OU5-5406102URP Detector UWB Radio PWA and Antenna Module

Optima XR220amx X-Ray System54400222-1ENRev 1 DRAFT 110920101-1 Operator Manual© 2010 General Electric Company. All rights reserved. Rev 1 DRAFT 10142010 Optima TM XR220amx X-Ray System Operator Manual 54400222-1EN Rev 1 DRAFT 11092010 © 2010 General Electric Company. All rights reserved. DRAFTREVIEW COPY CTRL+SHIFT+F to search using Search Index (faster) IMPORTANT!...X-RAY PROTECTION Optima XR220amx X-Ray System54400222-1ENRev 1 DRAFT 11092010i-i Operator Manual© 2010 General Electric Company. All rights reserved. IMPORTANT!...X-RAY PROTECTION X-Ray equipment if not properly used may cause injury. Accordingly the instructions herein contained should be thoroughly read and understood before you attempt to place this equipment in operation. The General Electric Company, Healthcare Division, will be glad to assist and cooperate in placing this equip- ment in use. Although this apparatus incorporates a high degree of protection against x-radiation other than the use- ful beam, no practical design of equipment can provide complete protection. Nor can any practical design compel the operator or his assistant to take adequate precautions to prevent the possibility of authorized or unauthorized persons carelessly, unwisely, or unknowingly exposing themselves or others to direct or secondary radiation. It is important that everyone having anything to do with x-radiation be fully acquainted with the recom- mendations of the National Council on Radiation Protection and Measurements as published in NCRP Reports available from NCRP Publications, 7910 Woodmont Ave., Bethesda, MD 20814, and of the Inter- national commission on Radiation Protection, and take adequate steps to insure protection against injury. It is assumed that all persons authorized to use the equipment are cognizant of the danger of excessive exposure to x-radiation and the equipment is sold with the understanding that the General Electric Com- pany, Medical Systems Division, its agents, and representatives have no responsibility for injury or dam- age which may result from exposure to x-radiation. Various protective materials and devices are available. It is urged that such materials and devices be used. DRAFTREVIEW COPY CTRL+SHIFT+F to search using Search Index (faster) Medical Device Directive Optima XR220amx X-Ray System54400222-1ENRev 1 DRAFT 11092010i-ii Operator Manual© 2010 General Electric Company. All rights reserved. Medical Device Directive This product complies with the following requirements: Council Directive 93/42/EEC concerning medical devices when it bears the following CE marking of con- formity: The location of the CE mark label on the equipment is in the service system manual. European registered place of business: GE Healthcare SCS Quality Assurance Manager 283 rue de la Minière 78530 BUC France Green QSD 1990 Standard issued by MDD (Medical Devices Directorate, Department of Health, UK). Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration, Department of Health, USA). Underwriters' Laboratories, Inc. (UL), an independent testing laboratory. Canadian Standards Association (CSA). International Electrotechnical Commission (IEC), international standards organization, when applicable. GE Healthcare reserves the right to make changes in specifications and features shown herein, or dis- continue the product described at any time without notice or obligation. The original language of this manual is English. DRAFTREVIEW COPY CTRL+SHIFT+F to search using Search Index (faster) Contact Information Optima XR220amx X-Ray System54400222-1ENRev 1 DRAFT 11092010i-iii Operator Manual© 2010 General Electric Company. All rights reserved. Contact Information Manufactured by: GE Healthcare United States address: GE Healthcare 3000 N Grandview Ave Waukesha WI 53188-1696 US Phone number: United States: 262-544-3011 International: +1-262-544-3011 Web address: www.gehealthcare.com DRAFTREVIEW COPY CTRL+SHIFT+F to search using Search Index (faster) Revision History Optima XR220amx X-Ray System54400222-1ENRev 1 DRAFT 11092010i-iv Operator Manual© 2010 General Electric Company. All rights reserved. Revision History Revision History Revision Number Pages Affected Description of Change 1 DRAFT 21 Oct 2010 AllPreliminary Copy DRAFTREVIEW COPY CTRL+SHIFT+F to search using Search Index (faster) Chapter 1: Introduction Optima XR220amx X-Ray System54400222-1ENRev 1 DRAFT 110920101-1 Operator Manual© 2010 General Electric Company. All rights reserved. Chapter 1: Introduction The equipment is intended for use by qualified personnel only. WARNINGUnited States Federal law restricts this device to sale by or on the order of a physi- cian. This Operator Manual should be kept with the equipment and be readily available at all times. It is impor- tant for you to periodically review the procedures and safety precautions. It is important for you to read and understand the contents of this manual before attempting to use this product . This chapter explains the purpose and design of this Operator Manual. It provides information on the organization, chapter format , and graphic conventions that identify the visual symbols used throughout the manual. Purpose Of This Manual This manual is written for health care professionals (namely, the radiologic technologist) to provide the necessary information relating to the proper operation of this system. The guide is intended to teach you the system components and features necessary to use it to its maximum potential. It is not intended to teach radiology or to make any type of clinical diagnosis. Prerequisite Skills This guide is not intended to teach radiology. It is necessary for you to have sufficient knowledge to com- petently perform the various diagnostic imaging procedures within your modality. This knowledge is gained through a variety of educational methods including clinical working experience, hospital based programs, and as part of many college and university …

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g GE Healthcare 3000 North Grandview Blvd Waukesha, Wisconsin 53188 November 15, 2010 Chief, Authorizations Branch Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Modular Approval Request Letter FCC ID: OU5-5406102 To Whom It may Concern: GE Medical Systems, LLC would like to have your authorization for singular modular certification of FCC ID OU5-5406102. The statements in the table below explain our compliance with the eight requirements listed in 47 CFR 15.212. 47 CFR 15.212 Requirement: Statement: i All shielding of RF emissions are mitigated by means of multilayer circuit board design that makes effective use of embedded signal layers between grounding layers for non-RF signals. ii Buffered data inputs are implemented within the RTU7105 chip implementation. iii Power regulation for the GE Healthcare 5406102 is implemented both at the circuit board level as well within the RTU7105 chip per the architecture block diagram shown below: g GE Healthcare 3000 North Grandview Blvd Waukesha, Wisconsin 53188 g GE Healthcare 3000 North Grandview Blvd Waukesha, Wisconsin 53188 iv In the 5406102 assembly, the antenna is coupled to the circuit board by means of a MMCX style coaxial connection that qualifies as a “unique” style connector. The image shown below displays both the antenna and PCB mount connectors for the 5406102 assembly: v The 5406102 assembly has been tested and verified in the stand alone configuration as detailed in the accompanying test report. vi The 5406102 assembly shall be labeled by means of a permanent silk screen graphic as shown below: (Actual size, all dimensions shown are in mm) g GE Healthcare 3000 North Grandview Blvd Waukesha, Wisconsin 53188 vii The accompanying test report details all information regarding compliance with 47 CFR part 15 subsection F. viii The 5406102 assembly complies with Maximum Permissible Exposure requirements and its calculation as detailed in the accompanying test report. John L. Schmidt Regulatory Affairs Leader - Xray GE Healthcare Phone: 262-548-4964 Email: [email protected]

FCC ID:OU5-5406102 Label Drawing (Actual size, all dimensions shown are in mm)

Wionics Research, Realtek Group, Irvine, CA 1 Theory of Operations [1] The transceiver is described in the block diagram of Figure 1. In receive mode, I and Q baseband signals are digitized at 528 MS/s by 5b ADCs. The packet detection and frame synchronization sequence is detected, and appropriate gain settings are provided to the RF transceiver. Channel estimation, phase tracking, and signal demapping is performed after transformation by a 128-point FFT. Different data rates are implemented through variations in the coding rate, coding type, and modulation. Convolutional codes with rates of 1/3, 1/2, 5/8, and 3/4 are supported, along with Dual-Carrier Modulation (DCM) and QPSK modulation. In addition, tone and symbol interleaving improve performance in fading channels. Soft decisions from the demapper are resolved by the Viterbi decoder and the decoded data is output at the MAC/PHY interface. For transmission, the process is reversed, except that I and Q signals sent to the 5b DACs are up-sampled to 1056 MS/s. A clock generation circuit provides clock signals for the digital PHY and data converters. In frequency-hopping mode, a band-select signal provides indication to the RF transceiver of the appropriate operating frequency A block diagram of the direct-conversion RF transceiver is shown in Figure 2. In order to enable agile frequency hopping, this design utilizes three separate RF blocks for each operating frequency in Band Group #1 [2]. Each block consists of a tuned amplifier stage, I/Q mixers, and integer-N frequency synthesizer. In frequency-hopping mode, the appropriate RF block is selected for each OFDM symbol, as indicated by the Band Select signal. Each mixer shares a common output connection to the RX baseband circuitry. Direct-conversion receivers are sensitive to LO carrier leakage. In addition, 13 on-chip linear voltage regulators are employed to provide circuit isolation and further limit coupling through package bondwires. Each voltage regulator design has a programmable output voltage, requires no external components, and occupies 0.007mm 2 . The receiver baseband circuitry is comprised of 5 th -order channel selection filters, PGAs, RSSI circuitry, and DC offset compensation. The fast-frequency hopping in this system places additional constraints on the design of a direct-conversion receiver. AC coupling cannot be employed reliably because DC offsets are in part carrier-frequency dependent, and the fast settling requirement of 9ns in the system prevents resettling of AC coupling circuitry. Furthermore, different frequency bands have different RF path loss parameters, resulting in different receiver gain settings. Therefore, any DC offset correction must remain effective for different gain and carrier frequency settings. The transmitter section employs many of the same concepts as the receiver for implementing frequency hopping. Figure 3 shows a simplified circuit diagram of the modulator circuit (one channel), and the shared switched-inductor load. Capacitors tuned with MOS switches result in high-Q tuning elements, but at the expense of additional parasitic capacitance at the output node. In this system, the 528-MHz channel bandwidth makes the use of high-Q resonant circuits undesirable. The balanced switch configuration used in this design allows the use of a smaller switch for a given parasitic resistance. Furthermore, the parasitic capacitance of the switch is partially transformed by the inductor when referred to the output node. The use of switched inductors also allows Wionics Research, Realtek Group, Irvine, CA 2 each inductor to be optimized separately, potentially allowing a wider operating range than a single inductor, switched-capacitor method. References [1] T. Aytur, et al., ìA Fully Integrated UWB PHY in 0.13 um CMOS,î Proc. ISSCC Conf., San Francisco, pp. 124-125, Feb. 2006 [2] B. Razavi, et al., ìA 0.13-mm CMOS UWB Transceiver,î ISSCC Dig. Tech. Papers, pp. 216-217, Feb. 2005. Figure 1: Block diagram of an integrated UWB OFDM PHY tone and symbol deinterl . conv. encoder Viterbi dec . demap QPSK DCM overlap and add 128- point FFT RF TX/RX MAC- PHY inter- face packet detection, frame synch., freq.-off. estimation tone and symbol interl . channel est. and phase tracking A DC D A C map QPSK DCM inverse 128- point FFT + zero prefix upsample and LP filter add pilot tones, add channel est. symbols RSSI AGC, f-hop,... control f-hop,... PLL 1 0 90 PLL 2 0 90 PLL 3 0 90 MUX LPFLPF DAC DAC LPFLPF ADCADC 5 55 5 IV IV RF TUNED Band Select REF Figure 2: Block diagram of a direct-conversion transceiver L 1 SEL 1 G M L 2 L 3 SEL 2 V LO+ V DD V LO- V LO+ V BB+ V BB- V OUT- V OUT+ From other channel From other channel Figure 3: Simplified modulator circuit (one channel) and inductive load

All services undertaken are subject to the following general policy. Reports are submitted for exclusive use of the client to whom they are addressed. Their significance is subject to the adequacy and representative character of the samples and to the comprehensiveness of the tests, examinations or surveys made. This report shall not be reproduced except in full, without written consent of TDK Test Services. This report must not be used to claim product endorsement by NVLAP, NIST nor any other agency of the US Government. Test Report for UWB Certification of URP detector Radio Customer: GE Healthcare Date: October 27, 2010 TDK Report: TTS-TR-T115-101 Test performed by: TDK R&D Corporation 1101 Cypress Creek Rd Cedar Park, TX 78613 Test Engineer Checked by Radiated 30 MHz to 40 GHz A. Medina N. Mellen Report A. Medina N. Mellen This document contains confidential information and cannot be disclosed outside of GE Healthcare or any affiliated company in whole or in part without the express written permission of TDK R&D Corporation. TTS-TR-T115-101 page 2 of 49 1. Executive Summary An EMC evaluation to determine compliance of the URP detector UWB Radio with requirements of FCC 47 CFR Part 15, Subpart F Section 15.519 was conducted. The following data is presented in support of the Certification of the URP detector UWB Radio. The client should retain a copy of this document on file for at least 5 years after the manufacturing of the product has been discontinued. Test Description FCC 47 CFR Section Compliance Operational Limitations 15.519(a) The client has been notified of these limitations. In normal operating mode the transmitter will only send data when associated with a receiver. See section 5 for detail UWB Bandwidth 15.519(b) Yes Radiated Emissions 15.519(c), 15.209 Yes Radiated Emissions in GPS Bands 15.519(d) Yes Peak Emissions within a 50 MHz Bandwidth 15.519(e) Yes Labelling Requirements 15.19/15.212 Yes Report prepared by Approved by Armando Medina Neal Mellen October 26, 2010 October 27, 2010 Page 3 of 49 2. Task Description 2.1. Scope Reference FCC 47 CFR, Part 15, Subpart F, Ultra-Wideband Operation; FCC ET Docket No. 98-153, FCC 02-48 First R&O, Revision of Part 15 of the Commission’s Rules Regarding Ultra-Wideband Transmissions Systems; FCC ET Docket No. 04-352, Petition for Waiver of the Part 15 UWB Regulations Filed by MBOA-SIG (Adopted: March 10, 2005). Purpose of Test To gain FCC Certification for technical requirements for Modular UWB Systems operating between 3.1 GHz and 10.6 GHz. Test Procedures The tests were conducted in accordance with the following documents: FCC ET Docket 98-153, FCC 02-48 First R&O ANSI C63.4: 2009: Methods of Measurement of Radio- Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz FCC Code of Federal Regulations 47, Part 15 Subpart A: General FCC ET Docket No. 04-352, Petition for Waiver of the Part 15 UWB Regulations Filed by MBOA-SIG (Adopted: March 10, 2005) General Procedures FCC Code of Federal Regulations 47, Part 2 Frequency Allocations and Radio Treaty Matter: General Rules and Regulations Classification of EUT Limited Modular Ultra-Wideband System (Hand-held limit) 2.2. Related Submittal(s)/Grant(s) As required in 07-56A1 and 47 CFR 15.212 a cover letter requesting limited modular approval is included in the application for equipment authorization. 2.3. Test Plan Reference Publication Year Title FCC 47 CFR, Part 15, Subpart A 10/2007 Code of Federal Regulations, Part 15 Subpart A: General Page 4 of 49 FCC 47 CFR, Part 15, Subpart B 10/2007 Code of Federal Regulations, Part 15 Subpart B: Unintentional Radiators FCC 47 CFR, Part 15, Subpart C 10/2007 Code of Federal Regulations, Part 15 Subpart C: Intentional Radiators FCC 47 CFR, Part 15, Subpart F 10/2007 Code of Federal Regulations, Part 15 Subpart F: Ultra-Wideband Operation FCC ET Docket 98-153, FCC 02-48 First R&O 04/2002 Revision of Part 15 of the Commission’s Rules Regarding Ultra-Wideband Transmissions Systems: First Report & Order ANSI C63.4 07/2009 Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz FCC ET Docket No. 04- 352 3/2005 Petition for Waiver of the Part 15 UWB Regulations Filed by MBOA-SIG FCC 47 CFR, Part 15, Subpart C 04/2007 Part 15.212 unlicensed Modular Transmitter Approval 2.4. Client Information APPLICANT Name GE Healthcare Address 3000 N. Grandview Blvd, m/s W622, Waukesha, WI 53188 Contact Person Luke Beno MANUFACTURER Name GE Healthcare Address 3000 N. Grandview Blvd, m/s W622, Waukesha, WI 53188 Contact Person Luke Beno 2.5. Equipment Under Test (EUT) The following information (with the exception of the date information) has been supplied by the applicant. The test results in this report pertain only to the item tested. General Brand Name GE Healtcare Product Name URP detector UWB radio PWA and antenna module Model Name or Number 5406102 Serial Number 1100035 Page 5 of 49 Type of Equipment UWB Radio Transmitter Input Power Supply Type Powered by PC USB port Antenna Classification Chip Manufacturer Mitsumi Electric Company Model Name or Number 5366181 Type and Description Mitsumi DCA-E03 chip antenna Antenna Connector Type MMCX Cable Length (cm) 26 Technical Power Supply Requirements +5Vdc RF Output Rating -42 dBm EIRP @ 3 meters Operating Frequency Range 3168 MHz to 4752 MHz RF Output Impedance 50  Channel Spacing N/A Pulse Width N/A Pulse Repetition Frequency N/A 10 dB Bandwidth >500 MHz Modulation/Constellation Multiband OFDM Oscillators’ Frequencies 66 MHz EUT Ports Mini-USB, 2-pin DC, RF-Port, SDIO-Interface Logistics EUT Receive Date October 18, 2010 EUT Receive Condition Good Test Start Date October 22, 2010 Test Completion Date October 24, 2010 2.5.1.Support Equipment Description Manufacturer Model No. Serial No. FCC ID Host PC COMPAQ Presario V2000 CNF5490P8P None AC Power Adapter (PC) HP PPP009D 1UW072807067318 A None …

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