kardiamobile 6l system - clinicians | alivecor · 2020. 8. 18. · kardiamobile 6l can be used in...

1 Inpatient User Guide 00LB27.1

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KardiaMobile 6L System

Inpatient User Guide


New FDA Guidance Allows Use of KardiaMobile 6L to Measure QTc in COVI D-19 Patients

World's only FDA-cleared six-lead personal ECG will be used by hea lthcare professionals to monitor QT duration in patients receiving medications that

can cause potentially life th reatening QT prolongat ion

MOUN TAIN VIEW, Calif ., March 23, 2020 - AliveCor, t he leader in artificia l intell igence (Al)-based, personal ECG tec hnology , and provider of enterp rise cardio logy

solutions, today announced that its KardiaMobile 6L - the world's on ly six- lead personal ECG - is now allowed for use in the measu rement of a patient's QTc and

detection of potent ially dangerous QT prolongat ion. A pro longed QTc can lead to a potentially fatal side effect, called drug-induced sudden cardiac death (DI

SCD), associated with the use of several medicines now be ing used in t he trea tme nt of COVID-19.oss the count ry, and to furthe r expand AliveCor's g lobal

foo tprint.

KardiaMobile 6L System Inpatient Indications for Use

KARDIAMOBILE 6L CAN BE USED IN THE INPATIENT SETTING TO RECORD ECGS AND IMMEDIATELY ASSESS THE MOST COMMON HEART RHYTHMS.

FDA-CLEARED INDICATIONS FOR USE

The KardiaMobile 6L System is intended to record, store, and transfer one- and two-channel electrocardiogram (ECG) rhythms. In single-channel mode, the KardiaMobile 6L System can record Lead-I. In two-channel mode, the KardiaMobile 6L System can record Lead-I and Lead-II simultaneously, and derive Lead-III and unipolar limb leads aVR, aVF, and aVL. The KardiaMobile 6L System also displays ECG rhythms and output of ECG analysis from AliveCor’s KardiaAI platform, including detecting the presence of normal sinus rhythm, atrial fbrillation, bradycardia, tachycardia, and others. The KardiaMobile 6L System is intended for use by healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals. The device has not been tested and is not intended for pediatric use.

KARDIAMOBILE 6L CAN BE USED IN THE CURRENT PUBLIC HEALTH CRISIS IN COVID-19 PATIENTS.

FDA EMERGENCY USE

KardiaMobile 6L can be used by healthcare professionals to monitor for QT prolongation in patients at home or in-hospital who are receiving QT prolonging medications, including hydroxychloroquine and azithromycin, whether alone or in combination, for the treatment of COVID-19.

KardiaMobile 6L can also be used by healthcare professionals for the detection and monitoring of other cardiac arrythmias in COVID-19 patients, including atrial fbrillation, tachycardia, and bradycardia.

[Excerpt]

To view the entire announcement, visit: click here.

QT Analysis results displayed in KardiaPro are adjunctive and should not be solely or primarily relied upon to treat COVID-19 or co-existing conditions.

https://www.alivecor.com/press/press_release/new-fda-guidance-allows-use-of-kardiamobile-6l-to-measure-qtc-in-covid-19-patients/


KardiaMobile 6L KardiaStation

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KardiaMobile 6L System Inpatient Use

When using KardiaMobile 6L in a hospital seting, you will need:

• KardiaMobile 6L device

• KardiaStation application installed on mobile phone(s) and/or tablet(s)

• KardiaPro web-based portal

FDA-Cleared 6-lead personal ECG Application for recording an ECG with KardiaMobile 6L

Web-based portal to access ECGs and QT results

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00LB27.1

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5 Inpatient User Guide

Setup

INPATIENT USER GUIDE

Geting ready to implement KardiaMobile 6L System in your hospital

SETUP

• Inpatient User Guide

• Inpatient Use Cases for QTc Monitoring

• KardiaStation

• KardiaStation Setup

• KardiaMobile 6L

• KardiaMobile 6L Setup

• Pairing KardiaMobile 6L

• KardiaPro

• KardiaPro Setup



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Inpatient Use Cases for QTc Monitoring Role of Cardiology

There are several workfow options for the medication management of COVID-19 patients in need of QTc monitoring depending on how your hospital chooses to utilize your cardiology department.

USE CASE 1 Insufcient resources for cardiology consult every time a QTc Use Case 2

measurement is needed for medication management Cardiology reviews • KardiaMobile 6L ECG recordings are sent to an all or prolonged

QT results independent testing facility for QT Analysis

• Prescribing physician accesses results to inform medication management

USE CASE 2 Cardiology reviews all QT results or only prolonged QT results

• KardiaMobile 6L ECG recordings are sent to an independent testing facility for QT Analysis

Cardiology consult unavailable

Use Case 1

Use Case 3

Cardiology conducts QT Analysis from ECG recording

ECG in KardiaPro Cardiology recording

with Patient reviews

KardiaMobile 6L

decisionmanagement

RequestQT Analysis

QT Analysisresults

available

QT Analysis results

Cardiology assessesECG recording and

conducts QT assessment

• Results are accessed by cardiologist who adds interpretation to ECG

• Prescribing physician accesses results and interpretation to inform medication management

USE CASE 3 Cardiology conducts QTc measurements directly from ECG

• Cardiology access ECG recording and conducts QTc measurement directly from an ECG recording

• QTc results and interpretation are added to ECG

• Prescribing physician accesses results and interpretation to inform medication management


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Record your ECG

KardiaStation Application

Artifcial Intelligence–enabled platform for clinicians to record six-lead ECGs from KardiaMobile 6L devices.


KardiaStation Setup Smart Device Compatibility

KardiaStation is available on Apple products via the App Store.

You can implement as many devices with KardiaStation as needed in your hospital.

iPhone iPhone 11 (iOS 13.3)

iPhone 11 Pro (iOS 13.3)

iPhone 11 Pro Max (iOS 13.3)

iPhone XR (iOS 13.3)

iPhone XS Max (iOS 13.3)

iPhone X (iOS 13.3)

iPhone 8 (iOS 13.3)

iPhone 8 Plus (iOS 13.3)

iPhone 7 (iOS 13.3)


iPhone 6s (iOS 13.3)

iPhone SE (iOS 13.3)

iPhone 6 (iOS 12.4)


iPhone 5s (iOS 12.4)

iPad iPad 2019 (7th Gen) (iOS 13.3) iPad 9.7” (2017) (iOS 13.3) iPad Air (3rd Gen) (iOS 13.3)

iPad Pro 12” (2nd Gen) (iOS 13.3) iPad Mini 5 (iOS 13.3) iPad Air 2 (iOS 13.3)

iPad Pro 10.5” (2nd Gen) (iOS 13.3) iPad Mini 4 (iOS 13.3) iPad Air (1st Gen) (iOS 12.4)

iPad Pro 12” (iOS 13.3) iPad Mini 3 (iOS 12.4)

iPad Pro 9” (iOS 13.3) iPad Mini 2 (iOS 12.4)

Tip: When you see “your mobile phones or tablets” in this guide, it is referring to the device(s) with KardiaStation installed.


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KardiaStation Setup Logging in

Open the KardiaStation app.

Enter user email and password If you do not have the login information, please see the individual in your hospital who manages your AliveCor account.

Select “Log in.”

Please note: “Request Access” is intended only for organizations that have not contracted for KardiaStation access yet.


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KardiaMobile 6L

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KardiaMobile 6L Device

KardiaMobile 6L is a six-lead personal ECG. This device delivers ECG Leads I, II, III, aVL, aVR, and aVF. It is the only FDA-cleared personal ECG that includes Lead II, which is the most critical for assessing patients for QT prolongation.


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KardiaMobile 6L About the Device

KardiaMobile 6L is a 3-electrode personal ECG device that records an ECG and wirelessly transmits the data to your mobile phone or tablet using KardiaStation.

• Contains two electrodes on the top surface, for use with the lef and right hands, and one on the botom surface, for use with the bare skin of the lef leg or lower lef abdomen

• Powered by a replaceable batery located under the botom electrode

Tips: You can access additional technical information about the KardiaMobile 6L in the Instructions for Use (outpatient) at support.alivecor.com.

Placement on the lower lef abdomen is for inpatient use only when the patient cannot reach the recommended placement options on the lef leg.

https://alivecor.zendesk.com/hc/en-us


6-Lead EKG X aVR

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Recording III aVF Time

KardiaMobile 6L Lead-II Critical for QT Analysis

KardiaMobile 6L is capable of recording a single-lead (1L) or a six-lead (6L) ECG.

When using the ECG to determine QT prolongation, a 6L ECG should be used in order to collect Lead-II data for QT measurement.

• Corrected QT (QTc) measurements calculated from Lead II are the most unbiased compared to other leads

• Threshold values defning prolonged QT are based on Lead-II calculations

• QTc calculated from other leads could potentially result in inappropriate medication decisions

Salvi et al, Ind Heart J. 2012;64(6):535-40.


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KardiaMobile 6L Setup Tagging the Device for Patient Identifcation

The serial number is located on the KardiaMobile 6L device packaging. This unique identifer for the device is the last the last nine digits of the barcode.

Due to the close proximity of multiple KardiaMobile 6L devices in the unit, it is possible that KardiaStation could pick up the Bluetooth signal of an unintended device up to 30 feet away.

Therefore, for patient safety purposes, you will be asked to verify the 6L device serial number each time you record an ECG.

Since the serial number is not printed on the outside of the device,* you must label the serial number on each device to be used in the verifcation process.

When you take your device out of the box, write the serial number on a sticker and afx to one of the black plastic areas on the back of the device.

Make sure you do not cover any part of the silver electrode.

In this example from a KardiaMobile 6L box, the serial number is underlined: +B210ACD1090/$$+7200112673L.

A sticker with the serial number writen on it has been afxed to the botom of the KardiaMobile 6L device.

* The serial number is printed under the botom electrode of the device. You must remove the batery to access the serial number.

20012673L


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Tap t he top two electrodes to pair IKardiaMobile BL with your phone.

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KardiaPro Setup First Time Signing in

These instructions are intended for the account administrator at your hospital only.

Simply enter www.kardiapro.com into your web browser.

Select “Forgot password?”

• Enter email address as your username

• You will receive an email to create a secure password to sign in to KardiaPro

If you are a KardiaPro user at your hospital and need access, your account administrator can grant you access (see User Setings).

http://www.kardiapro.com

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Recording an ECG


Using KardiaMobile 6L to record patients’ ECGs

RECORDING AN ECG

• Initiating KardiaStation

• Positioning KardiaMobile 6L

• Geting Instant Cardiac Rhythm Assessment Results

• Instant Analysis Descriptions

• Requesting QT Analysis



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Recording an ECG Initiating KardiaStation

Open the KardiaStation app on your mobile phone or tablet.

Select “Record an EKG.”

Enter MRN or Patient ID.

• Any alpha numeric combination

• This is how patients will be identifed in KardiaPro, so make sure the entry is correct

Confrm:

a. 6L serial number b. MRN or Patient ID • Select “Continue”

Confrm “Six-lead EKG” is selected.

• Although the KardiaMobile 6L can record a single-lead ECG, a 6L ECG should always be used for QT Analysis

MRN = Medical Record Number

If device pairing was not done during set up, you will receive a notifcation “Bluetooth Pairing Request”afer you enter the MRN. Select “Pair.”

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Recording an ECG Positioning KardiaMobile 6L

Assist the patient with positioning the 3 electrodes of the KardiaMobile 6L.

Instruct the patient to place fngers or thumbs on the top lef and right electrodes.

• Make sure the device is in the correct orientation, with the AliveCor “/\” pointing forward (as pictured)

Select placement option for the electrode on the botom of the 6L device:

a. If siting up, above lef knee b. If supine, lower lef quadrant of abdomen

ECG will begin recording when good skin contact is made on all 3 electrodes.

• Each electrode on the screen will turn green when a good contact is made

Tips: Too much body fat or body hair will prevent a good bare skin contact.

If the patient has dry skin, moisten with water. This is especially true for the leg or abdomen placement to ensure good skin contact throughout the recording.


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Recording an ECG Geting Instant Cardiac Rhythm Assessment Results

Instruct the patient to hold still during the 30-second ECG recording.

If you get either of the notifcations:

a. “Your EKG was interrupted” and too short to analyze

b. “Recording was unreadable due to interference”

• Select “Record Again”

When fnished recording, KardiaStation will display a cardiac rhythm assessment.

• Examples showing Normal Sinus Rhythm and Possible Atrial Fibrillation

• ECG recordings with instant heart rhythm analysis results are immediately available in KardiaPro


KardiaStation Instant Analysis Descriptions

Upon completion of an ECG recording, KardiaMobile 6L Instant Analysis Result Description transmits the ECG data to KardiaStation.

Possible Atrial Fibrillation ECG shows signs of atrial fbrillation The ECG is then processed by AliveCor’s Instant Analysis algorithms.

Bradycardia Heart rate is less than 50 beats per minute KardiaStation will display the full six-lead ECG and one of the following Instant Analysis results: Tachycardia Heart rate is more than 100 beats per minute • Possible Atrial Fibrillation

• Bradycardia Normal No rhythm abnormalities detected in ECG

• Tachycardia Atrial fbrillation was not detected and the ECG does not fall under the

• Normal algorithmic classifcations of Normal, Bradycardia, or Tachycardia. This may Unclassifed be caused by other arrhythmias, unusually fast or slow heart rates, or poor quality recordings.

• Unclassifed

• Too Short

• Unreadable ECG recording is of insufcient duration. Instant Analysis is not able to provide Too Short an analysis on ECG recordings shorter than 30 seconds. Re-record ECG.

If required, consult cardiology.

Unreadable There is too much interference in the recording. Re-Record ECG.

WARNING: Afer ECG analysis, the app may incorrectly identify ventricular futer, ventricular bigeminy and ventricular trigeminy heart conditions as unreadable.


s;50 AM Fri Apr 10

Kardia 0 Done

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25mm /s 10mm/mV

0 No rhythm abnormalities detected in your EKG.

Learn more>

Kardia cannot dotoct signs of a heart attack. If you be lieve you aro having a med ical emergency , call emorgency services.

Request OT Analysis

8 :57 AM Fri Apr 10

Kardia

25mm/s 10mm/mV

Your EKG recording must be at least 30 seconds to allow Instant Analysis algorithms to perform an analysis.

QT Analysis Are you sure you want to request

OT Anal ysis? e Cance l OK

Request QT Analysis

Done

70 BPM

Recording an ECG Requesting QT Analysis

QTc calculations are not a part of the Instant Analysis.

AliveCor’s independent testing facility will calculate QTc from the ECG upon request.

If you want to request a QT Analysis*

a. Select “Request QT Analysis” b. If requested, you will be asked to confrm

your request

• QT Analysis results will be available in KardiaPro in approximately one hour

Select “Done” to complete.

• Once you select “Done”, you will not be able to access the ECG in KardiaStation

• The ECG can be accessed immediately in KardiaPro

• If you forget to “Request QT Analysis”, access the ECG in KardiaPro where you can also request a QT Analysis of that ECG

At this time, you cannot tell which ECG has QT Analysis results from this list of ECGs. You must select and view a specifc ECG to see QT Analysis results.

*QTc Analysis is performed by an independent testing facility. Skip this step if you are calculating QTc on your own.

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Accessing an ECG and QT Analysis results


Using KardiaPro to access your patients’ ECG recordings and QT Analysis results

ACCESSING AN ECG AND QT RESULTS

• KardiaPro Dashboard

• KardiaPro Patient Directory

• Kardia Pro Reviewing a Patient File

• Reviewing ECGs

• KardiaPro User Setings



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Dashboard -Welcome, Morris, Robert

250 Total Patients

0 Connection Metr ics - Past 14 days

• 175 Connected

$ 2 patients have completed their connection period

@ 10 patients have connected

19 patients were sent an order but have not connected

@ B patients have canceled their order

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KardiaPro Dashboard

From this homepage, you can access all the areas of KardiaPro.

Patients: Access the list of patients in your hospital that have data.

ECG Inbox: Access both your Personal Inbox or the Hospital’s Inbox. Here you will fnd ECGs that have been fagged* for review.

Reports: Automatic reports for billing are for outpatient use only and not applicable for inpatient use.

Connection Metrics: This function is for outpatient use only and not applicable for inpatient use.

Add Patient: If you choose, you can add a new patient to KardiaPro before any ECGs are recorded in KardiaStation. Otherwise, the patient record is created when the ECG is recorded, based on the MRN entered.

Setings: All users can update their password here. Account Administrators have access to add and delete team members, set email notifcation frequency, and set default inbox setings.

Sign Out: Sign out of KardiaPro here. If you forget to sign out, the system will automatically sign you out afer 20 minutes of inactivity.

* At this time, QT results cannot be fagged for review and automatically sent to your ECG Inbox.


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Patient Search

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KardiaPro Patient Directory

The patient directory is used to search for a specifc patient. Once in a patient fle, you have access to all of the ECG recordings and QT Analysis results. You can also see notes, summary reports, and blood pressure data (if entered).

Select “Patients.”

To quickly fnd a specifc patient, type the MRN (medical record number) in the search feld.

• If name was entered into the Patient Profle in KardiaPro, you can also search on patient frst or last name. Otherwise, only the MRN or Patient ID that was used in KardiaStation will be listed

• To return to the full list of patients when fnished, press the “x” next to the patient’s name in the search feld

Select any row to open a patient’s fle.


Blake Smith 74 yrs old MRN 660979 (!l DOWN LOAD REPORT A ADD PATIENT

KardiaPro 0 Overview e Profile e Reports e Blood Pressure . - . C) weight LAST REFRESHED 04 :59 AM C e 42 Normal e OAbnormal o Other e 15 No Analysis

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MO RRIS CARDIOLOGY • i • • • 80 • • • • • • e • • May 8 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 01 02 03 04 OS 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21

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• 66 bpm ( 05-15-2018 Normal Kardia Instant Analysis 07:34 PM 0 Sett ing s • 77 bpm 0 D 05-04-2018 Normal Kardia Instant Analysis 06:59 PM 0 Sig n O ut

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KardiaPro Reviewing a Patient File

Overview – Outpatient only

• If patient has an outpatient connection plan, this tab would be an overview of the connection

Profle

• Add and edit patient name, DOB, and additional personal information

Reports – Outpatient only

ECG

• Review ECG recordings and QT Analysis results

Blood Pressure – Outpatient only

• Additional information on blood pressure readings if available

Weight – Outpatient only

• Additional information on weight measurements if available


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Barbara Smith MRN 979646 ~ DOWNLOAD REPORT fi... ADD PATIENT

Overview

70 yrs old

Profileo Reports ECG Blood Pressure Weight LAST REFRESHED 02 :29 PM C

Patient Information

0 tP FIRST NAME tP LAST NAME Barbara Smith

• PATIENT MRN (P • EMAIL tP SEX

979646 barbara@gmai l.com Female

tP DATE OF BIRTH tP ORDERING PROVIDER tP PHONE NUMBER

08-29-1948 Morris , Robert 312-555-7767

NOTES

Initia l dx of paroxysma l AF Jan 2018 and had cardioversion. Patient still present i ng w/intermittent AF episodes.

Started univac for BP control in July 2018.

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09-01-2018 08-31-2019 KardiaMob ile 6L + BP C1,1ff + 1 Year Connection Paroxysmal AF CPT99091

ORDER NUMBER

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2238756

KardiaPro Reviewing a Patient File, continued (Profle)

“Profle” tab of Patient File.

Patient demographic information, all felds are modifable by selecting the pencil icon.

• Patient email is not used in the inpatient seting. A dummy email can be entered

Access and modify notes section in concert with key points regarding patient care plan.

KardiaPro connection history is applicable to outpatient seting only.

If you desire patient information to appear on ECG recordings and reports then patient information must be completed in the Patient Profle.


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Barbara Smith 70 yrs old MRN 979646

Overview Profile Reports

• 2 Normal e 1Abnormal • 3 Undassified

180 160 • :i; 140 • 0. 120 • • ., • • 100 • BO • • • • • • • 60 • 40

Sepu~mber 20 21 22 23 24 25 26 27 28

DATE v ANALYSIS

FILTER FILTER

0 10-15-2018 11:00 PM Atrial Fibrillation

u 10-15-2018 04:43 PM Atrial Fibrillat ion

u 10-15-2018 04:40 PM Atrial Fibrillation

u 10-13-2015 Norm al 04:30 PM

[J 10-12-20 15 Normal 06 :00 PM

~ DOWNLOAD REPORT fi... ADD PATIENT

ECGO Blood Pressure W!!ight LAS. T REFRESHED 02 :15 PM C • 0 No Anolysis

• • • • • • • • • • • • • • • • • • • • • • October

29 30 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19

ANALYSIS BY BPM + ECG PREVIEW

FILTER FILTER

Morris, R • 105 bpm

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C, Confirmed


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• 73 bpm Kardia Instant Ana lysis

• 87 bpm Kardia Instant Ana lysis

KardiaPro Reviewing a Patient File, continued (ECG)

“ECG” tab of Patient File.

Use the scroll bar under the ECG graph to quickly scroll through months of ECGs to see visual representation for how frequently the patient is in and out of sinus rhythm. Tap on a dot in the graph to bring the ECG recordings to the top of the list.

View all ECGs this patient has recorded.

Open any ECG to access QT Analysis results and/or apply interpretations.

• 6L ECGs are marked with “6L” compared to 1L ECGs. QT results are only available on 6L ECGs

At this time, you cannot tell which ECG has QT Analysis results from this list of ECGs. You must select and view a specifc ECG to see QT Analysis results.


KardiaPro

0 e Robert Morris MOAA }S CARDIOLOGY

ihh Dashboard

0) Patients ,...."

ECG lnbox

~ Reports

{§? Sett ings

(J SignO ut

( ECG Recording -~-- 1 _of_S_1_~) )

Blake Smith

MRN : 660979

DOB: 01-05 -1945 (7Syrs old)

Sex: Male

OT Details

BP: 68 8PM

Reco rded: 07-03-2019 at 10:07 AM

Downlo ad ECG View Patient File

Provider: Morri s, J Conne ction Plan :

Conne ct ion Period : 0 e OT Analysis: Pendin g

QT: QTcf: RR:

25 mm/s 10 mm/mV

+ +

t t

Compare to Previous ECG

LAST OEFRESHED 09 :06 AM C

Patient Notes

Interpretation History (1)

I Kardia 1nstar1l Analysis 07-03-2019 ot 10:07 AM Norma l

+ Add Interpretation

- Remove from lnbox

Reviewing ECGs (QT Analysis Request)

QT Analysis status

Request QT Analysis buton

The following tables summarizes the status options for the QT Analysis results

1. Results status 2. Request buton

Analysis not requesteda Not requested

Green “Request Analysis” buton

Analysis requestedb Pending

“Request Analysis” buton grayed out

Results completed Completed No buton visible

a QT Analysis can be requested in KardiaPro by clicking on buton. b Regardless of whether the QT Analysis was requested in

KardiaStation or KardiaPro.


0 0 e

QTc QT interval in second s

F iac cycle in econds

ihh

0) ,...."

QT ~

KardiaPro

Robert Morr is MOAA}S CARDIOLOGY

Dashboard

Patients

ECG lnbox

Reports

{e:: Sett ings

(J Sign Out

< ECG Recording '------- 1 _of_ S_1 __ ] )

Blake Smith

MRN: 660 979

DOB : 01-05- 1945 (75 yrs old)

Sex: Male

ECG Deta ils

Heart Rate: 75 BPM

Prov ider : M or ris, J

Connection Plan:

Connection Period :

QT Analys is: Comp leted

Record ed: 04-01-2020 at 01:45 PM l!IJ Oar: 347 A

RR: 689 V

+

Down load ECG View Patient File

QTc: 393 e


LAST REfR..E!il-tEC 09 :06 AM C

Patient Notes

Interpretat ion History (1)

I Kardia Instant Analysis 04 -01-2020 at 01:45 PM Norma ,1


- U)NFRM

Reviewing ECGs, continued (QT Analysis Results)

The following results are presented from the QT Analysis:

QT: raw QT interval (not corrected)

RR: the R-R interval

QTc: corrected QT interval calculated using the Bazet formula:

The QT and R-R interval are essential for the verifcation of the QTc calculation result.


KardiaPro

0 Robert Morris MORRIS CARDIOLOGY

11111 Dashboard

0) Patients ,....,,

-'v- ECG lnbox

0 01 Reports

@ Sett ings

(J SignO ut

ECG Recording -Barbara Smith MRN: 979646 DOB: 08-29-1948 (70 yrs old ) Sex: Female

ECG Deta ils

Heart Rate: 75 8PM

Provider: Robe rt Mo rris Connection Plan: Kard laMobi le 6L + BP Cuff+ 1 Year Connec tion Connect,on Period: 09 -01-18 to 08-31-19

OT Analysis: Completed

Record ed: 04 -0 1-2020 at 01:45 PM Ci!J QT: 347 RR: 689

Export Recording

V iew Patient File

QTc: 393

25 mm/s 10 mm/mV

A ADD PATIENT

LAST REFRESHED 03 :46 PM C

Possible Atrial Fibrillation - 10-15-2018 at 12:16pm

ADD INTERPRETATION

I Search ... a Atrial Fibrillation

Atrial Flutter

Paced

Junctional

V l ach

ADDED INTERPRETATIONS

0 Atr ial Fibrillation

Comments ... 0

CANCEL

I

Reviewing ECGs, continued (Adding Interpretation)

REVIEWING, INTERPRETING & SIGNING:

Type in box or scroll to search for an interpretation. Time-saving tip: You can easily search for “Ventricular Premature Complex” by typing “PVC” in the search bar. Additionally, you can select more than one interpretation. The interpretations selected will appear in the “added interpretations” section.

Optional: Type additional comments or notes. In order to add comments or notes, an interpretation must be selected in step 1.

Select “Save.”

Hospitals in which Cardiology will be reviewing QT Analysis results or will be conducting QTc measurements themselves can use the Interpretation function to add their fndings to the ECG.


KardiaPro

0 Robert Morr is MOAA}S CARDIOLOGY

ihh Dashboard

0) Patients ,...."

0 ECG lnbox

~ Reports

e

e {e:: Sett ings (J Sign Out

< ECG Recording '------- 1 _of_S_1 _ ___,] )

Blake Smith

MRN: 660979 DOB: 01-05-1945(75 yrs old) Sex: Male

ECG Deta ils

Heart Rate: 75 BPM

Prov ider : M o rris, J

Connection Plan:

Connection Period :

QT Analys is: Comp leted

QT: 347 Recorded: 04-01-2020 at 01:45 PM l!IJ RR: 689

+

e e Download ECG View Patient File

QTc: 393


LAST REfR..E!il-tEC 09 :06 AM C

Patient Notes

Interpretat ion History (1)

I Kardia Instant Analysis 04 -01-2020 at 01:45 PM Norma ,1


0 - Remove from lnbox e 0

Reviewing ECGs, continued (Interpretation Workfow)

AFTER SAVING YOUR INTERPRETATION, YOU CAN EITHER

Select “Reassign” to send ECG to a diferent KardiaPro Inbox for review. The user must have a user account in your organization’s KardiaPro account.

OR

Select “Confrm” to save in the patient’s KardiaPro fle and add to summary report.

By confrming, you will no longer be able to add or modify interpretations to this ECG. Confrmed ECGs will be listed in the archived folder. Option to bulk export confrmed ECGs from the archived folder.

OTHER ACTIONS

Select “Remove from Inbox” to remove the ECG from your ECG Inbox workfow. The ECG is saved to the patient’s KardiaPro fle and added to the summary report.

Download an individual ECG as a PDF fle in one click.

Go to a patient’s fle to view the patient’s other ECGs. Then easily use your browser back buton to return to interpreting this ECG recording.


0 0 e 0 0

KardiaPro


lhh Dashboard

Patients

ECG lnbox

Reports

o @ Setti ngs ('.) Sign Out

Sett ings

- 0 Update Password Invite Member

Update Password

e CURR:SNiT PASSWORD e e NEW PASSWORD

0 Requ 'red

e CONFIRM NEW PASSWORD

You r passwo rd must inc lud e;

X 8-20 characte rs (no spac,es) X At least one upper case l,ette r X At least one lowe r case lett er X At least one number

A ADD PATIENT

Team Members In box Settings LAST REfllESHED 03:31 PM C

SAVE 0

KardiaPro User Setings

From Setings, all users can change their password.

For personnel designated as Account Administrators, you can add and remove members and modify Inbox default setings.

ALL KARDIAPRO USERS: UPDATE PASSWORD

Select “Setings.”

“Update Password” tab of Setings.

Enter your Current Password.

Enter your New Password twice.

Select “Save.”

Alternatively, if you don’t know your password and you’d like to reset your password, you can go to kardiapro.com and click “forgot password.” Enter your email. This will generate an email with a link to reset your password.

https://kardiapro.com


KardiaPro


0 lhh Dashboard

0 0) "'

Patients

e ECG lnbox

~ Report s

e

@ Setti ngs

('.) Sign Out

Sett ings

Update Password Invite Member 0 Team Members In box Settings Member Information When you add a team member to your practice, we will send an invite email to the email address provided.

e

e EMAIL

name@>example.com

Riequ'red

Member Roles

Account Adrriinistrator

0

Can manage team settings (e.g. edd/riemove members)

Pending Invites

0 Revoke

lehrli chm an !!>gmail .co m

v ic+morris@a'livecor.com

Provider

Acc.e.ss to Provider functions (e.g. Ordering Provider)


KardiaPro


0 0 lhh Dashboard

e 0) Patients "' 0

ECG lnbox

~ Report s

@ Settings

('.) Sign Out

Settings

Update Password Invite Member

Adams. W

Arguelles,A

Bahr, I

Barnett, K

Byron, J

Chang , M

Coker, J

Drambe l, E

Ehrlichman, L

Follmer, T

Hayes, B

NAME ,...._

e FILTER I Name ...

Hildebra ndt, B

Holzer, S

Hoyer, L

Jones, A

Koerne r, S

Lee, J

Locke , C

Team Members 0 In box Settings A ADD PATIENT

LAST REFRESHED 06 :11 PM C

EMAIL ISAOM IN IS ?ROVIOER

FILTER FILTER e FILTER [email protected] ml m [email protected] ml m [email protected] m ml

0 kba rnett+morris@a I ivetec.com m m james.l>[email protected] ml m [email protected] ml m jeff @alivecor.com ml m eddrambel #-yahoo .com ml ml

l.ehrlichman# gmai l.com ml m tod dfo llm e [email protected] ml ml

brandon.hayes @west.com ml m brittany @alivec ·or.com ml m stefan@a'livecor.com ml m elizabeth.hoye [email protected] ml m alison@alivec·or.com ml ml

samuel.koemer :twrest.com ml m [email protected] ml m co:[email protected] ml ml

KardiaPro User Setings, continued

ACCOUNT ADMINISTRATOR: MEMBER INFORMATION

“Team Members” tab of Setings.

Search by name or email by selecting “Filter.”

Quickly flter or sort list by Administrators and Providers.

You can open any team member information by selecting any row (see next page for details).


KardiaPro

Robert Morris MORR IS CARDIOLOGY

0 0 lhh Dashboa rd

e 0) Patients "' 0

ECG lnbox

~ Report s

0

@ Settings

('.) Sign Out

Barnett, IKim

Member Information

0 t' e FlRSl NAME /1 e LAST NAME Kim Barnett

Member Roles

0 Account Adm inistrator II Prov ide r Can menage teem settings (@.g. ;add/remove members) Access to Provider functions (e.g. Ord@ri ng Provider)

0 Unread ECG Reminders When there are unread ECGs in the ECG lnbox, an email reminder will be sent al the selected frequency.

0

FREQUENCY OF REMINDERS

Daily

Unread recordings in Personal lnbox

Unread recordings in Practice In box

0 DELETE SAVF: 0

A ADD PATIENT


KardiaPro


0 0 lhh Dashboard

0) Patients "'

ECG lnbox

~ Reports

{§} Setti ngs

('.) Sign Out

Settings

Update Password Invite Member

Team lnbox Sett ings

WHIQi RECORDINGS TO FLAG

!1111 abnormal recordings

All recordings

All non-normal recordings

No recordings

Custom

Team Members In box Sett ings 0 A ADD PATIENT

LAST •EF• ESHED 03:32 PM C

SAV,

KardiaPro User Setings, continued

ACCOUNT ADMINISTRATOR: INBOX SETTINGS

“Inbox Setings” tab of Setings.

Select the practice level default for which recordings to fag: All non-normal recordings, All Recordings, No Recordings, or Custom.

Select “Save.”

Note: The inbox setings tab sets the default that will appear when a user is adding a new patient. However, you can always modify the “default inbox setings” for each patient upon patient enrollment or within the overview tab of the patient fle.

MKT-0066 REV.1

00LB27.1


• 71 BPM

II aVL

~ Recording III aVF

Time


Other Functions and Information


This section contains useful information for administrators or coordinators that maintain KardiaStation, KardiaMobile 6L, and KardiaPro.

OTHER FUNCTIONS AND INFORMATION

• KardiaStation Additional Menu Items

• KardiaMobile 6L Technical Considerations



0

0

Have your heart screened for arrhythmias

Record an EKG

Set Device: KardiaMobile

Set Device: KardiaMobile 6L t,I

e KardiaStation Status About KardiaStation

Log out

rm=n ....

Cancel

0

X Close KardiaStation Status Configuration

Date Heart Rate Uploaded

4/6/20, 7:26 AM 61 BPM

Device

Device 1s set to Kard1aMobile 6L

Okay

m

KardiaStation Additional Menu Options

The menu has additional options.

• Password entry is needed to access and prevent logout from users

Changing the device pre-set.

• Devices should pair automatically without having to do so through menu

• Default for KardiaStation is the KardiaMobile 6L

KardiaStation Status.

• Shows the list of ECGs that have been uploaded to KardiaPro

• If your recorded ECG does not appear in KardiaPro, you may have lost your connection to transmit data from your mobile phone or tablet

About KardiaStation.

• Application technical details

Log out.

00LB27.1 41 Inpatient User Guide

KardiaMobile 6L Technical Considerations

The expected service life for KardiaMobile 6L is two years.

The device is powered by a CR2016 Coin Cell that is IEC 60086-4 compliant.

KardiaMobile 6L is IP22 rated. KardiaMobile 6L is protected against insertion of fngers and is not afected by vertically dripping water. KardiaMobile 6L has been tested with relevant requirement standard IEC 60601-1-11:2015.

DO NOT use the electrode on a portion of the body with too much body fat, body hair, or very dry skin, as a successful recording may not be possible.

DO NOT take a recording if electrodes are dirty. Clean them frst.

DO NOT immerse device or expose device to excessive liquid.

DO NOT use while charging your smart device.

DO NOT drop or bump with excessive force.

DO NOT expose to strong electromagnetic felds.

DO NOT expose the device to a magnetic resonance (MR) environment.

DO NOT use with a cardiac pacemaker, ICDs, or other implanted electronic devices.

DO NOT use during cautery and external defbrillation procedures.

DO NOT place electrodes in contact with other conductive parts including earth.

DO NOT use with un-approved accessories. Use of non-AliveCor approved accessories or transducers and cables could result in electromagnetic emissions or decreased electromagnetic immunity of this device and result in improper operation.

DO NOT use adjacent to or stacked with other equipment because it could result in improper operation.

DO NOT use portable RF communications equipment (including peripherals such as antenna cables and external antennas) closer than 30 cm (12 inches) to any part of the KardiaMobile 6L System. Otherwise, degradation of the performance of the KardiaMobile 6L System could result.

For a full list of warnings and environment considerations, consult the “Instructions for Use for KardiaMobile 6L.”


kardiamobile 6l system - clinicians | alivecor · 2020. 8. 18. · kardiamobile 6l can be used in...

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