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2AFBP-SR15PZIO SR ECG PATCH

iRhythm Technologies, Inc.
ZIO SR ECG PATCH - FCC ID 2AFBP-SR15P - iRhythm Technologies, Inc.
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Application Details

Equipment Class
DTS - Digital Transmission System
Date of Grant
Oct 09, 2015
Application Purpose
Original Equipment
Date of Application
Oct 08, 2015
Equipment Note
ZIO SR ECG PATCH
Frequency Range
2402.00000000 - 2480.00000000
Company
iRhythm Technologies, Inc.
Country
United States

Documents & Files

Select a file to view

Users Manual

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Cover Letter(s)

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External Photos

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ID Label/Location Info

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Internal Photos

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RF Exposure Info

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Test Report

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Test Setup Photos

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Document Text

Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.

Users Manual

PATIENT INSTRUCTIONS FOR SUPPORT, CALL 1- 888-693-2401 FOR SUPPORT, CALL 1- 888-693-2401 To be completed by patient TURN OVER FOR BUTTON PRESS LOG BUTTON PRESS LOG TURN OVER FOR PATIENT INSTRUCTIONS Date removed / / Name Serial # Enter your symptoms as shown on the sample page, or enter them using myZIO™ and enjoy these additional features: • Review and edit your symptom history • View Gateway transmissions • Access and edit your patient profile • Find patient instructions See page 5 to get started with myZIO K100A4030.D | September 2015 iRhythm Technologies, Inc. Clinical Centers 650 Townsend St., Suite 380 San Francisco, CA 94103 U.S.A. 2 Marriott Drive Lincolnshire, IL 60069 U.S.A. 363 N. Sam Houston Parkway East Suite 125 Houston, TX 77060 U.S.A. 1-888-693-2401 | irhythmtech.com | @iRhythmTech FOR SUPPORT, CALL 1-888-693-2401 If the Patch falls o, call 1-888-693-2401. If you feel severe itching or irritation, remove the Patch then call 1-888-693-2401. If you feel the need for immediate medical care at any time, call 911. The ZIO® SR device will not provide any medical assistance and cannot contact medical personnel for you. For use in the United States only. 1 Both parts of the ZIO ® monitor were turned on at your physician’s office, and are now recording your heart activity. The ZIO ® SR Patch records every heartbeat; each time you press the Patch button, the ZIO ® SR Gateway sends that information for analysis. Turn the page for advice on having the best possible patient experience. ZIO ® PATC H ZIO ® GATEWAY 1 2 USING YOUR ZIO ® SR With the ZIO monitor, you can sleep, shower and go through your normal daily activites. The Patch needs 24 hours to stick to your skin, so avoid any activities which cause sweating during this period. (If your skin is moist, pat it dry with a dry towel or cloth.) After those first 24 hours, you may resume normal activities, including moderate exercise. The Patch and Gateway will not flash or make noise when they are working correctly, but you can check your transmissions using myZIO. Turn to the next page or see the inside back cover for information about myZIO. 2 3 Troubleshooting Traveling Patch Removal FAQs Using ZIO SR 1 Each time you feel a symptom, press the button on your Patch. Then note the date, time, and what you felt in this booklet or using myZIO. 2 Try to keep the Gateway close by when you can – set it down nearby, and when you are on the move, carry it with you. The Gateway is in range if it remains within 10 feet of the Patch. 3 If the Patch or Gateway lights are flashing, it does not mean there is a problem with your heart, only that the device may have lost its connection. Turn to the Troubleshooting section or call 1-888-693-2401 for support. Three key things to keep in mind are: Using ZIO SR 4 Other tips to having the best ZIO experience possible: If the Patch feels a little itchy, or peels or lifts at the edges, it is okay. Press and hold the Patch to re-stick. Excessive sweating can cause the Patch to slide, become loose, fall off, and shorten wear time – especially if the sweating occurs in the first 24 hours after the Patch is put on. The Patch is water-resistant and should not be submerged. That means brief showering is okay, but no swimming or hot tubs. The Gateway is NOT waterproof. Please do not get it wet. It is okay if the Gateway is temporarily out of range, but do not leave it within 6 feet of transmitting devices (such as wireless routers, baby monitors and TV senders/transmitters). Sending heart rhythm data through the Gateway can take some time. Recent transmissions may not be available at myZIO for several hours. 5 Troubleshooting Traveling Patch Removal FAQs Using ZIO SR Use myZIO to enter and edit your symptoms electronically, and view transmissions from your Gateway.* iPhone ® users 1. Search for ‘myZIO’ in the App Store SM 2. Download app 3. Register before entering symptoms Internet Explorer ® users 1. Open internet browser 2. Navigate to myZIO.org 3. Register before entering symptoms * Recent transmissions may not be available at myZIO for several hours. Supported on iPhone 5s, 6 and 6s (iOS 7 and 8). Internet Explorer browser supported on versions IE 8, 9, and 11. iPhone, App Store and the Apple logo are registered trademarks of Apple Inc. Using ZIO SR 6 TROUBLESHOOTING: GATEWAY Slow flashing (once every 3 seconds): Indicates that the Gateway has lost the connection to your Patch. To remedy it, hold the star button for 3 seconds until the orange light stays on. Then, if you see green flashing, the gateway has found connection to the Patch. If orange flashing continues, call Customer Support at 1-888-693-2401. If the light on the outside of your Gateway is flashing, check inside. 7 Troubleshooting Traveling Patch Removal FAQs Using ZIO SR Slowflashing (once every 3 seconds): Indicates that the Gateway does not have a cell signal. To remedy it, move the Gateway to a place with a good cell signal (near a window or outside) and hold the star button for 3 seconds until the orange light stays on. Then, if you see green flashing, the Gateway has found a cell signal. Do not move the Gateway until the green flashing stops. If it does not flash green, move the Gateway to a new place and try again. If orange flashing continues, call Customer Support at 1-888-693-2401. Fast or flashing (3 times per second): Fast flashing indicates that your Gateway is not working. Call Customer Support at 1-888-693-2401. Troubleshooting 8 TROUBLESHOOTING: PATC H Slow flashing (once every 3 seconds): Indicates that your Patch is not making good contact. To remedy it, press evenly on the wings of the Patch for 3 to 5 minutes. If orange flashing continues, call Customer Support at 1-888-693-2401. Fast flashing (3 times per second): Indicates that your Patch is not recording. Call Customer Support at 1-888-693-2401. 9 Troubleshooting Traveling Patch Removal FAQs Using ZIO SR About the ZIO ® SR recording system What is the Patch doing? The Pat…

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External Photos

IRHYTHM TECHNOLOGIES, INC. ZIO® SR PATCH FCC ID: 2AFBP-SR15P SECTION 5 EXTERNAL PHOTOS CONFIDENTIAL 6.1 iRhythm ZIO SR Patch External Photos IRHYTHM TECHNOLOGIES, INC. ZIO® SR PATCH FCC ID: 2AFBP-SR15P SECTION 5 EXTERNAL PHOTOS CONFIDENTIAL

ID Label/Location Info

FILE: K101A3002.01 Type BF applied part 1.888.693.2401 iRhythm Technologies, Inc. Patents Pending FCC ID: 2AFBP-SR15PModel: K101A5001

Internal Photos

IRHYTHM TECHNOLOGIES, INC. ZIO® SR PATCH FCC ID: 2AFBP-SR15P SECTION 6 INTERNAL PHOTOS CONFIDENTIAL 6.1 iRhythm ZIO SR Patch Internal Photos IRHYTHM TECHNOLOGIES, INC. ZIO® SR PATCH FCC ID: 2AFBP-SR15P SECTION 6 INTERNAL PHOTOS CONFIDENTIAL IRHYTHM TECHNOLOGIES, INC. ZIO® SR PATCH FCC ID: 2AFBP-SR15P SECTION 6 INTERNAL PHOTOS CONFIDENTIAL IRHYTHM TECHNOLOGIES, INC. ZIO® SR PATCH FCC ID: 2AFBP-SR15P SECTION 6 INTERNAL PHOTOS CONFIDENTIAL

RF Exposure Info

CETECOM Inc. 411 Dixon Landing Road  Milpitas, CA 95035  U.S.A. Phone: + 1 (408) 586 6200  Fax: + 1 (408) 586 6299  E-mail: [email protected]  http://www.cetecom.com CETECOM Inc. is a Delaware Corporation with Corporation number: 2905571 V5.2 2013-02-15 © Copyright by CETECOM SAR Exclusion Report FOR: Manufacturer: iRhythm Technologies Model Number: K101A5001 FCC ID: 2AFBP-SR15P Test Report #: SAR_IRHYT-002-15001_FCC Date of Report: October 9, 2015 Test Report #: SAR_IRHYT-002-15001_FCC FCC ID: 2AFBP-SR15P Date of Report: October 9, 2015 Page 2 of 6 V1.0 2015-05-03 This report shall not be reproduced except in full without the written approval of: CETECOM Inc.  SAR  411 Dixon Landing Road  Milpitas, CA 95035  U.S.A. TABLE OF CONTENTS 1. Assessment ................................................................................................................................................................ 3 2. Administrative Data .................................................................................................................................................... 4 2.1. Identification of the Testing Laboratory Issuing the SAR Test Report ................................................... 4 2.2. Identification of the Client ..................................................................................................................... 4 2.3. Identification of the Manufacturer ......................................................................................................... 4 3. Equipment under Test (EUT) ..................................................................................................................................... 5 3.1. General Specification of the Equipment under Test .............................................................................. 5 3.1. Antenna Information ............................................................................................................................. 5 3.2. Technical Specification of Supported Radios ........................................................................................ 5 4. Subject of Investigation ............................................................................................................................................. 6 4.1. The FCC Exposure Criteria .................................................................................................................... 6 5. Stand-Alone SAR Evaluation Exclusion ................................................................................................................... 6 6. Report History ............................................................................................................................................................. 6 Test Report #: SAR_IRHYT-002-15001_FCC FCC ID: 2AFBP-SR15P Date of Report: October 9, 2015 Page 3 of 6 V1.0 2015-05-03 This report shall not be reproduced except in full without the written approval of: CETECOM Inc.  SAR  411 Dixon Landing Road  Milpitas, CA 95035  U.S.A. 1. Assessment The following device was evaluated against the limits for general population uncontrolled exposure specified in FCC 2.1093 according to SAR evaluation exclusion requirements specified in FCC regulation as listed in KDB 447498 and no deviations were ascertained during the course of the assessment. Manufacturer Description Model # iRhythm Technologies ZIO SR ECG Patch K101A5001 Responsible for Testing Laboratory: October 9, 2015 Compliance Josie Sabado (Test Lab Manager) Date Section Name Signature Responsible for the Report: October 9, 2015 Compliance James Donnellan (Sr. EMC Engineer) Date Section Name Signature The test results of this test report relate exclusively to the test item specified in Section 3. CETECOM Inc. USA does not assume responsibility for any conclusions and generalizations drawn from the test results with regard to other specimens or samples of the type of the equipment represented by the test item. The test report may only be reproduced or published in full. Reproduction or publication of extracts from the report requires the prior written approval of CETECOM Inc. USA. Test Report #: SAR_IRHYT-002-15001_FCC FCC ID: 2AFBP-SR15P Date of Report: October 9, 2015 Page 4 of 6 V1.0 2015-05-03 This report shall not be reproduced except in full without the written approval of: CETECOM Inc.  SAR  411 Dixon Landing Road  Milpitas, CA 95035  U.S.A. 2. Administrative Data 2.1. Identification of the Testing Laboratory Issuing the SAR Test Report Company Name CETECOM Inc. Department Compliance Address 411 Dixon Landing Road Milpitas, CA 95035 U.S.A. Telephone +1 (408) 586 6200 Fax +1 (408) 586 6299 Test Lab Manager Josie Sabado Responsible Project Manager James Devasia 2.2. Identification of the Client Applicant’s Name iRhythm Technologies Street Address 650 Townsend St., Ste 380 City/Zip Code San Francisco, CA 94103 Country USA 2.3. Identification of the Manufacturer Same as above client. Test Report #: SAR_IRHYT-002-15001_FCC FCC ID: 2AFBP-SR15P Date of Report: October 9, 2015 Page 5 of 6 V1.0 2015-05-03 This report shall not be reproduced except in full without the written approval of: CETECOM Inc.  SAR  411 Dixon Landing Road  Milpitas, CA 95035  U.S.A. 3. Equipment under Test (EUT) 3.1. General Specification of the Equipment under Test Model No: K101A5001 FCC ID: 2AFBP-SR15P Product Type: Portable RF Exposure Environment: General / Uncontrolled Exposure Conditions: Body Worn Supported Radios: Bluetooth LE (v4.0) 3.1. Antenna Information Antenna Type Frequency (MHz) Manufacturer Stated Max Peak Gain (dBi) Bluetooth Trace Antenna 2400 – 2483.5 2 3.2. Technical Specification of Supported Radios Signal Type Duty Cycle Type(s) of Modulation Uplink Transmit Frequency Range (MHz) Declared Maximum Conducted Output Power (dBm) Bluetooth 4.0 63% GFSK 2400 – 2483.5 0 Test Report #: SAR_IRHYT-002-15001_FCC FCC ID: 2AFBP-SR15P Date of Report: October 9, 2015 Page …

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Test Report

FCC listed A2LA Accredited IC recognized # 3462B CETECOM Inc. 411 Dixon Landing Road  Milpitas, CA 95035  U.S.A. Phone: + 1 (408) 586 6200  Fax: + 1 (408) 586 6299  E-mail: [email protected]  http://www.cetecom.com CETECOM Inc. is a Delaware Corporation with Corporation number: 2905571 V3.0 2010-10-30 © Copyright by CETECOM FCC Test Report FOR: iRhythm Technologies Model Name / Model #: ZIO SR / K101A5001 Product Description: ZIO SR ECG Patch FCC ID: 2AFBP-SR15P 47 CFR Part 15.247 (DTS) TEST REPORT #: EMC_IRHYT-002-15001_15.247_BTLE-Rev1 DATE: 2015-Oct-09 Test Report #: EMC_IRHYT-002-15001_15.247_BTLE-Rev1 FCC: 2AFBP-SR15P Date of Report : 2015-10-07 Page 2 of 55 TABLE OF CONTENTS 1 Assessment ......................................................................................................................................... 4 2 Administrative Data .......................................................................................................................... 5 2.1 Identification of the Testing Laboratory Issuing the Test Report............................................................. 5 2.2 Identification of the Client ........................................................................................................................ 5 2.3 Identification of the Manufacturer ............................................................................................................ 5 3 Equipment under Test (EUT) .......................................................................................................... 6 3.1 Specification of the Equipment under Test .............................................................................................. 6 3.2 Identification of the Equipment under Test (EUT)................................................................................... 7 3.3 Identification of Accessory equipment ..................................................................................................... 7 3.4 Identification of Ancillary equipment: .................................................................................................... 7 3.5 Environmental conditions during Test: .................................................................................................... 7 3.6 Dates of Testing: ....................................................................................................................................... 7 3.7 Test mode of operation: ............................................................................................................................ 7 4 Subject Of Investigation ................................................................................................................... 8 4.1 Summary of Measurement Results ........................................................................................................... 9 5 Measurement Uncertainty .............................................................................................................. 10 5.1 Environmental conditions during Test: .................................................................................................. 10 5.2 Dates of Testing: ..................................................................................................................................... 10 6 Measurements .................................................................................................................................. 11 6.1 Radiated Measurement ........................................................................................................................... 11 6.1.1 Sample Calculations for Field Strength Measurements ..................................................................... 14 6.2 Power Line Conducted Measurement Procedure.................................................................................... 14 7 Maximum Conducted Output Power and EIRP .......................................................................... 15 7.1 Limits: ..................................................................................................................................................... 15 7.2 Test Conditions: ...................................................................................................................................... 15 7.3 Test Procedure ........................................................................................................................................ 15 7.4 Test Data ................................................................................................................................................. 16 7.5 Measurement Result ............................................................................................................................... 16 7.6 Measurement Plots:................................................................................................................................. 17 8 Power Spectral Density ................................................................................................................... 21 8.1 Limits: ..................................................................................................................................................... 21 8.2 Test Conditions: ...................................................................................................................................... 21 8.3 Measurement procedure .......................................................................................................................... 21 8.4 Test Data: ................................................................................................................................................ 22 8.5 Measurement Result: .............................................................................................................................. 22 8.6 Measurement Plots:................................................................…

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Test Setup Photos

Project #: EMC_IRHYT-002-15001_15.247_BTLE_Pics FCC ID: 2AFBP-SR15P Date of Report : Oct10, 2015 Page 1 of 5 Test Setup Photographs Model Number: K101A5001 Product Description: ZIO SR ECG Patch Manufacturer: iRhythm Technologies FCC ID: 2AFBP-SR15P Test Site Information: CETECOM Inc. Milpitas, CA USA Project #: EMC_IRHYT-002-15001_15.247_BTLE_Pics FCC ID: 2AFBP-SR15P Date of Report : Oct10, 2015 Page 2 of 5 Radiated Spurious Emissions Test Setup: 9KHz – 30 MHz Project #: EMC_IRHYT-002-15001_15.247_BTLE_Pics FCC ID: 2AFBP-SR15P Date of Report : Oct10, 2015 Page 3 of 5 30M-1GHz measurement setup: Project #: EMC_IRHYT-002-15001_15.247_BTLE_Pics FCC ID: 2AFBP-SR15P Date of Report : Oct10, 2015 Page 4 of 5 >1GHz measurement setup:  Project #: EMC_IRHYT-002-15001_15.247_BTLE_Pics FCC ID: 2AFBP-SR15P Date of Report : Oct10, 2015 Page 5 of 5 >18 GHz measurement setup:

Contact Information

Applicant

Brice Bobzien(CFO)
[email protected]4156325700Fax: 8886932402

Test Firm

CETECOM Inc.Meinolf Glunz
[email protected]408-586-6301

Technical Specifications

#Rule PartsFrequency RangePower Output
115C2.40 GHz - 2.48 GHz1 W
Confidentiality
Long Term
Grant Notes
Output power is rms conducted.

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