LABORIE NXT Go Owner's Manual
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LABORIE NXT Go Owner's Manual

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LBL-00145[A]
Title:
NXT Go Owner's Manual MAN2030
Owner:
DAVID.BAK David Bak
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DAVID.BAK
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Expiration Date:
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21-Jan-2021
1/21/2021
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  • Page 1 DEFAULT 1/21/2021 Document Detail Type: Document No.: LBL-00145[A] Title: NXT Go Owner's Manual MAN2030 Owner: DAVID.BAK David Bak Status: DRAFT Effective Date: Expiration Date: Revision Notes Document Build Access Activity Accessed By Accessed Date Check In DAVID.BAK 21-Jan-2021 Note:...
  • Page 2 NXT Go Owner’s Manual Version A NXT Go Owner’s Manual, LBL-00145 [A], MAN2030...
  • Page 3 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.

  • Page 4: Table Of Contents

    Setting Up the Equipment ................18 Gathering Supplies and Equipment ..............19 Preparing the Urocap NXT ................21 Preparing the NXT Go Pump Hub ..............22 Preparing the Roam NXT ................22 Preparing the UPP Puller NXT (Optional) ............22 Assembling the UPP Puller NXT ..............
  • Page 5 4.1.2.1 User Account Setup and Password Reset ..........43 4.1.2.2 Managing User Role ................45 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 NXT Go Owner’s Manual, LBL-00145, MAN2030...
  • Page 6 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 UDS Intelligence ..................71 NXT Go Owner’s Manual, LBL-00145, MAN2030...
  • Page 7 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 ..............
  • Page 8 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 Configuration....................
  • Page 9 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 –...
  • Page 10 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 NXT Go Owner’s Manual, LBL-00145, MAN2030...
  • Page 11 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 ...............
  • Page 12 Table 19: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ... 120 Table 20: Separation Distances between Portable and Mobile RF ........121 NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 13: Introduction

    Introduction 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.

  • Page 14: 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. ...

  • Page 15: About This Manual

    Introduction 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.

  • Page 16: Standard Equipment And Optional Accessories

    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 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.
  • Page 17 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.
  • Page 18 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.

  • Page 19: Quick Start

    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.

  • Page 20: Gathering Supplies And Equipment

    Roam NXT (ROX2001) & PIM NXT for Fluid Roam NXT (ROX2001) & PIM NXT for T- (PIX2231) DOC (PIX2211) Urocap NXT Stand with Funnel (MSM1172 & UPP Puller NXT (UPX2001) and UPP Stand CHA1000) (UPP1006) NXT Go Owner’s Manual, LBL-00145, MAN2030...
  • Page 21 PIM NXT for Fluid to Medex Transducer (BRA230) Bracket for 3 Medex Pressure Cables (CAB1093) Transducers (BRA405) Roam NXT to PIM NXT Connector Cable Infusion Pump Tubing for Laborie NXT (CAB2111) Systems (TUBPTNXT or TUB500-RFID) NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 22: Preparing The Urocap Nxt

    NXT Go USB Cable (CAB1056) NXT Go Power Cord (POW006) Roam NXT Mounting Bracket (MSM1153) NXT Go Power Supply (POW1043) NXT Go IV Pole Bracket (MSM1062) NXT GO Carrying Case (PKG1091) 2.3 Preparing the Urocap NXT To prepare the Urocap NXT for use: Ensure that the Urocap NXT is charged and ready to use.

  • Page 23: Preparing The Nxt Go Pump Hub

    Place the device on a stable surface where it will not be a tripping hazard. Connect the NXT Go Infusion Hook to the NXT Go Pump Hub. Connect the NXT Go Pump Hub to supply mains using the NXT Go power cord and the NXT Go power supply.

  • Page 24: Assembling The Upp Puller Nxt Stand

    Connect the Pole Assembly to the H-Base Assembly using the provided Washer M8, Split Washer M8, and Screw M8. Use the 6mm HEX L-Key to secure the screw (Figure 8). Figure 8: Assembling the UPP Stand NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 25: Setting Up Consumables And Preparing The Patient

    62. Infusion Pump Tubing Setup LABORIE Infusion Pump Tubing is intended for single use only. Do not re-use, reprocess, or resterilize pump tubing. Use of the Infusion Pump Tubing outside of its intended use may affect pump accuracy. Do not run the pump at a speed exceeding the limitation of the catheter.

  • Page 26: Replacing The Pump Tubing

    Setup the new pump tubing as described in the Infusion Pump Tubing Setup section above. Setting Up Catheters and Transducers The NXT system is compatible with LABORIE T-DOC Air Charged Catheters and Fluid NXT Catheters equipped with SmartSense tags. Refer to the Gathering Supplies and Equipment...

  • Page 27: Roam Nxt, Pim Nxt For Fluid, And Transducer Setup

    Roam NXT, PIM NXT for Fluid, and Transducer Setup Ensure the PIM NXT for Fluid is connected to the Roam NXT. A solid green light bar on the Roam NXT indicates that the device is ready for use. For additional NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 28: Figure 11: Roam Nxt, Pim Nxt For Fluid, And Pressure Transducer Connected

    NOTE: Always secure the cartridge stopper cap whenever changing the stopcock lever’s position. Off to Syringe Off to Pressure Off to Cartridge Off to all Luers Open to all Luers Measurement Tubing Figure 13: Stopcock Lever Positions NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 29: Bladder Fluid Nxt Catheters

    15 cm, above the prostate, past any stool that may be present, along the anterior wall of the rectum. Open the stopcock to the syringe and the catheter and infuse approximately 1- 1.5cc of solution. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 30: Placing The Emg Patch Electrodes

    For ease of movement and accessibility during Urodynamic procedures, the Roam NXT may be mounted on an IV Pole (Figure 16) or on the procedure chair. When mounting the Roam NXT, always ensure the clamping mount is securely fastened. Figure 16: Roam Mounted on IV Pole NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 31: How To Perform A Study

    In the Device Manager window identify the Bluetooth Dongle NXT, Urocap NXT, Roam NXT, Pump NXT, and UPP Puller NXT and verify each device is properly connected as indicated by a green checkmark. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 32: Figure 18: Find Devices Window

    Device Manager and that all hardware channels are set. For more information on troubleshooting study start and workflow configuration, refer to the Study Management section on page 55. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 33: Freeflow Study

    A questionnaire window will appear alongside the study window. Press OK or Close to exit the questionnaire window. Refer to the Questionnaire section on page for an overview of the questionnaires available. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 34: Flow Phase

    If the beaker is filled to capacity utilize Calculated PVR or Input PVR options. c. Input PVR selection allows the operator to input the PVR measurement calculated by a separate measurement device. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 35: Freeflow Report

    Finish the Study. NOTE: Reference the Finishing the Studies section on page and the Printing the Study Result (Optional) section on page for instructions on completing the study. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 36: Urology Urodynamic Study

    Starting a Study section on page The study requires the use of the Urocap NXT, Roam NXT, NXT Go Pump Hub, and Bluetooth Dongle NXT. Ensure all modules are connected in the Synergy Software. Ensure that the Urocap NXT and Roam NXT are fully charged. The Synergy Software will recognize the PIM NXT and the Roam NXT as one device under the title Roam NXT.

  • Page 37: Filling Phase

    When the patient starts to feel discomfort or fullness, stop the Infusion Pump by clicking the Pump Off button in the Synergy software. Click the Start Voiding Phase button to move to the next phase. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 38: Voiding Phase

    How to Perform a Study Caution: Infusion can be stopped at ALL TIMES by pressing the grey pump stop button on the NXT Go Pump Hub, by opening the pump door, or by disconnecting the filling tube from the catheter or the water bag.

  • Page 39: Cystometry Study

    Pump Off button in the Synergy software. Caution: Infusion can be stopped at ALL TIMES by pressing the grey pump stop button on the NXT Go Pump Hub, by opening the pump door, or by disconnecting the filling tube from the catheter or the water bag.

  • Page 40: Review And Report Phases

    (Figure 25). Changing the designation will add or remove the events marked in the stress test. Figure 25: Stress Test Designation Window Repeat the test after every 150ml to 200ml infused until stress incontinence is documented or ruled out. Finish the selected study. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 41: Urethral Pressure Profile

    Select the Rest Profile (Off) toggle button to mark the end of the profile. Click the Puller Return button to return the UPP Puller NXT to the start position. Manually reinsert the catheter and position just proximal to the bladder neck to complete a Stress Profile. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 42: Finishing The Studies

    Print icon. 3.8 Troubleshooting  For FAQs and troubleshooting tips, refer to the Troubleshooting Guide section on page 91. If problems cannot be resolved, contact the LABORIE Service team at 1- 800-333-1039 or email service@laborie.com. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 43: Synergy Software

    To login to Synergy, follow the steps below. Double-click the Synergy shortcut icon on the desktop or launch the Synergy application from the LABORIE Dashboard. The Synergy Login Page will be displayed (Figure 26). Upon first login ensure to accept the End User License Agreement.

  • Page 44: Creating User Accounts

    46. IMPORTANT: Do not leave the computer unattended once login is completed. LABORIE recommends that the user manually lock the computer before leaving the computer workstation. Creating User Accounts Synergy facilitates four basic account structures: Local Admin, Local User, Domain Admin, and Domain User.

  • Page 45: Figure 28: User Setup Window

    Under the Update User Info tab, enter the new password and press OK (Figure 29). Figure 29: Password Reset NOTE: Local and Domain Users may reset their own passwords ONLY. Local or Domain Admin access is required to reset password information for other users. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 46: Managing User Role

    Create a new role by entering a new title in the Role category and selecting an Authentication Type from the dropdown menu (Figure 32). Select all the functions desired for access by the new user role, and press Save. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 47: Sections And Icons In The Main Window

    Save. 4.2 Sections and Icons in the Main Window This section overviews the various features accessible from the Main Window. Title Bar Patients New Studies Patient Details Figure 33: Synergy Main Window Reading Guide NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 48: Overview Of Sections

    Click this icon to close the Synergy application. Close Table 3: Title Bar Icon Overview 4.2.2.1 Settings The options under the Settings icon are described in Table 4 below. Options Description Contains System Information and System Configuration System Settings options. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 49: Admin

    Delete a patient  Search for a required patient  Reassign a study  View Patients entered through EMR For information on performing any of the listed tasks, refer to the instructions provided below. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 50: Adding A New Patient

    Select the patient in the Patients section and right-click to open the context menu. Select Delete <<Patient Name>> option. A User Notification window will appear. Click the Ok button to proceed. NOTE: Deleted Patients can be restored from the Database Management window. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 51: Searching For A Required Patient

    NOTE: If the study being re-assigned was previously sent to Electrical Medical Records, contact the EMR vendor and request the deletion of the previously sent report. Synergy will provide a warning message requesting confirmation of action when re-assigning a study previously sent to EMR. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 52: View Patients Entered Through Emr

    Save (Figure 38). Figure 38 Patient Settings – EMR NOTE: EMR is an add-on feature that must be configured to interact with Synergy. Contact LABORIE Service for information on EMR. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 53: Patient Details

    Select all symptoms that are relevant to the patient only once ready to start the study. Selected symptoms will be documented in the study report; symptoms are not saved in the Patient Details section. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 54: Database Management

    Select the Import Patients tab in the Database Management window. Click the Browse button and select an archived folder. All patients archived in this folder will be displayed in the Database Management window. Select patients for import by using the provided checkboxes. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 55: Restore Or Permanently Delete Patient Data

    To permanently delete patients in the Database management window, select patients using the check boxes provided or select all patients using the checkbox located on the header. Click Permanent Delete. Exhibit caution when using this feature as this information cannot be restored. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 56: Study Management

    Studies are suggested based on patient file inputs such as patient symptoms and patient history. Scientific references are available in the help menu of Synergy. NOTE: Studies must be shown in the UDS tab to be suggested. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 57: Customizing Workflows

    Use the Urocap Noise Reduction Level feature to detect and smooth chart spikes caused by environmental noise. Contact LABORIE Service for guidance on option selection. ii. Select UPP method, Manual Pull or Puller, using Profile Settings. If using the Puller method ensure to set Puller Speed. To run a...

  • Page 58: Workflow Step Settings Tabs

    Click the OK button to save the workflow. 4.4.2.1 Workflow Step Settings Tabs The following settings tabs are available under the Procedure Workflow Step:  Global: Graph Settings, Channel Settings, Other Settings, EMG Settings, Profile Settings NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 59: Customizing Control Panel

    To customize the control panel, first create a custom workflow as instructed in the Customizing Workflows section on page 56. Then follow the instructions below to customize the control panel per study phase: NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 60: Figure 45: Workflow Configuration Window - Control Panel

    Empty Button in the action window; click OK to implement the change. Figure 46: Action Window – Adding, Changing or Emptying Button Label NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 61: Accessing Hardware Channels

    Workflow dropdown menu. Click the Channels tab and confirm the presence of all desired phases. Click the Set Default Hardware Channels button. Click the OK button to save changes and proceed to start study. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 62: Start Study Button

    Refer to the Workflows section on page for phase break down per study workflow. This section provides an overview of workflow steps, their phases, and their functions from the start to the completion of the study. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 63: Procedure - Preview Phase

    71. Displays Quick Results and Nomograms for reference Quick Results and throughout the study. For more information, refer to Nomograms Quick Results and Nomograms section on page Table 7: Slide Sidebar Icon Overview NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 64: Consumable Traceability

    The user can do this by either scanning the SmartSense tag on the product using the registration systems embedded in the NXT Go Pump Hub and the PIM NXT for TDOC, or by manually entering the required information. Any information entered for the consumables will be displayed in the Consumable Traceability window (Figure 51).

  • Page 65: Procedure - Recording Phases

    Synergy Software a. To use the scanner, hold the SmartSense tag located on the consumable’s packaging in proximity to the scanner located on the NXT Go Pump Hub for 3 seconds. Verify that the consumable appears in the Consumable Traceability window.

  • Page 66: Questionnaire

    To edit the data fields in a report, a copy of the default configuration must be created within the Configuration Settings. Once a copy exists, any desired changes can be made to the copy. To create a copy of the report, NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 67: Adding Comments

    This option allows the addition of comments as a section in the report. To add comments to the report, follow the steps provided: Select the Add Report Comments button located in the toolbar. This will launch the Comments window (Figure 55). Figure 55: Comments Window NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 68: Quick Results And Nomograms

    . Check the Nomograms option and Apply Changes to add this feature to the report. Nomograms are intended as a summary analysis only.  Quick Results and Nomograms may be viewed during the study on the Slide Sidebar under the associated icon NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 69: Normal Values

    Synergy application configuration file. After 60 seconds from the time the report was sent to EMR, the process will timeout and show an Export Failed dialog if no acknowledgement had been received from EMR system (Figure 58). NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 70: Review

    Marker Type from the resulting menu to insert an event marker. Right click the event marker and select Delete Marker to remove an event marker from the graph. NXT Go Owner’s Manual, LBL-00145, MAN2030...
  • Page 71 Alternatively, click the Report button to load the Report window beside the Review window in split screen. To exit the review section of the split screen, click the Close button. To exit the report section of the split screen, click Finish. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 72: Uds Intelligence

    Blue submodules provide recommended actions regarding patient set-up. See Figure 60 below for examples of the color coding of the modules in the preview phase. Green Module and Submodules Red Module Blue Submodule Amber Module Plus/Minus Box Figure 60: Pre-test QC NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 73: Protocol Guidance

    Filling, and Voiding. Navigate the window by selecting the tab corresponding with the phase requiring review (Figure 62). Figure 62: Protocol Guidance and QC Score in the Review Phase NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 74: Qc Score And Qc Score Summary

    The QC Score Summary, accessible through the study report and review phase, provides an overview of points earned for each action per study phase. Table 8 below explains how the QC Score is allotted per phase: NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 75: Table 8: Qc Score Allotment Process

    Table 8: QC Score Allotment Process NOTE: Scientific references are available in the Help Menu of Synergy. Click the Help icon available in the title bar of the main window to launch the Help Menu. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 76: Maintenance And Service

     Ammonia based wipes CAUTION: LABORIE has not evaluated the use of cleaning/disinfection reagents which do not appear above. Use of unapproved reagents could damage the NXT system and should be avoided. Do not use wipes containing bleach. For questions on the compatibility of a reagent which is not listed above, contact LABORIE.

  • Page 77: Methods And Tools

    (e.g. presence of urine on the device), or, at minimum, daily. NXT Go Pump Hub and PC: Perform disinfection of the device, at minimum, once a week. 5.1.1.3 Methods and Tools ...

  • Page 78: Roam Nxt And Pim Nxt Preparation

    Urodynamic study. If dirt or debris is observed in the transducer channels as a part of daily inspection, Contact LABORIE for service and/or disposal instructions.

  • Page 79: Cleaning The Roam Nxt And Pim Nxt

    The transducer doors should only be kept open when reprocessing the area normally covered by the transducer doors. Once reprocessing of this area is complete, close the transducer doors to ensure that the transducer channels are not exposed to any liquids during any additional processing. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 80: Cleaning The Nxt Go Pump Hub And The Nxt Go Infusion Hook

    5.1.3.3 Cleaning the NXT Go Pump Hub and the NXT Go Infusion Hook To clean the outer surface area of the NXT Go Pump Hub and the NXT Go Infusion Hook follow the instructions provided in the Performing Manual Cleaning section.

  • Page 81: Disinfection

    Perform visual inspection of all units for corrosion, discoloration, pitting, or cracking. Contact LABORIE for service and/or disposal instructions if the unit is observed with these defects. NOTE: There are no rinsing steps required for the cleaning or disinfection processes.

  • Page 82: Disinfecting The Roam Nxt And Pim Nxt

    If previously disassembled, reassemble the UPP Puller NXT by connecting the motor and the nose. Reattach the Catheter Guide and the Clamp. Refer to the Assembling the UPP Puller NXT section on page 22.  Ensure to close the pump door. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 83: Packaging And Storage

    Storage Conditions. For long term storage, LABORIE recommends that the Roam NXT and the Urocap NXT be fully charged prior to storing. Press the “Reset” button on the module to cause the device to go into long-term sleep mode. To wake up the modules after storage, pair them with the laptop PC.

  • Page 84: Caring For The Urocap Nxt

    If the device’s Catheter Guide or Catheter Clamp are lost or damaged, contact LABORIE Service for a replacement.  If the UPP Puller Arm Clip is lost or damaged, contact LABORIE Service for a replacement. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 85: Verifying Calibration

    Maintenance and Service 5.3 Verifying Calibration LABORIE recommends users verify calibration annually, or when any module has been shaken, dropped, or transported between sites, to confirm system accuracy. IMPORTANT: NXT System modules do not require user calibration as the system modules are provided calibrated.

  • Page 86: Checking The Relative Weight With Water

    2. Ensure the PIM NXT is connected to the Roam NXT. Ensure to connect the PIM NXT that corresponds with the consumable type in use. 3. Connect the Urocap NXT, Roam NXT, and the Infusion Pump NXT to the Synergy software and setup the hardware channels. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 87: Verifying Emg Capability

    Urology Urodynamics test under the UDS tab, and click the Start Study button; the Preview phase will begin. g) Verify that the graph in the preview phase shows EMG as a 200µ sine wave. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 88: Verifying Pressure Measurement Capability

    NXT Go Pump Hub and Volume Transducer – Verifying Calibration To set up verification of calibration for the Infusion Pump NXT, located on the NXT Go Pump Hub, and the Infusion Volume Transducer, located in the NXT Go Infusion Hook, follow the instructions below: 1.

  • Page 89: Checking The Total Weight Without A Saline Bag

    Measure the weight of the saline bag using an external measuring device. c) Setup the Infusion Volume Transducer with the saline bag. d) The Total Weight in the diagnostic window should be the previously measured weight +/- 5%. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 90: Configuration

    Maintenance and Service 5.4 Configuration NXT Go Electrical Isolation Diagram Refer to the diagram shown below in Figure 71 for a visual representation of the NXT Go electrical isolation from mains supply. For further information regarding electrical isolation, contact LABORIE Service.

  • Page 91: Urocap Nxt And Wall Charger Isolation Diagram

    Figure 74: UPP Puller NXT and Wall Charger Isolation Diagram 5.5 Computer Virus Protection Each computer purchased from LABORIE is verified to be virus-free prior to shipment and is installed with an antivirus program. It is the customer’s responsibility to correctly use and maintain the antivirus program.

  • Page 92: Disposing Of Product After Use

    Maintenance and Service their own risk. LABORIE does not certify alternative antivirus programs for use with the NXT System. LABORIE is not responsible for any virus-related computer problems after delivery of the computer to the customer. 5.6 Disposing of Product After Use The NXT System equipment and disposables should be disposed of in the following manner: ...
  • Page 93 Pressure Pressure not Position of catheters? Check position and adjust as responding? necessary. Catheters are not Check connections and adjust as securely connected to necessary. the PIM NXT? NXT Go Owner’s Manual, LBL-00145, MAN2030...
  • Page 94 Uroflowmeter dish? the Uroflowmeter. Beaker placed or Ensure that the beaker is placed on the adjusted during study? Uroflowmeter before starting the study. Funnel is touching the Adjust commode chair or beaker? Uroflowmeter. NXT Go Owner’s Manual, LBL-00145, MAN2030...
  • Page 95 Load printer paper. steady or flashing? Printer cover open? Close cover of printer. Printer out of ink? Replace printer cartridges. Printer paper jammed or Clear the jammed paper and then misfed? press the paper feed button. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 96: Software Error Messages

    Workflows section on page 55. If problems continue, contact the LABORIE Service team at 1-800-333-1039 or email service@laborie.com. Software Error Messages If the following error messages are displayed in Synergy software, contact the LABORIE Service team at 1-800-333-1039 or email service@laborie.com:  Hardware Failure ...

  • Page 97: Hardware

    Bluetooth technology. This device allows the user to control the NXT System from a distance. Figure 76: Remote Control NXT Membrane Icons The Remote NXT key icons and their functionalities are described in Table 9 below. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 98: Remote Control Nxt Led Signals

    Blinking Blue Connecting through Bluetooth technology. Solid Red Disconnected. Solid Purple Idle mode. Green Indicates touch key input. Blinking Green Indicates the Remote Control NXT is losing connectivity. Table 10: Remote Control NXT LED Signals NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 99: Remote Control Nxt Battery Replacement

    Cable Input Figure 77: NXT Go Pump Hub The NXT Go Pump Hub must be connected to the power supply, the laptop, and the NXT Go Infusion Hook to function. Ensure the NXT Go Pump Hub appears in the Device Manager.

  • Page 100: Nxt Go Pump Hub Indicator Lights

    Hardware 6.4.1.1 NXT Go Pump Hub Indicator Lights Table 11 indicates the different statuses for the NXT Go Pump Hub. The NXT Go Pump Hub must be connected to the power supply to function. LABORIE Logo status Pump Status Arrow...

  • Page 101: Infusion Volume Transducer

    Hardware 6.6 Infusion Volume Transducer The infusion volume transducer is a part of the NXT Go Infusion Hook. The transducer allows Synergy to measure the fluid used to infuse the bladder during a Urodynamic study. The infusion volume transducer (Figure 80) is setup as follows: Hang the NXT Go Infusion Hook from an IV Pole.

  • Page 102: Pim Nxt For T-Doc

    EMG input ports to connect EMG accessories such as patches, fine wires, and needles. Figure 82 below displays the Roam NXT, PIM NXT for Fluid, Transducer Cables, Pressure Transducers, and Disposable Cartridges interlocked and indicates key parts and controls. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 103: Replacing The Pim Nxt

    To attach a new or existing PIM NXT, follow the instructions provided below.  Using a flat head screwdriver, loosen the screw(s) used to connect the PIM NXT and Roam NXT without fully detaching. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 104: Removing And Attaching The Clip

    Charge the Roam NXT by using the supplied wall charger and the NXT Magnetic Pogo Pin Cable. Attach the binder connector to the connector on the wall charger. Connect the wall charger to a power supply. Attach the Magnetic Pogo Pin connector to the Roam NXT. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 105: Table 12: Roam Nxt Led Signals

    PC. Table 12 indicates the different statuses for the Roam NXT and its battery. LABORIE recommends for the user to have the device plugged in, or for the device to have at least 1- 2 hours of battery charge before beginning a test.

  • Page 106: Urocap Nxt

    Figure 88 indicates the location of key controls on the Urocap NXT: Charging Port Vent Plug Air Vents Reset Button Figure 88: Urocap NXT Controls NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 107: Urocap Nxt-Charging The Battery And Pairing

    Table 13: Urocap NXT LED Signals LABORIE recommends for the user to have at least 1-2 hours of battery charge on the Urocap NXT prior to the start of a test or to complete the test with the Urocap NXT plugged in using the NXT Magnetic Pogo Pin Cable.

  • Page 108: Upp Puller Nxt

    Use the UPP Puller NXT Connector Cable with the USB to binder adapter cable to connect the UPP Puller NXT to the NXT Go laptop PC. The UPP Puller NXT will power on and will appear in the Synergy Device Manager window. Once the Bluetooth connection is established the cable can be disconnected for wireless use.

  • Page 109: T-Doc Air-Charged Catheters

    Table 14: UPP Puller NXT LED Signals 6.10 T-DOC Air-Charged Catheters The T-DOC NXT Air-Charged Catheter series are part of the next-generation LABORIE systems designed for use during Urodynamic studies (Figure 90). Figure 90: T-DOC NXT Air-Charged Catheter ...

  • Page 110: Emg Electrodes

    The Commode Chair (CHA181 or CHA171) and Funnel (CHA102) are required equipment for performing a FreeFlow or Urology Urodynamic study. Further information on how to setup the commode chair, funnel, and Urocap NXT, can be found in the Gathering Supplies and Equipment section on Page 19. NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 111: Appendix

    (-10° C to +40° C, 20% to 80% RH Non- Condensing) are labelled on the outside of the packaging. Laborie tests to more extreme conditions to ensure this product can withstand any unexpected conditions which may arise. Laborie has not performed testing to verify system functionality when transported outside of the limits provided Temperature: -20°...
  • Page 112 Infused Volume: 0mL to 1500mL (±2% of actual value or ±10mL whichever is greater) IP Rating Compliance: IPX0 Type BF Applied Part: N/A External materials: Aluminum 6061, Cycoloy C6200-111, Stainless Steel, PVC, Desmopan DP 9370AU NXT Go Owner’s Manual, LBL-00145, MAN2030...
  • Page 113 Flow Range: 0 to 50mL/s; Volume Range: 0-2L Output Channels: 1 Weight Measured Weight Range: 0 to 2000g Bandwidth: Flow=1Hz max.; Volume=5Hz. IP Rating Compliance: IP47 External Power Supply: 5VDC, 1,5A max Internal Power Supply: Li-Polymer Battery, 3.7V, 2400mAh NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 114: Table 15: Equipment Specifications

    Type BF Applied Part: N/A External Materials: Dow Corning QP1-250, Cycoloy C6200-111, Elastosil 3003/30 A/B, Gold-plated Brass, Loctite 401 & 242 IMPORTANT: LABORIE cannot guarantee the IP47 rating unless the vent plug is inserted into the open vent hole. UPP Puller NXT Dimensions: 18”(45.7cm) L X 2.5”(6.4cm) W X 4.5”(11.4cm) H...

  • Page 115: Classification And Applicable Directives

     EN 62304:2006/AC:2008  IEC 62366-1:2015  EN 62366:2008  IEC 62133:2012  TIR57:2016 Related Standards  ANSI/UL 2900-1:2017  ISO 15223-1:2016  IEC TR 62354:2014  ISO/IEC 17025:2017 Table 16: Classifications and Directives NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 116: Appendix B: Symbols Glossary

    NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 117: Medical Device Label Placement

    Table 17: Symbols Glossary Medical Device Label Placement Refer to Figure 93 below for the location of the Medical Electrical System label for the NXT Medical Device System Label Figure 93: NXT Go System Label Placement NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 118: Appendix C: Electronic Compatibility (Emc)

    EMC information provided in this manual. For EM compliance, it is important to only use catheters and accessories as supplied or recommended by LABORIE. Contact LABORIE for approved catheters. Recommendations for actions to assure that the NXT remains safe regarding EM disturbances: The equipment should be visually inspected regularly for damaged cables and connectors.
  • Page 119 (50/60 Hz) location in a typical magnetic field commercial or hospital IEC 61000-4-8 environment. Note: U is the AC mains voltage prior to application of the test level. NXT Go Owner’s Manual, LBL-00145, MAN2030...
  • Page 120 28 V/m survey, should be less 810/870/93 than the compliance level in 0 MHz each frequency range. Interference may occur 28 V/m near the equipment marked 1720/1845/ with the following symbol: NXT Go Owner’s Manual, LBL-00145, MAN2030...
  • Page 121 150 kHz to 80 Hz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d=1,17 √ �� d=1,17 √ �� d=2,33 √ �� 0.01 0,12 0,12 0,23 0,37 0,37 0,74 1,17 1,17 2,33 3,70 3,70 7,37 NXT Go Owner’s Manual, LBL-00145, MAN2030...

  • Page 122: Transmitter And Wireless Compliance Statements

    Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. NXT Go Owner’s Manual, LBL-00145, MAN2030...

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