Risks And Precautions; Safety Information - Arjo RIK Overlay Bedienungsanleitung

The RIK Overlay
The RIK Overlay has been designed to provide a high degree of pressure
™
redistribution, low shear, comfort and stability. To ensure proper use of the RIK
Overlay, please read these instructions and save them for future reference.
Features include:
• Attaches easily to most hospital mattresses
• Eliminates noise, heat and power consumption
• Self-adjusting during patient repositioning
Indication
• The RIK Overlay is indicated for patients at high risk of pressure ulcers.
Contraindications
• Unstable cervical, thoracic and / or lumbar fracture
• Cervical traction

Risks and Precautions

• Transfer - Precaution 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 or fatal injury
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.
• Skeletal Traction or Unstable Fracture (if not contraindicated) - With
skeletal traction, unstable pelvic fracture or any other unstable
fracture (to the extent not contraindicated), maintain physician-directed
angle of articulation and guard against risks of patient migration.

Safety Information

Serious Incident - If a serious incident occurs in relation to this medical device,
affecting the user, or the patient then the user or patient should report the serious
incident to the medical device manufacturer or the distributor. In the European
Union, the user should also report the serious incident to the Competent Author-
ity in the member state where they are located.
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 facil-
ity 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 entrap-
ment 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
4