2AA69002SmartLinx Neuron 2

Copyright ©2014 Capsule Technologie. DC-NU2-IM-DOC 2.0 August 22, 2014 SmartLinx Neuron 2 Hardware Installation and Maintenance Guide 2 English Legal Notice Copyright © 2014 Capsule Technologie. All rights reserved. This product and related documentation are protected by copyright and distributed under licensing restricting their use, copying, distribution, and decompilation. No part of this product or related documentation may be reproduced in any form or by any means without prior written authorization of Capsule Technologie. Trademarks SmartLinx Administrator, SmartLinx Axon, SmartLinx Chart Xpress, SmartLinx Client, SmartLinx ESP, SmartLinx IQ, SmartLinx Medical Device Information System, SmartLinx Neuron, SmartLinx Vitals Plus, SmartLinx Vitals Stream, and related marks, images, and symbols are the exclusive properties of Capsule Technologie. Adobe Acrobat is a trademark of Adobe Systems, Inc. DISPATCH® is a registered trademark of Caltech Industries, Inc. Clorox® is a registered trademark and Clorox Healthcare™ is a trademark of the Clorox Company. Sani-Cloth® is a registered trademark of PDI, Inc. Corepoint Integration Engine is a trademark of Corepoint Health. Intel, Dual Core, and Pentium are trademarks or registered trademarks of Intel Corporation. Windows, Framework .NET, Message Queuing, MSMQ, Internet Explorer, XP, Hyper-V, Server 2003 and Server 2008 are trademarks or registered trademarks of Microsoft. 3 Table of Contents English Contents Chapter 1: Introducing the SmartLinx Neuron 25 Overview5 Intended Use5 About this document6 Product designation in this document6 Purpose6 Audience6 Notes, cautions, warnings6 Related documents7 Manufacturer’s Information7 Distribution and Service8 Table of abbreviations8 Chapter 2: Setting up the SmartLinx Neuron 29 What’s in this chapter9 Unpacking and inspecting the package contents9 Contents of a product shipment10 Unpacking the cartons10 Hardware installation prerequisites11 Installing the batteries in the SmartLinx Neuron11 Installing the main battery in the SmartLinx Neuron11 Installing the optional extended battery in the SmartLinx Neuron12 Deploying the SmartLinx Neuron14 Precautions for all deployments14 Considerations for wall-mounted deployments14 Mounting the SmartLinx Neuron on the wall15 Mounting the SmartLinx Neuron on a roll stand15 Connecting the SmartLinx Neuron to the power supply16 Power requirements16 Connecting the SmartLinx Neuron to the power supply16 Before you use the SmartLinx Neuron for the first time17 Chapter 3: Operating the SmartLinx Neuron 218 Components on the SmartLinx Neuron18 Connectivity20 Serial Ports 21 USB Ports 21 Ethernet Port21 Powering on the SmartLinx Neuron21 Power on the SmartLinx Neuron21 Power Off the SmartLinx Neuron22 Working with the SmartLinx Neuron touch screen22 Reading the status LED22 Working with the batteries23 Battery Lifetime Terminology23 Battery Summary23 English 4 Table of Contents Charging the batteries24 Removing a battery24 Swapping a battery24 Connecting the SmartLinx Neuron to the network25 Connecting a vital signs monitor to the SmartLinx Neuron25 Before you connect25 Connecting the cables26 Connecting the devices26 For more on using the SmartLinx Neuron with the vital signs monitor26 Chapter 4: Maintaining the SmartLinx Neuron 227 Periodic cleaning and disinfection27 Cleaning Precautions 28 Periodic maintenance of the SmartLinx Neuron28 Authorized Access28 Inspections28 Storing the SmartLinx Neuron29 Maintenance of the SmartLinx Neuron batteries29 Cleaning29 Short-term maintenance29 Long-term storage and maintenance29 Chapter 5: Technical Information31 Guidance and manufacturer’s declaration31 SmartLinx Neuron technical specifications35 Device Identification Module (DIM) technical specifications36 Regulatory Information37 Explanation of Device and Packaging Symbols37 Safety and Regulatory Compliance39 EN/IEC39 Federal Communications Commission40 CE Declaration40 Industry Canada statement41 RoHS and WEEE Compliance42 Recycling and the Environment42 Introducing the SmartLinx Neuron 2 [Chapter 1] 5 English Introducing the SmartLinx Neuron 2 Overview The SmartLinx Neuron 2 is Capsule's point-of-care hardware platform for device connectivity. It is a flexible and scalable platform that you can configure to operate in various care areas of the hospital. In high acuity environments, such as the ICU, the SmartLinx Neuron 2 typically runs Capsule’s Vitals Stream Application to enable continuous collection of vital signs for one patient from multiple devices. In low acuity, non-critical care settings (such as med-surg), the SmartLinx Neuron 2 typically runs Capsule's Chart Xpress Application to enable the automatic collection, validation, and transmission of vital signs from multiple patients to the EMR directly from the point of care. Note:Do not operate the SmartLinx Neuron 2 until after you read and understand these instructions. Pay particular attention to all warnings and cautions. Note:For information about the administration of SmartLinx MDIS software, IT personnel should refer to the SmartLinx MDIS System Administrator’s Guide. Note:To operate the SmartLinx Neuron 2, clinicians require training in the procedures described in the Clinical User’s Guide for SmartLinx Chart Xpress on Neuron and the Clinical User’s Guide for SmartLinx Vitals Stream on Neuron. Note:To operate any medical device that connects to the SmartLinx Neuron 2, clinicians must be separately trained in the use of that device. Intended Use The intended use of the SmartLinx MDIS system is for data collection and clinical information management, either directly or through networks with independent bedside devices. Capsule's hardware and software are not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices/information systems) to which it is connected. There is no other known contraindication for the use of the SmartLinx Neuron 2…

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Page 1 CONSTRUCTION PHOTOS OF EUT Page 2 Page 3 Page 4

FCC LABEL LOCATION FCC ID:2AA69002 FCC LABEL FCC Statement 75 30 3 3 REV 4 2 1 3 5 D SIGN DESCRIPTION 1 C DATE 23 B A 123 SIZE: A4 SCALE:1:1 ANGLE 0~25 80~200 200~400 400~ 25~80 (mm) RANGE 0.40± FILE NO: 1°± APPROV CHECK DESIGN DRAWN UNIT:mm 0.10± 0.20± 0.30± 0.15± Common Tolerance ICP Electronics Inc. PART NO: TITLE MODEL C 45 B 6 A Note: The componet should be comply with the prohibit of hazardous substances in the RoHs Directive. Capsule AIO Label SmartLinx Neuron 2 REV 1.X FIRST RELEASEAngel Yao2013.08.30 1 2 3 4 5 6 7 8 910 Note : First Number : CTSXWD ABUJE USA Serial Number All productions ( all P / Ns ) of the Month indicated in digit 5 00000 ~ 99999 ICP Serial Number Naming Rule REF DC-NU2-UMPC00187D3599AB SA13B07760 ETH A44E311E3490 WLAN S N YYYY-MM Made in China Capsule Technologie SAS 9 villa Pierre Ginier, 75018 Paris, France Notes : 1.材質:50#不變色消銀龍+霧面 2.印刷顏色: 底色白(字體圖形為黑色). 3.文字,線條清晰不可缺劃斷線。 4.字稿需經擔當工程師確認才可製版。 5.背面印膠加離型紙 6.尺寸單位 = mm 7.X代表版本 8.印表機型號:Zebra 110xi4 9.色帶型號:Z302 Note: 1. Material : 50 # Metalized Polyester Film + Transparent Polyester 2. Printing color : White background 3. No broken lines allowed in text and drawing. 4. The wording must be approved before plate-make. 5. Add adhesive in back side. 6. Dimensions shown are in millimeters. 7. X stands for version. 8.Printer:Zebra 110xi4 9.Ribbon:Z302 Leo Wei Leo Wei Hill Wong Roder Ko 2015.01.26 中興廠 大同廠 上海廠 上海廠 興威 威強 鴻本 德演 廈普JapanEurope Code Factory ADD ETL MARK STATEMENTLeo Wei2014.08.13 2 Factory : Shanghai S Product Category : CPU C fi Backplane B fiCard Vfi Assembly A Produce Year 2002=02 2003=03 2004=04 ~ 2099=99 Month : 1(Jan) fi 2(Feb) fi 3(Mar) fi 4(Apr) fi 5(May) fi 6(Jun) fi 7(Jul) fi 8(Aug) fi 9(Sep) fi A(Oct) fi B(Nov) fi C(Dec) 20VDC, 3A 2222 DC-NU2-PS 222 FCC ID : 2AA69002 3 MODIFY PSU MODEL DC-NU-PS->DC-NU2-PS Leo Wei2014.09.17 4 Add RCM LogoLeo Wei2014.10.09 2015.01.26 2015.01.26 2015.01.26 1.Remove RCM Logo and ETL Mark 2.Change FCC ID To 2AA69002 Leo Wei2015.01.26 5 75 30 3 3 75 30 3 3

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Report No.: SA130923D14B Page No. 1 / 6 Report Format Version: 6.1.1 Reference No.: 150105D03 RF Exposure Report Report No.: SA130923D14B FCC ID: 2AA69002 Test Model: DC-NU2-UMPC Received Date: Jan. 05, 2015 Test Date: Jan. 10 ~ Feb. 04, 2015 Issued Date: Feb. 09, 2015 Applicant: Capsule Technologie SAS Address: 9 villa Pierre Ginier 75018 Paris, France Issued By: Bureau Veritas Consumer Products Services (H.K.) Ltd., Taoyuan Branch Lab Address: No. 47-2, 14th Ling, Chia Pau Vil., Lin Kou Dist., New Taipei City, Taiwan, R.O.C. Test Location: No. 19, Hwa Ya 2nd Rd, Wen Hwa Tsuen, Kwei Shan Hsiang, Taoyuan Hsien 333, Taiwan, R.O.C. This report is for your exclusive use. Any copying or replication of this report to or for any other person or entity, or use of our name or trademark, is permitted only with our prior written permission. This report sets forth our findings solely with respect to the test samples identified herein. The results set forth in this report are not indicative or representative of the quality or characteristics of the lot from which a test sample was taken or any similar or identical product specifically and expressly noted. Our report includes all of the tests requested by you and the results thereof based upon the information that you provided to us. You have 60 days from date of issuance of this report to notify us of any material error or omission caused by our negligence, provided, however, that such notice shall be in writing and shall specifically address the issue you wish to raise. A failure to raise such issue within the prescribed time shall constitute your unqualified acceptance of the completeness of this report, the tests conducted and the correctness of the report contents. Unless specific mention, the uncertainty of measurement has been explicitly taken into account to declare the compliance or non-compliance to the specification. The report must not be used by the client to claim product certification, approval, or endorsement by TAF or any government agencies. Report No.: SA130923D14B Page No. 2 / 6 Report Format Version: 6.1.1 Reference No.: 150105D03 Table of Contents Release Control Record .................................................................................................................................. 3 1 Certificate of Conformity ...................................................................................................................... 4 2 RF Exposure .......................................................................................................................................... 5 2.1 Limits For Maximum Permissible Exposure (MPE) ............................................................................. 5 2.2 MPE Calculation Formula ................................................................................................................... 5 2.3 Classification ....................................................................................................................................... 5 3 Calculation Result Of Maximum Conducted Power .......................................................................... 6 Report No.: SA130923D14B Page No. 3 / 6 Report Format Version: 6.1.1 Reference No.: 150105D03 Release Control Record Issue No. Description Date Issued SA130923D14B Original release Feb. 09, 2015 Report No.: SA130923D14B Page No. 4 / 6 Report Format Version: 6.1.1 Reference No.: 150105D03 1 Certificate of Conformity Product: SmartLinx Neuron 2 Brand: Capsule Test Model: DC-NU2-UMPC Sample Status: MASS-PRODUCTION Applicant: Capsule Technologie SAS Test Date: Dec. 27, 2014 ~ Jan. 19, 2015 Standards: FCC Part 2 (Section 2.1091) KDB 447498 D03 IEEE C95.1 The above equipment has been tested by Bureau Veritas Consumer Products Services (H.K.) Ltd., Taoyuan Branch, and found compliance with the requirement of the above standards. The test record, data evaluation & Equipment Under Test (EUT) configurations represented herein are true and accurate accounts of the measurements of the sample’s EMC characteristics under the conditions specified in this report. Prepared by : , Date:Feb. 09, 2015 Pettie Chen / Senior Specialist Approved by : , Date:Feb. 09, 2015 Ken Liu / Senior Manager Report No.: SA130923D14B Page No. 5 / 6 Report Format Version: 6.1.1 Reference No.: 150105D03 2 RF Exposure 2.1 Limits For Maximum Permissible Exposure (MPE) Frequency Range (MHz) Electric Field Strength (V/m) Magnetic Field Strength (A/m) Power Density (mW/cm 2 ) Average Time (minutes) Limits For General Population / Uncontrolled Exposure 300-1500 ... ... F/1500 30 1500-100,000 ... ... 1.0 30 F = Frequency in MHz 2.2 MPE Calculation Formula Pd = (Pout*G) / (4*pi*r 2 ) where Pd = power density in mW/cm 2 Pout = output power to antenna in mW G = gain of antenna in linear scale Pi = 3.1416 R = distance between observation point and center of the radiator in cm 2.3 Classification The antenna of this product, under normal use condition, is at least 20cm away from the body of the user. So, this device is classified as Mobile Device. Report No.: SA130923D14B Page No. 6 / 6 Report Format Version: 6.1.1 Reference No.: 150105D03 3 Calculation Result Of Maximum Conducted Power Frequency Band (MHz) Modulation Mode Max Power (dBm) Antenna Gain (dBi) Distance (cm) Power Density (mW/cm 2 ) Limit (mW/cm 2 ) 2412-2462 802.11b 17.43 2 20 0.017 1 802.11g 22.262200.0531 802.11n (20MHz) 22.10 5.01 200.102 1 802.11n (40MHz) 22.73 5.01 200.118 1 5180-5240 802.11a 15.34 2 200.011 1 802.11n (20MHz) 13.13 5.01 200.013 1 802.11n (40MHz) 13.18 5.01 200.013 1 5260-5320 802.11a 15.49 2 200.011 1 802.11n (20MHz) 13.36 5.01 200.014 1 802.11n (40MHz) 13.45 5.01 200.014 1 5500-5700 802.11a 15.272200.0111 802.11n (20MHz) 13.86 5.01 200.015 1 802.11n (40MHz) 13.37 5.01 200.014 1 5745-5825 802.11a 15.30 2 200.011 1 802.11n (20MHz) 13.97 5.01 200.016 1 802.11n (40MHz) 13.36 5.01 200.014 1 NOTE: 802.11n(20MHz)/ 802.11n(40MHz): Directional gain = 2dBi + 10lo…

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Report No.: RF130923D14B Page No. 1 / 52 Report Format Version: 6.1.1 Reference No.: 150105D03 FCC Test Report Report No.: RF130923D14B FCC ID: 2AA69002 Test Model: DC-NU2-UMPC Received Date: Jan. 05, 2015 Test Date: Jan. 10 ~ Feb. 04, 2015 Issued Date: Feb. 09, 2015 Applicant: Capsule Technologie SAS Address: 9 villa Pierre Ginier 75018 Paris, France Issued By: Bureau Veritas Consumer Products Services (H.K.) Ltd., Taoyuan Branch Lab Address: No. 47-2, 14th Ling, Chia Pau Vil., Lin Kou Dist., New Taipei City, Taiwan, R.O.C. Test Location: No. 19, Hwa Ya 2nd Rd, Wen Hwa Tsuen, Kwei Shan Hsiang, Taoyuan Hsien 333, Taiwan, R.O.C. This report is for your exclusive use. Any copying or replication of this report to or for any other person or entity, or use of our name or trademark, is permitted only with our prior written permission. This report sets forth our findings solely with respect to the test samples identified herein. The results set forth in this report are not indicative or representative of the quality or characteristics of the lot from which a test sample was taken or any similar or identical product unless specifically and expressly noted. Our report includes all of the tests requested by you and the results thereof based upon the information that you provided to us. You have 60 days from date of issuance of this report to notify us of any material error or omission caused by our negligence, provided, however, that such notice shall be in writing and shall specifically address the issue you wish to raise. A failure to raise such issue within the prescribed time shall constitute your unqualified acceptance of the completeness of this report, the tests conducted and the correctness of the report contents. Unless specific mention, the uncertainty of measurement has been explicitly taken into account to declare the compliance or non-compliance to the specification. This report should not be used by the client to claim product certification, approval, or endorsement by TAF or any government agencies. Report No.: RF130923D14B Page No. 2 / 52 Report Format Version: 6.1.1 Reference No.: 150105D03 Table of Contents Release Control Record .................................................................................................................................. 4 1 Certificate of Conformity ...................................................................................................................... 5 2 Summary of Test Results ..................................................................................................................... 6 2.1 Measurement Uncertainty ................................................................................................................... 6 2.2 Modification Record ............................................................................................................................ 6 3 General Information .............................................................................................................................. 7 3.1 General Description of EUT ................................................................................................................ 7 3.2 Description of Test Modes ................................................................................................................... 8 3.2.1 Test Mode Applicability and Tested Channel Detail ............................................................................. 9 3.3 Duty Cycle of Test Signal ................................................................................................................... 11 3.4 Description of Support Units ............................................................................................................. 12 3.4.1 Configuration of System under Test .................................................................................................. 12 3.5 General Description of Applied Standards ........................................................................................ 13 4 Test Types and Results ...................................................................................................................... 14 4.1 Radiated Emission and Bandedge Measurement ............................................................................. 14 4.1.1 Limits of Radiated Emission and Bandedge Measurement .............................................................. 14 4.1.2 Test Instruments ................................................................................................................................ 15 4.1.3 Test Procedures ................................................................................................................................. 16 4.1.4 Deviation from Test Standard ............................................................................................................ 16 4.1.5 Test Set Up ........................................................................................................................................ 17 4.1.6 EUT Operating Conditions ................................................................................................................. 17 4.1.7 Test Results ....................................................................................................................................... 18 4.2 Conducted Emission Measurement .................................................................................................. 31 4.2.1 Limits of Conducted Emission Measurement .................................................................................... 31 4.2.2 Test Instruments ................................................................................................................................ 31 4.2.3 Test Procedures ................................................................................................................................. 32 4.2.4 Deviation from Test Standard .....…

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Report No.: RF130923D14B-1 Page No. 1 / 75 Report Format Version:6.1.1 Reference No.: 150105D03 FCC Test Report Report No.: RF130923D14B-1 FCC ID: 2AA69002 Test Model: DC-NU2-UMPC Received Date: Jan. 05, 2015 Test Date: Jan. 10 ~ Feb. 04, 2015 Issued Date: Feb. 09, 2015 Applicant: Capsule Technologie SAS Address: 9 villa Pierre Ginier 75018 Paris, France Issued By: Bureau Veritas Consumer Products Services (H.K.) Ltd., Taoyuan Branch Lab Address: No. 47-2, 14th Ling, Chia Pau Vil., Lin Kou Dist., New Taipei City, Taiwan, R.O.C. Test Location: No. 19, Hwa Ya 2nd Rd, Wen Hwa Tsuen, Kwei Shan Hsiang, Taoyuan Hsien 333, Taiwan, R.O.C. This report is for your exclusive use. Any copying or replication of this report to or for any other person or entity, or use of our name or trademark, is permitted only with our prior written permission. This report sets forth our findings solely with respect to the test samples identified herein. The results set forth in this report are not indicative or representative of the quality or characteristics of the lot from which a test sample was taken or any similar or identical product unless specifically and expressly noted. Our report includes all of the tests requested by you and the results thereof based upon the information that you provided to us. You have 60 days from date of issuance of this report to notify us of any material error or omission caused by our negligence, provided, however, that such notice shall be in writing and shall specifically address the issue you wish to raise. A failure to raise such issue within the prescribed time shall constitute your unqualified acceptance of the completeness of this report, the tests conducted and the correctness of the report contents. Unless specific mention, the uncertainty of measurement has been explicitly taken into account to declare the compliance or non-compliance to the specification. The report must not be used by the client to claim product certification, approval, or endorsement by TAF or any government agencies. Report No.: RF130923D14B-1 Page No. 2 / 75 Report Format Version:6.1.1 Reference No.: 150105D03 Table of Contents Release Control Record .................................................................................................................................. 4 1 Certificate of Conformity ...................................................................................................................... 5 2 Summary of Test Results ..................................................................................................................... 6 2.1 Measurement Uncertainty ................................................................................................................... 6 2.2 Modification Record ............................................................................................................................ 6 3 General Information .............................................................................................................................. 7 3.1 General Description of EUT ................................................................................................................ 7 3.2 Description of Test Modes ................................................................................................................... 8 3.2.1 Test Mode Applicability and Tested Channel Detail ............................................................................. 9 3.3 Duty Cycle of Test Signal ................................................................................................................... 11 3.4 Description of Support Units ............................................................................................................. 12 3.4.1 Configuration of System under Test .................................................................................................. 12 3.5 General Description of Applied Standards ........................................................................................ 13 4 Test Types and Results ...................................................................................................................... 14 4.1 Radiated Emission and Bandedge Measurement ............................................................................. 14 4.1.1 Limits of Radiated Emission and Bandedge Measurement .............................................................. 14 4.1.2 Test Instruments ................................................................................................................................ 15 4.1.3 Test Procedures ................................................................................................................................. 16 4.1.4 Deviation from Test Standard ............................................................................................................ 16 4.1.5 Test Set Up ........................................................................................................................................ 17 4.1.6 EUT Operating Conditions ................................................................................................................. 17 4.1.7 Test Results ....................................................................................................................................... 18 4.2 Conducted Emission Measurement .................................................................................................. 52 4.2.1 Limits of Conducted Emission Measurement .................................................................................... 52 4.2.2 Test Instruments ................................................................................................................................ 52 4.2.3 Test Procedures ................................................................................................................................. 53 4.2.4 Deviation from Test Standard ....…

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Report No.: RF130923D14B-3 Page No. 1 / 29 Report Format Version: 6.1.1 Reference No.: 150105D03 FCC Test Report Report No.: RF130923D14B-3 FCC ID: 2AA69002 Test Model: DC-NU2-UMPC Received Date: Jan. 05, 2015 Test Date: Jan. 10 ~ Feb. 04, 2015 Issued Date: Feb. 09, 2015 Applicant: Capsule Technologie SAS Address: 9 villa Pierre Ginier 75018 Paris, France Issued By: Bureau Veritas Consumer Products Services (H.K.) Ltd., Taoyuan Branch Lab Address: No. 47-2, 14th Ling, Chia Pau Vil., Lin Kou Dist., New Taipei City, Taiwan, R.O.C. Test Location: No. 19, Hwa Ya 2nd Rd, Wen Hwa Tsuen, Kwei Shan Hsiang, Taoyuan Hsien 333, Taiwan, R.O.C. This report is for your exclusive use. Any copying or replication of this report to or for any other person or entity, or use of our name or trademark, is permitted only with our prior written permission. This report sets forth our findings solely with respect to the test samples identified herein. The results set forth in this report are not indicative or representative of the quality or characteristics of the lot from which a test sample was taken or any similar or identical product unless specifically and expressly noted. Our report includes all of the tests requested by you and the results thereof based upon the information that you provided to us. You have 60 days from date of issuance of this report to notify us of any material error or omission caused by our negligence, provided, however, that such notice shall be in writing and shall specifically address the issue you wish to raise. A failure to raise such issue within the prescribed time shall constitute your unqualified acceptance of the completeness of this report, the tests conducted and the correctness of the report contents. Unless specific mention, the uncertainty of measurement has been explicitly taken into account to declare the compliance or non-compliance to the specification. The report must not be used by the client to claim product certification, approval, or endorsement by TAF or any government agencies. Report No.: RF130923D14B-3 Page No. 2 / 29 Report Format Version: 6.1.1 Reference No.: 150105D03 Table of Contents Release Control Record .................................................................................................................................. 3 1 Certificate of Conformity ...................................................................................................................... 4 2 Summary of Test Results ..................................................................................................................... 5 2.1 Measurement Uncertainty ................................................................................................................... 5 2.2 Modification Record ............................................................................................................................ 5 3 General Information .............................................................................................................................. 6 3.1 General Description of EUT ................................................................................................................ 6 3.2 Description of Test Modes ................................................................................................................... 6 3.2.1 Test Mode Applicability and Tested Channel Detail ............................................................................. 7 3.3 Description of Support Units ............................................................................................................... 9 3.3.1 Configuration of System under Test .................................................................................................... 9 3.4 …

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