Your Contact:  Annette G Boelman | eMail: info@quantumleaps.ca | Phone: 2503442114  [ X ]
:  Annette G Boelman | : info@quantumleaps.ca | : 2503442114  [ X ]

BUYERS GUIDE

This comprehensive buyers guide is designed to provide accurate and up-to-date answers on the most critical questions you may ask prior to obtaining a PEMF device for your personal and professional use!

You can also download the buyers guide here.

Is the PEMF device safe to use?

Product safety of any PEMF device is the most basic and critical requirement. Proof of safety is defined by international regulations and the following norms have to be fulfilled by a PEMF manufacturer in order to legally market the device:

A) Electrical safety: Provision of a valid “CE” Certificate (electrical safety and electromagnetic compatibility), in the USA it can be also labelled as “UL”, in Canada as “CSA”!

B) Every PEMF manufacturer/supplier, advertising health/medical claims, needs to label their device with the official “CE” mark, followed by four digits, i.e. CE 0123 (the four digits representing the notified body to certify the device for the manufacturer/supplier) The four digits also validate the listing and approval of the country where the device is being marketed! In other words, the labeling assures that the respective device is legally registered and certified as an audited medical device, considered to be safe to use!

Is the intensity of the applied electromagnetic field crucial for its effectiveness?

PEMF systems appear on the market in all kinds of intensity levels. So-called high-intensity devices (mainly in the Tesla range) are usually used in a clinical environment and require highly trained staff as the electromagnetic field strength may harm if not applied properly! Nevertheless, a typical PEMF technology within the high Tesla range is known as “rTMS” (repetitive Transcranial Magnetic Stimulation). It is, among other things, clinically approved for depression, however NOT suitable for home use. Such systems are specifically certified as medical devices, fulfilling all necessary norms and regulations. In addition, they are listed, cleared and approved by governing agencies (FDA, Health Canada, Health Agency of the European Union etc.). There are several high intensity devices on the market aggressively advertised for home use using misleading medical claims. None of them carry a recognized safety certificate, are registered, cleared or approved by the governing agencies! For this reason, this buyers guide will not include their technical data nor function. Low-intensity PEMF systems (usually within the range of approximately 1-300 microTesla) are very safe for home use without the necessity of a trained technician onsite. They offer a vast collection of clinical studies, confirming superior suppor-
tive efficiency. Low-pulsed PEMF systems range between 1 and 300 microTesla, mimicking the earth’s natural magnetic field strength, nowadays measured between 20 to 70 microTesla.
Whole-body applications within these intensity levels have proven most effective in activating the body’s own healing capacity.

Is the frequency of the applied electromagnetic field crucial for its effectiveness?

In general frequency (measured in Hertz = Hz) is defined as the “information content” of the applied pulsed electromagnetic field. Similar to intensity, you can find PEMF devices emitting very high frequencies (up to the high kilohertz = KHz range) as well as very low frequencies (0-30 Hz). Evaluating existing clinical studies, the phrase “less is more” perfectly describes the best approach. Low carrier frequencies in the range between 0.1 and 30 Hz are also abundantly present in nature (Schumann waves, 7.83 Hz, carrier frequency of the earth magnetic field, roughly 11.7 – 11.9 Hz) as well as in our brainwaves (Beta, Alpha, Delta and Theta, between roughly 0.2 and 38 Hz). Low-frequency PEMF devices utilize the principal of resonance: It describes the phenomenon of increased amplitude that occurs when the frequency of a periodically applied force is equal or close to a body`s natural frequency!

Is the waveform of the applied electromagnetic field crucial for its effectiveness?

Another important parameter of a PEMF system is the so-called waveform. It describes the concept of transmitting frequency of a pulsed magnetic field as it would appear on a graph. The simplest waveform is hereby the sine wave. In order to transmit 5Hz from the sender to the receiver via a simple sine wave, the wave needs to repeat it`s cycle 5 times per second in sequence. This waveform is technically easy to gain but very limited in efficiency and extremely time-consuming in transferring information from the sender to the receiver. Surprisingly, most available low-pulsed PEMF systems on the market are still using simple sinewaves. Engineering, development and also manufacturing of such frequency generators are very cheap but also less effective. A more complex waveform is the so-called square wave. A square wave is a non-sinusoidal periodic waveform in which the amplitude alternates at a steady frequency between fixed minimum and maximum values, with the same duration at minimum and maximum. Square waves are also producing odd harmonics, which are very important to increase resonance effects. Due to its sharp rise and fall times, the immediate response rate of the targeted tissue is much higher. The most complex wave form used in modern PEMF systems is known as the saw tooth. Saw tooth waves are characterized by a constant rise and rapid fall time and are producing all odd and even harmonics of its basic frequency. Since the main objective of an effective PEMF system for home use is to target ALL cells of your body, the wave form is a very crucial parameter to be aware of. Some manufacturers advertise “patented” wave forms, which are not documented in common physics. Such waveforms are artificially altered sine wave combinations, offering little independent clinical evidence as to their effectiveness. Their published clinical trials are mostly conducted by the company itself (industry-friendly) and therefore not considered as publicly acknowledged scientific study designs.

How do PEMF systems transfer the electromagnetic field from the applicator to the user?

Electric fields are created by differences in voltage: the higher the voltage, the stronger the resultant field. Magnetic fields are created whenever an electric current flows through a conductor. Manufacturers of modern PEMF systems are using different concepts of conductive designs. The most simple and cheapest approach is the use of flexible, insulated mesh wire coils of all kinds of shapes and sizes (round, oval, square). Companies using this concept usually advertise the advantage of better transport handling since the applicators can be rolled. However, the major disadvantage of this concept is the inevitable spacing between consecutive, insulated windings which distorts the magnetic field lines leading to an impure signal, consequently diminishing the inductive force. High-end PEMF devices solely utilize pure, uninsulated and solid copper coils, assuring an uninterrupted signal structure which then creates the highest inductive force. Meaningful clinical study designs usually use prototypes which offer copper coils, known to be the most effective (Reference: NASA study for stem cell growth).

What does it mean, if a PEMF system switches the polarity of the applied electromagnetic field?

Switching the signal polarity consecutively from South to North and vice versa, is a very important feature of any state-of-the-art PEMF system. Our organism tends to acclimate or habituate to external, simplistic information and gets literally “used to it” or “tiresome” (i.e. static magnets or simple PEMF sine wave forms). As a result, over time, PEMF benefits may diminish and the application becomes less sustainable. Polarity changes in a PEMF device differ slightly from the South and North polarity of a static magnet. You will NOT find magnets in PEMF applicators, rather and ideally pure copper current loops, genera-
ting pulsed electromagnetic fields with a high variation in frequency. Therefore, switching polarity occurs once the current in the loop is changing direction. This added signal variety prevents the body’s fatigue to the same wave form.

What is the benefit of PEMF systems integrating a biorhythm clock?

The existence and function of an internal “organ clock” in living organisms is meanwhile scientifically proven as well as awarded (Nobel Prize in Medicine 2017, Hall, Rosbash and Young: Discoveries of Molecular Mechanisms Controlling the Circadian Rhythm). Our bodies and brains as well as planetary systems are changing frequencies at different times of the day. This has a profound impact on our wake/sleep cycles and our energetic/tiredness phases throughout 24 hours. While working and being active during the day, we “operate” on higher frequencies (brainwaves mainly in high beta ranges), whereas on lower frequencies during evening and night (alpha = awake but relaxed, delta and theta = sleep/dream). Sophisticated PEMF systems take this important fact into account and automatically deliver the appropriate frequency ranges according to the time the application is performed. This feature is only available in a very few PEMF devices, even though it represents an essential requirement in achieving the highest “biological” effect

Why is the coil layout of a PEMF whole- body mat very important?

Exposing an entire human organism (ideally, all 75 trillion body cells) to an electromagnetic field through a whole-body mat application guarantees the best holistic effect. For this reason, a whole-body mat offering pairs of conducting coils, capable of gradually increasing the magnetic field intensity from head towards feet, is the best choice. This means that the device needs to have 3 pairs of coils mimicking the flow of the earth’s magnetic field, ideally covering head/neck, hips/torso, legs/feet and each side of the body. To be even more detailed, the coils covering the upper body need to expose a lower intensity (achieved by fewer windings in the coils), while the coils toward the feet should have greater intensity (more windings in the coils). This is of utmost importance because in comparison to our head and neck, our most sensitive body parts towards electromagnetic fields, our legs and feet can tolerate much higher intensity levels. Lower intensity levels in the upper portion of a whole-body applicator are crucial for people who are chemically or magnetic field sensitive. In addition, higher intensity levels could overstimulate or irritate the thyroid. BE AWARE: Manufacturers with mesh wire mats claim to offer a more uniform field (and they do) but at the expense of exposing both feet and head to the same intensity. This in turn may lead to unpleasant reactions, especially with people, who are hypersensitive to electromagnetic exposure!

What are the most important properties of local applicators?

Local PEMF applicators are designed to treat specific body parts. Applicator designs come in different shapes and sizes. In general, the intensity levels (magnetic flux) of local applicators are higher than whole body applicators. Area applicators (pillows or pads) are designed to treat larger surfaces and come in two different variants: A) one-coil design (usually insulated mesh wire), delivering uniform field exposure. B) two-coil design (usually uninsulated, solid copper coils), delivering field exposure with two separate magnetic field hot spots. This design increases the probability to pinpoint the cause of a prevailing condition without knowing the exact location of the trigger. Spot applicators (spots or intensive applicators) are designed to treat very specific body areas. They usually emit the highest intensity levels and come in two different variants: A) one-coil design (mesh wire or solid copper coils), delivering a uniform field exposure or B) two-coil design (solid copper coils), utilizing a very specific physical effect, called the “Helmholtz Coil” effect. This particular spot applicator consists of two conductive coils, connected with an elastic band. The applicator can be wrapped around the treatment area and as both coils are now facing each other in the same axis, the magnetic field becomes uniform, cancelling out possible disturbing magnetic fields within that particular region. Two-coil spot applicators are very effective and widely used in a clinical environment for faster bone- and wound-healing, pain relief and to increase local blood circulation.

Do I have to be an expert to properly ope-rate a PEMF system?

During the development process, reliable and well-known manufacturers of modern PEMF systems for home use invest a lot of time, thoughts and knowledge into usability and user-friendly operation. Although several, crucial parameters have to be pre-adjusted prior to an application, the most modern devices are meanwhile equipped with so-called “Fast Start Programs”. Desired effects such as sleep improvement, regeneration, activation, relaxation, balance, performance etc. can be selected by pressing one single button and the system delivers all preprogrammed parameters for all applicators accordingly. In addition, these devices include a database of PEMF applications collected from clinical trials and comprehensive user feedback. It provides a customized protocol for specific effects. This not only enhances efficiency but also ensures a high level of application safety.

Are there PEMF systems on the market, capable of providing updates, upgrades and further developments?

Basically, the market for PEMF home systems can be divided in two groups:

A) Systems with a final product design and fixed operation structure. These systems are designed and programmed for a particular use. They cannot be updated or upgraded nor can they offer additional accessory development and expandability.

B) Systems with an integrated, processor-based hardware structure, a development
operating system, offering tools for future additions (hard and software). These systems are designed to provide the user with periodic improvement-based updates and upgrades, even additional application possibilities.
Consequently, investing in newer updated systems is no longer needed. Statistically, the operational life span of a certified PEMF home device can easily exceed 10 years. Based on the design, good care should eliminate any additional maintenance. It is therefore crucial to carefully investigate, which systems provide the greatest benefit for the user, not only in efficiency and usability, but also in their capability to sustain the newest, most advanced version.

Do PEMF systems also provide combining treatment modalities?

With the rapid development of digital technology, leading PEMF companies have already started to implement complementary and meaningful applications in their systems to provide a multimodality, therapeutic approach. State-of-the-art, processor-controlled PEMF systems with a comprehensive operating system are meanwhile capable of controlling and applying additional therapy methods within and outside of the electromagnetic spectrum, such as light-, sound- and color-therapy as well as far infrared technology. A regular PEMF treatment is usually performed while lying comfortably on a whole-body mat. Innovative inventions make it now possible to include far infrared therapy as well as brainwave entrainment in one single application. This approach not only saves valuable time for the user but enhances and optimizes the desired recovery processes. The described modalities are usually available as options and can be easily plugged into the system, controlled by the operating surface of the control unit. Ultimately, it saves a lot of money in comparison to obtaining similar therapeutic devices separately.

What kind of service/support can I expect from a trustworthy PEMF company?

There are basically two existing distribution channels for home use PEMF systems on the global market:

A) online-shopping platforms (either exclusive supplier websites or through existing online shopping platforms, such as Amazon, eBay etc.)

B) direct selling through independent and certified company distributors of the respective manufacturer. Buying a PEMF system online might be a simple and modern choice. Doing so, please be aware that a fancy website, attracting with all kinds of claims and promises does not necessarily guarantee a competitive, legalized product, nor a reliable customer-oriented professional service and support. The decision to buy a comprehensive PEMF system for home use comes with a considerable investment, requiring expert advice. However, in no case should price be the most important criteria in acquiring a device, rather the assurance of an established, well-known manufacturer. Another important criterion is the availability of personal assistance, a service which is offered only by companies that are aware of the responsibility which associates their product. You should be able to receive answers through first-class customer service and/or a contact person to assist. Obtaining a PEMF system through an independent certified manufacturer representative in your region can give you this confidence. Your assigned representative is also your “first responder” in case of product issues or service requirements which pertains to the manufacturer. Trusted companies also provide you with real contact people, faces and phone numbers, not just email addresses and/or contact forms!

Is it possible to monitor and evaluate the immediate effect of a PEMF application?

Only very few modern PEMF systems for home use are equipped with sophisticated monitoring and analyzing technology, capable of measuring physiological functions during an external stimulus. Specific sensors detect and mirror the body’s own biofeedback, providing pertinent information. One of the easiest, most effective and medically acknowledged forms of biofeedback is Heart Rate Variability (HRV), which can be easily and accurately measured through a pulse rate (finger or ear sensors). HRV analysis provides a “picture” of the autonomic nervous system which is constantly changing depending on activity, thoughts or external stimulus (PEMF). Depending on the HRV response during an application, the PEMF device is capable of adjusting the field intensity accordingly, thus providing a custom tailored therapy session. In addition, the recorded HRV data can be downloaded for further analysis, a software feature only provided by digital PEMF systems.

How can I find out, if a PEMF system is certified and legally approved for distribution?

A company and product background check needs to become an inevitable task prior to any purchase decision, especially in the health care industry. PEMF devices for home use are classified as medical devices, without exception! PEMF manufacturers/supplier, advertising any kind of health claims, need to be in compliance with the respective norms and regulations of the country the system is being offered to the public. Whether a medical device manufacturer/supplier or any electronic health product is considered legal, can easily be researched by demanding the following proof of concepts:

  1. Product Certificate “Electrical Safety and Electromagnetic Compatibility” (depending on country: CE/CB/UL/CSA…).
  2. Notified Body Certificate “Quality Management System for Medical Devices”:
    • if the manufacturer is a US company: FDA 21 CFR Part 820!
    • if the manufacturer is a European company: ISO 13485:2018!
    • if the manufacturer is a Canadian company: ISO 13485:2016 or higher!
  3. Every medical device manufacturer/supplier must provide proof of medical device clearance, regulation or approval within the respective country the product will be marketed. The approval usually depends on the “intent of use” of the respective device. You can find this information inside the product`s instructions for use (IFU), an important question to ask before you buy. The intent of use includes also product claims the company is legally allowed to publish and advertise. Demand the following proof of product clearance:
    • if the PEMF device is marketed in the US: FDA listing information (establishment listing AND product listing, eventually 510K exempt confirmation or 510K approval or premarket approval, always depending on the classification of the product)!
    • if the PEMF device is marketed in Europe: Product certificate MDR 2017/745!
    • if the PEMF device is marketed in Canada: Health Canada MDEL = Medical Device Establishment License AND MDL = Medical Device License!
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