Stratus EEG User Manual

Application Version 3.1

Last updated: Nov 9, 2020

Regulatory Compliance

K143487: FDA 510(k) Clearance for class ll medical device.

Product: Stratus EEG (formerly Lifelines iEEG).

Stratus EEG bears a CE mark issued by BSI (CE 2797).

Copyright

All rights reserved. This manual contains proprietary information which is protected by copyright and may not be copied in whole or in part except with the prior written permission of Kvikna Medical. The copyright and the foregoing restrictions on the copyright use extend to all media in which this information may be preserved.

This copy of the Stratus EEG User Manual shall be used only in accordance with the condition of sale of Kvikna Medical or their distributors.

Kvikna Medical make no representations or warranties of any kind whatsoever with respect to this document. Kvikna Medical disclaim all liabilities for loss or damage arising out of the possession, sale or use of this document.

Stratus EEG® is a trademark of Stratus Software Solutions LLC.

Lifelines® is a registered trademark of Lifelines ltd.

Microsoft Word®, Windows®, and Office® are registered trademarks of Microsoft Corporation.

All other trademarks and product names are the property of their relevant owners.

Kvikna Medical
Lyngháls 9
110 Reykjavik
Iceland
Tel: +354 578 8400
Email: kvikna@kvikna.com
www.kvikna.com
Report suggestions or complaints by email: support@kvikna.com
Physician Support Contact: productmanagement@stratusneuro.com

Contents

 

Device Description

This chapter describes the intended use, performance, and description of use of the Stratus EEG medical device.

Intended Use

Stratus EEG is an EEG system that allows acquisition, display, archive, storage and analysis of physiological signals. The intended user of this product is a qualified medical practitioner trained in electroencephalography who will exercise professional judgment in using the information.

The Stratus EEG system also includes the display of quantitative EEG plots, such as power spectrum, which is intended to help the user to monitor and analyze the EEG.

This device does not provide any diagnostic conclusion about the patient's condition to the user. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician licensed by the law of the state in which he practices to use or order the use of the device.

Indication for Use

Stratus EEG is used as an aid in the diagnosis of neurophysiological disorders such as epilepsy.

Performance Characteristics

The Stratus EEG Analysis variant is used to manage and review EEG examinations. It works on data acquired by the Stratus EEG Acquisition variant as well as data from selected third-party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Furthermore, it offers spectral analysis in the form of trend analysis on user-selected sections of EEG.

Essential Performance

The medical device is intended to be used as a tool to aid diagnosis of neurological diseases such as epilepsy. It does not provide life-support functions or monitoring of vital physiological signs. The symptoms to be diagnosed and treated are not acute in the sense that delay in the measurement will not result in harm to the patient. However, incorrect output from the device could lead to an inappropriate treatment that would present an unacceptable risk to the patient.

Therefore, the Essential Performance of the device is to deliver accurate data in the following ways:

Stratus EEG Analysis

Stratus EEG Analysis is used to manage and review EEG examinations. It is used to manage patient demographics, keep track of exams and manage user access to clinical data.

Exams can be opened for review and analysis of EEG data by clinical experts. The user can navigate within the EEG that can be many hours long, filtering and re-montaging as desired. Furthermore, the artifact removal feature can be used to automatically filter artifacts from the EEG. If video data is available, it can be shown synchronized to the EEG traces. Sections of relevance are manually marked by the user, and the relevant sections are archived for long-term storage.

 

Disclaimers and Warranties

The information in this section is subject to change without notice.

Except as stated below, Kvikna Medical ehf (Kvikna Medical) makes no warranty of any kind with regard to this device, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. Kvikna Medical shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance or use of this device.

Misuse, accident, modification, improper operating environment, improper maintenance or damage caused by using Stratus EEG with a product for which Kvikna Medical is not responsible will void the warranty.

Kvikna Medical does not warrant uninterrupted or error-free operation of its products.

No other party is authorized to make any warranty to assume liability for Kvikna Medical’s products. Kvikna Medical will not recognize any other warranty, either implied or in writing. In addition, services performed by someone other than Kvikna Medical or its authorized agents or any technical modification or changes of products without Kvikna Medical’s prior written consent may be cause for invalidating this warranty.

All warranties for third-party products used within the Stratus EEG system are the responsibility of the relevant manufacturer. Please refer to the relevant documentation on each product for further details.

This document contains proprietary information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced in any other form or translated into another language without the prior written consent of Kvikna Medical.

 

Compliance

Stratus EEG is designed to comply with the following medical safety standards.

EN 62304:2006 Medical device software – Software life cycle processes.
EN 62366:2008 Medical devices – Application of usability engineering to medical devices
EN ISO 13485:2016 Medical devices – Quality management systems - Requirements for regulatory purposes
EN ISO 14971:2012 Medical devices – Application of risk management to medical devices.
EN 60601‑2‑26:2015 Medical electrical equipment – Particular requirements for the basic safety and essential performance of electroencephalographs
US Standards US Code of Federal Regulations Title 21, Chapter 1, Subchapter H – Medical Device

 

Safety and Warnings

Warnings are directions which if they are not followed can cause fatal or serious injuries to a user, engineer, patient or any other person or can lead to a mistreatment.

WARNING: Safety of the Stratus EEG service cannot be ensured unless it is provided by Kvikna Medical or an authorized agent. Stratus EEG is a medical device compliant with medical safety standards and it is forbidden to tamper with or modify the software.

WARNING: Stratus EEG is intended to be installed, used and operated only in accordance with the procedures given within this manual and accompanying documentation for the purpose for which it was designed. Nothing stated in this manual reduces the user’s professional responsibilities for sound judgment and best practice.

WARNING: Users shall only install, use and operate Stratus EEG in such ways that do not conflict with applicable laws or regulations which have the force of law.

WARNING: Use of Stratus EEG for purposes other than those intended and expressly stated by the manufacturer, as well as incorrect use or operation, may relieve the manufacturer or his agent from all or some of the responsibility for resultant non-compliance, damage or injury.

WARNING: Stratus EEG is intended to be used by a healthcare professional.

WARNING: Stratus EEG is intended only as an adjunct device in patient assessment; it must be used in conjunction with other methods of patient diagnosis. Stratus EEG is not to be used for the determination of brain death.

WARNING: Stratus EEG is not intended to be used as a vital signs monitor.

Contra-indications

No contra-indications are considered to prevent usage of Stratus EEG.

Undesireable Side-effects

No side-effects are considered to result from using Stratus EEG

Useful Lifetime

The useful lifetime for the Stratus EEG software is 5 years.

Reporting Incidents

In the event of a malfunction or change in performance of the Stratus EEG device that may affect safety, send a report to support@kvikna.com

In the case of a serious incident that has occurred in relation to Stratus EEG device, report to the manufacturer and the competent authority of the member state in which the user of the device and/or patient is established.

Warning Symbols

warning symbol

Additional warnings are indicated by this symbol elsewhere in this manual.

 

Symbols Glossary

Symbols Defined in EN ISO 15223-1:2016
Manufacturer Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
Serial Number Indicates the manufacturer’s serial number so that a specific medical device can be identified.
Consult instructions for use Indicates the need for the user to consult the instructions for use.
Caution Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.
Symbols to Demonstrate Compliance with the MDR
Medical Device (Currently undergoing ISO process)
Unique Device Identifier (Currently undergoing ISO process)

 

File Formats & Browsers

Stratus EEG is compatible with the following file formats:

Supported Web Browsers:

 

Scope

This manual covers the use of the web based Stratus EEG system.

Accompanying Documentation

For installation of the server and other administrative functions, refer to the Stratus EEG Technical Manual.

 

Definitions

Before delving into the details of each feature of Stratus EEG, here is a short description of some of the concepts and terms we will be referring to. Some of these are user interface items you will see as you begin using the software.

Patient Visits

Patient Visits are managed automatically by the system. Users cannot specifically add, update or delete visits. When a patient is admitted into the system, a new Visit is created and a new exam is initiated. Subsequent exams are added to the current visit if the user creating or importing them has full access to the visit. Otherwise a new visit is created.

A visit is considered completed once all the exams contained in the visit have been archived. If the patient is re-admitted after the visit has been closed, a new visit is created. In short, each patient in the database can be associated with more than one visit, and each visit can contain several exams.

Patient Database

The Patient Database includes all available patients in the system, past and present plus their demographics. Patients are identified by a distinct Patient ID. The Patient Database is automatically searched when admitting a patient to the system, when uploading an exam, and when reassigning an exam to another patient.

Exams

All information and collected data associated with a clinical test make one exam, including reports, external files and workflow state. Each exam is identified by a distinct Exam ID.

Recorder ID

In addition to Patient ID and Exam ID, we will also be referring to Recorder IDs. This is a number or designation to identify the recording device and/or area in which the recording was made. The Recorder ID could be a name or number that refers to the acquisition device, or you may wish to use a bed or room number as your Recorder ID. Each Recorder ID will be associated with an actual acquisition device (computer name), as well as with a default exam type and a Site. Recorder IDs and computer names are defined by the account administrator during setup configuration, but admins can later edit the Recorder ID.

Workflow

Each exam type is associated with a customizable Workflow, which includes several stages beginning with Initiate and ending with Archive. The Workflow State refers to the step in the workflow that is in progress or most recently completed.

Permissions

Permissions are granted to patient visits by user group, and the permissions apply to every exam included in the visit. Individual users can belong to more than one group. When a user admits a new patient or creates a new exam where a new visit is created, the current user’s default group is given full access to the new visit. Users are only aware of groups they are members of, while administrators have access to all groups.

Sites

Sites are useful for separating large cloud accounts into smaller sections by location, building, or even by department. This has several benefits, including the ability to delegate exam reporting between sites and facilitate cooperation in monitoring patients. Sites are defined by the account administrator during setup configuration. Admins can then associate each user to a site. Patient Visits are assigned the site of the user initiating the visit.

 

Visit List

The Patient Visit tab displays a list of patients in the database with exams grouped by visit. Patient names are shown on the left, and each horizontal row represents one patient visit. Each visit contains one or more "cards" with each one representing one exam. An arrow to the right of the exam cards indicates that more exams exist in the visit. Press this arrow to view additional exams.

Note: See the Definitions tab for an explanation of how Stratus EEG defines visits.

Sort List

The visit list can be sorted by various criteria using the sort buttons at the top of the list. Press the button twice to sort in the other direction.

Search and Filter

Above the visit list is a search field plus various filters which allow you to display only exams that meet the selected criteria. You can also select the "Assigned to me" checkbox to show only those exams, or the "Include archived" box to show archived as well as current exams.

The filter icon is highlighted in green when anything in the search and filter area is selected. Press the green icon to clear the filters.

Refresh

Press the refresh icon to reload the visit list with the most recent patient visit info.

Exams

Each exam card displays some basic information about the exam: ID, type, start date and time, and length of exam if it has been recorded. Icons at the bottom indicate whether the exam includes video or has been pruned, and on the bottom left is the workflow state.

Review and Retrieve

If the exam has been recorded and uploaded to the system, the workflow state is highlighted in blue and the Review button (on the right) is activated. By pressing the review button, you can open the test for review in a new browser tab. See the Review section for a complete description of reviewing an exam.

If the exam has already been archived, the Review button is replaced by a Retrieve button. The exam must first be retrieved before it can be reviewed again.

List View

At the top left of the visit list is a button for displaying the visit list as a standard list. The main difference between list view and card view is that you will not see any exams until you select a visit to open the visit properties.

 

Visit Properties

Press anywhere on a row on the visit list to open the visit properties in a popup window. If you press on a particular exam card, you will open the visit properties with that exam selected, otherwise the first exam on the list will be the selected one.

The visit properties is basically a patient folder with tabs where you can manage exams, patient info, reports and permissions.

Exams Tab

The exams tab displays the exams of the current patient visit. If previous visits exist for that patient, they are accessible via a tab, headed by the date the visit was created.

On the exams tab, you can perform several actions to the selected exam, view its properties and see its workflow state visually represented on the workflow bar.

Multiple Selections

The selected exam has a blue shaded background. If you press the background of another exam, it becomes the selected one and the first one is deselected. You can select multiple exams at one time by clicking the checkbox circle on the left side of the exam card. This can be handy if you want to perform an action to several exams at once. Deselect multiple exams by pressing the background of one card.

Action Buttons

The action buttons appear to the right of the exam cards, and can be applied to the selected exam or exams. The actions are as follows:

Generate Report: This option allows you to create a new report associated with the exam that is based on an existing report template that you can choose from a drop-down menu.

Delete: This option deletes the selected exam or exams. You will be asked to confirm this action.

Merge: Select two or more exams to activate this option, which merges the exams into one exam. You will be asked to confirm this action.

Reassign: This action is used to reassign the exam to another patient, in the case that the exam was mistakenly assigned to the current one. A search tool appears so you can select the correct patient, and you will be asked to confirm this action in the next step. If you can't find the patient on your first search, clear the filters by pressing the green filter button and try another search criteria.

Export: Use this action to export an exam to another file format. You will be asked to select the file format, whether you want to include video and attachments, and whether the exam should be anonymized. If Anonymize is left unchecked, personal information will be included with the exam.

Go to the Tasks tab (on the main menu) to check the progress of the export and to download the exam when the task is complete.

Note: Please see the "About Stratus to Go" section below before choosing this file format for export.

Archive: Perform this action after an exam has been reviewed and is ready to be archived. After archiving, the exam will have to be retrieved before it can be reviewed again.

Detection: Use this button to perform spike and seizure detection on the selected exam.

Delete Video: Perform this action to delete video permanently from the exam. If the exam was recorded with dual video, you can choose to delete only one of the videos, or both.

In addition to the actions listed above, you can also open the exam for review in a new tab by pressing the Review button on the exam card, or retrieve an archived exam using the Retrieve button. See the Review section for a complete description of reviewing an exam.

About Stratus to Go

The Stratus to Go option exports the exam in a read-only Windows version of the Review client. This is useful to be able to send the exam to someone who does not have the client installed. The recipient can review the exam and view the patient demographics.

The recipient of the exam will be prompted to calibrate their monitor before reviewing the exam. Follow the instructions on the Calibration tab using a ruler as a guide to adjust the virtual rulers on the screen.

warning symbol

WARNING: It is important to calibrate the screen so exams can be interpreted correctly. The screen calibration must be performed for every new computer screen. It is important that the recipient of a Stratus to Go file is made aware of this warning.

Exam Properties

The exam properties are shown on the right side of the visit popup. These are the properties of the currently selected exam. Click the yellow pencil icon to edit the properties.

The exam notes are shown just under the exam properties. Press the header bar to view the notes, which can also be edited by clicking the yellow pencil icon.

Below exam notes are the exam history and the exam folder. Click the headers of those items to show the contents.

Workflow Bar

The workflow bar is displayed at the bottom of the visit popup. This will show the position of the current workflow state of the selected exam in relation to the other steps of the workflow.

Patient Demographics Tab

On the Patient Demographics tab, you can view patient information, including identity, biometrics and contact info, and also the patient notes and clinical history. To the right of each section is a yellow edit icon (pencil) which you can press to open that section in an editable form.

Reports Tab

Reports are displayed on the Reports tab as "cards", similar to the exam cards. Each card has buttons to download, update, or delete the report.

To update a report, you will be asked to browse to the new report file which will replace the current report.

There is an upload button on the right of the window to upload a new report. 

Permissions Tab

On the Permissions tab, you can view and edit the current permissions to the visit. Note that permissions apply to every exam in the visit.

Add a Permission

To add a permission to the list, select a User Group from the drop-down list, then the Access Level and press Add.

Change Access Level

To change the access level that is currently applied to a group, select a new one from the Access Level drop-down next to that group on the list.

Remove a Permission

To remove a permission, simply click the X on the line you want to delete.

Save

Remember to press Save to save your changes.

 

Patient Admission

Use the Patient Admission tab to enter a new patient into the database, or to initiate a new exam with an existing patient. Along the top of the screen, you can see the steps you need to complete with a Next button at the bottom right to advance to the next step.

Search

You must always begin with searching the database, as the patient may have been previously entered. Enter one or more search criteria into the fields. If some matches are found, they will appear on a list. If the patient is found, select it on the list and press Next.

If the patient is not found, you can try again by pressing the filter button to clear the filters and enter a new search criteria, or you can press the Enter New Patient button to create a new patient record.

Patient Demographics

If you selected a patient from the list, the patient demographics will be filled in with the information about patient you selected, with the option to edit or update the info by clicking on the yellow edit button (pencil icon).

If you arrived on this page by pressing Enter New Patient, you will see a form where you can fill in the information about the patient.

warning symbol

WARNING: It is important to enter the correct ID associated with the patient so exams can be interpreted correctly.

Press Next to continue.

Exam Properties

Choose an Exam ID and Exam Type, and any of the other optional details you wish.

Press Next to continue.

Permissions

If the patient already has a patient visit started, you may see several permissions already on the list. If the patient is new, or if the patients previous visit has been archived, only the default permission will be listed. It is important to know that permissions apply to every exam in the visit, and not only the current exam.

On this page, you can add, remove, or change the access level of permissions, just as you can do on the Visit Properties Permissions tab.

When you are finished, press Next to continue.

Summary

Here you will see a summary of all details pertaining to the admitted patient, with the option to edit any details before pressing Finish to complete the process.

 

Upload

The Upload tab is used to upload exams that were recorded on an Acquire or other device. The look of the upload page is very similar to the Patient Admission page, with steps to follow in a row along the top and a Next button at the bottom to proceed through the steps. The main difference is the addition of a page before the search step to attach the files you want to upload. Another difference is that the "summary" page is called Upload, as it is on this final step that you start the actual upload of files.

Attach Files

Here you can either drag and drop files or a folder, or you can press a button to browse to the files or folder you want to attach. The info on the file is displayed below and the files themselves are listed on the right.

Press Next to continue to the next step. See the section above, Patient Admission, for a description of the following steps: Search, Patient Demographics, Exam Properties and Permissions.

Upload

The final step, Upload, shows a summary of all the previous steps, including the files that have been attached. Press the Upload button at the lower right to complete the upload. A progress bar appears on the page, or you can also follow the progress on the Tasks tab.

The Cancel button will cancel the entire process and send you back to a blank Attach Files page.

 

Tasks

Some operations performed in Stratus EEG can take some time. You can track the progress of operations such as exporting or uploading exams, seizure detection and archiving on the Tasks page.

If an operation fails, an explanation appears below the task name, and buttons appear to either retry or cancel the operation.

When an exam is exported, a download button appears to download the exam.

 

Monitoring

The Monitoring page gives an overview of exams that are currently being monitored. You will notice four tabs located on the top right of the page, with the Overview tab being the first.

Overview

The Overview page gives a visual overview of all exams currently being monitored, sorted by user group.

The blue header of each group shows the user group name, and below that are the names of the monitoring techs assigned to that group. Below that is a chart that displays each patient name, a countdown timer, the recorder ID and the patient ID.

Any exams that are waiting to be assigned appear in the Overflow queue above the groups.

It is possible to switch between monitoring types by using the selection box at the top of the screen. The screen will then display only groups of that type.

The browser window needs to be refreshed every so often to make sure you are seeing the latest assignments to each group. Use your browser’s reload button or keyboard shortcut to do so (often Ctrl+R on Windows and cmd+R on Mac). The minutes since the last page refresh is displayed at the top right of the monitoring screen.

Patients

The Patients page shows a searchable, sortable list of all patients being monitored. Search by text string, or filter by monitoring type or workflow state. Press the green filter button to clear all filters. You can manually change the Monitoring Group that the patient has been assigned to using the drop-down list. This will override the automatic assignment.

The list can be sorted by the different criteria shown at the top of the list — just click the headers to sort, and click a second time to reverse the order of the sort. Change the monitoring group of the patient with the drop-down list. You can view the members of the group by clicking the yellow icon to the right of the drop-down. The Monitoring Tech column shows the tech who is currently monitoring the patient.

Monitoring Techs

The Monitoring Techs page works similarly to the Patients page, except the searchable list shows users who have been assigned to monitoring groups. Users can be reassigned to another monitoring group on this page, and you can see the login status of each user.

Logs

The Logs page keeps a searchable log of the date and time of all exam assignments, whether automatic or manually assigned.

 

Users

The Users page holds a searchable and sortable list of all users in the system. The table displays the user's full name, user name, role, user groups and site.

Icons indicate whether the user is a site administrator or administrator, and whether the user is currently locked out of the system.

Add, Delete or Edit User

Click the pencil icon to edit the user, and the trash icon to delete the user from the system.

Click the Add button located above the list to add a new user to the system.

You will be presented with a form to fill out, with required fields indicated by an asterisk. The user name can be a short name that the user will use to log into the system. Any of the info here, including the password, can be changed later using the edit button on the user list.

The user can be locked out temporarily by toggling the Locked Out toggle, and later allowed access again.

Be sure to click Save when finished adding a new user or editing an existing one.

 

User Groups

The User Groups page displays a searchable list of all user groups that have been created in the system.

Create a Group

To create a new group, press the Add button. You must first enter a name for your group, select a monitoring type, and then populate the group with users. This is done by pressing the arrow to the left of the user's name on the list on the right. The user is then moved to the "Users in Group" list on the left. Using the search field is helpful to find users if your list is long. Be sure to save your changes.

View/Edit a Group

To view or edit an existing group, press the View/Edit button (pencil icon) and you will open a page similar to the Add Group page, except the group will already be populated with users. You can edit the group name or the monitoring type, and you can also remove or add users. There is also a button to disable the user group.

 

Roles

On the Roles tab, you can create or edit roles. Click the Add button to create a new role, or the edit button (pencil icon) to edit the role. Roles defined here can then be assigned to users on the Users tab.

Check the checkbox if you want users who are assigned this role to have the ability to save Acquire config changes to the server. If this checkbox is left unchecked, the users can only make changes to their local Acquire.

 

Authentication

On this tab, you can create or edit the password policy and authentication parameters.

Password parameters include such items as minimum number of characters or whether you want the password to expire after a given time.

When multi-factor authentication is enabled, users are emailed a code which they need to type in before login is complete.

Remember to press Save when making any changes on this page.

 

Exam Types

When creating a new exam, you must associate it to an exam type. Use this tab to create and edit exam types.

Click the pencil icon to edit an exam type.

On the edit page you can change the name, monitoring type, modality, and perspectives of the exam type.

Use the disable toggle if you want to temporarily disable the exam type. Then the exam type will not be available for selection when adding a new exam.

Add custom workflow states to the exam type by dragging them from the list on the right to the list on the left. Change a custom state's position on the list by dragging it to a new position. A custom state can be removed by pressing the right arrow. The predefined workflow states cannot be modified or removed. Custom workflow states can be created and modified on the Workflow States tab.

Report templates can be added to a workflow state by selecting one from the drop down list to the right of the workflow state.

Remember to click save when you are finished.

To create a new exam type, press the Add button. You can then edit it to add custom workflow states.

 

Monitoring Types

Use this tab to create and edit monitoring types. The monitoring type can then be selected as part of an exam type.

Click the pencil icon to edit a monitoring type on the list, or click Add to create a new monitoring type.

Choose a name for the monitoring type, the number of maximum concurrent exams, the maximum inspection interval in minutes, whether the monitoring is continuous or intermittent, and type in a notification email. Then click Save.

 

Report Templates

This page shows a list of all available report templates that can be selected when generating reports, or when associating a report template to a workflow state in an exam type.

Associate User Groups

Click the View/Edit button (pencil icon) to view which user groups have access to the report template under the "Allowed User Groups" list.

To add a user group to this list, click the left arrow beside the user group name on the "Denied User Groups list. To remove access, click the right arrow next to the group you want to remove.

Click Save to save your changes.

Add or Edit Report Templates

If you have Microsoft Word installed with the Stratus EEG Report tab add-on, then you can create or edit report templates.

To base your template on an existing template, first download the template using the download button, then open it in Word to make your edits. Then click the Add button, give your template a name, and upload the template using the Browse for file button.

 

Recorder IDs

This page shows a searchable list of Recorder IDs. Each recorder ID is associated to an actual acquisition device (computer name) connected to the Stratus EEG system and is also associated with a Default Exam Type and a Site.

Click the pencil icon to edit the Recorder ID name, or to associate it to another default exam type or site.

See also Recorder ID in the Definitions section.

 

Workflow States

To create a custom workflow state, simply press Add and give your workflow state a name. The workflow state will then be available to be added to an Exam Type. Note that the predefined workflow states cannot be changed or removed.

 

Sites Management

The Sites Management pages contains two tabs: Billing and Perspective Sync.

Billing

Download a billing report in PDF format by selecting your site, the month and the year you want the report to cover.

Perspective Sync

On this page, you can select perspectives that you want to "push sync" to Acquire systems in the selected site. Users of those systems will get a popup message prompting them to synchronize perspectives from the server.

 

Auditing

The Auditing page keeps a searchable log of actions in the system by users. You can filter the list by Site, User, Patient, Date, Category and Action. The list can be sorted by clicking the list headers, and clicking a 2nd time to reverse the sort. Click the green filter button to clear all filters.

 

My Settings

On this page you can change your password by typing in the old password, then a new one, then confirm by typing the new password a second time.

 

Start Review

To open an exam for review, press the Review button on an exam card. Exam cards are found on the visit list and also on the visit properties.

The exam opens in the review interface in a new browser tab.

Screen Calibration

When you open an exam on a new monitor for the first time, the screen needs to be calibrated in order to accurately interpret the information. Choose the Screen Calibration option on the menu located at the top left of the screen.

This will open the Screen Calibration popup:

Hold an actual metric ruler up to the screen. Then drag the ends of the screen rulers to line up with the real ruler. You can fine tune the measurement by entering pixel sizes into the text boxes on the right, or by pressing the UP and DOWN arrows on your keyboard. Then press Save and Close to save your changes. Calibrating your screen will also cause the vertical ruler to be correctly displayed on the right side of the channel chart.

WARNING: To ensure accuracy, before reviewing an exam for the first time on a new screen, or when adding a second screen, the screen must be calibrated

Toolbar

At the top of the screen, just below the blue header bar, is the toolbar. From left to right, it contains the following tools:

Time Cursor: The time cursor is a vertical red cursor which moves across the screen when video is played. The time of the current position of the cursor is displayed on the left side of the toolbar.

Paging Buttons: Click the paging buttons to start paging through the exam, forward or backward. The arrow buttons turn into pause buttons which you can click to stop paging. Clicking anywhere on the channel chart will also stop the paging. It is also possible to step forward or backward one page by clicking once on the right or left of the screen.

Paging Speed: Change the paging speed by selecting another speed from the list, or by using the paging speed slider.

Sensitivity: Change the sensitivity of the trace display by selecting another value from the list, or by using the up/down arrows to bump the sensitivity up or down one step at a time.

Timebase: Change the timebase of the display by selecting another value from the list, or by using the up/down arrows to bump the timebase up or down one step at a time.

Montage: Select another montage from the list. The first button to the right quickly reverts back to the "As Recorded" montage, and the next button recalls the last used montage.

Low Cut Filter: Select a value in Hz from the list, or turn off the low cut filter.

High Cut Filter: Select a value in Hz from the list, or turn off the high cut filter.

Notch Filter: Toggle the notch filter on or off.

Timeline Overview

The Timeline Overview is located above the channel chart and provides a visual representation of the duration of the entire exam, or just a selected duration.

Duration

You can set the duration of the overview to show the full exam, or a part of it. This can be helpful with long recordings to be able to see the overview more clearly. This is done either by choosing the duration from the drop-down list, or by using the zoom bar (see below).

Zoom Bar

The Zoom Bar is another way to change the duration of the timeline. It is located at the top of the overview, just under the toolbar. Drag either the left or right end of the zoom bar to shorten it. The zoom bar then works a bit like a scrollbar. You can move the zoom bar to the right or left to show later or earlier parts of the timeline. When you have zoomed in using the zoom bar, the duration drop-down displays "custom".

Timeline

Tic marks on the timeline show evenly spaced intervals. The actual interval depends on the length of the exam. You can click anywhere on the timeline and the channel chart will display that page on the Review pane.

Current Page Marker

A red, translucent marker indicates where the currently displayed page is located on the timeline. You can drag the marker to any location on the timeline to display that page. The width of the marker increases if you zoom in on the timeline.

Event Overview

Events are indicated on the timeline as small rectangles in the color of the event marker. Duration events appear as horizontal bars for the length of the duration. Click on any event on the overview to go to the location of that event in the channel chart.

Video Overview

If video is present in the exam, a dark red bar appears in the overview just below the zoom bar. A second video appears in dark blue. A continuous bar indicates that video is present during the entire recording. Breaks in the bar indicate breaks in the video.

Segment Breaks

If there is a break in the recording, it is indicated by a white vertical line on the overview.

 

Channel Chart

The main area of the review window is the channel chart. To the left of the chart are the channel labels; to the right are the event markers which you can place on the chart.

Channel Editor

You can select one or more channels by clicking on the label and then change a number of display settings or filters on those channels.

Right-click on one of the selected labels to open the channel editor.

You can then change the filters, sensitivity, deflection, display type, color, polarity and baseline position by using the corresponding controls. You can also choose to hide the selected label(s) or display only the selected labels(s). Click Reset to remove the special channel settings from the selected labels.

A checkbox appears in front of the label on special channels. Unchecking the box resets the settings for that channel only.

At the bottom of the label area are two buttons. The checkmark selects all labels and the X clears all selections.

Ruler

A transparent vertical ruler appears on the right side of the channel chart. This is to give a visual indication of amplitude. The screen needs to be calibrated each time an exam is opened on a new monitor for the ruler to show an accurate display of 5 centimeters. See the Screen Calibration section for information on how this is done. Once this is done, the position of the ruler changes to accurately reflect the amplitude of the EEG.

Note: If your ruler does not appear to show an accurate 5cm, that is a hint that you need to calibrate your screen.

Ruler before screen calibration:

Ruler after screen calibration:

Events

The Event Palette contains a customizable set of event markers that can be placed either directly onto a channel, or at the top of the Channel Chart at the time of the event.

Use the drop-down list to quickly switch between different palette sets. You can hide/show the event palette using the arrow at the top of the palette.

Placing Events

To place an event, click the event on the event palette (it will become highlighted with a yellow outline), and then click on the channel chart where you want the event marker to appear. A vertical positioning line appears to help you with the positioning.

Place Multiple Events

To place multiple instances of the same event, double-click the event marker first, and then you can insert an event marker onto the channel chart with each subsequent click, without having to go back to the event palette. Right-click on the channel chart to stop this action.

Note: if the montage is changed such that the channel where the event was placed no longer appears, the event marker will be displayed at the point where the active electrode appears again, or at the top of the channel chart in the case that the active electrode does not appear.

Once the event is placed, it will appear behind the traces. If you hover over the event, it comes to the foreground to make it easier to read the label. A close box appears above the event if you want to delete the event.

Add Notes to Event

While hovering over the placed event, click the notes icon which appears below. you can then add notes to the event.

Event Shortcut Keys

Instead of clicking on the event markers, you can also use the F-keys F1-F10, which correspond to the first 10 event markers on the event palette. Press the F-key then click the channel chart to place the event.

Place Event at Video Marker

During video playback, simply click an event or its shortcut key to automatically place the event at the point of the video marker. The event marker appears at the top of the channel chart.

Duration Events

Duration Events are events that happen over a period of time. These event markers can be recognized as they are marked with a vertical dotted line at each end.

Place the duration event, then click the arrow at either end to extend the duration. Click again to set the new duration. If you need to page forward or back while extending the duration, use the right or left arrow keys on the keyboard.

Prune Events

Prune events are used to mark areas of the channel chart that you want to keep after pruning the exam. You can recognize prune events by the scissors icon.

Note that events can be both duration and prune events.

Pruning the Exam

After you have placed prune events, the Prune command becomes available on the menu. Click the "hamburger" icon at top left to see the menu.

Applying the prune command trims the exam down to the areas that have been marked with prune events. After pruning, the Undo Prune command appears on the menu. Press this to restore the exam back to its unpruned state.

Impedance Events

Hover over an impedance event to show the impedance button (omega symbol).

Press this button to display the impedance popup:

Impedance values are displayed in kOhms on a head diagram.

Panel

The panel is located to the right of the channel chart and contains additional tools for navigating and analysing the exam. You can hide/show the panel using the small arrow button located at the top of the panel.

Video

If video is included in the exam data, it is displayed in the panel and can be played in synchronization with the exam data.

Video Toolbar

Play

Click the play button to start video playback. The play button changes to a pause button while the video is playing, so you can press again to pause the video.

Time Cursor

A red, vertical time cursor moves across the channel chart to show the position of the video in the EEG data. The channel chart pages automatically at the rate of video playback. You can also drag the time cursor to a point in the EEG to start the video at that point. The time of the current position of the cursor is displayed on the left side of the toolbar.

Step Buttons

Next to the play button are buttons to step forward or backward in small increments.

Volume Control

Use the volume slider to adjust the volume. Click the speaker icon to mute the sound completely.

Video Speed Control

The video speed slider controls the video playback speed. Adjust this if you want to speed up or slow down the playback.

Zoom

You can zoom into the video by holding the mouse button down and dragging an area of the video. Zoom out by right-clicking anywhere on the video screen.

Open in New Window

A small button at the top of the video panel pops out the video into a new window that can be resized or moved to another screen.

Event List

The Event List shows a list of all placed events in the exam, with the time it was placed and duration, if applicable. The list can be sorted by clicking the headers at the top of the list. Click a second time to reverse the sort.

Select an event on the list to find it on the channel chart.

The buttons at the bottom of the event list perform the functions described below.

Open Event List Settings

This button opens a popup where you can filter the event list to show only selected events. Uncheck any events you don't want included.

You can also adjust the confidence threshold of system-detected spikes by using the slider.

Show Date

Show the date, as well as the time of the event.

Copy to Clipboard

Copy all events in the list to the clipboard. You can then paste the list into a document, such as a Word document.

Delete

Delete selected events from the exam. Select multiple events using the Ctrl or shift keys (cmd or shift on a Mac).

Stratus EEG Release Notes

Application Version 3.1

Last updated: Aug 25, 2020