MD. The Industry Canada OATS numbers are 3035A-1 and 3035A-2 for Washington Laboratories, Ltd. Site 1 and Site 2, respectively. Washington Laboratories, Ltd. has been accepted by the FCC and approved by ACLASS under Certificate AT-1448 as an independent FCC test laboratory. The Siemens Medical Solutions USA, Inc. ACUSON Freestyle Ultrasound System complies with the limits for a UWB Transmitter device under FCC Part 15.503 and 15.519. Summary of Results Test Description Rule Part Complies UWB Bandwidth 15.503(d) Yes Turn off time 15.519(a1) Yes Antenna Limitation 15.519(a2) Yes Operational Bandwidth 15.519(b) Yes Radiated Emissions 15.519(c) & 15.209 Yes GPS Bands 15.519(d) Yes Peak Power 15.519(e) Yes Revision History Description of Change Date Rev 0 Initial Release November 12, 2013 Rev 1 Corrected as per client comments January 15, 2014 Rev 2 Updated Company Name March 4, 2014 Rev 3 Updated FCC ID April 1, 2014 Rev 4 Corrected type errors, Model and EUT Name July 23, 2014 WLL Report #13187-01_Rev 4 - ii - Washington Laboratories, Ltd. Siemens Medical Solutions USA, Inc. ACUSON Freestyle Ultrasound System FCC Certification Test Report April, 2014 Table of Contents Abstract ........................................................................................................................................... ii 1 Introduction ..........................................................................................................................1 1.1 Compliance Statement .................................................................................................... 1 1.2 Test Scope ....................................................................................................................... 1 1.3 Contract Information ....................................................................................................... 1 1.4 Test Dates ....................................................................................................................... 1 1.5 Test and Support Personnel ............................................................................................ 1 1.6 Abbreviations .................................................................................................................. 2 2 Equipment Under Test .........................................................................................................3 2.1 EUT Identification & Description .................................................................................. 3 2.2 Test Configuration .......................................................................................................... 4 2.3 Testing Algorithm ........................................................................................................... 6 2.4 Test Location .................................................................................................................. 6 2.5 Measurements ................................................................................................................. 6 2.5.1 References ................................................................................................................... 6 2.6 Measurement Uncertainty ............................................................................................... 6 3 Test Equipment ....................................................................................................................8 4 Test Results ..........................................................................................................................9 4.1 Technical requirements for handheld UWB systems, §15.519 ....................................... 9 4.1.1 §15.519 (a) .................................................................................................................. 9 4.1.2 §15.519 (a1) ................................................................................................................ 9 4.1.3 §15.519 (a2) .........................................................................................................…

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1 | Page WLL SIEM13187 Test Setup Photos Siemens Healthcare 2 | Page WLL SIEM13187