Minze Flow Brazil 12 12+

The Minze Flow app is used to transfer uroflow measurements from the Minze uroflowmeter towards the central monitoring platform, and asks for direct patient input about his drinking and voiding behavior ("Voiding Diary"). The app can not be used without prescription and supervision of a medical professional.


The app can be used in 2 configurations:

1) HOMEFLOW: Used at the patient's home
Homeflow increases efficiency, enables post treatment follow-up from home and eliminates the stress and discomfort of a uroflow test at the hospital.
Minze Homeflow embodies a bluetooth connected uroflowmeter that fits into a normal toilet. It is connected to the Minze Flow app which allows patients to transfer the data from the uroflowmeter, and to keep a voiding diary of themselves or their child.

2) HOSPIFLOW: Used at the hospital and private practice
Hospiflow is a portable uroflowmeter that can be used on a normal toilet in the hospital and private practice of the urologist. Allowing uroflowtests on a normal toilet reduces stress of a patient in the hospital, leading to more representative uroflow test results


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DISCLAIMER
Jurisdiction statement: the Minze Flow app is part of a medical device that has been CE certified, FDA listed and TGA approved and shall only be used the following regions:
- United States of America
- all countries in the European Union (EU)
- other countries in the European Economic Area (EEA): Norway, Iceland, Liechtenstein
- Switzerland
- United Kingdom
- Turkey
- Thailand
- Lebanon
- Australia
- Japan
- Kingdom of Saudi Arabia
- Israel

In all other regions, usage is only allowed in the framework of research, clinical investigation or clinical trials.



The Minze Flow app is part of a CE Class 1(m) and FDA listed Class 2 certified medical device (Minze Uroflow System) that has been externally audited. Both safety and accuracy have been certified.
The development of the Minze flow app takes place within the framework of an ISO13485 certified quality management system.
All certificates can be found here:
https://minzehelpcenter.zendesk.com/hc/articles/4405438004370-Regulatory