Biowave PRO

iowavePRO®
Professional Neuromodulation
Pain Therapy System
1-877-BIOWAVE
www.biowave.com
biowave
Biowave Corporation
The Pathway to Pain Relief

Electrode Placements
BiowavePRO electrode placements are
different from conventional electrical
stimulation. The mixing of the proprietary
therapeutic signals occurs in a 2 - 3 inch
hemisphere beneath each electrode, not along
the surface of the skin between the electrodes.
As a result, to treat two equal points of pain or
to cover pain over a large area, two same sized
electrodes may be used and are placed directly
over the points of pain. To treat two unequal
points of pain, the small round electrode is
placed directly over the primary pain site. The
larger rectangular electrode is placed over a
secondary pain site or if there is no secondary
pain site, over a bony prominence near the
region being treated.
BiowavePRO ®
Key Features
• Advanced Deep Tissue Signal Technology—
optimized to pass through the skin
into deep tissue and to prevent action
potential propagation along pain fibers
• Long Carryover Effect — provides up
to 48 hours of pain relief and functional
improvement
• Hypoesthesia — remains at the location
of the pain site for up to 20 minutes
B
B
B
B
• Portable — hand held and easily used in
physical therapy during range of motion
or exercise therapy, in training rooms,
on the sidelines, in meeting rooms, on
airplanes, buses or at home
Bilateral Low Back Pain
Unilateral Low Back
Pain Focused on one
Side of Spine
Unilateral Low Back
Pain Focused Over a
Facet Joint
Low Back Pain Focused
Over the Spine
• Easy to Use — patient controlled
and no programming - the signals are
optimized for penetrating the skin,
blocking pain and improving function
• Comfortable — feels like a deep smooth
continuous sensation, not the noxious
electrical twitching sensation common
with other types of electrical stimulation
U
Hip Pain (or Other Pain
in One Location in the
Mid Torso Region)
E
Patellar Tendinitis
E
Medial Knee Pain
(e.g. MCL Sprain, Bursitis,
Osteoarthritis)
E
Lateral Knee Pain
(e.g. LCL Sprain, Bursitis,
Osteoarthritis, IT Band)
Facilitate and Accelerate
Rehabilitation
As part of a rehabilitation regimen,
BiowavePRO should be used first, for 8-10
minutes in place of heat. The patient obtains
a significant long acting period of pain
relief as well as a functional improvement
including an increase in range of motion.
E
Low Ankle or Foot Sprain
with Pain in One Location
E
Plantar Fasciitis
E
Cervical or Neck Pain in One
Location with Secondary
Pain in the Trapezius
E
Shoulder Pain at AC Joint
(e.g. AC Sprain or pain
throughout the shoulder)
BiowavePRO therapy then continues during
active or passive range of motion, exercise
or stretching therapy allowing patients to
control more resistance through a greater
range of motion with significantly less pain.
BiowavePRO is portable and hand held so
it is easy to move around the clinic with the
patient. BiowavePRO is an excellent tool
to facilitate motion, allowing the patient to
comfortably complete treatment protocols
set up by their physical therapist.
E
Anterior Shoulder Pain
(e.g. Biceps Tendinitis)
E
Lateral Elbow Pain
(e.g. Lateral Epicondylitis)
E
Medial Elbow Pain
(e.g. Medial Epicondylitis)
E
Anterior Wrist Pain
(e.g. Sprains, Strains,
Tendinosis)
Additionally, because of BiowavePRO’s
long carryover effect following the
treatment, the patient has a significant
reduction in post exercise soreness and is
often comfortable into the following day.
B Bilateral E Extremities U Unilateral
WARNING: Electrodes must not touch each other.
See back cover for electrode descriptions.

®
biowavePRO
The Future of Pain Relief Has Arrived.
The BiowavePRO ®
Neuromodulation Pain Therapy System is a first course
therapy for treating chronic, acute or postoperative musculoskeletal pain.
BiowavePRO utilizes a unique signal mixing
technology to deliver electrical signals through
the skin into deep tissue for inhibiting pain
transmission and improving function. The signal
technology is covered by numerous U.S. and
international patents.
Clinical studies have shown that BiowavePRO
can be used to reduce pain and improve function
including an increase in range of motion,
decrease in stiffness and reduction of muscle
spasm for up to 48 hours following a single
30-minute treatment.
How is BiowavePRO ®
Background
Low frequency signals (1-180Hz in frequency)
are required to inhibit transmission of pain
signals along nerve fibers in the body. However,
electrical signals in this frequency range cannot
pass through the skin because of the skin’s
impedance and capacitance. High frequency
signals (greater than 1000Hz in frequency) easily
pass through the skin. However, these signals
used individually do not elicit an electrical or
mechanical response from either muscle tissue
or nerve fibers to inhibit pain transmission.
TENS
TENS devices deliver pulsed low frequency
signals directly to the skin between two surface
electrodes placed on either side of the painful
area. The result is a surface effect and the patient
feels a noxious twitching, electrical sensation
between the electrodes. The sensation
produced by TENS may act as a distraction from
the pain while the device is on, however, there is
little residual benefit or functional improvement
once the therapy session is over.
BiowavePRO can be used to treat numerous
locations on the body including the lower back,
cervical spine, hip, groin, knee, shoulder, ankle, foot,
elbow, wrist, hand and finger. Doctors, physical
therapists and athletic trainers report excellent
results treating pain from joint sprains, ligaments
and tendons, osteoarthritis and postoperative pain.
Professional athletes that use BiowavePRO have
reported they experience better pain relief and
functional improvement than with any other
form of electrical stimulation and choose to
be treated with BiowavePRO every time they
return to the training room.
Superior to TENS
Interferential Current (IFC)
IFC uses four surface electrodes (two pairs of
electrodes) that are placed in an “X” pattern
surrounding a painful area. IFC delivers two
separate pulsed, high frequency signals, one
between each pair of electrodes. The two
pulsed signals cross paths on the surface of the
skin. At the point of intersection, an interference
pattern develops resulting in a new low
frequency signal equal to the difference
between the signals. This is called the beat
frequency. Since the two signals intersect on
the surface, the resulting beat frequency produces
mostly a surface effect similar to TENS.
BiowavePRO
There are three main differences between
BiowavePRO and IFC or TENS devices:
1
Deep Tissue Signal Technology
BiowavePRO utilizes a proprietary signal
mixing technology that delivers two continuously
summed, high frequency alternating current
signals that pass through the skin into deep
tissue where they interact with tissues to
BiowavePRO ®
System
The BiowavePRO System is a
professional neuromodulation
pain therapy system
for managing pain and
facilitating and accelerating
rehabilitation.
BiowavePRO can utilize
both Biowave ®
Noninvasive
Electrodes for pain
management, physical
therapy and athletic training
applications; and Biowave ®
Percutaneous Electrodes for
treating severe chronic pain in
a hospital, pain clinic or pain
management setting.
Biowave Corporation

produce a range of signals which include a
low frequency electrical field. This field is
optimized for blocking pain and providing
functional improvement including a greater
range of motion and a reduction in stiffness
and muscle spasm. In addition to providing
efficacy, these signals are significantly more
comfortable leading to improved patient
treatment compliance.
2
SmartPad Active Control and
Monitoring Technology
BiowavePRO utilizes SmartPad
technology – active monitoring and control
of the electrical signals to ensure the
accurate and safe delivery of therapeutic
energy into deep tissue. The SmartPad
technology automatically prevents patients
from receiving too much intensity which
could lead to a burn.
3
Electrode Options
There are two types of electrodes
designed to work with BiowavePRO:
Biowave ®
Noninvasive Electrodes
Biowave Noninvasive Electrodes are reusable
surface electrodes typically used to
reduce pain and facilitate physical therapy
in professional and college sports, in
physical and occupational therapy and in
chiropractic settings.
Biowave ®
Percutaneous Electrodes
Biowave Percutaneous Electrodes utilize
a patented microneedle technology
to further facilitate the delivery of the
BiowavePRO therapeutic signals through
the skin, directly into deep tissue.
Biowave Percutaneous Electrodes are
sterile, single-use electrodes, and are
used under the supervision of a physician
typically in a pain clinic, hospital or
physician office setting to reduce severe
acute, chronic or postoperative acute
pain.
Biowave Deep Tissue
Signal Technology
Biowave’s signal technology is based on
the discovery that when two sinusoidal high
frequency signals are summed (added)
together in the device and then delivered
into the body through a single electrode,
the signals will pass into deep tissue and
travel to a second opposing electrode. As
the summed signals pass through the body,
polarized structures like the membrane
of the C-fiber, A-delta fiber and muscle
tissue act in a non-linear fashion and force
the further multiplication of these signals,
resulting in a new spectrum of signals.
Multiplication of the high frequency signals
results in the formation of a therapeutic low
frequency electrical field that inhibits action
potential propagation along pain fibers.
This field is focused in a 2-3 inch diameter
hemisphere in the volume of tissue under
and surrounding each electrode. Since the
Biowave Percutaneous
Electrode
• Sterile, Single Use Electrode
• 1014 Microneedles 0.75mm
in length
• Feels like Velcro or sandpaper
to the touch
Professional Neuromodulation
Pain Therapy System
nerve fibers and muscle tissue under and
surrounding the electrodes are encompassed
by the low frequency field, at least
one electrode must be placed directly over
the center of the painful area.
“BiowavePRO ®
utilizes a
patented signal mixing
technology to deliver
electrical signals
through the skin into
deep tissue for inhibiting
pain transmission,
improving function and
providing a significant
carryover effect.”
BiowavePRO delivers the two summed
signals to the first electrode; they mix in the
tissue beneath that electrode, then pass
to the second electrode and return to the
device, completing the circuit. Instantaneously,
the summed signals are delivered
to the second electrode; they mix in the
tissue beneath that electrode, then pass
to the first electrode and return to the
device. The device alternates the delivery
of the summed signals so quickly between
the two electrodes that the patient cannot
distinguish that the signals left either
location. The net effect is there are two
active electrodes, each of which can treat
a distinct volume of tissue and there is no
noxious twitching sensation.
Focusing of the Biowave Signals
and Electrode Placement
With BiowavePRO, depending on the
nature and location of the painful area, the
electrical signals can be focused to different
parts of the body by pairing electrodes
of different sizes and types with one another.
If two electrodes of equal area are

used, then two distinct volumes of tissue
of similar pain magnitude can be treated
simultaneously. For example, if a patient
has bilateral low back pain, two equal area
electrodes can be placed over the respective
painful areas on each side of the spine.
Two equal area electrodes can also be
used to treat one larger volume of tissue by
placing these electrodes closer together so
that there is only 0.5 to 1.0 inch of space
between them.
With Biowave Noninvasive Electrodes, by
pairing an electrode of smaller area with an
electrode of larger area, the density of the
therapeutic low frequency field is greater
in the volume of tissue beneath the smaller
area electrode. Therefore, the smaller electrode
needs to be placed directly over the
primary painful area. The larger electrode
is still active (it is not a grounding pad) and
should be placed over a secondary point of
pain. If there is no secondary point of pain,
then the larger electrode must be placed
over a bony prominence near the treatment
site. Placement of the larger electrode over
a bony prominence allows the patient to
more comfortably increase the intensity of
the signal to higher levels allowing a stronger
electric field to encompass the pain site
under the smaller primary electrode.
With Biowave Percutaneous Electrodes,
the electrical signals can be focused by not
only pairing different area electrodes with
each other, but also by combining percutaneous
with noninvasive electrodes. Since
the summed high frequency signals pass
through the skin more easily when using
the percutaneous electrode, the impedance
is lower in this area than at the opposing
surface electrode. By having an impedance
difference between the electrodes,
the therapeutic low frequency field is more
concentrated where the impedance is lower.
Therefore, the electrical field in the volume
of tissue under the percutaneous electrode,
which is placed directly over the painful
area, allows the nerve fibers and muscle tissue
to be more readily encompassed by the
therapeutic low frequency electric field.
Treatment Regimen Protocol
In athletic training applications, because
athletes typically re-aggravate their pain
condition during practices or games, the
recommended regimen is to treat immediately
before a practice or game (which may
be in combination with heat), immediately
after a practice or game (which may be in
combination with cold therapy) and time
permitting, a third treatment 2 – 3 hours
later. Multiple treatments with Biowave-
PRO may provide cumulative benefit.
In physical therapy applications, Biowave-
PRO should be used first, in place of heat,
for 8 - 10 minutes. Intensity is then reduced
by about 5% and the patient begins active
or passive range of motion, exercise or
stretching therapy during the remainder of
the 30 minute treatment. Patients can do
more resistance through a greater range of
motion with significantly less pain. Biowave-
PRO significantly facilitates the ability of the
patient to perform therapy. Additionally, because
of the long carry over effect, patients
have little post exercise soreness.
For chronic pain conditions, BiowavePRO
with Biowave Percutaneous Electrodes may
be used. The recommended regimen is
6 treatments over 2 weeks, followed by
physician-prescribed BiowaveHOME
treatments that can be performed on a
daily or as needed basis. BiowavePRO with
Biowave Noninvasive Electrodes may also
be used for chronic or acute pain conditions.
Daily treatments are recommended
followed by physician prescribed Biowave-
HOME treatments that can be performed
on a daily or as needed basis.
More Comfortable
Because Biowave devices deliver the summation
of two high frequency sinusoidal
alternating current signals, the sensation is
smoother, deeper and more comfortable
compared to the noxious electrical twitching
sensation felt on the surface of the skin
that results from IFC and TENS.
Easy to Use
®
biowavePRO
Biowave’s early signal-dose-finding studies
demonstrated that there is an optimal set
of high frequency signals for delivering
energy through the skin into the body
which create an optimal low frequency
signal that inhibits pain transmission along
pain fibers. This resulted in the design of
a very simple to use device from which an
optimized set of signals for blocking pain
is delivered into deep tissue. The device
does not require any programming by the
physician, medical professional or patient.
Thus, Biowave devices are far simpler to
use than IFC or TENS devices.
Efficacy
Biowave devices provide rapid, long-lasting
efficacy. Responding patients experience
a significant reduction in pain, and often,
an improved range of motion, decrease in
stiffness and reduction of muscle spasm
by the end of the 30 minute treatment
period, which often lasts 24 hours to 48
hours or longer. Clinical studies have also
demonstrated that use of Biowave neuromodulation
pain therapy reduces the use
of concomitant pain medications.
Superior Clinical
Outcomes
Published randomized, controlled clinical
studies showing significant pain reduction
with a long carryover effect, functional
improvement and a reduction in pain
medication consumption have been
completed at several prestigious institutions
including:
• Hospital for Special Surgery,
New York, NY
• Rush University Medical Center,
Chicago, IL
• Weill Medical College at Cornell
University/NY Hospital, New York, NY
Clinical studies are available upon request.

®
biowavePRO
ORDERING INFORMATION
PRODUCT SPECIFICATIONS
Device
BWPD01
Electrodes -
BWEN01-B
BWEP01-B
Electrodes -
BWEN02-E
BWEP02-E
Electrodes -
BWEN03-U
Accessories
BWPL01
BWPTB1
BWPA01
BWPB01
BiowavePRO Neuromodulation Pain Therapy Device
B
Set
Biowave Noninvasive B-set: two 2” diameter round equal area
noninvasive electrodes for treating 2 equal points of pain or pain
over a large area.
Biowave Percutaneous B-set: two 2.5” diameter round equal area
percutaneous electrodes for treating 2 equal points of pain or pain
over a large area.
B-set electrodes are used for treating:
• bilateral or unilateral pain in the back including,
buttocks, lumbar or thoracic region
• radiculopathies
• pain in two locations in the hip or groin
• bilateral pain in the cervical spine, shoulders or knees
• pain centered directly in the spine
• pain presenting in a large area
E
Set
Biowave Noninvasive E-set: one 1.375” diameter small round
electrode for the primary pain site; and one 2” x 4” rectangular
electrode for a secondary pain site or to be placed over the bony
prominence in the region being treated.
Biowave Percutaneous E-set: one 2.5” diameter round percutaneous
electrode for the primary pain site; and one 2” x 4” noninvasive
rectangular electrode for a secondary pain site or to be placed
over a bony prominence (comfortable location) in the region being
treated.
E-set electrodes are used for treating:
• pain in the extremities including the knees, ankles, feet, toes,
neck, shoulders, elbows, wrists, hands and fingers
U Set
Biowave Noninvasive U-set: one 2” diameter round electrode for
the primary pain site; and one 5” x 8” large rectangular electrode
is placed horizontally across the lumbar region of the lower back.
U-set electrodes are used for:
• unilateral pain in the mid-torso region including, rib, oblique,
hip, buttock, groin, adductor, abductor, gluteus maximus, hamstring
and quadricep locations
BiowavePRO Leadwire Cable
BiowavePRO Padded Travel Bag
BiowavePRO AC Charger and Power Cord - US
BiowavePRO NiMH Rechargeable Battery
Physical Dimensions
Size (H x W x D): 8.80" x 6.31" x 3.07" /
22.35 cm x 16.02 cm x 7.79 cm
Weight: 2.9 lbs / 1.3 kg
Environmental Conditions
Operating Temperature: 0 – 40 °C / 32 – 104 °F
Humidity: 30 – 85% relative humidity,
non-condensing
Signal Output
Feed Frequency 1: 3858 Hz
Feed Frequency 2: 3980 Hz
Output Voltage Range: 0 – 27.5 V rms
Waveform: Sum of 2 sine waves
Power Source
12 V DC, 3850 mAh rechargeable NiMH battery
Provides 8 hours of power at 80% output into
500 Ohms
Leadwire
Rating complies with 21 CFR Part 898
(performance standards for electrode leadwires)
Biowave Noninvasive Electrodes
Biowave Noninvasive Electrodes are reusable and are of
a silver/carbon construction with a pre-applied hydrogel
and are cleared for marketing under 510(k) numbers
K962332, K900519 and K915333.
Biowave Percutaneous Electrodes
Biowave Percutaneous Electrodes are sterile, single-use
electrodes comprised of a 1.5 inch diameter microneedle
array within a 2.5 inch diameter hydrogel-based sterile
electrode. The microneedle array is comprised of 1014
microneedles, 0.74 mm in length, made from 316L surgical
stainless steel. Cleared for marketing under 510(k)
number K061166.
biowave
Manufactured by
Biowave Corporation
16 Knight Street
Norwalk, CT 06851
Device must only be used with
power supply provided.
1-877-BIOWAVE
info@biowave.com
www.biowave.com
©2012 Biowave Corporation
Biowave ® , BiowavePRO ® , BiowaveHOME ® and other trademarks are the property of
Biowave Corporation. Due to continual product innovation, system design and specifications
are subject to change without notice.
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