User Manual

LBL-xxxx Page 2
Proteus Two-part Patch Technical description Effective: xxXXX2016
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1. Product Identification
Two-Part Patch SPC-2005, SPC-2008
The Proteus Two-Part Patch is categorized as a Class II device under The Food and Drug
Administration’s regulations (in US), and as a Class IIa device, under the Medical Device Directive (in
EU).
2. Manufacturer
Proteus Digital Health, Inc
2600 Bridge Parkway
Redwood City, CA 94065
Customer Support: [phone]
 MedPass International Ltd.
Windsor House
Bretforton, Evesham
Worcestershire, WR11 7JJ, UK
3. Indications for Use
The Proteus® Digital Health Feedback Device consists of a miniaturized, wearable sensor (Proteus
Patch) for ambulatory recording of physiological and behavioral metrics such as heart rate, activity,
body angle relative to gravity (body position), and time-stamped patient logged events, including
events signaled by the co-incidence with, or co-ingestion with, the ingestible sensor accessory. When
the ingestible sensor is ingested, the Proteus Digital Health Feedback Device is intended to log, track
and trend intake times. When co-ingested with medication, the tracking and trending of intake times
may be used as an aid to measure medication adherence. The Proteus Digital Health Feedback
Device may be used in any instance where quantifiable analysis of event associated physiological
and behavioral metrics is desirable, and enables unattended data collection for clinical and research
applications.
4. Description
The two-part patch is made up of a reusable pod and a replaceable adhesive strip. The pod captures
information and sends this to an app. It can be used for weeks or months at a time. The pod is worn
on the torso using the adhesive strip. The strip contains a small coin cell battery to provide power to
the pod, and is changed weekly for comfort and a fresh battery.