wound shield tm user manual - nanovibronix

Wound Shield TM

User Manual

Cat. # WSUM001Ver. 03

Wound Shield User Manual

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Wound Shield user manual

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Table of Contents

GENERAL INFORMATION 4

CLINICAL INFORMATION 8

GENERAL DESCRIPTION 9

WOUNDSHIELD OPERATION 10

SPECIFICATIONS 14

LABELS 15

ELECTRICAL HAZARDS 16

ELECTROMAGNETIC COMPATIBILITY 16

TROUBLESHOOTING 23

SERVICE 25

ADDRESSES 26

Wound Shield user manual

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General Information

Introduction to ultrasoundUltrasound is a form of acoustical vibration occurring at frequencies above the 20 kHz perception limit ofthe human ear. Ultrasound therapy effectiveness depends on transmitting pressure and displacementwaves through body tissues. Since the body is actually composed of a variety of tissue types, thepenetration depth will depend on the thickness of each tissue in the pathway of the ultrasound beam.

Therapeutic ultrasound is produced through a reverse piezoelectric effect. Electric signals produced bythe driver are delivered to an electrode that is in contact with the piezo electric element. The signalapplied to the piezo element surface produces mechanical vibrations, or the so-called reverse piezoelectriceffect.Ultrasonic power is expressed in watts (W), or watts per square centimetre (W/cm2). Average intensity(W/cm2) is obtained by measuring the total output of the applicator (in watts) and then divided by the sizeof the effective radiating area of the applicator.High frequency waves (Megahertz range) are absorbed rapidly with consequent reduction in penetration.Conversely, lower frequencies (kilohertz range) support wave penetration and may lead to greater energydeposition.

The WoundShield Device

It is known in the art, that ultrasound is beneficial in all wound healing phases:inflammatory - it enhances the degranulation of mast cells resulting in therelease of histamine and other mediators that attract fibroblasts and endothelialcells to the injured area; proliferative - stimulates fibroblast migration andproliferation to secrete collagen, improving tensile strength of the healingconnective tissues; Epithelialization - stimulates the release of growth factorsneeded to regenerate epithelial cells; Maturation or Remodeling - affects thecollagen extensibility and enzyme activity and therefore also improves tensilestrength of the healing tissue

Figure1. Principal schema of Ultrasound beam radiation

Transducerdisk

Applicator

Ultrasound beam

WoundShield User Manual

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WoundShield is a therapeutic ultrasound system. The device delivers localizedenergy, creating therapeutic effect for expedited tissue healing. The deviceincludes a rechargeable battery powered driver unit that connects with a cableto the treatment patch. Ultrasonic waves are generated by transducer that isincorporated into the treatment patch which should be placed in closeproximity to the desired treatment area.The WoundShield proprietary technology allows the creation of a patch basedtherapeutic transducer that may be placed adjacent to the wound.WoundShield should be used under instructions of a physician.

Definitions

Driver: Electronic unit providing the electrical signals tothe transducer, incorporated into the treatmentpatch.

Ultrasoundtransducer

Piezoelectric element which converts the electricalsignals into ultrasound waves.

Applicator Treatment patch with incorporated ultrasoundtransducer that comes in direct contact with thetreatment area.

Reusable applicator A treatment patch intended for multiple treatments.

Charger: Device for battery recharging.


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Symbols

Class BF applied part CE mark

Do not reuse SN Serial number

Refer to instructionmanual/ booklet

LOT

Manufacturer Rated frequency or rated frequencyrange(s) (Hz)

Separate collection forelectrical and electronicequipment

European Authorized representative

Used byYYYY-MM-DD orYYYY-MM

BNR Beam non uniformity ratio

Power output 0.4 watts0.4W ERA Effective radiating area

Continues waveCW W Watts

mW/cm2Miliwatt (s) persquare centimeter,1W=1000mW

cm2 Square centimeters

kHz 1Kilohertz =1000 Hz


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Important Notices

WARNING! The unit is classified as internally powered, continuous operationordinary equipment with a disposable type BF applied part.The device is not intended for use in the presence of flammablemixtures.

WARNING! WoundShield device is not waterproof and therefore should notbe immersed in water or other liquid.

WARNING! Do not place the treatment patch directly over an open wound.

ATTENTION! WoundShield should be used under the instructions of aphysician.

ATTENTION! Following treatment, some redness might occur in the treatedarea. The redness should naturally resolve after a couple of hours.

ATTENTION! WoundShield device could not be used during charging.

CAUTION! WoundShield device should be used only in the manner describedin this User Manual.

CAUTION! The device contains rechargeable Lithium-Ion batteries: Do not disassemble Do not expose to extreme heat Do not incinerate or expose device to water

CAUTION! Treating children should be done under adultsupervision.


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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 WoundShield device should not be applied directly over the eye

Precautions

In young children it is preferable to avoid usage over the epiphysealgrowth plate area.

When hemorrhagic diathesis is present. Pregnant patients should be treated only with physician consent


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General Description

The WoundShield device delivers localized energy, creating therapeutic effectfor expedited tissue healing. The device includes a rechargeable batterypowered driver unit that connects with a cable to an applicator. The ultrasonicwaves are generated by a transducer that is incorporated into the applicator.The applicator should be placed in close proximity to the desired treatmentarea. For maximal effectiveness – the transducer should be in full contact withthe skin.

WoundShield device

Driver cable

Contact snaps

Reusable patch

WoundShieldDriver

ON / OFFButton

Ultrasoundtransducer

incorporated into thepatch


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WoundShield Operation

Pre-Use Preparations1. 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.3. Remove excess hair from the area prior to patch application

Using WoundShield Applicator

1. According to patch placement direction, use scissors to cut a part ofreusable patch (A or B as marked by dotted lines), to allow placement of thepatch in close proximity to the wound.

2. Remove the protective liner from the reusable patch.

A

B


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3. Connect the WoundShield cable to the patch snaps.

4. Place and adhere the patch so that actuator (flat metal part of thetreatment patch) is as close as possible to the wound.

Note: Ensure that actuator (flat metal part of the treatment patch) is in full

contact with the skin. 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 itfor 2 seconds.


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The reusable patch may be used multiple times due to a hydro geladhesive that may be refreshed. Gently moisten the hydro gel portions ofthe patch with some water after removal. It should then be placed back onthe transparent protective layer. Once this is done the patch can be storedin its original silver pouch.

WoundShield user interface (screens)1. Driver turned on

2. Working mode (Active

period)

After about 3 minute, screensaver display will turn on.Note: in order to return toWorking mode display, pressshortly on the On/Off button.

Treatment screen indicates treatment phase.Each cycle has an active period of 30 minutes followed by an inactive(IDLE) period of 30 minutes.The WoundShield battery allows for seven treatment sessions and thenit shuts down automatically.It is possible to turn the device off at any time by pressing the ON/OFFbutton and holding it for 2 seconds.

3. Working mode (IDLEperiod)

After about 3 minute, screensaver display will turn on.Note: in order to return toWorking mode display, pressshortly on the On/Off button.

4. Battery is discharged andrequires charging

5. Treatment patch isdisconnected or damaged

WoundShieldVer: 35.04

C1 0. 4 W

29 min

C1 0 WIDLE

Product name

Programversion

Treatment cycle number: C1-C6

Output power

1. numberTreatment time within

the cycle: 0-30 min

Battery level

NanoVibronixTMCompanyname


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6. Charging in progress

After about 1 minute, screen saver display willlight feebly.Note: in order to return to Charging modedisplay, press shortly on the On/Off button.

7. Driver is turning off

Screensaver screens:

1. In Charging mode2. In Working Mode

1. 2.

Charging the WoundShield driver1. When the battery is empty, the on screen battery icon blinks and a

beeping sound indicates that battery recharging is required.It is advised to charge the driver prior to each use, in order to assure 6.5hours of activation.

2. Connect the charger to the driver socket and then plug the adaptor to thewall outlet.

3. Battery icon on the driver screen indicates battery charging process.During charging, a screen saver is activated. To return to the normalinformation screen, briefly press the ON/OFF button.

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

-- Off ---3-

WoundShield


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SpecificationsDriver model FD-14A

Frequency 90 kHz modulated by 30 HzVoltage output 12 V p-pCurrent output Up to 0.3 A rmsRechargeable battery: Lithium-ion (full charging time ~ 6 h)Dimensions: 113 mm (h) x 39.4 mm (w) x 12.6 mm (h)Weight: ~ 70 gHousing: ABSHolding accessories(optional):

Hanging strip / pouch

Applicator

Patch model and type Reusable PRP-20Acoustic power: 0.4 WFrequency 90 kHzBeam non uniformity ratio(BNR)

6:1

Active treatment area ERA 6 cm²Adhesive area 33 cm2

Dimensions 120 mm*50 mm*6 mmWeight 10 gColor BeigeUsage Multiple uses (~ 7 treatment sessions)

Charger

Voltage input: 100-240 V ac, ~ 138mA, 50/60 HzOutput: 5 V dc, 1ANote: use an appropriate adaptor for local mains


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Labels

WoundShield driver's label

Reusable treatment patch label WoundShield Kit label

WS


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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.

Electromagnetic Compatibility

WoundShield complies with IEC 60601-1-2 EMC standard for medical devices.

WoundShield is suitable to be used in an electromagnetic environment, as per the limits

& recommendations described in the tables hereafter:

Emission Compliance level & limits (Table 1).

Immunity Compliance level & recommendations to maintain equipment clinical

utility (see Table 2, Table 3).

Note: This system complies with above mentioned EMC standard when used with

supplied power supply.


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Electromagnetic Emission

Guidance and manufacturer’s declaration – Electromagnetic EmissionsThe WoundShield is intended for use in electromagnetic environment specified below. Thecustomer or user of the WoundShield should assure that it is used in such an environment.

Emission test Compliance Electromagnetic environment - guidanceRF emissions,

CISPR 11

Group 1 The WoundShield uses RF energy only for its internal

function. Therefore, its RF emissions are very low and

are not likely to cause any interference in nearby

electronic equipment.

RF emissions,

CISPR 11

Class B The WoundShield is not directly connected to the

Public Mains Network.

The WoundShield is predominantly intended for use

(e.g. in hospitals) with an appropriate power supply.

Harmonic emissions,

IEC 61000-3-2

Class B

Voltage fluctuations/

flicker emissions

IES 61000-3-3

Complies

Table 1 - WoundShield Electromagnetic Emission.


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Electromagnetic Immunity

Guidance and manufacturer’s declaration – electromagnetic immunityThe WoundShield is intended for use in the electromagnetic environment specified below. Thecustomer or the user of the WoundShield should assure that it is used in such an environment.Immunity test IEC 60601

Test levelCompliance

levelElectromagnetic environment -

guidanceElectrostaticdischarge (ESD)IEC 61000-4-2

±6 kVcontact

±8 kV air

±6 kV contact

±8 kV air

Floors should be wood, concrete orceramic tile. If floors are covered withsynthetic material, the relative humidityshould be least 30%

Electrical fasttransfer/burstIEC 61000-4-4

±2 kV forpower supplylines±1 kV forinput/outputlines

±2 kV forpower supplylines±1 kV forinput/outputlines

Mains power quality should be that oftypical commercial or hospitalenvironment.

SurgeIEC 61000-4-5

±1 kVdifferentialmode±2 kVcommonmode

±1 kVdifferentialmode±2 kV commonmode

Mains power quality should be that oftypical commercial or hospitalenvironment.

Voltage dips, shortinterruptions andvoltage variationson power supplyinput linesIEC 61000-4-11

<5 % UT(>95% dip inUT) for 0.5cycle

40 % UT(60% dip inUT) for 5cycles

<5 % UT(>95% dip inUT) for 5 sec

<5 % UT(>95% dip inUT) for 0.5cycle

40 % UT(60% dip in UT)for 5 cycles

<5 % UT(>95% dip inUT) for 5 sec

Mains power quality commercial orhospital environment. The user of theWoundShield during continued operationnot depend from power mainsinterruptions, because WoundShieldpowered from a batteries. During systemcharging is recommended that theWoundShield be powered from anuninterruptible power supply.

Power frequency(50/60 Hz)magnetic fieldIEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields shouldbe at levels characteristic of a typicallocation in a typical commercial orhospital environment.

NOTE UT is the a. c. mains voltage prior to application of the test level.

Table 2 – WoundShield Electromagnetic Immunity.


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Guidance and manufacturer’s declaration – electromagnetic immunityThe WoundShield is intended for use in the electromagnetic environment specified below. Thecustomer or the user of the WoundShield should assure that it is used in such an environment.

Immunitytest

IEC 60601 testlevel

Compliancelevel

Electromagnetic environment- guidance

Conducted RFIEC 61000-4-6

Radiated RFIEC 61000-4-3

3 Vrms150kHz to 80MHz

3 Vrms80MHz to 2.5GHz

[V1] V

[E1] V/m

Portable and mobile RFcommunications equipment should beused no closer to any part of theWoundShield, including cables, thanthe recommended separation distancecalculated from the equationapplicable to the frequency of thetransmitter.

Recommended separation distance

PV

d

15.3

PE

d

15.3

80 MHz to 800 MHz

PE

d

17

800 MHz to 2.5 GHz

Where P is the maximum outputpower rating of the transmitter inwatts (W) according to the transmittermanufacturer and d is therecommended separation distance inmeters (m).

Field strengths from fixed RFtransmitters, as determined byelectromagnetic site survey, a shouldbe less than the compliance level ineach frequency range. b

Interference may occur in the vicinityof equipment marked with followingsymbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation isaffected by absorption and reflection from structures, objects and people.a 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 TVbroadcast cannot be predicated theoretically with accuracy. To access the electromagnetic


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Table 3 –WoundShieldElectromagnetic Immunity(Continued)

Recommended separation distances between portable and mobile RF

communications equipment and the WoundShieldThe WoundShield is intended for use in an electromagnetic environment in which radiated RFdisturbances are controlled. The customer or user of the WoundShield can help preventelectromagnetic interference by maintaining a minimum distance between portable and mobile RFcommunications equipment (transmitters) and the WoundShield as recommended below, accordingto the maximum output power of the communications equipment.

Rated maximumoutput power oftransmitter, W

Separation distance according to frequency of transmitter, m150 kHz to 80 MHz

PV

d

15.3

Separation Distance,meters

80 MHz to 800 MHz

PE

d

15.3


800 MHz to 2.5 GHz

PE

d

17


0.01 0.12 0.12 0.230.1 0.37 0.37 0.741 1.17 1.17 2.3310 3.69 3.69 7.38100 11.67 11.7 23.33

For transmitters rated at a maximum output power not listed above, the separation distance can beestimated using the equation in the corresponding column, where P is the maximum output ratingof the transmitter in watts (W) according to the transmitter manufacturer. V1 is COMPLIANCELEVEL for the IEC 61000-4-6 test and E1 is the COMPLIANCE LEVEL for the IEC 61000-4-3test. V1 and E1 are in V/m.NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range

applies.NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is

affected by absorption and reflection from structures, objects and people.

Table 4 – Recommended Separation Distances

environment due to fixed RF transmitters, an electromagnetic site survey should be considered.If the measured field strength in the location in which the WoundShield is used exceeds theapplicable RF compliance level above, the WoundShield should be observed to verify normaloperation. If abnormal performance is observed, additional measures may be necessary, suchas reorienting or relocating the WoundShield.

b Over the frequency range 150 kHz to 80 MHz, field strength should be less than [V1] V/m


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Safety MeasuresThis product was designed and manufactured to ensure maximum safety ofoperation. It should be operated and maintained in strict compliance with thesafety precautions, warnings and operating instructions contained in thismanual.The product in whole or in part shall not be modified in any way. No partshould be replaced with components or parts other then the originalssupplied by NanoVibronix.WoundShield is a stand-alone device and should not be connected to anyother device/system except to its own accessories.

CAUTION! Servicing, repairs and opening of the device may be carriedout only by authorized distributors.

Product classificationLow risk device classification:CE mark- Class II a

Compliance with standardsIEC 60601-1:2001; IEC-60601-2:2001ISO 10993


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Storage and MaintenanceStore 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 containflammable materials and will not accelerate a fire. The driver is not intendedfor use in the presence of flammable mixtures.

Patch Shelf life

According to expiration date printed on the patch package label.

Life Time

The life time of the driver is 5 years, subject to replacement batteries by the

manufacturer.

The life time of the patches is 1 year.

Operational period

The Driver is intended undergo up to 300 charging cycles.The reusable treatment patch can be used repeatedly for about 50 hours or~ 7 applications.Before storage moisten the hydro gel portion of the patch with a small amountof water, then place the patch back on the clear plastic liner. Once this is done thepatch can be stored in its original silver pouch.


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Cleaning

The driver unit can be wiped with disinfecting medical wipes.

CAUTION! Do not use solvents (such as acetone) as they may damage theproduct.

Troubleshooting

Problem Required action

The battery icon on the screen isblinking and audible alarm is heard

Low battery – charging is required

A patch icon is displayed on thescreen and audible alarm is heard

Patch is either disconnected or nonfunctional - check if the driver cable isconnected correctly to the patch's snapsor replace the treatment patch

The cable snaps connectors areloosened when connected to thepatch

Please contact NanoVibronix' localrepresentative


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Frequently Asked Questions

Question AnswerCan I put the patch over an openwound?

The patch should never be placed on anopen wound; it should be placed on thehealthy skin nearby the wound

I do not feel anything during thetreatment procedure. Is the deviceworking properly?

The WoundShield ultrasound therapymay produce only slight warming

How can I order additionalpatches?

Please contact NanoVibronix' localrepresentative

How do I place the patch correctly? The user should ensure that ultrasoundtransducer is placed directly on healthyskin next to the wound and theapplicator is in full contact with the skin

How can I extend reusable patchusage?

After patch removal, moisten the hydrogel portion of the patch with a smallamount of water, place the patch backon the clear plastic liner and store it inits original packaging


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Service

A faulty unit, which is under the warranty period, can be sent to NanoVibronixfor replacement


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Addresses

Manufactured by:

NanoVibronix Ltd.,9 Derech Hashalom St, P.O.B 515, Nesher 3665112, Israel.Tel: +972–4-8200581 Fax: +972-4-8202794E-mail: [email protected]: www.nanovibronix.com

Company Address:

NanoVibronix Inc.,

525 Executive Boulevard,Elmsford, N.Y. 10523, USATel.: 1 (914) 233-3004Fax: 1 (914) 376-6111Email: [email protected]: www.nanovibronix.com

European Authorize Representative

CEpartner4U BVEsdoornlaan 133951 DB Maarnthe NetherlandsTel.: +31.343.442.524Mobile: +31.6.516.536.26Fax: [email protected]

wound shield tm user manual - nanovibronix

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