Introduction; Indications; Contraindications; Risks & Precautions - Arjohuntleigh AtmosAir SAT Notice D'utilisation

INTRODUCTION

CAUTION: Please read and review these instructions prior to product use.
Carefully review the Indications, Contraindications, Risks and Precautions and Safety Information sections prior
to placing a patient on the AtmosAir™ Stretcher Mattress. Caregivers should make sure to discuss Safety
Information, Risks and Precautions and Contraindications with the patient (or the patient's legal guardians) and
the patient's family.

Indications

• For prevention or treatment of skin
Risks & Precautions
Transfer – Standard precautions should be taken during patient
instructions.
Side Rails and Restraints – WARNING: Use or non-use of restraints, including side rails, can be critical to patient
safety. Serious injury or death can result from the use (potential entrapment) or non-use (potential patient falls) of
side rails or other restraints. See related Safety Information.
Patient Migration – Specialty surfaces have different shear and support characteristics than conventional surfaces
and may increase the risk of patient movement, sinking and/or migration into hazardous positions of entrapment
and/or inadvertent stretcher exit.

Safety Information

Stretcher Frame – Always use a standard stretcher with this mattress, with any safeguards or protocols that may be
appropriate. Stretcher 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.
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
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 (220 mm). Consider
individual patient size, position (relative to the top of the side rail), and patient condition in assessing
fall risk.
breakdown.
Monitor patients frequently to guard against patient entrapment.
release the side rails) in case of fire or other emergency. Monitor

Contraindications

Unstable vertebral fracture
Ÿ
Cervical and skeletal traction
Ÿ
transfer. Refer to Patient Transfer section of these
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