In this section of the System Owner Manual, safety aspects in the responsibility of the System Owner (responsible body) are listed. Operators are requested to see the Instructions for Use regarding safety and operating instructions of the MR or PET/MR instrument.

Bruker MR and PET/MR instruments are subject to the safety demands given by the Low Voltage Directive (LVD) 2014/35/EU of the European Parliament. Safety is proven by the application of the Product Safety and Electromagnetic Compatibility.

In addition, safety aspects with regard to the magnetic field need to be considered. Thus, the System Owner is requested to establish and maintain a Controlled Access Area which in minimum extension is defined by the three dimensional region where the magnetic field exceeds 0.5 mT (see Magnetic Stray Field).

Furthermore, safety aspects related to the use of radioactive tracer (PET/MR), the infrastructure, anesthesia gases, maintenance and cleaning are mentioned in the following sections.