Often, we give little thought to terms we use frequently. Therefore, it's a good idea to create clarity and maintain a glossary within the project. This should also include the names of the patient connections.
We work extensively with electrophysiology. In our daily work, we develop devices for therapy using electrical stimulation or devices for recording physiological signals, which are often picked up via electrodes.
So, all the devices have electrode cables. But the standards already contain various terms that will be explained below.
Parts of patient connections
• Application part
The applied part is the part of the ME device that comes into physical contact with the patient. In an electrocardiograph, for example, this is the electrode.
• Part equivalent to the applied part
There are parts in every ME device that are not applied parts (i.e. no electrodes in the ECG), but which must be treated as applied parts with regard to the requirements for
Clearances and creepage distances, leakage currents, defibrillation resistance, etc. 60601–1 refers to such parts as “parts equivalent to the applied part” or “parts that must be treated like an applied part”.
In common usage, these parts of the ME device are often simply referred to as “application part”.
• Electrode lead
The electrode line is the line between the switch and the electrode.
• Electrode connector
The electrodes usually have plug-in connectors, since disposable electrodes (adhesive pads) are often used for ECGs, for example.
• Patient management
The patient line is the entire line from the device to the patient.
• Electrode
The electrode is the applied part. This comes into direct contact with the patient, usually for an extended period.
• Patient connection
The entire path between device and patient is called the patient connection.
I hope you found this article interesting. If you have any questions regarding the development of your medical devices, please call us or send us a short message.
Best regards
Martin Bosch