Stream DX Uroflowmeter User manual
Stream Dx®
User Manual
January 2019
SDX1-5005-04 Rev A
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Stream Dx Inc.
2305 South 1070 West
Salt Lake City, UT 84119
USA
Tel.: 385-549-8060
Website: www.streamdx.com
FDA Listing #: D340522
Manufactured by:
ZIEN Medical Technologies, Inc.
2757 S 300 W Ste. F
Salt Lake City, UT 84115
USA
www.streamdx.com
Document code: SDX1-10003-01
Model: SDX01
Version: V001
Date of release: 01 March 2019
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Table of Contents
1. Introduction...................................................................................................5
1.1. Stream Dx..........................................................................................5
1.2. Intended Use .....................................................................................6
1.3. Safety Information.............................................................................7
1.4. User Requirements………………………………………………………………………….7
1.5. About this Manual.............................................................................7
2. Physician Registration....................................................................................9
3. Ordering a Stream Dx Device .......................................................................10
3.1. Patient Registration..........................................................................10
3.2. Ordering a Stream Dx Uroflowmeter................................................12
3.3. Instruct the Patient...........................................................................12
4. Patient Explanation and Instruction.............................................................13
4.1. Explanation to the Patient................................................................13
4.2. Patient Instructions for Use..............................................................14
4.3. IPSS Survey.......................................................................................15
4.4. Items provided to the Patient...........................................................16
5. Device Return and Disposal..........................................................................17
5.1. Return of Stream Dx Puck................................................................17
5.2. Disposal of the Stream Dx Sleeve ....................................................17
6. Maintenance and Troubleshooting ..............................................................17
6.1. Introduction ....................................................................................17
6.2. Maintenance: Home Cleaning and Sensor Care...............................17
6.3. Troubleshooting ..............................................................................18
6.3.1. Stream Dx sensor does not function ...................................18
6.3.2. Explanation of the status LEDs ............................................18
6.3.3. Damage to Device……………………………………………………………..18
7. Navigating the Stream Dx Data Portal..........................................................19
7.1. Introduction ....................................................................................19
7.2. Accessing Patient Studies ................................................................19
7.3. Viewing Devices in Use....................................................................22
7.4. Other Website Features ..................................................................22
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8. Technical Specifications and General System Information............................23
8.1. Website ...........................................................................................23
8.2. Stream Dx........................................................................................23
8.3. Classification/approval ....................................................................24
Appendix A Safety Information.....................................................................25
Appendix B Symbol Meanings ......................................................................26
Appendix C Accessories and Detachable parts ..............................................27
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1Introduction
1.1 Stream Dx Uroflow System
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The Stream Dx Uroflow System includes both a device and a secure web portal which provides
urine voiding reports for physicians. The Stream Dx Uroflow system is designed to allow
physicians to order a device and have it sent to a patient for use in the comfort of the patient’s
home. The in-home device can collect a voiding diary which includes volume, flow rate, and time
of voiding events over a five-day period.
The device consists of two parts, the containment “Sleeve,”and the electronic “Puck.”The Sleeve
and Puck combine to create the urine collection vessel. When a patient is finished using the
device for the designated time, they will dispose of the Sleeve and return the Puck using a prepaid
envelope. The data will be uploaded to the Stream Dx Cloud once the device arrives at the Stream
Dx facility and the reports will be generated as soon as the data is uploaded. The uroflow reports
include a super trace of all flow traces, a Liverpool nomogram, an IPSS survey (if provided by the
patient), three super traces of flow rates broken down by time, daily volume voiding diaries, a
coding summary, and graphs representing each individual uroflow.
Stream Dx is primarily intended to capture data in the patient’s home and provide the data to
physicians as an aid in developing treatment plans. The ability to capture urine flow data outside
the clinic will lead to improved quality of data (due to collecting data in a more natural
environment), improved patient convenience, improved clinic workflow, and a larger amount of
data available to the physician leading to greater statistical significance in diagnosis.
There is one model of the Stream Dx System: Version 1.
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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.
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Feedback on the manual
Stream Dx welcomes your feedback to improve our manuals. Please send your questions and
Stream Dx Inc.
2305 South 1070 West
Salt Lake City, UT 84119
USA
Tel.: 385-549-8060
Website: www.streamdx.com
Manufactured by:
ZIEN Medical Technologies, Inc.
2757 S 300 W Ste. F
Salt Lake City, UT 84115
USA
www.streamdx.com
Document code: SDX1-10003-01
Model: SDX01
Version: V001
Date of release: 12 January 2018
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2 Physician Registration
2.1 Creating an Account
A clinician must create an account with Stream Dx before receiving a Stream Dx Uroflowmeter.
1. Use a web browser to visit https://streamdx.com. We recommend using Google Chrome
for accessing our data portal.
2. On the top right corner of the page, click the Login button.
3. This will bring you to the Login Page. Click the Physician Registration link to begin
creating an account.
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4. Follow the instructions on the page to create your physician account.
•Your username may be the same as your email.
•A Stream Dx sales rep code is required to finish the registration process.
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3 Ordering a Stream Dx Device for Patient Use
3.1 Patient Registration
1. Log into your physician account.
2. On the patient roster, click on the Register New Patient Button.
3. Enter in the patient information on the Register New Patient page and click submit.
•The patient’s address must be an address which the United States Postal Service
(USPS) delivers to.
4. A successful registration of the patient will bring you back to the patient’s roster page
and the newly registered patient should show up in the roster.
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