iRhythm Technologies AT18G Zio AT Gateway User Manual 3
iRhythm Technologies, Inc. Zio AT Gateway 3
Contents
- 1. User Manual
- 2. User Manual 2
- 3. User Manual 3
- 4. User Manual 1
User Manual 3
| Download: |  |
| Mirror Download [FCC.gov] | |
| Document ID | 3875359 |
| Application ID | TXe8wxFJxaTJWR+iXQ6Ohg== |
| Document Description | User Manual 3 |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 19.44kB (243020 bits) |
| Date Submitted | 2018-06-04 00:00:00 |
| Date Available | 2018-06-04 00:00:00 |
| Creation Date | 2017-06-12 18:00:06 |
| Producing Software | Adobe PDF Library 15.0 |
| Document Lastmod | 2018-04-11 16:58:22 |
| Document Title | User Manual 3 |
| Document Creator | Adobe InDesign CC 2017 (Macintosh) |
IMP O RTA NT I N F ORM AT I ON ABOUT THE ZIO AT Zio AT data analysis Your 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 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 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 final 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 suffer from transient symptoms such as palpitations, shortness of breath, dizziness, lightheadedness, 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 inpatient 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 defibrillators or high frequency surgical equipment near strong magnetic fields 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. Warnings (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 fields 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 1.888.693.2401 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 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 classified. • Safety and effectiveness of the Zio AT system on pediatric patients (younger than 18 years old) has not been established. • 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 operator Package Contents 1 Zio AT patch 1 Zio AT 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 • 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 off during the patient wear duration. Symbols Glossary SYMBOL STANDARD REFERENCE STANDARD TITLE SYMBOL TITLE DESCRIPTION/EXPLANITORY TEXT ISO 15223-1 Clause 5.1.1 Medical 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 equipment ISO 15223-1 Clause 5.1.3 Medical 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 manufactured 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 Use-by date Indicates the date after which the medical device is not to be used. 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 Batch code Indicates the manufacturer’s batch code so that the batch or lot can be identified. 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 Catalogue number Indicates the manufacturer’s catalogue number so that the medical device can be identified. 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 Serial number Indicates the manufacturer’s serial number so that a specific medical device can be identified. 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 Keep dry Indicates a medical device that needs to be protected from moisture. 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 Temperature limit Indicates the temperature limits to which the medical device can be safely exposed. 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 Humidity limitation Indicates the range of humidity to which the medical device can be safely exposed. ISO 7000-2620 Graphical symbols for use on equipment Symbols Glossary (cont’d) SYMBOL STANDARD REFERENCE STANDARD TITLE SYMBOL TITLE DESCRIPTION/EXPLANITORY TEXT ISO 15223-1 Clause 5.4.2 Medical 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. 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 electromagnetic 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. 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 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance ISO 15223-1 Clause 5.4.4 Medical devices — Symbols to be used with medical device labels, labelling and information 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 60601-1-2:2007, 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 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment Symbols Glossary (cont’d) SYMBOL STANDARD REFERENCE STANDARD TITLE SYMBOL TITLE DESCRIPTION/EXPLANITORY TEXT BS EN 50419:2006 Marking 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 60529 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance 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 Degrees of protection provided by enclosure Degrees of Protection Provided by Enclosures (IP Code) 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 diameter and greater, and protected against vertically falling water drops when enclosure tilted up to 15° 21 CFR 801.15(c)(1)(i)F 10 Labeling-Medical devices; prominence of required label statements Prescription only Requires prescription in the United States 11 Asymptomatic Arrhythmia Detection PATCH PERFORMANCE CHARACTERISTICS Asymptomatic arrhythmia events, as detected and transmitted during the monitoring period, are defined by the following parameters: ECG Channels 1 channel Memory capacity 14 days Recording Format Continuous Service Life Up to 14 days Shelf Life 2 months Rhythm Atrial Fibrillation Heart Rate Duration ≤40 bpm ≥60 seconds ≤180 bpm ≥60 seconds ELECTRICAL CHARACTERISTICS Medical Equipment Type BF Applied Part ECG Frequency Response 0.5Hz to 30Hz ECG Input Impedance ≥ 10 MΩ ECG Differential Range ±1.65 mV ECG A/D Sampling Rate 200 Hz ECG Resolution 10 bits ≥4 seconds ≥3 seconds back-to-back ≥ 120 bpm ≥ 30 seconds ≥150 bpm ≥15 seconds Complete Heart Block (day 05:00~23:00) ≤ 50 bpm ≥6 beats Patch Short-range RF Transmit/Receive Complete Heart Block (night 23:00~05:00) ≤ 47 bpm ≥6 beats Frequency Band of Transmission 2.4 GHz ≤30 bpm Bandwidth of the Receiver 2400-2480 MHz Bradycardia ≥60 seconds 1-Mbps GFSK Tachycardia ≥ 200 bpm Type and Frequency of Modulation ≥ 60 seconds Pause Ventricular Tachycardia Gateway Short-range RF Transmit/Receive Gateway Cellular RF Transmit/ Receive 12 2.4 GHz Bluetooth Low Energy Effective Radiated Power < 1mW 2.4 GHz Bluetooth Low Energy Effective Radiated Power < 1mW 800 MHz / 1900 MHz 750 LTE CatCDMA M1 Effective Radiated < 200 mW Power ≤300mW 13 POWER CHARACTERISTICS Patch Battery Type 2 Lithium Manganese Dioxide Coin Cells Gateway Battery Type 1 Lithium Polymer Cell Battery Life 14 days PHYSICAL CHARACTERISTICS Patch Dimensions 5.2 x 2.0 x 0.5 inches Patch Weight 24.7 g Gateway Dimensions 6.2 x 3.4 x 0.8 inches Gateway Weight 158 g EQUIPMENT CLASSIFICATION INFORMATION Patch IEC Classifications Gateway IEC Classifications Internally Powered ME Equipment Internally Powered ME Equipment Type BF Applied Part IPX4 - IP 22 Continuous Operation Continuous Operation Heart Rate Calculations ENVIRONMENTAL CHARACTERISTICS Operational Temperature 41 to 104 degrees F Operational Altitude -1,000 to 10,000 ft Operational & Storage Humidity 10% to 95% (non-condensing) Shipping (Short-term Storage) Temperature -4 to 104 degrees F Long-term Storage Temperature 55 to 85 degrees F Storage Altitude -1,000 to 14,000 ft Patch IP Classification IP24 Gateway IP Classification IP22 ESSENTIAL PERFORMANCE The 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. 14 Episode Heart Rates Overall Rhythm Heart Rates Max 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) Max The maximum overall heart rate (i.e., maximum of all rhythm episode maximum heart rates within the record) Min The minimum overall heart rate (i.e., minimum of all rhythm episode minimum heart rates exclusive of Pause heart rates within the record) Avg The average overall heart rate (i.e., duration-weighted average of all rhythm episode heart rates within the record) 15 Pause Determination Pause is defined 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. Table 1: Guidance and manufacturer’s declaration— electromagnetic emissions The Zio AT system is intended for use in the electromagnetic environment specified below. The customer or the user of the Zio AT system should assure that it is used in such an environment. Emissions test Compliance • CAUTION: Portable and mobile RF communications equipment can affect medical electrical equipment. Group 1 The 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 B The Zio AT system is suitable for use in all establishments, including domestic establishments. Harmonic emissions IEC 61000-3-2 Not applicable Not applicable Not applicable Not applicable • 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. RF emissions CISPR 11 • 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. Voltage fluctuations/ flicker emissions IEC 16 Electromagnetic environment guidance 17 Table 2: Guidance and manufacturer’s declaration— electromagnetic immunity Table 3: Guidance and manufacturer’s declaration— electromagnetic immunity The Zio AT system is intended for use in the electromagnetic environment specified below. The customer or the user of the Zio AT system should assure that it is used in such an environment. The Zio AT system is intended for use in the electromagnetic environment specified below. The customer or the user of the Zio AT system should assure that it is used in such an environment. Immunity test Electrostatic Discharge (ESD) IEC 610004-2 Power frequency (50/60 Hz) magnetic field IEC 610004-8 18 IEC 60601 test level Compliance level ±8 kV contact ±8 kV contact ±15 kV air ±15 kV air 30 A/m 30 A/m Electromagnetic environment guidance Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Continued on next page Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. 19 10 V/m 80 MHz to 2.7 GHz Radiated RF IEC 610004-3 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 20 10 V/m Portable 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. 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 affected by absorption and reflection from structures, objects, and people. Field strengths from fixed 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 fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field 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. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distance 28 V/m d = 1.2√P d = 1.2√P 80 MHz to 800 MHz d = 2.3√P 800 MHz to 2.5 GHz 9 V/m 28 V/m 9 V/m where 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 fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: 21 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. 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. Separation distance according to frequency of transmitter Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. 150 kHz to 80 MHz 80 MHz to 800 MHz 80 MHz to 2.5 GHz d = 1.2√P d = 1.2√P d = 2.3√P 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. 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 Rated maximum output power of transmitter For 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 affected by absorption and reflection from structures, objects, and people. 22 23 iRhythm Technologies, Inc. 650 Townsend St., Suite 500 San Francisco, CA 94103 USA 1.888.693.2401 irhythmtech.com ALB0032.01 • 2018-04-11
Source Exif Data:
File Type : PDF File Type Extension : pdf MIME Type : application/pdf PDF Version : 1.6 Linearized : No Create Date : 2017:06:12 18:00:06-07:00 Creator : Adobe InDesign CC 2017 (Macintosh) Modify Date : 2018:04:11 16:58:22-08:00 Language : en-US Tagged PDF : Yes Page Count : 13 XMP Toolkit : Adobe XMP Core 5.6-c015 84.159810, 2016/09/10-02:41:30 Metadata Date : 2018:04:09 09:58:51-07:00 Creator Tool : Adobe InDesign CC 2017 (Macintosh) Instance ID : uuid:1031f17d-0eb7-42f5-86cc-cc8840a8e326 Original Document ID : xmp.did:239e2403-8725-42f9-9f8d-75a905f6c827 Document ID : xmp.id:3166d6bc-876a-405e-847a-6f70360ba290 Rendition Class : proof:pdf Derived From Instance ID : xmp.iid:1bc8e3aa-06de-4ae7-b2ae-8c223ea4445b Derived From Document ID : xmp.did:58f6fddd-5b36-48cb-b819-824eef10577d Derived From Original Document ID: xmp.did:239e2403-8725-42f9-9f8d-75a905f6c827 Derived From Rendition Class : default History Action : converted History Parameters : from application/x-indesign to application/pdf History Software Agent : Adobe InDesign CC 2017 (Macintosh) History Changed : / History When : 2017:06:12 18:00:06-07:00 Format : application/pdf Producer : Adobe PDF Library 15.0 Trapped : False Slug Family : Minion Pro Slug Version : 2.068 Slug Outline File Size : 0 Slug Kerning Checksum : 0 Slug Foundry : Adobe Systems Slug Font Kind : OpenType - PS Slug Checksum : 16687415 Slug Post Script Name : MinionPro-Regular Slug Font Sense 12 Checksum : 16687415EXIF Metadata provided by EXIF.tools