Guidance on Medical Device Patient Labeling:- Appendix D

Posted on February 21, 2012. Filed under: Uncategorized |

Appearance of graphics:
What principles should be applied to the graphics of the medical device patient labeling?
Photographs and line art attract and keep a reader’s interest and are often remembered longer than words. Properly chosen and placed illustrations make the text more meaningful and reduce the burden of details in the text. Use the following principles in the graphics of the medical device patient labeling.
Graphics should:
  • attract attention,
  • re-emphasize the text of the medical device patient labeling,
  • be simple and clearly drawn, without clutter, unneeded background, or extraneous detail,
  • demonstrate one concept, single idea, or point of information at a time,
  • be placed next to corresponding text,
  • use cues such as circles or arrows to point out key information,
  • be clearly labeled,
  • be easy to understand,
  • improve understanding of essential information,
  • be recognizable to the audience, and
  • fit the target audience.
Set off text and graphic that go together by the use of lines, white space, or titles. If a graphic is referred to in the text, it should have a title, for example, Figure 1.
Use accurate and precise graphics.
  • When comparing two illustrations, show the difference. If the difference is not distinct, the reader may get confused.
  • Represent only simple concepts in your graphics, either of actions or of the device and its surroundings.
  • Confine action graphics to a single action whenever possible.
  • Use a separate graphic for each distinct idea.
Graphics should be large enough to see the focal point and important words clearly. Use as few words as possible. Captions should tell readers what to look for in the illustration. Eliminate detail that is not necessary. The clearest graphics have dark, sharp lines for good contrast. Line drawings and illustrations are clearer than photographs. Photos may have distracting extra images and poor contrast. Simple exploded views or cut-away views may be helpful. Use exploded views only for devices that the user should put together or take apart.
In instruction manuals, tables and graphs are normally not appropriate and their use should be minimized. If a table or graph is necessary, include instructions on its use. Label each table or graph clearly.
Apply the following to symbols and icons.
  • A symbol is a sign or picture that has been developed to represent an idea. A symbol should be defined or explained because it doesn’t mean anything by itself.
  • An icon is a drawing that looks like the idea it is meant to represent. Use icons only with text to explain them.
  • Use standardized symbols and icons, or those already understood by the general population. Make sure that your population understands the symbols that you use.
Do not use icons with commonly understood usages to illustrate examples inconsistent with those usages (e.g., a red octagon to indicate “go”).


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