
Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.
CARESTREAM DRX-1 System Safety and Regulatory Information with Hardware User’s Guide Version 3.0 PN 7H8166 6 April 2009 C a r e s t r e a m C a r e s t r e am D R X 1 S y s t e m H224_0028HC 7H81661 Table of Contents 1 Safety and Regulatory Information Document Conventions .................................................................................................................................... 1-1 Intended Use and Indications for Use ............................................................................................................... 1-1 Safety and Related Information......................................................................................................................... 1-2 Medical Equipment Classification ............................................................................................................... 1-2 Compatibility with Other Manufacturer’s Equipment .................................................................................. 1-3 Product Safety Standards ............................................................................................................................ 1-4 EMC Standards for Detector and System ..................................................................................................... 1-7 Safety ......................................................................................................................................................... 1-7 Additional Guidance and Manufacturer’s Declaration - Electromagnetic Emissions/Immunity.................... 1-7 Electromagnetic Compatibility Precautions........................................................................................... 1-7 Communications Equipment ................................................................................................................ 1-8 Replacement of Cables, Accessories, or Transducers ........................................................................... 1-8 Other Equipment.................................................................................................................................. 1-9 Shielded Locations ............................................................................................................................... 1-9 DRX-1 System Product Information ................................................................................................................ 1-14 DRX-1 System Detector ............................................................................................................................ 1-14 DRX-1 System Battery Charger.................................................................................................................. 1-15 DRX-1 System Battery ............................................................................................................................... 1-16 DRX-1 System Console ............................................................................................................................. 1-16 DRX-1 System Wireless Access Point ........................................................................................................ 1-17 DRX-1 System Tether Interface ................................................................................................................. 1-17 Patient Vicinity ......................................................................................................................................... 1-18 Mode of Operation ................................................................................................................................... 1-18 Labels ...................................................................................................................................................... 1-19 Disposal Information ..................................................................................................................................... 1-24 Operating Environment .................................................................................................................................. 1-24 For European Market Only ....................................................................................................................... 1-24 General Contact Information .................................................................................................................... 1-25 2 Hardware and Operation Overview .......................................................................................................................................................... 2-1 CARESTREAM DRX-1 System ............................................................................................................................ 2-2 27H8166 Table of Contents Cautions ........................................................................................................................................................... 2-3 Installing the Hardware .................................................................................................................................... 2-3 Attaching Accessories ................................................................................................................................. 2-4 Turning the System On and Off ................................................................................................................... 2-4 CARESTREAM DRX-1 System Battery................................................................................................................. 2-5 Installing the Battery .................................................................................................................................. 2-5 Removing the Battery ................................................................................................................................. 2-6 Labeling the Detector .....................................................................…
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HEALTH CarestreamHealth,Inc. 150 VeronaStreet Rochester,NY 14608 Date: June 29, 2010 FederalCommunicationsCommission 7435 OaklandMills Road Columbia,MD 21046 Re: FCC ID: U72DRX1 To WhomIt May Concern: CarestreamHealth,Inc., certifiesthat neitherthe applicantnor any party to this application,as definedin 47 CFR Ch. 1.2002(b),is subjectto 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 CarestreamHealth,Inc. fC;dL~ RonaldLee Cain CarestreamHealthInc. 150 VeronaSt. Rochester,NY 14608
HEALTH CorestreamHealth,Inc. 150 VeronaStreet Rochester,NY 14608 FederalCommunicationsCommission Authorizationand EvaluationDivision ConfidentialityRequestregardingapplicationfor certificationof FCC ill: U72DRXl-4. Pursuantto Sections0.457 and 0.459 of the Commission'sRules,we herebyrequest confidentialtreatmentof informationaccompanyingthis applicationas outlinedbelow: ExhibitType BlockDiagram OperationalDescription ElectricalSchematic File Name DRXI4 Blk Diag.pdf Theoryof Operation.pdf 2G6343.sheet1.pdf 2G6343.sheet2.pdf PermanentConfidentiality: The above materialscontaintrade secretsand proprietaryinformationnot customarily releasedto the public.The DRXl-4radio designis derivedunder a licenseagreement betweenCarestreamHealth,Inc. and anothercompany.Disclosureof the identified documentationwill violatethe conditionsof the licenseand will exposeCarestream Healthto legal actionand possiblefinancialhardship. Sincerely, ~;:~ RonaldL. Cain
External Photos for Carestream DRX1-4 Radio FCC ID: U72DRX1-4 Figure 1 – Cassette in which radio is housed Figure 2 – Back of cassette showing battery removal
Carestream Health DRX1-4 Radio FRN 0016195265 Carestream DRX-1C Detector FCC and IC Label Artwork for Band 4 Radio
Carestream Health DRX1-4 Radio FRN 0016195265 Carestream Health DRX-1 Detector with Band 4 Radio (5.725-5.825 GHz) Label with FCC Identifier and IC Registration Number
Internal Photos for Carestream DRX1-4 Radio FCC ID: U72DRX1-4 Figure 1 – Radio (left) shown with interface used for testing only (right) Figure 2 – Radio board only (top side) Figure 3 – Radio board only (back side) Figure 4 – Antenna(s) mounted in cassette
© 2010 RF Exposure Lab, LLC This report shall not be reproduced except in full without the written approval of RF Exposure Lab, LLC. 2867 Progress Place, Suite 4D • Escondido, CA 92029 • U.S.A. TEL (760) 737-3131 • FAX (760) 737-9131 http://www.rfexposurelab.com CERTIFICATE OF COMPLIANCE SAR EVALUATION Caresteam Health Dates of Test: March 17, 2010 150 Verona St. Test Report Number: SAR.20100302 Rochester, NY 14608 This wireless mobile and/or portable device has been shown to be compliant for localized specific absorption rate (SAR) for uncontrolled environment/general exposure limits specified in ANSI/IEEE Std. C95.1-1999 and had been tested in accordance with the measurement procedures specified in IEEE 1528-2003, OET Bulletin 65 Supp. C, RSS-102 and Safety Code 6 (See test report). I attest to the accuracy of the data. All measurements were performed by myself or were made under my supervision and are correct to the best of my knowledge and belief. I assume full responsibility for the completeness of these measurements and vouch for the qualifications of all persons taking them. RF Exposure Lab, LLC certifies that no party to this application has been denied FCC benefits pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). Jay M. Moulton Vice President Certificate # 2387.01 FCC ID: U72DRX1 IC Certificate: 7027A-DRX1 Model(s): DRX1 Test Sample: Engineering Unit Same as Production Serial No.: 001 Equipment Type: Wireless Digital Radiographic X-ray Classification: Portable Transmitter Next to Body TX Frequency Range: 5250 - 5350 MHz Frequency Tolerance: ± 25 ppm Maximum RF Output: 5200 MHz – 15.16 dBm Conducted Signal Modulation: OFDM Antenna Type (Length): Carestream Health Band 2 P/N 2G8506 Battery: Micro Power Electronics, Inc. P/N 6H7200 Application Type: C2PC FCC Rule Parts: Part 15C Industry Canada: RSS-102 FCC ID: U72DRX1 © 2010 RF Exposure Lab, LLC Page 2 of 74 This report shall not be reproduced except in full without the written approval of RF Exposure Lab, LLC. Table of Contents 1. Introduction ...........................................................................................................................3 SAR Definition [5]......................................................................................................................3 2. SAR Measurement Setup .....................................................................................................4 Robotic System .........................................................................................................................4 System Hardware .....................................................................................................................4 System Description ...................................................................................................................4 E-Field Probe ............................................................................................................................5 3. Robot Specifications .............................................................................................................7 4. Probe and Dipole Calibration ................................................................................................8 5. Phantom & Simulating Tissue Specifications........................................................................9 SAM Phantom ...........................................................................................................................9 Brain & Muscle Simulating Mixture Characterization ................................................................9 Device Holder ...........................................................................................................................9 6. Definition of Reference Points.............................................................................................10 Ear Reference Point................................................................................................................10 Device Reference Points ........................................................................................................10 7. Test Configuration Positions ...............................................................................................11 Positioning for Cheek/Touch [5] ..............................................................................................11 Positioning for Ear / 15 ̊ Tilt [5] ................................................................................................12 Body Worn Configurations ......................................................................................................13 8. ANSI/IEEE C95.1 – 1999 RF Exposure Limits [2]...............................................................14 Uncontrolled Environment.......................................................................................................14 Controlled Environment .......................................................................................................... 14 9. Measurement Uncertainty ...................................................................................................15 10. System Validation ........................................................................................................... 16 Tissue Verification...................................................................................................................16 Test System Verification .........................................................................................................16 11. SAR Test Data Summary ................................................................................................17 Procedures Used To Establish Test Signal.............................................................................17 Device Test Condition .............................................................................................................17 SAR Data S…
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© 2010 RF Exposure Lab, LLC This report shall not be reproduced except in full without the written approval of RF Exposure Lab, LLC. 2867 Progress Place, Suite 4D • Escondido, CA 92029 • U.S.A. TEL (760) 737-3131 • FAX (760) 737-9131 http://www.rfexposurelab.com CERTIFICATE OF COMPLIANCE SAR EVALUATION Caresteam Health Dates of Test: March 17, 2010 150 Verona St. Test Report Number: SAR.20100303 Rochester, NY 14608 This wireless mobile and/or portable device has been shown to be compliant for localized specific absorption rate (SAR) for uncontrolled environment/general exposure limits specified in ANSI/IEEE Std. C95.1-1999 and had been tested in accordance with the measurement procedures specified in IEEE 1528-2003, OET Bulletin 65 Supp. C, RSS-102 and Safety Code 6 (See test report). I attest to the accuracy of the data. All measurements were performed by myself or were made under my supervision and are correct to the best of my knowledge and belief. I assume full responsibility for the completeness of these measurements and vouch for the qualifications of all persons taking them. RF Exposure Lab, LLC certifies that no party to this application has been denied FCC benefits pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). Jay M. Moulton Vice President Certificate # 2387.01 FCC ID: U72DRX1-4 IC Certificate: 7027A-DRX1-4 Model(s): DRX1-4 Test Sample: Engineering Unit Same as Production Serial No.: 001 Equipment Type: Wireless Digital Radiographic X-ray Classification: Portable Transmitter Next to Body TX Frequency Range: 5.745 – 5.824 MHz Frequency Tolerance: ± 25 ppm Maximum RF Output: 5800 MHz – 15.09 dBm Conducted Signal Modulation: OFDM Antenna Type (Length): Carestream Health Band 4 P/N 2G8509 Battery: Micro Power Electronics, Inc. P/N 6H7200 Application Type: Certification FCC Rule Parts: Part 15C Industry Canada: RSS-102 FCC ID: U72DRX1-4 © 2010 RF Exposure Lab, LLC Page 2 of 74 This report shall not be reproduced except in full without the written approval of RF Exposure Lab, LLC. Table of Contents 1. Introduction ...........................................................................................................................3 SAR Definition [5]......................................................................................................................3 2. SAR Measurement Setup .....................................................................................................4 Robotic System .........................................................................................................................4 System Hardware .....................................................................................................................4 System Description ...................................................................................................................4 E-Field Probe ............................................................................................................................5 3. Robot Specifications .............................................................................................................7 4. Probe and Dipole Calibration ................................................................................................8 5. Phantom & Simulating Tissue Specifications........................................................................9 SAM Phantom ...........................................................................................................................9 Brain & Muscle Simulating Mixture Characterization ................................................................9 Device Holder ...........................................................................................................................9 6. Definition of Reference Points.............................................................................................10 Ear Reference Point................................................................................................................10 Device Reference Points ........................................................................................................10 7. Test Configuration Positions ...............................................................................................11 Positioning for Cheek/Touch [5] ..............................................................................................11 Positioning for Ear / 15 ̊ Tilt [5] ................................................................................................12 Body Worn Configurations ......................................................................................................13 8. ANSI/IEEE C95.1 – 1999 RF Exposure Limits [2]...............................................................14 Uncontrolled Environment.......................................................................................................14 Controlled Environment .......................................................................................................... 14 9. Measurement Uncertainty ...................................................................................................15 10. System Validation ........................................................................................................... 16 Tissue Verification...................................................................................................................16 Test System Verification .........................................................................................................16 11. SAR Test Data Summary ................................................................................................17 Procedures Used To Establish Test Signal.............................................................................17 Device Test Condition .......................................................................................................…
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FCC ID: U72DRX1-4 IC: 7027A-DRX1-4 Report No.: 31060258.003_DRX1-4 Radio.doc Page 1 of 62 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 QF0904.. Rev 1.0 Electromagnetic Compatibility Test Report Prepared in accordance with FCC Part 15 On DRX1-4 Radio DRX1-4 Prepared for: Carestream Health Inc. 150 Verona St Rochester NY, 14608 Prepared by: TUV Rheinland of North America, Inc. FCC ID: U72DRX1-4 IC: 7027A-DRX1-4 Report No.: 31060258.003_DRX1-4 Radio.doc Page 2 of 62 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 QF0904.. 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: DRX1-4 Radio Serien-Nr.: Serial No. 00403 Gegenstand der Prüfung: Test item: DRX1-4 Prüfdatum: Date tested: 03/12/2010 Prüfort: Testing location: TUV Rheinland of North America 336 Initiative Drive Rochester, NY 14624 U.S.A. Prüfgrundlage: Test specification: Emissions: FCC Part 15.407 Subpart E FCC Part 15.209(a) FCC part 15.407(a)(3), FCC Part 15.407(a)(5) RSS-210 Issue 7, FCC Part 15.407(a)(6), FCC Part 15.407(b)(8), FCC Part 15.205, FCC Part 15.407(c), FCC Part 15.407(g), FCC Part 15.203, RSS-210 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 19 April 2010 Date Name Signature 19 April 2010 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: U72DRX1-4 IC: 7027A-DRX1-4 Report No.: 31060258.003_DRX1-4 Radio.doc Page 3 of 62 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 QF0904.. Rev 1.0 TABLE OF CONTENTS 1 GENERAL INFORMATION ......................................................................................................................... 4 1.1 SCOPE......................................................................................................................................................... 4 1.2 PURPOSE..................................................................................................................................................... 4 1.3 SUMMARY OF TEST RESULTS..................................................................................................................... 5 2 LABORATORY INFORMATION ................................................................................................................ 6 2.1 ACCREDITATIONS & ENDORSEMENTS........................................................................................................ 6 2.2 MEASUREMENT UNCERTAINTY.................................................................................................................. 7 2.3 CALIBRATION TRACEABILITY.................................................................................................................... 7 2.4 MEASUREMENT EQUIPMENT USED............................................................................................................ 8 3 PRODUCT INFORMATION ......................................................................................................................... 9 3.1 PRODUCT DESCRIPTION.............................................................................................................................. 9 3.2 EQUIPMENT MODIFICATIONS..................................................................................................................... 9 3.3 TEST PLAN.................................................................................................................................................. 9 4 EMISSIONS.................................................................................................................................................... 11 4.1 RADIATED EMISSIONS....................…
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File: R78547 Page 1 of 23 Testing Cert #2016-01 TEST REPORT Covering the DYNAMIC FREQUENCY SELECTION (DFS) REQUIREMENTS OF FCC Part 15 Subpart E (UNII) Carestream Health Inc. Model(s): DRX-1 and DRX1-4 Radio (802.11 an) COMPANY: Carestream Health Inc. 1049 Ridge Road West Rochester, NY, 14615 TEST SITE: Elliott Laboratories 684 W. Maude Ave Sunnyvale, CA 94085 REPORT DATE: March 29, 2010 FINAL TEST DATE: March 4, 2010 TEST ENGINEER: Wayne Fisher AUTHORIZED SIGNATORY: ______________________________ Mark E. Hill Staff Engineer Elliott Laboratories is accredited by the A2LA, certificate number 2016-01, to perform the test(s) listed in this report. This report shall not be reproduced, except in its entirety, without the written approval of Elliott Laboratories Elliott Laboratories -- EMC Department Test Report Report Date: March 29, 2010 File: R78547 Page 2 of 23 REVISION HISTORY Rev # Date Comments Modified By 3/29/2010 Initial Release - Elliott Laboratories -- EMC Department Test Report Report Date: March 29, 2010 File: R78547 Page 3 of 23 TABLE OF CONTENTS COVER PAGE.............................................................................................................................................................1 REVISION HISTORY ................................................................................................................................................2 TABLE OF CONTENTS ............................................................................................................................................3 LIST OF TABLES.......................................................................................................................................................3 LIST OF FIGURES.....................................................................................................................................................4 SCOPE..........................................................................................................................................................................5 OBJECTIVE ................................................................................................................................................................5 STATEMENT OF COMPLIANCE...........................................................................................................................5 DEVIATIONS FROM THE STANDARD ................................................................................................................5 EQUIPMENT UNDER TEST (EUT) DETAILS ......................................................................................................6 GENERAL................................................................................................................................................................6 ENCLOSURE...........................................................................................................................................................6 MODIFICATIONS...................................................................................................................................................6 SUPPORT EQUIPMENT.........................................................................................................................................7 EUT INTERFACE PORTS ......................................................................................................................................7 EUT OPERATION ...................................................................................................................................................7 RADAR WAVEFORMS.....................................................................…
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| # | Rule Parts | Frequency Range | Power Output |
|---|---|---|---|
| 1 | 15E | 5.75 GHz - 5.80 GHz | 38.90 mW |

Remote control
Equipment Class
DSC - Part 15 Security/Remote Control Transmitter
X-RAY IMAGING FOR HEATHCARE
Equipment Class
NII - Unlicensed National Information Infrastructure TX
WiFi transmitter
Equipment Class
DTS - Digital Transmission System
Laser Imager
Equipment Class
DXX - Part 15 Low Power Communication Device Transmitter
Film Printer for Medical Images using 13.56 MHz Transmitter RFID
Equipment Class
DXX - Part 15 Low Power Communication Device Transmitter