S8QUPD-3Endoscope Position Detecting Unit

1 DRAFT INSTRUCTIONS ENDOSCOPE POSITION DETECTING UNIT UPD-3 USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician. (For 220 – 240V type equipment) CONFIDENTIAL 2 Contents Labels and Symbols Important Information — Please Read Before Use Summary of Equipment Functions Chapter 1 Checking the Package Contents Chapter 2 Nomenclature and Functions Chapter 3 Inspection Chapter 4 Operation Chapter 5 Functions Chapter 6 Care, Storage, and Disposal Chapter 7 Installation and Connection Chapter 8 Function setup Chapter 9 Troubleshooting Appendix CONFIDENTIAL 3 Labels and Symbols Safety-related labels and symbols are attached on the locations shown below. If labels or symbols are missing or illegible, contact OLYMPUS. Serial number plate Potential equalization terminal The product name and electric rating Endoscope Position Detecting Unit UPD-3 Input: 100-240V 50/60Hz 100VA CE marking Manufacturer name ○Back cover of this instruction manual Manufacturer Authorized representative in the European Community Caution that only the exclusive cable can be connected. CONFIDENTIAL 4 Important Information — Please Read Before Use Intended use This instrument has been designed to be used with Olympus endoscopes system for detection and displaying the shape of inserted endoscope. Instruction manual This instruction manual contains essential information on using this endoscope position detecting unit safely and effectively. Before use, thoroughly review this manual and the manuals of all equipment which will be used during the procedure and use the equipment as instructed. Keep this and all related instruction manuals in a safe, accessible location. If you have any questions or comments about any information in this manual, please contact Olympus. CONFIDENTIAL 5 ○Terms used in this manual Wall mains outlet: The wall mains outlet is a wall AC mains power outlet socket having the exclusive terminal for grounding Isolation transformer: The isolation transformer is a safety device that is used to isolate noninsulated equipment with potentially high leakage currents to decrease the possibility of electric shock. Scope model: The scope model is a computer graphic image that models the shape of the endoscope insertion tube. CONFIDENTIAL 6 User qualifications If there is an official standard on user qualifications to perform endoscopy and endoscopic treatment that is defined by the medical administration or other official institutions, such as academic societies on endoscopy, follow that standard. If there is no official qualification standard, the operator of this instrument must be a physician approved by the medical safety manager of the hospital or person in charge of the department (department of internal medicine, etc.). The physician should be capable of safely performing the planned endoscopy and endoscopic treatment following guidelines set by the academic societies on endoscopy, etc., and considering the difficulty of endoscopy and endoscopic treatment. This manual does not explain or discuss endoscopic procedures. Instrument compatibility Refer to the “System chart” in the Appendix to confirm that this balloon control unit is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury and/or equipment damage. Also review the manuals of all equipment that will be used during the procedure and use the equipment as instructed. This instrument complies with EMC standard for medical electrical equipment; edition 2 (IEC 60601-1-2: 2001) and edition 3 (IEC 60601-1-2: 2007). However, when connected with an instrument that complies with EMC standard for medical electrical equipment; edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1. Repair and modification This endoscope position detecting unit does not contain any user-serviceable parts. Do not disassemble, modify or attempt to repair it; patient or operator injury, equipment damage and/or the impossibility to obtain the expected functionality can result. Some problems that appear to be malfunctions may be correctable by referring to Chapter 9, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 9, contact Olympus. This instrument is to be repaired by Olympus technicians only. CONFIDENTIAL 7 Signal words The following signal words are used throughout this manual: [DANGER] Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. [WARNING] Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. [CAUTION] Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage. [NOTE] Indicates additional helpful information. Dangers, warnings and cautions Follow the dangers and cautions given below when handling this endoscope position detecting unit. This information is to be supplemented by the dangers and cautions given in each chapter. [DANGER] •As a TYPE BF applied part, the endoscope connected to this instrument must never be applied directly to the heart. Leakage current from the TYPE BF applied part may be dangerous and cause ventricular fibrillation or otherwise seriously affect the cardiac function of the patient. Accordingly, always adhere to the following: − Never apply the endoscope connected to this instrument to the heart or any area near the heart. − Never allow an EndoTherapy accessory or another endoscope applied to or near the heart to come in contact with the endoscope connected to this instrument. •Strictly observe the following precautions. Failure to do so may place the patient and medical personnel in danger of electric shock. − When this endoscope position detecting unit is used to examine a patient, do not allow metal parts of the endoscope or its accessories to touch metal parts of o…

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139  Recommended separation distance between portable and mobile RF communications equipment and this instrument [NOTE] The guidance may not apply in some situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Portable and mobile RF communications equipment such as cellular phones should be used no closer to any part of this instrument, including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. FCC information 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. F FCC ID:S8QUPD-3 IC information This equipment complies with the IC RSS210. IC: 4763B-UPD3 FCC warnings Change or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. All interface cables used to connect peripherals must be shielded in order to comply with the limits for a digital device pursuant to Subpart B of Part 15 of FCC Rules. IC note Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.

3-2, Sunayama, Kamisu-shi, Ibaraki-ken, 314-0255 Japan Telephone: +81 479 40 1097 Facsimile: +81 479 46 1788 www.intertek-etlsemko.com Intertek Japan K.K. Kashima Laboratory 3-2, Sunayama, Kamisu-shi, Ibaraki-ken, 314-0255 Japan November 19, 2010 Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Attn: Reviewing Engineer RE: Replacing the test report and test set-up photo FCC ID: S8QUPD-3 Applicant: Olympus Medical Systems Corp. Form 731 Confirmation Number: EA557439 To Whom It May Concern: This letter is to inform that the revised test report and the test set-up photo have been uploaded. The wrong certified body logo was placed in the front page of the test report, and it has been removed. Also the test report number is changed from JK10060009 to JK10060009 (R1). The test report number indicated in the test set-up photo has been changed along with this change. Best Regards, Kazuo Gokita Manager Kashima Laboratory Intertek Japan K.K.

External Photos Entire system Headquarters Shinjuku Monolith,3-1 Nishi-Shinjuku 2-chome,Shinjuku-ku, Tokyo 163-0914, Japan Technology Research Institutes 2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan 2-3 Kuboyama-cho, Hachioji-shi, Tokyo 192-8512, Japan Front of the main unit Rear of the main unit Right side of the main unit Leftt side of the main unit Front of the receiver dish Rear of the receiver dish Right side of the receiver dish Left side of the receiver dish

Headquarters Shinjuku Monolith,3-1 Nishi-Shinjuku 2-chome,Shinjuku-ku, Tokyo 163-0914, Japan Technology Research Institutes 2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan 2-3 Kuboyama-cho, Hachioji-shi, Tokyo 192-8512, Japan Labeling on device For US The back of the UPD-3 is shown in figure 1 below. FCC Identifier will be placed where figure 1 indicate “Affix FCC Label”. The detail is shown in figure 2. For Canada The back of the UPD-3 is shown in figure 1 below. IC Identifier will be placed where figure 1 indicate “Affix IC Label”. The detail is shown in in figure 2. Figure 1 Location of the label Figure 2 Datail of the label 230mm 28mm Affix FCC Label Affix IC Label Height of font 3mm

Internal Photos Front of the main unit Rear of the main unit Headquarters Shinjuku Monolith,3-1 Nishi-Shinjuku 2-chome,Shinjuku-ku, Tokyo 163-0914, Japan Technology Research Institutes 2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan 2-3 Kuboyama-cho, Hachioji-shi, Tokyo 192-8512, Japan Confidential Right side of the main unit Left side of the main unit Top of the main unit Module : TX circuit Top TX circuit Bottom Antenna unit (Hand cool & Reference plate) & Tx unit Antenna unit (Video endoscope) & Tx unit The part of antenna (coil) Antenna unit (Hand coil) Antenna unit (Reference plate) Antenna unit(coil probe in the video endoscope) *There are 19 coils in the probe The video endoscope contains the antenna unit(coil probe unit) Module : Receiving circuit top Receiving circuit bottom I/F unit Top I/F unit Bottom Receiver dish & receiving unit Inside of the receiver dish

Report No. JK10060009(R1) FCC ID: S8QUPD-3 IC ID: 4763B-UPD3 © Intertek Japan K.K. Page 1 of 21 FJP-EM001 Version2.1 TEST REPORT STANDARD : FCC Part15C, RSS-210 Issue 7, RSS-Gen Issue 2 Applicant Testing Laboratory Olympus Medical Systems Corp. 2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507 Japan Tel. +81 42 642 9249 Intertek Japan K.K. Tochigi Laboratory URL: http://www.japan.intertek-etlsemko.com 870, Nakaawano, Kanuma-shi, Tochigi-ken 322-0306 Japan Tel. +81 289 86 7121 Equipment Type Endoscope Position Detecting Unit Trademark Olympus Model(s) UPD-3 Serial No. 700K009 Equipment Authorization Certification (FCC ID : S8QUPD-3) (IC ID : 4763B-UPD3) Test Result Complied Report Number JK10060009(R1) Report Issue Date November 16, 2010 This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to permit copying or distribution of this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. The test report JK10060009 has been superseded by this test report. Approved by Tested by Kazuo Gokita [ Manager ] Koichi Wagatsuma Report No. JK10060009(R1) FCC ID: S8QUPD-3 IC ID: 4763B-UPD3 © Intertek Japan K.K. Page 2 of 21 FJP-EM001 Version2.1 TABLE OF CONTENTS Page SECTION 1. GENERAL INFORMATION .................................................................................................. 3 SECTION 2. SUMMARY OF TEST RESULTS ......................................................................................... 4 SECTION 3. EQUIPMENT UNDER TEST ................................................................................................ 5 SECTION 4. SUPPORT EQUIPMENT...................................................................................................... 7 SECTION 5. USED CABLE(S).................................................................................................................. 8 SECTION 6. TEST CONFIGURATION ..................................................................................................... 9 SECTION 7. OPERATING CONDITION ................................................................................................. 10 SECTION 8. TEST PROCEDURE(S) ......................................................................................................11 SECTION 9. MEASUREMENT UNCERTAINTY ..................................................................................... 14 SECTION 10. EVALUATION OF TEST RESULTS ................................................................................. 15 SECTION 11. LIST OF MEASURING INSTRUMENTS .......................................................................... 21 Report No. JK10060009(R1) FCC ID: S8QUPD-3 IC ID: 4763B-UPD3 © Intertek Japan K.K. Page 3 of 21 FJP-EM001 Version2.1 SECTION 1. GENERAL INFORMATION TEST PERFORMED Location Tochigi No.2 Test Site EUT Received June 28, 2010 Date of Test From June 29, 2010 to July 5, 2010 Standard Applied FCC Part15C RSS-210 Issue 7, RSS-Gen Issue 2 Measurement methods ANSI C63.4-2003 Test Procedure Document number : RJP-EM001, RJP-EM003 Deviation from Standard(s) None QUALIFICATIONS OF TESTING LABORATORY ACCREDITATION SCOPE LAB. CODE Remarks VLAC EMC Testing VLAC-008-5 JAPAN BSMI EMC Testing SL2-IN-E-6017, SL2-AI-E-6017 TAIWAN FILING VCCI EMC Testing R-257, C-260, C-284, T-1736, T-1737, G-124 R-258, C-261, C-285, T-1738, T-1739 R-259, C-262, T-1740, G-125 JAPAN FCC EMC Testing Designation Number : JP0011 USA IC EMC Testing 2042P-1, 2042P-2 CANADA SAUDI ARABIA EMC Testing N/A ABBREVIATIONS EUT Equipment Under Test DoC Declaration of Conformity AMN Artificial Mains Network ISN Impedance Stabilization Network LISN Line Impedance Stabilization Network Q-P Quasi-peak AMP Amplifier AVG Average ATT Attenuator PK Peak ANT Antenna Cal Calibration BBA Broadband Antenna N/A Not applicable or Not available DIP Dipole Antenna LCD Liquid-Crystal Display AE Associated Equipment HDMI High-Definition Multimedia Interface Report No. JK10060009(R1) FCC ID: S8QUPD-3 IC ID: 4763B-UPD3 © Intertek Japan K.K. Page 4 of 21 FJP-EM001 Version2.1 SECTION 2. SUMMARY OF TEST RESULTS The minimum margins to the limits are as follows: Test Reference <FCC> Reference <IC> Result AC Conducted Emission 15.207 RSS-Gen Issue 2 7.2.2 Pass Field Strength Emission 15.209 RSS-210 Issue 7 2.7 Table 3 Pass Spurious Emission – Radiated 15.209 15.205 RSS-210 Issue 7 A2.6 (d) 2.7 Table 1 2.7 Table 2 2.7 Table 3 Pass Variation Carrier Output Power 15.31(e) - Pass Restricted Band of Operation 15.205 RSS-210 Issue 7 2.7 Table 1 Pass Note : See Section 10 for details. < Measurement data correction > * Conducted disturbance at mains terminals Emission Level [dBμV] = Meter Reading [dBμV] + Factor [dB] Margin [dB] = Limit [dBμV] - Emission Level [dBμV] * Factor = LISN Factor + Cable Loss + ATT * Radiated disturbance Emission Level [dBμV/m] = Meter Reading [dBμV] + Factor [dB/m] Margin [dB] = Limit [dBμV/m] - Emission Level [dBμV/m] * Factor = Antenna Factor + Cable Loss - Amplifier Gain + ATT ( – Distance Conversion Factor) Report No. JK10060009(R1) FCC ID: S8QUPD-3 IC ID: 4763B-UPD3 © Intertek Japan K.K. Page 5 of 21 FJP-EM001 Version2.1 SECTION 3. EQUIPMENT UNDER TEST The equipment under test (EUT) consisted of the following apparatus. 3.1 System Configuration Symbo…

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