YYJ-5406102URP Radio Board

54400222-1EN r2 DRAFT June 17, 2011Optima XR220amx2-1 Chapter 2 Safety and Regulatory This chapter explains the safety considerations, general equipment and patient related precautions, and the symbols used for the safe operation of your equipment. This chapter also includes information about the emergency procedures. This chapter presents the concepts necessary to successfully operate your system safely. Safety and Regulatory 54400222-1EN r2 DRAFT June 17, 2011Optima XR220amx2-2 X-Ray Protection X-ray equipment if not properly used may cause injury. Accordingly, the instructions herein contained should be thoroughly read and understood by everyone who will use the equipment before you attempt to place this equipment in operation. GE Healthcare, will be glad to assist and cooperate in placing this equipment in use. Although this apparatus incorporates a high degree of protection against x-radiation other than the useful beam, no practical design of equipment can provide complete protection. Nor can any practical design compel the operator to take adequate precautions to prevent the possibility of any persons carelessly exposing themselves or others to radiation. It is important that everyone having anything to do with x-radiation be properly trained and fully acquainted with the recommendations of the National Council on Radiation Protection and Measurements as published in NCRP Reports available from NCRP Publications, 7910 Woodmont Avenue, Room 1016, Bethesda, Maryland 20814, and of the International Commission on Radiation Protection, and take adequate steps to protect against injury. The equipment is sold with the understanding that GE Healthcare, its agents, and representatives have no responsibility for injury or damage which may result from improper use of the equipment. Various protective material and devices are available. It is urged that such materials or devices be used. Safety and Regulatory 54400222-1EN r2 DRAFT June 17, 2011Optima XR220amx2-3 FCC Statement of Conformance 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. Safety and Regulatory 54400222-1EN r2 DRAFT June 17, 2011Optima XR220amx2-4 Indications for Use The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx, Optima XR200amx, Optima XR220amx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR220amx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR). Brivo XR285amx, Optima XR200amx, Optima XR220amx are self-contained; battery operated mobile radiographic imaging systems designed to generate diagnostic radiographic images (medical x-rays) that may increase the ability to detect disease or injury early enough for a medical problem to be managed, treated, or cured. Medical x-rays are used in many types of examinations and procedures, some examples include: x-ray radiography (to find orthopedic damage, tumors, pneumonias, foreign objects). The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. Its mobility enables general-purpose radiographic procedures throughout the clinical environment, or as needed within the emergency, intensive care, premature birth ward, cardiac and operating departments, for patients that may not be able to be moved or in cases where it is unsafe or impractical to move them to a traditional RAD room. The systems are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position. These devices are not intended for mammographic applications. WARNING:United States Federal law restricts this device to sale by or on the order of a physician. Safety and Regulatory 54400222-1EN r2 DRAFT June 17, 2011Optima XR220amx2-5 Contraindications This device is not intended for mammographic applications. Safety and Regulatory 54400222-1EN r2 DRAFT June 17, 2011Optima XR220amx2-6 Users The targeted clinical users include qualified trained doctors, radiographers, or radiologic technologists (RTs) working in various locations. Locations may include orthopedic clinics, radiology imaging centers, hospital radiology departments, or hospital orthopedic departments. Safety and Regulatory 54400222-1EN r2 DRAFT June 17, 2011Optima XR220amx2-7 Safety The electrical wiring of the relevant rooms complies with all national and local codes, as well as the Regulations for the electrical equipment of buildings published by the Institution of Electrical Engineers. All assembly operations, extensions, re-adjustments, or repairs must be carried out by qualified service representatives. Any modifications must be carried out by GE Healthcare Technologies authorized service representatives. The equipment must be used in accordance with the instructions for use. WARNING:This X-Ray unit may be dangerous to patient and operator, unless safe exposure factors, operating instructions and maintenance schedules are observed. To be used by authorized personnel only. WARNING:Electric Shock Hazard! Do not remove covers. The system contains high voltage circuits for generating and controlling X-rays. Prevent possible electric shock by leaving covers on the equipment. There are no operator serviceable parts or adjustments inside. Only trained and qualified personnel should be permitted access to the internal parts of this equipment. WARNING:To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. WARNING:All assembly operations, extensions, re-adjustments, or repairs must be carried …

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166 South Carter Street, Genoa City, WI 53128 Letter of Agency Date: June 21, 2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 To Whom It May Concern: Please be advised that GE Medical Systems, LLC authorizes D.L.S. Electronic Systems, Inc. to act on their behalf, until otherwise notified, for applications submitted to the FCC. We certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse ACT of 1988, U.S.C. 862. Further, no party, as defined in 47 CFR 1.2002(b), to the application is subject to denial of federal benefits, that includes FCC benefits. Thank you for your attention to this matter. Signatory, William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc. 166 South Carter Street, Genoa City, WI 53128 FCC Labeling Requirements and Information Date: June 21, 2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 RE: FCC Labeling Requirements FCC ID: YYJ-5406102 The following label information is required by the FCC Rules and Regulations for certified devices. Also attached, please find marketing information required by the FCC Rules and Regulations. Thank you for your attention to these matters. Sincerely, William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc. 166 South Carter Street, Genoa City, WI 53128 Modification Letter Date: June 21, 2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 RE: Certification Application FCC ID: YYJ-5406102 Please be advised that the following information is a list of modifications that will be included in the production process for the above-referenced equipment. Change 1: There were no modifications made during testing. Change 2: Change 3: Change 4: Change 5: Change 6: Change 7: Change 8: Change 9 Change 10: Thank you for your attention to this matter. Signatory William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc. 166 South Carter Street, Genoa City, WI 53128 Manufacturer’s Letter Date: June 21, 2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 RE: Certification Application FCC ID: YYJ-5406102 To Whom It May Concern: Please be advised that the manufacturer will ensure that the above-referenced model will be manufactured in accordance with the FCC Rules and Regulations. Thank you for your attention to this matter. Signatory William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc.

166 South Carter Street, Genoa City, WI 53128 Letter of Agency Date: June 21, 2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 To Whom It May Concern: Please be advised that GE Medical Systems, LLC authorizes D.L.S. Electronic Systems, Inc. to act on their behalf, until otherwise notified, for applications submitted to the FCC. We certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse ACT of 1988, U.S.C. 862. Further, no party, as defined in 47 CFR 1.2002(b), to the application is subject to denial of federal benefits, that includes FCC benefits. Thank you for your attention to this matter. Signatory, William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc. 166 South Carter Street, Genoa City, WI 53128 FCC Labeling Requirements and Information Date: June 21, 2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 RE: FCC Labeling Requirements FCC ID: YYJ-5406102 The following label information is required by the FCC Rules and Regulations for certified devices. Also attached, please find marketing information required by the FCC Rules and Regulations. Thank you for your attention to these matters. Sincerely, William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc. 166 South Carter Street, Genoa City, WI 53128 Modification Letter Date: June 21, 2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 RE: Certification Application FCC ID: YYJ-5406102 Please be advised that the following information is a list of modifications that will be included in the production process for the above-referenced equipment. Change 1: There were no modifications made during testing. Change 2: Change 3: Change 4: Change 5: Change 6: Change 7: Change 8: Change 9 Change 10: Thank you for your attention to this matter. Signatory William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc. 166 South Carter Street, Genoa City, WI 53128 Manufacturer’s Letter Date: June 21, 2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 RE: Certification Application FCC ID: YYJ-5406102 To Whom It May Concern: Please be advised that the manufacturer will ensure that the above-referenced model will be manufactured in accordance with the FCC Rules and Regulations. Thank you for your attention to this matter. Signatory William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc.

FCC ID: YYJ-5406102 D.L.S. ELECTRONIC SYSTEMS, INC. 166 South Carter Street Genoa City, WI 53128 June 21, 2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Gentlemen: We are submitting for GE Medical Systems, LLC, a URP Radio Board, with an FCC ID: YYJ-5406102 for Limited Single Modular Approval Certification. This unit has been tested and complies to Part 15, Subpart F. If there are any questions in regard to this application, please call D.L.S. Electronic Systems, Inc. at (262) 279-0210. Enclosed you will find a copy of our test report with the information and results of tests that is required under Part 15, Subpart F. Thank you for your assistance in this matter. Sincerely, William M. Stumpf DLS/js

166 South Carter Street, Genoa City, WI 53128 Request for Confidentiality Date: June 21, 2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 RE: Certification Application FCC ID: YYJ-5406102 Pursuant to 47 CFR Section 0.459 GE Medical Systems, LLC understands that requests for non disclosure and confidential treatment is being made for the following information as stated under the Code of Federal Regulations Chapter 47, Part 0.459: • Block Diagram • Schematics • Description of Operation The above materials contain trade secrets, proprietary and technical information that would customarily be guarded from competitors under 47 CFR section 0.457(d)(2). Disclosure or publication of any portion of this company confidential material to other parties could cause substantial competitive harm and provide unjustified benefits for competitors. GE Medical Systems, LLC understands that pursuant to 47 CFR section 0.457(d)(1)(ii) disclosure of the applicant and all accompanying documentation will not be made before the date of the grant. Thank you for your attention to this matter. Signatory William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc.

FCC ID: YYJ-5406102 D.L.S. ELECTRONIC SYSTEMS, INC. 166 South Carter Street Genoa City, WI 53128 June 21, 2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Gentlemen: We are submitting for GE Medical Systems, LLC, a URP Radio Board, with an FCC ID: YYJ-5406102 for Limited Single Modular Approval Certification. This unit has been tested and complies to Part 15, Subpart F. If there are any questions in regard to this application, please call D.L.S. Electronic Systems, Inc. at (262) 279-0210. Enclosed you will find a copy of our test report with the information and results of tests that is required under Part 15, Subpart F. Thank you for your assistance in this matter. Sincerely, William M. Stumpf DLS/js

166 South Carter Street, Genoa City, WI 53128 Request for Confidentiality Date: June 21, 2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 RE: Certification Application FCC ID: YYJ-5406102 Pursuant to 47 CFR Section 0.459 GE Medical Systems, LLC understands that requests for non disclosure and confidential treatment is being made for the following information as stated under the Code of Federal Regulations Chapter 47, Part 0.459: • Block Diagram • Schematics • Description of Operation The above materials contain trade secrets, proprietary and technical information that would customarily be guarded from competitors under 47 CFR section 0.457(d)(2). Disclosure or publication of any portion of this company confidential material to other parties could cause substantial competitive harm and provide unjustified benefits for competitors. GE Medical Systems, LLC understands that pursuant to 47 CFR section 0.457(d)(1)(ii) disclosure of the applicant and all accompanying documentation will not be made before the date of the grant. Thank you for your attention to this matter. Signatory William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc.

Company: GE Medical Systems, LLC Model: URP Radio Board Top Bottom

Company: GE Medical Systems, LLC Model: URP Radio Board Top Bottom

FCC ID: YYJ-5406102 “URP Radio Board” Label Drawing Circuit Board top-side screen print shown. Not to scale, dimensions of text “FCC ID: YYJ-5406102” are 18.9mm x 1.4mm.

FCC ID: YYJ-5406102 “URP Radio Board” Label Drawing Circuit Board top-side screen print shown. Not to scale, dimensions of text “FCC ID: YYJ-5406102” are 18.9mm x 1.4mm.

Company: GE Medical Systems, LLC Model: URP Radio Board Top Bottom Company: GE Medical Systems, LLC Model: URP Radio Board Board with Antenna

Company: GE Medical Systems, LLC Model: URP Radio Board Top Bottom Company: GE Medical Systems, LLC Model: URP Radio Board Board with Antenna

166 South Carter, Genoa City, WI 53128 Page 1 of 2 Company: GE Medical Systems, LLC Model Tested: 5436008-2 rev1 Report Number: 17001 (RF Exposure) Project Number: 4679 FCC Code of Federal Regulations 47 Part 1.1307(b) (1) RF Exposure Statement of Compliance THE FOLLOWING MEETS THE ABOVE TEST SPECIFICATION Formal Name: URP Radio Kind of Equipment: UWB Radio FCC ID Number: YYJ-5406102 Frequency Range: 3168 - 4752 MHz, 6336 – 7920 MHz Test Configuration: Hand-held transceiver tested table-top in worst case configuration of three orthogonal planes. Model Number(s): 5436008 rev3, 5436008-2 rev1 Model(s) Tested: 5436008-2 rev1 Serial Number(s): 11100098 Date of Tests: May 23 – 27, 2011 Test Conducted For: GE Medical Systems, LLC 3000 N. Grandview Blvd Mailstop W622 Waukesha, WI 53188 166 South Carter, Genoa City, WI 53128 Page 2 of 2 Company: GE Medical Systems, LLC Model Tested: 5436008-2 rev1 Report Number: 17001 (RF Exposure) Project Number: 4679 Maximum EIRP (Peak): BG1: -32.57 dBm 4.15 GHz BG3: -32.61 dBm 7.51 GHz Exposure Limit: Maximum Permissible Exposure (MPE) limit for General Population / Uncontrolled Exposure in the frequency range 1500 – 100,000 MHz: S = 1 mW/cm 2 MPE Calculation: Power Density (mW/cm 2 ): ൌܵ ܩܲ ܴߨ4 ଶ ݎ݋ ܵൌ ܴܲܫܧ ܴߨ4 ଶ S = Power Density (mW/cm 2 ) P = Power Input to the antenna (mW) G = Numeric Power Gain of the antenna R = Distance to the center of the radiation of the antenna (cm) EIRP = Equivalent (effective) isotropically radiated power Results: BG1: ൌܵ ଴.଴଴଴ହହଷ ௠ௐ ସగሺଶ଴ሻ మ ൌ0.000000110 ௠ௐ ௖௠ మ BG3: ൌܵ ଴.଴଴଴ହସ଼ ௠ௐ ସగሺଶ଴ሻ మ ൌ0.000000109 ௠ௐ ௖௠ మ Conclusion: The GE Medical Systems, LLC, URP Radio operating under FCC Part 15.519 complies with the requirements of FCC Part 1.1307(b) (1) for RF Exposure Evaluation by a large margin.

166 South Carter, Genoa City, WI 53128 Page 1 of 40 Company: GE Medical Systems, LLC Model Tested: 5436008-2 rev1 Report Number: 17001 Project Number: 4679 i. Cover Page Code of Federal Regulations 47 Part 15 – Radio Frequency Devices Subpart F – Ultra-Wideband Operation Section 15.519 Technical Requirements for hand held UWB systems THE FOLLOWING MEETS THE ABOVE TEST SPECIFICATION Formal Name: URP Radio Board Kind of Equipment: UWB Radio FCC ID Number: YYJ-5406102 Frequency Range: 3168 - 4752 MHz, 6336 – 7920 MHz Test Configuration: Hand-held transceiver tested table-top in worst case configuration of three orthogonal planes. Model Number(s): 5436008 rev3, 5436008-2 rev1 Model(s) Tested: 5436008-2 rev1 Serial Number(s): 11100098 Date of Tests: May 23 – 27, 2011 Test Conducted For: GE Medical Systems, LLC 3000 N. Grandview Blvd Mailstop W622 Waukesha, WI 53188 NOTICE: “This test report relates only to the items tested and must not be used by the client to claim product endorsement by NVLAP or any agency of the U.S. Government”. Please see the "Description of Test Sample" page listed inside of this report. © Copyright 1983 - 2011 D.L.S. Electronic Systems, Inc. COPYRIGHT NOTICE This report must not be reproduced (except in full), without the approval of D.L.S. Electronic Systems, Inc. 166 South Carter, Genoa City, WI 53128 Page 2 of 40 Company: GE Medical Systems, LLC Model Tested: 5436008-2 rev1 Report Number: 17001 Project Number: 4679 ii. Signature Page SIGNATURE PAGE Report By: Adam Alger Test Engineer June 20, 2011 Reviewed By: William Stumpf OATS Manager Approved By: Brian Mattson General Manager 166 South Carter, Genoa City, WI 53128 Page 3 of 40 Company: GE Medical Systems, LLC Model Tested: 5436008-2 rev1 Report Number: 17001 Project Number: 4679 iii. Table of Contents Table of Contents i. Cover Page .......................................................................................................................................1 ii. Signature Page .................................................................................................................................2 iii. Table of Contents .............................................................................................................................3 iv. NVLAP Certificate of Accreditation ...............................................................................................4 1.0 Summary of Test Report ..................................................................................................................5 2.0 Introduction ......................................................................................................................................5 3.0 Test Facilities ...................................................................................................................................5 4.0 Description of Test Sample ..............................................................................................................6 5.0 Test Equipment ................................................................................................................................7 6.0 Test Arrangements ...........................................................................................................................8 7.0 Test Conditions ................................................................................................................................8 8.0 Modifications Made To EUT For Compliance ................................................................................8 9.0 Additional Descriptions ...................................................................................................................9 10.0 Results ..............................................................................................................................................9 11.0 Conclusion .......................................................................................................................................9 Appendix A – Test Photos .........................................................................................................................10 Appendix B – Measurement Data ..............................................................................................................19 1.0 Fundamental Emission Bandwidth – 10 dB ............................................................................. 19 2.0 Radiated Spurious Emissions below 960 MHz ......................................................................... 26 3.0 Radiated / RF Conducted Spurious Emissions above 960 MHz .............................................. 27 4.0 Radiated Fundamental Emissions in band 3100 to 10600 MHz ............................................... 34 5.0 Radiated Spurious Emissions in GPS Band .............................................................................. 37 166 South Carter, Genoa City, WI 53128 Page 4 of 40 Company: GE Medical Systems, LLC Model Tested: 5436008-2 rev1 Report Number: 17001 Project Number: 4679 i v. NVLAP Certificate of Accreditation 166 South Carter, Genoa City, WI 53128 Page 5 of 40 Company: GE Medical Systems, LLC Model Tested: 5436008-2 rev1 Report Number: 17001 Project Number: 4679 1.0 Summary of Test Report It was determined that the GE Medical Systems, LLC URP Radio Board, Model 5436008-2 rev 1, complies with the requirements of CFR 47 Part 15 Subpart F Section 15.519. Subpart F Applicable Technical Requirements Tested: Section Description Procedure Note Compliant? 15.519 (b) Fundamental Emission Bandwidth – 10dB ANSI C63.4-2009 & ANSI C63.10-2009 1 Yes 15.519 (c) / 15.209 Radiated Spurious Emissions below 960 MHz ANSI C63.4-2009 & ANSI C63.10-2009 1 Yes 15.519 (c) Radiated / RF Conducted Spurious Emissions above 960 MHz ANSI C63.4-2009 & ANSI C63.10-2009 1,2 Yes 15.519 (c) & (e) Radiated Fundamental Emissions in band 3100 to 10600 MHz ANSI C63.4-2009 & ANSI C63.10-2009 1 Yes 15.519 (d) Radiat…

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Company: GE Medical Systems, LLC Model: URP Radio Board Setup Photos Radiated Emissions – Y – Worst Case Position Radiated Emissions – Y Position (2) Radiated Emissions – Y Position (3) Radiated Emissions – Y Position (4) Radiated Emissions – Y Position (5) Radiated Emissions – Z Position Radiated Emissions – Z Position (2) Radiated Emissions – X Position Radiated Emissions – X Position (2)

Company: GE Medical Systems, LLC Model: URP Radio Board Setup Photos Radiated Emissions – Y – Worst Case Position Radiated Emissions – Y Position (2) Radiated Emissions – Y Position (3) Radiated Emissions – Y Position (4) Radiated Emissions – Y Position (5) Radiated Emissions – Z Position Radiated Emissions – Z Position (2) Radiated Emissions – X Position Radiated Emissions – X Position (2)