NanoVibronix URO SHIELD User manual

User Manual
Cat. # 20-100-0022 ver. 02 (USA)

UroShield® User Manual
20-100-0022 Ver. 02 2
Without prior notice and without obligation, the contents of this manual may be revised
to incorporate changes and improvements.
Every effort is made to ensure that the information is complete and accurate at the time
of publication. Nevertheless, NanoVibronix cannot be held responsible for errors or
omissions.
Trademarks, patents, and copyrights apply.
NanoVibronix Inc.
525 Executive Boulevard,
Elmsford, N.Y. 10523, USA
Tel.: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.nanovibronix.com
NanoVibronix Ltd,
9 Derech Hashalom St,
Nesher 3665112, Israel.
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
Website: www.nanovibronix.com
CEpartner4U BV,
Esdoornlaan 13,
3951 DB Maarn,
The Netherlands
Tel.: +31.343.442.524
Mobile: [phone]
Fax: +31.343.442.162
[e-mail]

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Table of Contents
1 Introduction ......................................................................................... 6
1.1 Biofilm Formation and Urinary Tract Infections ......................... 6
1.2 General Safety ............................................................................ 7
2 Indications for Use ............................................................................... 8
3 Safety Warnings and Cautions ............................................................. 9
4 Product Features ............................................................................... 12
4.1 Mains and Battery Operation .................................................. 12
4.2 Operating Cycle ........................................................................ 12
5 Product Components ......................................................................... 13
5.1 The Actuator ............................................................................ 13
5.2 The UroShield
®
Driver .............................................................. 14
6 Operation .......................................................................................... 15
6.1 Connecting the UroShield
®
....................................................... 15
6.2 Switching the UroShield
®
ON or OFF ........................................ 18
6.3 Recharging the UroShield
®
Battery .......................................... 19
6.4 Instructing the Patient ............................................................. 20
6.5 Monitoring the UroShield
®
....................................................... 21
6.6 Disconnecting the Driver from the Actuator ............................ 23
6.7 Showering and Bathing ............................................................ 24
7 Frequently Asked Questions .............................................................. 25
8 Product Care ...................................................................................... 26
8.1 Storage ..................................................................................... 26
8.2 Environmental Operating Conditions ....................................... 26
8.3 The Driver ................................................................................ 26
8.4 The Actuator ............................................................................ 27
Appendix A: Electromagnetic Compliance .............................................. 28
UroShield Essential Performance ........................................................... 30

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Appendix B: Specifications...................................................................... 31
Appendix C: Labels.................................................................................. 32
Appendix D: Symbols .............................................................................. 33
Appendix E: Warranty ............................................................................ 34

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Disclaimer for Physicians and Patients
in the USA
The UroShield has neither been cleared or approved to aid in the
reduction of catheter-associated urinary tract infection (CAUTI)
incidence in patients requiring long-term (≥ 14 days) indwelling
catheterization.
The UroShield is under Enforcement Discretion for use during the
COVID-19 epidemic; and,
The UroShield is under Enforcement Discretion only for the duration of
the declaration that circumstances exist justifying the authorization of
the emergency use of medical devices under section 564(b)(1) of the
Act, 21 U.S.C. § 360bbb-3(b)(1)
Note for Healthcare Facilities:
Healthcare facilities using the UroShield should make available to
patients the accompanying Patient Insert and healthcare providers the
accompanying Healthcare Provider Insert.
Healthcare facilities using the UroShield should make NanoVibronix,
Inc., and FDA aware of any adverse events under 21 CFR Part 803.
Healthcare facilities should ensure healthcare providers using the
UroShield are adequately equipped, trained, capable, and will
maintain records of device usage

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1 Introduction
Thank you for choosing the UroShield®. This manual contains general
instructions for operation, application, precautions and care. In order to obtain
maximum life and efficiency from the UroShield® and to assist in its proper
operation, please read and understand this manual thoroughly. The UroShield®
device is to be used only as directed in this manual.
1.1 Biofilm Formation and Urinary Tract Infections
Catheter-associated urinary tract infection (CAUTI) and other indwelling-device
associated infections are a major cause of morbidity and mortality in
hospitalized patients.
(1)
Urinary catheters readily acquire biofilms after
insertion; and the longer the catheter remains in place, the greater is the
tendency for the formation of biofilms, resulting in urinary tract infections.
The initial step in biofilm formation is the adhesion or attachment of planktonic
bacteria to the catheter surface. It is thought that the bacteria use touch
sensors to attach to a solid surface.
(2)
This occurs within a few hours after
urinary catheter placement. After attachment the bacteria begin to interlock, a
process known as docking. The bacteria then secrete an extra-cellular
polymeric matrix (ECM), which allows them to survive and proliferate. The
complex of the bacteria and ECM, now adherent to the catheter surface, is
known as biofilm. The established biofilm is highly resistant to antibiotics and
to the body's immune system.
The UroShield® is intended to prevent bacterial biofilm formation by
generating acoustic waves on the inner and outer surfaces of the catheter.
1
Pugach JL, DiTizio V, Mittelman MW et al; Antibiotic Hydrogel Coated Foley Catheters
for Prevention of Urinary Tract Infection in a Rabbit Model. The Journal of Urology,
Volume 162, 883-887, September 1999.
2
Princeton University News- Discovery of bacterial touch sensor could lead to Biofilm
treatments. http://www.princeton.edu/pr/news/02/q1/0205-touchsensor.htm.

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1.2 General Safety
Thoroughly read and understand the precautionary and operating instructions
before attempting to operate the UroShield®. Observe the precautionary and
operational labels on the product. Periodically review the operation
procedures and safety precautions outlined in this manual.

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2 Indications for Use
The NanoVibronix™ UroShield™ is an extracorporeal accessory to indwelling
urinary catheters intended to aid in the reduction of catheter-associated
urinary tract infection (CAUTI) incidence in patients requiring long-term (≥ 14
days) indwelling catheterization.

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3 Safety Warnings and Cautions
W A R N I NG
 The UroShield is not intended for use for
suprapubic or other types of catheterization
other than catheterization through the
urethra with a Foley catheter.
 Insertion and removal of catheters and
connection, operation, and disconnection of
the UroShield® should be performed only by
qualified medical staff and in accordance
with the relevant medical facilities care
guidelines.
 Do not use the UroShield® as a treatment for
an active urinary infection.
 Do not use the UroShield® in the presence of
flammable materials and liquids. The
UroShield® is classified as internally-powered,
intermittently-operated, ordinary equipment
with a disposable type BF applied part.
 The UroShield® is not MRI compatible and
therefore, should be detached from the
catheter before entering the MRI suite.
 Use the UroShield® only as instructed in this
manual.
 Do not use the UroShield® or any accessories
if they appear to be damaged.
 Do not modify the UroShield® in any way.
 Healthcare professional or a caregiver should
periodically inspect and confirm integrity of
connection and operation of UroShield®
when used by a patient known to be
incapable of managing the device.

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WARNING
 The UroShield® has no user serviceable parts. If it is
not operating correctly, contact the local
representative of NanoVibronix. No part of the
UroShield® should be replaced with components or
parts other than those supplied by NanoVibronix.
 Use of accessories, transducers and cables other
than those specified or provided by the
manufacturer of this equipment could result in
increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and
result in improper operation.
 Portable RF communications equipment (including
peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12
inches) to any part of the UroShield®, including
cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment
could result.
 UroShield® needs special precautions regarding
EMC and needs to be installed and put into service
according to the specific instructions for
maintaining basic safety and essential performance
with regard to electromagnetic disturbances for the
expected service life provided in Appendix A of this
manual.

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C A U TION
 The UroShield® is intended for use in
professional healthcare facilities (e.g.,
Hospitals, , Temporary Hospitals,
Nursing Homes, Long-term Care, etc.).
 The UroShield® driver is not
waterproof. Do not expose it to water.
 Recharge the UroShield® only with the
supplied charger or recommended USB
power bank devices.
 Do not attempt to open or remove any
of the covers of the UroShield®.
 The lithium ion rechargeable battery in
the UroShield® must not be
disassembled, heated above 100
degrees Celsius, incinerated, or
exposed to water.
 The actuator cable can get caught /
entangled or even wrapped around a
person’s body and lead to potential
injury or restrict blood flow.

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4 Product Features
4.1 Mains and Battery Operation
The UroShield® can be powered by the AC mains or via its internal
rechargeable battery. During normal use it can be continuously connected to a
wall outlet. However, to provide patient mobility it can be powered by the
internal battery for up to 6 hours (when fully charged).
The internal battery can be fully charged in about 2 hours.
4.2 Operating Cycle
When the UroShield® is ON, it alternates between the following 2 phases:
 Active phase—the UroShield® generates acoustic waves on the
surface of the catheter. This phase is 15 minutes long (a low audible
sound can be heard).
 Idle phase—the UroShield® does not generate acoustic waves on the
surface of the catheter. This phase is 5 minutes long.

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5 Product Components
The UroShield® has two primary components: an actuator and a driver.
An AC power adapter with a recharging cable is also supplied.
5.1 The Actuator
The small, lightweight actuator clips onto the urinary catheter after the
catheter’s insertion into the patient's urethra. When the UroShield® is active,
the actuator generates acoustic waves on the surface of the catheter. The
actuator itself does not contact the patient’s skin. The actuator is intended for
single use only: that is, for use with one catheter only (until the catheter is
replaced or for a maximum use for 30 days).
The UroShield® actuator can be used with urinary catheters sized 12, 14, 16,
18, 20, or 22 French.

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5.2 The UroShield
®
Driver
The driver supplies electrical signals to the actuator. It has the following parts:
 Built-in rechargeable battery
 Charging USB port
 Connection cable (to connect the actuator)
 ON/OFF button
 Operational display screen
The driver is small and lightweight and can be attached (see figure below) using
a lanyard or placed on the patient’s bed. When the patient needs to be mobile,
the UroShield driver can be placed in a pocket, attached to a belt or a leg strap
if used to manage the catheter or attached to a walker (see figure below) or
wheel chair using a lanyard.

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6 Operation
6.1 Connecting the UroShield
®
1. Make sure that UroShield application occurs shortly following
catheter insertion into the bladder.
2. Gently pull on the catheter until you feel slight resistance.
3. Remove the actuator from its packaging.
4. Peel off the protective strips from the inside of both halves of the
actuator.

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5. Place the actuator on the catheter in accordance with the following:
- For women, make sure that there is 2 to 3 cm of space between
the actuator and the point where the catheter exits the body.
- For men, make sure that there is 5 to 10 cm of space between
the actuator and the point where the catheter exits the body.
- Make sure that the direction of the actuator connection cable is
towards the patient.
- Attach the actuator to the catheter so that the catheter enters
and exits the actuator through the grooves at either end of the
actuator.
6. Carefully close the actuator so that the two halves snap together.
7. Make sure that the catheter is not pinched or deformed at either end
of the actuator.

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8. Insert the actuator cable plug into the driver, making sure to orient
the plug correctly in relation to the socket, and also making sure that
the plug is fully inserted and secured.
9. Connect the supplied charger to the driver charging port.
10. Plug the charger into the mains.

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The driver display will show the following screens in quick succession:
The UroShield® is now working and charging at the same time (you do not
need to wait for the battery to charge fully, which takes about 2 hours).
6.2 Switching the UroShield
®
ON or OFF
To switch the UroShield® ON, when the driver is turned off and not connected
to the mains, press the ON/OFF button for 2–3 seconds.
About 30 seconds following above display sequence, the driver display shows
the battery level and actuator connection as shown in the following screen:
If another screen appears instead of the above, see section 6.5.2 Alerts and
Troubleshooting.
After another 3 minutes, the display shows the screensaver:
Note: when the screensaver is shown, you can return to the battery/actuator
status by pressing the ON/OFF button briefly (that is, for less than 2 seconds).
UroShield

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6.3 Recharging the UroShield
®
Battery
The UroShield® can be used for a duration of 6 hours without being constantly
recharged by connecting it to a AC wall outlet using the recharging adapter.
1. The internal battery should be recharged when the internal battery
capacity is less than 10% (see section 6.5.2).
2. The recharging adapter should be connected to the AC wall outlet
and the other end (USB connector) should be plugged into the
recharging port of the UroShield driver.
Alternatively, for patients who are wheelchair bound, geriatric patients
using a walker or ambulatory patients, a USB power bank can be used to
recharge the UroShield battery by connecting a USB cable from the power
bank to the UroShield rechargeable (USB-C) port.

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6.4 Instructing the Patient
Instruct the patient as follows:
 The patient should not pull, readjust, or open the actuator.
 The patient should not disconnect the actuator from the driver.
 The patient should not press the ON/OFF button.
 The patient should inform medical staff if an alarm is heard.
 The patient should not expose the driver to water: see section 0
Showering and Bathing