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LABORIE MMS Solar Blue User Manual

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  • Page 1 Solar Blue User Manual Solar Blue 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 2009–2021 LABORIE...

  • Page 3: Table Of Contents

    Intended Use .................. 12 Safety Information ................12 Accessories for the Solar Blue ............12 Troubleshooting ................12 LABORIE Software Program ............13 Computer Requirements ..............14 LABORIE Assistant ................ 14 About the Manuals ................. 14 1.10 Manual Conventions ..............15 Investigation Procedure ................
  • Page 4 Reusable Solid-State Catheters ............ 46 Air-charged Catheters ..............47 Water Catheters ................50 3.5.1 Introduction ..............50 3.5.2 Measuring Pves and Pabd ..........52 3.5.3 Measuring Pves, Pura and Pabd ........52 3.5.4 Measuring Pves and Pura ..........54 3.5.5 Flushing and zeroing water catheters ......
  • Page 5 Investigation ................... 90 Results ................... 94 Anorectal Manometry ................95 Introduction ..................95 Investigation Protocol ..............95 9.2.1 Edit the anorectal manometry protocol ......95 9.2.2 Select the catheter ............96 9.2.3 Select the anorectal manometry tests ......98 9.2.4 Filling ................
  • Page 6 9.5.2 Insert channel markers ........... 125 9.5.3 Channel definition ............126 9.5.4 Anorectal manometry settings ........128 9.5.5 Results ................129 9.5.6 Resting pressure test ............. 130 9.5.7 Squeeze test ..............130 9.5.8 Endurance squeeze test ..........132 9.5.9 Cough test ..............134 9.5.10 Push test ................
  • Page 7 12.5 Investigation protocol ..............174 12.5.1 Edit the protocol ............. 174 12.5.2 Include/exclude investigations for protocol ....176 12.5.3 General protocol settings ..........177 12.5.4 LABORIE assistant ............178 12.5.5 Compliance ..............179 12.5.6 Sensation markers ............179 12.5.7 Investigation specific settings ......... 180 12.5.8 Channel settings ............
  • Page 8 13.6 Settings ..................205 13.6.1 Menu overview ............... 205 13.6.2 Channel settings ............206 13.6.3 System settings .............. 207 13.7 Export ................... 209 13.8 Report ..................209 13.9 Configure Button Toolbar ............. 210 Appendix A Safety Information .............. 212 Appendix B Explanation of Symbols .............

  • Page 9: Introduction

    The Solar Blue measurement system is available in two models: • Solar Blue, table-top (LABORIE systems catalog code U3-1) • Solar Blue, Laptop integrated (LABORIE systems catalog code U3-3) The Solar Blue module can communicate via a wireless connection with the flowmeter, puller, and computer.
  • 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 Module Description Luna wireless Measures pressures, EMG (optional), module and conductance (optional) via wireless connection. Optionally, you can use the Luna for ambulatory urodynamic monitoring. Remote control The RC-1200 is used during the investigations to control the devices and to perform an investigation. The RC-1000 can also be used (described in the previous version of this manual).

  • Page 12: Intended Use

    Blue measurement system and its manuals, read the safety information presented in Appendix A. Accessories for the Solar Blue LABORIE offers a range of accessories that you can use with LABORIE measurement systems. For more information, contact your LABORIE representative.

  • Page 13: Laborie Software Program

    LABORIE Software Program The LABORIE software program is supplied with your Solar Blue measurement system to make the complete system function. For an overview of the software messages that require an action to resolve, see Appendix C. The program contains four parts (Figure 1.5):...

  • Page 14: Computer Requirements

    • Two-button mouse LABORIE Assistant The LABORIE assistant (Figure 1.6) is an intelligent assistant that can provide helpful advice to you via pop-up messages. The message and the assistant will disappear when you click the OK button in the message box. You can configure the behavior of the assistant in the database program and the measurement program.

  • Page 15: Manual Conventions

    13). The Solar Blue Service & Installation Manual (Document Code: LBL- 001019) is intended for all technical users who install, test, and maintain the measurement system. You can find the assembly instructions for the Solar Blue on the Solar pole MK III in a separate document (document code: MAN-00010).
  • Page 16 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 Solar Blue User Manual...

  • Page 17: Investigation Procedure

    Investigation Procedure Introduction You can consider the information provided in this chapter as a quick start guide toward getting underway to perform urodynamic investigations. Besides software instructions, you will find instructions for pump tube installation, positioning EMG electrodes, and preparing the flowmeter and the catheter puller.

  • Page 18: Start The Database Program

    Start the Database Program Double-click the Laborie-Login button on your desktop to log in to the database. Figure 2.1 Login 2.2.1 Administrator Authentication From the Login window, Click the button to enter the Administrator Authentication window to manage the User/Password.
  • Page 19 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 fields: • Local dir for the location of the locally installed software • Network dir for the location of the files on the network.
  • Page 20 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 21: Patient Database

    • Next, use Admin Level and User Level to select which AD/LDAP groups are considered Admin and which are regular users when they log in to the software. o A user who is in the Admin group will be automatically created with a permission level of 99 when logged in.

  • Page 22: Enter And Select The Patient

    Enter and Select the Patient Click the New patient button to add a new patient to the database. Figure 2.6 Enter new patient 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 text field via the mouse.

  • Page 23: Start The Measurement Program

    Start the Measurement Program In the database program, click the New investigation button to start the measurement program. When more than one system is installed, you need to select the stationary measurement system. Figure 2.7 Measurement program—select a new investigation The measurement program shows all available investigations.
  • Page 24 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 25 If there are no bypasses remaining, contact the LABORIE service desk for assistance. NOTE The current number of bypasses is displayed in the status bar of the Consumables traceability dialog box.
  • Page 26 consumable becomes unusable—for example, becoming 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 27: Pre-Test

    2.5.2 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 28 ▪ Flush the pump tube to expel any air from the tube (in the pre-test). ▪ Start the investigation. Pump calibration LABORIE advises NOT to calibrate the pump when the pump is performing well within acceptable ranges. When the pump performance deviates, LABORIE recommends that you first determine the cause of the problem; for example, the filling lumen of the catheter is blocked, the spike is not pushed all the way into the bag, or a non-specified pump tube is used.

  • Page 29: Solar Blue Module Control Panel

    calibrate the pump and to reset to factory default in the Solar Blue Service & Installation Manual (document code: LBL-001019). 2.5.4 Solar Blue Module Control Panel The control panel indicates the status of the Solar Blue module. The control panel contains: the status LED [1], the battery LED [2], the Bluetooth LED [3] and the infrared receiver [4].

  • Page 30: Prepare The Luna Wireless Module

    2.5.5 Prepare the Luna wireless module The Luna module (Figure 2.12) 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 during a stationary urodynamic investigation. Figure 2.12 Luna module Optionally, the Luna can be used: •...

  • Page 31: Prepare The Catheters And Transducers

    2.5.6 Prepare the catheters and transducers Catheters and transducers can be used to perform pressure measurements in the bladder, urethra, and rectum. Preparations can be different, depending on the following: • The type of the catheters (microtip/solid-state, air-charged, or water catheters) •...
  • Page 32 The procedure is as follows: ▪ Connect the EMG cable to the Solar Blue module or the Luna module. ▪ 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 33 EMG cables and electrodes The following types of EMG cables/leads and electrodes are recommended for use with the Solar Blue 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 34: Prepare The Flowmeter

    The recommended EMG cable for use with the Luna is the UD 597 A6 (= guarded EMG cable for three surface electrodes with press studs, 60 cm). The color coding is as follows: Signal + Signal – Reference Black Figure 2.18 EMG cable for Luna 2.5.8 Prepare the flowmeter The flowmeter can be used to measure the voided volume and the flow during...
  • Page 35 It is always possible to connect the Bluetooth flowmeter to the Solar Blue module by using a digital MMS-bus cable. All of the following three conditions must be met: • The Solar Blue module needs to communicate with the computer via USB. •...

  • Page 36: Prepare The Catheter Puller

    2.5.9 Prepare the catheter puller The catheter puller (Figure 2.20) can be used to aid in making pressure profiles of the urethra and the anal sphincter. The catheter will be withdrawn with a predetermined speed and/or over a predetermined distance by the puller.
  • Page 37 Prepare the wireless puller Figure 2.21 shows an overview of the puller parts. Puller motor enclosure DC receptacle for the power adapter Battery compartment (can be opened by removing the screws) Handle to position the puller Control panel Pin to mount the puller on the carrying arm Slider Slider protection disk...
  • Page 38 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 39: Run Quality Check

    Run Quality Check Click the Quality Check button to start the quality check. The software will display a message instructing the patient to cough (Figure 2.23). Figure 2.23 Run quality check The software will monitor P on cough peaks for 30 seconds. When a cough peak is detected, the check will be performed and shown immediately.

  • Page 40: Perform The Investigation

    Figure 2.25 Results quality check failed The information for the last quality check is stored in the investigation file and will be shown in the investigation information of the analysis program and in the report. Perform the Investigation After finishing the pre-test, you can start the actual investigation. Figure 2.26 Pressure-flow study Graphs begin to scroll and all data (channels) are measured and stored.

  • Page 41: Print The Investigation Report

    The investigation instructions depend on the investigation type and the protocol settings. See the investigation-specific instructions, as described in the following chapters: • Uroflowmetry, see Chapter 4 • Cystometry, see Chapter 5 • Pressure-flow study, see Chapter 6 • Urethra pressure profile (UPP), see Chapter 7 •...

  • Page 42: Cleaning Instructions

    You can find more information in the separate Database manual in PDF format, which you can open via the Manuals menu in the database program. Cleaning Instructions After each investigation, LABORIE recommends cleaning or replacement of the following parts: • Reusable catheters must be cleaned and sterilized after each investigation and maintained sterile until the next investigation is done.

  • Page 43: Exit The Database Program

    You can find detailed maintenance instructions in the Solar Blue Service & Installation Manual (document code: LBL-001019). The Solar Blue system, its components and accessories shall be disposed at the end of their expected service life in a manner that complies with all local environmental regulations.
  • Page 44 Shut down the computer After clicking Exit in the database program, you can shut down the computer by clicking the Start button of the Windows Start menu. Select Shutdown to exit Windows and turn off the system. CAUTION Never turn off the computer when the software program is still active, as this can result in the loss of data.

  • Page 45: 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 46: Prepare The Catheters And Transducers

    Prepare the Catheters and Transducers The procedure to prepare the catheters and transducers is as follows: ▪ Start the database program. ▪ Enter and select the patient name in the database program. ▪ Click the New investigation button in the database program ▪...

  • Page 47: Air-Charged Catheters

    Figure 3.4 Example reusable solid-state catheter The procedure to prepare the catheters is as follows: ▪ Premoisten the catheter in distilled sterile water as described in manual of the manufacturer (the minimum period is two minutes). ▪ Connect the premoistened catheter to the Solar Blue module as follows: o Connect P (vesical/bladder pressure) to P1 o Connect P...
  • Page 48 Figure 3.5 Example air-charged catheter Figure 3.6 Air-charged pressure transducer The catheters are connected to the Solar Blue module or the Luna module via air-charged pressure transducers (Figure 3.6). 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 moisture infiltration.
  • Page 49 ▪ Remove the cap from the abdominal catheter. Be sure that no moisture enters the catheter. ▪ Connect the abdominal catheter to the blue (P ) pressure transducer and tighten securely. Be sure to connect in the OPEN position (Figure 3.7). ▪...

  • Page 50: Water Catheters

    Water Catheters 3.5.1 Introduction Water catheters (Figure 3.10) can be used to perform pressure measurements in the bladder, urethra, and rectum. The bladder catheter has one or two pressure sensors with one filling lumen. One sensor is for measuring pressures in the bladder (P ), the second sensor is for measuring pressures in the urethra (P ).
  • Page 51 Figure 3.11 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 properly. 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 52: Measuring Pves And Pabd

    3.5.2 Measuring Pves and Pabd Figure 3.12 shows the catheter setup for two pressures: P and P . This catheter will be used for cystometry and pressure-flow studies. Figure 3.12 Measuring Pves and Pabd The procedure is as follows: ▪ Put the DT-XX pressure transducers in the holder and connect the transducers to the Solar Blue module.
  • Page 53 Figure 3.13 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 Solar Blue module. ▪ Place the pressure transducer holder at symphysis pubis level. ▪...

  • Page 54: Measuring Pves And Pura

    § 3.5.3. It is not necessary to measure the abdominal pressure (see also Figure 3.14). Figure 3.14 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 55 Figure 3.15 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 Solar Blue module. ▪ Place the pressure transducer holder at symphysis pubis level. ▪...

  • Page 56: Flushing And Zeroing Water Catheters

    ▪ Connect the syringes filled with sterile water to the pressure transducers as displayed in the figure above (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 57 ▪ Press the Zero all button to zero-balance all pressures to atmospheric pressure. ▪ 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...

  • Page 58: Uroflow

    Uroflow 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 59: 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 60 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 -. when only the volume is measured VOID = -/340/-.
  • Page 61 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. It is calculated as voided volume divided by the flow time. [E1 + E2 + E3 + E4] Voided volume (ml) Calculated: Average flow rate = -------------------------- = --------------------...

  • Page 62: 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 63: Results

    ❑ Prepare the EMG cables and apply the EMG electrodes (see § 2.5.7). Press the Start investigation button. Press the Pump ON button to start the pump. Press the First sensation button to mark the first sensation. Use this button for all sensation markers. When the patient is unable to tolerate further filling or if the bladder is filled sufficiently, press the Pump button to stop.
  • Page 64 Figure 5.1 Cystometry result selection Some parameters will be calculated after placing the corresponding markers. The parameters of the cystometry results are described in the subsections that follow. Initial bladder filling The patient’s bladder filling at the start of the investigation. This filling is either entered by the user or calculated from the previous investigation.
  • Page 65 Residual urine The residual urine is defined as the volume of the fluid remaining in the bladder immediately following the completion of micturition. It can be entered manually at the end of a cystometry. Pves max Pves max is the maximum bladder pressure (Pves) during the investigation. This parameter is valid as an absolute parameter only if the transducer is zeroed at atmospheric pressure.
  • Page 66 Pdet compliance Pdet compliance is the change in bladder volume for a change in detrusor pressure. It is defined as C= dV/dP, where dV is the volume increment, and dP is the change in pressure associated with this volume increment. The compliance can be determined over a certain filling part of the investigation, by placing two compliance markers.
  • Page 67 When valsalva markers are present but when no leak point marker is placed, the maximum pressure is shown in the results. Cough leak point results The cough results can be selected in the select results window. During the CLPP (Cough Leak Point Pressure) procedure, the patient is asked to cough. When an CLPP begins, a marker is present, and a leak point marker is placed, the software searches back in time (maximum 30 seconds) to find one or more peak amplitude.
  • Page 68 Other parameters You can find additional explanations about the calculation of other parameters by clicking the Help button in the Results window. Solar Blue User Manual Chapter 5...

  • Page 69: 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 70 ❑ Prepare and insert the catheters. Follow the procedure depending on the type of catheter being used: o Solid-state catheters (see § 3.3) o Air-charged catheters (see § 3.4) o Water catheters (see § 3.5) ❑ Connect the pump tube to the filling lumen of the catheter. ❑...

  • Page 71: 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 Valsalva begin/end to start/end the Valsalva maneuver. Click Spontaneous Miction to mark spontaneous miction. Press Shift and Leak point to start the Cough Leak Point Pressure (CLPP) procedure.

  • Page 72: Filling Phase Results

    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 in the following subsections. 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, as shown in Figure 6.2.

  • Page 73: Voiding Phase Results

    empty at the beginning of the investigation or that the contents is entered as initial bladder filling. Calculated: Volume lost through leakage = Micturition volume in filling phase This number is only determined when a flowmeter is connected and used during the investigation.
  • Page 74 The ICS nomogram divides patients into three classes based on the BOOI: unobstructed (BOOI ≤ 20), equivocal (BOOI = 20–40), and obstructed (BOOI ≥ 40). The BCI shows the Bladder Contractility Index: Pdet@Qmax + 5Qmax, The BCI nomogram divides patients into three classes: strong (BCI > 150), normal (BCI = 100–150) and weak (BCI <...
  • Page 75 [E1 + E2 + E3 + E4] Voided volume (ml) Calculated: Average flow rate = -------------------------- = -------------------- [B1 + B2 + B3 + B4] Flow time (s) When Flow markers are present, the average flow rate is calculated between the first and last flow marker.
  • Page 76 Compliance can be determined over a certain filling part of the investigation, by placing two compliance markers. The first marker [A] should be placed just after the start of the filling, the second marker [B] just before the end of the filling.
  • Page 77 This time lag can be measured by compressing the urethra completely during voiding, recording when compression is done and when it is seen on the flow tracing. Miction Index You can find an explanation of the Miction Index 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.

  • Page 78: Urethral Pressure Profile (Upp)

    Urethral Pressure Profile (UPP) Introduction The Urethral Pressure Profile (UPP) investigation assesses the intraluminal pressure along the length of the urethra. This pressure represents the ability of the urethra to prevent leakage. Two types of UPP may be measured: • Resting UPP, with the bladder and subject at rest •...

  • Page 79: 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 80 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 with one centimeter. An increase in urethral pressure (P ) indicates that the urethral sensor enters the urethra.
  • Page 81 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 cmH2O, a Profile start marker will be inserted automatically (backwards in time).

  • Page 82: 7.4 Results

    7.4 Results In the analysis program, from the menu, choose Results > Display results 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 in accordance with Dr. J Eberhard. This UPP analysis analyzes all profiles found in the investigation.
  • Page 83 • Functional profile length Figure 7.2 UPP results selection The parameters of the UPP results are described in the following subsections. Maximal urethral pressure (MUP) The maximal urethral pressure (P ) during the UPP study. Functional profile length The functional profile length is the length of the urethra, along which the urethral pressure exceeds vesical pressure.
  • Page 84 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 valid only 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 85 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; hence, this is the resting bladder pressure. Calculated: Resting bladder pressure = [F]. Maximum Urethral Closure Pressure (MUCP) Calculation method The Maximum Urethral Closure Pressure (MUCP) can be calculated in two...
  • Page 86 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...

  • Page 87: Transmission

    and inaccuracy in pulling speed. The puller speed, as set in the protocol, is used to calculate distance and area related parameters. 7.4.3 Transmission Figure 7.5 Transmission The letters between square brackets refer to the corresponding letters Figure 7.5. The pressure transmission ratio is the increment in urethral pressure on stress (cough) as a percentage of the simultaneously recorded increment in vesical pressure.
  • Page 88 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 be displayed only for stress profiles. The software distinguishes between stress and rest profiles by the presence of transmission markers.

  • Page 89: 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 90: Investigation

    Investigation Click the Gynecology study button to start the pre-test. ❑ Prepare the pump and the pump tube as described in § 2.5.3. ❑ Prepare the flowmeter as described in § 2.5.8. ❑ Prepare and insert the catheters. Follow the procedure depending on the type of catheter being used: o Solid-state catheters (see §...
  • Page 91 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 with one centimeter. An increase in urethral pressure P indicates that the urethral sensor enters the urethra.
  • Page 92 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 cmH2O, a Profile start marker will be inserted automatically (backwards in time).
  • Page 93 Filling phase (continued) 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 94: 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 95: 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 96: 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 four pressure channels for the most accurate results.
  • Page 97 Figures 9.2 and 9.3 show the layout of the two most common four-channel catheters: • One centimeter spacing between the four pressure channels (spiral) and a balloon at the tip to test the anorectal reflex (RAIR) and sensations. • Four pressure channels at the same location (radial) with an angle of 90 degrees and a balloon at the tip to test the anorectal reflex (RAIR) and sensations.

  • Page 98: Select The Anorectal Manometry Tests

    Radial catheter mode In the Edit investigation protocol window, you can select the catheter mode: staggered/helix (default selected) or radial mode. When radial mode is selected, on the Test selection tab, the resting pressure test, the squeeze test, and the push test are combined in one sequence. When the rest, squeeze, or push test is ended, the next test in the combined sequence will be activated.

  • Page 99: 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 change 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 100: Timers

    Figure 9.5 Filling with syringe settings The option 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 101: Squeeze

    Figure 9.6 Timers tab The Familiarization timer (default on) is used to let the patient become accustomed to the catheter at the beginning of the investigation. 9.2.6 Squeeze Click the More button and then select the Squeeze tab, as shown in Figure 9.7.

  • Page 102: Push

    9.2.7 Push Click the More button and then select the Push tab, as shown in Figure 9.8. Figure 9.8 Push settings During the push tests, you can mark the catheter position (insertion depth). This setting is often used for investigations with radial catheters. The puller can be used to withdraw the catheter step-wise (default = 1 cm).

  • Page 103: Rair

    9.2.8 RAIR Click the More button and then select the RAIR, as shown in Figure 9.9. 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.

  • Page 104: Sensation

    Figure 9.10 Filling with perfusion pump, auto deflate balloon setting For Syringe filling method, you can select Ask balloon volume. 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, as shown in Figure 9.11.
  • Page 105 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 tolerated 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 106: Compliance

    9.2.10 Compliance Click the More button and then select the Compliance tab, as shown in Figure 9.12. 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.

  • Page 107: Balloon Expulsion

    9.2.11 Balloon expulsion Click the More button and then select the Balloon expulsion tab, as shown in Figure 9.13. Figure 9.13 Balloon expulsion settings Balloon filling settings In the Volume section, you can set the Initial volume (default = 10 ml) and the Volume increment (default = 10 ml).

  • Page 108: Profiles

    9.2.12 Profiles Click the More button and then select the Profiles tab, as shown in Figure 9.14. Figure 9.14 Profile settings Rest and squeeze profile tests can be performed during anorectal manometry. A four-channel radial catheter is most accurate for these tests. In the profile settings, you can select how to withdraw the catheter: automatically by using the puller or manually with your hand.

  • Page 109: Prepare The Investigation

    Prepare the Investigation 9.3.1 Water catheters For measuring with water catheters and pressure transducers, perfusion of the channels is needed. The following items are included for perfusion with a pressure cuff (see also Figure 9.15): • Pressure cuff (300 mmHg) •...

  • Page 110: Air-Charged Catheters

    ▪ In the database program, enter and select the patient name. ▪ Again, in the database program, click the New investigation button. ▪ Click the Anorectal manometry button to start the pre-test. ▪ Place the pressure transducer holder at patient level. ▪...
  • Page 111 The procedure to prepare the investigation is as follows: ▪ Connect the pressure transducer cables (in OPEN position) to the Solar Blue module. For the GIM-60000A air charged catheter and transducers, the connection is as follows: Color pressure transducer Solar Blue module Yellow (distal) Green (medial distal) Blue (medial proximal)

  • Page 112: Solid-State Catheters

    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. Use a latex condom as a balloon. Cut the top, eight centimeters (approximately 3.5") off the condom.

  • Page 113: Investigation

    Investigation 9.4.1 Introduction For the anorectal manometry investigation, the following tests are available: • Resting pressure • Squeeze • Endurance squeeze • Cough • Push • Rectal anal inhibitory reflex (RAIR) • Sensation/Rectal compliance • Anal rest profile • Anal squeeze profile •...

  • Page 114: 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 Resting is displayed on the left button. Ask the patient to be quiet for 10 to 20 seconds (do not talk, move, squeeze).

  • Page 115: Cough Test

    Press the Next test button until 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 116: Rectal Anal Inhibitory Reflex (Rair) Test

    Ask the patient to stop pushing. Press the Push End button to mark the end of the test. This marker is automatically placed when the push timer is used. Reposition the catheter and repeat this procedure if necessary. 9.4.7 Rectal anal inhibitory reflex (RAIR) test The purpose of the RAIR test is to assess the rectal anal inhibitory reflex.
  • Page 117 You can choose to fill the balloon with air or water by using a syringe or the Solar Blue pump (see also the protocol settings in § 9.2.1). If you use the Solar Blue pump, install the pump tube as described in § 2.5.3. Both methods to fill the balloon are described here: Filling with water (Solar Blue pump) Press the Next test button until No sensation is displayed on the left...

  • Page 118: Rest And Squeeze Profiles Using A Puller

    Press this button when a patient (during infusion) states a certain sensation. The sensation markers are defined in the protocol settings: No sensation, First sensation, First urge, Modest urge, Intense urge, Maximum tolerable volume, and Pain. When the maximum tolerable volume is reached, stop inflating the balloon.
  • Page 119 NOTE Do not position the puller too close to the anal verge. This prevents the puller head from pollution by the catheter during withdrawing. The procedure is as follows: Press the Next test button until Start puller [Rest] is displayed on the left button.

  • Page 120: Rest And Squeeze Profile With Manual Pull

    Variations Instead of a rest profile, it also possible to perform stress profiles, as described earlier. To perform a stress profile, ask the patient to cough during the profile manometry. During the analysis, the software can calculate transmission parameters for the peaks. 9.4.10 Rest and squeeze profile with manual pull The purpose of the anal resting and squeeze pressure profile is to obtain a...

  • Page 121: Balloon Expulsion Test

    Figure 9.19 Rest profile manually After a short while, there should be an increase in the anal pressure. The software automatically marks the start and the end of the anal profile. Reposition the catheter and repeat the procedure if necessary. Press the Next test button until Start profile [Squeeze] is displayed on the left button.
  • Page 122 faeces. Therefore, the best way to perform this test is to use water at body temperature and a syringe or the Solar Blue pump to fill the balloon with water. In case of a multi-use catheter (without replacement of the balloon), it is advised to fill the balloon with air (with a syringe) instead of water.

  • Page 123: Rectal Compliance

    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. When the desired volume is reached, stop the pump by pressing the Pump button.
  • Page 124 Zero the transducer in open air. Press the Start investigation button. Press the ALT key on the remote control and press the Calibration begin button. Inflate the balloon in 10 ml increments, until you reach the maximum volume that you want to inflate it during the investigation. Press the Calibration end button and empty the balloon.

  • Page 125: Remote Control Buttons

    Analysis 9.5.1 Introduction Analysis can be performed by inserting channels markers or by using the channel definition settings. LABORIE recommends using the method with the channel markers. 9.5.2 Insert channel markers The channel markers should be inserted on the channels on which the specific test is registered.

  • Page 126: Channel Definition

    Figure 9.21 Example of anorectal manometry channel marker settings When you performed the investigation with, for instance, a spiral catheter, you must decide on which channel(s) you want to perform analysis for each test. After you set this, you can save the settings as default. For the next investigation (if performed with the same catheter and in the same way), you can use these settings again.
  • Page 127 Figure 9.22 Anorectal channel definition When using spiral catheters with one centimeter (or 0.5 cm) spacing between the pressure channels, you must define the sensor positions as well as the channels that will be analyzed, as shown in Figure 9.22. ▪...

  • Page 128: Anorectal Manometry Settings

    9.5.4 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 clicking Settings > Anorectal manometry settings. These anorectal settings (Figure 9.24) are stored with the investigation. This means that changes made here are in effect only for the current study.

  • Page 129: 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 130: Resting Pressure Test

    Figure 9.25 Select anorectal manometry results 9.5.6 Resting pressure test For the resting pressures, a table with the average pressure between the markers can be displayed. The level at which the resting pressures are obtained (when centimeter markers are placed) and the average resting pressure are also calculated.
  • Page 131 Figure 9.26 Squeeze test The letters between square brackets refer to the corresponding letters in Figure 9.26. During the squeeze test, the patient squeezes his External Anal Sphincter. The beginning and ending of the squeeze period are marked with two squeeze markers [A] and [B], as shown in Figure 9.26. Squeeze markers should always be set in pairs (it is a chained marker).

  • Page 132: Endurance Squeeze Test

    Squeeze duration The squeeze duration is the time between the squeeze markers [A] and [B] = [E]. Average squeeze pressure The average squeeze pressure is calculated as the average pressure between the squeeze markers minus the resting pressure. Area under the curve This is calculated as the integral of pressures between the squeeze markers and the resting pressure.
  • Page 133 Figure 9.27 Endurance Squeeze test The letters between square brackets refer to the corresponding letters in Figure 9.27. During the endurance squeeze test the patient squeezes his 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 134: Cough Test

    9.5.9 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 135: 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 136 markers should mark the IAS relaxation pressure. The last marker marks the end of the relaxation. Figure 9.29 RAIR test The letters between square brackets refer to the corresponding letters in Figure 9.28. 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 137: Sensation Test

    If no balloon marker is set between marker A and C, the reflex duration cannot be calculated. Balloon volume Is the volume with which the balloon was inflated and it is infused volume at the balloon marker [Bal]. External sphincter response Is the maximum pressure on the EAS channel between marker [A] and marker [C].
  • Page 138 Figure 9.30 Anal profile 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 139: Balloon Expulsion Test

    Squeeze profile As of this writing, only a profile pressure table can be included. This table displays the pressures for each channel over a certain distance of the profile. It is possible to display a 3D VVP for the squeeze profile. Vector Diagram can be displayed for the profile when at least three channels are measured radial.

  • Page 140: Vector Volume Plot

    The compliance is the change in volume for a change in pressure. It is defined as C= dV/dP, where dV is the volume increment and dP is the change in pressure associated with this volume increment. VolumeB - VolumeA Compliance = ------- = --------------------------------- Prect Prect B - Prect A Rectal filling begin compliance = VolumeA...
  • Page 141 Figure 9.32 Dimensional Vector volume plot The 3D vector volume plot is created from the pressures measured during the pull-through of the catheter through the rectum. The profile is divided in several segments of fixed length. The maximum pressure in each segment for each channel is used to draw the three-dimensional sphincter image.

  • Page 142: 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. 9.5.17 Rectal volume plot Click the Rectal volume plot button or Choose Options >...

  • Page 143: 10. Biofeedback

    10. Biofeedback 10.1 Introduction In the management of conditions such as stress incontinence, biofeedback training can be used to help patient train their 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 144: Prepare The Investigation

    10.2 Prepare the investigation Click the Biofeedback button to start the pre-test. The Biofeedback settings dialog box opens, as shown in Figure 10.2. If the patient hasn’t previously engaged in biofeedback training, the default protocol settings are loaded. Otherwise, the last applied settings for the current patient are displayed.
  • Page 145 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 146 Click the Auto scale button. The minimum and maximum values that are measured over the previous 10 seconds will be used to set the minimum and maximum scale (when you hover the mouse pointer 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 147: 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 challenge items. For example, in the sea world theme, the items of the challenge are air bubbles and, when the play sound setting is used, a sound is played when touching the items.

  • Page 148: 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 149: Channel Settings

    and then click the New investigation button), right-click the protocol name and then, on the menu that opens, choose Edit protocol. In the Edit investigation protocol dialog box, Select the Biofeedback tab, as shown in Figure 10.6. Figure 10.6 Biofeedback protocol The changes made in the protocol settings (and saved by clicking the OK button), are stored for the protocol.

  • Page 150: Biofeedback Settings

    Figure 10.7 Channel settings Here, 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 on the channel in the list and change the position in the lower part of the window.
  • Page 151 Figure 10.8 Biofeedback settings in the protocol The Biofeedback settings dialog box shows a preview of the selected challenge, as demonstrated in Figure 10.9. For each channel, a preview of the challenge is displayed. Figure 10.9 Biofeedback settings for two channels Biofeedback Solar Blue User Manual...
  • Page 152 A challenge consists mostly of challenge time and resting time. The challenge time is the worktime with a certain workload for the patient. The resting time is the time in between two challenges and serves as a moment of rest for the patient.

  • Page 153: Challenge Editor

    10.5.3 Challenge editor With the challenge editor, you can select another challenge or edit a challenge. The challenge editor offers basic edit mode and advanced edit mode. Challenges can be selected or edited only for the enabled channels in the channel settings (see § 10.5.1). To open the Edit challenge dialog box (Figure 10.11), in the Biofeedback settings dialog box, click the Edit challenge button, or click the preview image of the challenge.
  • Page 154 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.
  • Page 155 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 transitions 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 156 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 an anchor. To return to the Basic edit dialog box, click the Basic edit button. In basic edit mode, you can save the challenge by clicking the Save button.

  • Page 157: 11. 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 158: 11.2 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, as shown in Figure 11.1. The LCD display shows standby.

  • Page 159: 11.3 From Stationary To Ambulatory Measurement

    Figure 11.2 Connect catheter The software will remind you to change the battery when necessary. Connect the catheter and click the OK button. Now you can perform the investigation, as described in chapters 3 to 9 (depending on the investigation you choose).
  • Page 160 The procedure is as follows: ▪ In the database program, switch to ambulatory measurement by clicking the New investigation button and then selecting the Luna. ▪ The following dialog opens: Figure 11.3 Continue with an ambulatory investigation ▪ Click Yes to continue. Figure 11.4 Select protocol ▪...
  • Page 161 ▪ Click the Continue investigation button to proceed with the measurement. ▪ To change the battery, the following window opens: Figure 11.5 Change battery ▪ Disconnect the catheter and change the battery. Figure 11.6 Reconnect catheter ▪ After changing the battery, reconnect the catheter. ▪...

  • Page 162: 11.4 Analysis

    Figure 11.7 Check catheter position ▪ Click the Start recording button. The LCD display shows Record. ▪ Click the Exit button to return to the database. ▪ Explain to the patient the diary and the buttons on the Luna module. ▪...

  • Page 163: 12. 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. For a detailed overview, see the help information. To start the measurement program, in the database program, click the New investigation button.

  • Page 164: Main Menu

    12.2 Main menu To open the main menu, click the menu button, as shown in Figure 12.2. Figure 12.2 Main menu The following table describes each menu item: 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.

  • Page 165: Pre-Test

    In this section, you will find general information about the investigation procedures. You can find specific information in the corresponding chapters in this manual. 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.

  • Page 166: 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 as the result of different protocol settings or system settings.
  • Page 167 Buttons Description Select the proper EMG scale; the size of the EMG graph is increased. Activate the pause mode. Insert an event marker. It is also possible to add comment for the marker. Zero the detrusor pressure (P ) during the pre-test and, if necessary, during the measurement.

  • Page 168: Remote Control

    Buttons Description Activate/deactivate tap-water sound. The sound of running tap water is played. The sound continues until the button is clicked again. Run Quality check. Perform a quality check before starting the investigation. You can find more information in § 2.6. 12.3.4 Remote control The urodynamic investigations on the Solar Blue measurement system can be...
  • Page 169 Figure 12.4 RC-1200 diagram RC-1200 Name Description keys # 1–4 Keys The function of these keys varies throughout the program. The function is indicated on the screen buttons during the investigation. 5–8 User-definable These buttons are used to place user-definable markers markers during an investigation.
  • Page 170 RC-1200 Name Description keys # Down Menu down. Pump speed Change the pump speed during the investigation or the down pre-test with the down key. Previous Has specific meaning in some investigations. Used to select appropriate markers during an investigation. Next Has specific meaning in some investigations.

  • Page 171: Virtual Remote Control

    Figure 12.5 Covers RC-1200 Figure 12.6 Store remote control (example) 12.3.5 Virtual remote control is useful when the remote The virtual remote control (Figure 12.7) is a tool that control has depleted batteries, is malfunctioning, or if it is lost. The tool ensures that the user can always proceed with the investigations.

  • Page 172: Markers

    12.3.6 Markers During an investigation, markers can be placed to indicate interesting events or to invoke calculation of parameters. Markers are displayed as colored vertical lines on the screen. There are two types of markers: • Immediate markers are placed at the plot line. This is the line at which the curves start.

  • Page 173: Pause Mode

    Position markers (immediate markers) During the investigation, the patient’s position (supine, sit, or stand) can be indicated by setting a position marker. Position markers can be placed by clicking the buttons on the screen. Audio comment marker (immediate marker) When a sound card is present, you can add a spoken comment to the investigation.

  • Page 174: Stop Measurement

    12.3.9 Stop measurement Click the Stop investigation button to stop the investigation. In the analysis program, you may analyze the results and print the report. When in the investigation protocol the field Confirm stop investigation is set to Yes, the investigation is not immediately stopped.
  • Page 175 Figure 12.8 Select protocol When the measurement program is started (Figure 12.8), by default the window shows one investigation protocol. More protocols can be added (see the subsections that follow). The investigation protocol contains different settings. The last-used protocol is the default selection. To select another protocol, click the radio button in front of the protocol name.

  • Page 176: Include/Exclude Investigations For Protocol

    Figure 12.9 Copy protocol In the Copy protocol dialog box (Figure 12.9), choose the destination for the copied protocol. In the Protocol name textbox, enter a name for the copied protocol. Delete an investigation protocol Right-click the protocol name and then choose Delete protocol. Or, from the main menu, choose Settings >...

  • Page 177: General Protocol Settings

    On the Select tab you can exclude investigations from the current protocol (or include them if they were excluded). To do this, select the checkbox adjacent to the investigation type. When an investigation is excluded, the corresponding tab with investigation-specific settings will be invisible. In the Protocol name textbox, type the name of the protocol that you want to edit.

  • Page 178: Laborie Assistant

    You can enable or disable the appearance of the assistant during the measurement. In the protocol settings, select the Laborie assistant tab (Figure 12.12). To enable the assistant, select the Use the Laborie assistant checkbox. To disable the assistant, clear the checkbox.

  • Page 179: Compliance

    ), and the detrusor pressure (P ) are not within a certain range. You can also enable a message to ask the patient to cough after filling the bladder with a fixed amount. 12.5.5 Compliance Click the Compliance tab to set compliance for cystometry, pressure-flow studies, UPP studies, or gynecology studies.

  • Page 180: Investigation Specific Settings

    12.5.7 Investigation specific settings To change investigation-specific settings, click the tab that corresponds to the investigation, as demonstrated in Figure 12.14. Figure 12.14 Edit investigation protocol—Pressure-flow study tab A page opens showing settings for printing the report, storing on the disk, initial pump speed, sample rate, marker line distance, and so on.

  • Page 181: Channel Settings

    • 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 selected report configuration defined in the protocol.

  • Page 182: Connections Solar Blue

    Figure 12.15 Channel settings Put the cursor on the channel that you want to change. In the lower part of the window, you can now change the settings of the selected channel. 12.5.9 Connections Solar Blue For each investigation, you can set the channel numbers for the channels (signal) to be measured with the Solar Blue measurement system.

  • Page 183: System Settings

    In the left column, you will see the channels that have been selected via the Channels button (see § 12.5.8). For each channel (signal) to be measured, you must select the channel number. In this example, P is measured on channel 1 of the Solar Blue module; is measured on channel 2;...
  • Page 184 The settings are described here: Display These are specific settings for graphs and markers; for example, how to display a grid and show the markers as full names. If you select Vertical marker names, marker names will be displayed vertically instead of horizontally, which prevents marker names from overlapping.
  • Page 185 the colors in a color scheme. You can define more than one color scheme, so you can quickly change colors. Click the Markers button to change the colors of the available markers. General You can set some general settings; for example, whether hints are shown when the mouse cursor is moved over a button.

  • Page 186: 13. 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 (Figure 13.1). To start the analysis program, in the database program double-click the investigation name. Button toolbar Menu bar Channel information Figure 13.1 Analysis program...
  • Page 187 The following table lists pressure-unit conversions: 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 188: 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. For more information, see § 13.2.2. Edit investigation Edit investigation parameters; for example, patient parameters weight and name of the investigator. For more information, see §...

  • Page 189: Display Results

    Templates You can define and load templates 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 you can open via the Manuals menu in the database program.

  • Page 190: Edit Investigation Parameters

    In this section, you will find general information about results. The urodynamic parameters are described in the subsections pertaining to 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.

  • Page 191: 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 192: Zoom Function

    13.3.2 Zoom function Interesting sections of the investigation can be viewed in more detail with help of the zoom function. To zoom in on an area of interest, do the following: ▪ Move the cursor to the left side of the area. ▪...
  • Page 193 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 (Figure 13.4). Select a marker and click OK;...
  • Page 194 ▪ Release the mouse button on the correct position. Change the colors of the markers There are two ways to change the color: 1) Move the mouse cursor to the top of the marker, right-click and choose Color, or 2) via the system settings (§...
  • Page 195 Marker name Description 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 196: Options

    Marker name Description 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 Using this marker, numerical values of the channels are displayed at the marker position.
  • Page 197 Composite nomogram Display the Composite nomogram in a (Male patients only) pressure-flow, or gynecology study (see § 13.5.7). When an arrow is displayed in the nomogram (Siroky, ICS/Blaivas Detrusor Flow, Miscolc, Liverpool), it means that the result dot is out of bounce. The arrow points in the direction where the dot would be.

  • Page 198: Siroky Flow Rate Nomogram

    Figure 13.6 Enter free Qmax 13.5.2 Siroky flow rate nomogram The Siroky flow rate nomogram shows an x-y plot of the flow rate related to the bladder volume. It can be used as an aid to diagnose normal or obstructed urinary flow.

  • Page 199: Miskolc Flow Rate Nomogram

    Click the Liverpool flow plot button or, from the menu, choose Options > Liverpool plot to display the plot, as shown in Figure 13.8. Figure 13.8 Liverpool flow rate nomogram The Liverpool flow rate nomogram is age and gender dependent. The results can be divided in the following classifications: •...

  • Page 200: Ics Detrusor/Flow Plot

    Figure 13.9 Miskolc flow rate nomogram The Miskolc flow rate nomogram is used for children and is age and gender dependent. The results of the Miskolc flow rate nomogram can be divided in the following classifications: • Children age 3 or older and younger than 8 •...

  • Page 201: Schäfer Detrusor/Flow Plot

    Figure 13.10 ICS Detrusor/flow plot The ICS detrusor/flow plot is divided into 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 202 Figure 13.11 Schäfer Detrusor/flow plot A linear-PURR (Passive Urethral Resistance Relation) is determined by drawing a straight line from P to P represents the relative lowest Qmax detrusor pressure at which flow starts or stops. P is the pressure at Qmax maximum flowrate.

  • Page 203: Blaivas Detrusor/Flow Plot

    Linear PURR (LPURR) The linear PURR is the simple approximation of the PURR, a straight line, starting at P 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 204: Composite Nomogram

    The nomogram is constructed by two parameters: free Qmax and Pdet.max. The free Qmax (free-flow study) is used instead of Qmax (pressure-flow study) because of the adverse effect of the transurethral catheter in women undergoing pressure-flow studies. The first time the nomogram is displayed, you will be prompted to enter the free Qmax obtained with free-flow(s).

  • Page 205: Settings

    The results of the composite nomogram are validated only for male patients. 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.

  • Page 206: 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 § 9.5.4. 13.6.2 Channel settings Choose Settings > Channel settings from the menu to display the Channel settings dialog box, as shown in Figure 13.14.

  • Page 207: System Settings

    13.6.3 System settings From the menu, choose Settings > System settings to display the System settings dialog box, as shown in Figure 13.15. Figure 13.15 System settings analysis program You can select some pages with settings by clicking the appropriate tab. The settings are described in the subsections that follow.
  • Page 208 You can set the display for the EMG graphics. Also, settings for signal processing are available. You can choose ‘Slow average’ (default), ‘Fast 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, such as artefact, background, baselines, cursor, and grid.

  • Page 209: Export

    Report The following menu items are available: Menu item Function LABORIE Reporter Start LABORIE Reporter. can be found in the separate Reporter manual in PDF format, which can be opened via the Manuals menu in the database program. Print/PDF/JPG report Print or export the report immediately.

  • Page 210: Configure Button Toolbar

    13.9 Configure Button Toolbar You can configure the buttons and the position of the buttons on the button toolbar for each type of investigation. Right-click the button toolbar and then, from the pop-up menu, choose Properties to display the Speedbar properties dialog box, as shown in Figure 13.16.
  • Page 211 APPENDIXES AND INDEX Solar Blue User Manual...

  • Page 212: Appendix A Safety Information

    ▪ SGS contract no. 710253 The Solar Blue measurement system conforms to the requirements only when it is used with specified and approved LABORIE modules/devices as mentioned in this document. The Solar Blue measurement system complies with Part 15 of the FCC Rules.
  • Page 213 The instructions, precautions and warnings in this manual should be followed by the operator to ensure safe operation and to maintain the Solar Blue measurement system in a safe condition. Therefore, the use of the Solar Blue measurement system should be restricted to qualified personnel only. The following signs are printed in this manual in front of important warnings, cautions, and notes.
  • Page 214 All repairs, which are not performed by LABORIE personnel are for the responsibility of the hospital. LABORIE will not give any guarantee or take any responsibility for any part which has been opened, adjusted, or replaced by hospital personnel.
  • Page 215 WARNING If a safe system setup, in accordance with IEC-60601 cannot be guaranteed, a safety module is required. Please contact your LABORIE representative. WARNING Without a properly installed safety module, the laptop’s power must be supplied by its batteries only. The laptop...
  • Page 216 device that does not comply with the legally required safety standards. WARNING To ensure stability and safety, do not mount/attach other devices to the Solar pole then laptop, Solar Blue module, pressure transducer frame and holder, bag of saline (for infusion via pump), bag of saline and pressure-cuff (for perfusion of Pura).
  • Page 217 Safety module WARNING The mains plug must be inserted in a mains socket provided with a protective earth contact. WARNING All devices must be powered via the safety module. WARNING Do not place the safety module in an open, wet (patient) environment.
  • Page 218 However, its maximum torque is limited; indicated by a harmless rattling noise. WARNING Use only sterile filling liquids and sterile pump tubes with LABORIE part number OBS 275/C or 275/D for the pump. WARNING If you discover any abnormal behavior with the pump, stop the pump with the remote control or disconnect the catheter from the system.
  • Page 219 CAUTION Change the battery only when the patient is disconnected from the Luna system (unplug catheter and all patient leads from the Luna). CAUTION Do not carry or use a mobile telephone during the measurement to reduce risks involving electromagnetic disturbances.
  • Page 220 CAUTION Do not drop or throw the flowsensor. Do not apply excessive force on the flowsensor (maximum 3.5 kg) or let things drop on the flowsensor. This can permanently damage the flowsensor. CAUTION Avoid touching or kicking the flowsensor during an investigation.
  • Page 221 WARNING When adjusting the spring-balanced arm be aware not to pinch fingers or other objects. WARNING Connect the power adapter whenever the Bluetooth puller is not used to prevent batteries to become depleted. Deep discharging the batteries will damage the batteries internally and shorten the lifespan.
  • Page 222 WARNING Use only disinfected or sterile catheters. WARNING Do not use the catheter if the package is damaged. CAUTION Always check the expiry date where applicable as this may affect the measurement results. CAUTION To prevent drift, always pre-wet solid-state catheters (sensors) in accordance with instructions of the manufacturer.
  • Page 223 APPLIED PARTS and other conductive parts including those connected to protective earth. CAUTION Never turn off the computer when the LABORIE software program is still active. You may lose data. CAUTION Automatic safeguards built in to the software should be seen as an aid. They are not substitutes for careful personal monitoring and an alert investigator.
  • Page 224 Cleaning CAUTION To prevent damage of the Solar Blue measurement system do not use thinner or similar solvents. CAUTION Do not use excessive amounts of water for cleaning the Solar Blue measurement system to prevent damaging the electronics. CAUTION Never allow water to get inside the Solar Blue modules or any other part to prevent damage to the system.
  • Page 225 Safety regulations Module Protection Class Applied Ingress (depending on setup) part protection rate Solar Blue module Class II IPX1 — Luna wireless IP2X module — Bluetooth flowmeter Class II if powered by IPX1 (Mk III) power adapter — Safety module Class I IP20 —...

  • Page 226: Appendix B Explanation Of Symbols

    Appendix B Explanation of Symbols This appendix provides descriptions of the symbols on the Solar Blue system. Refer to instruction manual. Blue symbol Consult instructions for use. Caution: Federal law restricts this device to sale by or on the order of a physician. Triangle with black or red border: Caution, consult instructions for use.
  • Page 227 Type BF applied part conform IEC 60601-1. Protected against solid foreign objects of 12.5 mm Ø and IP20 greater and not protected against liquids. The pouch provides protection against ingress of dripping water IPX2 with harmful effects when tilted 15°. Protected against dripping water.
  • Page 228 CE (93/42/ EEC) approved. 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 229 –10°C to Storage Conditions: Temperature range +50°C. Storage Conditions: Relative humidity range 15% to 90%, noncondensing. –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 230 Energy source. Do not push or pull. Symbol with red border Manufacturer. May be combined with manufacturing date. Mass (including safe working load) in kilograms. Catalog number. Serial number. Quantity symbol: Numeral in symbol (in place of #) indicates the quantity of units in package. Solar Blue User Manual Appendix B...
  • Page 231 Explanation of PE-number PEYY-FXXXXNNNN Peripheral Equipment Two-digit manufacturing year number Product group number XXXX Three- or four-digit unique module abbreviation NNNN Four-digit incrementing unique number 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 symbols...

  • Page 232: 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 233 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 234 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 235 Message Cause Posible actions to resolve Luna EMG not present Luna channel expected but not Contact your LABORIE present representative Luna P1 not present Luna channel expected but not Contact your LABORIE present representative Luna P2 not present Luna channel expected but not...
  • Page 236 Message Cause Posible actions to resolve Perfusion system with balloon filling not Module expected but not Contact your LABORIE connected! connected representative Protocol could not be found Protocol file is corrupt Create new protocol Protocol file is corrupt. Open Protocol editor to...
  • Page 237 System is not powered Connect the power power connection The WPU [Name] has lost the connection Communication problems Contact your LABORIE representative There are more channels available in the Protocol file comes from a later Install correct software protocol file ([Filename]) then supported by this...
  • Page 238 Creating a backup also failed. All changes Failed to create a backup Contact your LABORIE made have gone lost. Contact your representative administrator. Creating safety backup failed! Safety backup could not be...
  • Page 239 Message Cause Posible actions to resolve File not found. Restore of patient aborted FCU file is incomplete Contact your LABORIE representative General database error, back-up failed! Database could not be opened Try again later or contact your LABORIE representative HIS interface module not initialized...
  • Page 240 Received patient number is not Contact your IT available representative Storage failure. Error in FCU file FCU file is corrupted Contact your LABORIE representative System number is empty. Archive of patient Patient system number is Contact your LABORIE aborted representative empty System number is incorrect.

  • Page 241: Index

    Index Accessories ............................12 Air-charged catheter (anorectal manometry) ..................110 Air-charged catheters ..........................47 Air-charged transducers ........................47 Analysis program buttons in the software ........................186 channel information ........................186 configure the toolbar ........................210 cursor line ............................186 introduction ..........................13, 186 menu ..............................
  • Page 242 EMG channel ..........................143 flow channel ............................ 143 introduction ............................. 143 investigation ........................144, 147, 148 measurement ........................... 147 pressure channel ..........................143 Bladder volume ........................... 166 Blaivas detrusor/flow plot ......................203, 204 BOOI ..............................73 Catheters air-charged catheters ......................... 47 air-charged transducers ........................
  • Page 243 adjust sensitivity ..........................32 buttons software ..........................166 cables..............................33 heartbeat filter ..........................146 position the electrodes ........................32 surface electrodes ..........................31 EMG connector Luna wireless module ........................30 Event markers ........................167, 172, 195 Export to HL/7 ............................209 to other file formats .........................
  • Page 244 Investigation buttons in the software ........................166 edit protocol, see Protocol settings ....................174 new investigation ........................23, 163 perform the investigation ........................40 pre-test............................. 165 procedure ............................17 quick start ............................178 remote control buttons ........................168 results .............................. 189 stop investigation ..........................
  • Page 245 compliance markers ........................195 delayed markers ..........................172 delete markers ..........................193 event markers ........................167, 172, 195 flow markers ........................... 195 immediate markers .......................... 172 insert markers ..........................192 leakpoint markers ..........................167 marker line measurement program ....................165 move markers ..........................
  • Page 246 PDF document save the results ..........................190 Peak flow markers ..........................195 Peak flowrate ........................... 60, 74 PE-number ............................166 Perfusion (low-cost) ..........................109 Pressure-cuff for water catheters ......................53 pressure-cuff for water catheters (anorectal manometry) ..............109 Pressure-flow study channel information ..........................
  • Page 247 MMS code OBS 275/C or 275/D ...................... 27 Remote control introduction ............................11 keys for measurement program ....................... 168 Report combined reports ..........................42 display results ..........................189 print all reports ..........................42 print the report ........................... 41 Results display results ..........................189 edit investigation parameters ......................
  • Page 248 System settings analysis program ..........................207 measurement program ........................183 Time to Qmax ..........................60, 74 Tracing clip-out markers ........................195 Transmission markers.......................... 195 Urethral pressure profile (UPP) catheter puller ............................ 81 channel information .......................... 78 introduction ............................78 investigation ............................79 manual pull ............................
  • Page 249 Windows ..............................10 Zero water catheters ..........................56 Index Solar Blue User Manual...

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