User's Manual

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LBL-0151 | User Supplemental Information, Effective: xxXXX2013

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Extended-Use PATCH 

1. 8 – European R&TTE Declaration of Conformity

Hereby, Proteus® Digital Health, Inc., declares that the Proteus Patch is in compliance

with the essential requirements and other relevant provisions of R&TTE (Radio and

Telecommunications Terminal Equipment) Directive 1999/5/EC. The product is compliant

with the following standards and/or other normative documents:

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Safety (art. 3.1a): EN 60601-1, 3

Ed, IEC 60601-1-11

EMC (art. 3.1b): EN 301 489-17 v2.2.1

Spectrum (art.

3. 2):

EN 300 328 v1.8. 1

Other: EN 60601-1-2 (2007)

The Proteus Patch can be used in countries in the European Union.

1. 9 – CISPR Interference Statement

MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be

installed and put into service according to the EMC information provided in this section of

the manual. Portable and mobile RF communications equipment can affect MEDICAL

ELECTRICAL EQUIPMENT. The Proteus Patch may be interfered with by other equipment,

even if that equipment complies with CISPR emission requirements.

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1. 10 – FCC Interference Statement

This device complies with Part 15 of the FCC Rules. Operation is subject to the following

two conditions: (1) this device may not cause harmful interference, and (2) this device

must accept any interference received, including interference that may cause undesired

operation. Changes or modifications not expressly approved by Proteus Digital Health

could void your authority to operate the equipment.

1. 11 – FCC Wireless Notice

This product emits radio frequency energy, but the radiated output power of this device is

far below the FCC radio frequency exposure limits.

Note:

This equipment has been tested and found to comply with the limits for a Class B digital

device, pursuant to part 15 of the FCC Rules. These limits are designed to provide

reasonable protection against harmful interference in a residential installation. This

equipment generates, uses and can radiate radio frequency energy and, if not installed