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Pause Determination

Pause is defined 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 affect 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 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

Electromagnetic 
environment - 
guidance

Summary of Contents for Zio QX

Page 1: ...EARING YOUR ZIO Flip for PRESS BUTTON LOG 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 M...

Page 2: ...h com iRhythmTech CALL 1 888 693 2401 IF The Zio QX patch falls off You experience severe itching or irritation For all other information please see the Troubleshooting and Frequently Asked Questions...

Page 3: ...h 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...

Page 4: ...our 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 m...

Page 5: ...ully stick to your skin we recommend showering briefly with your back to the water and avoid any activities that cause sweating during this period After those first 24 hours you may resume normal acti...

Page 6: ...oblem 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 o...

Page 7: ...he 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...

Page 8: ...re entering symptoms Android users 1 Search for myZio in the Google Play Store 2 Download app 3 Register before entering symptoms Computer users 1 Open your web browser 2 Navigate to www myZio com 3 R...

Page 9: ...LOW 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 flas...

Page 10: ...until the orange light stays on If the light then flashes green the Gateway has reconnected Do not move the Gateway until the green flashing stops If it does not flash green move the Gateway to a new...

Page 11: ...tes 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...

Page 12: ...e 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 n...

Page 13: ...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 activities...

Page 14: ...r connection outside the United States Can I fly with the Gateway Yes though the Gateway should be placed in airplane mode See Traveling What activities should I avoid Activities that cause heavy swea...

Page 15: ...s 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 unt...

Page 16: ...ghtly 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 s...

Page 17: ...Gateway flashing 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...

Page 18: ...ribed 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 p...

Page 19: ...Using the ZIO SR p 2 Troubleshooting p 6 FAQs p 9 Patch Removal p 18 Zio Patch Return Instructions Lift below to remove return envelope Remove Patch from skin Place Patch inside Gateway as shown Plac...

Page 20: ...move it as described below 1Using 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 Repea...

Page 21: ...shown 3Lift panel in the Gateway to remove 4Place 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...

Page 22: ...vice 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 Gatew...

Page 23: ...nxiety 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...

Page 24: ...Zio QX 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 The Zio QX...

Page 25: ...incorrectly classified 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...

Page 26: ...o Patch Splash Proof Equipment Zio Gateway Drip proof Equipment Protected Against Hazardous Parts with Finger Temperature Limitations Temperature Limitations Humidity Limitations Separate Collection D...

Page 27: ...lowing parameters Rhythm Heart Rate Duration Atrial Fibrillation 40 bpm 60 seconds 180 bpm 60 seconds Pause 4 seconds Ventricular Tachycardia 120 bpm 30 seconds 150 bpm 15 seconds Complete Heart Block...

Page 28: ...edance 10 M ECG Differential Range 1 65 mV ECG A D Sampling Rate 200 Hz ECG Resolution 10 bits Patch Short range RF Transmit Receive 2 4 GHz Bluetooth Low Energy Effective Radiated Power 1mW Frequency...

Page 29: ...ture 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 Tempe...

Page 30: ...e 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 Overall...

Page 31: ...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 a...

Page 32: ...g domestic establishments Harmonic emissions IEC 61000 3 2 Not applicable Not applicable Voltage fluctuations flicker emissions IEC Not applicable Not applicable Table 2 Guidance and manufacturer s de...

Page 33: ...A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Table 3 Guidance and manufacturer s declaration electromagn...

Page 34: ...ion distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P d 1 2 P 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz where P is the max...

Page 35: ...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 o...

Page 36: ...Hz 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 stru...

Page 37: ...oved 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 in...

Page 38: ...m d y m h AM PM describe activity 1 minute or less 10 minutes or less 1 hour or less More than 1 hour anxious arm or neck pain tingling chest pain or pressure dizziness faint light headed pounding fl...

Page 39: ...m d y m h AM PM describe activity 1 minute or less 10 minutes or less 1 hour or less More than 1 hour anxious arm or neck pain tingling chest pain or pressure dizziness faint light headed pounding fl...

Page 40: ...m d y m h AM PM describe activity 1 minute or less 10 minutes or less 1 hour or less More than 1 hour anxious arm or neck pain tingling chest pain or pressure dizziness faint light headed pounding fl...

Page 41: ...m d y m h AM PM describe activity 1 minute or less 10 minutes or less 1 hour or less More than 1 hour anxious arm or neck pain tingling chest pain or pressure dizziness faint light headed pounding fl...

Page 42: ...m d y m h AM PM describe activity 1 minute or less 10 minutes or less 1 hour or less More than 1 hour anxious arm or neck pain tingling chest pain or pressure dizziness faint light headed pounding fl...

Page 43: ...m d y m h AM PM describe activity 1 minute or less 10 minutes or less 1 hour or less More than 1 hour anxious arm or neck pain tingling chest pain or pressure dizziness faint light headed pounding fl...

Page 44: ...m d y m h AM PM describe activity 1 minute or less 10 minutes or less 1 hour or less More than 1 hour anxious arm or neck pain tingling chest pain or pressure dizziness faint light headed pounding fl...

Page 45: ...m d y m h AM PM describe activity 1 minute or less 10 minutes or less 1 hour or less More than 1 hour anxious arm or neck pain tingling chest pain or pressure dizziness faint light headed pounding fl...

Page 46: ...m d y m h AM PM describe activity 1 minute or less 10 minutes or less 1 hour or less More than 1 hour anxious arm or neck pain tingling chest pain or pressure dizziness faint light headed pounding fl...

Page 47: ...m d y m h AM PM describe activity 1 minute or less 10 minutes or less 1 hour or less More than 1 hour anxious arm or neck pain tingling chest pain or pressure dizziness faint light headed pounding fl...

Page 48: ...m d y m h AM PM describe activity 1 minute or less 10 minutes or less 1 hour or less More than 1 hour anxious arm or neck pain tingling chest pain or pressure dizziness faint light headed pounding fl...

Page 49: ...m d y m h AM PM describe activity 1 minute or less 10 minutes or less 1 hour or less More than 1 hour anxious arm or neck pain tingling chest pain or pressure dizziness faint light headed pounding fl...

Page 50: ...m h AM PM describe activity 1 minute or less 10 minutes or less 1 hour or less More than 1 hour anxious arm or neck pain tingling chest pain or pressure dizziness faint light headed pounding flutteri...

Page 51: ...www myzio com website and enjoy these additional features Review and edit your symptom history H ave easy access to help instructions and videos View Gateway transmissions Access and edit your patient...

Page 52: ...To be completed by patient NAME DATE REMOVED SERIAL Flip for WEARING YOUR ZIO Manual BUTTON PRESS LOG...

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