Arjohuntleigh Citadel Instructions For Use Manual page 9

caregivers, with facility protocols in mind. Caregivers should assess risks and
benefits of side rail / restraint use (including entrapment and patient falls from
bed) in conjunction with individual patient needs, and should discuss use or
non-use with patient and / or family. Consider not only the clinical and other
needs of the patient but also the risks of fatal or serious injury from falling
out of bed and from patient entrapment in or around the side rails, restraints
or other accessories. In the US, for a description of entrapment hazards,
vulnerable patient profile and guidance to further reduce entrapment risks,
refer to FDA's Hospital Bed System Dimensional and Assessment Guidance
To Reduce Entrapment.
Outside the US, consult the local Competent Authority or Government
Agency for specific local guidance on Medical Device Safety. Consult a care
giver and carefully consider the use of bolsters, positioning aids or floor pads,
especially with confused, restless or agitated patients. It is recommended
that side rails (if used) be locked in the full upright position when the patient
is unattended. Make sure a capable patient knows how to get out of bed
safely (and, if necessary, how to release the side rails) in case of fire or other
emergency. Monitor patients frequently to guard against patient entrapment.
When selecting a standard mattress (as defined by IEC 60601-2-52:2009),
make sure the distance between top of side rails (if used) and top of mattress
(without compression) is at least 22 cm (8.66 in) to help prevent inadvertent
bed exit or falls. Consider individual patient size, position (relative to the top
of the side rail) and patient condition in assessing fall risk.
Make sure the distance between top of side rails (if used)
and top of a speciality mattress (as defined by IEC 60601-
2-52:2009) (without compression) is approximately 11.4 cm
(4.5 in) or greater. Consider individual patient size, position
(relative to the top of the side rail) and patient condition in
assessing fall risk.
Skin Care – Monitor skin conditions regularly and consider adjunct or
alternative therapies for high acuity patients. Give extra attention to skin
over any raised side bolster and to any other possible pressure points
and locations where moisture or incontinence may occur or collect. Early
intervention may be essential to preventing skin breakdown.
Maximum Recommended Patient Weight - Total patient weight capacity
should not exceed 227 kg (500 lb). The use of accessories on the bed may
decrease the patient weight capacity of the bed. Contact ArjoHuntleigh
Customer Service for questions concerning the use of accessories and
see the Questions and Contact Information section of this guide for contact
information.
I.V. and Drainage Tubes – Prior to activating any positioning function assess
the security of all invasive lines and tubes to accommodate the desired angle
of articulation and minimize the risk of binding, disconnecting or dislodging.
Tubes and lines should always have sufficient slack for articulation and
patient movement.
Citadel Bed Frame System
9