Instructions for use - Dashboard
In accordance with the Medical Device Regulation (MDR), instructions for use for the CoroPrevention Dashboard will be supplied on this page. Aside from information about the product (name/trademark, product ID) and the manufacturer (name, address, contact information), information about the following is provided:
- intended purpose;
- indications and contra-indications;
- patient target group and intended users;
- specification of the clinical benefit to be expected;
- availability of the summary of safety and clinical performance (high-risk devices);
- the device's performance characteristics;
- specifications which are required for appropriate use of the device;
- sterilization, final assembly, calibration, cleaning and disinfection;
- necessary qualifications for users;
- any reconditioning procedures;
- storage, transport, durability;
- combination with other devices, including accessories;
- maintenance and repair;
- symbols and identification colors.