User's Manual

ManualsBrandsProteus Digital Health ManualsElectronicsProteus Patch, Model SPC-0800

LBL‐0176,Rev1|UserSupplementalInformation,

Proteus®Patch

Page1of1 Effective:19DEC2013

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THEPROTEUSPATCH

SPC‐0800

USERSUPPLEMENTALINFORMATION

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TableofContents

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1.TECHNICALINFORMATION................................................................................................................2

1.1–Classification....................................................................................................................................2

1.2–EnvironmentalConditions..........................................................................................................2

1.3–MinimizingSkinIrritation............................................................................................................2

1.4–ProtectionagainstIngressofSolidsandLiquids.................................................................2

1.5–AvoidingUnsafeUseConditions..............................................................................................2

1.6–InformationonElectromagneticandOtherInterferences...............................................3

1.7–InformationontheRadioSubsystem......................................................................................3

1.8–EuropeanR&TTEDeclarationofConformity.........................................................................7

1.9–CISPRInterferenceStatement....................................................................................................7

1.10–FCCInterferenceStatement.....................................................................................................8

1.11–FCCWirelessNotice.....................................................................................................................8

1.12–FCCIdentifier.................................................................................................................................8

2–DISPOSALOFWASTEPRODUCTS..................................................................................................8

3–MANUFACTURERCONTACTINFORMATION.............................................................................9

Summary of content (9 pages)

PAGE 1
THE PROTEUS PATCH SPC‐0800 USER SUPPLEMENTAL INFORMATION Table of Contents 1. TECHNICAL INFORMATION ................................................................................................................ 2 1.1 – Classification .................................................................................................................................... 2 1.2 – Environmental Conditions ..........................................................................................................
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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 The Proteus® Patch is intended for storage and operation in a room‐temperature environment.
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The Proteus Patch has not been tested or approved as safe for operation during air travel. DO NOT use the Patch during air travel; it may interfere with the aircraft navigational instruments. The Proteus Patch has not been tested or approved for use in the presence of strong magnetic or electric fields. DO NOT wear the Patch during magnetic resonance imaging (MRI), cautery, and external defibrillation procedures. Damage to the Patch, your skin, or an unexpected magnetic attraction may result.
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RF emissions CISPR 11 Harmonic emissions IEC 61000‐3‐2 Voltage fluctuations/ flicker emissions IEC 61000‐3‐3 Class B Not applicable to cause any interference in nearby electronic equipment. The Patch is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.
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Guidance and manufacturer’s declaration – electromagnetic immunity The Proteus Patch is intended for use in the electromagnetic environment specified below. The customer or the user of the Patch should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance Electromagnetic environment – level guidance Electrostatic +/‐ 6kV contact +/‐ 6kV Floors should be wood, concrete discharge (ESD) IEC +/‐ 8kV air contact or ceramic tile.
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used no closer to any part of the Proteus Patch, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
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Recommended separation distances between portable and mobile RF communications equipment and the Proteus Patch The Proteus Patch is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
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EQUIPMENT. The Proteus Patch may be interfered with by other equipment, even if that equipment complies with CISPR emission requirements. 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.
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3 – MANUFACTURER CONTACT INFORMATION To request technical information or to report unexpected events, please contact the manufacturer at one of these locations. United States United Kingdom Proteus Digital Health UK Ltd 6th Floor, 41‐44 Great Queen St.