GF Health Products, Inc. - www.grahamfield.com Zenith Series Service Manual 999-0831-190C DEC. 2013
5
ZENITH SERIES
On April 10, 2006, the FDA (U.S. Food and Drug Adminis-
tration) released long-awaited guidelines for reducing the risk
of bed entrapment: “Hospital Bed System Dimensional and
Assessment Guidance to Reduce Entrapment”. The new Guidance
identifies potential entrapment areas and those body parts most
at risk for entrapment; provides design criteria for manufacturers
of new hospital/convalescent beds; recommends particular test
methods to assess the conformance of existing hospital/conva-
lescent bed systems; and answers frequently-asked questions
about entrapment issues.
The new Guidance was a result of a long-standing collaboration
between the FDA and the Hospital Bed Safety Workgroup
(HBSW), formed in 1999. GF Health Products, Inc’s Long-
Term Care Bed division: Basic American Medical Products, is
an HBSW charter member. As a result of our commitment to
product safety, all our current long-term care beds have been
strictly tested and conform to the new FDA Guidance.
The guidelines set forth by the FDA Guidance layout specific
dimensional limitations on potentially injury-threatening gaps
and spaces that can occur between bed system components,
such as rails, when not properly installed. GF Health Products,
Inc. and Basic American Medical Products have conformed
to these guidelines from a manufacturing aspect. However,
entrapment issues can often arise when a healthcare provider/
facility has not correctly assembled the components on a bed.
It is essential that the provider/facility fully understand their
responsibility in complying to the guidelines set forth by the
FDA in order to avoid injury. To that end, we have provided
the FDA’s web address at right as a resource for understanding
and following these guidelines for the safety of patients/residents.
It is also essential to have the correct bed components/acces-
sories that correspond with the needs of the patient/resident
and the particular bed you have purchased. Matching the correct
bed component that correlates with the regulatory guidelines can
be a daunting task. Our sales team at GF Health Products, Inc.
and our friendly Customer Service Representatives at Basic
American Medical Products can help you sift through the wide
array of compliance and bed options. We will help you determine
which bed/bed part is best for the patient’s/resident’s particular
needs and help you with any compliance issues.
The Zenith APS 9000 bed and accessories listed in this
manual are in full compliance with FDA guidelines
for reducing the risk of bed entrapment: “Hospital
Bed System Dimensional and Assessment Guidance
to Reduce Entrapment”.
Details can be found at www.fda.gov
.
ENTRAPMENT & COMPLIANCE INFORMATION
The head/back and knee/foot decks can be lifted freely
by hand for easy cleaning access when patients are not
in the bed. If you lift the head/back or knee/foot deck
for any reason, please take great care when lowering
back down to the prone position - make sure that all
body parts are clear of the space between the deck and
the bed prior to slowly lowering any deck manually. To
avoid injury, DO NOT LET DECKS FALL FREELY
FROM ANY ANGLE.
Proper routing and tie-off of electrical cabling, especially
the power cord, is essential for proper operation and to
ensure safety from electrical shock. In the event you are
replacing any electrical cabling on your bed, you must
make sure the cables are free from any pinch points,
obstructions, or stretched so tight that they may come
loose or become damaged. In addition, cables should
be tied off in such a way to secure them and keep them
free from tangling on any part of the bed during normal
operation. Refer to your service manual’s electrical
section for proper cable routing.
IMPORTANT SAFETY AND WARNING INFORMATION
! !
Notice for California Customers -
California Proposition 65 WARNING: This product
contains a chemical known to the State of California to
cause cancer and reproductive or developmental harm.
!
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