The requirements of EN 60601-1-1 must always be complied with
Use none portable multiple sockets (e.g. multiple sockets with connecting cable) to connect the components to the mains.
If portable multiple sockets are used, they must comply with the requirements of EN 60601-1-1.
If portable multiple sockets are used, they must not be placed on the floor.
If portable multiple socket outlets or extension cables are used, they must not be used more than once or extended. They must always be plugged directly into a properly installed wall socket.
If portable multiple sockets or extension leads are used, their permissible rated load must not be exceeded by the system.
If portable multiple sockets are used, parts that are not part of the medical system may be connected to them. There is a risk that the leakage currents may increase beyond their permissible limits and thus endanger the patient and examiner.
The user or examiner must not touch non-medical system parts (e.g. printer, PC, CD player) and the patient at the same time.
Only (non-medical) devices that are operated with an AC voltage of 25 V or a DC or peak voltage of 60 V after disconnection from the mains may be connected.
A medical system is created by connecting the devices described. After completion of the system, a measurement of the leakage currents with the following permitted limit values must be carried out and documented on site.
Enclosure leakage current from or between parts of the system within the patient environment (Normal Condition) | < 0.1mA |
Enclosure leakage current from or between parts of the system within the patient environment (single fault condition) | < 0.5mA |
Patient leakage current (normal condition) | < 0.1mA |
Furthermore, it must be ensured that an interruption and restoration of the power supply to the connected non-medical devices does not lead to any danger.
Plug connections of application parts such as headphones, bone conductors or patient buttons that are intended to be connected to the audiometer must not be connected to other system components
Connecting cables between the system components must be protected against mechanical damage.