LABORIE NXT Go User manual

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Type: LBL
LBL-00145[A]Document No.:
NXT Go Owner's Manual MAN2030Title:
DAVID.BAK David BakOwner:
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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: [phone]
LABORIE International
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 CANADA L4V 1X1
[phone]
www.laborie.com
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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
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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 Urology Urodynamic Study ....................................................... 35
Performing a Urology Urodynamic Study ................................................... 35
3.3.2.1 Preview and Flow Phase....................................................................... 35
3.3.2.2 Preview 2 Phase .................................................................................35
3.3.2.3 Filling Phase ....................................................................................... 36
3.3.2.4 Voiding Phase..................................................................................... 37
3.3.2.5 Urology Urodynamics Report ................................................................ 37
3.4 Cystometry Study ........................................................................................ 38
Starting the Cystometry Study ................................................................ 38
Performing the Cystometry Study ............................................................ 38
3.4.2.1 Preview phase ....................................................................................38
3.4.2.2 Cystometry phase............................................................................... 38
3.4.2.3 Review and Report Phases ...................................................................39
3.5 Tests .......................................................................................................... 39
Stress Test............................................................................................ 39
Urethral Pressure Profile .........................................................................40
3.5.2.1 Manual Urethral Pressure Profile ...........................................................40
3.5.2.2 Mechanical Urethral Pressure Profile ...................................................... 40
3.6 Finishing the Studies .................................................................................... 41
3.7 Printing the Study Result (Optional) ...............................................................41
3.8 Troubleshooting ........................................................................................... 41
Synergy Software .............................................................................................. 42
4.1 User Access Control......................................................................................42
Login....................................................................................................42
Creating User Accounts...........................................................................43
4.1.2.1 User Account Setup and Password Reset................................................ 43
4.1.2.2 Managing User Role ............................................................................45
4.2 Sections and Icons in the Main Window ..........................................................46
Overview of Sections ..............................................................................47
Overview of Icons in the Title Bar ............................................................ 47
4.2.2.1 Settings............................................................................................. 47
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4.2.2.2 Admin ...............................................................................................48
4.3 Patient Management..................................................................................... 48
Patients ................................................................................................48
4.3.1.1 Adding a New Patient .......................................................................... 49
4.3.1.2 Deleting Patient Data .......................................................................... 49
4.3.1.3 Searching for a Required Patient........................................................... 50
4.3.1.4 Exporting Patient Data......................................................................... 50
4.3.1.5 Reassigning Study .............................................................................. 50
4.3.1.6 View Patients Entered through EMR....................................................... 51
Patient Details ....................................................................................... 52
4.3.2.1 Symptoms ......................................................................................... 52
Database Management ...........................................................................53
4.3.3.1 Archiving Patients ............................................................................... 53
4.3.3.2 Importing Archived Patient Data ........................................................... 53
4.3.3.3 Restore or Permanently Delete Patient Data ...........................................54
4.4 Study Management ...................................................................................... 55
Workflows.............................................................................................55
Customizing Workflows...........................................................................56
4.4.2.1 Workflow Step Settings Tabs ................................................................ 57
4.4.2.2 Customizing Control Panel ................................................................... 58
4.4.2.3 Accessing Hardware Channels ..............................................................60
Start Study Button ................................................................................. 61
4.5 Workflow Steps............................................................................................ 61
Procedure –Preview Phase ..................................................................... 62
4.5.1.1 Slide Sidebar...................................................................................... 62
4.5.1.2 Consumable Traceability ...................................................................... 63
Procedure –Recording Phases ................................................................. 64
Questionnaire........................................................................................ 65
Reports ................................................................................................ 65
4.5.4.1 Editing...............................................................................................65
4.5.4.2 Adding Comments............................................................................... 66
4.5.4.3 Quick Results and Nomograms .............................................................67
4.5.4.4 Normal Values ....................................................................................68
4.5.4.5 Sending Reports to EMR ...................................................................... 68
Review ................................................................................................. 69
4.6 UDS Intelligence ..........................................................................................71
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Quality Control (QC)...............................................................................71
4.6.1.1 Pre-test Quality Control .......................................................................71
4.6.1.2 Protocol Guidance ............................................................................... 72
4.6.1.3 UDS Intelligence in the Review Workflow Step........................................ 72
QC Score and QC Score Summary............................................................73
Maintenance and Service ....................................................................................75
5.1 Cleaning and Disinfection .............................................................................. 75
General Cleaning and Disinfection ............................................................75
5.1.1.1 Cleaning and Disinfection Reagents ....................................................... 75
5.1.1.2 Cleaning and Disinfection Frequency .....................................................75
5.1.1.3 Methods and Tools ..............................................................................76
Cleaning and Disinfection Preparation....................................................... 76
5.1.2.1 Containment and Transportation........................................................... 76
5.1.2.2 Urocap NXT Preparation....................................................................... 76
5.1.2.3 Roam NXT and PIM NXT Preparation ..................................................... 77
Cleaning ...............................................................................................77
5.1.3.1 Cleaning the Urocap NXT ..................................................................... 77
5.1.3.2 Cleaning the Roam NXT and PIM NXT .................................................... 78
5.1.3.3 Cleaning the NXT Go Pump Hub and the NXT Go Infusion Hook ................79
5.1.3.4 Cleaning the UPP Puller NXT................................................................. 79
5.1.3.5 Performing Manual Cleaning................................................................. 79
Disinfection ...........................................................................................80
5.1.4.1 Performing Manual Disinfection............................................................. 80
5.1.4.2 Disinfecting the Urocap NXT ................................................................. 80
5.1.4.3 Disinfecting the Roam NXT and PIM NXT................................................ 81
5.1.4.4 Disinfecting the UPP Puller NXT............................................................. 81
Completing Cleaning and Disinfection ....................................................... 81
5.1.5.1 Reconnect and Reassemble ..................................................................81
5.1.5.2 Packaging and Storage ........................................................................82
5.2 Preventive Maintenance ................................................................................ 82
General Maintenance .............................................................................. 82
5.2.1.1 Caring for the Interlocked Roam NXT & PIM NXT.....................................82
5.2.1.2 Caring for the Urocap NXT ................................................................... 83
5.2.1.3 Caring for the UPP Puller NXT ...............................................................83
5.3 Verifying Calibration ..................................................................................... 84
Urocap NXT –Verifying Calibration........................................................... 84
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5.3.1.1 Checking the Absolute and Relative Weight ............................................ 84
5.3.1.2 Checking the Relative Weight with Water ............................................... 85
Roam NXT –Verifying Calibration ............................................................ 85
5.3.2.1 Verifying EMG Capability...................................................................... 86
5.3.2.2 Verifying Pressure Measurement Capability ............................................87
NXT Go Pump Hub and Volume Transducer –Verifying Calibration ...............87
5.3.3.1 Checking the Total Weight without a Saline Bag .....................................88
5.3.3.2 Checking the Total Weight with a Saline Bag .......................................... 88
5.4 Configuration............................................................................................... 89
NXT Go Electrical Isolation Diagram ......................................................... 89
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
5.5 Computer Virus Protection ............................................................................ 90
5.6 Disposing of Product After Use....................................................................... 91
5.7 Environmental Consideration of Waste Disposal ...............................................91
5.8 Backups...................................................................................................... 91
5.9 Troubleshooting Guide ..................................................................................91
Software Error Messages ........................................................................ 95
Hardware .......................................................................................................... 96
6.1 Laptop Personal Computer ............................................................................ 96
6.2 Bluetooth Dongle NXT...................................................................................96
6.3 Remote Control NXT ..................................................................................... 96
Remote Control NXT LED Signals .............................................................97
Remote Control NXT Battery Replacement ................................................ 98
6.4 NXT Go Pump Hub ....................................................................................... 98
Infusion Pump NXT ................................................................................98
6.4.1.1 NXT Go Pump Hub Indicator Lights ....................................................... 99
6.5 NXT Go Carrying Case ..................................................................................99
6.6 Infusion Volume Transducer ........................................................................ 100
6.7 Roam NXT................................................................................................. 100
PIM NXT ............................................................................................. 100
6.7.1.1 PIM NXT for T-DOC ........................................................................... 101
6.7.1.2 PIM NXT for Fluid .............................................................................. 101
Replacing the PIM NXT ......................................................................... 102
6.7.2.1 Removing the PIM NXT ...................................................................... 102
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6.7.2.2 Attaching New PIM NXT ..................................................................... 102
6.7.2.3 Removing and Attaching the Clip ........................................................ 103
Roam NXT—Charging the Battery and Pairing .......................................... 103
6.8 Urocap NXT ............................................................................................... 105
Urocap NXT—Charging the Battery and Pairing ........................................ 106
6.9 UPP Puller NXT .......................................................................................... 107
UPP Puller NXT –Pairing ....................................................................... 107
UPP Puller NXT –Charging the Battery ................................................... 107
6.10 T-DOC Air-Charged Catheters ...................................................................... 108
6.11 EMG Electrodes.......................................................................................... 109
6.12 Commode ................................................................................................. 109
Appendix......................................................................................................... 110
Appendix A: System Specifications ........................................................................ 110
Equipment Specifications .................................................................................. 110
Classification 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 ................................................ 121
List of Figures
Figure 1: NXT Go .....................................................................................................12
Figure 2: Urocap NXT Setup ...................................................................................... 21
Figure 3: UPP Nose Locking Mechanism.......................................................................22
Figure 4: Connect the UPP Motor and Nose.................................................................. 22
Figure 5: Left Profile –Removable Parts......................................................................22
Figure 6:Connect UPP Puller NXT Arm Clamp and the Pole Clamp ...................................23
Figure 7: Mounting the UPP Puller NXT........................................................................23
Figure 8: Assembling the UPP Stand ...........................................................................23
Figure 9: Catheters Connected to PIM NXT ..................................................................26
Figure 10: Pressure Flow Preview Phase...................................................................... 26
Figure 11: Roam NXT, PIM NXT for Fluid, and Pressure Transducer Connected .................27
Figure 12: Transducer Setup ..................................................................................... 27
Figure 13: Stopcock Lever Positions ........................................................................... 27
Figure 14: EMG Patch Electrode Placements ................................................................ 29
Figure 15: EMG Cable Connected to PIM NXT ...............................................................29
Figure 16: Roam Mounted on IV Pole .......................................................................... 29
Figure 17: Device Manager Window ............................................................................30
Figure 18: Find Devices Window.................................................................................31
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Figure 19: FreeFlow Preview Phase............................................................................. 32
Figure 20: FreeFlow Record Phase .............................................................................. 33
Figure 21: Post Voided Residual Window ..................................................................... 34
Figure 22: FreeFlow Preview Report............................................................................ 34
Figure 23: Pressure Flow Filling Phase ........................................................................ 36
Figure 24: Pressure Flow Voiding Phase ...................................................................... 37
Figure 25: Stress Test Designation Window .................................................................39
Figure 26: Synergy Login Page ..................................................................................42
Figure 27: Accessing User Setup Application................................................................ 43
Figure 28: User Setup Window................................................................................... 44
Figure 29: Password Reset ........................................................................................44
Figure 30: Accessing the Manage User Role Application................................................. 45
Figure 31: Manage User Role Window ......................................................................... 45
Figure 32: Adding New User Role ...............................................................................46
Figure 33: Synergy Main Window Reading Guide .......................................................... 46
Figure 34: Patients Section........................................................................................ 49
Figure 35: Default Patient Details...............................................................................49
Figure 36: Export Document Window ..........................................................................50
Figure 37: Patient List - EMR ..................................................................................... 51
Figure 38 Patient Settings –EMR ............................................................................... 51
Figure 39: Patient Details –Symptoms Tab .................................................................52
Figure 40: Database Management –Archive Patients.................................................... 53
Figure 41: Database Management –Import Patients..................................................... 54
Figure 42: Database Management –Deleted Patients ................................................... 54
Figure 43: Workflow Configuration Window –Channels Tab ........................................... 56
Figure 44: Adding a Phase to a Custom Workflow.........................................................57
Figure 45: Workflow Configuration Window - Control Panel............................................ 59
Figure 46: Action Window –Adding, Changing or Emptying Button Label ........................59
Figure 47: Edit Control Panel Button ........................................................................... 60
Figure 48: Workflow Configuration with Hardware Channel Error .................................... 60
Figure 49: Start Study Button.................................................................................... 61
Figure 50: Start Study Button Tool Tip........................................................................ 61
Figure 51: Consumable Traceability –Air-Charged and Fluid Catheters ............................ 63
Figure 52: Manual Consumable Traceability ................................................................. 64
Figure 53: Change Channel Color ...............................................................................64
Figure 54: Configuration Settings –Editing the Report ..................................................66
Figure 55: Comments Window ...................................................................................66
Figure 56: Comments and Header Title Drop Down Menus.............................................67
Figure 57: Normal Values ..........................................................................................68
Figure 58: EMR Sending Status ..................................................................................69
Figure 59: Review –FreeFlow Study ........................................................................... 69
Figure 60: Pre-test QC ..............................................................................................71
Figure 61: Protocol Guidance - Total Score and Phase Score .......................................... 72
Figure 62: Protocol Guidance and QC Score in the Review Phase .................................... 72
Figure 63: QC Score Summary................................................................................... 73
Figure 64: Pump Rollers............................................................................................79
Figure 65: Cleaning the Area Between Motor and Nose .................................................79
Figure 66: Urocap NXT –Device Diagnostics................................................................84
Figure 67: Urocap NXT –Device Diagnostics with Water................................................ 85
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Figure 68: Wiring Diagram –EMG Calibration Verification with a Waveform Generator ...... 86
Figure 69: Roam NXT –Device Diagnostics ................................................................. 87
Figure 70: Infusion Pump NXT Diagnostics Window ......................................................88
Figure 71: NXT Go Isolation Diagram.......................................................................... 89
Figure 72: Roam NXT and Wall Charger Isolation Diagram ............................................ 89
Figure 73: Urocap NXT and Wall Charger Isolation Diagram........................................... 90
Figure 74: UPP Puller NXT and Wall Charger Isolation Diagram ...................................... 90
Figure 75: Bluetooth Dongle NXT ...............................................................................96
Figure 76: Remote Control NXT Membrane Icons ......................................................... 96
Figure 77: NXT Go Pump Hub .................................................................................... 98
Figure 78: Status of the Pump ...................................................................................98
Figure 79: NXT Go Carrying Case ...............................................................................99
Figure 80: Infusion Volume Transducer on IV Pole...................................................... 100
Figure 81: Roam NXT and PIM NXT Controls - Front and Back...................................... 101
Figure 82: Roam NXT and PIM NXT for Fluid Controls.................................................. 102
Figure 83: Roam NXT with a Detached PIM NXT ......................................................... 102
Figure 84: PIM NXT (with screw and belt clip) ............................................................ 103
Figure 85: PIM NXT and Roam NXT with the Connector Cable ...................................... 103
Figure 86: Removing the Roam NXT and PIM NXT Clips............................................... 103
Figure 87: Urocap NXT............................................................................................ 105
Figure 88: Urocap NXT Controls ............................................................................... 105
Figure 89: UPP Puller NXT Key Parts and Controls. ..................................................... 107
Figure 90: T-DOC NXT Air-Charged Catheter ............................................................. 108
Figure 91: T-DOC NXT Catheters –Color Coding ........................................................ 109
Figure 92: PIM NXT Color Coded Transducer Channels ................................................ 109
Figure 93: NXT Go System Label Placement .............................................................. 116
List of Tables
Table 1: NXT System Configuration –Standard Equipment............................................ 15
Table 2: Synergy Main Window Section Overview.........................................................47
Table 3: Title Bar Icon Overview ................................................................................ 47
Table 4: Settings Options Overview ............................................................................ 48
Table 5: Admin Options Overview............................................................................... 48
Table 6: Synergy Navigation Icons .............................................................................62
Table 7: Slide Sidebar Icon Overview.......................................................................... 62
Table 8: QC Score Allotment Process ..........................................................................74
Table 9: Remote Control NXT Icons ............................................................................97
Table 10: Remote Control NXT LED Signals .................................................................97
Table 11: NXT Go Pump Hub Indicator Signals ............................................................. 99
Table 12: Roam NXT LED Signals ............................................................................. 104
Table 13: Urocap NXT LED Signals ........................................................................... 106
Table 14: UPP Puller NXT LED Signals ....................................................................... 108
Table 15: Equipment Specifications .......................................................................... 113
Table 16: Classifications and Directives..................................................................... 114
Table 17: Symbols Glossary .................................................................................... 116
Table 18: Guidance and Manufacture’s Declaration – Electromagnetic Emissions ............ 117
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Table 19: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ........... 120
Table 20: Separation Distances between Portable and Mobile RF .................................. 121
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Introduction
NXT Go Owner’s Manual, LBL-00145, MAN2030 12
Introduction
The LABORIE NXT Go system is a partially 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 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 Go
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.
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1.3 Equipment Intended Use
Refer to the descriptions below for a breakdown of intended use per module.
Standard Equipment
NXT Go Pump Hub with NXT Go Infusion Hook: Wired device which uses a peristaltic
infusion pump to fill a patient’s bladder with saline and/or contrast.
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.
Laptop 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
Printer: Allows hardcopy reports to be created.
UPP Puller NXT: Wired or wireless and battery powered device which controls and
measures speed and distance during a Urethral Pressure Profile.
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.
SmartSense Barcode reader: Allows consumable device information to be recorded
by the system.
1.4 Contraindications
None known.
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Introduction
NXT Go Owner’s Manual, LBL-00145, MAN2030 14
1.5 About this Manual
The NXT Go Owner’s Manual is intended to provide important information and instruction
regarding the use of the NXT Go 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 90.
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
icon . Refer to the Overview of Icons in the Title Bar section on page 47 for
instructions on accessing the System Settings.
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Introduction
NXT Go Owner’s Manual, LBL-00145, MAN2030 15
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 Go
Standard Equipment
Computer: Laptop PC
Printer: Inkjet
Pump Hub: NXT Go Pump Hub with NXT Go Infusion Hook
Uroflowmeter: Urocap NXT (1)
UDS: Roam NXT (1) with PIM NXT for T-DOC or Fluid
Electronic Medical Records (EMR): Add-on feature
UPP Puller NXT: Add-on Equipment
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
LABORIE is not responsible for loss of patient files or test data. LABORIE recommends
that the user backup patient data on a regular basis.
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.
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Introduction
NXT Go Owner’s Manual, LBL-00145, MAN2030 16
Warnings:
The NXT Urodynamic System contains magnets which can interfere with control of a
pacemaker or ICD (Implanted cardioverter-defibrillator). 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 sufficient distance from any implanted device.
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.
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 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.
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.
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Introduction
NXT Go Owner’s Manual, LBL-00145, MAN2030 17
To avoid risk of electric shock, do not touch the pogo pins located inside the Urocap NXT
Charging Hub or the 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.
Electromagnetic Interference in the form of electrostatic discharge or radiated emissions
can cause the NXT System components to temporarily disconnect. Components may
require a power cycle before operation can resume after exposure to these
electromagnetic interferences.
Only connect devices specified and approved by LABORIE to the NXT System. Connecting
any device not approved by LABORIE to the Medical Electrical (ME) system alters the
functional integrity of the product creating a safety risk.
Do not connect any multiple socket-outlets or extension cords to the NXT GO System or
any of its components
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.
Do not make changes or modifications to the PIM NXT for TDOC and its
radiators. Changes to intentional or unintentional radiators not expressly approved by the
party responsible for compliance could void the user's authority to operate the equipment.
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.
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Quick Start
NXT Go Owner’s Manual, LBL-00145, MAN2030 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 NXT Go Pump Hub
Preparing the Roam NXT
Preparing the UPP Puller NXT
Setting Up Consumables and Preparing the Patient
2.1 Setting Up the Equipment
Unpack the NXT Go Pump Hub, Roam NXT, Patient Interface Module NXT (PIM
NXT), and Urocap NXT from their shipping boxes. Unpack the UPP Puller NXT. For
information on the NXT Go Pump Hub, Roam NXT, PIM NXT, Urocap NXT, NXT
Infusion Hook, Remote NXT, or UPP Puller NXT refer to the Hardware section on
page 96.
IMPORTANT: Lock all wheels of the pole or table used for equipment setup. Ensure all
wheels are locked during testing procedures to prevent injury to the patient.
If utilizing the UPP Puller NXT assemble and mount the UPP Puller NXT according
to the instructions provided in the Preparing the UPP Puller NXT section on page
22.For information on charging the UPP Puller NXT refer to the UPP Puller NXT –
Charging the Battery section on page 107.
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 102.
Connect the Roam NXT and the Urocap NXT to the PC using the NXT Magnetic
Pogo Pin Cable and the USB to Binder Cable Adapter to pair the devices. Once
paired unplug the devices for wireless use.
Hang the NXT Go Infusion Hook on an IV Pole. Connect the NXT Go Infusion Hook
to the NXT Go Pump Hub. Connect the NXT Go Power Cord to the NXT Go Pump
Hub and the NXT Go Power Supply, then connect to supply mains. Use the NXT
Go USB Cable to connect the NXT Go Pump Hub to the laptop PC. Refer to Figure
77 for a visual of inputs on the NXT Go Pump Hub.
For information on the NXT Go Pump Hub, refer to the NXT Go Pump Hub section on
page 98. For information on charging the Roam NXT, refer to the Roam NXT—
Charging the Battery section on page 103.For information on charging the Urocap
NXT, refer to the Urocap NXT—Charging the Battery section on page 106.
Refer to the Maintenance and Service section on page 75 for information on cleaning
and maintaining the modules, including all system check intervals and procedures for
verifying the integrity of the system.
Turn on the laptop PC by pressing the power button . Double click the
Synergy Icon to launch the Synergy Login Page.
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Quick Start
NXT Go Owner’s Manual, LBL-00145, MAN2030 19
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 33: Synergy Main Window Reading Guide.Ensure to update
access information from initial system install. Refer to the User Access Control
section on page 42 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:
NXT Go Pump Hub (DCX2101)
NXT Go Infusion Hook (MSM1185)
Urocap NXT (UCX2001)
Remote Control NXT (RCX2001)
Roam NXT (ROX2001) & PIM NXT for T-
DOC (PIX2211)
Roam NXT (ROX2001) & PIM NXT for Fluid
(PIX2231)
Urocap NXT Stand with Funnel (MSM1172 &
CHA1000)
UPP Puller NXT (UPX2001) and UPP Stand
(UPP1006)
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