LABORIE NXT Series User manual

NXT Owner’s Manual NXT-UM01-V9.00, MAN2010
NXT
Owner’s Manual
Version 9.00

NXT Owner’s Manual NXT-UM01, MAN2010 ii
Trademarks
NXT PRO 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. 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: NXT-UM01
Version Number: V9.00
Release Date: May 1, 2020
LABORIE Headquarters
6415 Northwest Dr., Unit 10
Mississauga, Ontario,
Canada L4V 1X1
Customer Service: +1.905.612.1170
Fax: [phone]
LABORIE International
Medical Measurement Systems B.V.
Colosseum 25
7521 PV Enschede, Netherlands
Tel: [phone]
Fax: [phone]
LABORIE USA
400 Avenue D, Suite 10
Williston, Vermont, USA 05495
Customer Service: +1.800.522.6743
Fax: [phone]
Laborie Medical Technologies Canada ULC
6415 Northwest Drive, Unit 10
Mississauga ON L4V 1X1 Canada

NXT Owner’s Manual NXT-UM01, MAN2010 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.................................................................20
2.3 Preparing the Urocap NXT .............................................................................21
2.4 Preparing the Roam NXT ...............................................................................21
2.5 Setting Up Consumables and Preparing the Patient ..........................................22
Infusion Pump Tubing Setup ...................................................................22
2.5.1.1 Replacing the Pump Tubing ..................................................................23
Setting Up T-DOC Air Charged Catheters ..................................................23
Placing the EMG Patch Electrodes.............................................................25
Performing Roam NXT Patient Setup ........................................................25
How to Perform a Study ......................................................................................26
3.1 Starting a Study ..........................................................................................26
3.2 FreeFlow Study............................................................................................28
Starting the FreeFlow Study ....................................................................28
Performing a FreeFlow Study...................................................................28
3.2.2.1 Preview Phase .................................................................................... 28
3.2.2.2 Flow Phase......................................................................................... 29
3.2.2.3 FreeFlow Report ................................................................................. 30
3.3 Urology Urodynamic Study ............................................................................ 31
Starting a Urology Urodynamic Study .......................................................31
Performing a Urology Urodynamic Study...................................................31
3.3.2.1 Preview and Flow Phase....................................................................... 31

NXT Owner’s Manual NXT-UM01, MAN2010 iv
3.3.2.2 Preview 2 Phase .................................................................................31
3.3.2.3 Filling Phase.......................................................................................32
3.3.2.4 Voiding Phase.....................................................................................33
3.3.2.5 Urology Urodynamics Report ................................................................33
3.4 Cystometry Study ........................................................................................34
Starting the Cystometry Study ................................................................34
Performing the Cystometry Study ............................................................34
3.4.2.1 Preview phase .................................................................................... 34
3.4.2.2 Cystometry phase...............................................................................34
3.4.2.3 Review and Report Phases ...................................................................35
3.5 Tests ..........................................................................................................35
Stress Test............................................................................................ 35
Urethral Pressure Profile (Manual)............................................................36
3.6 Finishing the Studies ....................................................................................36
3.7 Printing the Study Result (Optional) ...............................................................36
3.8 Troubleshooting...........................................................................................36
Synergy Software ..............................................................................................37
4.1 User Access Control......................................................................................37
Login....................................................................................................37
Creating User Accounts...........................................................................38
4.1.2.1 User Account Setup and Password Reset................................................38
4.1.2.2 Managing User Role ............................................................................40
4.2 Sections and Icons in the Main Window ..........................................................41
Overview of Sections..............................................................................42
Overview of Icons in the Title Bar ............................................................42
4.2.2.1 Settings............................................................................................. 42
4.2.2.2 Admin ............................................................................................... 43
4.3 Patient Management.....................................................................................43
Patients ................................................................................................43
4.3.1.1 Adding a New Patient ..........................................................................44
4.3.1.2 Deleting Patient Data ..........................................................................44
4.3.1.3 Searching for a Required Patient...........................................................44
4.3.1.4 Exporting Patient Data.........................................................................45
4.3.1.5 Reassigning Study ..............................................................................45
4.3.1.6 View Patients Entered through EMR....................................................... 46
Patient Details ....................................................................................... 47

NXT Owner’s Manual NXT-UM01, MAN2010 v
4.3.2.1 Symptoms .........................................................................................47
Database Management ...........................................................................48
4.3.3.1 Archiving Patients ...............................................................................48
4.3.3.2 Importing Archived Patient Data ...........................................................48
4.3.3.3 Restoring Patient Data.........................................................................49
4.4 Study Management ......................................................................................50
Workflows .............................................................................................50
Customizing Workflows...........................................................................51
4.4.2.1 Workflow Step Settings Tabs ................................................................53
4.4.2.2 Customizing Control Panel ...................................................................53
4.4.2.3 Accessing Hardware Channels ..............................................................55
Start Study Button .................................................................................56
4.5 Workflow Steps............................................................................................56
Procedure – Preview Phase ..................................................................... 57
4.5.1.1 Slide Sidebar......................................................................................57
4.5.1.2 Consumable Traceability ...................................................................... 58
Procedure – Recording Phases ................................................................. 59
Questionnaire........................................................................................ 60
Reports ................................................................................................60
4.5.4.1 Editing............................................................................................... 60
4.5.4.2 Adding Comments............................................................................... 61
4.5.4.3 Quick Results and Nomograms .............................................................62
4.5.4.4 Normal Values ....................................................................................63
4.5.4.5 Video Images ..................................................................................... 63
4.5.4.6 Sending Reports to EMR ......................................................................65
Review .................................................................................................65
4.6 UDS Intelligence .......................................................................................... 67
Quality Control (QC)...............................................................................67
4.6.1.1 Pre-test Quality Control .......................................................................67
4.6.1.2 Protocol Guidance ...............................................................................68
4.6.1.3 UDS Intelligence in the Review Workflow Step........................................68
QC Score and QC Score Summary............................................................69
Maintenance and Service ....................................................................................71
5.1 Cleaning and Disinfection..............................................................................71
General Cleaning and Disinfection ............................................................71
5.1.1.1 Cleaning and Disinfection Reagents.......................................................71