Description
The Bionix B4000 Bed System Measurement Device is the only device that validates compliance with FDA bed system guidance, testing the four critical entrapment zones with clear pass and fail indicators. It is covered by a 1-year limited warranty.
- Four zone testing – cone and cylinder tests against FDA guidance
- Pass or fail – clear indicators, objective 12 lb force
- Warranty covered – a 1-year limited warranty backs the device
Objective Entrapment Testing for Bed Systems
A bed system, meaning the bed, rails and mattress together, must be assessed against the FDA guidance on hospital bed entrapment, which was developed from the 2006 Hospital Bed Safety Workgroup guidelines. The B4000 tests the four critical zones of the seven zones in the guidance, using its cone for Zones 1 to 3 and the assembled cone and cylinder for Zone 4. A scale applies 12 pounds of force for the Zone 1 and Zone 2 tests, keeping measurements objective instead of estimated. The system must pass all four zones in both the fully raised and intermediate rail positions, and results must be documented. Retesting is needed when a rail or mattress is replaced or a new patient is placed. Annual calibration by Bionix technical services keeps the device in specification.
Features and Benefits
Compliance Testing
- Four critical zones – tests Zones 1 to 4 of the FDA bed entrapment guidance
- Pass and fail indicators – clear readouts instead of subjective estimates
- Objective force – the scale applies 12 lbs of force for Zone 1 and 2 testing
Ownership
- 1-year limited warranty – covered under the Bionix warranty for defects in materials and workmanship
- Annual calibration – calibration service through Bionix technical services, with a replacement scale available
- Documented results – testing supports the documentation CMS expects for bed safety
Product Specifications
Sizes and Packaging
- B4000 Bed System Measurement Device (B4000): 1 measurement device per box
Product Details
- Guidance basis: FDA Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment, from the 2006 Hospital Bed Safety Workgroup guidelines
- Tests: Cone for Zones 1-3, cone and cylinder for Zone 4, both rail positions
- Calibration: Annual calibration by Bionix technical services (service, not included)
- Cleaning: Disinfect with non-chlorine based solutions only
- Warranty: 1-year limited warranty (Bionix) covering defects in materials and workmanship
Explore More: Shop patient safety products | Shop more Bionix Products
Why Facilities Standardize on the B4000
Entrapment risk concentrates on the head, neck and chest, and it is assessed on every bed, rail and mattress combination a facility runs. The B4000 turns that assessment into a measured, documented test instead of a visual once-over.
- Defensible compliance – measured pass and fail results against the FDA guidance zones
- Consistent across staff – the same objective test whoever performs it
- Full fleet coverage – retest on rail or mattress changes with the same device
- Warranty and calibration support – a year of warranty coverage and an annual calibration path
Manuals and Troubleshooting Guides
- B4000 Bed System Measurement Device Sell Sheet
- B4000 Bed System Measurement Device Instructions for Use
- Guide to Bed Safety
- B4000 Bed System Measurement Device Worksheet
- Bionix 1 Year Limited Warranty
Frequently Asked Questions
What does the B4000 test?
It tests the four critical entrapment zones of a bed system (bed, rails and mattress) against the FDA bed system guidance, with clear pass and fail indicators.
When should a bed system be retested?
When a rail or mattress is replaced, or when a new patient is placed in the bed system. Results should be documented.
Is the B4000 under warranty?
Yes. It is covered by the Bionix 1-Year Limited Warranty against defects in materials and workmanship, with repair or replacement as the remedy.
Does it need calibration?
Yes. Bionix recommends annual calibration through its technical services. Calibration is a service and is not included with the device.
Which body areas does entrapment threaten?
The head, neck and chest are the at-risk body parts in bed entrapment, which is why the guidance zones focus on the gaps around rails and mattresses.
