CLINICAL REFERENCE MANUAL
Страница 1: ...CLINICAL REFERENCE MANUAL...
Страница 2: ...tly Asked Questions 11 Healthcare Provider Questions 11 Patient Questions 12 Troubleshooting the Patch 17 Troubleshooting the Gateway 18 Zio AT Service Notes 19 iRhythm Clinical Facility Certification...
Страница 3: ...data at iRhythm s Clinical Center iCC the data is processed byiRhythm sproprietaryalgorithmbeforeaniRhythmCertifiedCardiographic Technician CCT reviews the results and generates a report Upon explicit...
Страница 4: ...RF communications equipment can affect medical electrical equipment WARNING The Zio AT system should not be used adjacent to or stacked with other equipment WARNING The Zio AT system may be interfere...
Страница 5: ...ss log containing 1 adhesive remover wipe 1 patient consent form 1 patient survey 1 Skin preparation kit containing 1 patch card template 1 disposable razor 1 abrader disc 4 alcohol wipes DEVICE DIAGR...
Страница 6: ...eat ECG information and transmit patient triggered and asymptomatic ECG to provide accurate arrhythmia detection In special circumstances when patient data needs to be accessed by the physician during...
Страница 7: ...dual wear experiences the patient s actual wear time may be shorter than prescribed 2 Who should the patient call if they have questions about the Zio AT patch or gateway The patient can read the Wear...
Страница 8: ...elessly Do your best to keep the gateway in front of you and within 10 feet as much as possible The gateway should also be kept in a place with good cellular connection 13 Can I carry the gateway in a...
Страница 9: ...he patch falls off Call Customer Service at 1 888 693 2401 29 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...
Страница 10: ...d it is flashing orange Is this okay The patch may flash orange after removal It is okay to mail the device while it is flashing Turn to Patch Removal for return instructions TROUBLESHOOTING THE PATCH...
Страница 11: ...GLE FLASHING 3 times per second Indicates that the gateway is not working Call Customer Support at 1 888 693 2401 Situation Note myZio Registration Patient Enrollment In order for a patient to registe...
Страница 12: ...cribes our privacy practices our legal duties and your rights concerning your PHI We will follow the privacy practices described in this notice while it is in effect We reserve the right to revise thi...
Страница 13: ...For Business Operations We may use both De Identified and Limited Data Sets a data set that per the Health Insurance Portability and Accountability Act of 1996 regulations has had patient identifiable...
Страница 14: ...t required to agree to a requested restriction We will agree to restrict use or disclosure of your PHI provided that the law allows and we determine the restriction does not impact our ability to oper...
Страница 15: ...data at rest Patient data is protected during wear through use of proprietary data storage formats and access methods and physically protected data ports Once returned to iRhythm for processing data...
Страница 16: ...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 HEART RATE CALCU...
Страница 17: ...ssions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Zio AT system uses RF energy only for its internal function Therefore its RF emissions are very low and ar...
Страница 18: ...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 frequ...
Страница 19: ...eets 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 m...
Страница 20: ...hical symbols for use on equipment 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 dev...
Страница 21: ...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...
Страница 22: ...1 888 693 2401 zioreports com 1 888 693 2401 zioreports com 40 41 This page intentionally left blank This page intentionally left blank...
Страница 23: ...iRhythm Technologies Inc 650 Townsend St Suite 500 San Francisco CA 94103 USA 1 888 693 2401 irhythmtech com ALB0031 01 2018 04 11...
