NanoVibronix UROSHIELD User manual

1
User Manual
USA

2
NanoVibronix Inc.
525 Executive Boulevard
Elmsford
N.Y. 10523
USA
T +1 [914] 233 3004
F +1 [914] 376 6111
NanoVibronix Ltd,
9 Derech Hashalom St
Nesher 3665112
Israel
T [phone]
F [phone]
CEpartner4U BV
Esdoornlaan 13
3951 DB Maarn
The Netherlands
T [phone]
M [phone]
F [phone]
o[email protected]
[email protected]
www.nanovibronix.com
Without prior notice and without obligation, the contents
of this manual may be revised to incorporate changes
and improvements.
Every eort 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.

3
1.0 INTRODUCTION
1.1 Disclaimer for Physicians and Patients
in the USA
1.2 Contents
1.3 BiolmFormationandUrinary
Tract Infections
1.4 General Safety
1.5 Essential Performance
2.0 INDICATIONS FOR USE
3.0 SAFETY
3.1 Contraindications
3.2 Warnings
4.0 THE UROSHIELD®SYSTEM
4.1 The UroShield®Actuator
4.2 The UroShield®Driver
5.0 PRODUCT FEATURES
5.1 Operating Cycle
5.2 Mains and Battery Operation
6.0 PRODUCT CARE
6.1 The Driver
6.2 The Actuator
6.3 Storage
6.4 Environmental Operating Conditions
7.0 OPERATION
7.1 Charging the UroShield®Driver
7.2 Connecting the UroShield®
7.3 Switching the UroShield®ONorOFF
7.4 Monitoring the UroShield®
7.5 Alerts and Troubleshooting
7.6 Disconnecting the Driver from
the Actuator
7.7 Showering and Bathing
8.0 FREQUENTLY ASKED QUESTIONS
9.0 APPENDIX
9.1 Electromagnetic Compliance
9.2 UroShield®Specications
9.3 Symbol Index
9.4 Warranty
10
12
13
15
23
5
7
8
24
Contents

4
This user manual contains
the instructions for
operation, application and
care of UroShield®. To obtain
maximum life and eciency
from UroShield®and to assist
in its proper operation,
please read and understand
this manual thoroughly.
UroShield®is to be used
only as directed in this
user manual.

5
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.
CONTENTS
The UroShield®includes the
following items:
UroShield Driver.
Clip-on actuator with its connecting cable.
Lanyard.
Power supply charger.
1.1
1
Introduction
1.2

6
1
1.3
1.3 BIOFILM FORMATION AND URINARY
TRACT INFECTIONS
Urinarycathetersreadilyacquirebiolms
after insertion; and the longer the catheter
remains in place, the greater the tendency
fortheformationofbiolms,resultingin
urinary tract infections.
Theinitialstepinbiolmformationis
the adhesion of bacteria to the catheter
surface. This occurs a few hours after urinary
catheterplacement.Followingattachment,
the bacteria begin to secrete an extra-
cellular polymeric matrix, which allows them
to survive and proliferate. The bacteria
and extra-cellular polymeric matrix , now
adherent to the catheter surface, is known as
biolmwhichishighlyresistanttoantibiotics
and to the body’s immune system.
The UroShield®is intended to prevent
bacterialbiolmformationbygenerating
ultrasound waves on the inner and outer
surfaces of the catheter.
GENERAL SAFETY
Thoroughly read and understand the safety
and operating instructions before attempting
to operate the UroShield®. This user manual
should be retained for future reference.
ESSENTIAL PERFORMANCE
The UroShield® is applied on the urethral or
suprapubic catheter and emits ultrasound
energy to its surface. The waves interfere
with the attachment of bacteria, which is the
initialstepinbiolmformation,andincrease
antibioticecacyagainstbiolmbacteria.
1.5

7
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.
The UroShield®is to be worn continuously
and is intended to minimise bacterial
adhesion and colonisation on the catheter
surfaces.
The UroShield®can be used with urinary
catheterssized12,14,16,18,20,
or22French.
2
Indications For Use

8
3
Safety
CONTRAINDICATIONS
UroShield® is not intended as a treatment for
an active urinary tract infection.
WARNINGS
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 should
beperformedonlybyqualiedmedical
staandinaccordancewiththerelevant
medical facility’s care guidelines.
The UroShield®driver is not waterproof.
Do not expose it to water.
Do not use UroShield®in the presence of
flammable materials and liquids. The UroShield®
driver is classified as internally powered,
intermittently operated, ordinary equipment
withadisposabletypeBFappliedpart.
Use UroShield®only as instructed in
this manual.
Do not use the UroShield®driver or
accessories if they appear to be damaged.
Do not modify UroShield®in any way.
A healthcare professional or a caregiver
shouldperiodicallyinspectandconrm
integrity of connection and operation of
UroShield® when used by a patient known
to be incapable of managing the device.
UroShield®has no user serviceable parts.
If it is not operating correctly, contact the
local representative of NanoVibronix. No
part of the UroShield®system should be
replaced with components or parts other
than those supplied by NanoVibronix.
Do not connect UroShield®to any device or
system other than the parts supplied with it.
3.2
3.1

9
The lithium-ion rechargeable battery
in the UroShield®driver must not be
disassembled, heated above 100 degrees
Celsius, incinerated, or exposed to water.
Be aware of the actuator cable which can
get caught, entangled or even wrapped
around a person’s body and lead to
potentialinjuryorrestrictbloodow.
Use of UroShield®adjacent to or stacked
with other equipment should be avoided
as it could result in improper operation.
If such use is necessary, observe the
UroShield®system to verify it is
operating normally.
Use of accessories, transducers, and cables
otherthanthosespeciedorprovided
by NanoVibronix could result in increased
electromagnetic emissions or decreased
electromagnetic immunity
of this medical device and result in
improper operation.
PortableRFcommunicationsequipment
(including peripherals such as antenna
cables and external antennas) should not
be no closer than 30 cm (12 inches) to
any part of the UroShield®system during
operation. The performance of
UroShield®maybeaected.
RefertoAppendixAforinformation
on maintaining basic safety and
essential performance with regard to
electromagnetic disturbances
of UroShield®.
The UroShield®isnotMRIcompatibleand
therefore, should be removed from the
catheterbeforeenteringtheMRIsuite.
3
Saftey

10
UroShield®has two components:
A Driver and an Actuator
A Mains Adapter/Charger is also included
3cm
5-10cm
1
2
5
3
4
1 Driver
2 Actuator
3 Mains Adapter/
Charger
4 Power Button
5 Catheter
(Not Included)
The UroShield® System
4

11
THE UROSHIELD®ACTUATOR
The actuator is attached onto the urinary
catheter after the catheter’s insertion into
the patient’s urethra. When the UroShield®
driver is active, the actuator generates
ultrasound waves on the surface of the
catheter. The actuator is intended for single
use only, should be worn continually and
changed every 30 days.
FirsttimeusersoftheUroShield®
system should ensure that it is used on a
new catheter.
THE UROSHIELD® DRIVER
The driver supplies electrical signals to the
actuator. It has the following parts:
Built-in rechargeable battery
Charging port
Actuator port
ON/OFFbutton
Operational display screen
The driver is small and lightweight and can
be attached using a lanyard (g.1), 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 or wheelchair using
a lanyard.
4.2
4.1
The UroShield® System
4
3cm
5-10cm
1
2
5
3
4
g.1

12
OPERATING CYCLE
UroShield®ispreconguredtoprovide
intermittent ultrasound output at a pre-set
frequencywhichcannotbemodiedby
the user.
When in ON mode, UroShield®alternates
between 2 phases:
Active phase
UroShield®delivers 15 minutes of
ultrasound therapy on the surface of the
catheter. A low audible sound may be
heard.
Idle phase
UroShield®is idle for 5 minutes.
MAINS AND BATTERY OPERATION
The UroShield®can be powered by mains
or by its internal rechargeable battery. 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 approximately 2 hours.
The internal battery can undergo greater
than 500 full charge cycles. The operational
time may decrease over time when
running on the battery. Mains power use is
unaected.
5.2
5.1
Product Features
5

13
THE DRIVER
The life of the driver is dependent on the
battery use, refer to section 5.2. To clean
the driver, use 70/30 Iso Propyl Alcohol or
disinfectant medical wipes.
Do not use solvents such as acetone as
they may damage the product. Do not
immerse the UroShield®driver in water or
any other liquid.
Thedriverisameresistantaccordingto
UL-94HB.Itdoesnotcontainammable
materialsandwillnotaccelerateare.
The driver is not intended for use in the
presenceofammableliquids.
A faulty unit which is still under warranty,
can be sent to NanoVibronix for
replacement.RefertoAppendixDfor
conditions of warranty.
The driver does not contain recyclable
material.
THE ACTUATOR
The actuator is intended for single use
with one catheter only and should be
changed together with the catheter
(Maximum 30 days).
If the actuator becomes soiled, it can be
cleaned with a damp sponge and then
allowed to dry.
After use, the actuator must be disposed
of in accordance with the relevant medical
facility’s standards for the disposal of
used medical equipment.
Product Care
6
6.2
6.1

14
STORAGE CONDITIONS
UroShield®storage conditions:
ENVIRONMENTAL OPERATING
CONDITIONS
The recommended environmental
operating conditions are:
5 - 40°c
10 - 80%
70 - 106 kPa
5 - 35°c
10 - 80%
70 - 106 kPa
80%
10%
5°C
40°C
106kPa
70kPa
5°C
35°C
80%
10%
5°C
40°C
106kPa
70kPa
5°C
35°C
80%
10%
5°C
40°C
106kPa
70kPa
5°C
35°C
80%
10%
5°C
40°C
106kPa
70kPa
5°C
35°C
80%
10%
5°C
40°C
106kPa
70kPa
5°C
35°C
80%
10%
5°C
40°C
106kPa
70kPa
5°C
35°C
Product Care
6
6.3
6.4

15
Operation
7
CHARGING THE UROSHIELD®DRIVER
When the battery is fully charged, the
UroShield®can be used without mains power
for a duration of 6 hours.
Charge the driver in accordance with the
following guidelines:
Charge the driver with the supplied
charger only.
Beforerstuse,removethedriver
from its packaging and verify that it is
fully charged.
To charge the driver:
Connect the USB-C plug of the supplied
charger to the driver’s charging port.
Plug the charger into a mains power
outlet.
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.
When the driver begins to charge, the
screen lights up brightly and displays the
battery icon.
After approximately 3 minutes, the screen
dims.Torefreshthedisplay,brieypressthe
ON/OFFbutton.
Duringchargingthebatteryiconllsgradually.
Charging takes about 2 hours. When the
battery is fully charged, the battery icon
appears full.
The UroShield®should be recharged from
mains power when the internal battery
capacity is less than 10%.
7.1

16
7
Operation
CONNECTING THE UROSHIELD®
1
UroShield®application should occur after
catheter insertion into the bladder.
2
Removetheactuatorfromitspackaging.
3
Removethetwoprotectivestripsfrom
the inside of the actuator. (g.2)
4
Place the actuator on the catheter in
accordance with the following:
3cm
5-10cm
1
2
5
3
4
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.
3cm
5-10cm
1
2
5
3
4
g.2
7.2

17
3cm
5-10cm
1
2
5
3
4
Operation
7
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.
5
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.
8
Insert the actuator cable into the driver,
ensuring that the plug is correctly
orientated in relation to the socket, and
that the plug is fully inserted and secured.
(g.3)
3cm
5-10cm
1
2
5
3
4
g.3

18
7
Operation
3cm
5-10cm
1
2
5
3
4
9
Connect the supplied charger to the
driver charging port. (g.4)
10 Plug the charger into the mains power.
11
The UroShield®driver will automatically
turn on, showing the following screens
sequence.
The UroShield®is now working and charging
at the same time. The UroShield®is supplied
with a small amount of charge, to fully
charge the battery it takes approximately
2 hours.
NanoVibronix
UroShield
Ver: 41.05
UroShield
UroShield
Ver: 41.05
NanoVibronix
UroShield
Ver: 41.05
UroShield
UroShield
Ver: 41.05
g.4

19
Operation
7
SWITCHING THE UROSHIELD®
ON OR OFF
To switch the UroShield®ON, when the driver is
turnedoandnotconnectedtothemains,press
andholdtheON/OFFbuttonfor2–3seconds.
After the intro sequence, the driver display
shows the status of the battery and actuator
connection as shown in the following screen:
7.3
If another screen appears instead of
the above, see section 7.5 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brieyforless
than 2 seconds.
Instruct the patient as follows:
The actuator should not be pulled opened
or readjusted.
The actuator should not be disconnected
from the driver, except for bathing.
TheON/OFFbuttonshouldnotbe
pressed unless the patient or clinician
needstoturnthedeviceonoro
The driver should not be exposed to water or
other fluids.
NanoVibronix
UroShield
Ver: 41.05
UroShield
UroShield
Ver: 41.05

20
7
Operation
MONITORING THE UROSHIELD®
The following information explains the
symbols and text that may be displayed
on the driver display during normal
functioning of the UroShield®at
various times.
Manufacturer name
Displayed briey when you
switch ON the driver.
Product name
Software version number
Displayed briey in
the interval before the
information display appears.
Battery
1Battery charge indicator
2
Actuator status = correctly
connected and correctly
working.
The UroShield®is ON.
Battery charge indicator
The battery is charging.
The UroShield®is OFF.
The battery icon lls gradually
to show charging progress.
If the screen has dimmed, you
can brighten it by pressing the
ON/OFF button briey (that is,
for less than 2 seconds).
Screensaver
The UroShield®is ON.
You can show the battery
charge indicator and actuator
status by pressing the ON/OFF
button briey (that is, for less
than 2 seconds).
NanoVibronix
UroShield
Ver: 41.05
UroShield
UroShield
Ver: 41.05
NanoVibronix
UroShield
Ver: 41.05
UroShield
UroShield
Ver: 41.05
NanoVibronix
UroShield
Ver: 41.05
UroShield
UroShield
Ver: 41.05
Driver Display Glossary
21