7月17日 的 Minze Flow 應用程式分析

The Minze Flow app is used to transfer measurements from the Minze Uroflowmeter or Minze Diary Pod 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 For more information about our services, please visit https://www.minzehealth.com". DISCLAIMER Jurisdiction statement: the Minze Flow app is part of a medical device that has been CE certified and FDA listed 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 - 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 the Minze Platform, a CE-marked Class IIa and FDA Class 2 listed medical device software. The Minze Flow App serves as gateway for data collected via Bluetooth from a compatible medical hardware devices and allows user input, which is transferred unaltered to the central Minze monitoring platform. Compatible medical hardware devices are the 'Minze Uroflowmeter' (CE-marked Class Im, FDA Class 2 listed) and 'Minze Diary Pod' (CE-marked Class I, FDA Class 2 listed). The Minze Flow App does not control the hardware devices; both operate fully autonomously. Basic safety and essential performance of the Minze Uroflow System have been independently audited, and development is carried out under an ISO13485-certified Quality Management System. Certificates can be found here: https://minzehelpcenter.zendesk.com/hc/articles/4405438004370-Regulatory