U72DRXRGAGrid Alignment

DRX-Revolution Mobile X-ray System Safety and Regulatory Information 2012-02-07 9J0239 Version 3.0 9J02391 Table of Contents 1 Safety and Regulatory Information Manual Conventions ............................................................................................................................................ 1 Overview ............................................................................................................................................................. 1 Indications for Use ........................................................................................................................................ 2 Training ........................................................................................................................................................ 2 Safety and Related Information............................................................................................................................ 3 Manufacturer’s Responsibility ....................................................................................................................... 3 Safety Symbols............................................................................................................................................... 4 Radiation and X-ray System ........................................................................................................................... 6 Safety and General Compliance Information ............................................................................................ 6 Maximum Permissible Dose (MPD) ........................................................................................................ 7 Radiographic Performance ....................................................................................................... .............. 7 Radiation Protection ............................................................................................................................... 8 CDRH Compliance................................................................................................................................... 9 Classification in Accordance with IEC 60601-1........................................................................................ 9 IEC/EN 60601-1-3 Compliance................................................................................................................ 9 Conforming Safety Standards....................................................................................................................... 10 USA ....................................................................................................................................................... 10 Canada .................................................................................................................................................. 10 Europe .................................................................................................................................................. 10 International ......................................................................................................................................... 10 Cautions ............................................................................................................................................................ 11 Equipment Cautions ............................................................................................................. ....................... 11 Electrical/Mechanical.................................................................................................................................. 11 Mechanical ................................................................................................................................................. 11 General Use Cautions and Special Messages ................................................................................................ 11 Moving and Equipment Use Cautions........................................................................................................... 12 Electrical and Flammable Cautions.............................................................................................................. 12 Radiation and Magnetic Field Cautions ........................................................................................................ 13 Cleaning Cautions........................................................................................................................................ 13 Caution Regarding Small-Object Image Handling ........................................................................................ 14 Restrictions on Use ..................................................................................................................................... 15 29J0239 Disposal............................................................................................................................................................ 16 Usability ............................................................................................................................................................ 16 USB, Network, and Tether Connectors .............................................................................................................. 17 Conforming EMC Standards .............................................................................................................................. 18 For European Market Only.......................................................................................................................... 18 System Requirements .................................................................................................................................. 18 US and Canada EMC Statements .................................................................................................................. 19 Electromagnet…

Text truncated - open the document above for the full version.

Carestream CarestreamHealthInc. 150 VeronaStreet Rochester,NY 14608 Date: Jan. 9,2012 Subject:ConfidentialityRequestfor FCC ill: U72DRXRGA Pursuantto FCC 47 CRF 0.457(d)and 0.459 and IC RSP-100,Section10, the applicantrequests that a part of the subject FCC/ICapplicationbe held confidential. Typeof ConfidentialityRequested Exhibit DShort Term [gIPermanentBlockDiagrams [gI Short Term DPermanent InternalPhotos DShort Term [gIPermanent OperationDescription/Theoryof Operation DShort TermDPermanent Tune-UpProcedure DShort Term [gIPermanentSchematics DShort TermDPermanent User'sManual CarestreamHealthInc. has spent substantialeffort in developingthis productand it is one of the first of its kind in industry.Havingthe subjectinformationeasily availableto "competition" wouldnegatethe advantageour Companyhas achievedby developingthis product.Not protectingthe detailsof the designwill result in fmancialhardship. PermanentConfidentiality: The applicantrequeststhe exhibitslisted aboveas permanentlyconfidentialand to be permanentlywithheldfrom publicreviewdue to materialsthat containtrade secretsand proprietaryinformationnot customarilyreleasedto the public. Sincerely, By: RonaldL. Cain EMC ComplianceEngineer

Carestream CarestreamHealthInc. 150 VeronaStreet Rochester,NY 14608 Date:January6,2012 FederalCommunicationsCommission 7435 OaklandMills Road Columbia,MD 21046 Re: FCC ID: U72DRXRGA To WhomIt May Concern: CarestreamHealthInc., certifiesthat neitherthe applicantnor any party to this application,as definedin 47 CFR Ch. 1.2002(b),is subject to a denialto Federalbenefits, that includeFCC benefits,pursuantto section5301 of the Anti-DrugAbuseAct of 1998, 21 U.S.c.835(a). This authorizationis valid until furtherwrittennoticefrom CarestreamHealthInc. Sincerely, RonaldL. Cain ~lr?~ CarestreamHealth,Inc. 150 VeronaSt. Rochester,NY 14608

TUV Rheinland 336 Initiative Dr., Rochester, NY 14624 FCC ID: U72DRXRGA Tel: (585) 426-5555, Fax: (585) 568-8338 IC ID: 7027A-DRXRGA Page 1 of 1 External Photos Figure 1: Location of Intentional Radiator (Underneath x‐ray)

Carestream Grid Alignment Transmitter FRN 0016195265 FCC and Industry Canada ID Label Location For Grid Alignment Transmitter on Carestream DRX Revolution Mobile X-ray System

9J1989 REV. 2 N692 HHHH - AA - FFFF R 005XWAA0012 FCC ID U72DRXRGA IC: 7027A-DRXRGA COFETEL: XXXXXXXX-XXX ertified for use in Hong Kong C 經驗證可在香港使用 電訊管理局 Certificate No.證書號碼 ZZ ZZZYYXXXXX OFTA CCXXxxLPyyyZzW C02-XXXX Complies With IDA Standard Dealer Licence No. AA NNNNNN TA-2012/NNNN APPROVED 2“ 2.5” Carestream Grid Alignment Transmitter FRN 0016195265

TUV Rheinland 336 Initiative Dr., Rochester, NY 14624 FCC ID: U72DRXRGA Tel: (585) 426-5555, Fax: (585) 568-8338 IC ID: 7027A-DRXRGA Page 1 of 2 Internal Photos Figure 1: Internal View TUV Rheinland 336 Initiative Dr., Rochester, NY 14624 FCC ID: U72DRXRGA Tel: (585) 426-5555, Fax: (585) 568-8338 IC ID: 7027A-DRXRGA Page 2 of 2 Figure 2: Internal View

FCC ID: U72DRXRGA IC: 7027A-DRXRGA Report No.: 31152591.007_GA Radio.doc Page 1 of 24 The test results contained in this report refer exclusively to the product(s) presented for testing. No liability may be assumed for models or products not referred to herein. This test report may not be published or duplicated in part without permission of the testing body. This test report by itself does not constitute authorization for the use of any TUV Rheinland test mark. This report must not be used by the applicant to claim product endorsement by TUV Rheinland, NVLAP or any agency of the United States Government. TÜV Rheinland Inc., 336 Initiative Drive, Rochester NY 14624 – Tel (585) 426-5555 Fax (585) 568-8338 QF09G040 Rev 1.0 Electromagnetic Compatibility Test Report Prepared in accordance with FCC Part 15, RSS-210 and ANSI C63.10 On Grid Alignment Radio GA Prepared for: Carestream Health Inc. 150 Verona St Rochester NY, 14608 Prepared by: TUV Rheinland of North America, Inc. FCC ID: U72DRXRGA IC: 7027A-DRXRGA Report No.: 31152591.007_GA Radio.doc Page 2 of 24 The test results contained in this report refer exclusively to the product(s) presented for testing. No liability may be assumed for models or products not referred to herein. This test report may not be published or duplicated in part without permission of the testing body. This test report by itself does not constitute authorization for the use of any TUV Rheinland test mark. This report must not be used by the applicant to claim product endorsement by TUV Rheinland, NVLAP or any agency of the United States Government. TÜV Rheinland Inc., 336 Initiative Drive, Rochester NY 14624 – Tel (585) 426-5555 Fax (585) 568-8338 QF09G040 Rev 1.0 Auftraggeber: Client: Carestream Health Inc. 150 Verona St Rochester NY, 14608 Ronald Cain 585-627-8321 / 585-477-2718 [email protected] Bezeichnung: Identification: Grid Alignment Radio Serien-Nr.: Serial No. prototype Gegenstand der Prüfung: Test item: GA Prüfdatum: Date tested: 09/13/2011 Prüfort: Testing location: TUV Rheinland of North America 336 Initiative Drive Rochester, NY 14624 U.S.A. Prüfgrundlage: Test specification: Emissions: FCC Part 15.209(a), RSS-210 Issue 8 & RSS-GEN Issue 3, ANSI C63.10 RSS-210 Issue 8, RSS-GEN Issue 3 FCC Part 15.205 & RSS-GEN Issue 3, FCC Part 15.203 RSS-210 Issue 8 & RSS-GEN Issue 3, RSS-GEN Issue 3 Prüfergebnis: Test Result Der vorstehend beschriebene Prüfgegenstand wurde geprüft und entspricht oben genannter Prüfgrundlage. The above product was found to be Compliant to the above test standard(s) geprüft / tested by: Randall Masline reviewed by: Cecil Gittens 2 March 2012 Date Name Signature 2 March 2012 Date Name Signature Sonstiges : Other Aspects: None Abkürzungen: OK, Pass, Compliant, Complies = entspricht Prüfgrundlage Fail, Not Compliant, Does not Comply = entspricht nicht Prüfgrundlage N/A = nicht anwendbar Abbreviations: OK, Pass, Compliant, Complies = passed Fail, Not Compliant, Does Not Comply = failed N/A = not applicable Industry Canada BSMI US5253 NVLAP CODE 200313-0 3466C-1 SL2-IN-E-050R FCC ID: U72DRXRGA IC: 7027A-DRXRGA Report No.: 31152591.007_GA Radio.doc Page 3 of 24 The test results contained in this report refer exclusively to the product(s) presented for testing. No liability may be assumed for models or products not referred to herein. This test report may not be published or duplicated in part without permission of the testing body. This test report by itself does not constitute authorization for the use of any TUV Rheinland test mark. This report must not be used by the applicant to claim product endorsement by TUV Rheinland, NVLAP or any agency of the United States Government. TÜV Rheinland Inc., 336 Initiative Drive, Rochester NY 14624 – Tel (585) 426-5555 Fax (585) 568-8338 QF09G040 Rev 1.0 TABLE OF CONTENTS 1 GENERAL INFORMATION ......................................................................................................................... 4 1.1 S COPE ......................................................................................................................................................... 4 1.2 P URPOSE ..................................................................................................................................................... 4 1.3 S UMMARY OF TEST RESULTS ..................................................................................................................... 5 2 LABORATORY INFORMATION ................................................................................................................ 6 2.1 A CCREDITATIONS & ENDORSEMENTS ........................................................................................................ 6 2.2 M EASUREMENT UNCERTAINTY .................................................................................................................. 7 2.3 C ALIBRATION TRACEABILITY .................................................................................................................... 8 2.4 M EASUREMENT EQUIPMENT USED ............................................................................................................ 9 3 PRODUCT INFORMATION ....................................................................................................................... 10 3.1 P RODUCT DESCRIPTION............................................................................................................................ 10 3.2 E QUIPMENT MODIFICATIONS ................................................................................................................... 10 3.3 T EST PLAN ................................................................................................................................................ 10 4 EMISSIONS .................................................................................................................................................... 11 4.1 R ADIATED EMISSIONS ............…

Text truncated - open the document above for the full version.

TUV Rheinland 336 Initiative Dr., Rochester, NY 14624 FCC ID: U72DRXRGA Tel: (585) 426-5555, Fax: (585) 568-8338 IC ID: 7027A-DRXRGA Page 1 of 3 Test Setup Photos Figure 1: TUV Rheinland 336 Initiative Dr., Rochester, NY 14624 FCC ID: U72DRXRGA Tel: (585) 426-5555, Fax: (585) 568-8338 IC ID: 7027A-DRXRGA Page 2 of 3 Figure 2: Figure 3: TUV Rheinland 336 Initiative Dr., Rochester, NY 14624 FCC ID: U72DRXRGA Tel: (585) 426-5555, Fax: (585) 568-8338 IC ID: 7027A-DRXRGA Page 3 of 3 Figure 4: Figure 5: