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BiowavePRO

User’s Manual

Biowave Corporation

Read these instructions, including When the Neurostimulator Should Not

Be Used (Contraindications), Risks/Benefits, and all Warnings, Precautions

and Adverse Reactions BEFORE using BiowavePRO

to ensure proper use

of the BiowavePRO

System.

3.1 When the Neurostimulator Should Not Be

Used (Contraindications)

•

DO NOT

use if you have a cardiac pacemaker as the neurostimulator may

interfere with its function.

•

DO NOT

use any electrodes over the heart or across the thoracic volume.

Electrodes can be applied to the back of the thorax and lateral aspect of
the upper limb (i.e. below/down the shoulder).

•

DO NOT

place the electrodes on the front or side of the neck.

•

DO NOT

place the electrodes on the top of the head.

•

DO NOT

use on patients prone to seizure (for example, epileptics).

•

DO NOT

use the neurostimulator if you have pain of unknown origin.

•

DO NOT

use the BiowavePRO

Neurostimulator over sensitive skin areas.

• Keep the BiowavePRO

Neurostimulator away from children.

• Stimulation from BiowavePRO and BiowavePENS may be applied over or

in the proximity of implanted orthopedic hardware, including total joint
replacements, anchors, screws, pins, clips and plates.

3. When the Neurostimulator Should

Not Be Used (Contraindications),
Risks/Benefits, Warnings,
Precautions & Adverse Reactions

Содержание BiowavePENS

Страница 1: ...0 1 8 The BiowavePRO Neurostimulator is used as part of the following neuromodulation pain therapy systems biowavePRO Professional Neuromodulation Pain Therapy System biowavePENS Percutaneous Electric...

Страница 2: ...BiowavePRO User s Manual Biowave Corporation 2 Rev 11 180201...

Страница 3: ...cators 16 2 4 1 LCD Display 16 2 4 2 System Indicator Light 17 3 When the Neurostimulator Should Not Be Used Contraindications Risks Benefits Warnings Precautions and Adverse Reactions 18 3 1 When the...

Страница 4: ...ib or Oblique Pain in One Location 34 4 6 4 GROIN PAIN ELECTRODE PLACEMENT EXAMPLES 35 4 6 4 1 Placement for Groin Pain in One Location 35 4 6 4 2 Placement for Groin Pain in Two Locations 35 4 6 4 3...

Страница 5: ...acement for Neck or Cervical Pain in One Location 58 4 6 9 2 Placement for Neck or Cervical Pain in One Location with Dispersive Radiating Pain 59 4 6 9 3 Placement for Neck or Cervical Pain Over a La...

Страница 6: ...ave Percutaneous Electrodes 79 4 9 Turning on the BiowavePRO Neurostimulator 79 4 10 Using the BiowavePRO Neurostimulator 80 4 10 1 Starting Treatment 80 4 10 2 During Treatment 81 4 10 3 End of Treat...

Страница 7: ...From Patient s Body During Treatment 93 8 2 3 Use of Non Biowave Electrodes 94 8 2 4 Muscle Twitching 94 8 2 5 Patient Quickly Reaches Maximum Intensity 94 8 2 5 1 Maximum Intensity Reached Due To Hig...

Страница 8: ...BiowavePRO User s Manual Biowave Corporation 6 IMPORTANT Before using this product read the following information thoroughly Rx Only...

Страница 9: ...d Biowave Percutaneous Electrodes Both the BiowavePRO and BiowavePENS Systems are indicated for Symptomatic relief of chronic intractable pain post surgical and post traumatic acute pain Symptomatic r...

Страница 10: ...cent of maximum intensity the treatment time selected the remaining treatment time a battery indicator and error indications for example if the electrodes become disconnected from the patient A System...

Страница 11: ...n the connector mates with the keyhole in the opening on the neurostimulator and the connector gently slides in and clicks in place see photo above 2 Neurostimulator Description 2 1 Neurostimulator Ac...

Страница 12: ...ord when trying to remove the leadwire cable from the neurostimulator Connecting the Leadwire Cable to Electrodes BiowavePRO uses two electrodes for a treatment Either electrode can be connected to ei...

Страница 13: ...RGER The Universal AC Charger is only used to recharge the battery in the neurostimulator The cord from the AC Charger is plugged into the neurostimulator A larger power cord is plugged into the other...

Страница 14: ...cleared as a Neuromodulation Pain Therapy System Biowave Percutaneous Electrodes Biowave Percutaneous Electrodes utilize a patented technology involving an array of over 1000 needles to significantly...

Страница 15: ...ion typically over a bony prominence near the region being treated Used for treating single locations of pain in the extremities including knee ankle foot toe neck shoulder elbow wrist hand finger U S...

Страница 16: ...cations radiculopathies pain centered directly over the spine pain throughout the knee or shoulder pain over large areas E Set One round Percutaneous Electrode 2 5 inch diameter is placed over a singl...

Страница 17: ...3 2 PLUS BUTTON Pressing the PLUS Button increases the intensity of the signal and the level of the tingling pressure sensation felt by the patient The PLUS Button is also used to increase treatment t...

Страница 18: ...d on the lower left corner of the display Remaining Treatment Time is indicated on the lower middle of the display Battery Strength Indicator is indicated on the lower right corner of the display Prob...

Страница 19: ...ht shows the status of the treatment of the neurostimulator The Indicator Light remains solid GREEN during a treatment begins flashing GREEN with 5 minutes left and turns solid YELLOW at the end of th...

Страница 20: ...k of the thorax and lateral aspect of the upper limb i e below down the shoulder DO NOT place the electrodes on the front or side of the neck DO NOT place the electrodes on the top of the head DO NOT...

Страница 21: ...wavePENS treatments may provide the most profound treatment results for treating i pain from ligament and tendon related issues for example from joint sprains and from acute and chronic tendinopathies...

Страница 22: ...ier like wrap or a towel between the electrodes and the hot or cold stimulus For BiowavePRO treatments with compression therapy ensure that the blue connectors reside OUTSIDE the compression cuff 3 3...

Страница 23: ...to close the airway or cause difficulty in breathing Stimulation should not be applied transthoracically across the heart because the introduction of electrical current into the heart may cause cardi...

Страница 24: ...nce of the following Patients with a tendency to hemorrhage following acute trauma or fracture Painful area over the menstruating or pregnant uterus and Areas of the skin that lack normal sensation So...

Страница 25: ...y charging and the System Indicator Light above the display will begin flashing GREEN 4 Once the neurostimulator is fully charged the picture of the battery will stop animating and the LCD display wil...

Страница 26: ...ze the C fiber inhibiting action potential propagation along pain fibers Frequency Conduction Block Theory The active electrical field also induces hypoesthesia 5 minutes into the treatment and causes...

Страница 27: ...much lower and the sensation felt beneath it is significantly less It is important that this electrode be placed in a comfortable location to receive stimulation which is typically over a bony promine...

Страница 28: ...he posterior side is more taut Calf electrode placements The patient should adjust the direction they point their toes either toward them or away from them to put the calf in tension This allows the p...

Страница 29: ...ng of the Treatment Gentle motion during the treatment is encouraged However motion causes a change in the sensation felt by the patient because movement of the tissue in the region of the treatment c...

Страница 30: ...the minimum spacing between electrodes on the back 0 5 inches is the minimum spacing between electrodes on extremities There is NO maximum spacing between any electrodes The following section shows p...

Страница 31: ...one round electrode directly over where the pain first presents itself For example this may be on the buttock proximally where the pain first starts before it radiates down the sciatic nerve as in th...

Страница 32: ...t directly over the spine covering a primary pain site or multiple pain sites For example if the primary pain site is located at L3 then one round electrode should be placed over L3 The comfortable bo...

Страница 33: ...ch other If there is not enough room to place the second round electrode over the spine horizontally next to the first electrode then place the second round electrode either above or beneath the first...

Страница 34: ...receives a treatment in a volume of tissue covered by the electrodes of approximately 6 inches by 3 inches See placement example for a rotational strain in the photo to the right Body Position The to...

Страница 35: ...pine is the most desirable comfortable position for the patient during the treatment Legs should be kept straight 4 6 2 2 Placement for Hip Pain in Two Locations for example for anterior and lateral h...

Страница 36: ...electrode placement example for rib pain The round Pain Site Electrode should NOT be placed directly over the heart on the anterior of the thorax The comfortable location for the large rectangular Dis...

Страница 37: ...ations Use the B set Place each round Pain Site Electrode on the groin directly over each painful area If pubic hair is in the location of the painful area then the hair must be shaved so that the ele...

Страница 38: ...rior of the body and one round electrode directly over the sacrum to stimulate the sacral nerves at the base of the spine If hair is in the location of the pubis then the hair must be shaved so that t...

Страница 39: ...e quadriceps in this example that the muscle will be held in tension in the volume of tissue directly beneath the round Pain Site Electrode It may be difficult for some patients to withstand the belly...

Страница 40: ...should be placed distally about 1 0 inch beneath the first electrode and should cover directly over the location that any additional pain presents itself This placement will allow the therapeutic sig...

Страница 41: ...in the volume of tissue directly beneath the round Pain Site Electrode It may be difficult for some patients to withstand the belly of a muscle being held in continuous tension These patients may nee...

Страница 42: ...and should cover directly over the location that any additional pain presents itself This placement will allow the therapeutic signals to capture the entire region approximately 6 inches by 3 inches...

Страница 43: ...nce or comfortable location for the rectangular Dispersive Electrode is touching the lateral side of the patella starting about half way up the patella and angled to the anterior of the knee The recta...

Страница 44: ...Bursa on the medial side of the knee as shown in the second photo below The bony prominence or comfortable location for the rectangular Dispersive Electrode is on the lateral side of the knee three q...

Страница 45: ...mall round Pain Site Electrode should be placed directly over the primary source of pain typically over the quadriceps tendon just superior to the patella as shown in the photo to the right The bony p...

Страница 46: ...ular Dispersive Electrode should not be placed over the peroneal nerve and softer tissue on the posterior lateral side of the knee because delivering stimulation over the softer tissue or stimulating...

Страница 47: ...mall round Pain Site Electrode should be placed directly over the primary source of pain on the lateral side of the knee as shown in the photo to the right The bony prominence or comfortable location...

Страница 48: ...e the B set for two locations of pain If pain presents at both the distal and proximal ends of the illiotibial band then use the B set electrodes to provide an equal treatment at each location simulta...

Страница 49: ...ncision Body Position For treatments for pain from total knee arthroplasty if possible the knee should be bent as close to 90 degrees as possible yet still comfortable for the patient This angle provi...

Страница 50: ...f the knee starting just above the midline of the knee and angled to the anterior of the knee touching the edge of the patella and running across the patellar tendon as shown in the first photo above...

Страница 51: ...t If the electrodes are placed about 1 0 inch apart from one another the therapeutic electrical field formed beneath each electrode will overlap internally allowing the entire region beneath both elec...

Страница 52: ...nd running completely across the patellar tendon as shown in the second photo to the right This is the most comfortable place to receive stimulation into the knee and will allow the patient to achieve...

Страница 53: ...he bony prominence or comfortable location to place the rectangular Dispersive Electrode is on the lateral side of the malleolus and wrapping around the Achilles tendon a little higher up than shown i...

Страница 54: ...the foot can be elevated during the treatment The Biowave treatment may be done in combination with hot or cold therapy 4 6 8 2 Placement for High Ankle Sprain with only a Primary Pain Site Use the E...

Страница 55: ...sitting in a chair with the foot flat on the floor or sitting on a training or physical therapy table with the knee bent and the foot resting flat on a wedge are the most ideal positions during the t...

Страница 56: ...The rectangular electrode should not touch the medial side of the heel as it is sensitive to stimulation In some instances the primary pain can occur at the insertion point of the Achilles tendon so t...

Страница 57: ...off of the sensation Then while continuing the Biowave treatment flexion extension rotational exercise or range of motion therapy can now be performed by the patient with significantly less pain The p...

Страница 58: ...ded to hold both the round Pain Site Electrode and rectangular Dispersive Electrode in place Body Position For all plantar fasciitis treatments the foot should be kept at approximately 90 degrees to t...

Страница 59: ...e side or bottom of the foot For pain over the big toe for example from turf toe the small round Pain Site Electrode should be placed directly over the pain site on the top of the toe as shown in the...

Страница 60: ...his is a very comfortable location to receive stimulation from the rectangular Dispersive Electrode The rectangular Dispersive Electrode should not touch the deltoid because it may feel fatigued follo...

Страница 61: ...rom the small round Pain Site Electrode as shown in the first photo above In some cases pain may radiate downward from the pain site toward the rhomboid In this case the rectangular Dispersive Electro...

Страница 62: ...ning from the base of the skull to the crown of the head This is due to stimulation of the occipital nerve Body Position The head should be bent slightly forward so the tissue on the back of the neck...

Страница 63: ...es should be placed directly over the two painful areas For example if pain presents on the back of the neck and in the trapezius or rhomboid as in the photo to the right then each round Pain Site Ele...

Страница 64: ...to the AC joint and be placed along the spine of scapula as shown in the photo to the right The rectangular Dispersive Electrode should not touch the belly of the deltoid because the deltoid may feel...

Страница 65: ...hat region will prevent the patient from achieving a higher intensity level Generally the higher the intensity the greater the efficacy as long as the treatment remains comfortable Generally the recta...

Страница 66: ...lar Dispersive Electrode should not touch the deltoid because it may feel fatigued following the treatment and stimulation over the softer tissue in that region will prevent the patient from achieving...

Страница 67: ...for the rectangular Dispersive Electrode is just posterior to the AC joint and be placed along the spine of scapula as shown in the photo to the right The rectangular Dispersive Electrode should not t...

Страница 68: ...ior to the AC joint and be placed along the spine of scapula as shown in the photo to the right Make sure there is at least one inch of spacing between the electrodes If necessary the rectangular Disp...

Страница 69: ...stimulation in the shoulder from the rectangular Dispersive Electrode 4 6 10 7 Placement for 2 Locations of Pain in One Shoulder Use the B set For two equal locations of pain occurring in the shoulde...

Страница 70: ...sterior side of each shoulder as shown in the photo to the right There is no maximum distance limitation between the two electrodes Body Position For all shoulder treatments lying in a supine position...

Страница 71: ...t The bony prominence or comfortable location for the rectangular Dispersive Electrode is just posterior to the AC joint and be placed along the spine of scapula as shown in the photo above There is n...

Страница 72: ...y one electrode is placed on the elbow For pain occurring on the medial side of the elbow for example for pain from medial epicondylitis the small round Pain Site Electrode should be placed directly o...

Страница 73: ...ld rest their forearm in their lap and hold a ball or a rolled up towel to keep their fingers in a comfortable position Motion The patient should gently articulate their elbow and wrist rotation as we...

Страница 74: ...ectrode do not touch each other and that there is at least 0 5 inches of spacing between them In the first example in the first photo above the small round Pain Site Electrode is placed over the pain...

Страница 75: ...rode and the rectangular Dispersive Electrode do not touch each other and that there is at least 0 5 inches of spacing between them The use of a cohesive self adhering wrap elastic bandage or velcro s...

Страница 76: ...n Site Electrode and the rectangular Dispersive Electrode do not touch each other and that there is at least 0 5 inches of spacing between them For pain occurring in a metacarpal phalangeal or interph...

Страница 77: ...e stays off of the forearm and is partially covering the anterior or posterior of the bottom of the hand The use of a cohesive self adhering wrap elastic bandage or velcro strap is recommended to hold...

Страница 78: ...pain in the extremities including the knee ankle foot toe neck shoulder elbow wrist hand and finger The E set is comprised of one 1 375 inch diameter round Pain Site Electrode for the single location...

Страница 79: ...of pain ii a single location of pain and the origin or source of the pain For example pain from lumbar or cervical radiculopathies One percutaneous electrode is placed in the most proximal location th...

Страница 80: ...er of the plastic cup to which it is attached Be careful not to kink the array of metal needles 5 After removing the plastic cup from the percutaneous electrode carefully align and place both Percutan...

Страница 81: ...nector at the single end of the leadwire cable so the red dot and notch are facing upwards Line the notch up with the keyhole at 12 o clock in the mating receptacle on the lower front side of the Biow...

Страница 82: ...nt should continue to increase the intensity and pain control effect until a strong tingling pressure sensation is felt at the pain location treatment site This could be at an intensity level for exam...

Страница 83: ...e Plus Button 1 to 3 times If the sensation becomes too strong the patient can always press the Minus Button to reduce the intensity As an example if a patient reaches an intensity level of 42 in the...

Страница 84: ...oesthesia light numbness may last for up to 20 minutes following a 30 minute treatment A continued residual analgesic effect may last up to 72 hours and is proportional to the intensity of signal reac...

Страница 85: ...fore the athlete should also be treated immediately following practice or a game This second treatment may be completed in combination with cold therapy if so desired A thin waterproof plastic wrap sh...

Страница 86: ...for example by 10 15 as compared to other locations on the body Next have the patient begin active or passive range of motion exercise or stretching therapy during the remainder of the 30 minute Biow...

Страница 87: ...ability though the six treatments may occur over a longer time span than a three week period Multiple treatments may produce a cumulative benefit and reduce a patient s pain score to a new lower level...

Страница 88: ...reached during the treatment LOW BATTERY means that the stimulator cannot complete the next treatment with the remaining charge left on the battery and accordingly it will not allow a treatment to sta...

Страница 89: ...in the leadwire cable the AC Charger must first be unplugged from the neurostimulator 6 3 Replacing the Battery For battery replacement on the BiowavePRO neurostimulator contact Biowave Corporation a...

Страница 90: ...ovided by Biowave Corporation Wipe the neurostimulator with a cloth or paper towel that is lightly moistened with a non abrasive alcohol or ammonia based cleaner The neurostimulator does not require f...

Страница 91: ...disposal immediately following a treatment Do not expose the BiowavePRO Neurostimulator to extreme temperatures humidity or direct sunlight Store at room temperature The stimulator may not operate pr...

Страница 92: ...in and clicks into place If the screen does not change to show a different error condition or 0 0 intensity then there may be a short in the leadwire cable between the gray cord and the metal connect...

Страница 93: ...des particularly Biowave Noninvasive Electrodes and can cause this error condition to appear Use a washcloth with soap and water to clean the skin well and then dry thoroughly Use a new set of electro...

Страница 94: ...in and discard them Use a razor to shave the area where each electrode is to be placed Place a new set of electrodes back into position on the clean shaved skin The start screen with 0 0 intensity sho...

Страница 95: ...ly increase the intensity level from zero back up to a therapeutic level as described in Section 4 10 Using BiowavePRO 8 2 2 ELECTRODE S DETACH FROM PATIENT S BODY DURING TREATMENT If during the proce...

Страница 96: ...patient decrease the intensity by pressing the Minus Button If the twitching still persists and is uncomfortable then press the Power Button once to pause the stimulator The intensity will go to zero...

Страница 97: ...ach maximum intensity within the first several minutes could be due to a loss of proprioception due to surgery For example on postoperative ACL or total knee replacement patients it is common for the...

Страница 98: ...CD display to the right If this occurs then pressing the Plus Button to increase the intensity will be disabled Simultaneously the stimulator will automatically lower the intensity by 2 to 3 in approx...

Страница 99: ...D display to the right indicating it can be changed by pressing the PLUS or MINUS buttons 2 Press PLUS button to increase treatment time or MINUS button to decrease treatment time in 1 minute incremen...

Страница 100: ...the intensity from zero back up to a therapeutic level 8 4 3 CHANGE CONTRAST OF LCD DISPLAY Contrast can only be changed while the battery is charging while the LCD reads 0 0 or during mid treatment...

Страница 101: ...grity harmonic content and instant voltage level into a biological load with an impedance range from 250 to 1000 Power Source 10 8 V DC 6900 mAh rechargeable Li ion battery Provides 9 0 hours of power...

Страница 102: ...1 EN 61000 4 3 2002 A1 2002 EN 61000 4 8 1994 A1 2001 Biowave Noninvasive Reusable Electrodes Biowave Noninvasive Reusable Electrodes are of a silver carbon construction with a pre applied hydrogel an...

Страница 103: ...s and those directly connected to the public low voltage power supply network that supplies buildings used for commercial or domestic purposes Group 1 Class B Class A Not applicable RF emissions CISPR...

Страница 104: ...nes IEC 61000 4 11 Immunity test IEC 60601 test level Compliance level Guidance and Manufacturer s Declaration Electromagnetic Immunity Electromagnetic environment guidance Floors should be wood concr...

Страница 105: ...mobile RF communications equipment should be used no closer to any part of the BiowavePRO Neurostimulator including cables than the recommended separation distance calculated from the equation applic...

Страница 106: ...TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured...

Страница 107: ...le and Mobile RF Communications Equipment and the BiowavePRO Neurostimulator 800 MHz to 2 5 GHz d 0 7 P Rated Maximum Output Power of Transmitter in Watts W Separation Distance d in Meters m According...

Страница 108: ...and Electrodes as well as the following items 1 Damage caused during shipment 2 Damage caused by accident misuse or abuse of operation contrary to the instructions specified in the User s Manual 3 Da...

Страница 109: ...Biowave Corporation 107 Notes...

Страница 110: ...BiowavePRO User s Manual Biowave Corporation 108 Notes...

Страница 111: ......

Страница 112: ...Manufactured by Biowave Corporation Norwalk CT 1 877 BIOWAVE biowave com Neurostimulator must only be used with power supply provided MADE IN USA 2007 2018 Biowave Corporation...

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