LABORIE NXT Evo User manual

FOR DIGNITY. FOR LIFE.
laborie.com
NXT Evo
Owner’s Manual
Operation, care, and maintenance
UROLOGY &
UROGYNECOLOGY

ii Laborie NXT Evo Owner’s Manual LBL-00179 [D]
Laborie Medical Technologies Corp.
180 International Drive
Portsmouth, NH 03801 USA
+1.800.522.6743
Medical Measurement Systems BV
Colosseum 25
7521 PV Enschede NETHERLANDS
Tel.: [phone] Fax: [phone]
www.laborie.com
Trademarks
NXT Evo is a trademark of Laborie Medical Technologies Corp. Roam NXT, PIM NXT, Urocap NXT, T-DOC, and Unisensor are
trademarks of Laborie Medical Technologies Corp. Windows is a registered trademark of Microsoft Corp. Bluetooth is a registered
trademark of Bluetooth SIG Inc. LogiCal is a registered trademark of Smiths Medical. Other names may be trademarks of their
respective owners.
© Copyright 2023 Laborie Medical Technologies Corp.
Document Number: LBL-00179 (MAN2040)
Revision: D
Release Date: 2023-04
Laborie Medical Technologies Corp.
180 International Drive
Portsmouth, NH 03801 USA

Contents iii
Contents
1 Introduction 1
Intended Use 1
Indications for Use 1
Equipment Intended Use 2
Contraindications 2
Software and Equipment 2
Software Installation 2
Standard Equipment and Optional Accessories 3
Warnings and Precautions 4
To Report Product Complaints or Incidents 6
About This Manual 6
Symbols Used in This Manual 6
Feedback on the Manual 6
2 Quick Start 7
Setting Up the Equipment 7
Setting Up the NXT Go Pump Hub 8
Gathering Supplies and Equipment 8
Preparing the Urocap NXT 12
Preparing the NXT Go Pump Hub 12
Preparing the Roam NXT 12
Preparing the UPP Puller NXT (Optional) 13
Assembling the UPP Puller NXT 13
Assembling the UPP Puller NXT Stand 14
Assembling and Setting Up the NXT Evo System 15
Mounting the Roam NXT & PIM NXT Assembly to the Cart 16
Mounting the Urocap NXT to the Cart 17
Mounting the IV pole to the Cart—For Fluid Setup 18
Water Pressure Transducer Mount 19
Setting Up Consumables and Preparing the Patient 20
Consumable Traceability 20
Infusion Pump Tubing Setup 21
Replacing the Pump Tubing 22
Setting Up Catheters and Transducers 22
T-DOC G1 Air-Charged Catheters 24
Placing the EMG Patch Electrodes 28
Performing Roam NXT Patient Setup 28

iv Laborie NXT Evo Owner’s Manual LBL-00179 [D]
3 Performing a Study 29
Starting a Study 29
FreeFlow Study 30
Starting the FreeFlow Study 31
Performing a FreeFlow Study 31
Urology Urodynamic Study 33
Starting a Urology Urodynamic Study 33
Performing a Urology Urodynamic Study 34
Cystometry Study 36
Starting the Cystometry Study 36
Performing the Cystometry Study 36
Tests 37
Stress Test 37
Urethral Pressure Prole 38
Finishing the Studies 39
Printing the Study Result (Optional) 39
Troubleshooting 39
4 Synergy Software 40
User Access Control 40
Login 40
LDAP Setup 41
Creating User Accounts 42
Sections and Icons in the Main Window 45
Overview of Sections 46
Overview of the Icons on the Title Bar 46
Patient Management 47
Patients 47
Patient Details 50
Database Management 51
Study Management 53
Workows 53
Customizing Workows 54
Start Study Button 59
Workow Steps 59
Procedure—Preview Phase 60
Procedure—Recording Phases 62
Questionnaire 63
Reports 64
Review 69
UDS Intelligence 70
Quality Control (QC) 70
QC Score and QC Score Summary 72

Contents v
5 Maintenance and Service 75
Cleaning and Disinfection 75
General Cleaning and Disinfection 75
Cleaning and Disinfection Preparation 76
Cleaning 77
Disinfection 80
Completing Cleaning and Disinfection 81
Preventive Maintenance 81
General Maintenance 81
Caring for the Cart 82
Verifying Calibration 83
Urocap NXT—Verifying Calibration 83
Roam NXT—Verifying Calibration 85
NXT Go Pump Hub and Volume Transducer—Verifying Calibration 87
Conguration 88
NXT Evo Electrical Isolation Diagram 88
Roam NXT and Wall Charger Isolation Diagram 89
Urocap NXT and Wall Charger Isolation Diagram 90
UPP Puller NXT and Wall Charger Isolation Diagram 90
Computer Virus Protection 90
Disposing of Product After Use 91
Environmental Consideration of Waste Disposal 91
Backups 91
Troubleshooting Guide 91
Software Error Messages 94
6 Hardware 95
All-in-One Personal Computer 95
Bluetooth Dongle NXT 95
Remote Control NXT 95
Remote Control NXT LED Signals 96
Remote Control NXT Battery Replacement 96
NXT Go Pump Hub 97
Pairing a Version 2 (Wired Connection) NXT Go Pump Hub 97
Pairing a Version 3 (Wired/Wireless Connection) NXT Go Pump Hub 98
Information for All Pump Versions 98
Infusion Volume Transducer 99
Roam NXT 99
PIM NXT 99
Replacing the PIM NXT 101
Roam NXT—Charging the Battery and Pairing 102

vi Laborie NXT Evo Owner’s Manual LBL-00179 [D]
Urocap NXT 103
Urocap NXT—Charging the Battery and Pairing 104
UPP Puller NXT 105
UPP Puller NXT—Pairing 105
UPP Puller NXT—Charging the Battery 105
NXT Evo Cart 106
Mounting the NXT Go Pump Hub 106
T-DOC Air-Charged Catheters 107
EMG Electrodes 108
Commode 108
Appendix A: System Specications 109
Equipment Specications 109
Classication and Applicable Directives 113
Appendix B: Symbols Glossary 114
Medical Device Label Placement 115
Appendix C: Electromagnetic Compatibility (EMC) 116
Transmitter and Wireless Compliance Statements 119

LBL-00179 [D] Laborie NXT Evo Owner’s Manual 1
1 Introduction
The Laborie NXT Evo (NXT2400) system (Figure 1-1) is a partially-wireless-capable system providing mobility and
ease-of-use in the eld 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 allow for improved system setup and
use. For information on warranty and terms and conditions, visit http://www.laborie.com/terms-and-conditions/.
Figure 1-1: The NXT Evo System
Intended Use
NXT is a family of medical device systems used for urodynamics and pelvic oor assessment. These systems can
display, record, and store data such as vesical, urethral, and abdominal pressures, urine ow and volume, and pelvic
oor electromyography (EMG) from the patient for diagnostics purposes only.
Indications for Use
The NXT urodynamics system is indicated for urologic diagnostic testing to aid in the diagnosis of urine storage and
voiding disfunction diseases, including the following:
• 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 healthcare professionals.

2 Laborie NXT Evo Owner’s Manual LBL-00179 [D]
Equipment Intended Use
Refer to the following descriptions for a breakdown of intended use per module.
Standard Equipment
• NXT Go pump hub with NXT Go infusion hook: Peristaltic infusion pump used to ll a patient’s bladder with
saline solution and/or contrast.
■Version 2 NXT Go pump hub (wired connection): To enable communication between the All-in-One (AIO)
computer and the NXT Go pump hub, the two components must connected at all times via the supplied
USB cable.
■Version 3 NXT Go pump hub (wired/wireless connection): The pump must be connected at all times to
the AIO computer via the supplied USB cable.
NOTE
To determine which version pump you have, refer to lower-right corner of the label axed to the bottom of
the NXT Go pump hub. If the number printed there is V2.00, you have a Version 2 pump. If the number on
the label is V3.00 or higher, you have a Version 3 pump.
• Urocap NXT: Wired or wireless and battery-powered device that measures volume and ow rate of urine.
• Roam NXT: Wired or wireless and battery-powered detachable module that connects to the PIM NXT.
• PIM NXT: Device that is powered by the Roam NXT to measure pressure and electromyography.
• All-in-One (AIO) computer: Computer that controls the system activity and displays and stores data.
• Synergy: Application software that 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 that allows control of the system from a distance.
• Printer: For printing hardcopy reports of studies. The printer is connected via USB cable to the NXT Evo
(NXT2400) system.
Optional Equipment
• Video card/adaptor: Allows information from an external image source to be recorded by the system.
• UPP Puller NXT: Wired or wireless and battery-powered device that controls and measures speed and distance
during a Urethral Pressure Prole.
Accessories
The accessories of the equipment are as follows:
• Catheters, electrodes, tubing, pressure transducers: Disposable or reusable items used for infusion and to
measure pressure from the patient.
• Commode, procedure chair: Supports patient and facilitates position changing throughout the procedure.
• Flow stand, IV pole, carts, stands, trolleys: provides mountable surfaces for standard equipment and
accessories.
Contraindications
None known.
Software and Equipment
Software Installation
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/

Chapter 1 Introduction 3
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 section “Computer Virus Protection” on page 90.
• Do not upgrade any Microsoft Windows 10.0 PC 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 conrm
if changes can be safely made.
• To install any updates for the Synergy software, contact your Laborie support representative for
guidance.
• To access the Synergy Software Version, Serial Number, System Fingerprint, and GS1 information, click
the Settings icon ( ) and then open the System Settings dialog box. For instructions on accessing the
System Settings dialog box, refer to the section “Overview of the Icons on the Title Bar” on page 46.
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.
Table 1-1: NXT Evo—Standard and Add-On Equipment and Features
NXT Evo Standard Equipment Add-On Equipment and Features
Cart: Wheeled cart with an AIO PC mount, a pivot
arm for IV pole, and a bracket for NXT Go pump hub
Computer: All-in-One (AIO), including the Laborie
Synergy application
Printer: Inkjet
Pump Hub: NXT Go pump hub with NXT Go infusion
hook (wired Version 2 or wired/wireless Version 3)
Uroowmeter: Urocap NXT (1)
UDS: Roam NXT (1) with PIM NXT for T-DOC for
Fluid
Bluetooth Dongle: Enables wireless connection
using Bluetooth technology
Remote Control NXT: Wireless and battery-powered
device that allows control of the system from a
distance
Electronic Medical Records (EMR)
UPP Puller NXT
Video

4 Laborie NXT Evo Owner’s Manual LBL-00179 [D]
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 the following:
• The presence of a bladder infection
• Strictures in the urethra
Laborie is not responsible for loss of patient les or test data. Laborie recommends that you back up
patient data on a regular basis.
To prevent any risk of damage to the cart, do not exceed the marked maximum weight indications.
Laborie equipment and accessories are licensed by governments, approved by safety agencies, and
warranted to work only with one another.
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
The NXT urodynamic system contains magnets which can interfere with control of a pacemaker or
implanted cardioverter-debrillator (ICD). Follow instructions from the manufacturer of such devices and
ensure that the Roam NXT, Urocap NXT, and charger cable connectors are always kept at a sucient
distance from any implanted device.
Only Laborie-trained technicians may service the unit.
Do not use the NXT system 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 that 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.
Do not immerse the NXT System or any of its modules in water or any other liquids.
Do not place your ngers or any body parts inside the pump when the pump rollers are moving.
Do not use in the presence of a ammable 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 place the printer in the patient environment.
Do not reuse single-use accessories. After use, dispose of single-use accessories in accordance with local
regulations.
Reuse, 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 debrillation-proof.