NanoVibronix PAINSHIELD MD User manual

UserManual
Cat. # PSUM004 Ver. 09 (ROW)

PainShield® MD User Manual
PSUM004 Ver. 09 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
Manufactured by:
NanoVibronix Ltd.,
9 Derech Hashalom st.,
Nesher 36651, Israel.
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
Website: www.nanovibronix.com
Authorized representative in the European Community:
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......................................................................................... 4
1.1 General Safety............................................................................ 4
2 Indications for Use............................................................................... 5
3 Safety .............................................................................................. 6
3.1 Contraindications....................................................................... 6
3.2 Warnings.................................................................................... 7
3.3 Precautions ................................................................................ 8
4 Product Features ................................................................................. 9
4.1 Preset Treatment....................................................................... 9
4.2 Battery Operation ...................................................................... 9
4.3 PainShield®MD Patches............................................................. 9
5 Product Components......................................................................... 10
5.1 The PainShield®MD Treatment Patch...................................... 10
5.2 The PainShield®MD Driver....................................................... 11
6 Operation .......................................................................................... 12
6.1 Charging the Driver.................................................................. 12
6.2 Preparing the Treatment Area................................................. 13
6.3 Applying the Larger Patch........................................................ 13
6.4 Applying the Smaller Patch to Treat Trigeminal Neuralgia ...... 15
6.5 Applying Therapy ..................................................................... 17
6.6 Monitoring the PainShield®MD................................................ 17
6.7 Removing the Patch................................................................. 19
7 Frequently Asked Questions.............................................................. 21
8 Product Care...................................................................................... 22
Appendix A: Electromagnetic Compliance.............................................. 23
Appendix B: Specifications...................................................................... 27
Appendix C: Labels.................................................................................. 28
Appendix D: Symbols .............................................................................. 29
Appendix E: Warranty ............................................................................ 30

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1 Introduction
Thank you for choosing the PainShield® MD. This manual contains general
instructions for operation, application, precautions, and care. In order to
obtain maximum life and efficiency from the PainShield® MD and to assist in its
proper operation, please read and understand this manual thoroughly. This
PainShield® MD is to be used only as directed in this manual.
The PainShield® MD uses ultrasound therapy for the relief of acute or chronic
pain and muscle spasms.
The PainShield® MD was developed as a next generation wearable ultrasound
system which transforms conventional therapeutic ultrasound technology into
a small and portable ultrasound therapy system. It is designed to work with the
human body and maximize the safe and effective delivery of long-duration
therapeutic ultrasound.
Simple to administer and operate on a broad range of body types, the
PainShield® MD allows the delivery of ultrasound treatment for up to 6.5
hours. It operates at a preset frequency of 90kHz and is available with patches
in two sizes. The patch is applied and secured to the surface of the body using
the incorporated hydrogel adhesive coating.
1.1 General Safety
Thoroughly read and understand the precautionary and operating instructions
before attempting to operate the PainShield® MD. Know the limitations and
hazards associated with using any ultrasound device. 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 PainShield® MD is intended to apply ultrasonic energy to generate deep
heat within body tissues for the treatment of selected medical conditions. The
low intensity and low frequency ultrasound energy is effective within a
diameter of 20 cm and a depth of approximately 3 cm. The PainShield® MD
can therefore be effective in treating a wound by proximity and without direct
contact with it.
Selected medical conditions for treatment include:
Pain (including Trigeminal Neuralgia)
Muscle spasms
Joint contractures
Provide improvement in local blood circulation
Assist in soft tissue healing including post-surgery
Assist in healing chronic (such as diabetic) wounds
Improve penetration of topical ointment or gel

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3 Safety
3.1 Contraindications
The PainShield® MD is not 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 centers until bone growth is complete

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3.2 Warnings
W A R N I N G
Do not use the PainShield® MD in the
presence of flammable materials and
liquids. The PainShield® MD is classified
as internally-powered, intermittently-
operated, ordinary equipment with a
disposable type BF applied part.
Do not immerse any part of the
PainShield® MD in water or any other
liquid.
Use the PainShield® MD only as
instructed in this manual.
Do not use any part of the PainShield®
MD that appears damaged.
Do not modify the PainShield® MD in
any way.
Do not replace any part of the
PainShield® MD with components or
parts other than those supplied by
NanoVibronix.
Do not connect the PainShield® MD to
any device/system other than the parts
supplied with it.

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C AU T I O N
Charge the PainShield® MD only with the
supplied charger.
Do not attempt to open or remove the
cover of the PainShield® MD.
The lithium ion rechargeable battery in
the PainShield® MD must not be
disassembled, heated above 100 degrees
Celsius, incinerated, or exposed to water.
3.3 Precautions
Use with caution in the following areas
-Following a laminectomy involving major tissue removal
-In patients susceptible to bleeds
-Over anesthetized areas of impaired skin
Treatment of children should be performed under adult supervision.
In children, avoid use over the epiphyseal growth plate area.
The safety and effectiveness of the PainShield® MD 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.

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4 Product Features
4.1 Preset Treatment
The PainShield® MD is preconfigured to provide intermittent ultrasonic output
at a preset frequency of 90 kHz and low intensity neither of which can be
modified by the user.
When the PainShield® MD is ON, it alternates automatically between 2 phases:
Active phase—the PainShield® MD delivers 30 minutes of ultrasound
therapy.
Idle phase—the PainShield® MD is idle for 30 minutes.
1 active phase + 1 idle phase = 1 cycle.
The PainShield® MD automatically switches OFF after 6.5 hours, at which point,
the battery should be recharged.
4.2 Battery Operation
Powered by a rechargeable lithium-ion battery, the PainShield® MD can
provide 6.5 hours of continuous therapy on a single battery charge. After 6.5
hours, the PainShield® MD automatically switches OFF, and the battery must
be recharged.
You can switch the PainShield® MD OFF manually at any time.
4.3 PainShield®MD Patches
The PainShield® MD hydrogel adhesive patch secures the transducer to the
affected area. The transducer converts energy to ultrasonic therapeutic waves.
The patch is reusable and can be used approximately 7 times provided the
hydrogel layer is kept from drying.
The patches come in two sizes to better fit application in various body areas:
Large patch - Model PRP-20 120 mm x 50 mm x 6 mm
Small Patch - Model PRP-40 75 mm x 55 mm x 6 mm

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5 Product Components
The PainShield® MD has two components: a treatment patch and a driver. A
charger is included.
5.1 The PainShield®MD Treatment Patch
The reusable treatment patch comes in a pouch which also serves for storing
the patch between treatment sessions.
The patch comes in two sizes: a larger size (Model PRP-20) and a smaller size
(Model PRP-40). The smaller size should be used when the larger size is
inconvenient (e.g. treatment of Trigeminal Neuralgia). The two patch types
differ only in size.
One side of the patch is protected by a transparent liner. Under the liner the
patch has a layer of adhesive hydrogel. The liner is removed before treatment,

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and the side of the patch with hydrogel is placed on the skin. When the patch is
removed from the skin, the liner is replaced to protect the hydrogel coating.
The transducer in the center of the patch is the active element that converts
electric signals to ultrasound waves.
For effective treatment the transducer must be in full contact with the skin.
The reverse side of the patch has two snap contacts for connecting the driver
cable.
5.2 The PainShield®MD Driver
The driver supplies electrical signals to the transducer in the patch. It has the
following parts:
Built-in rechargeable battery
Charging port
Connection cable
ON/OFF button
Operational screen display

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6 Operation
6.1 Charging the Driver
When the battery is fully charged, the driver has an operating life of 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 first use, remove the driver from its packaging and verify that
it is fully charged.
To charge the driver:
1. Connect the mini USB plug of the supplied charger to the driver’s
charging port.
2. Plug the charger into a wall 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,
briefly press the ON/OFF button.
During charging the battery icon fills gradually.

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Charging takes about 2 hours. When the battery is fully charged, the battery
icon appears full.
6.2 Preparing the Treatment Area
1. Remove excess hair from the treatment area.
2. Clean the treatment area thoroughly with soap and water or alcohol
prep pad.
3. Dry the treatment area.
6.3 Applying the Larger Patch
Apply the patch over the area of the most intense pain or next to the wound.
1. Carefully cut open the pouch containing the patch. Save the pouch
for storing the patch between treatment sessions.
2. Connect the driver cable to the two snap contacts on the patch.
3. Remove the transparent protective liner from the patch. Save the
liner for protecting the patch during storage.

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4. Place the patch on the area of treatment over healthy skin. The
hydrogel adhesive attaches the patch to the skin.
5. If the skin is broken, place the patch on adjacent healthy skin as
illustrated below.
Over painful area
Next to wound
When applying the patch next to an open wound, you can remove
section A or section B of the patch by cutting along the dotted lines
as illustrated below. You can do so to increase the proximity of the
patch to the wound or for more effective treatment.
A
B

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6. Make sure that the ultrasonic active element is in full contact with
the skin.
Note: To ensure full contact of the active element with the skin,
particularly when using the smaller patch or during prolonged use,
consider using a wrap-type dressing (e.g. 3MTM Coban™ Self-
Adherent Wrap, supplied with the kit).
6.4 Applying the Smaller Patch to Treat Trigeminal
Neuralgia
The PainShield® MD has been found highly effective in relieving Trigeminal
Neuralgia (TN) pain. In rare cases some patients may feel an initial pain
increase before experiencing the benefit of the treatment. It is therefore
recommended that you proceed gradually,applying treatment first for 2 hours
and then for 4 hours before continuing to daily 6.5-hour treatments. Apply the
first and second treatments while you are awake. You can subsequently apply
treatment during sleep. If you use the PainShield® MD overnight, remove it on
waking up.
1. Carefully cut open the pouch containing the patch. Save the pouch
for storing the patch between treatment sessions.

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2. Connect the driver cable to the two snap contacts on the patch.
3. Remove the transparent protective liner from the patch. Save the
liner for protecting the patch during storage.
4. Place the patch next to the cheekbone when the pain is in the
maxillary nerve (V2) or next to the lower jaw bone when the pain is in
the mandibular nerve (V3).
If local sensitivity makes patch application painful, apply the patch to
the forehead on the pain-free side.
5. Make sure that the ultrasonic active element is in full contact with
the skin.
For overnight use, apply a wrap type dressing (e.g. 3MTM CobanTM
Self-Adherent Wrap) to secure the patch. Wrap twice around the
head.

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6.5 Applying Therapy
Use the ON/OFF button to switch the driver ON and OFF.
To switch the driver ON:
Press the ON/OFF button until you hear a beep and the NanoVibronix
logo appears on the screen.
To switch the driver OFF:
Press the ON/OFF button until you hear the shut-off beep.
Note: Briefly pressing the ON/OFF button refreshes the information screen.
The screen saver is replaced by the information screen.
6.6 Monitoring the PainShield®MD
The driver screen displays information on the functioning of the PainShield®
MD. The table below explains the symbols and text that may be displayed on
the screen at various times.
Symbols/Text Displayed
Explanation
Manufacturer name
(displayed briefly when you switch ON
the driver)
Product name
Software version number
(displayed briefly in the interval before
the information display appears)

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Symbols/Text Displayed
Explanation
Working mode information
(ACTIVE phase)
1. Battery indicator
2. Treatment cycle number (C1 to C6)
3. Output power
4. Time elapsed since the beginning of
the current ACTIVE phase.
Working mode information
(IDLE phase)
1. Battery indicator
2. Treatment cycle number
3. Output power
4. The PainShield® MD is in IDLE phase.
Screensaver during working mode
(automatically replaces the information
screen after 3 minutes)
The PainShield® MD is ON.
To refresh the display of information,
briefly press the ON/OFF button.
The battery is discharged and requires
recharging.
①
②
③
④
①
②
③
④

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Symbols/Text Displayed
Explanation
Charging mode information
The battery icon fills gradually to show
charging progress.
Screensaver in Charging Mode
The display is dimmed and keeps scrolling
vertically.
To refresh the display of information
press the ON/OFF button briefly (that is,
for less than 2 seconds).
The treatment patch is damaged or not
connected to the driver.
The driver is switching OFF
Switching off takes 3 seconds. The
number indicates how many seconds to
complete shut off.
6.7 Removing the Patch
1. Unsnap the driver cable from the patch.
2. Gently lift the patch off the skin.

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3. Moisten the hydrogel layer with a little water.
4. Replace the clear patch protective liner.
5. Return the patch to its pouch.
C AU T I O N
Do not leave the patch unpackaged in a dry place.
It will lose its hydration and will no longer adhere
to the skin.