NanoVibronix PAINSHIELD MD 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.

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1.0 INTRODUCTION
1.1 PainShield®essential performance
1.2 General Safety
1.3 Prescription Use Only
1.4 Contents
2.0 INDICATIONS FOR USE
3.0 SAFETY
3.1 Contraindications
3.2 Warnings
3.3 Precautions
4.0 THE PAINSHIELD®SYSTEM
4.1 The PainShield®Treatment Actuator
4.2 PainShield®Adhesive Patches
4.3 The PainShield®Driver
5.0 PRODUCT FEATURES
5.1 Operating Cycle
5.2 Battery Operation
6.0 PRODUCT CARE
6.1 Storage
6.2 Environmental Operating Conditions
6.3 The Driver
6.4 The Actuator
6.5 The Patch
7.0 OPERATION
7.1 Charging the PainShield®Driver
7.2 Preparing the Treatment Area
7.3 Preparing the Actuator and Patch for Use
7.4 Applying Therapy
7.5 PainShield®Displays
7.6 Removing the Actuator Patch
7.7 Replacing the Actuator
7.8 Troubleshooting
8.0 FREQUENTLY ASKED QUESTIONS
9.0 APPENDIX
9.1 Electromagnetic Compliance
9.2 PainShield® Specications
9.3 Symbol Index
9.4 Warranty
5
7
6
10
12
13
15
24
27
Contents

4
This manual contains general
instructions for the operation,
application and care of
PainShield®. To obtain
maximum life and eciency
from PainShield®and to assist
in its proper operation, please
read and understand this
manual thoroughly.
PainShield® is to be used only
as directed in this manual.
PainShield® uses ultrasound therapy for the relief
of acute or chronic pain and muscle spasms. It
was developed as a next generation wearable
ultrasound system which transforms conventional
therapeutic ultrasound technology into a small and
portable ultrasound therapy unit. It is designed to
work along with the human body and maximise the
safe and eective delivery of a long- duration
therapeutic eect.
PainShield®is simple to use and operates on a
broad range of body areas, allowing the delivery
of ultrasound treatment for up to 6.5 hours, at a
preset frequency of 90 kHz. Treatment is delivered
via an ultrasound actuator, which is applied and
secured to the surface of the body using single-use
adhesive patches.
01

5
PAINSHIELD®ESSENTIAL PERFORMANCE
PainShield®produces low frequency, low
intensity ultrasonic waves for the relief
of pain, muscle spasm and improvement
of local circulation. The ultrasonic waves
are generated by a transducer that is
incorporated into the actuator.
GENERAL SAFETY
Thoroughly read and understand the safety
and operating instructions before attempting
to operate the PainShield®. This user manual
should be retained for future reference.
PRESCRIPTION USE ONLY
Federal law restricts this device to sale by or
on the order of a practitioner licensed by the
law of the state in which he/she practices to
use or order the use of the device.
CONTENTS
The PainShield®MD includes the
following items:
PainShield Driver.
Actuator with its connecting cable
30 disposable patches
Lanyard.
Power supply charger.
Introduction
1
1.1
1.2
1.3
1.4
02

6
0
Indications For Use
2
2.1 INDICATIONS FOR USE
PainShield®MD is required to be prescribed
by a licensed healthcare provider.
The PainShield®MD is intended to apply
ultrasonic energy to generate deep heat
within body tissues for the treatment of
selected medical conditions such as:
Pain.
Muscle spasms.
Joint contractures.

7
CONTRAINDICATIONS
PainShield®is contraindicated for use in
the following cases:
Patients with cancer and bone metastases
under treatment area.
Directly on the eye.
Directly over an open wound.
Directly over ischemic tissues in individuals
with vascular disease.
Over the uterus in pregnant patients.
Over bone growth centres until bone
growth is complete.
WARNINGS
Do not use PainShield®in the
presence of ammable materials or liquids.
PainShield® is classied as an internally
powered, intermittently-operated,
ordinary equipment with a disposable type
BF applied part.
Do not immerse any part of PainShield®in
water or any other liquid.
Refer to Appendix A for information
on maintaining basic safety with regard
to electromagnetic disturbances of
PainShield®.
The PainShield®is not MRI compatible
and therefore, should be removed before
entering the MRI suite.
Use PainShield®only as instructed in
this manual.
Do not use the PainShield®driver or
accessories if they appear to be damaged.
Do not modify PainShield®in any way.
Safety
3
3.2
3.1

8
3.3
Safety
3
CAUTIONS
PainShield®has no user serviceable parts.
If it is not operating correctly, contact the
local representative of NanoVibronix. No
part of the PainShield®system should be
replaced with components or parts other
than those supplied by NanoVibronix.
Do not connect PainShield®to any device
or system other than the parts supplied
with it.
Charge the PainShield®driver only with
the supplied charger.
Do not attempt to open or remove the
cover of the PainShield®driver.
The Lithium-Ion rechargeable battery
in the PainShield®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 or wrapped around a person’s
body and lead to potential injury or
restrict blood ow.
Use of PainShield®adjacent to or stacked
with other equipment should be avoided as
it could result in improper operation. If such
use is necessary, observe the PainShield®
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 PainShield®system
during operation. The performance of
PainShield® may be aected.

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PRECAUTIONS
Use PainShield®with caution in the
following areas:
Following a laminectomy involving major
tissue removal.
In patients susceptible to bleeds.
Over anesthetised areas of impaired skin.
Treatment of children should be
performed under adult supervision.
In children, avoid use over the epiphyseal
growth plate area.
Use caution when removing the actuator
patch from the skin after use.
The safety and eectiveness of
PainShield®has not been established in
patients who are or have been treated by
other medical devices including but not
limited to:
Pacemakers.
Electrical stimulators.
Radiofrequency generators.
Surgical meshes.
Intra-Uterine devices (IUDs).
Other surgical implants.
When the actuator is applied in a location
you are lying on you may experience slight
redness of the skin, which will resolve in a
few hours.
3.4
Safety
3

10
PainShield®has three components:
A Treatment Actuator Adhesive Patches
and a Driver A charger is also included.
3cm
5-10cm
1
3
4
5 2
1 Driver
2 Actuator
3 Charger
4 Power Button
5 Adhesive Patch
The PainShield® System
4
0

11
The PainShield® System
THE PAINSHIELD®TREATMENT ACTUATOR
The treatment actuator incorporates an
ultrasonic transducer and connects to the
driver with a cable.
The transducer is the active element that
converts electric signals to ultrasound waves.
For eective treatment, the transducer must
be in full contact with the skin.
PAINSHIELD®ADHESIVE PATCHES
The adhesive patches secure the actuator to
the aected area.
THE PAINSHIELD®DRIVER
The driver that supplies electrical signals to
the actuator. It has the following parts:
Built-in rechargeable battery.
Charging port.
Actuator port.
ON/OFF button.
Operation screen display.
4.2
4.3
4.1
4

12
OPERATING CYCLE5.1
5.2
Product Features
5
0
PainShield® is precongured to provide
intermittent ultrasonic output at a pre-set
frequency which cannot be modied by the user.
When in ON mode, the PainShield®alternates
between 2 phases:
Active phase — PainShield®delivers 30 minutes
of ultrasound therapy.
Idle phase — PainShield®is idle for 30
minutes.
1 active phase + 1 idle phase = 1 cycle.
PainShield®counts the number of cycles,
which is displayed as “C1” to “C6” and
automatically switches to OFF mode after 6.5
hours.
The battery should be recharged following use.
BATTERY OPERATION
Powered by a rechargeable lithium-
ion battery, PainShield®can provide
approximately 6.5 hours of continuous
therapy on a single battery charge. After 6.5
hours, PainShield® automatically switches o,
and the battery must be recharged.
You can switch PainShield®to OFF mode
manually at any point of time.
The internal battery can undergo greater
than 500 full charge cycles. The operational
time may decrease over time.
When not in use, it is recommended to store
the driver with 50% charge on the battery.

13
Product Care
6.1
6.2
6
STORAGE CONDITIONS
PainShield®storage conditions:
ENVIRONMENTAL OPERATING
CONDITIONS
The recommended environmental
operating conditions are:
0
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

14
6
6.3
6.4
6.5
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 IPA or disinfectant medical
wipes. Do not use solvents, such as acetone,
as they may damage the product.
Do not immerse any part of PainShield®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.
Use the actuator with a new patch for each
treatment session.
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
It is recommended to replace the actuator
after 30 treatments.
New actuators can be ordered from
NanoVibronix or your local distributor.
THE PATCH
Do not use the patch more than once, as this
may aect performance.

15
Operation
7
7.1
CHARGING THE PAINSHIELD®DRIVER
When the battery is fully charged, the
PainShield
®
can be used without mains power
connection for approximately 6.5 hours.
Charge the driver in accordance with the
following guidelines:
Charge the driver only with the supplied
charger.
Therapy is not available while the driver is
being charged.
Before rst use, remove the driver from its
packaging and place on charge.
To charge the driver:
1
Connect the USB-C plug of the supplied
charger to the driver’s charging port.
2
Plug the charger into a mains power outlet.
When the driver begins to charge, the screen
lights up brightly and displays the battery icon:
After approximately 1 minute, the screen
dims. To refresh the display, briey press the
ON/OFF button. During charging the battery
icon lls gradually.
0
Charging takes about 2 hours. When the
battery is fully charged, the battery icon
appears full.

16
7
Operation
PREPARING THE TREATMENT AREA
1
Remove excess hair from the
treatment area.
2
Clean the treatment area thoroughly with
soap and water or an alcohol wipe.
3
Ensure the treatment area is dry and free
from any creams or oils which could aect
the adherence of the actuator patch.
PREPARING THE ACTUATOR AND PATCH
FOR USE
1Remove the actuator from it’s packaging
and connect the actuator plug into
the driver socket, ensuring the plug is
correctly orientated in relation to the
socket, and make sure the plug is fully
inserted and secured. (g.1)
7.2
7.3
3cm
5-10cm
1
3
4
5 2
g.1
2Take adhesive patch. Remove the
protective layer from an adhesive pad,
taking care to remove the central piece
rst as illustrated below. (g.2)

17
3cm
5-10cm
1
3
4
5 2
Operation
7
3
Place the actuator on the exposed
adhesive at the centre of the patch, with
the metal transducer facing up and the
wire aligned with the open notch in
the patch. (g.3)
3cm
5-10cm
1
3
4
5 2
3cm
5-10cm
1
3
4
5 2
g.2
g.3

18
7
Operation
3cm
5-10cm
1
3
4
5 2
4Attach the actuator patch to the skin,
with the adhesive side down over the area
where the pain is most intense. (g.4)
5If the skin is broken or if the pain is located
near a joint, attach the actuator to the at
healthy skin area adjacent to the source of
pain. Be sure to place the actuator within
10cm (4 inches) of the aected area
to ensure the pain source is within the
treatment area
g.4

19
APPLYING THERAPY
Use the ON/OFF button to switch the driver
ON and OFF.
To switch the driver ON:
Press and hold the ON/OFF button until
you hear a beep, and the NanoVibronix logo
appears on the screen.
Note: Briey pressing the ON/OFF button
refreshes the information screen. The screen
saver is replaced by the information screen.
To switch the driver OFF:
Press and hold the ON/OFF button until
you hear the shut-o beep.
7.4
Operation
7

20
PAINSHIELD®DISPLAYS
The information below explains the symbols
and text that may be displayed on the driver
display during normal functioning of the
PainShield®at various times.
7.5
Manufacturer name
Displayed briey when you switch
ON the driver.
Product name
Software version number
(Displayed during device initiation).
Working mode information
(ACTIVE phase)
1Battery indicator
2 Treatment cycle number (C1 to C6)
3Output power.
4
Time elapsed since the beginning
of the current ACTIVE phase.
Screensaver : In Charging Mode
The display is dimmed and keeps
scrolling vertically.
To refresh the display of information,
press the ON/OFF button for less
than 2 seconds.
Screensaver : In Working Mode
(Automatically replaces the information
screen after 3 sec)
PainShield®is ON.
To refresh the display, briey press the
ON/OFF button.
Communication Error
The actuator is not connected to the
driver, or damaged.
Switching o
Switching o takes 3 seconds. The
number indicates how many seconds
to complete shut o.
1 2 3 4
7
Operation