LABORIE NXT Go User manual

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

ii Laborie NXT Go Owner’s Manual LBL-00145 [E]
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 Go 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-00145 (MAN2030)
Revision: E
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 3
Software Install 3
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 for NXT2100 Systems 8
Setting Up the NXT Go Pump Hub for NXT Go with Cart System (NXT2300) 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
Setting Up Consumables and Preparing the Patient 14
Consumable Traceability 14
Infusion Pump Tubing Setup 15
Setting Up Catheters and Transducers 16
T-DOC G1 Air-Charged Catheters 18
Placing the EMG Patch Electrodes 22
Performing Roam NXT Patient Setup 22
3 Performing a Study 23
Starting a Study 23
FreeFlow Study 24
Starting the FreeFlow Study 25
Performing a FreeFlow Study 25
Urology Urodynamic Study 27
Starting a Urology Urodynamic Study 28
Performing a Urology Urodynamic Study 28

iv Laborie NXT Go Owner’s Manual LBL-00145 [E]
Cystometry Study 30
Starting the Cystometry Study 30
Performing the Cystometry Study 30
Tests 31
Stress Test 31
Urethral Pressure Prole 32
Finishing the Studies 33
Printing the Study Result (Optional) 33
Troubleshooting 33
4 Synergy Software 34
User Access Control 34
Login 34
LDAP Setup 35
Creating User Accounts 36
Sections and Icons in the Main Window 39
Overview of Sections 40
Overview of the Icons on the Title Bar 40
Patient Management 41
Patients 41
Patient Details 44
Database Management 45
Study Management 47
Workows 47
Customizing Workows 48
Start Study Button 53
Workow Steps 53
Procedure—Preview Phase 54
Procedure—Recording Phases 56
Questionnaire 57
Reports 58
Review 63
UDS Intelligence 64
Quality Control (QC) 64
QC Score and QC Score Summary 66
5 Maintenance and Service 69
Cleaning and Disinfection 69
General Cleaning and Disinfection 69
Cleaning and Disinfection Preparation 70
Cleaning 71
Disinfection 74
Completing Cleaning and Disinfection 75

Contents v
Preventive Maintenance 75
General Maintenance 75
Verifying Calibration 77
Urocap NXT—Verifying Calibration 77
Roam NXT—Verifying Calibration 79
Infusion Pump NXT and Volume Transducer—Verifying Calibration 81
Conguration 82
NXT Go Electrical Isolation Diagram 82
NXT Go with Cart Electrical Isolation Diagram 83
Roam NXT and Wall Charger Isolation Diagram 84
Urocap NXT and Wall Charger Isolation Diagram 84
UPP Puller NXT and Wall Charger Isolation Diagram 84
Computer Virus Protection 85
Disposing of Product After Use 85
Environmental Consideration of Waste Disposal 85
Backups 85
Troubleshooting Guide 86
Software Error Messages 89
6 Hardware 90
Laptop Personal Computer 90
Bluetooth Dongle NXT 90
Remote Control NXT 90
Remote Control NXT LED Signals 91
Remote Control NXT Battery Replacement 91
NXT Go Pump Hub 92
Pairing a Version 2 (Wired Connection) NXT Go Pump Hub 92
Pairing a Version 3 (Wired/Wireless Connection) NXT Go Pump Hub 93
Information for All Pump Versions 93
Infusion Volume Transducer 95
Roam NXT 95
PIM NXT 95
Replacing the PIM NXT 97
Roam NXT—Charging the Battery and Pairing 98
Urocap NXT 99
Urocap NXT—Charging the Battery and Pairing 100
UPP Puller NXT 101
UPP Puller NXT—Pairing 101
UPP Puller NXT—Charging the Battery 101

vi Laborie NXT Go Owner’s Manual LBL-00145 [E]
NXT Go with Cart (NXT2300) 102
Mounting the NXT Go Pump Hub 103
Mounting the NXT Roam & PIM Assembly to the Cart 104
Mounting the Urocap NXT to the Cart 105
Mounting the IV Pole to the Cart 106
Water Pressure Transducer Mount 107
EMG Electrodes 109
Commode 109
Appendix A: System Specications 110
Equipment Specications 110
Classication and Applicable Directives 114
Appendix B: Symbols Glossary 115
Medical Device Label Placement 116
Appendix C: Electronic Compatibility (EMC) 117
Transmitter and Wireless Compliance Statements 120

LBL-00145 [E] Laborie NXT Go Owner’s Manual 1
1 Introduction
The Laborie NXT Go 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 Laborie’s
Synergy software. The wireless and battery-powered features allow for improved system setup and use. For
information on warranty and terms and conditions, visit https://www.laborie.com/terms-conditions/.
Figure 1-1: The NXT Go 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 diagnostic 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 Go Owner’s Manual LBL-00145 [E]
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 laptop 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): Communication with the laptop computer does
not require a USB cable connection, allowing free movement of the NXT Go system (NXT2100) (within a
10 meter operating range) to the most convenient location.
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.
NOTE
Laborie recommends that NXT Go with Cart owners leave the USB cable connected at all times.
• 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.
• Laptop Computer: Computer that controls the system activity and displays and stores data.
• Synergy: The application software that runs on the laptop computer 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. For the NXT Go 2100 system, you can connect to the printer
via WiFi or WiFi direct. For the NXT Go 2300 system, the printer requires a USB cable connection.
Optional Equipment
• 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.

Chapter 1 Introduction 3
Software and Equipment
Software Install
The Synergy software is installed prior to shipping. The supported operating system for Synergy is Microsoft
Windows10.0. To view the end-user software license agreement, visit https://www.laborie.com/terms-conditions/
and then click the link adjacent to END-USER SOFTWARE LICENSE AGREEMENT.
IMPORTANT
• Ensure that Windows automatic updates is 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 85.
• Do not upgrade any Microsoft Windows 10.0 device (desktop 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 if you upgrade the operating system. For more
information, contact your Laborie support representative.
• Changes to the Windows Group Policies can prevent the NXT system from operating correctly. Before
making any Group Policy changes, contact your Laborie support representative for guidance to conrm
whether you can safely make changes.
• 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 40.
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 shipped for service.
Table 1-1 lists the standard NXT system conguration.
Table 1-1: NXT System Conguration—Standard Equipment
NXT Go Standard Equipment Add-On Features and Equipment
Computer: Laptop computer, including the Laborie Synergy application
Printer: WiFi/Direct compatibility
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): Add-
on feature
UPP Puller NXT: Add-on equipment

4 Laborie NXT Go Owner’s Manual LBL-00145 [E]
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 that can interfere with the control of a pacemaker or
implanted cardioverter-debrillator (ICD). Follow the 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 installation 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 heavy 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 area Do not place the laptop computer in the patient area. Do not
touch the patient while touching the laptop computer or printer (refer to the diagrams in Figure 5-8 and
Figure 5-9 to view the delineations for patient and non-patient areas). For the NXT Go 2100 system,
connect the printer wirelessly.