Stream DX Uroflowmeter User Manual
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Stream DX Uroflowmeter User Manual

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Stream Dx Uroflowmeter
User Manual
Last Updated: March 2020
SDX1-5005-04 Rev B

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Summary of Contents for Stream DX Uroflowmeter

  • Page 1 Stream Dx Uroflowmeter User Manual Last Updated: March 2020 SDX1-5005-04 Rev B...

  • Page 2: Table Of Contents

    About this Manual ................5 2. Clinic Registration ..................7 2.1. Creating an Account ................7 3. Ordering a Stream Dx Uroflowmeter for Patient Use ........8 3.1. Patient Registration ................8 3.2. Ordering a Stream Dx Uroflowmeter ..........8 3.3.
  • Page 3 6.3.2. Explanation of the Status LEDs ..........13 6.3.3. Damage to Device ............... 15 7. Navigating the Stream Dx Data Portal ............16 7.1. Introduction ..................16 7.2. Accessing Patient Reports..............16 7.3. Viewing In-Progress Orders ............. 16 7.4. Other Website Features ..............17 8.

  • Page 4: Introduction

    Assembly). The Sleeve and Electronic Base combine to create the Uroflowmeter. The Stream Dx Uroflow System is designed to allow physicians to order a device to be sent to a patient for use in the comfort of the patient’s home. Data collected by the in-home device can be used to create a voiding diary which includes volume, flow rate, and time of voiding events.

  • Page 5: Intended Use

    This information will be provided to the patient’s provider 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.
  • Page 6 • Maintenance and Troubleshooting (Chapter 6) • Navigating the Stream Dx Data Portal (Chapter 7) • Technical Specifications (Chapter 8) The Stream Dx Instruction Manual (trifold pamphlet) is intended for patients using Stream Dx Uroflowmetry System in a home setting. Feedback on this manual Stream Dx welcomes your feedback to improve our manuals.

  • Page 7: Clinic Registration

    2 Clinic Registration 2.1 Creating an Account A clinician must create an account with Stream Dx before ordering a Stream Dx Uroflowmeter. 1. Use a web browser to visit https://streamdx.com. We recommend using Google Chrome for accessing our data portal.

  • Page 8: Ordering A Stream Dx Uroflowmeter For Patient Use

    Dx Uroflowmeter. 3.3 Instructing the Patient Inform the patient that they will be receiving a call from Stream Dx to confirm their address and phone number prior to shipment of the device. The device will arrive approximately 2-3 business days after a patient’s address and number has been confirmed.

  • Page 9: Patient Explanation And Instruction

    4 Patient Explanation and Instruction 4.1 Explanation to the Patient When ordering a Stream Dx Uroflowmeter for a patient, the clinic must explain the use and return instructions to the patient. Please refer to Section 4.2 to view the Patient Instructions for Use and review them with the patient.

  • Page 10: Patient Instructions For Use

    Inform the patient that it is acceptable to start a recording and terminate if they are unable to void. This will not affect their test or the ability for the device to record a future void. Refer to Section 6.3.2 for an explanation of status LED lights and review these with the patient. 4.2 Patient Instructions for Use The following two-sided, trifold pamphlet will be sent to the patient as instructions on how to use the device.

  • Page 11: I-Pss Survey

    An I-PSS (International Prostate Symptom Score) survey will be provided to each patient who receives a Stream Dx Uroflowmeter. Instruct patients to fill out the survey and return to Stream Dx. I-PSS surveys returned by patients will be included in the final reports for each order. A Spanish version of the I-PSS survey is printed on the reverse side of the page.

  • Page 12: Device Return And Disposal

    1. The patient should twist the top Sleeve portion (Counter-clockwise when looking down into the Sleeve) off of the electronic base. 2. The Stream Dx Electronic Base should be placed in the pre-paid return envelope along with the I-PSS survey and sealed closed. The patient may drop off the pre-paid return envelope at any USPS mailbox or USPS office.

  • Page 13: Maintenance And Troubleshooting

    6.2 Maintenance: Home Cleaning and Sensor Care The Stream Dx Uroflowmeter is clean and ready to use when it is sent to the patient; the Sleeve is new and the electronic base has been disinfected. The patient should follow the instructions below to maintain the Uroflowmeter during the testing period.
  • Page 14 Green (Left) Red (Right) Indication Stream Dx Uroflowmeter is not functioning. Possible reasons: • Device is off • Device has run out of battery. (Less likely) Flashing Green The device has been activated and is ready to record. Flashing Green 3...

  • Page 15: Damage To Device

    6.3.3 Damage to Device Prior to use, visually inspect the device for damage. If any damage is seen, such as cracked or broken plastic components, do not use the device. Contact Stream Dx directly at 385-549-8060 and notify us of the issue.

  • Page 16: Navigating The Stream Dx Data Portal

    4. To go to a patient’s history page, click on the row the patient appears on in the patient list. 5. If the patient has completed Stream Dx Uroflow Testing and a report is available, you can click on show report to view the report or update the report to classify each individual void.

  • Page 17: Other Website Features

    • You will not be able to order a second device for any patients who have any orders currently in progress. 7.4 Other Website Features Physicians will be able to update account details such as payment and contact information using the website.

  • Page 18: Technical Specifications

    For best results, instruct the patient to place the Stream Dx Uroflowmeter on a flat, closed toilet lid such that the opening of the Stream Dx Uroflowmeter is around groin height. Ensure that the Stream Dx Uroflowmeter is as level as possible during use.

  • Page 19: Classification

    10 Hours A minimum of 10 hours in active mode and 160 hours Battery life in standby mode. The Stream Dx Uroflowmeter includes a Bluetooth Chip Frequency Band of Transmission which operates in the frequency band of 2.4 GHz. 8.3 Classification...

  • Page 20: Appendix A Safety Information

    Dx Uroflowmeter. Otherwise, degradation of the performance of this equipment could result. • 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.

  • Page 21: Appendix B Explanation Of Symbols

    Appendix B - Explanation of Symbols Consult Instructions for Use Type BF Applied Part Manufacturer Bluetooth logo Catalogue Number Lot Code Button used to start and end recording of a voiding event SDX1-5005-04 Rev B Page 21 of 22...

  • Page 22: Appendix C Applied Parts

    Appendix C – Applied Parts Applied Parts Type Probability of contact Duration of contact Sleeve Type BF 100% <1 minute per use x up to 50 uses/day Electronic Base Type BF 100% <1 minute per use x up to 50 uses/day SDX1-5005-04 Rev B Page 22 of 22...

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