Q: WHAT IS CEFALY?

Ans: Cefaly is a CE and ISO certified medical device designed to treat and prevent migraine headaches. Cefaly can considerably reduce or replace the consumption of side effect producing medications. Cefaly is the first cranial analgesic electrotherapeutic device to acquire ISO medical certification proven effective on migraine pain with no side effects. Cefaly’s patented design uses TENS technology which has been researched in medical circles for over 40 years. TENS technology is known for its safety and dramatic absence of side effects, making Cefaly unique to all other headache and migraine pain treatments. Cefaly is designed and developed in accordance with the strictest quality standards eliminating all possible short-term and long-term dangers. Tens of millions of Cefaly devices have been in regular use for several years and not a single incident has ever been reported. Cefaly is a tried-and-tested migraine pain reliving technique that is extremely well respected in scientific reviews and has confirmed its effectiveness for several years. Cefaly is an innovative, lightweight and extremely cost effective pain relieving solution. Its self adhesive electrode is placed directly on to the forehead. Worn conveniently like a pair of eyeglasses, Cefaly connects to the electrode and begins its subtle treatment. For a full detailed step by step guide on how to use Cefaly, click here.

Q: HOW TO USE CEFALY?

Ans: For a full detailed step by step guide on how to use Cefaly, click here.

Q: HOW DOES CEFALY WORK?

Ans: Muscle cells and Nerve cells are the only two types of cells that respond well to electrical stimulus: Cefaly was designed to work specifically on nerve cells affected by pain. Cefaly works by introducing safe, and painless electric impulses to act on the very nerves that transmit migraine pain, a bifurcation of nerves known as the trigeminal nerve. Often referred to as “the great sensory nerve of the head and neck”, the trigeminal nerve is an Endorphin-producing mechanism that carries information about touch, temperature, perception and pain from the face and scalp to the brainstem. The patented Cefaly design covers this bifurcation and therefore acts on the main part of the trigeminal nerve. Through an electrode covering the middle of the forehead, Cefaly sustains a constant link between migraine pain specific nerves and the electric impulses it generates. Cefaly transmits extremely specific and perfectly adapted electrical impulses to safely stimulate the trigeminal nerve. Cefaly generates very precise electrical impulses to stimulate the nerve fibers selectively. As the impulses are produced very slowly, they are virtually imperceptible. Cefaly’s advanced technology enables an electronic feedback mechanism to adjust the electrical impulses to the specific requirements of the individual user for personalized efficacy and comfort. Cefaly specifically stimulates the endorphin-producing, and the touch sensitive nerve fibers of the trigeminal nerve. Cefaly purposely increases the production of endorphins and the influx of touch sensitivity – a mechanism called the Gateway Control System – both are increased to the point that they do not leave any space for the influx of pain stimulus. With a higher level of endorphins, the trigger threshold of headaches or migraine pain is altered by partially blocking the entry of migraine pain into the nervous system.

Q: WHY CEFALY?

Ans: Pain Prevention: A prevention program designed to increases the production of endorphins and raises the trigger threshold of the pain. No Side effects: Stop depending on pain killers and side effect producing medication. Cefaly can replace or reduce the consumption of painkilling medication, with no side-effects. Effective pain relief: A Attack program blocks pain and provides relief during attacks. Reduce Stress: An anti-stress program produces general relaxation and a strong sense of well-being.

Q: IS IT SAFE?

Ans: Cefaly is harmless and very safe to use. Its safety has been demonstrated in test and clinical studies Cefaly is a patented medical device supported by numerous clinical studies and safety tests. Clinically studied over 5 years in university hospital pain clinics and in specialist laboratories. Designed and developed in line with a strict risk analysis compliant with international standard ISO 14971 applicable to medical equipment. Cefaly complies with directive 93/42/EEC pertaining to medical devices and with all associated international IEC standards.

Q: WHO CAN USE CEFALY?

Ans: Migraine Headaches affect people of all ages. Cefaly is designed to only to act on physiological mechanisms therefore it is not age dependent, although as added precaution we recommend it only to children over 8 years old. Cefaly is ideal for pregnant or nursing mothers who have no choice but to stay away from dangerous pain killing medication. If used as directed children over 8 years old may use Cefaly if supervised by an adult.

Q: ANY SIDE EFFECTS?

Ans: Cefaly was designed with safety in mind, all the substances and materials used are bio-compatible and have been subjected to skin testing. No clinical studies carried out with Cefaly have revealed any evidence of side effects or problems. Millions of pain treatments using Cefaly have been monitored and no problems or side effects were reported.

Q:  Will the pain disappear immediately after the 20-minute session?

Ans: In anterior tension headaches, after a 20-minute session of programme 1, either the pain will disappear or the period of instability will last for a further two hours.

Q: How long to the electrodes last?

Ans: The electrodes are good for 10 to 15 uses (depending on usage and storage). The conductive gel needs to stay moist in order to work properly. Once the gel dries, the electrode needs to be changed. We suggest keeping it in a sealed plastic bag between uses.

Q: What do I do when forehead clensing wipes run out?

Ans: You may use soap and water to cleanse the forehead when wipes run out.

Q: Can I just reorder the electrodes?

Ans: Yes.

Q: How much time does it take to increase the intensity to a level of effectiveness?

Ans: The more the intensity is increased, the higher the dose and therefore the more effective the treatment. The threshold of effectiveness varies greatly from one individual to another. But generally speaking, once you are used to the system, the intensity should be increased for 6 to 8 minutes in order to step up to the effective zone.

Q: When should Cefaly NOT be used?

Ans: There are very few contraindications to the use of Cefaly. Cefaly should not be used when driving, or in the following situations:

1. If you have had recent brain or facial trauma

2. If you have Skin conditions, rashes or abrasion on the forehead in the area of application of the electrode

3. If you have Meniere’s disease

Q: Can Cefaly be used by pregnant women?

Ans: Cefaly can be used by pregnant women without any problems.

Q: Can Cefaly be used on children?

Ans: Children aged 8 and over can use Cefaly under the supervision of an adult. In children under the age of 8, Cefaly is not formally contra-indicated, however it would be better for the child’s paediatrician to get in touch with SXT-Med’s medical department to discuss the details of a usage protocol.

Can Cefaly be used by people who have a pacemaker?

Having a pacemaker is not a contraindication to using Cefaly, which has no effect on this type of device.

Note

Redness of the skin in the area around the electrode may persist for a few minutes after the session has ended