6
1.2
Intended Use
The Stream Dx Uroflowmeter is intended to electronically collect adult male patient voiding data
to assist in the diagnosis of lower urinary tract disorders. This device is intended for home use.
Stream Dx will calculate a patient's flow rate and their maximum voided volume based on
recorded 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 the diagnosis of a condition. It is not intended to be used alone as the sole method of
diagnosis.
1.3
Safety Information
The Stream Dx User's Manual is intended for physician instruction of the Stream Dx Uroflowmetry
System. Safety information can be found in Appendix A.
1.4
User Requirements
To use the Stream Dx Uroflowmeter, no special skills are required. A patient and/or caregiver
should be capable of filling the Pre-Fill Cup, pressing the start button to start and stop data
recording, emptying out the device, and rinsing the inner part of the cup when finished.
Physicians are recommended to verbally instruct patients on how to use the device. Instructions
will be included with every order (See Section 4). No environmental restrictions are currently in
place for use location.
1.5
About this Manual
The Stream Dx User's Manual is intended for all physicians performing investigations with the
Stream Dx Uroflow System.
This manual provides you with detailed information concerning:
•
Physician Registration (Chapter 2)
•
Ordering a Stream Dx Device for Patient Use (Chapter 3)
•
Patient Use, Return, and Disposal of the Stream Dx Device (Chapter 4)
•
Maintenance and Troubleshooting (Chapter 6)
•
Technical Specifications (Chapter 8)
The Stream Dx Quick Start Guide is intended for the patient using Stream Dx Uroflowmetry
system in a home setting.
