LABORIE MMS Solar Blue User manual

Solar Blue User Manual 1
Solar BlueTM
User Manual

2 Solar Blue 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 2009–2021 LABORIE
Document Number: LBL-001016
Revision: B
Release Date: 2021-09
Medical Measurement Systems BV
Colosseum 25
7521 PV Enschede NETHERLANDS

Solar Blue User Manual 3
Table of Contents
1. Introduction..............................................................................................9
1.1 Solar Blue Measurement System ....................................................9
1.2 Intended Use..................................................................................12
1.3 Safety Information..........................................................................12
1.4 Accessories for the Solar Blue.......................................................12
1.5 Troubleshooting .............................................................................12
1.6 LABORIE Software Program .........................................................13
1.7 Computer Requirements................................................................14
1.8 LABORIE Assistant........................................................................14
1.9 About the Manuals.........................................................................14
1.10 Manual Conventions......................................................................15
2. Investigation Procedure........................................................................17
2.1 Introduction ....................................................................................17
2.2 Start the Database Program..........................................................18
2.2.1 Administrator Authentication............................................18
2.2.2 Patient Database..............................................................21
2.3 Enter and Select the Patient..........................................................22
2.4 Start the Measurement Program ...................................................23
2.5 Prepare the Investigation (Pre-Test)..............................................23
2.5.1 Consumables Traceability................................................23
2.5.2 Pre-Test ...........................................................................27
2.5.3 Prepare the pump and pump tube ...................................27
2.5.4 Solar Blue Module Control Panel.....................................29
2.5.5 Prepare the Luna wireless module...................................30
2.5.6 Prepare the catheters and transducers............................31
2.5.7 Prepare EMG cables and electrodes...............................31
2.5.8 Prepare the flowmeter......................................................34
2.5.9 Prepare the catheter puller...............................................36
2.6 Run Quality Check.........................................................................39
2.7 Perform the Investigation...............................................................40
2.8 Print the Investigation Report ........................................................41
2.9 Cleaning Instructions .....................................................................42
2.10 Exit the Database Program............................................................43
3. Urodynamic Catheters & Transducers ................................................45
3.1 Introduction ....................................................................................45
3.2 Prepare the Catheters and Transducers .......................................46

4 Solar Blue User Manual
3.3 Reusable Solid-State Catheters ....................................................46
3.4 Air-charged Catheters....................................................................47
3.5 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..............................56
4. Uroflow....................................................................................................58
4.1 Introduction ....................................................................................58
4.2 Channels........................................................................................58
4.3 Investigation...................................................................................58
4.4 Results...........................................................................................59
5. Cystometry.............................................................................................62
5.1 Introduction ....................................................................................62
5.2 Channels........................................................................................62
5.3 Investigation...................................................................................62
5.4 Results...........................................................................................63
6. Pressure-flow study ..............................................................................69
6.1 Introduction ....................................................................................69
6.2 Channels........................................................................................69
6.3 Investigation...................................................................................69
6.4 Results...........................................................................................71
6.4.1 Filling phase results .........................................................72
6.4.2 Voiding phase results.......................................................73
7. Urethral Pressure Profile (UPP)............................................................78
7.1 Introduction ....................................................................................78
7.2 Channels........................................................................................78
7.3 Investigation...................................................................................79
7.4 Results...........................................................................................82
7.4.1 Rest profile.......................................................................82
7.4.2 Stress profile ....................................................................82
7.4.3 Transmission....................................................................87
8. Gynecology Study .................................................................................89
8.1 Introduction ....................................................................................89
8.2 Channels........................................................................................89

Solar Blue User Manual 5
8.3 Investigation...................................................................................90
8.4 Results...........................................................................................94
9. Anorectal Manometry............................................................................95
9.1 Introduction ....................................................................................95
9.2 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................................................................................99
9.2.5 Timers ............................................................................100
9.2.6 Squeeze.........................................................................101
9.2.7 Push...............................................................................102
9.2.8 RAIR...............................................................................103
9.2.9 Sensation .......................................................................104
9.2.10 Compliance ....................................................................106
9.2.11 Balloon expulsion...........................................................107
9.2.12 Profiles ...........................................................................108
9.3 Prepare the Investigation.............................................................109
9.3.1 Water catheters..............................................................109
9.3.2 Air-charged catheters.....................................................110
9.3.3 Solid-state catheters ......................................................112
9.3.4 Positioning of the catheter..............................................112
9.4 Investigation.................................................................................113
9.4.1 Introduction ....................................................................113
9.4.2 Resting pressure test.....................................................114
9.4.3 Squeeze test ..................................................................114
9.4.4 Endurance squeeze test ................................................114
9.4.5 Cough test......................................................................115
9.4.6 Push test ........................................................................115
9.4.7 Rectal anal inhibitory reflex (RAIR) test.........................116
9.4.8 Sensation test ................................................................116
9.4.9 Rest and squeeze profiles using a puller.......................118
9.4.10 Rest and squeeze profile with manual pull ....................120
9.4.11 Balloon expulsion test....................................................121
9.4.12 Rectal compliance..........................................................123
9.4.13 Remote control buttons..................................................125
9.4.14 Stop the investigation.....................................................125
9.5 Analysis........................................................................................125
9.5.1 Introduction ....................................................................125

6 Solar Blue User Manual
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 ........................................................................134
9.5.11 Rectal anal inhibitory reflex (RAIR) test.........................135
9.5.12 Sensation test ................................................................137
9.5.13 Anal rest and squeeze profiles.......................................137
9.5.14 Balloon expulsion test....................................................139
9.5.15 Rectal compliance..........................................................139
9.5.16 3D Vector volume plot....................................................140
9.5.17 Rectal volume plot..........................................................142
10. Biofeedback .........................................................................................143
10.1 Introduction ..................................................................................143
10.2 Prepare the investigation.............................................................144
10.3 Investigation.................................................................................147
10.4 Analysis........................................................................................148
10.5 Investigation Protocol...................................................................148
10.5.1 Channel settings ............................................................149
10.5.2 Biofeedback settings......................................................150
10.5.3 Challenge editor.............................................................153
11. Investigation with Luna Wireless Module .........................................157
11.1 Introduction ..................................................................................157
11.2 Stationary Measurement..............................................................158
11.3 From Stationary to Ambulatory Measurement.............................159
11.4 Analysis........................................................................................162
12. Measurement Program........................................................................163
12.1 Introduction ..................................................................................163
12.2 Main menu ...................................................................................164
12.3 Investigation.................................................................................164
12.3.1 Pre-test...........................................................................165
12.3.2 Start measurement.........................................................165
12.3.3 Button toolbar.................................................................166

Solar Blue User Manual 7
12.3.4 Remote control...............................................................168
12.3.5 Virtual remote control.....................................................171
12.3.6 Markers ..........................................................................172
12.3.7 Pause mode...................................................................173
12.3.8 Change filling liquid........................................................173
12.3.9 Stop measurement.........................................................174
12.4 Settings Menu..............................................................................174
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 ............................................................181
12.5.9 Connections Solar Blue..................................................182
12.6 System Settings...........................................................................183
13. Analysis Program ................................................................................186
13.1 Introduction ..................................................................................186
13.2 Results.........................................................................................188
13.2.1 Menu overview...............................................................188
13.2.2 Display results................................................................189
13.2.3 Edit investigation parameters.........................................190
13.3 Graph...........................................................................................191
13.3.1 Menu overview...............................................................191
13.3.2 Zoom function ................................................................192
13.4 Marker..........................................................................................192
13.4.1 Menu overview...............................................................192
13.4.2 Insert markers ................................................................192
13.5 Options.........................................................................................196
13.5.1 Menu overview...............................................................196
13.5.2 Siroky flow rate nomogram ............................................198
13.5.3 Liverpool flow rate nomogram........................................198
13.5.4 Miskolc flow rate nomogram ..........................................199
ICS Detrusor/flow plot..................................................................200
13.5.5 Schäfer Detrusor/flow plot..............................................201
13.5.6 Blaivas Detrusor/flow plot...............................................203
13.5.7 Composite nomogram....................................................204

8 Solar Blue User Manual
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.....................................................226
Appendix C Software Messages............................................................232
Index .............................................................................................................241

Solar Blue User Manual 9
1. Introduction
1.1 Solar Blue Measurement System
The Solar BlueTM measurement system is developed by Medical Measurement
systems (MMS) to perform urodynamic investigations in hospitals and private
clinics.
Figure 1.1 Solar Blue wireless table-top setup
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. It receives infrared commands from an
optional remote control. The result is a setup that is versatile and flexible. You
can choose the table-top setup, mount the Solar Blue module on an
investigation chair (Figure 1.2), or on the Solar pole (Ø38 mm; see Figure 1.3).
The laptop and printer can be installed on the pole, as well (Figure 1.4).
For more details about the setup possibilities, read the Solar Blue Service &
Installation Manual (Document Code: LBL-001019).

10 Solar Blue User Manual Chapter 1
Figure 1.2 Solar Blue
mounted on investigation
chair
Figure 1.3 Solar Blue mounted
on Solar pole
Figure 1.2 Solar Blue mounted on
Solar pole with integrated laptop
CAUTION
For USA only: Federal law restricts this device to sale by
or on the order of a physician.
The Solar Blue measurement system is used in combination with a computer
and the LABORIE software program. To run the program, you will need
Windows 7 Professional (32 or 64 bit), Windows 8 (8.1) Professional (32 or 64
bit), or Windows 10 Professional Edition (64 bit).
1
The Solar Blue measurement system consists of a Solar Blue module and
some additional and/or optional devices. The following table provides an
illustration and description of these devices.
Module
Description
Solar Blue
module
The Solar Blue module contains the
main urodynamic investigation
functionalities:
•The pump to fill the bladder
•Four connectors to measure
pressures
•One EMG connector
•One infrared receiver for the
remote control
1
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 Solar Blue User Manual 11
Module
Description
Luna wireless
module
Measures pressures, EMG (optional),
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).
Wireless
flowmeter (Mk III)
The flowmeter can be used to
measure voided volume and flow via
a wireless connection. Under certain
conditions a cable can be used.
Wireless puller
(Mk III)
The puller can be used to make
urethral pressure profiles via a
wireless connection.
RFID Reader
The RFID reader is used to scan
boxes of consumables for
consumable traceability.
Safety module
This safety module contains a power
insulation between the mains and the
Solar Blue measurement system,
including computer and its
peripherals.

12 Solar Blue User Manual Chapter 1
1.2 Intended Use
The Solar Blue measurement system is intended for urodynamic testing and
anorectal manometry investigations. The Solar Blue 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 Solar Blue User’s Manual is intended for users performing investigations
by using the Solar Blue measurement system. Before working with the Solar
Blue measurement system and its manuals, read the safety information
presented in Appendix A.
1.4 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.
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.

Introduction Solar Blue User Manual 13
1.6 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):
•Database program. When you start the program, you will enter the database in
which all available patient information, investigations, 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 and printed as investigation reports.
•Hardware test (diagnostic) program. This program is started from the database
to maintain the Solar Blue system. For Information on this, see the Solar Blue
Service & Installation Manual (document code: LBL-001019) for information.
Hardware test (diagnostic) program
Measurement program
Database program
Analysis program
Figure 1.3 LABORIE software program

14 Solar Blue User Manual Chapter 1
1.7 Computer Requirements
The minimum computer requirements for the Windows software for the Solar
Blue system are as follows:
•Processor: Intel Core I3-6100
•CPU 2.3 GHz
•Internal memory: 4.0 GB
•Operating system Windows 10 PRO
•Hard disk: 500 GB
•DVD-RW
•Soundcard/speakers
•4 to 7 USB ports (Solar Blue module, USB protection key, keyboard,
mouse, printer); possible USB additions: Bluetooth dongle, memory stick
•17-inch color monitor
•Two-button mouse
1.8 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. If you prefer, you can disable the appearance of the
assistant.
Figure 1.4 LABORIE assistant
1.9 About the Manuals
The Solar Blue User’s Manual is intended for all users of the Solar Blue
measurement system. This manual provides you with detailed information
(step-by-step) about the urodynamic investigation procedures (chapters 4 to
11), and the measurement program and analysis program (chapters 12 and

Introduction Solar Blue User Manual 15
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).
1.10 Manual Conventions
In this manual, we use some conventions for readability. This section
describes the most important ones:
•Use of bullets
•Headings
•The use of the words “click,”“press,” and “choose”
•Warnings, cautions, and notes
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, choose, and press
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.

16 Solar Blue User Manual Chapter 1
Figure 1.5 Screen
Choose Report > Print report means that you must click Report on the menu
bar and then choose Print report. Press a button means pressing the key on
the RC-1200 remote control; for example, the Start investigation button .
Press a key means pressing the key on the keyboard; for example, the Shift
function key.
Warnings, cautions, and notes
The following symbols are used in this manual to indicate important warnings
and cautions as well as informative notes. It is important to pay attention to
these warnings and cautions to provide patient safety and to prevent damage
to the equipment.
WARNING
A warning is a statement that alerts the user to the
possibility of injury, death, or other serious adverse
reactions associated with the use or misuse of the
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]
Screen
Button

Investigation Procedure Solar Blue User Manual 17
2. Investigation Procedure
2.1 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.
You can find detailed information about preparing the catheters and
transducers in Chapter 3. 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 database program
▪Enter and select the patient
▪Start the measurement program
▪Prepare the investigation (pre-test)
▪Run a quality check
▪Perform the investigation
▪Print the investigation report
▪Clean the system and catheters
▪Exit the database program
You can find detailed information about the database program and the reporter
program in separate manuals in PDF format, which you can open via the
Manuals menu in the database program.
For detailed information about the measurement program and analysis
program, see chapters 12 and 13.

18 Solar Blue User Manual Chapter 2
2.2 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.
Figure 2.2 Administrator Authentication
•Input Username and Password (the initial username/password is
Admin/admin) and then click the OK button to enter the Login Settings
window.

Investigation Procedure Solar Blue User Manual 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.
•Use Cache dir to run network programs locally; for example, the
location c:\mms-cache\

20 Solar Blue User Manual Chapter 2
Figure 2.4 Login Settings—Active Directory / LDAP tab
Here, you can do the following:
•Enable Active Directory Login.
•Configure the Login Format. %username% refers to the username that
the user will type in the login window. This eliminates the need for the
user to enter the domain name (or email address) each time they log in.
•Enable Use Secure LDAP. This sets the default port number to 636.
For this option to function correctly, the SSL certificate being used on
the AD/LDAP server needs to be installed on the machine running the
Laborie software.
•Set the LDAP Host and Port.
•Set the LDAP Base DN Groups, which is the base node from which all
groups will be searched recursively.
•Set the LDAP Base DN Users, which is the base node from which all
users will be searched.
•In Permission Groups, you first need to “poll” all groups from LDAP.
Click the Poll button and then enter valid Active Directory credentials.