The Actiheart Guide to Getting Started Ver 4.0.40 Feb 2013

Regulatory Information Medical Devices Directive (EU) The Actiheart is a Class 2a Medical Device conforming to the essential safety & health requirements and provisions of EC Council Directives 93/42/EEC, Annex V. CamNtech Ltd has been assessed and certified as meeting the requirements of the above directive by SGS United Kingdom Ltd, Notified body number 0120 (Certificate number GB06/67703). FDA 510(k) Clearance (USA) The Actiheart has been cleared by the FDA as a Class II device for prescription use. The Actiheart is indicated for use as an ambulatory heart rate and activity recorder. Actiheart may be used to quantifiably measure Heart Rate, Activity, and estimates of caloric expenditure. This device is not intended for use as an ECG monitor. The Actiheart has product code GWK and 510(k) number K052489. Manufacturer: For assistance with set-up, use or maintenance of the Actiheart or to report any unexpected operation or events, please contact CamNtech using the details below or contact your local representative.

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

EN60601-1:2006

Medical electrical equipment – Part 1: General requirements for basic safety & essential performance [including applicable collateral standards]

EN60601-1-2:2002

Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests. See section Appendix 1 for declaration and guidance

EN62304:2006

Medical device software – Software life-cycle processes

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IMPORTANT SAFETY INFORMATION WARNINGS  Contains Lithium Battery – DO NOT ATTEMPT TO DISSASEMBLE: No user serviceable parts, danger of chemical hazard if battery is damaged.  Not Defibrillation proof.  Not indicated for use on areas of broken, damaged or irritated skin.  Devices removed from subjects must be considered to be contaminated – see Appendix 1. Safety Classification Information:  The Actiheart is INTERNALLY POWERED EQUIPMENT.  The Actiheart mode of operation is CONTINUOUS OPERATION. Device and Packaging Symbols and Markings:

MEANING

SYMBOL

DESCRIPTION

General Warning

Potential hazard -refer to the warnings in the instructions for use (i.e. this user guide).

Consult Instructions for Use

This symbol indicates that important operational information is contained in the user instructions (i.e. this user guide).

Ingress Protection Rating

IPX7

The Actiheart is suitable for temporary immersion in water (up to 1 hour at 1m).

Serial Number

SN

This number provides a unique identification for a particular device. Always quote this number when seeking technical assistance.

REF

This number identifies this particular variant of the product range.

Catalogue Number

Manufacturer and Date of Manufacture

Electrical Safety Classification

This symbol is accompanied by a date in the format yyyymm which indicates when the device was manufactured. The symbol is also accompanied by the address and contact details of the manufacturer The Actiheart is a TYPE B APPLIED PART.

FOR FURTHER HANDLING & ENVIRONMENTAL INFORMATION PLEASE REFER TO APPENDIX 1

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Contents Regulatory Information ... 2 Medical Devices Directive (EU)... 2 FDA 510(k) Clearance (USA)... 2 Manufacturer: ... 2 Applicable Standards: ... 2

IMPORTANT SAFETY INFORMATION ... 3 WARNINGS... 3 Safety Classification Information: ... 3 Device and Packaging Symbols and Markings: ... 3

1. Introduction to the Actiheart System ... 6 1.1 Overview ... 6 1.2 Intended Use ... 6 1.3 Contraindications ... 6 1.4 Required Skills, Training & Knowledge of Intended Users. ... 6 1.5 General Description of Use ... 6

2. Installing the Actiheart Software ... 8 2.1 System Requirements ... 8 2.2 Software Installation Menu ... 8 2.3 Software & Driver Installation ... 9 2.4 Installing the USB Drivers ... 9 2.5 Users upgrading from an earlier version of Actiheart Software ... 10 2.6 Installing the Software ... 11 2.7 Using the Software for the first time ... 12

3.0 Charging the Actiheart ... 13 3.1 Charging Actihearts from the PC ... 13 3.2 Testing the Actiheart Battery ... 14 3.3 Charging the Actiheart using the Mains Power Supply... 15

4.0 Setting up a Database ... 16 4.1 Reason for the Creation of a new Database ... 16

5.0 Preparing for a Recording... 18 5.1 Selection of appropriate ECG Pads and Preparation of the Skin ... 18 5.2 Skin Preparation ... 18 5.3 Electrode Positioning ... 19 5.4 Positioning of the Actiheart ... 20 5.5 Use of the Actiheart in Water ... 20

6.0 Setting up a User in the Database ... 21 6.1 Selecting an existing User from the Database ... 22 6.2 Setting up a new User ... 23

7.0 Checking Signal Integrity and Performing a Test Recording ... 25 7.1 How to set up a Signal Test ... 25 7.2 Downloading recorded Data from the Actiheart ... 27 7.3 Storing Comments with the Data ... 28 7.4 Powering down the Actiheart ... 28 7.5 Analysing the Signal Quality ... 29

8.0 Summary of Recording, Reading and Analysis Options ... 30 8.1 Set-up Activity and Heart Rate Options ... 30 8.1.1 Short Term Recording ... 30 8.1.2 Long Term Recording ... 30 8.1.3 Signal Test ... 30

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8.2 Set-up Energy Expenditure Options ... 31 8.2.1 Daily Energy Expenditure... 31 8.2.2 Advanced Energy Expenditure ... 31 8.2.3 Step Test ... 31 8.2.4 Exercise Test ... 31 8.3 Reading the Data ... 31 8.4 Analyzing the data ... 32 8.5 Recording Options for Activity and Heart Rate ... 33 8.6 Recording Capability for ADVANCED Energy Expenditure ... 33 8.7 Recording Capability for DAILY Energy Expenditure ... 34

Appendix 1 - Handling & Environmental Information ... 35 A1.1 Decontamination ... 35 A1.2 Battery Care ... 35 A1.3 Disposal ... 35 A1.4 ENVIRONMENTAL ... 36 A1.5 EMC Guidance & Declaration ... 36 A1.5.1 Electromagnetic Emissions ... 36 A1.5.2 Electromagnetic Immunity ... 37

Appendix 2 – Troubleshooting ... 39 Appendix 3 – Installing USB Drivers Manually ... 40 To begin installing drivers: ... 40

IMPORTANT BATTERY CARE INFORMATION! The Actiheart device contains a miniature rechargeable battery which must be cared for correctly to maximise service life. Observing the following points will ensure maximum service life of the battery:  

Following download of data, always fully re-charge the Actiheart. Following a full re-charge, ensure the device is ‘powered down’ (this will delete any data).

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1. Introduction to the Actiheart System 1.1 Overview The Actiheart is a compact lightweight device that: a. Records:

  

Heart Rate Physical activity 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.

An Actiheart system consists of 3 components:

  

The Actiheart device Actiheart Reader/Charger (USB connection for configuration & charging) Actiheart Analysis Software

1.2 Intended Use The Actiheart is a medical device that is intended to be used for human beings to assist in the diagnosis, prevention, monitoring, treatment or alleviation of disease or disorder. Typical applications are in sports and exercise science, obesity and lifestyle studies, stress monitoring, sleep medicine and research. 1.3 Contraindications The Actiheart is indicated for use on healthy, undamaged areas of skin. Where the patient has a history of skin irritation, a sample ECG electrode should be tested for skin irritation prior to commencing any recording. 1.4 Required Skills, Training & Knowledge of Intended Users. It is intended that the device be administered only by duly qualified health care professionals, researchers and or trained nursing staff, mainly in a hospital environment. 1.5 General Description of Use The Actiheart measures the small electrical activity of the heart by means of two self-adhesive electrodes (not supplied by CNT) placed upon the chest of the patient. This Electrocardiogram (ECG) signal is processed within the Actiheart and, dependent upon storage mode selected, a full waveform, heart rate, Inter-Beat Interval (IBI) or a combination thereof are stored within an internal non-volatile memory.

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The Actiheart is typically worn by the patient during their normal daily activities over a period of up to 21 days thus providing a benefit over lab based ECG tests which only provide a short ‘snapshot’ of heart activity. Furthermore the Actiheart contains a miniature accelerometer to allow measurement and recording of physical movement of the body. These data may be recorded synchronously with the ECG derived data thus providing a further insight into the physical condition of the patient.

The Actiheart has an LED indicator 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 3 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. 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 are required to 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 charg e 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. IMPORTANT NOTES ABOUT USB CHARGING:   

Many Computers have power saving functions which shut down all or part of the PC after a period of time – this will stop the charging of the Actiheart. Un-powered USB hubs can have an output voltage below that required for Actiheart charging. For reliable charging of the Actiheart, CamNtech recommend using the supplied mains power supply (see 3.3 below).

3.2 Testing the Actiheart Battery It is possible to test the capacity of the Actiheart battery to determine the maximum length of recording. As with all rechargeable batteries, the Actiheart battery capacity will reduce with age/usage. To test the battery, first fully charge the Actiheart overnight using the mains power supply (see section 3.3 below). Place the Actiheart onto the reader and click ‘utilities’ then ‘test & maintenance’. Click on the battery test tab and then click the ‘run full battery test’ button. Note that this will take several hours to complete and that the Actiheart software cannot be used during this period. At the end of the test the following message will be shown: “Estimated battery level was nnn% of nominal capacity.” Where ‘nnn’ is a number from 0 to 100% and 21 days is the nominal capacity. The Actiheart should be fully recharged overnight using the mains adaptor following the battery test (see section 3.3 below).

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3.3 Charging the Actiheart using the Mains Power Supply The Actiheart Reader/Charger is supplied with a 5V USB mains power adaptor which is safety approved to EN60950-1 and EMI standard EN55022 (also FCC part 15, Class B). This adaptor is supplied with appropriate adaptors to suit mains outlets in most world regions.

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 USB type A socket on the mains power supply. 3. Plug the mains power supply into the wall outlet. 4. Place Actihearts onto Reader/charger. 5. The status LED will remain red while the Actiheart is charging. 6. The status LED will turn green when charging is completed. 7. 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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