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- Australia
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Hilo Bracelet G1 has been CE-marked under the Medical Device Regulation (EU)2017/745 as a class IIa medical device.
Average weekly number of cuff readings according to Hilo survey of 1,337 blood pressure cuff users. For Hilo, actual number of measurements displayed per week may vary, as the Hilo App will discard readings with insufficient signal quality. Successful readings are often averaged together for easier viewing in the Hilo App.
Frequent errors in using BP cuffs can be as a result of body or cuff positioning, activity level before or during measurement, and many other factors. Hilo will not display readings when non-optimal conditions are detected, and accuracy has been demonstrated via multiple clinical trials.
Rated IP68 Water proof – Suitable for shower and bath.
In total 5 clinical trials were required during the design, development and validation of Hilo technology. Of these, 2 clinical trials supported the validation of the Hilo device for CE marking purposes.