How safe are electric pelvic floor trainers?
Die Anwendung von Reizstrom bei Beckenbodentrainern
Training the pelvic floor muscles is a very important topic. The most common symptom of pelvic floor weakness is incontinence. Causes can be the strain of pregnancy, injuries to the nerves or increasing age.
To train the pelvic floor, you can use pelvic floor exercises, manual pelvic floor trainers or electric pelvic floor trainers. You can choose the method according to your personal preferences.
With a pelvic floor trainer, some people have concerns about delivering electricity to their own body before using it for the first time. But you don't need to worry, our pelvic floor trainers are certified medical products and stand for high quality.
At axion, you will receive all the information you need for using an electric pelvic floor trainer. This includes the functionality of stimulation current for pelvic floor training, the presentation of quality standards and also the contraindications of an electric pelvic floor trainer.
Under the pelvic floor category, we have compiled a lot of information on and about pelvic floor trainers, as well as various exercises for pelvic floor training. If you still have any questions, please feel free to contact us at service@axion.shop or +49 7152 - 353 911 - 0.
Our recommendations for pelvic floor training
Hohe Produktqualität für eine sichere Anwendung
To ensure that your safety is paramount during use, our pelvic floor trainers, which work like an EMS device, are tested in accordance with the Medical Device Directive MDD (93/42/EEC)[1]. Without this certification, the medical devices would not be allowed to be marketed within the EU. It lists some requirements that have to be fulfilled. If you are interested, you can read the complete directive, you will find the link in the sources. A very important requirement for our pelvic floor trainers can be found under paragraph 12.8 (protection against risks resulting from the transfer of energy or substances to the patient). Since May 2021, this directive has been replaced by MDR 2017/745, where you will find the following paragraph under 21.1[2].
12.8.1
Devices for supplying the patient with energy or substances must be designed and constructed in such a way that the flow-rate can be set and maintained accurately enough to guarantee the safety of the patient and of the user.
Medical devices must be divided into classes by the manufacturer/distributor. The subdivision of the classes is based, among other things, on the risk to the patient (i.e. the vulnerability of the human body), the duration of use and the degree of invasiveness and activity of the product[3]. Depending on the defined class, different requirements arise that the product has to fulfil in order to be certified as a medical device. Our devices are class IIa medical devices and are tested accordingly.
In addition, our medical products are certified according to ISO standard 13485:2016/NS-EN ISO 13485:2016, which contains requirements for the manufacture and sale of medical products, which includes pelvic floor trainer.[4]
At axion, you can be sure that treatment with an electric pelvic floor trainer is safe when used correctly. Please note the contraindications for use with an electric pelvic floor trainer in the following section.
Contraindications
Electrical muscle stimulation with stimulation current is considered a training method with few side effects when used correctly. However, some people may find the sensation of the electrical impulses unpleasant, although most customers describe the sensation as a pleasant tingling sensation. If you suffer from a nickel allergy, you can also order our electric pelvic floor trainer with a gold-coated probe. When used correctly, the likelihood of side effects is minimal. However, there are also circumstances under which you should not use an electric pelvic floor trainer.
Please note:
If any of the following apply to you, be sure to consult your doctor before using an electric pelvic floor trainer and discuss its use with him or her:
- With infections in the vaginal or rectal area.
- With a pacemaker
- Immediately after childbirth (you can start pelvic floor exercises similar to postnatal exercises about 6-8 weeks after childbirth).
- Haemorrhoids
- If you are using an IUD for contraception
- If you have an overflow bladder
- If the entire pelvic floor is denervated
- Piercings or implants in the pelvic floor area
- If you have recently had a prostate operation (you should wait until everything has healed before you start pelvic floor training).
The TENS world of axion
We are happy to advise you
You still have questions about the correct application for your pelvic floor training? Our expert advisors are there for you!
Studies and scientific sources
[1] COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices (1993). https://eur-lex.europa.eu/legal-content/DE/TXT/PDF/?uri=CELEX:31993L0042&from=DE
[2] REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices (2017). https://eur-lex.europa.eu/legal-content/DE/TXT/PDF/?uri=CELEX:32017R0745&from=DE
[3] European Comission. Classification of medical devices. https://ec.europa.eu/docsroom/documents/10337/attachments/1/translations/en/renditions/native
[4] Wikipedia (2006, 12. August). ISO 13485. Wikipedia. https://en.wikipedia.org/wiki/ISO_13485