User's Manual

ManualsBrandsProteus Digital Health ManualsElectronicsProteus Wearable Sensor Module, Model SPC-0655

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LBL-0151 | User Supplemental Information, Effective: xxXXX2013

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Extended-Use PATCH 

THE PROTEUS Extended-Use PATCH

SPC-0655

USER SUPPLEMENTAL INFORMATION

Table of Contents

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

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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........................................................................................3

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...............................................................8

1.9 – CISPR Interference Statement.............................................................................................8

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

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

1.12 – FCC Identifier.............................................................................................................................9 

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

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

Summary of content (12 pages)

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THE PROTEUS Extended-Use PATCH SPC-0655 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. Do not subject the Proteus Patch to transport conditions for more than 7 days.
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continued safety, should the enclosure become penetrated or torn, remove the Patch immediately and replace it with a new one. 1. 5 – Avoiding Unsafe Use Conditions The Proteus Patch is not a diagnostic device. DO NOT attempt to use it to diagnose heartrelated conditions, an incorrect diagnosis may result. 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.
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The transmit modulation is frequency-hopping using GFSK (Gaussian Frequency Shift Keying) with a bandwidth-bit period product BT=0.5. The Modulation index is between 0.28 and 0.35. The effective radiated power is -15dBm ( P = 0.032mW ) Guidance and manufacturer’ s declaration – electromagnetic emissions The Proteus Patch is intended for use in the electromagnetic environment specified below. The customer or the user of Proteus Patch should ensure that it is used in such an environment.
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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 ensure that it is used in such an environment.
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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 Proteus Patch should ensure that it is used in such an environment.
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affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
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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: Safety (art. 3. 1a): EMC (art. 3. 1b): Spectrum (art. 3. 2): Other: EN 60601-1, 3 rd Ed, IEC 60601-1-11 EN 301 489-17 v2. 2. 1 EN 300 328 v1. 8.
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and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: — Reorient or relocate the receiving antenna.
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both used and unused, should not be disposed with household waste. Return to a recycling point for electric and electronic devices.
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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, Inc Proteus Digital Health UK Ltd 2600 Bridge Parkway, Suite 101 Redwood City, CA 94065 6th Floor, 41-44 Great Queen St.
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LBL-0151 | User Supplemental Information, 12 Extended-Use PATCH Effective: xxXXX2013