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Proteus Two-part Patch Technical description Effective: xxXXX2016

Proteus Patch

Technical Description

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Table of Contents

1. Product Identification.......................................................................................................................................2

2. Manufacturer........................................................................................................................................................2

3. Indications for Use.............................................................................................................................................2

4. Description.............................................................................................................................................................2

5. Cautions And Warnings..................................................................................................................................3

6. Equipment Symbols..........................................................................................................................................4

7. Specifications.......................................................................................................................................................4

7.1. Environmental Specifications..................................................................................................................4

7.2. Compliance to IEC 60601-1....................................................................................................................5

7.3. Compliance to ANSI/AAMI EC13:2002.............................................................................................5

7.4. Compliance to other Standards.............................................................................................................5

7.5. Patch Specifications....................................................................................................................................6

7.6. Blueetooth Wireless Technology Specifications...........................................................................6

7.7. EMC Information............................................................................................................................................6

8. European R&TTE Declaration of Conformity....................................................................................10

9. FCC Declarations.............................................................................................................................................10

9.1. FCC Interference Statement.................................................................................................................10

9.2. FCC Wireless Notice.................................................................................................................................10

9.3. FCC Identifier................................................................................................................................................11

Summary of content (11 pages)

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Proteus Patch Technical Description Table of Contents 1. 2. 3. 4. 5. 6. 7. 7.1. 7.2. 7.3. 7.4. 7.5. 7.6. 7.7. 8. 9. 9.1. 9.2. 9.3. Product Identification ....................................................................................................................................... 2 Manufacturer ........................................................................................................................................................ 2 Indications for Use................................
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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: +1 877 285 9803 MedPass International Ltd. Windsor House Bretforton, Evesham Worcestershire, WR11 7JJ, UK 3.
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The pod measures heart rate, activity, body angle relative to gravity (body position) and the time of ingestible sensor detection. The pod is connected with a mobile device via Bluetooth®, using a mobile application (app), such as Proteus Discover. Your app will prompt you when it is time to change your patch strip. Always refer to your app when changing your strip to ensure your patch is put together correctly and connected with your mobile device.
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 Do not continue use until further instructed by a physician if your skin is irritated, inflamed, or red around the replaceable adhesive strip.  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 drop or bump with excessive force.  Do not use to diagnose heart-related conditions.
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Short tern (< 30 days) Storage/Transportation, Strip Humidity Operating, Patch: Storage/Transportation, Pod Storage/Transportation, Strip Altitude Operating, Patch +0°C – +40°C - +32°F – 104°F 15% - 93% (non condensing) 15% - 93% (non condensing) 15% - 93% (non condensing) 700 hPa – 1060 hPa 7.2.
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    This product complies with all applicable provisions of the EU Restriction of Hazardous Substances directive (RoHS) This product complies with all applicable provisions of the EU Medical Device Directive (MDD) The pod and strip do not contain natural latex rubber Strip and Pod packaging materials meet the meet transit requirements per ASTM D4169, distribution cycle 13, Assurance Level II. 7.5.
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antennas) should be used no closer than 30 cm (12 inches) to any part of the Patch. Otherwise, degradation of the performance of the Patch could result. 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 assure that it is used in such an environment.
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Guidance and manufacturer’s declaration – electromagnetic immunity Voltage dips, short <5 % UT (>95 % dip in Not applicable interruptions and UT) voltage variations for 0,5 cycle on power supply 40 % UT (60 % dip in input lines UT) IEC 61000-4-11 for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 s Power frequency 30A/m 30A/m Power frequency magnetic fields (50/60 Hz) should be at levels characteristic magnetic field of a typical location in a typical IEC 61000-4-8 commercia
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recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations.
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Not applicable 3.7 7.4 100 Not applicable 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
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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 and used in accordance with the instructions, may cause harmful interference to radio communications.