Biomedical Engineering Reference
In-Depth Information
Figure 11.8
Consult instructions for use symbol.
Figure 11.9
Caution symbol.
Figure 11.10
Caution symbol pointing the user to read “foolscap/2003 rev 1.2” before use.
11.2.8 Consult Instructions for Use
Both of these are very important symbols.
Figure 11.8
appears on every label of every device.
It says “the end-user should read the IFU before using.”
Figure 11.9
is a caution; this is often
used where there are surgical techniques in which there are particular precautions. This is
especially useful if you have a surgical guide that is available; point the user to this by putting
the document reference under the symbol (see
Figure 11.10
).
11.2.9 Prescription Only
In the USA “prescription only” means something different to when it's used in many
European countries. In the UK, for example, “prescription only” means the doctor/surgeon/
clinician needs to write an actual prescription and the device will need to come from the
pharmacy. In the USA “prescription only” means it can only be used by or under the
instruction of a clinician: it is an essential requirement for your label if your device cannot be
used by the general public. Hence, be careful when using the recognized R× symbol - it will
cause problems in the EC. If you are going to sell in the USA then there are accepted words
that mean the same thing, but do not affect your device in the EC:
Caution: U.S. federal law restricts this device to sale by or on the order of a physician.
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