Safety Information
KCI is committed to working with healthcare professionals to help provide a safer environment for both patients and caregivers while delivering the positive clinical and financial outcomes you expect from our products. The following information has been provided to help you make informed decisions regarding your patients.
Bariatric Care Surfaces Product and Patient Safety
Risks, precautions and safety information
KCI is committed to working with healthcare professionals to help provide a safer environment for both patients and caregivers while delivering the positive clinical and financial outcomes you expect from our products. The following information has been provided to help you make informed decisions regarding your patients.
Side Rails and Restraints
Use or non-use of restraints, including side rails, can be critical to patient safety. Consider not only the clinical and other needs of the patient but also the risks of death or serious injury from falling out of bed and from patient entrapment in or around the Side Rails, restraints or other accessories.
Consider the use of bolsters, positioning aids, floor pads or KCI Padded Side Rail Accessories, especially with confused, restless or agitated patients. Make sure a capable patient knows how to get out of bed safely (and, if side rails are used, how to release them) in case of an emergency. Monitor patients frequently to guard against patient entrapment and migration.
WARNING: Serious injury or death can result from the use (potential entrapment) or non-use (potential patient falls) of side rails or other restraints.
For a description of entrapment hazards, a description of at risk patients, and guidance to further reduce entrapment risks, refer to FDA’s Hospital Bed System Dimensional and Assessment Guidance To Reduce Entrapment. FDA Device Regulation & Guidance
Patient Migration
As with all specialty bed products that are designed to reduce shear and pressure on the patient's skin, the risk of gradual movement and/or sinking into hazardous positions of entrapment and/or inadvertent bed exit may be increased.
Traction
With any traction or unstable fractures (to the extent not contraindicated), maintain physician-directed angle of articulation and guard against risks of patient migration or inadvertent deflation of patient surface.
Oxygen Use
Be aware of the risk of explosion if oxygen is used in the presence of flammable anesthetics. Use of this product in an oxygen-enriched environment may produce potential of fire hazard. This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
Electromagnetic Interference
All electrical equipment may produce interference. If interference is suspected, move equipment away from sensitive devices or contact the manufacturer.
Skin Care
Monitor skin conditions regularly, particularly in areas where incontinence and drainage occur or collect, and consider adjunct or alternative therapies for high acuity patients. Early intervention may be essential to preventing serious skin breakdown.
Brakes
Caster brakes should always be locked once a bed or frame is in position.
Bed Height
To minimize the risks of falls or injury the patient surface should always be in the lowest practical position when the patient is unattended. Make sure area under and around unit frame is clear of objects, persons and parts of body before adjusting height.
Ambulatory Patient Entrance and Exit
Lower the patient surface completely during assisted patient entrance and exit.
Transfer
Precaution should be taken during patient transfer, including the locking of caster brakes and caster steering and deflation of surface. Refer to Patient Transfer section in the Patient Placement chapter of the applicable product manual.
Bed Frame
For overlay and mattress replacement systems, always use a standard healthcare bed frame with Side Rails and any other safeguards or protocols that may be appropriate. Frame and Side Rails (if used) must be properly sized to eliminate any gaps that might entrap a patient's head or body.
Fluids
Avoid spilling fluids on unit controls. If spills do occur, unplug unit. Clean fluid from unit, wearing rubber gloves to avoid any possibility of shock. Once fluid is removed, check operation of components in area of spill. Fluids remaining on controls can cause corrosion, which may cause components to fail or to operate erratically, possibly producing hazards for patient and staff.
Lock Outs
Lock out of bed functions and air functions should be used at the staff's discretion to ensure against unintentional operation of system settings.
Moving Parts
Powered bed mechanisms can cause serious injury. Keep all equipment, tubes and lines, loose clothing, hair and parts of the body away from moving parts and pinch points.
Power Cord
Ensure power cord is kept free from all pinch points and moving parts and is not trapped under casters nor covered with rugs or carpets. Visusally inspect the cord for signs of damage or wear. Improper handling of the power cord can cause damage to the cord, which may produce risk of fire or electric shock.
Avoid Fire Hazards
To minimize the risk of fire, connect the unit's power cord directly into a wall-mounted outlet. Do not use extension cords or multiple outlet strips.
Scale Readings
For products containing this feature, scales/patient weights are for reference only. Scale readings should not be relied upon for medication dosage. All equipment on the weighed portion of the unit is included in weight displayed.
Tobacco Smoke
If routine laundering and cleaning procedures are not followed, tobacco smoke buildup may conceivably reduce the amount of airflow through the product. Severe air restrictions (whatever the source) may cause the unit to overheat and deactivate automatically.
Please see product labeling and instructions for use for risks, precautions and safety information specific to a particular product prior to use.