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User Manual | Users Manual | 393.08 KiB | April 13 2023 / October 10 2023 | delayed release | ||
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1 | User Manual | Users Manual | 393.08 KiB | April 13 2023 / October 10 2023 | delayed release |
Zio MCT IMPORTANT INFORMATION CONFIDENTIAL - DRAFT ABOUT THE ZIO MCT Zio MCT data analysis Your Zio MCT data is analyzed at the iRhythm Clinical Centers. iRhythm is an Independent Diagnostic Testing Facility (IDTF) dedicated to providing world-class diagnostic service. As an IDTF, we adhere to Medicare Independent Diagnostic Testing Facility Performance Standards. A link to these standards (42 C.F.R. Section 410.33) can be found at the iRhythm website www.irhythmtech.com. Patient identification Before placing your device in the prepaid envelope, please write your name on the line above the return address. By writing your name on the envelope you are providing another method of identification for the Patch and Gateway and are consenting to the potential viewing of your name on the envelope. You may choose to not write your name on the envelope. Notice of privacy practices As participants in your health care, we are required by applicable federal and state law to maintain the privacy of your Protected Health Information (PHI). Our full Notice of Privacy Practices, found at www.irhythmtech. com, describes our privacy practices, our legal duties, and your rights concerning your PHI. Indications for use The Zio MCT ECG Monitoring System is intended to capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram (ECG) information for long-term monitoring. While continuously recording patient ECG, both patient-triggered and automatically detected arrhythmia events are transmitted to a monitoring center for reporting. After wear, a final report is generated based on 2 CONFIDENTIAL - DRAFT beat-to-beat information from the entire ECG recording. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-
headedness, pre-syncope, syncope, fatigue, or anxiety. The reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience. It is not intended for use on critical care patients. Contraindications Do not use Zio MCT for patients with symptomatic episodes where variations in cardiac performance could result in immediate danger to the patient or when real-
time or in- patient monitoring should be prescribed. Do not use the Zio MCT for patients with known history of life-threatening arrhythmias. Do not use the Zio MCT in combination with external cardiac defibrillators or high frequency surgical equipment near strong magnetic fields or devices such as MRI. Do not use the Zio MCT on patients with neuro-
stimulator, as it may disrupt the quality of ECG data. Do not use the Zio MCT on patients who do not have the competency to wear the device for the prescribed monitoring period. Warnings Do not use the Zio MCT Patch on patients with known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies. Patient may experience skin irritation. Do not reuse the Zio MCT Patch on multiple patients. It is a single patient use device. Reuse will cause incorrect patient data and patient may experience skin irritation. Do not use the Zio MCT on patients residing in areas with limited to no cellular reception. CONFIDENTIAL - DRAFT 3 Do not modify the Zio MCT system. 4 CONFIDENTIAL - DRAFT Warnings (contd) The Zio MCT system is MR Unsafe!
-Do not expose the Zio MCT patch or gateway to a magnetic resonance (MR) environment.
-The Zio MCT patch or gateway may present a risk of projectile injury due to the presence of ferromagnetic materials that can be attracted by the MR magnet core.
-Thermal injury and burns may occur due to the metal components of the Zio MCT patch that can heat during MR scanning.
-The Zio MCT patch may generate artifacts in the MR image.
-The Zio MCT patch or gateway may not function properly due to the strong magnetic and radiofrequency fields generated by the MR scanner. If skin irritation such as severe redness, itching or allergic symptoms develop, remove the Zio MCT Patch from the patients chest. Call iRhythm Customer Care at 1.888.693.2401 CAUTION: Federal (USA) law restricts the sale of this device to or on the order of a physician. Precautions Safety and effectiveness of the Zio MCT Patch on patients receiving any form of pacing therapy has not been established. Paced cardiac rhythms may not be accurately detected and may be incorrectly classified. Safety and effectiveness of the Zio MCT system on pediatric patients (younger than 18 years old) has not been established. The Zio MCT system includes temperature and humidity limitations when stored/transported. If exposed during storage/transport, patients may experience degradation of adhesive performance causing the Zio MCT patch to slip or fall off during the patient wear duration. CONFIDENTIAL - DRAFT 5 The Zio MCT system has a shelf-life date. Use of expired device may cause a degradation of ECG signal quality and/or low battery condition. Do not use the Zio MCT system if package is damaged. Device may not perform as intended. Keep device and packaging away from young children. Contents may be harmful if swallowed. Patch contains button cell batteries that are not accessible during normal use but, if exposed, are known choking hazards and may cause severe tissue injury if ingested. Registration errors may result in limited functionality or erroneous ECG reporting. Utmost caution should be applied to ensure that patient registration is accurate and complete. The patient is an intended operator Package Contents 1 Zio MCT patch 1 Zio MCT gateway, containing:
1 postage-paid return envelope 1 Skin Prep & Placement Kit containing:
1 patch card template 1 disposable razor 1 abrader disc 4 alcohol wipes 1 Application instructions 1 Wearing your Zio manual & button press log containing:
1 adhesive remover wipe 6 CONFIDENTIAL - DRAFT Symbols Glossary SYMBOL STANDARD REFERENCE STANDARD TITLE ISO 15223-1 Clause 5.1.1 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied ISO 7000-3082 Graphical symbols for use on equipment ISO 15223-1 Clause 5.1.3 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied ISO 7000-2497 Graphical symbols for use on equipment ISO 15223-1 Clause 5.1.4 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied ISO 7000-2607 Graphical symbols for use on equipment ISO 15223-1 Clause 5.1.5 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied ISO 7000-2492 Graphical symbols for use on equipment ISO 15223-1 Clause 5.1.6 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied ISO 7000-2493 Graphical symbols for use on equipment ISO 15223-1 Clause 5.1.7 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied ISO 7000-2498 Graphical symbols for use on equipment ISO 15223-1 Clause 5.3.4 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied ISO 7000-0626 Graphical symbols for use on equipment ISO 15223-1 Clause 5.3.7 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied ISO 7000-0632 Graphical symbols for use on equipment ISO 15223-1 Clause 5.3.8 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied ISO 7000-2620 Graphical symbols for use on equipment CONFIDENTIAL - DRAFT 7 Manufacturer Indicates the medical device manufacturer. Date of manufacture Indicates the date when the medical device was manufactured Use-by date Batch code Indicates the date after which the medical device is not to be used. Indicates the manufacturers batch code so that the batch or lot can be identified. Catalogue number Indicates the manufacturers catalogue number so that the medical device can be identified. Serial number Indicates the manufacturers serial number so that a specific medical device can be identified. Keep dry Indicates a medical device that needs to be protected from moisture. Temperature limit Indicates the temperature limits to which the medical device can be safely exposed. Humidity limitation Indicates the range of humidity to which the medical device can be safely exposed. 8 CONFIDENTIAL - DRAFT Symbols Glossary (contd) SYMBOL STANDARD REFERENCE STANDARD TITLE ISO 15223-1 Clause 5.4.2 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied ISO 7000-1051 Graphical symbols for use on equipment ISO 15223-1 Clause 5.4.3 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied ISO 7000-1641 Graphical symbols for use on equipment IEC 60601-1 Table D.1, Symbol 11 ISO 15223-1 Clause 5.4.4 Medical electrical equipment Part 1: General requirements for basic safety and essential performance Medical devices Symbols to be used with medical device labels, labelling and informa-
tion to be supplied ISO 7000-0434 Graphical symbols for use on equipment IEC 60601-1 Table D.1, Symbol 10 Medical electrical equipment Part 1: General requirements for basic safety and essential performance ISO 15223-1 Clause 5.7.1 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied IEC 60417-5140 Graphical symbols for use on equipment IEC 60601-1-2:2014, Clause 5.1.1 Medical electrical equipment Part 1-2:
General requirements for basic safety and essential performance Collateral standard:
Electromagnetic compatibility Requirements and tests IEC/TR 60878-5140 Graphical symbols for electrical equipment in medical practice IEC 60417-5333 Graphical symbols for use on equipment IEC 60601-1, Table D.1, Symbol 20 ASTM F2503-13 Medical electrical equipment Part 1: General requirements for basic safety and essential performance Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment CONFIDENTIAL - DRAFT 9 Do not re-use Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. Consult instructions for use Indicates the need for the user to consult the instructions for use. Caution Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself. Patient number Indicates a unique number associated with an individual patient. Non-ionizing electromagnetic radiation To indicate generally elevated, potentially hazardous, levels of nonionizing radiation, or to indicate equipment or systems e.g. in the medical electrical area that include RF transmitters or that intentionally apply RF electromagnet-
ic energy for diagnosis or treatment. Type BF Applied Part To identify a type BF applied part complying with IEC 60601-1. Magnetic Resonance (MR) unsafe Keep away from magnetic resonance imaging (MRI) equipment. 10 CONFIDENTIAL - DRAFT Symbols Glossary (contd) SYMBOL STANDARD REFERENCE BS EN 50419:2006 STANDARD TITLE Marking of electrical and electronic equipment in accordance with article 11(2) of Directive 2002/96/EC (WEEE) IEC 60601-1, Table D.3 Symbol 2 IEC 60529 Medical electrical equipment Part 1: General requirements for basic safety and essential performance Degrees of Protection Provided by Enclosures
(IP Code) 21 CFR 801.15(c)(1)(i)F Labeling-Medical devices; prominence of required label statements CONFIDENTIAL - DRAFT 11 Separate Collection To indicate that the product shall be separated when disposed. Degrees of protection provided by enclosure Manufacturer-determined degree of particle and water ingress protection, where:
N1 = Degrees of protection against access to hazardous parts N2 = Degrees of protection against water Protected against solid foreign objects of 12,5 mm diameter and greater, and protected against splashing water Protected against solid foreign objects of 12,5 mm diam-
eter and greater, and protected against vertically falling water drops when enclosure tilted up to 15 Prescription only Requires prescription in the United States 12 CONFIDENTIAL - DRAFT Asymptomatic Arrhythmia Detection Asymptomatic arrhythmia events, as detected and transmitted during the monitoring period, are defined by the following parameters:
Rhythm Heart Rate Duration Atrial Fibrillation Ventricular Tachycardia Supraventricular Tachycardia Pause 40 bpm 60 seconds Between 40 180bpm 60 seconds until first documentation of AF 180 bpm 60 seconds 120 bpm 30 seconds 150 bpm 10 seconds 180 bpm 60 seconds
4 seconds 3 seconds back-to-back Complete Heart Block 50 bpm 6 beats Sinus Tachycardia 200 bpm 60 seconds Sinus Bradycardia 30 bpm 60 seconds CONFIDENTIAL - DRAFT 13 PATCH PERFORMANCE CHARACTERISTICS ECG Channels 1 channel Memory capacity Recording Format Service Life Shelf Life
> 14 days Continuous Up to 14 days 6 months ELECTRICAL CHARACTERISTICS Medical Equipment Type BF Applied Part ECG Frequency Response 0.4 Hz to 40 Hz ECG Input Impedance ECG Differential Range ECG A/D Sampling Rate ECG Resolution Patch Short-range RF Transmit/Receive
>10 M 1.65mV 200 Hz 15.5 bits Bluetooth Low Energy 2.4GHz ISM Band (2400-
2483.5 MHz) Patch Receiver Frequency Band 2402-2480 MHz Patch Receive Channel Bandwidth 2 MHz Patch Transmitter Frequency Band 2402-2480 MHz Patch Effective Radiated Power
< 1 mW Patch Frequency Modulation 1-Mbps GFSK Gateway Short-range RF Transmit/Receive Gateway Receiver Frequency Band Bluetooth Low Energy 2.4 GHz ISM Band (2400-
2483.5 MHz) 2402-2480 MHz 14 CONFIDENTIAL - DRAFT Gateway Receive Channel Bandwidth 2 Mhz Gateway Transmitter Frequency Band 2402-2480 MHz Gateway Effective Radiated Power
< 1 mW Gateway Frequency Modulation 1-Mbps GFSK Gateway Cellular RF Transmit/
Receive LTE Cat M1 Gateway Downlink Frequency Band 746-756 MHz Gateway Downlink Frequency Modulation Gateway Receive Channel Bandwidth OFDMA 1.4 Mhz Gateway Uplink Frequency Band 777-787 MHz Gateway Uplink Frequency Modulation Gateway Effective Radiated Power SC-FDMA
< 200 mW CONFIDENTIAL - DRAFT 15 POWER CHARACTERISTICS Patch Battery Type 1 lithium manganese dioxide coin cell Gateway Battery Type 1 Lithium Polymer Cell Battery Life
> 14 days PHYSICAL CHARACTERISTICS Patch Dimensions 5.5 2.2 0.4 in Patch Weight 10 g Gateway Dimensions 6.2 x 3.4 x 0.8 inches Gateway Weight 158 g ENVIRONMENTAL CHARACTERISTICS Operational Temperature 41 to 104 degrees F Operational Altitude
-1,000 to 10,000 ft Operational & Storage Humidity Shipping (Short-term Storage) Temperature 10% to 95%
(non-condensing)
-4 to 104 degrees F Long-term Storage Temperature 64 to 80 degrees F Storage Altitude
-1,000 to 14,000 ft Patch IP Classification Gateway IP Classification IP24 IP22 ESSENTIAL PERFORMANCE The Zio MCT system records and transmits ECG segments for analysis upon receipt at iRhythm Technologies, Inc. clinical center. In the event it cannot record or transmit as intended, the Zio MCT alerts the patient that functionality is impaired. Risks associated with failure of the device to perform as intended have been mitigated to an acceptable level. 16 CONFIDENTIAL - DRAFT EQUIPMENT CLASSIFICATION INFORMATION Patch IEC Classifications Gateway IEC Classifications Internally Powered ME Equipment Type BF Applied Part IPX4 -
Internally Powered ME Equipment
IP 22 Continuous Operation Continuous Operation Heart Rate Calculations Episode Heart Rates Overall Rhythm Heart Rates Max Min Avg Max Min Avg The maximum episode heart rate (i.e., maximum of all instantaneous heart rates within the episode) The minimum episode heart rate (i.e., minimum of all instantaneous heart rates within the episode) The average episode heart rate
(i.e., average of all instantaneous heart rates within the episode) The maximum overall heart rate (i.e., maximum of all rhythm episode maximum heart rates within the record) The minimum overall heart rate
(i.e., minimum of all rhythm episode minimum heart rates exclusive of Pause heart rates within the record) The average overall heart rate
(i.e., duration-weighted average of all rhythm episode heart rates within the record) CONFIDENTIAL - DRAFT 17 Pause Determination Pause is defined as an RR interval greater than 3 seconds. Electrical Safety and Compatibility CAUTION: The Zio MCT system needs special precautions regarding EMC and needs to be utilized according to the EMC information provided in the following tables. CAUTION: Portable and mobile RF communications equipment can affect medical electrical equipment. WARNING: The Zio MCT system should not be used adjacent to or stacked with other equipment. WARNING: The Zio MCT system may be interfered with by other equipment, even if that other equipment complies with CISPR EMISSIONS requirements. WARNING: Portable RF communications equipment
(including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Zio MCT patch or gateway. Otherwise, degradation of the performance of this equipment could result. 18 CONFIDENTIAL - DRAFT Table 1: Manufacturers declaration electromagnetic emissions The Zio MCT system is intended for use in the electromagnetic environment specified below. The customer or the user of the Zio MCT system should assure that it is used in such an environment. Emissions test Compliance RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Not applicable Voltage fluctuations/ flicker emissions IEC Not applicable CONFIDENTIAL - DRAFT 19 Table 2: Manufacturers declaration electromagnetic immunity The Zio MCT system is intended for use in the electromagnetic environment specified below. The customer or the user of the Zio MCT system should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electrostatic Discharge (ESD) IEC 61000-4-2 8 kV contact 15 kV air 8 kV contact 15 kV air Power frequency
(50/60 Hz) magnetic field IEC 61000-4-8 30 A/m 30 A/m Table 3: Manufacturers declaration electromagnetic immunity The Zio MCT system is intended for use in the electromagnetic environment specified below. The customer or the user of the Zio MCT system should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level 20 CONFIDENTIAL - DRAFT Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz outside ISM bands 3Vrms 10 Vrms 150 kHz to 80 MHz in ISM bands 10Vrms CONFIDENTIAL - DRAFT 21 Table 4: Manufacturers declaration electromagnetic immunity The Zio MCT system is intended for use in the electromagnetic environment specified below. The customer or the user of the Zio MCT system should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Continued on next page 22 CONFIDENTIAL - DRAFT Radiated RF IEC 61000-
4-3 10 V/m 28 V/m 9 V/m 28 V/m 9 V/m 10 V/m 80 MHz to 2.7 GHz 28 V/m 385, 450, 810, 870, 930 MHz 18 Hz pulse 9 V/m 710, 745, 780 MHz 217 Hz Pulse 28 V/m 1720, 1845, 1970, 2450 MHz 217 Hz pulse 9 V/m 5240, 5500, 5783 MHz 217 Hz pulse CONFIDENTIAL - DRAFT 23 24 CONFIDENTIAL - DRAFT This system complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this system may not cause harmful interference, and (2) this system must accept any interference received, including interference that may cause undesired operation. For body worn operation, this system has been tested and meets FCC RF exposure guidelines when used with an accessory that contains no metal, such as the belt clip provided, and that positions the Gateway a minimum 1 cm from the body. Use of other accessories may not ensure compliance with FCC RF exposure guidelines. Changes or modifications not expressly approved iRhythm Technologies Inc. could void the users authority to operate the equipment. The gateway has been tested and meets FCC RF exposure guidelines when used and operated for its intended purpose and as instructed in the manual. CONFIDENTIAL - DRAFT 25 iRhythm Technologies, Inc. 699 8th St., Suite 600 San Francisco, CA 94103 1.888.693.2401 irhythmtech.com
1 | ID Label | ID Label/Location Info | 166.86 KiB | April 13 2023 |
PN# LB10097 rev. 02 Zio Monitor Bottom Housing Laser Mark Page 1 of 2 SPECIFICATIONS:
NOTE CATEGORY SPECIFICATION 1 2 3 4 5 PRINT METHOD Permanent indelible high-resolution mark on the substrate surface via Keyence MD-
U1020C UV Laser Marker (ETS0167) PRINT COLOR Black (REFERENCE ONLY) ARTWORK LB10097_02.MX4 - Refer to Reference Images
(Provided by iRhythm) FONT Print using Shne Krftig font in Medium (See attached Sohne-Kraftig.otf ) INSPECTION N/A. THIS SPEC DEFINES THE LASER MARK INTENT AND DESIGN, NOT THE PHYSICAL LASER MARK. INSPECTION FOR LASER MARKING TO BE PERFORMED AT THE UPPER LEVEL PHYSICAL COMPONENT OR SUBASSEMBLY THAT USES LB10097. IRHYTHM TECHNOLOGIES, INC. CONFIDENTIAL REFERENCE IMAGES Standard (Zio monitor, Zio MCT) Configuration example SN is MMM8888MMM :
PN# LB10097 rev. 02 Zio Monitor Bottom Housing Laser Mark Page 2 of 2 Demonstration Unit Configuration (Human Readable SN and 2D code will read DEMODEVICE):
IRHYTHM TECHNOLOGIES, INC. CONFIDENTIAL
1 | Agent Authorization Letter | Cover Letter(s) | 171.86 KiB | April 13 2023 |
February 13, 2023 To whom it may concern, We, the undersigned, hereby authorize David W. Bare of NTS Labs, LLC to act on our behalf, as our agent, in the following matters related to the FCC and/or Industry Canada approval of our products: report submittal, related correspondence, the signing of all documents relating to these matters, and any other lawful activity necessary to obtain such certification. Any act carried out by NTS Labs, LLC within the scope of this authorization shall have the same affect as our own. This authorization shall expire 12 months from original date. Sincerely, Brice Bobzien Chief Financial Officer DocuSign Envelope ID: 820006C0-BB8A-426D-9F7B-E6774E86B630
1 | Antenna Info | Operational Description | 3.96 MiB | April 13 2023 |
WARNING:pdfminer.pdfpage:The PDF <_io.BufferedReader name='/Volumes/Scratch/Incoming/eg-scratch/6473390.pdf'> contains a metadata field indicating that it should not allow text extraction. Ignoring this field and proceeding. Use the check_extractable if you want to raise an error in this case 41039 Boyce Road Fremont, CA. 94538 510-578-3500 Phone Over the Air Pseudo Active Antenna Measurements iRhythm Technologies Inc. Model: Zio MCT ECG Monitor PN: DSB0002 APPLICANT:
iRhythm Technologies Inc. 699 8th St #600 San Francisco, CA 64103 US TEST SITE(S): NTS Labs LLC 41039 Boyce Road. Fremont, CA. 94538-2435 PROJECT NUMBER:
PR134700 REPORT DATE:
September 21, 2022 REISSUE DATE: April 12, 2023 FINAL TEST DATE(S):
September 21, 2022 TOTAL NUMBER OF PAGES:
22 This report and the information contained herein represent the results of testing of only those articles / products identified in this document and selected by the client. The tests were performed to specifications and/or procedures selected by the client. NTS Labs LLC makes no representations expressed or implied that such testing fully demonstrates efficiency, performance, reliability, or any other characteristic of the articles being tested, or similar products. This report should not be relied upon as an endorsement or certification by NTS Labs LLC of the equipment tested, nor does it present any statement whatsoever as to its merchantability or fitness of the test article or similar products, for a particular purpose. This report shall not be reproduced except in full without written approval from NTS Labs LLC. Test Report FR-163245.01-OTA Rev 1"
NTS Labs LLC Report Date September 21, 2022 Project number PR163245 Reissue Date April 12, 2023 VALIDATING SIGNATORIES TECHNICAL REVIEWER:
______________________________ Deniz Demirci Senior Wireless / EMC Engineer FINAL REPORT PREPARER:
______________________________ Deniz Demirci Senior Wireless / EMC Engineer QUALITY ASSURANCE DELEGATE ______________________________ David Guidotti Senior Technical Writer Test Report FR-163245.01-OTA Rev 1 Page 2 of 22 NTS Labs LLC Report Date September 21, 2022 Project number PR163245 Reissue Date April 12, 2023 REVISION HISTORY Rev #
0 1 Date September 21, 2022 April 12, 2023 Comments Draft Release Antenna gain information calculated. TRP, Directivity and Efficiency results removed. Modified By
Deniz Demirci Test Report FR-163245.01-OTA Rev 1 Page 3 of 22 NTS Labs LLC Report Date September 21, 2022 TABLE OF CONTENTS Project number PR163245 Reissue Date April 12, 2023 OVER THE AIR PSEUDO ACTIVE ANTENNA MEASUREMENTS ........................................................................................................ 1 VALIDATING SIGNATORIES .................................................................................................................................................. 2 REVISION HISTORY ................................................................................................................................................................. 3 TABLE OF CONTENTS ............................................................................................................................................................. 4 PHYSICAL LAYOUT AND SITE DESCRIPTION ................................................................................................................. 5 WIRELESS TEST FACILITY ...................................................................................................................................................... 5 ANECHOIC CHAMBER .............................................................................................................................................................. 5 MULTI AXES POSITIONING SYSTEM (MAPS) ........................................................................................................................ 5 QUIET ZONE .............................................................................................................................................................................. 6 EMQUEST SOFTWARE ............................................................................................................................................................. 6 TEST METHODS ......................................................................................................................................................................... 6 TOTAL RADIATED POWER ...................................................................................................................................................... 6 EQUIPMENT UNDER TEST (EUT) INFORMATION ........................................................................................................... 7 MODIFICATIONS .................................................................................................................................................................... 7 MEASUREMENTS ...................................................................................................................................................................... 7 TESTED BY ............................................................................................................................................................................ 13 TEST EQUIPMENT LIST ........................................................................................................................................................ 15 APPENDIX A: CHAMBER REFERENCE SETUP ............................................................................................................... 16 APPENDIX B: EUT PHOTOS .................................................................................................................................................. 17 APPENDIX C: TEST SETUP PHOTOS .................................................................................................................................. 19 END OF REPORT ...................................................................................................................................................................... 22 Test Report FR-163245.01-OTA Rev 1 Page 4 of 22 NTS Labs LLC Report Date September 21, 2022 Project number PR163245 Reissue Date April 12, 2023 Physical Layout and Site Description Wireless Test Facility All tests were performed in NTS Labs LLC state-of-the-art Wireless Test Facility consisting of a fully anechoic chamber equipped with a heavy duty pedestal turntable, a dual polarized multi-measurement antenna ring, goniometer, and two circularly polarized communication antennas. A base station simulator is used to establish communication with the EUT and place it in the proper mode and a spectrum analyzer and RF switch combination is used for measuring the signal from the EUT at each position and polarization. ETS-Lindgrens proprietary EMQuest EMQ-100 Pattern Measurement Software is used for data acquisition, post-processing and generation of the required output. Anechoic Chamber The chamber consists of a 16 ft. x 16 ft. x 16 ft. shielded enclosure and is constructed with shielded modular panel sections that are assembled with a clamping system into a self-supporting room structure. The three-quarter inch thick panels with 28 gauge galvanized steel laminates on both sides provide the best shielding effect to magnetic and electric fields and plane waves. To attenuated electromagnetic interference inside, the chamber is lined with pyramidal shaped microwave absorbers. The absorbers are treated with a FlexSorb coating to resist breakage. Lighting in the chamber is RF-filtered and consists of fiber optic LED light fixtures in the chamber ceiling. The chamber uses forced air ventilation to maintain a consistent ambient temperature. A single leaf semi-automatic pneumatic locking/unlocking RF shielded door is provided for equipment and personal access into the chamber. The Anechoic Chamber is capable of meeting RF attenuation level of over 100 dB throughout the frequency range of 200 kHz to 10 GHz. Therefore testing performed within the chamber does not interfere with other testing activities at the facility and vice versa. All power supplied to the chamber are routed through a power line filter on separate circuits. All power filters provide a minimum of 100 dB attenuation over a frequency range of 14 kHz to 18 GHz when tested per MIL STD 220A, MIL-F-15733 and UL 1283 standards. Multi Axes Positioning System (MAPS) The Multi Axes Positioning System consist a ring housing an array of 23 dual polarized antennas, a goniometer, and a heavy duty pedestal turntable. The array of dual polarized antennas support measurements over the range of 400 MHz to 6 GHz and are permanently fixed at every 15 degree along the ring with anechoic absorbing materials. This enables measurements from -165 to +165 in the Theta axis with a 1.95 m path length to the EUT. The goniometer will enable the pedestal to shift 7.5 allowing the EUT be measured at a higher angular resolution - down to 0.1 degrees. The heavy pedestal turntable allows the EUT to rotate in the Phi Axis with full 360 degree angular range. In conjunction with the EM Q-100 Pattern Measurement Software, it can perform positioning for data acquisition in both continuous and stepped movement modes. A EUT and SAM head and/or hand is positioned on the polystyrene foam pedestal to minimize RF obstruction during measurement. The electrically driven MAPS does not introduce conducted or radiated electrical noise above the ambient levels existing within the chamber. The pedestal turntable rotation and array antenna switching is controlled by EMCenter Modular RF Platform Model 7000 with IEEE-488 data/control for automation. Test Report FR-163245.01-OTA Rev 1 Page 5 of 22 NTS Labs LLC Quiet Zone Report Date September 21, 2022 Project number PR163245 Reissue Date April 12, 2023 A standard 30 cm diameter by 30 cm tall cylindrical quite zone and an extended 50 cm diameter by 36 cm tall cylindrical quiet zone for large EUT were qualified on each axis of the MAPS and polarization of the receive antenna per requirements of the CTIA test plan for Wireless Device Over-the-Air Performance. The associated effects are included in the measurement uncertainty section of this report. EMQuest Software ETS-Lindgrens EMQuest proprietary pattern measurement software is used to automate the data acquisition process and provides all post-processing calculations and data output required by the CTIA. Its parameterized test configuration system and conscientiously validated design helps to insure repeatable and correct results. Safeguards prevent data tampering and ensure that the original raw measured data is always available for review. Test Methods Total Radiated Power The Total Radiated Power (TRP) test is performed with the conical cut test method according to CTIA Test Plan for Wireless Device Over-the-Air Performance. At each position on the phi axis, the measurement antennas on the ring housing will electronically switch on and activate each measurement antenna in 15 degree increments between -165 and 165 degrees along the theta axis. The EUT will then rotate 15 degrees in the phi axis from 0-180 degrees to complete the data acquisition. Data is recorded using the spectrum analyzer for both theta and phi polarization at each position. Depending on the protocol, an appropriate filter is used in the EMQuest software to process the data per Appendix E of the CTIA Test Plan for Wireless Device Over-the-Air Performance. Upon completion of the test, the net power (Angular dependent EIRP) is calculated at each measurement point and the required values of TRP and Near Horizontal Partial Radiated Power (NHPRP) are automatically calculated. This test procedure is repeated for each channel, band, and configuration as required. Test Report FR-163245.01-OTA Rev 1 Page 6 of 22 NTS Labs LLC Report Date September 21, 2022 Project number PR163245 Reissue Date April 12, 2023 Equipment under Test (EUT) Information The sample was received on September 21, 2022 and tested on September 21, 2022. Manufacturer Model Serial number Firmware Version MODIFICATIONS iRhythm Technologies Inc DSB0002 CAA23TTAYV SFW0210.02 No modifications were made to the EUT during the time the product was at NTS Labs LLC. Measurements Test summary EUT serial number CAA23TTAYV Peak EIRP (dBm) Frequency (MHz) 2440
-7.1 2480
-8.3 2402
-7.4 Conducted RF (dBm) Frequency (MHz) 2440
-8 2480
-7.9 2402
-8.1 Antenna gain (dBi) Frequency (MHz) 2440 0.9 2402 0.7 2480
-0.4 Note: Antenna gain (dBi) = Peak EIRP (dBm) Conducted RF (dBm) RBW: 3 MHz VBW: 10 MHz Detector: RMS Span: Zero span Sweep time: 0.7 ms Point per trace: 10001 Trigger mode: Video Test Report FR-163245.01-OTA Rev 1 Page 7 of 22 NTS Labs LLC Report Date September 21, 2022 Project number PR163245 Reissue Date April 12, 2023 SN: CAA23TTAYV 2402 MHz Test Report FR-163245.01-OTA Rev 1 Page 8 of 22 NTS Labs LLC Report Date September 21, 2022 Project number PR163245 Reissue Date April 12, 2023 SN: CAA23TTAYV 2440 MHz Test Report FR-163245.01-OTA Rev 1 Page 9 of 22 NTS Labs LLC Report Date September 21, 2022 Project number PR163245 Reissue Date April 12, 2023 SN: CAA23TTAYV 2480 MHz Test Report FR-163245.01-OTA Rev 1 Page 10 of 22 NTS Labs LLC Report Date September 21, 2022 Project number PR163245 Reissue Date April 12, 2023 SN: CAA23TTAYV 2402 MHz Test Report FR-163245.01-OTA Rev 1 Page 11 of 22 NTS Labs LLC Report Date September 21, 2022 Project number PR163245 Reissue Date April 12, 2023 SN: CAA23TTAYV 2440 MHz Test Report FR-163245.01-OTA Rev 1 Page 12 of 22 NTS Labs LLC Report Date September 21, 2022 Project number PR163245 Reissue Date April 12, 2023 SN: CAA23TTAYV 2440 MHz TESTED BY Deniz Demirci on September 21, 2022 Test Report FR-163245.01-OTA Rev 1 Page 13 of 22 NTS Labs LLC Report Date September 21, 2022 Project number PR163245 Reissue Date April 12, 2023 TRP Measurement Uncertainty ISO/IEC 17025 requires that an estimate of the measurement uncertainties associated with the emissions test results be included in the report. The measurement uncertainties given below are based on a 95%
confidence level and were calculated in accordance with UKAS document LAB 34. Free Space Standard Uncertainty, u Expanded Uncertainty, U, with 95% Confidence Interval LTE / WLAN / BT 2300 - 2800 MHz 0.5 dB 1.1 dB WLAN 5150 - 5825 MHz 0.6 dB 1.3 dB Laptops over 30 cm Standard Uncertainty, u Expanded Uncertainty, U, with 95% Confidence Interval 2300 - 2800 MHz 5150 - 5825 MHz 0.6 dB 1.2 dB 0.8 dB 1.5 dB Alternate Methods (Worst Case) Free Space Standard Uncertainty, u Expanded Uncertainty, U, with 95% Confidence Interval 2300 - 2800 MHz 5150 - 5825 MHz 0.6 dB 1.2 dB 0.7 dB 1.3 dB Laptops over 30 cm Standard Uncertainty, u Expanded Uncertainty, U, with 95% Confidence Interval 2300 - 2800 MHz 5150 - 5825 MHz 0.6 dB 1.3 dB 0.8 dB 1.5 dB Test Report FR-163245.01-OTA Rev 1 Page 14 of 22 NTS Labs LLC Report Date September 21, 2022 Project number PR163245 Reissue Date April 12, 2023 Test Equipment List TYPE OF EQUIPMENT MODEL NUMBER MANUFACTURER Asset #
CALIBRATION DATE 10/26/2021 CALIBRATION DUE DATE 10/26/2022 Anechoic Chamber Reference Sleeve Dipole Antenna Multi-Antenna Array with 23 Dual Polarized Antennas
(400 MHz - 6 GHz) Circularly Polarized Communication Antenna Antenna Position Controller /
RF Switch Desktop Computer Pattern Measurement Software AMS 8923-195 ETS-Lindgren WC062429 3126-2500 ETS-Lindgren WC064964 10/05/2021 10/05/2023 11870-1 ETS-Lindgren WC062429 N/R 3102, 3102L ETS-Lindgren WC062429 EMCenter 7000-001 ETS-Lindgren WC062429 Dell Workstation Tower 5810 EMQuesttm EMQ-
100 Dell Computer WC072264 ETS-Lindgren
N/R N/R N/R N/R N/R N/R N/R N/R N/R Signal analyzer FSV Rhode & Schwarz WC064873 05/12/2022 05/12/2023 Note:
N/A = Equipment does not need to be calibrated. N/R = Equipment is not required to be calibrated, due to the fact that it is included in the chamber calibration Test Report FR-163245.01-OTA Rev 1 Page 15 of 22 NTS Labs LLC Report Date September 21, 2022 Project number PR163245 Reissue Date April 12, 2023 APPENDIX A: Chamber Reference Setup RF Absorbers 23 Measurement Antennas Z EUT X Y Communication Antenna Communication Antenna Test Report FR-163245.01-OTA Rev 1 Page 16 of 22 NTS Labs LLC Report Date September 21, 2022 APPENDIX B: EUT Photos Project number PR163245 Reissue Date April 12, 2023 Test Report FR-163245.01-OTA Rev 1 Page 17 of 22 NTS Labs LLC Report Date September 21, 2022 Project number PR163245 Reissue Date April 12, 2023 EUT Photos Test Report FR-163245.01-OTA Rev 1 Page 18 of 22 NTS Labs LLC Report Date September 21, 2022 Project number PR163245 Reissue Date April 12, 2023 APPENDIX C: Test Setup Photos Test Report FR-163245.01-OTA Rev 1 Page 19 of 22 Z NTS Labs LLC Report Date September 21, 2022 Test Setup Photos Project number PR163245 Reissue Date April 12, 2023 Z Y X Test Report FR-163245.01-OTA Rev 1 Page 20 of 22 NTS Labs LLC Report Date September 21, 2022 Test Setup Photos Project number PR163245 Reissue Date April 12, 2023 Test Report FR-163245.01-OTA Rev 1 Page 21 of 22 NTS Labs LLC Report Date September 21, 2022 Project number PR163245 Reissue Date April 12, 2023 End of Report This page is intentionally blank and marks the last page of this test report. Test Report FR-163245.01-OTA Rev 1 Page 22 of 22
1 | Attestation regarding covered equipment | Attestation Statements | 215.67 KiB | April 13 2023 |
March 16, 2023 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Re: Attestation regarding covered equipment and the Covered List FCC ID: 2AFBP-MCT22P To whom it may concern, Per 2.911(d)(5)(i), iRhythm Technologies, Inc. certifies that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Per 2.911(d)(5)(ii), iRhythm Technologies, Inc. certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List as an entity producing covered equipment. Sincerely, Brice Bobzien Chief Financial Officer DocuSign Envelope ID: 15265A8F-DC94-4D0C-AF7E-737A89DD1851
1 | Cover letter | Cover Letter(s) | 60.32 KiB | April 13 2023 |
41039 Boyce Road Fremont, CA. 94538 510-578-3500 Phone October 13, 2022 Federal Communications Commission Office of Engineering and Technology Laboratory Division 7435 Oakland Mills Road Columbia, MD 21046 FCC ID: 2AFBP-MCT22P To whom it may concern:
The enclosed documents constitute a formal submittal and application for FCC Equipment Authorization (original certification) for a medical patch with Bluetooth Low Energy (BLE) transceiver pursuant to the following rules:
Subpart C of Part 15 of FCC Rules (CFR 47), 15.247 NTS Labs, LLC, as duly authorized agent prepared this submittal. A copy of the letter of our appointment as agent is included with the application. If there are any questions or if further information is needed, please contact National Technical Systems for assistance. Sincerely, David W. Bare Chief Engineer DWB/dmg Page 1 of 1
1 | Request for Confidentiality | Cover Letter(s) | 228.35 KiB | April 13 2023 |
Request for Confidentiality September 21, 2022 Subject: Confidentiality Request for: 2AFBP-MCT22P Pursuant to FCC 47 CRF 0.457(d) and 0.459 and/or RSP-100, the applicant requests that a part of the subject FCC and/or ISED application be held confidential. Permanent Type of Confidentiality Requested Short Term Short Term Short Term Short Term Short Term Short Term Short Term Permanent Permanent Permanent Permanent*
Exhibit Block Diagrams External Photos Internal Photos Operation Description/Theory of Operation Schematics Test Setup Photos Users Manual iRhythm Technologies, Inc. has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to
"competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality:
The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality:
The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of 180 days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify FCC in the event information regarding the product or the product is made available to the public. FCC will then release the documents listed above for public disclosure pursuant to FCC KDB 726920 D01. The applicant understands that until such time that Innovation Science and Economic Development Canada distinguishes between Short Term and Permanent Confidentiality, either type of marked exhibit above will simply be marked Confidential when submitted to ISED. Sincerely, By:
(Signature/Title)
(Printed name) DocuSign Envelope ID: D837F816-7322-4C3C-A665-280AE8A7AC58Brice BobzienCFO
1 | Test Setup Photos | Test Setup Photos | 926.48 KiB | April 13 2023 / October 10 2023 | delayed release |
1 | US Agent Attestation | Attestation Statements | 180.31 KiB | April 13 2023 |
March 16, 2023 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Re: section 2.911(d)(7) filing To whom it may concern, This letter is to confirm that Brice Bobzien has accepted responsibility to act as the agent for service of process as acknowledged by the applicant, iRhythm Technologies, Inc. Brice Bobzien confirms he is not associated with or part of any TCB or test lab. U.S. Agent: Brice Bobzien Title: Chief Financial Officer Company Name:
iRhythm Technologies, Inc. Address: 699 8th Street, Suite 600, San Francisco, CA 94103 Telephone No: 415-632-5700 Email: brice.bobzien@irhythmtech.com FRN (FCC Registration Number):
0024652950 The applicant accepts and acknowledges the obligation to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. Signature of Applicant: iRhythm Technologies, Inc.
(must be signed by the contact of record in the FCC database for the applicant grantee code):
Signature of U.S. Agent (if different from applicant): N/A Name: Brice Bobzien Date: March 16, 2023 Name: N/A Date: N/A DocuSign Envelope ID: B773A352-C3EF-4F15-900B-00688309474C
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2023-04-13 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2023-04-13
|
||||
1 | Applicant's complete, legal business name |
iRhythm Technologies, Inc.
|
||||
1 | FCC Registration Number (FRN) |
0024652950
|
||||
1 | Physical Address |
699 8th Street
|
||||
1 |
San Francisco, California 94103
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
j******@element.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2AFBP
|
||||
1 | Equipment Product Code |
MCT22P
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
B**** B****
|
||||
1 | Title |
CFO
|
||||
1 | Telephone Number |
41563********
|
||||
1 | Fax Number |
88869********
|
||||
1 |
b******@irhythmtech.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 10/10/2023 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Zio MCT ECG Patch Monitor | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output power is conducted | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
NTS Labs, LLC Fremont & Newark
|
||||
1 | Name |
D**** B******
|
||||
1 | Telephone Number |
510-5********
|
||||
1 | Fax Number |
510 5********
|
||||
1 |
d******@nts.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0002000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC