FAQ

1.1 WHAT IS TANYX?

TANYX is a device designed to be a smaller, wireless and easier-to-use version than other TENS (Transcutaneous Electrical Nerve Stimulation) technology devices. It is the single ready-to-use, self-applicable product available in the market, with frequency adjusted for pain relief (TENS may have other purposes), as cheap as a treatment with medicines and disposable after the battery is discharged

TANYX is a revolutionary electronic system, developed to apply an electrical stimulation directly into the body, aiming at the relief of or elimination of pains in general, such as muscle, tendinous, articular and tensional pain.

1.2 WHAT ARE THE MAIN INDICATIONS OF TANYX?

• Fibromyalgia
• Plantar fasciitis
• Chronic epicondylitis
• Osteoarthritis and arthrosis
• Refractory chronic pelvic pain
• Cervical pain (neck pain)
• Contusions and chronic tendinitis
• Menstrual cramps (dysmenorrhea)
• Carpal tunnel syndrome (CTS)
• Postoperative pain
• Low back pain
• Bursitis, such as trochanteric and shoulder bursitis
• Chronic pelvic pain (e.g. endometriosis)
• Work-related musculoskeletal disorders (WMSD)
• Chronic muscle pain in upper and lower extremities (arms and legs)

1.3 WHAT ARE THE MAIN CONTRAINDICATIONS OF TANYX?

1.3.1 TANYX must not be applied:

• To the breast;
• To open wounds;
• Over irritated skin;
• To the forehead and face;
• Over the carotid artery (side region of the neck).

1.3.2 TANYX must not be used:

• In body parts with metal prostheses;
• By patients whose pain etiology is unknown;
• In patient bearing pacemaker or defibrillator;
• Simultaneously with high frequency surgical devices;
• During pregnancy (the safety of electrical stimulation in pregnant women is not established);
• In painful conditions caused by: appendicitis, gastralgia (stomach pain), hepatitis, etc.

1.4 IS TANYX DISPOSABLE?

Yes. It can be used several times until the battery is discharged and then it must be disposed of properly in a collector aimed to electronic devices and according to the local regulations.

2.1 WHAT IS TENS?

Conventional TENS (Transcutaneous* Electrical Nerve Stimulation) offers a noninvasive and drug free way to treat pain.

Moderate, safe and comfortable electric waves are transcutaneously delivered by electrodes, providing pain control to users.

TENS has been used by health professionals for decades and there are several explanations for its application in pain control. In a simple terminology, TENS reduces or controls the pain stimulus by disrupting its transmission to the brain (Gate Control Theory) and/or increasing the production and release of natural chemical substances by the body in order to reduce pain (Endorphin Theory).

*Transcutaneous: through the skin

2.2 WHAT MAKES TANYX DIFFERENT FROM THE OTHER TENS PRODUCTS?

TANYX is different from the other TENS devices because it was specifically designed to relieve pain.

Its previously adjusted frequency makes it an easy-to-use device for the final consumer, without the need of help by specialists, as it happens with other TENS products currently found in the market.

TANYX is actually the single self-applicable, disposable and cheap TENS.

3.1 HOW MANY STIMULATION MODES DOES TANYX HAVE?

TANYX has two stimulation modes:

• Continuous: the electrical stimuli are continuously emitted, without interruptions.
• Intermittent (pulse): the electrical pulses are emitted with intervals, not constantly. The intermittent mode must be chosen when the device is used for more than half an hour in the continuous mode; after that period, we recommend switching to the "pulse" mode.

3.2 HOW MANY LEVELS OF INTENSITY DOES THE DEVICE OFFER?

The device has 3 levels of intensity:

• L (Low)
• M (Medium)
• H (High)

3.3 WHAT'S THE BEST LEVEL TO BE USED?

The consumer must use the level that provides the highest comfort and/or pain relief

3.4 HOW SHOULD IT BE USED?

The Continuous Mode is the most indicated for usage up to 30 minutes. After 30 minutes in the Continuous Mode, switch to the "Pulse" mode to avoid the accommodation of nerve fibers and to improve the efficacy in pain relief.

3.5 WHERE SHOULD I PLACE TANYX?

It should be applied to the location of the pain or on the nerve fibers sending the pain sign to the brain, as, for example, vertebrae C7 or S5.

3.6 IS PAIN IMMEDIATELY RELIEVED AFTER THE APPLICATION?

Pain has distinct etiologies and organisms are different one from the others. For some people and their respective diseases, pain might disappear some minutes after the application of TANYX. However, sometimes, the treatment must be repeated to get relief of the pain.

3.7 HOW LONG CAN I USE TANYX EFFICIENTLY?

TANYX is free of overdose risk and may be used as long as you need or according to your doctor's prescription, but 20 minutes sessions are usually enough for pain relief. The analgesic effect provided may last for hours and the device may be used again and again if pain comes back, without risks, differently from several medicines that need medical prescriptions to avoid drug overdose.
It means that every TANYX session is cheaper than a traditional drug treatment for pain.

3.8 CAN TANYX BE USED MORE THAN ONCE?

Yes, the battery lasts a minimum of 10 hours. The average session lasts 20 minutes. However, TANYX may be used for longer periods because it's free of overdose risk. It means that it may be used for up to 30 times.
Cover TANYX gel with the protecting cover after use and keep it inside the blister to maintain its adherence.

3.9 MAY CHILDREN USE IT?

Yes. TANYX may be used in children aged 11 years or more if they don't feel uncomfortable and do not present any reaction during the treatment.

3.10 MAY TANYX BE USED DURING WORK, PHYSICAL ACTIVITIES OR ROUTINE ACTIVITIES?

Yes. There are no problems in using TANYX while you work, drive or do any other kind of physical or routine activities, being sure the device is properly attached to avoid releasing.

4.1 IS IT SAFE TO USE TANYX?

Yes. The safety of TENS technology is proven by clinical studies performed in Brazil and abroad. Moreover, TANYX is registered at the Brazilian Sanitary Surveillance Agency (ANVISA), at the FDA (Food and Drug Administration) and is certified by the UL.

4.2 IS THERE ANY OVERDOSE RISK?

No. The product may be used as many times and as long as you need. There isn't any risk or problem in using the device for a long time because TANYX is drug free.

4.3 BESIDES RELIEVING THE PAIN, CAN TANYX RESTRAIN OTHER RELATED PROBLEMS?

TANYX works like other analgesics by eliminating or relieving pain, but the pain etiology must be investigated. We always suggest that you see a doctor for an accurate diagnosis.

4.4 CAN TANYX BE WET?

No. Like any other electrical/electronic device, it must not be wet, be used in wet places (saunas, pools, etc.) or be exposed to high temperatures. These restrictions do not apply to the gel moistening with wet fingertips for better adherence to the skin.

4.5 IS THERE ANY RISK OF ELECTRICAL SHOCK DURING HANDLING?

No. The intensity and the frequency of the electric waves are totally safe. However, touching the electrodes with the power ON makes you feel a slight and perhaps uncomfortable electrical shock, but without any risk or warning.

5.1 ARE THERE STUDIES CARRIED OUT WITH TANYX?

Yes. Studies were carried out in a partnership with the University of São Paulo (USP) in Ribeirão Preto (Pain Clinic), where (double-blind) trials were performed for cervicalgia (neck pain), dysmenorrhea, low back pain, fibromyalgia and osteoarthrosis of the knee. Besides, a study about the use of TANYX to control deep endometriosis in women was carried out and it was chosen as the best research presented at the 20th São Paulo Congress of Gynecology and Obstetrics in 2015 and, afterwards, published in the European Journal of Gynecology and Obstetrics. Currently, other trials and studies are being carried out at USP and UNICAMP (University of Campinas) to prove the efficacy of TANYX in pain relief. Moreover, there are many studies published in qualified indexed scientific journals that assure the efficacy and safety of TENS technology, with similar parameters to the ones used by TANYX. Therefore, when we refer to TENS for pain relief, scientific evidence is unquestionable.

5.2 WHAT IS A DOUBLE-BLIND STUDY?

Double-blind study is a clinical trial performed with a methodology in which neither the participants nor the investigators know what is being used as a therapy in a certain moment. It is frequently used as a validation criterion of quantitative experimental practices in science.
In the case of TANYX, we used placebo devices in which the connections between the software and the electrodes were cut; thus, the device was normally turned on, but the stimuli were not produced (sham procedure).

5.3 MAY THOSE STUDIES BE QUESTIONED SOMEHOW?

They are double-blind studies carried out using a placebo and with a significant number of patients. The studies were concluded with positive results, presented in congresses and published in indexed international scientific journals.

6.1 IS ANY DRUG INSERTED IN THE ORGANISM DURING THE APPLICATION?

No. The product is totally free of medicines and there isn't any absorption of drugs. Pain is interrupted by electrical stimuli that promote analgesia and muscle relaxation and block the pain signs sent to the brain.

6.2 MAY I USE TANYX TOGETHER WITH OTHER TREATMENTS OR MEDICINES?

Yes, TANYX does not have any harmful interaction with medicines.

6.3 MAY TANYX BE PRESCRIBED WITH NSAI AND ANALGESICS FOR THE SAME TREATMENT?

Yes. TANYX has a hemodynamic, "drug-delivery" effect, reinforcing and improving the action of medicines in the site of pain. This effect was proven by image exams at the Nuclear Medicine Department of the Syrian-Lebanese Hospital, in São Paulo.

6.4 IS THERE ANY INTERACTION WITH DRUGS?

No. TANYX is a great supportive therapy in several treatments and it can be used simultaneously with drugs.

7.1 IS TANYX EXPENSIVE?

TANYX yields, at least, 30 applications in sessions of 20 minutes each, for pain relief. The treatment with TANYX costs, at most, the equivalent of a reference analgesic treatment.

8.1 WHAT ARE TANYX TECHNICAL SPECIFICATIONS?

• Pulse Frequency: 55 Hz
• Pulse Width: 80 µs
• Adjustable intensity: L; M; H
• Operating band: (500 ohm load) 40 mA to 50 mA (peak current)
• Modes: Continuous or Pulse ï‚· Minimum duration: 10 hours
• Power supply: CR2025 3V lithium battery
• Working temperature: -25ºC to 40ºC
• Protection Class: IP22
• Storage: Dry and, temperature between -5°C to 40°C
• Protection of the applied part against electrical shock: BF
• The product complies with the biocompatibility criteria of ISO 10993-5:2009

9.1 IS TANYX MORE EFFICIENT FOR CHRONIC OR ACUTE PAIN?

Studies have shown that the TENS technology is more efficient in chronic pain; however, it may be used for acute pain with good results, according to the site and etiology of the pain.

10.1 DOES TANYX HAVE REGULATORY FILINGS?

Yes. Following international technical regulations, TANYX efficacy and safety are proved by means of regulatory filings in the FDA and ANVISA and by the UL certification.

11.1 WHAT IF MY DEVICE STOPS WORKING AFTER 5 MINUTES?

The device may not be recognizing the skin contact. Check gel adherence. If the problem persists, change the intensity by pressing the (M) "Medium" button of your TANYX.

11.2 THE LIGHT IS FLASHING TOO FAST

The battery of your TANYX will be discharged in the next 30 minutes of use.

11.3 THE GEL DOES NOT ADHERE TO THE SKIN

Touch the gel with wet fingertips. Check whether the skin is too oily; if so, remove the excess of oiliness.
Check whether the application area is too hairy. If so, remove hair for better fixation.
In case the user wishes to use the product during body movement, a band may be used to keep the device fixed in the application site.

11.4 THE BATTERY IS DISCHARGED

The product must be disposed of properly and according to the local regulations

11.5 WHAT TO DO AFTER THE BATERY IS DISCHARGED?

The product must be disposed of after the battery is discharged. The battery cannot be replaced.

11.6 HOW DO I KNOW WHEN THE BATTERY IS DISCHARGED?

The LED light stops blinking and electrical signs are not emitted anymore
When the battery is about to be discharged, some people may not feel the electrical stimulations, but TANYX keeps on controlling pain.