The Actiheart Guide to Getting Started Ver 4.0.25 Feb 2009

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.

0120

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

Applicable Standards: EN60601-1:2001

Medical electrical equipment – 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.

Note: For safety and

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. handling advice please refer to Section 9

Contents

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1 Introduction to the Actiheart System...4 1.1 An Overview of the Actiheart System...4 2 Installing the Software...5 2.1 System Requirements ...5 2.2 New Users ...5 2.3 Existing Users...5 2.4 Installing the Drivers - New Users...6 2.5 Installing the Software...10 2.6 Using the Software for the first time...13 2.7 Selection of the correct Communications Port...14 3 Charging the Actiheart...15 3.1 Charging the Actiheart from the PC...15 3.2 Normal Operating Voltages...15 3.3 Charging the Actiheart using the Mains Power Supply ...16 Setting up a Database...17 3.4 Reason for the Creation of a new Database...17 4 Preparing for a Recording...19 4.1 Selection of appropriate ECG Pads and Preparation of the Skin...19 Range of Pads...19 Short Term Recording Pads...19 Long Term Recording Pads...19 4.2 Skin Preparation...19 Procedure for Skin Preparation ...20 4.3 Electrode Positioning...20 4.4 Positioning of the Actiheart ...21 4.5 Use of the Actiheart in Water...22 5 Setting up a User in the Database...23 5.1 Selecting an existing User from the Database...24 5.2 Setting up a new User...25 6 Checking Signal Integrity and Performing a Test Recording...27 6.1 How to set up a Signal Test ...27 6.2 Downloading recorded Data from the Actiheart...29 6.3 Storing Comments with the Data 30 6.4 Powering down the Actiheart ...31 7 Summary of Recording, Reading and Analysis Options...32 7.1 Recording...32 Activity and Heart Rate options...32 The Energy Expenditure options...33 7.2 Reading the Data...34 7.3 Analysis...34 1.1 Recording Options for Activity and Heart Rate...36 1.2 Recording Capability for Energy Expenditure...36 8 Safety and Handling Information...37 1.3 Decontamination...37 1.4 Battery...37 1.5 Water Ingress...37 1.6 Warnings – general...37 1.7 Disposal...37

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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 Interbeat 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 (Optional Add-in for research purposes only) The Actiheart system consists of 4 components: • • • •

Actiheart Actiheart Reader Actiheart Analysis Software Optional 3-unit Multi-charger

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

Short Term Every beat -------------

---------------------

Long Term ------------Every 15 sec Every 30 sec Every 30 sec

Flashing Frequency Advanced EE Daily Living Every beat Every 15 sec ------------Every 30 sec -------------Every 30 sec Every 30 sec

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Step Test -----------------------

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2 Installing the 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 2000, NT or XP 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) In general, a faster processor will provide superior performance. 2.2

New Users

Please install the drivers as described in Section 2.4 before attempting a software installation as described in Section 2.5. 2.3

Existing Users

The section on installing drivers does not apply.  



If you have already installed USB drivers previously, go directly to Section 2.5. 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 CD ROM is run for the first time. The option to remove should be selected and then the software CD run for a second time to install the new version as described in Section 2.5. The following message may be displayed – click ‘Run’ to accept.

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2.4

Installing the Drivers - New Users

Insert the supplied CD ROM into the CD/DVD drive on the host PC and plug the USB Reader into a free USB Port. The computer will display a message saying ‘Found New Hardware USB-Serial’ and the following screen will then be displayed:

Select ‘No, not this time’ and click on ‘Next’. The following screen will be shown:

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Make sure that the supplied CD ROM is in the drive, select ‘Install from a list or specific location (Advanced)’ and click ‘Next’.

Select ‘Don’t search. I will choose the driver to install.’ and click ‘Next’. The window below should appear. Sometimes, windows will decide to display some other windows first, possibly appearing to lock up for a minute or two at one point. If

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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.

Ignore the items in the list, and click ‘Have Disk…’ instead.

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’.

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You can now select the correct driver in the list and click ‘Next’. Depending on your system settings, the window below may appear.

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.

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When this window appears your drivers are installed. The Actiheart reader requires two sets of drivers which work together, so it may appear to begin the whole procedure again after you click ‘Finish’ here. You should follow through in exactly the same way again. It will not happen a third time – there are simply two sets of drivers. 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

Installing the Software

Once the hardware is installed, select ‘My Computer’ from the Start menu on the host PC. Select the drive which contains the CD with the software on. This is typically either the D drive or E drive. Double click on the Actiheart software folder which will bring up the following screen:

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Then double click on the Installation file called ‘Actiheart4.msi’. The following screen will be displayed:

Follow the on screen prompts through the following screens:

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Please note the copyright warning. By accepting this, the user is accepting the CNT terms and conditions of use of the Actiheart software. Again select ‘Next’.

Click ‘Next’ to accept the default folder.

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This will then install the Actiheart software in the selected file destination. It will also create an Actiheart software icon on the desktop. 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.

2.6

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

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enable the user to obtain software support from CamNtech. Once this is done, the software is ready to use. 2.7

Selection of the correct Communications Port

The first time that the software is used, the correct communications port for the Reader will automatically be set and a screen will be shown saying that this has been done. Which port is selected will depend on the number of other USB and serial port devices connected to the host PC.

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3 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. It is possible to charge the Actiheart from the Reader or from a separate 3-unit charger. The Reader can be powered either from the PC, or from an optional separate power supply. The same power supply is used for the 3-unit charger. The advantage of the 3-unit charger and the separate power supply for the Reader are that they are mains powered and do not rely on power being available from the host PC. 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 the Actiheart from the PC

When the Actiheart is to be charged from the PC, ensure that the Actiheart is on the Reader and select ‘Charge’ from the Utilities menu. The screen shown below will be displayed:

3.2

Normal Operating Voltages

The coloured blocks 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 2.4-2.5 2.5-2.6 2.6-2.75

None Red Orange 1 Orange 2 Green 1

12 hours 8 hours 4 hours 2 hours 1 hour

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2.75-3.0V

Green 2

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.

VOLTS

ACTIHEART DISCHARGE CURVE IN LONG TERM RECORDING MODE 3 2.9 2.8 2.7 2.6 2.5 2.4 2.3 2.2 2.1 2

Series1

3

2.56

2.57

2.5 2.42

2.4 2.38

0

2

4

6

8

10

12

14

16

18

20

DAYS

3.3

Charging the Actiheart using the Mains Power Supply

1. Select and fit appropriate ac input adaptor for country of use. 2. The power supply is fitted with the correct power plug to suit the AH charger. 3. Plug cable into USB Reader or the multi-charger. 4. Place Actiheart on Reader or multi-charger. 5. When the Actiheart is on the Reader the red LED doesn’t flash whilst the AH is charging and it flashes when the unit is fully charged. 6. When the Actiheart is on the multi-charger the LED is red during charging and turns to green when charging is completed.

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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.

3.4

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 ActiheartDemo database first installed will not be overwritten when a later version is installed.

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4 Preparing for a Recording 4.1

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. 4.2

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: 4.3

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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