Validation Testing

Three nursing students and MSN Ed. RN Chelsea Lebo from The College of New Jersey conducted the validation of the device. The objective of this study is to confirm the efficacy of the Vac-assisted Male External Catheter System. Each participant was provided with the following questions to evaluate, rating them on a qualitative incremental scale ranging from 1 to 4.

Attachment Component Survey

Question	Score 1	Score 2	Score 3	Score 4	Average Results
Does the Attachment site stay securely attached?	No	Somewhat	Mostly	Yes	4
Does the catheter efficiently collect urine at the lowest flow rate?	No	Somewhat	Mostly	Yes	4
Does the catheter efficiently collect urine at the nominal flow rate?	No	Somewhat	Mostly	Yes	4
Does the catheter efficiently collect urine at the highest flow rate?	No	Somewhat	Mostly	Yes	4
Does the attachment site fit on the nominal model?	No	Somewhat	Mostly	Yes	4

Overall System Functionality Survey

Question	Score 1	Score 2	Score 3	Score 4	Average Results
Is the auditory alarm loud enough?	No	Somewhat	Mostly	Yes	4
Does the auditory alarm trigger at the appropriate volume?	No	Somewhat	Mostly	Yes	4
Does the auditory alarm trigger at the appropriate time for urinalysis?	No	Somewhat	Mostly	Yes	4
Are the light indicators appropriate for visibility?	No	Somewhat	Mostly	Yes	4
Are the light indicators appropriate for canister overflow?	No	Somewhat	Mostly	Yes	4
Are the light indicators appropriate for urine sampling?	No	Somewhat	Mostly	Yes	4
Is the digital display understandable for volume collection?	No	Somewhat	Mostly	Yes	4
Is the digital display understandable for urinalysis?	No	Somewhat	Mostly	Yes	4
Did the device activate in the proper time frame when urinating?	No	Somewhat	Mostly	Yes	4
Did the urine collect at the proper location?	No	Somewhat	Mostly	Yes	4
Was the device in range when in use?	No	Somewhat	Mostly	Yes	4