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The Actiheart USER MANUAL Document Reference: Issue Version: Issue Date:
30071 4.0.35 07/01/2010
0120 The Actiheart is a Class 2a Medical Device
This manual is designed to be read in conjunction with ‘The Actiheart Guide to Getting Started’
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Regulatory Information – CE Notice (European Union) Actiheart – Medical device information: The Actiheart is a Class IIa Medical Device conforming to the essential safety & health requirements and provisions of EC Council Directives 93/42/EEC, Annex V and VII. CamNtech Ltd has been assessed and certified as meeting the requirements of the above directive by SGS United Kingdom Ltd, Notified body number 0120 (Actiheart certificate number GB06/67703).
Manufacturer: CamNtech Ltd Upper Pendrill Court Papworth Everard Cambridgeshire CB233UY, UK
Tel: 01480 831223 Fax: 01480 831733 Email: [email protected] Web: www.camntech.co.uk
Applicable Standards: Standard
Description
EN60601-1:1990
Medical electrical equipment – Part 1: General requirements for safety.
EN60601-1-2:2002
Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests. Group 1 equipment / Class B – (emissions only)
EN60601-1-2:2002
Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests. Non life supporting equipment (immunity section only)
EN60601-1-4:1997
Medical electrical equipment – Part 1-4: General requirements for safety – Collateral standard: General requirements for programmable electrical medical systems.
Safety Classification Information: The Actiheart is INTERNALLY POWERED EQUIPMENT. The Actiheart is a TYPE B APPLIED PART. The Actiheart mode of operation is CONTINUOUS OPERATION.
For further safety and handling advice please refer to section 6.0 Actiheart User Manual 4.0.35 (Jan 2010)
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Contents 1. Actiheart Databases ... 8 1.1 Recordings Database... 8 1.1.1 Read Info Table ... 8 1.1.2 User Info Table ... 9 1.2 Settings Database... 9 1.2.1 Energy Models ... 10 2. Settings and Utilities ... 12 2.1 Test & Maintenance ... 12 2.1.1 Testing Actiheart Operation... 13 2.1.2: Battery Test ... 14 2.1.3: Reader Test ... 14 2.1.4: Firmware Update ... 14 2.1.5: Terminal Window... 15 2.2 Recharge Actiheart... 16 2.3 Read Actiheart ... 16 2.4 Communications Settings ... 16 2.5 Verify Actiheart Setup ... 17 2.6 Database Management ... 17 2.6.1 Adding or Changing Databases ... 17 2.6.2 Managing User Information ... 18 2.7 Software Preferences ... 18 3.0 Activity and Heart Rate ... 19 3.1 Short Term Recording ... 19 3.1.1 Overview ... 19 3.1.2 Setting Up a Short Term Recording... 19 3.1.3 Delayed Start for Short Term Recording ... 19 3.1.4 Downloading Short Term Recording Data from the Actiheart ... 20 3.1.5 Viewing Details of a Short Term Recording ... 20 3.1.6 Database Export and File Export ... 21 3.2 Analysing a Short Term Recording ... 21 3.2.1 Heart Rate & Activity Graph Controls ... 22 3.2.2 Analysis of IBI Data Graphs ... 23 3.2.3 Analysis of IBI Data Statistics ... 24 3.2.4 Printing a Short Term Report ... 25 3.2.5 Copying Short Term Data to the Clipboard ... 25 3.2.6 Exporting Short Term Data ... 25 3.2.7 Editing IBI Data. ... 26 3.2.8 Editing IBI Data with an external program ... 27 3.3 Long Term Recording ... 29
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3.3.1 Setting up a Long Term Recording ... 29 3.3.2 Summary of Long Term Recording Times ... 30 3.3.3 Setting Up a Recording – Delayed Start ... 30 3.3.4 Downloading Long Term Data from the Actiheart... 30 3.3.5 Viewing Details of a Long Term Recording ... 30 3.3.6 Database Export and File Export ... 30 3.4 Analysing a Long Term Recording ... 31 3.4.1 Long Term Tools Tabs & Controls ... 32 3.5 Previewing & Printing Long Term Data ... 34 3.6 Auto Clean ... 35 3.7 Estimate Sleeping HR ... 36 3.8 Select Day ... 36 3.9 Copying data to the clipboard... 36 3.9.1 Copy all data... 36 3.9.2 Copy Circadian Components ... 36 4.0 Energy Expenditure Analysis ... 37 4.1 Overview ... 37 4.1.1 Choosing an Application for Making a Recording ... 37 4.1.2 Choosing an Application for Analysis ... 37 4.1.3 Differences between the two Applications ... 37 4.2: Factors Affecting the Calculation of Energy Expenditure ... 38 4.2.1 The Branched Model Settings ... 38 4.2.2 Branched Model Adjustment in the Presence of Recovered Data ... 38 4.2.3 Branched Model Adjustment in the Presence of Stress ... 38 4.2.4 Individual Calibration ... 38 4.2.5 Resting Energy Expenditure (REE) ... 38 4.2.6 Sleeping Heart Rate (SHR) ... 39 4.2.7 Lost Heart Rate Data ... 39 4.2.8 Gaps in the Data ... 40 4.3 Daily Energy Expenditure ... 41 4.3.1 Steps in Performing an Analysis ... 41 4.3.2 Setting Up & Downloading / Reading a Recording ... 41 4.3.3 Selecting an Energy Model... 41 4.3.4 Individual Calibration ... 42 4.3.5 Analysing a recording ... 42 4.3.6 Gaps in the Data ... 44 4.3.7 The Distribution of AEE ... 44 4.3.8 Previewing & Printing Data ... 44 4.3.9 Copying Data ... 45 4.3.10 Analyse All ... 45 4.4 Advanced Energy Expenditure ... 46 4.4.1 Steps in Performing an Analysis ... 46 4.4.2 Setting up a Recording ... 46 4.4.3 Setting up a Recording – Delayed Start ... 47 4.4.4 Downloading an Advanced EE Recording ... 47
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4.4.5 Viewing Details of an Advanced EE Recording... 48 4.4.6 Database Export and File Export ... 48 4.4.7 Selecting an Energy Model... 48 4.4.8 Individual Calibration ... 49 4.4.8.1 Measured RMR ... 50 4.4.8.2 Sleeping Heart Rate ... 50 4.4.8.3 Maximum Heart Rate ... 50 4.4.8.4 VO2 Max... 50 4.4.9 Analysing an Advanced Energy Expenditure Recording... 51 4.4.10 Viewing a Specific Point ... 53 4.4.11 The Display Tab ... 53 4.4.12 The AEE Tab... 54 4.4.13 The Model Tab ... 54 4.4.14 The Comments Tab ... 54 4.4.15 The Utilities Tab ... 54 4.4.16 Printing and Previewing Data... 55 4.4.17 Copying all Days ... 55 4.5 The Step Test... 56 4.5.1 Overview ... 56 4.5.2 Setting-Up a Step Test... 56 4.5.3 Downloading Step Test Data from the Actiheart ... 58 4.5.4 Viewing Details of a Step Test Recording... 58 4.5.6 Analysing a Step Test Recording ... 58 4.5.7 The Energy Regression Equations ... 59 4.5.8 Setting-Up Multiple Users ... 60 4.5.9 Marking Bad HR data ... 60 4.5.10 Copying Data for a User ... 60 4.5.11 Printing and Previewing ... 60 4.5.12 Create Derived Short Term Recording ... 60 4.5.13 Analyse All ... 60 4.5.14 Saving an Individual Calibration ... 61 5.0 Sleep Analysis [Research Only] ... 62 5.1 Overview ... 62 5.1.1 Choosing an Application for Making a Recording ... 62 5.2 Sleep Analysis ... 63 5.2.1 Setting up a Sleep Recording ... 63 5.2.2 Setting up a Recording – Delayed Start ... 64 5.2.3 Reading / Downloading a Sleep Analysis Recording ... 64 5.3 Analysing a Sleep Analysis Recording ... 64 5.3.1 Viewing a Specific Data Point ... 66 5.3.2 Beat to Beat Zoom ... 66 5.3.3 Previewing Data ... 67 5.3.4 Printing Data ... 67 5.3.5 Copying Data ... 67 5.3.6 Exporting Data... 67
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5.4 Sleep Staging ... 68 5.4.1 Previewing Data ... 70 5.4.2 Printing Data ... 70 5.4.3 Copying Data ... 70 5.4.4 Exporting Data... 70 5.5 Apnoea Screening ... 71 5.5.1 Previewing Data ... 72 5.5.2 Printing Data ... 72 5.5.3 Copying Data ... 72 5.5.4 Exporting Data... 72 5.6 Apnoea Search ... 73 5.6.1 Previewing Data ... 75 5.6.2 Printing Data ... 75 5.6.3 Copying Data ... 75 5.6.4 Exporting Data... 75 5.7 Spectrogram ... 76 5.7.1 Previewing Data ... 76 5.7.2 Printing Data ... 76 5.7.3 Copying Data ... 76 5.7.4 Exporting Data... 77 6.0 Safety and Handling Information ... 78 6.1 Decontamination ... 78 6.2 Battery... 78 6.3 Water Ingress ... 78 6.4 Warnings – general ... 78 6.5 Disposal ... 78 Appendix 1: Technical Specifications of the Actiheart System ... 79 Accelerometer specification ... 79 Acceleration measurement... 79 ECG specification... 80 Heart Rate Measurement ... 80 Actiheart Recording Times ... 81 Sensor Calibration and Reproducibility... 81 Time Keeping... 81 Waterproof Case ... 81 The Actiheart and Static Electricity ... 81 Appendix 2: The Branched Model, Calibration Equations and Other Equations ... 82 Estimating Energy Expenditure (EE) from Activity and Heart Rate ... 82 Techniques used for Estimating Energy Expenditure from Activity and Heart Rate ... 82 The Branched Equation Model for Estimating AEE from Simultaneous Activity and HR ... 83 Default Parameter Values for the Branched Model. ... 87 Activity Only or Heart Rate Only Mode ... 88 Individual Calibration ... 88 Customising the Equations and the Model ... 89 Branched Model Adjustment in the Presence of Recovered Data ... 89
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Branched Model Adjustment in the Presence of Stress ... 89 Appendix 3: The Schofield Equations ... 91 Schofield Equations ... 91 Appendix 4: The Step Test Calculations ... 92 HR Calibration ... 92 Activity Calibration ... 93 Appendix 5: Calculation of Energy Expenditure ... 94 Appendix 6: Validation Posters ... 95
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1. Actiheart Databases The Actiheart uses two Microsoft Access databases to store data and settings respectively. Access is not required in order to record, read and analyse data. However Access is required if a user wishes to view the details of certain records which are not viewable through the user interface or if a user wishes to customise certain settings. If Access is to be used then it should be version 2002 or later. The database(s) which hold the recorded data are created and named by the user and by default are saved in C:Documents and SettingsComputer User IdActiheart Data. The software is shipped with a database „actiheartdemo.mdb‟ which contains demonstration files. The Settings database is also shipped with the software and is placed in the Actiheart Program File during installation. 1.1 Recordings Database This database holds recorded data and has five tables two of which, Energy Calibration and Weights are not used. The two key tables are Read Info and User Info. 1.1.1 Read Info Table This is probably one of the most important tables in that it contains all the raw data. This database is populated every time that the Actiheart is read. The following information is stored along with the raw data.
Computer Name
Computer User
Read Time
Start Time. This is the time at which the recording started.
Serial No.
Bat Voltage. This is the battery voltage when the data was read.
User Id. This is the User name which was used for the recording. If a Test Id was also used then the User Id field will be displayed as User Id_ Test Id e.g. 99934_ bike + treadmill.
Test type. This is the recording mode, e.g. IBI, Variability , Waveform (see Section 8 of the Guide to Getting Started).
Samples. This is the file size.
Step Size. This is the step size at which a test was conducted and is very important reference information for the reasons given in Section 4.4.
Mask Comments. Describes the type of mask applied to the data. For a description of masks please see Section 3.4.1 on the „Edit‟ tab in long term recording.
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1.1.2 User Info Table This table contains User details many of which affect the calculation of energy expenditure. These are all entered from the AH application and they are:
User Id
Height
Date of Birth
Weight. This is used to calculate Resting Metabolic Rate (RMR) from the
Schofield equations (see Appendix 3). It is also used to calculate Energy Expenditure from Energy Intensity. The database field is called Start Weight.
Resting Heart Rate (Resting HR). See Section 4.4.8.2 for more details.
Measured RMR. This is whichever value the user has opted for i.e. equation based or actually measured. See Section 4.4.8.1 for more details.
HR max. This is whichever the user has opted. i.e. equation based or user entered. See Section 4.4.8.3 for more details.
VO2 max. See Section 4.4.8.4 for more details.
The table also contains individual Activity and Heart Rate calibration data obtained either from the built-in Step Test or from an external calibration. The Step Test data is generated automatically when a Step Test is saved (see Section 4.5 for more details). The data is contained in the fields labelled Energy 20 to Energy 280. The data is in Joules/min/Kg. Heart Rate calibration data is contained in the fields Hree 20 to Hree 280 and Activity Calibration data is contained in the fields Act EE 50 to Act EE 6400. This data is entered by the user. Please see Section 4.4.8 on individual calibration for more details. 1.2 Settings Database This database has seven tables of which only two, PAEE and Step PAI are key operational tables. The PAEE table is shown overleaf. This table contains information about:
Group calibration equations.
Branched Model Discriminants and Weighting factors. See Appendix 2 for more details.
Compensation factors for recovered Heart Rate data and for stress (see Appendix 2).
Flags to enable individual calibration.
The group calibration equations shown in the table are the default ones supplied with the software but a user can specify his own. The branched model discriminants can also be varied at will. This information can be viewed directly from the application without having to open the database (see Sections 4.3.3 and 4.4.7).
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The Step PAI table contains the PAI-HRaS regression equation obtained from the Step Test (see Appendix 4). StepPAI FAC 1
2
3
4
5
2.9
1.1
2.9
1.3
-10
6
7 0
8 0
9 0
0
10
11
-75
0
WARNING When creating new equations or varying any of the branched model values do not replace any of the default values but create a new record in the database. 1.2.1 Energy Models The different energy models available to analyse recordings are controlled by entries in the „paee‟ table of the settings database. If you wish to experiment with a new model or combinations of existing models, you may add new rows to this database. You should do this with some caution, and we can make no guarantee as to the energy expenditure results you will gain. You must not alter the existing rows. Each row added to the table will result in a new energy model being added to the list available within the software. Most of the columns needed for each entry are shown in the diagram on the following page, linked to the corresponding entries in the branched model parameters window. The remaining columns are explained immediately below: ViewOrder: This number determines the order in which the models will be displayed within the software. If adding a new model, simply choose a higher number, for example starting from 100. ActiheartFlex: This controls the „flex point‟ value of activity counts where the EE prediction switches between a linear projection from the origin to the Act EE equation. HRflex: This controls the „flex point‟ value of heart rate where the EE prediction switches between a linear projection from the origin to the HR EE equation. Jap2007Activity: This controls whether the piecewise linear activity to EE model from the JAP2007 paper will be used. common: This determines whether the model appears when „Show Common Models‟ is selected.
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2. Settings and Utilities Clicking on the „Utilities‟ button from the front screen will display the Actiheart settings and utilities screen as shown below.
There are a number of buttons and software settings which are described below: 2.1 Test & Maintenance Clicking the „Test & maintenance‟ button brings up the following screen;
This screen shows information about the Actiheart. In this case, the Actiheart is functioning correctly. If there is no response from the Actiheart, because for example it has been powered down, it may be necessary to manually reboot the Actiheart using the „Manually Reboot Actiheart‟ button at the bottom of the screen. If the „Powerdown’ function has been used it will have destroyed any stored data.
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2.1.1 Testing Actiheart Operation It is also possible to test the internal memory and circuitry of the Actiheart. This is done by selecting the „Test‟ tab. This brings up the following screen:
Clicking on the „Perform Tests‟ button will run a series of inbuilt tests which check the functionality of the unit. These tests may take up to a minute to complete. WARNING! Performing these tests will cause any data and settings stored in the Actiheart to be lost. If the Actiheart is functioning correctly, the following screen will be shown:
A message will be displayed stating that the tests have been successful. If there is a problem then a warning message will be displayed. In this case, please contact the technical department at CamNtech for further help.
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2.1.2: Battery Test It is possible to test the condition of the battery in the Actiheart unit. Selecting the „Battery test‟ tab of the „Test Actiheart‟ screen will bring up the screen. Selecting „Run full battery test‟ will then run a load test on the battery in the Actiheart. The LED in the Actiheart will flash continuously and various voltages will be displayed. If a user suspects a problem with the battery of an Actiheart and contacts CamNtech for advice, these voltages may be requested to aid diagnosis so they should be noted. 2.1.3: Reader Test This function should only be used if requested by a CamNtech representative. 2.1.4: Firmware Update NOTE: This section applies to ‘Actiheart 4’ only (serial numbers beginning with 90). To ensure optimal performance via product enhancements, it may be necessary to update the operating software contained within the Actiheart. The latest operating software (firmware) file is distributed with the latest version of the Actiheart PC software and can also be provided upon request. To update the firmware, click on the „firmware‟ tab to view the firmware update screen. At the bottom right of the screen the currently available firmware version will be displayed. This will typically be shown as 84.nn where nn = current version number. To proceed with the update, ensure that the Actiheart is correctly placed upon the reader and then click „Load new firmware‟. Accept the warning messages and wait for the update/verification to complete. WARNING! The Actiheart must not be removed and the computer should not be used for other activities until the firmware update is complete. If the update is interrupted, the Actiheart may need to be returned to CamNtech for repair. Upon successful completion of the update, the following screen will be displayed:
The Actiheart may now be removed and used as normal.
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2.1.5: Terminal Window Allows direct communication with the Actiheart and is used for diagnostic purposes if the Actiheart cannot be read. It is a check that the communications between the PC and the Actiheart are working properly and it is also a check that the recorded header (date, time, ID, Serial No.) has not become corrupted. Clicking „Test and Maintenance, then the „Terminal‟ tab brings up the following screen with a three step routine. Please note that the routine below will not cause any stored data to be lost.
First press F1. The LED on the reader will flash. This will reset the Actiheart. If a „>‟ prompt appears thereafter, the communications are working normally. If there is no „>‟ prompt then there could be a fault with the Actiheart. Press F1 again and if the „>‟ prompt is still not displayed please contact CamNtech for assistance. If communications are OK press F2. This will read the header information recorded in the Actiheart. The format of this header information is as follows unless it has become corrupted. If the latter has occurred proceed to step 3 below in order to recover the recorded data. 12 Feb 2009 12:37 Mike_Purday.Step Test. 030F100000 019057 H90000001 7E 02 0A 16 Pressing F3 will load a dummy header to enable the unit to be read. The header will be of the same form as above but will not reflect the true date of the actual recording or its ID. After the file is read and saved, the header can be changed to the correct one for the recording from the recordings database (see Section 1.1 for further information on the user data table).
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2.2 Recharge Actiheart For full details on charging the Actiheart, see Section 3 of the Guide to Getting Started.
2.3 Read Actiheart This is a general Read function for reading all types of recording. For full details of the Read function and how to read a recording, please see Section 7 of the Guide to Getting Started. 2.4 Communications Settings Clicking the „Communication Settings‟ button will display the following window:
Status information for the multi channel reader-charger will be displayed in the right hand part of the screen when the reader/charger is correctly installed and connected. There are no user settings for this device. The older style single channel reader may require the selection of the correct COM port (this is typically automatic when the software and drivers are installed). If the reader is not detected, click the „search‟ button to detect the reader and assign the correct port. Note that it is not possible to manually change the port numbers. If there are persistent problems with the reader, please follow the appendix at the rear of the „Actiheart Guide to Getting Started‟ detailing the installation of USB drivers. The latest drivers are also available for download from our website at: www.camntech.com/drivers.htm
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2.5 Verify Actiheart Setup This facility is provided in order to easily check the setup parameters of a recording Actiheart.
2.6 Database Management The lower part of the Actiheart Settings and Utilities windows provides information and tools for the management of the database.
The currently selected database (and its location) are shown within the „Database selection‟ area. A listing of all users contained within the current database is shown in the „Users in this database‟ area. 2.6.1 Adding or Changing Databases To add a new blank database (no users or records) click on the „New‟ button. A Windows file dialogue box will be displayed where you can supply the name and location of the new database before clicking „Open‟ to save the database.
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To select a different existing database, click on the folder button: This will open a standard Windows folder dialogue where it is then possible to locate and select the required database. 2.6.2 Managing User Information It is possible to manage user information with the controls located in the „Users in this database‟ area. Theses controls provide the following options: Add: This will invoke the „Add new user wizard‟ as described in section 6 of the „Actiheart Guide to Getting Started‟. View: Click on any user in the list then click the „View‟ button to view details for that user. Edit: Click on a user in the list then click the „Edit‟ button to show the following screen: It is possible to change the following user details from this screen: o o o o
Weight Height Maximum Heart Rate Sleeping Heart Rate
When changes have been made, click „Save‟ to store the information.
Erase: If a user‟s details are no longer required, click on a user in the list then click the „Erase‟ button to permanently erase the details.
2.7 Software Preferences There are three controls available in the preferences section as described below: Enable Sleep Analysis: This allows the Sleep Analysis function to be accesses from the main screen. See section 5.2 of this manual for more information. Add components: This allows the addition of optional software components where available. Contact CamNtech to obtain a license and software key to enable components. Change Language: Allows the software to be localised for the required language. This is achieved by means of a text file containing translations of English into the required language. The software will only show languages with a valid translation file present. Contact CamNtech Ltd for more information.
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3.0 Activity and Heart Rate 3.1 Short Term Recording 3.1.1 Overview The short term recording mode is designed for recording up to 440,000 heartbeats. This recording mode allows for detailed heart rate variability (HRV) analysis.1 Heart rate, activity and every Inter-beat Interval (IBI) of the heart rate are recorded in this mode. The epoch length for this mode is fixed at 15 seconds. Selecting the „Short Term Recording‟ tab brings up the following screen:
3.1.2 Setting Up a Short Term Recording A Short Term recording is set up in the same way as a Signal Test recording by clicking on the „set-up‟ button then following the set-up wizard .(For further details please see Sections 6 & 7 of the Guide to Getting Started). 3.1.3 Delayed Start for Short Term Recording Delayed Start allows the user time to set up an Actiheart or several Actihearts and for them to start recording at a time in the future. This can be useful, for example, when setting up a group of subjects together. The maximum start delay is 72 hours. The Actiheart will not begin recording until the start time is reached. All times are taken from the clock on the host PC.
1
The term HRV is a generic term used in this manual to indicate the variability of the cardiac Interbeat Interval. The number of intervals available for analysis and the measure of variability used varies according to the application.
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3.1.4 Downloading Short Term Recording Data from the Actiheart Click on the „Read‟ button to download the short term data. This process is the same as for any other recording (for further details please see Section 7 of the Guide to Getting Started). The data is stored in the selected database ready for analysis. 3.1.5 Viewing Details of a Short Term Recording Once the recording has been stored in the database, it is possible to view information about it. Highlight the required recording from the Short term BPM screen and then click the „Info‟ button to produce the screen shown below:
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3.1.6 Database Export and File Export It is possible to export a particular file or to export a user‟s data and experiment data from this field. This is done by selecting either the „File export‟ or „Database export‟ tab from the bottom of this screen.
‘Database export’ exports the full user details and experiment details to a target database which is selected by clicking on the yellow Open File icon. Click „OK‟ to export the database; when this is complete, a confirmation message is shown.
‘File export’ exports a file in either Tab Delimited or Comma Delimited text format. The default text file name and location are shown and clicking „Save‟ will export the data. Alternatively, clicking „Save As‟ allows an alternative file name/folder location to be specified.
The export procedure is identical for all recording modes. 3.2 Analysing a Short Term Recording The recording required for analysis can be selected by either double clicking on it, or highlighting it and clicking on „Analyse‟. The Short Term analysis screen will be shown which is divided into 4 areas as shown below:
A B
C
D
A. User and Recording Details. This area shows the parameters of the chosen recording namely those for the user and those for the start and finish times of the recording.
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