Nexam Pro User Manual Rev b Sept 2021

Table of Contents 1.

Introduction ... 9 1.1 Nexam Pro Measurement System ... 9 1.2 Intended 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 2.3 Enter 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

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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 3.6.3 Measuring 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

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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 Nexam Pro User Manual

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9.5

9.4.14 Stop the Investigation... 145 Analysis ... 145 9.5.1 Insert Channel Markers ... 146 9.5.2 Channel Definition ... 146 9.5.3 Anorectal Manometry Settings ... 148 9.5.4 Results ... 149 9.5.5 Resting Pressure Test... 150 9.5.6 Squeeze Test ... 151 9.5.7 Endurance Squeeze Test... 152 9.5.8 Cough 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

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12.4 12.5

12.6 12.7

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 Settings Menu ... 196 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 System Settings ... 207 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 Nexam Pro User Manual

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13.6

13.7 13.8 13.9

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 Settings ... 234 13.6.1 Menu Overview ... 234 13.6.2 Channel Settings ... 235 13.6.3 System Settings ... 236 Export ... 237 Report ... 238 Configure Button Toolbar ... 238

Appendix A

Safety Information ... 240

Appendix B

Explanation of Symbols ... 255

Appendix C

Software Messages ... 262

Index

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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 CIM1

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 solidstate 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. Nexam Pro User Manual

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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. 10

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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 Measures pressures, EMG interface (optional) and conductance module (optional). (CIM) Luna wireless module

Introduction

Measures pressures, EMG (optional) and conductance (optional) via wireless connection. Optionally, you can use the Luna for ambulatory urodynamic monitoring.

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12

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.

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1.2

Module

Description

RFID Reader

RFID reader is used to scan boxes of consumables for consumable traceability.

Bluetooth® Smart Long Range USB dongle (BTSLR 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.

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. Introduction

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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.

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• 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

LABORIE database program

Measurement 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 Introduction

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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).

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Manual

LABORIE document code

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

Nexam Pro

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. Introduction

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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. Screen 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.

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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]

Introduction

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2. 2.1

Investigation Procedure

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.

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2.2

Start the LABORIE Database Program

On your desktop, double-click the Laborie-Login button the LABORIE database.

to log in to

Figure 2.1 The Login window

2.2.1

Administrator Authentication

From the Login window, click the button to open the Administrator Authentication window to manage the User/Password

Figure 2.2 The Administrator Authentication window

• Enter the Username and Password (the initial username/password is Admin/admin) and then click the OK button to enter the Login Settings dialog box.

Investigation Procedure

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