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Biowave HOME User Manual

Neuromodulation pain therapy system
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Neuromodulation
Pain Therapy System
User's Manual
Designed to Block Pain
at the Source
™

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Summary of Contents for Biowave HOME

  • Page 1 Rx Only Prescription Neuromodulation Pain Therapy System User’s Manual Designed to Block Pain at the Source ™...
  • Page 2 BioWaveHOME User’s Manual ® BioWave Corporation...

  • Page 3: Table Of Contents

    2. 1 .2 AC Charger ..........................1 1 2.2 BioWave Electrodes ......................12 2.2. 1 BioWave Noninvasive Reusable Electrodes .................13 2.2. 1 . 1 B-Set: Two Locations of Pain or Back Pain ............13 2.2. 1 .2 E-Set: Single Location of Pain in the Extremities ...........14 2.2.
  • Page 4 4. 1 .2 Quick Operating Steps ......................24 4.2 Rationale for Electrode Placements ..................26 4.3 Focusing of the BioWave Signals and Electrode Set Choice ..........27 4.3. 1 Two Locations of Pain ......................27 4.3.2 Large Area of Pain ......................... 27 4.3.3 Single Location of Pain in the Extremities ................
  • Page 5 (for example from Rotator Cuff Tendinitis) ............62 4.4. 1 0.4 Placement for Pain on Top or Throughout the Inside of the Shoulder Joint (for example from pain in the Acromioclavicular (AC) Joint or from Frozen Shoulder/Adhesive Capsulitis) ......62 (continued) BioWave Corporation...
  • Page 6 4.8.2 During Treatment ........................77 4.8.3 End of Treatment........................78 4.9 Importance of Monitoring the Activity of the Stimulator ..........78 Treatment Regimen Protocols ..................79 5. 1 Treatment Regimen for Chronic Pain ......................79 5.2 Treatment Regimen for Acute Pain BioWave Corporation...
  • Page 7 8.2 Error Conditions on LCD Display ......................86 8.2. 1 Cable Connection to the Stimulator ..................87 8.2.2 Electrode Connection to the Patient ..................87 8.3 Use of Non-BioWave Electrodes ......................90 8.4 Muscle Twitching ..........................90 8.5 Automatic Safety Function ........................91 8.5.
  • Page 8 BioWaveHOME User’s Manual ® IMPORTANT! Before using this product, read the following information thoroughly. Rx Only BioWave Corporation...

  • Page 9: Indications For Use

    Mid Torso and Elbow Thoracic Spine Forearm Lower Back, Lumbar and Groin Sacral Spine Wrist, Hand Buttock and Fingers Hamstring Quadriceps IT Band Knee Calf Shin Ankle, Foot and Toes See Section 4.4 for examples of electrode placements. BioWave Corporation...

  • Page 10: Stimulator Description

    1. Power ON/OFF button 2. PLUS (+) button to increase intensity 3. MINUS ( – ) button to decrease intensity 4. PAUSE ( || ) button to pause the treatment The default treatment time is 30 minutes. BioWave Corporation...

  • Page 11: Stimulator Accessories

    Leadwire cable with your other hand to disconnect the cable. Never pull on the black wire portion of the Leadwire Cable to remove it Dongle Adapter from the Dongle Adapter. Leadwire Cable Plugging Single End of Leadwire Cable into Dongle Adapter BioWave Corporation...
  • Page 12 To remove the electrodes from the leadwire cable, grasp each side of the blue connector with your thumb and index finger and pull them straight apart. You do not need to squeeze the prongs on the electrode connector to insert or remove them. BioWave Corporation...

  • Page 13: Ac Charger

    AC Charger is plugged into the receptacle on the side of the stimulator as shown in the photo to the right. The other end is plugged into a standard electrical outlet. (100-240 Volts at 50-60 Hz). AC Charger Plugs into Receptacle BioWave Corporation...

  • Page 14: Biowave Electrodes

    BioWaveHOME User’s Manual ® 2.2 BioWave Electrodes There are two types of BioWave Electrodes designed to work with the BioWaveHOME Stimulator: BioWave Noninvasive Electrodes and BioWave Percutaneous Electrodes. BioWave Noninvasive Reusable Electrodes BioWave Noninvasive Electrodes are reusable surface electrodes typically used to reduce ®...

  • Page 15: Biowave Noninvasive Reusable Electrodes

    2. Stimulator Description 2.2.1 BioWave NONINVASIVE REUSABLE ELECTRODES There are three different sized sets of BioWave Noninvasive Electrodes for focusing the therapeutic signals to different locations in the body: •B-set •E-set •U-set 2.2.1.1 B-Set: Two Locations of Pain BWEN01-B or Back Pain The B-set is comprised of two 2”...

  • Page 16: E-Set: Single Location Of Pain In The Extremities

    Electrode that is placed over a bony prominence (a comfortable location to receive stimulation) near the region being treated. The E-Set is used for treating single locations of pain in the extremities: •knees •ankles, feet and toes •neck •shoulders •elbows •wrists •hands and fingers BioWave Corporation...

  • Page 17: U-Set: Single Location Of Pain In The Mid Torso Region

    The U-Set is used for treating single locations of pain in the mid torso region: •rib •oblique •hip •buttock •groin •adductor •abductor •gluteus maximus •hamstring •quadriceps The U-set is not used for treating single locations of pain on the low back (use the B-set). BioWave Corporation...

  • Page 18: Biowave Percutaneous Electrodes

    BioWaveHOME User’s Manual ® 2.2.2 BioWave PERCUTANEOUS ELECTRODES There are two different sized sets of BioWave Percutaneous Electrodes for focusing the ® therapeutic signals to different locations in the body: 2.2.2.1 B-Set: Two Locations of Pain BWEP01-B The B-Set is comprised of two round same area Percutaneous Electrodes (2.5 inch diameter) which...

  • Page 19: Stimulator Controls

    Pressing the PAUSE ( || ) Button immediately reduces the intensity to 0.0% and pauses the countdown timer. The countdown timer will begin to flash. To restart the treatment, press the PLUS (+) button to manually increase the intensity of the signal from 0.0% back up to the desired level. BioWave Corporation...

  • Page 20: Stimulator Indicators

    This indicates the electrodes should be reattached to the body (see Section 8 - Troubleshooting). BioWave Corporation...

  • Page 21: Charging Light Indicator

    The Indicator Light remains a steady BLUE during charging, and turns off when the battery is fully charged. The BioWaveHOME stimulator cannot be operated while the AC charger is plugged in recharging the stimulator’s battery system. Blue Charging Indicator Light BioWave Corporation...

  • Page 22: When The Stimulator Should Not Be Used (Contraindications), Warnings, Precautions And Adverse Reactions

    • DO NOT place the electrodes on the front or side of the neck. • DO NOT place the electrodes on top of the head. • DO NOT place electrodes over wounds, broken skin or sensitive skin areas (for example, sunburned skin). BioWave Corporation...

  • Page 23: Warnings

    - There is NO maximum spacing between any Pain Relief Pads - If the edges of the Pain Relief Pads touch during the treatment, it may cause a burn. • BioWave Percutaneous Electrodes are sterile and can only be used for a single treatment.

  • Page 24: Precautions

    • Avoid use of electrodes, conductive gels, leadwires, or accessories other than those supplied with the system or recommended by BioWave. The safety of other products has not been established and their use may result in skin irritations and burns beneath the electrodes.

  • Page 25: Adverse Reactions

    • Pacemaker interference • Cardiac arrhythmias from use over the heart • Laryngeal and pharyngeal muscle spasms or changes in blood pressure from use over the front or side of the neck • Infection from use of Percutaneous Electrodes BioWave Corporation...

  • Page 26: User Instructions

    Make sure your skin is clean. Place at least one round electrode over the pain site on your body. Place the second electrode for your particular pain condition as shown in the appropriate photo in Section 4.4 - Electrode Placement Examples. Electrodes must not touch each other. BioWave Corporation...
  • Page 27 Try to get the sensation you feel from the electrical signals to encompass your location of pain - this will provide the best treatment outcome (see Section 4.7 - Motion During Treatment). BioWave Corporation...

  • Page 28: Rationale For Electrode Placements

    The sensation felt at each location is a deep smooth tingling and pressure sensation. There is no uncomfortable twitching sensation that is common to other types of electrical stimulation devices. BioWave Corporation...

  • Page 29: Focusing Of The Biowave Signals And Electrode Set Choice

    4.3 Focusing of the BioWave Signals and Electrode Set Choice With BioWave, 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 areas with one another.

  • Page 30: Single Location Of Pain In The Extremities

    This allows you 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 Pain Site electrode. See PHOTOS for examples of optimal electrode placements in Section 4.4. BioWave Corporation...

  • Page 31: Biowave Noninvasive Electrode Placement Examples

    The following section shows photos of Examples of Pain Relief Pad placements for pain presenting in different parts of the body. Note: BioWave is not intended to treat any of the conditions provided as examples, only the associated, symptomatic pain.

  • Page 32: Low Back Pain - Electrode Placement Examples

    Body Position: Sitting is the best position during the treatment. The torso should be roughly at a right angle to the legs. This position keeps the tissue in the buttock and low back area a little taut which will provide for a better treatment result. However, if sitting BioWave Corporation...

  • Page 33: Placement For Pain At The Bottom Of The Spine (E.g. Sacroiliac (Si) Joint Pain)

    Body Position: Sitting is the best position during the treatment. The torso should be approximately at a right angle to the legs causing the tissue in the lower back to be more taut. However, if sitting causes pain, you may lie down during your treatment. BioWave Corporation...

  • Page 34: Placement For Pain Centered Over The Spine

    The torso should be approximately at a right angle to the legs causing the tissue in the lower back to be more taut. However, if sitting causes pain, you may lie down during your treatment. BioWave Corporation...

  • Page 35: Placement For Low Back Pain In One Location

    The torso should be approximately at a right angle to the legs causing the tissue in the lower back to be more taut. However, if sitting causes pain, you may lie down during your treatment. BioWave Corporation...

  • Page 36: Placement For Pain Over A Large Area On The Back

    There is no limit on the maximum distance the electrodes can be placed apart from on another. Body Position: For hip placements, sitting in a reclined position or lying down on your back with a pillow under your buttocks and legs straight is the most desirable position during the treatment. BioWave Corporation...

  • Page 37: Rib Or Oblique Pain - Electrode Placement Examples

    Body Position: For groin treatments, sitting reclined or lying down on your back with a pillow under your buttocks and legs straight is the best position during the treatment. BioWave Corporation...

  • Page 38: Placement For Groin Pain In Two Locations

    90 degrees to your legs to help keep the tissue in the area of the sacrum more taut. For the alternative placement with one electrode on the pubis and one on the sacrum, you should lie down on your back with your legs straight during the treatment. BioWave Corporation...

  • Page 39: Quadriceps Pain - Electrode Placement Examples

    1.0 inch away from the first electrode and should also cover over the location that any additional pain presents itself. This placement will allow the therapeutic signals to capture the entire region beneath as well as between the electrodes. BioWave Corporation...

  • Page 40: Hamstring Pain - Electrode Placement Examples

    Body Position: For hamstring treatments, sitting upright or partially reclined in a supported position on a bed with the legs straight is the best position during the treatment. Keeping the hamstring in a slightly more taut position will provide a better treatment outcome. BioWave Corporation...

  • Page 41: Placement For Hamstring Pain Over A Large Area

    Body Position: For hamstring treatments, sitting upright or partially reclined in a supported position on a bed with the legs straight is the best position during the treatment. Keeping the hamstring in a slightly more taut position will provide a better treatment outcome. BioWave Corporation...

  • Page 42: Knee And Lower Leg Pain - Electrode Placement Examples

    (knee cap). Body Position: For treatments on the anterior of the knee, the knee should be bent at approximately 90 degrees. This angle provides the strongest sensation in the knee during the treatment which will yield the best outcome. BioWave Corporation...

  • Page 43: Osteoarthritis Throughout The Knee)

    90 degrees if possible. Then while continuing the BioWave treatment, flexion or extension exercise or range of motion therapy can be performed with significantly less pain. You should be able to move more resistance through a greater range of motion both in flexion as well as extension.

  • Page 44: Placement For Pain Below The Kneecap

    Dispersive Electrode on the inside (medial side) of the knee starting at the midline of the joint and running at a slight angle toward the front (anterior) of the knee (see second photo above). BioWave Corporation...

  • Page 45: Placement For Pain On The Inside Of The Knee

    Body Position: For treatments for pain on the inside of the knee, the knee should be bent at approximately 90 degrees. This angle provides the strongest sensation in the knee during the treatment and will yield the best outcome. BioWave Corporation...

  • Page 46: Placement For Pain Above The Kneecap (E.g. From Quadriceps Tendinitis)

    Pain Site Electrode. Body Position: For treatments for pain from quadriceps tendinitis, the knee should be bent at approximately 90 degrees. This angle provides the strongest sensation in the knee during the treatment and will yield the best outcome. BioWave Corporation...

  • Page 47: Placement For Pain On The Outside Of The Knee

    Body Position: For treatments for pain on the outside of the knee, the knee should be bent at approximately 90 degrees. This angle provides the strongest sensation in the knee during treatment and will yield the best outcome. BioWave Corporation...

  • Page 48: Placement For Pain On The Outside Of The Thigh (E.g. Pain From Illiotibial (It) Band Pain)

    45 and 90 degrees. The patient should find the angle of bend at the knee that provides the strongest sensation from the electrical field in the IT Band during the treatment, as this will yield the best outcome. BioWave Corporation...

  • Page 49: Placement For Pain On The Backside Of The Knee

    Body Position: For treatments for pain on the backside of the knee, sitting with the knee kept straight (not bent) so the tissue on the backside of the knee is more taut, will produce the best treatment outcome. BioWave Corporation...

  • Page 50: Placement For Pain On The Front Of The Lower Leg (E.g. From Shin Splints)

    6 inches by 3 inches to be stimulated and treated. Body Position: Sitting in a supported position with the knees at about 90 degrees is typically the most comfortable position in which to receive stimulation for shin splints. BioWave Corporation...

  • Page 51: 0 Placement For Calf Pain (E.g. From A Gastrocnemius Strain)

    Adjust the direction you point your toes either toward you or away from you to put the calf in tension, which is a more comfortable position in which to tolerate a higher level of stimulation in the calf. BioWave Corporation...

  • Page 52: Ankle And Foot Pain - Electrode Placement Examples

    Therefore sitting in a chair with the foot flat on the floor is the most ideal position during the treatment. However, if necessary, the foot can be elevated during the treatment. BioWave Corporation...

  • Page 53: Placement For Pain On The Outside (Lateral Side) Of The Ankle Or

    Therefore sitting in a chair with the foot flat on the floor is the most ideal position during the treatment. However, if necessary, the foot may be elevated during the treatment. BioWave Corporation...

  • Page 54: Placement For Pain Around The Ankle (E.g. Pain From A High Ankle Sprain With Only A Primary Pain Site)

    The bony prominence or comfortable location to place the rectangular Dispersive Electrode is on the outside of the ankle, wrapping around the Achilles tendon as shown in the second photo to the right. BioWave Corporation...

  • Page 55: Placement For Two Equal Locations Of Pain In The Ankle Or Foot

    The rectangular electrode should not touch the inside of the heel. The electrodes should have at least one inch of spacing between them. BioWave Corporation...
  • Page 56 (into flexion and extension) to find a treatment position that causes the sensation felt by the electrical signals to focus directly onto the primary location of pain. Make sure the edges of the electrodes do not touch each other if you are placing your foot into plantar flexion. BioWave Corporation...

  • Page 57: Placement For Pain On The Bottom Of The Foot (E.g. From Plantar Fasciitis)

    Motion: While resting the foot on a flat surface it is recommended to gently articulate the foot into flexion and extension to find a treatment position that causes the sensation felt by the electrical signals to focus directly onto the primary location of pain. BioWave Corporation...

  • Page 58: Placement For Pain On The Top Of The Foot (E.g. From Phalange, Metatarsal Or Turf Toe Pain)

    Motion: While resting the foot on a flat surface it is recommended to gently articulate the foot into flexion and extension to find a treatment position that causes the sensation felt by the electrical signals to focus directly onto the primary location of pain. BioWave Corporation...

  • Page 59: Neck, Cervical & Tmj Pain - Electrode Placement Examples

    For all neck treatments, in addition to the strong sensation beneath and surrounding both Pain Site Electrodes, it is common to feel a mild pleasant tingling sensation from the base of the skull up to the crown of the head. BioWave Corporation...

  • Page 60: Placement For Bilateral Neck Or Cervical Pain

    Pain Site Electrode, it is common to feel a mild pleasant tingling sensation from the base of the skull up to the crown of the head. BioWave Corporation...

  • Page 61: Placement For Neck Or Cervical Pain In One Location

    It is normal for the facial muscles to pull toward the small round electrode and there may be slight twitching in the eye closest to the small round electrode. Patients may also feel stimulation into their molars if they have amalgam fillings. BioWave Corporation...

  • Page 62: Shoulder Pain - Electrode Placement Examples

    Motion: Gently and slowly move the shoulder joint to shift the location of the electrical field so that the sensation from the electrical signals focuses directly over and encompasses the pain site. BioWave Corporation...

  • Page 63: (For Example From An Infraspinatus Strain)

    The arm can rest against the side of the body with the elbow slightly bent. Motion: Gently and slowly move the shoulder joint to shift the location of the electrical field so that the sensation from the electrical signals focuses directly over and encompasses the pain site. BioWave Corporation...

  • Page 64: (For Example From Rotator Cuff Tendinitis)

    Acromioclavicular (AC) sprain, or from Frozen Shoulder (Adhesive Capsulitis), the small round Pain Site Electrode should be placed directly over the pain site, at or slightly behind the AC joint as shown in the photo to the right. BioWave Corporation...

  • Page 65: 0.5 Placement For Two Locations Of Pain In One Shoulder

    Body Position: For all shoulder treatments, sitting in a supported position is generally the best position during the treatment. The arm can rest against the side of the body with the elbow slightly bent. BioWave Corporation...

  • Page 66: 0.6 Placement For Trapezius Pain In One Location

    Motion: Gently and slowly move the shoulder joint to shift the location of the electrical field so that the sensation from the electrical signals focuses directly over and encompasses the pain site. BioWave Corporation...

  • Page 67: 0.7 Placement For Shoulder Pain In 2 Locations (E.g. Bilateral Trapezius Pain)

    Motion: Gently move the shoulder joint to shift the location of the electrical field so that the sensation from the electrical signals focuses directly over and encompasses the pain site. BioWave Corporation...

  • Page 68: Elbow Pain - Electrode Placement Examples

    Motion: Gently move your elbow and slowly rotate and/or bend your wrist to shift the electrical field so that the sensation from the electrical signals focuses on and encompasses the pain site in the elbow. BioWave Corporation...

  • Page 69: (E.g. Medial Epicondylitis)

    Motion: Gently move your elbow and slowly rotate and/or bend your wrist to shift the electrical field so that the sensation from the electrical signals focuses on and encompasses the pain site in the elbow. BioWave Corporation...

  • Page 70: (E.g. Triceps Tendinitis)

    Motion: Gently move your elbow and slowly rotate and/or bend your wrist to shift the electrical field so that the sensation from the electrical signals focuses on and encompasses the pain site in the elbow. BioWave Corporation...

  • Page 71: Wrist, Hand And Finger Pain - Electrode Placement Examples

    Motion: Gently move your wrist (slow rotation as well as slight bending back and forth) to shift the electrical field so that the sensation from the electrical signals focuses on and encompasses the pain site in the wrist. BioWave Corporation...

  • Page 72: 2.2 Placement For Hand Or Finger Pain

    The rectangular Dispersive Electrode may be placed across the inside (anterior side) of the wrist as shown in the second photo to the right. An alternative comfortable placement for the rectangular Dispersive Electrode is across the back (posterior) of the wrist. BioWave Corporation...
  • Page 73 Motion: Gently move your wrist (slow rotation as well as slight bending back and forth) to shift the electrical field so that the sensation from the electrical signals focuses on and encompasses the pain site in your hand or finger. BioWave Corporation...

  • Page 74: Electrode Placement Tips

    Electrodes must not touch each other. 5. Save plastic liners and resealable bag for electrode storage following the treatment. Electrodes may be placed back on either side of the plastic liner. BioWave Corporation...

  • Page 75: Body Position During The Treatment

    4.6.5 Neck For neck electrode placements, the head should be bent forwards slightly to make the tissue on the back of the neck more taut. BioWave Corporation...

  • Page 76: Shoulders

    For groin and hip treatments, lying on your back with your legs straight is the most comfortable position. Placing a pillow under your buttock can help provide a little more of a stretch in the area being treated. BioWave Corporation...

  • Page 77: Motion During The Treatment And Fine Tuning Of The Treatment

    The ideal treatment location is when you feel like saying, “wow, that’s hitting the spot!” BioWave Corporation...

  • Page 78: Using The Biowavehome Stimulator

    (treatment site). This could be at an intensity level, for example, of 30 - 40%. The body adapts quickly to the electric field in the first 2 - 5 minutes of treatment and the edge of the sensation you feel will begin to diminish BioWave Corporation...

  • Page 79: During Treatment

    This is considered the therapeutic level. For most treatments with BioWave Noninvasive Electrodes, you should try to get above a minimum intensity level of 30%. Most patients advance in the first 2 minutes to an intensity level of between 30% and 60%.

  • Page 80: End Of Treatment

    “donE”. Press the Power Button to turn the stimulator off. For treatments with BioWave Noninvasive Electrodes, remove both electrodes, place them back onto their respective plastic release liners, return the electrodes into and reseal the resealable bag.

  • Page 81: Treatment Regimen Protocols

    5. Treatment Regimen Protocols 5.1 Treatment Regimen for Chronic Pain For treating chronic pain the recomended treatment time with BioWave Noninvasive Electrodes is 30 minutes. Multiple treatments using BioWave Noninvasive Electrodes with about 2 to 3 hours of spacing between treatments may produce the most effective cumulative benefit and may knock down your pain to a new lower level.

  • Page 82: Treatment Regimen For Acute Pain

    A barrier like a towel, an Ace bandage or another type of wrap should be placed over the BioWave Noninvasive Electrodes before placing a heating pad on top of them.

  • Page 83: Treatment Regimen For Postoperative Pain And During Physical Therapy And Rehabilitation

    ® of physical therapy. In addition, because of BioWaveHOME’s long carryover effect, you may experience little or no post-exercise soreness. Consult your physical therapist for more information. BioWave Corporation...

  • Page 84: Battery Indicator And Charging The Battery

    If the BioWaveHOME stimulator determines that there is not enough charge in the battery to complete a treatment, the LCD display will show “LO bAt” and the stimulator will not allow a treatment to start until the battery has been recharged. BioWave Corporation...

  • Page 85: Charging The Battery

    18 to 24 months depending upon usage. The battery system is soldered to the internal circuit board and can only be replaced by BioWave Corporation. Contact Customer Service at 1-877-BIOWAVE (+1-877-246- 9283) if the battery is not holding a charge and needs to be replaced.

  • Page 86: Maintenance, Cleaning And Storage Instructions

    • The user should ensure that the stimulator, leadwires, electrodes and AC Charger are dry prior to using them. If the stimulator, leadwires, electrodes or AC Charger do become wet, DO NOT USE them. Please contact BioWave for technical support at 1-877-BioWave ext 2.

  • Page 87: Disposal Of Waste Products

    Applying and rubbing in 3 to 6 drops of saline into the hydrogel surface of the BioWave Noninvasive Electrodes can help rehydrate and improve the conductivity and adhesion of the electrodes (see Section 8. 1 .3 - Electrode Connection to the Patient on page 80).

  • Page 88: Troubleshooting

    30:00 As shown in each of the two illustrations above, for these three error conditions, a picture will appear on the right side of the LCD display with a flashing arrow indicating the specific problem to be addressed. BioWave Corporation...

  • Page 89: Cable Connection To The Stimulator

    Lotion on the skin. Lotion dramatically reduces adhesion and conductivity of the electrodes and can cause this error condition to appear. Use a washcloth with soap and water to clean BioWave Corporation...
  • Page 90 Use saline to restore the electrode or use a new set of electrodes. The life of BioWave Noninvasive Electrodes can be prolonged by placing 3 to 6 drops of saline solution or spraying saline on the hydrogel surface and spreading the saline evenly with your finger over the hydrogel so the entire surface “glistens.”...
  • Page 91 Once the error condition disappears from the display, you can press the PLUS (+) Button to manually increase the intensity level from zero back up to a therapeutic level as described in Section - 4.8 Using BioWaveHOME ® BioWave Corporation...

  • Page 92: Use Of Non-Biowave Electrodes

    8.3 Use of Non-BioWave Electrodes BioWave Nonivasive or BioWave Percutaneous Electrodes must be used. The BioWaveHOME stimulator will only recognize and work with BioWave Noninvasive Electrodes or BioWave Percutaneous Electrodes, which are designed to safely work with this stimulator. 8.4 Muscle Twitching The muscle is typically held in comfortable tension during the treatment without any noticeable twitching.

  • Page 93: Automatic Safety Function

    The MINUS ( – ) Button to reduce intensity always remains active. There is no reason for concern and you should continue and complete the remainder of the treatment. The active monitoring and control of the signal helps prevent you from receiving a burn. BioWave Corporation...

  • Page 94: Electrode Spacing

    The minimum spacing between the B-set or U-set electrodes is one inch (1”). The minimum spacing between the E-set electrodes is half of one inch (0.5”). 8.5.2.2 Maximum Electrode Spacing There is NO maximum distance between the two electrodes. The electrodes are independent of one another. BioWave Corporation...

  • Page 95: Technical Specifications And Classifications

    Expected service life of the device is 5 years. When exhausted, dispose of device properly and in accordance with local codes and regulations. Dongle Adapter and Leadwire Cable Rating complies with 21 CFR Part 898 (performance standards for electrode leadwires) BioWave Corporation...

  • Page 96: Classifications

    K072123 and K152437. BioWave Percutaneous Electrodes BioWave Percutaneous Electrodes are supplied sterile via gamma radiation and are comprised of a 1.5 inch diameter microneedle array within a 2.5 inch diameter hydrogel-based electrode. The microneedle array is comprised of 1014 microneedles, 0.74 mm in length, made from 316L surgical stainless steel.
  • Page 97 CISPR 1 1 use in all establishments, including domestic establishments and those directly connected to Harmonic Not applicable the public low-voltage power supply network that emissions* supplies buildings used for domestic purposes. Voltage Not applicable fluctuations/ flicker emissions BioWave Corporation...
  • Page 98 0%, 0.5 cycles, at 0, 45, 90, 135, 180, 225, 270, and 315 degrees of the phase angle. 0%, 1 cycle, and 70%, 30 cycles, at 0 degrees of the phase angle. 0%, 300 cycles. Electrostatic Discharge +/-8kV contact BioWave Corporation...
  • Page 99 If abnormal performance is observed, additional measures may be necessary, such as re- orienting or relocating the BioWaveHOME Neurostimulator. For frequency ranges above 150 kHz to 80 MHz, field strengths should be less than 10 V/m. BioWave Corporation...
  • Page 100 • At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. • These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. BioWave Corporation...

  • Page 101: Definition Of Symbols

    Prescription use only Model Number Manufacturer Serial Number Caution Non-Sterile Sterilized using irradiation Single-Use Only Use By Lot Code Do not use if package is damaged The device complies with UL 60601-1 CSA C22.2 No. 601. 1 E1 14972 BioWave Corporation...

  • Page 102: Contact Information And Warranty

    10. Contact Information and Warranty 10.1 Reorder Information and Technical Support To reorder BioWave Noninvasive or Percutaneous Electrodes, or for reimbursement, technical support or to report unexpected operation or events, please contact your BioWave representative or contact BioWave Corporation directly at:...
  • Page 104 Need help? Contact us! • +1 (877) BIOWAVE +1 (877) 246-9283 • support@biowave.com • biowave.com UK RESPONSIBLE PERSON Agenoria Medical Ltd. Device must only be BioWave Corporation BioWave Ltd. Kyletelogue House 8 Knight St., Suite 201 used with power 65 Bath Road...

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