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Zone 5, 6 and 7
Although seven potential zones of entrapment have been identified by HBSW,
FDA is recommending dimensional limits for zones 1-4 because these zones
were most frequently reported as having entrapments.
FDA continues to receive entrapment reports for Zones 5 and 6, and Zone 7
remains a potential for entrapment FDA will monitor entrapments in these zones
and consider harmonization with the IEC standard once it is available.
Zone 5 — Between Split Bed Rails
This zone occurs when partial length head and foot side rails (split rails) are used
on the same side of the bed. The space between the split rails may present a
risk of either neck entrapment or chest entrapment between the rails if a patient
attempts to, or accidentally, exits the bed at this location. In addition, any
V-shaped opening between the rails may present a risk of entrapment due to
wedging. FDA recognizes this area as a potential for entrapment and encourages
facilities and manufacturers to report entrapment events at this zone.
Zone 6 — Between the End of the Rail and the Side Edge of the
Head or Foot Board
This is the space between the end of the rail and the side edge of the headboard
or footboard. This space may present a risk of either neck entrapment or chest
entrapment. In addition, any V-shaped opening between the end of the rail and
the head or footboard may present a risk of entrapment due to wedging. This
space may change when raising or lowering the head or foot sections of the
bed. This space may increase, decrease, become less accessible, or disappear
entirely. Thus, in some positions, the potential for entrapment may exist when the
deck is articulated. FDA recognizes this area as a potential for entrapment and
encourages facilities and manufacturers to report entrapment events at this zone.
User Manual & Entrapment Guide
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