DEFAULT 1/21/2021 Document Detail 1 Type: Document No.: Title: LBL LBL-00145[A] 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 No.
Status DRAFT Effective NXT Go Owner’s Manual Version A NXT Go Owner’s Manual, LBL-00145 [A], MAN2030
Trademarks NXT Go is a trademark of LABORIE Medical Technologies Canada ULC. Roam NXT, PIM NXT, Urocap NXT, and Urocap NXT are trademarks of LABORIE Medical Technologies Canada ULC. T-DOC is a trademark of T-DOC Company, LLC. Unisensor is a trademark of Unisensor AG. Windows is a registered trademark of Microsoft Corp. Bluetooth is a registered trademark of Bluetooth SIG Inc. LogiCal® is a trademark of Smiths Medical. Other names may be trademarks of their respective owners. Copyright All rights reserved.
Contents Introduction ...................................................................................................... 12 1.1 Intended Use ............................................................................................... 12 1.2 Indications of Use ........................................................................................ 12 1.3 Equipment Intended Use ............................................................................... 13 1.4 Contraindications ..............
Performing a FreeFlow Study ................................................................... 32 3.2.2.1 Preview Phase .................................................................................... 32 3.2.2.2 Flow Phase ......................................................................................... 33 3.2.2.3 FreeFlow Report ................................................................................. 34 3.3 Urology Urodynamic Study ....................................................
4.2.2.2 Admin ............................................................................................... 48 4.3 Patient Management..................................................................................... 48 Patients ................................................................................................ 48 4.3.1.1 Adding a New Patient .......................................................................... 49 4.3.1.2 Deleting Patient Data .........................................
Quality Control (QC) ............................................................................... 71 4.6.1.1 Pre-test Quality Control ....................................................................... 71 4.6.1.2 Protocol Guidance ............................................................................... 72 4.6.1.3 UDS Intelligence in the Review Workflow Step ........................................ 72 QC Score and QC Score Summary ............................................................
5.3.1.1 Checking the Absolute and Relative Weight ............................................ 84 5.3.1.2 Checking the Relative Weight with Water ............................................... 85 Roam NXT – Verifying Calibration ............................................................ 85 5.3.2.1 Verifying EMG Capability ...................................................................... 86 5.3.2.2 Verifying Pressure Measurement Capability ............................................
6.7.2.2 Attaching New PIM NXT ..................................................................... 102 6.7.2.3 Removing and Attaching the Clip ........................................................ 103 Roam NXT—Charging the Battery and Pairing .......................................... 103 6.8 Urocap NXT ............................................................................................... 105 Urocap NXT—Charging the Battery and Pairing ........................................ 106 6.
Status DRAFT Effective Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure 19: FreeFlow Preview Phase ............................................................................. 32 20: FreeFlow Record Phase ..........
Status DRAFT Effective Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure 68: 69: 70: 71: 72: 73: 74: 75: 76: 77: 78: 79: 80: 81: 82: 83: 84: 85: 86: 87: 88: 89: 90: 91: 92: 93: Wiring Diagram – EMG Calibration Verification with a Waveform Generator ...... 86 Roam NXT – Device Diagnostics .................................................................
Status DRAFT Effective Table 19: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ........... 120 Table 20: Separation Distances between Portable and Mobile RF ..................................
Introduction Introduction Status DRAFT Effective 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 batterypowered features allow for improved system setup and use. For information on warranty and terms and conditions, visit http://www.laborie.com/terms-and-conditions/. Figure 1: NXT Go 1.
Introduction 1.3 Equipment Intended Use Refer to the descriptions below for a breakdown of intended use per module. Standard Equipment Status DRAFT Effective NXT Go Pump Hub with NXT Go Infusion Hook: Wired device which uses a peristaltic infusion pump to fill a patient’s bladder with saline and/or contrast. Urocap NXT: Wired or wireless and battery powered device which measures volume and flow rate of urine.
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. The symbols outlined below highlight helpful tips and important cautions that will aide in guiding the reader through the manual.
Introduction Standard Equipment and Optional Accessories Prior to use, verify that all ordered equipment and accessories have been received. Contact LABORIE if there are any discrepancies between ordered and received equipment. Inspect the equipment for any visible signs of damage or mishandling. Notify the carrier immediately if damage is found. NOTE: LABORIE recommends keeping the carrying cases and cartons provided with the devices to use during transport if the equipment must be sent in for service.
Introduction Warnings: The NXT Urodynamic System contains magnets which can interfere with control of a pacemaker or ICD (Implanted cardioverter-defibrillator). Follow instructions from the manufacturer of such devices and ensure that the Roam NXT, Urocap NXT and charger cable connectors are always kept at a sufficient distance from any implanted device. Only LABORIE trained technicians may service the unit.
Introduction To avoid risk of electric shock, do not touch the pogo pins located inside the Urocap NXT Charging Hub or the Urocap NXT Wall Charger. To avoid the risk of electric shock, only connect this equipment to a mains power supply with protective earth. This device is intended for use in a clinical environment with controlled EMC standards to limit potential interference. The NXT System may be adversely affected by Bluetooth, cellular, or EMC interference.
Quick Start Quick Start To prepare for a typical study, follow the steps provided below. Setting Up the Equipment Gathering Supplies and Equipment Preparing the Urocap NXT Preparing the NXT Go Pump Hub Preparing the Roam NXT Preparing the UPP Puller NXT Setting Up Consumables and Preparing the Patient Status DRAFT Effective 2.1 Setting Up the Equipment Unpack the NXT Go Pump Hub, Roam NXT, Patient Interface Module NXT (PIM NXT), and Urocap NXT from their shipping boxes. Unpack the UPP Puller NXT.
Quick Start Login to Synergy by inputting the account User Name and Password, assigned during system install, into the Synergy Login Page. The Synergy Main Window will load. Refer to Figure 33: Synergy Main Window Reading Guide. Ensure to update access information from initial system install. Refer to the User Access Control section on page 42 for more information on logging in to Synergy and accessing controls. 2.
Quick Start Status DRAFT Effective Commode Chair (CHA181 or CHA171) and Funnel (CHA102) Snap-on electrodes (ELE428) and cable (CAB1091, CAB1092, CAB1103, CAB1104) Inkjet Printer supplied by Laborie Beaker (UD575) T-DOC NXT Abdominal Catheter (CATT3A17) T-DOC NXT 7FR Single and Dual Sensor Bladder Catheters (CATT3BXXX part number series) Single, Dual, and Triple Lumen Bladder Fluid NXT Catheters (DLC-6D-RFID, DLC7D-RFID, CDLC-6D-RFID, CDLC-7D-RFID, 9021P5892-RFID) Abdominal Pressure, Fluid NXT Cathe
Quick Start UPP Puller NXT Cable (CAB1109) NXT Magnetic Pogo Pin Cable, Binder Termination, 3m Length (CAB1081) Status DRAFT Effective NXT Go Power Cord (POW006) USB to Binder Cable Adapter (CAB1117) Power Supply, Medical Grade, Class II Wall Plug (POW1033) NXT Go USB Cable (CAB1056) NXT Go Power Supply (POW1043) Roam NXT Mounting Bracket (MSM1153) NXT Go IV Pole Bracket (MSM1062) NXT GO Carrying Case (PKG1091) 2.
Quick Start 2.4 Preparing the NXT Go Pump Hub To prepare 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. Connect the NXT Go Pump Hub to the computer using the NXT Go USB cable.
Quick Start IMPORTANT: Removal of the Catheter Clamp may expose a sharp piece of metal protruding from the hinge. Take care when handling. To mount the UPP Puller NXT, slide the Pole Clamp onto the post of the UPP Stand. Ensure that the yellow bushing is facing upwards. Lock it in position with the Rubber Knob Screw located on the Pole Clamp. Loosen the thumb screw on the Pole Clamp and place the UPP Puller NXT Arm Clamp Insert into the clamp’s yellow bushing (Figure 6).
Quick Start 2.7 Setting Up Consumables and Preparing the Patient Synergy uses Consumable Traceability to track consumables used during studies. Prior to beginning consumable setup, ensure to start a study. For instructions on starting the study refer to the Start Study Button section on page 61. Complete consumable and patient setup in the preview phase of the study. Catheters and tubing must be scanned into Consumable Traceability to proceed from the preview phase.
Quick Start 2.7.1.1 Replacing the Pump Tubing To replace the pump tubing: Close the tubing clamp. Disconnect the pump tubing from the catheter. Remove the pump tubing spike from the bag and empty the saline bag. Open the pump door and remove the pump tubing. Discard the pump tubing according to your institution’s standard operating procedures on medical waste handling. Setup the new pump tubing as described in the Infusion Pump Tubing Setup section above.
Quick Start Figure 9: Catheters Connected to PIM NXT Verify that the catheter appears in the consumable traceability window in Synergy. If the catheter does not register in Synergy, disconnect the catheter and reconnect. Status DRAFT Effective Confirm positioning of the catheter using the Synergy interphase. Ask the patient to cough to confirm the catheter’s positioning. When recording two pressures at the same time, the cough will show equal deflection on both channels (Figure 22).
Quick Start information on connecting the PIM NXT to the Roam NXT, refer to the Replacing the PIM NXT section on page 102 Use the PIM NXT for Fluid to Medex Transducer Cables to connect the pressure transducers to the Pressure Channel Connectors on the PIM NXT for Fluid (Figure 11). Figure 11: Roam NXT, PIM NXT for Fluid, and Pressure Transducer Connected IMPORTANT: The Pressure Channel Connectors on the PIM NXT for Fluid are color coated blue for Pves, yellow for Pura, and red for Pabd.
Quick Start 2.7.2.3 Bladder Fluid NXT Catheters Scan the SmartSense tag located on the catheter’s packaging. Ensure the catheter is logged into the Synergy Consumable Traceability window. Aseptically remove the catheter from its package and apply a light film of waterbased lubricant to the distal end. Catheterize the patient. For female patients: Insert the Bladder Fluid NXT catheter 8-10 cm for single sensor, 12-14 cm for dual sensor.
Quick Start Slowly open the stopcock to the luer where the pressure measurement tubing will be attached. Connect the tubing to the stopcock as the meniscus forms on the stopcock luer. Take care not to lose fluid from the catheter. At the beginning of the study the abdominal pressure must equal vesicle pressure in Synergy. If Pabd is higher than Pves, slowly open the stopcock to the free luer connector and allow a drop of solution to escape. Repeat until Pabd equals Pves.
How to Perform a Study How to Perform a Study To perform a typical study, follow the instructions provided. Starting a Study Running the Study i) FreeFlow Study ii) Urology Urodynamic Study iii) Cystometry Study iv) Tests Finishing the Studies Printing the Study Result (Optional) 3.1 Starting a Study Status DRAFT Effective Ensure that the computer and printer are turned on. Start the Synergy application, and login using your credentials. A successful login will load the Synergy Main window.
How to Perform a Study c) To connect the Remote Control NXT, ensure the remote control is active then click the Search for devices button. This will cause the Find Devices window to popup (Figure 18). Select the Remote Control NXT and click the OK button. Figure 18: Find Devices Window Status DRAFT Effective Choose the patient from the Patients section. a) If the patient already exists in the system, select the patient and proceed to the next step.
How to Perform a Study 3.2 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 Gathering Supplies and Equipment section on Page 19. Starting the FreeFlow Study Start the FreeFlow study as described in the Starting a Study section on page 30.
How to Perform a Study Click the Zero Volume button to prepare the Urocap NXT and then click the Start Flow Phase button to start the study and move to the Flow phase. NOTE: Pause the study by clicking the Pause by clicking the resume 3.2.2.2 button and resume the study button. Flow Phase Instruct the patient to void. The Synergy application will automatically start to record data when the transducer detects the start of the flow.
How to Perform a Study Figure 21: Post Voided Residual Window Click OK on the Post Void Residual window to save data and advance to the Report. Pressing Cancel skips the PVR window. NOTE: Post Voided Residual may also be entered and edited in the Report. 3.2.2.3 FreeFlow Report Status DRAFT Effective A preview of the FreeFlow Report will be generated using the default (UDS) configuration settings (Figure 22). The user can apply the default configuration for the report or customize the report.
How to Perform a Study 3.3 Urology Urodynamic Study The Urology Urodynamic Study is a urologic diagnostic test that provides aid in the diagnosis of urine storage and voiding disfunction. The Urology Urodynamic Study includes a FreeFlow test and a Pressure Flow test. A Pressure Flow test involves filling the bladder and determining the Detrusor pressure Pdet = Pves – Pabd (the difference between the pressure inside the bladder (Pves) and the pressure inside the abdomen (Pabd)).
How to Perform a Study 3.3.2.3 Filling Phase Click the Start Filling Phase button window will display. NOTE: Pause the study by clicking the Pause by clicking the resume . The Filling phase button and resume the study button. If necessary, the Pabd channel value can be set to equal the Pves channel value by pressing the Equalize Pdet button. Status DRAFT Effective Click the Pump On button to start the Infusion Pump and begin filling the bladder.
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. 3.3.2.4 Voiding Phase The Voiding phase will begin (Figure 24). Click the Permission To Void button and ask the patient to void through the commode chair into the Urocap NXT setup.
How to Perform a Study 3.4 Cystometry Study A Cystometry study involves filling the bladder and determining the Detrusor pressure Pdet = Pves – Pabd (the difference between the pressure inside the bladder (Pves) and the pressure inside the abdomen (Pabd)). The Cystometry study provides one phase to complete filling and voiding. This allows the user flexibility in procedure structure. Starting the Cystometry Study Start the Cystometry study as described in the Starting a Study section on page 30.
How to Perform a Study Permission to Void button is selected in error, delete the event and continue “filling phase” activities by pressing the Pump On button. The Cystometry phase will stop 60 seconds after voiding ends. Alternatively click the Finish Procedure button. A Post Void Residual window will pop-up. Select the preferred method of capturing Post Voided Residual (PVR), meaning the amount of fluid remaining in the bladder at the completion of the voiding phase. Click OK to move to the Review phase.
How to Perform a Study Urethral Pressure Profile To start a Urethral Pressure profile (UPP) follow instructions provided in the Customizing Workflows section on page 56 on adding a UPP phase to a study or select a study template that contains a UPP phase. Ensure to complete patient and consumables setup as instructed in the Setting Up Consumables and Preparing the Patient section on page 24. 3.5.2.
How to Perform a Study Select the Stress Profile (On) toggle button to start the stress profile. The UPP Puller will begin pulling at the speed selected in the Workflow Configuration window. Select the Stress 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 repeat the profile.
Synergy Software Synergy Software This section provides an overview of Synergy software functions and features based on standard workflow: Accessing Synergy i. User Access Control ii. Sections and Icons in the Main Window Overview of Synergy Setup Features Required to Start a Study i. Patient Management ii. Study Management Overview of Synergy Functions Available During a Study i. Workflow Steps Study Process Review Status DRAFT Effective i. UDS Intelligence 4.
Synergy Software A successful login will display the Synergy Main Window. For an overview of features available on the Main Window, refer to the Sections and Icons in the Main Window section on page 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.
Synergy Software Status DRAFT Effective Figure 28: User Setup Window To reset the password of an active account, select the existing account from the user list. 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.
Synergy Software 4.1.2.2 Managing User Role All Synergy account types have pre-set permissions that control which function users may access based on user roles. Local and Domain Admins may manage user role permissions with the Manage User Role window. Follow the instructions provided below for managing user roles. Click the Admin icon Role (Figure 30).
Synergy Software Status DRAFT Effective Figure 32: Adding New User Role To reassign the account role, click the Admin icon located on the Synergy title bar and select User Setup > Update User Info Tab. Select the newly created role; press Save. 4.2 Sections and Icons in the Main Window This section overviews the various features accessible from the Main Window.
Synergy Software Overview of Sections A brief overview of the sections in the Main Window is provided in Table 2. Refer to Figure 33 for a visual guide showcasing the location of all sections described. Section Name Section Description Patients Lists all the patients. Add a new patient, delete patient, and search for a required patient.
Synergy Software Device Manager Displays the Device Manager window. Patient Settings Contains Patient Display Settings, Deleted Patients, Attending Doctors, Investigators, Referrals, and Patient Groups options. Database Management Contains Archive Patients, Import Patients, and Deleted Patients options. Workflow Contains Editor, Import Custom Workflow, and Export Custom Workflow. Editor displays the Workflow Configuration page; create new workflows and set hardware channels.
Synergy Software Figure 34: Patients Section 4.3.1.1 Adding a New Patient Click the New Patient button in the Patients section. Enter the patient details in the Patient Details section under the Info tab (Figure 35). Click the Save button under the Info tab to save the patient details. Status DRAFT Effective If required, enter the relevant past medical history under the History tab. Synergy will automatically save information entered.
Synergy Software 4.3.1.3 Searching for a Required Patient The Patients section will not show patient information until a search is initiated. Use the Search List search box located in the Patients section to search for a required patient. Enter an asterix “*” to view all patients, a plus sign “+” to view the last entered patient, or an element of the patient’s name to view a specific patient. All fields provided in the Patients section are searchable. 4.3.1.
Synergy Software 4.3.1.6 View Patients Entered through EMR The Patient section will show an icon indicating patients entered through the Electronic Medical Records (EMR) functionality in the EMR column (Figure 37). Figure 37: Patient List - EMR Status DRAFT Effective By default, this EMR column is not visible. To make it visible, navigate to Settings > Patient Display Settings. By default, the EMR field will be off. Select Table in the table options column and click Save (Figure 38).
Synergy Software Patient Details The Patient Details section (Figure 35) in the Main Window allows the user to: View previously conducted studies under the Studies tab View EMR status: report successfully sent or report not sent Create or edit patient information under the Info tab Enter relevant medical history under the History tab Select symptoms under the Symptoms tab . NOTE: All studies, including partial studies, will be stored under patient details once the study has started.
Synergy Software Database Management Navigate to the Toolbar and select Settings > Database Management. From this option select Archive Patients, Import patients, or Deleted Patients to launch the Database Management window. 4.3.3.1 Archiving Patients Patient data can be archived into an encrypted file on the computer system or on an external hard drive. Follow the instructions below for archiving patient data. Status DRAFT Effective Select the patients for archiving.
Synergy Software Click the Import button. A pop-up window will appear to confirm a successful import. Figure 41: Database Management – Import Patients Status DRAFT Effective 4.3.3.3 Restore or Permanently Delete Patient Data When a Patient is deleted from the Patients section, it can be restored from the Database Management window. Select the Deleted Patients tab in the Database Management window (Figure 42).
Synergy Software 4.4 Study Management Workflows Synergy Workflows control the structure and content of each study. Each Workflow has standard Workflow Steps: Procedure, Questionnaire, Report, and Review. Workflows vary by the phases contained in the default configuration of their Procedure workflow step. Access Workflow settings in the Workflow Configurator window by navigating to Settings > Workflow > Editor.
Synergy Software Customizing Workflows The Workflow Configuration window has three main sections: Workflow drop down menu, Workflow Steps, and Settings Tabs. To customize workflows or add workflows to the UDS tab, begin by creating a copy of the workflow template. Click Settings > Workflow > Editor in the title bar to launch the Workflow Configuration window (Figure 43).
Synergy Software 3P Urodynamics. Alternatively create a custom workflow by adding a UPP phase to the default workflow templates provided. b. The Phases setting tab allows for customization of auto and manual event markers per phase and of phase layout. i. Refer to the Customizing Control Panel section on page 58 for information on customizing event markers. Status DRAFT Effective ii. The Phases tab provides a phase layout for the workflow selected.
Synergy Software Channels: Channel Name, Channel Position, Channel Type, Unit, ScaleMax, ScaleMin, Color, Hardware channel, Chartdown Sampler Phases: Phase Name, Visible Channels, Channel Values Shown Separately, Workflow Additional Configuration Items, Additional Status Bar Items, Fluid Density Settings, Control Panel Events Summary: Select Event Names for inclusion in the Event Summary and view Marker type.
Synergy Software Status DRAFT Effective Click the Phases tab on the Workflow Configuration Window. Select a phase to customize from those listed. Scroll down to the control panel section located at the bottom of the window. Refer to Figure 45. Figure 45: Workflow Configuration Window - Control Panel Verify that the desired number of Control Panel buttons are provided. Use the Row Count and Column Count fields to increase or decrease the number of buttons shown in the control panel.
Synergy Software To customize the appearance of buttons, click the Options icon located beside the button. A window will appear where minor button functions and appearance may be adjusted (Figure 47). Options include button caption, colors, and connectivity. Once edits are complete click OK. Figure 47: Edit Control Panel Button Status DRAFT Effective Click the OK button located at the top of the Workflow Configuration window to implement all changes to the custom workflow. 4.4.2.
Synergy Software Start Study Button The Start Study button (Figure 49) launches Synergy into the Preview Study phase. Figure 49: Start Study Button Status DRAFT Effective Once all study inputs are received the button will shift to blue. When greyed out the button cannot be activated. Hover the curser over the Start Study button to activate tool tip functionality which will suggest troubleshooting options, as shown in Figure 50.
Synergy Software To proceed through the workflow steps and their phases, utilize the icons described below in Table 6: Icon Button Description Allows the user to proceed to the next phase of the study. During a Urodynamic study the ‘Next’ icon will be accompanied by the title of the next study phase. Next Pause Resume Close Allows the user to pause the study. Allows the user to resume the study. Allows the user to close the phase window.
Synergy Software 4.5.1.2 Consumable Traceability During the Preview phase, the user will need to enter each of the consumables applicable for the study under the Consumable Traceability window. 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.
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. b. To manually enter data into Synergy, press the Add Other Consumable button.
Synergy Software In the Flow and Voiding phases, the Synergy software will automatically start to record data when the Urocap NXT detects the start of the flow. The Voiding phase will stop 60 seconds after voiding ends by default. The user may also click the Next icon to proceed to the next step. Events are marked on the graph as they are entered by the user or automatically generated by the software.
Synergy Software Select the patient from the Patients Section in the Main Window, refer to Figure 34 for a visual reference. Open the report from the Patient Details section. The report will automatically generate in conformance to the UDS report configuration. Press the copy button located beside the Configuration title (Figure 54). If desired, change the title of the new report configuration under the Name category.
Synergy Software Enter any comments in the window and select the save icon Comments window’s toolbar. on the Ensure the Comments option is checked under Report content in the Configuration settings. To edit comments from the Configuration Settings, open the Comments dropdown menu and select the click to enter text! option. This will open the Comments window. Status DRAFT Effective The Comments dropdown menu includes a secondary dropdown called Header title.
Synergy Software 4.5.4.4 Normal Values Normal Values is a data field available for activation within report customization. The Normal Values field is intended to provide an expected range of values for different events which may occur during the study (Figure 57). By default, the Normal Values field will be unchecked in the Configuration Settings for the report.
Synergy Software Figure 58: EMR Sending Status NOTE: The Send to EMR button will not be accessible when using the Preview Changes feature to view report configuration. Click Apply Changes on the report Configuration Settings panel to access the Send to EMR button. Review Status DRAFT Effective The Review workflow step allows the user to assess the information recorded during the study.
Synergy Software NOTE: fixed events, such as pump markers, cannot be moved or deleted from the graph. Use the vertical red marker to zoom in on a specific portion of the graph. Left click and drag the red marker to select the portion of the graph to expand. Use the Previous Zoom button in the control panel to return to the previous magnification or click Zoom 100% to view the full graph. Move the phase boundaries in the graph.
Synergy Software 4.6 UDS Intelligence Quality Control (QC) The UDS Intelligence capabilities within Synergy allow the software to provide feedback on user adherence to required standards and procedures throughout the study. The Quality Control window can be accessed by selecting the Quality Control Icon on the Slide Sidebar at any time during the study. The quality feedback provided in the Quality Control window will vary based on the workflow step. 4.6.1.
Synergy Software 4.6.1.2 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 61). The Quality Control icon will shift colors as the phase score evaluation changes. The Protocol Scores are color coded in accordance with QC Score values. Green signifies an excellent score, Amber a good score, and blue a fair score.
Synergy Software QC Score and QC Score Summary The QC Score is an aggregated estimate of the quality of the workflow tasks performed while conducting a study. The QC Score can be viewed in a summary at the end of study Report or from the Quality Control icon in the Slide Sidebar. By default, the QC Score Summary field will be unchecked in the Configuration Settings of the report (Figure 63).
Synergy Software Flow Phase Volume Voided Pediatric Volume Voided Adult PVR Beaker Blue=0 points No uroflow volume recorded No uroflow volume recorded No PVR value entered Beaker not empty at start of flow (Beaker weight >= 25 gm) Yellow=+5 points Volume voided > 0 Volume voided > 0 Not Possible Beaker empty at start of flow (Beaker weight < 25 gm) Green=+10 points Volume voided ≥ 50% EBC Volume voided > 150 ml Any PVR value, including 0 ml Not Possible Filling Phase Blue=0 points Yellow=+5 points Gre
Maintenance and Service Maintenance and Service 5.1 Cleaning and Disinfection General Cleaning and Disinfection This section provides limitations and recommendations for the cleaning and disinfection processes to be performed by the user on the standard modules of the NXT System. See the Equipment Intended Use section on page 13. Synergy is an application software. It does not require reprocessing. The Bluetooth Dongle is not intended for reprocessing.
Maintenance and Service 5.1.1.3 Status DRAFT Effective Disinfection – Devices should be disinfected in accordance with the frequency defined below. o Roam NXT, PIM NXT, Urocap NXT, UPP Puller NXT: Perform disinfection after the device has contact with the patient’s skin, contact with a contaminated catheter, or after contamination has been observed (e.g. presence of urine on the device), or, at minimum, daily.
Maintenance and Service 5.1.2.3 Roam NXT and PIM NXT Preparation To prepare for cleaning or disinfection, remove the belt clips from the Roam NXT and the PIM NXT. Refer to the Removing and Attaching the Clip section on page 103 for instructions on removing the clip. When performing cleaning or disinfection, the Roam NXT and PIM NXT can be separated by unfastening the screw holding the Roam NXT and the PIM NXT together.
Maintenance and Service Visually inspect the vent hole for soiling. If soiling or debris is observed, gently wipe the affected area with a cleaning wipe. Take care to prevent any excess cleaning reagent from entering the vent hole. Repeat as necessary using a fresh wipe or the clean side of the existing wipe until the affected area is visibly clean. If visible soil persists, use a soft bristle brush to gently brush away or loosen the remaining soil, then wipe again using a fresh wipe.
Maintenance and Service 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. To clean the Infusion Pump NXT rollers, located on the NXT Go Pump Hub (Figure 64), open the pump door and wipe each roller with an approved cleaning reagent. Refer to the Cleaning and Disinfection Reagents section on page 75.
Maintenance and Service Remove any visible soiling by hand immediately after the completion of a study using a dry, soft, lint free cloth. Gently wipe down the surface of the Computer, NXT module, or peripherals using a fresh cleaning wipe to remove visible soil. Use a fresh wipe to thoroughly wet the external surfaces of the device. Wipe around cables, edges, cracks, crevices, corners, and hard-to-reach areas. Ensure that all surface areas and connectors have been in contact with the wipe.
Maintenance and Service 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. Re-insert the vent plug. 5.1.4.
Maintenance and Service To use the system after cleaning or disinfection, re-connect power to the system, dock devices, and follow the instructions provided for normal use. 5.1.5.2 Packaging and Storage Devices may be packaged flat in a clean, anti-static box or wrapped in a lint free cloth postcleaning or disinfection. Do not stack devices on top of each other and ensure that devices are not pressed against each other or against the container.
Maintenance and Service 5.2.1.2 Caring for the Urocap NXT Ensure the Urocap NXT cover is not displaced or stretched after completing the cleaning or disinfection process. 5.2.1.3 If the cover of the Urocap NXT becomes displaced, gently apply pressure around its circumference to ease the cover back into place. If the device’s rubber feet are lost or damaged, contact LABORIE Service for a replacement. If the device’s vent plug is lost or damaged, contact LABORIE Service for a replacement.
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. If verification procedures reveal a calibration malfunction, contact LABORIE Service for a replacement device.
Maintenance and Service d) Press the Zero Weight button. e) The Relative Weight for Urocap NXT should measure at 0.0g +/- 2g immediately following zeroing. To verify calibration, check the absolute and relative weight with water. f) The Absolute Weight should measure 0.0g +/- 1kg. 5.3.1.2 Checking the Relative Weight with Water To complete calibration verification for the Urocap NXT, check the relative weight with water: a) Take a beaker and place it on the Urocap NXT. Wait 10s.
Maintenance and Service 5.3.2.1 Verifying EMG Capability To begin verifying calibration for Roam NXT EMG capability, gather one calibrated signal generator (capable of generating sinusoidal waves at 10Hz-200 µV) with one alligator cable, three Touchproof 1.5mm connectors, and one EMG input cable. To complete calibration verification: a) Setup a signal generator; prepare to create a sine wave with 10 Hz, and 200 µV. b) Connect the touchproof connectors to the signal generator using the alligator cable.
Maintenance and Service 5.3.2.2 Verifying Pressure Measurement Capability To begin verifying calibration for the PIM NXT transducers, gather one Cylinder at least 25 cm tall and one NXT Catheter. To complete calibration verification: a) Fill a cylinder with 20cm of water. b) Coil the NXT Catheter inside the cylinder so that all pressure ports touch the bottom of the cylinder. c) Connect the catheter to the relevant PIM NXT channel.
Maintenance and Service 5.3.3.1 Checking the Total Weight without a Saline Bag To begin calibration verification, measure the total weight of the Infusion Pump NXT and Infusion Volume Transducer without a saline bag: a) Setup the Infusion Volume Transducer without a saline bag. b) Click the Settings icon in the title bar, then click System Settings > Device Manager option. The Device Manager window will pop-up. c) Click the Infusion Pump NXT option, then click the Run Diagnostics button.
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.
Maintenance and Service Urocap NXT and Wall Charger Isolation Diagram Refer to the diagram below in Figure 73 for a visual representation of the method to isolate the Urocap NXT from supply mains when configured with a wall charger. For further information regarding electrical isolation, contact LABORIE Service.
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.
Maintenance and Service Symptoms Computer or Printer cannot power on? Possible Cause(s) Corrective Action(s) Devices not connected in software? Reconnect the devices to the system through the USB cables provided. Consult Device Manager Window to confirm device connection. No power on electrical outlet? Ensure electrical outlet is working, power cords are not damaged, and all power cords are secure at both ends.
Maintenance and Service Symptoms Possible Cause(s) Corrective Action(s) Zeroes not set properly? Reset zeroes in Preview workflow step. Catheter kinked? Replace catheter if necessary. Pump pressure limit reached? Reset Pves to zero. Check for kinked bladder catheter. Ensure Pump pressure does not exceed 150 ml/min. Pump settings? Check Pump and Infusion lines. Check if Pump door is closed. Check if Pump tubing is inserted correctly.
Maintenance and Service Symptoms Possible Cause(s) Corrective Action(s) Incorrect beaker in use? Use beakers supplied by LABORIE only. Connection broken? Reduce the distance between the device and the computer. The maximum distance between the processor and the computer can be up to 10 meters (33 feet). Bluetooth Connection Unable to connect via Bluetooth? Clear any physical barriers between the device and the computer.
Maintenance and Service Symptoms Possible Cause(s) Corrective Action(s) When performing Valsalva procedure, patient is triggering a sharp rise in pressure resembling a cough spike? Activate Bristol cough marker in the workflow configuration. Software Valsalva readings are being marked automatically as coughs. Click on Settings>Workflow Settings>Phases. Create a copy of the workflow.
Hardware Hardware 6.1 Laptop Personal Computer For information on the specifications of the laptop personal computer provided with the NXT System, refer to Table 15: Equipment Specifications in the Appendix section beginning on page 110. 6.2 Bluetooth Dongle NXT Status DRAFT Effective The Bluetooth Dongle NXT, as shown in Figure 75, allows modules such as the Roam NXT and Urocap NXT to wirelessly communicate with the NXT system. Figure 75: Bluetooth Dongle NXT 6.
Hardware Status DRAFT Effective Key Icon Function Key Icon Function Begin Recording Pump Speed Increase Stop Active Hardware Pump Speed Decrease First Sensation Marker Pump On/Off First Desire to Void Marker Balance/Equalize 1 (Standard) Normal Desire to Void Marker Balance/Equalize 2 Maximum Capacity Marker Zero All Pressures Cough Marker Stress Profile On/Off Valsalva Marker Rest Profile On/Off Urgency Marker Puller Return/Stop Leak Marker Record Video Burst User Custom 1-4 Vide
Hardware Remote Control NXT Battery Replacement To replace the Remote Control NXT battery: Use a Philips screwdriver to unscrew the two screws on the battery door at the back of the Remote NXT. Remove the used battery and replace it with the new battery. Ensure that there is correct battery contact orientation. Always use 3xAAA batteries. Place the screws in the two screw holes on the battery door and tighten the screws to secure the battery door using a Philips screwdriver. 6.
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.
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. Ensure the NXT Go Infusion Hook connector cable is attached to the NXT Go. Hang a 1000 ml bag of sterile saline or water on the NXT Infusion Hook.
Hardware 6.7.1.1 PIM NXT for T-DOC The PIM NXT has four transducer channels for use with T-DOC NXT catheters and two EMG input ports to connect to EMG accessories such as patches, fine wires, and needles. The PIM NXT houses SmartSense tag readers in each transducer channel to scan catheters upon insertion of the catheter connector into each channel. Refer to the Consumable Traceability section on page 62 for more information on scanning catheters into Synergy software.
Hardware Interlocked Roam NXT, PIM NXT for Fluid, and Cables - Front View Battery LED Status PIM NXT for Fluid – Front View Clip Roam NXT LED Status EMG Port Pressure Channel Connectors PIM NXT for Fluid to Medex Transducer Cables Medex LogiCal® Pressure Transducer Disposable Cartridge Figure 82: Roam NXT and PIM NXT for Fluid Controls Status DRAFT Effective Replacing the PIM NXT Follow the instructions provided below for replacing the PIM NXT.
Hardware a. To directly connect the PIM NXT (Figure 84) and the Roam NXT, fit the loosened screw through the slot in Roam NXT base. Figure 84: PIM NXT (with screw and belt clip) Status DRAFT Effective b. To use the connector cable (Figure 85), fit the loosened screw on the PIM NXT through the slot in the cable connector and fit the loosened screw on the cable connector through the slot in the Roam NXT. Figure 85: PIM NXT and Roam NXT with the Connector Cable 2.
Hardware Pair the device by using the USB cable adapter and the pogo pin cable to connect the device to the laptop PC. Once the device displays in the Synergy Device Manager, disconnect the cable from the laptop and the laptop 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 12 hours of battery charge before beginning a test.
Hardware 6.8 Urocap NXT The Urocap NXT with wireless technology (Figure 87) is a portable Uroflowmeter that provides a non-invasive and accurate measurement of urinary voiding functions. The Urocap NXT is intended to be used to quantify the flow characteristics of the lower urinary tract. Using a built-in transducer, the system performs standard Uroflowmetry studies that measure both flow rate and voided volume.
Hardware Urocap NXT—Charging the Battery and Pairing Charge the Urocap 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 Urocap NXT. Pair the device by using the USB cable adapter and the pogo pin cable to connect the device to the laptop PC.
Hardware 6.9 UPP Puller NXT The UPP Puller NXT supports the completion of Urethral Pressure Profile Studies. The UPP Puller NXT consists of the motor, nose, arm, and pole clamp. The UPP Puller NXT comes with a wall charger and the UPP Puller NXT Cable for charging or pairing. The Puller NXT pole clamp allows the UPP puller to be mounted on the UPP Stand or IV Pole. Refer to Figure 89 for an overview of important parts and controls.
Hardware UPP Puller NXT Battery Status UPP Puller NXT Status Breathing Green: Sufficiently charged or charging. Breathing Green: Ready Breathing Amber: Battery is low (less than 60 minutes of operation). Breathing Amber: Puller is not ready for sampling or motion. Status DRAFT Effective Lack of illumination: Empty/Sleep mode (No declared battery capacity) Breathing Green - Fast: Sampling or actuator is in motion. Breathing Blue: Firmware upgrade is in progress.
Hardware To disconnect the catheter from the PIM NXT, press down on the thumb tab and gently pull the connector from the PIM NXT. T-DOC catheters provide the option of an integrated infusion lumen that connects to the LABORIE Infusion Pump Tubing. Each catheter connector contains a SmartSense tag that allows the user to scan information into the Synergy software facilitating consumable traceability.
Appendix Appendix Appendix A: System Specifications Equipment Specifications NXT Go Power Requirements For proper operation, the system requires main power 120-240 VAC, 50/60Hz. POW1043: PSU, Medical Grade, 24V, 1.33A AC/DC POW006: Power Cord, 110V, 18AWG, 10ft, 125V, 10A CAB1056: Cable, USB 2.
Appendix Ports: 3x USB, 1x USB-C, 1 HDMI, 1 Ethernet, Micro SD Wireless: Wireless LAN 802.11 ac Dual Band Bluetooth: Laborie Bluetooth Dongle required Audio: Internal speakers, Headphone & Microphone Conference: Integrated Webcam with microphone Keyboard: 102/3 keys with function keys & number pad Variants: USA, UK, Canadian bilingual, Spanish QWERTY, French AZERTY, German QWERTZ Battery: Up to 4 hours Dimensions: 24 x 36 x 1.5 cm, 1.9kg, 9.5 x 14 x 0.6”, 4.
Appendix Roam NXT Dimensions: 154mmx65mmx38mm P/N: ROX2001 Weight: 229 g Power Supply: 5VDC, 1.5A max IP Rating Compliance: IP47 Type BF Applied Part: EMG/CMG, Pressure transducers External Materials: Cycoloy C6200-111, Makrolon, Dow Corning, Elastosil 3003/70 A/B, Gold-plated brass, Lexan 8010 Film, Loctite. PIM NXT for T-DOC Dimensions: 76mmx72mmx26mm P/N: PIX2211 Weight: 90g Pressure Range: -70 to +400 cmH20; EMG Range: ±1mV Output Channels: 4 Pressure /2 EMG Bandwidth: Pressure= 20Hz; EMG=0.
Appendix 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 P/N: UCX2001 Weight: 1.8 lbs. (0.82kg) Arm extension: 32” (81.3cm) Speed: 0 to 2 mm/s IP Rating Compliance: IP54 Supported catheter sizes: 4.
Appendix Classification and Applicable Directives Classifications Class I Type BF Applied Part Mode of Operation: Continuous Status DRAFT Effective Equipment not suitable for use in the presence of a Flammable Anesthetic Mixture with Air or Oxygen or Nitrous Oxide. Applicable Directives and Standards IEC 60601-1:2012 CAN/CSA C22.2 No. 60601-1:14 AAMI/ANSI ES60601-1:2005/(R)2012 + A1:2012 EN 60601-1:2006/A1:2013 IEC 60601-1-6:2006 + A1:2013 IEC 60601-2-49:2011 CAN/CSA C22.
Appendix Appendix B: Symbols Glossary Authorized Representative in the European Community (5.1.2)1: Status DRAFT Effective Indicates the manufacturer’s device representative in the European Community. SGS certification certified to U.S. and Canadian safety standards. Lot - Batch Code (5.1.5) 1: Catalogue Number (5.1.6)1: Indicates the batch or lot code for identification and tracking purposes. Indicates the device model or catalogue number. Sterile (5.2.1)1: Indicates a sterile device.
Appendix Do Not Stack Protective Earth, Grounding (2402) 3: (Table D.1, 7) : Indicates the items shall not be vertically stacked, either because of the nature of the transport packaging or the nature of the items themselves. Identifies any terminal intended for connection to an external conductor for protection against electric shock in case of a fault, or the terminal of protective earth electrode. System Safe Working Load Status DRAFT Effective 1. 2. 3. 4. 5.
Appendix Appendix C: Electronic Compatibility (EMC) The NXT needs special precautions regarding EMC (Electro Magnetic Compatibility) 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 only use catheters and accessories as supplied or recommended by LABORIE. Contact LABORIE for approved catheters.
Appendix Guidance and Manufacturer’s Declaration—Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment — Guidance Electrostatic discharge (ESD) ±8 kV contact ±8 kV contact ±15 kV air ±15 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Appendix Guidance and Manufacturer’s Declaration—Electromagnetic Immunity Immunity test IEC 60601 Test level Compliance Level Electromagnetic Environment— Guidance Portable and mobile RF communications equipment should be used no closer to any part of the NXT, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Appendix 1970 MHz 28 V/m 2450 MHz 9 V/m 5240/5500/ 5785 MHz Status DRAFT Effective Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a.
Appendix 100 11,70 11,70 23,30 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts(W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations.
