Performance Testing
LILAC carries a patient’s arm weight throughout a PCI procedure. Hence, it should be able to withhold the weight without deforming or breaking. A test will be performed separately for each part. For this test, an assigned amount of weights will be placed on each main component, and a passing score will be given if the component does not fail. LILAC is designed to accommodate at least 95% of patients. Accordingly, the required amount of weight will be calculated using the maximum weight of 95% of population. With the rotating arm board and table, the required weight is only the weight of a patient’s arm. However, the table attachment has to bear the whole device with a patient’s arm on it. Since nurses are required to lift a maximum of 35lbs, the maximum weight that the table attachment needs to hold should be 35lbs.
The main function of LILAC is to hold the patient hand still during the procedure. This securement helps a physician to easily insert a catheter through the insertion point without having to constantly fix a patient’s hand position. Therefore, to ensure the effectiveness of the device, a test will be performed on the rotating arm board and elbow cup. During a procedure, the securement method will undergo forces from the arm wanting to fall back to the patient’s side and frictional forces from the physician pushing a catheter inside the patient. These forces are 12 lbs from maximum arm’s weight of 95% population, 4 lbs maximum push measured from a physician, and a 25% safety factor. The total forces result in 20 lbs. Therefore, each component requiring this test will be pushed and torqued on all faces interacting with the arm at 20 lbs using a validated force gauge. A passing grade will be given if the securement method does not fail or disengage.
In addition, an arm stability test will be carried out to make sure the insertion point on a patient’s arm not deviate more than 1 inch from its set position once locked. With a stable insertion point, the physician must not have to continually adjust the arm during a procedure. An one-inch radius circle from the initial point will allow continued access to the site throughout the procedure. For this test, a physician will perform a predetermined mock procedure on a subject moving the hand as he or she normally would in true surgery. Video recording will be set up and later analyzed using Matlab to determine the maximal displacement of the insertion point in the mock procedure.
Comfort Testing
Beside caring about the performance of the device, we also want to provide comfort to the patient throughout the procedure. These procedures commonly require the patient to be in position for about an hour. For this test, we will have each subject wear the device for an hour and report on their experience.