The Actiheart Guide to Getting Started
Contents
1. Every beat 15 sec en Every 15 sec Every 15 sec Sen EE Every 30 sec Every 30 sec Go Sen GET Every 30 sec Every 30 sec Every 30sec __ Actiheart Guide to Getting Started 4 0 37 Apr 2010 5 2 Installing the Actiheart Software 2 1 System Requirements The Actiheart system is supplied with a CD ROM containing all of the components of the software package ordered and the drivers to support the hardware required by the system The following are the minimum requirements of a host PC for installing the Actiheart software e IBM compatible 300Mhz e Windows XP Vista or Windows 7 operating system e 100 MB hard disk space e USB port e A CD ROM drive or equivalent e Graphics 800 x 600 pixels minimum e Printer if hard copy output is required 2 2 Software Installation Menu Place the CD ROM into the drive the software should start automatically and display the following installation menu Install Actiheart Software Fe Install Actiheart PC Software Install CamNtech USB Drivers Install software for setting up and downloading the Actiheart and for analysing Actiheart results for energy expenditure heart rate vanability and other functions To install the software click on Install Actiheart PC Software and follow the installation process Note that the installation will differ for new users and existing users as described in Section 2 3 below If the above menu is not display2. Next produces the following screen Enter the Weight and Height of the User Weight 600 Ko Metic l mperal Cancel The weight and height of the user are selected from this screen It is possible to input the user details either in Metric or Imperial units The increments are 1cm and 0 1 Kg Once entered selecting Next produces the following screen Select a Fitness Rating for the User Select an estimate of the max HR Unknown Le Select an estimate of the sleeping heart rate Resting HR 10 ZU Actiheart Guide to Getting Started 4 0 37 Apr 2010 20 This screen allows selection of a fitness rating and an estimate of the maximum heart rate and sleeping heart rate to be entered Once this is done clicking Next shows the message Do you want to save this user data Selecting Yes produces a conformation message that the new user has been saved correctly into the database Click OK to finish and exit Actiheart Guide to Getting Started 4 0 37 Apr 2010 21 7 0 Checking Signal Integrity and Performing a Test Recording 7 1 How to set upa Signal Test Before starting any serious recording it is recommended that a short signal test be carried out This is to check that the level of R wave signal being picked up by the Actiheart is adequate and helps to avoid serious recordings being marred by artefacts due to either high noise or a low R wave signal The test involves making
3. 0 37 Apr 2010 7 2 5 Users upgrading from an earlier version of Actiheart Software lf the drivers loaded automatically simply close this menu and the drivers should be ready to use If the drivers do not load automatically or if you wish to make sure they install correctly you should select Install CamNtech USB Drivers and carefully follow the on screen instructions If you still experience problems with the USB drivers follow the procedure Installing USB Drivers Manually which is included in Appendix A of this manual Windows should automatically search the CD drive for the driver but if it does not do so you will be required to Search manually and then Browse to point to the CD drive A screen may appear that tells the user that the driver is not digitally signed by Microsoft Select Continue Anyway Please note that this is NOT a problem and just means that the Actiheart version of the driver software has not been assessed by Microsoft In fact the actual drivers are Microsoft approved The drivers will be installed and the computer will then tell the user that the new hardware is ready to use If you change the USB port that the reader is plugged into then the driver may be automatically re installed by Windows This is an automatic process and the user need take no action If you have any problems installing the drivers please read the help document and download the latest drivers from http Awww ca
4. 23 Jun 2008 16 06 FirstUser_Exercise010201 23 Jun 2008 16 06 DOUT D wave 17 Alund 2008 11 22 Reports and export 99901_A wave 11 Jun 2008 11 22 99901_R wave 11 Alun 2008 11 22 Print E RER RS Actiheart Guide to Getting Started 4 0 37 Apr 2010 22 Selecting Setup brings up a screen allowing where you may add a new user by clicking Add New see section 6 2 for details or find an existing user by clicking Find the following screen will then be displayed IST J d Ai Locate an Existing User Pick an existing User ID from the list Cancel To select the required user simply click on the user ID in the list The user details will be displayed in the DOB weight and height boxes Click Next to proceed to the setup screen as shown below Z Heart Signal Test Setup lt Actiheart monitor Serial No H90000658 Battery volts Z bi E Actiheart detected and ready USE Communications Transmit ee Receive You may enter an additional Test ID i e to identify this particular test for this user Click the Send button to write the setup information into the Actiheart You will see a confirmation message when this is complete WARNING The Actiheart MUST be removed IMMEDIATELY from the Reader Failure to do so may lead to the Actiheart being unable to record in which case the setup procedure would need to be repeated Once the Actiheart is removed from the
5. Electromagnetic compatibility Requirements and tests See section 9 7 2 for declaration and guidance EN62304 2006 Medical device software Software life cycle processes Safety Classification Information A The Actiheart mode of operation is CONTINUOUS OPERATION The Actiheart is INTERNALLY POWERED EQUIPMENT The Actiheart is a TYPE B APPLIED PART For further safety and handling advice please refer to section 9 Actiheart Guide to Getting Started 4 0 37 Apr 2010 2 Contents The ACUNEATU cscs sac seems cee toes nee seeegwau sent anee see dwoeseec accu EEEE EEN EN 1 Guide to Getting Started assess ccscccisceserccsneseassnensasccsenseessnzesarncesnsacssanesansseansacasemmcnesseansancucaneeskseoussncesaneesasnesssnoenes 1 DOCUIMCNLINCICECNCO K 1 The Actiheart is a Class 2a Medical Device EU ccsccescceseeneensecneeneeenecesecnscenecaseessonssessonssensonssensoness 1 1 Introduction to the Actiheart System cccccesseeeseeseeseecenseeeaseeceneesenseeeenseeeasesoaseeoessesonseeoneesensesoenessens 5 1 1 An Overview of the Actiheart System cccccccccccccceeeeseseseeeeeeeeesaeeeeeeeeeeeeesseesseeeeeeeeeseeeeseeeeeeessseeaeeeeeeeeessaaeaeeseeeeeeeaaas 5 2 Installing the Actiheart Software ccccessesssseeeeeseeceeeeeenseeeeseecenseseaseeoessesenseeoaseeoensseoaseesegsesensesonseesenees 6 2T oy Ste MI re CUI CNC E 6 2 2 Software Installation Men EE 6 2 3 Software amp Driver
6. IBI d LONG TERM With HRV Without HRV Variability Normal d d ADVANCED ENERGY EXPENDITURE Short Term IBI d Actiheart Guide to Getting Started 4 0 37 Apr 2010 Long Term Daily Living Variability Compatible d x d x 30 8 7 Recording Capability for DAILY Energy Expenditure Epoch 15 sec 30 sec 1 min DAILY ENERGY EXPENDITURE With HRV Without HRV Variability Normal x x x x d x Actiheart Guide to Getting Started 4 0 37 Apr 2010 31 9 0 Safety and Handling Information 9 1 Decontamination 9 2 Battery 9 3 Water Ingress 9 4 Warnings general 9 5 Disposal Devices used in the field must be considered to be contaminated Returned devices must be cleaned with alcohol wipes to minimise any potential contamination The operator must use gloves to handle such devices before and during de contamination The device is battery operated and operates at voltages below 3VDC there is hence no risk from electric shock equipment Type B The battery is NOT user replaceable The device is tested to 2 BAR and is considered to be suitable for exposure to moisture in normal daily living and swimming for short durations The device is NOT defibrillation proof Electrical and Electronic Equipment Directive 2002 96 EC that manufacturers and or K Waste Electrical amp Electronic Equipment WEEE The EU requires under the Waste distributors of Electronic
7. IMSTAMNAUO Mis isc cccsscnssctaisencenacansntnecnaneadansnacevadancaetbdencchndsesaaaebaaseabacdencaobeacnedbaddaneatnnuaseistencaaeaedesdseimencet 7 2 4 Installing the USB Drivers ws 20e sc2ecssasescntasetscetasdtesesanesechtadeds tatatavedbhesdesddsesadecbheiotesatescugthossbecddestadacehadededebasecsetieateeddeannes 7 2 5 Users upgrading from an earlier version of Actiheart Software ccccccessccccseeeeeeeeeeeeeceeeeeeeaeeeeesseeeeeeseaseeeseeeeessaeeees 8 ZO asta ne TS OMA EE 9 2 7 Using the Software for the first me 10 3 0 Charging the Actiheart dE 11 EE 11 3 2 Charging the Actiheart using the Mains Power Guppiy 12 B10 SO TUING UH a DAA ASO xtc nce A E A E A A T T A A TT 13 4 1 Reason for the Creation of a new Database ccccccccccccssssseeeeeeeeeeeeseseeeceeeeesaueuseeeeeeeessseeaseeeeeesssaeaaeeeceeeessssaaaeeeeeeees 13 5 0 Preparing for a RecordiN D 15 5 1 Selection of appropriate ECG Pads and Preparation of the km 15 TRAS IN ee EE 15 5 3 Electrode FO E Oe in e Te EE 16 5 4 Positioning of the Actiheart ER 17 5 5 Use of the Actiheart in Waler 17 6 0 Setting up a User in the E E CT 18 6 1 Selecting an existing User from the Databaee 19 6 2 Setting Up a New USGr E 20 7 0 Checking Signal Integrity and Performing a Test Recording ccceseceeseseeseeeseeeeseeenseeeneseneeeeaeeoeaes 22 FLRW O SetuP Ee OR EE 22 7 2 Downloading recorded Data from the Actiheart ccccccceeecceecceeeeeeeeceeeeeeeeseeeeseee
8. Immunity Guidance and Manufacturers Declaration Electromagnetic Immunity The Actiheart is intended for use in the electromagnetic environment specified below The customer or the user of the Actiheart should assure that it is used in such an environment Electrostatic Discharge ESD IEC 61000 4 2 Electrical Fast Transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60Hz magnetic field IEC 61000 4 8 6kV Contact 8kV Air 2kV for power supply lines 1kV for input output lines 1kV differential mode 1kV common mode lt 5 U gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles 5 Ur 95 dip in Ur for 5 seconds 6kV Contact N A 1 2kV for power supply lines 1kV for input output lines Immunity Test IEC 60601 Test Compliance Electromagnetic environment Level Level guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material The relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Uris the a
9. Reader it can be placed onto the user by clipping onto the previously attached pads Actiheart Guide to Getting Started 4 0 37 Apr 2010 23 7 2 Downloading recorded Data from the Actiheart Once the subject has worn the Actiheart for the required length of time making sure that the subject has moved around to fully test pad contact the data can then be downloaded to the PC After placing the Actiheart on the Reader there are two options for reading the data The data can either be read from the recording mode application that the unit was set up in e g the Signal Test in this instance or alternatively the general Read function can be selected after clicking the Utilities button from the main screen Selecting the general read function produces the following screen detailing the different recorded file formats and where in the software they can be analysed This message does not appear if the Actiheart has been set up and read from within a particular application or using one of the specific recoding modes detailed in Section 8 of this guide Actiheart 4 Actiheart recording type Waveform LIST OF RECORDING TYPES IBI Can be analysed using short term recording Advanced EE Sleep Normal Can be analysed using long term recording Advanced EE Variability Can be analysed using long term recording Advanced EE Daily EE Waveform May be viewed in R signal wave test Clicking OK then commences the download of the da
10. Utilities Serial number 9999 9919 y mo sion www camntech com The user is now is a position to begin using the Actiheart and software IMPORTANT The Actiheart Demo database first installed will not be overwritten when a later version of the software is installed Actiheart Guide to Getting Started 4 0 37 Apr 2010 14 5 0 Preparing for a Recording 5 1 Selection of appropriate ECG Pads and Preparation of the Skin 5 2 Skin Preparation Range of Pads Before the Actiheart can be used the subject has to be fitted with ECG pads to clip the Actiheart to Selection of appropriate pads is difficult because there are many different types of skin and different skin types react differently to different pads There are a huge variety of electrode pads available CamNtech has tried many but suggest as a Starting point the following Short Term Recording Pads These tend to be foam backed pads with high adhesion 3M Red Dot 2560 These are extremely adhesive pads that provide very good adhesion for short term use The downside of this is that on removal CamNtech has noticed some gel residue left on the skin They are not really suitable for long term use Long Term Recording Pads These tend to be micro porous cloth backed pads which allow the skin to breathe during longer term recordings Unomedical Unilect Long Term 4620M These are cloth backed pads and are small in size These pads would be the most suitable type for paedia
11. a short recording and analysing the signal using a built in utility called Signal Test which provides a Pass Fail indication of whether the signal is acceptable For full details on analysing a signal test recording please see the main Actiheart User Manual Since artefacts are often aggravated by poor adhesion of the pads with the skin and movement of the pads relative to the skin during exercise it is important that a The pads are worn for at least 30 minutes before conducting the test b The subject moves around and even jogs on the spot for a few minutes during the test The user has the ability to record for up to 12 minutes in this mode although four or five minutes will be sufficient The method described below for making a recording and downloading the data to the PC for analysis applies equally to the various recoding modes described in the User Manual and summarised in Section 8 of this guide Place the Actiheart onto the Reader The face of the Reader indicates which way round the Actiheart should be placed From the Utilities tab select the Actiheart tab then click the Signal Test button to show the screen shown below Le R Wave Signal Test User details UserID Sleeping HR ER E Sex Weight Height BMI 10 Second Activity and R wave display Display options ECG Mf Activity Tests available to view 199901 D wave 22 ug 2008 11 15 99901 A wave 22 Aug 2008 10 56 FirstUser_Exercise010201
12. 1 1 Short Term Recording Maximum 440 000 beats Maximum 96hrs at an average of 76 BPM Fixed 15 sec epoch Activity and Heart Rate recorded epp Every Interbeat Interval IBI is logged for HRV analysis if required WARNING The recording time is dependent on the signal quality A poor signal with many artifacts will result in a shorter recording time 8 1 2 Long Term Recording a Maximum 21 days recording b Choice of 15sec 30 sec or 1 minute epoch c Activity and Heart Rate recorded d Optionally limited IBI logging i e min max interval per epoch 8 1 3 Signal Test See section 7 of this manual Actiheart Guide to Getting Started 4 0 37 Apr 2010 27 8 2 Set up Energy Expenditure Options 8 2 1 Daily Energy Expenditure a Fixed 1 minute epoch for daily living studies b Limited IBI logging as standard Maximum recording time 21 days 8 2 2 Advanced Energy Expenditure a Maximum recording time 21 days b Choice of 15 sec with every IBI and 15 sec 30 sec or 1 minute epoch with limited IBI logging as standard The table below summarises the recording durations refers to Actiheart 4 Epoch 15 sec 30 sec 1 min Recording time HR 21 days 21 days 21 days Activity Recording time HR 10 days 20 days 21 days Activity IBI Max Min Maximum 96 hrs at 76 BPM Recording IBI 440 000 depending on beats maximum signal quality 8 2 3 Step Test Activity and R wave waveform recording for 13 minutes of standardised
13. A standardized procedure for locating and documenting ECG chest electrode positions consideration of the effect of breast tissue on ECG amplitudes in women J Electrocardiol 1998 Jan 31 1 17 29 Actiheart Guide to Getting Started 4 0 37 Apr 2010 16 5 4 Positioning of the Actiheart 5 5 Use of the Actiheart in Water Fig A Fig B For good accurate measurement of activity the Actineart needs to be placed with the cable exit as near the horizontal as possible A 10 degree tilt Fig B gives a theoretical activity reading error of 3 A 45 degree tilt would mean that the detected magnitude is 30 less than the actual The electrodes should be positioned so that the cable is stretched to its full length Fig A This will avoid unnecessary rotation of the sensor in situ The diagram below shows an illustration of this Direction of Motion Accelerometer Orientation Measured Acceleration A Cosa Angle a A Actual Vertical Acceleration For more information about the implications of electrode placement on physical activity estimates please refer to S ren Brage Niels Brage Ulf Ekelund Jan an Luan Paul W Franks Karsten Froberg Nicholas J Wareh Effect of combined movement and heart rate monitor placement on physical activity estimates during treadmill locomotion and free living Eur J Appl Physiol 2005 DOI 10 1007 s00421 005 01 12 6 Although the Actiheart is waterproof use in the water
14. ails of the manufacturer wl 9 6 4 Consult instructions for use This symbol indicates that important operational information is contained in the user d LU instructions i e this user guide Actiheart Guide to Getting Started 4 0 37 Apr 2010 33 9 7 EMC Guidance amp Declaration The following tables provide a declaration of compliance and user guidance regarding Electromagnetic compatibility of the Actiheart system 9 7 1 Electromagnetic Emissions Guidance and Manufacturers Declaration Electromagnetic emissions The Actiheart is intended for use in the electromagnetic environment specified below The customer or the user of the Actiheart should assure that it is used in such an environment Emissions Tests Compliance Electromagnetic environment guidance RF Emissions Group 1 The Actiheart uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions Class B The Actiheart is suitable for use in all CISPR 11 establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic Emissions Not Applicable EN61000 3 2 Voltage Fluctuations Not Applicable flicker emissions EN61000 3 3 Actiheart Guide to Getting Started 4 0 37 Apr 2010 34 9 7 2 Electromagnetic
15. and or Electrical Equipment manage and pay for the collection and further handling of WEEE products as well as provide WEEE related information to their customers CamNtech has taken the following approach to complying with this Directive 9 6 Symbols used for marking devices amp packaging CamNtech has registered with an approved producer compliance scheme PCS in accordance with the requirements of the WEEE Directive CamNtech will provide free recycling for all of its WEEE products when returned to them CamNtech WEEE products will be designed with recycling reuse and waste management as a consideration CamNtech WEEE products will be labelled or stamped with the WEEE marking in accordance with European Standard EN 50419 Medical devices carry symbols to provide universally recognised warnings and information The Actiheart uses the following markings on the device and or packaging Actiheart Guide to Getting Started 4 0 37 Apr 2010 32 9 6 1 Serial Number SN This number indicates a unique identification for a particular device Always quote this number when seeking technical assistance 9 6 2 Catalogue Number R E F This number identifies this particular variant of the product range 9 6 3 Manufacturer amp Date of manufacture This symbol is accompanied by a date in the format yyyy mm which indicates when the device was manufactured The symbol is also accompanied by the address and contact det
16. argeable battery The maximum voltage is 3 0V However a rapid drop to 2 75 volts is normal When fully charged the battery will last about 21 days when doing a long term recording The battery life in the short term recording mode is only 4 days due to the LED flashing with every heart beat Select and fit appropriate ac input socket adaptor for country of use Plug the USB cable from the reader charger directly into the socket on the mains power supply Place Actihearts onto Reader charger The status LED will remain red while the Actiheart is charging The status LED will turn green when charging is completed Note that it is normal for the LED to alternate between red green towards the end of the charging period this ensures that the Actiheart battery is kept fully charged Actiheart Guide to Getting Started 4 0 37 Apr 2010 12 4 0 Setting up a Database 4 1 Reason for the Creation of a new Database All data used in the Actiheart system is stored in Microsoft Access databases For full details of the databases used by the system please see the chapter in the main manual on databases Once the software and drivers for the USB Reader have been installed the Actiheart software will be installed by default in the following folder C Program Files Actiheart A shortcut icon will also have been created on the desktop If this is double clicked the message below appears and a database called ActiheartDemo containing a selection of sho
17. c mains voltage prior to application of the test level 1 Test not applied because contact discharge could be applied to all points 2 Not tested because the 2 operating modes where essential operation is important do not have a mains connection Actiheart Guide to Getting Started 4 0 37 Apr 2010 35 Appendix A Installing USB Drivers Manually Sometimes the automatic installation of drivers will not work often because your computer has previously had similar but different drivers installed on it before and sometimes because of flaws in the Windows installation process To install drivers manually follow the procedure below To begin installing drivers Plug the device into a USB port Something similar to the window shown below should appear If it does not then open it manually like this e Click on the Start menu and open the Control Panel e Open System If you can t see this choose Performance and Maintenance then System e Select the Hardware tab and click the Device Manager button e Scroll down and open up the section called Universal Serial Bus controllers The device you are trying to install should be listed here It may have a yellow question mark next to it e Right click on the device name and select Update Driver The window below should then appear Hardware Update Wizard Welcome to the Hardware Update Wizard Windows will search for curent a
18. cam tech The Actiheart Guide to Getting Started Document Reference 30072 Issue Version 4 0 37 Issue Date 27 04 2010 CE 0120 The Actiheart is a Class 2a Medical Device EU This manual is designed to be read in conjunction with The Actiheart User Manual Actiheart Guide to Getting Started 4 0 37 Apr 2010 Regulatory Information CE Notice European Union Actiheart Medical device information The Actiheart is a Class Ila Medical Device conforming to the essential safety amp 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 Tel 01480 831223 Upper Pendrill Court Fax 01480 831733 Papworth Everard Email technical camntech co uk Cambridgeshire Web www camntech co uk CB233UY 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 See section 9 7 1 for declaration and guidance EN60601 1 2 2002 Medical electrical equipment Part 1 2 General requirements for safety Collateral standard
19. dio Prep from Unomedical stock code 2121M These are low cost adhesive backed skin preparation pads which are supplied in packs of 50 In the absence of an abrasive material a suitable alternative is to rub the skin with a towel or other cloth If this is done it should be vigorous enough to remove the top layer of skin Some redness will be seen and this is normal and should not be cause for concern Apply the chosen pads to the chest This is best achieved by placing the pad in the centre of the chest and locating the Actiheart on it Attach the second pad to the other clip on the Actiheart and use the wire to position the second electrode Further details on positioning of the Actiheart are shown below The best ECG signals can usually be picked up by placing the round end of the Actiheart unit in a position midway between and below V1 and V2 The other electrode can be placed at V4 or V5 A position on the upper chest shown in the diagram below can also be used This may be either more or less acceptable for female users depending on their breast size According to Rauharju et al breast tissue appears to have a practically negligible effect on ECG amplitudes and in women the placement of chest electrodes on the breast rather than under the breast is recommended in order to facilitate the precision of electrode placement at the correct horizontal level and at the correct lateral positions 1 Rautaharju PM Park L Rautaharju FS Crow R
20. e to Getting Started 4 0 37 Apr 2010 3 9 0 Safety and Handling lu e du Ce E 32 SHED ege AMON N E E E E A E E E E uted EE E EE 32 GT EE 32 G AE le ele 32 EV dn ln Tee LEE E 32 Di DISD OS E E A A A E A E E E A TE A E A A A A E A S 32 9 6 Symbols used for marking devices amp PACKAGING cccseesccccceeeeeeeeeceeeeeceeesaeeeeeeeeseesseeeessaeeeeeesseaeceeessaeeeeeesseeeeeeeeeaas 32 GE SE Tir 33 9 6 2 Catalogue Number 33 9 6 3 Manufacturer amp Date Of manufacture nnneannnnanneoeannnsrnrerrnrrrsrnrrrsnrrrsnnrrrsnrrrsrnrrrsnrtronntrrsnrtronntrrnrerrannrrnreernnnenne 33 9 6 4 Consult instructions MOM EE 33 9 7 EMC Guidance amp Declaratiol ssnacisenisinesie ionn aa AEE E EEEE AEA DEERE RE T EERE EEEa 34 9 7 1 Electromagnetic EMISSIONS A 34 9 2 Electromagnetic e inn i anesthe ined a EEEn aE eared ra Pareek riadia inaia 35 Appendix A Installing USB Drivers Manually cccceseeceseeeeseeeseeeeseeeneeoeseeenseeeneeoeseeeaseoeneeonseseneeonaes 36 FOTOS Une E lef ele 36 Actiheart Guide to Getting Started 4 0 37 Apr 2010 4 1 Introduction to the Actiheart System 1 1 An Overview of the Actiheart System The Actiheart is a compact lightweight device that Records e Physical activity e Heart rate e Variability of R R Inter beat Interval IBI if a relevant recording mode is selected Calculates energy expenditure based on the activity and heart rate data Detects the presence of Obstructi
21. ed browse the CD and run the file SplashMenu exe Actiheart Guide to Getting Started 4 0 37 Apr 2010 6 2 3 Software amp Driver Installation 2 4 Installing the USB Drivers The software and driver installation requirements will differ for new users existing V2 xx users and existing V4 xx users Use the decision tree below to select the appropriate installation route Install USB Drivers Install Software See Section A Upgrade Install USB Drivers See Section 2 4 Upgrade Software from V2 xx Upgrade from earlier V4 xx This section applies to new installations and upgrades from V2 xx of the Actiheart Software Insert the supplied CD ROM into the CD DVD drive on the host PC and plug the Actiheart reader charger into a free USB Port Depending upon the operating system in use and the current driver status the computer may display a message saying Found New Hardware and will then load the drivers with no user intervention No further action will be required The Installation menu should be automatically displayed as shown below Install Actiheart Software Install Actiheart PC Software Install CamNtech USB Drivers Install USB drivers for the Actiheart and other CarNtech products H your hardware is not already recognised by windows use this option rou may not need to do this you have already installed Cambltech drivers on your computer Actiheart Guide to Getting Started 4
22. eesaeeseeeeeseeseceeesseaeeeeeessaaeeeeeessageeeees 24 Lo SONG Commens WITT the Dl E 25 7 4 Powering GOWN the Actiheart cccccssesccccccesssececcceeesececccaeuseceeceuaueeeeeseeeuseeeeeseaaseeeeesauaeceeessauaeceeessaaseceesssaaeeeeessaaageeess 25 7 5 Analysing the Signal e E E 26 8 0 Summary of Recording Reading and Analysis Options cccscecseeseeeseeseeeeeeeseeeensesenneesenseseeneesens 27 E RE Die Acivity and Heat Rate Coins EE 27 E Ee nOn TEn eC Ol GUNG ee eeeececSaeeeroseassuseecu seoneenesaeab attsnessianseeie Passones yest ee so qcenoouhat ores 27 Ores LONG PORT e re EE 27 Be fd SIG Mall OSE EE 27 8 2 Set up Energy Expenditure Options cccccccccccssseseeceeeeeeeaaeeseeeeeeeeeeseeaseeceeeeeeseueesseceeeeseseeeeaseeeeesessaaaaeeeeeeesseaeaseess 28 8 2 1 Daily Energy e En el EE 28 8 2 2 Advanced Energy EXP Ee TI 28 OS KE 28 9 24 Exercise TOST eei latte a saree ea RE betes ERER E E EEEE E EE EAEE 28 Ee e e ME RE WE 28 8 4 Analyzing the CAA E 29 8 5 Recording Options for Activity and Heart Rate cccccccccssssseeceeeeeeeeeeeeeeeeeeeeesaeeeeseeeeeeesssueeaeeeeeeeesseeeaaeeeeeeesssaaaasses 30 8 6 Recording Capability for ADVANCED Energy Expenditure nnnnannnnennnenennnontnnnsrnrrnsrrrrnrnrrrstrrrsrnrrrnnrernnnrrrsnreennnreene 30 8 7 Recording Capability for DAILY Energy Expenditure ccccseeccccceeeeeeceeeeeeeseeeeeeeeeeeeeseueeeesaaeeeesaaseeessaneeessaneeeesaaes 31 Actiheart Guid
23. for example when swimming can result in movement of water and the Actiheart which will result in noise on the ECG signal This can be avoided by covering the Actiheart unit completely with a swimsuit which will isolate movement over that area or large waterproof plaster or equivalent whilst swimming Actiheart Guide to Getting Started 4 0 37 Apr 2010 17 6 0 Setting up a User in the Database Once the subject has been fitted with ECG pads and before a recording is started it is necessary to set up the user in the selected database A user can be set up in any of the recording modes but prior to commencing a long term or short term recording it is recommended that the level of signal being picked up by the unit is checked by recording a short signal test so this is usually the most appropriate place to set up a new user Actiheart Software Version 4 0 6 Actiheart Software signal Test View or set up Activity amp Heart Rate 3 Daily EE View or set up Energy Expenditure Advanced EE step Test Utilities Serial number 9999 9919 L mo Yersion www_camntech com Click on the Signal Test button This brings up the screen shown below R Wave Signal Test User details User ID Sleeping HR H e Age Sex Enae Weight SM Height 7 BM jE 10 Second Activity and A wave display Signal levels R wave signal 46 6 C Noise level EI 17 05 Scan all 11 16 55 Display options al Tests available to vie
24. g the Software for the first time Double clicking on the Actiheart icon on the desktop will produce the following screen asking the user to input a serial number for the software Serial Number Registration mm E Enter your d digit serial number from the label on the CD Into this screen enter the 8 digit serial number that will have been supplied with the software on the front of the CD case This serial number is unique to the user and will enable the user to obtain software support from CamNtech Once this is done the software is ready to use Actiheart Guide to Getting Started 4 0 37 Apr 2010 10 3 0 Charging the Actiheart 3 1 Charging Actihearts from the PC Before the Actiheart can be used the user must ensure that it is fully charged The charging function is accessed in the Utilities tab in the software The Actiheart system is supplied with a combined reader charger that allows an Actiheart to be set up and read on one port and up to 3 Actihearts to be re charged During charging the reader charger unit may be powered from the host PC USB port or from the supplied mains adaptor IMPORTANT After an Actiheart is read it should be powered down and then recharged as soon as possible either for storage or for making a new recording Storage of the Actiheart with little or no charge will shorten battery life WARNING Charging an Actiheart will disable recording Recorded data will not be lost However any fur
25. heart 4 Welcome to the Actiheart 4 Setup Wizard gt The installer will quide you through the steps required to install Actiheart 4 on your computer Yo u m u st a cce pt t h e Li ce n si n g Ciok Next to continue agreement for use of the Actiheart software WARNING This computer program is protected by copyright law and international treaties Unauthorized duplication or distribution of this program or any portion of it may result in severe civil or criminal penalties and will be prosecuted to the maximum extent possible under the law Cancel i Actiheart 4 Select Installation Folder The installer will install Actiheart 4 in the following folder S e e ct t h e d e st i n a t i O n To install in this folder click Next To install to a different new or existing folder enter one below or click Browse folder or accept default Folder C Program Files Actiheart A You can install the software on the following drives recommended Volume Disk Size Sc 74GE 22 22661 lt J Cr Bean CG Actiheart 4 Confirm Installation The installer is ready to install Actiheart 4 on your computer Click Next to start the installation Cancel Previous H IMPORTANT The Actiheart V4 software will be installed in a folder labelled Actiheart 4 in C Program Files Any existing installation of V 2 x software will not be affected Actiheart Guide to Getting Started 4 0 37 Apr 2010 9 2 7 Usin
26. mntech com drivers htm Upon following the procedure described in Section 2 6 users upgrading older versions of software may be asked if they wish to repair or remove the existing version of the software when the new software installation is run for the first time The option to remove should be selected and then the software installation run for a second time to install the new version as described in Section 2 6 The following message may be displayed click Run to accept Open File Security Warning The publisher could not be verified Are you sure you want to run this software A Name Actiheart4 msi fe Publisher Unknown Publisher Type Windows Installer Package From C Documents and Settings Tom Evans tmp Always ask before opening this file This file does not have a valid digital signature that verifies its publisher ou should only run software from publishers you trust How can decide what software to run Actiheart Guide to Getting Started 4 0 37 Apr 2010 8 2 6 Installing the Software Insert the Actiheart CD which should automatically run the installation menu see Section 2 2 Select Install Actiheart PC Software from the menu and follow the on screen instructions as shown below If the installation menu is not shown use Windows explorer to browse to the CD and then double click on the file called Actiheart4 msi Follow the on screen instructions to complete the installation i Acti
27. nd then recharged as soon as soon as possible either for storage or for making a new recording Storage of the AH with little or no charge will shorten battery life lf a user tries to re read an Actiheart after it has been powered down the following message will be displayed Actiheart 4 This Actiheart was powered down after reading The data ts invalid To use this Actiheart it must be setup for a mew recording Actiheart Guide to Getting Started 4 0 37 Apr 2010 25 7 5 Analysing the Signal Quality Once the recording has been downloaded with the correct user ID and in the correct database it can be analysed for the quality of the signal Select the recording requiring analysis from the list of available recordings and click Scan all This will examine the recording in detail and the message shown below will then be displayed Actiheart 4 Any areas of the recording that have failed the test are displayed in red on the scan as shown in the screen below r R Wave Signal Test User details UserID Sleeping HR HE Age Sex Weight Height BM jE 10 Second Activity and A wave display Display options ECG Activity 2 Aug 2008 11 15 22 amp ug 2008 10 56 23 Jun 2008 16 06 234Jun 2008 16 06 11 4Jun 2008 11 22 S 11 4Jun 2008 11 22 DOUT D wave 114Jun 2008 11 22 WW Delete WR we It should normally be obvious from the recording why an area of the recording has failed for example due to movement a
28. nd updated software by looking on your computer on the hardware installation CD or on Can Windows connect to Windows Update to search for software Yes this time only Yes now and every time connect a device Gei No not this time Click Nest to continue Select No not this time and click Next Actiheart Guide to Getting Started 4 0 37 Apr 2010 36 Hardware Update Wizard This wizard helps you install software for Actiwave reader charger C H your hardware came with an installation CD lt or floppy disk insert it now What do you want the wizard to do Install the software automatically Recommended Click Next to continue Select Install from a list or specific location Advanced and click Next Hardware Update Wizard Please choose your search and installation options O Search for the best driver in these locations Use the check boxes below to limit or expand the default search which includes local paths and removable media The best driver found will be installed kasmi nero ree wT PTT oi Choose this option to select the device driver from a list Windows does not guarantee that the diver you choose will be the best match for your hardware Select Don t search will choose the driver to install and click Next The window on the next page should appear Sometimes windows will decide to display some other windows firs
29. rt term and long term recordings is installed in C Documents and Settings Username Actiheart Data Actiheart 4 The program is using the demonstration database Actiheartderma mdb The data in this database may be lost on any re installation For important data you must create a new database Do you wank to create your new database now The reason why the software recommends that a new database is created is that if in the future a new version or update of the software is installed this may overwrite any data stored in the demo database If Yes is selected at this point then the following screen is shown Look in 9 Actiheart data lal actiheartdb2 e En actiheartdema My Recent eh actiheartdemoz Documents Eh Actiheartdemod 4 eh ActiheartdemoS Mike Purday Desktop eh New database Mu Documents Mu Computer a File name vike Purday My Network Files of type Actiheart database mdb L Cancel Places Open as read only Actiheart Guide to Getting Started 4 0 37 Apr 2010 13 This new database will then be stored in the following folder C Documents and Settings Username Actiheart Data database name mdb When OK is selected the following screen is produced ee Actiheart Software Version 4 0 7 N Actiheart Software oignal Test Daily EE View or set up Energy Expenditure Advanced EE View or set up Activity amp Heart Rate Exercise Test
30. rtefacts If it is not obvious selecting the Display Activity box will show the activity trace recorded with the R wave and this may help the user identify if the problems have been caused by movement If a recording has failed overall this usually means that either the noise level is too high or the R wave is too low The following tests are applied to determine this 16 signal noise x 2 lt 7 signal noise gt 4 75 signal gt 9 6 but this is normally true anyway In either case it is necessary to check the position and impedance of the ECG pads For further details on the selection of ECG pads and skin preparation please see Section 5 of the Guide to Getting Started Actiheart Guide to Getting Started 4 0 37 Apr 2010 26 8 0 Summary of Recording Reading and Analysis Options Once a Signal Test has been successfully completed the collection of data can then commence It is important to choose the recording mode taking into account a Type of data required Activity and average heart rate are always recorded but the Interbeat Interval IBI is not b The recording resolution epoch which is fixed in some modes and selectable in others c The duration of the recording which is dependent on both a and b see table below d The type of analysis required 8 1 Set up Activity and Heart Rate Options Recording can be set up for one of two main objectives namely Activity Heart rate and Energy Expenditure 8
31. step test and can be used for individual calibration 8 2 4 Exercise Test Activity and R wave waveform recording for 53 minutes and can be analysed for other exercise tests such as walking running rowing etc 8 3 Reading the Data Data can be downloaded from the Actiheart using the read button from any of the above set up screens or from the utilities menu Note however that the mode of set up determines which analysis can be performed upon the data Actiheart Guide to Getting Started 4 0 37 Apr 2010 28 8 4 Analyzing the data IBF files can be analysed using Short Term Recording or Advanced Energy Expenditure Normal files can be analysed using Long Term Recording or Advanced Energy Expenditure Variability files can be analysed using Long Term Recording or Advanced Energy Expenditure or Daily Energy Expenditure The following flow chart and tables summarise the various recording and analysis capabilities mentioned ENERGY EXPENDITURE SLEEP ANAL YSIS SET UP ACTIVITY amp SET UP SLEEP SET UP ENERGY HEART RATE ANALYSIS EXPENDITURE optional Daily Living IBI Logging IBF File 15 second 29 Actiheart Guide to Getting Started 4 0 37 Apr 2010 8 5 Recording Options for Activity and Heart Rate Epoch 15 sec 30 sec 1 min 8 6 Recording Capability for ADVANCED Energy Expenditure Epoch 15 sec 30 sec 1 min SHORT TERM With IBI
32. t possibly appearing to lock up for a minute or two at one point If it does this you may be forced to choose a device category Choose any and look out for the Have Disk button next which you must find in order to proceed Actiheart Guide to Getting Started 4 0 37 Apr 2010 37 Hardware Update Wizard Select the device driver you want to install for this hardware Select the manufacturer and model of your hardware device and then click Next H you have a disk that contains the driver you want to install click Have Disk Actiwave reader changer Version 2 4 6 0 13 03 2008 Actiwave reader changer Version 7 4 6 0 13 03 2008 Actiwave reader changer Version 3 1 2 0 01 12 2005 Actiwave reader changer Version 3 1 2 0 01 12 2005 EE digitally signed ortant ity This driver is not hy driver signing is im Tell me Ignore the items in the list and click Have Disk instead Install From Disk Insert the manufacturer s installation disk and then make sure that the correct drive is selected below Click on Browse and then use the standard file window to find the USB drivers folder on the CD Select ftdibus inf from this folder and click on Open The window above will re appear with a filename at the bottom Then click Ok Hardware Update Wizard Select the device driver you want to install for this hardware ae SS Select the manufacturer and model of yo
33. ta and the screen below is shown Actiheart Read User ID FirstUser_R wave Senal No Battery olts 2 550 Recording Started at 29 Aug 2008 14 13 to 29 Aug 2008 14 13 Achheart ready for reading Actiheart Guide to Getting Started 4 0 37 Apr 2010 24 The data recorded on the Actiheart is then downloaded to the PC via the Reader USB interface Download progress is indicated by means of the yellow progress bar Once this is finished the following screen is shown 7 3 Storing Comments with the Data Comments stored along with this recor E This allows the user to add comments on the recording which will be stored along with the data This could be for example the type of ECG pads that were used for the recording etc Once any comment required is entered into this screen pressing finish saves the data into the selected database and produces the following message 7 4 Powering down the Actiheart Power Down Actiheart IF you want to stop making recordings the Actheart unit should be powered down and recharged Storage of the 4H without powernng down and recharging will shorten battery lite Powering down will make the data unreadable We recommend that you quickly view your recording before clicking on the button below to power dowr Selecting Power Down Actiheart will power down the Actiheart and the data stored in the unit will then become unreadable After an Actiheart is read it should be powered down a
34. ther recording will require a new setup to be initiated When Actihearts are to be charged from the PC select Utilities from the main screen then select the Recharge Actiheart button A screen similar to that shown below will be displayed Actiheart Multiple Battery Charge CHARGE ONLY The Actiheart uses a lithium rechargeable battery The maximum charging voltage is about 3V The normal operating voltage is about Z DV A rapid drop to this 2 5 level is normal To charge fully wait until the Actiheart symbol above stops flashing red green for a few minutes If no Actinearts are placed on the Reader charger the display will show Searching for Actinearts As an Actiheart is placed in each location it will be detected and the battery status will be displayed The battery gauge provides an estimated indication of battery charge level remaining charge time with the following interpretation Actiheart Guide to Getting Started 4 0 37 Apr 2010 11 3 2 Charging the Actiheart using the Mains Power Supply a SS eS The coloured bands in the gauge represent the voltage level in the Actiheart and correspond to the very approximate voltages and estimated charging times as follows Voltage Colour Expected charging time lt 2 3 None No Actiheart detected 12 hours 2 3 2 4 Red 4 to 8 hours 2 4 2 6 Orange 2 to 4 hours 2 6 2 75 Green 1 to 2 hours 2 75 2 9V Upper Green Charged The Actiheart uses a lithium rech
35. tric use Unomedical Unilect Long Term 4060M These are similar to the 4620M but larger in size They have a raised section of the backing plastic that is designed for use in skin preparation Bio Protech ECG electrode E5 Tele815 These are very similar in construction to the Unilect Long Term 4060M pads They also appear to be good value financially In all cases adequate skin preparation is vital to the success of any recording The R wave signal that the Actiheart requires is usually low and adequate skin preparation is required to ensure that the levels captured by the device are high enough and consequently that noise levels are low enough for a good quality recording The purpose of skin preparation is to remove the top layer of the skin the Stratum Corneum and to scratch the surface of the next layer of skin down the Stratum Granulosum The recommended skin preparation procedure Is as follows Actiheart Guide to Getting Started 4 0 37 Apr 2010 15 5 3 Electrode Positioning Procedure for Skin Preparation Clean the skin to ensure that it is clean and oil free This can easily be achieved by using warm water and soap or other detergent Alcohol should not be used as this can potentially cause skin irritation which needs to be avoided Use an abrasive material to remove the top layer of skin The ideal preparation material is a Cardio prep which is similar to very fine emery paper One that CNT has tried with success is the Car
36. ur hardware device and then click Next If you Gen have a disk that contains the driver you want to install click Have Disk Show compatible hardware Model Actiwave reader charger A This driver is not digitally signed Tell me why driver signing is important Actiheart Guide to Getting Started 4 0 37 Apr 2010 38 You can now select the correct driver in the list and click Next Depending on your system settings the window below may appear Hardware Installation The software you are installing for this hardware Actiwave reader charger has not passed Windows Logo testing to verify its compatibility with Windows XP Tell me why this testing is important Continuing your installation of this software may impair or destabilize the correct operation of your system ther i fiat Mi ft strongly If this window appears click Continue Anyway The underlying drivers are in fact tested and approved by Microsoft but the certification is invalidated when they are configured to match our reader devices Hardware Update Wizard Completing the Hardware Update Wizard The wizard has finished installing the software for S Actiwave reader charger Click Finish to clase the wizard Finish When this window appears your drivers are installed If you still have issues installing the USB drivers then please check our website for up to date information at the link below http www camntech com dri
37. ve Sleep Apnoea and identifies Sleep Stages for research purposes only The Actiheart system consists of 4 components e Actiheart e Actiheart Reader Charger e Actiheart Analysis Software For up to date pricing and availability of these components please contact CamNtech The Actiheart clips onto a single standard ECG electrode with a short ECG lead to another electrode that picks up the ECG signal It is normally worn on the upper or lower chest It is comfortable to wear continuously for long periods of time and is the first truly lightweight and waterproof self contained logging device which allows physical activity to be correlated with heart rate and energy expenditure to be calculated from both The Actiheart contains a rechargeable battery providing up to 21 days of continuous operation It is easily recharged via the purpose built interface that links to a computer USB port or via a 3 unit mains multi charger The Actiheart simply clips on to the two 4mm studs on the interface The same interface is used for downloading data to a PC where the data is analysed using the Actiheart software The Actiheart has a red LED on the front which flashes with a frequency that depends on the recording mode selected see table below for further details on the recording modes please see Section 8 1 on recording modes Epoch Flashing Frequency Short Term Long Term Advanced EE Daily Living Step Test 15 sec with IBI Every beat __
38. vers htm Actiheart Guide to Getting Started 4 0 37 Apr 2010 39
39. w Actiheart monitor 99901 D wave 22 ug 2008 11 15 Setup 99901_A wave 22 4ug 2008 10 56 FirstUser_Exercise010201 23 Jun 2008 16 06 FirstUser_Exercise010201 23 Jun 2008 16 06 99901_R wave 11 Jun 2008 11 22 Reports and export 99901_A wave 11Jun 2008 11 22 199901 H wave 11 Jun 2008 11 22 Print Copy info _Preview Actiheart Guide to Getting Started 4 0 37 Apr 2010 18 Clicking the Setup button produces the following screen 5 Find or Add a User What do you want to do Find An Existing User Find Create a New User C Users garnungless 4 ppD ata ctiheart data4 cthheartdemo mdb Clicking Find allows the settings for an existing user to be retrieved Clicking Add New allows the details for a new user to be added 6 1 Selecting an existing User from the Database If the user is already present in the selected database selecting Find will produce the following screen Locate an Existing User Weight Height IR az The required user can now be selected from the list and the recording can be set up as detailed in Section 7 Actiheart Guide to Getting Started 4 0 37 Apr 2010 19 6 2 Setting up a new User If a new user is being set up selecting Add New produces the following screen Add New User Personal Details Enter the New User ID Date of Birth and Sex The user ID date of birth and sex are entered in this screen Selecting
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