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CANADA
2101 Boul. Lapinire
Brossard, Qubec, Canada J4W 1L7
Montreal: 450.671.5901
Customer Service: 888.522.6743
Technical Support: 800.333.1039
Fax: 450.671.7182
service@laborie.com
INTERNATIONAL
6415 Northwest Dr., Unit 10
Mississauga, Ontario, Canada
L4V 1X1
Customer Service: 905.612.1170
Fax: 905.612.9731
internationalsupport@laborie.com
LATIN AMERICA
Al. Madeira, 258 salas 801, 805, 806
Alphaville - Barueri - So Paulo
06454-010 BRAZIL
+55.11.4208.3652
Fax +55.11.4134.8480
Trademarks
AQUARIUS, RoamDX, Urocap, and i-LIST Office Reporter are trademarks of Laborie Medical
Technologies Canada ULC. T-DOC is a trademark of T-DOC Company, LLC. Unisensor is a
trademark of Unisensor AG. Windows is a registered trademark of Microsoft Corp. NitroPDF is
a registered trademark of Nitro PDF, Inc. Bluetooth is a registered trademark of Bluetooth SIG
Inc.
www.laborie.com
Copyright
All rights reserved. No part of this publication may be reproduced in any form whatsoever
without the prior written permission of LABORIE.
Copyright 2014 LABORIE
Document Number: AQS-UM01
Version Number: 5.0
Release Date: September 15, 2014
Issued By: R.A.
TABLE OF CONTENTS
Introduction and Guidelines for Use ....................................................................................................................................... 1
Caution and Warnings.......................................................................................................................................................................... 2
Caution ............................................................................................................................................................................................. 2
Warnings .......................................................................................................................................................................................... 2
Intended Use ........................................................................................................................................................................................ 7
Target Population................................................................................................................................................................................. 7
Contraindications ................................................................................................................................................................................. 7
Software and Equipment........................................................................................................................................................ 8
Standard Equipment and Optional Accessories................................................................................................................................... 8
Additional Configuration Option........................................................................................................................................................ 10
AQUARIUS CTS ............................................................................................................................................................................... 10
Lockable Wheels ................................................................................................................................................................................ 11
Flowstand ........................................................................................................................................................................................... 11
Bubble Detector (Optional)................................................................................................................................................................ 11
UPX UPP Puller (optional) .................................................................................................................................................................. 12
Equipment Status and Light Signals ...................................................................................................................................... 13
Pump Hub .......................................................................................................................................................................................... 13
ROAM DX............................................................................................................................................................................................ 15
Urocap V............................................................................................................................................................................................. 20
UPX ..................................................................................................................................................................................................... 21
Transducer Setup and Connection ........................................................................................................................................ 22
Uroflow Transducer ........................................................................................................................................................................... 22
Pump Setup ........................................................................................................................................................................................ 22
RoamDX Setup for Pressure and EMG ............................................................................................................................................... 23
Pressure Transducer Setup for Fluid-based Disposables ................................................................................................................... 24
Water Pressure Transducer Setup ..................................................................................................................................................... 25
Infusion Volume Transducer (optional) ............................................................................................................................................. 26
Catheter Setup ..................................................................................................................................................................... 27
Record Bladder Pressures .................................................................................................................................................................. 27
Two Catheter Technique .................................................................................................................................................................... 27
Abdominal (rectal) Balloon Catheters................................................................................................................................................ 27
T-Doc Catheter Setup ......................................................................................................................................................................... 30
Electronic Catheter ............................................................................................................................................................................ 30
Set up Remote Control (optional) ......................................................................................................................................... 31
LABORIE
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LABORIE
WARNINGS
1. Only technicians and physicians trained in Urodynamics should operate this device. The operator must read the Owners manual
entirely and refer to any additional training materials before using the device. Optional In-Service is available from LABORIE.
2. The UDS system and associated devices are intended for indoor use only and under the following standard operating conditions:
3. Before connecting the patient, verify that the UDS system and software are functioning properly.
4. DO NOT USE in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide.
5. DO NOT USE electromyography (EMG) simultaneously with high frequency surgical equipment.
6. Where applicable, utilize single-use disposable tubing and catheters designed for Urodynamics measurements. Do not reuse
disposable devices. After use, dispose in accordance with local regulations.
NOTE: Pump accuracy is not guaranteed if the pump head tubing is used more than once. DO NOT run pump at a speed
exceeding the limitation of the catheter or run pump at a high speed with a contrast medium.
7. Re-use, reprocessing or resterilization of disposables could lead to device failure and create a risk of cross-infection and/or cross
transmission of infectious disease(s) from one patient to another. Result of sterilization failure could lead to cross infection and/or
cross-transmission of infectious disease from one patient to another.
8. DO NOT USE the AQUARIUS system in the same room as an operating magnetic resonance imaging device (MRI). The strong
magnetic field produced during MRI may cause disruption of the system.
9. All transducers should be calibrated prior to use. Calibration should be checked at least every six (6) months or whenever there is a
suspicion that the calibration is incorrect. ONLY calibrate the transducers if necessary.
10. Use the AQUARIUS with LABORIE equipment and accessories ONLY.
11. DO NOT ATTEMPT TO OPEN OR REPAIR the system by yourself or by an unauthorized party. ONLY LABORIE trained technicians may
service the unit.
LABORIE
12. LABORIE equipment is licensed by Governments and approved by Safety Agencies to work with LABORIE accessories ONLY.
13. LABORIE accessories are licensed by Governments and approved by Safety Agencies to work with LABORIE equipment ONLY.
14. LABORIE equipment is warranted to work with LABORIE accessories ONLY.
15. LABORIE accessories are warranted to work with LABORIE equipment ONLY.
16. DO NOT LEAN anywhere on the unit. The unit is not designed to support the weight of a person.
17. DO NOT HANG any additional items on the mobile platform other than standard LABORIE accessories. Excess weight may cause the
unit to become unstable and tip over.
18. Exercise caution when raising or lowering platform while patient is connected to the AQUARIUS.
19. Do not place or insert fingers in the slot when the platform is raised or lowered.
20. Exercise caution when repositioning the AQUARIUS Urodynamic processor while patient is connected.
21. If using a water pressure transducer cartridge (UDS-D-M-Px), make sure the pressure transducer cartridge is latched securely into
the pressure transducer plate before use.
22. If using a Unisensor electronic catheter, do not immerse electrical connector in water. Refer to Operating Manual of Unisensor
catheter for additional information.
28. Do not plug in or unplug any transducers when a procedure is running. Always stop the procedure before plugging in or unplugging
transducers.
29. Do not place your fingers inside the pump head when the pump rollers are moving.
30. Ensure all wheels are locked during testing procedures to prevent injury to the patient.
31. Make sure to lock the height adjustment lever firmly after every adjustment.
32. LABORIE is not responsible for loss of patient files or test data. We recommend that you back up patient data on a regular basis.
33. Any additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g.
IEC 60950 for data processing equipment). Any and all configurations shall comply with the requirements for medical electrical
systems. Anyone connecting supplementary equipment to medical electrical equipment configures a medical system and is
therefore responsible that the system complies with the requirements for medical electrical systems. Attention is drawn to the
fact that local laws take priority over the above-mentioned requirements. If in doubt, consult your local LABORIE representative
or the technical service department.
34. Transthoracic stimulation, such as maintaining anode and cathode stimulation sites in close proximity, must be avoided.
LABORIE
35. Connection of a patient to high frequency surgical equipment and an electromyograph or evoked response equipment may result in
burns at the site of the electrical stimulator of biopotential input part electrodes and possible damage to the electrical stimulator or
biological amplifiers.
36. Operation in close proximity (1 meter) to shortwave or microwave therapy equipment may produce instability in the Stimulator
output.
37. Avoid accidental contact between connected but unused applied parts and other conductive parts including those connected to
protective earth to prevent damage or injury.
38. Customers providing their own computer, monitor, or printer for use with the LABORIE system may require the use of a Line
Isolation Transformer (LIT) to maintain system compliance. In all cases it is advised to check with your local regulations before
proceeding.
39. The use of cellular phones, smartphones, mobile internet devices, and other portable wireless devices within close proximity of the
system is not recommended and may cause artifacts to appear on the channels.
40. To reduce the risk of tipping, the equipment does not overbalance when tilted at an angle of 10.
41. To prevent patient injury, the device complies with EN 60601-1: Instability in transport position safety test for medical electrical
equipment.
42. To prevent possible injury to the patient, ensure all castor wheels are locked during testing procedures.
43. Do not lean on the equipment nor hang excessive weighted objects other than LABORIE standard accessories on the platform.
44. The maximum load for the printer shelf and for the workstation shelf is 9kg (20lbs.)
45. To prevent possible injury to the patient, always use the UPP puller with the UPP puller adaptor.
46. To ensure patient safety, do not exceed a pressure of 150cmH2O or a volume of 750mL in the pump settings.
47. Pump can be manually stopped if volume warning limit appears in Pediatric Mode.
48. The red reset stop button is used as a panic stop. It will stop all moving components such as the pump and UPP as well as provide a
reset to the digital portion of the Urodynamic processor. System is designed to automatically stop or reset when the firmware is
unresponsive after 5 seconds.
49. To maintain patient safety during normal use, the pressure limit for the pump is preset to 150cmH 2Oand the volume limit is preset
to 750mL.
50. The software will send a periodic command to the hardware to keep the pump running. Once the feedback from the PC stops, the
pump will stop within 5 seconds.
51. To avoid the risk of device connection interruption, reduce the distance between the device and the computer. The maximum
distance between the processor and the computer can be up to 10 meters (33 feet). Remove any physical barriers like walls, posts,
doors, or people.
52. To ensure proper interpretation of results during normal mode, the device is EN 60601-1-2 EMC as well as EN 62304:2006 compliant.
53. To ensure proper and safe use of the UDS equipment and accessories, follow the instructions outlined in this owners manual.
54. To reduce the risk of EMG reading misinterpretation, the EMG channel scales are modifiable.
55. Procedures can be repeated as necessary.
LABORIE
56. To ensure proper data transfer between the software and computer, an error-checking mechanism is implemented for verifying the
integrity of sent and received data.
57. To prevent electric shock, patients and equipment operators are protected in single fault conditions since resultant leakage currents
fall well below acceptable standards for open ground conditions.
58. The device requires mains power (110VAC or 240VAC) to operate properly.
59. To prevent unexpected power failures, the device is compliant to safety standards: EN 60601, UL60601, CSA 22.2 No. 601.
60. To reduce the risk of patient injury, AC-DC power supplies are spaced so that they have short circuit protection and can withstand
the DC outputs being short circuited.
61. Insulation is maintained by a combination of dielectric insulators and minimum physical separation (creep distances).
62. Device uses approved wire for connection, and adheres to EN 60601-1 air clearance and creepage distance requirements.
63. To prevent exposure to potential electric shock, the device meets and exceeds the insulation breakdown specifications for EN
60601-1, EN 60601-1-2 EMC standards & CSA 22.2 medical standards.
64. To prevent insulation failure, the insulation requirements are of higher quality and resist cuts and breakage above and beyond
consumer grade cable insulation.
65. To prevent exposure to potential electric shock, the power entry module (connector for mains input) is rated as medical grade. It
meets IEC standards for insulation.
66. To prevent exposure to potential electric shock, the power entry module is also situated in the back (or recessed) so that access to
the connection point is reduced.
67. To reduce any EMI artifacts, the system already incorporates the use of a 2-stage pre-amplifier circuit with shielding cable, and is
further improved by shield cabling and inductor/choke placement to achieve the EMC conformance.
68. To prevent unexpected exposure to radiation, the device has been tested against EN 60601-1-2 EMC standards.
69. User manual states in Caution and Warnings section: IMPORTANT! The UPP puller is intended for catheter withdrawal only.
70. The risk of a potential shock hazard is reduced as the LIT circuit breaker ensures no power is supplied to connected UDS systems if
there is an excessive current surge.
71. To prevent patient injury, warning symbols on all labels comply with EN ISO 15223-1 and EN 1041.
72. Do not use if device packaging has been opened, or damaged, or if it presents any fault due to improper transport, storage, or
handling that could in any way hamper its use.
73. To reduce the risk of cross-contamination or infection, physicians should be knowledgeable and qualified in applying the appropriate
aseptic technique during the intended use of the device. The use of prophylactic antibiotics are at the discretion of the physician
and the policies of the institution.
74. Do not immerse the UDS equipment or any components in water or any other liquids.
75. To reduce the risk of serious patient injury, it is vital that physicians and clinicians performing Urodynamics studies on patients with
a Spinal Cord Injury be prepared to recognize and treat Autonomic Dysreflexia. Proper patient screening before Urodynamics testing
and continued monitoring for spikes in blood pressure and pulse during test procedures is also required. If a rise in blood pressure or
LABORIE
other symptoms are detected, bladder must be emptied immediately. Raise the patients head if not already in a sitting position.
Physicians must monitor patients with Autonomic Dysreflexia at least 2 hours after resolution of the episode.
76. To prevent cross-contamination, waist belts and lanyards are made of machine washable materials and should be washed with hot
water and dried between uses.
77. To reduce the risk of serious patient injury, it is vital that physicians and clinicians performing Urodynamics studies be prepared to
recognize and treat symptoms associated with vasovagal syncope (fainting) during Urodynamics procedures.
78. To reduce the risk of urinary tract infection, the physician should be knowledgeable and qualified in applying the appropriate aseptic
technique during the intended use of the device. The use of prophylactic antibiotics are at the discretion of the physician and the
policies of the institution.
79. To reduce the risk of invalid test results, catheters should not be used on patients who suffer from bladder infections or strictures in
the urethra.
80. Prior to testing, a urinalysis and urine culture should be considered to rule out the presence of infection.
81. To reduce the potential for discomfort during the procedure and/or transient discomfort, dysuria and hematuria, technicians and
physicians should explain any additional risks of the procedure to the patient.
82. To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
83. No modification of this equipment allowed.
84. Connecting electrical equipment to a multiple socket outlet effectively leads to creating a medical electrical system and can result in
a reduced level of safety.
85. The UDS system must be positioned in such a way so as to provide unobstructed access to the power cord connector in the event of
a required emergency stop.
86. To ensure misinterpretation of results / incorrect flow readings during normal mode is significantly reduced the device complies with
the EN 60601-1-2 EMC test standards and EN 60601-1-4 PEMS.
87. To reduce the risk of software communication interruptions during a procedure, a pressure feedback feature is implemented in the
software to command the pump to keep running until feedback is no longer received after 10 seconds.
88. To further reduce the risk of software communication interruption, a IsAlive command between the PC and SBC is implemented to
reset communication.
89. Ensure the weight/IV bag for the infusion transducer is not touching any parts and is free-standing.
90. In case of power failure the computer software will display a lost connection dialog message that requires operator
acknowledgement before proceeding to any other function in the system.
91. Device uses internal Watchdog peripheral to monitor firmware and external independent watchdog. In case of firmware failure,
watchdog will reset the unit and the device will stop running.
92. System incorporates the use of shielding and RF filters and pre amplifier circuit with shielding cable to reduce any EMI artifacts. It is
further improved at the design stage by shield cabling and inductor/choke placement to achieve the EMC conformance.
93. The UDS system must be positioned in such a way so as to provide unobstructed access to the power cord connector when an
appliance coupler or separable plug is used as isolation means.
LABORIE
INTENDED USE
The AQUARIUS LT, AQUARIUS CT, and AQUARIUS XT are diagnostic analyzer systems. The product is a data acquisition
system for Urodynamics and peripheral diagnostics that records and displays physiological data from the patient. It is to be
used as medical diagnostic equipment. Details are described as follows:
Central Hub Computer: has a touch LCD as a new HMI and collects/synchronizes data from all procedure modules and
sends data to PC. It also displays the device status and provides interface for calibration and pump setup.
Pump Module: The pump on the Central Hub is used to infuse a patients bladder with saline from an IV bag.
Pressure transducers: These are the sensors for pressure measurement.
EMG: Electromyography (EMG) transducer for measuring the raw and enveloped muscle activity.
Urocap/Uroflow: Load cell transducer to detect volume and flow of liquid into a beaker.
UPP Puller: Retracts a catheter at a constant speed from the patient.
Roam DX: Wireless Battery Powered EMG Measurement Device.
PC: Computer which controls the system activity, displays, and stores data.
ARM: LABORIEs ARM system is intended to measure physical parameters such as pressures and EMG of the terminal end
of the digestive tract as it relates to Urodynamics, Incontinence, and the Pelvic Floor.
TARGET POPULATION
The major application of Urodynamics is the diagnosis of uncontrolled loss of urine (incontinence), abnormal urinary retention,
neurological causes of Micturition disorders, or anorectal manometry.
The major application of anorectal manometry (ARM) is to aid in the diagnosis of anorectal disorders and incontinence. ARM has
shown applicability in men, women, and children in the diagnosis of these conditions.
CONTRAINDICATIONS
The AQUARIUS system is contraindicated for any patient who is not a candidate for Urodynamic testing.
Catheters should not be used on patients who suffers from:
Bladder infections
Strictures in the urethra
Single use, disposable catheters provided by Laborie Medical Technologies are sterile, unless stated otherwise on the
packaging label and instructions.
Reusable catheters are cleaned but not sterilized before shipping.
LABORIE
A detailed list of system parts and accessories can be found on page II under the APPENDIX section at the back of the manual.
LABORIE LT
The AQUARIUS is available in three models each with a central hub that houses the pump, Bluetooth connections, and
connection ports for cables:
LABORIE
Laptop
Keyboard/workspace shelf
1 Roam DX maximum
AQUARIUS Central Hub
1 Charging Bay for Roam DX
Bubble detector (optional)
Infusion transducer holder with drip cup (optional)
Pump - 4 roller
LIT
Urocap V (separate charging plug supplied)
UPX puller stand (optional)
AquaVU 360 (optional)
LABORIE CT
LABORIE XT
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Industrial mini-PC
AQUARIUS
Tower
and
AQUARIUS
Computer
Workstation
Keyboard/workspace shelf
2 RoamDX
AQUARIUS Central Hub
2 Charging Bays for Roam DX
Bubble detector (Optional)
Infusion transducer holder with drip cup (Optional)
Pump 4 Roller
2 LIT one for workstation and one for tower
Urocap V (up to 2; separate charging plug supplied)
UPX puller stand (optional)
AquaVU 360 (optional)
Video (For Industrial PC only - Optional)
LABORIE
Industrial PC
LCD Monitor display
Keyboard/workspace shelf
2 RoamDX
AQUARIUS Central Hub
2 Charging Bays for Roam DX
Pump 4 roller
LIT
Urocap V (up to 2; separate charging plug supplied)
Color Printer
Bubble detector (optional)
Infusion transducer holder with drip cup(optional)
UPX puller stand (optional)
AquaVU 360 (optional)
Remote (optional with Industrial mini-PC version only)
Video (For Industrial PC only Optional)
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LOCKABLE WHEELS
The AQUARIUS system comes equipped with built-in locking castor
wheels, making it a mobile unit that can be moved from room to
room. This is also a safety feature to ensure that the unit will remain
securely in place and will not move during tests.
To lock the wheels, press down on the lever with the bottom of your
foot.
To unlock, push the lever up from underneath with the top of your IMPORTANT! Ensure all wheels are locked during
foot.
testing procedures to prevent injury to the patient
FLOWSTAND
For assembly instructions see the AQUARIUS Flowstand User Assembly Instruction booklet on the LABORIE Software Disc.
LED light:
Green = no air bubbles
Red=air bubbles detected
NOTE: To avoid errors, make sure the pump tubing is pushed securely and completely into the groove.
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Figure 1:UPP1001
Figure 2:UPP1002
Remember to connect the UPX to the system. For more information on connection see How to Add a Device to the System on
page 51.
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3
2
1
1.Infusion Transducer Connection: plug the infusion transducer cable into the
port(s)
2. USB port: connect the USB cable from the UPX or the Urocap V into the
port
3. BDT: plug the cable from the bubble detector into this port
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ROAM DX
3
2
1
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OK key:
Manual wake-up from hibernation.
Press for 5 seconds to enter Changing Settings mode (see screen descriptions).
Single push exit from Changing Settings mode.
STOP key:
Press for 5 seconds to force device to hibernation mode.
Single push exit from Changing Settings mode.
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UROCAP V
BT (Bluetooth)
blue = connected
green = system at work but not connected
orange = system fault
light off = not connected
Equipment status
green = connected
blinking green = connected and sampling
orange = System fault
blinking orange = not connected
light off = system off
Front of Urocap V
Power
green = battery full and plugged into charger
blinking green= battery good
orange = charger plugged and battery charging;
battery not fully charged
blinking orange = low battery; time to re-charge
light off = battery empty; re-charge
ON button
use to wake up uroflowmeter
Reset button
Press and hold for 5 seconds or longer to
bring to sleep
Bottom of Urocap V
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UPX
The control pad on the UPX arm provides the following controls and signals during tests.
NOTE: Closely monitor the battery level of the UPX when in use.
1 Arrows (up and down):
Press UP to pull the arm
Press DOWN return the arm
1.
2.
5.
3.
4.
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PUMP SETUP
1.
2.
3.
4.
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The patients anal area should be clean, dry, and free of hair.
Once the patients skin is properly prepared, the electrodes may be applied.
1. Two electrodes are placed peri-anally at the 10 oclock and 2 or 3 oclock positions. Place as close as possible to the
anus for pelvic floor muscle readings.
2. The third electrode is placed on a bony prominence such as the patients hip bone or knee.
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Make sure the electrodes are placed as close to the anal sphincter as possible or the EMG activity will be weak.
NOTE: It is recommended that each electrode be secured in place with an additional piece of surgical tape. If the electrodes
detach, dry the skin and apply new surgical tape.
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to transducer
cartridge
to catheter
1. Attach a pressure transducer cartridge to the pressure transducer plate. Connect the 3-way stopcock side of the TUB101
interface tubing to the bottom male Luer connector of the pressure transducer cartridge.
2. Attach the catheter port to the other end of the TUB101 interface tubing.
3. Attach a syringe filled with water or saline to the 3-way stopcock.
4. Turn the "OFF" position of the stopcock to the catheter (see Figure 6 B).
5. Make sure the line between the syringe and the pressure transducer cartridge is open. (Example: Remove the Luer plug
and/or open the stopcock through the pressure transducer cartridge).
6. Prime the pressure transducer cartridge by using the syringe to fill it with water until there are no air bubbles.
7. Close the pressure transducer cartridge (example: put a Luer plug on the pressure transducer cartridge).
8. Turn the "OFF" position of the stopcock to the pressure transducer cartridge (see Figure 6D).
9. Prime the catheter by using the syringe to fill the catheter with water (see Figure 6D).
10. Turn the OFF position of the stopcock to the syringe (see Figure 6 A).
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NOTE: The infusion transducer is calibrated for up to 1000 ml of sterile saline or water. If you are using a different medium, such as hypaque,
re-calibration is required.
Remember! Keep transducers level with the patients symphysis pubis at all times.
Important!
Ensure that the infusion line is not pulled or else the transducer reading will not be accurate.
The infusion transducer is calibrated for up to 1000 ml of sterile saline or water. If you are using a different medium, such as
hypaque, re-calibration is required.
The saline bag must not touch any other mechanical component of the system (such as transducers, etc).
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CATHETER SETUP
The following section is a reference guide to catheter setup and connection.
It is recommended that the single-, twin-, and triple-lumen catheters supplied by Laborie Medical Technologies be used for
Urodynamic tests involving the UDS System.
IMPORTANT! Do NOT use Foley catheters, as these catheters are not designed for pressure
measurement, bladder infusion, or pressure recording. Do NOT use catheters on patients that suffer from
bladder infections or strictures in the urethra.
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NOTE: Bladder catheter placement is 6-8 cm (no more than 10cm) for women, and 5 cm plus the length of the penis for men. Place the
abdominal catheter rectally to the 15 cm mark.
2.
3.
4.
5.
6.
7.
8.
9.
NOTE: If Pabd is higher than Pves, try repositioning the Pabd catheter. If repositioning does not work, ask the patient to cough to confirm that
both pressures are reacting appropriately, and click the Equalize button on the UDS120 control panel.
10. Continue with the testing procedure.
ELECTRONIC CATHETER
Connect the cables to the Electronic catheters as follows:
P1 Pves Blue -> S1 distal of dual catheter
P2 Pabd Red -> Single catheter
P3 Pura Black -> S2 proximal of dual catheter
Refer to the following diagram for more information.
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2. Tap Settings.
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6. Tap OK.
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9. Tap OK.
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Remote control setup is complete. To learn how to change button names and set the display on the remote, see page 174.
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The AQUARIUS system is non-immersible. It should be wiped down with a clean cloth dampened with a cleaning
solution such as soap and water or as per hospital cleaning instructions.
The Uroflow beaker should be rinsed and dried after use. Soap and water, or a mild detergent solution, can be used for
cleaning. NOTE: Although the beaker is reusable, it will discolor over time and may need to be replaced.
The EMG electrodes, tubing, disposable catheters, optional strap, and cartridges are intended for SINGLE PATIENT USE
only. Do NOT re-use disposables.
The chair, Flowstand, funnel, and EMG headstage/processor can be wiped clean with a cloth dampened with soap or
mild detergent and wiped dry immediately.
o NOTE 1: The insertion points of the EMG headstage/processor must be kept dry; never immerse the EMG into
water or any liquids.
o NOTE 2: When cleaning the funnel, the maximum cleaning temperature should not exceed 80C (176F).
For the pressure transducer cartridges, clean any fluids or other foreign matter from the external surfaces of the
transducer and cable using a slightly damp cloth and a mild detergent solution. Do not immerse. Do not use chlorinebased cleaning solutions/agents. Do not autoclave or EtO sterilize the transducer.
Performing regular maintenance will reduce the need for costly repairs. As a necessary step in maintaining optimal
system performance check the calibration every 6 months or whenever you suspect the transducers are off
calibration.
Always wear protective gloves when cleaning the equipment to prevent biological contamination.
Pay close attention to the LED lights on each device. If they indicate a broken connection and/or low battery, then make
sure that the connection is re-established or the battery is fully charged. For information on LED lights see page 11.
For best performance it is recommended to always charge the devices when alerted to do so by the system.
The RoamDX is not immersible. Wipe the outside only with soap and water or with a hospital-grade disinfectant. DO
NOT SPRAY CLEANING SOLUTION DIRECTLY ON OR IN THE ROAMDX.
The optional strap is disposable, non-sterile, and recommended for single-use only.
The holster can be cleaned with standard hospital wipes.
NOTE: It is recommended to charge and use the RoamDX at least once or twice a year to maintain optimal performance. If it will
be placed in storage, make sure it is stored with the battery fully charged.
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UPX: Plug the USB cable from the UPX stand into the front USB port under the
central pump hub to charge the UPX. It will take approximately 7.5 hours to charge
(about 9 hours if sampling).
It is recommended to plug the UPX in at the end of every day to ensure a full charge
for testing.
NOTE: it is recommended to have the device plugged in or have at least 40% battery
charge before the start of a test.
NOTE: The equipment can still be used during battery charge time.
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PREVENTIVE MAINTENANCE
Do not step on, drop, drop in water, or puncture the battery. If misuse, abuse, or damage is suspected, or any form of
mechanical damage to the casing is visible, then discontinue use and return the battery to LABORIE.
If a sudden change in the batterys ability to hold a charge or a sudden change in battery life time is noticed, discontinue
use and return the battery to LABORIE.
It is recommended to charge all device batteries overnight to ensure proper function. Once the battery level drops to
40% charge, it is best to start recharging.
After use, discard the contaminated, plastic, single-use disposables and any packaging according to your institutions
standard operating procedures on medical waste handling.
For end of life product, waste electrical and electronic equipment should be collected separately and returned to the
designated local recycling service.
For end of battery life, disposal must be handled according to local regulations.
Packaging waste should be collected separately for available national packaging collection and recycling services.
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Check Flow
1.
2.
3.
4.
5.
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at 50% strain
5. Keep palm open and lift your arm further up
until it is parallel to the floor. You will notice
more activity on the EMG channel.
at 100% strain
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relaxed
50% strain
100%
strain
contraction
relaxed
If the EMG channel does not display any activity, then calibration is required. Once calibration is complete perform a re-check
by following steps 1 to 8 listed here. Contact LABORIE service for assistance if problems continue after the calibration and recheck.
With a pencil, mark two points 50mm apart along the UPX puller shaft.
Open the AQUARIUS software and start a sample UPX test.
Move the UPX to the distal (furthest) marker on the puller shaft.
Start a timer and then run the puller and measure the time it takes for the UPX puller to move to the proximal (closer)
mark on the puller shaft.
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The puller should stop at the proximal mark after 50 seconds (+/- 3 seconds). If the UPX puller does not move to the proximal
mark in the required range of time, then calibration is required. Once calibration is complete perform a re-check by following
steps 1 to 4 listed here. Contact LABORIE service for assistance if problems continue after the calibration and re-check.
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5
1
2
3
4
5
6
7
8
9
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PC connection wired
or wireless
Calibration tap to open calibration procedure for each device
Pump Controls tap to open pump settings menu
Settings tap to add devices, remove devices, and configure
connections
(optional) Remote Control connected
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Or
4. Tap the Home icon at top left of the screen to go back to the
home screen.
The devices and their type of connections will be displayed.
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CALIBRATION
IMPORTANT NOTES!
Do not plug in or unplug any USB device to or from the Central Hub during the calibration procedure.
Run the calibration procedure in one continuous process to ensure proper function and battery status of the devices.
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CALIBRATE PRESSURE
NOTE: Calibration points are displayed only for air-charged catheters.
1. Tap the Calibration icon on the home screen.
2. Tap to select the RDX device.
3. Tap to select the transducer type used with the system.
4. Tap the boxes for the transducers to calibrate and tap Next to
continue.
Note: Scroll the screen to see the other checkboxes (P4, P5)
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CALIBRATE EMG
1. Tap the Calibration icon on the home screen.
2. Select the RDX device.
3. Tap to select Electromyography Calibration.
4. Tap to select EMGR1 transducer and tap Next to continue.
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5. Short the EMG leads. The green progress bar moves when
moving the leads.
6. Tap Next.
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4. Tap the empty box and type a calibration name. For example,
Saline8f. This name is required for proper pump setup as outlined
on page 101.
5. Tap Next to continue.
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8. Select a Urocap device from the listing and then tap Next to
continue.
11. Select the fluid density from the combo box and then tap Next to
continue.
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Note: the number should be in the format: NAXX-1YYYYYYYY where: XX = the system model type of LT
or CT or XT; and YYYYYYYY = all numerical digits. In
the example above, the serial number entered is
NALT-1-12345678.
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4. Tap Set.
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8. In the Add a device window, click Add device to begin searching for the NGM system. The NGM system name will
appear as XX-NAXX-YYYYYYYY where: XX = the system model type LT, CT, or XT; and YYYYYYYY = all numerical digits.
In the following example, the system chosen is LT-NALT-1-12345678.
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b. If it is the CT or XT system then a passkey will need to be manually generated. Click Create a pairing code for
me to continue.
Once the passkey is generated, enter that pass key in the field on the central hub screen.
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NOTE: For LT systems, ensure the code on the central hub and the computer are the same; only then continue by selecting Yes.
Then click Next to continue.
After clicking Next, the following window may appear. Close the window by clicking the X in the top-right corner. Do not make
any setting changes under this window.
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10. When the following window appears to confirm that the Bluetooth pairing between the NGM system and the PC
(Desktop/Laptop) is complete, click Close.
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Bluetooth Error:
This occurs when the Central Hub attempts to
connect to the device module via Bluetooth but
fails. The device may be out of range or the
battery has been depleted.
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USB Error:
This occurs when the Central Hub attempts to
connect to the device module via USB but fails.
The device`s USB cable may not be plugged-in.
Communication Error:
This occurs when the Central Hub successfully
connects via Bluetooth or USB but fails to
communicate (Bond) with the firmware on the
device module. Try resetting the power on the
device module.
Device Hibernation:
This occurs when the Central hub puts the device
module into Sleep mode. This is usually after 2
hours of inactivity. After 5 minutes, the LCD turns
off.
If the UDS software is running, it will put the
device to sleep.
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Battery LOW:
This occurs when the device battery is very low.
Recharge the battery.
Battery SUSP:
This occurs when the battery reaches a
temperature above 45C (113F) or the power
supply is not properly connected to the central
hub.
Disconnect the RoamDx from the power supply
and then connect it back again. If the message
still appears, contact LABORIE technical support.
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The Pretest screen allows for a check of proper catheter placement and to verify pressure response before the start of a test.
Data is not recorded while this screen is running.
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Click the Summ. Review button at any time to view the summary results of the test at that stage.
Click Return to Test to go back to the test screen.
Click the Main Menu button to return to the main welcome screen.
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NOTE: zoom values are always set as 2X, 3X, 4X, etc which corresponds to 2X=200%, 3X=300%, 4X=400% etc
4. Click OK.
5. Press and hold the left mouse button and drag the cursor to highlight the particular area on the UDS graph to zoom.
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FILE MENU
FILE is the first menu located on the menu bar at the top of the screen.
OPEN
The Open feature on the File menu opens patient tests that have already been created.
Before opening a saved data file, be sure that any currently running patient tests are saved. Once the file is saved, opening a
saved file automatically closes the old one.
To open a saved file:
1. Click File from the menu bar.
2. Select Open.
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Click the Show Scheduled Tests for this Computer option to see the tests entered in the i-LIST database for the local
computer.
Click the Show Scheduled Tests for all Computers option to see ALL tests entered in the i-LIST database for the assigned
computers.
Select any test from the list and select OK to continue.
You will see the patient information screen as well as any other pertinent information.
SAVE AS
The Save As feature is used to:
When choosing a new file name, keep the following points in mind:
It is important that a system for filing be established so that test data may be recognized and retrieved
easily.
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6. Select the type of file you would like to save from the Save As Type list.
7. Click Save.
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Number
Description
Print Output
(1) Preferences
Uroflow Report
PNTML Summary
Tetra NIRS Summary
Printout of PNTML (EVOX) tests. See the PNTML (EVOX) operating manual for
more information.
Not available with AQUARIUS UDS software.
UDS Report
Graph Pages
Report Pages
Report pages.
Address-o-graph
Physical Exam.
Standard Report
Voiding Summary
UPP Summary
Event Summary
CHESS
(2)
(3)
ARM
URA
WF
LinPURR
Diagnosis
Compliance
History
Pressure
Profile ARM Pressure Summary as part of the report pages (ARM option).
Summary
Stationary Summary
ARM Stationary Summary as part of the report pages (ARM option).
Pressure
Variation ARM Pressure Variation Summary tables as part of the report pages (ARM
Summary
option).
Squeezing Summary
ARM Squeezing Summary table as part of the report pages (ARM option).
Rectal Volume Summary ARM Rectal Volume Summary as part of the report pages (ARM option).
(4)
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RAIR Summary
Expulsion Summary
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Number
Description
Print Output
Eberhard
UPP Static and Stress curves and summary information as part of report
pages.
Pediatric Nomograms This option is only available if the patient is between 3 16 years of age.
(optional)
Both the Voiding Summary screen and the Pediatric Nomogram option must
also have been opened to enable this feature.
Liverpool Nomogram
Optional feature for Uroflow procedures.
(optional)
Siroky
(optional)
(5)
Print Border
This feature will frame the graph with a simple line border.
(6)
Number of Copies
(7) Grids
Fine
Coarse
None
No grid squares.
Default
UPP Sections
Apply
Click this button to set up a default configuration when printing each test.
1-Page Graph
Standard
Min/page
Selectable number of minutes per graph page. Use the scroll bar to adjust the
desired number of minutes per page view.
Manually select up to 8 segments or sections of the graph to be printed as
opposed to printing out the entire graph.
Graph Displays a sample of the graph printout.
(11)
Segments
(12)
Preview
Segments
Font
The Font button can change the look of some of the items on the printed
report. Once the Font button is clicked, double-click the name of the feature
that will have a font change. Select the size and style and click OK to confirm
the changes.
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*The URA may be difficult for first time AQUARIUS users to interpret. The URA must be viewed on the screen before printing.
Once the curve is viewed, the options in the dialog box become available.
BATCH PRINT
Batch Printing allows you to print multiple procedures together (for example, during a particular day or at different time
periods).
To access Batch Print for tests performed on the same day:
1. Click File from the menu bar and select Batch Print.
Result: The Batch Print window appears.
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To cancel printing a file after it has been selected in the Print Files box:
1. Click on the file from the Print Files box.
2. Click Remove.
Result: The file name disappears from the Print Files box and reappears in the File List box.
NOTE: The Re-Index option is only needed when an Index file is corrupt (A corrupt file means that the file is
damaged. If the file is corrupt, a message box will tell you to use the Re-Index option). This option generates the
index file that contains the patients name, comments, file date, and the procedure date for quick look up. The Index file
can be re-generated by re-indexing.
PRINT SETUP
1. Click on File from the menu bar.
2. Select Print Setup.
Result: The Print Setup dialog box appears.
To change the.... Then...
Printer: Select the appropriate printer in the printer name
combo box.
Paper size: Click in the Paper size field.
Select the appropriate paper size.
Paper source: Click in the source field.
Select the appropriate paper source.
Orientation of the printout so Click Portrait.
that it is viewed vertically:
3. Click OK.
The changes to the Printer setup will be applied to the printing process of the test.
Properties: To change the options, please refer to the printer users manual.
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You can also create a fax cover sheet that can be sent to the Support department for inquiries into any problems you may be
experiencing with the equipment or software.
To access About UDS Client information:
1. Click File from the menu bar.
2. Select About UDS Client.
This window provides the phone number and e-mail address to LABORIE Technical Support.
Update
The Update button is to be used by the LABORIE Technical Support team.
Fax Cover
Click the Fax Cover button to open the Fax Cover sheet window.
In this window you can fill in the areas with all the information that will help LABORIEs Support team identify the problem and
provide a solution. Once you have filled in the information, click the Print button to print the cover sheet. Once it is printed, fax
the sheet(s) to LABORIE Support with the fax number provided.
IMPORT ASC
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This allows for the importing and opening of test data saved in ASCII format.
IMPORT ICS
This allows for the importing and opening of test data saved in ICS format.
EXIT
The Exit feature closes the UDS software.
EDIT MENU
The EDIT menu is used to mark and copy an image of the screen that will be pasted into another Windows application for
reports or presentations.
UNDO
The undo feature clears the selected (marked) image block. This menu item is only enabled if an image block has been selected.
To unmark a marked portion of a test:
After selecting an image block, click Undo from the Edit menu.
Result: The marked selection is unmarked.
COPY
Once an image block has been marked, it may be copied onto the clipboard for pasting into another Windows application.
The clipboard is a temporary storage area that holds all marked items for the purpose of transferring data from one application
to another in Windows. These marked items are not displayed on the screen.
To copy a test:
1. Mark the image block to be copied.
2. Click Edit from the menu bar.
3. Select Copy.
Result: The marked image block is copied into the clipboard until it is pasted into another application or deselected
by using the Undo command.
4. Paste the marked image block into a document in Word, PowerPoint, and Notepad and so on.
MARK BLOCK
The Mark Block feature marks an image block (for example, a graph or graph segment) so that it can be copied and pasted into
another application which supports Windows image pasting (for example: Microsoft Word, PowerPoint). This feature can also be
used in the workstation mode.
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NOTE: The Mark Block feature is not available when a test is running. Stop the test to enable this feature.
To mark an image block:
1. Open a saved test or stop the procedure if it is running.
2. Click Edit from the menu bar and select Mark Block.
Result: The cursor changes to a "+" symbol.
3. Drag the + cursor from the top left corner of the area to be marked to the bottom right corner.
Result: This area is highlighted and is ready to be copied.
Refer to the Copy section for instructions on how to copy the marked area.
To unmark a copy, refer to Undo.
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3. Highlight an area of the zoomed graph again and select Zoom Selected Area to continue zooming in if necessary,
or
click Edit > Zoom Back to return to the original graph.
NOTE: A Zoom button can be created for one-click zoom-in to a preferred magnification level. See page 76 for more information.
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CONFIG MENU
Clicking the CONFIG menu title lists the following menu items:
OPEN
The Open feature in the Config menu is similar to the task of pressing a Control Panel procedure button to load a test
configuration file and start a procedure.
To open a configuration using the open feature:
SAVE AS
The Save As feature under the Config menu is used to save or redefine a configuration.
Remember, a new file name should not include any punctuation marks.
It is important that a system for filing be established so that test data may be recognized and retrieved easily. For example: A file
may be named Uroflow.CFG for Uroflow studies or CMG.CFG for Cystometry.
To save a configuration with a different file name:
NOTE: All of the test configuration files are automatically stored in the C:\CFG folder.
2.
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Result: The file extension ".CFG" stands for "configuration" and is automatically added to the configuration filename.
3. Click Save.
Result: The file is saved with the new name.
SET UP/MODIFY
The Set up/Modify menu items allow you to:
Connect devices to a test configuration file
Change data rate
Change channel order
Change channel title, scale, and units
Change test name
Add channels
And more.
NOTE: Depending on the software configuration for the system, some or all of the tabs will be visible.
For access to Configuration:
1. Click Config from the menu bar and select Set up/Modify.
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NOTE: If you would like to resize the columns or rows in the Configuration window so that you can easily read any information
in the boxes, place the pointer on the shaded areas along the top or left side of the window. Move the pointer over the lines
between the columns or rows until it changes to a double-ended arrow. Once it is a double-ended arrow, drag the arrow across
to resize the columns, or up and down to resize the rows, until you get the right size for the particular column or row. You will
need to perform this function each time you open the Configuration window, as this setting is not saved.
Devices
Depending on the system, when a new test file is configured the devices
belonging to the system will need to be linked with the new test file to
ensure proper data recording.
Select the device from the listings for the RoamDX and the Urocap devices.
NOTE 1: this must be set up first before any other settings are configured in
this screen.
NOTE 2: If at any time devices are removed or added to the system, the
configuration tab needs to be updated with the newly added or removed
device.
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Channel Title
The channel title may be changed for easy identification purposes by
entering a new name in the Channel Title field of the Configuration
dialog box.
For example, if the default name "flow" is too vague, it may be
replaced with "Uroflow."
To change the channel title:
1. Click in the Channel Title field box. Result: The channel
title is highlighted.
2. Type a new channel title using the keyboard.
3. Click OK. Result: The new channel title is saved and
displayed on the graph.
Scale-Min/Max
The Scale range of a test curve can be specified.
To change the Maximum and Minimum scale:
1. Click on the Scale (Min) or Scale (Max) box of a channel.
2. Type the desired value for the Min and the Max using the keyboard. Result: The change in scale range is displayed
on the graph.
NOTE: If the full-scale value entered is a lower number than the recorded peak value, the peak of the curve is clipped off or
extended into the curve above it, depending on the graph clipping setting. For additional information on graph clipping, refer
to page 188.
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Units
The default units for each channel can be changed.
To change the scale units:
1. Click the Units box of a channel.
2. Click the down arrow beside the Units combo box.
3. Select the desired unit. Result: The unit change is displayed on
the graph channel.
Math Def.
Math Channels can be used to perform arithmetic operations between
one or more channels. The math channels support basic arithmetic
operations (for example addition, subtraction, multiplication, and
division) and the parenthesis operator ().
For instance:
If you have the pressure channel labeled Pves calibrated in cmH2O and you
wish to display the pressure in mmHg. Knowing 1mmHg = 1.36cmH2O, you
can type the following in the Math Definition for the Math1 channel and
change the units of Math1 channel to mmHg.
Pves / 1.36
Note that the channel label used in the math definition must match exactly
with the title of the channel you want to use. In addition, you can combine
the operators to make complex expressions like:
((Pves+100) - Pabd) / 1.36
To create a math channel:
1. Select Config and then select Set up/Modify.
2. Select a new channel.
3. Select the Curve Index number.
4. Select Math 1 under the Channel Name column.
5. Type the name of the math channel under the Channel Title column.
6. Select the Units.
7. Type the Math Def.
8. Verify the Data Rate as desired.
9. Select Display Curve under the Display Attributes column to show
the curve on the screen.
10. Click Apply.
11. Click OK to close the window.
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Data Rate
The Data Rate is the number of data points collected and stored per second during the recording process.
Variable High-Rate Sampling mode II: date rate 10 to 3000 Limitation: Multiple of 10
Variable High-Rate Sampling mode III: data rate 10 to 5000 Limitation: Multiple of 10
A higher data rate means the recorded curve has more data points, and therefore is more precise. However, higher data rate
uses more memory storage. As a result, the maximum duration for the test is reduced.
To edit the text box containing the data rate:
1. Click in the Data Rate box corresponding to the specific channel. Result: A Data Rate box will appear with a listing
of data rates.
2. Select the desired value from the list. Result: The new data rate is displayed on the graph.
3. Repeat for other channels (High Rate Sampling mode only).
Display Options
Display Attribute: Select to display the channel data as a curve on the
graph or in the digital window.
Curve Appearance: This feature allows you to customize the channel
color. Both the channel curve color and the channel information will
be displayed (and printed on a color printer) in the new color.
Display Line Width: This feature allows you to make the channel
curve thicker (in pixels) on the display. Click the box under the Display
Line Width column of the test channel and type the desired display
line width in pixels.
Print Line Width: This feature allows you to make the channel curve
thicker (in pixels) on the print out only. Click the box under the Print
Line Width column of the test channel and Type the desired print line
width in pixels.
Symmetry: This feature allows you to mirror a channels curve to
make a negative mirrored curve. Click the box under the Symmetry
column for the test channel and select Mirrored or Simple.
Interior: This feature allows you to fill the area under the curve with
the channel color.
Use Filter
This feature allows you to select curve filter options. You can select to not use a Filter, use a Standard Filter, use a 2 Second
Filter, or use a RealTime 2 Second Filter. The 2 Second Filter and the RealTime 2 Second Filter options can be applied to any
pressure channel and removes any positive and negative spikes on the test curve.
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Display Original
This option allows you to display the original graph also if you have selected to apply a filter to the graph.
Printable
This option allows you to see the graph on the printout of test results.
i-LIST Channel
(for i-LIST Office Reporter users only)
Select the channels that will have its data appear on the i-LIST reports.
EMG Slider
If you have selected a test that contains EMG, the resulting EMG
channel on screen will have a slider next to it.
Instead of manually adjusting the values, this allows you to adjust the Max
and Min scale values of the EMG channel using the slider. The slider control
range is from (-10V+10 V) to (-1000 V...+1000 V).
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UPP TAB
Under this tab you can set the UPP Puller speed or you can calculate the UPP Distance Summary based on the distance a
catheter is pulled with an attached sensor.
NOTE: Make sure to first select the UPP test button on the Control Panel before setting up this feature.
1. Connect the Distance Sensor/Catheter to Ch1.
NOTE: Make sure the Sensor has been calibrated first.
2. Select the Distance Sensor Channel option.
3. Select Ch1 from the listing.
4. Click OK.
5. Run a UPP test and press the Stop button to stop the test.
6. Click Info > UPP Summary to open the UPP Summary screen.
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7.
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NOTE: The preview button is only available when you are using the UPP Distance Summary option.
8. Click OK to close the screen.
9. You can print the results by clicking File > Print Study and selecting the UPP Summary option. (example printout shown
here)
If you would like to go back to using the UPP Puller speed, click the Configure button and select the UPP Puller Speed option.
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PUMP TAB
Under this tab, you can set the parameters for the pump such as fluid density and auto pump actions. Select the pump to use
during a test and configure its settings.
Feature
Function
When selected, the VH2O values are automatically calculated by the software based on the IH2O.
Volume Channel
Pressure Channel
Specifies the channel used for pressure feedback. NOTE: this channel must not contain a math
channel.
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Pressure Limit
Stops the pump if the pressure channel exceeds this limit. CAUTION: Do not exceed 150 cm H20
Volume Limit
Displays a warning message when the infused volume reaches the specified limit.
When the value entered is greater than zero the UDS software will display the following warning
message without stopping the pump: Infusion bag is nearing empty! when the infusion
transducer registers the value equal or less than the value entered inside the Infusion Bag Warning
Limit box but greater than the threshold value for the Infusion Bag is empty. By default the threshold
value is 5 ml.
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This option starts the pump at the selected pump speed when the test starts. Choose Stop if you do
not want to use this option.
This option records events automatically when the pump runs or stops. This option is enabled by
default. Deselect the box to disable the feature.
Select the appropriate calibration line from the dropdown list. The name contains all the information
given during pump calibration on the central hub.
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Bubble Detector
The bubble detector helps monitor the presence of any air
bubbles in the pump tubing. If a bubble is detected in the tubing
(when the selected Bubble Channels value is detected by the
sensor to be lower than the Bubble Channel Limit specified in this
section) the software will display a warning message asking if the
pump should be stopped.
If a bubble is detected during infusion, prime the tubing, reset,
and try again.
To set the bubble detector:
1. Click Config > Set up/Modify and then click the Pump
tab in the Configuration window.
2. In the Bubble Detector section, select the Always on
option to enable the bubble detector, set the channel that will be
sensing the change in pressure, and set the value for the Bubble
Channel Limit.
3. Click Apply and then click OK.
When a bubble is detected, the resulting screens will appear depending upon the settings configured in this tab.
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FILTER TAB
Under this tab, you can set the filter frequency. Lowest value available is 0.5 Hz. (anything lower will not yield significant results).
UROFLOW TAB
Under this tab, you can set the parameters for Uroflow such as auto Voiding Summary and auto printing. See page 135 for
more information.
ARM TAB
Under this tab you can set the channels that correspond to the ARM measurements. You can have either a four-channel ARM
test or an eight-channel ARM test. For more information on setting up and performing ARM tests, please refer to the ARM
Owners Manual. NOTE: select the Enable Reverse Pump option to activate the reverse pump button on the control panel.
SECURITY TAB
Under this tab you can set the security features to protect, or encrypt, a patients name and information such as Medical Record
Number, History, Diagnosis, Doctors name, Clinic name, and Comments. Once encryption is set, only the software key that is
associated to the patient file can see the decrypted information.
NOTE: This security feature needs to be set before you start running a test, and make sure that a software key is installed in
your PC.
To encrypt patient information:
1. Click Config > Setup/Modify.
2. Click the Security tab.
3. Make sure that the Enable Encryption of Patient Information box is selected.
4. Click the Add button to add your software keys serial number to the secure list.
5. Click Apply to save your selections.
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Events that are not in the I-LIST Events Linking may not appear in some of the printed reports.
Try the following to check if an event is available in the Event Summary:
1. In the software click Config > Set up/Modify.
2. Click the I-LIST Events Linking tab.
i-LIST Office Reporter will display only the events that appear in the list under this tab. Also, the Annotation Alias needs to
exactly match what you mark on the UDS test in order to appear in the Event Summary.
If you need to add an event, or if you are using the software with a language other than English, then you will need to add or
translate the Event name in the Annotation Alias listing on the left-hand side. Click on the event name once, then click on the
name again, and then type in the word as needed. For example, the event Strong Cough is added to the list. If we then click the
Event button on the control panel, the newly added event will appear in the Event Annotation box.
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Click Graph Segments to customize the width, height and minutes per page for reports. Select Channels to specify the channels
to appear on the graph segment.
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COMPLIANCE TAB
The Bladder Compliance feature can be configured by manually selecting the segment(s) or automatically calculate compliance.
To open the compliance calculation window, select the Compliance tab under Setup/Modify OR click the Configure button in the
Compliance Measurement Range window (see page 148).
NOTE: By default the change in volume is calculated from the VH20 channel and the change in pressure from the Pdet
channel.
2. Select the Compliance Method.
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Manual manually select the segments. Close the Compliance tab window. Click Info in the top menu bar and select
Bladder Compliance to manually select the segments. Auto compliance features are not available when Manual is
selected.
Auto: Events select the events for the auto compliance calculation.
Auto: Infusion/100mL Infusion volumes of 100mL are used as the auto compliance calculation reference points.
3. Select the Auto Compliance Calculation Method.
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INFO MENU
INFO is the next menu located on the menu bar at the top of the screen.
PATIENT INFORMATION
The details of a patients file are easily added to and accessed through the Patient Information dialog box.
IMPORTANT! When entering information into the Patient Information dialog box, remember that:
The patients date of birth must be entered as month/day/year/, with one or two digits for the month or day and four
digits for the year. For example: A patient born on September 8, 1972 would be entered as 09/08/1972 or 9/8/1972.
Once the date of birth field is filled, the Age field is automatically calculated. Pediatric patients (patients 16 years of age
and younger) require additional setup. See page 247 for more information.
NOTE: The age is calculated from the date of birth to the date of the procedure.
LABORIE
The patients gender must be correctly selected to have the appropriate statistical deviation appear in the Voiding
Summary.
The Patient Name field must be complete for the appropriate statistical deviation to print. Enter blank spaces into
the Patient Name field if you do not want to enter a name.
The MR# (medical record number) box keeps track of the patients medical records, especially when names appear
more than once.
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You can add more than one doctors name to the Doctor listing. Type in a name and click the Add Doctor button. To
remove names, click the Clear List button.
If there is a change in any patient information in this window, you will need to save the CFG and/or DTA file again to
confirm any changes.
Patient names (first and last) can only be up to 44 characters in length.
Medical record numbers cannot contain a back slash (\) or a forward slash (/).
HISTORY
A brief patient history can be saved with the study. The information in the History box is easily retrievable for future reference.
1. Click Info from the menu bar and select History.
Result: The History window appears.
2. Enter helpful information about the patient.
3. Click OK.
Result: The information is saved.
TIP:
The History feature can
also be accessed from
the Patient Information
dialog box.
DIAGNOSIS
The diagnosis feature consists of notes made about a patient's condition after the test has been performed. It can be saved with
the test, and the information in the Diagnosis box is easily retrievable for future reference.
1. Click Info from the menu bar and select Diagnosis.
Result: The Diagnosis box appears.
1. Enter information about the patient using the keyboard.
2. Click OK to exit.
Result: The information is saved when the file is saved.
TIP:
X-Y PLOT
The X-Y Plot can be used to calculate the urethral resistance factor (URA), the bladder work function (WF), the Linear Passive
Urethral Resistance (LinPURR) graph, and CHESS functionality.
The formulas used to determine ICS Nomogram (URA) and WF are authorized for use by Dr. Derek Griffithsi and are located in
the appendix of the article.
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The URA Curve is a curve calculation based on the mathematical model of the equation. Please refer to the article by Dr. Derek
Griffiths for more information.
Mathematical equations used for calculating the URA are listed here:
URA index:
URA=
The URA
Pdet* =
at Maximum flow
Where:
d = 3.8 x 10
Q = maximum flow
Pdet = Detrusor pressure
Pdet* = Detrusor pressure at maximum flow
In the URA plot figure, the solid curve is Flow vs. Pdet and the dotted curve is URA.
To cancel the URA option select Exit! in the URA Plot window.
To display the URA Curve select URA.
URA Curve
Pressure/Flow Curve
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4. Click Confirm.
5. Click OK.
By default, the complete test is plotted on the graph and the scale is determined by the scale of the channels. This information is
configured in the X-Y Plot options window.
To change a channel name, threshold, or scale:
1. Click Options! from the URA plot window.
2. Double-click in the text box of the name, threshold, or scale to be changed.
3. Type the appropriate modification.
4. Repeat steps 2 and 3 until all parameter changes are complete.
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5. Click OK to exit.
LinPURR
The LinPURR graphii is based on the work by Dr. Werner Schfer. The LinPURR (Linear Passive Urethral Resistance) feature is
available after a Micturition (pressure-flow) test has been run. A LinPURR graph determines urethral resistance by comparing
flow and pressure.
To access the LinPURR Graph:
1. Select the Info menu and select X-Y Plot.
2. Select LinPURR.
Result: The LinPURR graph is displayed.
To cancel the LinPURR Option:
1. Select Exit! in the LinPURR window.
A complementary analysis of pressure/flow data can be made using Dr. Schfers techniques combined with Abrams/Griffiths.
This representation is also in an X-Y format; however, the Flow and Pdet channels are plotted on the Y-axis and X-axis
respectively.
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2. Refer to the following table to change the Channel parameters or the Graph Range:
To...
Then...
Activate/Deactivate the Display Click the check box beside the appropriate option.
Options*:
Color of Display:
* These Options are regions of discrimination to assist the clinician in categorizing the pressure/flow event.
The following list explains these regions:
Pressure Flow Curve: This curve plots Uroflow and Pdet. It is similar to a URA curve, but LinPURR plots the pressure
channel on a horizontal axis and the flow channel on a vertical axis.
URA Curve: Please refer to page 112.
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URA Region Border: These lines on the graph divide the obstructed, unobstructed, and equivocal regions.
Detrusor Contractility: Detrusor Contractility is displayed as six regions marked in a left-diagonal fashion by the
following labels: VW, W-, W+, N-, N+, and S. The software looks at the dataset to determine the relative strength of the
bladder using Pdet and Flow as factors.
Normalized Detrusor Contractility: Normalized Detrusor Contractility represents the pressure at which the minimum
"normal" bladder performance has been achieved on the Detrusor Contractility Scale. If this value is 0, then a minimum
pressure has not been achieved.
OBI Pressure: This pressure represents the point at (50% of Qmax+2.4ml/s.)
LinPURR Grade: To perform a LinPURR Grade, use the following 2 above data points:
o Pdet at max. Flow
o Pdet at min. flow
The LinPURR plot can show a rough estimate of the relative grade (0 to VI.)
The digital parameters for LinPURR can be viewed from the LinPURR Summary box.
To access the LinPURR Summary Box:
1. Click Summary from the LinPURR window.
2. Refer to the following table to change the information in the LinPURR Summary Box:
To...
Then...
Change any channel or pressure Double-click the text box to be changed and type the new
values in the boxes:
information using the keyboard.
Change the LinPURR Grade or Select the appropriate option.
Detrusor Contractility:
Save the information for Click Save Diagnosis.
printing:
Result: The numerical results of the LinPURR calculation appear in
the Info-Diagnosis section of the software.
Select the Exit! button in the LinPURR plot window to close the LinPURR Plot Window.
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Result: The WF plot is displayed and the complete test is plotted on the screen. The parameters can be changed in
the WF Configuration window.
To change the Default Settings of the WF Plot using the WF Configuration Window:
1. Click Options from the WF window.
2. Change the range by using the Change button, if applicable.
3. Type any other changes using the keyboard.
4. Click OK.
NOTE:
By default, the Inflow Channel is
the infused volume (VH2O) and
the Outflow Channel is the
voided volume (Volume).
Usually the volumes are equal in value; however, if a patient has a residual volume of urine in the bladder, the volumes will not
be the same.
Residual volume: The difference between the inflow and the outflow. It is automatically calculated and is displayed in the
Residual Volume text box.
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WF=
(units: W/mm2)
Q Vol Vt
3
vdet =
2 4.188790205
Where:
2
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6. Click File > Print Study. NOTE: Ensure that the URA and CHESS items are checked.
7. Click OK to print test.
Siroky Nomogram
The Siroky Nomogram was developed to provide an accurate and reliable indication of outflow obstruction.v The UDS software
provided by LABORIE will help you compare the results of a patients pre-therapy and post-therapy Uroflow test.
To view the Siroky Nomogram:
1. Start the UDS software and click File > Open to open a saved Uroflow test.
2. Click Info > X-Y Plot > Siroky Nomogram.
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Once you select the Siroky Nomogram option, a window opens that contains the graphical representation of the Average and
Maximum flow rates as developed by Siroky et al.
NOTE: The Siroky Nomogram is valid for male adult patients only.
From here you can compare the average and maximum flow rates for the specific test. The plotted circles on the graph
represent where the patient lies on the curve.
Once you have viewed the graph, click the X in the upper-right corner to exit and return to the UDS graph window.
Liverpool Nomogram
The Liverpool Nomogram was developed to provide an accurate and reliable indication of normal Uroflow rates.vi You can
compare a patients pre-therapy and post-therapy urinary flow rate with LABORIEs software and the built-in Liverpool
Nomograms.
To view the Liverpool Nomogram:
1. Start the UDS software and click File > Open to open a saved Uroflow test.
2. Click Info > X-Y Plot > Liverpool Nomogram.
Once you select the Liverpool Nomogram option, a window opens that contains the graphical representation of the Average and
Maximum flow rates as developed by Siroky et al.
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NOTE: The Liverpool Nomogram is valid for male and female adult patients only. Depending on the sex of the patient, the
resulting Nomogram window will appear for either the male or female averages.
From here you can compare the average and
maximum flow rates for the specific test. The plotted
circles on the graph represent where the patient lies
on the curve.
Once you have viewed the graph, click the X in the
upper-right corner to exit and return to the UDS
graph window.
EVENT SUMMARY
You can add events throughout the test to record what occurs during the procedure. Events are automatically stored and displayed when you
register the markings. The summary of these events is available for reviewing at a later time. You can add events by using the Control Panel
event buttons or right-mouse click on the graph window when you want to add the event. An event marker will be shown on the Graph
window. Refer to the following table for different event markers:
To see
Events
Set Zeroes
Peaks
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Look for
V
Z
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2. Enter the text in the text box using the keyboard or pick from the list.
3. Click OK.
Result: The Event Annotation box closes.
TIP: Remember to always save the CFG file in order to keep the event annotation changes with the files.
Deleting Events from the Event Summary
1. Highlight the event. (To highlight multiple events, hold down the Ctrl key while clicking on the events.)
2. Click Delete!
Result: The Confirm Event Delete message box is displayed.
3. Click OK.
Result: The event(s) is deleted from the Event Summary.
Deleting or renaming events Quick Method
To delete or rename an event on a graph, right-click on an event located on the graph and select an option from the resulting
menu.
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If you would like to know the Maximum Filling Detrusor Pressure (Max Pdet) between the
start of a test and the moment the patient voids, you can mark this specific event on the
graph. Add the Permission to Void item to the event list and mark the event while testing.
With the Permission to Void event marker, the filling phase and the voiding phase segments
will be printed out on the report when you select to print the study.
NOTE: If a Permission to Void event is added after the end of a Uroflow segment (each stop is
automatically marked as Ur on the graph to signal the end of a segment), a message will
appear asking for confirmation to remove the previous Uroflow segment.
Click Yes to remove the marker or click No to keep the marker in the same spot.
Move to Event
Once you are in the Event Summary window double-click on an event to move to the point on
the graph that corresponds to that particular event.
TIP: Remember to always save the DTA file in order to keep the event annotation changes
with the files.
Stress Events
The Stress Test and Stress Leak event buttons provide precise LPP (Leak Point Pressure) calculations.
Remember to attach the leak point detector to the catheter that will be measuring the pressure before starting the
test.
Click the Start Stress Test button to start or stop the stress test calculation segment.
Click the Stress Leak button to manually add a stress leak during the stress test detection phase.
A Calculated LPP event is added to the graph when the stress test is stopped. This calculation is the change in Pves
pressure from baseline (as found at Start Stress Test) to the point of leakage.
When a test is stopped a message box appears with options to select and help differentiate between a cough leak
and a valsalva leak.
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If No is selected then a peak with No Leak event is added at the peak pressure value within the Stress Test
segment.
If Yes is selected then a Calculated LPP event is also automatically added at the peak pressure value within the Stress
Test segment along with the Stress Leak event.
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NOTE: Stress events can also be recorded without a Stress Test event. Just program the buttons on the control panel as
follows and click the buttons during a test when the event needs to be recorded.
TRSS Events
TRSS (Tone, Reflex, Sensation, and Structure) events can be added to tests that are stopped or saved.
1. Right-click the graph on the spot where you would like to add a TRSS event and select Insert TRSS Event.
2. Select the TRSS #.
3. Select the region to add the TRSS event by left-clicking the mouse button and dragging the cursor across to select the
segment for TRSS calculation. Release the mouse button when area is selected.
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The TRSS Start and TRSS Stop events are added to the graph and the TRSS Event values are visible in the Event
Summary window.
Opening Time refers to the time between the initial rise in bladder pressure (Rise Pdet) and Uroflow start.
The mathematical definition for this is:
Opening Time = Time at Flow Start Time at Pdet rise
o The Rise Pdet event is automatically placed between the Permission To Void and Uroflow Start events.
o The event is placed on the Pdet channel. Remember to verify the position of the event on the graph. It can be
moved to another area of the graph if necessary.
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Once the event is added to the graph, it automatically activates the calculations associated with the event and the results are
visible in the reports.
In the report, the Fillingphase Results section will display the following information:
Maximal Cystometric capacity (in ml): the value from VH2O at Permission to Void
Incontinence during filling (in ml): the value of the Volume Channel at Permission to Void
Bladder filling (Maximal cystometric capacity Incontinence during filling) (in ml): value from Bladder Volume math
channel or equivalent calculation in report.
Note that the physiological opening time may be approximately one second shorter than what is displayed.
Event Line Coloring
To highlight an event placed on the graph, add a colored line to make it easily visible.
1. Open a test file if not already open.
2. Click Options > Event Summary to open the Event Summary window.
3. Click to select an event from the list, for example select the First Sensation event.
The selected event is automatically highlighted on the graph.
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131
7. Click the color box of the new color, for example change from blue to orange, and click OK.
Result: the events line marking will change to the newly selected color.
VOIDING SUMMARY
The Voiding Summary menu item applies only to tests involving Uroflow information like the Uroflowmetry and pressure-flow procedures.
The Summary compares a patients test results with normal values. Statistical deviations are calculated using these standards and are
intended strictly for comparison purposes and should not be used solely for diagnostic purposes.
IMPORTANT! Since this comparison is based on patient gender, the gender must be correctly entered in the Patient
Information dialog box.
1. Click Info from the menu bar and select Voiding Summary.
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Then click
OK.
Options.
Result: The Uroflow Options box appears.
IMPORTANT! The software calculates the summary results only if the minimum voided volume is 55 ml.
Mean Flow:
Flow Time:
These percent values are found in the patient statistics of the Voiding Summary printout. The M% represents the male values
and the F% represents the female values.
134
Uroflow Options
From the Uroflow Options box you can:
Customize how the summary is calculated.
Make changes to the channels and configuration parameters.
To change Parameters:
1. Click Options located in the Voiding Summary box.
Result: The Uroflow Options dialog box appears.
2. Refer to the following diagram and its legend to change any parameters in the Uroflow Options dialog box.
(1)
(3)
(2)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
Number
(1)
(2)
(3)
(4)
(5)
(6)
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Description
Default channels: Flow, Volume, and Pressure.
Range: Default range is from start to end of test.
Threshold: The minimum flow rate value used in calculating the Voiding Summary. Anything below this
threshold is considered noise or insignificant flow.
Enable Artifact Recognition: Select check box to enable.
Artifact Recognition Threshold: Indicates the maximum acceptable change in Flow (acceleration) that is
physiologically possible.
OEM Uroflow Transducer: Original Equipment Manufacturer (for optional non-LABORIE Uroflow
transducers).
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135
Number
(7)
(8)
(9)
(10)
(11)
(12)
(13)
Description
Auto Event Marking: Automatically adds events to graph.
Auto Recording: With Auto Recording on, tests are automatically started and stopped once the
transducer senses fluid in the beaker.
Auto Voiding Summary: A Uroflow auto recording option to display Voiding Summary after a test is
finished. Auto recording must be enabled for this to work.
Auto Patient Info Prompting: A Uroflow auto recording option to display the Patient Info window when a
test is stopped.
Auto Filing: An auto recording option to save a file when a test is stopped.
Auto Printing: An auto recording option to print a file when a test is stopped.
Auto Display Print Option: An auto printing option to display print option before auto printing
To change a Channel:
1. Click the Channel box beside the channel to be changed.
Result: A channel list appears.
2. Select the appropriate channel name.
Result: The selected channel name appears in the channel field.
NOTE: Normally the default settings for threshold are not changed for performing Uroflowmetry on patients. Consult with your
LABORIE representative for modifications to default settings.
The calculating channels may be replaced with other channels as long as the units are consistent in definition.
Example: Flow may be replaced with another math channel depicting corrected flow rate.
To change the Time Range:
1. Click Change.
Result: The Uroflow Options segment selection window appears.
2. Click and drag mouse pointer across the graph window from the start to the end of the Uroflow segment.
Result: A bold black line runs across the top of the box indicating the selection.
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Click
Confirm
Cancel
To
Then click
OK
Cancel
Result: The Uroflow Options window closes and returns to the Voiding Summary window.
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Always
On/Selectable
Always On
Description
Auto Start
Always On
Auto Stop
Auto Patient Info
Prompting
Auto Calculation
Auto
Voiding
Summary
Auto Filing
Auto Printing
Auto Display Print
Option
Auto Set up next test
Always On
Selectable
Always On
Selectable
Always On
Selectable
Automatically saves the test in the form YYMMDDxx.QTA
Selectable
Automatically selects the test for printing.
Selectable if Auto Automatically
displays
the
Print
Option
dialog
Printing on
confirmation/customization.
Always On
Automatically sets up the next test.
box
for
138
You can change the font by using the Font menu items.
You can change the scales by using the Options menu items.
You can close the Pediatric Nomogram window by clicking Exit!
UPP SUMMARY
The UPP (Urethral Pressure Profile) test is one of the most effective methods for analyzing and determining a patients urethral
length and resistance. Once the urethral pressure and the vesicle pressure data are obtained, the software can provide a UPP
summary.
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UPP start and stops are marked as events on the UDS screen. If you pass the pointer over a UPP start or stop event, a ToolTip
will display the events. You can reposition the event by clicking the line and moving it along the graph to a new location.
To open a UPP summary:
1. Click Info from the menu bar and select UPP Summary.
Result: The UPP Summary window appears. Each UPP pull represents a segment.
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For more information on the preview button and its function, please see page 99.
To select and modify a segment to analyze:
1. Click the column heading (Pull 1, Pull 2, etc...) of a UPP pull.
Result: The start and stop times will be highlighted in green, and the graph on screen will scroll to TIP: You can
the end position of the selected UPP pull.
select up to
eight
2. Click the Auto Detect button to automatically adjust the start and end range.
segments
-orfor
UPP
calculation.
Manually move one of the UPP start or stop events on the UDS screen.
Result: The events are updated on the screen and in the UPP Summary window.
1.
2.
3.
4.
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5. Select the Preview button to display the UPP Plots. This will give you a preview of what will be printed out in the report.
To print the UPP Summary:
1. Click File > Print Study.
2. Select UPP Summary from the Preferences
section on the left side of the window.
3. Select UPP Sections from the Print Range
section.
4. Select the desired segments.
5. Click OK to print.
Elements in the UPP Summary
The length of the urethra (functional length) is included in the UPP summary. The UDS software calculates the urethral length by
multiplying the withdrawal rate by the period of the functional segment of the graph.
NOTE: The recommended withdrawal speed is approximately one millimeter per second.
Obstruction Zone Peak
You can set the maximum pressure at an observed obstruction point. This setting will recalculate the peak pressure point.
To set the UPP obstruction zone:
1. Right-click inside a UPP range to set the Obstruction Zone.
Result: the context menu appears.
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Both peak events are movable. Obstruction Zone Peak parameters are shown in the UPP Summary as well as printed on the
UPP Summary report.
Re-marking UPP Segments
The UPP segments should mark automatically when using the Start Pull and Stop Pull Control Panel buttons to perform the UPP
test. It creates three unique events named UPP Start X, UPP Peak X, and UPP Stop X (where X is the Pull #) for each UPP pull
performed. For the first UPP pull, it will mark events called UPP Start 1, UPP Peak 1, and UPP Stop 1 automatically.
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In some circumstances you may need to re-mark the UPP Segments. To do this you will need to:
1. Remove the UPP Segments that you want to change:
a. Right-click on the UDS graph to open a context menu.
b. Near the bottom of the menu, click the UPP Segments option to open a smaller menu that lists all the UPP Pulls
that are marked on the graph. Uncheck the UPP pull you want to re-mark and the events corresponding to that
UPP pull will disappear from the graph. (i.e. UPP 1) as illustrated in the following images.
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2. Re-mark the UPP Segment: Highlight the UPP pull by left-clicking on the UDS Graph before the UPP pull you want to
mark, and continue to hold down the left mouse button as you drag the mouse cursor to the end of the UPP pull and
then let go of the mouse button. It will highlight the UPP pull in black.
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3. Right-click on the highlighted section of the graph to open the context menu.
4. Click the UPP Segments option near the bottom of the menu, and now check on an unused UPP Segment (our example
will re-mark UPP 1 as it was removed in step 1). It will now add the UPP Start, UPP Peak, and UPP Stop events to the
graph for that pull.
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5. Verify the UPP Summary (found under the Info menu) is updated with the newly marked UPP pull information.
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Re-marking complete.
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Then...
Manually:
Cancel
UPP
This option contains optional software features such as Eberhard Curves and Pressure Transmission Ratio.
Eberhard Curves (Optional)
The Eberhard feature measures the static and stress UPP profile for female patients.
This feature in the UDS software is based on the work of J. Eberhard and P. Lienhard.viii A complete copy of this article is available
upon request.
IMPORTANT! The following criteria must be established first for to properly calculate values.
LABORIE
Verify that the Pves, Pura, and Pclo reference the correct channels.
Verify that the position of the patient is selected.
Verify that the UPP Puller speed is correct.
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3. Select the Static and the Stress UPP portions of the graph.
Static UPP:
a) Click the Configure button in the Static section to open the Range Selection window.
b) Select the range for calculating the static UPP Segment by clicking on the graph at the starting point of the range,
holding the left mouse button down, and then dragging the mouse across the graph until you reach the end of the
segment. Once the end of the segment is reached release the mouse button.
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The segment will be marked by red lines to the left- and right-side along with a black line across the top to highlight the
selected portion of the graph.
NOTE: if the selected segment is incorrect, click Cancel and select a new segment.
c) Click Confirm.
Stress UPP:
a) Click the Configure button in the Stress section to open the Range Selection window.
b) Select the range representing the dynamic UPP Segment by clicking on the graph at the starting point of the range,
holding the left mouse button down, and then dragging the mouse across the graph until you reach the end of the
segment. Once the end of the segment is reached release the mouse button.
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The segment will be marked by red lines to the left- and right-side along with a black line across the top to highlight the
selected portion of the graph.
NOTE: if the selected segment is incorrect, click Cancel and select a new segment.
c) Click Confirm.
4. Click OK.
Result: The Eberhard window opens to display the curves along with Total Urethral Length, Pressures, Functional
Urethral Length, and change information.
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5. Click Print! in the upper-left of the window to print a copy of the curve results.
6. Click Exit! to close the window.
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X 100%
Pves
Where:
Pura refers to the change from baseline in urethral pressure during a cough
Pves refers to the change from baseline in vesicle pressure during a cough
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To...
Then...
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Then...
Then click...
Deselect any segments and return to the Pressure Cancel
Transmission window:
Confirm
Keep the selection and return to the test:
Result: The pressure transmission ratio is calculated and
displayed as an event in the Event Summary.
Manual PTR
Manual PTR allows you to customize the cough point selection. It also allows each Pura and Pves peak to be zoomed in and
modified accordingly. This is the most accurate method of calculating PTR.
156
2. Click one of the settings. (Refer to the following table to determine the appropriate zoom size.)
Result: The test automatically changes to the size of the setting. The selected setting is saved when the test is saved.
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Setting
Display
25%
33%
50%
1X
2X
3X
4X
Full Screen
Full Screen On Stop
Custom
OPTIONS MENU
The OPTIONS menu activates and accesses miscellaneous functions of the software.
TEST RESTART
Sometimes when the patient coughs, sneezes, or kicks the transducer during a test, a re-evaluation is required. The Restart feature restarts a
procedure from the beginning of the test.
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TEST PLAYBACK
The playback feature enables a pre-saved test to be played back as if it is being recorded. After the test is complete, it may be viewed by
using the playback feature. However, the playback speed may be different from that when it was recorded.
To view the test as it is running:
o
Click Options and select Test Playback. Result: The test plays from the beginning of the test and runs until the
procedure is over.
To
Then
Click Stop.
Resume playback:
1. Click Options.
2. Select Test Playback.
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NOTE: There are seven buttons on each row; the last two buttons of the first and second rows are reserved for system use. You
can program the rest of the buttons.
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Then
Name of the
function button:
Double-click the Label text box of the button. (The entered text will be displayed on the Control
Panel button in the UDS Client screen.
Enter the name of the function button using the keyboard.
Repeat steps 1 and 2 until all the function buttons are labeled appropriately.
Definition of the
name on the
function button:
Type of function
button:
Click on the down arrow of the appropriate combo box to the right of each buttons function.
Select the appropriate function command type.
Repeat steps 1 and 2 until the type of all function buttons in the row are set.
3. Click the down arrow of the Current Row to move to the second row of function buttons.
4. Click OK when all buttons are configured completely.
IMPORTANT! The Control
Panel Set used when the
UDS software closes is
saved as the Default
Control Panel set and is
automatically loaded when
the UDS Client is restarted.
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The Button Height slider can be used to adjust the size of the buttons in the Control Panel. Slide it to the right to increase the
size of the button.
Multiple Control Panel Sets and Hot Key Configuration
Multiple Control Panel Sets can be set up in the UDS software, which will allow two or more users to use the same equipment
but each having a customized Control Panel. Up to 16 Control Panel Sets can be set up in addition to the Default Control Panel
Set.
The Hot Key configuration feature allows you to create a shortcut key combination for a particular control panel button.
To Configure Multiple Control Panel Sets:
1.
Click Options > Control Panel Settings.
NOTE:
Result: The Control Panel Command box appears.
A maximum of
15 characters
2.
Type in a new name in the Control Panel Set Name box.
(including
3.
Customize the Control Panel buttons to your liking.
spaces) can be
used for the
4.
Click OK to save the Control Panel Set.
name.
Result: The new settings are saved and ready to be used.
To use another configured Control Panel Set:
1.
Click Options > Control Panel Settings.
Result: The Control Panel Command box appears.
2.
Click the drop down button of the Control Panel Set Name box and select the appropriate name.
3.
Click OK.
Result: The selected Control Panel appears.
To add a new Control Panel set by duplicating the settings of an existing Control Panel set:
1.
Click Options > Control Panel Settings.
Result: The Control Panel Command box appears.
2.
Click the drop-down button of the Control Panel Set Name box and select the name of the Control Panel set
to be copied.
Result: The settings for the selected Control Panel set are displayed.
3.
Type over the displayed Control Panel Set Name with a new name.
4.
5.
Click OK.
Result: The new name and settings are saved and ready to use.
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3.
4.
Click OK.
NOTE: the PLUS (+), MINUS (-), and EQUAL (=) keys can also be used for the
Hot Key configurations.
With this configuration, you can choose to either press CTRL+R or click
the control panel button labeled First Sensation whenever a first sensation
needs to be recorded.
To Configure Sound
Each button can be configured to play a unique sound when clicked.
NOTE: To properly use the Sound feature, you must have a sound card installed on
your PC.
1.
2.
3.
4.
5.
LABORIE
Open the Properties window by clicking the P button next to a particular Control Panel button. In our example
the First Sensation button will have a sound file attached to it.
Select the Play sound when button clicked option.
Click Browse to locate the sound file that will be used for the button click.
Select the file and click Open to attach the file to the button.
Click OK to exit the screen.
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Control Panel
Select an option from the listing to launch a default control panel that appears each time the button is clicked.
3. In the Properties window, click the Browse button in the Image section to locate the image. Our picture in this
example will be a picture of the Uroflowmeter.
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4. Once the image is found, click Open to add the image name to the blank line in the Properties window.
5. Click OK, and then click OK again to close the window.
The image will now appear in the button on the control panel.
Before
After
1.
Click inside the colored box under the Text or Button column for the particular button type.
Result: The Color window appears.
2.
Select the colors you want for the button and/or text.
3.
Click the F button next to the button type under the Font column and select the font you would like for the button from
the resulting font selection window.
4.
Click OK.
You can also select to have all Control Panel buttons with the same color and font. In the All Buttons section at the bottom
of the window, select the button property to change and then click the rectangle next to the property to select the color or
font.
The chosen colors will display once you click OK and exit the Command window and return to the main UDS screen.
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To configure Area Start and Area End events for the Event Annotation box:
1. Select a test to run.
2. Click the Event button on the control panel to
open the Event Annotation box.
3. Type the area start event with the format
AS:(pressure channel):(threshold value).
In this example AS:Pves:0 means that the area
under the Pves curve above a threshold of 0 will
be calculated.
4. Click Add.
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When applicable, click the Area End button to establish the end point of area calculation.
Complete the test and click Info > Event Summary to review the Area Start and Area End values.
To calculate the Area under Curve for a saved test or after a test is stopped:
1. When a test is stopped or a saved test is open, right click on the graph at the starting point of area calculation and select
Insert Event.
2. Select the area start event AS: .
3. Click Annotate Event.
4. Move the cursor pointer to the end point of the area calculation and right-click on the graph.
5. Select Insert Event.
6. Select the area end event AE: .
7. Click Annotate Event.
Result: The area calculated will be appended to Area End Event Annotation in the format AE: Pves: xxxx where xxxx is the
calculated area.
8. Click Info and select Event Summary to review the Area Start and Area End values.
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Definition
Type
Comments
First Sensation
First Urge
Capacity
Valsalva
Cough
Area Start
Area End
Uroflow
CMG
UPP
Micturition
Slow Fill
Medium Fill
Fast Fill
First Sensation
First Urge
Capacity
Valsalva
Cough
AS:Pves:0
AE:
Full path of CFG file
Example: c:\cfg\
Event
Config
SF
MF
FF
Pump
Command
XXX ml/min
+YY ml/min
Event - Unique
-ZZ ml/min
Controls the reverse pump fill
rate
RSF
RMF
RFF
Start Pump
Pumprunstop
PumpRunStopResume
Resume Pump
Auto Start
Set Zeroes
N/A
N/A
Auto Start
Set Zeroes
Pura = Pves or
Pabd = Pves
Channel X = Channel Y
Example: Pura = Pves
Equalize
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Definition
IN (returns the puller as fast as possible;
for positioning the puller)
UPP
Command*
Refer to the
UPP
Puller
manual
for
more
information.
IC02 Command
Stop IC02
Patient Info
Rest
Slow Waves
MSP
Compliance
Expulsion
XXcc
Resting Profile
Squeezing Profile
Squeeze 5 cm
Squeeze 4 cm
Squeeze 3 cm
Squeeze 2 cm
Squeeze 1 cm
Rest 5 cm
Rest 4 cm
Rest 3 cm
Rest 2 cm
Rest 1 cm
10 cc
20 cc
30 cc
40 cc
50 cc
60 cc
70 cc
80 cc
90 cc
100 cc
110 cc
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Type
Comments
Controls the UPP puller speed.
Patient Info
ARM
ARM 4&8
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Definition
Single
Burst
Manual
Single Capture
Burst Capture
Manual Burst
Peak Image
Peak Burst
(vbninitialize)
(vbnloadfile)
(vbnsavefile)
(vbndrawremovecurves)
(vbninterpretationalhelp)
(VBNPatientFile)
(VBNGlobalValues)
(VBNBladder)
(VBNSphincter)
(VBNUrethra)
(vbnchangeview)
(vbncontrolanimation)
(vbnaspectratio)
(vbncurveadjustments)
(vbnotheroptions)
(vbnimportfile)
(vbnclose)
Pre-set definitions
Type
Image Event
Image EventUnique
Peak
Event
VBN
Image
Please refer to
the VBN section
in this manual
for
more
information.
i-LIST Config
i-LIST Event
(optional)
Comments
Defines buttons for use with UDS
Video Software.
Please refer to your video systems
Owners Manual for more
information.
Optional feature for bladder
modeling. Controls the functions
of the VBN feature.
i-LIST
Command
i-LIST
Event
LABORIE
Pre-set definitions
Image
i-LIST
Event
Unique
Evoked
Potential
N/A
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Definition
Type
Plot
Plot
Stress Test
Stress Test
Main Menu
Main
Stress
Test
Command
Load CP
Summ. Review
PFReview
Load CP
Zoom
2x
3x
4x
Zoom
None
Comments
Click the plot button to open the
Nomograms that are applicable to
the test being performed.
For stress leak tests. See page 128
for more information.
Sets the default control panel for
each time the UDS software starts.
View the summary results control
panel to review the current test.
Zooms in on the highlighted area
of the graph when clicked.
Cancel the control panel button
PU XX (pulls the UPP puller XX millimeters at the default UPP speed; for example PU 15 will pull the UPP for 15 mm at the
default speed)
PUH XX (pulls the UPP puller XX millimeters as fast as possible; used for positioning the UPP puller)
IN XX (returns the UPP puller XX millimeters as fast as possible; used for positioning the UPP puller)
You can set the puller to automatically stop or pull at preset intervals with the click of a button. When a UPP Command is
selected in the drop list and the definition is either PU or IN, a pop-up box appears and you can select the interval at which the
puller will stop.
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NOTE 2: The Reverse Fill pump feature runs the pump in reverse and is used during ARM testing when you want to quickly fill
and then drain the large balloon that is used to provoke sensation. (If you program your pump commands as ff, mf, and sf, then
you can add the rff, rmf, and rsf. If you program the commands as fast fill, medium fill and slow fill, then you can program the
reverse as reverse fast fill, reverse medium fill, and reverse slow fill. IMPORTANT! Reverse Fill is not a feature meant to drain
the bladder! It is to be used only for the draining of the large balloon during ARM testing!
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NOTE 4: When the Resume Pump button is clicked it will restart the fill at the last used rate.
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2. Click OK.
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To remove a button:
1. Click Options > Remote Control
Designer to open the Remote
Control Designer screen.
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The procedure stops and the buttons are automatically refreshed on both the
central hub screen and on the remote control device screen.
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EXPORT DATA
The Export Data option enables curve data to be exported in a text file format and used in another software program.
To export data:
1. Click Options from the menu bar.
2. Select Export Data.
Result: The Export window appears with the default export
file name (xxxx.out) and the whole test selected.
3. To change the file name, type a name for the text file with
the appropriate directory using the keyboard.
4. To change the range, click in the Export Data field and enter
the appropriate values of the time the data should be
exported.
5. Click Export.
Result: The text file is created and is ready to be imported
into another software program
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And see
1. Guideline
A dotted line
2. Annotation Abbreviation
3. Channel Values
1. Guideline
A dotted line
2. Annotation Abbreviation
3. Channel Values
4. Click OK.
Result: The Event Display Options box disappears and the curve shows the changes made to events and peaks.
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2.
3.
4.
5.
In the Select Paired Event listing choose UPP or Uroflow and select the Show region for this event option.
Click the Select Color button to open the color selection screen.
Select the color that will highlight the region containing the events.
Once color is selected, click Close and then click OK to close the Event Display Options window.
Once you run the test the graph will display the highlighted areas where the events occur.
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Result: After running and stopping a test, a peak event for each channel is added.
2. Click Options > Auto Mark Peaks to disable Mark Peaks.
GRAPH CLIPPING
The Graph Clipping option clips the top and bottom of a curve if it exceeds the display scales of a channels display area. By default this
option is disabled and the curves can exceed the display area of a channel.
NOTE: The channel scale range determines the height of the curve.
Click Options > Graph Clipping to cancel the Graph Clipping option.
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SMART TRACING
This feature allows the curves to be displayed similar to inked display. Lines that have repeated data will be displayed in a darker
color. This feature is useful when a long test is compressed into a smaller display area.
However, if you decide to change the bag before the system alerts you, you will need to select the Change Infusion Bag item
under the Options menu.
To manually change the infusion bag during a test:
1. Click Options > Change Infusion Bag.
Result: The pump stops and the graph will continue to scroll. A message box appears asking you to change the infusion bag.
2. Click OK.
3. Replace the bag and reconnect the IV tubing.
4. Click OK to resume testing.
Result: The pump continues with its normal activity.
AUDIO
This option contains the Audio Settings and Event Playback features.
Audio Settings (Optional Sound Feature Only)
This menu item is present only when the sound feature is enabled. It allows you to change sound recording parameters.
To change the Sound Recording Parameters:
1. Click Options > Audio > Audio Settings.
2. Make the appropriate changes.
3. Click OK.
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VBN
This option contains the VBN Settings and VBN Overlay features.
VBN Settings
If you have VBN enabled with our software you can set the catheter size that is used so that the renderings in VBN are correct.
1. Click Options > VBN > VBN Settings to open the VBN settings window.
2. Type the size of the catheter (between 0 and 15) and click OK.
VBN Normal Curve Overlay
This is a normalized Flow curve that is overlaid on the
patients Flow curve after a Uroflow or Pressure/Flow
test. It provides a basis of comparison between the
normal flow curve (for the patients gender and
voided volume) and the patients actual flow curve.
The match to the normal curve is visible in the shaded
area under the curve.
The normal flow curve is recalculated if there is a
gender change in the patient info screen.
By default, the curve is visible once you select this
option under the options menu.
To hide the curve, click Options > VBN >VBN Normal
Curve Overlay.
When VBN Normal Curve Overlay is selected in
the menu, it will have a checkmark next to it.
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The UDS Software will transfer the data to the i-LIST Message Queue.
Right-click on the graph and select the Export to i-LIST menu item.
Click on the name of the event to export.
Save the test file. The UDS software will automatically transfer files to the i-LIST Server.
PUMP MENU
The PUMP menu is the next menu located on the menu bar at the top of the screen.
CONFIGURE PUMP
The Configure Pump option allows you to customize the pump options to your preference.
NOTE: The Prime rate feature runs the pump at the speed set in the prime box in the Configure Pump screen. The default
speed is 150 ml/min.
To configure the Pump:
1. Select Configure Pump from the Pump menu.
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Function
Volume Channel
Pressure Channel
Pressure Limit
Stops the pump if the pressure channel exceeds this limit. CAUTION: Do not exceed
150 cm H20.
Volume Limit
Displays a warning message when the infused volume reaches the specified limit.
This option starts the pump at the selected pump speed when the test starts. Choose
Stop if you do not want to use this option.
This option records events automatically when the pump runs or stops. This option is
enabled by default. Deselect the box to disable the feature.
PRIME PUMP
Priming the pump removes all the air bubbles from the tubing, which may cause incorrect pressure readings.
SLOW FILL
Select this menu item to run the pump at the slow rate set in the Configure Pump window.
MEDIUM FILL
Select this menu item to run the pump at the medium rate set in the Configure Pump window.
FAST FILL
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Select this menu item to run the pump at the fast rate set in the Configure Pump window.
STOP PUMP
Select this menu item to stop the pump.
Volume Warning Limit
The Volume Warning Limit is used in the pediatric Uro Mode which applies to patients under 16 years of age. This limit is the
maximum amount of fluid that can be infused into the patient according to bladder capacity at a given age.
The Volume Warning Limit is determined by Minimal Acceptable Total Bladder Capacity (MATBC.)
MATBC = 16 x (Age of child in years) + 70 ml.
The pump receives the information to calculate the MATBC from the data entered in the Patient Information dialog box.
If the infused volume exceeds the limit specified in the Volume Warning Limit box, a message appears.
Important! After the warning appears, the pump does not automatically stop. It must be manually stopped.
NOTE: The MATBC is calculated automatically and cannot be changed.
RESET CONNECTION
The Reset Connection feature resets the connection to the hardware. It should not be used during the test. It is intended for use
only by qualified technical service personnel.
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CONNECTION TYPE
Select the option that matches the connection set up in the touchscreen settings. IF the connection type is changed, then it must
be changed in the touchscreen module software too.
NOTE: when a connection is changed (such as switching from USB to Bluetooth and vice versa, exit then restart the software to
enable the change.
VIDEO
Starts the video functions of the UDS software. Refer to the Saturn Owners Manual for more information.
NOTE: The EMG channel must always be set to zero through this menu.
To zero the transducers, perform one of the following procedures:
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To set
Then click.
Set Zeroes from the menu bar and then click All.
Result: The transducer(s) are set to zero and the studies are ready to start.
TRANSDUCER TYPE
Select the type of transducer used with the system before a test starts to ensure proper data recording. Ensure the system has been
calibrated to the transducer type selected.
Remember to only use one type of transducer with the Roam; select either air-charged, or water, or electronic for all tests.
NOTE: a transducer type event will be added to the start of the graph when Run is clicked.
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VBN
VBN is a mathematical model of the lower urinary tract and is based on the research and standards set by the members of the
International Continence Society. VBN is a powerful and non-invasive tool to predict the after effects of surgery and/or
prescribed treatment.
The features available to you are dependent upon the VBN options installed on your system.
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NOTE: Once Normal Curve Overlay has been selected, a blue curve representing the normal flow for the sex of
the patient will be overlaid on top of the patients actual flow curve.
3. Press F9 to enable the Cursor box. Move the mouse over the blue calculated curve and the patients actual
measured curve.
You should be able to see the difference at that point between the patients flow and the normal flow as the pointer
is moved across the graph.
4. Left-click the bottom of the Flow Channel box (below the ml/s text) to change the channel label to the normal flow
channel (CALQ).
o
The label should become blue and say CALQ with a peak flow measurement in ml/s. This peak flow should
be the value of the highest point on the normal flow curve.
5. Left click the box again to change the flow channel box from CALQ back to Flow.
o
You can also playback the test with the Normal Curve Overlay enabled, and watch the test with playback as
the overlay is drawn.
6. Click Options >VBN Normal Curve Overlay while it is selected to disable the overlaid curve.
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Patient Info
Click the Patient Info button to input or review patient information for the current test.
You can adjust the sex of the patient by clicking the Mr. or Mrs. button. The equations used by
VBN during its many calculations are dependent on the gender of the patient, so make sure that
this selection is accurate.
Global Values
The Global Values window can be left open while you are performing other VBN features.
Use this window to observe some measured values (for example, Volume Voided) to the values
computed by the VBN software. This is especially useful when used in combination with the
Interpretational Help feature, as you can compare how close the calculated values are to the original
values for each solution.
Bladder
Click this button to open the Bladder dialog box.
Use this to adjust variables that affect the bladder, such as Initial Volume, Detrusor Force, and so on.
Some of these values are automatically adjusted when you use the Interpretational Help to discover
solutions. From this window you can also input the initial volume inside the bladder, which has a
significant effect on the calculations.
Detrusor Force: A higher detrusor force will decrease the time it takes the patient to
void, providing they are able to void at all.
Initial Volume: The size of the bladder in the animation window should change depending
on the Initial Volume. A Greater initial volume also means it will take longer for the
patient to void.
Time Of Break and Quality: The patient should not be able to continue voiding much
longer the value (in seconds) of the Time of Break setting. How much the patient can
continue voiding past this point depends on the Quality setting.
Neck/Detrusor Coupling: No observable effect for animation.
Sphincter
Click this button to open the Sphincter dialog window.
Use this to adjust variables that affect the Sphincter. Some of these values are automatically adjusted when
you use the Interpretational Help to discover solutions.
Pre excitation: For strong enough values, the voiding does not depend on it. For insufficient value the
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Opening Time: The area of the urethra that the sphincter force effects will not open until this amount of time has
passed. You will notice that Subsonic and Sonic forces will be in this area until the sphincter has opened.
Excitation: Can have an effect on how long it takes the patient to void, but it also depends on other settings.
Urethra
Click this button to open the Urethra window.
Use this to adjust variables that affect the Urethra. Some of these values are automatically adjusted
when you use the Interpretational Help to discover solutions. From this window you can also select
the size (in French units) of the catheter that is inserted into the urethra. This has a great impact on
the calculations.
Neck Disease: A very low setting (for example: 0.1) will increase the time it takes the
patient to void. You can observe the sonic/subsonic forces being located near the neck. No
effect if greater than 0.2.
Neck Pressure (Male Only): Increasing this value increases the pressure on the neck, which
will increase the time it takes the patient to void.
Prostrate Pressure (Male Only): Increasing this value increases the pressure from the prostate, which will increase the
time it takes the patient to void.
Ura Comp. (Female Only): Increasing this value will increase the time it takes the patient to void.
Urethra Area (Female Only): Has an effect on the size of the Urethra. Will also affect the time it takes the patient to
void.
Probe: Sets the size of the probe (if any) inserted into the patients urethra. A red bar will be visible in the animation
window. A probe will greatly increase the amount of time it takes the patient to void.
Select View
Click this button to open up the Select a View window.
Select Normal to open up the normal graph window, or select Separate P and Q to open up a graph
window that separates the pressure curves and the flow curves onto two different graphs.
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Normal
Separate P and Q
NOTE: If you are just using the Animation only version of VBN, the first two
buttons will not be available.
These two graphing windows display several measured and calculated curves. The curves each have a corresponding label that
matches their color. In both graphs, the top-most graph always displays curves relating to the Detrusor and Sphincter forces. In
the Separate P and Q window, the pressure and flow curves are separated into two different graphs. Use the scrollbar to view
the different graphs.
Animation Window
The Animation Window displays a simulated model of the bladder for the
current patient.
Adjustments to variables such as prostate pressure, size of catheter, initial
volume, and the sex of the patient can be directly observed in this
window.
When you are playing back an animation, this window displays the
current flow rate, and the time that has elapsed at that stage of the
animation. During an animation playback, the size of the bladder should
gradually decrease provided the patient would be able to void during this
simulation. The Sonic and Supersonic forces inside the urethra are also
highlighted during the animation playback.
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Other Options
Click this button to open the Other Options window.
You can enable or disable different laws that are used during VBNs calculations. Some of
these laws affect which calculations are used during Interpretational help.
From this window you can also adjust the thickness of curves being displayed on the graph
windows. The Save and Restore buttons can be used to save your current window layout or
to restore a previously saved window layout.
Close VBN Windows
Select this button to close all VBN related windows that have been opened at once. This is
useful when you are done using VBN but which to continue using another part of the UDS
software.
UDS device
PC
UDS/ARM software
Failure to power up in this sequence could result in devices not being properly recognized.
If you skip a step, then simply repeat the steps in reverse order to power off and start again.
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iv.
v.
vi.
vii.
Figure 12: Example: ARM channel setting configuration for four pressures, EMG, and integrated LABORIE pump.
ARM Study Units
The following units of calibration may be used:
ARM Study Units
Description
Calibrate pressure transducers in cmH2O and display data in cmH2O.
cmH2O
mmHg
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Description
Calibrate pressure transducers in cmH2O and display data in mmHg using the software
conversion unit mmHg.
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Click Yes or No to either start or stop the reverse pump action. NOTE: The reverse pump action is intended only for deflating
the rectal balloon before catheter removal. Do not run the reverse pump feature for any other actions.
A Start Infusion and Stop Infusion event will also be added to the graph when reverse pump is started and stopped.
Part 3: Configure the Control Panel for ARM Studies
1. Click Options from the menu bar.
2. Select Control Panel Settings.
Result: The Command box appears displaying the first row of Control Panel buttons.
3. Click the arrow next to the Control Panel Set Name and select ARM 4&8.
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ARM Properties
Each ARM button has a start and a stop event. Some of the ARM buttons can be configured to stop automatically after a
specified time and to shade regions between start and stop events.
1. Open the Properties window by clicking the PLUS (+) button next to an ARM Control Panel button.
2. Select Automatically insert STOP event after and enter a value in seconds. The default value is 10 seconds.
3. To add shading between start and stop events, select show region for the ARM event, and click the Select Color box to
choose the color.
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Select the Input volume immediately after inserting events option (as shown below) and click OK. Subsequently, when First
Sensation, Urge, or Max Tolerance events are selected, a Volume box will appear asking you to enter the infused volume. If
the VH2O channel is added and specified in the tests Configuration file, the volume will be automatically read from the
specified VH2O channel and the resulting message box will not appear.
5. Click OK.
6. Click Config > Save As to name the file and to make this a default setting.
Glossary of ARM 4&8 Control Panel Commands
Suggested Button Label
Definition
Type
First Sensation
First Urge
Max Tolerance
ARM 4 Radial
ARM 8 Radial
Set Zeroes
First Sensation
Urge
Maximum Tolerance
Full path of CFG file
Example: c:\cfg\
N/A
Event
Marks an event with the definition text as Event
Annotation.
Config
Opens a .cfg file.
Set Zeroes
Sets all channels to zero.
UPP Command (Controls the puller speed)
Return
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Definition
Type
Pull
Pull X cm
PU XX
Stop Pull
Patient Info
Resting
Squeezing
6 cm Squeeze
5 cm Squeeze
4 cm Squeeze
3 cm Squeeze
2 cm Squeeze
1 cm Squeeze
6 cm Rest
5 cm Rest
4 cm Rest
3 cm Rest
2 cm Rest
1 cm Rest
10 cc
20 cc
30 cc
40 cc
50 cc
60 cc
70 cc
80 cc
90 cc
100 cc
110 cc
RAIR
Expulsion
Slow Fill
Medium Fill
Fast Fill
XXX ml/min
+YY ml/min
-ZZ ml/min
SF
MF
FF
SP=XXX (where XXX is in ml/min)
SP+YY (where YY is the
incremental rate)
SP-ZZ (where ZZ is the
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Patient Info
Opens Patient Info window.
ARM
Controls Anorectal Manometry procedures
performed with 4 or 8 pressure circumferential
catheters.
Pump Command
Controls the pump fill rate.
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Definition
Type
decremental rate)
Reverse Slow Fill
Reverse Medium Fill
Reverse Fast Fill
RSF
RMF
RFF
The Reverse Fill pump feature runs the LABORIE pump in reverse direction and can be used during ARM tests to quickly fill and
then drain the large balloon used for evoking responses based on the sensation of rectum filling. Depending on the software
version you are running, if you program your pump commands as ff, mf, and sf, then you can add the rff, rmf, and rsf. If you
program the commands as fast fill, medium fill and slow fill, then you can program the reverse as reverse fast fill, reverse
medium fill, and reverse slow fill.
IMPORTANT! Reverse Fill is not a feature meant to drain the bladder during Urodynamics testing! It is to be used only to
drain the large balloon during ARM testing!
Optional Accessories
EMG unit and surface electrodes [CAB155, CAB154 or
CAB153 (EMG cable) with ELE200 or ELE428 or
ELE370&ELE365 (EMG electrodes)]
UPP Puller
Desktop PC or laptop
211
symbol. Place the Roam cartridge into the Hub and make sure the connector at the bottom of the Roam cartridge clicks
securely into place into the Hub.
1. Connect the color-coded transducer cables to the air-charged catheter with the following configuration: Each directional
sensor is identified by color, and this color corresponds to the transducer/cable connection for ease of identification
The black line on the catheter indicates the posterior orientation. This line should be directly in line with
the patients spine. If the patient is on their left side, the line will be facing their back.
LABORIE
212
P1
P2
P4
P3
Figure 16: View from distal end. The Posterior channel (P1) is in line with the black line on the catheter.
3. Gently squeeze then release each balloon/sensors to remove air. NOTE: This is not the large rectal balloon, but rather the
four small sensors located directly beneath the rectal balloon.
4. Click Set Zeros on the software control panel.
5. Switch the transducer to the CHARGE position.
213
Standard Equipment
For a Fluid-filled Gravity Feed System
ARM 4 or 8 channel water-perfused catheter with balloon [CAT006 (4-Pressure) CAT008 (8-Pressure)]
IV BAG 1000 ml
IV line
Starter kit (nova domes, stopcocks, tubing, pump tubing, catheters, beaker etc. Will vary according to system setup)
Software CD containing ARM software (ARM100) and the Anorectal Manometry Owners Manual
Optional Accessories
LABORIE
EMG unit and surface electrodes [CAB155, CAB154 or CAB153 (EMG cable) with ELE200 or ELE428 or
ELE370&ELE365 (EMG electrodes)]
UPP Silent Drive Mechanical Puller (UPP715)
Desktop printer with USB printer cable
AQUARIUS XT/CT/LT/CTS Owners Manual
214
IMPORTANT! Keep the roller clamps closed when you puncture the bags
3. Pump each pressure cuff to a minimum of 300 mmHg.
4. Prime each IV line.
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215
It is recommended that you use the PUM010 pump if you are using an eight-pressure system.
LINE FROM IV
OR
Figure 18: Fluid-Filled Pressure Transducer Setup with transducer cartridge DIS125
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216
IMPORTANT! AIR BUBBLES MUST NOT BE PRESENT IN THE SYSTEM DURING TESTING.
NOTE: Ensure that the Luer lock plug is always securely in place whenever the stopcock position is changed.
Pressure Transducer Setup Using Nova Domes
NOTE: Refer
1. Verify that the pressure transducer plate is level with the patients hipbone.
2. Remove the protective covering and connect a nova dome to each pressure transducer. Begin with the novadome turned
turn to the left, place it over the transducer and turn clockwise to lock in place. The female end of the nova dome
should be at the top and the male end of the nova dome should be at the bottom.
3. Connect a 3-way stopcock with pressure measurement tubing attached to the bottom/male end of each nova dome.
4. Attach a 20 ml sterile-fluid filled syringe to the side port of the stopcock on each pressure transducer.
5. By turning the stopcock in the appropriate directions, flush fluid from the syringe through the nova dome and the
pressure measurement tubing. Repeat for each pressure transducer.
7. Open the roller clamps and prime each system ensuring that no air bubbles remain.
8. Close the roller clamps.
LINE FROM IV
OR
FEMALE END
MALE END
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217
IMPORTANT! AIR BUBBLES MUST NOT BE PRESENT IN THE SYSTEM DURING TESTING.
NOTE: Ensure that the Luer lock plug is always securely in place whenever the stopcock position is changed.
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218
Figure 21: Fluid-filled catheter diagram. View from distal end; P1 is in line with the blue line.
EMG Setup
See page 23.
Pump Tubing Setup for Integrated LABORIE Pump (optional)
See page 213.
Prior to catheter insertion, the rectal ampulla must be empty of all fecal debris. Some doctors recommend that patients
with constipation use an enema before coming in for the test.
Place the patient in a left-lateral position with knees and hips flexed in or as close to a 90-degree position as possible.
Above all, the patient must be resting comfortably and be willing and able to cooperate.
Only 4-channel and 8-channel radial catheters are acceptable for use with the ARM software. If you are using linear
catheters then adjustments must be made to the software. Contact your LABORIE representative for further
information.
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219
Channel Title
Scale
Math Definition
ARM4
P1 (or Posterior)
P2 (or Right)
P3 (or Anterior)
P4 (or Left)
Math1 (Average)
150mmHg
150mmHg
150mmHg
150mmHg
150mmHg
ARM8
P1 (or Posterior)
P2 (or Right Posterior)
P3 (or Right)
P4 (or Right Anterior)
P5 (or Anterior)
P6 (or Left Anterior)
P7 (or Left)
P8 (or Left Posterior)
Math1
150mmHg
150mmHg
150mmHg
150mmHg
150mmHg
150mmHg
150mmHg
150mmHg
150mmHg
ARM4 configuration
plus:
EMG
ARM8 configuration
plus:
EMG
ARM4 using
ARM4 configuration
Integrated LABORIE plus:
pump
IH2O
VH2O
ARM8 using
ARM8 configuration
Integrated pump
plus:
IH2O
VH2O
-300uV
+300uV
Null
Null
Null
Null
(P1+P2+P3+P4)/4 or
(Posterior+Right+Anterior+ Left)/4
Null
Null
Null
Null
Null
Null
Null
Null
(P1+P2+P3+P4+P5+P6+P7+P8)/8 etc
Data Rate
10points/s
10points/s
10points/s
10points/s
10points/s
Display
Attribute
Curve
Curve
Curve
Curve
Curve
10points/s
10points/s
10points/s
10points/s
10points/s
10points/s
10points/s
10points/s
10points/s
Curve
Curve
Curve
Curve
Curve
Curve
Curve
Curve
Curve
to Null
100points/s Curve,
mirrored, and
filled
-300uV to Null
+300uV
100points/s Curve,
mirrored, and
filled
150mL/min Null
600mL
Null
10points/s
10points/s
Digital
Digital
150mL/min Null
600mL
Null
10points/s
10points/s
Digital
Digital
Resting Profile
220
NOTE: The control panel for your software may have a different look than the examples shown here (such as colors, button size,
etc) To change the appearance of the control panel buttons, click the Button Color button in the Command window and make
selections for appearance.
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221
NOTE: The patient must remain as relaxed as possible throughout the procedure and should not move, talk, or cough during
the withdrawal of the catheter.
4. Click Resting on the Control Panel to mark the start of the resting profile.
5. Click Pull on the Control Panel; the puller will slowly begin to remove the catheter at a set rate of 1mm/s.
Clinical note: You do not need to use the puller controls if you are manually withdrawing the catheter If you are manually
withdrawing the catheter, withdraw very slowly; it should take about 60seconds to go from 6cm to 0cm (or to when you can
just visualize the sensors). Do not completely remove the catheter from the body.
6. Click the Stop Pull button to stop the puller when the sensors have passed the anal verge.
7. Click Resting again on the control panel to mark the end of the resting profile.
NOTE: The Resting Profile test should be performed at least twice to confirm a pressure pattern.
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222
8. To perform a second resting profile, remove the catheter from the puller guides and manually re-insert the catheter to
the initial starting position 6cm beyond the anal verge. Click Return on the control panel to setup the puller for the next
profile.
IMPORTANT! The Puller must NOT be used for catheter reinsertion; doing so may result in injuries to the patient. Use the
RETURN button on the control panel only to reposition the puller guide close to the tip of the puller.
9. Attach the distal end of the catheter to the puller using the puller guides and
above steps to perform a second resting profile.
repeat the
10. Leave the catheter in if you are proceeding to the Squeezing Profile.
-ORPull the catheter out carefully if you have finished testing.
Squeezing Profile
1. Gently insert the well-lubricated catheter 6cm beyond the anal verge with Channel 1 (S1) in the appropriate and
preferred dorsal position. Use the markings on the catheter as a guide.
2. Attach the distal end of the catheter to the puller using the puller guides.
Clinical note: If you are manually withdrawing the catheter, withdraw very slowly; it should take about 60seconds to go from
6cm to 0cm (1mm/sec) (or to when you can just visualize the sensors). Do not completely remove the catheter from the body.
3. Ask the patient to squeeze during the entire length of the catheter withdrawal.
4. Click Squeezing on the Control Panel to mark the start of the squeezing profile.
5. Click Pull on the Control Panel to start the pulling of the catheter.
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223
NOTE: You do not need to use the puller controls if you are manually withdrawing the catheter.
6. Click Stop Pull to stop the puller when the sensors have passed the anal verge.
7. Click Squeezing on the Control Panel to mark the end of the test.
NOTE: The Squeezing Profile test should be performed at least twice to confirm a pressure pattern.
8. To perform a second squeezing profile, remove the catheter from the puller guides and manually re-insert the catheter
to the initial starting position, 6cm beyond the anal verge.
IMPORTANT! The Puller should NOT be used for catheter reinsertion; doing so may result in injuries to the patient.
Use the RETURN button on the control panel only to reposition the puller guide close to the tip of the puller.
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224
9. Attach the distal end of the catheter to the puller using the puller guides and repeat the above steps to perform a
second profile.
10. Leave the catheter in if you are proceeding to the Stationary Rest and Squeeze Study.
- OR -
Click Options from the menu bar and select Control Panel Definition.
Result: The Command box appears displaying the first row of Control Panel buttons.
ii. Click the down arrow next to Current Row and scroll down to a row that has blank button spaces. If needed you can add
an entirely new row of buttons by changing the number in the box next to Number of Rows.
iii. Under the Label column, type 6 cm Rest.
iv. Under the Definition column type SR6.
v. Click the pull down arrow on the third column and select ARM.
vi. If necessary find another free button space.
vii. Under the Label column type 6 cm Squeeze.
viii. Under the Definition column, type ST6.
ix. Click the pull down arrow on the third column and select ARM.
x. Open the Properties window by clicking the PLUS (+) button next to an ARM Control Panel button.
xi. Select Automatically insert STOP event after and enter a value in seconds. The default value is 10 seconds.
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225
xii. To add shading between start and stop events, select show region for the ARM event, and click the Select Color box to
choose the color.
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226
1. Allow the patient to relax for several minutes, with the catheter inserted, in order to record true resting pressures.
2. Ask the patient to relax and click the 5 cm Rest button to mark the start of the 5 cm resting period. (If you are starting
the test at 6 cm beyond the anal verge then start with the 6 cm Rest button instead.)
Result: The control panel button will start flashing and a shaded area will scroll across the graph. After 10 seconds, the
software will automatically mark the end of the resting period. The control panel button will no longer flash and the
shading will stop.
3. Ask the patient to squeeze as hard as they can for 10 seconds. At the start of the squeeze click the 5 cm Squeeze (or 6
cm Squeeze if starting at 6 cm beyond anal verge) button and ask the patient to hold the squeeze for as long as the
shading appears on the graph.
Result: After 10 seconds, the software will automatically mark the end of the squeeze period. The control panel button
will no longer flash and the shading will stop. The patient should stop squeezing at this time.
4. Click the Pull 1 cm button on the control panel to withdraw the catheter 1 cm.
-ORManually pull the catheter out 1 cm.
Result: The catheter tip should now be 4 cm (or 5cm) from the anal verge.
Continue the testing by going through the steps in the 1 cm increments as programmed on the control panel. Therefore,
if you start at 6 cm beyond anal verge then continue by moving the catheter to the 5cm, 4cm, 3 cm, 2cm, and 1 cm
positions. The remaining steps in this section will describe the process if testing starts at 5cm beyond the anal verge.
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227
7. Ask the patient to squeeze as hard as they can for 10 seconds. At the start of the squeeze, click the 4 cm Squeeze
button. Ask the patient to hold the squeeze as long as the shading appears on the graph.
Result: After 10 seconds, the software will automatically mark the end of the squeeze period. The control panel button
will no longer flash and the shading will stop. The patient should stop squeezing at this time.
8. Click the Pull 1 cm button on the control panel to withdraw the catheter 1 cm.
- OR Manually pull the catheter out 1 cm.
Result: The catheter tip should now be 3 cm from the anal verge.
9. Ask the patient to relax and click 3cm Rest to mark the start of the 3 cm resting period. Result: The button will start
flashing and a shaded area will scroll across the graph. After 10 seconds the software will automatically mark the end of
the resting period. The control panel button will no longer flash and the shading will stop.
10. Ask the patient to squeeze as hard as they can for 10 seconds. At the start of the squeeze, click the 3 cm Squeeze
button. Ask the patient to hold the squeeze for as long as the shading appears on the graph.
Result: After 10 seconds, the software will automatically mark the end of the resting period. The control panel button
will no longer flash and the shading will stop.
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228
Result: The catheter tip should now be 2cm from the anal verge.
12. Ask the patient to relax and click 2cm Rest to mark the start of the 2 cm resting period. Result: The button will start
flashing and a shaded area will scroll across the graph. After 10 seconds, the software will automatically mark the end of
the resting period. The control panel button will no longer flash and the shading will stop.
13. Ask the patient to squeeze as hard as they can for 10 seconds. At the start of the squeeze, click the 2 cm Squeeze
button. Ask the patient to hold the squeeze for as long as the shading appears on the graph. After 10 seconds, the
software will automatically mark the end of the resting period. The control panel button will no longer flash and the
shading will stop.
14. Click Pull 1 cm on the control panel and the puller will withdraw the catheter 1 cm.
OR
Manually pull the catheter out 1 cm.
Result: The catheter tip should now be in 1 cm from the anal verge.
15. Ask the patient to relax and click 1cm Rest to mark the start of the 1 cm resting period. The button will start flashing and
a shaded area will scroll across the graph. After 10 seconds, the software will automatically mark the end of the resting
period. The control panel button will no longer flash and the shading will stop.
16. Ask the patient to squeeze as hard as they can for 10 seconds. At the start of the squeeze, click the 1 cm Squeeze
button. Ask the patient to hold the squeeze as long as the shading appears on the graph. After 10 seconds, the software
will automatically mark the end of the resting period. The control panel button will no longer flash and the shading will
stop. The patient should stop squeezing at this time.
17. Leave the catheter in if you are proceeding to another study (such as RAIR or Rectal Volume). Catheter position will
depend upon the test you choose to perform next
- OR Pull the catheter out carefully if you have finished testing.
LABORIE
AQUARIUS XT/CT/LT/CTS Owners Manual
229
Figure 24: Sample data of a Stationary Rest and Squeeze Study. This example only measures pressure beginning at 4cm from the anal
verge instead of 5cm. The alternating color patterns highlight the areas of Rest and Squeeze.
4. Inject 10 cc of air into the balloon and withdraw the 10 cc of air immediately. NOTE: The air should be withdrawn within
5 seconds of being introduced.
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230
If RAIR is not present, repeat these steps using greater increments of air such as 20cc, 30cc, and so on.
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231
TECHNIQUE #2:
1. Click RAIR on the control panel.
3. Inject 10 cc of air into the balloon and withdraw the 10 cc of air immediately.
NOTE: The air should be withdrawn within 5 seconds of being introduced.
4. Click RAIR again to mark the stop.
Result: You will be prompted with a pop up window to state whether or not RAIR is present or absent as shown below.
Enter the appropriate result.
LABORIE
If RAIR is not present, repeat steps 3-6 using greater increments of air such as 20cc, 30cc, and so on.
232
1. Fill a 60cc Luer lock syringe with lukewarm water and attach it to the catheters filling port.
2. Gently insert a well-lubricated catheter into the patient. The catheter should be inserted well beyond the anal verge
(approximately 6 cm beyond the anus) where the area of highest pressure was previously recorded. The balloon will be
positioned inside the rectum.
NOTE: The catheter should have a balloon fastened at the tip; the balloon must be completely empty upon insertion.
4. When the patient feels the first sensation of fullness, click First Sensation on the control panel and then enter the
infused volume when prompted.
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233
8. When the patient states they cannot hold any more, stop the pump and click Max Tolerance on the Control Panel and
then enter the infused volume when prompted.
9. Leave the catheter in if you are proceeding to the Expulsion study. If proceeding to the Expulsion Testing, do not deflate
the balloon, and turn the stopcock to the OFF position.
- ORDraw back on syringe to empty balloon and remove the catheter carefully if you have finished testing.
Rectal Volume using Fluid and the Integrated LABORIE Pump
1. Setup IV bag of room temperature water and pump tubing. Connect the pump tubing to the catheters filling port.
2. Gently insert a well-lubricated catheter into the patient.
NOTE 1: The catheter should have a balloon fastened at the tip; the balloon must be completely empty upon insertion.
NOTE 2: The catheter should be inserted so the rectal balloon is in the rectum. The catheter should be inserted well beyond the
anal verge (approximately 6 cm beyond the anus) where the area of highest pressure was previously recorded. The balloon will
be positioned inside the rectum.
11. Use the reversible pump feature to remove fluid in the rectal balloon before removing catheter.
Expulsion Test
Clinical note: Patient may be allowed to expel balloon in the left lateral decubitus position or move to a seated position over a
commode chair.
1. If balloon has not already been filled from the Rectal Sensation testing, and the stopcock is closed on the catheter, then
fill the rectal balloon using a syringe to a standardized volume for the expulsion test (50mL recommended).
2. Click Expulsion to start the test.
3. Ensure that the patient is comfortable and then ask the patient to expel the balloon.
4. After approximately 1 minute, click on Expulsion again to end the test.
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234
NOTE: If the VH2O channel is not specified in the test's Configuration file, the volume and response will need to be entered in
the resulting message box. If the VH2O channel is added and specified in the test's Configuration file, the volume will be
automatically read from the specified VH2O channel and the response will be displayed in the resulting message box.
5. Enter the result (whether the patient was capable of expelling the balloon or not) and what fluid volume was used.
6. If patient did not expel the balloon, it is recommended that some volume be removed and have patient try again to
expel the balloon
7. Testing will end when catheter is expelled. If the patient is unable to expel the balloon even when all the volume is
removed, move the catheter carefully.
TESTING IS COMPLETE.
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Summary of pressure data for each stationary squeeze position (6 cm, 5 cm,
4 cm, 3cm, 2 cm, and 1 cm).
Refers to the first set of stationary squeeze pressure data.
Summary of pressure data for each stationary squeeze position (6 cm, 5 cm,
4 cm, 3cm, 2 cm, and 1 cm).
Refers to the first set of squeeze pressure data and allows user to view two
positions simultaneously.
Anorectal Summary
1. Click Info > ARM 4 & 8.
2. Select Anorectal Summary.
Result: The Anorectal Summary window appears.
Profile
Select the Add to Report
box to add that sections
data to the final report
(and
will
also
be
transferred to i-LIST
Office Reporter.
Enter
the
Threshold
value.
Default
value is 0
(zero).
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236
Rest / Squeeze Length to Max Pressure (cm): Distance in centimeters from position of start of test until max
pressure is reached.
Rest / Squeeze Anal Canal Length (cm): Total length in centimeters of anal canal (the total distance between start
and stop of test).
Rest / Squeeze Max Pressure (mmHg): Maximum rest and squeeze pressures (mean, min, max, etc) in mmHg.
Rest / Squeeze HPZ (High Pressure Zone): Sphincter length in centimeters where the pressure is greater than the
(Max Pressure*2/3) of the segment.
Rest / Squeeze HPZ (High Pressure Zone) Area: The sum of the area underneath the pressure curve where the
pressure is greater than the (Max Pressure*2/3) of the segment (the Area of the HPZ is calculated in cm*mmHg).
NOTE REGARDING CALCULATIONS:
The Mean value is the total sum of the calculated values of each channel divided by the number of channels used in the
test.
o
Where:
( )
Formula:
is the calculated value of the channel; n represents the channel number (which can be from 1 to 8).
The SD (standard deviation) is the square root of the sum of the calculated value of each channel minus the mean value,
squared, and then divided by the total number of channels minus 1.
o
Formula :
)
)
Where: is the calculated value of the channel; n represents the channel number (which can be from 1 to 8); and Mean is
the value from the Mean column.
Stationary
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237
Anal Canal Length (cm): Displays the length of the anal canal. Calculated by measuring stationary resting
pressure for each channel at each resting position (1cm, 2cm. etc). If the value at the start of measurement is
greater than the Threshold then 1 cm is added to the anal canal length.
Pressure Variations: utilized to detect the presence or calculate the values associated with slow and ultra-slow waves.
o
Click the Select Region button and select the region on the graph where slow waves exist.
Average Amplitude: The average pressure value in mmHg of the selected region.
Stationary Squeezing Summary: Displays all values relevant to Squeeze data dependent on position and specific
sensor/lumen.
o
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238
FRI (Fatigue Rate Index): Value in minutes used to correlate to the fatigue rate of the sphincter. Calculated as the
difference between max squeeze and max resting pressure (mmHg) divided by the slope of a line of best fit of
the squeeze curve (mmHg / min).
Rectal Volume
Select the Add to Report box to add that sections data to the final report (and will also be transferred to i-LIST Office Reporter.
First Sensation: The value in ml where the patient first felt rectal distention.
Urge: The value in ml where the patient first felt the urge to defecate.
Max Tolerance: The value in ml where the patient felt they could not tolerate further rectal distention.
Compliance: (ONLY possible when Rectum Pressure is measured and is only available on select systems; to activate
this, first map the rectal pressure row in the channel mapping section). Compliance, in mmHg, is the average change
in pressure (mmHg)) as a result of a change in volume (ml) from first sensation to max tolerance. NOTE: compliance
measurements are not possible with T-DOC air-charged catheters.
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RAIR
RAIR: allows user to select whether RAIR is
present or absent at given volume.
Volume: Allows user to select which RAIR
test to view and print with report.
Simple vs. Detailed RAIR:
o Simple RAIR: RAIR test used to only
detect whether RAIR is present or
absent.
o Detailed RAIR: Includes simple RAIR with
the detailed data below.
Reference Resting Pressure: Pressure in
mmHg at which the RAIR test starts.
Excitation:
o Linear Change: Increase in Pressure in %
(based on using the Reference Resting
Pressure as 100%) during the initial rise
in pressure associated with RAIR test.
o Latency: Time taken for the excitation
response to occur post event initiation.
Inhibition:
o Linear Change: Decrease in Pressure in % (based on using the Reference Resting Pressure as 100%) during the
main drop or pressure inhibition associated with RAIR test.
o Latency: Time taken for the inhibition response to occur post event initiation.
Pop-up window to input RAIR Present/Absent after test: Select whether the RAIR Present/Absent pop-up window
is displayed after a test.
Select the Add to Report box to add that sections data to the final report (and will also be transferred to i-LIST
Office Reporter.
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240
Expulsion
Result: Select whether the balloon was expelled or not expelled by the patient.
Select the Add to Report box to add that sections data to the final report (and will also be transferred to i-LIST Office
Reporter.
241
The ARM Resting Profile example displays a pressure summary and 3D profile representation for the first resting profile. To view
results for a second profile, open the Events Summary (Info > Events Summary) and delete the events marking the first profile.
3D Profile Control Buttons
Rotation controls
Position controls
Zoom in and Zoom out controls
Increase and decrease rotational speed
Show 3D figure as a polygon mesh. Click again to return to solid 3D
figure.
ARM Stationary Rest and Squeeze
242
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243
ARM
Profile
Summary
Pressure Profile
Summary
Stationary
Summary
Pressure
Variation
Summary
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244
Squeezing
Summary
Rectal Volume
Summary
RAIR Summary
Expulsion
Summary
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245
NOTE: To print a saved test file, open the test file in the File > Open window of the UDS software and then click the Reporter
button on the control panel to open the i-LIST Office Reporter software.
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246
TBC: Total Bladder Capacity shown in milliliters - automatically calculated based on patients age.
MATBC: Minimal Acceptable Total Bladder Capacity. This limit is the maximum amount of fluid that can be infused into
the patient according to bladder capacity at a given age.
o MATBC = 16 x (Age of child in years) + 70 mlxi.
Height: add height in centimeters
Weight: add weight in kilograms
Surface Area: of the bladder - shown in square meters automatically calculated based on height and weight.
MPUR: Maximum Physiological Urinary Rate - shown in milliliters per minute automatically calculated based on
patients height and weight.
Fill Rate: fill rate of the pump. For more information on pump fill rates for pediatric patients, see page 247.
o Current Pump Speed: allows for selection of slow, medium, or fast fill rate
o Use MPUR for pump speeds: automatically sets the ideal pump filling rate based on MPUR value.
o Sq.Root Bladder Volume: automatically sets the ideal pump filling rate based on TBC value.
NOTE: To enable pediatric pump settings, select the test configuration (.cfg) file first then enter patient information. MPUR and
Sq Root Bladder Volume fill rates can then be selected for the test.
Important! After the warning appears, the pump does not automatically stop. It must be manually stopped.
NOTE: The MATBC is automatically calculated and cannot be changed.
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247
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248
6. Turn on the computer, start the devices, and then turn on the printer.
7. Invite the patient to get ready to take the test.
8. Start the UDS software and enter Patient Information.
9. Click the Uroflow button on the control panel.
10. Click Set Zeroes on the control panel and click Run to start the test.
11. Instruct the patient to void. If possible, leave the room to allow patient privacy.
CAUTION! DO NOT TOUCH the beaker during voiding.
16. Type the post-void residual volume in the PVR box and click OK.
17. Click the Save button or click Reporter to view and print a test report.
18. When the Save Test File box appears click the Save button in the box.
19. Empty the beaker. It can be thoroughly washed and reused.
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249
250
NOTE: Make sure the battery is fully charged before the start of the test.
1. Gather supplies needed for testing (catheters, beaker, commode chair, funnel, transducers, etc).
2. Ensure that the pressure cartridges and pressure transducer tubing are primed. Ensure that the infusion line is primed (free
of air bubbles).
3. Make sure the RoamDX and Urocap V are at full battery and are connected.
4. Plug the HASP key into a USB port on the computer and turn on the computer.
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251
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252
2. Make sure the pressure transducer cartridges and the pressure measurement tubing are primed.
3. Invite the patient to take the test. Ask the patient to void or perform a Uroflow test if required.
4. Open the UDS software and select the UPP test from the Control Panel. (if the UPP button is not visible click Options >
Control Panel Settings and select the PressureFlowUPP control panel set.)
5. Add the patients information, if not already added.
6. Insert a triple-lumen catheter into the patients bladder. At the other end of the catheter, make the appropriate
connections (such as: Pves, Pura, and Pump if applicable).
7. Make sure the pressure transducers are responding by pressing the 100 mm Hg button on the pressure transducer
cartridge.
8. Set the zeroes with the perfusion line dripping at 1 drop every 2 to 3 seconds.
9. Click Run on the Control Panel.
10. Infuse a minimum of 50 cc into the bladder using either the pump or the Infusion Transducer.
11. Once the bladder is filled, stop the pump or close the roller valve on the infusion line. i.e. stop the pump line and not the
UPP drip line.
12. Click Start Pull (or press F6 on the keyboard) and begin to remove the catheter from the patients bladder. If using the
UPX puller, it will begin to remove the catheter from the patients bladder at the preset speed.
13. When the Pura sensor on the catheter is completely out, select Stop Pull (or press F6).
14. Select Return to set up for the next catheter pull.
15. Click the SUMM. Review button at any time to view the UPP summary results at that stage of the test. Then click Return
to Test to continue.
16. When finished click Save to save the test.
LABORIE
253
Possible Cause(s)
Check/Corrective Action(s)
No power on electrical
outlet?
Power
cord
not
connected properly?
Ensure power cord is secure at the base of system and at the electrical
outlet.
Computer or Printer
cannot power on?
No power on electrical
outlet?
Damaged power cord?
Power
cord
not
connected properly?
Ensure electrical outlet is working, power cords are not damaged, and
all power cords are secure at both ends.
Software HASP
not working?
Key
Plugged in to
port?
Software HASP key must not be plugged in to the USB 3.0 ports.
USB
power
connected but
is
only
battery is empty
ALL DEVICES
No response from the
devices?
LABORIE
wrong
254
Symptom(s)
Possible Cause(s)
Check/Corrective Action(s)
No external power is
connected and cannot
wake-up ROAM using
OK
button
or
Bluetooth connection?
Need to restart
Adjust scale on the fly by clicking on the scale values and typing in new
values.
Shave area if necessary and wipe dry. Apply a good amount of tape to
keep moisture out.
Detached electrode?
Re-attach electrode.
No spike response in
EMG and baseline is
flat?
EMG
EMG
reading
high/low?
LABORIE
too
255
Symptom(s)
Possible Cause(s)
Check/Corrective Action(s)
Position of catheters?
Reset zeroes.
Catheter kinked?
Using
water-based
disposables?
Flush lines and reset zeroes. Make sure all stopcocks are in the correct
position.
Calibrate Pump.
Pump pressure
reached?
PRESSURES
Pressure not
responding?
PUMP
Pump not running?
Pump
incorrect?
Pump rate
1ml/min?
Pediatric pump
settings incorrect?
limit
calibration
set
at
Close UDS software and wait a minute. Then restart the software.
In order for pump speeds to be set up correctly for pediatric patients,
follow these steps.
Open a Cystometry test (or any test file using a pump).
Enter patient information for pediatric patient.
Enter Height and Weight to view the calculated MPUR.
Select the Use MPUR for pump speeds option under the Fill
Rate section.
Click Save.
Click Yes.
Click Run and then click Start Pump on the control panel.
Continued on next page..
LABORIE
256
Symptom(s)
Possible Cause(s)
Check/Corrective Action(s)
UROCAP V
Uroflowmeter signal
shows
vibration
and/or spike patterns?
Incorrect
flow
volume readings?
or
Plastic
touching
funnel?
beaker
is
the
flow
Floor is unsteady?
Funnel
beaker?
is
touching
257
Symptom(s)
Possible Cause(s)
Check/Corrective Action(s)
Error message on
screen
reads:
Calibration
Failure(Flow out of
range.)
More
than
500mL
poured into beaker?
Error message on
screen
reads:
Calibration
Failure(Volume delta
out of range.)
BLUETOOTH CONNECTION
Unable to connect via
Bluetooth?
Connection broken?
Reduce the distance between the device and the computer. The
maximum distance between the processor and the computer can be up
to 10 meters (33 feet).
Remove any physical barriers like walls, posts, doors, or people.
Unable to connect
devices to Bluetooth
at first setup?
EVENTS
A transducer change
event is marked on the
graph?
LABORIE
Cable
connected/disconnected
from device?
258
Symptom(s)
Possible Cause(s)
Check/Corrective Action(s)
.NET Framework
needs repair
file
UDS
report
not
transferring to i-LIST
Office Reporter?
Make
sure
i-LIST
MsgQListener is running.
LABORIE
Click Start > Control Panel > and double-click Add or Remove
Programs. OR- Click Start > Control Panel > Programs > Programs
and Features.
In the resulting list, right-click the Microsoft .NET Framework 4
Client Profile file and select Change OR select Uninstall/Change
Select to Repair the file and wait for the repair to complete before
continuing.
Restart the computer.
259
Symptom(s)
Possible Cause(s)
Check/Corrective Action(s)
Printer power
unplugged?
PC
PC does not power on?
PRINTER
Printer LED does not
light up?
cable
Pump
tubing
inserted securely?
Make sure the pump tubing is placed securely into the groove on the
sensor.
BUBBLE DETECTOR
Red light on sensor lit
even though bubbles
are not visible
LABORIE
not
260
Symptom(s)
Possible Cause(s)
Check/Corrective Action(s)
Program
file
for
formatting buttons not
set properly?
The program used for formatting script buttons must use the
AutoHotKey.ahk format. To verify the program is correct follow these
steps:
Go to C:\UDS120 and open the HK folder.
Make sure the file format icons are set to the AutoHotKey
application as follows:
CONTROL PANEL
Script
(Uroflow
Summary
etc)
working?
buttons
Summary,
Review,
stopped
If the icons are not as shown above, for example they are in the
Notepad format (as seen here) then you must change it to the
AutoHotKey application.
LABORIE
261
Symptom(s)
Possible Cause(s)
Check/Corrective Action(s)
LABORIE
Click OK.
262
Symptom(s)
Possible Cause(s)
Check/Corrective Action(s)
TOUCHSCREEN
Touchscreen on tower
frozen?
LABORIE
Press the reset button on the central hub for 5 seconds to reset the
system.
263
LABORIE
264
APPENDIX
APPENDIX A. SYSTEM SPECIFICATIONS
EQUIPMENT SPECIFICATIONS
AQUARIUS Carts
Operating Conditions
Transport
Conditions
and
Storage
Pump Hub
P/N: PMP1000
RoamDX
P/N: RMX1000
Urocap V
P/N: TRA1002
UPX
(arm and stand)
P/N: UPP1001
AQUARIUS CT CART
SINGLE DISPLAY
L = 36 (90.0cm)
W = 26 (66.0cm)
H = 48 (120.0cm)
DUAL DISPLAY
L = 36 (90.0cm)
W = 34.5 (88.0cm)*
H = 48 (120.0cm)
*operational width described can pivot to pass through doors.
L = 29.8 (75.7cm)
W = 25.2 (64.0cm)
H = 49.2 (125.0cm)
Temperatures: 15C to 35C (59F to 95F)
Humidity: 30% to 75% relative humidity (non-condensing)
Pressure: 700 hPa to 1014hPa
Temperature: -10C to 50C (14F to 122F)
Humidity: 20% to 80% relative humidity (non-condensing)
Pressure: 700hPa to 1014hPa
Output Channels: 2 Infusion / 1 Bubble/1 USB type A/ 1 USB type B
Dimensions: 5.5(14cm) L X 3.6(9.3cm) W X 1.6(3.9) H
Weight: 0.60 lbs (0.27kg)
Pressure Range: -50 to +350 cmH20; EMG Range: 0 to 1000uV
Output Channels: 4 Pressure / 1 EMG / 1 Pressure/EMG
Sampling Rate (each channel): Pressure= 50Hz max.; EMG=5000Hz max. / 10 100 Hz (increments of 10Hz)
Dimensions: 6.3(16.0cm) L X 6.3(16.0cm) W X 2.6(6.6cm) H
Weight: 0.95lbs (0.43kg)
Flow Range: 0 to 50mL/s; Volume Range: 0 to 1000mL
Output Channels: Flow; Volume
Sampling Rate: Flow=100Hz max.; Volume=100Hz max.
Dimensions: 23.5(59.7cm) L X 23.5(59.7cm) W X 35.6(90.4cm) H / arm extension : 30 (76cm)
Luxo: Extension 36.0 (91.5cm) / Weight: 3.3 lbs. (1.5kg)
Speed: 0 to 3 mm/s
AQUARIUS XT
TOWER
L = 24 (60.0cm)
W = 26 (66.0cm)
H = 48 (120.0cm)
AQUARIUS XT PC CART
SINGLE DISPLAY
L = 36 (90.0cm)
W = 26 (66.0cm)
H = 48 (120.0cm)
DUAL DISPLAY
L = 36 (90.0cm)
W = 34.5 (88.0cm)*
H = 48 (120.0cm)
*operational width described - can
pivot to pass through doors.
AQUARIUS LT
L = 32 (81.0cm)
W = 26 (66.0cm)
H = 48 (120.0cm)
AQUARIUS CTS
L = 36 (90.0cm)
W = 26 (66.0cm)
H = 48 (120.0cm)
EMG/CMG
Pressure transducers
LABORIE
II
AQS1001
COM532
AQUARIUS CT
AQS2000
AQS2001
COM532
Optional: COM905/COM451
AQUARIUS XT
AQS3000
AQS3001
AQS3002
AQS3003
COM447 / COM450
AQUARIUS CTS
AQS2002
AQS2004
MON185
COM905 / COM451
SOFTWARE COMPONENTS
LAB1000
LAB1001
LAB1002
LIS224
COM397
CDR120
MAN048
LABORIE
III
Roam DX
TRA615/TRA616/ TRA617/TRA618/
TRA619/TRA620/ TRA621
MSM1068
FEA262
CAB1032
CAB1034
ELE350
CAB151
CAB1033
CAB1035
ELE200
CAB150
TRA100
UROCAP V Uroflowmeter
CHA171
CHA181
CHA102
PRI087
MSM1045
POW1016
CAB465
Cable, Power Supply Connector Converter to Plug into LIT, North American
LIT1000
LIT1001
DISPOSABLES
Patient Mounting Accessories for T-DOC Short Cables
HAR144
HAR575
CAT895
LABORIE
IV
CAT880
TUB101
Measurement Tubing
TUB500
DIS950
DIS900
Graduated beaker
ELE428
ELE425
Patch Electrodes, 3 pk
Infusion Sensor
TRA1001
Bubble Sensor
CAB1032
CAB1034
ELE350
CAB151
CAB1033
CAB1035
ELE200
CAB150
MSM1064
MSM1078
CHA1000
ARM100
TRA618
TRA622
CAT003
UPP1001
UPP1002
CAB1000
PRI090
LABORIE
Date Of Manufacture
Manufacturer
Alternating Current
Direct Current
Keep Dry
Sterile
Catalogue Number
Serial Number
LABORIE
Use By
VI
PRODUCT LABELS
Device labels can be found on either the cart leg or the side of the LIT enclosure:
radio equipment
certification
codes
LABORIE
product barcode
VII
LABORIE
VIII
Electromagnetic Compatibility (EMC); Part 3-2 - Limits for harmonic current emissions (equipment input
current up to and including 16A per phase)
Electromagnetic Compatibility (EMC); Part 3 Limits
Section 3: Limits of voltage fluctuations and flicker in low-voltage supply systems for equipment with
rated current 16A
Medical Electrical Equipment -- Part 1-2: General Requirements for Safety -- 2. Collateral Standard:
Electromagnetic Compatibility -- Requirements and Tests
Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment - Electromagnetic
Disturbance Characteristics - Limits and Methods of Measurement
Electrostatic Discharge, 8kV air, 6kV contact
Radiated RF, 3V/m, 80-2500MHz, 80% AM Modulation with a 1.0 KHz sine wave
+A1: 1998
EN 61000-4-4:1995
Electrical Fast Transients, 1kV (5kHz) input/output lines 2kV (5kHz) power supply lines
+A1: 2001
EN 61000-4-5:1995
Fast Surge, 1kV - AC input power port (differential mode)2kV - AC input power port (common mode)
+A1: 2001
EN 61000-4-6:1996
+A1: 2001
EN 61000-4-8: 1993
+A1: 2001
EN 61000-4-11:1994
Conducted RF Immunity, 3V/m, 0.15-80 MHz, 80% AM modulation with a 1kHz sine wave
Power Frequency Magnetic Field, 3A/m
Voltage Dips and Short Interruptions Dips: 95% reduction for 0.5 cycle, 60% for 5 cycles, 30% reduction for
25cycles; interruption > 95% for 5 sec
+ A1: 2001
1. These limits are designed to provide reasonable protection against harmful electromagnetic or other interference in most installations.
However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful
electromagnetic or other interference, which can be determined by turning the equipment off and on, the user is encouraged to try to
correct the interference by one or more of the following measures:
Reorient or relocate AQUARIUS unit.
Increase the separation between AQUARIUS unit and the affected equipment.
Connect the non-medical system equipment into an outlet on a circuit different from that to which the AQUARIUS unit is connected.
Consult the dealer or experienced technical personnel for help.
WARNING! Changes or modifications not expressly approved by LABORIE could void the users authority to operate the
equipment.
2.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause
harmful interference and (2) this device must accept any interference received, including interference that may cause undesired
operation. This device contains:
FCC ID: PVH0925 IC: 5325-0925A
LABORIE
IX
LABORIE
LABORIE
XI
LABORIE
XII
LABORIE
XIII
Uroflowmetry
Cystometry
with
EMG
Advanced
CMG
Simple
Pressure/Flow
Advanced
Pressure/Flow
CO2 Gas
Cystometry
(optional)
UPP
LABORIE
Channel
Titles
Flow
Volume
Pves
EMG
IH2O
VH2O
Pves
Pabd
Pdet
EMG
IH2O
VH2O
Pves
Flow
Volume
Pves
Pabd
Pdet
Flow
Volume
IH2O
VH2O
EMG
Pves
ICO2
VCO2
Pura
Pves
Pclo
Scale
Math Definition
Data
Rate
Display
Attribute
40ml/s
Null
Null
Null
Null
Null
Null
Null
Null
Pves-Pabd
Null
Null
Null
Null
Null
Null
Null
Null
Pves-Pabd
Null
Null
Null
Null
Null
Null
Null
Null
Null
Null
Pura-Pves
5points/s
5points/s
5points/s
5points/s
5points/s
5points/s
4point/s
4point/s
4point/s
4point/s
4point/s
4point/s
3points/s
3points/s
3points/s
3points/s
3points/s
3points/s
3points/s
3points/s
3points/s
3points/s
3points/s
5points/s
5points/s
5points/s
5points/s
5points/s
5points/s
Graphical
Graphical
Graphical
Graphical
Graphical
Graphical
Graphical
Graphical
Graphical
Graphical
Digital
Digital
Graphical
Graphical
Graphical
Graphical
Graphical
Graphical
Graphical
Digital
Digital
Digital
Graphical
Graphical
Graphical
Graphical
Graphical
Graphical
Graphical
600ml
100cmH2O
400(none)
200ml/min
1000ml
100cmH2O
100cmH2O
100cmH2O
400(none)
200ml/min
1000ml
100cmH2O
40ml/s
1000ml
100cmH2O
100cmH2O
100cmH2O
40ml/s
1000ml
200ml/min
1000ml
400(none)
100cmH2O
200cmH2O
1000ml
150cmH2O
150cmH2O
150cmH2O
XIV
abdominal pressure: (Pabd) the pressure surrounding the bladder, usually measured via rectum or vagina.
o Standard channel on CMG or pressure/flow studies, measured in cmH2O.
abdominal leak point pressure: (ALPP) the intravesical pressure at which there is leakage of fluid from the bladder
caused by increasing abdominal pressure by straining or coughing. ALPP less than 60cmH2O pressure is considered
intrinsic sphincter dysfunction. ALPP greater than 90cmH2O pressure can indicate urethral hypermobility, and shows a
low risk of intrinsic sphincter dysfunction.
o Standard annotation in Event Menu, often on Control Panel.
acontractile detrusor: (formerly arreflexic bladder) absence of detrusor contraction under Urodynamic evaluation.
area under the curve: a calculation of the area contained by the curve of a urethral pressure profile.
LABORIE
XV
detrusor pressure: (Pdet) the calculated pressure measurement reflecting that component of total intravesical pressure
that is generated by the detrusor muscle. Pves-Pabd=Pdet.
o Standard on CMG or pressure/flow tests, measured in cmH2O.
electromyogram: the measurement of nerve activity in Urodynamics to monitor sphincter muscle activity.
enuresis: involuntary loss of urine, usually subcategorized as nocturnal enuresis meaning involuntary loss of urine during
sleep.
filling phase: (storage phase) often used to describe the CMG portion of a Urodynamic examination, this phase ends
prior to voiding.
filling rate: the recommendation by ICS is greater than the predicted maximum filling rate (calculated at body weight in
kg divided by 4). Defined as between 10100ml/min, the typical filling rate during Urodynamics with adults is 5060ml/min.
o Usually displayed as a digital channel during CMG or pressure/flow tests, measured in ml per minute.
first desire to void: during Urodynamics, the feeling that would lead the patient to pass urine at the next convenient
moment, but voiding can be delayed.
o Standard annotation in Event Menu, often on Control Panel.
first sensation of filling: during Urodynamics, the feeling when he/she is first aware of bladder filling. The reported
sensation of coldness (secondary to room temperature infused fluid) is not usually considered the first sensation.
o Standard annotation in Event Menu, often on Control Panel.
frequency: the complaint of voiding too often by day.
functional profile length: the length of the urethra along which the urethral pressure exceeds bladder pressure
o calculated within a UPP segment, displayed in mm, as length of continence zone.
idiopathic detrusor overactivity: (formerly detrusor instability) incontinence due to an involuntary detrusor
contraction with no defined cause.
incompetent urethral closure mechanism: when the urethra allows leakage of urine in the absence of a detrusor
contraction.
incontinence: the involuntary loss of urine. May be further defined as: stress incontinence, urge incontinence, mixed
(both stress and urge) incontinence, nocturnal enuresis, and situational incontinence.
International Continence Society: (ICS) The primary interest of the International Continence Society is to study storage
and voiding function of the lower urinary tract, its diagnosis and the management of lower urinary tract dysfunction, and
to encourage research into pathophysiology, diagnostic techniques and treatment. This group sets standards for
Urodynamic testing followed by Laborie Medical Technologies ULCs training programs.
intravesical pressure: (Pves) pressure measured within the bladder. Note that pressure within the bladder can come
from two sources pressure from the body (Pabd) and pressure from the muscle surrounding the bladder (Pdet).
Formerly known as total intravesical pressure.
o Standard channel on CMG, pressure/flow, and UPP tests, measured in cmH2O.
LABORIE
XVI
intrinsic sphincter dysfunction: (ISD) is usually indicated by maximum urethral closure pressure less than 20cmH2O
pressure, or ALPP less than 60cm H2O pressure.
leak point pressure: (LPP, ALPP, VLPP, CLPP) the intravesical pressure at which involuntary urine leakage in noted during
increased abdominal pressure, in the absence of a detrusor contraction. Ex: leakage noted during Urodynamics when
patient is asked to cough or bear down. This can be notated with the modifier of A for abdominal, V for Valsalva, or C for
cough, but all are technically leak point pressures.
o Referred to in cmH2O pressure.
lower urinary tract symptoms: (LUTS) these may include frequency, urgency, incontinence, nocturia, recurrent urinary
tract infections, and many others.
maximum cystometric capacity: (capacity) the volume at which the patient can no longer delay voiding. During
Urodynamics, this is usually the point at which permission to void is given.
o Measured in ml, this is a standard annotation in Event Menu, often on Control Panel.
maximum urethral closure pressure: (MUCP) the maximum difference between urethral pressure and intravesical
pressure. During Urodynamics, this is measured on the Pclo channel, and can be recorded independently or during a
urethral pressure profile.
o Measured in cmH2O.
maximum urethral pressure: (MUP) maximum pressure of the measured profile.
o Measured in cmH2O.
micturition study: a pressure/flow study. This study includes pressure measurements such as Pves and Pabd as well as
Uroflow measurements. This allows documentation of the relationship between the pressure generated during the
voiding event and the resultant flow rate and pattern.
neuropathic detrusor overactivity: (formerly hyperreflexia) detrusor overactivity where there is a relevant neurological
condition.
nocturia: complaint that patient has to wake one or more times to void.
nocturnal enuresis: the complaint of loss of urine during sleep.
normal detrusor function: allows bladder to fill with little or no change in pressure, with no involuntary contractions
despite provocation.
permission to void: annotation placed at time of reported sensation of bladder capacity, recommended by ICS to
document when patient was told to allow voiding. This helps differentiate between contractions that are involuntary,
and contractions that are voluntarily generated to initiate voiding.
phasic detrusor overactivity: a characteristic wave form, which may or may not lead to incontinence post-void residual:
(PVR) the volume of urine left in the bladder after voiding.
pressure/flow study: (Micturition study) a Urodynamic study that includes pressure measurements such as Pves and
Pabd as well as Uroflow measurements. This allows documentation of the relationship between the pressure generated
during the voiding event and the resultant flow rate and pattern.
LABORIE
XVII
Standard will include: Pves, Pabd, Pdet, EMG, Flow, Volume voided, and digital display of volume infused and
infusion rate.
pump rates: using the pump, the rate at which fluid is infused into bladder during Urodynamic testing.
o See filling rate for recommendations.
sensation: in Urodynamics, the reported sensations during testing such as first sensation, first desire, strong desire, and
sense of reaching bladder capacity.
o These are recorded as annotations, in the Event Menu and usually on the Control panel.
stress urinary incontinence: (SUI) the symptom of a loss of urine associated with exertion, often with cough or sneeze.
This is considered a complaint unless proven urodynamically, when it then is known as Urodynamic stress incontinence
(formerly genuine stress incontinence).
strong desire to void: described as the persistent desire to void without fear of leakage.
subtracted pressure: usually referring to the difference between total intravesical pressure and abdominal pressure
Pdet.
o Pves-Pabd=Pdet.
terminal detrusor overactivity: a single involuntary detrusor contraction occurring at capacity, which cannot be
suppressed and results in incontinence, usually resulting in emptying of bladder.
total profile length: not generally accepted as a useful parameter. This is the length of the urethra measured from
where the sensor enters the urethra to where the sensor exits the body.
uninhibited: acting without conscious inhibition often used to describe a bladder contraction which the patient is
unable to suppress.
urethra: the tube leading from the bladder to the outside of the body.
urethral pressure: (Pura) the pressure needed to just open a closed urethra.
o Measured in cmH2O.
urethral pressure profile: (UPP) the pressures recorded throughout the length of the urethra, measured by withdrawing
the catheter at a slow known rate (recommended: 1mm/sec). Most accurately done using a mechanical puller.
o Standard will include: Pves, Pura, and Pclo .
urethral relaxation incontinence: leakage due to urethral relaxation in the absence of raised abdominal pressure or a
detrusor contraction.
urgency: a sudden, compelling desire to void.
o If reported during Urodynamic testing, this can be annotated.
urge incontinence: symptom of incontinence associated with a strong compelling desire to void.
Urodynamic stress incontinence: (formerly genuine stress incontinence, SUI, or stress incontinence) the involuntary
leakage of urine during increased abdominal pressure, in the absence of a detrusor contraction.
valsalva: the attempt to forcibly exhale with a closed glottis often used to increase intra-abdominal pressure.
o Used to provoke stress incontinence, can be annotated as VLPP.
LABORIE
XVIII
voiding phase: (emptying phase) often used to describe the portion of a Urodynamic evaluation that records both
pressures and flow parameters during a voiding event, this would immediately follow the filling phase.
CALCULATIONS
LABORIE
XIX
Number of
Patients (F:M)
39 (35/4)
89 (72/17)
42 (24/18)
35 (19/16)
41 (30/11)
Resting Pressure
(mmHg)
51 (20-100)
62 (18-144)
62 (18-169)
88 (43-164)
88 (30-139)
Squeeze Pressure
(mmHg)
88 (36-200)
123 (0-420)
178 (0-395)
204 (62-380)
173 (60-390)
Rectal Sensory
Volume (mL)
31 (5-120)
27 (5-23)
40 (10-100)
19 (5-60)
43 (10-120)
REUSABLE CATHETERSxix
LABORIE
XX
References
i
Griffiths, Derek Ph.D et al. Quantification of Urethral resistance and Bladder Function During Voiding, With Special Reference to
the Effects of Prostate Size Reduction on Urethral Obstruction Due to Benign Prostatic Hyperplasia. (1989). Neurourology and
Urodynamics. 8:17-27, p. 17.
ii
W. Schfer. Bladder Outflow Obstruction: Urodynamic Measurement and Data Analysis. World J Urol (1995) 13; 47-58.
iii
Griffiths et al. Quantification of Urethral Resistance and Bladder Function During Voiding, With Special Reference to the Effects
of Prostrate size Reduction on Urethral Obstruction Due to Benign Prostatic Hyperplasia. Neurourology and Urodynamics (1989)
8; 17-27.
iv
CHESS Classification of Bladder Outflow Obstruction. World J Urol. 1995; 13(1): 59-64.
v
Siroky MB, Olsson CA, and Krane RJ. The Flow Rate Nomogram: II.Clinical Correlation. J Urol 1980;123:208-10.
vi
Haylen BT, Ashby D, Sutherst JR, Frazer MI and West CR. Maximum and Average Urine Flow Rates in Normal Male and Female
Populations the Liverpool Nomograms. British Journal of Urology. (1989). 64:30-38.
vii
Churchill BM, Gilmour RF, Williot P. Urodynamics. Pediatr Clin North Am. 1987;34:11331157.
viii
Stress Incontinence in Women Evaluation and Interpretation of Urethra Pressure Profiles: Tests with Microtransducers in
Obstetrics and Gynecology 39 (1979) 195-208, Womens Clinic of the Munsterlingen Canton Hospital (Chief Physician: PD E.
Hochuli, M.D.)
viii
THE STANDARDISATION OF TERMINOLOGY IN LOWER URINARY TRACT FUNCTION: Report from the Standardisation Subcommittee of the International Continence Society. Neurourol.Urodyn (2002) 21: 167-178
x
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