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The Actiheart Guide to Getting Started Document Reference: Issue Version: Issue Date:
30072 4.0.37 27/04/2010
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)
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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. 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: 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: 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 9 Actiheart Guide to Getting Started 4.0.37 (Apr 2010)
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Contents The Actiheart ... 1 Guide to Getting Started ... 1 Document Reference: 30072 ... 1 The Actiheart is a Class 2a Medical Device (EU) ... 1 1. Introduction to the Actiheart System ... 5 1.1 An Overview of the Actiheart System ... 5
2. Installing the Actiheart Software ... 6 2.1 System Requirements ... 6 2.2 Software Installation Menu ... 6 2.3 Software & Driver Installation ... 7 2.4 Installing the USB Drivers ... 7 2.5 Users upgrading from an earlier version of Actiheart Software ... 8 2.6 Installing the Software ... 9 2.7 Using the Software for the first time ... 10
3.0 Charging the Actiheart ... 11 3.1 Charging Actihearts from the PC ... 11 3.2 Charging the Actiheart using the Mains Power Supply ... 12
4.0 Setting up a Database ... 13 4.1 Reason for the Creation of a new Database ... 13
5.0 Preparing for a Recording... 15 5.1 Selection of appropriate ECG Pads and Preparation of the Skin ... 15 5.2 Skin Preparation ... 15 5.3 Electrode Positioning ... 16 5.4 Positioning of the Actiheart ... 17 5.5 Use of the Actiheart in Water ... 17
6.0 Setting up a User in the Database ... 18 6.1 Selecting an existing User from the Database ... 19 6.2 Setting up a new User ... 20
7.0 Checking Signal Integrity and Performing a Test Recording ... 22 7.1 How to set up a Signal Test ... 22 7.2 Downloading recorded Data from the Actiheart ... 24 7.3 Storing Comments with the Data ... 25 7.4 Powering down the Actiheart ... 25 7.5 Analysing the Signal Quality ... 26
8.0 Summary of Recording, Reading and Analysis Options ... 27 8.1 Set-up Activity and Heart Rate Options ... 27 8.1.1 Short Term Recording ... 27 8.1.2 Long Term Recording ... 27 8.1.3 Signal Test ... 27 8.2 Set-up Energy Expenditure Options ... 28 8.2.1 Daily Energy Expenditure... 28 8.2.2 Advanced Energy Expenditure ... 28 8.2.3 Step Test ... 28 8.2.4 Exercise Test ... 28 8.3 Reading the Data ... 28 8.4 Analyzing the data ... 29 8.5 Recording Options for Activity and Heart Rate ... 30 8.6 Recording Capability for ADVANCED Energy Expenditure ... 30 8.7 Recording Capability for DAILY Energy Expenditure ... 31
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9.0 Safety and Handling Information ... 32 9.1 Decontamination ... 32 9.2 Battery ... 32 9.3 Water Ingress ... 32 9.4 Warnings – general ... 32 9.5 Disposal... 32 9.6 Symbols used for marking devices & packaging ... 32 9.6.1 Serial Number ... 33 9.6.2 Catalogue Number ... 33 9.6.3 Manufacturer & Date of manufacture ... 33 9.6.4 Consult instructions for use ... 33 9.7 EMC Guidance & Declaration ... 34 9.7.1 Electromagnetic Emissions ... 34 9.7.2 Electromagnetic Immunity ... 35
Appendix A – Installing USB Drivers Manually ... 36 To begin installing drivers: ... 36
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1. Introduction to the Actiheart System 1.1 An Overview of the Actiheart System The Actiheart is a compact lightweight device that: a. Records:
Physical activity Heart rate Variability of R-R Inter-beat Interval (IBI) if a relevant recording mode is selected
b. Calculates energy expenditure based on the activity and heart rate data. c. Detects the presence of Obstructive Sleep Apnoea and identifies Sleep Stages (for research purposes only) The Actiheart system consists of 4 components:
Actiheart Actiheart Reader/Charger 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 15 sec with IBI 15 sec 30 sec 60 sec
Flashing Frequency Short Term Every beat -------------
---------------------
Long Term ------------Every 15 sec Every 30 sec
Advanced EE Every beat Every 15 sec Every 30 sec
Daily Living
Step Test
--------------------------
-----------------------
Every 30 sec
Every 30 sec
Every 30 sec
-----------
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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:
IBM compatible 300Mhz + Windows XP, Vista or Windows 7 operating system 100 MB hard disk space USB port A CD-ROM drive or equivalent Graphics (800 x 600 pixels minimum) 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:
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 displayed, browse the CD and run the file „SplashMenu.exe‟.
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2.3 Software & Driver Installation 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.
New User?
Y
Install USB Drivers: See Section 2.4
Install Software:
Install USB Drivers: See Section 2.4
Upgrade Software:
See Section 2.6
N
Upgrade from V2.xx?
Y
See Section 2.5
N Upgrade from earlier V4.xx
2.4 Installing the USB Drivers 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:
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If 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://www.camntech.com/drivers.htm. 2.5 Users upgrading from an earlier version of Actiheart Software 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.
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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 onscreen 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.
You must accept the Licensing agreement for use of the Actiheart software
Select the destination folder or accept default (recommended).
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.
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2.7 Using 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:
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.
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3.0 Charging the Actiheart 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 further recording will require a new setup to be initiated. 3.1 Charging Actihearts from the PC 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:
If no Actihearts are placed on the Reader/charger the display will show – „Searching for Actihearts‟. 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:
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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
<2.3 2.3-2.4 2.4-2.6 2.6-2.75 2.75-2.9V
None (No Actiheart detected) Red Orange Green Upper Green
12 hours 4 to 8 hours 2 to 4 hours 1 to 2 hours Charged
The Actiheart uses a lithium rechargeable 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.
3.2 Charging the Actiheart using the Mains Power Supply
1. Select and fit appropriate ac input socket adaptor for country of use. 2. Plug the USB cable from the reader/charger directly into the socket on the mains power supply. 3. Place Actihearts onto Reader/charger. 4. The status LED will remain red while the Actiheart is charging. 5. The status LED will turn green when charging is completed. 6. 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.
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4.0 Setting up a 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 FilesActiheart. 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 short term and long term recordings is installed in C:Documents and Settings‘Username’Actiheart Data.
4.1 Reason for the Creation of a new Database 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:
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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:
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.
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5.0 Preparing for a Recording 5.1 Selection of appropriate ECG Pads and Preparation of the Skin 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 paediatric 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.
5.2 Skin Preparation 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:
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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 Cardio 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: 5.3 Electrode Positioning 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.1 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. 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.
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5.4 Positioning of the Actiheart For good accurate measurement of activity the Actiheart 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
Fig A
Measured Acceleration = A Cos a Angle a
Tilt = a
Fig B
A = Actual Vertical Acceleration
For more information about the implications of electrode placement on physical activity estimates please refer to: Søren Brage, Niels Brage, Ulf Ekelund, Jian’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/s00421-005-0112-6.
5.5 Use of the Actiheart in Water Although the Actiheart is waterproof, use in the water, 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.
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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.
Click on the „Signal Test‟ button. This brings up the screen shown below:
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Clicking the ‘Setup’ button produces the following screen:
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:
The required user can now be selected from the list and the recording can be set up as detailed in Section 7.
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6.2 Setting up a new User If a new user is being set up, selecting „Add New‟ produces the following screen:
The user ID, date of birth and sex are entered in this screen. Selecting „Next‟ produces the following screen:
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:
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