The ECG app is not intended for use by people under 22 years old.

Transcription

1 ECG App Instructins fr Use Apple Inc. One Apple Park Way Cupertin, CA INDICATIONS FOR USE The ECG app is a sftware-nly mbile medical applicatin intended fr use with the Apple Watch t create, recrd, stre, transfer, and display a single channel electrcardigram (ECG) similar t a Lead I ECG. The ECG app determines the presence f atrial fibrillatin (AFib) r sinus rhythm n a classifiable wavefrm. The ECG app is nt recmmended fr users with ther knwn arrhythmias. The ECG app is intended fr ver-the-cunter (OTC) use. The ECG data displayed by the ECG app is intended fr infrmatinal use nly. The user is nt intended t interpret r take clinical actin based n the device utput withut cnsultatin f a qualified healthcare prfessinal. The ECG wavefrm is meant t supplement rhythm classificatin fr the purpses f discriminating AFib frm nrmal sinus rhythm and nt intended t replace traditinal methds f diagnsis r treatment. The ECG app is nt intended fr use by peple under 22 years ld. USING THE ECG APP App Set-Up/On-barding The ECG app is available n Apple Watch Series 4 with watchos r later, paired with iphne 5s r later with ios r later. Open the Health app n yur iphne. In the Health Data tab, tap Heart, then select Electrcardigram (ECG) Fllw the nscreen instructins. Yu may exit n-barding at any time by pressing Cancel. Recrding an ECG Make sure yur Apple Watch is snug n the wrist yu selected in Settings > General > Watch Orientatin. Open the ECG app n yur Apple Watch. Revisin F, Nvember 16, 2018 Page 1 f 5

2 Rest yur arms n a table r in yur lap, and hld yur finger n the Digital Crwn. Yu d nt need t press the crwn during the sessin. The recrding takes 30 secnds. ECG Analysis After a successful reading, yu will receive ne f the fllwing classificatins n yur ECG app: Sinus Rhythm: A sinus rhythm result means the heart is beating in a unifrm pattern between BPM. Atrial Fibrillatin: An AFib result means the heart is beating in an irregular pattern between BPM. Incnclusive: An incnclusive result means the recrding can t be classified. This can happen fr many reasns such as nt resting yur arms n a table during a recrding, r yur Apple Watch is t lse. Certain physilgical cnditins may prevent a small percentage f users frm creating enugh signal t prduce a gd recrding. Lw r High Heart Rate: A heart rate under 50 BPM r ver 120 BPM affects the ECG app s ability t check fr Afib and the recrding is cnsidered incnclusive. After an ECG recrding is cmplete, the ECG data is analyzed t determine if it is at least 25 secnds lng, and, if s, if either Sinus Rhythm r AFib is present, r if an Incnclusive result is warranted. The ECG recrding result n the ECG app prvides a detailed display f the result. A detailed explanatin will als be prvided n yur iphne. Presence f AFib in yur ECG results may represent nly ptential findings. If yu are experiencing any symptms r have cncerns, cntact yur physician. If yu believe yu are experiencing a medical emergency, yu shuld cntact emergency services. A result f Sinus Rhythm means yur heart rate is between 50 and 100 beats per minute and is beating in a unifrm pattern. Incnclusive ECG results may mean that there may have been t much artifact r nise t acquire a gd signal, r yu may have an arrhythmia ther than AFib the app cannt classify, r yur heart rate is between 100 and 120 BPM. A small percentage f peple may have certain physilgical cnditins preventing the user frm creating enugh signal t prduce a gd recrding. Yu can learn mre abut Incnclusive ECG results during n-barding, by Revisin F, Nvember 16, 2018 Page 2 f 5

3 accessing educatinal infrmatin in the ECG area f the Health app n yur iphne, r by tapping the i icn n the ECG app fr mre infrmatin. A heart rate can be lw because f certain medicatins r if electrical signals are nt prperly cnducted thrugh the heart. Training t be an elite athlete can als lead t a lw heart rate. A heart rate can be high because f exercise, stress, nervusness, alchl dehydratin, infectin, AFib, r ther arrhythmia. If yu receive an Incnclusive result due t a pr recrding, yu might try t re-recrd yur ECG. Yu can review hw t take an ECG during n-barding r by tapping n Take a Recrding in the ECG area f the Health app n yur iphne. All ECGs are synced t the Health app n yur iphne. Yu may use the Health app t share yur ECG with a clinician. SAFETY AND PERFORMANCE The ECG app s ability t accurately classify an ECG recrding int AFib and sinus rhythm was extensively tested in a clinical trial f apprximately 600 subjects. Rhythm classificatin f a 12-lead ECG by a cardilgist was cmpared t the rhythm classificatin f a simultaneusly cllected ECG frm the ECG app. The ECG app demnstrated 98.3% sensitivity in classifying AFib and 99.6% specificity in classifying sinus rhythm in classifiable recrdings. In this clinical trial, 12.2% f recrdings were incnclusive and nt classifiable as either sinus rhythm r AFib. When incnclusive recrdings were included in the analysis, the ECG app crrectly classified sinus rhythm in 90.5% f subjects with sinus rhythm and AFib in 85.2% f subjects with AFib. The clinical validatin results reflect use in a cntrlled envirnment. Real wrld use f the ECG app may result in a greater number f strips being deemed incnclusive and nt classifiable. The mrphlgy f the wavefrm was als tested in this clinical trial by visual assessment f the PQRST wave and R wave amplitude in cmparisn t a reference. During this clinical trial, n adverse events were bserved. TROUBLESHOOTING If yu experience difficulties in perating yur ECG app, refer t the trubleshting guide belw. Prblem: I cannt get the ECG app t take a reading. Revisin F, Nvember 16, 2018 Page 3 f 5

4 Slutin: Ensure that yu have cmpleted all f the n-barding steps in the Health app n yur iphne. Make sure yur wrist and yur Apple Watch are clean and dry. Water and sweat can cause a pr recrding. Ensure that yur Apple Watch, arms, and hands remain still during recrdings. Prblem: I have a lt f artifact, nise, r interference in my recrding. Slutin: Rest yur arms n a table r in yur lap while yu take a recrding. Try t relax and nt mve t much. Make sure yur Apple Watch isn t lse n yur wrist. The band shuld be snug and the back f yur Apple Watch needs be tuching yur wrist. Mve away frm any electrnics that are plugged int an utlet t avid electrical interference. Prblem: The ECG wavefrms appear upside dwn. Slutin: The watch rientatin may be set t the wrng wrist. On yur iphne, g t the Watch app. Tap My Watch > General > Watch Orientatin. All data recrded during an ECG app sessin is saved t Health app n yur iphne. If yu chse t, yu can share that Infrmatin by creating a PDF. New ECG data cannt be recrded nce yur Apple Watch s strage is full. If yu are nt able t take a recrding due t strage space issues, yu shuld free up space by deleting unwanted apps, music r pdcasts. Yu can check yur strage usage by navigating t the Apple Watch app n yur iphne, tapping My Watch, tapping General, and then tapping Usage. CAUTIONS: The ECG app cannt check fr signs f a heart attack. If yu believe yu re having a medical emergency, call emergency services. DO NOT take recrdings when Apple Watch is in clse vicinity t strng electrmagnetic fields (e.g. electrmagnetic anti-theft systems, metal detectrs). Revisin F, Nvember 16, 2018 Page 4 f 5

5 DO NOT take recrdings during a medical prcedure (e.g., magnetic resnance imaging, diathermy, lithtripsy, cautery and external defibrillatin prcedures). DO NOT take recrdings when Apple Watch is utside f the peratinal temperature range (0 C - 35 C) indicated in the Apple Watch user manual and humidity range f 20% t 95% relative humidity. DO NOT use t diagnse heart-related cnditins. DO NOT use with a cardiac pacemaker, ICDs, r ther implanted electrnic devices. DO NOT take a recrding during physical activity. DO NOT change yur medicatin withut talking t yur dctr. Nt intended fr use by individuals under age 22. Yu shuld talk t yur dctr if yur heart rate is under 50 r ver 120 at rest and this is an unexpected result. Interpretatins made by this app are ptential findings, nt a cmplete diagnsis f cardiac cnditins. The user is nt intended t interpret r take clinical actin based n the app utput withut cnsultatin f a qualified healthcare prfessinal. The wavefrm generated by the ECG app is meant t supplement rhythm classificatin fr the purpses f discriminating AFib frm nrmal sinus rhythm and nt intended t replace traditinal methds f diagnsis r treatment. CAUTION: Apple des nt guarantee that yu are nt experiencing an arrhythmia r ther health cnditins when the ECG app labels an ECG as Sinus Rhythm. Yu shuld ntify yur physician if yu detect pssible changes in yur health. SECURITY: Apple recmmends that yu add a passcde (persnal identificatin number [PIN]), Face ID r Tuch ID (fingerprint) t yur iphne and a passcde (persnal identificatin number [PIN]) t yur Apple Watch t add a layer f security. It is imprtant t secure the iphne since yu will be string persnal health infrmatin. EQUIPMENT SYMBOLS Manufacturer Read instructins befre use Revisin F, Nvember 16, 2018 Page 5 f 5