LABORIE Nexam Pro WPU-L4 User manual

Nexam Pro
User Manual

2 Nexam Pro User Manual
Laborie Medical Technologies, Corp.
180 International Drive
Portsmouth, NH 03801 USA
+1.800.522.6743
LABORIE EUROPE/International
Medical Measurement Systems BV
Colosseum 25
7521 PV Enschede NETHERLANDS
Tel: [phone] Fax: [phone]
www.laborie.com
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
Document Number: LBL-001021
Revision: B
Release Date: 2021-09
Medical Measurement Systems BV
Colosseum 25
7521 PV Enschede NETHERLANDS

Nexam Pro User Manual 3
Table of Contents
1. Introduction..............................................................................................9
1.1 Nexam Pro Measurement System...................................................9
1.2Intended Use..................................................................................13
1.3 Safety Information..........................................................................13
1.4 Accessories....................................................................................14
1.5 Troubleshooting .............................................................................14
1.6 LABORIE Software Program .........................................................14
1.7 Computer Requirements................................................................15
1.8 LABORIE Assistant........................................................................16
1.9 About the Manuals.........................................................................16
1.10 Manual Conventions......................................................................17
2. Investigation Procedure........................................................................20
2.1 Introduction ....................................................................................20
2.2 Start the LABORIE Database Program .........................................21
2.2.1 Administrator Authentication..............................................21
2.2.2 LABORIE Patient Database...............................................24
2.3Enter and Select the Patient..........................................................24
2.4 Start the Measurement Program ...................................................25
2.5 Prepare the Investigation (Pre-Test)..............................................26
2.5.1 Start the Pre-Test...............................................................26
2.5.2 Consumables Traceability..................................................26
2.5.3 Pre-Test .............................................................................30
2.5.4 Install the Pump Tube........................................................30
2.5.5 Prepare the Combination Interface Module .......................37
2.5.6 Prepare the Luna Wireless Module....................................38
2.5.7 Prepare the Wireless Patient Module ................................39
2.5.8 Prepare the WPU...............................................................40
2.5.9 Prepare the Catheters and Transducers............................45
2.5.10 Prepare EMG Cables and Electrodes................................45
2.5.11 Prepare the Flowmeter.......................................................48
2.5.12 Prepare the Catheter Puller ...............................................50
2.6 Run Quality Check.........................................................................53
2.7 Perform the Investigation...............................................................54
2.8 Print the Investigation Report ........................................................55
2.9 Cleaning Instructions .....................................................................56
2.10 Exit the LABORIE Database Program...........................................58

4 Nexam Pro User Manual
3. Urodynamic Catheters & Transducers ................................................59
3.1 Introduction ....................................................................................59
3.2 Prepare the Catheters and Transducers .......................................60
3.3 Reusable Solid-State Catheters ....................................................60
3.4 Single-Use e•Sense Solid-State Catheters....................................61
3.5 Air-Charged Catheters...................................................................62
3.6 Water Catheters.............................................................................65
3.6.1 Introduction ........................................................................65
3.6.2 Measuring Pves and Pabd.................................................66
3.6.3Measuring Pves, Pura and Pabd .......................................67
3.6.4 Measuring Pves and Pura..................................................69
3.6.5 Flushing and Zeroing Water Catheters..............................71
4. Uroflowmetry..........................................................................................73
4.1 Introduction ....................................................................................73
4.2 Channels........................................................................................73
4.3 Investigation...................................................................................73
4.4 Results...........................................................................................74
5. Cystometry.............................................................................................77
5.1 Introduction ....................................................................................77
5.2 Channels........................................................................................77
5.3 Investigation...................................................................................77
5.4 Results...........................................................................................79
6. Pressure-Flow Study.............................................................................84
6.1 Introduction ....................................................................................84
6.2 Channels........................................................................................84
6.3 Investigation...................................................................................85
6.4 Results...........................................................................................86
6.4.1 Filling Phase Results..........................................................87
6.4.2 Voiding Phase Results.......................................................89
7. Urethral Pressure Profile (UPP)............................................................94
7.1 Introduction ....................................................................................94
7.2 Channels........................................................................................94
7.3 Investigation...................................................................................95
7.4 Results...........................................................................................98
7.4.1 Rest Profile.........................................................................98
7.4.2 Stress Profile......................................................................99
7.4.3 Transmission....................................................................103

Nexam Pro User Manual 5
8. Gynecology Study ...............................................................................105
8.1 Introduction ..................................................................................105
8.2 Channels......................................................................................105
8.3 Investigation.................................................................................106
8.4 Results.........................................................................................110
9. Anorectal Manometry..........................................................................111
9.1 Introduction ..................................................................................111
9.2 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............................114
9.2.4 Filling................................................................................115
9.2.5 Timers ..............................................................................116
9.2.6 Squeeze...........................................................................117
9.2.7 Push.................................................................................118
9.2.8 RAIR.................................................................................119
9.2.9 Sensation.........................................................................121
9.2.10 Compliance......................................................................122
9.2.11 Balloon Expulsion.............................................................124
9.2.12 Profiles .............................................................................125
9.3 Prepare the Investigation.............................................................126
9.3.1 Water Catheters...............................................................126
9.3.2 Air-Charged Catheters.....................................................127
9.3.3 Solid-State Catheters.......................................................129
9.3.4 Positioning of the Catheter...............................................129
9.4 Investigation.................................................................................130
9.4.1 Introduction ......................................................................130
9.4.2 Resting Pressure Test......................................................131
9.4.3 Squeeze Test...................................................................131
9.4.4 Endurance Squeeze test..................................................131
9.4.5 Cough Test.......................................................................132
9.4.6 Push Test.........................................................................132
9.4.7 Rectal Anal Inhibitory Reflex (RAIR) Test........................133
9.4.8 Sensation Test.................................................................134
9.4.9 Rest and Squeeze Profiles Using a Puller.......................137
9.4.10 Rest and Squeeze Profile with Manual Pull.....................138
9.4.11 Balloon Expulsion Test.....................................................140
9.4.12 Rectal Compliance...........................................................142
9.4.13 Remote Control Buttons...................................................145

6 Nexam Pro User Manual
9.4.14 Stop the Investigation.......................................................145
9.5 Analysis........................................................................................145
9.5.1 Insert Channel Markers....................................................146
9.5.2Channel 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.................................................152
9.5.8Cough Test.......................................................................154
9.5.9 Push Test.........................................................................154
9.5.10 Rectal Anal Inhibitory Reflex (RAIR) Test........................155
9.5.11 Sensation Test.................................................................157
9.5.12 Anal Rest and Squeeze Profiles ......................................157
9.5.13 Balloon Expulsion Test.....................................................158
9.5.14 Rectal Compliance...........................................................159
9.5.15 3D Vector Volume Plot.....................................................160
9.5.16 Rectal Volume Plot...........................................................161
10. Biofeedback .........................................................................................163
10.1 Introduction ..................................................................................163
10.2 Prepare the Investigation.............................................................163
10.3 Investigation.................................................................................167
10.4 Analysis........................................................................................168
10.5 Investigation Protocol...................................................................168
10.5.1 Channel Settings..............................................................169
10.5.2 Biofeedback Settings .......................................................170
10.5.3 Challenge Editor...............................................................173
11. Investigation with Luna Wireless Module .........................................177
11.1 Introduction ..................................................................................177
11.2 Stationary Measurement..............................................................178
11.3 From Stationary to Ambulatory Measurement.............................179
11.4 Analysis........................................................................................182
12. Measurement Program........................................................................183
12.1 Introduction ..................................................................................183
12.2 Main Menu ...................................................................................184
12.3 Investigation.................................................................................184
12.3.1 Pre-Test ...........................................................................185

Nexam Pro User Manual 7
12.3.2 Start Measurement...........................................................185
12.3.3 Button Toolbar..................................................................186
12.3.4 Remote Control................................................................188
12.3.5 Virtual Remote Control.....................................................193
12.3.6 Markers ............................................................................194
12.3.7 Pause Mode.....................................................................195
12.3.8 Change Filling Liquid........................................................196
12.3.9 Stop Measurement...........................................................196
12.4 Settings Menu..............................................................................196
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..............................................................205
12.5.9 Connections Nexam Pro..................................................206
12.6 System Settings...........................................................................207
12.7 Filling Liquid Settings...................................................................209
13. Analysis Program ................................................................................210
13.1 Introduction ..................................................................................210
13.2 Results.........................................................................................212
13.2.1 Menu Overview................................................................212
13.2.2 Display Results ................................................................213
13.2.3 Edit Investigation Parameters..........................................214
13.3 Graph...........................................................................................215
13.3.1 Menu Overview................................................................215
13.3.2 Zoom Function.................................................................215
13.4 Marker..........................................................................................216
13.4.1 Menu Overview................................................................216
13.4.2 Insert Markers ..................................................................216
13.4.3 Reference Cursor.............................................................220
13.5 Options.........................................................................................220
13.5.1 Menu Overview................................................................220
13.5.2 Siroky Flow Rate Nomogram...........................................223
13.5.3 Liverpool Flow Rate Nomogram ......................................224
13.5.4 Miskolc Flow Rate Nomogram.........................................225

8 Nexam Pro User Manual
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..................................................233
13.6 Settings........................................................................................234
13.6.1 Menu Overview................................................................234
13.6.2 Channel Settings..............................................................235
13.6.3 System Settings...............................................................236
13.7 Export...........................................................................................237
13.8 Report ..........................................................................................238
13.9 Configure Button Toolbar.............................................................238
Appendix A Safety Information..........................................................240
Appendix B Explanation of Symbols ................................................255
Appendix C Software Messages........................................................262
Index 271

Nexam Pro User Manual 9
1.Introduction
1.1 Nexam Pro Measurement System
The Nexam Pro measurement system is developed by Medical Measurement
Systems (MMS) to perform urodynamic investigations in hospitals and private
clinics.
Figure 1.1 Nexam Pro CIM
1
The Nexam Pro measurement system has a modular setup on a movable
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).
The Nexam Pro measurement system is a prescription device to be used only
by physicians or individuals who have been trained and authorized by a
physician or by a medical institution, under the supervision of a physician. The
Nexam Pro measurement system must be purchased under the supervision of
a physician.
1
Actual product may vary slightly from image.

10 Nexam Pro User Manual Chapter 1
CAUTION
For USA only: Federal law restricts this device to sale by
or on the order of a physician.
The Nexam Pro measurement system is used in combination with a computer
and the LABORIE software program. To run the LABORIE program, you will
need Windows 7 Professional (32 or 64 bit), or Windows 8 (8.1) Professional
(32 or 64 bit), or Windows 10 Professional Edition (64 bit).
2
The Nexam Pro is a modular system that allows the user to design a system to
meet their requirements. LABORIE offers custom made modules for
measuring pressures, EMG, conductance, and flow. Software modules are
available for different types of investigations and offer different levels of
functionality.
Figure 1.2 Example of the Nexam Pro trolley system with WPU
2
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.

Introduction Nexam Pro User Manual 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. Descriptions and images may be
different because of Nexam Pro hardware and software changes.
Module
Description
U2M module
Interface (main) module between
computer and Nexam Pro modules.
STF
Separating Transformer, standard
supplied with Nexam Pro trolleys.
Nexam
Pump Unit
(NPU)
Used to fill the bladder.
Combination
interface
module
(CIM)
Measures pressures, EMG
(optional) and conductance
(optional).
Luna
wireless
module
Measures pressures, EMG
(optional) and conductance
(optional) via wireless connection.
Optionally, you can use the Luna for
ambulatory urodynamic monitoring.

12 Nexam Pro User Manual Chapter 1
Module
Description
Wireless
patient
module
This module can measure one
pressure and two EMG signals via a
wireless connection.
Wireless
Patient Unit
(WPU-L4 /
(WPU-eS)
This module can measure four
pressures and one EMG signal via a
wireless or a wired connection.
Catheter
puller
The wireless puller withdraws the
catheter with constant speed to
obtain a pressure profile (optional
for UPP, gynecology, and anorectal
manometry).
Flowmeter
Collects urine to calculate voided
volume and flow rate via a wireless
or wired connection.
Remote
control
Controls the Nexam Pro during an
investigation.

Introduction Nexam Pro User Manual 13
Module
Description
RFID
Reader
RFID reader is used to scan boxes
of consumables for consumable
traceability.
Bluetooth®
Smart Long
Range USB
dongle (BT-
SLR dongle)
The BT-SLR dongle is used for
communication between the
computer and Bluetooth Smart
modules like the RC-1600 (Remote
control), WPU (Wireless Patient
Unit), etc.
1.2 Intended Use
The Nexam Pro measurement system is intended for urodynamic testing and
anorectal manometry investigations. The Nexam Pro measurement system is
intended to assist physicians in executing specific urodynamic and anorectal
studies, analyzing collected data, preparing written reports, and archiving
patient and testing information. Designated catheters and accessories are
required for measurement in each specific area.
General indications for use include patients with lower urinary tract voiding or
incontinence problems and for patients with anorectal dysfunction. More
specifically for incontinence patients, patients with bladder outlet obstructions,
patients with neurogenic bladder dysfunction, and children with complex
voiding/incontinence problems.
Contraindication: Urodynamics should not be performed in the setting of a
symptomatic urinary tract infection.
1.3 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.

14 Nexam Pro User Manual Chapter 1
You can find safety information for users who install, test, and maintain the
Nexam Pro measurement system in the Nexam Pro Service & Installation
Manual (Document Code: MAN-00031). Safety information of the Neuro
module (HEM) can be found in the Neuro Module User’s Manual (Document
Code: LBL-001000). For safety information on the HRAM (High-Resolution
Anorectal Manometry) hardware modules, see the HRAM Service &
Installation Manual (document code: MAN-00037).
1.4 Accessories
LABORIE offers a range of accessories that you can use with LABORIE
measurement systems. For more information, contact your LABORIE
representative.
1.5 Troubleshooting
In case of malfunctioning or unexpected behavior of the system, check the
connection of all cables and then restart the system. If you are not able to
solve the problem, contact your LABORIE representative.
1.6 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 .
The LABORIE program comprises four parts:
•Database program. When you start the LABORIE program, you will enter
the database in which all available patient information, investigation
parameters, reports, and memos are stored. Selection of a patient will give
easy access to all information for that patient.
•Measurement program. This program is started from the database. The
software guides the user through the investigation procedure and saves the
measured data under the relevant patient name.
•Analysis program. This program is started from the database. Graphs and
parameters can be displayed, printed in investigation reports, and exported
to other text editor and database programs.

Introduction Nexam Pro User Manual 15
•Hardware test (diagnostic) program. This maintenance program is started
from the database. For more information, see the Nexam Pro Service &
Installation Manual (LABORIE Document Code: MAN-00031).
Hardware test (diagnostic) program
Measurement program
LABORIE database program
Analysis program
Figure 1.3 LABORIE software program
1.7 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
•Operating system: Windows 7 PRO
•Hard disk: 500 GB
•CD-RW/DVD-RW
•Soundcard/speakers
•USB ports: 7 to 8 (U2M module, USB protection key, Bluetooth dongles,
printer, memory stick, keyboard, mouse)
•17-inch color monitor
•Two-button mouse

16 Nexam Pro User Manual Chapter 1
1.8 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. If you prefer, you can disable the appearance of the LABORIE
assistant.
Figure 1.4 LABORIE assistant
1.9 About the Manuals
The Nexam Pro User’s Manual is intended for all users of the Nexam Pro
measurement system. This manual provides you with detailed information
(step by step) about the urodynamic investigations. The Nexam Pro Service &
Installation Manual is intended for all technical users who install, test, and
maintain the measurement system.
In the following table, you will find an overview of the manuals supplied with
the Nexam Pro measurement system (depending on your configuration).

Introduction Nexam Pro User Manual 17
Manual
LABORIE
document code
Nexam Pro
Nexam Pro User Manual
LBL-001021
Nexam Pro Service &
Installation Manual
MAN-00031
Mounting instructions for
Nexam Pro O-pole
MAN-00032
Neuro add-on
Neuro Module User’s Manual
LBL-001000
Video option
Video User’s Manual
LBL-000984
Network option
Network User’s & Installation
manual
LBL-001005
HIS/DICOM
option
HIS/EMR Integration User’s &
Installation manual
MAN-00028
Luna
Luna User’s & Service
manual3
0075-MAN-032
HRAM option
HRAM User’s Manual
LBL-001028
HRAM Service & Installation
Manual
MAN-00037
Hardware and software changes
After receiving new manuals, always keep the old manuals as supplied with
your system. Descriptions and images may be different because of hardware
and software changes
1.10 Manual Conventions
In this manual, we use some conventions for readability of the manual. This
section provides a description of the most important ones:
•Use of bullets
•The use of the words “click,”“press,” and “choose”
•Warnings, cautions, and notes
3
The Luna User’s & Service Manual is supplied with the Nexam Pro if the system is configured for
ambulatory urodynamic monitoring, as well.

18 Nexam Pro User Manual Chapter 1
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.
When you need to click a button, you will see the button on the left, and the
screen itself appears to the right of the button (e.g., the Print report button).
The name of the button appears in bold; for example, click the Print report
button.
Figure 1.5 Screen
Choose Report > Print report means that you need to click Report on the
menu bar and then choose Print report. Press a button means pressing the
key on the remote control; for example, the Start investigation button .
Press a key means pressing the key on the keyboard; for example, the
Shift key.
Warnings, cautions, and notes
The symbols that follow and their format are used in this manual to signify
important warnings and cautions. It is important to pay attention to the
warnings and cautions, both to provide patient safety as well as to prevent
damage to the equipment. Notes are indicated by their symbol.
Screen
Button

Introduction Nexam Pro User Manual 19
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
device.
CAUTION
A caution is a statement that alerts the user to the
possibility of a problem with the device associated with
its use or misuse. Such malfunctions include device
malfunction, device failure, damage to the device, or
damage to other property.
NOTE
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:
[email protected]

Nexam Pro User Manual 20
2. Investigation Procedure
2.1 Introduction
The information in this chapter can be seen as a quick start 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.
Detailed information about preparing the catheters and transducers can be
found in Chapter 3. The chapters 4 to 8 explain the specific urodynamic
investigations. Chapters 9 and 10 explain anorectal manometry and
biofeedback. 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.
▪Prepare the investigation (pre-test).
▪Run quality check.
▪Perform the investigation.
▪Print the investigation report.
▪Clean system and catheters.
▪Exit the LABORIE database program.
Detailed information about the database program and the reporter program
can be found in separate manuals in PDF format, which can be opened via the
Manuals menu in the database program.
Detailed information about the measurement program and analysis program
can be found in the chapters 12 and 13.