S8QEC-S10Low Power Transmitter

OLYMPUS CAPSULE ENDOSCOPE SYSTEM SYSTEM MANUAL 1 INSTRUCTIONS OLYMPUS CAPSULE ENDOSCOPE SYSTEM CAPSULE ENDOSCOPE SYSTEM SET MAJY0136 MAJ-Y0136 CAPSULE ENDOSCOPE EC-Y0005 Refer to the companion manual, the “WORKSTATION MANUAL” and “Cautions for Capsule Endoscopy Patient” for operating information of the MAJY0134. USA:CAUTION:Investigational device. Limited by Federal (or United State) Law to investigational use. 2 OLYMPUS CAPSULE ENDOSCOPE SYSTEM SYSTEM MANUAL Contents Labels and Symbols.................................................................................................................................1 Symbols...................................................................................................................................................1 Labels......................................................................................................................................................2 Important Information — Please Read Before Use...............................................................................9 Intended use ...........................................................................................................................................9 Instruction manual...................................................................................................................................9 User qualifications.................................................................................................................................10 Instrument compatibility ........................................................................................................................10 Repair and modification ........................................................................................................................10 Signal words..........................................................................................................................................11 Dangers, warnings and cautions ..........................................................................................................12 Danger, warning and cautions for patients...........................................................................................21 Expiration date of the capsule endoscope............................................................................................23 Color Tone of the Capsule Endoscope Image......................................................................................24 EMC (Electromagnetic Compatibility)...................................................................................................27 Limits of the technology ........................................................................................................................27 Chapter 1 Checking the Package Contents.........................................................................................28 1.1 Capsule endoscope system MAJY0136 (MAJY0136).................................................................29 1.2 Capsule endoscope (ECY0005)....................................................................................................30 Chapter 2 Nomenclature and Functions..............................................................................................32 2.1 System components .......................................................................................................................32 2.2 Capsule endoscope (ECY0005)....................................................................................................34 2.3 Antenna unit (X43226221).............................................................................................................35 2.4 Recorder unit (X43226211) ...........................................................................................................36 2.5 Recorder unit cradle (X43226231) ................................................................................................38 2.6 Recorder unit harness (X43225140) .............................................................................................39 2.7 Antenna harness (X43225251)......................................................................................................40 2.8 Capsule activator (MAJ1478) ........................................................................................................41 2.9 Battery pack (X4322621112)........................................................................................................41 2.10 Workstation (MAJY0134).............................................................................................................41 Chapter 3 Installation and Connection.................................................................................................42 3.1 Preparation......................................................................................................................................42 3.2 Exterior............................................................................................................................................43 3.3 Capsule endoscope ........................................................................................................................43 3.4 Preparation of the recorder unit......................................................................................................44 3.5 Preparation of the recorder unit cradle...........................................................................................46 Chapter 4 Operation...............................................................................................................................48 4.1 Preparation and Inspection before examination.............................................................................48 4.2 Attaching the equipment to the patient...........................................................................................54 4.3 Preparing the c…

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Headquarters Shinjuku Monolith,3-1 Nishi-Shinjuku 2-chome,Shinjuku-ku, Tokyo 163-0914, Japan Technology Research Institutes 2951 Ishikawa-machi, Hachioji-shi, Tokyo 192-8507, Japan 2-3 Kuboyama-cho, Hachioji-shi, Tokyo 192-8512, Japan External Photo Size: φ11mm（diameter） 26mm(length)

Headquarters Shinjuku Monolith,3-1 Nishi-Shinjuku 2-chome,Shinjuku-ku, Tokyo 163-0914, Japan Technology Research Institutes 2951 Ishikawa-machi, Hachioji-shi, Tokyo 192-8507, Japan 2-3 Kuboyama-cho, Hachioji-shi, Tokyo 192-8512, Japan Labeling on device packaging For US The FCC identifier will be placed on the Capsule’s packaging. This is because the capsule is Too small to have the FCC identifier placed on it, and is always within its packaging or otherwise inside the patient. For Canada The IC identifier will be placed on the Capsule’s packaging. This is because the capsule is too small to have the IC identifier placed on it, and is always within its packaging or otherwise inside the patient. Annex A Page 2 of 2 85.0mm 109.6mm MODEL： OLYMPUS EC-Y0005 FCC ID:S8QEC-S10 IC:4763B-ECS10 IPX8 OLYMPUS EC-Y0005 IC : 4763B-ECS10 Figure 1. Label for EC-Y0005 Headquarters Shinjuku Monolith,3-1 Nishi-Shinjuku 2-chome,Shinjuku-ku, Tokyo 163-0914, Japan Technology Research Institutes 2951 Ishikawa-machi, Hachioji-shi, Tokyo 192-8507, Japan 2-3 Kuboyama-cho, Hachioji-shi, Tokyo 192-8512, Japan For US The box package shown in Figure 2 contains 5 Capsules. FCC identifier is placed where Figure 2 indicates “Affix FCC Label”. The detail is shown in the next page(please refer to Figure 3). For Canada The box package shown in Figure 2 contains 5 Capsules. IC identifier is placed where Figure 2 indicates “Affix IC Label”. The detail is shown in the next page(please refer to Figure 3). Figure 2. Package appearance of EC-Y0005 SPECIFICATIONS ■ CAPSULE ENDOSCOPE OLYMPUS MAJ-Y000x × 5pcs. 70mm 143mm 195mm Top Affix FCC Label Affix IC Lavel 25mm 80mm Rear Side Left Side Right Side Front Side SPECIFICATIONS ■ CAPSULE ENDOSCOPE OLYMPUS MAJ-Y000x × 5pcs. 70mm 143mm 195mm Top Affix FCC Label Affix IC Lavel 25mm 80mm Rear Side Left Side Right Side Front Side Headquarters Shinjuku Monolith,3-1 Nishi-Shinjuku 2-chome,Shinjuku-ku, Tokyo 163-0914, Japan Technology Research Institutes 2951 Ishikawa-machi, Hachioji-shi, Tokyo 192-8507, Japan 2-3 Kuboyama-cho, Hachioji-shi, Tokyo 192-8512, Japan For US Figure 3 is an enlarged view of the part”Affix FCC Label” of Figure 2 in the precedent page. For Canada Figure 3 is an enlarged view of the part “Affix IC Label” of Figure 2 in the precedent page. FCC ID ：S8QEC-S10 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. IC：4763B-ECS10 Figure 3. Particular of label for EC-Y0005

Reviewed by: FCC ID: S8QEC-S10 FCC Pt. 15.209 MEASUREMENT REPORT (CERTIFICATION) Quality Manager Test Report S/N: Test Date(s): EUT Type: 0Y1105100855-R4.S8Q May 10, 2011 Olympus Capsule Endoscope System Page 1 of 16 © 2011 PCTEST Engineering Laboratory, Inc. REV 1.0RFFI 03/08/2010 Applicant Name: Date of Testing: OLYMPUS MEDICAL SYSTEMS CORP. May 10, 2011 2951 Ishikawa-machi, Hachioji-shi Test Site/Location: Tokyo, 192-8507 Japan PCTEST Lab, Columbia, MD, USA Test Report Serial No.: 0Y1105100855-R4.S8Q FCC ID: S8QEC-S10 IC CERTIFICATION NO.: 4763B-ECS10 APPLICANT: OLYMPUS MEDICAL SYSTEMS CORP. Model(s): EC-Y0005 EUT Type: Olympus Capsule Endoscope System Frequency: 315MHz FCC Classification: Low Power Communications Device Transmitter (DXX) FCC Rule Part(s): FCC Part 15 Subpart C (15.209) IC Specification(s): RSS-210 Issue 8 IC Classification: Low Power Transmitter * This revised test report (S/N: 0Y1105100855-R4.S8Q) supersedes and replaces the previously issued test report on the same subject EUT for the same type of testing as indicated. Please discard or destroy the previously issued test report (S/N: 0Y1105100855-R3.S8Q) and dispose of it accordingly. The device bearing the FCC Identifier specified above has been shown to comply with the applicable technical standards as indicated in the measurement report and has been tested in accordance with the measurement procedures specified in ANSI C63.4-2003 (See Test Report). These measurements were performed with no deviation from the standards. Test results reported herein relate only to the item(s) tested. I authorize and attest to the accuracy of data. All measurements reported herein were performed by me 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. PCTEST certifies that no party to this application has been subject to a denial of Federal benefits that includes the FCC benefits pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. PCTEST ENGINEERING LABORATORY, INC. 6660-B Dobbin Road, Columbia, MD 21045 USA Tel. 410.290.6652 / Fax 410.290.6654 http://www.pctestlab.com MEASUREMENT REPORT FCC Part 15.209 / INDUSTRY CANADA RSS-210 Reviewed by: FCC ID: S8QEC-S10 FCC Pt. 15.209 MEASUREMENT REPORT (CERTIFICATION) Quality Manager Test Report S/N: Test Date(s): EUT Type: 0Y1105100855-R4.S8Q May 10, 2011 Olympus Capsule Endoscope System Page 2 of 16 © 2011 PCTEST Engineering Laboratory, Inc. REV 1.0RFFI 03/08/2010 TABLE OF CONTENTS FCC Part 15.209 MEASUREMENT REPORT...............................................................................3 1.0 INTRODUCTION ..............................................................................................................................4 1.1 SCOPE .................................................................................................................................................. 4 1.2 PCTEST TEST LOCATION ................................................................................................................... 4 2.0 PRODUCT INFORMATION..............................................................................................................5 2.1 EQUIPMENT DESCRIPTION ................................................................................................................ 5 2.2 OPERATION MODE.............................................................................................................................. 5 2.3 EMI SUPPRESSION DEVICE(S)/MODIFICATIONS ............................................................................. 5 2.4 LABELING REQUIREMENTS ............................................................................................................... 5 3.0 DESCRIPTION OF TEST.................................................................................................................6 3.1 EVALUATION PROCEDURE................................................................................................................ 6 3.2 RADIATED EMISSIONS........................................................................................................................ 6 4.0 ANTENNA REQUIREMENTS ..........................................................................................................7 5.0 SAMPLE CALCULATIONS ..............................................................................................................8 5.1 RADIATED EMISSION MEASUREMENT SAMPLE CALCULATION.................................................... 8 6.0 TEST EQUIPMENT CALIBRATION DATA ......................................................................................9 7.0 TISSUE SIMULATING MIXTURE CHARACTERIZATION ............................................................10 8.0 ENVIRONMENTAL CONDITIONS .................................................................................................11 9.0 TEST DATA ....................................................................................................................................12 9.1 SUMMARY .......................................................................................................................................... 12 9.2 20DB BANDWIDTH MEASUREMENT ................................................................................................ 13 9.3 RADIATED SPURIOUS EMISSION MEASUREMENTS..................................................................... 14 RADIATED SPURIOUS EMISSION MEASUREMENTS............................................................................... 15 10.0 CONCLUSION................................................................................................................................16 Reviewed by: FCC ID: S8QEC-S10 FCC Pt. 15.209 MEASUREMENT REPORT (CERTIFICATION) Quality Manager Test Report S/N: Test Date(s): EUT Type: 0Y1105100855-R4…

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Reviewed by: FCC ID: S8QEC-S10 FCC Pt. 15C / RSS-210 MEASUREMENT REPORT (CERTIFICATION) Quality Manager Test Report S/N: Test Dates: EUT Type: 0Y1105100855.S8Q May 10, 2011 Olympus Capsule Endoscope System Page 1 of 5 © 2011 PCTEST Engineering Laboratory, Inc. REV 6.0CT 10/22/10 TEST SETUP PHOTOGRAPHS Reviewed by: FCC ID: S8QEC-S10 FCC Pt. 15C / RSS-210 MEASUREMENT REPORT (CERTIFICATION) Quality Manager Test Report S/N: Test Dates: EUT Type: 0Y1105100855.S8Q May 10, 2011 Olympus Capsule Endoscope System Page 2 of 5 © 2011 PCTEST Engineering Laboratory, Inc. REV 6.0CT 10/22/10 Reviewed by: FCC ID: S8QEC-S10 FCC Pt. 15C / RSS-210 MEASUREMENT REPORT (CERTIFICATION) Quality Manager Test Report S/N: Test Dates: EUT Type: 0Y1105100855.S8Q May 10, 2011 Olympus Capsule Endoscope System Page 3 of 5 © 2011 PCTEST Engineering Laboratory, Inc. REV 6.0CT 10/22/10 Reviewed by: FCC ID: S8QEC-S10 FCC Pt. 15C / RSS-210 MEASUREMENT REPORT (CERTIFICATION) Quality Manager Test Report S/N: Test Dates: EUT Type: 0Y1105100855.S8Q May 10, 2011 Olympus Capsule Endoscope System Page 4 of 5 © 2011 PCTEST Engineering Laboratory, Inc. REV 6.0CT 10/22/10 1.0 EUT PHOTOGRAPHS Reviewed by: FCC ID: S8QEC-S10 FCC Pt. 15C / RSS-210 MEASUREMENT REPORT (CERTIFICATION) Quality Manager Test Report S/N: Test Dates: EUT Type: 0Y1105100855.S8Q May 10, 2011 Olympus Capsule Endoscope System Page 5 of 5 © 2011 PCTEST Engineering Laboratory, Inc. REV 6.0CT 10/22/10