User's Manual

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LBL-0151 | User Supplemental Information, Effective: xxXXX2013
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Extended-Use PATCH 
1. TECHNICAL INFORMATION
1. 1 – Classification
Caution: Federal (U.S.A) law restricts this device to sale by or on the order of a physician.
The Proteus Patch is categorized as Class II (in US) and IIa (in EU).
The User (patient) is the intended Operator of the Proteus Patch.
1. 2 – Environmental Conditions
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The Proteus® Patch is intended for storage and operation in a room-temperature
environment. Do not subject the Proteus Patch to transport conditions for more than 7
days.
Condition: Temperature Humidity Pressure
(Altitude)
Operating 20C – 30C 15% - 93% 700 hPa – 1060 hPa
Storage 20C – 28C 15% - 93% 700 hPa – 1060 hPa
Transport 2C – 38C 15% - 85% 700 hPa – 1060 hPa
1. 3 – Minimizing Skin Irritation
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The Proteus Patch has been designed to minimize the possibility of skin irritation.
Observing these cautions will reduce the likelihood of skin irritation or bruising under the
Patch:
DO NOT continue use until further instruction by a physician if your skin is irritated
or inflamed around the patch.
DO NOT place in locations where your skin is scraped, cracked, inflamed, or
irritated.
DO NOT place in a location that overlaps the area of the most recently removed
Patch.
DO NOT use if you are allergic to adhesive tape.
DO NOT wear the same Patch for more than one week.
DO NOT drop or bump with excessive force.
1. 4 – Protection against Ingress of Solids and Liquids
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The Proteus Patch has an Ingress Protection rating of IP27. This means that the enclosure
has no penetrations and it has been rated for immersion in liquid up to 1m depth. For