Instruction Manual for Apple models including: Irregular Rhythm Notification Feature, Software-Only Mobile Medical Application, Irregular Rhythm Notification Feature Software-Only Mobile Medical Application

Instructions for Use

Instructions for Use

099-12479-AA IRN Instructions for Use (IFU).pages - Apple

2022-03-23 — 수입업자: 이머고코리아 (유). 06236) 서울특별시 강남구 테헤란로 152 강남파이낸스센터 26층. 제조원: Apple Inc. (본사) One Apple Park Way, Cupertino, CA 95014, ...

Not Your Device? Search For Manuals / Datasheets:

File Info : application/pdf, 8 Pages, 102.93KB

Document
irn-1-0-en US
Instructions for Use

ENGLISH (EN)
Irregular Rhythm Notification Feature Instructions for Use
Apple Inc. One Apple Park Way Cupertino, CA 95014 www.apple.com
Apple Distribution International Hollyhill Industrial Estate, Hollyhill, Cork, Ireland Contact: [email protected]
UKRAINE COUNTRY SPECIFIC INFORMATION:  - 01033, , . ,    33-,  27 e-mail: [email protected] . +38 (044) 360 30 11
TURKEY COUNTRY SPECIFIC INFORMATION: Apple Teknoloji ve Sati Limited irketi Bykdere Caddesi Levent 199 Kat:22-23 34394 ili stanbul Trkiye Product Tracking Number for Irregular Rhythm Notification feature: 8682450178007 BRAZIL COUNTRY SPECIFIC INFORMATION: ANVISA N0: 80117580881

RESPONSVEL TCNICO: Luiz Levy Cruz Martins  CRF-SP: 42415 IMPORTADOR: Emergo Brazil Import Importao e Distribuio de Produtos Mdicos Hospitalares Ltda. Avenida Francisco Matarazzo, 1.752, Salas 502/503, gua Branca, So Paulo-SP, CEP  05001-200 CNPJ: 04.967.408/0001-98
E-mail: [email protected]
COLOMBIA COUNTRY SPECIFIC INFORMATION: PRODUCTO: Funcin de notificacin de ritmo irregular (IRNF por sus siglas en ingles) IMPORTADOR: IMPOMED S.A.S Calle 1 SUR NO. 77A-21 Interior 201 Medellin Colombia
REGISTRO SANITARIO NO.: INVIMA 2020DM-0021835
ISRAEL COUNTRY SPECIFIC INFORMATION: AMAR REGISTRATION HOLDER: Medogar Medical Equipment Ltd. Hasadna St. 8 P.O.B 2586 Raannana 4365104 ISRAEL Office Tel: +972-9-7401457 Fax:+972-9-7401459 "    4365104  2566 .. 8  09-7401457 : 09-7401459 :       2566 .. 8   4365104  www.medogar.co.il [email protected]
AMAR Certificate Number: 21080017
REPUBLIC OF KOREA COUNTRY SPECIFIC INFORMATION:   "" . :  () 06236)    152  26 : Apple Inc. () One Apple Park Way, Cupertino, CA 95014, USA () 20450 Stevens Creek Blvd., Cupertino, CA 95014, USA :  20-176   (, , ):    , , Irregular Rhythm Notification Feature (IRNF)  : 1.X : 2020 8
: 1ea
AUSTRALIA COUNTRY SPECIFIC INFORMATION: Sponsor Details: Apple Pty Ltd Level 3, 20 Martin Place

Sydney, NSW, 2000 Australia https://www.apple.com/au/
TEL: 1-300-321-456
PERU COUNTRY SPECIFIC INFORMATION: Registro Sanitario N0 :DB6240E IMPORTADOR: Drogera Emergo Peru S.R.L. Calle Las Orqudeas Nro. 585, Int. 1301, San Isidro, Lima, Per
RUC: 205 52 75 65 34
MALAYSIA COUNTRY SPECIFIC INFORMATION: Authorized Representative: Nyprax Business Solutions 37 Jalan Terasek Lima, Bangsar Baru, 59100 Bangsar, Kuala Lumpur Device License: Apple Irregular Rhythm Notification Feature (IRNF)
GB7830421-55921
INDIA COUNTRY SPECIFIC INFORMATION: Voluntary Registration Number: Apple-USA/I/MD/002975 IMPORTER: Asia Actual India (OPC) Pvt. Ltd. 523A, Tower A, Spaze I-Tech Park, Sector 49,
Gurgaon, Haryana, India
INDONESIA COUNTRY SPECIFIC INFORMATION: Product License Number: KEMENKES RI AKL 20502121725 REGISTRANT: PT. ASIA ACTUAL INDONESIA, DKI Jakarta Gandaria 8 Office Tower, Unit 6J. Jl. Sultan Iskandar Muda Jakarta Selatan 12240  Indonesia
+62 (021) 2930-3747
MOLDOVA COUNTRY SPECIFIC INFORMATION: Registration Number: DM000322301, DM000322302 AUTHORIZED REPRESENTATIVE: JERELO S.R.L. MD-2024, str. Pietrriei, nr 19A, of. 3. mun. Chiinu, Republica Moldova
+37378538295

INDICATIONS FOR USE (NON-EU REGIONS)
The Irregular Rhythm Notification Feature is a software-only mobile medical application that is intended to be used with the Apple Watch. The feature analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification to the user. The feature is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis. These data are only captured when the user is still. Along with the users risk factors, the feature can be used to supplement the decision for AFib screening. The feature is not intended to replace traditional methods of diagnosis or treatment.
The feature has not been tested for and is not intended for use in people under 22 years of age. It is also not intended for use in individuals previously diagnosed with AFib.
INTENDED PURPOSE (EU REGION & REPUBLIC OF KOREA)
Intended Use
The Irregular Rhythm Notification Feature (IRNF) is intended to pre-screen and notify the user of the presence of irregular rhythms suggestive of atrial fibrillation (AFib). The feature can be used to supplement a clinicians decision to screen for possible AFib. The feature is intended for over-thecounter (OTC) use.
The feature has not been tested for and is not intended for use in people under 22 years of age. It is also not intended for use in individuals previously diagnosed with AFib.
Indications
The feature is indicated to pre-screen for irregular rhythms suggestive of AFib for anyone aged 22 years and over.
RUSSIA COUNTRY SPECIFIC INFORMATION
The Irregular Rhythm Notification Feature is not considered a medical device per ROSZDRAVNADZOR (Russian Health Authority).

The Irregular Rhythm Notification Feature is a software-only application that is intended to be used with the Apple Watch. The feature analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification to the user. The feature is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis. These data are only captured when the user is still. Along with the users risk factors, the feature can be used to supplement the decision for AFib screening. The feature is not intended to replace traditional methods of diagnosis or treatment.
The feature has not been tested for and is not intended for use in people under 22 years of age. It is also not intended for use in individuals previously diagnosed with AFib.
In order to receive appropriate healthcare advice please visit a qualified healthcare professional.
USING THE IRREGULAR RHYTHM NOTIFICATION FEATURE
Set-Up/On-boarding
For region availability and device compatibility for the IRNF, please visit https://support.apple.com/HT208931
Update Apple Watch and iPhone to latest OS.
Open the Health app on your iPhone and select "Browse".
Navigate to "Heart", then select "Irregular Rhythm Notifications".
Follow the onscreen instructions.
You may exit on-boarding at any time by tapping "Cancel".
Receiving a Notification
Once the feature is turned on, you will receive a notification if the feature identified a heart rhythm suggestive of AFib and confirmed it on multiple readings.
If you have not been diagnosed with AFib by a physician, you should discuss the notification with your doctor.
All data collected and analyzed by the Irregular Rhythm Notification Feature is saved to the Health app on your iPhone. If you choose to, you can share that information by exporting your health data in the Health app.

New data cannot be collected once your Apple Watchs storage is full. You should free up space by deleting unwanted apps, music or podcasts. You can check your storage usage by navigating to the Apple Watch app on your iPhone, tapping "My Watch", tapping "General", and then tapping "Storage".
SAFETY AND PERFORMANCE
In a study of 226 participants aged 22 years or older who had received an AFib notification while wearing Apple Watch and subsequently wore an electrocardiogram (ECG) patch for approximately 1 week, 41.6% (94/226) had AFib detected by ECG patch. During concurrent wear of Apple Watch and an ECG patch, 57/226 participants received an AFib notification. Of those, 78.9% (45/57) showed concordant AFib on the ECG patch and 98.2 % (56/57) showed AFib and other clinically relevant arrhythmias. A total of 370 irregular rhythm notifications with readable ECG patch data was received by the 57 participants. Of those 370 notifications, 322 (87.0%) were assessed to be AFib, 47 (12.7%) were arrhythmias other than AFib, and 1 (0.3%) was sinus rhythm. These results demonstrate that, while in the majority of cases the notification will accurately represent the presence of AFib, in some instances, a notification may indicate the presence of an arrhythmia other than AFib. No serious device adverse effects were observed.
CAUTIONS
The Irregular Rhythm Notification Feature cannot detect heart attacks. If you ever experience chest pain, pressure, tightness, or what you think is a heart attack, call emergency services.
The Irregular Rhythm Notification Feature is not constantly looking for AFib and should not be relied on as a continuous monitor. This means the feature cannot detect all instances of AFib, and people with AFib may not get a notification.
Apple Watch may be unable to collect data when Apple Watch is in close vicinity to strong electromagnetic fields (e.g. electromagnetic anti-theft systems, metal detectors).
A number of factors can impact the ability of the feature to measure your pulse and detect an irregular rhythm suggestive of AFib. These include factors like motion, hand and finger movements, dark tattoos on the wrist, and the amount of blood flow to your skin (which can be reduced by cold temperatures).
DO NOT wear your Apple Watch during a medical procedure (e.g., magnetic resonance imaging, diathermy, lithotripsy, cautery and external defibrillation procedures).
DO NOT change your medication without talking to your doctor.
Not intended for use by individuals under age 22.
Not intended for use by individuals previously diagnosed with AFib.

Notifications made by this feature are potential findings, not a complete diagnosis of cardiac conditions. All notifications should be reviewed by a medical professional for clinical decision-making.
Apple does not guarantee that you are not experiencing an arrhythmia or other health conditions even in the absence of an irregular rhythm notification. You should notify your physician if you experience any changes to your health.
For best results, make sure your Apple Watch fits snugly on top of your wrist. The heart rate sensor should stay close to your skin.
This is a notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
SECURITY: Apple recommends that you add a passcode (personal identification number [PIN]), Face ID or Touch ID (fingerprint) to your iPhone and a passcode (personal identification number [PIN]) to your Apple Watch to add a layer of security. It is important to secure the iPhone since you will be storing personal health information. Users will also receive additional iOS and watchOS update notifications on the device, and updates are delivered wirelessly, encouraging rapid adoption of the latest security fixes. See "iOS and watchOS Security Guide" which describes Apples security practices and is available to all of our users. For the iOS and watchOS Security guide please visit https://support.apple.com/guide/security/welcome/web.
EQUIPMENT SYMBOLS
Manufacturer
Consult instructions for use
European Authorized Representative
Medical Device
099-12479 Revision X, January 2022



References

wkhtmltopdf 0.12.6-dev Qt 4.8.7