LABORIE Nexam Pro WPU-L4 User Manual

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Page 1 Nexam Pro User Manual...
Page 2 MMS is a registered trademark of Medical Measurement Systems BV, Enschede, the Netherlands All rights reserved. IMAGES/RENDERINGS OF LABORIE DEVICES IN THIS PUBLICATION ARE PROPERTY OF LABORIE AND MAY NOT BE REPRODUCED WITHOUT THE PRIOR WRITTEN PERMISSION OF LABORIE. © Copyright 2011–2021 LABORIE...
Page 3: Table Of Contents
2.5.11 Prepare the Flowmeter ............48 2.5.12 Prepare the Catheter Puller ..........50 Run Quality Check ................. 53 Perform the Investigation ............... 54 Print the Investigation Report ............55 Cleaning Instructions ..............56 2.10 Exit the LABORIE Database Program ........... 58 Nexam Pro User Manual...
Page 4 Urodynamic Catheters & Transducers ..........59 Introduction ..................59 Prepare the Catheters and Transducers ........60 Reusable Solid-State Catheters ............ 60 Single-Use e•Sense Solid-State Catheters ........61 Air-Charged Catheters ..............62 Water Catheters ................65 3.6.1 Introduction ................ 65 3.6.2 Measuring Pves and Pabd ..........
Page 5 Gynecology Study ................105 Introduction .................. 105 Channels ..................105 Investigation ................. 106 Results ..................110 Anorectal Manometry ................111 Introduction .................. 111 Investigation Protocol ..............112 9.2.1 Edit the Anorectal Manometry Protocol ......112 9.2.2 Select the Catheter ............113 9.2.3 Select the Anorectal Manometry Tests ......
Page 6 9.4.14 Stop the Investigation ............145 Analysis ..................145 9.5.1 Insert Channel Markers ............ 146 9.5.2 Channel Definition ............146 9.5.3 Anorectal Manometry Settings ......... 148 9.5.4 Results ................149 9.5.5 Resting Pressure Test ............150 9.5.6 Squeeze Test ..............151 9.5.7 Endurance Squeeze Test..........
Page 7 12.5 Investigation Protocol ..............197 12.5.1 Edit the Protocol ............... 197 12.5.2 Include/Exclude Investigations for Protocol ..... 198 12.5.3 General Protocol Settings ..........199 12.5.4 LABORIE Assistant ............201 12.5.5 Compliance ..............201 12.5.6 Sensation Markers ............202 12.5.7 Investigation Specific Settings ......... 203 12.5.8 Channel Settings ..............
Page 8 13.5.5 Detrusor Volume Plot ............226 13.5.6 ICS Detrusor/Flow Plot ............. 226 13.5.7 Griffiths Detrusor/Flow Plot ..........227 13.5.8 Schäfer Detrusor/Flow plot..........228 13.5.9 CHESS Detrusor/Flow plot ..........230 13.5.10 WF/Volume Plot ............231 13.5.11 Blaivas Detrusor/Flow Plot ..........232 13.5.12 Composite Nomogram ..........
Page 9: Introduction
Nexam Pro trolley. Following are the models of the Nexam Pro system are: • Nexam Pro WPU trolley system—For air-charged catheters and solid- state catheters (LABORIE systems catalog code U8-3), and • Nexam Pro CIM trolley system—For water catheters and pressure transducers with Argon or Memscap connectors (LABORIE systems catalog code U8-4).
Page 10 Windows 7, Windows 8, and Windows 10 are trademarks of Microsoft Corporation, USA. The Microsoft Office User Interface is subject to protection under US and international intellectual property laws and is used by Medical Measurement Systems under license from Microsoft. The LABORIE software includes the Fatcow icon pack from www.fatcow.com/free-icons.
Page 11 You can find a description of all modules in the Nexam Pro Service & Installation Manual (Document Code: MAN-00031). The most common modules are described in the table that follows. After receiving new manuals, always keep the old manuals as supplied with your Nexam Pro measurement system.
Page 12 Module Description Wireless This module can measure one patient pressure and two EMG signals via a module wireless connection. Wireless This module can measure four Patient Unit pressures and one EMG signal via a (WPU-L4 / wireless or a wired connection. (WPU-eS) Catheter The wireless puller withdraws the...
Page 13: Intended Use
Safety Information The Nexam Pro User Manual is intended for users performing investigations by using the Nexam Pro measurement system. Before working with the LABORIE measurement system and its manuals, read the safety information presented in Appendix A. Introduction Nexam Pro User Manual...
Page 14: Accessories
LABORIE representative. LABORIE Software Program The LABORIE software program is provided on USB or DVD and should be installed on the computer to make the complete system function. For an overview of the software messages that require an action to resolve, see Appendix C .
Page 15: Computer Requirements
LABORIE database program Analysis program Figure 1.3 LABORIE software program Computer Requirements The minimum computer requirements for the LABORIE Windows software for the Nexam Pro system are as follows: • Processor: Intel Core I3-4160 • CPU 3.6 GHz • Internal memory: 4.0 GB •...
Page 16: Laborie Assistant
LABORIE Assistant The LABORIE assistant (Figure 1.4) is an intelligent assistant that can provide helpful advice to you via pop-up messages. The message and the assistant will close when you click the OK button in the message box. You can configure the behavior of the assistant in the database, measurement, and analysis program.
Page 17: Manual Conventions
LABORIE Manual document code Nexam Pro Nexam Pro User Manual LBL-001021 Nexam Pro Service & MAN-00031 Installation Manual Mounting instructions for MAN-00032 Nexam Pro O-pole Neuro Module User’s Manual Neuro add-on LBL-001000 Video User’s Manual Video option LBL-000984 Network User’s & Installation...
Page 18 Use of bullets Bullets are used in a list. • (round bullet): Used for an item of a list. ▪ (square bullet): Used for a step of a procedure. Click, press, and choose In this manual, we distinguish the use of the software (clicking buttons and choosing a menu item) and the use of the keys on your keyboard.
Page 19 The note sign appears when it is important to read the information. Feedback on the manual LABORIE welcomes your opinions and ideas to improve our manuals. Please send your questions and remarks to our Training & Education department: education@laborie.com Introduction...
Page 20: Investigation Procedure
Chapter 11 explains the Luna module and the procedure to switch from stationary to ambulatory measurement. The investigation procedure can be as follows: ▪ Start the LABORIE database program. ▪ Enter and select the patient. ▪ Start the measurement program.
Page 21: Start The Laborie Database Program
Start the LABORIE Database Program On your desktop, double-click the Laborie-Login button to log in to the LABORIE database. Figure 2.1 The Login window 2.2.1 Administrator Authentication From the Login window, click the button to open the Administrator Authentication window to manage the User/Password Figure 2.2 The Administrator Authentication window...
Page 22 Figure 2.3 Login Settings—General tab If the location of the files of the LABORIE network software changes, you can enter them in the following fields: • Local dir for the location of the locally installed software. • Network dir for the location of the files on the network.
Page 23 636. For this option to function correctly, the SSL certificate being used on the AD/LDAP server needs to be installed on the machine running the Laborie software. • Set the LDAP Host and Port. • Set the LDAP Base DN Groups, which is the base node from which all groups will be searched recursively.
Page 24: Laborie Patient Database
LABORIE Patient Database From the Login window, enter the username and password and then click OK to start the LABORIE patient database program. Figure 2.5 Database program In the patient database, you will find a list with all patients and the investigations performed on the selected patient.
Page 25: Start The Measurement Program
Enter the patient information before starting a new investigation. You can switch to the next field by pressing the Tab key on your keyboard or by clicking in the field via the mouse. Click the OK button to save the information of the new patient. The patient is now displayed and selected in the patient list.
Page 26: Prepare The Investigation (Pre-Test)
Select the appropriate investigation protocol and then click the investigation name to start the pre-test of the selected investigation. Prepare the Investigation (Pre-Test) 2.5.1 Start the Pre-Test After selecting the investigation name in the measurement program, the pre-test will start. Figure 2.8 Pre-test pressure-flow study 2.5.2 Consumables Traceability...
Page 27 Figure 2.9 The Consumables traceability dialog box This feature registers what catheters and infusion pump tubing (type and lot number) have been used for each study and patient. It also will warn when consumables are about to expire as well as ensure that single-use consumables are not reused on other patients.
Page 28 Bypass option. By selecting this option, traceability will not be possible for the investigation; however, you can continue to perform the investigation. If there are no bypasses remaining, contact the LABORIE service desk for assistance.
Page 29 consumable becomes unusable (for example, it has become non-sterile), you can manually remove it from the repository by selecting it in the repository overview and then clicking the Delete button. This removes only the single consumable that you selected. Consumables Display After an investigation is performed, the used consumables will be shown in the database next to the preview of the investigation.
Page 30: Pre-Test
2.5.3 Pre-Test In the pre-test you will prepare the patient and the measurement system; for example, install the pump tube, insert the catheters, and zero the pressures. Note that data will not be stored, and markers cannot be placed. After finishing the pre-test and running the quality check, you are ready to start the actual investigation.
Page 31 Figure 2.9 Nexam Pump Unit with bag of saline Control panel The control panel of the pump unit has the following: • Two white LEDs (for indicating the rotation direction) • One status LED • One flush button For more information about the Flush button and rotation direction, see the next page.
Page 32 Control panel Figure 2.10 NPU Status LED Figure 2.11 Status LED on control panel The following table describes the status LED: Status LED Description Green on Pump unit is connected to the system and operational Orange on Pump unit is in IPL mode. Firmware can be loaded. Pump unit is not connected to system or defect.
Page 33 (see the Nexam Pro Service & Installation Manual, LABORIE Document Code: MAN-00031). The default flush time is five seconds. When the volume flushed through the pump tube is too low or too high, you can change the setting. The flush speed and flush time can be set in the diagnostic program (see the Nexam Pro Service &...
Page 34 1. Lever to press the tube clamp over the tube 2. Mark on tube clamp to indicate 5-roller or 10-roller pump 3. Tube clamp 4. Rollers 5. Control panel 6. Flush button 7. Weighing hook (infused volume transducer) Figure 2.13 Transparent view of pump unit Install the pump tube as follows: ▪...
Page 35 Pump tube pulled down in round opening Figure 2.15 Pump tube pulled all the way down ▪ While placing the pump tube, note the following: 1. For correct functioning of the pump, it is essential that the pump tube is inserted on both sides of the pump head into the V-shaped grooves and pulled all the way down into the round openings.
Page 36 NOTE For correct functioning of the pump, it is essential that the bag of saline hangs freely on the hook of the pump. When the pump is running, the bag should not be touched, because this can affect the infused volume measurement.
Page 37: Prepare The Combination Interface Module
the investigation protocol. The default is 150 cmH O; the maximum setting is 200 cmH 2.5.5 Prepare the Combination Interface Module The Combination Interface Module (CIM module) combines interfaces for pressures, EMG and/or conductance in one housing. Depending on your configuration, the module contains: •...
Page 38: Prepare The Luna Wireless Module
Figure 2.18 CIM module for Argon transducers 1. Argon connectors for DT-XX pressure 3. Ground reference transducers 4. EMG 6-pole DIN connector 2. Connector for cable to U2M module 5. Holder for DT-XX transducers 2.5.6 Prepare the Luna Wireless Module The Luna module is a wireless interface for measurement of pressures, EMG and/or conductance.
Page 39: Prepare The Wireless Patient Module
Optionally, the Luna can be used as follows: • As a stand-alone system for ambulatory urodynamic investigations • To start with a stationary urodynamic investigation and to continue with the ambulatory urodynamic investigation The Luna is supplied with a Bluetooth wireless interface for communication with the computer.
Page 40: Prepare The Wpu
Figure 2.21 shows the WPM with the status LED [1] indicating the battery and the Bluetooth connection. In the second figure you see the connectors of the WPM: one pressure connector [1] and two EMG connectors [2] and [3] . The wireless patient module communicates through a wireless Bluetooth connection with the computer.
Page 41 The WPU communicates with the computer via a wireless Bluetooth connection, using a Bluetooth Smart Long-Range USB dongle (BT-SLR dongle). Figure 2.24 Bluetooth Smart Long-Range dongle The WPU module is powered by one battery (type AA alkaline 1.5 Volt). Install or change the battery by removing the rubber cover of the battery compartment (at the back of the WPU) by pressing on the cover, forcing the small tab upward, which can be used to remove the cover.
Page 42 disturbances that compromise the wireless connection or in case high speed EMG is used. The WPU-L4 module contains: • Lemo 4 receptacles for reusable solid-state catheters or single-use air- charged catheters. • EMG receptacles for EMG electrode leads. The WPU-eS module contains: •...
Page 43 Figure 2.27 WPU-eS with its connectors RJ-45 receptacle for e•Sense bladder RJ-45 receptacle for e•Sense pressure catheter or e•Sense bladder and abdominal pressure catheter urethral pressure catheter The WPU can be affixed to the patient’s leg by using an elastic disposable strap.
Page 44 Figure 2.29 Best position WPU Figure 2.30 Position WPU not correct As an alternative for the leg strap, the neck cord can be used. Figure 2.31 neck cord The WPU has one status LED. The following table provides a description: Indication for Indication for cable wireless...
Page 45: Prepare The Catheters And Transducers
Indication for Indication for cable wireless application application Orange on WPU in IPL mode. No valid firmware available in the WPU. No or empty battery. No MMS-bus connection, no USB Place a new battery in the connection on U2M, no power battery compartment.
Page 46 Figure 2.32 Surface EMG electrodes The procedure is as follows: ▪ Connect the EMG cable/leads to the CIM (see § 2.5.5), Luna module (see § 2.5.6), WPM (see § 2.5.7), or WPU (see § 2.5.8). ▪ Position two EMG surface electrodes on either side of the anal sphincter: o With a gloved hand, spread the buttocks until the entire anal sphincter is visualized.
Page 47 EMG cables and electrodes The following types of EMG cables/leads and electrodes are recommended to use with the CIM module: • EMGC-D5-SUR (= guarded EMG cable with DIN-5 connector and integrated DIN 42 802 and three electrodes with press studs, 180 cm). •...
Page 48: Prepare The Flowmeter
• LABORIE EMG-PE (= disposable waterproof protected EMG surface electrodes including lead wires) to be used with EMGC-3DIN-TP-40 (= guarded EMG cable with three x DIN42802 plug and three x DIN 42802 receptacle). • EMGC-3DIN-CN200 (short EMG adaptor cable with three x DIN42802 to female DIN 5 and 200 cm reference lead), to be used for needle EMG electrodes.
Page 49 Status LED flowsensor The status LED may show different colors; the indication is as follows: Indication Orange on IPL error. Contact your LABORIE representative. Green on Digital cable is connected. Investigation Procedure Nexam Pro User Manual...
Page 50: Prepare The Catheter Puller
Green blinking Bluetooth communication flowsensor powered by (short periods off) power adapter. Green blinking Bluetooth communication flowsensor powered by (long periods off) batteries. Red blinking Low battery message, place new batteries in the battery compartment. No or empty batteries. Place new batteries in the battery compartment.
Page 51 The wireless catheter puller communicates through a Bluetooth connection with the computer. The puller is powered by four AA type rechargeable batteries (NiMH) or the supplied medical-grade dedicated power adapter. While powered by the adapter, the batteries are being charged. 1.
Page 52 Orange on IPL mode and/or downloading firmware. Red on The puller has detected an internal failure. Contact your LABORIE representative. Battery Green on The rechargeable batteries are fully charged. Green blinking The power adapter is connected to the puller (and charging the batteries).
Page 53: Run Quality Check
Red blinking The batteries are depleted. You can connect the power adapter to perform the investigation and to charge the batteries. If you don’t follow up the instruction, then the puller will be switched off and lose the wireless connection with the computer.
Page 54: Perform The Investigation
Figure 2.42 Results quality check OK When no cough peaks are detected after 30 seconds, the message no cough detected is displayed. When the check is not OK, the failed channels are mentioned in the Result dialog box. Figure 2.43 Results quality check failed The information of the last quality check will be stored in the investigation file and will be shown in the investigation information in the analysis program and in the report.
Page 55: Print The Investigation Report
• Biofeedback, see Chapter 10 Print the Investigation Report In the database program, double-click the Investigation name to start the analysis program. Click the Reporter button to open the Laborie Reporter dialog box; click Print to print the report. Investigation Procedure...
Page 56: Cleaning Instructions
PDF format, which you can open via the Manuals menu in the database program. Cleaning Instructions After each investigation, LABORIE recommends cleaning/replacement of the following parts: • Reusable catheters must be cleaned and sterilized after each investigation and kept sterile until the next investigation is done.
Page 57 • The urine container and the funnel can be cleaned in an instrument washer with a maximum temperature of 80°C (176°F). On a monthly basis, LABORIE recommends cleaning the NPU and its parts with a slightly moistened cloth. To prevent friction of the pump rollers, open the cover of the pump and clean the rollers, one by one, with a moistened cloth.
Page 58: Exit The Laborie Database Program
2.10 Exit the LABORIE Database Program To exit the LABORIE program, you must first return to the database program by clicking the Exit button to close the LABORIE analysis program. Figure 2.46 Return to the database program Click the Exit button in the database program to close the LABORIE database program.
Page 59: Urodynamic Catheters & Transducers
Urodynamic Catheters & Transducers Introduction In this chapter, you will find instructions about preparing the catheters and the pressure transducers before performing one of the following investigations: • cystometry, • pressure-flow study, • urethral pressure profile (UPP), • gynecology study. The preparations of the catheters and transducers can be different, depending on the type of catheters and transducers used, and the number of pressures measured:...
Page 60: Prepare The Catheters And Transducers
Prepare the Catheters and Transducers The procedure to prepare the catheters and transducers is as follows: ▪ Start the LABORIE database program. ▪ Enter and select the patient name in the database program. ▪ Click the New investigation button in the database program ▪...
Page 61: Single-Use E•Sense Solid-State Catheters
Figure 3.4 Example reusable solid-state catheter The procedure to prepare the catheters is as follows: ▪ Pre-wet the catheter in distilled sterile water as described in manual of the manufacturer (the minimum period is two minutes). ▪ Connect the pre-wetted catheter to the WPU as follows. o Connect P (vesical/bladder pressure) to P1 o Connect P...
Page 62: Air-Charged Catheters
Figure 3.5 Single-use e•Sense solid-state catheters The procedure to prepare the catheters is as follows: ▪ Connect the catheters to the WPU-eS as follows: o The blue connector of the pressure catheter (with bladder pressure or bladder and urethral pressure) should be connected to input P1/3 (blue) of the WPU-eS.
Page 63 ). The rectal catheter has one sensor for measuring the abdominal pressure (P Figure 3.7 Air-charged pressure transducer Figure 3.6 Example air-charged catheter The catheters are connected to the WPU-L4 or Luna module via air-charged pressure transducers. The transducers must be left in the OPEN position. It is also important to notice that caps are placed on the catheter to protect against any moisture infiltration.
Page 64 ▪ Insert the abdominal catheter in the rectum or the vagina. ▪ Remove the cap from the abdominal catheter. Be sure that no moisture is getting into the catheter. ▪ Connect the abdominal catheter to the blue (P ) pressure transducer (tighten securely!).
Page 65: Water Catheters
The rectal catheter has one sensor for measuring the abdominal pressure Figure 3.10 DT-XX transducer Figure 3.11 Water catheter LABORIE U-70000 product line The catheters are connected to the CIM or Luna via external pressure transducers. In this section, you will find instructions and illustrations explaining the setup of single-use DT-XX pressure transducers and water catheters with the CIM module.
Page 66: Measuring Pves And Pabd
Figure 3.12 Setup DT-XX transducers Note the following information: • When there are air bubbles in the catheter or water transducer, the pressure will not be recorded well. You must flush the catheters to expel all air bubbles. • If the water transducers are not placed at symphysis pubis level, the pressures may be too high or too low.
Page 67: Measuring Pves, Pura And Pabd
Figure 3.13 Measuring Pves and Pabd The procedure is as follows: ▪ Put the DT-XX pressure transducers in the holder and connect the transducers to the CIM module. ▪ Place the pressure transducer holder at symphysis pubis level. ▪ Disinfect the genital area. ▪...
Page 68 Figure 3.14 Measuring Pves, Pura and Pabd The procedure is as follows: ▪ Put the DT-XX pressure transducers in the holder and connect the transducers to the CIM module. ▪ Place the pressure transducer holder at symphysis pubis level. ▪ Install a bag of saline in the pressure-cuff. ▪...
Page 69: Measuring Pves And Pura
§ 3.6.3. It is not necessary to measure the abdominal pressure (see also Figure 3.15). Figure 3.15 Setup for UPP studies LABORIE can provide you with a special UPP catheter, containing urethral rings to measure circumferential urethral pressures. One lumen is used for measuring the bladder pressure (P...
Page 70 Figure 3.16 Special UPP catheter with circumferential rings The procedure is as follows: ▪ Put the DT-XX pressure transducers in the holder and connect the transducers to the CIM module. ▪ Place the pressure transducer holder at symphysis pubis level. ▪...
Page 71: Flushing And Zeroing Water Catheters
▪ Connect the syringes filled with sterile water to the pressure transducers as displayed in Figure 3.17 (optionally, the LABORIE flush set can be used). ▪ Push the blue flushing devices and flush the pressure transducers and catheter lumens to expel all air bubbles.
Page 72 ▪ Turn all stopcock handles clockwise, the text “OFF” pointed to the zeroing side. ▪ Ask the patient to cough and check the registration of all pressures. The spikes of P , and P should rise equally in response to the cough and the detrusor pressure (P ) pressure should remain relatively flat.
Page 73: Uroflowmetry
Uroflowmetry Introduction Uroflowmetry is a simple, diagnostic screening procedure used to calculate the amount of urine (volume), flow rate in seconds, and length of time until completion of the void. Channels During the uroflowmetry the following channels can be measured: •...
Page 74: Results
Results In the analysis program, choose Results > Display results from the menu to display the calculated parameters. Figure 4.1 shows the parameters that can be calculated. Figure 4.1 Uroflow result selection Some parameters will be calculated after placing the corresponding markers. The parameters of the uroflow results are described below.
Page 75 The letters between square brackets in the formulas refer to the corresponding letters in Figure 4.2. Void The voiding function is reported as expressed by maximum flowrate together with voided volume and post-void residual urine in the format: VOID = Qmax/VV/VRU (Maximum flow/Volume Voided/Residual Volume) Undetermined values are substituted by a hyphen -.
Page 76 Whenever a Permission to void marker was placed during the investigation, the hesitancy is calculated as the elapsed time between placement of the Permission to void marker and the onset of the flow. Calculated: hesitancy = [A] Average flow The average flow is the total voided volume divided by the flow time. The average flow rate is only meaningful if flow is continuous and without terminal dribbling.
Page 77: Cystometry
Cystometry Introduction During the cystometry investigation, the pressure/volume relationship of the bladder is measured. It is used to assess detrusor activity, sensation, capacity, and compliance. Channels The following channels can be measured during a cystometry: • Vesical pressure (P1) • Abdominal pressure (P2) •...
Page 78 o Water catheters (see § 3.6). ❑ Connect the pump tube to the filling lumen of the catheter. ❑ Prepare the EMG cables and apply the EMG electrodes (see § 2.5.10). Press the Start investigation button. Press the Pump ON button to start the pump. Press the First sensation button to mark the first sensation.
Page 79: Results
Results In the analysis program, choose Results > Display results from the menu to display the calculated parameters. The following parameters can be calculated: Figure 5.1 Cystometry result selection Some parameters will be calculated after placing the corresponding markers. The parameters of the cystometry results are described below. Initial bladder filling The patient’s bladder filling at the start of the investigation.
Page 80 Infused volume The infused volume is the volume of the fluid pumped into the patient during an investigation. Bladder filling The filling of the bladder at the end of the investigation. It is calculated as the sum of the initial bladder filling and the infused volume subtracted with the volume lost through leakage.
Page 81 MUP is the maximum urethral pressure in the urethra during an investigation. Pabd. max Pabd. max is the maximum pressure measured in the abdomen during the investigation. Bladder filling, vesical pressure, and detrusor pressure at sensation markers For all sensation markers present in a cystometry, the bladder filling, the vesical pressure, and the detrusor pressure will be determined and displayed on the result screen.
Page 82 Figure 5.3 Compliance Valsalva results The valsalva results can be selected in the select results window. When a valsalva begin marker is present and a leak point marker is placed, the table shows the pressure at the leak point: When a valsalva begin marker is present but when no leak point marker is placed, the maximum pressure is shown in the table: Cough results The cough results can be selected in the select results window.
Page 83 When no leak point marker is present after the CLPP marker, no results are present. Leak point only results The leak point results can be selected in the select results window. When a leak point marker is present without valsalva marker or CLPP marker, the leak point results table is displayed.
Page 84: Pressure-Flow Study
Pressure-Flow Study Introduction The pressure-flow study consists of two phases: • Filling phase (cystometry). • Voiding phase (uroflow). During the filling phase, the pressure/volume relationship of the bladder is measured. The filling phase is used to assess detrusor activity, bladder sensation, capacity, and compliance.
Page 85: Investigation
Investigation Click the Pressure-flow study button to start the pre-test. ❑ Prepare the pump and the pump tube as described in § 2.5.4. ❑ Prepare the flowmeter as described in § 2.5.11. ❑ Prepare and insert the catheters. Follow the procedure for: o Reusable solid-state catheters (see §...
Page 86: Results
the buzzer of the remote control will beep after the flow has stopped. (You can find more information in § 12.3.4). Press the Stop investigation button. Enter the residual urine if prompted. Remote control buttons Buttons Description Press Shift and Zero all simultaneously to zero the detrusor pressure (P ) during the pre-test and, if necessary, during the measurement.
Page 87: Filling Phase Results
Figure 6.1 Pressure-flow study result selection Some parameters will be calculated after placing the corresponding markers. The parameters of the pressure-flow results (for the filling phase and the voiding phase) are described below. 6.4.1 Filling Phase Results Sensation results For all sensation markers present in a Pressure-flow study, the bladder filling, the vesical pressure, and the detrusor pressure will be determined and displayed on the result screen.
Page 88 Initial bladder filling The patient's bladder filling at the start of the investigation. This filling is either entered manually by the user or calculated from the previous investigation. Infused volume The infused volume is the volume of fluid infused in the patient’s bladder during the filling phase of the pressure-flow study.
Page 89: Voiding Phase Results
Leak point, valsalva and cough results The explanation of the leak point, Valsalva, and cough results can be found in § 5.4. 6.4.2 Voiding Phase Results The voiding phase is separated from the filling phase by means of an end filling phase marker.
Page 90 Time to Qmax The time to Qmax is the elapsed time from the onset of the flow to the Qmax. Calculated: Time to Qmax = [C] Pdet at Qmax The detrusor pressure at the Qmax. Voided volume The voided volume is the total volume expelled via the urethra. Calculated: Voided volume = [E1 + E2 + E3 + E4] Flow time The flow time is the time over which measurable flow actually occurs.
Page 91 This derivation depends on the hydrodynamic laws of flow through rigid tubes. The urethra is both irregular and distensible. Computed residual urine The computed residual urine is calculated as the sum of the total infused volume and the initial bladder filling minus the volume lost through leakage and minus the voided volume.
Page 92 The LABORIE analysis software offers an option to enter a flow delay time (Settings > System settings > General Tab > Flow delay). When the correct time is entered here, the tracings are really simultaneous, and results will be accurate.
Page 93 Miction Index The explanation of the Miction Index can be found in § 4.4. Bladder voiding efficiency (BVE) is a product of bladder contractility against urethral resistance and is measured to the degree of bladder emptying. The BVE treatment of lower urinary tract symptoms (LUTS) suggestive can be defined as a percentage.
Page 94: Urethral Pressure Profile (Upp)
Urethral Pressure Profile (UPP) Introduction The Urethral Pressure Profile (UPP) investigation assesses the intra luminal pressure along the length of the urethra. This pressure represents the ability of the urethra to prevent leakage. Two types of UPP can be measured: •...
Page 95: Investigation
Investigation If you have already performed a cystometry or pressure-flow study, leave the catheter in the bladder and remove the tape of the bladder catheter. Do not zero! You can start the investigation immediately. Click the Urethral pressure profile button to start the pre-test. ❑...
Page 96 Rest profile (manual pull) Press the Start Pull button to mark the start of the profile (note: this is an immediate marker). The metronome will help you to pull the catheter with a constant speed. One beep corresponds to one centimeter. An increase in urethral pressure (P ) indicates that the urethral sensor enters the urethra.
Page 97 Rest profile (use the catheter puller) Press the Start Puller button to start the puller. An increase in urethral pressure (P ) indicates that the urethral sensor enters the urethra. When P increases > 10 cmH O, a Profile start marker will be inserted automatically (backwards in time).
Page 98: Results
7.4 Results In the analysis program, choose Results > Display results from the menu to display the calculated parameters. Some parameters will be calculated after placing the corresponding markers. Extended analysis of Urethral Pressure Profile—Dr. Eberhard The extended UPP analysis is according to Dr. J. Eberhard. This UPP analysis analyzes all profiles found in the investigation.
Page 99: Stress Profile
7.4.2 Stress Profile For each stress profile, the following parameters are default calculated: • Average transmission • Resting bladder pressure • Maximum urethral closure pressure (MUCP) • Maximum urethral pressure (MUP) • Functional profile length Figure 7.2 UPP results selection The parameters of the UPP results are described below.
Page 100 The speed at which the catheter is withdrawn through the urethra. The speed unit is mm/minute. The ICS standard is 60 mm/minute (= 1 mm/second). The profilometry results for this investigation are only valid if a LABORIE catheter puller is used to pull out the catheter during the investigation. Pulling the catheter manually yields unpredictable, erroneous results due to variations and inaccuracy in pulling speed.
Page 101 Resting bladder pressure The resting bladder pressure is the urethra pressure at the position of the profile begin marker. It is only calculated when the profile begin marker is present. At the moment the profile starts (just before the urethral pressure increases because the catheter reaches the beginning of the urethra), the transducer measuring the urethral pressure Pura is still in the bladder;...
Page 102 pressure increases because the catheter reaches the beginning of the urethra), the transducer measuring the urethral pressure (P ) is still in the bladder; hence, this is the resting bladder pressure. – P MUCP = Max (P MUCP is the maximum difference between the urethral pressure (P ) and the bladder pressure (P ), i.o.w the maximum pressure on the P...
Page 103: Transmission
The resting area under stress is the area under a stress profile, minus the area of the peaks. The profilometry results for this investigation are only valid if a LABORIE catheter puller is used to pull out the catheter during the investigation. Pulling the catheter manually yields unpredictable, erroneous results due to variations and inaccuracy in pulling speed.
Page 104 Calculated: Transmission: [A]/[B] * 100 % Transmission-profile graph Click the Transmission/Profile button to display the Transmission-profile graph (software option). Figure 7.6 Transmission-profile graph The transmission-profile graph displays a visual representation of the change in transmission along the urethra. The transmission-profile graph can only be displayed for stress profiles. The software distinguishes between stress and rest profiles by the presence of transmission markers.
Page 105: Gynecology Study
Gynecology Study Introduction The Gynecology study consists of three parts: • Filling phase (cystometry) • Urethral rest and stress profiles (UPP) • Voiding phase (uroflow) During the filling phase the pressure/volume relationship of the bladder is measured. The filling phase is used to assess detrusor activity, bladder sensation, capacity, and compliance.
Page 106: Investigation
Investigation Click the Gynecology study button to start the pre-test. ❑ Prepare the pump and the pump tube, as described in § 2.5.4. ❑ Prepare the flowmeter as described in § 2.5.11. ❑ Prepare and insert the catheters. Follow the procedure for: o Reusable solid-state catheters (see §...
Page 107 Rest profile (manual pull) Press the Start Pull button to mark the start of the profile (note: this is an immediate marker). The metronome will help you to pull the catheter with a constant speed. One beep corresponds to one centimeter. An increase in urethral pressure (P ) indicates that the urethral sensor enters the urethra.
Page 108 Rest profile (use the catheter puller) Press the Start Puller button to start the puller. An increase in urethral pressure (P ) indicates that the urethral sensor enters the urethra. When P increases > 10 cmH O, a Profile start marker will be inserted automatically (backwards in time).
Page 109 Filling phase (continue) Press the Pump button to start the pump. You can mark the sensations. At different filling volumes you may stop the pump to perform rest and stress profiles. When the patient is unable to tolerate further filling or if the bladder is filled sufficiently, press the Pump button to stop.
Page 110: Results
Remote control buttons Buttons Description Press Shift and Zero all simultaneously to zero the detrusor pressure (P ) during the pre-test and if necessary during the measurement. Press Shift and Start puller simultaneously to start/end the Valsalva maneuver. Press Shift and Leak point to start the Cough Leak Point Pressure procedure (CLPP).
Page 111: Anorectal Manometry
Anorectal Manometry Introduction The anorectal manometry investigation is used to objectively assess the apparatus and defecation provided by the anorectal sphincter. With anorectal manometry, you can measure resting and squeeze pressure, as well as the length of the functional anal canal. More detailed assessment of radial and longitudinal pressure profiles can be obtained from a vector volume plot.
Page 112: Investigation Protocol
Investigation Protocol 9.2.1 Edit the Anorectal Manometry Protocol In the measurement program, right-click the protocol name and then choose Edit protocol. Select the Anorectal manometry tab in the Edit investigation protocol window. Figure 9.1 Anorectal manometry protocol A page is shown with settings, regarding the use of the printer, sample rate, marker line distance, and so on.
Page 113: Select The Catheter
Anorectal manometry investigations can be performed by either using (a) water catheters with DT-NN pressure transducers, (b) air-charged catheters with external pressure transducers or (c) solid state catheters. LABORIE advises to use catheters with 4 pressure channels for the most accurate results.
Page 114: Select The Anorectal Manometry Tests
Click the Catheter button to display the Catheter selection window. Select your catheter from the list; for example, the disposable water catheter LABORIE G-84481 or the LABORIE G-84482. Radial catheter mode In the Edit investigation protocol window, you can select the catheter mode: staggered/helix (default selected) or radial mode.
Page 115: Filling
Figure 9.4 Anorectal manometry protocol, test selection In the Use column, you will see the tests that will be available during the investigation. Use the arrow buttons to add or remove a test. You can choose the order in which the tests appear during the investigation: use the U button to move the selected test in the Use column up.
Page 116: Timers
Figure 9.5 Filling tab, Syringe settings Ask balloon volume is available for the syringe filling method (most common method) and can be used for the push test, RAIR test, sensation test and balloon expulsion test. After inserting the end marker during the test, the software will ask to enter the balloon volume.
Page 117: Squeeze
Figure 9.6 Timers tab The familiarization timer (default on) is used to let the patient get used to the catheter at the beginning of the investigation. 9.2.6 Squeeze Click the More button and then select the Squeeze tab. The window shown in Figure 9.7 is displayed.
Page 118: Push
Figure 9.7 Squeeze settings During the squeeze test, you can mark the catheter position (insertion depth). The settings are often used for investigations with radial catheters. The puller can be used to withdraw the catheter step-wise (default 1 cm). 9.2.7 Push Click the More button and then select the Push tab.
Page 119: Rair
Figure 9.8 Push settings During the push test you can mark the catheter position (insertion depth). These settings are often used for investigations with radial catheters. The puller can be used to withdraw the catheter step-wise (default 1 cm). Balloon filling settings You can set the initial volume (default 10 ml) and the volume increment (default 10 ml) under Volume on the Push tab.
Page 120 Figure 9.9 RAIR settings You can enable the option to place markers directly on the plotline (default off). You can set the initial volume (default 10 ml) and volume increment (default 10 ml) for the RectoAnal Inhibitory Reflex (RAIR) test. The initial inflation volume is the volume that will be inflated the first time in the balloon to assess the RAIR.
Page 121: Sensation
Figure 9.10 Filling with perfusion pump, auto deflate balloon setting For syringe filling method, you can select Ask balloon volume on the Filling tab. After inserting the RAIR end marker during the test the software will ask to enter the balloon volume. 9.2.9 Sensation Click the More button and then select the Sensation tab.
Page 122: Compliance
Figure 9.11 Sensation settings During the sensation test different sensation markers can be placed. The following markers can be enabled in the protocol: no sensation, first sensation, first urge, modest urge, intense urge, maximum tolerable volume, and pain. The setting display balloon markers can be (de)selected. Balloon filling settings On the Filling tab, you can set the filling method.
Page 123 Figure 9.12 Compliance settings Rectal compliance Rectal compliance can be calculated after the sensation test. A catheter with a balloon mounted on the tip and a filling lumen (opening at the tip), can be used to determine the compliance. If you want to perform a rectal compliance test, you need to select a catheter in the protocol with balloon pressure (Pbal).
Page 124: Balloon Expulsion
Save standard balloon calibration When a balloon calibration has been performed, it can be saved as the standard balloon calibration. This setting controls whether this will be the case. Balloon filling settings On the Filling tab, you can set the filling method. Filling automatically with the MPP Plus is recommended.
Page 125: Profiles
expulsion end marker during the test the software will ask to enter the balloon volume. For filling the balloon with the pump (water) you can enter the pump speed (default 50 ml/min) on the Filling tab. 9.2.12 Profiles Click the More button and then select the Profiles tab. The window shown in Figure 9.14 is displayed.
Page 126: Prepare The Investigation
anal canal at a constant speed. A metronome function can be activated in the protocol to aid in withdrawing the catheter. You have to set the pull (withdrawal) speed and length (distance). During the investigation, each step will be displayed on the screen at the set speed. The metronome makes a sound at each step.
Page 127: Air-Charged Catheters
The procedure to prepare the investigation is as follows: ▪ Put the DT-NN pressure transducers in the holder and connect the transducers to the CIM module. ▪ Install a bag with distilled water in the pressure-cuff. ▪ Put the spike of the 4-way catheter flushing set into the bag. ▪...
Page 128 The transducers must be left in the OPEN position. The procedure to prepare the investigation is as follows: ▪ Connect the pressure transducer cables (in OPEN position) to the CIM module. For the GIM-60000A air-charged catheter and transducers, the connection is as follows: Color pressure transducer CIM module Yellow (distal)
Page 129: Solid-State Catheters
▪ Press the Start investigation button to start the investigation. Follow the procedure for the tests as described in the next sections. 9.3.3 Solid-State Catheters You can use reusable solid-state catheters with filling lumen and a balloon fixation point at the tip. You can use standard balloons or make a balloon catheter as follows.
Page 130: Investigation
withdraw the catheter 1 cm and repeat these tests. The insertion depth must be marked with the cm button in the software. Investigation 9.4.1 Introduction For the anorectal manometry investigation, the following tests are available: • Resting pressure • Squeeze •...
Page 131: Resting Pressure Test
9.4.2 Resting Pressure Test The purpose of this test is to determine the resting pressure. Press the Next test button until the text Resting is displayed on the left button. Ask the patient to be quiet for 10 to 20 seconds (do not talk, move, squeeze).
Page 132: Cough Test
Press the Next test button until the text En. Squeeze is displayed on the left button. Ask the patient to squeeze and to maintain the squeeze. Press the En. Squeeze button to mark the start of the test. The endurance squeeze will cause an increase in pressure on the EAS channel, which slowly will drop due to sphincter fatigue.
Page 133: Rectal Anal Inhibitory Reflex (Rair) Test
Ask the patient to push. Press the Push button to mark the start of the test. Ask the patient to stop pushing. Press the Push End button to mark the end of the test. This marker is placed automatically when the push timer is used.
Page 134: Sensation Test
Filling with air (Perfusion Pump Plus) Press the Next test button until the text RAIR is displayed on the left button. Connect the filling lumen of the catheter to the perfusion pump. Press the RAIR button to mark the start of the test. This is a delayed marker and is used to determine the baseline pressure.
Page 135 tube which is placed on the pump of the pump module. The filling speed is displayed on the Pump button in the upper-left corner of the screen (e.g., 10 ml). Press the Pump button to start the pump. The balloon in the rectum will be slowly filled.
Page 136 Filling with air (Perfusion Pump Plus) Press the Next test button until the text ‘No sensation’ is displayed on the left button. Connect the filling lumen of the catheter to the perfusion pump. Press the Start filling button to inflate the balloon with air according to the volume displayed on the button (default 250 ml;...
Page 137: Rest And Squeeze Profiles Using A Puller
Insert more of the same sensation markers It is possible to perform the sensation test more than once and thus insert more than one of the same type of sensation marker. To reset (restart) the sensation test, press the Next test button until the text No sensation is displayed on the left button, or Right-click this button until the sensation marker you want to insert is displayed.
Page 138: Rest And Squeeze Profile With Manual Pull
Wait until the onset of the rise in anal pressure is at the marker line. Press the Anal profile button to mark the start of the test. Wait until the drop of anal pressure to zero reaches the marker line. Press the Profile end button to mark the end of the test.
Page 139 or manually. In this section, you will find a description of the investigation with manual pull. When pressures are measured radially throughout the sphincter, the software can create cross-sectional and longitudinal graphs of the sphincter (3D vector volume plots). The anal channels should all be marked with sensor positioning Anal in the catheter definition (see §...
Page 140: Balloon Expulsion Test
Ask the patient to squeeze and to maintain the squeeze. Press the Start profile [Squeeze] button. A window is displayed with the distance you have to withdraw the catheter. Withdraw the catheter with the speed and distance as displayed (setting in the protocol). After a short while, there should be an increase in the anal pressure.
Page 141 Press the Balloon expulsion End button to mark the end of the test. The software asks whether the balloon expulsion was successful. Select Failed, Partial, or Success and then click OK. Figure 9.20 Balloon expulsion test Filling with water (pump module) Press the Next test button until the text Balloon expulsion is displayed on the left button.
Page 142: Rectal Compliance
Press the Next test button until the text Balloon expulsion is displayed on the left button. Connect the filling lumen of the catheter to the perfusion pump. Click the Inflate balloon tool button (in the upper- left corner of the screen) to inflate the balloon with air according to the volume displayed on the button (e.g., 10 ml).
Page 143 During infusion the sensation markers can be set by pressing the appropriate softkey. When the maximum tolerable volume is reached, the investigation can be stopped and the balloon can be deflated. Filling with LABORIE Perfusion pump plus (when available) • On the Filling tab: Filling method: Perfusion pump (Automatic, Air) •...
Page 144 Click the Anorectal manometry button to start the pre-test. Zero the transducer in open air. Press the ALT key on the remote control and then press the Calibration begin button. Automatic calibration is done by the perfusion pump. Press OK to continue. After inserting and positioning the catheter, press the Start investigation button.
Page 145: Remote Control Buttons
Press the Stop investigation button to stop the investigation. Analysis Analysis can be done by inserting channels markers or by using the channel definition settings. LABORIE recommends using the method with the channel markers. For analysis with the HRAM quick view software (applicable for the HRAM software option), see the HRAM User’s Manual, LABORIE document code...
Page 146: Insert Channel Markers
9.5.1 Insert Channel Markers The channel markers should be inserted on the channels on which the specific test is registered. The results will then be calculated on these channels. When you open the investigation for the first time, the anorectal manometry channel marker settings dialog window will display automatically.
Page 147 Figure 9.22 Anorectal channel definition When using spiral catheters with one cm (or 0,5 cm) spacing between the pressure channels, you have to define the sensor positions and so the channels which will be analyzed. The previous figure serves as an example. ▪...
Page 148: Anorectal Manometry Settings
9.5.3 Anorectal Manometry Settings During analysis, you can define how certain results should be calculated. This can be done in the anorectal manometry settings window, which can be activated by Settings > Anorectal manometry settings. These anorectal settings are stored with the investigation. This means that changes made here are in effect only for the current study.
Page 149: Results
Endurance squeeze setting When placing the endurance squeeze markers, two channel markers will be automatically placed on the EAS channel as defined in the channel definition (Settings > Channel definition). The first channel marker will be placed on the maximum pressure between the two endurance squeeze markers. The second channel marker will be placed a certain time later.
Page 150: Resting Pressure Test
Figure 9.25 Select anorectal manometry results Almost all results can be individually enabled or disabled. This makes the report much more flexible, and you can select exactly those results that are important. Explanation about the calculation of the parameters can also be found by clicking the Help button in the Results window.
Page 151: Squeeze Test
9.5.6 Squeeze Test The squeezes should be marked with two squeeze markers. The first squeeze marker should be placed at the onset of the squeeze. The second squeeze marker should be placed at the end of the squeeze. Normally the markers are already placed during the investigation.
Page 152: Endurance Squeeze Test
Using the squeeze markers following parameters are calculated: Resting pressure The resting pressure is the average pressure over a one-second period before the squeeze begin marker [A]. Maximum squeeze pressure The maximum squeeze pressure (i.e., the pressure increment during squeeze) is calculated as the highest squeeze pressure (between marker [A] and [B]) minus the resting pressure.
Page 153 Figure 9.27 Endurance Squeeze test The letters between square brackets refer to the corresponding letters in the above figure. During the endurance squeeze test, the patient squeezes their External Anal Sphincter and maintains the squeeze for about 30 seconds. The beginning and ending of the squeeze period are marked with two squeeze markers [A] and [B], as shown in Figure 9.27.
Page 154: Cough Test
9.5.8 Cough Test The coughs should be marked with two cough markers. The first cough marker should be placed at the onset of the cough. The second cough marker should be placed at the end of the cough. Normally the markers are already placed during the investigation. You can reposition the cough markers or insert new cough markers if coughs are not marked during the investigation.
Page 155: Rectal Anal Inhibitory Reflex (Rair) Test
Figure 9.28 Push test The letters between square brackets refer to the corresponding letters in Figure 9.28. The software will calculate the following results for each marked push: • Resting pressure • Residual pressure • % Relaxation • Duration Resting pressure The resting pressure is the pressure at the push begin marker [A].
Page 156 Figure 9.29 RAIR test The letters between square brackets refer to the corresponding letters in Figure 9.29. Residual pressure Minimum pressure between Marker [A] and Marker [B]. Amplitude of relaxation The amplitude of relaxation is the pressure difference between the resting pressure and the residual pressure.
Page 157: Sensation Test
External sphincter response Is the maximum pressure on the EAS channel between marker [A] and marker [C]. This result is only calculated when an EAS channel is present. 9.5.11 Sensation Test The sensations should be marked with sensation markers. Normally sensation markers are already placed during the investigation.
Page 158: Balloon Expulsion Test
Rest profile The following results will be calculated for anal pressure profiles: • Length of anal zone. • Average internal sphincter pressure. • Pressure transmission ratios at transmission markers when these markers are present. • Length of HPZ (High Pressure Zone). This is the profile area where the pressures are higher than 50% of the maximum pressure.
Page 159: Rectal Compliance
expulsion markers if they are not marked during the investigation. The balloon expulsion results show whether the expulsion was successful, partial or failed, balloon volume, and duration. 9.5.14 Rectal Compliance During the analysis, the compliance can be determined by placing compliance markers.
Page 160: Vector Volume Plot
• Balloon volume at sensation marker • Rectal pressure at sensation marker • IAS pressure at sensation marker 9.5.15 3D Vector Volume Plot When you want to create 3D vector volume plots of the anal-canal, you need a catheter with at least three radially oriented channels. To display the plot, profile tests must have been performed.
Page 161: Rectal Volume Plot
In the graphs and the segment menu, you will find the option to export the VVP and the Radial Segment to a BMP file (Save as). You can find more information in the LABORIE Help information. 9.5.16 Rectal Volume Plot Click the Rectal volume plot button or Choose Options >...
Page 162 This plot displays the relation to the balloon volume and the rectal pressure. To include the rectal volume plot in the report, select Rectal volume plot in the Report setup. The X-axis represents volume (auto scale). The Y-axis represents rectal pressure (auto scale).
Page 163: Biofeedback
10. Biofeedback 10.1 Introduction In the management of, for exmple stress incontinence, biofeedback training can be used for training of the patient’s pelvic floor muscles or anal sphincter. During the training, one or more challenges can be presented to the patient; for example, the patient must squeeze the pelvic floor until a certain level.
Page 164 Otherwise, the last applied settings for the current patient are displayed. You can change the theme, challenge time, or resting time (for more information see § 10.5.2). If you want to return to the main screen of the measurement program, you need to click the Menu button. Figure 10.2 Biofeedback settings ❑...
Page 165 General and More tab Maximum scale Actual measured value Heart beat filter Figure 10.3 Pretest window Biofeedback on EMG Minimum scale Image representing the current value For EMG continue as follows: ❑ Apply EMG electrodes / insert probe. ❑ Ask the patient to squeeze the muscles to check the EMG signal. For pressure continue as follows: ❑...
Page 166 minimum and maximum scale (when you move the mouse cursor over the Auto scale button, it will show the time window that is used). Manually change scale Use the triangular buttons at the maximum or minimum scale to change the scale manually.
Page 167: Investigation
10.3 Investigation The animation that represents the challenge scrolls from right to left. The patient should try to follow the goal line of the challenge and collect the items of the challenge. For example, in the Seaworld theme, the items of the challenge are air bubbles.
Page 168: Analysis
Pressure test The Biofeedback pressure test uses pressure channel 1 of the measurement system to control the animated object. The higher the pressure the higher the object appears on the screen. Flow test The flow test is a normal uroflow except instead of the curves, a moving animated object appears on the screen.
Page 169: Channel Settings
and then click the New investigation button), right-click the protocol name and then choose Edit protocol from the menu. In the Edit investigation protocol window, select the Biofeedback tab. Figure 10.6 Biofeedback protocol The changes made in the protocol settings (and saved with the OK button), are stored for the protocol.
Page 170: Biofeedback Settings
Figure 10.7 Channel settings In this window, you can define the channels to be measured. To enable a channel, the setting Off in the column Position must be set to a position on the screen, for example position 1. Click the channel in the list and change the position in the lower part of the window.
Page 171 Figure 10.8 Biofeedback settings in the protocol The Biofeedback settings window shows a preview of the selected challenge. For each channel a preview of the challenge is displayed. Figure 10.9 Biofeedback settings for two channels A challenge consists mostly out of challenge time and resting time. The challenge time is the worktime with a certain workload for the patient.
Page 172 clicking in the field and changing the time. To select another challenge or to edit an existing challenge, click the Edit challenge button (for more information, see § 10.5.3). Select Theme In the Biofeedback settings window, it is possible to select another theme by clicking the Select Theme button or the image of the theme.
Page 173: Challenge Editor
10.5.3 Challenge Editor With the challenge editor, it is possible to select another challenge or to edit a challenge. The challenge editor consists of basic edit mode and advanced edit mode. Challenges can be selected or edited only for the enabled channels in the channel settings (see §...
Page 174 Remove challenge To remove a challenge, select the challenge and then click the Remove button. This is not possible for default challenges, only for saved challenges. Copy challenge To copy a challenge, select the challenge and then click the Copy button. The new challenge can be edited (see below).
Page 175 used for indicating an increase or decrease of workload (for example contract or relax). Advanced edit mode A challenge can consist of more than one work level with transition between them. The transition is the time in between two work levels and interpolates between the preceding work level to the next work level.
Page 176 Anchor Figure 10.14 Advanced edit mode The anchor points can be used to modify duration. To modify the height, the horizontal dashed lines can be moved. To add a part, right-click on an anchor. To return to the Basic edit window you need to click the Basic edit button. In the basic edit mode you can save the challenge by clicking the Save button.
Page 177: Investigation With Luna Wireless Module
11. Investigation with Luna Wireless Module 11.1 Introduction The Luna module is a wireless interface for measurement of pressures, EMG, and/or conductance. This allows free movement of the patient without moving the complete measurement system. After a wireless stationary investigation, you can choose to continue an ambulatory investigation without removing the catheter.
Page 178: Stationary Measurement
11.2 Stationary Measurement After selecting the protocol and investigation name (i.e., pressure-flow study) in the measurement program, the software will search for a registered Luna. If you have registered more than one Luna, select the Luna module that you want to use by clicking on it. The LCD display shows standby. Figure 11.1 Select Luna After a connection between the Luna and the computer had been established, the LCD display shows stationary.
Page 179: From Stationary To Ambulatory Measurement
The software will remind you to change the battery when necessary. Connect the catheter and then click the OK button. Now you can perform the investigation as described in chapters 3 to 9 (depending on the investigation you choose). To stop the investigation: Click the Stop investigation button to finish the stationary measurement or use the remote-control button.
Page 180 ▪ Click Yes to continue. Figure 11.4 Select protocol ▪ Select the protocol. ▪ Click the Continue investigation button to proceed with the measurement. ▪ To change the battery, the following window appears: Figure 11.5 Change battery Nexam Pro User Manual Chapter 11...
Page 181 ▪ Disconnect the catheter and change the battery. Figure 11.6 Reconnect catheter ▪ After changing the battery, reconnect the catheter. ▪ Check catheter position. Figure 11.7 Check catheter position Investigation with Luna Wireless Module Nexam Pro User Manual...
Page 182: Analysis
▪ Click the Start recording button. The LCD display shows Record. ▪ Click the Exit button to return to the database. ▪ Explain the diary and the buttons on the Luna module to the patient. ▪ When using a flowmeter explain the flow procedure to the patient. Refer to the Luna User’s &...
Page 183: Measurement Program
12. Measurement Program 12.1 Introduction In this chapter, you will find a description of the menu items and settings in the measurement program. Click the New investigation button in the database program to start the measurement program. If more than one system is installed, you need to select the measurement system, for example the stationary system.
Page 184: Main Menu
12.2 Main Menu The main menu can be activated by clicking the menu button. Figure 12.2 Main menu Menu item Function Settings A description of the menu items can be found in § 12.4. Bluetooth devices Register Bluetooth modules while installing the system. See the Nexam Pro Service &...
Page 185: Pre-Test
12.3.1 Pre-Test When an investigation is selected from the measurement program, the pre-test starts. The pre-test differs from the actual investigation in that data will not be stored and markers cannot be placed. In general, the pre-test is a final check and preparation before the actual investigation.
Page 186: Button Toolbar
indicated on the software buttons. Clicking the button will have the same effect as pressing the corresponding button on the remote control. The main part of the screen shows the plot windows for the selected channels. Your screen may look different depending on the protocol settings or system settings.
Page 187 Buttons Description Move the catheter puller and the puller clamp in the direction of the bladder or out of the bladder. Insert an event marker. It is also possible to add comment for the marker. Insert an artefact marker (delayed marker). Activate the pause mode.
Page 188: Remote Control
Buttons Description Consumables Traceability button. Displays the Consumables traceability dialog box. This feature is accessible only during pre-test. You can find more information in § 2.5.2 12.3.4 Remote Control The urodynamic investigations on the Nexam Pro measurement system can be performed by using the RC-1600 (orange) remote control. The RC-1600 communicates with the computer via a wireless Bluetooth connection, using a ®...
Page 189 Red light on Bluetooth communication remote control and a key is pressed, but the batteries are almost empty. Replace the batteries. Remote control is in sleeping mode until a key is pressed. No or empty batteries. Place new batteries in the battery compartment.
Page 190 Figure 12.5 RC-1600 diagram RC-1600 Name Function SHIFT function • Next sensation (anorectal Arrow left The function of this button varies throughout the sensation test) program. The function is indicated by the software • Reload zero values during Square The function of this button varies throughout the pretest.
Page 191 RC-1600 Name Function SHIFT function • Next sensation (anorectal – sensation test) • Valsalva maneuver (gynecology) • Select previous test Diamond The function of this button varies throughout the (anorectal) • Insert CLPP marker program. The function is indicated by the software (cystometry, pressure- flow, gynecology) —...
Page 192 RC-1600 Name Function SHIFT function Scale down Decrease the sensitivity for the pressure channels Increment filling (anorectal – Increase the sensitivity for EMG channel 2 expulsion, RAIR and sensation tests) Down Decrease the sensitivity for Decrement filling (anorectal – expulsion, RAIR and EMG channel 2.
Page 193: Virtual Remote Control
RC-1600 Name Function SHIFT function Video Store video (single image, cineloop or loop to disk). Video Grab video (cineloop). SHIFT Press this button together with another button to activate the SHIFT function for that key. To activate or deactivate ALTernate functions (anorectal) Asterics No function yet...
Page 194: Markers
The virtual remote control is a tool that is useful when the remote control has depleted batteries, is malfunctioning, or when it is lost. The tool ensures that the user can always proceed with the investigations. A tool button is available that controls the display of the virtual remote control during pre-test and measurement.
Page 195: Pause Mode
In the investigation protocol you can specify automatic artefact detection. The software will then automatically place artefact markers around an artefact. When artefact is active, the Artefact button will be down and the curves show red borders. Event marker An event marker marks a point of interest during an investigation and has no influence on parameter calculations.
Page 196: Change Filling Liquid
12.3.8 Change Filling Liquid During an investigation, you can remove the empty bag of saline from the pump module and place a full bag. The procedure is as follows: ▪ Click the Pause button in the measurement software program. ▪ Click the Change liquid button to display the Change liquid window. ▪...
Page 197: Investigation Protocol
System settings Configure the measurement program to your wishes. For more information, see § 12.6. LABORIE assistant Configure the assistant to your wishes. Filling liquid settings Change filling liquid settings. For more information, see § 12.7. 12.5 Investigation Protocol 12.5.1 Edit the Protocol The investigation protocol can be set in the measurement program.
Page 198: Include/Exclude Investigations For Protocol
Add investigation protocol An unlimited number of protocols is available. Right-click the protocol name and then choose Add protocol (or choose Settings > Add investigation protocol from the main menu). A new protocol with all investigations will be created. The new protocol will contain the default values. Copy investigation protocol An entire protocol with all settings can be copied.
Page 199: General Protocol Settings
Figure 12.9 Select investigations for protocol On the Select tab, you can exclude investigations from the current protocol (or include them if they were excluded). This can be done by selecting the checkbox adjacent to the investigation type. When an investigation is excluded, the corresponding tab with investigation-specific settings will be invisible.
Page 200 Figure 12.10 Edit investigation protocol User definable markers In the General window, you can change the names of the user definable markers. Immediate markers (A, B, C, D) are placed by pressing A, B, C, or D on the keyboard or the remote control. Delayed markers (A’, B’, C’, D’) are placed by pressing the SHIFT key simultaneously with the keys A, B, C, or D.
Page 201: Laborie Assistant
You can always enable or disable the appearance of the assistant during the measurement. In the protocol settings, select the Laborie assistant tab. To enable the assistant, select the Use the Laborie assistant checkbox. To disable the assistant, clear the checkbox.
Page 202: Sensation Markers
Figure 12.12 Compliance 12.5.6 Sensation Markers Click the Sensation tab to select the sensation markers that can be placed during cystometry, pressure-flow, and gynecology studies. Figure 12.13 sensation markers Select the checkboxes of the sensations markers that you want to use for the cystometry, pressure-flow, and gynecology studies.
Page 203: Investigation Specific Settings
12.5.7 Investigation Specific Settings To change the settings that are specific for an investigation, click the tab that corresponds to the investigation. Figure 12.14 Edit investigation protocol, Pressure-flow tab A page is shown with settings, regarding settings for printing the report, storage on disk, initial pump speed, sample rate, marker line distance, and so on.
Page 204 • Enable DURR (Dynamic Urethral Resistance) channel (pressure-flow study) • Enter residual urine • Confirm stop investigation • Use puller for profile • Puller speed/manual pull speed • Artefact detection • Initial values marker Create report immediately after the investigation When the setting Print report is set to always or optional, the report can be created immediately after the investigation using the report configuration that is selected in the protocol.
Page 205: Channel Settings
12.5.8 Channel Settings Click the Channels button to display the dialog box shown in Figure 12.15. Figure 12.15 Channel settings The channel settings window shows an overview of all available channels. For each investigation you can set the following: • The channels to be measured (for example P , EMG) •...
Page 206: Connections Nexam Pro
12.5.9 Connections Nexam Pro For each investigation, you can set the channel numbers for the channels (signal) to be measured with the Nexam Pro measurement system. In the protocol settings window, select the investigation tab and then click the Connections button to set the connections for that investigation. The window shown in Figure 12.16 opens.
Page 207: System Settings
12.6 System Settings Choose Settings > System settings from the main menu to display the dialog box shown in Figure 12.17. Figure 12.17 System settings measurement program You can select some pages with settings by clicking the appropriate tab. The settings are described below. Display Specific settings for graphs and markers;...
Page 208 Investigation settings You can save investigation data at certain intervals during the investigation to secure the data. Select the Auto save checkbox and enter during which interval the measurement data has to be saved. You can also set the scroll mode and the position of the channel information.
Page 209: Filling Liquid Settings
General You can set some general settings; for example, if hints are shown when the mouse cursor is moved over a button. Video You can set video settings as the video input signal. For more information, see the Video User’s Manual. Reports You can set some report settings: thick graphs, tracing clip-out time, or video image.
Page 210: Analysis Program
13. Analysis Program 13.1 Introduction In this chapter, you will find a description of the menu items and settings in the analysis program. Double-click the investigation name in the database program to start the analysis program. Menubar Channel information Button toolbar Figure 13.1 Analysis program Scrollbar Cursor line...
Page 211 Following is the pressure unit conversion table. Pressure unit Conversion 1 mmHg 0,13 kPa 1,36 cmH 0,54 inchH 1 cmH 0,10 kPa 0,74 mmHg 0,39 inchH 1 kPa 10,20 cmH 4,01 inchH 7,50 mmHg 1 inchH 1,87 mmHg 0,25 kPa 2,53 cmH By using the mouse cursor, you can zoom in to show details.
Page 212: Results
13.2 Results 13.2.1 Menu Overview The following menu items are available: Menu item Function Display results Display the results of the selected investigation. Edit investigation Edit investigation parameters, for example patient parameters weight and name of the investigator. For more information, see §...
Page 213: Display Results
Templates Templates can be defined and loaded in the investigation memo/conclusion to make standard letters; for example, for referring doctors. In these templates, patient information and investigation parameters can be replaced automatically. Memo-templates are described in a separate Database manual in PDF format, which can be opened via the Manuals menu in the database program.
Page 214: Edit Investigation Parameters
In this section, you will find general information about results. The urodynamic parameters are described in the sections of the different investigations. Click Select results to enable or disable parameters. Click Investigation memo to add comment to the investigation. Click Save to PDF to save the results as PDF file. Click Print to print the selected results only.
Page 215: Graph
For the selected investigation, you can do the following: • Enter the residual urine and the initial bladder filling. • Enter the weight of the patient, the length of the patient, complaints, and the name of the investigator. These parameters can be included in the header of the investigation report.
Page 216: Marker
▪ Press and hold the left mouse button while moving the cursor to the right side of the area. A rectangle will now be drawn around the area to be enlarged. ▪ When the left mouse button is released, the investigation will be zoomed in. Repeat this until the area of interest is on your screen.
Page 217 an overview of some important markers which can be placed in the analysis program. To select a marker: ▪ Press the Insert key on your keyboard, or ▪ Choose Marker > Insert marker from the menu, or ▪ Right-click and choose Insert marker from the pop-up menu A list appears with all available markers.
Page 218 Move the mouse cursor to the top of the marker and then right-click. From the pop-up menu, choose Comment. Description of markers In the following table, you will find a description of some markers. For a complete overview of the markers, see the LABORIE help information in the analysis program. Marker name Description Artefact This marker excludes data from the calculations.
Page 219 Marker name Description ▪ Bladder filling (at begin channel and end channel) and delta filling volume. In case a puller is used for UPP, gynecology or anorectal manometry studies, the puller distance (at begin and end channel) and the delta puller distance are displayed. Point the mouse on the channel marker to see the results of the calculation.
Page 220: Reference Cursor
Marker name Description markers. The first marker should be placed on the base of the cough peak, the second marker at the peak of the cough peak. The software will calculate the % transmission for each transmission marker chain. Value marker With this marker, numerical values of the channels are displayed at the marker position.
Page 221 Menu item Function Liverpool plot Display the Liverpool flow rate nomogram in a uroflow, pressure-flow or gynecology study (see § 13.5.3). Miskolc plot Display the Miskolc flow rate nomogram in a (children only) uroflow, pressure-flow or gynecology study (see § 13.5.4). Detrusor volume plot Display the detrusor-volume plot in a cystometry, pressure-flow or gynecology study (see §...
Page 222 Figure 13.5 Arrow indicating result out of bounce Plots in the report Default, all detrusor/flow plots are enabled in the report. Via the edit configuration function of the reporter program you can adapt this. You can find more more information about the reporter program in the separate Reporter manual in PDF format, which can be opened via the Manuals menu in the database program.
Page 223: Siroky Flow Rate Nomogram
Detrusor pressure offset For the plots in which the detrusor pressure is shown, a detrusor offset can be entered by clicking the button or by selecting Options > Detrusor offset. The curves are displayed with an offset added to the detrusor channel. This offset is used to correct the initial detrusor pressure in such a way that the detrusor pressure is the same as the vesical pressure at the start of the investigation.
Page 224: Liverpool Flow Rate Nomogram
13.5.3 Liverpool Flow Rate Nomogram The Liverpool flow rate nomogram shows an x-y plot of the flow rate related to the voided volume. It can be used as an aid to diagnose normal or obstructed urinary flow. Click the Liverpool flow plot button or choose Options > Liverpool plot from the menu to display the plot.
Page 225: Miskolc Flow Rate Nomogram
13.5.4 Miskolc Flow Rate Nomogram The Miskolc flow rate nomogram shows an x-y plot of the flow rate related to the voided volume. It can be used as an aid to diagnose normal or obstructed urinary flow. Click the Miskolc flow plot button or choose Options > Miskolc plot from the menu to display the plot.
Page 226: Detrusor Volume Plot
13.5.5 Detrusor Volume Plot A detrusor-volume plot shows an x-y plot of the detrusor pressure related to the bladder volume. It can be used to determine the bladder compliance. Click the Detrusor/Volume plot button or choose Options > Detrusor/Volume plot from the menu to display the plot. Figure 13.10 Detrusor-volume plot 13.5.6 ICS Detrusor/Flow Plot The ICS detrusor/flow plot shows an x-y plot of detrusor pressure related to...
Page 227: Griffiths Detrusor/Flow Plot
Figure 13.11 ICS Detrusor/flow plot The ICS detrusor/flow plot is divided in three areas: Obstructed, Equivocal and Unobstructed. The Obstructed and Unobstructed areas give a clear result. The maximum flow rate is indicated in the plot as a dot. When this dot is in the Obstructed or Unobstructed area, the result is obvious.
Page 228: Schäfer Detrusor/Flow Plot
Figure 13.12 Griffiths Detrusor/flow plot The black curves in the Griffiths detrusor-flow plot show values of URA. URA is a urethral resistance factor. The URA of a patient is determined by the point representing the peak flow and the detrusor pressure at peak flow for one micturition.
Page 229 Figure 13.13 Schäfer Detrusor/flow plot A linear-PURR (Passive Urethral Resistance Relation) is determined by drawing a straight line from P to P qmax represents the relative lowest detrusor pressure at which flow starts or stops. P is the pressure at maximum flowrate. Qmax For easy application of the linear PURR, a diagram was developed by dr.
Page 230: Chess Detrusor/Flow Plot
Linear PURR (LPURR) The linear PURR is the simplest approximation of the PURR, a straight line, starting at Pmuo and ending at the point Qmax/PdetQmax. The position and slope of the linear PURR provides most clinical information from the original PURR to define the individual outflow conditions.
Page 231: Wf/Volume Plot
A CHESS class is determined depending on the PURR (Passive Urethral Resistance Relation) value and the Pmuo (detrusor pressure at which flow starts) value. Pmuo values are divided in four regions A,B,C,D. PURR values are divided in four regions 1,2,3,4. Four examples make clear how to interpret the CHESS classes.
Page 232: Blaivas Detrusor/Flow Plot
A work factor-volume shows an x-y plot of the work factor related to the bladder volume. It serves as an aid for diagnosing bladder outlet obstruction. WF (work factor) represents the strength of the bladder contraction during voiding. During normal voiding, WF rises slowly, attaining its maximum value when the bladder is nearly empty.
Page 233: Composite Nomogram
study), because of the adverse effect of the transurethral catheter in women undergoing pressure-flow studies. The first time the nomogram is displayed, you can will be prompted to enter the free Qmax obtained with free-flow(s). The Pdet.max will be obtained from the current study as the maximum detrusor pressure that was measured during the current study.
Page 234: Settings
The nomogram is divided into six areas: three categories for obstruction (Obstructed, Equivocal, and Unobstructed), and three for bladder contractility (Weak, Normal, and Strong). In the information bar below the nomogram, a qualitative description of the category is displayed, as suggested by the publication. It ranges from 1 (= no obstruction and good contractility) to 9 (= obstructed with weak contractility).
Page 235: Channel Settings
Gynecology settings Define how to calculate the Maximum Urethral Closure Pressure (MUCP). This setting is for gynecology studies only. Anorectal manometry Define how to calculate anorectal manometry settings results. For more information, see § 9.5.3. 13.6.2 Channel Settings Choose Settings > Channel settings from the menu to display the dialog box shown in 13.18.
Page 236: System Settings
13.6.3 System Settings Choose Settings > System settings from the menu to display the following dialog window. Figure 13.19 System settings analysis program You can select some pages with settings by clicking the appropriate tab. The settings are described below. The settings are valid for all existing investigations in the database and for all new investigations.
Page 237: Export
average, or Peak amplitude (in case you want the fastest response of the EMG channel without a filter). Colors You can change the colors of the various items displayed on the screen: artefact, background, baselines, cursor, grid, and so on. Select the object and then click on the new color.
Page 238: Report
The following menu items are available: Menu item Function LABORIE Reporter Start LABORIE Reporter. You can find more information in the separate Reporter manual in PDF format, which can be opened via the Manuals menu in the database program. Print / PDF / JPG Print or export the report immediately.
Page 239 Figure 13.20 Configure button toolbar To place a button on the toolbar, do the following: ▪ Select a category and click on a button in the commands list. ▪ Press and hold down the mouse button and then move the cursor to the toolbar.
Page 240: Appendix A Safety Information
• SGS contract no. 710253 The Nexam Pro measurement system conforms to the above mentioned requirements only when it is used with specified and approved LABORIE modules/devices as mentioned in this document. The instructions, cautions, and warnings in this manual should be followed by the operator to ensure safe operation and to maintain the Nexam Pro measurement system in a safe condition.
Page 241 The following signs are printed in this manual in front of important warnings, precautions and notes. It is important to pay good attention to these warnings and precautions to provide patient safety and to prevent damaging of the equipment. WARNING A warning is a statement that alerts the user to the possibility of injury, death or other serious adverse reactions associated with the use or misuse of the...
Page 242 All repairs that are not performed by LABORIE personnel are the responsibility of the hospital. LABORIE will not give any guarantee or take any responsibility for any part that has been opened, adjusted, or replaced by hospital personnel. The Nexam Pro measurement system may be opened for any adjustment, replacement, maintenance, or repair by LABORIE qualified personnel only.
Page 243 60601 system requirements should be applied prior to use. WARNING Do not use High-Frequency (HF) surgical equipment on the patient or in the vicinity of the Nexam Pro system as the patient may experience burns. Device is not intended for use with HF surgical equipment. WARNING Do not place the safety module/Multiple Socket-Outlet (MSO) on the floor.
Page 244 Make sure that both primary and secondary voltage selection switches are in the same position, to prevent permanent damage to the system. Contact your LABORIE representative if this is not the case or when you are in doubt. Computer CAUTION...
Page 245 Nexam Pump Unit WARNING Do not switch on the roller pump if the clamp is removed. Never put fingers or any other body parts in the pump while it is running! Do not put any objects in the roller pump. The pump is designed to maintain a constant speed;...
Page 246 Combination interface module WARNING Do not clamp the combination interface module upside down in a wet environment. WARNING When there is some friction, use a brush to put a little silicon oil on the orange Argon (formerly B-D) rings. Never put the oil on the contacts of the connectors. Luna wireless module The Luna complies with part 15 of the FCC Rules.
Page 247 CAUTION Change the battery only when the patient is disconnected from the WPM (unplug catheter and all patient leads from the WPM). CAUTION After low battery indication, exchange the batteries within 15 minutes. CAUTION Remove the batteries when the wireless patient module is not used for a longer period (month).
Page 248 Wireless (Bluetooth) flowmeter Mk III The flowmeter complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
Page 249 CAUTION Remove the batteries when the flowsensor is not used for a longer period (more than three months). CAUTION Do not use chloride-based solutions for cleaning the flow stand. Check that the solution does not affect stainless steel (AISI304L). Clean the flow stand if it was contaminated with urine.
Page 250 CAUTION When using the Bluetooth puller, do not clamp the catheter at the position of a pressure transducer, as this will damage the transducer permanently. CAUTION Use rechargeable AA batteries (≥ 2300 mAh NiMH) of good quality only and replace all four at once. CAUTION After low battery indication, connect the power adapter within five minutes and charge the batteries.
Page 251 CAUTION To prevent drift, always pre-wet solid-state catheters (sensors) according to the instruction of the manufacturer. CAUTION Only use the accessories specified in the document “Declaration of Compatibility for MMS accessories” (document code: 0060-DEC-007). NOTE For cleaning and sterilization of the catheters or accessories (e.g., EMG needle electrodes), see the manufacturer’s instructions.
Page 252 Nexam Pro System or any patient modules. The Nexam Pro system does not contain defibrillation proof applied parts. CAUTION Never turn off the computer when the LABORIE software program is still active. You may lose data. CAUTION Automatic safeguards built into the software should be seen as an aid.
Page 253 previous software version due to changed/improved analysis techniques or changed medical opinion/insight. Although precautions have been taken in this apparatus to prevent malfunctions due to abnormal environmental conditions and/or abnormal handling, such malfunctions can occur in some circumstances. Abnormal environmental conditions include, but are not limited to: •...
Page 254 Safety regulations Nexam Pro modules Module Protection Class Applied Ingress (depending on setup) part protection rate Separating Transformer Class I IP20 (STF) U2M module (U2M) Class II IPX1 Nexam Pump Unit IPX2 (NPU) Combination Interface IPX1 Module (CIM) Luna wireless module IP2X Wireless Patient Module (WPM)
Page 255: Appendix B Explanation Of Symbols
Appendix B Explanation of Symbols This appendix provides explanations of the symbols on the Nexam Pro measurement system. Refer to instruction manual. Blue symbol Caution, consult instructions of use. Consult instructions for use. Caution: Federal law restricts this device to sale by or on the order of a physician.
Page 256 Protected against dripping water. Equipment provided with an enclosure preventing entry of such an amount of falling liquid IPX1 as might interfere with the satisfactory and safe operation of the equipment. Protected against solid foreign objects of 12,5 mm Ø and IP20 greater and not protected against liquids.
Page 257 CE (93/42/EEC). Nationally Recognized Testing Laboratories. Never put fingers or any other body parts in the pump while it is running! Symbol with red border Double insulated conform IEC 60601-1. Atmospheric pressure range 700 hPa to 1060 hPa. Operating Conditions: Temperature range +15°C to +35°C.
Page 258 –10°C to Storage Conditions: Temperature range +50°C. Storage Conditions: Relative humidity range 15% to 90%, non-condensing. –25°C to Transport Conditions: Temperature range +70°C. Transport Conditions: Relative humidity range ≤90%, non- condensing. This device uses a RF transceiver for data transfer purposes. This product is subject to WEEE directive 2012/19/EU.
Page 259 Manufacturer. May be combined with manufacturing date. Keep dry. Fuse. Equipotentiality. Protective earth. Earth (ground). Signal reference. Explanation of Symbols Nexam Pro User Manual...
Page 260 Polarity of DC power connection. USB port (upstream from U2M module to PC). Input. Output. Input/output. Separating Transformer input and output voltage selection switch. Mass (including safe working load) in kilograms. Nexam Pro User Manual Appendix B...
Page 261 Catalog number. Serial number. Quantity symbol: Numeral in symbol (in place of #) indicates the quantity of units in package. Explanation of SN-number SN YYXXNNNN Serial Number Two-digit manufacturing year number One- or two-digit product identification number NNNN Four-digit incrementing unique number Explanation of PE-number PEYY-FXXXXNNNN Peripheral Equipment...
Page 262: Appendix C Software Messages
Software messages measurement and analysis Message Cause Posible actions to resolve An error occurred related to the video digitizer! Error with video digitizer Contact your LABORIE Video will be disabled. representative Blood pressure meter not active. Retry to Module not active Retry connecting connect? Bluetooth flowmeter connection lost.
Page 263 Cannot move a Pause marker (Display pause Cannot move marker Pause data is hidden data) Changes in marker data could not be written! Error during saving of marker data Contact your LABORIE Disk error representative Channel settings could not be written! Error during saving of channel...
Page 264 Increase the non-paged non-paged memory size in Milconfig. buffers memory size in Milconfig Fatal error during reading of the testdata! Exception during reading test data Contact your LABORIE representative Fatal error occurred during the measurement! Exception during measurement Contact your LABORIE representative...
Page 265 Service Pack 2 to use the Microsoft Bluetooth stack or re-install the software to install the Widcomm Bluetooth stack. LABORIE perfusion pressure too high - The Perfusion problem Contact your LABORIE pressure release valve is probably polluted.
Page 266 Please contact your dealer. The Solar Blue is connected to the computer via Solar Blue is connected via USB Contact your LABORIE USB but not all LABORIE bus ports were representative recognized The Solar Blue is connected to the computer via...
Page 267 Message Cause Posible actions to resolve the pump. If the error remains, the system should be sent to LABORIE for maintenance. Warning: compliance marker in miction phase Compliance marker in miction Remove marker phase Warning: No more Profile markers! No more profile markers available...
Page 268 Error during copying of file Disk is full or file size is too Free up disk space large Error executing program Application cannot be executed Contact your LABORIE representative Error in FCU file. Archive of patient aborted FCU file is corrupted Contact your LABORIE representative Error in FCU file.
Page 269 LABORIE representative Login program was not used! Network software, but Use LABORIE login LABORIE Login was not used Maximum of investigations for patient The maximum number of Paste investigation reached investigations (99) for this with a different...
Page 270 LABORIE representative This function is not available Network software, but Contact your LABORIE LABORIE login is not available representative Unknown user: [Username] Program halted. Unknown login user, Use a known user to application stopped login Nexam Pro User Manual...
Page 271: Index
Index Air-charged catheter (anorectal manometry) ..................127 Air-charged catheters ..........................63 Analysis program buttons in the software ........................210 channel information ........................210 configure the toolbar ........................238 cursor line ............................210 introduction ............................. 210 menu ..............................210 scrollbar............................210 system settings ..........................
Page 272 challenge editor ..........................173 EMG channel ..........................163 flow channel ............................ 163 introduction ............................. 163 investigation ............................ 167 measurement ........................... 167 prepare investigation ........................163 pressure channel ..........................163 protocol ............................168 settings ............................170 Bladder volume ........................... 186 Blaivas detrusor/flow plot ........................232 BOOI ..............................
Page 273 Detrusor/volume plot ........................... 226 DT-XX pressure transducers ......................65, 71 adjust sensitivity ..........................46 cables..............................47 heartbeat filter ..........................166 position the electrodes ........................46 prepare............................... 45 settings ............................208 surface electrodes ..........................45 Event markers ........................187, 195, 219 Export to HL/7 ............................
Page 274 Investigation buttons in the software ........................186 edit protocol, see Protocol settings ....................197 new investigation ........................25, 183 pre-test............................26, 185 procedure ............................20 quick start ............................200 remote control buttons ........................188 results .............................. 213 stop investigation ..........................196 Keyboard keys .............................
Page 275 flow markers ........................... 219 immediate markers .......................... 194 insert markers ..........................216 marker line measurement program ....................185 move markers ..........................218 peak flow markers ........................... 219 sensation markers ..........................202 show sticky note ..........................200 tracing clip-out markers ........................219 transmission markers ........................
Page 276 PDF document save the results ..........................214 Peak flow markers ..........................219 Peak flowrate ........................... 75, 89 Perfusion (low-cost) ..........................126 Pressure-cuff for water catheters ......................68 pressure-cuff for water catheters (anorectal manometry) ..............127 Pressure-flow study channel information .......................... 84 introduction ............................
Page 277 introduction ............................12 keys for measurement program ....................... 188 Report combined reports ..........................56 display results ..........................213 print all reports ..........................56 print the report ........................... 55 Results display results ..........................213 edit investigation parameters ......................214 investigation information ........................ 212 print results ............................
Page 278 Urodynamic transducers ........................59 Uroflow channel information .......................... 73 introduction ............................73 investigation ............................73 results ..............................74 Valsalva manoeuvre ........................... 78 Valsalva results ............................. 82 Value marker ............................220 Voided volume ..........................75, 90 Voiding time ............................ 75, 90 Water catheters ............................

This manual is also suitable for:

Nexam pro wpu-es Nexam pro cim

LABORIE Nexam Pro WPU-L4 User Manual

1 Introduction

2 Investigation Procedure

3 Urodynamic Catheters & Transducers

4 Uroflowmetry

5 Cystometry

6 Pressure-Flow Study

7 Urethral Pressure Profile (UPP)

8 Gynecology Study

9 Anorectal Manometry

10 Biofeedback

11 Investigation with Luna Wireless Module

12 Measurement Program

13 Analysis Program

Appendix A Safety Information

Appendix B Explanation of Symbols

Appendix C Software Messages

Index

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Summary of Contents for LABORIE Nexam Pro WPU-L4