Entrapment Guide; Key Body Parts At Risk; Head; Neck - Proactive Protekt Akra PMSEBHR User Manual & Entrapment Manual

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ENTRAPMENT GUIDE

Bed Rails in Nursing Homes and the Home Health Care Environment

KEY BODY PARTS AT RISK

Three key body parts at risk for life-threatening entrapment in the seven zones of
a hospital bed system discussed in this guidance are the head, neck, and chest.
The body part dimensions used to develop FDA's dimensional limit
recommendations are summarized as follows:
Key Body Part

Head

Neck

Chest

Head
To reduce the risk of head entrapment, openings in the bed system should not
allow the widest part of a small head (head breadth measured across the face
from ear to ear) to be trapped.
FDA is therefore using a head breadth dimension of 120 mm (4-¾ inches) as the
basis for its dimensional limit recommendations. This dimension is consistent
with the dimensions recommended by the HBSW and the IEC.
Neck
consistent with the dimensions recommended by the HBSW and the IEC (see
IEC 60601-2-38-1).
Chest
The openings in a bed system should be wide enough not to trap a large chest
through the opening between split rails.
FDA concurs with the IEC recommended dimension of 318 mm (12-½ inches) to
represent chest depth for the population vulnerable to entrapment, and has used
this dimension as the basis for its recommended dimensional limits.
User Manual & Entrapment Guide
Dimension
120 mm (4-3∕
60 mm (2-3∕
angle >60º
318 mm (12-1∕
To reduce the risk of neck entrapment, openings
in the bed system should not allow a small neck to
become trapped.
Given the adult population at risk for wedging
entrapments in hospital beds, FDA recommends a
dimension of 60 mm (2-3/8 inches) to represent neck
diameter.
Additionally, to prevent wedging, a limit of greater
than 60º is recommended for V-shaped openings
that a neck could enter. These dimensions are
inches)
4
inches and
8
inches)
2
19

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