iRhythm Technologies AT18G Zio AT Gateway User Manual 3

iRhythm Technologies, Inc. Zio AT Gateway 3

User Manual 3

IMPORTANT INFORMATION
2 3ABOUT THE ZIO ATZio AT data analysisYour Zio AT 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 identicationBefore 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 identication 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 practicesAs 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 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 reporting. After wear, a nal report is generated based on 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 suer 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 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 the Zio AT for patients with known history of life threatening arrhythmias. • Do not use the Zio AT in combination with external cardiac debrillators or high frequency surgical equipment near strong magnetic elds or devices such as MRI. • Do not use the Zio AT on patients with neuro-stimulator, as it may disrupt the quality of ECG data. • Do not use the Zio AT on patients who do not have the competency to wear the device for the prescribed monitoring period.Warnings • 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 skin irritation. • Do not use the Zio AT on patients residing in areas with limited to no cellular reception. • Do not modify the Zio AT system.
4 5Warnings (cont’d) • The Zio AT system is MR Unsafe! - Do not expose the Zio AT patch or gateway to a magnetic resonance (MR) environment. - The 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. - Thermal injury and burns may occur due to the metal components of the Zio AT patch that can heat during MR scanning. - The Zio AT patch may generate artifacts in the MR image. - The Zio AT patch or gateway may not function properly due to the strong magnetic and radiofrequency elds generated by the MR 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 the sale of this device to or on the order of a physician. Precautions • Safety and eectiveness of the Zio AT 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 classied. • Safety and eectiveness of the Zio AT system on pediatric patients (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 patch to slip or fall o during the patient wear duration. • 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.The patient is an intended operatorPackage Contents1 Zio AT patch1 Zio AT gateway, containing: 1 postage-paid return envelope1 Skin Prep & Placement Kit containing: 1 patch card template 1 disposable razor 1 abrader disc 4 alcohol wipes1 Application instructions1 Wearing your Zio manual & button press log containing: 1 adhesive remover wipe
6 7SYMBOL STANDARD REFERENCE STANDARD TITLE SYMBOL TITLE DESCRIPTION/EXPLANITORY TEXTISO 15223-1 Clause 5.1.1Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied Manufacturer Indicates 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 supplied Date of manufacture Indicates 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 supplied Use-by date Indicates 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 supplied Batch code Indicates 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 supplied Catalogue number Indicates the manufacturer’s catalogue number so that the medical device can be identied.ISO 7000-2493 Graphical symbols for use on equipmentISO 15223-1 Clause 5.1.7Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied Serial number Indicates 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 supplied Keep dry Indicates 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 supplied Temperature limit Indicates 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 supplied Humidity limitation Indicates the range of humidity to which the medical device can be safely exposed.ISO 7000-2620 Graphical symbols for use on equipmentSymbols Glossary
8 9SYMBOL STANDARD REFERENCE STANDARD TITLE SYMBOL TITLE DESCRIPTION/EXPLANITORY TEXTISO 15223-1 Clause 5.4.2Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied 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.ISO 7000-1051 Graphical symbols for use on equipmentISO 15223-1 Clause 5.4.3Medical devices — Symbols to be used with medical device labels, labelling and information to be suppliedConsult instructions for use Indicates 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 informa-tion 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.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 performanceISO 15223-1 Clause 5.7.1Medical devices — Symbols to be used with medical device labels, labelling and information to be suppliedPatient number Indicates a unique number associated with an individual patient.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 electromagnet-ic energy for diagnosis or treatment.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/TR 60878-5140 Graphical symbols for electrical equipment in medical practiceIEC 60417-5333 Graphical symbols for use on equipmentType BF Applied Part To 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.Symbols Glossary (cont’d)
10 11SYMBOL STANDARD REFERENCE STANDARD TITLE SYMBOL TITLE DESCRIPTION/EXPLANITORY TEXTBS EN 50419:2006Marking of electrical and electronic equipment in accordance with article 11(2) of Directive 2002/96/EC (WEEE)Separate Collection To indicate that the product shall be separated when disposed.IEC 60601-1, Table D.3 Symbol 2 IEC 60529Medical electrical equipment — Part 1: General requirements for basic safety and essential performance Degrees 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 partsN2 = 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 diam-eter and greater, and protected against vertically falling water drops when enclosure tilted up to 15°21 CFR 801.15(c)(1)(i)F Labeling-Medical devices; prominence of required label statements Prescription only Requires prescription in the United StatesSymbols Glossary (cont’d)
12 13Asymptomatic Arrhythmia DetectionAsymptomatic arrhythmia events, as detected and transmitted during the monitoring period, are dened by the following parameters:Rhythm Heart Rate DurationAtrial Fibrillation≤40 bpm ≥60 seconds≤180 bpm ≥60 secondsPause-≥4 seconds-≥3 seconds back-to-backVentricular Tachycardia≥ 120 bpm ≥ 30 seconds≥150 bpm ≥15 secondsComplete Heart Block (day 05:00~23:00)≤ 50 bpm ≥6 beatsComplete Heart Block (night 23:00~05:00)≤ 47 bpm ≥6 beatsBradycardia ≤30 bpm ≥60 secondsTachycardia ≥ 200 bpm ≥ 60 secondsPATCH 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 ≥ 10 MΩECG Dierential Range ±1.65 mVECG A/D Sampling Rate 200 HzECG Resolution 10 bitsPatch Short-range RF Transmit/Receive2.4 GHz Bluetooth Low EnergyEective Radiated Power < 1mWFrequency 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 Eective Radiated Power < 1mWGateway Cellular RF Transmit/Receive800 / 1900 MHz CDMA Eective Radiated Power ≤300mW750 MHz LTE Cat M1Power < 200 mW
14 15POWER CHARACTERISTICSPatch Battery Type 2 Lithium Manganese Dioxide Coin CellsGateway Battery Type 1 Lithium Polymer CellBattery 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 degrees FOperational Altitude -1,000 to 10,000 ftOperational & Storage Humidity 10% to 95% (non-condensing)Shipping (Short-term Storage) Temperature-4 to 104 degrees FLong-term Storage Temperature 55 to 85 degrees FStorage Altitude -1,000 to 14,000 ftPatch IP Classication IP24Gateway IP Classication IP22ESSENTIAL PERFORMANCEThe Zio AT system 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.EQUIPMENT CLASSIFICATION INFORMATIONPatch IEC ClassicationsGateway IEC ClassicationsInternally Powered ME EquipmentInternally Powered ME EquipmentType BF Applied Part -IPX4 - IP 22Continuous Operation Continuous OperationHeart Rate CalculationsEpisode Heart RatesMaxThe maximum episode heart rate (i.e., maximum of all instantaneous heart rates within the episode)MinThe minimum episode heart rate (i.e., minimum of all instantaneous heart rates within the episode)AvgThe 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)
16 17Pause DeterminationPause is dened as an RR interval greater than 3 seconds.Electrical 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. • CAUTION: Portable and mobile RF communications equipment can aect 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.Table 1: Guidance and manufacturer’s declaration— electromagnetic emissionsThe 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 emissions CISPR 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 emissions CISPR 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 IECNot applicable Not applicable
18 19Table 2: Guidance and manufacturer’s declaration—electromagnetic immunityThe 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 testIEC 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 %.Power frequency (50/60 Hz) magnetic eld IEC 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.Table 3: Guidance and manufacturer’s declaration—electromagnetic immunityThe 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 testIEC 60601 test levelCompliance levelElectromagnetic environment - guidanceContinued on next page
20 21NOTE 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.Radiated RF IEC 61000-4-310 V/m 80 MHz to 2.7 GHz28 V/m 385, 450, 810, 870, 930 MHz 18 Hz pulse 9 V/m 710, 745, 780 MHz 217 Hz pulse28 V/m 1720, 1845, 1970, 2450 MHz 217 Hz pulse9 V/m 5240, 5500, 5783 MHz 217 Hz pulse10 V/m 28 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:
22 23This 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 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.Table 4: Recommended separation distances between portable and mobile RF communications equipment and the Zio AT system.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 transmitter WSeparation distance according to frequency of transmitter m150 kHz to 80 MHz 80 MHz to 800 MHz80 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 0.731 1.2 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.
ALB0032.01 • 2018-04-11iRhythm Technologies, Inc. 650 Townsend St., Suite 500 San Francisco, CA 94103 USA1.888.693.2401 irhythmtech.com

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