LABORIE UROCAP IV User manual

LABORIE Urocap™ IV Owner’s Manual – UC4-UM01-V13.00
UROCAP™ IV
Owner’s Manual
Standalone Model

2 LABORIE Urocap™ IV Owner’s Manual UC4-UM01
LABORIE Headquarters
6415 Northwest Dr., Unit 10
Mississauga, Ontario, Canada L4V 1X1
Tel: [phone]
Fax: [phone]
LABORIE USA
400 Avenue D, Suite 10
Williston, Vermont, USA 05495
Tel: [phone]
Fax: [phone]
LABORIE Europe/International
Medical Measurement
Systems B.V.
Colosseum 25
7521 PV Enschede
The Netherlands
Tel.: [phone]
Fax: [phone]
www.laborie.com
TRADEMARKS
Urocap is a trademark of LA B O R I E Medical T e c hn o l o g i e s Canada ULC. B l u e toot h is a r e g i s t e r e d trademark o f B l u e toot h S I G .
Android is a
trademark of G oo g l e I n c . Wi-Fi is a r e g i s t e r e d trademark of the Wi-Fi A lli a n c e . MOTOROLA and product i m a g e s are
trademarks or r e g i s t e r e d trademarks of M oto r o l a Trademark H o l d i n g s , LLC. ASUS and product i m a g e s are trademarks or
r e g i s t e r e d trademarks of A S U S T e K Computer I n c .
Other names may be trademarks of their r e s p e c t i v e o w n e r s . C O P Y R I G H T
All rights r e s e r v e d . No part of this p u b li c a t i o n may be reproduced in any form whatsoever without the prior w r i tt e n p e r m i ss i o n of
LA B O R I E .
©
C o p y r i g h t 2017-2020 LA B O R I E
I M A G E S / R E N D E R I NG S OF LA B O R I E DE V I C E S I N T H I S P UB LI C AT I O N ARE P R O P E R T Y OF LA B O R I E AND M A Y NOT BE REPRODUCED
W I T H O UT THE P R I O R W R I TT E N P E R M I SS I O N OF LA B O R I E .
Document Number: UC4-UM01-V13.00 / MAN401
Version: 13.00
Release Date: April 15, 2020
Laborie Medical Technologies Canada ULC
6415 Northwest Drive, Unit 10
Mississauga ON L4V 1X1
CANADA

LABORIE Urocap IV Owner’s Manual UC4-UM01 3
CONTENTS
About This Manual ............................................................................................................................................................7
1Introduction................................................................................................................................................................8
1.1 General Description..........................................................................................................................................8
1.2 Main Features....................................................................................................................................................8
1.3 Cautions and Warnings ....................................................................................................................................9
1.4 Intended Use...................................................................................................................................................11
1.5 Target Population ...........................................................................................................................................11
1.6 Contraindications............................................................................................................................................11
2Cleaning and Maintenance .....................................................................................................................................12
3Battery: Charging and Maintenance.......................................................................................................................13
3.1 Charging the Battery ......................................................................................................................................13
3.2 Preventative Maintenance..............................................................................................................................13
3.3 Treating and Disposing of Product After Use...............................................................................................13
3.4 Environmental Consideration of Waste Disposal .........................................................................................14
4Device Setup ............................................................................................................................................................14
4.1 Perform an Equipment Check........................................................................................................................14
4.2 Set Up Equipment ..........................................................................................................................................16
4.3 Install Software................................................................................................................................................16
4.4 Connect Urocap™ IV to Software.................................................................................................................16
4.5 Wireless Printer Setup ....................................................................................................................................18
4.5.1 Before You Begin........................................................................................................................................18
4.5.2 Set Up the Printer on Your Wireless Network...........................................................................................19
4.5.3 Print Using Wi-Fi Direct ..............................................................................................................................19
4.5.4 Change the Connection Type....................................................................................................................20
5Device Features and Functions...............................................................................................................................22
5.1 LED Lights .......................................................................................................................................................22
5.2 Connection Status...........................................................................................................................................22
5.3 Battery Status ..................................................................................................................................................23
5.4 Device Connector and System Reset Button ................................................................................................24
6Software Features and Functions............................................................................................................................24
6.1 Quick Start.......................................................................................................................................................25
6.2 File Menu.........................................................................................................................................................25
6.2.1 Open............................................................................................................................................................25
6.2.2 Open from Data File...................................................................................................................................25
6.2.3 Save As ........................................................................................................................................................25

4 LABORIE Urocap™ IV Owner’s Manual UC4-UM01
6.2.4 File Saving Directory...................................................................................................................................25
6.2.5 Print Study...................................................................................................................................................26
6.2.6 Batch Print (Optional Feature) ...................................................................................................................26
6.2.7 About UDS Client .......................................................................................................................................26
6.2.8 Exit ...............................................................................................................................................................26
6.3 Config Menu ...................................................................................................................................................26
6.3.1 Save As ........................................................................................................................................................26
6.3.2 Set Up/Modify (Optional) ...........................................................................................................................27
6.3.3 Unlock CFG .................................................................................................................................................29
6.4 Info Menu ........................................................................................................................................................30
6.4.1 Patient Info ..................................................................................................................................................30
6.4.2 X-Y PLOTS ...................................................................................................................................................30
6.4.3 Event Summary ...........................................................................................................................................32
6.4.4 Voiding Summary........................................................................................................................................33
6.4.5 Uroflow Options..........................................................................................................................................34
6.5 Options Menu .................................................................................................................................................35
6.5.1 Test Restart .................................................................................................................................................35
6.5.2 Test Playback ..............................................................................................................................................35
6.5.3 Uroflow Auto Start ......................................................................................................................................36
6.5.4 Cursor Value Indicator................................................................................................................................36
6.5.5 Digital Value Indicator ................................................................................................................................36
6.5.6 Control Panel Settings................................................................................................................................36
7Run a Uroflow Test ...................................................................................................................................................44
7.1 Auto Method...................................................................................................................................................44
7.2 Manual Method...............................................................................................................................................45
8Print a Test................................................................................................................................................................46
8.1 Printing From iLIST Office Reporter ..............................................................................................................46
9Calibration ................................................................................................................................................................48
10 Quick Reference and FAQ..................................................................................................................................48
11 Troubleshooting..................................................................................................................................................49
11.1 Urocap™ IV .....................................................................................................................................................49
11.2 Bluetooth Connection ....................................................................................................................................50
11.3 Software Error Messages................................................................................................................................51
11.4 Printer ..............................................................................................................................................................51
12 Appendices .........................................................................................................................................................52
APPENDIX A. Specifications and System Information .................................................................................................52

LABORIE Urocap IV Owner’s Manual UC4-UM01 5
Classifications...............................................................................................................................................................52
Applicable Standards and Directives .........................................................................................................................53
APPENDIX B. Symbols and Labeling ............................................................................................................................53
Symbols Glossary.........................................................................................................................................................53
APPENDIX C. Electromagnetic Compatability (EMC)..................................................................................................54
APPENDIX D. TABLES OF GUIDANCE AND DECLARATION REGARDING ELECTROMAGNETIC IMMUNITY....55
IEC 60601-1-2: 2014 - Table 1 Requirements .........................................................................................................56
IEC 60601-1-2:2014 – Table 2 Requirements..........................................................................................................56
IEC 60601-1-2: 2014 – Table 4 Requirements.........................................................................................................57
IEC 60601-1-2: 2014 – Table 6 Requirements.........................................................................................................58
APPENDIX E. End User License Software Agreement.................................................................................................59
APPENDIX F. Print Options for UDS120 Goby Software for Urocap™ IV.................................................................60
APPENDIX G. Nomogram Tables for Uroflowmetry – Male ........................................................................................62
APPENDIX H. Nomogram Table for Uroflowmetry – Female......................................................................................63
APPENDIX I. Glossary...................................................................................................................................................64
Terms Used in Urodynamic Testing............................................................................................................................64
Common Acronyms .....................................................................................................................................................65
LIST OF FIGURES
Figure 1 – Do not immerse the Urocap ™ IV.................................................................................................................12
Figure 2 – Cleaning the Urocap™ IV.............................................................................................................................12
Figure 3 – Urocap™ IV charging port location.............................................................................................................13
Figure 4 – Urocap™ IV Main Controls............................................................................................................................24
Figure 5 – Save Test File Window...................................................................................................................................25
Figure 6 – Change Data Directory Window ...................................................................................................................25
Figure 7 – Configuration Window ..................................................................................................................................27
Figure 8 – Configuration Window, Security Tab............................................................................................................28
Figure 9 – Unlock CFG ....................................................................................................................................................29
Figure 10 – Lock CFG ......................................................................................................................................................29
Figure 11 – Patient Information Window .......................................................................................................................30
Figure 12 – Siroky Nomogram Window .........................................................................................................................31
Figure 13 – Liverpool Nomogram Window....................................................................................................................31
Figure 14 – Pediatric Nomogram Window.....................................................................................................................32
Figure 15 – Using and Adapting Event Markers............................................................................................................33
Figure 16 -- Voiding Summary Window .........................................................................................................................33
Figure 17 – Select Color Window ...................................................................................................................................41
Figure 18 – iList Office Report Main Window ................................................................................................................46
Figure 19 – iList Office Report Section Overview ..........................................................................................................47
Figure 20 – Selecting Report Template .........................................................................................................................47
Figure 21 – Calibrating the Urocap™ IV with UDS120..................................................................................................48
Figure 22 – Print Options Window .................................................................................................................................60

6 LABORIE Urocap™ IV Owner’s Manual UC4-UM01
LIST OF TABLES
Table 1 – Standard Equipment .......................................................................................................................................15
Table 2 – Optional Equipment .......................................................................................................................................16
Table 3: Connecting Urocap™ IV to the Software ........................................................................................................18
Table 4 – Device Manager System Status Indicator Icons ............................................................................................23
Table 5 – Device Manager Battery Status indicator Icons ............................................................................................23
Table 6 – Parameters Available in the Uroflow Options Dialogue Box........................................................................35
Table 7 – Configuring Control Panel Settings ...............................................................................................................37
Table 8 – Control Panel Commands ..............................................................................................................................38
Table 9 – Configuring Control Panel Sets......................................................................................................................39
Table 10 – Adding an Images to Control Panel Buttons...............................................................................................40
Table 11 – Modifying Graph Appearance......................................................................................................................42
Table 12 – Adapting Channel Order ..............................................................................................................................42
Table 13 – Adjusting Event Marker Location .................................................................................................................43
Table 14 – Adjusting Channel Font ................................................................................................................................43
Table 15 – Performing a Uroflow Study using Automatic Flow Detection...................................................................45
Table 16 – Performing the Uroflow Study Utilizing Manual Start .................................................................................46
Table 17 – Troubleshooting Urocap™ IV Usage ...........................................................................................................50
Table 18 – Troubleshooting Bluetooth Connectivity ....................................................................................................50
Table 19 – Understanding Error Messages....................................................................................................................51
Table 20 – Troubleshooting Printer Usage ....................................................................................................................51
Table 21 – Equipment Specifications .............................................................................................................................52
Table 22 – Classification..................................................................................................................................................52
Table 23 – Applicable Directives and Standards...........................................................................................................53
Table 24 – Symbols Glossary ..........................................................................................................................................53
Table 25 – Label Placement ...........................................................................................................................................54
Table 26 – Electromagnetic Environment Emissions Requirements, Compliance, and Guidance ............................56
Table 27 – Electromagnetic Environment Immunity Requirements, Compliance, and Guidance ............................57
Table 28 -- Electromagnetic Environment Immunity Requirements, Compliance, and Guidance for RF Transmitting
Devices.............................................................................................................................................................................58
Table 29 – Separation Distance Requirements..............................................................................................................59
Table 30 – Print Preferences Options.............................................................................................................................61
Table 31 – Nomogram Tables – Male ............................................................................................................................63
Table 32 – Nomogram Tables - Female.........................................................................................................................63

LABORIE Urocap IV Owner’s Manual UC4-UM01 7
ABOUT THIS MANUAL
As you read through the manual, you will find i n fo r m a t i o n on how t o c on fi g u r e f e a t u r e s in the Urocap™ IV
software, as well a s i n for m a t i on on care and m a i n t e n a n c e of the Urocap™ IV s y s t e m .
Throughout the manual you will also find specially marked s e c t i on s t h a t e m p h a s i z e i m p or t a n t r e m i n d e r s
and
i n f or m a t i o n to help you understand the features of the system, as marked h e r e :
C AU T ION
Provides in
f o r m a t io n users need to know in order t o
p r e v e n t minor injury or product d am ag e .
I M PO R T AN T
Provides important in f o r m at io n regarding use of
device
o r s o f t w a r e
N OT E
Provides useful in
f o r m at io n or reminders while
o p e r at in g the device or s o f t w ar e .

8 LABORIE Urocap™ IV Owner’s Manual UC4-UM01
1INTRODUCTION
LABORIE’s Urocap™ IV is a simple and easy-to-use Uroflowmeter with built-in comparative studies. These studies,
along with other unique features, will deliver highly accurate Uroflowmetry recordings that are easy to produce
and interpret. An added feature is the built-in Bluetooth® technology — providing you with the ease and
flexibility of wireless connection to perform all your Uroflowmetry procedures.
Uroflowmetry (Uroflow) is a standard Urodynamic test, whereby the urine flow rate and volume are measured.
Uroflowmetry is used to verify or disprove patient symptoms via scientific methodology. It is a prerequisite for
you, as a user of this equipment, to understand the basic measuring principles and techniques of Uroflowmetry
analysis.
The purpose of this manual is to familiarize you with the installation, use, and operation of the Urocap™ IV
Uroflowmeter.
For further information or technical service, please contact your local LABORIE sales representative or contact
LABORIE.
For warranty information and terms and conditions, visit www.laborie.com.
1.1 GENERAL DESCRIPTION
The Urocap™ IV uses Uroflowmetry as a form of Urodynamic testing. The urinary flow rate and volume are
measured and the results, in general, are used to verify or disprove patient symptoms via scientific methodology.
Data acquisition occurs as the transducer collects and processes data, which is displayed via the Urocap™ IV
software application. It prints the data in graphical form through the Urocap™ IV software or the i-LIST™ Office
Reporter software, and is followed by a calculated Voiding Summary.
1.2 MAIN FEATURES
Features include:
•Hardcopy printout of Uroflow report including:
oPatient information section
oUroflow graph including Flow and Volume channels
oVoiding Summary
•On-site calibration
•Software interface with real-time graph scrolling

LABORIE Urocap IV Owner’s Manual UC4-UM01 9
1.3 CAUTIONS AND WARNINGS
READ CAREFULLY BEFORE USE
CAUTION
United States Federal Law restricts this device to sale or use by, or on the order of, a licensed physician.
GENERAL SYSTEM WARNINGS:
•Only technicians and physicians trained in Urodynamics should operate this device. The operator must read
the Owner’s manual entirely and refer to any additional training materials before using the device. Optional
In-Service is available from LABORIE.
•The Urocap™ IV system and associated devices are intended for indoor use only and under the following
standard operating conditions:
oTemperature: +10ºC to +40ºC
oHumidity: 30% to 75% relative humidity
oPressure: 700 to 1060 hPa (up to 2000m)
•Physicians and technicians MUST inform patient of any potential risks of the procedure including potential
discomfort, dysuria and hematuria.
•DO NOT USE in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
•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.
•DO NOT STAND anywhere on the system or its devices. The devices are not designed to support the weight
of a person.
•DO NOT immerse the Urocap™ IV equipment or any components in water or any other liquids.
•DO NOT USE the Urocap™ IV in the presence of a magnetic resonance imaging system as it may contain
ferromagnetic objects that pose a risk to the patient in the presence of a magnetic core. The strong
magnetic field produced by the MRI may cause disruption of the system.
•DO NOT ATTEMPT TO OPEN OR REPAIR the Urocap™ IV system components by yourself or by an
unauthorized party. ONLY Laborie-trained technicians may service the Urocap™ IV system components.
•LABORIE equipment and accessories are licensed by Governments and approved by Safety Agencies to
work with each other ONLY.
•LABORIE equipment and accessories are warranted to work with each other ONLY.
•No modification of this equipment is allowed.
•DO NOT STERILIZE the Urocap™ IV system components.
•Use Input and Output Cables and Cords provided by LABORIE only.
•Exposure to ESD may cause the system to RESET.
•To avoid risk of electric shock, this equipment must only be connected to supply mains with protective earth
to prevent damage or injury.

10 LABORIE Urocap™ IV Owner’s Manual UC4-UM01
•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.
•The Urocap™ IV system must be positioned in such a way to provide unobstructed access to the power cord
connector in the event of a required emergency stop.
•Do not place the printer in the patient environment unless it is powered via the Laborie provided Line
Isolation Transformer (Separating transformer).
•Only connect items that have been approved by Laborie to the system. Any additional connections become
the responsibility of the operator and shall tested to meet the IEC 60601-1, ME SYSTEMS requirements.
•There is the risk of electrical shock if the operator plugs in Non-ME Equipment (i.e. printer or laptop) directly
into the MAINS supply that is intended to be powered by a Line Isolation Transformer (Separating
transformer)
•Do not touch the printer/laptop and the patient simultaneously.
General System Important Information
•Before the procedure, verify that the Urocap™ IV system components and software are functioning properly.
•LABORIE is not responsible for loss of patient files or test data. It is strongly recommended to back up patient
data on a regular basis.
•To avoid the potential of incorrect data reporting, always verify all remote events are downloaded with data.
•Avoid accidental contact between connected but unused applied parts and other conductive parts including
those connected to protective earth to prevent damage or injury.
•Do not plug or unplug devices, or pair or unpair Bluetooth devices, while the Urocap™ IV system is in 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.
•To ensure proper system use, follow the equipment setup instructions in the Equipment Setup section in this
manual.
•To avoid disruption, ensure the Urocap™ IV uroflowmeter is plugged in to a power outlet during test
procedures.
•It is important that the beaker is well centered on the Urocap uroflowmeter and does not touch the funnel.
DO NOT TOUCH the beaker during voiding and ensure the patient does not touch or move the beaker
during a procedure.
•In case of device connection/Bluetooth connection interruption, reconnect the devices as outlined in this
manual
•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).
Also, remove any physical barriers like walls, posts, doors, or people.
•To reduce the risk of equipment connection failure, the software contains built-in algorithms that add
checksum (CRC) protocols to data transmissions. In the event the data received is not correct, an alert
message is displayed to the user.
Generals System Safety Compliance
•The Urocap™ IV uroflowmeter enclosure is classified IP54 according to degree of protection against ingress
of water and particulate matter as per the test requirements of IEC 60529.