Halo 77301 User Manual

HALO SAFETY RING - WARNINGS
WARNING! The Halo Safety Ring must only be used with bed systems that are reset
to the manufacturer's original specifications and that have been individually tested. Do
not assume all bed systems in your facility are the same or set to manufacturer's origi-
nal specifications. Each bed system must be tested and measured individually. Bed sys-
tems should be evaluated, measured, and tested by your assessment team.
WARNING! Improper assessment of the bed system and failure to evaluate the spe-
cific needs of each resident will prevent a correct bed system measurement device
evaluation of certain entrapment zones. This improper assessment could lead to the
possibility of injury or death. Each resident must be evaluated individually. To qualify
for the Halo Safety Ring, a bed system must first meet the following standards:
1. Mattress height must be between 6 and 7 inches.
2. Mattress width must be 36, 37, or 38 inches.
3. Only high-quality mattresses should be used to ensure a proper weight to
compressibility factor.
4. The mattresses used must be the proper length and width per the bed frame
manufacturer's standards.
WARNING! Mattress compression and gap space creation is the uncontrollable factor
in the failure of bed systems. Resident must be assessed based on body type i.e.
height, weight, girth, etc. Continuous movement in bed increases compression, gap
spaces, and the possibility of injury or death.
WARNING! If you improperly measure, assess, or test a resident or his or her bed
system, the Halo Safety Ring may not provide adequate protection. If the Halo Safety
Ring is installed improperly, it may not provide the intended entrapment protection.
WARNING! Bed systems and each resident should be reevaluated periodically to
ensure that the system still provides the resident adequate entrapment protection.
Proper patient assessment and monitoring, and proper maintenance and use of equip-
ment is required to reduce the risk of entrapment. Variations in mattress thickness,
size or density could increase the risk of entrapment. Visit the FDA website at
www.fda.gov to learn about the risks of entrapment.
WARNING! Bed system assessments should be conducted within the context of, and
in compliance with, 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. Further information can be obtained at:
www.fda.gov by searching for HBSW.
Tel: (262) 370-4556
kundehalo@gmail.com
kundehealthcareservices.com
Kunde Healthcare Services, Inc.
P.O. BOX 325 | Oconomowoc, WI 53066
IS-77301 HALO-77302 HALO REV 12/04/17