SKU:B4000

B4000 Bed System Measurement Device

Avoid immediate jeopardy with the B4000. The ONLY device that validates compliance set forth by the FDA.

Description

The B4000 Bed System Measurement Device provides clear pass/fail indicators when assessing the four critical entrapment zones of a hospital bed system.

In 2006, the Hospital Bed Safety Workgroup (HBSW) established guidelines to improve bed system safety. In response, we created the FDA-approved B4000 Bed System Measurement Device, which tests four key entrapment zones to reduce risks.

The B4000 ensures CMS compliance with fast validation, clear pass/fail results and documentable outcomes. It tests the bed rail; rail and mattress; mattress and rail; and compressed mattress and rail end zones.

  • Bed rail measurement device.
  • Bed rail measurement device being used
  • Bed rail measurement device being used
Entrapment zones

Quantity

1

Who Should Use This Product

Professional Use Only

Warranty

1 Year

Warranty Information

FAQs

  • How do I order this product?

    You can order by contacting Bionix directly (bionix@bionix.com or 800.551.7096) or contacting your distributor of choice.

  • How many zones are tested using the Bed System Measurement Device?

    The FDA guidance document titled “Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment” describes the seven entrapment zones of a hospital bed system.  The B4000 Bed System Measurement Device was designed to test the four critical entrapment zones.  Currently, there is no tool or specifications to test Zones 5-7.

  • What key body parts are at risk for entrapment in a hospital bed system?

    According to the FDA guidance document, the head, neck and chest are at risk for entrapment. 

  • When should a bed system be assessed?

    You should be testing to manufacturer’s recommendations, when hardware is replaced, when the mattress is changed, and anytime a new patient is put into the bed.  You should discuss the best practices with your risk assessment team.

  • If a side rail is replaced after a bed system has passed, does the bed system need to be re-tested with the new rail?

    Yes, each time a rail or mattress is replaced it creates a new bed system.  You must re-test a bed system to ensure there is no risk for entrapment.

  • If your facility has removed side rails and is using assistive positioning devices, do you still need to test the bed systems?

    Yes, if you provide assistive devices as bed attachments for patients, your bed must be tested.  In addition, rails and assistive devices often play an important role in a resident’s life. Physical Therapists (PT) often requests these devices to help residents perform their Activity of Daily Living (ADL’s), for independence, rehabilitation and dignity.  They often play a vital role in the resident’s daily life as well as individualized quality of care and quality of life needs.

  • Can you test a bed system with a patient lying in the bed?

    For ease of mattress movement and measurement, the patient should not be in the bed during test procedures.

  • In what rail position do you test a bed system?

    A bed system must be measured in both the fully raised position and the intermediate position. 

  • Do you articulate the bed?

    Yes, articulate the bed until you see the largest gap, then test the bed system.

  • Should any items remain on the bed while assessing a bed system?

    The sheets should be on the bed, but pillows and blankets should be removed prior to assessing a bed system.

  • How do you use the strap?

    The strap is a safety harness.  Use the strap to secure the cone to the rail being tested.  For good safety practices always use the strap to prevent injury to the tester if the tool were to fall while assessing a bed system.

  • Which critical entrapment zone uses both the cone and cylinder assembled?

    The cone is used to test Zones 1-3, the cone and cylinder are assembled together to test Zone 4.

  • Which zones require you to pull 12lbs of force with the scale?

    The scale is used when testing Zone 1 and Zone 2.

  • Do the tests need to be completed in order from Zone 1 thru Zone 4.

    No, the tests can be conducted in any order.  Please ensure all zones are tested for each bed system.

     

  • If the bed system passes Zones 1-3, but fails Zone 4, does the bed pass?

    The bed system must pass all four zones, in both the fully raised position and the intermediate position to “pass”.

  • When testing Zone 4 the rail meets the cylinder on the PASS/FAIL line, is it a PASS or a FAIL?

    The result would be a FAIL for Zone 4.  Always ere on the side of caution. If any result is a “close call” the bed fails.

  • Was the Bed System Measurement Device designed to test air fluidized therapy beds?

    No, the B4000 was not designed to test air fluidized therapy beds, bariatric (obesity) beds, pediatric beds, cribs, or stretchers. 

  • Should you be documenting testing results?

    Yes, all results must be documented.  CMS (Centers for Medicare & Medicaid Services) wants to see documentation.  If it’s not documented, then there’s no proof the testing was completed. 

  • How do you clean/disinfect the B4000?

    To avoid cross contamination, disinfect the B4000 each time a different bed is assessed. Use only NON-chlorine based disinfection solution(s)/wipe(s) on the tool.  Follow the disinfectant solution/wipe manufacturer’s instruction for use.  Do NOT immerse or saturate the B4000 or any of its components in disinfecting solution.  Ensure the tool is dry before beginning a test.

     

  • What is the calibration process for the B4000?

    The B4000 should be shipped back to the technical services office for annual calibration.  The calibration service options and instructions can be found on the website under instructions or call 800-678-7074.

  • What components make up a bed system?

    The bed system, as described by the FDA guidance document, is comprised of the bed, rails, and mattress.

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  • Zak Huttner

    National Account Manager, Distribution

  • Josephine Murphy

    Program Manager, Safety & Compliance

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