NanoVibronix PainShield User manual

User Manual
Cat. # 20-100-0001 Ver. 03 (USA)

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PainShield® MD User Manual
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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
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
Email: [e-mail]

PainShield® MD User Manual
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Table of Contents
1Introduction......................................................................................... 5
1.1 General Safety............................................................................ 5
1.2 Prescription Use Only................................................................. 5
2Indications for Use............................................................................... 6
3Safety……………………………………………………………………………………………….7
3.1 Contraindications....................................................................... 7
3.2 Warnings.................................................................................... 8
3.3 Precautions ................................................................................ 9
4Product Features ................................................................................. 9
4.1 Preset Treatment..................................................................... 10
4.2 Battery Operation .................................................................... 10
4.3 PainShield®MD Adhesive Patches............................................ 10
5Product Components......................................................................... 11
5.1 The PainShield®MD Treatment Actuator................................. 11
5.2 The PainShield®MD Driver....................................................... 12
6Operation .......................................................................................... 13
6.1 Charging the Driver.................................................................. 13
6.2 Preparing the Treatment Area................................................. 14
6.3 Preparing the Actuator for Use................................................ 14
6.4 Applying Therapy ..................................................................... 16
6.5 Monitoring PainShield® MD...................................................... 17
6.6 Removing the Actuator Patch .................................................. 19
6.7 Replacing the Actuator ............................................................ 20
7Frequently Asked Questions.............................................................. 21
8Product Care...................................................................................... 22
Appendix A: Electromagnetic Compliance.............................................. 23
Appendix B: Specifications...................................................................... 27
Appendix C: Labels.................................................................................. 28
Appendix D: Symbols .............................................................................. 29
Appendix E: Warranty ............................................................................ 30

PainShield® MD User Manual
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1Introduction
Thank you for choosing the PainShield® MD. This manual contains precautions
and general instructions for the operation, application and care of PainShield®
MD. In order to obtain maximum lifetime and efficiency from PainShield® MD
and to ensure it is properly operated, please read and understand this manual
thoroughly. PainShield® MD is to be used only as directed in this manual.
PainShield® MD uses ultrasound therapy for the relief of acute or chronic pain
and muscle spasms.
PainShield® MD 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 maximize the safe and effective delivery of a long-
duration therapeutic effect.
PainShield® MD is simple to administer, 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 90kHz. Treatment is delivered via an ultrasound actuator,
which is applied and secured to the surface of the body using single-use
adhesive patches.
1.1 General Safety
Please thoroughly read and understand the precautionary and operating
instructions before attempting to operate 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.
1.2 Prescription Use Only
CAUTION
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.