LABORIE NXT Evo Owner's Manual
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LABORIE NXT Evo Owner's Manual

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

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Summary of Contents for LABORIE NXT Evo

  • Page 1 FOR DIGNITY. FOR LIFE. NXT Evo Owner’s Manual UROLOGY & UROGYNECOLOGY Operation, care, and maintenance laborie.com...
  • Page 2 Trademarks NXT Evo is a trademark of Laborie Medical Technologies Corp. Roam NXT, PIM NXT, Urocap NXT, T-DOC, and Unisensor are trademarks of Laborie Medical Technologies Corp. Windows is a registered trademark of Microsoft Corp. Bluetooth is a registered trademark of Bluetooth SIG Inc.

  • Page 3: Table Of Contents

    Preparing the UPP Puller NXT (Optional) Assembling the UPP Puller NXT Assembling the UPP Puller NXT Stand Assembling and Setting Up the NXT Evo System Mounting the Roam NXT & PIM NXT Assembly to the Cart Mounting the Urocap NXT to the Cart Mounting the IV pole to the Cart—For Fluid Setup...
  • Page 4 Patient Management Patients Patient Details Database Management Study Management Workflows Customizing Workflows Start Study Button Workflow Steps Procedure—Preview Phase Procedure—Recording Phases Questionnaire Reports Review UDS Intelligence Quality Control (QC) QC Score and QC Score Summary Laborie NXT Evo Owner’s Manual LBL-00179 [D]...
  • Page 5 Urocap NXT—Verifying Calibration Roam NXT—Verifying Calibration NXT Go Pump Hub and Volume Transducer—Verifying Calibration Configuration NXT Evo Electrical Isolation Diagram Roam NXT and Wall Charger Isolation Diagram Urocap NXT and Wall Charger Isolation Diagram UPP Puller NXT and Wall Charger Isolation Diagram...
  • Page 6 Mounting the NXT Go Pump Hub T-DOC Air-Charged Catheters EMG Electrodes Commode Appendix A: System Specifications Equipment Specifications Classification and Applicable Directives Appendix B: Symbols Glossary Medical Device Label Placement Appendix C: Electromagnetic Compatibility (EMC) Transmitter and Wireless Compliance Statements Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 7: Introduction

    1 Introduction The Laborie NXT Evo (NXT2400) system (Figure 1-1) is a partially-wireless-capable system providing mobility and ease-of-use in the 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 8: Equipment Intended Use

    • Remote Control NXT: Wireless and battery-powered device that allows control of the system from a distance. • Printer: For printing hardcopy reports of studies. The printer is connected via USB cable to the NXT Evo (NXT2400) system. Optional Equipment •...

  • Page 9: Standard Equipment And Optional Accessories

    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.

  • Page 10: Warnings And Precautions

    • 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, do not exceed the marked maximum weight indications.
  • Page 11 Only connect devices specified and approved by Laborie to the NXT system. Connecting any device not approved by Laborie to the ME system alters the functional integrity of the product, creating a safety risk. Only connect devices specified and approved by Laborie to the NXT system multiple-socket outlets.

  • Page 12: To Report Product Complaints Or Incidents

    Email: helpdesk@laborie.com About This Manual The NXT Evo Owner’s Manual is intended to provide important information and instruction regarding the use and care of the NXT system. Symbols Used in This Manual This manual provides important information to help you understand the features and safe use of the NXT system and its modules.

  • Page 13: Quick Start

    Figure 2-1: Lockable Wheels 2. Connect the NXT Evo power chord to mains power. 3. Turn on the AIO PC by pressing the power button(   ). Double-click the Synergy icon to launch the Synergy Login page.

  • Page 14: Setting Up The Nxt Go Pump Hub

    97. 1. Hang the NXT Go infusion hook on the NXT Evo cart IV pole. Connect the NXT Go infusion hook to the NXT Go pump hub. For a visual of inputs on the NXT Go pump hub, refer to Figure 6-3.
  • Page 15 Procedure-Specific Items: • Straight catheter • Exam gloves • Catheterization supplies such as cleansing swabs • Tape and lubricant • Preparation tray • Saline bag System-Specific Items: NXT Go pump hub (DCX2101) Remote Control NXT (RCX2001) Roam NXT (ROX2001) & PIM NXT for T-DOC (PIX2211) Roam NXT (ROX2001) &...
  • Page 16 Pressure cuff for perfusion for fluid UPP only (DIS302) Medex LogiCal pressure transducers (Medex TRA60X) PIM NXT for Fluid–to–Medex transducer cables (CAB1093) Snap-on electrodes (ELE428) and cable Infusion pump tubing for Laborie NXT systems (TUBPTNXT) (CAB1091, CAB1092, CAB1103, CAB1104) Laborie NXT Evo Owner’s Manual LBL-00179 [D]...
  • Page 17 Roam NXT–to–PIM NXT connector cable (CAB2111) NXT Magnetic Pogo Pin cable, binder termination, 3 m length (CAB1081) Power supply, medical grade, class II wall plug (POW1033) NXT Evo power cord (POW006) NXT Evo USB cable (CAB1056) Cart (NXT-2400) NXT Go pump hub mount bracket (MSM7001)

  • Page 18: Preparing The Urocap Nxt

    21. Preparing the Roam NXT 1. Ensure that the Roam NXT is charged. Laborie recommends charging the device overnight to ensure optimal battery power for a full day of procedures. 2. Confirm that the Roam NXT and PIM NXT are securely connected. The PIM NXT and the Roam NXT must be connected to function.

  • Page 19: Preparing The Upp Puller Nxt (Optional)

    Preparing the UPP Puller NXT (Optional) Ensure that the UPP Puller NXT is charged. Laborie recommends charging the device overnight to ensure optimal battery power for a full day of procedures. For instructions on how to charge the device, refer to the section “UPP...

  • Page 20: Assembling The Upp Puller Nxt Stand

    To assemble the puller stand (UPP1006), prepare one 6 mm and one 4 mm HEX L-KEY. Connect the pole assembly to the H-Base assembly (Figure 2-8) using the provided Washer M8, split washer M8, and screw M8. Use the 6 mm HEX L-Key to secure the screw. Figure 2-8: Assembling the UPP Stand Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 21: Assembling And Setting Up The Nxt Evo System

    Assembling and Setting Up the NXT Evo System Figure 2-9 shows the fully assembled NXT Evo system and identifies its major components. Infusion Hook AIO Computer Spine NXT Go Pump Hub Roam NXT Mount Urocap NXT Printer Shelf Castors Figure 2-9: The Major Components of the NXT Evo System To assemble and set up the NXT Evo system, complete the procedure that follows.

  • Page 22: Mounting The Roam Nxt & Pim Nxt Assembly To The Cart

    Place the Roam NXT & PIM NXT assembly into its docking mount on the spine to be charged, as demonstrated in Figure 2-15. Figure 2-15: Place the NXT Roam & PIM Assembly into Its Docking Mount to Charge Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 23: Mounting The Urocap Nxt To The Cart

    To adjust the mount height, remove the Roam NXT from the mount to reveal the two set screw hole locations in the center of the mount (Figure 2-16), loosen the set screws, and then raise or lower the Roam NXT mount to the desired height.

  • Page 24: Mounting The Iv Pole To The Cart-For Fluid Setup

       Figure 2-20: Installing the IV Pole Bracket into the Spine Bracket You can position the IV pole to either the right or left side of the cart, as illustrated in Figure 2-21. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 25: Water Pressure Transducer Mount

    Figure 2-21: Position the IV Pole to Either the Left or Right Water Pressure Transducer Mount Remove the fluid-filled catheters from their box and locate the water pressure transducer mount, as shown in Figure 2-22. Connect the catheter receivers to the transducer cables going into the PIM, as in depicted in Figure 2-23. Figure 2-22: Water Pressure Transducer Mount Figure 2-23: Connecting the Catheter Transducer Cables to the PIM NXT for Fluid...

  • Page 26: Setting Up Consumables And Preparing The Patient

    You need to scan the tags on these boxes to add the consumables contained within them to the repository, and you must select these consumables from the repository before starting an investigation. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 27: Infusion Pump Tubing Setup

    Infusion Pump Tubing Setup Laborie infusion pump tubing is intended for single use only. Do not reuse, 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 28: Replacing The Pump Tubing

    5. Set up the new pump tubing as just described in the previous section. 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. For a list of compatible catheters, refer to the section “Gathering Supplies and Equipment”...
  • Page 29 T-DOC G3 Air-Charged Catheters To set up the T-DOC Air-Charged Catheters for use with the NXT, perform the following steps: 1. Ensure that the PIM NXT for T-DOC is connected to the Roam NXT. A solid-green light bar on the Roam NXT indicates that the device is ready for use.

  • Page 30: T-Doc G1 Air-Charged Catheters

    (Pdet) is equal to zero and that both Pabd and Pves pressures are reacting appropriately. If Pabd is higher than Pves, reposition the Pabd catheter. In Synergy, on the control panel, click the Equalize Pdet button. 11. Continue with the study procedure when ready. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...
  • Page 31 IMPORTANT Do not plug in or unplug any transducers when a procedure is running. Always stop the procedure before plugging in or unplugging transducers. Always consult the Instructions for Use provided with the product. Roam NXT, PIM NXT for Fluid, and Transducer Setup 1.
  • Page 32 5. Open the stopcock to the syringe and the catheter and infuse approximately 1 cc to 1.5 cc of solution. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...
  • Page 33 6. Slowly open the stopcock to the Luer Lock where the pressure measurement tubing will be attached. Connect the tubing to the stopcock as the meniscus forms on the stopcock Luer Lock. Take care not to lose fluid from the catheter. 7.

  • Page 34: Placing The Emg Patch Electrodes

    For ease of movement and accessibility during urodynamic procedures, you can mount the Roam NXT on an IV Pole (Figure 2-35) or on the procedure chair. When mounting the Roam NXT, always ensure that the clamping mount is securely fastened. Figure 2-35: Roam NXT Mounted on the IV Pole Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 35: Performing A Study

    In the title bar of the Synergy software, click the Settings icon (   ) and then click the Device Manager option; the Device Manager window opens, as shown in Figure 3-1. Figure 3-1: Device Manager Window LBL-00179 [D] Laborie NXT Evo Owner’s Manual...

  • Page 36: Freeflow Study

    FreeFlow Study A FreeFlow study provides a measurement of the rate at which urine flows out of the body. It can be performed using the Urocap NXT and Synergy software provided as part of the Laborie NXT system. NOTE Before beginning the FreeFlow Study ensure that you have completed the tasks outlined in the section “Gathering Supplies and Equipment”...

  • Page 37: Starting The Freeflow Study

    Starting the FreeFlow Study Start the FreeFlow study as described in the section “Starting a Study” on page 29. The FreeFlow study requires the use of the Urocap NXT and Bluetooth Dongle NXT. Ensure that the Urocap NXT device is ready to use (i.e., fully charged, with the beaker in place). For information on preparing the Urocap NXT, refer to the section “Preparing the Urocap NXT”...
  • Page 38 In the Post Void Residual dialog box, click OK to save data and advance to the report. Clicking Cancel abandons information you input and closes the Post Void Residual dialog box. NOTE Post Voided Residual can also be entered and edited in the Report. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 39: Urology Urodynamic Study

    FreeFlow Report 1. A preview of the FreeFlow Report will be generated using the default (UDS) configuration settings (Figure 3-6). You can apply the default configuration for the report or customize it. For information on customizing the report, refer to the section “Reports”...

  • Page 40: Performing A Urology Urodynamic Study

    5. Encourage the patient to give feedback on sensation or urge. Mark relevant events (First Sensation, First Desire, Strong Desire, etc.) by clicking the First Sensation drop-down menu and selecting the relevant event (refer to Figure 3-7). Laborie NXT Evo Owner’s Manual LBL-00179 [D]...
  • Page 41 Figure 3-7: Pressure Flow Filling Phase 6. When the patient begins to feel discomfort or fullness, stop the infusion pump by clicking the Pump Off button. To move to the next phase, click the Start Voiding Phase button. CAUTION You can stop infusion at ANY TIME by pressing the gray 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 42: Cystometry Study

    3. Click the Pump On button to start the infusion pump and begin filling the bladder. Click Smart Pump Up or Smart Pump Down buttons to increase or decrease the pump speed, respectively. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 43: Tests

    NOTE To change the infusion bag, click the Change Infusion Fluid button. A window opens, and the study pauses. If desired, you can update the Fluid Density setting using the drop-down menu available in this window. Click OK to resume the study. You must configure the fluid density options in the Workflow Configuration dialog box before starting the study.

  • Page 44: Urethral Pressure Profile

    3. Feed the catheter through the catheter guide and use the catheter clamp to secure the catheter to the UPP Puller NXT. 4. Select the Rest Profile (On) button to start the rest profile. The UPP Puller NXT will begin pulling at the speed selected in the Workflow Configuration dialog box. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 45: Finishing The Studies

    Print icon. Troubleshooting For FAQs and troubleshooting tips, refer to the section “Troubleshooting Guide” on page 91. If problems cannot be resolved, contact the Laborie Service Team at 1-800-333-1039 or by email at service@laborie.com. Chapter 3 Performing a Study...

  • Page 46: Synergy Software

    To log in to Synergy, do the following: 1. On the desktop, double-click the Synergy shortcut icon, or, from the Laborie Dashboard, start the Synergy application. The Synergy Login window opens, as shown in Figure 4-1. Upon first login, you must accept the End User License Agreement.

  • Page 47: Ldap Setup

    “Sections and Icons in the Main Window” on page 45. IMPORTANT Do not leave the computer unattended after you have logged in. Laborie recommends that you manually lock the computer if you expect to be away from it for an extended time. LDAP Setup To use Microsoft Active Directory for Synergy access, you first must configure this option in the Login Settings dialog box (Figure 4-2) by clicking the Settings icon ( ...

  • Page 48: Creating User Accounts

    SSL certificate being used on the AD/LDAP server needs to be installed on the machine running the Laborie software. Select the appropriate AD Groups for the admin and the user level. Admins will have full access to audit logs, user creation, EMR settings, and more. Regular users from the user group will not have access to these settings.
  • Page 49 Figure 4-4: The User Setup Dialog Box 3. To reset the password of an active account, from the user list, select the existing account. On the Update User Info tab, in the New Password text box, type the new password and then click OK (Figure 4-5). Figure 4-5: Resetting a Password Chapter 4 Synergy Software...
  • Page 50 3. In the Role text box, create a new role by typing a new title category and then, from the Authentication Type list box, select an authentication type (Figure 4-8). Select the checkboxes for all the functions for which the new user role can have access, and then click Save. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 51: Sections And Icons In The Main Window

    Figure 4-8: Adding a New User Role 4. To reassign the account role, on the Synergy title bar, click the Admin icon ( ), select User Setup, and then click the Update User Info tab. Select the newly created role and then press Save. Sections and Icons in the Main Window This section provides an overview of the various features accessible from the Synergy main window, as presented in Figure 4-9.

  • Page 52: Overview Of Sections

    Reporter Settings Contains Import Custom Report Template, and Export Custom Report Templates. Workflow Contains Editor, Import Custom Workflow, and Export Custom Workflow. Editor displays the Workflow Configuration page; create new workflows and set hardware channels. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 53: Patient Management

    Admin Table 4-4 presents the options that you can access by clicking the Admin icon (   ). Table 4-4: Admin Options Overview Options Description User Setup Displays the User Setup dialog box, in which you can add new users (for Local accounts) and update user information (for Local users).
  • Page 54 3. Click the export icon ( ) to open the Export Document dialog box, as shown in Figure 4-12. NOTE Click the Export button ( ) to select the desired format in which to export the report. The Export Document dialog box opens. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...
  • Page 55 Figure 4-12: Export Document Dialog Box 4. Select the required format, file path, and other required options, and then click OK. Reassigning a Study The reassign function allows you to transfer study results from one patient to another if the wrong patient was initially selected.

  • Page 56: Patient Details

    • Involuntary Leakage associated with urgency as well as effort/exertion • Post-Prostatectomy Leakage • Urgency with Involuntary Leakage • Low Capacity • High Capacity • Frequency • Urgency without Leakage • Decreased Bladder Sensation Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 57: Database Management

    • Increased Bladder Sensation • Absent Bladder Sensation • Feeling of incomplete bladder emptying • Weak / intermittent stream • Post-void dribbling • Hesitancy • Straining to Void • Position-dependent Micturition • Dysuria (Painful Voiding) • Vaginal Prolapse Symptoms • Polyuria •...
  • Page 58 Database Management window. 3. Choose patients for import by selecting the corresponding checkboxes. 4. Click the Import button. A message box opens to confirm a successful import. Figure 4-17: Database Management—Import Patients Tab Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 59: Study Management

    Restore or Permanently Delete Patient Data In the Database Management window, you can restore patients who were previously deleted from the Patients section. 1. In the Database Management window, select the Restore/Delete Patients tab (Figure 4-18). Figure 4-18: Database Management—Restore/Delete Patients Tab 2.

  • Page 60: Customizing Workflows

    2. From the Workflow drop-down menu, select the workflow template that you want to edit and then click Copy. This unlocks the editing options for the Workflow Steps and settings tabs. 3. In the Workflow Name text box, rename the workflow. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...
  • Page 61 ■ Use the Urocap Noise Reduction Level feature to detect and smooth chart spikes caused by environmental noise. For guidance on option selection, contact Laborie Service. ■ Activate or disable Video for custom workflows and set your Desired Frame Rate.
  • Page 62 You can customize buttons per study phase using custom workflows. IMPORTANT Workflows cannot be reconfigured while a study is in progress. All workflow settings must be adjusted prior to starting a study. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...
  • Page 63 To customize the control panel, first create a custom workflow, as instructed in the section “Customizing Workflows” on page 54. Then, follow the instructions provided here to customize the control panel per study phase: 1. In the Workflow Configuration window, click the Phases tab. From the list, select a phase to customize. Scroll down to the control panel section located at the bottom of the window (refer to Figure 4-21).
  • Page 64 To set hardware channels, first ensure that you select the required Workflow option from the Workflow Steps drop- down menu. Click the Channels tab and confirm the presence of all desired phases. Click the Set Default Hardware Channels button. Click OK to save the changes and proceed to start the study. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 65: Start Study Button

    Start Study Button Clicking the Start Study button (Figure 4-25) initiates the Preview Study phase. Figure 4-25: The Start Study Button After all study inputs are received, the button will change color to blue. If the button is gray, it cannot be activated. Hover the pointer over the Start Study button to display a ToolTip that will suggest troubleshooting options, as shown in Figure 4-26.

  • Page 66: Procedure-Preview Phase

    Displays live video feed, saved images, recorded video, brightness slider, and contrast slider. The Video Panel is available only if Video Settings are turned on in the workflow of the study under Global Settings. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...
  • Page 67 Consumable Traceability During the Preview phase, you will need to specify in the Consumable Traceability panel each of the consumables that will be used for the study. • You can do this by either scanning the SmartSense tag on the product using the RFID reader embedded in the NXT Go pump hub or by manually typing the required information.

  • Page 68: Procedure-Recording Phases

    Channel Name to open the editing window. Click the assigned color, select a new color from the color palette that opens, and then click OK to save changes (Figure 4-29). NOTE The channel color can be changed during all workflow steps or configured in the workflow before beginning the study. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 69: Questionnaire

    Figure 4-29: Change Channel Color • In the Flow and Voiding phases, Synergy automatically begins recording data as soon as the Urocap NXT detects the start of the flow. By default, the Voiding phase will stop 60 seconds after voiding ends. You can also click the Next icon to proceed to the next step.

  • Page 70: Reports

    Name text box. NOTE New report configurations will be saved by Synergy upon application and may be selected from the Configuration list box for future formatting. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...
  • Page 71 Figure 4-31: Configuration Settings—Editing the Report 3. To enable or disable various data fields, in the Configuration Settings panel, select or clear the corresponding checkbox for the data field. You can change the position of some data fields in the report by using the Up and Down buttons. To move a data field, select the applicable field.
  • Page 72 1. Select the required configuration copy and then expand the Report content option by clicking the right-facing triangle adjacent to the title (see Figure 4-33). 2. Select the checkbox for the Normal Values option. 3. Save the changes to the report by clicking the Apply Changes button. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...
  • Page 73 Figure 4-34: Normal Values Video Images Video Images is an option available for activation in report customization for applicable workflows. When Video Settings are activated in the workflow configuration of a study, the Video panel provides access to live video and image capture.
  • Page 74 The Send to EMR button will not be accessible when using the Preview Changes feature to view report configuration. To access the Send to EMR button, in the report Configuration Settings panel, click Apply Changes. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 75: Review

    Review The Review workflow step allows you to assess the information recorded during the study. To review the study, in the Patients section, select the patient, click the Studies tab in the Patient Details section, and then click the Review button;...

  • Page 76: Uds Intelligence

    Green indicates the completion of all actions for the setup of the module. d. Blue submodules provide recommended actions regarding patient setup. Figure 4-39 presents examples of the color coding of the modules in the Preview phase. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...
  • Page 77 Green Module and Submodules Red Submodule Blue Submodule Amber Module Plus/Minus Box Figure 4-39: Pre-test QC Protocol Guidance During the Recording phases of the Procedure workflow step, the Quality Control window will display Protocol Guidance. Two protocol fields are provided: Total Score and Phase Score (Figure 4-40). The Quality Control icon will shift colors as the phase score evaluation changes.

  • Page 78: Qc Score And Qc Score Summary

    2. In the Configuration Settings panel, expand the Report content option by clicking the right-facing arrow adjacent to the title. 3. Select the checkbox for the QC Score Summary option to turn on this function. 4. To save changes to the report, click Apply Changes. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...
  • Page 79 Figure 4-42: 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 4-7 explains how the QC Score is allotted per phase. Table 4-7: QC Score Allotment Process Flow Phase Blue = 0 points Yellow = +5 points...
  • Page 80 Any PVR value, including 0 ml NOTE Scientific references are available in the Help menu of Synergy. To open the Help menu, on the title bar of the main window, click the Help icon (   ). Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 81: Maintenance And Service

    Laborie has not evaluated the use of cleaning/disinfection reagents which do not appear in the preceding list. 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 that is not in this list, contact Laborie. IMPORTANT Ensure that the reagents are used for at least the contact time stated in the reagent instructions.

  • Page 82: Cleaning And Disinfection Preparation

    Transport the soiled device individually in a closed container to a designated cleaning and disinfection area. • Do not transport the device in a container with other devices. • Do not soak the device prior to cleaning. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 83: Cleaning

    This area should not require cleaning, given that it is protected by the transducer doors while not in use or by the catheter connector during 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 84 NXT Go pump hub (Figure 5-1), open the pump door and wipe each roller with an approved cleaning reagent. Refer to the section “Cleaning and Disinfection Reagents” on page 75. Figure 5-1: Pump Rollers Laborie NXT Evo Owner’s Manual LBL-00179 [D]...
  • Page 85 10. Perform a 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.

  • Page 86: Disinfection

    3. Repeat this process, if necessary, using either a fresh wipe or the clean side of the existing wipe until the affected area is visibly clean. 4. Reattach and then close the transducer doors. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 87: Completing Cleaning And Disinfection

    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 AIO PC.

  • Page 88: Caring For The Cart

    Do not attempt to remove any lodged objects from the PIM NXT for T-DOC transducer channels using a tool. Do not attempt to clean or remove dirt or debris from the transducer channels. Contact Laborie Service for repair or replacement.

  • Page 89: Verifying Calibration

    • Keep the monitor free of any obstacles. Verifying Calibration Laborie recommends that you 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; the system modules are provided precalibrated. If verification procedures reveal a calibration malfunction, contact Laborie Service for a replacement device.
  • Page 90 ). Wait 10 seconds and then click the Zero Weight button. 2. Add 500 ml of water to the beaker. 3. Verify that the Relative Weight for the Urocap NXT in the diagnostic window is 500.00 g ±3%, as illustrated in Figure 5-4. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 91: Roam Nxt-Verifying Calibration

    Figure 5-4: Urocap NXT—Device Diagnostics with Water Roam NXT—Verifying Calibration To set up verification of calibration for the Roam NXT, perform the following steps: 1. Log in to Synergy. 2. Ensure that the PIM NXT is connected to the Roam NXT. Connect the PIM NXT that corresponds with the consumable type in use.
  • Page 92 4. In Synergy, on the title bar, click the Settings icon (   ) and then click Device Manager. The Device Manager window opens. 5. Click the Roam NXT option and then click the Run Diagnostics button. The device diagnostics window opens (Figure 5-6). Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 93: Nxt Go Pump Hub And Volume Transducer-Verifying Calibration

    Figure 5-6: Roam NXT—Device Diagnostics Window The Pressure should show approximately 20 cm of water ±3%. 6. Repeat for each channel. 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, do the following: 1.

  • Page 94: Configuration

    Configuration NXT Evo Electrical Isolation Diagram Refer to the diagram shown in Figure 5-8 for a visual representation of the NXT Evo electrical isolation from mains supply. For further information regarding electrical isolation, contact Laborie Service. Laborie NXT Evo Owner’s Manual...

  • Page 95: Roam Nxt And Wall Charger Isolation Diagram

    Figure 5-8: NXT Evo Isolation Diagram Roam NXT and Wall Charger Isolation Diagram Refer to the diagram shown in Figure 5-9 for a visual representation of the method used to isolate the Roam NXT from mains supply when configured with a wall charger. For further information regarding electrical isolation, contact Laborie Service.

  • Page 96: Urocap Nxt And Wall Charger Isolation Diagram

    Figure 5-11: UPP Puller NXT and Wall Charger Isolation Diagram 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. Customers may use an alternative antivirus program at their own risk.

  • Page 97: Disposing Of Product After Use

    Packaging is 80% recyclable/renewable by weight. Environmental Consideration of Waste Disposal The NXT system is designed to perform urodynamics studies. Laborie recommends disposing of waste generated from these studies, such as urine, properly to prevent environmental pollution. The waste should be disposed of in such a way that it will not pollute the fresh water supply system, especially the drinking water system.
  • Page 98 For V3 pumps: Perform the procedure presented in the section “Pairing a Version 3 (Wired/Wireless Connection) NXT Go Pump Hub” on page 98. If these steps fail to resolve the problem, contact Laborie technical support. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...
  • Page 99 Workflow > Editor to open the Workflow Configuration window. Then, select the Global tab. The Urocap Noise Reduction Level feature provides three options: None, Narrow, or Wide. Consult Laborie Service for guidance on setting selection. Incorrect flow or volume Beaker is not properly seated on...

  • Page 100: Software Error Messages

    If problems continue, contact the Laborie Service team at 1-800-333-1039 or by email at 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 by email at service@laborie.com: •...

  • Page 101: Hardware

    The Remote Control NXT (Figure 6-2) is a battery-powered device that connects to the computer wirelessly via Bluetooth technology. This device allows the user to control the NXT system from a distance. Figure 6-2: Remote Control NXT Membrane Icons LBL-00179 [D] Laborie NXT Evo Owner’s Manual...

  • Page 102: Remote Control Nxt Led Signals

    1. Using a cross-tip screwdriver, remove the two screws on the battery compartment cover at the back of the Remote Control NXT and set the cover aside. 2. Remove the used batteries and replace them with ones. Ensure that the batteries are installed in the correct contact orientation. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 103: Nxt Go Pump Hub

    1. Verify that all external connections to the pump have been made. For details, see the section “Assembling and Setting Up the NXT Evo System” on page 15. 2. In Synergy, open the Device Manager and verify that the pump hub is available.

  • Page 104: Pairing A Version 3 (Wired/Wireless Connection) Nxt Go Pump Hub

    1. Verify that all external connections to the pump have been made. For details, see the section “Assembling and Setting Up the NXT Evo System” on page 2. In Synergy, open the Device Manager and verify that the pump hub is available.

  • Page 105: Infusion Volume Transducer

    To set up the infusion volume transducer, do the following: 1. Hang the NXT Go infusion hook from the NXT Evo cart spine. Ensure that the NXT Go infusion hook connector cable is attached to the NXT Go pump hub.
  • Page 106 Roam NXT, PIM NXT for T-DOC G1 Air-Charged Catheters, T-DOC G1 on NXT adapter cables, and indicates the PIM NXT pressure-channel connectors. T-DOC G1 on NXT Interlocked Roam NXT Adapter Cables and PIM NXT for Fluid Pressure-Channel Connectors Figure 6-7: Roam NXT and PIM NXT for T-DOC Controls Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 107: Replacing The Pim Nxt

    PIM NXT for Fluid The PIM NXT for Fluid has four pressure channel connectors for use with the PIM NXT for Fluid–to–Medex transducer cables and NXT fluid catheters. The PIM NXT for Fluid provides two EMG input ports to connect EMG accessories such as patches, fine wires, and needles.

  • Page 108: Roam Nxt-Charging The Battery And Pairing

    Charge the Roam NXT by using the supplied wall charger and the NXT Magnetic Pogo Pin cable. 1. Attach the binder connector to the connector on the wall charger. 2. Connect the wall charger to a power supply. 3. Attach the Magnetic Pogo Pin connector to the Roam NXT. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 109: Urocap Nxt

    Synergy Device Manager, disconnect the cable from the Roam NXT and the AIO PC. Table 6-4 indicates the different statuses for the Roam NXT and its battery. Laborie recommends that you have the device plugged in, or for the device to have at least one to two hours of battery charge before beginning a test. Always connect the Roam NXT device to the wall charger at the completion of working hours to ensure full charge for the next study period.

  • Page 110: Urocap Nxt-Charging The Battery And Pairing

    PC. Laborie recommends that you have at least one to two 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. Always return the device to the Urocap NXT charging hub at the completion of working hours to ensure a full charge for the next study period.

  • Page 111: 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 Evo AIO PC. The UPP Puller NXT will power on and will appear in the Synergy Device Manager window. After the Bluetooth connection is established, the cable can be disconnected for wireless use.

  • Page 112: Nxt Evo Cart

    Lack of illumination: Empty/Sleep mode (No declared battery Solid red: Fault capacity) Lack of illumination: Puller is sleeping or shut off. NXT Evo Cart The NXT Evo is a cart-based system with an integrated All-in-One (AIO) PC. Figure 6-16 identifies the major components. Infusion Hook AIO Computer Spine...

  • Page 113: T-Doc Air-Charged Catheters

    Figure 6-17: Mount Bracket for the NXT Go pump (left); Pump Hub Seated on Its Mount (right) T-DOC Air-Charged Catheters The T-DOC NXT Air-Charged catheter series (Figure 6-18) is part of the next-generation Laborie systems designed for use during urodynamic studies.

  • Page 114: Emg Electrodes

    Urology urodynamic study. You can find additional information on how to set up the commode chair, funnel, and Urocap NXT in the section “Pairing a Version 3 (Wired/Wireless Connection) NXT Go Pump Hub” on page 98. Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 115: Appendix A: System Specifications

    IMPORTANT The Laborie-recommended transport conditions (–10°C to +40°C, 20% to 80% RH non- condensing) are displayed on the labels on the outside of the packaging. Laborie tests to more extreme conditions to ensure this product can withstand any unexpected conditions that may arise.
  • Page 116 Temperature: –20°C to +40°C Humidity: up to 85 ± 5% RH non-condensing Pressure Range: 700 hPa to 1,040 hPa IMPORTANT Laborie has not performed testing to verify system functionality when stored outside of the limits provided. All-in-One PC Computer: All-in-One medical-grade PC ×...
  • Page 117 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. Continued on Next page Appendix A...
  • Page 118 Type BF Applied Part: N/A Accessories External Materials Funnel: Cycolac Resin, acrylonitrile-butadiene-styrene terpolymer Beaker: Polypropylene Commode: Powder-coated steel and plastic EMG Cable (CAB1091, CAB1092): Polyamide and thermoplastic elastomer EMG Cable (CAB1103, CAB1104): PVC, Polyolefin, PA Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 119: Classification And Applicable Directives

    Classification and Applicable Directives Table A-2: Classifications and Directives Classifications Class I Type BF Applied Part Mode of Operation: Continuous Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide. Applicable Directives and IEC 60601-1:2012 Standards CAN/CSA C22.2 No.

  • Page 120: Appendix B: Symbols Glossary

    Do not stack federal law restricts grounding this device to sale Do not dispose of Testing laboratory or use by or on the electronic products order of a licensed in the general waste physician. stream Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 121: Medical Device Label Placement

    NOTE: Sterility symbols are applicable to consumable devices only. Please refer to consumable device Instructions for Use for complete symbol and instructional overview. Medical Device Label Placement For the location of the Medical Electrical System label for the NXT Evo urodynamics system, refer to Figure B-1. Figure B-1: NXT Evo System Label Placement Appendix B...

  • Page 122: Appendix C: Electromagnetic Compatibility (Emc)

    The NXT needs special precautions regarding Electromagnetic Compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this manual. For EM compliance, it is important to use only catheters and accessories as supplied or recommended by Laborie. Contact Laborie for approved catheters.
  • Page 123 Table C-2: Guidance and Manufacturer’s Declaration—Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic ±8 kV contact ±8 kV contact Floors should be wood, concrete, or ceramic tile. discharge (ESD) If floors are covered with synthetic material, the ±15 kV air ±15 kV air relative humidity should be at least 30%.
  • Page 124 If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the NXT. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.   Laborie NXT Evo Owner’s Manual LBL-00179 [D]...

  • Page 125: Transmitter And Wireless Compliance Statements

    Table C-3: Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the NXT The NXT is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the NXT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the NXT as recommended below, according to the maximum output power of the communications equipment.

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