12月9日的RemeCare应用程序分析

RemeCare is a software platfom that enables a team of careproviders to guide patients during their treatment(s). Patients can register parameters and symptoms using the online platform or the RemeCare smartphone application. *** Remark *** To use this app you need a login. You will receive this once you are a registered user on the RemeCare platform. *** Compatible devices *** Compatible remote monitoring devices: - A&D Blood Pressure Monitor UA-651BLE& UA-656BLE - A&D Weight Scale UC-352BLE Other remote monitoring devices are not supported. *** Intended use *** Remecare is a software suite intended to enable the remote monitoring of vital and non-vital parameters at home, where the nature of the variations in these parameters is such that it cannot result in immediate danger to the patient. *** Intended user *** The intended users of Remecare are patients being treated at home and professional healthcare providers. *** Use-related risks *** Although Remecare is equipped with layered protection against security incidents and cyber-attacks, a limited residual risk of patient data leakage or a temporary platform outage remains. *** Reporting of a serious incident *** The user is asked to report any serious incident related to the use of the application to the manufacturer and the competent authority of the member state where the user is located. *** Warning *** For the treatment to proceed optimally, the user is expected to perform regular recordings in the app. The patient is asked to contact their treating healthcare provider when the app suggests this to the user. *** Use limitations *** Remecare is not suitable for patients who are incapable of using a smartphone app. *** Regulatory compliance *** - MD: Medical Device - CE 1639: European Conformity Marking - eIFU: Electronic instructions for use available for the Remecare app at manuals.remecare.eu - Manufacturer: Remecare BV, Boomsesteenweg 46, 2630 Aartselaar, België, 2025, D-U-N-S 372468945 - REF: Remecare app 1.8.0 as part of Remecare 4.3_1 *** EC declaration of conformity *** SRN: BE-MF-000018364 The declaration is made on base of the EC certificate No. BE18/819942934 issued by Notified Body No. 1639, SGS Belgium NV on 04/05/2019 supported by a confirmation letter in the framework of Regulation EU 2023/607 amending Regulation (EU) 2017/745 as regards the transitional provisions for certain medical devices from Notified Body No. 1912, Kiwa Dare BV on 03/06/2024.