1-800-657-6009
info@magne-tec.com

Frequently Asked Questions

Frequently Asked Questions About Our Lasers

Low-level laser therapy is the use of low intensity photonic energy as a treatment modality.

Photonic stimuli excite the body’s cells infusing them with energy, with the three primary reactions being, reduction of inflammation, cell function and increased blood flow.

The potential applications of low-level laser are almost limitless, however; to date Erchonia has received market clearance for Neck and Shoulder Pain, Breast Augmentation, Acne, Laser Assisted Liposuction, and Non-Invasive Body Contouring. Erchonia continues to conduct clinical trials on other applications.

Low level laser therapy is a non-invasive, fast and effective modality that has been proven in clinical trials to reduce pain, reduce edema, and promote healing.

Low level laser therapy is very safe; the only general precaution is the use of special filtering glasses when a class 3B laser is in use.

The depth of penetration is dependent on multiple factors including mass and density, however since low-level laser has been proven in clinical studies to effect subcutaneous cells; the point is low-level laser, does penetrate; as opposed to the heat lamp devices that do not.

Like their names imply, constant wave is a continuous emission of laser energy, without disruption, for the length of time the device is ON. Pulsed wave is controlled breaks in the wave, at predefined and programmed intervals.

No, most people do not feel anything. For those that have reported a feeling, it is nothing more than a slight tingling.

The mechanics of low low-level laser therapy is administered is based on the indication for use; however, the general process is the probe containing the laser diode(s) are held in place or moved gently over the treatment area at a distance of anywhere from 4” – 12.”

This is dependent of the application; however, progress is immediately evident.

Erchonia 3LT® devices used electric diodes, which are high end, culminated and strictly measured within a plus/minus .05%. LEDs are inexpensive, non-focused wide range light sources. The primary difference is in performance and depth of penetration. Laser diodes penetrate, working subcutaneously, LEDs do not affecting the surface only.

Erchonia has a make and model for every type of application and each budget. Contact us today to learn how to grow your business!

The FDA clears for market devices and specific indications for use, this is sometime referred to by persons outside the FDA as “FDA Approval”, although it is a term unacceptable to the FDA. All Erchonia devices have received a FDA market clearance or were self-certified in accordance to FDA regulation.

Erchonia Corporation develops, designs, and manufactures devices in accordance to both FDA and International Standards for Medical Device Quality Standards. Prior to release to production, finished devices are tested to Medical Safety Standards for Laser Controls, EMC, and Safety.

There are no code regulated contraindications; however, since there are no long term evaluations on certain conditions, Erchonia does not recommend use on pregnant women or persons with a pace maker.

No, low-level laser by virtue of design is non-heat producing and does not alter the cell structure. The laser irradiation is non-ionizing, meaning it does not collect in the tissue.

Some persons have reported a sense of deep relaxation that may cause drowsiness.

There are no known and / or published adverse effects of low-level laser therapy.

Frequently Asked Questions About Swiss DolorClast Shockwave

The Swiss DolorClast Method is the most clinically proven shock wave technology, combined with training to provide end users with the best treatment outcomes.

It should not hurt but should be uncomfortable ((VAS score < 7)).

The therapeutic effects of shock waves on the musculoskeletal system (pain relief and healing) are based on a multitude of molecular and cellular mechanisms. Without going into detail, the main short-term effects are depletion of presynaptic substance P in C nerve fibers (resulting in pain relief) and improved blood circulation in the treated area (which is the basis for healing). The main long-term effects are blockade of neurogenic inflammation and improved tendon gliding ability (resulting in pain relief) as well as activation of mesenchymal stem cells and new bone formation (both essentially involved in healing).

Treatment over air-filled tissue (lung, gut), treatment of preruptured tendons, treatment of pregnant women, treatment of patients under the age of 18 (except for the treatment of Osgood-Schlatter disease), treatment of patients with blood-clotting disorders (including local thrombosis), treatment of patients treated with oral anticoagulants, treatment of tissue with local tumours or local bacterial and/or viral infections, treatment of patients treated with local cortisone injections (within the six-week period following the last local cortisone injection).

It is absolutely correct that reduction of pain within a few days does not mean that healing has taken place in such a short time. On the other hand, sustained and statistically significant pain relief even two years after treatment of chronic plantar fasciopathy with the Swiss DolorClast method11 is a strong indicator of healing. The final proof of healing would require taking biopsies which is not possible for ethical reasons.

References:
11) Ibrahim MI, Donatelli RA, Hellman M, Hussein AZ, Furia JP, Schmitz C. Long-term results of radial extracorporeal shock wave treatment for chronic plantar fasciopathy: A prospective, randomized, placebo-controlled trial with two years follow-up. J Orthop Res Epub ahead of print on Aug 27, 2016.

In general, this is possible. However, the following points must be considered: (i) The Swiss DolorClast method is not yet approved for the treatment of fresh injuries; related clinical research is ongoing. (ii) With regard to tendon pathology, it is critical to note that there are no acute tendinopathies, only newly diagnosed ones. Safety and efficacy of the Swiss DolorClast method for treating newly diagnosed tendinopathies was demonstrated in the international peer-review literature for plantar fasciopathy (Rompe et al., 201012), primary long bicipital tenosynovitis (Liu et al., 201213) and lateral or medial epicondylitis (Lee et al., 201214)

References:
12) Rompe JD, Cacchio A, Weil L Jr, Furia JP, Haist J, Reiners V, Schmitz C, Maffulli N. Plantar fascia-specific stretching versus radial shock-wave therapy as initial treatment of plantar fasciopathy. J Bone Joint Surg Am 2010;92:2514-2522.
13) Liu S, Zhai L, Shi Z, Jing R, Zhao B, Xing G. Radial extracorporeal pressure pulse therapy for the primary long bicipital tenosynovitis a prospective randomized controlled study. Ultrasound Med Biol 2012;38:727-735.
14) Lee SS, Kang S, Park NK, Lee CW, Song HS, Sohn MK, Cho KH, Kim JH. Effectiveness of initial extracorporeal shock wave therapy on the newly diagnosed lateral or medial epicondylitis. Ann Rehabil Med;36:681-687.

These conditions usually require great care and very gentle treatment. In particular, the handpiece of the Swiss DolorClast should not be pressed against the patient’s skin. Furthermore, the therapist should be aware that even the lowest settings of the Swiss DolorClast may be too much and cause excessive pain during treatment. In these cases the treatment should be stopped. Good patient compliance is usually achieved when explaining to the patient that it is worth a try and that the treatment can be stopped at any time if it is too painful.

Yes, this is possible. Loosening of implants or surgical osteosynthesis material (such as screws, plates, nails) after exposure to shock waves has not been reported in the literature. In any case, direct contact between the applicator of the Swiss DolorClast and implants or surgical osteosynthesis material should be avoided. Furthermore, shock waves should not be applied “through” an implant or surgical osteosynthesis material in order to treat a pathology located behind it; shock waves would not reach their target.

A cardiac pacemaker is not a contraindication for the Swiss DolorClast method. However, direct exposure of a pacemaker and its wires to shock waves must be avoided at all cost. Accordingly, treatment of the left shoulder should be performed with great care in case the patient has a cardiac pacemaker.

No, mild thinning of a tendon is not a contraindication for careful and mild use of the Swiss DolorClast method. On the other hand, treatment of pre-ruptured tendons is a contraindication. As a general rule, tendons with a tear of more than 50% of the cross-sectional area must not be treated with shock waves. This is because due to pain relief, the tendon could rupture during augmented physical strain.

The Swiss DolorClast has not yet been approved for the treatment of erectile dysfunction. This is because there is no sufficient clinical evidence to predict a good treatment outcome with a high enough probability.

A real frozen shoulder cannot be successfully treated with shock waves; this indication requires manual mobilization (under general anesthesia). On the other hand, it should be carefully evaluated whether the patient really suffers from a frozen shoulder. If there is only partial immobilization, treatment with the Swiss DolorClast method can substantially improve the situation. Other women may experience pain during shoulder movements because of an incipient or existing secondary lymphedema (due to resection of regional lymph nodes as part of the mastectomy surgery). The Swiss DolorClast is approved for the treatment of primary and secondary lymphedema, and good results were reported by Prof. Sandro Michelini (Rome, Italy).

Development of lymphedema due to shock wave treatment has never been reported. The treatment of lymphedema with the Swiss DolorClast method has been reported to be efficient and safe in the literature15. The Swiss DolorClast is approved for this indication. It does not matter whether the patient has had full axillary node clearance or just the sentinel nodes removed; what is relevant is the clinical picture (i.e. the development of a secondary lymphedema). As a rule, the earlier the treatment is started, the better the outcome.

References:
15) Michelini S, Failla A, Moneta G, et al.: Treatment of primary and secondary lymphedema with shockwave therapy. Eur J Lymphol 2008;19:10.

Development of lymphedema due to shock wave treatment has never been reported. The treatment of lymphedema with the Swiss DolorClast method has been reported to be efficient and safe in the literature15. The Swiss DolorClast is approved for this indication. It does not matter whether the patient has had full axillary node clearance or just the sentinel nodes removed; what is relevant is the clinical picture (i.e. the development of a secondary lymphedema). As a rule, the earlier the treatment is started, the better the outcome.

References:
15) Michelini S, Failla A, Moneta G, et al.: Treatment of primary and secondary lymphedema with shockwave therapy. Eur J Lymphol 2008;19:10.

The Swiss DolorClast method is suitable for the following indications: tendinopathies, muscle pain, ostheoartritis, non-union fractures, spasticity, cellulitis, acute and chronic soft tissue wounds and lymphedema.

The Swiss DolorClast Classic is FDA approved as a “Generator, Shock Wave, For Pain Relief” device, Class III. It is the only FDA approved shock wave radial device.

All our competitors have registered their radial devices with the FDA as Electric Therapeutic Massagers (Class I). They are not allowed to use the terminology shock wave device. Furthermore, doctors in the USA must not bill treatment performed with these devices according to any Current Procedural Terminology (CPT) code. Electric Therapeutic Massagers are intended for minor muscle aches and pain.

Most of the clinical studies proved the efficacy of the Swiss DolorClast Method with 3 sessions. Nevertheless, there is no contraindication to add more sessions as long as the patient’s condition improves. In most cases you should not go over 8 to 10 sessions.

We recommend keeping a one-week interval between two sessions to let the inflammation caused by shock wave treatment decrease. Nevertheless, if a patient is feeling well after 3-4 days without inflammatory signs such as redness or swelling, the next treatment can be given.

Yes, you can. In case of chronic midportion Achilles tendinopathy, it was shown that the combination of radial ESWT and eccentric loading resulted in a statistically significant improvement in clinical outcome compared to eccentric loading alone (Rompe et al., 20097), radial ESWT being as effective as eccentric loading for this indication (Rompe et al., 20078). The same was shown for the combination of radial ESWT and plantar fascia-specific stretching in case of chronic plantar fasciopathy (Rompe et al., 20159).

References:
7) Rompe JD, Furia JP, Maffulli N. Eccentric loading versus eccentric loading plus shock-wave treatment for midportion Achilles tendinopathy: a randomized controlled trial. Am J Sports Med 2009;37:463-470.
8) Rompe JD, Furia JP, Maffulli N. Eccentric loading compared with shock wave treatment for chronic insertional Achilles tendinopathy. A randomized, controlled trial. J Bone Joint Surg Am 2008;90:52-61.
9) Rompe JD, Furia J, Cacchio A, Schmitz C, Maffulli N. Radial shock wave treatment alone is less efficient than radial shock wave treatment combined with tissue-specific plantar fascia-stretching in patients with chronic plantar heel pain. Int J Surg 2015;24:135-142.

Grow Your Business!

Selecting the best equipment for your clinic not only can make sure that you have better patient care, this decision can make you money from day one. We offer flexible plans that help to grow your business.

60

Month Lease*

$99

Per Month*

Deferred

3 Months Payment*

OAC subject to change.