PATIENT INSTRUCTIONS TURN OVER FOR BUTTON PRESS LOG FOR SUPPORT, CALL

Transcription

1 PATIENT INSTRUCTIONS TURN OVER FOR BUTTON PRESS LOG FOR SUPPORT, CALL

2 FOR SUPPORT, CALL If te Patc falls off, call If you feel severe itcing or irritation, remove te Patc ten call If you feel te need for immediate medical care at any time, call 911. Te ZIO SR device will not provide any medical assistance and cannot contact medical personnel for you. For use in te United States only. irytm Tecnologies, Inc. Clinical Centers 650 Townsend St., Suite 380 San Francisco, CA U.S.A. 2 Marriott Drive Lincolnsire, IL U.S.A. 363 N. Sam Houston Parkway East Suite 125 Houston, TX U.S.A

3 ZIO GATEWAY ZIO PATCH Bot parts of te ZIO monitor were turned on at your pysician s office, and are now recording your eart activity. Te ZIO SR Patc records every eartbeat; eac time you press te Patc button, te ZIO SR Gateway sends tat information for analysis. Turn te page for advice on aving te best possible patient experience. 1

4 USING YOUR ZIO SR Wit te ZIO monitor, you can sleep, sower and go troug your normal daily activites. Te Patc needs 24 ours to stick to your skin, so avoid any activities wic cause sweating during tis period. (If your skin is moist, pat it dry wit a dry towel or clot.) After tose first 24 ours, you may resume normal activities, including moderate exercise. Te Patc and Gateway will not flas or make noise wen tey are working correctly, but you can ceck your transmissions using myzio. Turn to te next page or see te inside back cover for information about myzio. 2

5 Tree key tings to keep in mind are: 1 Eac time you feel a symptom, press te button on your Patc. Ten note te date, time, and wat you felt in tis booklet or using myzio. 2 Try to keep te Gateway close by wen you can set it down nearby, and wen you are on te move, carry it wit you. Te Gateway is in range if it remains witin 10 feet of te Patc. 3 If te Patc or Gateway ligts are flasing, it does not mean tere is a problem wit your eart, only tat te device may ave lost its connection. Turn to te Troublesooting section or call for support. 3 Patc Removal Traveling FAQs Troublesooting Using ZIO SR

6 Oter tips to aving te best ZIO experience possible: If te Patc feels a little itcy, or peels or lifts at te edges, it is okay. Press and old te Patc to re-stick. Excessive sweating can cause te Patc to slide, become loose, fall off, and sorten wear time especially if te sweating occurs in te first 24 ours after te Patc is put on. Te Patc is water-resistant and sould not be submerged. Tat means brief sowering is okay, but no swimming or ot tubs. Te Gateway is NOT waterproof. Please do not get it wet. It is okay if te Gateway is temporarily out of range, but do not leave it witin 6 feet of transmitting devices (suc as wireless routers, baby monitors and TV senders/transmitters). Sending eart rytm data troug te Gateway can take some time. Recent transmissions may not be available at myzio for several ours. 4

7 Use myzio to enter and edit your symptoms electronically, and view transmissions from your Gateway.* ipone users 1. Searc for myzio in te App Store SM 2. Download app 3. Register before entering symptoms Internet Explorer users 1. Open internet browser 2. Navigate to myzio.org 3. Register before entering symptoms * Recent transmissions may not be available at myzio for several ours. Supported on ipone 5s, 6 and 6s (ios 7 and 8). Internet Explorer browser supported on versions IE 8, 9, and 11. ipone, App Store and te Apple logo are registered trademarks of Apple Inc. 5 Patc Removal Traveling FAQs Troublesooting Using ZIO SR

8 TROUBLESHOOTING: GATEWAY If te ligt on te outside of your Gateway is flasing, ceck inside. Slow flasing (once every 3 seconds): Indicates tat te Gateway as lost te connection to your Patc. To remedy it, old te star button for 3 seconds until te orange ligt stays on. Ten, if you see green flasing, te gateway as found connection to te Patc. If orange flasing continues, call Customer Support at

9 Slow flasing (once every 3 seconds): Indicates tat te Gateway does not ave a cell signal. To remedy it, move te Gateway to a place wit a good cell signal (near a window or outside) and old te star button for 3 seconds until te orange ligt stays on. Ten, if you see green flasing, te Gateway as found a cell signal. Do not move te Gateway until te green flasing stops. If it does not flas green, move te Gateway to a new place and try again. If orange flasing continues, call Customer Support at Fast or flasing (3 times per second): Fast flasing indicates tat your Gateway is not working. Call Customer Support at Patc Removal Traveling FAQs Troublesooting Using ZIO SR

10 TROUBLESHOOTING: PATCH Slow flasing (once every 3 seconds): Indicates tat your Patc is not making good contact. To remedy it, press evenly on te wings of te Patc for 3 to 5 minutes. If orange flasing continues, call Customer Support at Fast flasing (3 times per second): Indicates tat your Patc is not recording. Call Customer Support at

11 FREQUENTLY ASKED QUESTIONS (FAQs) About te ZIO SR recording system Wat is te Patc doing? Te Patc is recording every eartbeat. Your doctor will use te data from te Patc to look at your eart rytm and determine te rigt course of action. Wat is te Gateway doing? Te Gateway wirelessly sends eart rytm data from te Patc, eac time te Patc button is pressed. irytm receives and analyzes te data, and provides a report to your doctor. How do I know te Patc and te Gateway are working? Wen tey were turned on, te staff at your doctor s office made sure tat te Patc and Gateway were working. Wen tey are working wit no problems, te Patc and Gateway will not flas or make noise. 9 Patc Removal Traveling FAQs Troublesooting Using ZIO SR

12 Do I need to do anyting wit te Gateway to send eart rytm data wirelessly? No, you only need to keep te Gateway in arm s reac and in view to stay connected wirelessly after you press te Patc button. Te Gateway sould also be kept in a place wit good cell signal. Wat kinds of devices can affect wireless connection wit te Gateway? Oter wireless devices tat use 2.4 GHz signals suc as baby monitors, TV senders/ transmitters, and wireless routers can interrupt communication between te Patc and Gateway if used witin 6 feet. About your activities Can I exercise wile wearing te Patc? Yes, but excessive sweating may sorten wear time. Can I sower wit te Patc on? Yes, but sowers sould be sort and try to keep your back to te sower as muc as possible. Keep soaps and lotions away from te Patc. Wen towel-drying, old te Patc down wit one and. Press te Patc against your skin to secure it. Keep te gateway away from all water. 10

13 Can I take a bat? Yes, but keep te Patc above water. Keep te Gateway away from all water. Can I go swimming or in a ot tub? No. Te Patc sould not be put under water and eavy sweating will sorten wear time. Keep te Gateway away from all water. Can I travel wit te Patc on? Yes. If questioned during security screening, sow te statement in te Traveling section. Note tat te Gateway will not ave cellular connection outside te United States. Can I fly wit te Gateway? Yes, toug te Gateway must be in airplane mode. See Traveling. Wat activities sould I avoid? Activities tat cause eavy sweating sould be avoided. Sweat can cause te Patc to slide, become loose, fall off, and sorten wear time. About recording symptoms Wat sould I do if I feel a symptom? Press te button and fill out a page of te Button Press Log in tis booklet or 11 Patc Removal Traveling FAQs Troublesooting Using ZIO SR

14 using myzio. Please try to use eiter te booklet or myzio for recording symptoms and not bot. Wat if I don t ave symptoms? Tat is okay. Te Patc records every eartbeat. Wat if I forget to press te button wen I feel a symptom? Wile pressing te button is important to tag and wirelessly send an event, te Patc is recording every eartbeat. Wat if I press te button but forget to write down te information in tis booklet? Wile te Button Press Log information is useful, pressing te button indicates tat you felt your symptoms at tat time. Wat if I press te Patc button wile te Gateway is not in range? Te Patc will store te data until te Gateway is in range, ten te data will be sent. Wat appens if I press te Patc button wile te Gateway doesn t ave cell signal? Te Gateway will store te data until it as cell signal, ten te data will be sent. 12

15 About te Patc Wat sould I do if te Patc peels or lifts at te edges? Press and old along te edges to re-stick. Wat sould I do if te Patc falls off? Call Customer Support at I tink I see blood under my Patc. Wat sould I do? Call Customer Support at It is probably due to a small saving cut wen te Patc was applied to your cest. Is it normal for te ZIO SR Patc wings to become cloudy? Yes, te wings of te Patc may become cloudy after a few days of wear. Is it normal for te Patc to move sligtly from its original position? Yes. Te Patc may move sligtly from its original position. A blue gel may be seen under te wings of te Patc. 13 Patc Removal Traveling FAQs Troublesooting Using ZIO SR

16 Is it normal to experience skin irritation or itciness in te area of te Patc? Most patients do not experience skin irritation or itciness. However, some patients ave reported minor skin irritation and/or itcing wile wearing te Patc. If te irritation or itcing is severe or ives or blisters develop, remove te Patc, ten call Customer Support at About flasing ligts Will te Gateway sow any ligts or make any sounds? No. As long as it is able to send data, te Gateway will not flas or make noise. Wat if te Patc flases orange wile I am wearing it? If you see te Patc flasing orange, tis does not mean tere is a problem wit your eart; it just means tat te Patc is not well attaced. Press evenly on te wings of te Patc for 3 to 5 minutes. If te flasing continues or comes back, call Customer Support at

17 Wat sould I do if my Gateway is flasing orange? If you see te Gateway flasing orange, tis does not mean tere is a problem wit your eart; it just means tat te Patc cannot send information wirelessly. Turn to Troublesooting or call Customer Support at About returning te Patc How long am I supposed to wear te Patc? Wear te Patc for as long as your doctor prescribed but no longer tan 14 days. NOTE: Eac person s wear experience is different and actual wear time may be sorter tan prescribed. How do I return te Patc and Gateway? You can drop off te sealed envelope at te Post Office, in a USPS (blue) mailbox or give it to your mail carrier. Turn to Patc Removal for return instructions. I ave removed te Patc and it is flasing orange. Is tis okay? Te Patc may flas orange after removal. It is okay to mail te device wile it is flasing. Turn to te Patc Removal for return instructions. 15 Patc Removal Traveling FAQs Troublesooting Using ZIO SR

18 SECURITY SCREENING STATEMENT Tis person is wearing an irytm ZIO SR Patc prescribed by teir pysician. Tis device is currently adered to te patient s cest and is monitoring teir eart. It can only be removed under te direction of teir pysician. If you ave any questions, please contact te irytm Clinical Center at ours/day, 7 days/week. 16

19 TRAVELING WITH YOUR ZIO SR Flying wile wearing a ZIO SR is straigtforward. Simply sow te security statement (opposite) during screening, and remember to put te Gateway in Airplane Mode. To turn Airplane Mode ON Press and old te airplane button inside te Gateway for 3 seconds, until te ligts flas orange quickly. Te airplane ligt on te outside of te Gateway will flas as long as it is in Airplane Mode. To turn Airplane Mode OFF Press and old te airplane button inside te Gateway for 3 seconds, until te ligts flas green quickly. Te outside airplane ligt will stop flasing. 17 Patc Removal Traveling FAQs Troublesooting Using ZIO SR

20 REMOVING AND RETURNING THE PATCH Wen you ave worn te Patc for te time prescribed by your doctor, remove it as d below. 1 Using te adesive remover from te opposite page, tilt te center of te Patc up and sweep between your skin and te Patc wile lifting one side from te center out. Repeat for te oter side, lifting from te center out. Was te skin wit mild soap, rinse wit water, and pat dry. 18

21 2 3 4 Place te Patc inside te Gateway as sown. Lift panel in te Gateway to remove te return envelope. Place only te Patc, Gateway and tis booklet inside te envelope and seal. Mail it back via te U.S. Postal Service as soon as possible. ADHESIVE REMOVER 19 Patc Removal Traveling FAQs Troublesooting Using ZIO SR

22 ABOUT THE ZIO SR ZIO SR data analysis Your ZIO SR data is analyzed at te irytm Clinical Centers. irytm is an Independent Diagnostic Testing Facility (IDTF) dedicated to providing world-class diagnostic service. As an IDTF, we adere to Medicare Independent Diagnostic Testing Facility Performance Standards. A link to tese standards (42 C.F.R. Section ) can be found at te irytm website Patient identification Before placing your device in te prepaid envelope, please write your name on te line above te return address. By writing your name on te envelope you are providing anoter metod of identification for te Patc and Gateway and are consenting to te potential viewing of your name on te envelope. You may coose to not write your name on te envelope. Notice of privacy practices As participants in your ealt care, we are required by applicable federal and state law to maintain te privacy of your Protected Healt Information (PHI). Our full Notice of Privacy Practices, found at s our privacy practices, our legal duties, and your rigts concerning your PHI. Indications for use Te ZIO SR is a prescription-only, single patient use, continuously recording ECG monitor wit wireless patient event transmission tat can be worn up to patients 18 years or older, patients 20

23 wo may be asymptomatic or wo may suffer from transient symptoms suc as palpitations, sortness of breat, dizziness, ligt-eadedness, pre-syncope, syncope, fatigue, or anxiety. Contraindications Do not use te ZIO SR for patients wit symptomatic episodes were instance variations in cardiac performance could result in immediate danger to te patient. Do not use te ZIO SR for patients wit known istory of life treatening arrytmias. Do not use te ZIO SR in combination wit external cardiac defibrillators or ig frequency surgical equipment near strong magnetic fields or devices suc as MRI. Do not use te ZIO SR on patients wit neuro-stimulator, as it may disrupt te quality of ECG data. Do not use te ZIO SR on patients wo do not ave te competency to wear te device for te prescribed monitoring period. Warnings Do not use te ZIO SR Patc on patients wit known allergic reaction to adesives or ydrogels or wit family istory of adesive skin allergies. Patient may experience skin irritation. Do not reuse te ZIO SR. It is a single patient use device. Reuse will cause incorrect patient data and patient may experience skin irritation. Do not use te ZIO SR on patients residing in areas wit limited to no cellular reception. If skin irritation suc as severe redness, itcing or allergic symptoms develop, remove te Patc. 21

24 CAUTION: Federal (USA) law restricts te sale of tis device to or on te order of a pysician. Precautions Te ZIO SR includes temperature and umidity limitations. If exposed, patients may experience degradation of adesive performance causing te device to slip or fall off during te patient wear duration. Te ZIO SR as a self-life date. Use of expired device may cause a degradation of ECG signal quality and/or low battery condition. Do not use te ZIO SR if package is damaged. Device may not perform as intended. Safety and effectiveness of te ZIO SR on pediatric patients (younger tan 18 years old) as not been establised. Safety and effectiveness of te ZIO SR on patients receiving any form of pacing terapy as not been establised. Paced cardiac rytms may not be accurately detected and may be incorrectly classified. Prescription- Use Only RF Transmitter Keep Dry Type BF applied part Separate collection Consult Instructions for Use 22

25 Tis device complies wit part 15 of te FCC Rules. Operation is subject to te following two conditions: (1) tis device may not cause armful interference, and (2) tis device must accept any interference received, including interference tat may cause undesired operation. Canges or modifications not expressly approved by te party responsible for compliance could void te user s autority to operate te equipment. Te Gateway as been tested and meets FCC RF exposure guidelines wen used and operated for it s intended purpose and as instructed in te manual. 23

26 I pressed te button on: m m d d y y : m m AM PM because I felt anxious arm or neck pain/tingling cest pain or pressure dizziness faint ligt eaded pounding fluttering or racing sort of breat skipped or irregular beat(s) oter: for tis duration 1 minute or less 10 minutes or less 1 our or less More tan 1 our wile I was activity

27 I pressed te button on: m m d d y y : m m AM PM because I felt anxious arm or neck pain/tingling cest pain or pressure dizziness faint ligt eaded pounding fluttering or racing sort of breat skipped or irregular beat(s) oter: for tis duration 1 minute or less 10 minutes or less 1 our or less More tan 1 our wile I was activity

28 I pressed te button on: m m d d y y : m m AM PM because I felt anxious arm or neck pain/tingling cest pain or pressure dizziness faint ligt eaded pounding fluttering or racing sort of breat skipped or irregular beat(s) oter: for tis duration 1 minute or less 10 minutes or less 1 our or less More tan 1 our wile I was activity

29 I pressed te button on: m m d d y y : m m AM PM because I felt anxious arm or neck pain/tingling cest pain or pressure dizziness faint ligt eaded pounding fluttering or racing sort of breat skipped or irregular beat(s) oter: for tis duration 1 minute or less 10 minutes or less 1 our or less More tan 1 our wile I was activity

30 I pressed te button on: m m d d y y : m m AM PM because I felt anxious arm or neck pain/tingling cest pain or pressure dizziness faint ligt eaded pounding fluttering or racing sort of breat skipped or irregular beat(s) oter: for tis duration 1 minute or less 10 minutes or less 1 our or less More tan 1 our wile I was activity

31 I pressed te button on: m m d d y y : m m AM PM because I felt anxious arm or neck pain/tingling cest pain or pressure dizziness faint ligt eaded pounding fluttering or racing sort of breat skipped or irregular beat(s) oter: for tis duration 1 minute or less 10 minutes or less 1 our or less More tan 1 our wile I was activity

32 I pressed te button on: m m d d y y : m m AM PM because I felt anxious arm or neck pain/tingling cest pain or pressure dizziness faint ligt eaded pounding fluttering or racing sort of breat skipped or irregular beat(s) oter: for tis duration 1 minute or less 10 minutes or less 1 our or less More tan 1 our wile I was activity

33 I pressed te button on: m m d d y y : m m AM PM because I felt anxious arm or neck pain/tingling cest pain or pressure dizziness faint ligt eaded pounding fluttering or racing sort of breat skipped or irregular beat(s) oter: for tis duration 1 minute or less 10 minutes or less 1 our or less More tan 1 our wile I was activity

34 I pressed te button on: m m d d y y : m m AM PM because I felt anxious arm or neck pain/tingling cest pain or pressure dizziness faint ligt eaded pounding fluttering or racing sort of breat skipped or irregular beat(s) oter: for tis duration 1 minute or less 10 minutes or less 1 our or less More tan 1 our wile I was activity

35 I pressed te button on: m m d d y y : m m AM PM because I felt anxious arm or neck pain/tingling cest pain or pressure dizziness faint ligt eaded pounding fluttering or racing sort of breat skipped or irregular beat(s) oter: for tis duration 1 minute or less 10 minutes or less 1 our or less More tan 1 our wile I was activity

36 I pressed te button on: m m d d y y : m m AM PM because I felt anxious arm or neck pain/tingling cest pain or pressure dizziness faint ligt eaded pounding fluttering or racing sort of breat skipped or irregular beat(s) oter: for tis duration 1 minute or less 10 minutes or less 1 our or less More tan 1 our wile I was activity

37 I pressed te button on: m m d d y y : m m AM PM because I felt anxious arm or neck pain/tingling cest pain or pressure dizziness faint ligt eaded pounding fluttering or racing sort of breat skipped or irregular beat(s) oter: for tis duration 1 minute or less 10 minutes or less 1 our or less More tan 1 our wile I was activity

38 I pressed te button on: m m d d y y 1 0 : 1 5 m m x AM PM because I felt x x x x anxious arm or neck pain/tingling cest pain or pressure dizziness faint ligt eaded pounding fluttering or racing sort of breat skipped or irregular beat(s) oter: SAMPLE for tis duration 1 minute or less 10 minutes or less 1 our or less More tan 1 our wile I was activity getting out of bed

39 Enter your symptoms as sown on te sample page, or enter tem using myzio and enjoy tese additional features: Review and edit your symptom istory View Gateway transmissions Access and edit your patient profile Find patient instructions See page 5 to get started wit myzio K100A4030.D September 2015

40 BUTTON PRESS LOG TURN OVER FOR PATIENT INSTRUCTIONS Serial # To be completed by patient Name Date removed / / FOR SUPPORT, CALL