ARI-VISI-MOBILE-192-10010

1 Monitoring System User manual July2015 Reference Number (USB): 95-10134 Reference Number (Hardcopy): 95-10060 Part Number: 6-000212-15 10020 Huennekens Street San Diego, California 92121 USA Phone: +1 (866) 232-6126 (U.S.) +1 (858) 427-4620 (Intl) Fax:+1 (858) 999-2487 Email: [email protected] EMERGO EUROPE Molenstraat 15, 2513BH The Hague The Netherlands For additional information or assistance, please contact Sotera ® Wireless, Inc. or an authorized Sotera Wireless, Inc. representative in your area. 0297 2 Copyright This publication is provided for informational purposes only and Sotera Wireless, Inc., makes no warranties, either express or implied, in this document. Information in this document is subject to change without notice. The entire risk of the use or the results of the use of this document remains with the user. Unless otherwise noted, the example companies, organizations, products, domain names, e-mail addresses, logos, people, places, and events depicted herein are fictitious, and no association with any real company, organization, product, domain name, e-mail address, logo, person, place, or event is intended or should be inferred. Complying with all applicable copyright laws is the responsibility of the user. Without limiting the rights under copyright, no part of this document may be reproduced, stored in or introduced into a retrieval system, or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise), or for any purpose, without the express written permission of Sotera Wireless, Inc. Sotera Wireless, Inc., may have patents, patent applications, trademarks, copyrights, or other intellectual property rights covering subject matter in this document. Except as expressly provided in any written license agreement from Sotera Wireless, Inc., the furnishing of this document does not give you any license to these patents, trademarks, copyrights, or other intellectual property. For additional information or assistance, please contact Sotera Wireless, Inc. or an authorized Sotera Wireless, Inc. representative in your area. © 2015 Sotera Wireless, Inc. All rights reserved. ViSi Mobile ® Monitoring System is a trademark of Sotera ® Wireless, Inc. 1 Contents Chapter 1. Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Chapter 2. ViSi Mobile Warnings and Cautions. . . . . . . . . . . . . . . . . . 13 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Disposable Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Patient Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Vital Signs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Chest Sensor CableChest Sensor: ECG, Respiration, Temperature (Skin). . . . . . . . . . 19 Cuff Module / NIBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Alarms / Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 User Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Wireless Communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Off-The-Shelf (OTS) Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Service / Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Equipment / Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Cleaning / Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Chapter 3. General Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Intro…

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Sotera Wireless, Inc.  10020 Huennekens St.  San Diego, California 92121  858.427.4620 6 August 2015 TUV SUD BABT TCB Octagon House, Segensworth Road, Fareham, Hampshire, PO15 5RL Dear Sir or Madam, We, (Sotera Wireless, 10020 Huennekens St., San Diego, CA), hereby authorize Alex Chang, TUV SUD America Inc, 10040 Mesa Rim Rd, San Diego, CA 92121, Tel +1 (858) 678-1467, to act as our agent in all matters relating to applications for equipment authorization, including the signing of all documents relating to these matters. This authorization expires on 13 January 2016 Company Officer: Larry D. Walker Telephone Number: 858-999-2450 email: [email protected]

Sotera Wireless, Inc.  10020 Huennekens St.  San Diego, California 92121  858.427.4620 6 August 2015 TUV SUD BABT TCB Octagon House, Segensworth Road, Fareham, Hampshire, PO15 5RL Confidentiality Request FCC ID: ARI-VISI-MOBILE-1 Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commission’s Rules, Sotera Wireless hereby requests permanent confidential treatment of information accompanying this application as outlined below:  Schematics  Design Drawings  Bill of Materials/Parts List  Block Diagrams  Operation Description/Theory of Operation  Internal photos Permanent confidentiality for internal photos is requested because devices are permanently glued shut and the inside of the device is not accessible to users. Sotera Wireless also hereby requests short-term confidential treatment of information accompanying this application as outlined below for a period of (up to 180) days:  External Photos  User Manual  Test Set-up Photographs The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457(d)(1)(ii), disclosure of this Application and all accompanying materials will not be made before the date of the Grant for this Application. Yours sincerely, Company Officer: Larry D. Walker Telephone Number: 858-999-2450 email: [email protected]

FCC ID: ARI-VISI-MOBILE-1 IC: 8810A-VISIMOBILE2 Report No.: SD72106244-0515 FCC ID: ARI-VISI-MOBILE-1 IC: 8810A-VISIMOBILE2 Report No.: SD72106244-0515 FCC ID: ARI-VISI-MOBILE-1 IC: 8810A-VISIMOBILE2 Report No.: SD72106244-0515

FCC ID: ARI-VISI-MOBILE-1 IC: 8810A-VISIMOBILE2 Report No.: SD72106244-0515 ID Label Label location

TÜV SÜD AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 FAX: 858 546 0364 August 25, 2015 TUV SUD BABT Octagon House, Concorde Way Segensworth Rd N, Fareham PO15 5RL Attention: Director of Certification RE: Analysis of Limb SAR Exemption for Portable according to FCC Rule Part 2.1093 and KDB 447498 D01. FCC ID: ARI-VISI-MOBILE-1 Limb SAR Exemption using a 5.7mm separation distance: The “Wrist Cradle and Strap” provides a separation distance of 1.4cm. According to KDB 447498 D01 Clause 4.3.1: Limb SAR Exemption Formula is: [ P (mW) / d (mm) ] * sqrt (f (GHz) < 7.5 Using d = 5.7mm in calculation provides the following Power exemption thresholds Frequency (GHz) Separation Distance (mm) Measured Power (mW) Calculation [ P (mW) / d (mm) ] * sqrt (f (GHz) < 7.5 2.412 (802.11b) 5.7 27.1 7.38 < 7.5 2.462 (802.11g & 802.11n 2.4GHz) 5.7 23.5 6.47 < 7.5 5.745 (802.11a & 802.11n 5GHz) 5.7 14.72 6.19 < 7.5 Therefore the device meets the FCC Limb SAR exemption requirements. Sincerely, Xiaoying Zhang Name Authorized Signatory Title: EMC/Wireless Test Engineer

Report No. SD72106244-0515A June 2015 America Report On Application for Grant of Equipment Authorization of the Sotera Wireless Visi Mobile 92-10010 Wrist Transceiver Dual Band FCC Part 15 Subpart C §15.247: 2014 IC RSS-Gen Issue 4 November 2014 IC RSS-247 Issue 1 May 2015 FCC ID: ARIV-VISI-MOBILE-1 IC: 8810A-VISIMOBILE2 Report No. SD72106244-0515A Page 2 of 71 TÜV SÜD AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 FAX: 858 546 0364 REPORT ON TEST REPORT NUMBER PREPARED FOR Radio Testing of the Sotera Wireless Visi Mobile 92-10010 Wrist Transceiver Dual Band SD72106244-0515A Sotera Wireless 10020 Huennekins St. San Diego, CA 92121 CONTACT PERSON Alex Hermphill Electrical Engineer (858) 373-4867 [email protected] PREPARED BY Xiaoying Zhang Name Authorized Signatory Title: EMC/Wireless Test Engineer APPROVED BY Ferdinand S. Custodio Name Authorized Signatory Title: EMC/Senior Wireless Test Engineer DATED June 29, 2015 FCC ID: ARIV-VISI-MOBILE-1 IC: 8810A-VISIMOBILE2 Report No. SD72106244-0515A Page 3 of 71 TÜV SÜD AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 FAX: 858 546 0364 Revision History SD72106244-0515A Sotera Wireless Visi Mobile Wrist Transceiver Dual Band DATE OLD REVISION NEW REVISION REASON PAGES AFFECTED APPROVED BY 06/29/2015 Initial Release Ferdinand S. Custodio FCC ID: ARIV-VISI-MOBILE-1 IC: 8810A-VISIMOBILE2 Report No. SD72106244-0515A Page 4 of 71 TÜV SÜD AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 FAX: 858 546 0364 CONTENTS Section Page No 1 REPORT SUMMARY ............................................................................................................................... 5 1.1 Introduction ................................................................................................................................................ 6 1.2 Brief Summary Of Results ........................................................................................................................... 7 1.3 Product Information ................................................................................................................................... 8 1.4 EUT Test Configuration ............................................................................................................................. 10 1.5 Deviations From The Standard ................................................................................................................. 12 1.6 Modification Record ................................................................................................................................. 12 1.7 Test Methodology ..................................................................................................................................... 12 1.8 Test Facility Location ................................................................................................................................. 12 1.9 Test Facility Registration ........................................................................................................................... 13 2 TEST DETAILS ...................................................................................................................................... 14 2.1 Peak Output Power ................................................................................................................................... 15 2.2 Conducted Emissions ................................................................................................................................ 19 2.3 99% Emission Bandwidth .......................................................................................................................... 20 2.4 Minimum 6 dB RF Bandwidth ................................................................................................................... 27 2.5 Out-Of-Band Emissions - Conducted ........................................................................................................ 33 2.6 Band-Edge Compliance Of RF Conducted Emissions ................................................................................ 39 2.7 Spurious Radiated Emissions .................................................................................................................... 43 2.8 Radiated Band Edge Measurements And Immediate Restricted Bands ................................................... 57 2.9 Power Spectral Density ............................................................................................................................. 61 3 TEST EQUIPMENT USED ...................................................................................................................... 64 3.1 Test Equipment Used ................................................................................................................................ 65 3.2 Measurement Uncertainty ....................................................................................................................... 66 4 DIAGRAM OF TEST SETUP ................................................................................................................... 67 4.1 Test Setup Diagram ................................................................................................................................... 68 5 ACCREDITATION, DISCLAIMERS AND COPYRIGHT ............................................................................... 70 5.1 Accreditation, Disclaimers And Copyright ................................................................................................ 71 FCC ID: ARIV-VISI-MOBILE-1 IC: 8810A-VISIMOBILE2 Report No. SD72106244-0515A Page 5 of 71 TÜV SÜD AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 FAX: 858 546 0364 SECTION 1 REPORT SUMMARY Radio Testing of the Sotera Wireless Visi Mobile 92-10010 Wrist Transceiver Dual Band FCC ID: ARIV-VISI-MOBILE-1 IC: 8810A-VISIMOBILE2 Rep…

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FCC ID: ARI-VISI-MOBILE-1 IC: 8810A-VISIMOBILE2 Report No.: SD72106244-0515 Antenna conducted port measurement FCC ID: ARI-VISI-MOBILE-1 IC: 8810A-VISIMOBILE2 Report No.: SD72106244-0515 Radiated Emission Below 1GHz Front FCC ID: ARI-VISI-MOBILE-1 IC: 8810A-VISIMOBILE2 Report No.: SD72106244-0515 Radiated Emission Above 1GHz Front and Rear FCC ID: ARI-VISI-MOBILE-1 IC: 8810A-VISIMOBILE2 Report No.: SD72106244-0515 EUT X, Y and Z orientation