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

NXT Owner’s Manual NXT-UM01, MAN2010 vi
5.1.1.2 Cleaning and Disinfection Frequency .....................................................72
5.1.1.3 Methods and Tools ..............................................................................72
Cleaning and Disinfection Preparation.......................................................72
5.1.2.1 Containment and Transportation...........................................................72
5.1.2.2 Urocap NXT Preparation....................................................................... 73
5.1.2.3 Roam NXT and PIM NXT Preparation .....................................................73
Cleaning ...............................................................................................73
5.1.3.1 Cleaning the PC ..................................................................................73
5.1.3.2 Cleaning the Urocap NXT .....................................................................74
5.1.3.3 Cleaning the Roam NXT and PIM NXT ....................................................74
5.1.3.4 Cleaning the Infusion Pump NXT...........................................................75
5.1.3.5 Performing Manual Cleaning.................................................................75
Disinfection ........................................................................................... 76
5.1.4.1 Performing Manual Disinfection.............................................................76
5.1.4.2 Disinfecting the Urocap NXT .................................................................76
5.1.4.3 Disinfecting the Roam NXT and PIM NXT................................................77
Completing Cleaning and Disinfection .......................................................77
5.1.5.1 Reconnect and Reassemble ..................................................................77
5.1.5.2 Packaging and Storage ........................................................................77
5.2 Preventive Maintenance ................................................................................ 78
General Maintenance..............................................................................78
5.2.1.1 Caring for the Interlocked Roam NXT & PIM NXT.....................................78
5.2.1.2 Caring for the Urocap NXT ................................................................... 78
Caring for Cart and its Components.......................................................... 79
5.2.2.1 Safely Moving the Cart ........................................................................79
5.3 Verifying Calibration ..................................................................................... 81
Urocap NXT – Verifying Calibration........................................................... 81
5.3.1.1 Checking the Absolute and Relative Weight ............................................81
5.3.1.2 Checking the Absolute and Relative Weight with Water............................82
Roam NXT – Verifying Calibration ............................................................82
5.3.2.1 Verifying EMG Capability......................................................................83
5.3.2.2 Verifying Pressure Measurement Capability ............................................84
Infusion Pump NXT and Volume Transducer – Verifying Calibration ..............84
5.3.3.1 Checking the Total Weight without a Saline Bag .....................................85
5.3.3.2 Checking the Total Weight with a Saline Bag ..........................................85
5.4 Configuration...............................................................................................86

NXT Owner’s Manual NXT-UM01, MAN2010 vii
NXT PRO Electrical Isolation Diagram .......................................................86
Urocap NXT and Wall Charger Isolation Diagram........................................86
5.5Computer Virus Protection ............................................................................87
5.6 Disposing of Product After Use.......................................................................87
5.7 Environmental Consideration of Waste Disposal ...............................................87
5.8 Backups......................................................................................................87
5.9 Troubleshooting Guide..................................................................................88
Software Error Messages ........................................................................92
Hardware .......................................................................................................... 93
6.1 AIO Computer .............................................................................................93
6.2 Bluetooth Dongle NXT................................................................................... 93
6.3 Remote Control NXT.....................................................................................93
Remote Control NXT LED Signals .............................................................94
Remote Control NXT Battery Replacement ................................................95
6.4 NXT Docking Station.....................................................................................95
Infusion Pump NXT ................................................................................ 95
6.5 Infusion Volume Transducer .......................................................................... 96
6.6 Roam NXT...................................................................................................97
Replacing the PIM NXT ...........................................................................98
6.6.1.1 Removing the PIM NXT ........................................................................98
6.6.1.2 Attaching New PIM NXT .......................................................................98
6.6.1.3 Removing and Attaching the Clip ..........................................................99
Roam NXT—Charging the Battery.............................................................99
6.7 Urocap NXT ............................................................................................... 100
Urocap NXT—Charging the Battery......................................................... 101
Urocap NXT Charging Hub..................................................................... 102
Urocap NXT Configuration with Wall Charger ........................................... 102
6.8 NXT Pro Cart ............................................................................................. 103
6.9 T-DOC Air-Charged Catheters ...................................................................... 104
6.10 EMG Electrodes.......................................................................................... 105
6.11 Commode ................................................................................................. 105
Appendix......................................................................................................... 106
Appendix A: System Specifications ........................................................................ 106
Equipment Specifications .................................................................................. 106
Classification and Applicable Directives ............................................................... 109
Appendix B: Symbols Glossary.............................................................................. 110

NXT Owner’s Manual NXT-UM01, MAN2010 viii
Medical Device Label Placement ......................................................................... 111
Appendix C: Electronic Compatibility (EMC) ............................................................ 112

NXT Owner’s Manual NXT-UM01, MAN2010 ix
List of Figures
Figure 1: NXT Pro System Cart ..................................................................................12
Figure 2: Lockable Wheels.........................................................................................18
Figure 3: Roam NXT and Urocap NXT inserted in NXT Docking Station ............................19
Figure 4: Connecting the NXT Pro Cart to Supply Mains ................................................19
Figure 5: Urocap NXT Setup ......................................................................................21
Figure 6: Consumable Traceability – Preview Window ...................................................22
Figure 7: Catheters Connected to PIM NXT .................................................................. 24
Figure 8: Pressure Flow Preview Phase........................................................................24
Figure 9: EMG Patch Electrode Placements ..................................................................25
Figure 10: EMG Cable Connected to PIM NXT ............................................................... 25
Figure 11: Roam Mounted on IV Pole ..........................................................................25
Figure 12: Device Manager Window ............................................................................26
Figure 13: Find Devices Window.................................................................................27
Figure 14: FreeFlow Preview Phase.............................................................................28
Figure 15: FreeFlow Record Phase .............................................................................. 29
Figure 16: Post Voided Residual Window .....................................................................30
Figure 17: FreeFlow Preview Report............................................................................30
Figure 18: Pressure Flow Filling Phase ........................................................................32
Figure 19: Pressure Flow Voiding Phase ......................................................................33
Figure 20: Stress Test Designation Window .................................................................35
Figure 21: Synergy Login Page ..................................................................................37
Figure 22: Accessing User Setup Application................................................................38
Figure 23: User Setup Window...................................................................................39
Figure 24: Password Reset ........................................................................................39
Figure 25: Accessing the Manage User Role Application.................................................40
Figure 26: Manage User Role Window .........................................................................40
Figure 27: Adding New User Role ............................................................................... 41
Figure 28: Synergy Main Window Reading Guide ..........................................................41
Figure 29: Patients Section........................................................................................ 43
Figure 30: Default Patient Details...............................................................................44
Figure 31: Export Document Window.......................................................................... 45
Figure 32: Patient List - EMR .....................................................................................46
Figure 33 Patient Settings – EMR ...............................................................................46
Figure 34: Patient Details – Symptoms Tab .................................................................47
Figure 35: Database Management – Archive Patients....................................................48
Figure 36: Database Management – Import Patients..................................................... 49
Figure 37: Database Management – Deleted Patients ...................................................49
Figure 38: Workflow Configuration Window – Channels Tab ...........................................51
Figure 39: Adding a Phase to a Custom Workflow......................................................... 52
Figure 40: Workflow Configuration Window - Control Panel............................................54
Figure 41: Action Window – Adding, Changing or Emptying Button Label ........................54
Figure 42: Edit Control Panel Button...........................................................................55
Figure 43: Workflow Configuration with Hardware Channel Error ....................................55
Figure 44: Start Study Button.................................................................................... 56
Figure 45: Start Study Button Tool Tip........................................................................56
Figure 46: Consumable Traceability ............................................................................58

NXT Owner’s Manual NXT-UM01, MAN2010 x
Figure 47: Manual Consumable Traceability .................................................................59
Figure 48: Change Channel Color ...............................................................................59
Figure 49: Configuration Settings – Editing the Report..................................................61
Figure 50: Comments Window ...................................................................................61
Figure 51: Comments and Header Title Drop Down Menus.............................................62
Figure 52: Normal Values ..........................................................................................63
Figure 53: Select Images/Burst for Report Window.......................................................64
Figure 54: Video Panel – Image Selection....................................................................64
Figure 55: EMR Sending Status..................................................................................65
Figure 56: Review – FreeFlow Study ...........................................................................65
Figure 57: Pre-test QC .............................................................................................. 67
Figure 58: Protocol Guidance - Total Score and Phase Score..........................................68
Figure 59: Protocol Guidance and QC Score in the Review Phase ....................................68
Figure 60: QC Score Summary...................................................................................69
Figure 61: Pump Rollers and Drip Tray........................................................................75
Figure 62: Adjusting the Worksurface ......................................................................... 79
Figure 63: Moving the NXT Pro in Transport Position..................................................... 80
Figure 64: Urocap NXT – Device Diagnostics................................................................81
Figure 65: Urocap NXT – Device Diagnostics with Water................................................82
Figure 66: Wiring Diagram – EMG Calibration Verification with a Waveform Generator ...... 83
Figure 67: Roam NXT – Device Diagnostics .................................................................84
Figure 68: Infusion Pump NXT Diagnostics Window ......................................................85
Figure 69: NXT Pro Isolation Diagram .........................................................................86
Figure 70: Urocap NXT and Wall Charger Isolation Diagram...........................................86
Figure 71: Bluetooth Dongle NXT ...............................................................................93
Figure 72: Remote Control NXT Membrane Icons .........................................................93
Figure 73: NXT Docking Station .................................................................................95
Figure 74: Status of the Pump ...................................................................................95
Figure 75: Infusion Volume Transducer Setup.............................................................. 96
Figure 76: PIM NXT Connected to Roam NXT ...............................................................97
Figure 77: Roam NXT and PIM NXT Controls - Front and Back........................................ 97
Figure 78: Roam NXT with a Detached PIM NXT ...........................................................98
Figure 79: PIM NXT (with screw and belt clip)..............................................................98
Figure 80: Removing the Roam NXT and PIM NXT Clips.................................................99
Figure 81: Urocap NXT............................................................................................ 100
Figure 82: Urocap NXT Controls ............................................................................... 101
Figure 83: Attaching the NXT Magnetic Pogo Pin Cable to the Urocap NXT Charging Hub . 102
Figure 84: Cable Clasps and Urocap NXT Charging Hub Binder Attachment.................... 102
Figure 85: NXT Pro Cart .......................................................................................... 103
Figure 86: NXT Pro Cart Power Switch and Equalization/Grounding Connector Accessories
............................................................................................................................ 103
Figure 87: T-DOC NXT Air-Charged Catheter ............................................................. 104
Figure 88: T-DOC NXT Catheters – Color Coding ........................................................ 104
Figure 89: PIM NXT Color Coded Transducer Channels ................................................ 105
Figure 90: NXT Pro Cart Label Placement .................................................................. 111

NXT Owner’s Manual NXT-UM01, MAN2010 xi
List of Tables
Table 1: NXT System Configuration – Standard Equipment............................................15
Table 2: Synergy Main Window Section Overview ......................................................... 42
Table 3: Title Bar Icon Overview ................................................................................42
Table 4: Settings Options Overview ............................................................................43
Table 5: Admin Options Overview...............................................................................43
Table 6: Synergy Navigation Icons .............................................................................57
Table 7: Slide Sidebar Icon Overview..........................................................................57
Table 8: QC Score Allotment Process ..........................................................................70
Table 9: Remote Control NXT Icons ............................................................................94
Table 10: Remote Control NXT LED Signals .................................................................94
Table 11: Roam NXT LED Signals ............................................................................. 100
Table 12: Urocap NXT LED Signals ........................................................................... 101
Table 13: Equipment Specifications .......................................................................... 109
Table 14: Classifications and Directives..................................................................... 109
Table 15: Symbols Glossary .................................................................................... 111
Table 16: Guidance and Manufacture’s Declaration – Electromagnetic Emissions ............ 112
Table 17: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ........... 115
Table 18: Separation Distances between Portable and Mobile RF .................................. 116

Introduction
NXT Owner’s Manual NXT-UM01, MAN2010 12
Introduction
The LABORIE NXT system is a fully wireless capable system providing mobility and ease-of-
use in the field of Urodynamics. It allows studies to be performed with mountable modules
and is controlled by the LABORIE Synergy software. The wireless and battery-powered
features of each device allow for improved system setup and use. For information on
warranty and terms and conditions, visit http://www.laborie.com/terms-and-conditions/.
Figure 1: NXT Pro System Cart
1.1 Intended Use
The NXT family are medical device systems used for Urodynamics and pelvic floor
assessment. These systems can display, record, and store data such as vesical, urethral,
and abdominal pressures, urine flow and volume, and pelvic floor EMG from the patient for
diagnostics purposes only.
1.2 Indications of Use
The NXT Urodynamics System is indicated for urologic diagnostic testing to aid in the
diagnosis of urine storage and voiding disfunction diseases including:
•Urinary incontinence and retention
•Bladder outlet obstructions
•Neurogenic bladder dysfunction
•Other complex voiding/urine storage problems
This device is indicated for use under the direction of licensed and trained health care
professionals.

Introduction
NXT Owner’s Manual NXT-UM01, MAN2010 13
1.3 Equipment Intended Use
Refer to the descriptions below for a breakdown of intended use per module.
Standard Equipment
•NXT Docking Station with Pump: Wired device which uses a peristaltic infusion
pump to fill a patient’s bladder with saline and/or contrast from an IV bag.
•Urocap NXT: Wired or wireless and battery powered device which measures
volume and flow rate of urine.
•Roam NXT: Wired or wireless and battery powered detachable module that
connects to the PIM NXT.
•PIM NXT: Device which is powered by the Roam NXT to measure pressure and
electromyography.
•PC: Computer which controls the system activity and displays and stores data.
•Synergy: Application software which runs on the PC to control the system activity
and display, and store data.
•Bluetooth Dongle NXT: Allows wireless communication between modules and the
system.
•Remote Control NXT: Wireless and battery powered device which allows control
of the system from a distance.
Optional Equipment
•Video Card/Adaptor: Allows information from an external image source to be
recorded by the system
•Printer: Allows hardcopy reports to be created.
Accessories
The accessories of the equipment are as follows:
•Catheters, Electrodes, Tubing, Pressure Transducers: Disposable or reusable
items used to record data from the patient.
•Commode, Procedure Chair: Supports patient to allow a procedure to be
performed more easily.
•Flow Stand, IV Pole, Carts, Stands, Trolleys: allow procedures to be performed
more easily.
•SmartSense Barcode reader: Allows accessory device identifiers to be recorded
by the system.
1.4 Contraindications
The NXT Urodynamic System is contraindicated for use in patients with a pacemaker or ICD
(Implanted cardioverter-defibrillator).

Introduction
NXT Owner’s Manual NXT-UM01, MAN2010 14
1.5 About this Manual
The NXT Owner’s Manual is intended to provide important information and instruction
regarding the use of the NXT System.
Manual Symbols
This manual provides important information to help in understanding the features and safe
use of the NXT System and its modules. The symbols outlined below highlight helpful tips
and important cautions that will aide in guiding the reader through the manual.
Symbol Description
Caution/warning symbol describes information that the user
needs to know to prevent minor injury or product damage.
Important symbol describes important information about
using the device.
Note symbol describes additional information about the
device.
1.6 Software and Equipment
Software Install
Synergy software is installed prior to shipping. The supported operating system for Synergy
Software is Microsoft Windows®10.0. For the end-user software license agreement, visit
http://www.laborie.com/terms-and-conditions/end-user-software-license-agreement/
IMPORTANT:
•Ensure that Windows automatic updates are always enabled.
•LABORIE strongly recommends that BitLocker remain enabled on the NXT system
to comply with the HIPAA standard regarding data privacy and security.
•Ensure that an antivirus program is always enabled. For more information about
the use of antivirus programs, refer to the Computer Virus Protection section on
page 87.
•Do not upgrade any Microsoft Windows®10.0 PC or laptop to any other version of
Microsoft Windows®. The UDS Urodynamics system and software provided by
LABORIE are tested as a complete package and will not work correctly after
updating the operating system. Contact your LABORIE support representative for
more information.
•Changes to the Windows Group Policies may prevent the NXT system from
operating correctly. Before making any Group Policy changes, contact your
LABORIE support representative for guidance to confirm if changes can be safely
made.
•To install any updates for the Synergy software, contact your LABORIE support
representative for guidance.
•Access Synergy Software Version, Serial Number, System Fingerprint, and
GS1 information by navigating to the System Settings window under the Settings

Introduction
NXT Owner’s Manual NXT-UM01, MAN2010 15
icon . Refer to the Overview of Icons in the Title Bar section on page 42 for
instructions on accessing the System Settings.
Standard Equipment and Optional Accessories
Prior to use, verify that all ordered equipment and accessories have been received. Contact
LABORIE if there are any discrepancies between ordered and received equipment. Inspect
the equipment for any visible signs of damage or mishandling. Notify the carrier
immediately if damage is found.
NOTE:LABORIE recommends keeping the carrying cases and cartons provided with the
devices to use during transport if the equipment must be sent in for service.
Standard NXT System Configuration:
NXT Pro
Cart Plenary
PC All-In-One (AIO)
Computer
PN: POC-W243
Printer Inkjet
Pump Hub Docking Station
with Pump
Uroflowmeter Urocap NXT: 1-2
UDS Roam NXT: 2
Electronic Medical
Records (EMR)
Add-on feature
Video Add-on feature
Table 1: NXT System Configuration – Standard Equipment
1.7 Warnings and Precautions
Precautions:
Prior to Urodynamic testing, a urinalysis and urine culture should be considered to rule
out the presence of infection.
Care should be taken when performing a Urodynamic study on patients with:
oThe presence of a bladder infection
oStrictures in the urethra

Introduction
NXT Owner’s Manual NXT-UM01, MAN2010 16
LABORIE is not responsible for loss of patient files or test data. LABORIE recommends
that the user backup patient data on a regular basis.
To prevent any risk of damage to the cart:
oEnsure the monitor is free of any obstacles.
oDo not hang anything on, or suspend extra weight from, the monitors.
oDo not exceed the maximum weight indications: 10kg for the printer shelf,
10kg for the worksurface, and 1 kg for the mouse tray.
LABORIE equipment and accessories are licensed by Governments, approved by Safety
Agencies, and warranted to work only with each other.
The Roam NXT and the PIM NXT are not intended for long-term direct patient contact. If
the devices must be attached to a patient, place gauze or another material between the
devices and the patient’s skin.
Caution: United States Federal Law restricts this device to sale or use by or on the
order of a licensed physician.
Warnings:
Only LABORIE trained technicians may service the unit.
Do not use if the device packaging has been opened, damaged, or if it presents any fault
due to improper transport, storage, or handling that could in any way hamper its use.
The NXT System is intended for install by trained personnel ONLY.
Ensure all wheels are locked during testing procedures to prevent injury to the patient. Do
not lean on the equipment or hang excessively weighted objects on the platform; only
hang LABORIE standard accessories on the platform.
Exhibit caution when adjusting the PC and monitor from its lowest or highest position;
ensure all extremities are clear of moving parts. If the PC or monitor are removed from
the mount, the unit may rise abruptly as the gas spring triggers used are calibrated to
handle the weight of the original configuration.
Do not immerse the NXT System or any of its modules in water or any other liquids.
Do not place your fingers or any body parts inside the pump when the pump rollers are
moving.
Do not use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous
oxide.
Do not use electromyography (EMG) simultaneously with high frequency surgical
equipment.
Do not operate the NXT System near shortwave or microwave therapy equipment as
proximity may produce instability in the APPLIED PARTS.
Do not allow applied parts linked to a PATIENT CONNECTION, but not connected to the
PATIENT, to contact other conductive parts including those connected to protective earth.
Preserve the patient connection electrical isolation.
Do not reuse single-use accessories. After use, dispose of single-use accessories in
accordance with local regulations.

Introduction
NXT Owner’s Manual NXT-UM01, MAN2010 17
Re-use, reprocessing, or resterilization of disposables can lead to device failure and create
a risk of cross-infection and/or cross transmission of infectious disease(s) from one
patient to another.
NXT System Accessories are not intended to be defibrillation-proof.
Improper processing of reusable items prior to initial use or reuse can result in cross
infection and/or cross-transmission of infectious disease from one patient to another.
Risks associated with catheterization increase immediately after urethral or bladder
surgery. The performance of Urodynamic studies with post-operative patients is at the
discretion of the physician.
Medical care professionals performing Urodynamic studies should be prepared to
recognize and treat symptoms associated with ureteral catheterization, vasovagal
syncope (fainting), and Autonomic Dysreflexia.
To avoid potential patient injury never clean or service any module or component of the
NXT System while in use with a patient.
The use of the Medical Electrical equipment is restricted to one patient at a time.
Do not use the NXT System in the presence of a magnetic resonance imaging system as
the NXT System may contain ferromagnetic objects that pose a risk to the patient in the
presence of a magnetic core.
To avoid risk of electric shock, do not touch the pogo pins located inside the NXT Docking
Station, Urocap NXT Charging Hub, or Urocap NXT Wall Charger.
To avoid the risk of electric shock, only connect this equipment to a mains power supply
with protective earth.
This device is intended for use in a clinical environment with controlled EMC standards to
limit potential interference. The NXT System may be adversely affected by Bluetooth,
cellular, or EMC interference. Minimize interference from other Bluetooth devices by
setting up all modules of the system in proximity to each other.
Only connect devices specified and approved by LABORIE to the NXT System multiple
socket outlets. Connecting any device not approved by LABORIE to the Medical Electrical
(ME) system alters the functional integrity of the product creating a safety risk.
Always position the NXT System to facilitate ease of access to all electrical connections
and plugs. The device operator must be able to disconnect the device quickly and safely
in case of an emergency.
Do not alter or add to the NXT medical electrical system. Any alteration to the NXT
System by an unauthorized party transfers responsibility for meeting ME system
requirements from LABORIE to the altering party. Anyone connecting supplementary
equipment to ME equipment configures a medical system and is therefore responsible for
ensuring that the system complies with the requirements for medical electrical systems,
encompassed in the IEC/EN 60601 series.
Batteries are not operator replaceable (except for in the Remote Control NXT). Do not
attempt to remove the battery. All servicing of the NXT System, modules, or attachments
must be completed by LABORIE authorized personnel.
NOTE:Local laws take priority over the above-mentioned requirements and warnings;
if in doubt, consult your local LABORIE representative or the technical service department.

Quick Start
NXT Owner’s Manual NXT-UM01, MAN2010 18
Quick Start
To prepare for a typical study, follow the steps provided below.
Setting Up the Equipment
Gathering Supplies and Equipment
Preparing the Urocap NXT
Preparing the Roam NXT
Setting Up Consumables and Preparing the Patient
2.1 Setting Up the Equipment
Unpack the NXT Cart, Roam NXT, Patient Interface Module NXT (PIM NXT), and
Urocap NXT from their shipping boxes. For information on the NXT Cart, Roam
NXT, PIM NXT, Urocap NXT, Infusion Pump NXT, or Remote NXT, refer to the
Hardware section on page 93.
IMPORTANT:
Lock all wheels of the NXT Cart for equipment setup and anytime the
NXT System is not actively being transported. Ensure all wheels are
locked during testing procedures to prevent injury to the patient.
To lock the wheels, press down on the lever with the bottom of your
foot as shown in Figure 2. To unlock, push the lever up from
underneath with the top of your foot.
Connect the PIM NXT to the Roam NXT. For instructions on how to connect these
devices, refer to the Replacing the PIM NXT section on page 98.
If utilizing Video function for Urodynamic study prepare the connecting device.
Synergy supports HDMI and DVI connections provided by the AIO PC. BNC
connection is supported with the use of the supplied (where applicable) DVI to
BNC adaptor.
CAUTION: Consult LABORIE Service before connecting any video device to the NXT
System. Anyone connecting supplementary equipment to ME equipment configures a
medical system and is therefore responsible for ensuring that the system complies with the
requirements for medical electrical systems, encompassed in the IEC/EN 60601 series.
Insert the Roam NXT into the NXT Docking Station and the Urocap NXT into its
Charging Hub, located on the NXT Cart, as shown in the figure below.
Figure 2: Lockable
Wheels

Quick Start
NXT Owner’s Manual NXT-UM01, MAN2010 19
Figure 3: Roam NXT and Urocap NXT inserted in NXT Docking Station
The NXT Pro Cart’s power cable plugs in at base of the NXT system. Connect the
NXT system power cord to the NXT Pro Cart as shown in the figure below, then
plug the NXT Cart’s power cable to an external power source. Once the NXT
System is connected, press the ON button as indicated in the Figure 4 below.
Figure 4: Connecting the NXT Pro Cart to Supply Mains
For information on charging the Roam NXT, refer to the Roam NXT—Charging the
Battery section on page 99.For information on charging the Urocap NXT, refer to
the Urocap NXT—Charging the Battery section on page 101.
Refer to the Maintenance and Service section on page 71 for information on cleaning
and maintaining the modules, including all system check intervals and procedures for
verifying the integrity of the system.
NXT Docking Station
Urocap NXT
Charging Hub

Quick Start
NXT Owner’s Manual NXT-UM01, MAN2010 20
Turn on the AIO PC by pressing the power button .Double click the Synergy
Icon to launch the Synergy Login Page.
Login to Synergy by inputting the account User Name and Password, assigned
during system install,into the Synergy Login Page. The Synergy Main Window will
load. Refer to Figure 28: Synergy Main Window Reading Guide.Ensure to update
access information from initial system install. Refer to the User Access Control
section on page 37 for more information on logging in to Synergy and accessing
controls.
2.2 Gathering Supplies and Equipment
Prior to beginning a Urodynamics study, the user should ensure that the following supplies
and equipment have been gathered and prepared for use during the procedure.
IMPORTANT: Place the required supplies on a table or tray for easy access when
preparing the patient for full Urodynamic testing.
Procedure Specific items:
•Straight catheter
•Catheterization supplies such as
cleansing swabs, lubricant, etc.
•Saline bag
•Exam gloves
•Tape
•Preparation tray
System Specific Items:
Roam NXT (ROX2001) & PIM NXT
(PIX2211)
Urocap NXT (UCX2001)
Commode Chair (CHA181 or CHA171) and
Funnel (CHA102)
Beaker (UD575)
All-in-one Printer, HP Envy 5055 (PRI1000)
Remote Control NXT (RCX2001)
T-DOC NXT Abdominal Catheter
(CATT3A17)
T-DOC NXT 7FR Single and Dual Sensor
Catheters (CATT3BXXX part number
series)