The document summarizes a senior design project to address human error in loading disposable kits for the Spectra Optia centrifuge. Two concepts were selected: a machine vision system using cameras to detect misloads, and an audio system using microphones. The systems would detect loading errors before blood enters the centrifuge and alert the operator. A valve block modification was also proposed to prevent tubing from being loaded behind the cassette and eliminate potential misloads.
1. CONFIDENTIAL
TERUMO BCT SENIOR DESIGN PROJECT - CENTRIFUGE LOADING HUMAN FACTORS
COLORADO STATE UNIVERSITY SCHOOL OF BIOMEDICAL ENGINEERING
Team Members: Brett Baeverstad1, Emma Lichtenfels1, Minh Anh Nguyen1, Megan Rives1, Evan Siebenmorgen1, Briden Stanton2
1 Colorado State University, 2 Terumo BCT
Abstract
Centrifuge leaks in the Spectra Optia machine due to the misloading of
the disposable kit is identified as a human factor error. These errors
can either be designed out, or signal a notification to the operator
before blood enters the system. A machine vision and audio system
have been selected as final concepts and are in development as the
methods for detecting misloads in the Spectra Optia.
Goals Objectives
Design out Human Error in
Loading the Disposable
OR
Notify operator prior to leak
in the Machine
Develop non-leak related
modification of machine
1. Detect Misload prior to end of
disposables check
2. Detect Misload Channel Height
3. Detect Camera Image Differences
4. Detect Audio Signal Differences
1.Prevention of tubing behind cassette
Acknowledgments
We would like to thank Terumo BCT, Jeff Carroll, Dr. Ellen Brennan-Pierce, Nicole Ramo, Cognex,
Colorado Water Jet and the School of Biomedical Engineering for their help and contributions
to the project.
Channel Loading
•A LED casts a beam of light parallel to the centrifuge filler top surface.
•Using the AIM camera, light gradient can be determined and processed
using external control systems
•If there is light detected on top surface, the test is considered a FAIL
•If no light is detected on top surface, the test is considered a PASS
Control Systems
• The MATLAB program is
used to analyze and
compare both image and
audio files.
• If one image or audio file is
not correctly set, then an
error message will display.
Human Factors
• As devices become more
prevalent, there is a need to
mitigate human-based errors.
• Mistakes made during operation
can obstruct effective patient
treatment, and monitoring.
• Knowledge-based errors occur
when the user is unfamiliar with
the device.
• Slip errors occur due to
forgetfulness.
Detection Systems
• For the detection of the misloaded upper and/or lower bearing component(s) inside
the centrifuge basin
• A microphone detection and machine vision system (Cognex In-Sight Explorer)
• Both systems will verify correct loading prior to patient connection
Valve Block Modification
• The valve block modification acts to block tube access to the loading area of
the cassette
• Designed for reliability, manufacturability, and user-friendliness
• Potential for human factor errors have been eliminated through the design
Initial Project Goals
Background
• Terumo BCT is a Global Leader in blood component technologies
• The Spectra Optia is a therapeutic apheresis device used for blood
component separation, collection, and exchange
• Misloaded kits by the operator in the Spectra Optia may cause
Centrifuge leaks
• Human Error is common among Medical Device usage
• In a continual effort to pursue new ways to ensure customer safety,
Terumo BCT is constantly developing improvements for this device
Spectra Optia Machine
Valve Block Modification
Audio File Error
Image File Error
Correctly LoadedIncorrectly Loaded Loading ProcessLower Bearing Misload
Upper Bearing Misload
Mounted Cameras and Microphone