Is a TENS device safe?

Safe use of stimulation current

A big advantage of a TENS device is its flexible applicability. You can take it with you anywhere or use it in the comfort of your own home. For many people, however, the question arises whether treatment with electricity can also be dangerous when it comes to self-application . This applies in particular to people who do not already know a TENS application from their physiotherapist or who have not yet had any contact with pain treatment using electrical stimulation . TENS is a recognized method, which is why it was included in the service catalog of the statutory health insurance companies in 1987.

We at axion would like to provide you with all the information that can enable you to use our devices safely and successfully. In addition to explaining how a TENS device works, this also includes the presentation of quality standards, contraindications and possible side effects .

If you have any further questions about how TENS or our devices work, you can contact our trained medical product experts on +49 7152 - 353 911 - 0 or by e-mail at customerservice@axion.shop .

If medically certified TENS devices are used strictly according to the instructions for use, they represent a safe method for pain relief.

High quality standards for safe use

Our TENS/EMS devices and electrodes are tested according to the MDD (93/42/EEC) Medical Devices Directive [1] so that your safety is the top priority during use. Without this certification, the medical devices should not be sold within the EU. It lists some requirements that must be met. If you are interested, you can read the full policy, you can find the link in the sources. For a very important requirement for our devices, see paragraph 12.8 ( Protection against risks arising from the delivery of energy or substances to the patient). Since May 2021, this guideline has been replaced by MDR 2017/745 , where you will find the following paragraph under 21.1[2].

12.8.1

Devices intended to deliver energy or substances to the patient must be designed and manufactured in such a way that the delivered quantity can be adjusted with sufficient accuracy to ensure patient and user safety and this adjustment can be maintained.

We also have a certificate for our medical products according to ISO standard 13485:2016/NS-EN ISO 13485:2016. This standard includes requirements for the manufacture and sale of medical products.[3]

At axion you can be sure that treatment with TENS is completely harmless if used correctly. On our TENS applications overview page you will find both the correct electrode placement and the recommended program for your application. Please note the contraindications for use with a TENS device in the following section.

contraindications

TENS is considered a treatment method with few side effects, quite the opposite of the administration of painkillers. The feeling of the electrical impulses can be uncomfortable for some people, but most users describe the application as a pleasant tingling sensation. In people with an allergy to adhesives, the electrodes may cause skin irritation and redness. In these cases, you should stop using TENS and EMS. Otherwise, if used correctly, there are no side effects to worry about.

If one or more of the contraindications listed below apply to you, it is essential that you clarify the use of a TENS device with your doctor beforehand:

• heart disease and cardiac arrhythmias
• pacemaker
• open wounds
• pregnancy
• tumors
• implants or metals
• epilepsy
• febrile illnesses
• thrombosis

You should also not place the electrodes directly over the heart, on the larynx or the carotid artery. We have given you a possible electrode placement for each individual application.