Introduction; Indications; Contraindications; Risks & Precautions - Arjohuntleigh AtmosAir 4000 User Manual

Introduction

CAUTION: It is important that you carefully read and review these instructions with your healthcare professional.
If you have any questions of a medical nature, please contact your healthcare professional.
It is recommended that all sections of this manual be read prior to product use. Carefully review the Indications, Contraindications,
Risks and Precautions and Safety Information sections prior to placing a patient on any AtmosAir™ Mattress Replacement System.
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 breakdown

Contraindications

• Unstable vertebral fracture
• Cervical and skeletal traction
CAUTION: Federal (US) law restricts this device to sale or rental by or on the order of a licensed healthcare practitioner.
Risks & Precautions
Transfer – Standard precautions should be taken during patient transfer
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 bed exit. Monitor patients
frequently to guard against patient entrapment.

Safety Information

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 (220 mm). Consider individual patient size,
position (relative to the top of the side rail), and patient condition in assessing fall risk.
Bed Frame – Always use a standard healthcare bed frame with safeguards or protocols that may be appropriate. It is recommended that bed and
side rails (if used) comply with all applicable regional and local regulations and protocols. Frame and side rails must be properly sized relative to the
mattress to help minimize any gaps that might entrap a patient's head or body. Inappropriate, incorrect, poorly fitted or poorly maintained bed rails and
mattress replacements can potentially produce gaps that might entrap a patient's head or body.
Bed Height – To minimize risk of falls or injury, the bed should always be in the lowest practical position when the patient is unattended.
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.
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