iRhythm Technologies AT17P Zio AT ECG Patch User Manual

iRhythm Technologies, Inc. Zio AT ECG Patch Users Manual

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AT17P User Manual

Users Manual

55WEARING YOUR ZIO Flip for PRESS BUTTON LOGRecord any events during your wear period here, the myZio app or at myzio.com.Return this booklet, your Zio QX patch and Zio QX gateway after your wear period:MANUALA100A4007.01 4.26.2017 DRAFT

iRhythm Technologies, Inc. — Clinical Centers650 Townsend St., Suite 500 San Francisco, CA 94103 U.S.A.2 Marriott Drive Lincolnshire, IL 60069 U.S.A.363 N. Sam Houston Parkway East, Suite 125 Houston, TX 77060 U.S.A.1.888.6932401 | irhythmtech.com | @iRhythmTechCALL 1.888.693.2401 IF… •TheZioQXpatchfallso. • You experience severe itching or irritation.For all other information please see the Troubleshooting and Frequently Asked Questions section of this booklet. If you feel the need for immediate medical care at any time, call 911. The Zio QX device will not provide any medical assistance and cannot contact medical personnel for you.For use in the United States only.

1 The Zio® QX System consists of three components: 1. Zio QX Patch 2. Zio QX Gateway 3. myZioTM App and WebsiteThe Zio QX Patch records every heartbeat. Each time you press the Patch button or when Zio QX automatically detects an arrhythmia, the Zio QX Gateway transmits information to iRhythm for analysis. myZio is one way for you to enter your symptoms and verify that your heart data transmission has been received by iRhythm.Zio PatchZio Gateway

2APPLYING YOUR ZIO QXFollow the instructions in the Zio QX Application Instructions guide to apply your Zio QX PatchIt is important that you follow the steps in the Applications Instructions guide to ensure that your Patch sticks to your skin correctly and remains on your skin for the duration of monitoring.The Patch should only be applied to healthy, unbroken skin that was not previously irritated.

3TROUBLESHOOTINGFAQsPATCH REMOVAL TRAVELING USING ZIOUSING YOUR ZIO QXWith the Zio monitor, you can go through your normal daily activities aftertherst24hours.The Patch needs 24 hours to fully stick to your skin, we recommend showering briey with your back to the water, and avoid any activities that cause sweating during this period. After those rst 24 hours, you may resume normal activities, including showering and moderate exercise.The Patch and Gateway will not ash or make noise when they are working correctly, but you can check your transmissions using myZio or www.myzio.com.

4Remember:1Each time you feel a symptom, press the button on your Patch. Then note the date, time, and what you felt in this booklet. Or, you may enter your symptoms in the myZio App or on www.myzio.com. See page 6.2 If the Patch or Gateway lights are ashing, it does not mean there is a problem with your heart, only that a device may have lost its connection. Turn to the Troubleshooting section or call 1.888.693.2401 for support.3 Keep the Gateway close by when you can, and when you are on the move carry it with you. It is okay if the Gateway is temporarily out of range, but iRhythm will not receive heart rhythm data from your Patch or Gateway while it is out of range. For the Gateway to remain connected it needs to be kept in front of you and within 10 feet of the Patch.

5TROUBLESHOOTINGFAQsPATCH REMOVAL TRAVELING USING ZIOAdditional tips:If your skin around the Patch feels a little itchy, it is okay. If the Patch peels or lifts at the edges, press and hold the Patch to re-stick. Excessive sweating can cause the Patch to slide, become loose, fall o, and shorten wear time – especially if sweating occurs in the rst 24 hours after the Patch is put on. The Patch is water-resistant but should not be submerged. Brief showering is okay, but no swimming or hot tubs. The Gateway is NOT water resistant. Please do not get it wet. Do not place the Gateway within 6 feet of transmitting devices, such as wireless routers, baby monitors and TV senders/transmitters. These devices may cause interference between the Patch and the Gateway. Sending heart rhythm data through the Gateway may take some time after the Patch button is pressed. Recent transmissions may not be viewable on myZio until several hours later.

7FAQsUSING ZIOPATCH REMOVAL TRAVELINGTROUBLESHOOTING: GATEWAYIf the light on the outside of your Gatewayisashing,checkinside.SLOW FLASHING(once every 3 seconds):Indicates that the Gateway has lost the connection to your Patch.To reconnect, hold the star buttonfor 3 seconds until the orange light stays on. If the light then ashes green, the Gateway has reconnected to the Patch.Iforangeashingcontinues, call Customer Service at 1.888.693.2401. TROUBLESHOOTING

8SLOW FLASHING(once every 3 seconds):Indicates that the Gateway does not have a cell signal.To reconnect, 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.If the light then ashes green, the Gateway has reconnected. Do not move the Gateway until the green ashing stops.If it does not ash green, move the Gateway to a new place and try again.Iforangeashingcontinues, call Customer Service at 1.888.693.2401.FAST OR FLASHING(3 times per second):FastashingindicatesthatyourGatewayis not working. Call Customer Service at 1.888.693.2401.

9FAQsUSING ZIOPATCH REMOVAL TRAVELING TROUBLESHOOTINGTROUBLESHOOTING: PATCHSLOW FLASHING(once every 3 seconds):Indicates that your Patch is not making good contact with your skin.To correct this, press evenly on the wings of the Patch for 3 to 5 minutes.Iforangeashingcontinues, call Customer Service at 1.888.693.2401.FAST FLASHING(3 times per second):Indicates that your Patch is not recording. Call Customer Service at 1.888.693.2401.

10FREQUENTLY ASKED QUESTIONS (FAQS)The Zio® AT monitoring systemWhat is the Patch doing?The Patch is recording every heartbeat. Your doctor will use the heart rhythm data from the Patch to determine the right course of action.What is the Gateway doing?The Gateway wirelessly sends heart rhythm data from the Patch, each time the Patch button is pressed and each time the system automatically detects an arrhythmia. iRhythm receives and analyzes the data, and provides a report to your doctor.How do I know the Patch and the Gateway are working?When they are working normally, the Patch and Gateway do not ash or make noise.Do I need to do anything after pressing the Patch button to send heart rhythm data wirelessly?No, you only need to keep the Gateway in front of you and within 10 feet of the Patch to stay connected wirelessly after you press the Patch button. The Gateway should also be kept in a place with good cell signal.

11TROUBLESHOOTING USING ZIOPATCH REMOVAL TRAVELING FAQsCan I carry the Gateway in a purse, bag or pocket?Yes. However, when carrying the Gateway keep it in line of sight of the Patch. The Gateway will need to be in front of your body and within 10 feet of the Patch.What can aect wireless connection between the Patch and the Gateway? Wireless devices that use 2.4 GHz signals such as baby monitors, some cordless home telephones, 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.Your activitiesCan I exercise while wearing the Patch? Yes, you may exercise moderately, but excessive sweating may shorten wear time.Can I shower with the Patch on?Yes, but showers should be short and try to keep your back to the shower as much as possible. Keep soaps and lotions away from the Patch. When towel-drying, hold the Patch down with one hand. Press the Patch against your skin to secure it. Keep the Gateway away from all water.

12Can I take a bath?Yes, but keep the Patch above water. Keep the Gateway away from all water.Can I go into a pool or a hot tub?No. The Patch should not be put under water. Keep the Gateway away from all water.Can I travel with the Patch on?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.Can I y with the Gateway?Yes, though the Gateway should be placed in “airplane mode.” See Traveling.What activities should I avoid? Activities that cause heavy sweating should be avoided. Sweat can cause the Patch to slide, become loose, fall o, and shorten wear time.Recording symptomsWhat should I do if I feel a symptom? First, press the button on the Patch. Then, ll out a page of the Button Press Log in this booklet, use the myZio App or .myzio.com to enter your symptoms. Please choose only one option for recording symptoms but not all.

13TROUBLESHOOTING USING ZIOPATCH REMOVAL TRAVELING FAQsWhat if I forget to press the button when I feel a symptom?While pressing the button is important to “tag” and wirelessly send an event, the Patch is recording every heartbeat.What if I press the button but forget to write down the symptom?Recording your symptoms and activity gives your physician additional information about what may have caused the symptom. While this is useful, the more important thing is to press the button.What if I press the Patch button while the Gateway is not within 10 feet and in line of sight of the Patch?The Patch will store the data until the Gateway is in range, then the data will be sent.What happens if I press the Patch button while the Gateway doesn’t have cell signal?The Gateway will store the data until it has cell signal, then the data will be sent to iRhythm.The PatchWhat should I do if the Patch peels or lifts at the edges?Press and hold along the edges to re-stick.What should I do if the Patch falls o?Call Customer Service at 1.888.693.2401.

14I think I see blood under my Patch. What should I do?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.Is it normal for the Zio® AT Patch wings to become cloudy?Yes, the wings of the Patch may become cloudy after a few days of wear.Is it normal for the Patch to move slightly from its original position?Yes. The Patch may move slightly from its original position. A clear gel may be seen under the wings of the Patch.Is it normal to experience skin irritation or itchiness in the area of the Patch?Most patients do not experience skin irritation or itchiness. However, some patients have reported 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, then call Customer Service at 1.888.693.2401.Flashing lightsWill the Gateway show any lights or make any sounds?No. As long as it is able to send data, the Gateway will not ash or make noise.

15TROUBLESHOOTING USING ZIOPATCH REMOVAL TRAVELING FAQsWhat if the Patch ashes orange while I am wearing it?If you see the Patch ashing 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 ashing continues or comes back, call Customer Service at 1.888.693.2401.What should I do if my Gateway is ashing orange?If you see the Gateway ashing orange, this does not mean there is a 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.End of the wear periodHow long am I supposed to wear the Patch?Wear the Patch for as long as your doctor prescribed but no longer than 14 days. NOTE: Each person’s wear experience is dierent and actual wear time may be shorter than prescribed.I have removed the Patch and it is ashing orange. Is this okay?The Patch may ash orange after removal. It is okay to mail the device while it is ashing. Turn to Patch Removal for return instructions.

16SECURITY SCREENING STATEMENTThis person is wearing an iRhythm Zio QX Patch prescribed by their physician. This device is currently adhered to the patient’s chest and is monitoring their heart. It can only be removed under the direction of their physician.If you have any questions, please contact the iRhythm Clinical Center at1.888.693.240124 hours/day, 7 days/week.

17TROUBLESHOOTINGFAQsUSING ZIOPATCH REMOVAL TRAVELINGTRAVELING WITH YOUR ZIO QXFlying while wearing a Zio QX is straightforward. Simply show the security statement (opposite) during screening, and remember to put the Gateway in Airplane Mode.Refer toor Call Support Flashing lightsabove? Your Zio Patch is not sending usinformation Patient NameStart Date RxRemoval Date daysFor Support Call: 1.888.693.2401or visitmyZIO.com4321Quick Reference Patient InstructionsUsing the ZIO® SR p.2Troubleshooting p.6 FAQs p.9Patch Removal p.18 Zio® Patch Return InstructionsLift below to remove return envelopeRemove Patch from skinPlace Patch inside Gateway as shownPlace Patient booklet and Gateway in return envelope Lift for Return Envelope To turn Airplane Mode ONPress and hold the airplane button inside the Gateway for 3 seconds, until the lights ash orange quickly. The airplane light on the outside of the Gateway will ash as long as it is in “Airplane Mode.”To turn Airplane Mode OFFPress and hold the airplane button inside the Gateway for 3 seconds, until the lights ash green quickly. The outside airplane light will stop ashing.

18REMOVING AND RETURNING THE PATCHWhen you have worn the Patch for the time prescribed by your doctor, remove it as described below.1 Using the adhesive remover from the opposite page, tilt the center of the Patch up and sweep between your skin and the Patch – while lifting one side from the center out. Repeat for the other side, lifting from the center out. Wash the skin with mild soap, rinse with water, and pat dry.

19TROUBLESHOOTINGFAQsUSING ZIOTRAVELINGPATCH REMOVAL2 Place the Patch inside the Gateway as shown. 3 Lift panel in the Gateway to remove4Place only the Patch, Gateway and this booklet inside the envelope and seal. Mail it back via the U.S. Postal Service as soon as possible.*ADHESIVE REMOVER *You may be held responsible for the cost of the device if both the Patch and Gateway are not returned.

20ABOUT THE ZIO QXZio QX data analysisYour Zio QX 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.

21Indications for useThe Zio QX ECG Monitoring System is intended to capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram 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 comprehensive report is generated based on the entire ECG recording. It is indicated for use on patients 18 years or older who may suer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety and patients who are asymptomatic. 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 the Zio QX for patients with symptomatic episodes where variations in cardiac performance could result in immediate danger to the patient. • Do not use the Zio QX for patients with known history of life threatening arrhythmias. • Do not use the Zio QX 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 QX on patients with neuro-stimulator, as it may disrupt the quality of ECG data. • Do not use the Zio QX on patients who do not have the competency to wear the device for the prescribed monitoring period.

22Warnings • Do not use the Zio QX 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 QX 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 QX on patients residing in areas with limited to no cellular reception. • No modication of this equipment is allowed.If skin irritation such as severe redness, itching or allergic symptoms develop, remove the Zio QX 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 • The Zio QX System includes temperature and humidity limitations. If exposed, patients may experience degradation of adhesive performance causing the device to slip or fall o during the patient wear duration. • The Zio QX 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 QX System if package is damaged. Device may not perform as intended. • Safety and eectiveness of the Zio QX System on pediatric patients (younger than • 18 years old) has not been established. • Keep device and packaging away from young children.

23Contents 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. • Safety and eectiveness of the Zio QX 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. • 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. • Device is not intended for infants under 10kg.The patient is an intended operatorPackage Contents1 Zio QX Patch1 Zio QX Gateway, containing: 1 postage-paid return envelope1 Skin Prep & Placement Kit containing: 1 patch card template 1 disposable razor 1 abrader disc 4 alcohol pads1 Patient Instructions & Button Press Log containing: 1 adhesive remover wipe1 Zio QX Get Started guide

24SymbolsConsult Instructions for Use Caution Prescription Use OnlyManufacturer Date of Manufacture Serial NumberUse By Do Not Reuse Zio Patch Splash-Proof EquipmentZio Gateway Drip-proof Equipment Protected Against Hazardous Parts with Finger Temperature LimitationsTemperature LimitationsHumidity LimitationsSeparate Collection Do Not Use if Package is Damaged Type BF Applied PartRF Transmitter Net Quantity of Contents Keep DryDo Not Open Until Time of Application

25Asymptomatic 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 secondsVentricular 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 seconds

26PERFORMANCE CHARACTERISTICSECG Channels 1 channelMemory capacity 14 daysRecording Format ContinuousService Life Up to 14 daysShelf Life 6 monthsOut-of-Pouch Shelf Life 1 dayELECTRICAL 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 ≤300mW

27POWER 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 IPX4Gateway IP Classication IP22ESSENTIAL PERFORMANCEThe Zio QX 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 QX alerts the patient that functionality is impaired.

28EQUIPMENT 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)

29Pause DeterminationPause is dened as an RR interval greater than 3 seconds.Electrical Safety and Compatibility • CAUTION: The Zio QX 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 QX should not be used adjacent to or stacked with other equipment. • WARNING: The Zio QX 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 QX Patch. Otherwise, degradation of the performance of this equipment could result.Table 1: Guidance and manufacturer’s declaration— electromagnetic emissionsThe Zio QX device is intended for use in the electromagnetic environment specied below. The customer or the user of the Zio QX device should assure that it is used in such an environment.Emissions test Compliance Electromagnetic environment - guidance

30RF emissions CISPR 11 Group 1The Zio QX device 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 QX device 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 applicableTable 2: Guidance and manufacturer’s declaration—electromagnetic immunityThe Zio QX device is intended for use in the electromagnetic environment specied below. The customer or the user of the Zio QX device should assure that it is used in such an environment.Immunity testIEC 60601 test levelCompliance levelElectromagnetic environment - guidance

31Electrostatic 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 QX device is intended for use in the electromagnetic environment specied below. The customer or the user of the Zio QX device should assure that it is used in such an environment.Immunity testIEC 60601 test levelCom- pliance levelElectromagnetic environment - guidance

32Radiated 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 QX device, 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:

33NOTE 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 QX is used exceeds the applicable RF compliance level above, the Zio QX 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 QX Patch.b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.Table 4: Recommended separation distances between portable and mobile RF communications equipment and the Zio QXThe Zio QX is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Zio QX can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Zio QX as recommended below, according to the maximum output power of the communications equipment.

34Rated 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. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device 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 device 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.

35Changes 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.

because I felt…I pressed the button on:while I was…for this duration…:m d y mhm d y mhAMPMdescribe activity1 minute or less10 minutes or less1 hour or lessMore than 1 houranxiousarm or neck pain/tinglingchest pain or pressuredizzinessfaintlight headedpoundinguttering or racingshort of breathskipped or irregular beat(s)other: describe

because I felt…I pressed the button on:while I was…for this duration…:m d y mhm d y mhAMPMdescribe activity1 minute or less10 minutes or less1 hour or lessMore than 1 houranxiousarm or neck pain/tinglingchest pain or pressuredizzinessfaintlight headedpoundinguttering or racingshort of breathskipped or irregular beat(s)other: describe

because I felt…I pressed the button on:while I was…for this duration…:m d y mhm d y mhAMPMdescribe activity1 minute or less10 minutes or less1 hour or lessMore than 1 houranxiousarm or neck pain/tinglingchest pain or pressuredizzinessfaintlight headedpoundinguttering or racingshort of breathskipped or irregular beat(s)other: describe

because I felt…I pressed the button on:while I was…for this duration…:m d y mhm d y mhAMPMdescribe activity1 minute or less10 minutes or less1 hour or lessMore than 1 houranxiousarm or neck pain/tinglingchest pain or pressuredizzinessfaintlight headedpoundinguttering or racingshort of breathskipped or irregular beat(s)other: describe

because I felt…I pressed the button on:while I was…for this duration…:m d y mhm d y mhAMPMdescribe activity1 minute or less10 minutes or less1 hour or lessMore than 1 houranxiousarm or neck pain/tinglingchest pain or pressuredizzinessfaintlight headedpoundinguttering or racingshort of breathskipped or irregular beat(s)other: describe

because I felt…I pressed the button on:while I was…for this duration…:m d y mhm d y mhAMPMdescribe activity1 minute or less10 minutes or less1 hour or lessMore than 1 houranxiousarm or neck pain/tinglingchest pain or pressuredizzinessfaintlight headedpoundinguttering or racingshort of breathskipped or irregular beat(s)other: describe

because I felt…I pressed the button on:while I was…for this duration…:m d y mhm d y mhAMPMdescribe activity1 minute or less10 minutes or less1 hour or lessMore than 1 houranxiousarm or neck pain/tinglingchest pain or pressuredizzinessfaintlight headedpoundinguttering or racingshort of breathskipped or irregular beat(s)other: describe

because I felt…I pressed the button on:while I was…for this duration…:m d y mhm d y mhAMPMdescribe activity1 minute or less10 minutes or less1 hour or lessMore than 1 houranxiousarm or neck pain/tinglingchest pain or pressuredizzinessfaintlight headedpoundinguttering or racingshort of breathskipped or irregular beat(s)other: describe

because I felt…I pressed the button on:while I was…for this duration…:m d y mhm d y mhAMPMdescribe activity1 minute or less10 minutes or less1 hour or lessMore than 1 houranxiousarm or neck pain/tinglingchest pain or pressuredizzinessfaintlight headedpoundinguttering or racingshort of breathskipped or irregular beat(s)other: describe

because I felt…I pressed the button on:while I was…for this duration…:m d y mhm d y mhAMPMdescribe activity1 minute or less10 minutes or less1 hour or lessMore than 1 houranxiousarm or neck pain/tinglingchest pain or pressuredizzinessfaintlight headedpoundinguttering or racingshort of breathskipped or irregular beat(s)other: describe

because I felt…I pressed the button on:while I was…for this duration…:m d y mhm d y mhAMPMdescribe activity1 minute or less10 minutes or less1 hour or lessMore than 1 houranxiousarm or neck pain/tinglingchest pain or pressuredizzinessfaintlight headedpoundinguttering or racingshort of breathskipped or irregular beat(s)other: describe

because I felt…I pressed the button on:while I was…for this duration…:m d y mhm d y mhAMPMdescribe activity1 minute or less10 minutes or less1 hour or lessMore than 1 houranxiousarm or neck pain/tinglingchest pain or pressuredizzinessfaintlight headedpoundinguttering or racingshort of breathskipped or irregular beat(s)other: describe

because I felt…I pressed the button on:while I was…for this duration…:m d y mhm d y mhAMPMdescribe activity1 minute or less10 minutes or less1 hour or lessMore than 1 houranxiousarm or neck pain/tinglingchest pain or pressuredizzinessfaintlight headedpoundinguttering or racingshort of breathskipped or irregular beat(s)other: describeSAMPLE

Enter your symptoms as shown on the sample page, or enter them using myZio™ or www.myzio.com website and enjoy these additional features: • Review and edit your symptom history • Have easy access to help instructions and videos • View Gateway transmissions • Access and edit your patient proleSee page 6 in the Wearing Your Zio manual to get started with myZio

To be completed by patient:NAMEDATE REMOVED / /SERIAL #Flip for WEARING YOUR ZIO ManualBUTTON PRESS LOG

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