Urocap IV™

Quick Start Guide

Standalone Model
The Quick Start Guide is an addition
to the owner’s manual provided with
your Urocap IV™ uroflowmeter.
It should only be regarded as a
helpful reminder of procedures and
is not intended to be comprehensive
or to replace the Urocap IV™
Owner’s Manual.
To order supplies:
USA: 1-800-522-6743
Canada: 1-888-522-6743
International: contact marketing@laborie.com to find your
local representative

LABORIE devices and names are trademarks of LABORIE. All rights reserved. No part of
this publication may be reproduced in any form whatsoever without the prior written
permission of LABORIE.

© Copyright 2015 LABORIE

Document Number: UC4-UM02; Version: 4.0; Release Date: May 22, 2015; Issued By: R.A.

MAN400

Published in Canada.

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 PLEASE 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.

Warnings
1. 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.
2. The Urocap IV system and associated devices are intended for indoor use only and under the following
standard operating conditions:
 Temperature: +10ºC to +40ºC (50ºF to 104ºF)
 Humidity: 30% to 75% relative humidity (non-condensing)
 Pressure: 70 to 106 kPa
3. Before connecting the patient, verify that the Urocap IV system components and software are functioning
properly.
4. Prior to testing, a urinalysis and urine culture should be considered to rule out the presence of infection.
5. 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 at T6 or above 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 other
symptoms are detected, bladder must be emptied immediately. Raise the patient’s head if not already in a
sitting position. Physicians must monitor patients with Autonomic Dysreflexia at least 2 hours after
resolution of the episode.
6. To reduce the risk of cross-contamination or urinary tract 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 is at the discretion of the physician and the policies of the institution.
7. 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.
8. 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.
9. DO NOT USE in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
10. DO NOT USE electromyography (EMG) simultaneously with high frequency surgical equipment.
11. 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.
12. 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.
13. 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.
14. Do not immerse the Urocap IV equipment or any components in water or any other liquids.
15. 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.
16. To prevent cross-contamination, belt and leg straps are made of machine washable materials and should
be washed with hot water between patient use.
17. To prevent external injuries, patients and equipment operators are protected from moving parts of the
pump roller head by limiting the torque of the motor.
18. To ensure patient safety, do not exceed a pressure of 150cmH2O or a volume of 750mL in the pump
settings.
19. Do not place your fingers inside the pump head when the pump rollers are moving.
20. Prime pump tubing before start of procedure. Always continue to monitor for the presence of air bubbles
during infusion and during procedures.
21. DO NOT USE the Urocap IV 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 devices.

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22. 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.
23. Use the Urocap IV system with LABORIE equipment and accessories ONLY.
24. 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.
25. LABORIE equipment is licensed by Governments and approved by Safety Agencies to work with LABORIE
accessories ONLY.
26. LABORIE accessories are licensed by Governments and approved by Safety Agencies to work with LABORIE
equipment ONLY.
27. LABORIE equipment is warranted to work with LABORIE accessories ONLY.
28. LABORIE accessories are warranted to work with LABORIE equipment ONLY.
29. To ensure proper system use, follow the equipment setup instructions in the Equipment Setup section in
this manual.
30. To avoid disruption, ensure the Urocap IV uroflowmeter is plugged in to a power outlet during test
procedures.
31. 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.
32. DO NOT LEAN anywhere on the system or its devices. The devices are not designed to support the weight
of a person.
33. To prevent possible injury to the patient, ensure all castor wheels are locked during testing procedures.
34. Exercise caution when repositioning the Urocap IV system/accessories while patient is connected.
35. The built-in pump is designed for use with water and saline only.
36. The IV pole is not designed to support the weight of the system. Do not lift the cart or table by holding
the IV pole.
37. DO NOT ADJUST the IV pole with an infusion bag/bottle on the hook. Always remove the infusion
bag/bottle before IV pole adjustments.
38. To prevent possible injury to the patient, exercise caution when adjusting IV pole height during a
procedure.
39. DO NOT STERILIZE the Urocap IV system components.
40. Use Input and Output Cables and Cords provided by LABORIE ONLY.
41. To prevent insulation failure, the insulation requirements are of higher quality and resist cuts and breakage
above and beyond consumer grade cable insulation.
42. 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.
43. 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.
44. Exposure to ESD may cause the system to RESET.
45. Do not plug in or unplug any transducers when a procedure is running. Always stop the procedure before
plugging in or unplugging transducers.
46. In case of device connection/Bluetooth connection interruption, reconnect the devices as outlined in the
owner’s manual.
47. 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.
48. 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.
49. 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.
50. 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.
51. 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.
52. To reduce the potential of patient information loss or the compromising of patient data, the Urocap IV
software automatically encrypts patient data.
53. To reduce the potential of data loss during download, the data stored in the system is not erased until
download is fully complete.
54. To prevent unauthorized access to patient and test data, the software requires valid user name and
password login.
55. To reduce the risk of incorrect report generation or incorrect data recording, the software ensures that
each patient’s MRN is unique and avoids the potential for duplicate MRNs.
56. To avoid loss of data during a test, the Urocap IV software automatically backs up test data every 1 minute.

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57. To avoid the potential of incorrect data reporting, always verify all remote events are downloaded with
data.
58. To reduce the risk of EMG reading misinterpretation, the EMG channel scales are modifiable.
59. To reduce the risk of incorrect Compliance Event calculations, the software employs sample averaging
when calculating Compliance.
60. To reduce the risk of incorrect automatic Pdet event placement, always check the position of the event
when marked on the graph.
61. 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.
62. Transthoracic stimulation, such as maintaining anode and cathode stimulation sites in close proximity,
must be avoided.
63. 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.
64. Operation in close proximity (1 meter) to shortwave or microwave therapy equipment may produce
instability in the Stimulator output.
65. Avoid accidental contact between connected but unused applied parts and other conductive parts
including those connected to protective earth to prevent damage or injury.
66. 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.
67. 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.
68. Do not plug or unplug devices, or pair or unpair Wi-Fi or Bluetooth devices, while the Urocap IV system is in
use.
69. To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective
earth.
70. No modification of this equipment allowed.
71. Connecting electrical equipment to a multiple socket outlet effectively leads to creating an a medical
electrical system and can result in a reduced level of safety.
72. The Urocap IV 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.
73. To prevent patient injury, the device complies with EN 60601-1: Instability in transport position safety test
for medical electrical equipment.
74. To prevent misinterpretation or misdiagnosis, the device complies with EN 60601-1-2: EMG Test
requirements in Failure Mode and with EN 62304 Medical Device Software - Software life cycle processes.
75. To prevent unexpected power failures, the device is compliant to safety standards: “EN 60601, UL60601,
CSA 22.2 No. 601.
76. To prevent unexpected exposure to radiation, the device has been tested against EN 60601-1-2 EMC
standards.
77. 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.
78. To prevent connection failure between the Urocap IV and the PC, the device complies with EN 60601-1-2
EMC standards.
79. To prevent patient injury, warning symbols on all labels comply with EN ISO 15223-1 and EN 1041.

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STEP 1: GATHER EQUIPMENT

Urocap IV Beaker Commode Funnel

Chair
PLUS:
 Straight catheter (CAT380[female], CAT383[male])
 Power supply and charger

STEP 2: SET UP THE UROCAP IV AND

ACCESSORIES
• Plug the power cord into an
electrical outlet.
• Place the funnel on the commode
chair.
• Carefully place the Urocap IV on
the floor.
• Gently place a graduated beaker
on top of the Urocap IV.
• Place the commode chair and
funnel over top of the Urocap IV
and beaker.
• Confirm that the beaker is flat and
centered on the platform, and that
the funnel is not touching the
beaker.
 Turn on the computer and printer.
 Invite the patient to get ready to take the test.

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STEP 3: RUN THE UROFLOW TEST

• Double-click the Urocap IV

shortcut icon on the computer
desktop.

• Confirm the Urocap IV is connected.

• Click the Uroflow Auto Recording

button on the control panel.

• Confirm that all channels display zero

values.

CAUTION! DO NOT TOUCH the • Instruct the patient to void; provide

beaker during voiding. privacy if possible.

• The graph will start scrolling once flow

is detected and will stop automatically
50 seconds after voiding ends.

• When the Patient Information screen

appears, enter information, as
necessary, and click OK.

Perform a PVR • Straight catheterize patient to obtain

post void residual measurement.

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 • Remove the catheter.

• When the Voiding Summary screen

appears enter the PVR value and click
OK.

• Wait for the data to be transferred to

the i-LIST™ Office Reporter
application.

• In the fields on the left side of the

screen, enter information to include in
the printed report.

• Click the printer icon to print the report.

 Empty the beaker. It can be

thoroughly washed and reused.

Test complete.