The Stream Dx Uroflowmeter is intended to, under the direction of a medical professional, electronically record adult male patient voiding data to assist in the diagnosis of lower urinary tract disorders and is designed for home use. Stream Dx will calculate a patient's flow rate and their maximum voided volume based on the collected data. This information will be provided to the caregiver by Stream Dx. The data obtained from the Stream Dx Uroflowmeter is meant to be used exclusively as a tool to aid in diagnosis of a condition. It is not intended to be used alone as the sole method of diagnosis.
An electronic device intended to be used to measure the flow and volume of urine from a patient during the course of normal urination in order to identify micturition disturbances. It is usually operated by healthcare personnel who instruct the patient to empty their bladder into the measuring chamber of the device; some types may be operated by the patient at home. It may employ mechanical and/or electrical measurements of parameters such as total voided volume, volume at maximum flow, maximum flow rate, mean flow rate, flow time, and time of maximum flow; it may provide digital or printed data. This is a reusable device.