NanoVibronix Wound Shield User manual

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

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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

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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.
Therapeutic ultrasound is produced through a reverse piezoelectric effect. Electric signals produced by
the driver are delivered to an electrode that is in contact with the piezo electric element. The signal
applied to the piezo element surface produces mechanical vibrations, or the so-called reverse piezoelectric
effect.
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 size
of 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 energy
deposition.
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 the
release of histamine and other mediators that attract fibroblasts and endothelial
cells to the injured area; proliferative - stimulates fibroblast migration and
proliferation to secrete collagen, improving tensile strength of the healing
connective tissues; Epithelialization - stimulates the release of growth factors
needed to regenerate epithelial cells; Maturation or Remodeling - affects the
collagen extensibility and enzyme activity and therefore also improves tensile
strength of the healing tissue
Figure1. Principal schema of Ultrasound beam radiation
Transducer
disk
Applicator
Ultrasound beam

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WoundShield is a therapeutic ultrasound system. The device delivers localized
energy, creating therapeutic effect for expedited tissue healing. The device
includes a rechargeable battery powered driver unit that connects with a cable
to the treatment patch. Ultrasonic waves are generated by transducer that is
incorporated into the treatment patch which should be placed in close
proximity to the desired treatment area.
The WoundShield proprietary technology allows the creation of a patch based
therapeutic 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 to
the transducer, incorporated into the treatment
patch.
Ultrasound
transducer
Piezoelectric element which converts the electrical
signals into ultrasound waves.
Applicator
Treatment patch with incorporated ultrasound
transducer that comes in direct contact with the
treatment 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 instruction
manual/ booklet
LOT
Manufacturer
Rated frequency or rated frequency
range(s) (Hz)
Separate collection for
electrical and electronic
equipment
European Authorized representative
Used by
YYYY-MM-DD or
YYYY-MM
BNR
Beam non uniformity ratio
Power output 0.4 watts
0.4W
ERA
Effective radiating area
Continues wave
CW
W
Watts
mW/cm2
Miliwatt (s) per
square 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 operation
ordinary equipment with a disposable type BF applied part.
The device is not intended for use in the presence of flammable
mixtures.
WARNING!
WoundShield device is not waterproof and therefore should not
be 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 a
physician.
ATTENTION!
Following treatment, some redness might occur in the treated
area. 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 described
in 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 adult
supervision.

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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 epiphyseal
growth 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 effect
for expedited tissue healing. The device includes a rechargeable battery
powered driver unit that connects with a cable to an applicator. The ultrasonic
waves are generated by a transducer that is incorporated into the applicator.
The applicator should be placed in close proximity to the desired treatment
area. For maximal effectiveness – the transducer should be in full contact with
the skin.
WoundShield device
Driver cable
Contact snaps
Reusable patch
WoundShield
Driver
ON / OFF
Button
Ultrasound
transducer
incorporated into the
patch

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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.
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 of
reusable patch (A or B as marked by dotted lines), to allow placement of the
patch 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 the
treatment 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 it
for 2 seconds.

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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. Once this is done the patch can be stored
in its original silver pouch.
WoundShield user interface (screens)
1. Driver turned on
2. Working mode (Active
period)
After about 3 minute, screen
saver display will turn on.
Note: in order to return to
Working mode display, press
shortly 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 then
it shuts down automatically.
It is possible to turn the device off at any time by pressing the ON/OFF
button and holding it for 2 seconds.
3. Working mode (IDLE
period)
After about 3 minute, screen
saver display will turn on.
Note: in order to return to
Working mode display, press
shortly on the On/Off button.
4. Battery is discharged and
requires charging
5. Treatment patch is
disconnected or damaged
WoundShield
Ver: 35.04
C1 0. 4 W
29 min
C1 0 W
IDLE
Product name
Program
version
Treatment cycle number: C1-C6
Output power
1. number
Treatment time within
the cycle: 0-30 min
Battery level
NanoVibronixTM
Company
name

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6. Charging in progress
After about 1 minute, screen saver display will
light feebly.
Note: in order to return to Charging mode
display, press shortly on the On/Off button.
7. Driver is turning off
Screensaver screens:
1. In Charging mode
2. In Working Mode
1. 2.
Charging the WoundShield driver
1. 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 6.5
hours of activation.
2. Connect the charger to the driver socket and then plug the adaptor to the
wall outlet.
3. Battery icon on the driver screen indicates battery charging process.
During charging, a screen saver is activated. To return to the normal
information 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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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)
Weight:
~70 g
Housing:
ABS
Holding accessories
(optional):
Hanging strip / pouch
Applicator
Patch model and type
Reusable PRP-20
Acoustic power:
0.4 W
Frequency
90 kHz
Beam non uniformity ratio
(BNR)
6:1
Active treatment area ERA
6 cm²
Adhesive area
33 cm2
Dimensions
120 mm*50 mm*6 mm
Weight
10 g
Color
Beige
Usage
Multiple uses (~ 7 treatment sessions)
Charger
Voltage input:
100-240 V ac, ~ 138mA, 50/60 Hz
Output:
5 V dc, 1A
Note: 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 Emissions
The WoundShield is intended for use in electromagnetic environment specified below. The
customer or user of the WoundShield should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment - guidance
RF 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 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.
Immunity test
IEC 60601
Test level
Compliance
level
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV
contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be least 30%
Electrical fast
transfer/burst
IEC 61000-4-4
±2 kV for
power supply
lines
±1 kV for
input/output
lines
±2 kV for
power supply
lines
±1 kV for
input/output
lines
Mains power quality should be that of
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV
differential
mode
±2 kV
common
mode
±1 kV
differential
mode
±2 kV common
mode
Mains power quality should be that of
typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 % UT
(>95% dip in
UT) for 0.5
cycle
40 % UT
(60% dip in
UT) for 5
cycles
<5 % UT
(>95% dip in
UT) for 5 sec
<5 % UT
(>95% dip in
UT) for 0.5
cycle
40 % UT
(60% dip in UT)
for 5 cycles
<5 % UT
(>95% dip in
UT) for 5 sec
Mains power quality commercial or
hospital environment. The user of the
WoundShield during continued operation
not depend from power mains
interruptions, because WoundShield
powered from a batteries. During system
charging is recommended that the
WoundShield be powered from an
uninterruptible power supply.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
NOTE UTis 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 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.
Immunity
test
IEC 60601 test
level
Compliance
level
Electromagnetic environment
- guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150kHz to 80MHz
3 Vrms
80MHz to 2.5GHz
[V1] V
[E1] V/m
Portable and mobile RF
communications equipment should be
used no closer to any part of the
WoundShield, including cables, than
the recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
P
V
d






1
5.3
P
E
d






1
5.3
80 MHz to 800 MHz
P
E
d






1
7
800 MHz to 2.5 GHz
Where Pis the maximum output
power rating of the transmitter in
watts (W) according to the transmitter
manufacturer and dis the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by
electromagnetic site survey, ashould
be less than the compliance level in
each frequency range. b
Interference may occur in the vicinity
of equipment marked with following
symbol:
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 is
affected by absorption and reflection from structures, objects and people.
aField 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

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Table 3 –
WoundShield
Electromagnetic Immunity
(Continued)
Recommended separation distances between portable and mobile RF
communications equipment and the WoundShield
The WoundShield is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or user of the WoundShield can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the WoundShield as recommended below, according
to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter, W
Separation distance according to frequency of transmitter, m
150 kHz to 80 MHz
P
V
d






1
5.3
Separation Distance,
meters
80 MHz to 800 MHz
P
E
d






1
5.3
Separation Distance,
meters
800 MHz to 2.5 GHz
P
E
d






1
7
Separation Distance,
meters
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.17
1.17
2.33
10
3.69
3.69
7.38
100
11.67
11.7
23.33
For transmitters rated at a maximum output power not listed above, the separation distance can be
estimated using the equation in the corresponding column, where P is the maximum output rating
of the transmitter in watts (W) according to the transmitter manufacturer. V1 is COMPLIANCE
LEVEL for the IEC 61000-4-6 test and E1 is the COMPLIANCE LEVEL for the IEC 61000-4-3
test. 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 the
applicable RF compliance level above, the WoundShield should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such
as reorienting or relocating the WoundShield.
bOver the frequency range 150 kHz to 80 MHz, field strength should be less than [V1] V/m