Safety Information - GETINGE Arjohuntleigh AtmosAir Fit Notice D'utilisation

Safety Information

Skin Care - Monitor skin conditions regularly and consider adjunct or alternative therapies for high
acuity patients. Give extra attention to any possible pressure points and locations where moisture or
incontinence may occur or collect. Early intervention may be essential to preventing skin breakdown.
Patient Weight - The maximum patient weight for these devices is 1000 lb (454 kg). In addition,
consult the specifications for the bed frame being used. Additional weight limitations may apply.
Patient Entrance / Exit - Caregiver should always aid patient in exiting the bed. 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.
Brakes - Caster brakes should always be locked once the bed is in position. Verify wheels are locked
before any patient transfer to or from the bed.
Bed Height - To minimize risk of falls or injury, the bed should always be in the lowest practical
position when the patient is unattended.
Bed Frame - Always use a standard bariatric healthcare bed frame with these mattresses, with any
safeguards or protocols that may be appropriate. Bed frame and side rails (if used) must be properly
sized relative to the mattress to help minimize any gaps that might entrap a patient's head or body.
In the U.S. it is recommended that bed and side rails (if used) comply with the FDA's Hospital Bed
System Dimensional and Assessment Guidance To Reduce Entrapment.
Head of Bed Elevation - Keep head of bed as low as possible to help prevent patient migration.
Side Rails / Patient Restraints – Whether and how to use side rails or restraints is a decision that
should be based on each patient's needs and should be made by the patient and the patient's family,
physician and 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. This includes
assessment of the bed occupant and the combination of bed frame, side rail and mattress (or
mattresses where overlays are used). Risk assessment should be repeated if the bed frame, mattress,
side rail or condition of patient changes. 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, a description of at-risk patients and guidance to further entrapment risks, refer to the FDA's
Hospital Bed System Dimensional and Assessment Guidance To Reduce Entrapment. Outside the US,
consult the local Competent Authority or Government Agency for Medical Device Safety for specific
local guidance. Consult a caregiver 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.
CAUTION: To help prevent inadvertent bed exit or falls, ensure the distance
between top of side rails (if used) and top of mattress (without compression)
is approximately 8.66 in (22 cm). Consider individual patient size, position
(relative to the top of the side rail) and patient condition in assessing fall risk.
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