Frequently Asked Questions
About The Healing Process
When the body is injured, whether a cut/scrape or a surgical procedure, signals are released from the injured tissues that tell the body to begin the healing process. Inflammation is the first and most uncomfortable phase of the healing process. In this phase, the small vessels that carry blood throughout the body enlarge to allow blood and infection-fighting white blood cells to easily pass through the vessel walls and enter the surrounding tissues. Although painful, this is a very important part of the healing process.
In the next phase of healing (proliferation), oxygen that is carried to the injured tissues promotes the growth of new blood vessels and cellular-level tissues. The final phase of healing is completed with the development of new collagen and tissue/skin regrowth (remodeling).
For Providers
Why SofPulse?
Treatment with SofPulse allows you to better manage pain without the adverse side effects of narcotics and anti-inflammatory medication. SofPulse reduces edema, the resulting pain level and thereby decreases the requirement for medication. With less pain and less medication, you can move around sooner, which stimulates the body’s natural response to healing.
SofPulse Decreases Pain
Patients who use SofPulse therapy report half as much post-procedure discomfort as patients who do not use the therapy.
SofPulse Reduces Swelling
SofPulse enhances the release of the signaling molecule nitric oxide, which is involved in the anti-inflammatory process and therefore helps to reduce pain.
SofPulse Reduces the Need for Prescription Medications
Because patients experience far less pain when using SofPulse, they also require far less prescription medications. Studies have shown a greater than 2.2-fold reduction in narcotic use over the first 48 hours post-procedure.
FAQs
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SofPulse® is a unique technology that utilizes targeted pulsed electromagnetic fields (tPEMF) therapy and is cleared by the FDA to treat pain and edema resulting from operative procedures. The SofPulse® device is simple, automated and easy to use. It has a compact design with a flexible applicator and is battery operated.
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SofPulse® is cleared by the FDA as a Class II medical device.
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SofPulse® is indicated for adjunctive use in palliative treatment of postoperative pain and edema in superficial soft tissue.
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The contraindications include patients with implanted electrical leads, like pacemakers, deep brain stimulators and similar technology. SofPulse® has not been tested in pregnant or lactating women or children.
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SofPulse® has demonstrated outstanding clinical results, with significant reductions in postoperative opioid use, pain, and edema:
2.2x reduction in the use of narcotics at 48 hours
3x reduction in mean pain scores at 5 hours
2.75x reduction in inflammation and swelling at 18 hours
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SofPulse® delivers targeted pulsed electromagnetic field (tPEMF) therapy by emitting gentle electric pulses of a very low level non-invasively into cells. Through these pulses, SofPulse® creates an electromagnetic field which evenly penetrates both soft and hard body tissue around the target area. This electromagnetic field causes a chemical cascade, which activates the Nitric Oxide cycle. Nitric Oxide (NO), a key anti-inflammatory and cellular pathway, increases blood and lymph flow thereby reducing pain and edema.
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The treatment area of SofPulse® includes the area within the applicator ring (7.5” diameter) and approximately 5 inches deep.
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The SofPulse® treatment duration is 15 minutes.
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Each SofPulse® unit provides 100 +/- treatments. Using the preprogrammed mode, SofPulse® automatically delivers 15 minutes of therapy every two hours, providing 8 days of continuous therapy.
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In multiple trials, the use of SofPulse® has resulted in significant reductions in pain and use of narcotics:
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The SofPulse® micro-current levels are extremely low. To put it in perspective, SofPulse® emits an electromagnetic field that has 1,000 times LESS peak power than a mobile phone. The SofPulse® device has been manufactured and tested in accordance with IEC 60601-1, 60601- 1-2, and 60601-2-3. SofPulse® is non-pharmacologic with no potential for overdose or dependency and is noninvasive and safe for use with other pain treatments.
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In general, most patients will not feel anything while using SofPulse®. Patients with reduced blood flow peripherally may report warming or tingling in the area of treatment. Similarly, reports of tingling and other sensations have been reported in patients with neuropathies. These sensations are normal and can be increased blood flow.
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In acute injury, like surgical incisions, the effect of SofPulse® on pain reduction is felt very quickly, typically in the first day.
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Unlike prescription drugs or narcotic painkillers, no side effects have been reported with the use of SofPulse®. While unlikely, since SofPulse® therapy increases circulation; some patients may feel a subtle warming or tingling sensation. With SofPulse® therapy, the body does not respond to the low energy signal unless there is inflamed tissue so there is no risk of side effects.
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SofPulse® is an adjunctive therapy. Pain medication should be allowed as per the standard of care. Patients generally decide at some point how and when to use pain medication. SofPulse® has been shown to decrease pain medication use significantly post-surgically and each patient will determine how much pain medication they need.
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No. The SofPulse® device is intended to be used over sterile dressing and should not come in direct contact with the surgical wound.
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Yes. Multiple units can be used but should not overlap nor be used in opposition (one on top and one on the bottom of a knee), for example.
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SofPulse® is available in single configuration:
SofPulse® 7.5” Single Patient Use (product code # 1IVSP7.5)
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Item descriptionSofPulse® should be applied with its circular geometry intact as well as possible in the treatment area within the same plane as the applicator loop. It is possible to loop the unit around the affected area (thus in the perpendicular plane) when appropriate. Tape or otherwise secure the SofPulse® applicator loop over the dressing of the desired treatment area. SofPulse® is designed to be worn continuously during the 8-day treatment period but may be removed for short periods of time for dressing changes or washing, after which, it should be re-secured to the body. Do not get SofPulse® wet. SofPulse® can also be affixed to any orthopedic brace, wrap, sling, or splint and is effective through dressings, casts, and clothes, but should not be used over external metal items such as metal braces.
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SofPulse® can be used after joint replacement and spine procedures using metal implants.
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SofPulse® is not intended to be placed on bare skin to avoid pressure and/or friction against the skin. The SofPulse® electromagnetic field penetrates unimpeded through non-metallic dressings, clothing and casting material.
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Distorting the circular treatment antenna will deform the treatment field. In moderate displacement the SofPulse® will function, but folding the unit beyond 30 degrees or pulling the loop into an extreme elliptical form can lead to significant distortion and reduction of the treatment field.
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Any configuration generating friction or pressure against the skin should be avoided.
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There are no restrictions on areas of the body. SofPulse® has been used on post-facial procedures. Research on treating brain injuries has also been conducted without any adverse events nor known side effects.
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LVAD systems generally use an electromagnetic field (EMF) based pump and there is a potential for the SofPulse® to interfere with the pump. Use with EMF dependent pumps should be avoided.
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SofPulse® is safe for use in most environments except oxygen enriched environments such as hyperbaric oxygen treatment.
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Once powered on, SofPulse® will operate automatically turning itself on and off on its own schedule (automatic treatment mode). When in this mode, treatments last for 15 minutes every two hours.
During active treatment -- 2 therapy indicator lights will blink every 1 second.
In between treatments -- 1 therapy indicator light will blink approximately every 6 seconds indicating the device is in stand-by mode. To turn the device off, press the power button. The SofPulse® is off when the indicator lights do not flash. When the device is turned on again, it will begin a new 15-minute active treatment. If you do not stop the treatment, the SofPulse® will go back into stand-by mode after 15 minutes and will continue in automatic mode (15 minute treatments every 2 hours).
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Properly shielded consumer electronics should not be affected permanently by the SofPulse® device. Some older technologies may have intermittent interference.
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TENS units use direct electrical current to generate action potentials in nerves to mask pain or contract muscles. SofPulse® is vastly lower powered and does not cause action potentials to be generated nor does it produce electrical currents. SofPulse® generates an electrical field that improves electrochemical activity in the constitutive nitric oxide synthase (cNOS) pathways.
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SofPulse® is a nonpharmacologic pain solution clinically proven to reduce postoperative pain and edema. Exparel®, On-Q® and Ofirmev® are only indicated to reduce postoperative pain, not edema.
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Ice and cold therapies can reduce the effectiveness of the SofPulse® device because they reduce blood flow. We advise using the SofPulse® before ice application or after the cooling effect has worn off.
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No, due to the medical device regulations, the SofPulse® case must be sealed. Breaking the case seal for any reason renders the device non-compliant with the conditions of its 510(k) clearance.
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SofPulse® does not make sound while working. Please refer to the indicator lights:
During active treatment -- 2 therapy indicator lights will blink every 1 second.
In between treatments -- 1 therapy indicator light will blink approximately every 6 seconds indicating the device is in stand-by mode.
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Please consult your local and state regulations for proper disposal of a product of this type.
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SofPulse® presently has no insurance coverage. SofPulse® when adopted by hospitals, is covered by the hospital under the DRG for that specific hospital. Reimbursement for SofPulse® when not covered by hospital DRG, is through direct patient payment to cover SofPulse® use and application.
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SofPulse® is available for prescription through Pain Free Innovation’s website.