NiSV training for the pelvic floor chair.

NiSV stands for the “Verordnung zum Schutz vor schädlichen Wirkungen nichtionisierender Strahlung bei der Anwendung am Menschen” (Ordinance on Protection against the Harmful Effects of Non-Ionizing Radiation when Applied to Humans) of November 29, 2018. Non-ionizing radiation is an umbrella term that covers, among other things, lasers, intense light, radio frequency, ultrasound and electric and magnetic fields.

The regulation is meant to protect the people on whom such devices are used outside of medicine. To do this, it governs two things: what obligations the operator of a device has, and what expertise the person applying it needs.

Under § 1, the NiSV applies to the operation of devices that apply non-ionizing radiation to people commercially for cosmetic or other non-medical purposes. A pelvic floor chair uses a magnetic field to stimulate the muscles. For exactly this, § 7 contains its own rules on expertise for magnetic field stimulation.

If a device is used as a medical device, medical device law takes precedence insofar as it sets the same or more extensive requirements. How your specific device and your use should be classified is something you should clarify before you start.

The expertise is needed by the person who applies the device to people. Under § 4, the operator must ensure that this person has it. For a studio, that means every person who sets up and starts sessions needs the certificate, and you as the owner are responsible for it.

In addition, § 3 lists further operator obligations, for example instructing the people who apply the device, checking that it works, informing the client before the application and keeping records. § 3 also requires notification to the competent authority no later than two weeks before commissioning. Which obligations apply to which device is set out in the text of the regulation. If in doubt, ask the competent state authority.

§ 7 names three routes for magnetic field stimulation:

• a successfully completed training course under Annex 3 Part A in conjunction with Part E of the regulation,
• training under the German Masseurs and Physiotherapists Act, or
• medical specialist training or continuing medical education.

Part E of Annex 3 is the module “Elektromagnetische Felder (Niederfrequenz-, Gleichstrom- oder Magnetfeldgeräte) zur Stimulation” (electromagnetic fields from low-frequency, direct current or magnetic field devices for stimulation). It comprises at least 23 teaching units of 45 minutes each. Under § 7, exactly which sections are required depends on the purpose, for example muscle building and toning or other purposes. EMS and magnetic field stimulation are covered in the same module.

Under § 4, the expertise should enable you to apply the procedure safely, avoid risks and appropriately reduce unavoidable risks. This includes knowledge of:

• the physical properties of the respective radiation,
• its biological effects and risks,
• the extent of exposure of the body,
• the technical design and operating rules of the device,
• anatomy, physiology and the exclusion criteria, i.e. when a device must not be used.

Under § 4, the expertise must be refreshed every five years through an update. Plan this date and its costs from the start, for yourself and for everyone on your team who operates the chair.

Before they start, partners receive training on operation, workflow and consultation. Which expertise training course you need beyond that depends on your starting point: a physical therapist brings something different than someone starting a new studio with no prior knowledge. We clarify this in the intro call based on your credentials.

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