2AXRJ-TDOC3Patient Interface Module (PIM)

DEFAULT 1/21/2021 1 Document Detail Type:LBL LBL-00145[A]Document No.: NXT Go Owner's Manual MAN2030Title: DAVID.BAK David BakOwner: DRAFTStatus: Effective Date:Expiration Date: Document Build No. Access ActivityAccessed ByAccessed Date Revision Notes 1 Check In 21-Jan-2021DAVID.BAK Note: NXT Go Owner’s Manual, LBL-00145 [A], MAN2030 NXT Go Owner’s Manual Version A Status DRAFT Effective NXT Go Owner’s Manual, LBL-00145, MAN2030 ii Trademarks NXT Go is a trademark of LABORIE Medical Technologies Canada ULC. Roam NXT, PIM NXT, Urocap NXT, and Urocap NXT are trademarks of LABORIE Medical Technologies Canada ULC. T-DOC is a trademark of T-DOC Company, LLC. Unisensor is a trademark of Unisensor AG. Windows is a registered trademark of Microsoft Corp. Bluetooth is a registered trademark of Bluetooth SIG Inc. LogiCal® is a trademark of Smiths Medical. Other names may be trademarks of their respective owners. Copyright All rights reserved. Images/renderings of LABORIE devices in this publication are property of LABORIE and may not be reproduced without the prior written permission of LABORIE. © Copyright 2019-2020 LABORIE Document Number: LBL-00145 Version: [A] Release Date: January 20, 2021 LABORIE Headquarters 6415 Northwest Dr., Unit 10 Mississauga, Ontario, Canada L4V 1X1 Customer Service: +1.905.612.1170 Fax: +1.905.612.9731 LABORIE International Colosseum 25 7521 PV Enschede, Netherlands Tel: +31.53.4803700 Fax: +31.53.4803701 LABORIE USA 400 Avenue D, Suite 10 Williston, Vermont, USA 05495 Customer Service: +1.800.522.6743 Fax: +1.802.878.1122 Laborie Medical Technologies Canada ULC 6415 Northwest Drive, Unit 10 Mississauga ON CANADA L4V 1X1 +1 905 612 1170 www.laborie.com Status DRAFT Effective NXT Go Owner’s Manual, LBL-00145, MAN2030 iii Contents Introduction ...................................................................................................... 12 1.1 Intended Use ............................................................................................... 12 1.2 Indications of Use ........................................................................................ 12 1.3 Equipment Intended Use ............................................................................... 13 1.4 Contraindications ......................................................................................... 13 1.5 About this Manual ........................................................................................ 14 Manual Symbols .................................................................................... 14 1.6 Software and Equipment ............................................................................... 14 Software Install ..................................................................................... 14 Standard Equipment and Optional Accessories ........................................... 15 1.7 Warnings and Precautions ............................................................................. 15 Quick Start ........................................................................................................ 18 2.1 Setting Up the Equipment ............................................................................. 18 2.2 Gathering Supplies and Equipment ................................................................. 19 2.3 Preparing the Urocap NXT ............................................................................. 21 2.4 Preparing the NXT Go Pump Hub .................................................................... 22 2.5 Preparing the Roam NXT ............................................................................... 22 2.6 Preparing the UPP Puller NXT (Optional) ......................................................... 22 Assembling the UPP Puller NXT ................................................................ 22 Assembling the UPP Puller NXT Stand ....................................................... 23 2.7 Setting Up Consumables and Preparing the Patient .......................................... 24 Infusion Pump Tubing Setup ................................................................... 24 2.7.1.1 Replacing the Pump Tubing .................................................................. 25 Setting Up Catheters and Transducers ...................................................... 25 2.7.2.1 T-DOC Air Charged Catheters ............................................................... 25 2.7.2.2 Roam NXT, PIM NXT for Fluid, and Transducer Setup .............................. 26 2.7.2.3 Bladder Fluid NXT Catheters ................................................................. 28 2.7.2.4 Abdominal Fluid NXT Catheters ............................................................. 28 Placing the EMG Patch Electrodes ............................................................. 29 Performing Roam NXT Patient Setup ........................................................ 29 How to Perform a Study ...................................................................................... 30 3.1 Starting a Study .......................................................................................... 30 3.2 FreeFlow Study ............................................................................................ 32 Starting the FreeFlow Study .................................................................... 32 Status DRAFT Effective NXT Go Owner’s Manual, LBL-00145, MAN2030 iv Performing a FreeFlow Study ................................................................... 32 3.2.2.1 Preview Phase .................................................................................... 32 3.2.2.2 Flow Phase ......................................................................................... 33 3.2.2.3 FreeFlow Report ................................................................................. 34 3.3 Urology Urodynamic Study ............................................................................ 35 Starting a…

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Applicant Declaration Applicant Declaration Rev:0.0 SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia 30024 United States Applicant Legal Business Name Laborie Medical Technologies, ULC Address 6415 Northwest Drive, Unit 10, Mississauga, ON L4V 1X1 Grantee Code 2AXRJ FCC ID 2AXRJ-TDOC3 Authorized Contact Name Kristen Bushey Contact Email [email protected] Contact Phone 905-612-1170 x1783 I, the undersigned, certify that I am an authorized signatory for the Applicant and therefore declare; a) in accordance with 47CFR2.911(d), all of the statements herein and the exhibits attached hereto are true and correct to the best of my knowledge and belief. b) in accepting a Grant of Equipment Authorization issued by a TCB, under the authority of the FCC, as a result of the representations made in this application, the Applicant is responsible for: (1) labeling the equipment with the exact FCC ID as specified in this application, (2) compliance statement labeling pursuant to the applicable rules, (3) compliance of the equipment with the applicable technical rules, c) if the Applicant is not the actual manufacturer of the equipment, appropriate arrangements have been made with the manufacturer to ensure that production units of this equipment will continue to comply with the FCC’s technical requirements. d) in accordance with 47 CFR 2.909 and KDB394321, the Applicant has read, understood and agrees to accept that they are the responsible party and agree to abide by their responsibilities as specified under 47 CFR 2.909 and KDB394321. e) in accordance with ISO17065, FCC KDB641163, FCC KDB610077, KDB394321 and RSP-100, the Applicant has read, understood, accepts and agrees to abide by the post market surveillance requirements. (1) the Applicant understands, accepts and agrees that a sample may be requested for surveillance testing. (2) the Applicant shall make provisions to always have a production sample available upon request by SGS, FCC and/or ISED. (3) the Applicant shall, upon request by SGS, at the Applicant’s expense, provide a production sample of the requested product to SGS, FCC and/or ISED as instructed. The sample shall include all support devices, cables, software, accessories or other hardware or software required for evaluation, review, certification and audit surveillance of products certified by SGS. f) neither the Applicant nor any party to the application is subject to a denial of Federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. §862 because of a conviction for possession or distribution of a controlled substance. See 47CFR 1.2002(b) for the definition of a “party” for these purposes. g) the Applicant has read, understood, accepts and agrees to abide by the SGS North America, Inc.(TCB) terms and conditions. Link to CFRs: https://www.fcc.gov/wireless/bureau-divisions/technologies-systems-and-innovation-division/rules-regulations-title-47 Link to KDBs: https://apps.fcc.gov/oetcf/kdb/index.cfm Link to RSP-100: https://www.ic.gc.ca/eic/site/smt-gst.nsf/eng/sf01130.html Applicant Signature: Date: December 3, 2020 Print Name: Kristen Bushey Title: QA Engineering Manager *NOTE: This declaration cannot be signed by an Agent, it shall be signed by an authorized person listed in the FCC database

SGS North America Inc. Consumer and Retail 620 Old Peachtree Road Suite 100 Suwanee GA 30024 t (770) 570-1800 f (770) 277-1240 www.sgs.com Member of the SGS Group (SGS SA) Attn: Director of Certification Confidentiality Request regarding application for FCC ID: 2AXRJ-TDOC3 LONG TERM CONFIDENTIALITY Pursuant to 47 CFR Section 0.459 and 0.457 of the commission’s rules, the applicant hereby requests confidential treatment of the documents listed below, associated with the certification application referenced above. • Schematics • Block diagrams • Technical Description The documents above contain proprietary information not released to the public. Public disclosure of this information may prove harmful to the business of the applicant. Sincerely, Jeremy Pickens Agent for Laborie Medical Technologies, ULC SGS North America Title: RF Lab Manager Date: 03 December 2020

EXTERNAL PHOTOS FCC ID: 2AXRJ-TDOC3 IC: 20484-TDOC3 2 © SGS SA 2016 ALL RIGHTS RESERVED 3 © SGS SA 2016 ALL RIGHTS RESERVED 4 © SGS SA 2016 ALL RIGHTS RESERVED 5 © SGS SA 2016 ALL RIGHTS RESERVED 6 © SGS SA 2016 ALL RIGHTS RESERVED WWW.SGS.COM

INTERNAL PHOTOS FCC ID: 2AXRJ-TDOC3 IC: 20484-TDOC3 2 © SGS SA 2016 ALL RIGHTS RESERVED 3 © SGS SA 2016 ALL RIGHTS RESERVED 4 © SGS SA 2016 ALL RIGHTS RESERVED 5 © SGS SA 2016 ALL RIGHTS RESERVED WWW.SGS.COM

LABEL LOCATION FCC ID: 2AXRJ-TDOC3 IC: 20484-TDOC3 2 © SGS SA 2016 ALL RIGHTS RESERVED Label Device Label Location 3 © SGS SA 2016 ALL RIGHTS RESERVED Packaging Label Location WWW.SGS.COM

LABEL EXHIBIT FCC ID: 2AXRJ-TDOC3 IC: 20484-TDOC3 2 © SGS SA 2016 ALL RIGHTS RESERVED Device Label 3 © SGS SA 2016 ALL RIGHTS RESERVED Packaging Label WWW.SGS.COM

INTERNAL PHOTOS FCC ID: 2AXRJ-TDOC3 IC: 20484-TDOC3 2 © SGS SA 2016 ALL RIGHTS RESERVED 3 © SGS SA 2016 ALL RIGHTS RESERVED 4 © SGS SA 2016 ALL RIGHTS RESERVED 5 © SGS SA 2016 ALL RIGHTS RESERVED WWW.SGS.COM

Test Report Number: 4645918EMC02 Rev: 2 Laborie / PIX2211 Page: 1 of 23 Remarks: This report details the results of the testing carried out on one sample; the results contained in this test report do not relate to other samples of the same product. The manufacturer should ensure that all products in series production are in conformity with the product sample detailed in this report. This document is issued by the Company under its General Conditions of Service accessible at http://www.sgs.com/en/Terms-and- Conditions.aspx. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful, and offenders may be prosecuted to the fullest extent of the law. EMC Test Report Project Number: 4645918 Proposal: 10559 Rev 1 Report Number: 4645918EMC02 Revision Level: 2 Client: LABORIE Medical Technologies, ULC Equipment Under Test: NXT T-DOC PIM Model: PIX2211 FCC ID: 2AXRJ-TDOC3 IC ID: 20484-TDOC3 Applicable Standards: FCC Part 15 Subpart C, §15.225 RSS-210, Issue 10, December 2019 ANSI C63.10: 2013 RSS-GEN, Issue 5, March 2019 Report issued on: 18 January 2021 Test Result: Compliant Prepared by: Jeremy Pickens, RF Lab Manager Reviewed by: David Schramm, Operations Manager Test Report Number: 4645918EMC02 Rev: 2 Laborie / PIX2211 Page: 2 of 23 SGS North America Inc. Consumer and Retail 620 Old Peachtree Road NW, Suite 100, Suwanee, GA 30024 t (770) 570-1800 www.us.sgs.com/crs Member of the SGS Group (SGS SA TABLE OF CONTENTS 1 SUMMARY OF TEST RESULTS ............................................................................................................................... 3 1.1 MODIFICATIONS REQUIRED TO COMPLIANCE ........................................................................................................... 3 2 GENERAL INFORMATION ...................................................................................................................................... 4 2.1 CLIENT INFORMATION ............................................................................................................................................ 4 2.2 TEST LABORATORY ................................................................................................................................................ 4 2.3 GENERAL INFORMATION OF EUT ............................................................................................................................ 4 2.4 OPERATING MODES AND CONDITIONS ..................................................................................................................... 4 2.5 EUT CONNECTION BLOCK DIAGRAM ...................................................................................................................... 5 2.6 SYSTEM CONFIGURATIONS...................................................................................................................................... 5 3 OCCUPIED BANDWIDTH ......................................................................................................................................... 6 3.1 TEST RESULT ......................................................................................................................................................... 6 3.2 TEST METHOD ........................................................................................................................................................ 6 3.3 TEST SITE............................................................................................................................................................... 6 3.4 TEST EQUIPMENT ................................................................................................................................................... 6 3.5 TEST DATA ............................................................................................................................................................ 7 4 FIELD STRENGTH OF THE FUNDAMENTAL....................................................................................................... 8 4.1 TEST RESULT ......................................................................................................................................................... 8 4.2 TEST METHOD ........................................................................................................................................................ 8 4.3 TEST SITE............................................................................................................................................................... 9 4.4 TEST EQUIPMENT ................................................................................................................................................... 9 4.5 TEST DATA ............................................................................................................................................................ 9 5 RADIATED EMISSIONS .......................................................................................................................................... 10 5.1 TEST RESULT ....................................................................................................................................................... 10 5.2 TEST METHOD ...................................................................................................................................................... 10 5.3 TEST SITE..............................................…

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TEST SETUP PHOTOS FCC ID: 2AXRJ-TDOC3 IC: 20484-TDOC3 2 RADIATED EMISSIONS –9K-30MHZ 3 RADIATED EMISSIONS –9K-30MHZ 4 RADIATED EMISSIONS –30-1000MHZ 5 RADIATED EMISSIONS –30-1000MHZ 6 AC CONDUCTED EMISSIONS 7 AC CONDUCTED EMISSIONS WWW.SGS.COM WWW.SGSGROUP.US.COM © SGS Group Management SA – 2018 – All rights reserved - SGS is a registered trademark of SGS Group Management SA