SleepImage Website Instructions for Use Wellness Clinician Account Version 1
MyCardio SleepImage Website Copyright 2017 MyCardio. All rights reserved. Distributed by MyCardio LLC Issued Sept, 2017 Printed in the USA REF D-6.00277 rev 5 MyCardio LLC 370 Interlocken Blvd, Suite 650 Broomfield, CO 80021 USA support@sleepimage.com www.sleepimage.com European Representative Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands Australian Sponsor Emergo Australia Level 20 Tower II, Darling Park 201 Sussex Street Sydney, NSW 2000 Australia Copyright Notice No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language or computer language, in any form, or by any means, electronic, mechanical, optical, chemical, manual, or otherwise, without the prior written consent of MyCardio. Disclaimer This document may contain technical inaccuracies or typographical errors. Changes are periodically made to the information herein; these changes will be incorporated in future revisions of this document. MyCardio does not accept any liability for the use or misuse, direct or indirect, of this product. Users must accept all responsibility for any results obtained by or concluded from data obtained by the SleepImage software. All clinical conclusions and decisions that are made based on the use of this product are the responsibility of the User. MyCardio does not accept any liability or responsibility for damages arising out of the use of or inability to use the SleepImage software. Trademarks MyCardio and SleepImage are registered trademarks of MyCardio LLC. All other trademarks and registered trademarks, used as part of the SleepImage Website are the property of their respective owners. Go to: Table of Contents Page 2 of 20
Table of Contents Introduction... 3 Clinician Accounts... 5 Accessing Patient Sleep Data... 5 Using your Account... 6 Patients... 7 Studies... 8 Trends... 12 Reports... 13 Profile... 14 Account Settings... 15 Invitations... 16 Help... 17 SleepImage Store... 18 Apply Product Keys... 20 Introduction This document refers to licensed Healthcare Practitioners as Clinician and Clinicians and individuals who set up their own accounts to be able to upload their sleep studies as User and Users. Before using the SleepImage website, please read this manual carefully, paying particular attention to the Cautions and Warnings. Go to: Table of Contents Page 3 of 20
The SleepImage System The SleepImage System for a User Account is a sleep screening system consisting of the separate Sleep Data Recorder and the SleepImage Application software SleeIimage.com. The Clinician Account and the Sleep Data Recorders are covered under separate Instructions for Use documents. The SleepImage Application Software displays sleep quality data on SleepImage.com. SleepImage.com is a dedicated website for uploading, reviewing, and documenting data collected during sleep. The website is an interactive and flexible application designed to work in conjunction with the Sleep Data Recorder. The Website stores sleep study data collected from the Recorders with demographics provided by the Users. Sleep study data is presented in the form of tables and graphics and has tools to track trending information collected from multiple studies for each User. The website also contains an ecommerce store for purchasing User registrations, Memberships, Recorders, and accessories. Intended Use The SleepImage Application Software is intended to analyze ECG and accelerometer data to display wakesleep duration, snoring, body movement and the resulting sleep quality. The Sleep Data Recorder and SleepImage Application Software do not monitor or diagnose the patient and do not issue any alarms. For Wellness Users Intended users are individuals that are interested in observing how the quality of their sleep leads to optimizing Wellness and promoting healthy lifestyle choices. For Prescription and Clinician Users Federal law restricts access to this secure (password protected) interface to sale by, or on the order of, a physician. It is also assumed that the Clinicians using the website have received training in the use (and limitations) of Cardiopulmonary Coupling (CPC) to confidently interpret the data. Cautions, Warnings The SleepImage Application Software is intended to analyze ECG and accelerometer data to display wake-sleep duration, snoring, body movement and the resulting sleep quality. The Sleep Data Recorder and SleepImage Application Software do not monitor or diagnose the patient and do not issue any alarms. It is assumed that the User is trained in the use of the Internet and personal computers before reading this manual. Certifications The CE mark is a declaration that the SleepImage Website is in compliance with the EU Medical Device Directive. The MyCardio System complies with EN ISO 13485:2012 The SleepImage Website complies with ISO14971:2000 Medical Devices Application of Risk Management to Medical Devices. The SleepImage Website is cleared by the FDA (K092003). Go to: Table of Contents Page 4 of 20
Clinician Accounts An individual account that licensed healthcare providers can create free of charge to view, monitor and analyze their Patients uploaded sleep studies. Clinicians are linked to their Patients accounts by an embedded invitation process using email addresses. No sleep study data is stored in Clinician Accounts. Study data lives on Patient accounts and is accessed by the Clinician Account via a Patient s Prescription Membership or Clinician Reports once the Clinician/Patient link is established via Invitations. Accessing Patient Sleep Data Once invited, Clinicians can access Patients Sleep Data in two ways: 1) If the Patient has a Prescription Membership, the Clinician has access to all Sleep Studies performed during the term of their Membership. 2) If the User does not have a Prescription Membership, the Clinician may purchase access to studies on a per-report basis and by applying report Credits See more in the Reports section. Clinician Reports and Accessories can be purchased at the SleepImage Store. Go to: Table of Contents Page 5 of 20
Using your Account After having created an account go to the www.sleepimage.com website and click on Sign In. Access your account using the User Name and Password that you created. Users will see the menu list on the left side of screen with the following tabs. Patients Profile Account Settings Invitations Help Go to: Table of Contents Page 6 of 20
Patients Use the Patients Tab to access linked Patient Accounts. Use the search field to find a particular Patient. Click on the name of a Patient to be taken to their Patient Data Page. This page contains your Patients Studies, Trends and Reports and is the page you will use to interact with the Patient s sleep data. Studies This tab has all the Traces of information that you will use during your analysis: ECG, Snore, Actigraphy, Heart Rate & Respiration and Body Position as well as the Spectrogram Trends This Tab shows the Trending Sleep Data as recorded by the Sleep Data Recorder: Sleep Quality %, elfcbb/nb %, Sleep Duration as well as the Patient s weight, if logged. Reports This Tab shows you the Printable Patient Report and lets you export to PDF. Go to: Table of Contents Page 7 of 20
Studies This Tab shows the Spectrogram, the 90 Spectrogram View as well as all the Traces of information that you will use during your analysis: ECG, Snore, Actigraphy, Heart Rate & Respiration and Body Position. Use the Dropdown box to select a study by date. If your Patient does not have a Prescription Membership, studies may appear as greyed out with a red bar. Go to the reports tab and click on the red bar to apply a clinician report to view the study. This section describes the basic components of this web page and how to navigate the data. For more information on how to utilize the data provided by SleepImage, download and read the PDF document called A Clinical Guide to SleepImage which can be found in the Help Tab. The Clinical Guide document contains a comprehensive review of the Clinical aspects of the SleepImage system with guidelines for how to review the Graphs for associations and patterns to better understand your Patients sleep. The Studies Tab has several segments you use to navigate and review the sleep data Spectrogram 90 Spectrogram Traces (ECG, Snore, Actigraphy, Heart Rate, Respiration, & Body Position) Go to: Table of Contents Page 8 of 20
Spectrogram The Spectrogram is an overall representation of how the Patient slept. It also shows a graphical representation of Body position, Actigraphy, Snore and signal quality. The Spectrogram image is wider or narrower depending on how long the Sleep Data Recorder was worn by the Patient. The time is shown along the bottom of the Spectrogram. If desired, the graph can be manipulated to calculate based only on a certain section of the study by moving the two slider bars, located on either side of the image and clicking on the button. This narrows the timeframe you are reviewing. The orange dashed line on the spectrogram references the specific point in time shows on the traces below the spectrogram. Below, the orange dashed line is sitting at 11:30pm. For more information on this, download and read the PDF document A Clinician s Guide to SleepImage which can be found in the Help Tab. Go to: Table of Contents Page 9 of 20
90 Spectrogram The 90 Spectrogram is a look at the SleepImage spectrogram from the side (90 degree angle) for a more detailed view of the low frequency range. To see this graph, click on the button. This view helps interpret sleep quality and differentiate different Sleep-Disordered Breathing (SDB) phenotypes. For more information on how to utilize the data provided by SleepImage, download and read the PDF document called A Clinician s Guide to SleepImage which can be found in the Help Tab of your SleepImage account. The Clinician s Guide contains a comprehensive review of the Clinical aspects of the SleepImage system with guidelines for how to review the Graphs for associations and patterns to better understand your Patients sleep Go to: Table of Contents Page 10 of 20
Traces This information is used in conjunction with the Spectrogram to evaluate the Patient s sleep quality. If there is a time on the spectrogram you want to investigate more closely, double click on the time along the bottom of the graph. The orange dashed line on the spectrogram will move to that spot. This sets the reference for the traces in the windows below. Next, set your interval (how much time you want the window to show in the field at one time (10 sec, 30 sec, 1 min, 2 min, or 4 min). Then use the arrow buttons (circled in red below) next to the windows to move backward or forward from that point in time. This lets you looks for patterns and associations for concurrent events (i.e. body position and snoring, or increased actigraphy during a period of unstable sleep) For more information on how to utilize the data provided by SleepImage, download and read the PDF document called A Clinician s Guide to SleepImage which can be found in the Help Tab of your SleepImage account. The Clinician s Guide contains a comprehensive review of the Clinical aspects of the SleepImage system with guidelines for how to review the Graphs for associations and patterns to better understand your Patients sleep Go to: Table of Contents Page 11 of 20
Trends This Tab shows the trend of your Patient s Sleep Quality and Weight, if tracked. If you are reviewing this with regularity and see a lot of fluctuation on the quality of the Patient s sleep, it can be an indicator that the Patient may not be compliant with therapy protocols, or that the therapy may need to be reassessed. For more information on how to utilize the data provided by SleepImage, download and read the PDF document called A Clinician s Guide to SleepImage which can be found in the Help Tab of your SleepImage account. The Clinician s Guide contains a comprehensive review of the Clinical aspects of the SleepImage system with guidelines for how to review the Graphs for associations and patterns to better understand your Patients sleep Go to: Table of Contents Page 12 of 20
Reports Use this Tab to apply purchased sleep reports and print out a report to PDF, if desired. If the Patient has a Prescription Membership, the Clinician has free access to all Sleep Studies performed by that patient during the term of their Membership. If the Patient does not have a Prescription Membership, the Clinician can purchase Report Credits to review sleep studies on a per-report basis Clinician Reports and Accessories can be purchased online through the SleepImage Store. Once purchased, Apply Product Keys to credit the reports to your account. Then, choose the Patient and report to which you would like to apply report credits. Apply Clinician Reports To apply Clinician Reports to Patient Sleep Studies, select the study from the drop down, and click on the Red bar. A window pops up telling you how many reports are available on your account and asking if you d like to apply a credit for that report. Click the Yes button to retrieve the report. To get a PDF of the Sleep Report, click on the PDF button. Go to: Table of Contents Page 13 of 20
Profile Clinicians can update their profile here, including their name, Clinic name and Location as well as Specialty. A Note about the Location field for Patients: Should you encounter times on a Patient s report that don t make sense, it may be due to a timezone difference. For example, a Patient is on an extended business trip overseas and performs sleep studies while there then does not change the location when Uploading to SleepImage. The sleep times in that scenario may not correspond to typical sleep times in your time zone. We notify the Patient of the importance of Location in a few areas as follows: When entering their location on their profile When selecting your city, if your hometown does not appear in the list, search for a large city in your area that you share a timezone with. This field establishes the time link between the Sleep Data Recorder and the uploaded sleep studies and is significant in Report analysis. When Uploading For correct interpretation of the sleep study, enter the City/State where the study was conducted, if it occurred in an area outside the time zone of the location you specified during the sign up process. Go to: Table of Contents Page 14 of 20
Account Settings In this Tab, Clinicians can update their password, User name (email address) and apply Product Keys to their account. If Clinician Reports have been applied to the account, the quantity available will be listed here. Purchased Reports are accessible after entering a Product Key in this Tab. Enter the Product Key, select Apply and the reports will be credited to your account. You may then choose the Patients and individual sleep studies to which you would like to apply the credits. You can read more about this in the Reports section. Please also see the section in this manual regarding the SleepImage Store. Go to: Table of Contents Page 15 of 20
Invitations A Clinician who wants access to the Sleep Data of their Patient will need to invite the Patient to connect using SleepImage s embedded Invitation process. The Clinician can utilize SleepImage as a screening tool to assess sleep complaints and sleep dysfunction, as a therapy tracking tool to assess therapy efficacy and benefit or in combination with a detailed patient history to understand comorbid disorders. The Invitation can be initiated by either the Patient or the Clinician. Both parties must have a registered account in order for the invitation to successfully complete. Clinician Invites the Patient to link accounts. 1. Go to the Invitations Tab on the Left side of the screen. 2. Enter the Patient s email address After sending the invitation, the status will show as Waiting for acceptance 3. The Patient will receive an invitation email. When the Patient accepts the invitation, the status will change to: Accepted. Patient Invites the Clinician to link accounts. If a Patient invites you to connect you will receive an Invitation email. Sign In to your SleepImage account and go to the Invitations Tab. Click on the Accept Button to confirm the connection. Clinicians can see data only after the invitation has been accepted. Go to: Table of Contents Page 16 of 20
Help Instructions for Use documents are located in this Tab along with the Clinician s Guide to SleepImage. This Tab will be updated from time to time to update IFUs, tools, tutorials, and other system messages. Go to: Table of Contents Page 17 of 20
SleepImage Store At the SleepImage online Store, you can purchase Clinical Reports, Recorders and Accessories. To access the SleepImage Store, you must first Sign In to your account and click on the Store button. The system will open a new browser window and you will be automatically signed into the SleepImage Store. Your SleepImage User name and password are considered to be your Store login and the Store is only accessible through your secure SleepImage User account. Some items may be restricted for purchase depending on your Account type or Invitation status. For example, Users not connected to a Clinician will not be able to purchase a Prescription Membership, nor can any non-clinician User purchase Clinician Reports whereas Clinicians can purchase Reports, Sleep Data Recorders and Accessories, but not Memberships. Users must utilize a Sleep Data Recorder and Electrodes in order to complete a sleep study. Sleep Data Recorders are multiple-use and multiple-user devices. A User can obtain a Sleep Data Recorder from a Family member, a Friend, a Clinician or purchase a Sleep Data Recorder Kit from the SleepImage Store. Go to: Table of Contents Page 18 of 20
During the check-out process on the Store, and to complete your order, you will enter your name, billing address and shipping address. This information only resides in the Store on this ecommerce site and you may update it any time. Credit card information is not stored on the website. After completion and payment of your Sales Order, the Store will send an order confirmation to the email address on record (your username). You can review your historical Sales Orders within your account on the Store. The Store only accepts orders for U.S. payments and shipments. If you are a Non-U.S. customer, please set up your account, add the products to your cart then contact Sales to help complete your order by sending an email including: your name, username, and phone number to weborders@sleepimage.com. For more information please read the ecommerce Privacy Policy and FAQs contained on the Store website. Go to: Table of Contents Page 19 of 20
Apply Product Keys If you purchased Reports, the unique Product Key will appear in your Sales Order in the email confirmation. Apply the Product Key in the Account Settings Tab of your SleepImage account. Go to: Table of Contents Page 20 of 20