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25 

 

Operating Conditions 

Temperature: 

+10

⁰

C to +40 

⁰

C 

Humidity: 

30% -75% non-condensing 

Range 

Flow 

Volume 

0-25 mL/s 

25-700 mL 

Accuracy 

Flow 

Volume 

+/-2.5 mL/s 

+/- 30 mL 

Maximum volume 

700 mL 

Recording time 

10 Hours 

Battery life 

A minimum of 10 hours in active mode, 

and 160 hours in standby mode. 

Frequency Band of Transmission 

The Stream Dx Uroflowmeter has a 

frequency band of reception of 2.4 GHz. 

The preferred frequency band of 2.4 GHz 

and has a bandwidth of the receiving 

section of the Stream Dx Uroflowmeter in 

those bands. 

 

8.3

 

Classification/approval 

 

Type BF Applied Part, approved for continuous operation in non-oxygen rich environments

 

ANSI/AAMI ES60601-1:2005+A2 (R2012) +A1 

IEC 60601-1-11:2015 

CAN/CSA-C22.2No. 60601-1:14 

CAN/CSA-C22.2No. 60601-11:15 

 

 

 

 

 

 

 

Содержание Uroflowmeter

Страница 1: ...Stream Dx User Manual January 2019 SDX1 5005 04 Rev A ...

Страница 2: ...9 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 ...

Страница 3: ...atient 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...

Страница 4: ...cifications 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 ...

Страница 5: ...e 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...

Страница 6: ...eter 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 environmen...

Страница 7: ...am Dx at support streamdx com 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 ...

Страница 8: ...ceiving 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 ...

Страница 9: ...9 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 ...

Страница 10: ... 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 ...

Страница 11: ... Patient s History page 2 Review that the Patient s shipping and contact information are current and submit the order A patient who currently has an In Progress order cannot be ordered a new device until the In Progress order has been completed The patient should receive a confirmation email once the order has been placed This email will include a link to an instructional video on how to use the S...

Страница 12: ...er the information covered in Section 4 Patient Explanation and Instruction with the patient An IPSS survey will be provided to the patient when they receive the Stream Dx Uroflowmeter Ask the patient to complete the IPSS Survey and return it with the return package at the end of their study Refer to Section 4 3 for a sample of the IPSS Survey ...

Страница 13: ...device is around the groin area 3 Press the power button on the Stream Dx Uroflowmeter and ensure that the green light is flashing indicating that it is recording data 4 Completely fill a Pre Fill cup included in the package with water and pour slowly into the device This step must be completed before every voiding event 5 Urinate into the Stream Dx Uroflowmeter and aim towards the target on the i...

Страница 14: ...e prior to sending the Stream Dx Uroflowmeter home with the patient Inform the patient that it is acceptable to start a recording and terminate if they are unable to void This will not affect their study Refer to Section 6 3 3 for an explanation of status LED lights and review these with the patient ...

Страница 15: ...atient Instructions for Use The following pages will be sent to the patient as instructions on how to use the device The pages included here are for reference only and should remain with the instruction manual ...

Страница 16: ...urvey will be provided to each patient which receives a Stream Dx Uroflowmeter Instruct patients to fill out the survey and return to Stream Dx IPSS surveys returned by patients will be included in the final reports for each order ...

Страница 17: ...ent Each Stream Dx Uroflowmeter package will include the following items Quantity Item Identifier 1 Stream Dx Disposable Sleeve 1 1 Stream Dx Puck 2 2 Pre Fill Cup 3 1 Return Envelope 4 1 IPSS Patient Survey 5 1 Instructions for Use 6 ...

Страница 18: ...k 2 The Stream Dx Puck should be placed in the pre paid return envelope along with the IPSS survey and sealed closed The patient may drop off the pre paid return envelope at any USPS mailbox or USPS office 5 2 Disposal of the Stream Dx Sleeve 1 The patient may dispose of the Sleeve in the trash once they are finished with it ...

Страница 19: ... period 1 After disposal of urine rinse the inside of the device with tap water External parts of the device can be wiped clean with cloth and water 2 Store in the upright position in preparation for the next use 3 DO NOT remove the Sleeve from the Puck between uses The separation of device components should be completed only once at the end of the use period 4 If the Sleeve is accidentally remove...

Страница 20: ...ly Flashing Green 3 times after Button is pushed Off The device has successfully saved the recorded data and is entering low power mode Flashing Green Off The device has been activated and is ready to record Flashing Green Flashing Red Device is not on a level surface Please place device on a level surface Red light will turn off when the device is at a satisfactory tilt Off Solid Red Device is no...

Страница 21: ... 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 If you suspect the device has been damaged during use do not use the device Contact Stream Dx directly at 385 549 8060 and notify us of the issue ...

Страница 22: ... recommend using Google Chrome for accessing our data portal 2 On the top right corner of the page click the Login button 3 Log in by entering in your username and password 4 To go to a patient s history page click on the row the patient appears on in the patient roster 5 If the patient has completed a Stream Dx Uroflow study and a report is available you can click on show report to view the repor...

Страница 23: ...ess for the patient You will not be able to order a second device for any patients who have an In Progress order 7 4 Other Website Features Physicians will be able to update account details such as payment and contact information using the website To update these settings click on the My Account drop down and click on the Settings button ...

Страница 24: ... 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 The Stream Dx Device is made up of two components the Puck and Sleeve When the patient receives the device the two are already assembled together Following the study period the Sleeve will be removed from the Puck by the patient by twisti...

Страница 25: ...andby mode Frequency Band of Transmission The Stream Dx Uroflowmeter has a frequency band of reception of 2 4 GHz The preferred frequency band of 2 4 GHz and has a bandwidth of the receiving section of the Stream Dx Uroflowmeter in those bands 8 3 Classification approval Type BF Applied Part approved for continuous operation in non oxygen rich environments ANSI AAMI ES60601 1 2005 A2 R2012 A1 IEC ...

Страница 26: ... other equipment should be observed to verify that they are operating normally Intended for urine collection measurement only and is intended for indoor use only with the conditions specified in Section 8 of this document Do not use the device if the packaging has been opened or damaged Improper use of the device using accessories other than what is provided with the device could result in increas...

Страница 27: ...Consult Instructions for Use TUV certification TUV Rheinland certified this product to U S safety standards Type BF Applied Part Manufacturer Bluetooth logo Catalogue Number Lot Code Button used to start and end recording of voiding event ...

Страница 28: ...28 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 Puck Type BF 100 1 minute per use x up to 50 uses ...

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