Medical-device user manuals are also subject to legal regulations based on Medical Device Directive 93/42/EEC. Due to their particular importance for users, there are numerous criteria for user manual preparation. Moreover, there are a large number of harmonized standards on medical devices which contain additional requirements for user manuals and also deal with the issues of "preparation of instructions".
Necessary content and details of user manuals among others are:
- Performance and undesirable side effects
- All the features when combined with other products
- Setup instructions
- Instructions on the type and frequency of maintenance measures
- Icons for reusable products
- Instructions on appropriate procedures such as cleaning and disinfection
- Precautions in case of magnetic fields, pressure, acceleration, heat and other effects
- Explanation about the non-standardized symbols and colours used
- Date of issue or revision status of the user manual
In accordance with relevant requirements and the contained information, the user manual requirement-profile for every medical device can be drawn. BEO BERLIN® can advise you and also prepare your user manual, ready for printing.