iRhythm Zio QX Manual
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iRhythm Zio QX Manual

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5
5
Record 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:
Flip for PRESS BUTTON LOG
A100A4007.01 4.26.2017 DRAFT
WEARING
YOUR ZIO
MA NUA L

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Summary of Contents for iRhythm Zio QX

  • Page 1 WEARING YOUR ZIO MA NUA L Record 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: Flip for PRESS BUTTON LOG...
  • Page 2 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.
  • Page 3 Zio QX Patch Zio QX Gateway myZio App and Website The 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...
  • Page 4 APPLYING YOUR ZIO QX Follow the instructions in the Zio QX Application Instructions guide to apply your Zio QX Patch It 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.
  • Page 5 USING YOUR ZIO QX With the Zio monitor, you can go through your normal daily activities after the first 24 hours. The Patch needs 24 hours to fully stick to your skin, we recommend showering briefly with your back to the water, and avoid any...
  • Page 6 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...

  • Page 7: Additional Tips

    Additional 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 off, and shorten wear time –...
  • Page 8 Use myZIO to enter your symptoms electronically and check transmissions sent from your Gateway.* Through myZio you have easy access to help instructions and videos. iPhone® users 1. Search for ‘myZio’ in the App Store 2. Download app 3. Register before entering symptoms Android™...

  • Page 9: Troubleshooting

    TROUBLESHOOTING: GATEWAY If the light on the outside of your Gateway is flashing, 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 flashes green, the Gateway has reconnected to the Patch.
  • Page 10 SLOW 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.
  • Page 11 TROUBLESHOOTING: PATCH SLOW 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 flashing continues, call Customer Service at 1.888.693.2401. FAST FLASHING (3 times per second): Indicates that your Patch is not recording.

  • Page 12: Frequently Asked Questions (Faqs)

    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...
  • Page 13 Can 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 affect wireless connection between the Patch and the Gateway? Wireless devices that use 2.4 GHz signals...

  • Page 14: Recording Symptoms

    Can 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.
  • Page 15 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 Patch What should I do if the Patch peels or lifts at the edges? Press and hold along the edges to re-stick.

  • Page 16: Flashing Lights

    I 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.
  • Page 17 What if the Patch flashes orange while I am wearing it? If you see the Patch flashing orange, this does not mean there is a problem with your heart; it just means that the Patch is not well attached. Press evenly on the wings of the Patch for 3 to 5 minutes.
  • Page 18 SECURITY SCREENING STATEMENT This 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.
  • Page 19 TRAVELING WITH YOUR ZIO QX Flying while wearing a Zio QX is straightforward. Simply show the security statement (opposite) during screening, and remember to put the Gateway in Airplane Mode. Patient Name Flashing lights Start Date above? days Your Zio Patch...
  • Page 20 REMOVING AND RETURNING THE PATCH When you have worn the Patch for the time prescribed by your doctor, remove it as described below. Using the adhesive remover from the opposite page, tilt the center of the Patch up and sweep between your skin and the Patch –...
  • Page 21 Place the Patch inside the Gateway as shown. Lift panel in the Gateway to remove 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...

  • Page 22: Patient Identification

    ABOUT THE ZIO QX Zio QX data analysis Your 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.
  • Page 23 • 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 defibrillators or high frequency surgical equipment near strong magnetic fields or devices such as MRI.
  • Page 24 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.

  • Page 25: Package Contents

    • Safety and effectiveness 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 classified.
  • Page 26 Symbols Consult Instructions for Use Caution Prescription Use Only Manufacturer Date of Manufacture Serial Number Use By Do Not Reuse Zio Patch Splash-Proof Equipment Zio Gateway Temperature Humidity Drip-proof Equipment Protected Limitations Limitations Against Hazardous Parts with Finger Temperature Limitations Separate Collection Do Not Use if Package is Damaged...
  • Page 27 Asymptomatic Arrhythmia Detection Asymptomatic arrhythmia events, as detected and transmitted during the monitoring period, are defined by the following parameters: Rhythm Heart Rate Duration ≤40 ≥60 seconds Atrial Fibrillation ≤180 ≥60 seconds Pause ≥4 seconds ≥ 120 ≥ 30 seconds Ventricular Tachycardia ≥150...

  • Page 28: Performance Characteristics

    PERFORMANCE CHARACTERISTICS ECG Channels 1 channel Memory capacity 14 days Recording Format Continuous Service Life Up to 14 days Shelf Life 6 months Out-of-Pouch Shelf Life 1 day ELECTRICAL CHARACTERISTICS Medical Equipment Type BF Applied Part ECG Frequency Response 0.5Hz to 30Hz ECG Input Impedance ≥...

  • Page 29: Power Characteristics

    Gateway IP Classification IP22 ESSENTIAL PERFORMANCE The 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.
  • Page 30 EQUIPMENT CLASSIFICATION INFORMATION Patch IEC Gateway IEC Classifications Classifications Internally Powered Internally Powered ME Equipment ME Equipment Type BF Applied Part IPX4 - IP 22 Continuous Operation Continuous Operation Heart Rate Calculations The maximum episode heart rate (i.e., maximum of all instantaneous heart rates within the episode) The minimum episode heart...
  • Page 31 Table 1: Guidance and manufacturer’s declaration— electromagnetic emissions The Zio QX device is intended for use in the electromagnetic environment specified below. The customer or the user of the Zio QX device should assure that it is used in such an environment. Emissions test Compliance...
  • Page 32 Table 2: Guidance and manufacturer’s declaration— electromagnetic immunity The Zio QX device is intended for use in the electromagnetic environment specified below. The customer or the user of the Zio QX device should assure that it is used in such an environment. Electromagnetic Immunity...
  • Page 33 Table 3: Guidance and manufacturer’s declaration— electromagnetic immunity The Zio QX device is intended for use in the electromagnetic environment specified below. The customer or the user of the Zio QX device should assure that it is used in such an environment. Com- Electromagnetic...
  • Page 34 Portable and mobile RF communications equipment should be used no closer to any part of the Zio QX device, including cables, than the 10 V/m 10 V/m recommended 80 MHz to separation distance calculated from the 2.7 GHz equation applicable to the frequency of the 28 V/m transmitter.
  • Page 35 RF transmitters, an electromagnetic site survey should be considered. If the measured field 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.
  • Page 36 Rated Separation distance according to maximum frequency of transmitter output power of 150 kHz to 80 MHz to 80 MHz to transmitter 80 MHz 800 MHz 2.5 GHz d = 1.2√P d = 1.2√P d = 2.3√P 0.01 0.12 0.12 0.23 0.38 0.38...
  • Page 37 Changes or modifications 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.

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