NXT Pro Owners Manual Ver C Oct 2021

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: +31.53.4803700 Fax: +31.53.4803701 laborie.com Trademarks NXT PRO 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 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 2019–2021 Laborie Document Number: LBL-00146 Revision: C Release Date: 2021-10 Laborie Medical Technologies Corp. 180 International Drive Portsmouth, NH 03801 USA

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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 ... 19 2.1

Setting Up the Equipment ... 19

2.2

Gathering Supplies and Equipment ... 21

2.3

Preparing the Urocap NXT ... 23

2.4

Preparing the Roam NXT ... 23

2.5

Preparing the UPP Puller NXT ... 23 Assembling the UPP Puller NXT ... 24 Assembling the UPP Puller NXT Stand ... 25

2.6

Setting Up Consumables and Preparing the Patient ... 25 Infusion Pump Tubing Setup ... 25 2.6.1.1 Replacing the Pump Tubing ... 26 Setting Up Catheters and Transducers ... 27 2.6.2.1 T-DOC Air-Charged Catheters ... 27 2.6.2.2 Roam NXT, PIM NXT for Fluid, and Transducer Setup ... 28 2.6.2.3 Bladder Fluid NXT Catheters ... 29 2.6.2.4 Abdominal Fluid NXT Catheters ... 29 2.6.2.5 Confirming Catheter Placement ... 30 Placing the EMG Patch Electrodes ... 31 Performing Roam NXT Patient Setup ... 32

How to Perform a Study ... 33 3.1

Starting a Study ... 33

3.2

FreeFlow Study ... 34 Starting the FreeFlow Study ... 35

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Performing a FreeFlow Study ... 35 3.2.2.1 Preview Phase ... 35 3.2.2.2 Flow Phase ... 36 3.2.2.3 FreeFlow Report ... 37 3.3

Urology Urodynamic Study ... 38 Starting a Urology Urodynamic Study ... 38 Performing a Urology Urodynamic Study ... 38 3.3.2.1 Preview and Flow Phase ... 38 3.3.2.2 Preview 2 Phase ... 38 3.3.2.3 Filling Phase ... 39 3.3.2.4 Voiding Phase ... 40 3.3.2.5 Urology Urodynamics Report ... 40

3.4

Cystometry Study ... 41 Starting the Cystometry Study ... 41 Performing the Cystometry Study ... 41 3.4.2.1 Preview phase ... 41 3.4.2.2 Cystometry phase ... 41 3.4.2.3 Review and Report Phases ... 42

3.5

Tests ... 42 Stress Test... 42 Urethral Pressure Profile ... 43 3.5.2.1 Manual Urethral Pressure Profile ... 43 3.5.2.2 Mechanical Urethral Pressure Profile ... 43

3.6

Finishing the Studies ... 44

3.7

Printing the Study Result (Optional) ... 44

3.8

Troubleshooting ... 44

Synergy Software ... 45 4.1

User Access Control... 45 Login ... 45 Creating User Accounts ... 46 4.1.2.1 User Account Setup and Password Reset ... 46 4.1.2.2 Managing User Role ... 47

4.2

Sections and Icons in the Main Window ... 49 Overview of Sections ... 49 Overview of Icons on the Title Bar ... 50 4.2.2.1 Settings ... 50

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4.2.2.2 Admin ... 51 4.3

Patient Management... 51 Patients ... 51 4.3.1.1 Adding a New Patient ... 52 4.3.1.2 Deleting Patient Data ... 52 4.3.1.3 Searching for a Required Patient ... 52 4.3.1.4 Exporting Patient Data... 53 4.3.1.5 Reassigning Study ... 53 4.3.1.6 View Patients Entered through EMR ... 54 Patient Details ... 54 4.3.2.1 Symptoms ... 55 Database Management ... 55 4.3.3.1 Archiving Patients ... 56 4.3.3.2 Importing Archived Patient Data ... 56 4.3.3.3 Restore or Permanently Delete Patient Data ... 57

4.4

Study Management ... 58 Workflows ... 58 Customizing Workflows ... 59 4.4.2.1 Workflow Step Settings Tabs ... 61 4.4.2.2 Customizing the Control Panel ... 61 4.4.2.3 Accessing Hardware Channels ... 63 Start Study Button ... 64

4.5

Workflow Steps... 64 Procedure-Preview Phase ... 65 4.5.1.1 Slide Sidebar ... 65 4.5.1.2 Consumable Traceability ... 66 Procedure-Recording Phases ... 67 Questionnaire ... 68 Reports ... 69 4.5.4.1 Editing... 69 4.5.4.2 Adding Comments... 70 4.5.4.3 Quick Results and Nomograms ... 71 4.5.4.4 Normal Values ... 71 4.5.4.5 Video Images ... 72 4.5.4.6 Sending Reports to EMR ... 74 Review ... 74

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4.6

UDS Intelligence ... 75 Quality Control (QC) ... 75 4.6.1.1 Pre-Test Quality Control ... 76 4.6.1.2 Protocol Guidance ... 76 4.6.1.3 UDS Intelligence in the Review Workflow Step ... 77 QC Score and QC Score Summary ... 77

Maintenance and Service ... 80 5.1

Cleaning and Disinfection ... 80 General Cleaning and Disinfection ... 80 5.1.1.1 Cleaning and Disinfection Reagents ... 80 5.1.1.2 Cleaning and Disinfection Frequency ... 81 5.1.1.3 Methods and Tools ... 81 Cleaning and Disinfection Preparation ... 81 5.1.2.1 Containment and Transportation ... 81 5.1.2.2 Urocap NXT Preparation ... 82 5.1.2.3 Roam NXT and PIM NXT Preparation ... 82 Cleaning ... 82 5.1.3.1 Cleaning the PC ... 82 5.1.3.2 Cleaning the Urocap NXT ... 83 5.1.3.3 Cleaning the Roam NXT and PIM NXT ... 83 5.1.3.4 Cleaning the Infusion Pump NXT ... 84 5.1.3.5 Cleaning the UPP Puller NXT ... 84 5.1.3.6 Performing Manual Cleaning ... 85 Disinfection ... 85 5.1.4.1 Performing Manual Disinfection ... 85 5.1.4.2 Disinfecting the Urocap NXT ... 86 5.1.4.3 Disinfecting the Roam NXT and PIM NXT ... 86 5.1.4.4 Disinfecting the UPP Puller NXT... 86 Completing Cleaning and Disinfection ... 87 5.1.5.1 Reconnect and Reassemble ... 87 5.1.5.2 Packaging and Storage ... 87

5.2

Preventive Maintenance ... 87 General Maintenance ... 87 5.2.1.1 Caring for the Interlocked Roam NXT & PIM NXT... 88 5.2.1.2 Caring for the Urocap NXT ... 88 Caring for the Cart and its Components ... 88

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5.2.2.1 Safely Moving the Cart ... 88 5.3

Verifying Calibration ... 90 Urocap NXT-Verifying Calibration ... 90 5.3.1.1 Checking the Absolute and Relative Weight ... 90 5.3.1.2 Checking the Absolute and Relative Weight with Water ... 91 Roam NXT-Verifying Calibration ... 91 5.3.2.1 Verifying EMG Capability ... 92 5.3.2.2 Verifying Pressure Measurement Capability ... 93 Infusion Pump NXT and Volume Transducer-Verifying Calibration ... 93 5.3.3.1 Checking the Total Weight without a Saline Bag ... 94 5.3.3.2 Checking the Total Weight with a Saline Bag ... 94

5.4

Configuration... 95 NXT PRO Electrical Isolation Diagram ... 95 Roam NXT and Wall Charger Isolation Diagram... 95 Urocap NXT and Wall Charger Isolation Diagram ... 96 UPP Puller NXT and Wall Charger Isolation Diagram ... 96

5.5

Computer Virus Protection ... 96

5.6

Disposing of Product After Use ... 97

5.7

Environmental Consideration of Waste Disposal ... 97

5.8

Backups ... 97

5.9

Troubleshooting Guide ... 97 Software Error Messages ... 101

Hardware ... 102 6.1

AIO Computer ... 102

6.2

Bluetooth Dongle NXT... 102

6.3

Remote Control NXT ... 102 Remote Control NXT LED Signals ... 103 Remote Control NXT Battery Replacement ... 104

6.4

NXT Docking Station... 104 Infusion Pump NXT ... 104

6.5

Infusion Volume Transducer ... 105

6.6

Roam NXT ... 106 PIM NXT ... 106 6.6.1.1 PIM NXT for T-DOC ... 106 6.6.1.2 PIM NXT for Fluid ... 107 Replacing the PIM NXT ... 107

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6.6.2.1 Removing the PIM NXT ... 107 6.6.2.2 Attaching New PIM NXT ... 108 6.6.2.3 Removing and Attaching the Clip ... 108 Roam NXT-Charging the Battery... 109 6.7

Urocap NXT ... 110 Urocap NXT-Charging the Battery ... 111 Urocap NXT Charging Hub ... 111 Urocap NXT Configuration with Wall Charger ... 112

6.8

NXT Pro Cart ... 112

6.9

UPP Puller NXT ... 113 UPP Puller NXT-Pairing ... 114 UPP Puller NXT-Charging the Battery ... 114

6.10

T-DOC Air-Charged Catheters ... 115

6.11

EMG Electrodes ... 116

6.12

Commode ... 116

Appendix... 117 Appendix A: System Specifications ... 117 Equipment Specifications ... 117 Classification and Applicable Directives ... 121 Appendix B: Symbols Glossary ... 122 Medical Device Label Placement ... 123 Appendix C: Electronic Compatibility (EMC) ... 124 Transmitter and Wireless Compliance Statements ... 128

List of Figures Figure 1: NXT Pro System Cart ... 12 Figure 2: Lockable Wheels ... 19 Figure 3: Roam NXT and Urocap NXT inserted in NXT Docking Station ... 20 Figure 4: Connecting the NXT Pro Cart to Supply Mains ... 20 Figure 5: Urocap NXT Setup ... 23 Figure 6: UPP Nose Locking Mechanism... 24 Figure 7: Connect the UPP Motor and Nose ... 24 Figure 8: Left Profile-Removable Parts ... 24 Figure 9: Connecting UPP Puller NXT Arm Clamp and the Pole Clamp ... 24 Figure 10: Mounting the UPP Puller NXT ... 25 Figure 11: Assembling the UPP Stand ... 25 Figure 12: Catheters Connected to PIM NXT ... 27 Figure 13: Roam NXT, PIM NXT for Fluid, and Pressure Transducer Connected ... 28

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Figure 14: Transducer Setup ... 29 Figure 15: Stopcock Lever Positions ... 29 Figure 16: Preview Phase-T-Doc Catheter Cough Deflection ... 31 Figure 17: EMG Patch Electrode Placements ... 32 Figure 18: EMG Cable Connected to PIM NXT ... 32 Figure 19: Roam Mounted on IV Pole ... 32 Figure 20: Device Manager Window ... 33 Figure 21: Find Devices Window... 34 Figure 22: FreeFlow Preview Phase ... 35 Figure 23: FreeFlow Record Phase ... 36 Figure 24: Post Voided Residual Window ... 37 Figure 25: FreeFlow Preview Report ... 37 Figure 26: Pressure Flow Filling Phase ... 39 Figure 27: Pressure Flow Voiding Phase ... 40 Figure 28: Stress Test Designation Window ... 42 Figure 29: Synergy Login Window ... 45 Figure 30: Accessing User Setup Application ... 46 Figure 31: User Setup Dialog Box ... 46 Figure 32: Resetting a Password ... 47 Figure 33: Accessing the Manage User Role Application ... 47 Figure 34: Manage User Role Dialog Box ... 48 Figure 35: Adding a New User Role... 48 Figure 36: Synergy Main Window Reading Guide ... 49 Figure 37: Patients Section ... 51 Figure 38: Default Patient Details ... 52 Figure 39: Export Document Window ... 53 Figure 40: Patient List-EMR ... 54 Figure 41 Patient Settings-EMR ... 54 Figure 42: Patient Details-Symptoms Tab ... 55 Figure 43: Database Management-Archive Patients Tab ... 56 Figure 44: Database Management-Import Patients Tab ... 57 Figure 45: Database Management-Restore/Delete Patients Tab ... 57 Figure 46: Workflow Configuration Window-Global Tab ... 59 Figure 47: Adding a Phase to a Custom Workflow ... 60 Figure 48: Workflow Configuration Window-Control Panel ... 62 Figure 49: Action Window-Adding, Changing, or Emptying Button Label ... 62 Figure 50: Edit Control Panel Button ... 63 Figure 51: Workflow Configuration with Hardware Channel Error ... 63 Figure 52: Start Study Button ... 64 Figure 53: Start Study Button ToolTip ... 64 Figure 54: Consumable Traceability-Air-Charged and Fluid Catheters ... 66 Figure 55: Manual Consumable Traceability ... 67 Figure 56: Change Channel Color ... 68 Figure 57: Default Report Template ... 69 Figure 58: Configuration Settings-Editing the Report ... 70 Figure 59: Comments Window ... 70 Figure 60: Comments and Header Options ... 71 Figure 61: Normal Values ... 72 Figure 62: Select Images/Burst for Report Window... 73

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Figure 63: Video Panel-Image Selection ... 73 Figure 64: EMR Sending Status ... 74 Figure 65: Review-FreeFlow Study ... 74 Figure 66: Pre-test QC ... 76 Figure 67: Protocol Guidance-Total Score and Phase Score ... 77 Figure 68: Protocol Guidance and QC Score in the Review Phase ... 77 Figure 69: QC Score Summary ... 78 Figure 70: Pump Rollers and Drip Tray ... 84 Figure 71: Cleaning the Area Between Motor and Nose ... 84 Figure 72: Adjusting the Worksurface ... 89 Figure 73: Moving the NXT Pro in Transport Position ... 89 Figure 74: Urocap NXT-Device Diagnostics ... 90 Figure 75: Urocap NXT-Device Diagnostics with Water ... 91 Figure 76: Wiring Diagram-EMG Calibration Verification with a Waveform Generator ... 92 Figure 77: Roam NXT-Device Diagnostics Window ... 93 Figure 78: Infusion Pump NXT-Device Diagnostics Window ... 94 Figure 79: NXT Pro Isolation Diagram ... 95 Figure 80: Roam NXT and Wall Charger Isolation Diagram ... 95 Figure 81: Urocap NXT and Wall Charger Isolation Diagram ... 96 Figure 82: UPP Puller NXT Wall Charger Isolation Diagram ... 96 Figure 83: Bluetooth Dongle NXT ... 102 Figure 84: Remote Control NXT Membrane Icons ... 102 Figure 85: NXT Docking Station ... 104 Figure 86: Status of the Pump ... 104 Figure 87: Infusion Volume Transducer Setup ... 105 Figure 88: Roam NXT and PIM NXT Controls-Front and Back ... 106 Figure 89: Roam NXT and PIM NXT for Fluid Controls... 107 Figure 90: Roam NXT with a Detached PIM NXT ... 107 Figure 91: PIM NXT (with screw and belt clip) ... 108 Figure 92: PIM NXT and Roam NXT with the Connector Cable ... 108 Figure 93: Removing the Roam NXT and PIM NXT Clips... 108 Figure 94: Urocap NXT ... 110 Figure 95: Urocap NXT Controls ... 110 Figure 96: Attaching the NXT Magnetic Pogo Pin Cable to the Urocap NXT Charging Hub . 112 Figure 97: Cable Clasps and Urocap NXT Charging Hub Binder Attachment ... 112 Figure 98: NXT Pro Cart ... 113 Figure 99: NXT Pro Cart Power Switch and Equalization/Grounding Connector Accessories ... 113 Figure 100: UPP Puller NXT Key Parts and Controls... 114 Figure 101: T-DOC NXT Air-Charged Catheter ... 115 Figure 102: T-DOC NXT Catheters-Color Coding ... 116 Figure 103: PIM NXT Color-Coded Transducer Channels ... 116 Figure 104: NXT Pro Cart Label Placement... 123

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List of Tables Table 1: NXT System Configuration-Standard Equipment ... 15 Table 2: Synergy Main Window Section Overview ... 49 Table 3: Title Bar Icon Overview ... 50 Table 4: Settings Options Overview ... 50 Table 5: Admin Options Overview... 51 Table 6: Synergy Navigation Icons ... 65 Table 7: Slide Sidebar Icon Overview ... 65 Table 8: QC Score Allotment Process ... 79 Table 9: Remote Control NXT Icons ... 103 Table 10: Remote Control NXT LED Signals ... 103 Table 11: Roam NXT LED Signals ... 109 Table 12: Urocap NXT LED Signals ... 111 Table 13: UPP Puller NXT LED Signals ... 115 Table 14: Equipment Specifications ... 121 Table 15: Classifications and Directives ... 121 Table 16: Symbols Glossary ... 123 Table 17: Guidance and Manufacture’s Declaration – Electromagnetic Emissions ... 124 Table 18: Guidance and Manufacturer’s Declaration-Electromagnetic Immunity ... 127 Table 19: Separation Distances between Portable and Mobile RF ... 128

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Introduction

Introduction The Laborie NXT system (Figure 1) 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 batterypowered 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 NXT is a family of 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 diagnostic 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 the following: • •

Urinary incontinence and retention Bladder outlet obstructions

•

Other complex voiding/urine storage problems

This device is indicated for use under the direction of licensed and trained healthcare professionals.

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Introduction

1.3 Equipment Intended Use Refer to the following descriptions for a breakdown of intended use per module. Standard Equipment • • • • • • • •

NXT docking station with pump: Wired device that 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 that measures volume and flow rate of urine. Patient Interface Module NXT (PIM NXT): Device that is powered by the Roam NXT to measure pressure and electromyography. Roam NXT: Wired or wireless and battery-powered detachable module that connects to the PIM NXT. PC: Computer that controls the system activity as well as displays and stores data. Synergy: Application software that runs on the PC to control the system activity as well as displays and stores 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.

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. UPP Puller NXT: Wired or wireless and battery-powered device that 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

1.5 About this Manual The NXT Owner’s Manual is intended to provide important information and instruction regarding the use and care 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 in the table that follows highlight helpful tips and important cautions that will aide in guiding you 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

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 http://www.laborie.com/terms-and-conditions/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 96. 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 confirm whether you can safely make changes. To install any updates for the Synergy software, contact your Laborie support representative for guidance.

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Introduction •

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 Icons on the Title Bar on page 50.

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 lists the standard NXT system configuration. NXT Pro

Standard Equipment Cart: Plenary PC: All-In-One (AIO) computer (POC-W243) Printer: Inkjet Pump Hub: Docking station with pump Uroflowmeter: Urocap NXT (1–2) UDS: Roam NXT (1–2) with PIM NXT for T-DOC or Fluid Electronic Medical Records (EMR): Add-on feature Video: 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 the following: o o

The presence of a bladder infection Strictures in the urethra

Laborie is not responsible for loss of patient files or test data. Laborie recommends that you back up patient data on a regular basis. To prevent any risk of damage to the cart: o o o

Ensure that the monitor is free of any obstacles. Do not hang anything on, or suspend extra weight from, the monitors. Do not exceed the maximum weight indications: 10 kg for the printer shelf, 10 kg for the work surface, and 1 kg for the mouse tray.

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Introduction

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-defibrillator (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 sufficient 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. Use caution when adjusting the PC and monitor from its lowest or highest position; ensure that all extremities are clear of moving parts. If the PC or monitor is removed from the mount, the unit can 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. 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 defibrillation-proof.

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Introduction

Improper processing of reusable items prior to initial use or reuse can result in crossinfection 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 (ME) equipment is restricted to one patient at a time. Do not use the NXT system in the presence of a magnetic resonance imaging (MRI) 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. All devices must be powered by the Line Isolation Transformer or the wall charger specified in the Instructions for Use. Do not connect any additional multiple-socket outlets or extension cords to the NXT system or any of its components. 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 one another. 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 multiplesocket outlets. Connecting any device not approved by Laborie to the 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. Avoid use of this equipment adjacent to or stacked with other equipment, as it could result in improper operation. If such use is necessary, observe this equipment and the other equipment to verify that they are operating normally. 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 ME systems, encompassed in the IEC/EN 60601 series.

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Introduction

Do not make changes or modifications to the PIM NXT for T-DOC 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 those 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 aforementioned requirements and warnings; if in doubt, consult your local Laborie representative or the Technical Service department.

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Quick Start

Quick Start To prepare for a typical study, perform the following steps: Setting Up the Equipment Gathering Supplies and Equipment Preparing the Urocap NXT 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 Cart, 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 cart, Roam NXT, PIM NXT, Urocap NXT, Infusion Pump NXT, Remote NXT, or UPP Puller NXT, refer to the section Hardware on page 102. IMPORTANT: Lock all wheels of the NXT Cart for equipment setup and anytime the NXT system is not actively being transported. To prevent injury to the patient, ensure that all wheels are locked during testing procedures. To lock the wheels, press down on the lever with the bottom of your foot as shown in Figure 2. To unlock, pull up the lever up from underneath using the top of your toes.

Figure 2: Lockable Wheels

If you’re utilizing Video function for a urodynamic study, prepare the connecting device. Synergy supports HDMI and DVI connections provided by the AIO PC. The 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 ME systems, encompassed in the IEC/EN 60601 series. If you’re utilizing the UPP Puller NXT, assemble and mount the UPP Puller NXT according to the instructions provided in the section Preparing the UPP Puller NXT on page 23. For information on charging the UPP Puller NXT, refer to the section UPP Puller NXT-Charging the Battery on page 114. Connect the PIM NXT to the Roam NXT. For instructions on how to connect these devices, refer to the section Replacing the PIM NXT on page 107. 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 Figure 3.

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Quick Start

NXT Docking Station

Urocap NXT Charging Hub

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 Figure 4, and then plug the NXT cart’s power cable to an external power source. After the NXT system is connected, press the ON button, as indicated in Figure 4.

Figure 4: Connecting the NXT Pro Cart to Supply Mains

For information on charging the Roam NXT, refer to the section Roam NXT-Charging the Battery on page 109. For information on charging the Urocap NXT, refer to the section Urocap NXT-Charging the Battery on page 111. Refer to the section Maintenance and Service on page 80 for information on cleaning and maintaining the modules, including all system check intervals and procedures for verifying the integrity of the system.

Laborie NXT Pro Owner’s Manual

LBL-00146 [C], MAN2010

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