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SPAN Encore Series - Entrapment Risk and Compliance

SPAN Encore Series
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Span Medical Retractable Bed
MC9R / Series
7
DANGER - RISK OF ENTRAPMENT
The U.S. Food and Drug Administration (FDA) and Health Canada have warned against the potential danger
of entrapment and published safety guidelines for hospital beds. They have identified seven zones in the
hospital bed system where there is a potential for patient entrapment. Entrapment may occur in flat or
articulated bed positions, with the rails fully raised or in intermediate positions. The seven entrapment zones
are identified in the drawing below.
ENTRAPMENT ZONES:
Zone 1: Within the Rail
Zone 2: Between the Top of the Compressed
Mattress and the Bottom of the Rail, Between
the Rail Supports
Zone 3: Between the Rail and the Mattress
Zone 4: Between the Top of the Compressed
Mattress and the bottom of the Rail, at the End
of the Rail.
Zone 5: Between the Split Bed Rails
Zone 6: Between the End of the Rail and the Side
Edge of the Head or Foot Board
Zone 7: Between the Head or Foot Board and the Mattress End
COMPLIANCE - Entrapment Safety
The entrapment zones are a resultant of the dimensional interaction between the bed and components that
are often assembled by the Healthcare Facility and not the Manufacturer.
The Healthcare Facility is responsible for compliance with the Entrapment Guidelines by matching the right
components and accessories to the right bed.
To learn more about the entrapment zones, assessment methods and guidelines for compliance with the
entrapment regulation visit the FDA and Health Canada websites.
Span Medical Products Canada is available to work with customers to minimize the risk of patient entrapment.
WARNING! Always evaluate patients for and guard against patient risk of side rail entrapment in
accordance with medical protocols. Failure to do so could result in injury and/or death.
DISCLAIMER The MC9R/Encore
®
low beds are intended to be used for resting and sleeping in a Long
Term Care Environment* and are not intended to be used in a Home Care Environment**. The beds are not to
be used as a tool for diagnosis (determining cause of an illness), treatment (action(s) taken to change the
course of an illness) or monitoring (reading and/or recording physiological parameters).
*Application Environment 3 as per IEC 60601-2-52
** Application Environment 4 as per IEC 60601-2-52
Safety Precautions

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