Faros Explorer Manual

Transcription

1 Faros Explorer Manual Date of issue: May 30, 2017 Mega Electronics Ltd, Pioneerinkatu 6, FI Kuopio, Finland,

2 Contents 1. Introduction Intended use Symbols General safety precautions Warnings Security Getting started Faros Explorer software installation Faros Explorer software overview Measurement preparation Patient preparation Electrode position and lead placement Positioning of the Fast-Fix electrode Stingray and textile belt position Event settings in Faros Manager Required measurement settings Event threshold settings Software settings Reporting settings Institute settings Language setting Sensor Licenses settings Importing measurement files Event data review Main page/view Events page Summary page Written analysis page Sleep diary page Create report Example report Settings i

3 5. Database Report generation from database Maintenance Troubleshooting Regulatory information Classification EU Declaration of Conformity Intended Use Manufacturer ii

4 1. Introduction The Faros Explorer software allows fast and flexible analysis of Event ECG data utilizing the latest ECG technology for event detection. The events (including Pause, Bradycardia, Tachycardia, Atrial Fibrillation and patient markers) recorded by the ECG sensors can be displayed in the software and chosen to be reported or not in an efficient manner. It is also possible to add events in the software after the recording. Each event can be selected to the final report or removed from the analysis. The final report includes the patient and measurement information, event distribution information, heart rate trend of the whole recording and an ECG strip of each selected cardiac event. Note: The software is delivered with everything you need for proper use of the software User manual (this document) Software installer Faros sensor licenses 1.1. Intended use The Faros explorer software is intended to display the events detected by the algorithms of the ECG sensor and allow the user to modify the event data and select the reported events. The algorithm detected events include Pause, Bradycardia, Tachycardia and Atrial Fibrillation. Additionally patient marker events are displayed and events can be added by the user in the software. The raw ECG data of the whole duration of the ECG recording is also always available for extracting from the software. The Faros Explorer software is meant only for use by trained experts who are familiar with ECG monitoring in general and able to interpret the data Symbols Symbol Description The ECG sensor is CE-marked for the conformity to Council Directive 93/42/EEC regarding medical devices. Consult Instructions for use. For EU only: This symbol indicates that this device shall be disposed according to European Union directive 2002/96/EC on Waste Electrical and Electronic Equipment (WEEE). The device is equipped with type BF applied parts fulfilling the EN (IEC ) standard. 1 / 33

5 1.3. General safety precautions Faros Explorer software does not provide diagnosis 1.4. Warnings Do not attempt self-diagnosis or self-treatment based on acquisitioned data Physicians are responsible for diagnosis of measurement data 1.5. Security Faros Explorer application is recommended to be used with computer protected by proper anti-virus protection. Use of firewall is also recommended. 2 / 33

6 2. Getting started 2.1. Faros Explorer software installation Follow these instructions to install the Faros Explorer software. Browse to Faros Explorer Software folder. To install the software double-click the setup.exe file. After this follow the instructions on screen. Figure 1 User Account Control In case you get the user account control notification click Yes to continue. Figure 2 SW installation installer start Figure 3 Select destination folder Click Next to continue. Use default or select desired destination folder for installation. Click Next to proceed. 3 / 33

7 Figure 4 Beginning installation Click Install to begin the installation. Figure 5 Installation complete Click Finish to close the Installer. Select the Open release notes after install if you wish to see the release notes. After a successful installation you can start the Faros Explorer software by double-clicking the icon on the desktop. Figure 6 Faros Explorer desktop icon 4 / 33

8 2.2. Faros Explorer software overview The Faros Explorer software is a PC application for data monitoring and reporting as well as for collecting, configuring and managing patient information. The main purpose of the software is to monitor patient ECG data and generate reports of the measurement data. Faros Explorer software is divided into different segments: File download section is used for analyzing the session recording data. Database contains the measurement session data. You can review generated measurement reports and generate new reports from existing measurement data. In the Settings section you can manage the settings for monitoring and reporting configuration. 5 / 33

9 Following buttons are available in the main view: Table 1Main view buttons Buttons Description Exits the application. Opens the Settings view. Also available in the top right-hand corner of the main view. Table 2 Main view top buttons Buttons Description Shows information about the software. Opens the Faros Explorer User Manual. Opens the Settings. Figure 7 Faros Explorer main view 6 / 33

10 2.3. Measurement preparation Before recording make sure that the sensor s battery is fully charged. The sensor can be charged with the USB cable included in the Faros package or with a regular micro-usb recharger. The blue light indicator is blinking when the battery is charging When the battery is full, the blue light indicator shines continuously. The emotion Faros ECG Sensor has one pushbutton. The device starts when you push the button. The device will power off when you push the button continuously for 5 seconds. For a full description of Faros sensors, please see emotion Faros Series Manual Patient preparation Step 1: Prepare the skin of the patient in areas where the electrodes are placed: 1. Shave the hair off from the areas where the electrodes are placed. 2. Clean the skin with appropriate alcohol (for example denat. 80% alcohol) or electrode preparation pads. Step 2: Attach the electrodes to the patient s skin: 3. Electrode placement is instructed in the next chapter. 4. Check that the adhesive sticks properly. 5. Check that there is no air between the electrode gel and the patient s skin. 6. Check that there is no hair under the adhesive. Step 3: Attach the sensor to the cable set and the cable set to the electrodes 7. Attach the cables to corresponding electrodes (see electrode placement pictures in the next chapter Electrode position and lead placement). 8. If necessary, the cables can be attached to the skin by tape. Notice that the tape should not touch the electrode. Step 4. Start the measurement: 9. Press the sensor button once. 10. Green light indicator starts to blink the sensor is now recording. 7 / 33

11 Electrode position and lead placement The operator should be familiar with the correct placement of electrodes. Incorrectly placed electrodes will weaken the reliability of the data. Cable sets are compatible with 4 mm snap connector ECG electrodes. 2-lead, 1-channel position 3-lead, 1-channel position 5-lead, 3-channel position Figure 8 Positioning the electrodes and leads 8 / 33

12 Positioning of the Fast-Fix electrode The recommended position for the Fast-Fix electrode is on the left border of the sternum as seen in the left side of the figure. If this positioning is not possible for some reason, the electrode can be placed diagonally on the left side of the chest, seen in the figure on the right. Sternum position Diagonally on chest position Figure 9 Positioning the Fast-Fix electrode Stingray and textile belt position The heart rate belt is positioned under the chest muscle line as illustrated in the figure below. Belt position Figure 10 Heart rate belt position 9 / 33

13 2.5. Event settings in Faros Manager Event recordings can be performed with every Faros model. The configuration for the measurement parameters and event detection thresholds is set using Faros Manager. 1. Run emotion Faros Manager. 2. Select Datalogger mode from Manager main view. 3. Select the required measurement parameters. a. RR Intervals b. Acceleration (optional) c. ECG 4. Select values for acquisition parameter. a. Accelerometer - Sampling Rate b. Accelerometer - Dynamic Range c. ECG - Sampling Rate 5. ECG Channel count (ONLY with Faros 360). 6. Synchronize clock. 7. Press Save to apply the configuration. Figure 11 Main view of the Faros Manager software NOTE! With pediatric patients, ECG sampling rate must be 500Hz. Event detection settings can be set through Faros Manager software s Advanced settings view. 10 / 33

14 Access to these advanced settings is protected by a PIN code. The default PIN-code is Figure 12 Advanced settings PIN code Advanced settings configure the following features: Measurement duration (for example automatic stop after 24h) Bluetooth timeout (automatic shutdown of Bluetooth in offline mode after a given period) Bluetooth Hidden Mode o Bluetooth Hidden Mode is a cyber-security enhancement which makes the Faros device undiscoverable and non-pairable with untrusted devices Pacemaker Event Recording RR-based nonlethal arrhythmia detection (AF, pause, bradycardia, tachycardia) o o o o o Enable / disable arrhythmia detection Tachycardia (high heart rate) detection onset and offset values Bradycardia (low heart rate) detection onset and offset values Pause detection onset and offset values AF detection is always on when arrhythmia detection is switched on Enable / disable accelerometer-based patient activity monitor Advanced settings appear on the right side of the view. 11 / 33

15 Figure 13 Advanced settings view Required measurement settings The following parameters need to be activated to perform event recordings with the Faros sensors: 1. RR intervals 2. ECG 3. RR Monitor selection from the Advanced Settings view must be set to Yes Figure 14 Required measurement settings for event recording 12 / 33

16 Event threshold settings Event threshold settings include pause detection thresholds, bradycardia detection thresholds and tachycardia detection thresholds. For Atrial Fibrillation detection there are no separate threshold settings. Pause detection thresholds define the minimum length of pause events that need to be detected, and the amount of heart beats that need to be detected before the pause is determined to be over. For example in Figure 15 the threshold for pause onset is 3 seconds (when there is no heartbeat detected within 3 seconds from the last beat), and pause event ends after 4 heart beats have been detected. The total length of pause events is calculated from onset to offset marker. Figure 15 Pause detection settings Bradycardia and Tachycardia detection thresholds define the onset BPM and offset BPM values, as well as the onset and offset beat count. For example in Figure 16 the Bradycardia events are detected when eight heart beats with BPM value below 50 have been detected, and the event is offset when eight heart beats over 50 BPM have been detected. Tachycardia settings use the same principle. Figure 16 Bradycardia and Tachycardia detection settings 13 / 33

17 Advanced settings (default detection values)*** Pause; Offset beats 4, Pause duration (seconds) 3 Bradycardia; Onset / Offset beats 8, Onset / Offset bpm 50 Tachycardia; Onset / Offset beats 16, Onset / Offset bpm 140 Atrial fibrillation; activated Table 3 Advanced settings 2.6. Software settings Faros Explorer software settings can be accessed by clicking the Settings button on the start screen. The settings can be also accessed from any view by clicking the same icon in the top right-hand side of the view. The Settings is divided into four areas: Reporting, Institute, Language and Licenses Reporting settings It is recommended that Reporting-related settings are adjusted before generating a report. Report language has three options; Automatic, Finnish and English (US). Automatic selects the reporting language based on the UI language of the installed operating system. If the language is not supported, this setting reverts back to English (US) as default. Heart rate trend section allows adjusting various components in the heart rate trend graph shown in the report. Y-range: The Y-range setting can be selected by choosing either Fixed or Dynamic from the drop-down list. Y-axis maximum (BPM): This setting is for adjusting the maximum heart rate (BPM) value. Y-axis minimum (BPM): This setting is for adjusting the minimum heart rate (BPM) value. Y-axis grid visible: Toggles between showing the Y-axis or not. X-axis grid visible: Toggles between showing the X-axis or not. 14 / 33

18 In the Event settings part you can adjust the following settings: Y-range: The Y-range can be either set to Dynamic or Fixed from the drop-down list. Dynamic setting allows the SW to adjust the y- range so that the whole signal is visible. Y-axis maximum (mv): Set the Y-axis maximum range in millivolts. Y-axis minimum (mv): Set the Y-axis minimum range in millivolts. AFib event: The pre-and post setting can be used to add a time signal in seconds before and after the AFib event using the + and buttons. Bradycardia event: The pre-and post setting can be used to add a time signal in seconds before and after the bradycardia event using the + and buttons. Tachycardia event: The pre-and post setting can be used to add a time signal in seconds before and after the tachycardia event using the + and buttons. Pause event: The pre-and post setting can be used to add a time signal in seconds before and after the pause event using the + and buttons. Figure 17 Settings - Reporting In the ECG Settings section you can adjust X- axis time in seconds as well as the millimeter speed of all ECG graphs. Available options are 10 mm/s, 25 mm/s and 50 mm/s. Patient event: The pre-and post setting can be used to add a time signal in seconds before and after the patient event using the + and buttons. Add event: The pre-and post setting can be used to add a time signal in seconds before and after the added event using the + and buttons. 15 / 33

19 Institute settings The Institute settings contain the following fields: Your organization: Logo: Name Department Address Postal code State City Country Contact person Phone number Your own logo can be added to the report Please note that institute details are used in reporting. Currently only Name and Department information is added to individual patient reports. Figure 18 Settings - Institute 16 / 33

20 Language setting Language setting contains these fields: User interface language: This setting has three options; Automatic, Finnish and English (US). Automatic selects the reporting language based on the UI language of the installed operating system. If the language is not supported, this setting falls back to English (US) as default. User interface format: This setting has three options; Automatic, Finnish and English (US). This setting changes the way time and date is shown, for example. 17 / 33

21 Sensor Licenses settings In the Licenses setting you must import the license data for all the Faros devices that are used in recording the measurement data. This can be either done by adding a single license or importing a license file if multiple devices are used. Note that it will not be possible to select recording data for a device if the device license information is missing! 1. To add a single license click the + symbol. 2. Enter your device serial number and click OK. 3. Enter the license key and click OK. Alternatively you can enter multiple device information at once by selecting the Add new license file button. 1. Browse for the license file and click Open. 2. Click OK after successful license import. Table 4. Licenses view buttons Buttons Description Adds a single license. Details must be entered manually. Adds a new license file. Figure 19 Importing licenses 18 / 33

22 3. Importing measurement files After the license information has been added in Settings ->Licenses you can select recording data. 1. Click File download on the main view. 2. Session details view opens. Figure 20 Session details view 3. Enter the first name and last name of the patient as well as the date of birth and possible optional ID. Also additional information can be written in the Additional information- field. You can also use the search button to find the details for an already existing patient entry. 4. Select the recording for analysis and review. Nota that you can also delete recording(s) by selecting the recording to be removed and clicking Remove selected recordings. 5. Click Next to continue. Data upload screen opens. Table 5 Session details buttons Buttons Description Search for existing patient information. Select recording data. Remove selected recording data. 19 / 33

23 Figure 21 Record download Once the process is complete click Review to continue. 20 / 33

24 4. Event data review 4.1. Main page/view Once the recording data has been downloaded the main data review view opens. Figure 22 Data review main view On the left hand side you can see the patient details as well as the duration of the recording. Directly under these are then the reported events for AFib (atrial fibrillation), Tachy (tachycardia), Brady (bradycardia), Patient marker (if any), Pause and Added. Added events are those that are inserted directly into the ECG area at the lower half of the main view. This can be done by right-clicking on the view and selecting Add event. At the top of the view there are buttons (from left to right) for the Main view (shown in the figure above), Events, Summary, Analysis, Sleep diary, Create report and Settings. Below these are the synchronized views for the heart rate, events and the ECG view. In the heart rate view there is a slider that can be used to move to a specific time as required. Also the sleeping times are marked with a dark grey color. The specific events marked in the middle of the view with different colors can be selected by clicking them. The selected event is then shown on the ECG view as in this case Bradycardia event as shown in the figure above. In the ECG view you can adjust the paper speed (10, 25 and 50 mm/s) with the and arrows as well as the amplitude with the and arrows. In the figure above the amplitude is set to millivolts and the paper speed is set to 50 mm/s. 21 / 33

25 Button Description Closes the session and returns to Main page. This button is available in all the views. Table 6 Home button 4.2. Events page In the Events part you can view the events detail by selecting the event type from the top of the view: All, Added, AFiB, Brady, Tachy, Pause, Marker (Patient marker) and Deleted. In this case in the figure below only the first three Bradycardia events can be seen. The exact time of the event is shown, and you can write comments in the Comments-field. On the right-hand side of the view you have three functions Select All, Report and Delete. Select All selects all the recorded events for easier data filtering. Note that after clicking the Select All button it changes to Clear All to undo the select all function. If you select the Report check box this event will be added to the generated report. If you click the Delete button the event in question will be deleted. Note that this deletion is not permanent, and all the deleted events can later be added back if required from the Deleted-view with the Undo button. Note also that the paper speed settings can be adjusted also for this view from the Settings button. Figure 23 Events view 22 / 33

26 4.3. Summary page The Summary page shows a summary of all the reported events during the measurement period. You can see the patient details, device details, session event info as well as a summary of the events in total. The Analysis field at the bottom of the page can be used to write an analysis based on the reported data. Figure 24 Summary view 23 / 33

27 4.4. Written analysis page The Analysis window can be used to create an analysis of the overall recording data. The text is saved to session details and shown also in the summary page. The analysis is also stored to the database and it can be edited when the session is opened. Figure 25 Analysis window 24 / 33

28 4.5. Sleep diary page The Sleep diary page shows the sleep periods in the recorded data. The default sleeping period is between hrs PM and 7.00 hrs AM, but these can be adjusted by double-clicking on a time and entering the correct time. New sleep times can be added and sleep times deleted by using the buttons at the bottom of the view. Table 7 Sleep diary view buttons Buttons Description Adds a new sleep time. Deletes a selected sleep time. Figure 26 Sleep diary view 25 / 33

29 4.6. Create report Once all the required events have been selected you can create a report of the data. Before a report is created a confirmation message is shown in case there are many entries for the report. If all is ok, click Yes to continue. Report is generated. Figure 27 Create report Following buttons become available when the report is generated: Table 8 Report view buttons Buttons Description Left button goes back to report generation. If report is generated straight after measurement right button navigates back to the measurement finish view, if the report is generated from database the right button navigates back to the database view. Opens the generated report. Opens the report location folder. 26 / 33

30 Example report Below is a part of an example report. This overview lists all the recorded events as well as an overall summary of the data gathered during the measurement period. Also a graph is shown for the heart rate trend in addition to a graph presenting any cardiac events. Figure 28 PDF report When the report is scrolled down you can see details for all those events selected for the report. If an event type is not included in the report it is mentioned in the beginning of the page: <number and type of event> events were detected during measurement but none of these were selected for reporting. Below is a sample view from one of the bradycardia events. 27 / 33

31 Figure 29 PDF report - event details The comment-field of the report shows the comment entered in the Event view. In this case no comment was entered so the field is empty Settings The same settings that were done in 2.6 Software settings are also available for adjusting the event data in the event data review phase. Click the Settings-icon to adjust the settings. 28 / 33

32 5. Database 5.1. Report generation from database 1. New report from database. Click the Database button on Home screen. 2. Select a measurement. Select a desired measurement from the list. After the selection the buttons below the list become active. Buttons (from left to right): review selected measurement open a previously generated report open the measurement folder Click Review selected measurement. Select Create report to create the report. 3. Report is generated. Report is generated and it can be viewed by clicking the Open the generated report button in the middle. Click the Folder button to open report folder destination. The arrow buttons can be used to move back to the report generation view or to the database. 29 / 33

33 6. Maintenance System hardware parts do not require any particular maintenance procedure except recharging of the battery. For a correct functioning please follow these simple precautions: Handle system parts carefully Store the system away from dusty or dirty areas Keep sensors away from moisture or extreme temperature Disconnect Cable Set from the Sensor if the device is not used Do not disassemble sensor or data transfer hub If you cannot solve the problem with the system, please contact mega@megaemg.com for support Troubleshooting Sensors do not work or operation is unpredictable: try recharging the sensors test that your Faros sensor is recognized on your PC when connected to USB (you should be able to see the FAROS_DATA hard drive). If recognized, check that your device is in Online mode with the Faros Manager. Charger station will not charge Faros sensors Charger station s battery might be empty. Connect the Faros Base to PC or USB Power adapter Charger station s battery charges about 15 minutes before sensor recharging starts if station s battery is completely empty. Check that the green light next to the charger station s USB connector is shining when the charger is connected to the wall adapter. 30 / 33

34 7. Regulatory information 7.1. Classification EU In accordance with MDD 93/42/EEC: EN : Class IIa product Internally powered equipment 7.2. Declaration of Conformity We herewith declare under our sole responsibility that the product listed below is in conformity with the provisions of the Council Directive 93/42/EEC of 14 June 1993 (and the Finnish national laws 1505/94 and 1506/94) concerning medical devices. When used with external evaluation software this declaration of conformity is valid for the Faros hardware. Trade Name: Faros Product Family Model(s): emotion Faros 90 MDD Classification: emotion Faros 180 emotion Faros 360 Class IIa Following standards were used to meet requirements: EN rd edition (IEC rd ed.) Medical electrical equipment. Part 1: General requirements for safety EN rd edition (IEC rd ed.) Medical electrical equipment. General requirements for safety. 2. Collateral Standard. Electromagnetic compatibility - Requirements and safety ECG functions are evaluated using relevant parts of the EN :2012 (IEC ) standard taking into account the intended use of the device. According to the manufacturer of the Bluetooth modules: The Bluetooth modules meet the requirements of the EMC Directive 89/336/EEC as amended by Directives 92/31/EEC and 93/68/EEC within CE marking requirement. 31 / 33

35 7.3. Intended Use The emotion Faros is an ambulatory recorder and transmitter for ECG and motion (accelerometer) data. Faros can perform ECG measurement, R-R interval data measurement and capture patient motion. All data is recorded to sensor internal memory. emotion Faros monitors patient ECG and generates event markers using the in-built arrhythmia detection algorithms. Data recorded by the device can be analyzed by other processing systems to provide reports or transferred via Bluetooth to companion systems for further analysis. These systems can be either third party systems or designed, maintained and/or owned by Mega. emotion Faros is indicated for adult and pediatric patients who require vital sign monitoring inside or outside hospital or healthcare facility environment. The emotion Faros does not provide interpretive statements. Final interpretation and diagnosis is the responsibility of a physician. 32 / 33

36 Manufacturer Mega Electronics Ltd Pioneerinkatu Kuopio Finland Phone +358 (0) Fax +358 (0) Mail mega@megaemg.com Website 33 / 33