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APPENDIX

SPECIAL NOTE

For your convenience, we have provided the April 2010 edition of the FDA’s guide to bed safety.  This information from the 

FDA’s brochure, published by Hospital Bed Safety Workgroup, is replicated verbatim; the latest version is available at  

http://www.fda.gov.

A Guide to Bed Safety Bed Rails in Hospitals, Nursing Homes and Home Health Care: The Facts

Bed Rail Entrapment Statistics

Today there are about 2.5 million hospital and nursing home beds in use in the United States. Between 1985 and January 

1, 2009, 803 incidents of patients* caught, trapped, entangled, or strangled in beds with rails were reported to the U.S. Food 

and Drug Administration. Of these reports, 480 people died, 138 had a nonfatal injury, and 185 were not injured because staff 

intervened. Most patients were frail, elderly or confused.

* In this brochure, the term patient refers to a resident of a nursing home, any individual receiving services in a home care 

setting, or patients in hospitals.

Patient Safety

Patients who have problems with memory, sleeping, incontinence, pain, uncontrolled body movement, or who get out of 

bed and walk unsafely without assistance, must be carefully assessed for the best ways to keep them from harm, such as 

falling. Assessment by the patient’s health care team will help to determine how best to keep the patient safe. Historically, 

physical restraints (such as vests, ankle or wrist restraints) were used to try to keep patients safe in health care facilities. In 

recent years, the health care community has recognized that physically restraining patients can be dangerous. Although not 

indicated for this use, bed rails are sometimes used as restraints. Regulatory agencies, health care organizations, product 

manufacturers and advocacy groups encourage hospitals, nursing homes and home care providers to assess patients’ needs 

and to provide safe care without restraints.

The Benefits and Risks of Bed Rails

Potential benefits of bed rails include:

  •  Aiding in turning and repositioning within the bed.

  •  Providing a hand-hold for getting into or out of bed.

  •  Providing a feeling of comfort and security.

  •  Reducing the risk of patients falling out of bed when being moved.

  •  Providing easy access to bed controls and personal care items.

Potential risks of bed rails may include:

  •  Strangling, suffocating, bodily injury or death when patients or part of their body are caught between rails or between  

    the bed rails and mattress.

  •  More serious injuries from falls when patients climb over rails.

  •  Skin bruising, cuts, and scrapes.

  •  Inducing agitated behavior when bed rails are used as a restraint.

  •  Feeling isolated or unnecessarily restricted.

  •  Preventing patients, who are able to get out of bed, from performing routine activities such as going to the bathroom  

    or retrieving something from a closet.

Meeting Patients’ Needs for Safety

Most patients can be in bed safely without bed rails. Consider the following:

  •  Use beds that can be raised and lowered close to the floor to accommodate both patient and health care worker needs.

  •  Keep the bed in the lowest position with wheels locked.

  •  When the patient is at risk of falling out of bed, place mats next to the bed, as long as this does not create a greater  

    risk of accident.

  •  Use transfer or mobility aids.

  •  Monitor patients frequently.

Summary of Contents for 15003P

Page 1: ...lectric Low Bed This manual must be given to the Owner User of this bed and should be read carefully before putting this product into use Keep manual in an accessible location for future reference 150...

Page 2: ...12 14 Frame Assembly 15 19 Bed Operation 20 21 Bed Rail Installation 22 24 Emergency Power Outage Manual Adjustment Crank 25 Maintenance Safety Checks 26 27 Warnings 28 29 Troubleshooting 30 Appendix...

Page 3: ...RNING Information that appears under the WARNING symbol concerns the protection of personnel from possible hazards that can result in injury or death in addition to damage of the equipment CAUTION Inf...

Page 4: ...safe working load PRODUCT SYMBOLS PRODUCT HANDLING SYMBOLS Do not remove motor cover or repair yourself Contact your local Provider or Dealer for technical assistance Do not stack more than 5 cartons...

Page 5: ...3 WARNING LABELS...

Page 6: ...or Death may occur if accessories are not provided by Drive DeVilbiss Healthcare Please contact Drive DeVilbiss Healthcare for accessories that are compatible with this bed Possible injury or Death ma...

Page 7: ...occur due to pendant cord being a source for entangling patient resident Patients residents with decreased mental acuity should NOT have access to pendant FIRE HAZARD 15005LP 15004P Electric Beds Only...

Page 8: ...used on this bed Make sure mattress is the correct size for bed frame and the Side rails are secured to frame to decrease the risk of entrapment If bed frames have been serviced or any other adjustme...

Page 9: ...ns regarding EMC when put into service according to the EMC information provided in the user manual and special precautions need to be observed FULL ELECTRIC SEMI ELECTRIC BEDS with no ESSENTIAL PERFO...

Page 10: ...the power cord from the electrical supply outlet and take the bed out of service for repair If a liquid is spilled in or around the electric bed unplug the electric bed before cleaning Clean up the sp...

Page 11: ...cation 2A 250V 2A 250V N A Duty Cycle T_On 2 Min T_Off 18 Min T_On 2 Min T_Off 18 Min N A Battery Backup N A N A N A Relative Humidity 15 to 93 relative humidity non condensing 15 to 93 relative humid...

Page 12: ...r actuators Hand Pendant Control 15003P 15210P HeadSpring and Head Board w casters for 15004P 15003P 15211P Foot Spring and Foot Board manual 3 crank for 15003P OPERATING TEMPERATURE If bed has been s...

Page 13: ...for cuts or damage 4 Inspect the motors for damage loose connections cuts or damage to the wires 5 Ensure motor connection to junction box and pendant are connected correctly and secure STORAGE 1 If...

Page 14: ...Head Board D Low Height Foot Board E Hi Low Drive Shaft F Locking Pins 2 G Emergency Manual Hand Crank H Casters 4 2 locking 2 non locking I Head Foot Pull Tube Transport Straps A B I I C D E F G H Ca...

Page 15: ...rs Junction Box Hand Pendant Power cord plug B Head Spring C Standard Height Head Board D Standard Height Foot Board E Hi Low Drive Shaft F Locking Pins 2 G Hand Crank H Casters 4 2 locking 2 non lock...

Page 16: ...ot Spring w 2 Manual Cranks B Head Spring C Low Height Head Board D Low Height Foot Board E Hi Low Drive Shaft F Locking Pins 2 G Hand Crank H Casters 4 2 locking 2 non locking I Head Foot Pull Tube T...

Page 17: ...pright on their sides at approximately a 90 degree angle to on another D Connect the Head Spring to the Foot Spring by aligning the mounting latches and swinging both ends away from each other so both...

Page 18: ...ot Spring Lift Arm Secure in place with the tethered locking pin and clip NOTE Extend the inner pull tube until the spring button clicks into the adjustment hole of the outer tube The spring button sh...

Page 19: ...and Foot Boards by tilting the Boards toward your body and aligning mounting pins located on the Spring Sections with the Hooks on the Head Foot Boards B Stand the Head Board as close to the Head Spri...

Page 20: ...ection with indicators and align with the Full Semi or Manual indicator hole ASSEMBLY B Install the Hi Lo Driveshaft to the bed 15005LP Lift the Head Spring and install the foot end of the Hi Lo Drive...

Page 21: ...h spring links ASSEMBLY 15004P 15003P Lift the Head Spring and install the foot end of the Hi Lo Drive Shaft to the Foot Board drive pin then install head end of the Hi Lo Drive Shaft to the Head Boar...

Page 22: ...d Depress buttons to actuate desired adjustment NOTE Operate the bed through all phases of its operation If any problems arise during the test recheck all electrical connections and mechanical hook up...

Page 23: ...er limbs under the frame when lowering the bed When lowering the bed be aware this may cause INJURY if limbs or personal items interfere with bed movement Stay clear of the frame and ensure children a...

Page 24: ...re intended to prevent an individual from inadvertently rolling out of bed DO NOT use for restraint purposes When used with a manual electrical bed side rails DO NOT fall under any weight limitations...

Page 25: ...occur between bed system components such as side rails when improperly installed Please be aware that entrapment issues can still arise when components and accessories are not properly installed on t...

Page 26: ...the Full Rail Cross Brace that must be positioned in between the two black springs A second Label will indicate alignment for the Half Rail clamp to be positioned with the Black Spring centered betwee...

Page 27: ...under the mattress 2 From the Foot Board end of the bed locate the exposed shaft connection of the motor according to the function you want to perform 3 Attach the emergency crank to A Head Section m...

Page 28: ...the bed to remove dust from frame Remove mattress and clean mattress deck Remove all gross solid contaminants then wash and sanitize all components DO NOT submerge the bed frame or electrical compone...

Page 29: ...l purchaser of the equipment SALES AND SERVICE Contact Drive DeVilbiss Healthcare if you need any help with installation usage or maintenance of the product Corporate Office Drive DeVilbiss Healthcare...

Page 30: ...more than one person on in the bed at any time DO NOT use outdoors For Dealers Only Set up and Assembly Instructions are in the front of this manual These procedures must be performed by qualified tec...

Page 31: ...ive means of patient protection Once patient assessment concludes that the patient s condition increases the chance of entrapment the bed MUST be in the flat position when left unattended Proper patie...

Page 32: ...poradic movements Call Local Provider Bed does not stay in place Check Caster locks to ensure they are engaged Bed Deck does not elevate Check pull tube s for proper installation and ensure spring but...

Page 33: ...hat physically restraining patients can be dangerous Although not indicated for this use bed rails are sometimes used as restraints Regulatory agencies health care organizations product manufacturers...

Page 34: ...n sleep safely without bed rails Reassess the need for using bed rails on a frequent regular basis To report an adverse event or medical device problem please call FDA s Med Watch Reporting Program at...

Page 35: ...99 Seaview Boulevard Port Washington NY 11050 Phone 516 998 4600 Toll Free 877 224 0946 Fax 516 998 4601 www drivemedical com...

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