iRhythm Technologies AT18G Zio AT Gateway User Manual 2

iRhythm Technologies, Inc. Zio AT Gateway 2

User Manual 2

CLINICAL REFERENCE MANUAL
1.888.693.2401 • zioreports.comDescription ........................................................2Indications for Use ..................................................3Contraindications ...................................................3Warnings ..........................................................4Package Contents ..................................................6Device Diagrams ...................................................7Account Setup ......................................................8During Patient Visit .................................................8 Registration .....................................................8Application Instructions .............................................8During Monitoring ..................................................8Reports ...........................................................9 Zio AT Reports ...................................................9Asymptomatic Arrhythmia Detection .................................10Troubleshooting ...................................................11 Frequently Asked Questions .......................................11 Healthcare Provider Questions .................................11 Patient Questions .............................................12 Troubleshooting the Patch ........................................17 Troubleshooting the Gateway ......................................18Zio AT Service Notes ...............................................19 ................................20Notice of Privacy Practices (NOPP) ...................................21Cybersecurity Measures and Controls ................................26 ..............................................27Electrical Safety and Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30Symbols Glossary .................................................35TABLE OF CONTENTSiRhythm Technologies, Inc.650 Townsend Street, Suite 500San Francisco, CA 94103 USATel. +1.888.693.2401 (USA Only)Fax. +1.888.693.2402irhythmtech.com
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com2 3DESCRIPTIONThe Zio AT connected continuous ambulatory monitoring system (“Zio AT system”) is an electrocardiogram (ECG) monitoring system. It consists of four components: (1) Zio AT patch ECG monitor that records continuously through the entire wear period, (2) Zio AT wireless gateway that provides connectivity between the patch and the iRhythm monitoring center, (3) Zio arrhythmia detection algorithm and (4) ZioReports.com clinician portal.The Zio AT system is a single-patient-use ECG monitor that provides a continuous, single-channel recording in addition to symptomatic and asymptomatic data transmission for up to 14 days. The Zio AT patch is applied and activated by the patient. Once activated, the patch records ECG without patient interaction, with the goal of improving patient compliance via simplicity of operation. The Zio AT patch, in conjunction with the wireless gateway and the Zio arrhythmia detection algorithm, has arrhythmia auto-detection capabilities. Additionally, patients have the option of pressing a convenient trigger button which marks the continuous record and initiates a wireless transfer of a 90 second ECG strip. The wireless transfer of data is enabled by the Zio AT gateway, which requires proximity and reception but no patient interaction to transmit to the monitoring center. The patient is encouraged to document symptomatic events, which will support symptom-rhythm correlation in the Zio AT reports.At the conclusion of the wear period (up to 14 days), the patient removes the Zio AT patch and returns it, along with the gateway, by mail to an iRhythm data processing center.Upon receipt of symptomatic/asymptomatic transmissions or downloaded continuous ECG data at iRhythm’s Clinical Center (iCC), the data is processed Technician (CCT) reviews the results and generates a report.Upon explicit request from a clinician responsible for the patient’s healthcare, segments of ECG data from the continuous recording on the patch can also be wirelessly retrieved during the wear period.INDICATIONS FOR USEThe Zio AT 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           information from the entire ECG recording. It is indicated for use on patients             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 AT 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 Zio AT for patients with known history of life threatening arrhythmias. •                   devices such as MRI. •Do not use Zio AT on patients with a neuro-stimulator, as it may disrupt the quality of ECG data. •Do not use Zio AT on patients who do not have the competency to wear the device for the prescribed monitoring period.
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com4 5WARNINGS •Do not use the Zio AT 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 AT patch on multiple patients. It is a single patient use device. Reuse will cause incorrect patient data and patient may experience cross contamination. •Do not use Zio AT system on patients residing in areas with limited to no cellular reception. •Do not modify the Zio AT system. •The Zio AT system is MR Unsafe! oDo not expose the Zio AT patch or gateway to a magnetic resonance (MR) environment. oThe Zio AT 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. oThermal injury and burns may occur due to the metal components of the Zio AT patch that can heat during MR scanning. oThe Zio AT patch may generate artifacts in the MR image. oThe Zio AT patch or gateway may not function properly due to the         scanner.If skin irritation such as severe redness, itching or allergic symptoms develop, remove the Zio AT patch from the patient’s chest. Call iRhythm Customer Service at 1.888.693.2401CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.ELECTRICAL SAFETY COMPATABILITY •CAUTION: The Zio AT system needs special precautions regarding EMC and needs to be utilized according to the EMC information provided in the following tables. •medical electrical equipment. •WARNING: The Zio AT system should not be used adjacent to or stacked with other equipment. •WARNING: The Zio AT 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 AT patch or gateway. Otherwise, degradation of the performance of this equipment could result.PRECAUTIONS •      form of pacing therapy has not been established. Paced cardiac rhythms  •          (younger than 18 years old) has not been established. •The Zio AT system includes temperature and humidity limitations when stored/transported. If exposed during storage/transport, patients may experience degradation of adhesive performance causing the Zio AT  •The Zio AT 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 AT 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.
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com6 7PACKAGE CONTENTS1 Zio AT patch1 Application instructions 1 Important information pamphlet1 Zio AT gateway, containing: • 1 postage-paid return envelope1 Wearing Your Zio manual & button press log containing: • 1 adhesive remover wipe • 1 patient consent form • 1 patient survey1 Skin preparation kit containing: • 1 patch card template • 1 disposable razor • 1 abrader disc • 4 alcohol wipesDEVICE DIAGRAMSOuter BorderAdhesive WingsElectrode ElectrodeLightZio PatchZio Gateway ExteriorAirplane Mode LightOutside Status LightZio Gateway InteriorAirplane Button Star Button Cell Connection LightPatch Connection LightReturn Envelope‘Zio’ Button
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com8 9ACCOUNT SETUP            management system (www.zioreports.com) is assigned to the clinic.Ensure you can access iRhythm patient management system via provided username and password. If you are unable to access zioreports.com please contact iRhythm Customer Service at 1.888.693.2401DURING PATIENT VISITREGISTRATIONRegister patient online at www.zioreports.com.iRhythm may contact the patient if any additional information is required. APPLICATION INSTRUCTIONSThe Zio AT package contains instructions on how to apply the patch and activate the patch and gateway.DURING MONITORINGDuring monitoring the Zio AT device will record continuous beat to beat ECG information and transmit patient triggered and asymptomatic ECG to provide accurate arrhythmia detection.In special circumstances, when patient data needs to be accessed by the physician during the wear period, a Device Data Request can be made. In order to make a Device Data Request, the clinician should call iRhythm at 1.888.693.2401. (Note: Device Data Requests are limited by availability of remaining battery power and may not be successful late in a monitoring period.)REPORTSZIO AT REPORTSAll Zio AT Reports will be available in ZioReports.com.                                         
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com10 11ASYMPTOMATIC ARRHYTHMIA DETECTIONAsymptomatic arrhythmia events, as detected and transmitted during the Rhythm Heart Rate DurationAtrial Fibrillation  Pause--Ventricular Tachycardia  Complete Heart Block (day 05:00~23:00) < 50 bpm Complete Heart Block (night 23:00~05:00) < 47 bpm Bradycardia  Tachycardia  Sensitivity (%) AHA  AHA 98.80 99.33 99.45 99.43For each of the arrhythmias listed above, the Zio AT patch will transmit up to two ECG strips per hour.TROUBLESHOOTINGFOR CUSTOMER SUPPORT, CALL 1.888.693.2401FREQUENTLY ASKED QUESTIONSHEALTHCARE PROVIDER QUESTIONS1. A patient can wear the Zio AT patch for up to 14 days or as prescribed. Note: The Zio AT patch will not record ECG data after 14 days. Based on individual wear experiences the patient’s actual wear time may be shorter than prescribed.2.             The patient can read the Wearing your Zio Manual & Button Press Log or call Customer Service at 1.888.693.2401.3. The Zio AT patch records every heartbeat. It also automatically detects and transmits asymptomatic arrhythmias, even if the patient does not feel them.4. The patient only needs to keep the gateway within 10 feet of the patch and within range of good cellular reception. No action is required for the gateway to send symptomatic heart rhythm data other than pressing the Zio button on the patch.5. Are there tests or treatments that are not compatible with the Zio AT Yes. The following are not recommended during wear of the Zio AT patch: a. Magnetic Field(s): Magnetic Resonance Imaging (MRI); MRI Technician; Any job where the patient may be exposed to a large b. Neuromuscular Stimulators: Brain Stimulator; Neurostimulator; Spinal Stimulator; TENS UnitNOTE: Data may not be interpretable during the time the stimulators are being used. Usage is at physician’s discretion.
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com12 136.            No, the Zio AT patch should be removed if the patient requires PATIENT QUESTIONSThe Zio AT Monitoring System 7. The patch is recording every heartbeat. Your doctor will use the heart rhythm data from the patch to determine the right course of action. 8. The gateway wirelessly sends heart rhythm data recorded by your patch to iRhythm. iRhythm analyzes the data and provides a report to your doctor. 9.      devices are working. When they are working normally, the patch and 10. No. If the Zio AT patch is over the heart in a slight diagonal as shown, the positioning should be acceptable. DO NOT attempt to reapply the Zio AT patch.11. The top label may have separated. Peel the remaining white labels from the center of the Zio AT patch outward. 12. Do your best to keep the gateway in front of you and within 10 feet as much as possible. The gateway should also be kept in a place with good cellular connection.13. Yes. However, the gateway will need to be in front of your body and within 10 feet of the patch. You may also use the provided belt clip to carry the gateway. 14.          Wireless devices that use 2.4 GHz signals such as baby monitors, TV senders, and wireless routers can interrupt communication between the patch and gateway if used within 6 feet. Objects placed inside the gateway can also cause communication problems.Activities 15. Yes, you may exercise moderately, but excessive sweating may shorten wear time. 16. After 24 hours following application, you may take brief showers. Try to keep your back faced toward the shower. Hold the patch down while towel drying to prevent accidental removal. Avoid getting the gateway wet.17. Yes, but keep the patch above water. Keep the gateway away from all water. 18. No. The patch should not be submerged under water. Keep the gateway away from all water. 19. Yes. If questioned during airport security screening, show the statement in the Traveling section. Note that the gateway will not have cellular connection outside the United States. 20. Yes, the gateway should be placed in “airplane mode.” See Traveling section.
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com14 1521. Avoid activities that cause heavy sweating. Sweat can cause the patch to water should also be avoided.22. First, press the button on your patch. Then enter your symptoms in the      Press Log in this manual. Please choose only one option for recording your symptoms. 23. The patch will still record your heartbeat and the gateway will send any information that is important for your doctor to know. 24. Recording your symptoms and activity gives your physician additional information about what may have caused the symptom. While this is useful, it is most important to press the button. 25. The patch will store the data until the gateway is in range, then the data will be sent. 26.            The gateway will store the data until it has cell signal, then the data will be sent.The Patch 27. Press evenly on the wings of the patch for 3 to 5 minutes to re-stick. 28. Call Customer Service at 1.888.693.2401. 29. Call Customer Service at 1.888.693.2401. It is probably due to a small shaving cut when the patch was applied to your chest. 30. Yes. The patch may move slightly from its original position. A blue gel may be seen under the wings of the patch. 31. Yes. The patch may move slightly from its original position. A blue gel may be seen under the wings of the patch.32. Many patients do not experience skin irritation or itchiness. However, some patients report minor skin irritation and/or itching while wearing the patch. If the irritation or itching is severe or hives or blisters develop, remove the patch and then call Customer Service at 1.888.693.2401.Flashing Lights 33. noise. 34. If you see the patch flashing orange, this does not mean there is a problem with your heart; it just means that the patch is not well attached. Press evenly on the wings of the patch for 3 to 5 minutes. If the flashing continues or comes back, call Customer Service at 1.888.693.2401 35.           problem with your heart; it just means that the patch cannot send information wirelessly. Turn to Troubleshooting or call Customer Service at 1.888.693.2401.
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com16 1736. Wear the patch for as long as your doctor prescribed but no longer than           wear time may be shorter than prescribed. 37. TROUBLESHOOTING THE PATCHSLOW FLASHING (once every 3 seconds):  that the patch is not making good contact. , press evenly on the wings of the patch for 3 to 5 minutes. , call Customer Service at 1.888.693.2401.FAST FLASHING (3 times per second):  that the patch is not recording. Call Customer Service at 1.888.693.2401.
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com18 19TROUBLESHOOTING THE GATEWAYSLOW  (SQUARE) FLASHING (once every 3 seconds):that the gateway has lost connection to the patch.   hold the star button for 3 seconds until the orange             connection to the Patch. , call Customer Service at 1.888.693.2401.SLOW  (TRIANGLE) FLASHING (once every 3 seconds): that the gateway does not have cell signal.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., call Customer Support at 1.888.693.2401.FAST  (SQUARE) OR  (TRIANGLE) FLASHING (3 times per second):Indicates that the gateway is not working. Call Customer Support at 1.888.693.2401.Situation NotemyZio Registration – Patient EnrollmentIn order for a patient to register with myZio they must rst be enrolled by the clinic in www.zioreports.com. In the event that the patient attempts to register prior to completion of enrollment by the clinic they will receive a notication indicating “This Zio patch is currently not available for use. Please call Customer Service at 1.888.693.2401.”, until enrollment has been completed. (SYS-2281)Patient Timeline – Paper Booklet Diary EntriesFor patients with the Zio AT Patch, ZioReports provides a timeline screen that displays along with Transmission, DDR, Daily, and Final reports, patient provided diary entries. For each diary entry the date and time of the symptom reported is displayed. In the event that a patient does not provide the date/time for a symptom on the paper booklet, the timeline will display a date with a year starting in 3000. Dates that have a year of 3000 or greater indicate that the patient did not provide the timestamp of the symptom experienced.(SYS-2315)ZIO AT SERVICE NOTES
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com20 21IRHYTHM CLINICAL FACILITY CERTIFICATIONThe Zio AT monitoring system is analyzed at the iRhythm Clinical Center. 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.NOTICE OF PRIVACY PRACTICES (NOPP)iRhythm is committed to protecting the privacy of your personal information. We are required by the U.S. - EU Safe Harbor Framework to maintain the privacy of your personal information, and to notify you of our privacy practices, our legal duties, and your rights concerning your personal information.Why?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"). This notice describes our privacy practices, our legal duties, and your rights concerning your PHI. We will follow the privacy practices described in this notice while it is in eect. We reserve the right to revise this notice and to make the new notice provisions eective for all PHI we maintain. If we revise this notice, we will post the revised notice on this page.Why?In providing diagnostic services, the types of information we collect may include:- Name- Gender- Date of Birth- Medicare and Secondary Insurance Information- Address and Phone Number- Prescribing Physician and Oce- Primary Indication- ECG Recording- Symptoms and Activities You Report, by Time and Date- Activity Level During Monitoring- Patient Identication Number- Clinical Information and Diagnostic ResultsHow?By providing diagnostic services to our patients, we regularly collect information through:- Phone conversations- Patient submitted documents- Prescribing physician submitted documents- ZioEvent card transmissions- Return of Zio XT or Zio AT PatchesWe have the right to use and disclose health information for your treatment, to secure payment for your health care, and to operate our business.
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com22 23DoesiRhythmCan YouLimitThisTo You We must disclose your PHI to you, as described in the "Your Rights" section of this notice. Yes YesFor PaymentWe may use and disclose PHI to obtain payment for services provided to you. We may also disclose your PHI to a health care provider or health plan so that the provider or plan may obtain payment of a claim or engage in other payment activities.Yes YesFor TreatmentWe may use and disclose PHI to provide and manage your diagnostic services. That may include consulting with other health care providers about your diagnostic services. For example, we will release the results of your diagnostic services to your prescribing physician, to the physician treating you, or in a medical emergency, if applicable.Yes NoFor Health Care OperationsWe may use or disclose PHI to conduct quality assessment and improvement activities, to conduct fraud and abuse investigations, to engage in care coordination or case management, or to communicate with you about health related benets and services or treatment alternatives that may be of interest to you. We may also disclose PHI to a health care provider or health plan subject to federal privacy laws, as long as the provider or plan has or had a relationship with you and the PHI is disclosed only for certain health care operations of that provider or plan. We may also disclose PHI to other entities with which we have contracted to perform or provide certain services on our behalf (e.g.,business associates).Yes NoDoesiRhythmCan YouLimitThisFor Business OperationsWe may use both De-Identied and Limited Data Sets (a data set that, per the Health Insurance Portability and Accountability Act of 1996 regulations, has had patient-identiable data removed except for dates of service) for development of future products, devices or services. Once information is De-Identied through an approved method, the data is stripped of individual identiers, at which point iRhythm may share this information without restriction externally to support research, market development, trend analysis, etc.Information containing Limited Data Sets may be provided externally to support market and product development. However, iRhythm will obtain the required data use agreements when transferring Limited Data Sets to external parties.Yes YesFor Public Health And SafetyWe may use or disclose PHI to the extent necessary to avert a serious and imminent threat to the health or safety of you or others. We may also disclose PHI for public health and government health care oversight activities and to report suspected abuse, neglect or domestic violence to government authorities.Yes NoAs Required By LawWe may use or disclose PHI when we are required to do so by law. Yes NoFor Process And ProceedingsWe may disclose PHI in response to a court or administrative order, subpoena, discovery request, or other lawful process.Yes NoFor Law EnforcementWe may disclose PHI to a law enforcement ocial with regard to crime victims and criminal activities.Yes NoSpecial Government FunctionsWe may disclose the PHI of military personnel or inmates or other persons in lawful custody under certain circumstances. We may disclose PHI to authorized federal ocials for lawful national security activities.Yes NoFor Research, Death, And Organ DonationWe may use or disclose PHI in certain circumstances related to research, death or organ donation.Yes No
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com24 25DoesiRhythmCan YouLimitThisFor Workers' CompensationWe may disclose PHI as permitted by workers' compensation and similar laws. Yes NoDoesiRhythmCan YouLimitThisYou may give us written authorization to use your PHI or disclose it to anyone for any purpose not otherwise permitted or required by law. If you give us such authorization, you may revoke it in writing at any time. Your revocation will not aect any use or disclosure permitted by your authorization while it was in eect.Yes YesWhile the law permits us in certain circumstances to disclose your PHI to family, friends and others, we will do so only with your authorization. In the event you are unable to authorize such disclosure, but emergency or similar circumstances indicate that disclosure would be in your best interest, we may disclose your PHI to family, friends or others to the extent necessary to help with your health care coverage arrangements.Yes YesYour RightsAccessWith limited exceptions, you have the right to review in person, or obtain copies of, your PHI. We may charge you a reasonable fee as allowed by law to obtain this information.Amendment With limited exceptions, you have the right to request that we amend your PHI.Disclosure AccountingYou have the right to request and receive a list of certain disclosures made of your PHI. If you request this list more than once in a 12-month period, we may charge you a reasonable fee as allowed by law to respond to any additional request.Use/Disclosure RestrictionYou have the right to request that we restrict our use or disclosure of your PHI for certain purposes. We are not required to agree to a requested restriction. We will agree to restrict use or disclosure of your PHI provided that the law allows and we determine the restriction does not impact our ability to operate our business, provide diagnostic services, and comply with the law. Even when we agree to a restriction request, we may still disclose your PHI in a medical emergency and use or disclose your PHI for public health and safety and other similar public benet purposes permitted or required by law.Condential CommunicationYou have the right to request that we communicate with you in condence about your PHI at an alternative address.Privacy NoticeYou have the right to request and receive a copy of this notice at any time. For more information or if you have questions about this notice, please contact us using the information listed at the end of this notice.If you are concerned that we may have violated your privacy rights, you may inquire with us using the contact information listed at the end of this notice. You may also submit a written complaint to the U.S. Department of Health and Human Services. We will provide you with the address for the U.S. Department of Health and Human Services upon request.To Limit Our Sharing Or Submit ComplaintsCall 1.888.693.2401 - our Customer Service sta will assist youQuestions? Call 1.888.693.2401Who We AreWho Is Providing This Notice?This privacy notice is being provided by iRhythm Technologies, Inc., and applies to the diagnostic services oered in connection with prescribed health care.What We DoHow Does iRhythm Protect My PHI?To protect your PHI from unauthorized access and use, iRhythm has implemented security safeguards that comply with federal law to secure physical and electronic information.Company Contact DetailsAddress:iRhythm Technologies, Inc.650 Townsend StreetSuite 500San Francisco, CA 94103Attn: Privacy Ocialwww.irhythmtech.comPhone: 415.632.5700Fax: 415.632.5701
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com26 27CYBERSECURITY MEASURES AND CONTROLSAs a connected medical device, the Zio AT patch was developed with careful consideration of cybersecurity risks and their compensating controls. Key measures include manufacturing steps to exclusively pair one AT patch with one Gateway, thus preventing Bluetooth communication with any other          devices. Similarly, encryption of all cellular communication between the iRhythm regularly evaluates the integrity of our cloud-based infrastructure through both vulnerability and penetration testing of all internet-accessible servers. Industry-standard encryption is employed for all data transfers to, from and within the Cloud, and for protecting data at rest. Patient data is protected during wear through use of proprietary data storage formats and access methods, and physically protected data ports. Once returned to iRhythm for processing, data integrity checks are used to ensure the integrity of all recorded data.DEVICE SPECIFICATIONSPATCH PERFORMANCE CHARACTERISTICSECG Channels 1 channelMemory capacity 14 daysRecording Format ContinuousService Life Up to 14 daysShelf Life 2 monthsELECTRICAL CHARACTERISTICSMedical Equipment Type BF Applied PartECG Frequency Response 0.5Hz to 30HzECG Input Impedance  ±1.65 mVECG A/D Sampling Rate 200 HzECG Resolution 10 bitsPatch Short-range RF Transmit/Receive2.4 GHz Bluetooth Low EnergyFrequency Band of Transmission 2.4 GHzBandwidth of the Receiver 2400-2480 MHzType and Frequency of Modulation 1-Mbps GFSKGateway Short-range RF Transmit/Receive2.4 GHz Bluetooth Low EnergyGateway Cellular RF Transmit/Receive800 / 1900 MHz CDMA 750 MHz LTE Cat M1< 200 mW
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com28 29POWER CHARACTERISTICSPatch Battery Type 2 Lithium Manganese Dioxide Coin CellsGateway Battery Type 1 Lithium Polymer CellBattery Life ContinuousService Life 14 daysPHYSICAL CHARACTERISTICSPatch Dimensions 5.2 x 2.0 x 0.5 inchesPatch Weight 24.7 gGateway Dimensions 6.2 x 3.4 x 0.8 inchesGateway Weight 158 gENVIRONMENTAL CHARACTERISTICSOperational Temperature 41 to 104 degreesOperational Altitude -1,000 to 10,000 ftOperational & Storage Humidity 10% to 95% (non-condensing)Shipping (Short-term Storage) -4 to 104 degrees FTemperatureLong-term Storage Temperature 55 to 85 degrees FStorage Altitude -1,000 to 14,000 ft IP24 IP22ESSENTIAL PERFORMANCEThe Zio AT device records and transmits ECG for analysis after receipt of data. In the event it cannot record or transmit in a timely fashion, the Zio AT alerts the patient that functionality is impaired.HEART RATE CALCULATIONSEpisode Heart RatesMax The maximum episode heart rate (i.e., maximum of all instantaneous heart rates within the episode)Min The minimum episode heart rate (i.e., minimum of all instantaneous heart rates within the episode)Avg The average episode heart rate (i.e., average of all instantaneous heart rates within the episode)Overall Rhythm Heart RatesMaxThe maximum overall heart rate (i.e., maximum of all rhythm episode maximum heart rates within the record)MinThe minimum overall heart rate (i.e., minimum of all rhythm episode minimum heart rates exclusive of Pause heart rates within the record)AvgThe average overall heart rate (i.e., duration-weighted average of all rhythm episode heart rates within the record)PAUSE DETERMINATIONned as an RR interval greater than 3 seconds.
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com30 31ELECTRICAL SAFETY AND COMPATIBILITY •CAUTION: The Zio AT system needs special precautions regarding EMC and needs to be utilized according to the EMC information provided in the following tables. •medical electrical equipment. •WARNING: The Zio AT system should not be used adjacent to or stacked with other equipment. •WARNING: The Zio AT 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 AT patch or gateway. Otherwise, degradation of the performance of this equipment could result.The Zio AT system is intended for use in the electromagnetic environment specied below. The customer or the user of the Zio AT system should assure that it is used in such an environment.Emissions test Compliance Electromagnetic environment - guidanceRF emissionsCISPR 11 Group 1The Zio AT system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.RF emissionsCISPR 11 Class BThe Zio AT system is suitable for use in all establishments, including domestic establishments.Harmonic emissions IEC 61000-3-2 Not applicable Not applicableVoltage uctuations/ icker emissions IEC 61000-3-3Not applicable Not applicableThe Zio AT system is intended for use in the electromagnetic environment specied below. The customer or the user of the Zio AT system should assure that it is used in such an environment.Immunity test IEC 60601 test levelCompliance levelElectromagnetic environment - guidanceElectrostatic Discharge (ESD)IEC 61000-4-2±8 kV contact±15 kV air±8 kV contact±15 kV airFloors should be wood, concrete, or ceramic tile. If oors are covered with synthetic material, the relative humidity should be at least 30 %.wPower frequency(50/60 Hz)magnetic eldIEC 61000-4-830 A/m 30 A/mPower frequency magnetic elds should be at levels characteristic of a typical location in a typical commercial or hospital environment.
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com32 33The Zio AT system is intended for use in the electromagnetic environment specied below. The customer or the user of the Zio AT system should assure that it is used in such an environment.Immunity test IEC 60601 test levelCompliance levelElectromagnetic environment - guidanceRadiated RFIEC 61000-4-310 V/m80 MHz to 2.7 GHz28 V/m385, 450, 810, 870, 930 MHz18 Hz pulse9 V/m710, 745,780 MHz217 Hz pulse28 V/m1720, 1845, 1970, 2450 MHz217 Hz pulse9 V/m5240, 5500, 5783 MHz217 Hz pulse10 V/m28 V/m9 V/m28 V/m9 V/mPortable and mobile RF communications equipment should be used no closer to any part of the Zio AT system , including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended separation distanced = 1.2√Pd = 1.2√P 80 MHz to 800 MHzd = 2.3√P 800 MHz to 2.5 GHzwhere P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).Field strengths from xed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.bInterference 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. Electromagnetic propagation is aected by absorption and reection from structures, objects, and people.a Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the Zio AT system is used exceeds the applicable RF compliance level above, the Zio AT system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Zio AT patch or gateway.b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com34 35The Zio AT system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Zio AT system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Zio AT system as recommended below, according to the maximum output power of the communications equipment.Rated maximum output power of transmitterWSeparation distance according to frequency of transmitterm150 kHz to 80 MHz 80 MHz to 800 MHz 80 MHz to 2.5 GHzd = 1.2√P d = 1.2√P d = 2.3√P0.01 0.12 0.12 0.230.1 0.38 0.38 0.7311.2 1.2 2.310 3.8 3.8 7.3100 12 12 23For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined 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.NOTE 2—These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects, and people.• 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 device 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 ensurecompliance with FCC RF exposure guidelines.• Changes or modications not expressly approved by the party responsible for compliance could void the user's 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.SYMBOL STANDARD REFERENCE STANDARD TITLE SYMBOL TITLEDESCRIPTION / EXPLANATORY TEXTISO 15223-1 Clause 5.1.1Medical devices — Symbols to be used with medical device labels, labelling and information to be suppliedManufacturerIndicates the medical device manufacturer.ISO 7000-3082 Graphical symbols for use on equipmentISO 15223-1 Clause 5.1.3Medical devices — Symbols to be used with medical device labels, labelling and information to be suppliedDate of manufactureIndicates the date when the medical device was manufacturedISO 7000-2497 Graphical symbols for use on equipmentISO 15223-1 Clause 5.1.4Medical devices — Symbols to be used with medical device labels, labelling and information to be suppliedUse-by dateIndicates the date after which the medical device is not to be used.ISO 7000-2607 Graphical symbols for use on equipmentISO 15223-1 Clause 5.1.5Medical devices — Symbols to be used with medical device labels, labelling and information to be suppliedBatch codeIndicates the manufacturer’s batch code so that the batch or lot can be identied.ISO 7000-2492 Graphical symbols for use on equipmentISO 15223-1 Clause 5.1.6Medical devices — Symbols to be used with medical device labels, labelling and information to be suppliedCatalogue numberIndicates the manufacturer’s catalogue number so that the medical device can be identied.ISO 7000-2493 Graphical symbols for use on equipmentSYMBOLS GLOSSARY
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com36 37SYMBOL STANDARD REFERENCE STANDARD TITLE SYMBOL TITLEDESCRIPTION / EXPLANATORY TEXTISO 15223-1 Clause 5.1.7Medical devices — Symbols to be used with medical device labels, labelling and information to be suppliedSerial numberIndicates the manufacturer’s serial number so that a specic medical device can be identied.ISO 7000-2498 Graphical symbols for use on equipmentISO 15223-1 Clause 5.3.4Medical devices — Symbols to be used with medical device labels, labelling and information to be suppliedKeep dryIndicates a medical device that needs to be protected from moisture.ISO 7000-0626 Graphical symbols for use on equipmentISO 15223-1 Clause 5.3.7Medical devices — Symbols to be used with medical device labels, labelling and information to be suppliedTemperature limitIndicates the temperature limits to which the medical device can be safely exposed.ISO 7000-0632 Graphical symbols for use on equipmentISO 15223-1 Clause 5.3.8Medical devices — Symbols to be used with medical device labels, labelling and information to be suppliedHumidity limitationIndicates the range of humidity to which the medical device can be safely exposed.ISO 7000-2620 Graphical symbols for use on equipmentISO 15223-1 Clause 5.4.2Medical devices — Symbols to be used with medical device labels, labelling and information to be suppliedDo not re-useIndicates a medical device that is intended for one use, or for use on a single patient during a single procedure.ISO 7000-1051 Graphical symbols for use on equipmentSYMBOL STANDARD REFERENCE STANDARD TITLE SYMBOL TITLEDESCRIPTION / EXPLANATORY TEXTISO 15223-1 Clause 5.4.3Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied Consult instructions for useIndicates the need for the user to consult the instructions for use.ISO 7000-1641 Graphical symbols for use on equipmentIEC 60601-1 Table D.1, Symbol 11Medical electrical equipment — Part 1: General requirements for basic safety and essential performanceISO 15223-1 Clause 5.4.4Medical devices — Symbols to be used with medical device labels, labelling and information to be suppliedCautionIndicates 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.of reasons, be presented on the medical device itself.ISO 7000-0434 Graphical symbols for use on equipmentIEC 60601-1 Table D.1, Symbol 10Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
1.888.693.2401 • zioreports.com 1.888.693.2401 • zioreports.com38 39SYMBOL STANDARD REFERENCE STANDARD TITLE SYMBOL TITLEDESCRIPTION / EXPLANATORY TEXTBS EN 50419:2006Marking of electrical and electronic equipment in accordance with article 11(2) of Directive 2002/96/EC (WEEE)Separate CollectionTo indicate that the product shall be separated when disposed.IEC 60417-5140 Graphical symbols for use on equipmentNon-ionizing electromagnetic radiationTo 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 IEC 60601-1-2:2007, Clause 5.1.1Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and testsIEC 60417-5333 Graphical symbols for use on equipmentType BF Applied PartTo identify a type BF applied part complying with IEC 60601-1.IEC 60601-1, Table D.1, Symbol 20Medical electrical equipment — Part 1: General requirements for basic safety and essential performanceASTM F2503-13Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance EnvironmentMagnetic Resonance (MR) unsafeKeep away from magnetic resonance imaging (MRI) equipment.SYMBOL STANDARD REFERENCE STANDARD TITLE SYMBOL TITLEDESCRIPTION / EXPLANATORY TEXTIEC 60601-1, Table D.3 Symbol 2IEC 60529Medical electrical equipment — Part 1: General requirements for basic safety and essential performanceDegrees of Protection Provided by Enclosures (IP Code)Degrees of protection provided by enclosureManufacturer- determined degree of particle and water ingress protection, where:N1 = Degrees of protection against access to hazardous parts N2 = Degrees of protection against waterProtected against solid foreign objects of 12,5 mm diameter and greater, and protected against splashingwaterProtected against solid foreign objects of 12,5 mm diameterand greater, and protected against vertically falling water drops when enclosure tilted up to 15°21 CFR 801.15(c)(1)(i)FLabeling-Medical devices; prominence of required label statementsPrescription onlyRequires prescription in the United States
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iRhythm Technologies, Inc. 650 Townsend St., Suite 500 San Francisco, CA 94103 USA1.888.693.2401 irhythmtech.com ALB0031.01 • 2018-04-11

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