NanoVibronix Wound Shield User Manual
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NanoVibronix Wound Shield User Manual

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Wound Shield
User Manual
TM
Cat. # WSUM001
Ver. 03

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Summary of Contents for NanoVibronix Wound Shield

  • Page 1 Wound Shield User Manual Cat. # WSUM001 Ver. 03...
  • Page 2 Wound Shield User Manual NanoVibronix Page 2 of 26...

  • Page 3: Table Of Contents

    Wound Shield user manual Table of Contents GENERAL INFORMATION CLINICAL INFORMATION GENERAL DESCRIPTION WOUNDSHIELD OPERATION SPECIFICATIONS LABELS ELECTRICAL HAZARDS ELECTROMAGNETIC COMPATIBILITY TROUBLESHOOTING SERVICE ADDRESSES NanoVibronix Page 3 of 26...

  • Page 4: General Information

    Wound Shield user manual General Information Introduction to ultrasound Ultrasound is a form of acoustical vibration occurring at frequencies above the 20 kHz perception limit of the human ear. Ultrasound therapy effectiveness depends on transmitting pressure and displacement waves through body tissues. Since the body is actually composed of a variety of tissue types, the penetration depth will depend on the thickness of each tissue in the pathway of the ultrasound beam.
  • Page 5 Applicator Treatment patch with incorporated ultrasound transducer that comes in direct contact with the treatment area. A treatment patch intended for multiple treatments. Reusable applicator Charger: Device for battery recharging. NanoVibronix Page 5 of 26...
  • Page 6 Wound Shield User Manual Symbols Class BF applied part CE mark Do not reuse Serial number Refer to instruction manual/ booklet Rated frequency or rated frequency Manufacturer range(s) (Hz) Separate collection for European Authorized representative electrical and electronic equipment Used by...
  • Page 7 The device contains rechargeable Lithium-Ion batteries: CAUTION!  Do not disassemble  Do not expose to extreme heat  Do not incinerate or expose device to water Treating children should be done under adult CAUTION! supervision. NanoVibronix Page 7 of 26...

  • Page 8: Clinical Information

    Wound Shield User Manual Clinical Information Intended Use  Improve local blood circulation and oxygen delivery  Assist in tissue regeneration  Relieve wound associated pain  Improve immune system resistance  Assist in wound healing Contraindications  Should not be applied directly on open wounds ...

  • Page 9: General Description

    For maximal effectiveness – the transducer should be in full contact with the skin. WoundShield device ON / OFF Button WoundShield Driver Driver cable Ultrasound transducer incorporated into the patch Contact snaps Reusable patch NanoVibronix Page 9 of 26...

  • Page 10: Woundshield Operation

    Wound Shield User Manual WoundShield Operation Pre-Use Preparations 1. Ensure that the driver is charged. If required, charge according to instruction (See page 13). 2. Prior to attaching the treatment patch to the skin, ensure that the designated area is clean and dry.
  • Page 11 Treatment patch actuator is effective for 40-50 hours of use and  should not be used for more than 10 treatment sessions 5. Turn the WoundShield ON by pressing the ON / OFF button and holding it for 2 seconds. NanoVibronix Page 11 of 26...
  • Page 12 Wound Shield User Manual The reusable patch may be used multiple times due to a hydro gel adhesive that may be refreshed. Gently moisten the hydro gel portions of the patch with some water after removal. It should then be placed back on the transparent protective layer.
  • Page 13 4. Complete charging process takes approximately 2 hours. 5. When the battery is fully charged, the battery indicator on the screen will stay constantly lit. CAUTION! WoundShield should not be used while charging. CAUTION! Use original charger only NanoVibronix Page 13 of 26...

  • Page 14: Specifications

    Wound Shield User Manual Specifications Driver model FD-14A Frequency 90 kHz modulated by 30 Hz Voltage output 12 V p-p Current output Up to 0.3 A rms Rechargeable battery: Lithium-ion (full charging time ~ 6 h) Dimensions: 113 mm (h) x 39.4 mm (w) x 12.6 mm (h)

  • Page 15: Labels

    WoundShield User Manual Labels WoundShield driver's label Reusable treatment patch label WoundShield Kit label NanoVibronix Page 15 of 26...

  • Page 16: Electrical Hazards

    Wound Shield User Manual Electrical Hazards  Do not attempt to remove any of the WoundShield panels, nor open any covers.  When recharging, always use the charger which is supplied with the device.  Do not plug the device in for recharging when barefoot or with moisture on your hands.
  • Page 17 Public Mains Network. The WoundShield is predominantly intended for use Harmonic emissions, Class B (e.g. in hospitals) with an appropriate power supply. IEC 61000-3-2 Voltage fluctuations/ Complies flicker emissions IES 61000-3-3 Table 1 - WoundShield Electromagnetic Emission. NanoVibronix Page 17 of 26...
  • Page 18 Wound Shield User Manual Electromagnetic Immunity Guidance and manufacturer’s declaration – electromagnetic immunity The WoundShield is intended for use in the electromagnetic environment specified below. The customer or the user of the WoundShield should assure that it is used in such an environment.
  • Page 19 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicated theoretically with accuracy. To access the electromagnetic NanoVibronix Page 19 of 26...
  • Page 20 Wound Shield User Manual environment due to fixed RF transmitters, an electromagnetic site survey should b If the measured field strength in the location in which the WoundShield is used ex applicable RF compliance level above, the WoundShield should be observed to v Table 3 –...
  • Page 21 The product in whole or in part shall not be modified in any way. No part should be replaced with components or parts other then the originals supplied by NanoVibronix. WoundShield is a stand-alone device and should not be connected to any other device/system except to its own accessories.
  • Page 22 Wound Shield User Manual Storage and Maintenance Store WoundShield device under the following conditions: Temp: 0-40 °C; Humidity: 20-85%. The driver is flame resistant according to UL-94HB. It does not contain flammable materials and will not accelerate a fire. The driver is not intended for use in the presence of flammable mixtures.

  • Page 23: Troubleshooting

    - check if the driver cable is connected correctly to the patch's snaps or replace the treatment patch The cable snaps connectors are Please contact NanoVibronix' local loosened when connected to the representative patch NanoVibronix...
  • Page 24 Wound Shield User Manual Frequently Asked Questions Question Answer Can I put the patch over an open The patch should never be placed on an wound? open wound; it should be placed on the healthy skin nearby the wound I do not feel anything during the The WoundShield ultrasound therapy treatment procedure.

  • Page 25: Service

    WoundShield User Manual Service A faulty unit, which is under the warranty period, can be sent to NanoVibronix for replacement NanoVibronix Page 25 of 26...

  • Page 26: Addresses

    Wound Shield User Manual Addresses Manufactured by: NanoVibronix Ltd., 9 Derech Hashalom St, P.O.B 515, Nesher 3665112, Israel. Tel: +972–4-8200581 Fax: +972-4-8202794 E-mail: info@nanovibronix.com Website: www.nanovibronix.com Company Address: NanoVibronix Inc., 525 Executive Boulevard, Elmsford, N.Y. 10523, USA Tel.: 1 (914) 233-3004 Fax: 1 (914) 376-6111 Email: info@nanovibronix.com...

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