How-to

Features & Benefits

Why the ReviStim?   The ReviStim is a DC Stimulator where this pulse direct current goes deeply into the tissue bed to promote increase microcirculation, reduction of edema, which in turn promotes healing.  The ReviStim will help relieve pain while reducing muscle spasms and increasing range of motion, the ReviStim dosages the stimulation in the micro-amperage range.  This critically important to have a biological effect rather than just masking the pain, because body operates on DC signaling.  Origins for this DC Stimulation goes back 50 years where it was invented for healing chronic wounds and stimulation was delivered via very large devices.  Now you can use it your practice or have your patients take it home!

ReviStim

TENS

Brief Instructions

Pain relief; increase microcirculation; muscle spasms and increase range of motion

1. Make sure the skin is clean on the treatment area.
2. Snap ReviStim™ lead wires into the back of the device.
   Place the lead wires on the back of the ReviStim™, making sure that the Black button (-) is attached to the negative snap and that the red button is attached to the positive (+) snap.
3. Place the two (2) AAA in battery compartment.
4. Place the ReviStim™ 3” round electrodes to the red and black lead wire pins. And then place the black lead wire /electrode furthest away from the heart on a muscle bed and the red lead wire four to five inches away on another muscle. (see photos illustrations below here)
5. Turn on the ReviStim™ by pushing down the On/Active button on the left hand side of the ReviStim™; this on switch actives the device for a 30 minute treatment P1; by pushing the right hand button this activated the 8 hour treatment P2.
6. P1 is a 30 min. treatment and if selected the ReviStim™ will automatically turn off after the 30 min. treatment is complete.
7. P2 is an 8 hour treatment where the ReviStim™ will cycle on and off automatically over 8 hours. It will be on for 20 min and off for 40 min. during the treatment period.
8. Then pump the increase button (+) to light sensation or comfort level and then you can reduce sensation by decrease button (-) to below sensory feeling. Note:  that using the 8 hour treatment at night while sleeping the therapeutic level of stimulation is always below sensory
9. The ReviStim™ will turn off automatically once the 30 min (P2) or 8 hr. (P2) treatments are completed. If you want to stop the stimulation, hold down the button On/Active for 5 seconds.
10. If you experience any skin irritation, stop the therapy and consult your clinician.
11. The ReviStim™ is very safe to use and you should use them as often as you can both daily as well as at night.

ReviStim Foot Pain Instructions

Why is this product unique?
The ReviStim™ is an innovative, convenient pain reducing product. Simply apply the small electrodes to your area of pain, click a button and the pain will start to go away. The ReviStim unit is different than most TENS type machines because pain reduction is generated by a very comfortable micro-current DC stimulator that delivers penetrating energy deep into the affected area. The ReviStim is small and the current is barely perceptible so you can use it at home and during sleep while the body is in a natural state of healing.
*Please note that this is a TENS device, but it is different in that it is a DC current that delivers stimulation in the micro amperage range instead AC current which doses in the milliamp range.

When should I see results?
Your results may vary, depending on the type of pain you are experiencing, the intensity of your pain, and of course depending on the regularity of daily use. However, you will usually begin to see benefit within the first week, assuming daily and nightly use.

Will I feel the current?
One of the key reasons for the ReviStim effectiveness is that you control the amount of current you use. The best results do not require a very strong sensation and it is recommended to slowly increase the current strength over a several weeks so you can learn how you best respond.

How long can I keep it on for at a time?
ReviStim offers two program options, a thirty-minute program or an eight-hour treatment cycle. The eight-hour cycle can be used day or night, with the treatment sensation going on and off at programmed intervals. Both programs make it easy to customize the intensity and are completely safe.

Are there are points in the body where ReviStim should not be used?

• The electrodes should not be placed over the front of the neck, as the electrical signals can stimulate the carotid sinus, which controls heart rate.
• They should also not be used over the heart, and never to those with pacemakers, for fear of producing heart rhythm problems.
• Don’t place the electrodes on areas of skin that have been affected by severe nerve damage. Mild to moderate nerve impairment may be OK. Please check with your medical provider if you have questions about your individual use.
• ReviStim should not be used with those with a history of cancer.

Can ReviStim be used during pregnancy?
ReviStim should NOT be used during pregnancy.

Where do I place the electrodes?

• Option 1 – Place the red (+)electrode  above (proximal to) the painful area and the black (-) electrode  below (distal to)the painful area.  Be careful to keep the electrodes separated from each other DO NOT place them touching each other as they work best with separation.
• Option 2 – Place the red (+) electrode on most painful area and the black (-)electrode about 2 inches below the area of pain.

How do I best take care of the electrodes?
Disposable self-adhesive electrodes are very convenient. With proper care they typically last though two weeks of continuous use. For best results:

• Always place the electrodes on non-hairy, clean, dry skin. Do not place them on skin that has hand cream or body oil on it. Poor skin contact increases the current needed to stimulate the area, and causes the batteries to discharge faster than usual.
• Prevent the electrodes from drying out. After use, dampen the side of the electrode that was in contact with the skin with a drop of tap water. Then place the electrodes back in the zipper lock bag they came in. Seal the bag properly and make sure all the air is expelled from it. This will help keep the electrodes from drying out between use. A dry electrode reduces ReviStim effectiveness, increases the current required, and drains batteries faster.
• Between uses keep the electrodes cool. Don’t store them next to any heat source like a radiator or sunny window.

Trouble Shooting

Problem: I’ve connected everything up, switched on the machine, and nothing happens.

Are the batteries dead? – ReviStim runs on 2 AA batteries.
Solution: Replace the batteries

Are the batteries properly oriented in the battery compartment?
Solution: Make sure the that (+) pole is connected to the (+) end. Same for (-) pole.

Have the electrodes dried out?
When you place the electrodes on your skin they should feel slightly wet, and when you pull them off they should still feel sticky. If neither of these is the case, then replace them. The whole electrode should have contact with the skin, and there should be no curled edges.

Problem: My machine works initially for a short time, but after a while the sensation declines or stops completely.

• Are the batteries nearly dead? – Replace with new batteries
• Have the leads fallen off? – Are the electrodes moving under your clothes so that contact with the skin is lost? Experiment with the way that the leads hang when they are in place. Try securing the electrodes with micropore tape around the edges.
• Are the electrodes past their effectiveness? – If the electrodes feel dry or have lost their stickiness, replace them with a fresh pair.
• Have you become tolerant to the signal strength? – As you become more confident with using your ReviStim, you may find that you will benefit from higher signal strengths. Try increasing the (+) power output to see whether this is the case.

Problem: I have developed a red itchy rash where my electrodes have been.

• Try varying the position of the electrodes, and the length of time of contact with the skin.
• Sometimes pre-treating the skin with low strength hydrocortisone cream can reduce the severity of a reaction. If symptoms persist, please speak to your doctor.
• Try using different manufacturers electrodes (which may have different chemicals in the adhesive).

Wound Healing Suggested Protocols

DEFINITIONS:

Electrical stimulation is defined as the use of an electrical current to transfer energy to a wound. The type of electricity that is transferred is controlled by the electrical source. Capacitatively coupled electrical stimulation involves the transfer of electric current through an applied surface electrode pad  (capacitatively coupled) with the external skin surface and /or wound bed. When capacitatively coupled electrical stimulation is used, two electrodes are required to complete the electric circuit. Electrodes are usually placed 2’ to 3’ bracketing the wound on skin.

When discussing electrical stimulation, it is important to distinguish the waveform used for the protocol. Although there are many waveforms available on electrotherapy equipment, the one that has the most thorough and consistent evaluation in vitro, in animal studies and in controlled clinical trials is monophasic twin peaked high voltage pulsed current ( HVPC). The pulse width varies with a range from 20-200 microseconds. The HVPC devices also allow for selection of polarity and variation in pulse rates both of which seem to be important in wound healing. It is a very safe current because it’s very short pulse duration prevents significant changes in both tissue pH and temperature. Therefore, the most tested and safe type of stimulation is the one recommended.

Other types of waveforms and have been tested in clinical trials but will not be discussed here due to limited space. They are discussed in the full chapter.

THEORY AND SCIENCE OF THE THERAPY

Acceptance of electrical stimulation for wound healing by the medical community has been a long and complex task. In 1994, the Agency for Health Care Policy and Research (AHCPR) panel issued Treatment of Pressure Ulcers, Clinical Practice Guideline, Number 15. The panel of pressure ulcer care experts used an explicit science-based methodology and expert clinical judgment to develop statements regarding pressure ulcer treatment. Extensive literature searches, critical review and synthesis were used followed by peer and field review to evaluate the validity, reliability and utility of the guideline in clinical practice. AHCPR panel issued a statement about use of electrical stimulation as an adjunctive therapy for pressure ulcers: ” Consider a course of treatment with electrotherapy for Stage III and IV pressure ulcers that have proved unresponsive to conventional therapy. Electrical stimulation may also be useful for recalcitrant Stage II ulcers. Strength of Evidence = B.” The panel found that data from 5 clinical trials involving 147 patients to support the effectiveness of this therapy for pressure ulcers.

Bioelectric System

The body has its own bioelectric system. This system influences wound healing by attracting the cells of repair, changing cell membrane permeability, enhancing cellular secretion through cell membranes and orientating cell structures. A current termed the “current of injury” is generated between the skin and inner tissues when there is a break in the skin. The current will continue until the skin defect is repaired. Healing of the injured tissue is arrested or will be incomplete if these currents no longer flow while the wound is open. A moist wound environment is required for the bioelectric system to function. A rationale for applying electrical stimulation is that it mimics the natural current of injury and will jump start or accelerate the wound healing process. 

Research Wisdom:

Keeping a wound moist with normal ( 0.9% ) saline ( sodium chloride ) maintains the optimal bioelectric charge because it is like the electrolytic concentration of wound fluid. Dressings such as amorphous hydrogels and occlusive dressings help promote the body’s “current of injury” by keeping the wound moist. Research Wisdom: Moist wounds promote the “current of injury”

Debridement and Thrombosis

Debridement is helped if the tissue is solubilized such as with enzymatic debriding agents. ES using negative current has been shown to solubilize clotted blood. Necrotic tissue is made up of coalesced blood elements. The negative pole has been used to begin treatment in all controlled clinical studies and most of the wounds have necrotic tissue. This research would lend support to that part of protocol. The positive electrode has been found to induce clumping of leukocytes and forming of thrombosis in the small vassals this was reversed with the negative electrode. (Gentzkow 91) This may explain a clinical observation that hematoma or hemorrhaging at the wound margin or on granulation tissue are dissolved and reabsorbed following application of HVPC with the negative pole. Hemorrhagic material goes on to necrosis if not dissolved and reabsorbed quickly.

Clinical Wisdom:

Clinical experience has repeatedly shown that treatment with the inflammation protocol, using negative polarity, promotes rapid absorption of hemorrhagic material, usually within 48 hours.

Clinical Wound Healing Studies: Early studies using direct current stimulation reported long treatment times of 20-40 hours per weeks. Four controlled clinical studies and three uncontrolled studies with HVPC report a mean healing time of 9.5 weeks with 45-60 minute treatment 5-7x/wk.

Summary of Scientific Rationale for Application

Electrical stimulation affects the biological phases of wound healing in the following ways:
Inflammation phase

• Initiates the wound repair process by its effect on the current of injury
• Increases blood flow
• Promotes phagocytosis
• Enhances tissue oxygenation
• Reduces edema perhaps from reduced microvascular leakage
• Attracts and stimulates fibroblasts and epithelial cells
• Stimulates DNA synthesis
• Controls infection ( Note: HVPC proven bacteriocidal at higher intensities than use in clinic and may not be tolerated by patient)
• Solubilizes blood products including necrotic tissue

Proliferation phase

• Stimulates fibroblasts and epithelial cells
• Stimulates DNA and protein synthesis
• Increases ATP generation
• Improves membrane transport
• Produces better collagen matrix organization,
• Stimulates wound contraction

Epithelialization phase

• Stimulates epidermal cell reproduction and migration
• Produces a smoother, thinner scar

INDICATIONS FOR THE THERAPY

Use and application of the modality is not pathology dependent.

Types of wounds for which there is indication to use HVPC include:

• Pressure Ulcers Stage I through IV
• Diabetic ulcers due to pressure, insensitivity and dysvascularity
• Venous Ulcers
• Traumatic Wounds
• Surgical Wounds
• Ischemic Ulcers
• Vasculitic Ulcers
• Donor Sites
• Wound Flaps
• Burn wounds

PROCEDURE

The protocols change as the wound healing phase changes. Assessment and diagnosis of the wound healing phase determines the treatment protocol.

Protocol for treatment:

• Necrosis free,
• Erythema free,
• Edema free,
• Exudate free
• Red granulation

Stimulator settings:

• Polarity – Place the negative pole distal and positive pole proximal to the wound on a muscle mass.
• Pulse rate – 100 for 15 min and 10 PPS for 10 min
• Intensity – 50 volts
• Duration – 60 minutes or two P1
• Frequency 5-7 x per week, once daily

Research Wisdom:
A saline based amorphous hydrogel, which has the ability to conduct electric current has been tested and the conductivity is comparable to saline. Whether the healing of the wound is improved when this product is used for conducting current and then left in the wound has not been tested. In the meantime, such a product may have the added advantage of being used as the wound dressing to keep the wound moist after the electrical stimulation treatment is completed.

Research Wisdom: Use of Amorphous Hydrogel for Conduction

Setting Up the Patient

1. Have supplies ready before undressing the wound.
2. Position patient for ease of access by staff and comfort of both.
3. Remove the dressing and place in an infectious waste bag.
4. Cleanse wound thoroughly to remove slough, exudate and any petrolatum products
5. Sharp debride necrotic tissue, if required, before HVPC treatment
6. Open gauze pads and fluff, then soak in normal saline solution, squeeze out excess liquid. An alternative is to use an amorphous hydrogel impregnated gauze. Hydrogel sheets can also be used to conduct current under the electrodes
7. Fill the wound cavity with gauze including any undermined/tunneled spaces. Pack gently.
8. Place a negative electrode 2” to 3” distal to the wound on a muscle mass.
9. Connect to stimulator lead
10. Positive electrode placement:

Usually placed proximal electrode 2” to 3” from the wound

Place over soft tissues  a muscle mass, avoid bony prominences

Clinical wisdom: All petrolatum products including enzymatic debriding agents such as collagenase, Santyl , and fibrinolysin, Elase , which are petrolatum-based products, must be removed before treatment or current will not be conducted into the wound tissues.

Clinical Wisdom: Remove Petrolatum Before Stimulation

Aftercare

After the electrical stimulation treatment is complete, slip the electrode out. The wound can be left undisturbed. If additional topical treatments are required such as enzymatic debriding agents or antibiotics, then the packing will need to be removed, topical agent applied and redressed.

Research wisdom:
 Frequent dressing changes are being discouraged because it disturbs the wound healing environment by removing important substances in wound exudate and cooling the wound. It takes three hours for a chilled wound to re-warm and slows leukocytic and mitotic activity

Research Wisdom: Avoid Wound Chilling

PRECAUTIONS

Signs of adverse effects were evaluated in the various clinical trials and none were found except some skin irritation or tingling under the electrodes in a few cases. Patients with severe peripheral vascular occlusive disease (PVD), may experience some increased pain, usually described as throbbing, in the leg after electrical stimulation.

CONTRAINDICATIONS

Contraindications for treatment with electrical stimulation include:

• 1-Placement of electrodes tangential to the heart
• 2-Presence of a cardiac pacemaker
• 3-Placement of electrodes along regions of the phrenic nerve
• 4-Presence of malignancy
• 5-Placement of electrodes over the carotid sinus
• 6-Placement of electrodes over the laryngeal musculature
• 7-Placement of electrodes over topical substances containing metal ions
• 8-E.I. povidone iodine and mercurochrome, unless thoroughly cleaned.
• 9-Placement of electrodes over osteomyelitis