BioWavePENS Unit User Guide

BioWavePENS Unit

quick reference
for BioWave Percutaneous Electrodes

for use with BioWavePRO + BioWaveHOME

There are 3 buttons that control both neurostimulators

1. Power ON/OFF button
2. PLUS (+) button to increase intensity
3. MINUS (–) button to decrease intensity

BioWavePRO also has a TIME button to change treatment time and an OK button to accept and set a new treatment time.

BioWaveHOME also has a PAUSE button to pause the treatment.

Designed to Block Pain at the Source™

BioWave Percutaneous Electrodes

The BioWavePENS Percutaneous Electrical Nerve Stimulation System is comprised of either a BioWavePRO or BioWaveHOME neurostimulator and BioWave Percutaneous Electrodes.

BioWave Percutaneous Electrode Arrays are sterile, single-use and comprised of over 1000 needles that are 0.74 mm in length within a 1.5” diameter
array. These electrode arrays feel like Velcro to the touch and are designed to provide a direct conductive pathway through skin, bypassing the impedance of skin, and allowing the therapeutic electrical field to form in deep tissue encompassing pain nerves. BioWavePENS may only be used with BioWave Percutaneous Electrodes.

B-Set Two Locations of Pain
B-Set Percutaneous Electrodes are are sterile, single use and comprised of two 2.5” diameter round percutaneous electrodes for treating:

• directly over 2 locations of pain;
• over the origin or source of pain, and over the most painful location that is closest to the origin of pain (for example, for sciatica, one pad is placed over the spine (origin) and one pad is placed on the buttock (most painful location closest to the origin);
• one inch apart from one another to treat a large area of pain The B-Set is used for treating pain in the following areas:
• pain in two locations in the back including, buttocks, lower back or mid back region
• radiculopathies (radiating pain down the back or side of the leg)
• pain in two locations in the hip or groin
• pain in two locations in the cervical spine, shoulders or knees
• pain centered directly in the spine
• pain presenting in a large area

E-Set Single Location of Pain
The E-set is comprised of one 2.5” diameter round percutaneous electrode that is placed directly over the single location of pain; and one 2”x 4” rectangular Dispersive 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:

• back, neck, knees, ankles, feet, toes, shoulders, elbows, wrists, hands and fingers

NOTE: Electrodes MAY BE PLACED directly over or in the proximity of implanted metal hardware, including total joint replacements, anchors, plates, rods, screws and pins.
WARNING: ELECTRODES MUST NEVER TOUCH EACH OTHER

• 1.0 inch (2.6 cm) is the minimum spacing between electrodes on the back.
• 0.5 inches (1.3 cm) is the minimum spacing between electrodes on joints or extremities.
• There is NO maximum spacing between any electrodes.
• If the edges of the electrodes touch during the treatment, it may cause a burn.

Electrode Placement Rationale For Percutaneous Electrodes

BioWavePENS percutaneous electrode array placements are different from conventional surface electrical stimulation. The active therapeutic electrical field forms in a 3.5 inch diameter hemisphere
(volume of tissue the size of half of a grapefruit) beneath and surrounding each electrode, not along the surface of the skin between the electrodes – see illustration below:

As a result, electrodes need to be placed either:

1. directly over two locations of pain;
2. over one location of pain and the origin of the pain;
3. spaced one inch apart to cover a large area of pain.

Electrodes are independent of one another and there is no maximum distance between the two electrodes.
Electrodes must not touch each other.

Different Electrode Sets for Focusing the Electric Field

B-Set: 2 Locations of Pain

The B-Set is comprised of two percutaneous electrodes so two distinct pain sites can be treated simultaneously. If the two percutaneous electrodes are placed close together so that there is only 1.0 inch of space between them, the pair can be used to treat one larger volume of tissue. The B-Set is also used to treat pain from radiculopathies. One electrode is placed over the origin of the pain, for example, directly over the spine, but 0.5 inches to the side in the direction of the nerve root in which the pain signals are traveling. The second electrode is placed proximally over the location the pain first presents, for example, on the buttock.

E-Set: 1 Location of Pain

The E-Set is comprised of one percutaneous electrode and one noninvasive dispersive electrode. By pairing a percutaneous electrode with a noninvasive dispersive electrode, the impedance is much lower beneath the percutaneous electrode allowing for a stronger and deeper penetraring electrical field. Therefore, the percutaneous electrode needs to be placed directly over the primary painful area. The noninvasive rectangular electrode is still active but acts as a dispersive electrode and must be placed over a bony prominence typically near the treatment site. Placement of the noninvasive 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 round percutaneous electrode.

Treatment Regimen Protocol

BioWave’s Preauthorization Service typically preauthorizes 6, 30-minute treatments which are performed in an office setting over a 2-3 week period. Multiple treatments may provide a cumulative benefit. Additional treatments may be beneficial. The same pain site location may be treated up to two times per day with each 30-minute treatment separated by at least 8-hours.

Contraindications

• DO NOT use if you have an impanted cardiac pacemaker.
• DO NOT use if you have epilepsy or are prone to seizures.
• DO NOT place electrodes over the heart or across the thoracic volume (not on either side of the heart). 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 top of the head.
• DO NOT place electrodes over wounds, broken skin or sensitive skin areas (for example, sunburned skin).

Body Position During Treatment

The body should remain in a static position during the treatment. The tissue being treated should be taut or in a stretch position. Generally, sitting in a supported position in a comfortable chair is best for most treatment locations on the body.

Intensity Range

Patients should increase the intensity based on sensation (not an intensity number) to a level that is as strong as possible but still comfortable. The body adapts to the electrical field very quickly over the first 5 minutes and then less so over the remainder of the 30-minute treatment. As hypoesthesia is induced in the volume of tissue beneath the percutaneous electrodes and the sensation diminishes, patients should continue to increase the intensity level with individual presses of the PLUS (+) button.
Generally, patients should try to reach a minimum intensity level of 20%. Some patients may tolerate more, some less. Certain parts of the body may be more sensitive to stimulation and therefore harder to achieve higher intensity levels. The typical maximum intensity level reached during the treatment ranges from 20% – 50%.

Motion During Treatment

The sensation from the treatment is a deep, smooth, strong tingling and pressure sensation. Generally patients should remain in a static position during the treatment. Motion may cause a stronger or weaker sensation and will cause the location of the electrical field to shift slightly internally. Shifting of the electrical field is most prevalent when treating upper and lower extremities.
The goal is to have the patient very gently articulate the joint at the treatment location to shift the sensation caused by the electrical field so that it focuses directly onto and encompasses the primary pain location.

Percutaneous Electrode Placement Examples

WARNING: Electrodes must not touch each other.
See back cover for electrode description.

Protocol for Placing Percutaneous Electrodes

Directions for Use PENS Treatments

Treatment Set Up

1. For users at home, if treating a part of the body that is difficult to reach with your own hands, have another person help you
2. See Photos of Percutaneous Electrode Placement Examples on prior pages and identify photo closest to your pain condition
3. Determine B or E set electrodes for pain condition (B-set = 2 locations of pain, E-set = 1 location of pain)
4. Palpate to find center of pain location
5. Mark skin with Sharpie marker over center of each pain site – See A
6. Clean skin with alcohol prep – See B
7. Gently peel electrode from protective cup – See C
8. Place electrode centered over Sharpie mark – See D
9. Insert percutaneous electrodes through skin; press 3X applying 10 lbs of force perpendicular to the back of the electrode as follows:
10. Use two thumbs next to each other in center of electrode – See E
11. Use two thumbs at 12 o’clock and 6 o’clock over needle array – See F
12. Use two thumbs at 9 o’clock and 3 o’clock over needle array – See G
13. Connect lead wire cable to percutaneous electrodes and stimulator
14. Turn stimulator on and sit in a comfortable position

Operation of the Device

12. User begins treatment by pressing PLUS button. User always controls the intensity setting and their comfort level.
13. Continue to increase intensity by pressing PLUS button to keep sensation strong during entire 30 minute treatment
14. During treatment, intensity level that you reach is about half the level you would have reached if you used non invasive electrodes
15. As hypoesthesia develops in first 5 minutes, initial sharper sensation is masked and treatment becomes even more comfortable

End of Treatment

16. When countdown timer reaches 0:00 minutes, intensity automatically is reduced to zero. Press power button to turn unit off.
17. Gently peel electrodes off of skin
18. Place needle side of electrodes together and dispose of in Sharps disposal
19. 1.5” diameter pink circle with 1014 dimple marks will appear at treatment site
20. 50% of patients have several tiny drops of blood present – See H
21. Clean skin with an alcohol prep or with a sterile gauze pad – no dressing is necessary
22. Pink circle resolves typically within 24 hours

Need help? Contact us!
+1 (877) BIOWAVE
+1 877-246-9283
[email protected]
biowave.com

BioWave Corporation 8 Knight St., Suite 201 Norwalk, CT 06851
©2008 -2022 BioWave Corporation

Agenoria Medical Ltd. Kyletelogue House 9 Cherrywood Tallanstown, Dundalk Ireland

UK RESPONSIBLE PERSON
P14 Medical Ltd.
65 Bath Road
Stroud GL5 3LA
United Kingdom

Device must only be used with power supply provided.
Rev 12 – 220610

References

• Homepage - BioWave

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