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1-800-634-7328 DirectSupply.com
Important Warnings
•
WARNING:
Risk of serious injury or death. This
product is intended only for use with beds that are
capable of supporting assist devices via mounting holes
in the bed’s head deck. This assist device is designed for
use only on beds with assist device mounting holes which
align with the slots provided on the assist’s mounting
plate. Do not modify the assist device or your bed if the
holes do not align. Do not use this device with any other
model or brand of bed. Use of this product on any bed
it was not designed for could result in an unproven or
unsafe configuration, potentially resulting in serious injury
or death. For questions regarding compatibility, contact
your Direct Supply account manager.
•
WARNING:
This assist device is designed to fit
multiple models of beds and can be configured to pivot to
various positions. It may be possible to install this device
in a manner which could result in entrapment concerns,
resident injury and/or damage to your bed.
•
WARNING:
This assist device is designed to pivot to
four positions, enabling the device to be mounted to either
side of a bed. Failure to use the pivot-lock system will allow
the device to pivot toward the floor, potentially creating a
crush hazard and/or a risk of damage to your bed.
•
WARNING:
This manual covers the Direct Supply
Zero Opening Assist Device. For warnings and
instructions related to the bed itself, please see your
bed’s Owner’s Manual. Be sure to read and follow all
instructions and warnings in both manuals.
Bed System Entrapment Information
In April 1999, the U.S. Food and Drug Administration
(FDA) in partnership with representatives from the
hospital and Post-Acute bed industry, national healthcare
organizations, resident and patient advocacy groups, and
other federal agencies formed the Hospital Bed Safety
Workgroup (HBSW). The workgroup’s goal is to improve
the safety of bed frames for residents and patients
in all healthcare settings who are most vulnerable to
the risk of entrapment. The efforts of the FDA and the
HBSW culminated in the FDA’s release of recommended
guidelines intended to reduce the risk of entrapment,
including dimensional limits for critical gaps and spaces
between bed system components and clinical guidance
for assessment and implementation of bed assist rails in
various healthcare settings. Entrapment zones involve the
relationship of bed components often directly assembled
by the healthcare facility rather than the manufacturer.
Therefore, compliance is the responsibility of the facility.
•
WARNING:
Only use the included hardware to attach
this assist device to a bed. Do not substitute hardware.
•
WARNING:
Risk of serious injury or death. Use
a properly sized mattress in order to minimize the
gap between the side of the mattress and the assist
device. This gap must be small enough to prevent a
resident from getting his or her head or neck caught
in this location. Make sure raising or lowering the
bed, or articulating the sleep surface, does not create
hazardous gaps. Failure to do so could result in serious
injury or death.
•
WARNING:
Risk of serious injury or death. Do not
use this assist device if any openings within the assist
device body will allow a resident to get his or her head
or neck lodged within these openings. Failure to do so
could result in serious injury or death.
•
WARNING:
Risk of serious injury or death. Do not
use this assist device until you have verified it is locked
in place. Injury to resident or caregiver may result if
this procedure is not followed.
•
WARNING:
An optimal bed system assessment
should be conducted on each resident by a qualified
clinician or medical provider to ensure maximum safety
of the resident. The assessment should be conducted
within the context of, and in compliance with, the
state and federal guidelines related to the use of
restraints and bed system entrapment guidance,
including the
Clinical Guidance for the Assessment
and Implementation of Side Rails
published by the
Hospital Bed Safety Workgroup of the U.S. Food and
Drug Administration.
•
WARNING:
In the event worn or broken parts
are identified, remove the device from service until
repairs are made. Do not use substitute parts. Use
only approved replacement parts. Non-approved
replacement parts could cause entrapment, personal
injury and damage to assist devices.
NOTE:
The assist device is intended for use as an
aid in entering or exiting the bed sleep area, as well
as a stable handhold during self-positioning within
the bed sleep area. The devices may deform or
break when subjected to excessive side pressure.
Do not exert excessive side pressure on the assist
devices. Do not use them as push handles for
moving the bed. These activities could result in
personal injury and damage to the assist devices
and/or your bed.
This assist device is only one part of your healthcare bed
system. Proper combinations of bed, mattress, head/
foot panels and assist rails are needed to minimize the
risk of entrapment. For more information, contact your
Direct Supply account manager.
•
WARNING:
Do not permit residents to climb over
the device.
•
WARNING:
Some states may prohibit assist devices
or consider assist devices to be resident restraints in all
or some instances. Always assess whether this assist
device may meet the definition of a restraint on a
case-by-case basis and document the need for any
resident restraint. Contact your state surveyor for
further guidance regarding assist devices and restraints.
Warnings
