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General Risks and Precautions

Side Rails and Restraints -
Use or non-use of restraints, including side rails, can be critical to patient safety.  Side rails must be in the up position when the patient surface is rotating.  When not turning, whether and how to use side rails or other restraints is a decision that should be based on each patient’s individual needs and should be made by the patient and the patient’s family, physician, and caregivers, with facility protocols in mind.  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. For a description of entrapment hazards, refer to FDA Safety Alert dated August 23, 1995, the JCAHO Sentinel Event Alert #27, dated September 6, 2002 and other information referenced at http://www.kci1.com/ products/FDASafetyAlert.  Consult a physician and carefully 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.  See related Safety Information below and on product labeling and instructions for use.

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 - DANGER: Risk of explosion if 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.

CAUTION:  When using half-bed-length-type oxygen administering equipment, ensure that side rails are outside of oxygen tent and not contained within the oxygen environment.  Hand control not available with this product.

Electromagnetic Interference - Although this equipment conforms with the intent of the directive 89/336/EEC in relation to Electromagnetic Compatibility, all electrical equipment may produce interference.  If interference is suspected, move equipment away from sensitive devices or contact the manufacturer.

Shock Hazard - Electrical shock hazard; do not remove covers.  Refer to qualified service personnel.

Caregivers should make sure to discuss Safety Tips, Risks and Precautions with the patient (or the patient’s legal guardians) and the patient’s family.
General Safety Information

General Protocols –
Follow all applicable safety rules and institution protocols concerning patient and Caregiver safety.

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 the unit 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.

Bed Exit Alarm – For products containing this feature, activation of the Bed Exit Alarm is recommended whenever a patient is unattended. Be sure to reactivate the Bed Exit Alarm each time the patient returns to bed.

Bed Exit Alarm is triggered by dramatic weight reduction and may not alarm if patient is only partially exited from bed.  Monitor patient frequently to guard against patient entrapment and migration.

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.  Review and follow FDA’s Safety Tips for Preventing Hospital Bed Fires (dated December 18, 2003) and other information referenced at
http://www.kci1.com/ products/FDASafetyAlert.

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 air flow through the product.  Severe air restrictions (whatever the source) may cause the unit to overheat and deactivate automatically.

Blank Display – If Main Control Panel remains blank, call for service immediately.

Batteries – For products containing this feature, unit must be plugged in when not in service.

Disposal – At the end of useful life, dispose of waste according to local requirements or contact the manufacturer for advice.  There may be special requirements for disposal of batteries, leaded foam and/or angle sensors (if present in this product).

Please see product labeling and instructions for use for risks, precautions and safety information specific to a particular product prior to use.