CamNtech MotionWatch 8, MotionWare User Manual

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The MotionWatch 8 and MotionWare
User Guide
Document Reference: 30147 Version: 1.2.1 Date of current version: 30/03/2017
The MotionWatch is a Class I Medical Device (EU)
Document revision history located at end of document
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MotionWatch Regulatory Information
Medical Device Directive (European Union)
The MotionWatch is a Class I Medical Device conforming to the essential safety & health requirements and provisions of EC Council Directives 93/42/EEC, Annex VII. An EC declaration of Conformity will be provided upon request.
US FDA status
The MotionWatch is FDA cleared for prescription use only with FDA
510(k) number K132764.
Health Canada
The MotionWatch is licensed for clinical use in Canada with HC license number 94219.
Australian TGA
The MotionWatch has been cleared by the Australian TGA and is listed on the ARTG with ref no: 219452
Australian Sponsor: Please note that the sponsor should be contacted ONLY to report adverse events – all sales and support issues must be directed to CamNtech in the UK.
Emergo Australia Level 20 Tower II, Darling Park 201 Sussex Street Sydney, NSW 2000 Australia
Manufacturer:
CamNtech Ltd Upper Pendrill Court Papworth Everard Cambridgeshire CB23 3UY, UK
Tel: 01480 831223 Fax: 01480 831733 Email: technical@camntech.co.uk Web: www.camntech.co.uk
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IMPORTANT SAFETY INFORMATION
WARNINGS
Coin cell battery – potential swallowing hazard for small
children!
Not Defibrillation proof. Not indicated for use on areas of broken or irritated skin. Devices removed from subjects must be considered to be
contaminated – see APPENDIX C.
Safety Classification Information:
 MotionWatch is INTERNALLY POWERED EQUIPMENT.  MotionWatch mode of operation is CONTINUOUS OPERATION.
MotionWatch is for PRESCRIPTION USE ONLY (R
x
Only) - USA.
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 MotionWatch is suitable for temporary immersion in water (up to 1 hour at 1m).
Serial Number
This number provides a unique identification for a particular device. Always quote this number when seeking technical assistance.
Catalogue Number
This number identifies this particular variant of the product range.
Manufacturer and 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 details of the manufacturer
Electrical Safety
Classification
The MotionWatch is a TYPE B APPLIED PART.
FOR FURTHER HANDLING & ENVIRONMENTAL INFORMATION PLEASE
REFER TO APPENDIX C
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Contents
IMPORTANT SAFETY INFORMATION .................................................................... 3
WARNINGS ....................................................................................................... 3
Safety Classification Information: ............................................................... 3
Device and Packaging Symbols and Markings: .......................................... 3
1 Introduction to the MotionWatch System ....................................................... 8
1.1 An Overview of the MotionWatch System .................................................. 8
Components Required for a System .......................................................... 8
The MotionWatch ....................................................................................... 8
Opening the MotionWatch Casing .............................................................. 9
Closing the MotionWatch Casing ............................................................. 10
1.2 Indications For Use .................................................................................. 10
1.3 Contraindications ..................................................................................... 10
1.4 Required Skills, Training & Knowledge of Intended Users........................ 11
1.5 General Description of Use ...................................................................... 11
2 Installing the MotionWare Software .............................................................. 12
2.1 System Requirements .............................................................................. 12
2.2 Installing the Software .............................................................................. 12
2.3 Updating the Software ............................................................................. 13
2.4 Installing the USB Drivers ................................................................ ........ 13
2.5 Software Serial Number ........................................................................... 14
2.6 Running the Software – Main Screen ....................................................... 14
2.7 MotionWare Settings ................................................................................ 15
View or Enter Software Serial Number ..................................................... 15
Set Institution Name................................................................................. 15
Warn of Firmware Updates ...................................................................... 15
Default Action for Recent items ................................................................ 16
Automatically show the MotionWatch Manager… .................................... 16
Updates ................................................................................................... 16
Save Settings and Exit ................................................................ ............. 16
2.8 Bulk Export .............................................................................................. 16
2.9 Updates ................................................................................................... 16
Checking for Updates .............................................................................. 16
Automatically Check for Updates ............................................................. 17
3 The MotionWatch Manager ............................................................................ 18
3.1 MotionWatch Current Set-up .................................................................... 18
3.2 Applying a New Set-up ............................................................................ 19
Immediate or Delayed Start ................................ ................................ ..... 19
Recording Mode ...................................................................................... 20
Body Position ........................................................................................... 20
Epoch ...................................................................................................... 20
Light Recording ........................................................................................ 20
Recording Lengths ................................................................................... 20
Battery Life Gauge ................................................................................... 21
Battery Life .............................................................................................. 22
Compress Data ................................ ................................ ........................ 22
Disable Marker Button ............................................................................. 22
Recommended Setup for Sleep Recording .............................................. 22
Recommended Setup for Daytime Activity Recording .............................. 22
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4 Downloading Data .......................................................................................... 23
4.1 MotionWatch Download ........................................................................... 23
4.2 Saving MotionWatch Data........................................................................ 23
4.3 Shutdown after Download ................................ ................................ ........ 24
4.4 Join Files ................................................................................................. 24
5 Preparing to Analyse Data ............................................................................. 25
5.1 Selecting Recent Recordings ................................................................... 25
5.2 Managing Recent Recordings .................................................................. 25
5.3 Browse for Recordings ............................................................................. 26
5.4 Import Legacy Recordings ................................ ................................ ....... 26
5.5 The MotionWise Window ......................................................................... 28
5.6 The MotionWise Graphs .......................................................................... 29
5.7 MotionWise Graph View Options ............................................................. 29
Row Length ............................................................................................. 29
Row Height ................................ ................................ .............................. 30
Start Rows at ........................................................................................... 30
Horizontal Scale ....................................................................................... 30
Finer Detail Grid Lines ............................................................................. 30
Annotations .............................................................................................. 30
5.8 Printing the MotionWise Graphs............................................................... 30
5.9 Selecting the Analysis Period ................................................................... 30
Select Any ............................................................................................... 31
Select Days ............................................................................................. 31
Select All .................................................................................................. 31
5.10 Saved Periods and Longer Periods .......................................................... 31
5.11 Editing Data ............................................................................................. 32
5.12 Generating Reports.................................................................................. 33
Include Recording Properties ................................................................... 33
Include Markers ....................................................................................... 33
Include Sleep Analysis ................................................................ ............. 33
Transpose Table ...................................................................................... 34
Copy with Rounded, Formatted Values .................................................... 34
Print in Landscape ................................................................ ................... 34
Copy Results Tables (for spreadsheet) .................................................... 34
Copy to Word Processor .......................................................................... 34
Save as (PDF, RTF, DOC, ODT)… .......................................................... 34
Print Preview............................................................................................ 34
Print ......................................................................................................... 35
Filter Visible Columns .............................................................................. 35
5.13 Daylight Saving Adjust ............................................................................. 35
5.14 Restore original download........................................................................ 36
6 Sleep Analysis ................................................................................................ 37
6.1 Introduction .............................................................................................. 37
6.2 Sleep Analysis Statistics .......................................................................... 37
6.3 Saving or Removing Analysis Statistics ................................................... 39
6.4 Adjusting Analysis Threshold ................................................................... 39
6.5 Exporting Sleep Analysis Results ............................................................. 40
6.6 Printing Sleep Analysis Results................................................................ 40
6.7 Sleep Summary Table ............................................................................. 40
7 NPCRA Analysis ................................ ................................ ............................. 42
7.1 Introduction .............................................................................................. 42
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7.2 Reference ................................................................................................ 42
7.3 Analysis ................................................................................................... 42
7.4 Non-Parametric Variables ........................................................................ 43
7.5 Exporting NPCRA Analysis Results ......................................................... 44
7.6 Printing NPCRA Analysis Results ................................ ............................ 44
7.7 Save NPCRA Analysis Period .................................................................. 44
8 24 Hour Average Plot ..................................................................................... 45
8.1 Select Data for Analysis ........................................................................... 45
Smoothing Period .................................................................................... 45
Daytime Period ........................................................................................ 45
Activity Average ....................................................................................... 45
Day/Night Average Ratio.......................................................................... 45
Fitted Cosine Peak................................................................................... 45
9 Nap Analysis ................................................................................................... 46
9.1 Overview .................................................................................................. 46
9.2 Select Data for Analysis ........................................................................... 46
9.3 Select Nap Activity Threshold .................................................................. 46
9.4 Select Min Nap Length ............................................................................. 46
9.5 Select Max Nap Length ............................................................................ 47
9.6 Analysis Results ...................................................................................... 47
9.7 Export Nap Periods .................................................................................. 47
10 Day Activity Analysis ..................................................................................... 48
10.1 Overview .................................................................................................. 48
10.2 Day Analysis ............................................................................................ 48
Selecting Days ................................................................ ......................... 49
Highlighted Activity Graph ........................................................................ 49
Summary Activity ..................................................................................... 49
Definition of Results ................................................................................. 49
10.3 Set Calibration ......................................................................................... 50
10.4 Weekly Summary ..................................................................................... 53
Selecting a Week ..................................................................................... 53
Weekly Summary Graph .......................................................................... 53
Weekly Summary Totals .......................................................................... 54
10.5 Totals & Averages.................................................................................... 55
Weekly Totals .......................................................................................... 55
Day of Week Averages ............................................................................ 55
11 Cloud Data Management (CDM) .................................................................... 57
11.1 Overview .................................................................................................. 57
11.2 HQ / Management Site Computer Configuration ...................................... 57
Create Encryption Keys ........................................................................... 57
Enter Login Information ............................................................................ 58
Sync Folder ............................................................................................. 59
11.3 Syncing with Cloud .................................................................................. 59
11.4 Branch Configuration File......................................................................... 60
11.5 Branch Site Computer Configuration ........................................................ 62
Loading a Configuration File .................................................................... 62
Auto-Upload ............................................................................................. 63
Clear Settings .......................................................................................... 63
11.6 Synchronising Recordings with the Cloud ................................................ 63
Appendix A - Maintenance and Utilities ............................................................... 65
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A1 - The Utilities Tab ........................................................................................ 65
A2 - Firmware Update ................................................................ ...................... 66
A3 - Shutdown Options ..................................................................................... 66
A4 - Test Watch................................................................................................ 67
A5 - Changing the Battery ................................................................................ 67
A6 - Waterproof Seal ........................................................................................ 68
A7 - MotionWatch Strap ................................................................................... 68
A8 – Alternative Mountings ............................................................................... 69
Appendix B – FAQ & Troubleshooting ................................................................ 70
Appendix C – Safety & Environmental Information ............................................ 71
C1 - Decontamination ....................................................................................... 71
C2 - Battery ...................................................................................................... 71
C3 - Warnings – General ................................................................ .................. 71
C4 - Disposal at End of Life .............................................................................. 71
C5 - EMC Declaration and Guidance ................................................................ 72
Electromagnetic Emissions ...................................................................... 72
Electromagnetic Immunity ........................................................................ 73
C6 - Applicable Standards: ............................................................................... 74
Appendix D – Technical Specifications ............................................................... 75
Specifications ................................ ................................................................ ... 75
Operating & Storage Conditions ....................................................................... 75
Accelerometer Processing ................................................................................ 76
Tri-Axial Mode Data Processing ....................................................................... 77
Appendix E – Utilities ............................................................................................ 78
E1 – CSV Import Utility ..................................................................................... 78
Step 1 – Export the CSV .......................................................................... 78
Step 2 – Convert the CSV Data ............................................................... 78
Step 3 – Load the AWD File ..................................................................... 79
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1 Introduction to the MotionWatch System
1.1 An Overview of the MotionWatch System
The MotionWatch is a compact, lightweight, body-worn activity monitoring device that may be used to document physical movement associated with applications in physiological monitoring. The device is intended to monitor limb or body movements during daily living and sleep. The MotionWatch can be used to assess activity in any instance where quantifiable analysis of physical motion is desired. MotionWare allows for the set-up, download and analysis of data captured with the MotionWatch. The MotionWatch also incorporates a light sensor to record luminous intensity (lux) of white light and an event marker button. Utilizing the latest low-power MEMs technology, the MotionWatch provides a convenient, flexible platform for Actigraphy studies of all sizes. See Appendix D – Technical Specifications for Technical and operational specifications.
Components Required for a System
A MotionWatch system consists of 2 elements:
One or more MotionWatch devices. PC based MotionWare Software providing set-up,
download and analysis functions.
Note that no reader or interface is required – the MotionWatch has a direct USB connection.
The MotionWatch
Light sensor
Status Indicator
Event Marker Button
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Opening the MotionWatch Casing
The MotionWatch utilises a novel ‘twist-lock’ casing which provides a waterproof seal for the electronics and USB connection while facilitating easy access to the battery. To open the casing, grasp the front of the watch by the two finger grips and rotate anti-clockwise by approximately 15 degrees to release.
WARNING!
DO NOT ATTEMPT TO FORCE OPEN/CLOSED THE MOTIONWATCH CASING WITHOUT TWISTING TO UNLOCK/LOCK. DOING SO WILL DAMAGE THE CASING AND INVALIDATE THE WARRANTY!
Now gently lift out the front section of the casing…
Then turn over to access the USB connection…
USB Connection
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When the MotionWatch is connected for the first time, the USB drivers will automatically be installed (see Section 2.4 Installing the USB Drivers).
Closing the MotionWatch Casing
The casing must be closed with the parts correctly aligned. To aid with alignment, coloured indicators have been provided as shown in the figure below:
With the indicators aligned, drop the top part of the casing into the lower part and then turn clockwise by
approximately 15 degrees to close. WARNING!
DO NOT ATTEMPT TO FORCE OPEN/CLOSED THE MOTIONWATCH CASING WITHOUT TWISTING TO UNLOCK/LOCK. DOING SO WILL DAMAGE THE CASING AND INVALIDATE THE WARRANTY!
1.2 Indications For Use
The MotionWatch is a compact, lightweight, body-worn activity monitoring device that may be used to document physical movement associated with applications in physiological monitoring. The device is intended to monitor limb or body movements during daily living and sleep. The MotionWatch can be used to assess activity in any instance where quantifiable analysis of physical motion is desired.
1.3 Contraindications
The MotionWatch is indicated for use on healthy, undamaged areas of skin. Where the patient has a history of skin irritation, a device should be worn for a brief period to test for skin irritation prior to commencing any recording. Any device in close contact with the skin can trap sweat or moisture and cause redness or slight skin irritation. If this
Alignment Indicators
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occurs, remove the watch and do not wear it for 2-3 days to allow the irritation to clear.
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, possibly in a hospital environment.
1.5 General Description of Use
The MotionWatch contains a miniature accelerometer to allow measurement and recording of physical movement of the wrist which provides a close correlation to whole body movement. The data are sampled at 50Hz and processed
into ‘epochs’ of user selectable length. These data are
stored into an internal non-volatile memory and then downloaded for analysis at the end of the study period.
Data recorded by the MotionWatch may be downloaded and analysed off-line using the MotionWare Software Package.
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2 Installing the MotionWare Software
2.1 System Requirements
The MotionWare software is supplied on a CD-ROM or USB Memory Stick containing all of the components required to install the software package. The following are the minimum requirements of a host PC for installing the MotionWatch software:
Windows XP, Vista, Windows 7 or 8, 32 or 64bit
operating systems
IBM compatible 2GHz + processor speed
recommended
100 MB hard disk space One free USB port A CD-ROM or DVD drive for software installation Graphics SVGA(1280 x 1024) recommended
In general, a faster processor will provide superior performance.
2.2 Installing the Software
Place the CD ROM into the drive (or insert the USB stick into a free port); the MotionWare software installation menu should start automatically as shown below:
If it does not start automatically (this functionality has sometimes been disabled for security reasons) you will need to browse with Windows Explorer to view the CD ROM or USB stick then double-click on the file
‘SplashScreen.exe’. Click on the ‘Install MotionWare PC Software’ option.
Follow the installation wizard’s onscreen prompts until the installation is complete. It is recommended that you install
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the software in the default location. The operation of this software on a remote server is not guaranteed as network settings vary considerably. The MotionWare software requires the Microsoft .Net Framework to be installed; the installation wizard will check and install this if required. This may result in a protracted installation procedure.
For USB driver installation see Section 2.4 Installing the USB Drivers below.
2.3 Updating the Software
If you are updating or reinstalling the software you should first remove the old version. The installation has to then be restarted by removing and re-inserting the CD ROM or by double-clicking on the ‘SplashScreen.exe’ file.
2.4 Installing the USB Drivers
This section on installing drivers only applies to new installations.
The MotionWatch utilises generic Windows USB drivers which are provided as part of the Windows operating system. To install the drivers, attach the supplied USB cable to a free USB port and connect to the MotionWatch. Depending upon the version of Windows, a sequence of messages similar to that shown below will be displayed at the bottom of the screen:
If prompted, you may be required to restart the PC.
The driver installation is now complete.
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2.5 Software Serial Number
Double clicking on the MotionWare icon on the desktop will start the software. The software will run for a 30 day evaluation period and then the software serial number will be required. If you do not already have a serial number you will need to register the software. Click the ‘Get Serial Number’ button to link to the CamNtech website and register the software (note: you will need the reference number supplied on the CD or media).
When you have received your serial number, enter the 8 digits and then click the ‘Apply Serial Number’ button.
2.6 Running the Software – Main Screen
Double clicking on the MotionWare icon on the desktop will start the software. If a MotionWatch is connected it will be automatically detected and the MotionWatch Manager screen will be displayed. The front screen of the software with no MotionWatch connected will be similar to that shown below:
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2.7 MotionWare Settings
Click on the Settings button on the start-up screen to open the MotionWare settings Window:
View or Enter Software Serial Number
Click this button to open the serial number entry window, see section 2.5 above
Set Institution Name
You may also choose to enter an institution name in the settings window, which will then be included near the top of all printed reports. This may be desirable if you wish to hand the actogram or other reports directly to participants after use.
Warn of Firmware Updates
New firmware (software that is programmed into the MotionWatch) is sometimes provided within the software
update. Check the ‘Warn if new firmware available’
selection to be automatically notified if new firmware is available.
It is recommended to check and update the MotionWatch firmware following a software update – see Appendix A2 ­Firmware Update
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Default Action for Recent items
Choose whether to open the data with either Sleep analysis or Daytime Activity Analysis upon double click in the recent items list.
Automatically show the MotionWatch Manager…
Controls whether or not to automatically show the MotionWatch Manager Window when a MotionWatch is connected to the computer.
Updates
See section 2.9.
Save Settings and Exit
Click the ‘Close’ button to save the new settings – note that a check for updates will be immediately performed if the selection is checked. Click the close [x] icon at the top right to close the window without saving the settings.
2.8 Bulk Export
This function allows you to export the raw data from every motion file in a directory into corresponding csv files. It may be useful if you wish to analyse the data yourself rather than using the MotionWare software. You may choose the directory to target using either the directory browser window, or the file browser to choose an example from that directory.
2.9 Updates
Checking for Updates
Your web login information is required before updates can be downloaded. To do enter this information, open the Settings window ( Settings), and enter your user name and password in the specified fields. Click the Save & Close button to save the information.
To check for updates, click on the menu button and select the Check for Update menu item, or alternatively click the Check for Update button on the Settings window.
If a new version is available following dialogue will be shown:
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Click the Yes button to start the download. This will produce the following window:
When the download has completed, click the Exit & Run Update button to close the application and initiate the installer.
Automatically Check for Updates
Tick this checkbox if you would like the application to automatically check for new versions once a day.
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3 The MotionWatch Manager
3.1 MotionWatch Current Set-up
With the MotionWare Software already started, connect a MotionWatch to the USB cable; the watch will automatically be detected and the ‘MotionWatch Manager’ screen will be displayed as shown below:
If a MotionWatch is connected but the above screen is not shown, click on the ‘Use MotionWatch’ button on the front screen.
The MotionWatch Manager screen is automatically closed when the MotionWatch is disconnected.
The MotionWatch setup options will be explained in detail in the following section.
3 MAIN OPTIONS:
Setup Watch: click to start a new
MotionWatch setup (Section 3.2)
Read Data: click to download the data from the MotionWatch (Section 4.1)
Exit: Close the MotionWatch Manager window.
CURRENT SETUP INFORMATION
Details of the current set-up stored in the MotionWatch.
UTILITIES TAB
Click to view/edit advanced functions (Appendix A)
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3.2 Applying a New Set-up
Click the ‘Setup Watch’ button, the new setup tab is activated and the settings may now be edited:
Immediate or Delayed Start
Select ‘Immediate Start’ to ensure that the MotionWatch begins recording straight away. The start date and time are taken from the PC clock so please ensure that this is
correct. A delay of up to 2 minutes is added to the current
time and the recording will start on a complete minute. If for example the set-up is applied at 16:46:27, the delay will be one minute and 33 seconds and the recording will begin at 16:48:00.
Select ‘Delayed Start’ to show the start date/time controls. This option allows the recording to be delayed for up to 30 days into the future. Use the date, hours and minutes controls to select the required start date and time.
NOTE: Applying a new set-up to the MotionWatch will result in the loss of any existing stored data or set-up information – please ensure that any required data has
been downloaded first. Click the ‘Cancel Setup’ button
to return to the current setup tab without applying the new setup.
User ID: Enter characters to identify the
subject/patient/study.
Full Name: [optional] Enter characters to identify
the patient/study. Note that the maximum length is 64 characters shared between user ID and Full Name.
Gender: Use the dropdown to select M, F or X (if
gender is to be undisclosed).
Date of Birth: Use the date control to enter the
date of birth of the subject.
Start Date & Time: Select delayed start to begin
a recording up to 30 days in the future. Immediate start will begin in 1-2 minutes after disconnection.
Recording Mode: Use the drop down control to
select the recording mode.
Light Recording: Check the box to enable light
recording.
Compress Data: Check the box to compress the
activity data (see below).
Body Position: Choose the mounting location of
the MotionWatch.
Epoch: Use the drop down to select the required
recording epoch.
Recording Length: Shows the expected
maximum length of the recording based upon the chosen settings.
Battery Life: Indication of approximate battery life
remaining in % and colour coded battery gauge. Hover over with the mouse for more information.
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Recording Mode
The MotionWatch offers the following recording modes:
MotionWatch Mode 1 – This is an epoch based
recording mode designed to produce similar behaviour to legacy Actiwatch and similar products, using a single axis algorithm and peak detection.
Tri-Axial Mode 3 – This is an epoch based
recording mode that uses all three of the accelerometer axes to produce a vector magnitude result per epoch. This mode is used for recording daytime activity when the watch can be mounted at other locations on the body (See body position below). Note that this mode will shorten the battery life as there is more data processing.
Body Position
For daytime activity analysis it is recommended to note the location upon the body where the MotionWatch is mounted. The physical mounting position will have an effect upon the data (e.g. data from the wrist will differ from that recorded at the waist). This is an optional field that does not affect the data processing.
Epoch
The epoch is the duration for which the MotionWatch will accumulate samples before storing the result in memory. For example, using a 1 minute epoch, one result will be stored in memory every one minute. The MotionWatch offers the following epoch length options:
1 Second 2 Seconds 5 Seconds 15 Seconds 30 Seconds 60 Seconds
Note: the algorithms used for sleep analysis are validated using a 30 second epoch.
Light Recording
The MotionWatch has a built in ambient light sensor. Light recording may be enabled or disabled by checking or
unchecking the ‘Record light’ checkbox during setup.
When enabled the MotionWatch will store light values in lux at the same epoch as the activity samples. The light sensor records white light with a response optimised to match the human eye. The light is sampled once per second and averaged over the epoch. The results are stored as lux values.
Recording Lengths
The MotionWatch calculates and displays the expected recording length as the settings are changed. The recording mode, epoch, light settings and compression will
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all affect the maximum recording length. The following table summarises the (rounded) recording lengths for each setting.
Recording lengths for MotionWatch Mode
Epoch
(Seconds)
Activity
Only (days)
Activity &
Light (days)
Activity
Compressed*
1
3
1.5
6
2
6 3 12
5
15 8 30
15
45
23
90
30
91
46
120
60
120
91
120
*see below for details of data compression
Note that for Tri-Axial Mode, the maximum recording time is limited to 90 days due to battery life.
Battery Life Gauge
The MotionWatch Manager screen shows the battery life gauge to provide an indication of remaining battery life using a colour coded bar. The bar will change colour to provide a clear indication of battery status as the battery becomes depleted. The battery life gauge has the following indications:
Green 60% to 100% 72 to 120 days (MW Mode) 54 to 90 days (Tri Mode)
Yellow 40% to 59% 48 to 71 days (MW Mode) 36 to 53 days (Tri Mode)
Orange 20% to 39% 24 to 47 days (MW Mode) 18 to 35 days (Tri Mode)
Red 0% to 19% 0 to 23 days (MW Mode)
0 to 17 days (Tri Mode)
When the battery life falls below 15%, the gauge will flash and an additional message will be displayed in the status area (as shown above).
ALWAYS REPLACE THE BATTERY IF THE RECORDING IS LONGER THAN THE EXPECTED BATTERY LIFE.
If set-up is attempted with a short battery life, an additional warning message will be displayed.
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Battery Life
The MotionWatch uses a standard non-rechargeable CR2032 coin cell which is easily replaced by the user (Appendix A5 - Changing the Battery). The MotionWatch incorporates smart battery monitoring to measure actual device usage and battery voltage to calculate an expected life remaining. Typically the expected battery life will be 4 months (MotionWatch Mode), 3 Months (Tri-axial Mode) and the battery life indication will provide a percentage of life remaining. Hovering over the battery life in either the current or new setup screens will show the expected battery life in days in the information pane of the MotionWatch Manager. The MotionWatch monitors several parameters to automatically detect when a new battery is fitted. The watch will shut down when the battery is depleted – light recording will cease before activity recording. The MotionWatch requires some time to shut down fully when the battery is removed. Always wait at least 1 minute before inserting the new battery.
If the battery is replaced but the battery life indicator is not updated to 100%, click on the ‘new battery button under the Utilities tab to reset it manually.
Compress Data
It is possible to compress the activity data to allow longer recordings at shorter epochs. The light data is not compressed. The function uses a logarithmic compression which provides lower accuracy with higher values (quantized data). At low levels, the accuracy is not affected hence for sleep analysis the compression function will have minimal effect upon data. Note that the validations were performed without data compression.
Disable Marker Button
Select to disable the marker button.
Recommended Setup for Sleep Recording
The recommended settings for sleep recording are:
MotionWatch Mode 1 30 second epoch
These are the settings with which the validation studies were performed. It is possible to use other settings if required including tri-axial mode.
Recommended Setup for Daytime Activity Recording
The recommended settings for daytime activity recording are:
Tri-Axial Mode 3 Any epoch
Also set the body position during set-up so that this is noted within the data.
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4 Downloading Data
4.1 MotionWatch Download
From the MotionWatch Manager Window click on the ‘Read Data’ button. The download will begin and the progress notification will be displayed
If the data download is not required, click the cancel button and the operation will be aborted.
When the all data has downloaded (full memory will take less than 1 minute) the ‘Save Recording…’ dialog will open to allow the data to be saved.
Note that the recorded data in the MotionWatch is not
erased after download; It is only erased when the watch is
set up again.
4.2 Saving MotionWatch Data
Upon completion of the download, the ‘Save Recording…’
dialog will open automatically to allow the data to be saved.
This window allows the destination for the file save to be specified. Type the name of the file as required and click
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the ‘Save’ button. The file will be saved in the default
*.MTN format. If you do not wish to save the file, click the ‘Cancel’ button to return to the MotionWatch Manager.
Note that the MotionWatch Manager will not automatically close when the MotionWatch is disconnected if data has been downloaded and not saved. This serves as a reminder to save the data; you may manually close the window if the data is not required.
4.3 Shutdown after Download
The MotionWare software defaults to shut-down the MotionWatch into sleep mode to save the battery following download. Data will NOT BE LOST but the watch will cease recording. It is possible to disable this function such that the MotionWatch will continue to record following download and disconnection (see Appendix A3 - Shutdown Options).
NOTE! The MotionWatch cannot record movement data whilst connected to the PC. If a continuous recording is desired then the watch should be removed from the USB cable and returned to the subject as promptly as possible.
4.4 Join Files
It is possible to join (Concatenate) two MotionWatch recordings to create a single recording. The recordings must contain the same user details/setup and be concurrent.
1. Load the first data file for sleep analysis by selecting from the list of recent recordings or by browsing for Motion file.
2. From the ‘file’ menu select ‘Join…’
3. In the file dialogue, browse and/or select the second motion file that is to be joined to the first.
4. A save dialogue will open to allow the file name and location for the joined file to be specified.
5. Click save to save the new file – both original files will be kept unless the joined file is given the same name (an overwrite warning will be given in this case).
6. The new joined file may now be loaded from the recent recordings list.
7. Any gap between the two recordings will show as ‘missing data’ and will be marked in grey.
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5 Preparing to Analyse Data
5.1 Selecting Recent Recordings
When data is saved following download, the file automatically appears in the ‘Recent Recordings’ list on the front screen of the software. The recent recordings list provides a quick access method to the most recently opened or downloaded files.
It is possible to adjust the recording for daylight saving – see section 5.13 below for more information.
Click once on a file in the list to select it; more details of the file are displayed in the information pane below. The
file can be opened after selection by clicking on the ‘Open selected recording’ button. Alternatively, double clicking on
the file will open the file directly (choose which analysis type to open with double click in MotionWare Settings). Right click on the file for more options.
5.2 Managing Recent Recordings
If the recent recordings list becomes full or cluttered, it is possible to remove entries from the list or to fully delete the related file. To manage the recent recordings, right click on the required file name in the list to show a pop-up menu with the following options:
Open in Sleep Analysis Open in Day Analysis
Recent Recordings: Click an item to view the file details in the information pane then open by clicking the Open Selected Recording button. Alternatively, double click an item to open directly. Where a file is a legacy file-type, this will be shown in the list entry.
Open in Sleep Analysis: Click to open the item selected in the Recent Recordings list with Sleep Analysis.
Information Pane: Provides more detail about the selected recording.
Open in Day Analysis: Click to open the item selected in the Recent Recordings list with Daytime Activity Analysis.
Browse for Motion File: Opens file manager dialog to select a file.
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Properties Remove From List Delete File Clear Recent Items List
Select ‘Remove from list’ to keep the file on the disk but
remove it from the list; the file will not be deleted. Select ‘Delete File’ to remove from the list and delete the file from the disk. A warning message will be displayed before the file is permanently deleted.
Select ‘Clear Recent Items List’ to remove all files from the
list the files will not be deleted. Clicking ‘Properties’ allows the recording details to be
viewed.
5.3 Browse for Recordings
It is also possible to locate and load recordings that do not appear in the Recent Recordings list. From the main
screen, click on the ‘Browse for Motion File’ button to open
a standard Windows File dialogue. Use the folder controls to browse to the location of the required files. Note that the default file format is .MTN (depicting MoTioN) and this type of file will be displayed automatically. It is possible to change the file-type filter to browse for other file types (see below).
5.4 Import Legacy Recordings
As certain legacy products (such as CamNtech Actiwatch) used an open file format, it is possible to import existing .AWD format files. To import a legacy file, follow the instructions to browse for a file in Section 5.3 above and then change the file-type filter to ‘Actiwatch (*.AWD)’:
The table below lists the compatibility with various Actiwatch model data:
Actiwatch Model
Compatibility
Actiwatch 7
Y
Actiwatch 4
Y
Actiwatch Light Plus
Y
Actiwatch Mini
Y
Actiwatch Spectrum
Y1
Actiwatch 2
Y1
CamNtech will give consideration to adding import functionality for unsupported/unlisted actigraphs where customers have large existing data sets and where such data can be converted.
1. It is not possible to directly open this type of file but it is possible to export data from the Actiware Software in
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.csv format and then use the csv import utility to re­save the data in compatible format (see Appendix E1 – CSV Import Utility).
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5.5 The MotionWise Window
When a recording is opened the MotionWise window is displayed:
The MotionWise window provides a multiple-day, single or double plotted motion graph (actogram) within a flexible, scalable and scrollable window. The MotionWise window is the key tool for the selection of data for more detailed analysis. The top region of the window provides summary patient information. The entire window may be stretched and dragged by manipulating the corners of the window. The window can also be maximised to fill the full screen by using the window control.
Scroll through the days by using the slider control at the right hand side of the screen or by using the mouse scroll wheel.
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5.6 The MotionWise Graphs
For each day containing data, a graph similar to that shown below will be displayed.
5.7 MotionWise Graph View Options
The Actogram view can be adjusted for different purposes using the window below. This is found under the ‘Options’ item in the ‘View’ menu. The Actogram will adjust to give immediate feedback after you have changed any of the options.
Row Length
Select 24 or 48 hour graphs to show single day or double day plotted graph respectively. Each row of the graphs will then correspond to the length chosen, but the change forwards between rows will be 24 hours in both cases.
Reduce
Activity
Scale
Reduce
Light
Scale
Increase
Activity
Scale
Increase
Light
Scale
Activity Plot
(Black)
Light Plot
(Yellow)
Event Marker
(Blue)
No Data
(Grey)
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Row Height
Using this slider, you can adjust the heights of each row of the Actogram to show lots of detail on each graph, or very compressed rows to present a longer time period onscreen. Note that the range available here depends on the setting of the ‘Horizontal scale below.
Start Rows at
The MotionWise graphs default to a plot start time at the start of the recording. However, when comparing data between multiple users, it can be useful to have a fixed start time for the plots. So you can select either to always start from the beginning of the recording, or enter a fixed time in the text box.
Horizontal Scale
Using this option, you can choose to show self-contained graphs with a horizontal scale on each row, or close-fitted graphs with no horizontal axis on each. In the latter case, a time scale is added at the top and bottom of the actogram instead.
Finer Detail Grid Lines
Show or hide the light grey hourly grid lines on the graphs (these will also depend upon the resolution of the monitor or printer).
Annotations
The marker lines or highlighted periods on the graph can be shown at full graph height or just at the top of the graph. This can help to make the graph more clear when there are many marker events and selected periods.
5.8 Printing the MotionWise Graphs
You may produce a printed copy of the MotionWise graphs covering all days of data, by selecting the ‘Print preview”
option from the ‘File’ menu. This preview allows you to
view and step through all of the report pages using the ‘Prev’ and ‘Next’ buttons.
The printed Actogram can be adjusted similarly to the on screen Actogram by clicking the ‘Actogram Options’ button. This includes an additional setting to include or exclude a list of the recording properties with the Actogram printout.
5.9 Selecting the Analysis Period
There are three main selection options which may be chosen by use of the control buttons in the MotionWise window:
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Select Any
The ‘Select Any’ option provides a flexible means of
selecting any analysis period between your chosen start and end points.
In the MotionWise window, choose the period of data for analysis by pointing at the start point, hold down the left mouse button and then drag to select the period required. The selected period is highlighted and the Analysis window is automatically displayed. The figure below shows a single overnight period selected:
It is possible to select a very short period (i.e. a few minutes) to several days using this method. By dragging off the bottom or top of the MotionWise graph area, the window will automatically scroll to allow selection of days that are not currently displayed.
Select Days
The ‘Select Day(s)’ option will select a period starting and ending at midnight on the chosen day(s). To make a selection, point anywhere within the graph on the day of interest, hold down the left mouse button and then drag to select the day(s) required. Drag across multiple graphs to select several days and drag off the bottom or top of the MotionWise graph area to automatically scroll while selecting.
Select All
The ‘Select All’ option allows a one-click selection for all days of data ready for a multiple day analysis such as NPCRA.
5.10 Saved Periods and Longer Periods
The Analysis functions allow the selected periods to be saved. These periods will remain highlighted in the MotionWise Window and the analysis can be quickly re­opened by clicking anywhere in the highlighted region. If the saved period is longer than 24 hours (i.e. for an NPCRA analysis) then the highlight is not shown in the graph. These longer saved periods may be chosen from the ‘Long periods’ menu in the MotionWise Window.
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5.11 Editing Data
It is possible to edit periods where there is believed to be some problem with the recorded data to change or remove the activity during that period. This may be necessary where for example the watch was not worn for a period, or where it is believed an activity gave particularly misleading activity counts for analysis purposes. The Edit function may be accessed by selecting a period for analysis in the manner described in Section 6 Sleep Analysis, then selecting the Edit analysis function from the list in the bottom-left of the window.
After selecting the Edit tool, it is possible to fine tune the time period for the edit either by dragging the ‘Start’ and End bars on the graph, or by changing the text boxes containing times below the graph.
Next you must choose to change either the ‘Activity’ or Light channel as appropriate. Note that marking missing data will cause both to be considered as missing.
The data samples within the selected period can be changed in four different ways:
Missing data – this will set the data as missing,
where the period is shown with a grey background, and analysis functions which take an average will ignore the missing samples.
Fixed value – this will set the data samples (either
activity or light) to the value entered in the box.
Average of – this will set the data samples to either
the average of the entire day (including the selected period), or the average of the day excluding the selected period. The day is taken as
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the 24-hour period between midnights which contains the start time of the edit.
Original data – because all of the data and changes
are contained as an audit log within the motion file, this option allows you to restore the original values first recorded before any edit took place.
If the last part of the recording is marked as “Missing data”,
then this will also reduce the length of the printed Actogram to avoid printing unnecessary missing days. This is particularly useful if the watch has been left recording invalid data for some time after being worn, but before download. In this case, simply select all of the time after the valid recording and mark it as missing data. This
can be restored at any point using the “Original data”
option above.
5.12 Generating Reports
In the MotionWise window select ‘Tools -> Report’ to open the report generator window.
This tool provides a number of flexible reporting options which are discussed in more detail below.
Include Recording Properties
Select this option to include the User ID, Gender, DOB, Device information and start time within the report.
Include Markers
Select this option to include a date/time stamped listing of marker events within the report.
Include Sleep Analysis
Select this option to include full Sleep Analysis results for all saved analysis periods within the report (see Section 6 Sleep Analysis).
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Transpose Table
Select this sub-option to swap the row/column layout of the report.
Copy with Rounded, Formatted Values
This sub-option applies to data exported via the clipboard only. When selected, the results will contain rounded values with periods formatted as hours and minutes. When un-selected, the results will be exported as un-rounded values and periods will be formatted in seconds. The latter option is useful when importing data into external packages for further analysis.
Print in Landscape
This option swaps the default (portrait) report format to
landscape orientation. This can be useful to best ‘fit’ the
report to the page. This option only applies to printed reports.
Copy Results Tables (for spreadsheet)
Having selected the required report options, click the ‘Copy Results Tables’ button to export the data. The data may now be imported into external software (e.g. a spreadsheet) for further analysis or formatting.
Copy to Word Processor
Places the selected results and actograms for all days onto the clipboard formatted to paste directly into a word processor. This facilitates rapid production of custom reports.
Save as (PDF, RTF, DOC, ODT)…
The selected results and actograms for all days are saved into your selected file format. Choose the document type in the ‘Save as type…’ dropdown, choose from the following options:
RTF – Rich Text Format open in most word
processors.
PDF – Portable Document Format open in Adobe
Acrobat Reader.
DOC – Microsoft Word Document. ODT – Open Document – use with Open Office.
Enter a file name/location to save the file. These options facilitate rapid production of custom reports.
Print Preview
Having selected the required report options, click the ‘Print Preview’ button to view the report on screen before
printing.
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The print preview window has a number of formatting and zoom options. There is also a ‘Print’ button in the menu to allow printing without the need to close the window.
Print
Having selected the required report options, click the ‘Print’
button to send the report to the printer. A standard printer dialogue will be displayed allowing the target printer options to be selected.
Filter Visible Columns
It is possible to further customise the parameters that will be included in the report.
Click on the ‘filter visible columns’ button for either the
marker or sleep analysis data. A window containing a checklist of parameters will be displayed (sleep parameters are shown in this example). Ensure that the required parameters are checked for inclusion in the report.
5.13 Daylight Saving Adjust
If a clock change is detected (daylight saving) during a recording, a message will be displayed upon first opening of the recording:
Select ‘Yes’ to apply a daylight saving adjustment
to the data. This will default to the local regional
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settings of the computer (typically add or remove 1 hour of data at 2am.) This can be undone – see
5.14 below.
Select ‘No’ to ignore the daylight saving adjustment
(Adjustment can be applied later if required)
It is possible to apply the daylight saving adjustment by
clicking on the ‘Tools’ menu then selecting ‘Daylight
Savings Adjust’. The following window will be displayed:
The adjustment values can be changed here if required and then be applied to the data by clicking ‘Apply now’.
5.14 Restore original download
To reverse (undo) any daylight saving adjustment or any other edits or any saved analysis, first close the recording and then re-open it.
Next select ‘Restore original download’ from the ‘Tools’
menu. A warning will be displayed as follows:
Click ‘Ok’ to restore the original download or cancel to
keep the adjusted data. Note that all edits have been made to the data, will be lost (including any saved sleep periods or analysis).
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6 Sleep Analysis
6.1 Introduction
The Sleep analysis function is designed to provide a number of objective sleep measures from overnight actigraphy data. It can be easily applied either to normal overnight periods, or used to examine any sleep period from an altered phase recording such as a shift worker. First select a region using the MotionWise window (see Section 5.9 Selecting the Analysis Period above) which includes a short period of daytime activity at the start and end. The detailed analysis window will be displayed and may initially default to the summary function. To select Sleep Analysis, choose ‘Sleep’ from the Analysis Function options at the left of the screen. The detailed Sleep Analysis window will be displayed:
It is now possible to drag the Lights Out and Got Up markers to the appropriate positions in the data, and the thinner red markers inside which denote Fell Asleep and Woke Up will be automatically adjusted from the combination of your markings and the activity data. All of these four times are also displayed in the information box below the graph.
6.2 Sleep Analysis Statistics
Once the desired sleep region is selected, the software will automatically perform a categorisation of each epoch of
the period between ‘Fell Asleep’ and ‘Woke Up’ as either Sleep or Wake, and also as either Mobile’ or ‘Immobile’,
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and use these results to provide a number of measures from the period. These are described below:
Time in bed: The total elapsed time between the ‘Lights
Out and Got Up times.
Assumed sleep: The total elapsed time between the Fell
Asleep and Woke Up times.
Actual sleep time: The total time spent in sleep according
to the epoch-by-epoch wake/sleep categorisation.
Actual sleep (%): Actual sleep time expressed as a
percentage of the assumed sleep time.
Actual wake time: The total time spent in wake according
to the epoch-by-epoch wake/sleep categorisation.
Actual wake (%): Actual wake time expressed as a
percentage of the assumed sleep time.
Sleep efficiency (%): Actual sleep time expressed as a
percentage of time in bed.
Sleep latency: The time between Lights Out and Fell
Asleep.
Sleep bouts: The number of contiguous sections
categorised as sleep in the epoch-by-epoch wake/sleep categorisation.
Wake bouts: The number of contiguous sections
categorised as wake in the epoch-by-epoch wake/sleep categorisation.
Mean sleep bout: The average length of each of the sleep
bouts.
Mean wake bout: The average length of each of the wake
bouts.
Immobile mins: The total time categorised as Immobile in
the epoch-by-epoch mobile/immobile categorisation.
Immobile time (%): The immobile time expressed as a
percentage of the assumed sleep time.
Mobile mins: The total time categorised as mobile in the
epoch-by-epoch mobile/immobile categorisation.
Mobile time (%): The mobile time expressed as a
percentage of the assumed sleep time.
Immobile bouts: The number of contiguous sections
categorised as immobile in the epoch-by-epoch mobile/immobile categorisation.
Mean immobile bout: The average length of each of the
immobile bouts.
Immobile bouts <=1min: The number of immobile bouts
which were less than or equal to one minute in length.
Immobile bouts <=1min (%): The number of immobile
bouts less than or equal to one minute expressed as a percentage of the total number of immobile bouts.
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Total activity score: The total of all the activity counts
during the assumed sleep period.
Mean activity /epoch: The total activity score divided by
the number of epochs in the assumed sleep period. Note that this result will be expected to scale depending on the length of the epoch.
Mean nonzero activity per epoch: The total activity score
divided by the number of epochs with greater than zero activity in the assumed sleep period. Note that this result will be expected to scale depending on the length of the epoch.
Fragmentation Index: The sum of the Mobile time (%)
and the Immobile bouts <=1min (%). This is an indication of the degree of fragmentation of the sleep period, and can be used as an indication of sleep quality (or the lack of it).
Threshold: The threshold used for analysing movement
data. The MotionWatch was validated with a threshold of 20, but this may be chosen differently depending on the population.
Rest per 24h (%): The percentage of epochs in a 24 hour
period which would be counted as sleep if the whole period were analysed as night time. The period runs for 24 hours from midday to midday around the “To Bed” time of the analysis.
6.3 Saving or Removing Analysis Statistics
With the analysis for the period complete, the analysis may be saved by clicking on the ‘Save Sleep Period’ button. The detailed analysis window will close automatically and the analysis period will remain highlighted in the MotionWise window. To re-open the saved analysis, simply click anywhere on the highlighted region in the MotionWise window.
If the saved analysis is no longer required, click on the ‘Delete Sleep Period’ button in the sleep analysis screen to remove it.
6.4 Adjusting Analysis Threshold
The threshold used for sleep analysis can be adjusted under the Options’ button. Note that the MotionWatch system has been validated with a threshold of 20, so this should normally be the default choice.
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6.5 Exporting Sleep Analysis Results
The Copy Results button and Epoch Results or Statistics options will allow you to transfer either the
detailed epoch-by-epoch results or the overall statistics easily into a spreadsheet program or similar. Simply click the button, transfer to a spreadsheet window on your computer, and use the normal Windows paste function to create a table of your results.
6.6 Printing Sleep Analysis Results
Click on the ‘Print Preview’ button to preview the report and click on the ‘Print’ button to send the report to the
printer.
6.7 Sleep Summary Table
From the MotionWise window, select ‘Sleep Summary Table’ from the ‘Tools’ menu. This window provides a
summary of the saved Sleep analysis periods.
Furthermore, it is possible to edit the ‘lights out’ and ‘got up’ times within this window using patient provided
information (i.e. a sleep diary).
To enter data, highlight the required time and then type in the data in HH:MM format.
Click on ‘Save Changes’ when complete and the analysis
periods will be automatically highlighted in the MotionWise window. Click on any highlighted period to open Sleep
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Analysis. This will perform the analysis on the visible data. After checking the data and results for any anomalies, you must then re-save the sleep period to capture the night’s results for the report output.
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7 NPCRA Analysis
7.1 Introduction
Traditional analysis of circadian rhythms has attempted to fit physiological indicators to a Cosine waveform shape (Cosinor analysis). Activity-rest data do not typically fit well with this type of analysis, hence the MotionWare software provides the function of Non-Parametric Circadian Rhythm Analysis (NPCRA). With this approach, we do not assume that the data fit any pre-defined distribution. The method used is to analyse full-days of data over several days to determine some useful variables which are explained in more detail below. Studies have shown that the non­parametric variables are a valuable indicator of rhythm disturbances caused by disease or aging and their associated treatments.
7.2 Reference
The NPCRA analysis is based upon the work of Dr. Eus Van Someren at the Netherlands Institute for Brain Research e.van.someren@nin.knaw.nl The original paper published by Dr. Van Someren is:
Van Someren, E J W, DF Swaab, C C Colenda, W Cohen, W V McCall, and P B Rosenquist. Bright
Light Therapy: Improved sensitivity to its effects on rest-activity rhythms in Alzheimer patients by application of nonparametric methods.
Chronobiology Int. (1999) 16 (4) 505-518.
7.3 Analysis
NPCRA analysis requires complete data from as many full days as possible. It is not recommended to attempt analysis with less than 7 days of data and best results are obtained with 14 or more days.
To select the analysis days, use the ‘Select All’ button in
the MotionWise screen to automatically select all available
days. Alternatively, use the ‘Select Days’ or ‘Select any’
tools to specify the analysis period (see Section 5.9 Selecting the Analysis Period).
Note also that the analysis is sensitive to periods of inactivity when the MotionWatch has not been worn.
Having selected the analysis period, the analysis window will be displayed. Select ‘NPCRA’ from the sidebar functions.
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7.4 Non­Parametric Variables
The NPCRA window provides a table of resulting Non­Parametric variables with the following meanings:
IS (Interdaily Stability): quantifies the degree of regularity
in the Activity-Rest pattern with a range of 0 to 1 where a value of 0 indicates a total lack of rhythm and a value of 1 indicates a perfectly stable rhythm.
IV (Intra-Daily Variability): quantifies the degree of
fragmentation of activity-rest periods. Typical healthy subjects will show a single prolonged activity period and a single prolonged rest period per 24 hour cycle. Certain physiological conditions may lead to multiple short-length periods of activity-rest within any 24 hour period. The variable has a theoretical range of 0 to 2 with higher values indicating higher fragmentation. Typical values for healthy subjects will be below 1.
L5 (Least 5) Average: all days of data are overlaid and
averaged in 24-hour periods. The L5 average provides the average activity level for the sequence of the least five active hours. This value provides an indication of how restful (inactive) and regular the sleep periods are.
L5 Start Hour: Indicates the onset of the L5 sequence and
provides an indication of the phase of the most restful hours.
M10 (Most 10) Average: all days of data are overlaid and
averaged in 24-hour periods. The M10 average provides the average activity level for the sequence of the highest (most) ten active hours. This value provides an indication of how active and regular the wake periods are.
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M10 Start Hour: Indicates the onset of the M10 sequence
and provides an indication of the phase of the most active hours.
RA (Relative Amplitude): First we calculate the Amplitude
(AMP) which is the difference between the average activity level in the M10 and that in the L5 periods. To remove sensitivity to overall activity level, we then calculate the RA by dividing the AMP by the sum of the L5 and M10. The variable has a theoretical range of 0 to 1 with higher values indicating a rhythm with higher amplitude.
7.5 Exporting NPCRA Analysis Results
The ‘Copy Statistics’ button will allow you to transfer the overall statistics easily into a spreadsheet program or similar. Simply click the button, transfer to a spreadsheet window on your computer, and use the normal Windows paste function to create a table of your results.
7.6 Printing NPCRA Analysis Results
Click on the ‘Print Preview’ button to preview the report and click on the ‘Print’ button to send the report to the
printer.
7.7 Save NPCRA Analysis Period
Click on the ‘Save Period’ button to save the selected
analysis. Long periods are not highlighted in the MotionWise window as they would hide shorter periods
and become confusing. Instead use the ‘Longer periods’
menu from the MotionWise window to select any saved periods greater than 24 hours.
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8 24 Hour Average Plot
8.1 Select Data for Analysis
From the MotionWise window, use the ‘select days’ option to choose a range of days or use the ‘select all’ option to
analyze all days. The analysis window will open automatically; if not already selected, select ‘24h Average’ from the analysis functions side bar. A screen similar to that shown below will be displayed.
Smoothing Period
The smoothing period allows a time constant to be applied to the plotted data which is useful when analyzing for trends. The period may be selected between no smoothing and 60 minutes.
Daytime Period
It is possible to specify the start and end of the daytime period to be used for the analysis. This will affect the daytime and nighttime average values accordingly.
Activity Average
The data per epoch for each day are day totalized and averaged over the number of days in the analysis. The average activity in the daytime and nighttime periods are then calculated and displayed. Note MW counts are MotionWatch counts.
Day/Night Average Ratio
This is the daytime activity average / nighttime activity average.
Fitted Cosine Peak
A cosine is fitted to the averaged data and the time of day where the cosine peak occurs is displayed.
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9 Nap Analysis
9.1 Overview
The Nap analysis function allows detection of periods of inactivity that could be attributed to daytime napping or micro-sleeps. The function provides user adjustable parameters for duration and threshold to detect the potential naps.
9.2 Select Data for Analysis
From the MotionWise window, use the ‘select any’ option
to a period of data to analyze – this will typically be during the normal active daytime period. The analysis window will open automatically; if not already selected, select
‘Napping’ from the analysis functions side bar. A screen
similar to that shown below will be displayed.
9.3 Select Nap Activity Threshold
The ‘Napping activity level (/epoch)’ is used to set the
activity threshold for nap detection. The activity level in every epoch within the specified period must be less than or equal to the entered value for the period to be scored as a nap. For example, if the threshold is set to 10, the period will be scored as a nap if every epoch <=10 counts. Change the threshold value by typing the number of counts.
9.4 Select Min Nap Length
Set the minimum period of inactivity required to be scored as a nap. The value should be typed in the format hh:mm:ss. Periods shorter than the selected value will not be scored as a nap period.
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9.5 Select Max Nap Length
Set the maximum period of inactivity required to be scored as a nap. The value should be typed in the format hh:mm:ss. Periods longer than the selected value will not be scored as a nap period.
9.6 Analysis Results
The analysis window will show the number of potential naps detected. The analysis graph will display the potential nap periods as green highlighted areas.
9.7 Export Nap Periods
To export the nap analysis details, click on the ‘Export Nap
periods’ button. The nap analysis details will be copied to
the clipboard which may then be pasted into Excel or similar for further analysis.
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10 Day Activity Analysis
10.1 Overview
The day activity analysis function provides an overview and summary of the activity levels of the wearer during the daytime. It is intended to assist in monitoring of the amount of time spent active on a daily or weekly basis, and the approximate intensity of that activity.
To use the Day Analysis function, single click to select a recording from the recent files list and then click the “Day Activity Analysis” button.
10.2 Day Analysis
Once the recording has been opened with the daytime analysis function, the Day Analysis window will show as below. It allows you to step through every day of the recording and see the highlighted activity periods and daily summary data.
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Selecting Days
To select which day of the recording to view, note the sequence of small day graphs across the top of the Day Analysis window. You can click on any of these to view that day in more detail below. You can also scroll this selection to view more days later in the recording. Days which contain some moderate or vigorous activity are highlighted with the “M” or “V” stamp respectively on the quick selection view.
In addition, the left and right arrows to the right of the day calendar, as well as the directional keys on the keyboard can be used to step through all days of the recording.
Highlighted Activity Graph
The main activity graph in the Day Analysis window highlights periods of constant activity – those where higher levels of movement are maintained for 10 minutes or more. You can control whether moderate and vigorous periods are highlighted in this way using the View menu of this window.
Summary Activity
Below the main activity graph, a bar chart summarises the amount of time spent in constant activities of vigorous, moderate or low intensity alongside sedentary time. The table of results below this includes both the constant totals drawn in the bar chart and highlighted on the activity graph (where only 10 minute or greater periods are counted), and the total times in each category (where every epoch is counted).
Definition of Results
The following tables describe the criteria used when categorising time expenditure:
Vigorous Activity Time
The total amount of time when the activity count exceeds the ‘Vigorous’ calibration threshold.
Moderate Activity Time
The total amount of time when the activity count is greater than
or equal to the ‘Moderate’
calibration threshold and is less than ‘Vigorous’ threshold.
Low Activity Time
The total amount of time when the activity count is greater than
or equal to the ‘Sedentary’
calibration threshold and is less than ‘Moderate’ threshold.
Sedentary Activity Time
The total amount of time when the activity count is greater than zero and is less than the ‘Sedentary’ threshold.
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Empty Time
The total amount of time when the recording did not take place – such as at the start or end of the recording (for example the difference between 00:00 and the start time or the end time and 24:00).
Non-zero Time
Any data within the recording with a count value above zero.
Zero Time
Any data within the recording with a count value of zero.
If the ‘Show Only Continuous Activity’ option is checked under the ‘View’ menu, ‘Vigorous Activity Time’ and Moderate Activity Time’ are replaced with:
Continuous Vig. Activity
As ‘Vigorous Activity Time’, but
only when the amount of time is 10 minutes or more.
Continuous Mod. Activity
As ‘Moderate Activity Time’,
but only when the amount of time is 10 minutes or more.
10.3 Set Calibration
It is possible to set the calibration for the intensity of activity used in classification. This can be done by clicking the Tools menu on the Day Summary and selecting the “Set Calibration” function.
The analysis function uses a calibration to derive reference thresholds for vigorous, moderate, low and sedentary activity types. These values differ from patient-to-patient depending on their capabilities, so it is desirable to perform a calibration for each patient or recording (where applicable).
The best way to calibrate a recording is to arrange for the patient to perform a brisk walk (3-4 mph) for at least 5 minutes. This should take place at the start, or at the end of a recording to ensure that it is easily identifiable when selecting it in the calibration window [1]. The calibration period can be selected by either clicking the highlighted period in the activity graph [2], or by selecting a reported period in the detected periods list [3]. The selected period will use an average of the activity counts found within the period to produce the moderate threshold. This value will also be used to derive the vigorous and sedentary thresholds. The low threshold accounts for any values found between the sedentary and moderate thresholds.
The entire recording will be analysed to detect any bouts of
activity which are longer than 5 minutes and who’s activity
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counts are within an acceptable range. These can be selected as alternative calibration values but they may not reflect the values of a brisk walk and should be used with caution. Calibration periods can also be selected manually by dragging the mouse cursor over a period on the activity graph, or by entering fixed values in the thresholds fields
[4].
[1] Calibration Window
[2] Detected Calibration Period
[3] Detected Calibration List
[4] Threshold Fields
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Definition
Physical activity includes everyday activity such as walking and cycling to get from A to B, work-related activity, housework, DIY and gardening. It also includes recreational activities such as working out in a gym, dancing, or playing active games, as well as organised and competitive sport. (See the
Chief Medical Officers' [CMOs'] report.)
National recommendations
The CMOs' current recommendations for physical activity (see UK physical
activity guidelines) state that:
All adults aged 19 years and over should aim to be active daily. Over a week, this should add up to at least 150 minutes (2.5 hours) of
moderate intensity1 physical activity in bouts of 10 minutes or more.
Alternatively, comparable benefits can be achieved through 75 minutes of
vigorous intensity2 activity spread across the week or combinations of moderate and vigorous intensity activity.
All adults should also undertake physical activity to improve muscle strength
on at least 2 days a week.
They should minimise the amount of time spent being sedentary (sitting) for
extended periods.
Older adults (65 years and over) who are at risk of falls should incorporate
physical activity to improve balance and coordination on at least 2 days a week.
Individual physical and mental capabilities should be considered when
interpreting the guidelines, but the key issue is that some activity is better than no activity.
1 Moderate-intensity physical activity leads to faster breathing, increased heart
rate and feeling warmer. Moderate-intensity physical activity could include walking at 3–4 mph, and household tasks such as vacuum cleaning or mowing the lawn.
2 Vigorous-intensity physical activity leads to very hard breathing, shortness of
breath, rapid heartbeat and should leave a person unable to maintain a conversation comfortably. Vigorous-intensity activity could include running at 6–8 mph, cycling at 12–14 mph or swimming slow crawl (50 yards per minute).
NICE Public Health Guidance 44, 2013
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10.4 Weekly Summary
The Weekly Summary window can be opened through the Tools menu of the Day Analysis window. It shows a graph of the wearer’s activity levels over a single week at once:
Selecting a Week
The available weeks can be scrolled through in the first graphic of the Weekly Summary window. Use the scroll bar at the right to move through the weeks and click on the one of interest. Alternatively, you can scroll through the weeks using the up and down arrows to the right of the week calendar, or by using the directional keys on the keyboard.
Note that using the Options menu, the weeks can be chosen to begin either on Monday (Calendar Week), or on the first day of the recording (Consecutive Week).
Weekly Summary Graph
The main graph in the Weekly Summary window shows the time spent in different constant intensity levels on each
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day of the selected week. You can see both how the time each day compares to the target time illustrated by the black line, and how it varies across the week. For instance, the graphic above clearly shows that whilst the target for moderate activity was missed during most of the week, the wearer was then very active on Saturday. The View menu can be used to turn on and off the highlighting of Low, Medium and Vigorous levels.
Weekly Summary Totals
Below the summary graph, a bar chart illustrates the total amounts of time spent in each of Vigorous, Moderate and Low activity, and Sedentary time. Along with the graph above, this will be updated as the weeks of the recording are stepped through. The bar graph also shows the target black line, controlled by the weekly exercise target figure below it.
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10.5 Totals & Averages
The Totals & Averages window can be opened through the Tools menu of the Day Analysis window. This window is designed to illustrate the variation of activity over the full length of the recording. The upper graph shows the changes between weeks, and the lower graph shows the average variation within weeks.
Weekly Totals
The upper graph of the Totals & Averages window shows the total time spent in different activity bands over the weeks of the recording. In the example shown, the recording spanned over 6 weeks and showed relatively steady levels apart from an increase in week 4 and a lower total in week 6. It is easy to see both the absolute level versus the target black line (set at the bottom of the window), and the variation between weeks.
Day of Week Averages
The lower graph of the Totals & Averages window is produced by averaging each weekday across all weeks of
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the recording. This shows up any variation caused by weekly patterns of behaviour. In the example shown the wearer is clearly far more active on Saturday than on an average weekday, but there is more variation within those also.
Note that both graphs can be affected by the View and Options menus. The View menu controls whether highlights are shown for each of the intensity levels. The Options menu controls whether the discrete weeks are considered to always start on a Monday (Calendar Week), or on the first day of the recording (Consecutive Week).
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11 Cloud Data Management (CDM)
11.1 Overview
Our CDM system allows you to securely manage recordings from multiple sites. It is available as an additional service which you may add to your account at any time. Please contact us to find out more information.
The system uses a HQ and Branch model, where the Branch site(s) will upload their data to our cloud server, and the HQ site(s) will download the data from our cloud server.
All data is encrypted using the encryption keys created at your HQ management site, and is completely secure when distributed from Branch to Cloud to HQ.
Note: CamNtech has no access to your raw data or encryption keys at any time.
11.2 HQ / Management Site Computer Configuration
To set up your software as a HQ site, click the HQ Manager button on the main window to open the HQ
window as shown below.
Create Encryption Keys
Before any data is transferred over the internet, it must be encrypted with keys specific to your project. This function will allow you to create and store those keys. Click on the
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HQ Configuration menu and click the Manage Encryption Keys menu item.
Before any branch can be configured, you must click on the link to Create New Encryption Keys. Do this now.
When prompted, you should create backup copies of the encryption keys to keep in order to prevent loss of data. If you lose the encryption keys, you will lose access to all of your data encrypted with them. CamNtech will not be able to help you read your encrypted data – we do not have copies of your keys.
Close the Encryption Keys window after creating your new keys.
Enter Login Information
You will have been provided with your HQ login information by CamNtech as part of your purchase. To use this, first click on HQ Configuration Login Information.
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Enter all of the fields and click on the Save button. This will allow the software to connect to the data server as necessary.
Sync Folder
You must also select a folder for the software to store data on the HQ computer. Click on HQ Configuration Set Local Sync Folder in the menu to do so. This folder will contain all data transferred from the branch sites.
After configuring all of the items above, you may click on Sync Sync Now. This should produce no new data in the list, but no error messages either. This is because there is no data available yet on the server. Your HQ system is now configured.
11.3 Syncing with Cloud
To sync with the Cloud, click the Sync Now menu item in the Sync menu.
New recordings will be downloaded and decrypted, with a corresponding entry added to the recordings list as shown below:
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These recordings can be opened by selecting them in the recordings list and clicking the Sleep Analysis / Day Analysis options.
11.4 Branch Configuration File
A configuration file is used to automatically configure your branch computer(s) to sync recordings with the cloud. The configuration file is created by your HQ site computer and contains information such as login details and public encryption key.
Note: a single configuration file can be used on more than one computer per site but we would recommend using one configuration file per geographical location.
To create a new configuration file, click the Branch Configuration menu found on the HQ Manager window, and the click the Create New Configuration File menu item. The following window will be shown:
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Overview of fields: Site Name: provide a name for the site which the
configuration file will be used on. Site Code: provide a site code used to identify the site’s
recordings when data is synchronised with the HQ site. Recordings Folder Location: this is location of the
Recordings Folder Name (see below) on the branch computer where the encrypted recordings will be stored after they have been downloaded from a MotionWatch.
Recordings Folder Name: this is the name of the folder inside the Recordings Folder Location where the encrypted recordings will be stored after they have been downloaded from a MotionWatch.
Destination File Preview: shows the combined Recordings Folder Location and Recordings Folder Name and the folder structure within it.
Configuration File Name (without extension): provide a file name for the configuration file without an extension.
Configuration File Save Folder: click the Browse… link to specify a folder to save the configuration file to.
After providing the necessary information, click the Save button to save the configuration file and create the branch account on the cloud server.
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At this stage, you should transfer the configuration file to your branch site(s) using your own delivery method (such as secure email).
11.5 Branch Site Computer Configuration
Ensure you have created a configuration file as discussed in section 11.4.
Loading a Configuration File
Open the Cloud Data Configuration window from the main window (Menu Cloud Data Configuration).
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To load a configuration file, click the Browse… button and select your configuration file using the file selection dialogue.
The configuration information will be loaded and a configuration file and login check will be performed. A green tick will be shown next to the Configuration File field and one will be shown next to the Login Check field if these checks succeed.
Auto-Upload
The Auto-Upload feature automatically uploads new recordings to the cloud immediately after they have been downloaded from a MotionWatch.
To turn the feature on or off, click the On/Off buttons.
Clear Settings
To clear the currently loaded configuration information, click the Clear Settings button at the bottom of the window.
11.6 Synchronising Recordings with the Cloud
If you are using the Auto-Upload feature, recordings will automatically be uploaded to the cloud after they have been downloaded from a MotionWatch.
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If previously downloaded recordings were not uploaded (such as loss of Internet connection), you can manually sync them by clicking the Sync Now button on the Settings menu (Main Window Menu Sync Now).
The sync indicator will show on the Main Menu:
Clicking this indicator will open the Sync Status window:
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Appendix A - Maintenance and Utilities
A1 - The Utilities Tab
The MotionWatch manager has an additional tab called
‘Utilities’, click on this tab to display a window similar to the
following:
This screen shows some technical information about the MotionWatch:
Bootloader Ver: This is the version number of part
of the embedded operating software that allows the MW8 to be updated remotely.
Firmware Ver: This is the version number of the
main operating software for the MW8.
Serial Number: The watch serial number Battery voltage: Typically this will show a value
above 3.0V for a new battery and will decline gradually over the usage period.
Reset Count: Used as debug information the
number of unexpected reset events.
Run Time: amount of run time since last battery
change – should reset to zero when a new battery is fitted.
Battery Fitted Date: the date that the watch
battery was fitted.
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A2 - Firmware Update
The MotionWatch has the ability to be re-programmed when new features become available. It is always recommended that the most up-to-date firmware and PC software are used to avoid possible conflicts and data loss. To check for an update, select the ‘Utilities’ tab then click on the ‘Check for Update’ button. The software will provide a confirmation if an update is available for the MotionWatch.
To update the firmware, ensure that the MotionWatch is connected and then click on the ‘Update Firmware’ Button. Take note of the warning message and click OK if you wish to proceed.
IMPORTANT: All data and settings will be destroyed by
the firmware update process. Please ensure that any data has been downloaded before commencing.
WARNING! Do not interrupt the firmware update process –
doing so may damage the MotionWatch which will then require factory re-programming. A progress bar will indicate the update progress (this will take a few seconds). The MotionWatch will then automatically disconnect, apply the firmware, then re-connect. The MotionWatch Manager window will be temporarily closed during this period and will automatically re-load and show a verification message upon completion.
Depending upon the type of update, it may be necessary to manually re-set the MotionWatch. If the MotionWatch Manager does not re-load automatically, disconnect the Watch, remove the battery for at least 1 minute, re-fit and re-connect the USB. The verification message should then be shown.
A3 - Shutdown Options
The MotionWatch has a low power shutdown function which will help maximise the life of the battery. In the utilities windows, there are two options as follows:
Auto Shutdown After Download: this option
allows the MotionWatch to shutdown automatically following download. Data in the watch will NOT be lost but the watch will stop recording. When not selected, the MotionWatch will continue to record until its memory is full and then shutdown.
Shutdown Watch: Allows the watch to be
shutdown manually. Click this button to ensure the watch will be shut down when disconnected from the USB cable.
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A4 - Test Watch
These functions are not required in normal use of the MotionWatch. Do not use unless instructed to do so by a CamNtech representative.
A5 - Changing the Battery
The MotionWatch has been designed to facilitate quick and simple battery changing.
The change the battery, open the MW8 casing as
described in Section 1.1 An Overview of the MotionWatch System to expose the USB connection and battery.
Do not connect the USB cable!
Using a suitable tool, carefully push the battery out
from the holder towards the USB connector.
Grasp the battery and withdraw it completely from
the holder.
Wait at least 1 minute or press the marker button
3 times then place a fresh CR2032 battery into the
holder (ensuring correct orientation!) and push back until fully home.
Note: Data will NOT be lost by removal of the battery.
Observe the LED on the front of the MotionWatch, the correct start sequence is indicated as follows:
LED stays on for 4 seconds. LED goes off for 8 to 12 seconds. LED flashes once.
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This sequence is critical to the correct watch operation – if the LED does not flash, remove the battery and repeat the process.
The MotionWare software will automatically detect that a new battery has been fitted and display a warning
message requesting confirmation. Select ‘Yes’ and the
software should display 100% in the battery life indication. If the new battery is not detected it is possible to use the
‘new battery’ button in utilities. Note that there are two
levels of warning message. Do not use this option if a new battery has NOT been fitted – the watch may stop prematurely with no warning and the battery life indicator will be incorrect.
A6 - Waterproof Seal
The MotionWatch relies upon a rubber O-ring seal around the top face of the lower part of the casing. The seal should be periodically checked to ensure that it is correctly seated, clean and not damaged. (note that some silicone grease residue will be apparent – do not remove this). Periodically apply a small amount of silicone grease to ensure the seal remains supple.
A7 - MotionWatch Strap
The MotionWatch is supplied as standard with an extra­long moulded silicone watch strap. The strap is fitted with two standard 12-14mm watch spring bars. These bars are spring loaded to allow fitting and removal from the watch casing (see photo).
To remove the Strap: Use a flat bladed tool to gently
depress one end of the spring bar by levering against the side of the casing. Take care not to damage the MotionWatch casing.
To Fit a Strap: Push the spring bar into the hole through
the strap then place one end of the spring bar into one hole in the watch casing. Gently depress the exposed end of the spring bar and then slide into the hole in the casing; a positive ‘click’ will be heard.
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Replacement straps and alternative straps are available from CamNtech.
It is possible to use any standard watch strap with a 12 to 14mm shoulder with the MotionWatch.
A8 – Alternative Mountings
The MotionWatch may be worn at locations on the body other than the wrist. A range of elasticated straps is available to allow location on the waist, ankle, thigh or upper arm. There are also special straps for mounting on the feet for use with PLMS analysis. These mountings require the removal of the watch strap and the use of special Velcro mounting tabs. These attach using the same spring bars as the watch straps (see photos).
Fitted to Waist Strap with Adaptor
Velcro Mounting Tabs Fitted
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Appendix B – FAQ & Troubleshooting
What does ‘No data integrity
check’ mean?
The data is protected by a security key which is generated when the data is originally downloaded. Any changes to the data after the download (e.g. data corruption, tampering, editing, daylight saving adjustment) will result in the data integrity check failure. If a deliberate change has been made, the warning can be safely ignored. The original data can be restored if required following any deliberate edit.
Will I lose my data if I fit a new battery?
The MotionWatch uses non-volatile memory so any data stored will not be lost if the battery is removed or replaced. Note that the MotionWatch will automatically shut down when the battery voltage is low to prevent erroneous data. Always try to download data BEFORE fitting a new battery. If this fails, fit a new battery and then download immediately to prevent data loss.
The MotionWatch is not recognised or will not communicate:
Ensure that the battery has sufficient charge. If the battery has run down, the watch will not be recognised when attached to the USB port. Disconnect from the USB and remove then refit/replace the battery (see maintenance section for details of battery changing). Wait at least 1 minute before re-fitting the
battery and observe the correct start-up sequence.
Some types of Micro USB cable will not make a positive
connection – please use the cable supplied.
Occasionally the cable connector may become damaged
or worn – try a new USB cable.
The software offers to update the MotionWatch firmware – what does this mean?
The MotionWatch Software is shipped with the latest device operating firmware. If the software detects that any MotionWatch has older firmware, it will inform you that an update is available. It is recommended that firmware updates are applied to ensure that you benefit any improvements to the device (see maintenance section for details of battery changing).
What are the potential effects of Electromagnetic interference?
The MotionWatch system was designed to minimise the effects of external EMI upon the device and to minimise the effect upon the environment from the device. The system conforms to the appropriate standards with respect to EMI performance (see Appendix C5 - EMC Declaration and Guidance). In cases where strong EMI does affect the MotionWatch, the device will recover with no user intervention.
Can I change the Watch Strap?
Yes – see Appendix A7 - MotionWatch Strap above.
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Appendix C – Safety & Environmental Information
C1 - Decontamination
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 should use gloves to handle such devices before and during de-contamination.
C2 - Battery
The device is battery operated and operates at voltages
below 5V DC; there is hence no risk from electric shock.
The battery is user replaceable (refer to Appendix A5 -
Changing the Battery).
The battery is a standard Coin Cell type CR2032.
Always ensure that the battery used conforms to the safety standard EN60086-4:2007.
Battery is a swallowing hazard for small children –
do not leave small children unattended when the device casing is open. Take care when handling and disposing of coin cell battery.
C3 - Warnings – General
The MotionWatch is NOT defibrillation proof.
C4 - Disposal at End of Life
Waste Electrical & Electronic Equipment (WEEE) The EU requires, under the Waste Electrical and Electronic Equipment Directive 2002/96/EC that manufacturers and/or distributors of Electronic and/or Electrical Equipment manage and pay for the collection and further handling of WEEE products, as well as provide WEEE­related information to their customers. CamNtech has taken the following approach to complying with this Directive:
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 CNT.
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
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C5 - EMC Declaration and Guidance
The following tables provide a declaration of compliance and user guidance regarding Electromagnetic compatibility of the MotionWatch system.
Electromagnetic Emissions
Guidance and Manufacturers Declaration –
Electromagnetic emissions
The MotionWatch is intended for use in the electromagnetic environment specified below. The customer or the user of the MotionWatch should assure that it is used in such an environment.
Emissions Tests
Compliance
Electromagnetic environment ­guidance
RF Emissions
CISPR 11
Group 1
The MotionWatch uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF Emissions
CISPR 11
Class B
The MotionWatch is suitable for use in all 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
EN61000-3­2
Not
Applicable
Voltage Fluctuations / flicker emissions
EN61000-3­3
Not
Applicable
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Electromagnetic Immunity
Guidance and Manufacturers Declaration – Electromagnetic Immunity
The MotionWatch is intended for use in the electromagnetic environment specified below. The customer or the user of the MotionWatch should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test Level
Compliance
Level
Electromagnetic environment - guidance
Electrostatic Discharge (ESD)
IEC 61000-4-2
+/-6kV Contact
+/-8kV Air
+/-6kV Contact
N/A (#1)
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material. The relative humidity should be at least 30%.
Electrical Fast Transient/burst
IEC 61000-4-4
+/-2kV for power supply lines
+/-1kV for input/output lines
+/-2kV for power supply lines
+/-1kV for input/output lines
Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5
+/-1kV differential mode
+/-1kV common mode
N/T (#2)
N/T (#2)
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11
<5% UT (>95% dip in
UT) for 0.5
cycle. 40% UT
(60% dip in UT) for 5 cycles.
70% UT (30% dip in UT) for 25 cycles.
5% UT (95% dip in UT) for 5 seconds.
N/T (#2)
N/T (#2)
N/T (#2)
N/T (#2)
Power frequency 50/60Hz magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE - UT is the a.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.
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C6 - Applicable Standards:
The appropriate clauses of the following standards have been used as a means of demonstrating compliance.
Standard
Description
EN60601-1:2006
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
EN60601-1-2:2007
Medical electrical equipment – Part 1-2: Collateral standard: Electromagnetic compatibility – Requirements and tests.
See Appendix C for declaration and guidance
EN60601-1-11:2010
Medical electrical equipment – Part 1-11: Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
EN60601-1-6:2010
Medical electrical equipment – Part 1-11: Collateral standard: Usability
EN62304:2006
Medical device software – Software life-cycle processes
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Appendix D – Technical Specifications
Specifications
Functional Specifications
Size mm:
36(l) x 28.2(w) x 9.4(d) excluding strap
Weight:
9.1 grams (including battery, excluding strap)
Sensor:
Tri-axial, MEMs technology. 0.01g to 8g range, 3 – 11Hz
Battery:
CR2032 Lithium Coin Cell
Battery Life:
4 Months run time*; simple user change
Memory:
4Mbits non-volatile (120 days recording @ 1min epoch ­uncompressed)
Waterproof:
IPX7 - up to 1 hour at 1m (suitable for swimming)
Marker button:
Yes – with visual feedback
Epoch:
1, 2, 5, 15, 30, 60 seconds
Comms:
Direct USB, Plug & Play drivers, Micro USB cable.
Download:
All data in 50 seconds approx.
Strap:
Bespoke XL 12mm silicone (245mm overall length) or 12mm nylon
Light Sensor
Type:
Digital – human eye response optimized.
Range:
Automatic ranging; 0 to 64000lux
Resolution:
0.25lux (0-1000 lux range)
1.00lux (1000-4000 lux range)
4.00lux (4000-16000 lux range)
16.0lux (16000 – 64000 lux range)
Sampling:
1 sample per second – averaged over epoch
*Applies to MotionWatch Mode, Tri-Axial Mode is 3 Months.
Operating & Storage Conditions
Complies with the requirements of EN60601-1-11:2010
Operating
Storage
Temperature
+5°C to + 40°C
-25°C to +70°C
Relative Humidity
0 to 93%
0 to 93%
Atmospheric Pressure
70kPa to 106kPa
70kPa to 106kPa
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Accelerometer Processing
Raw acceleration measurements are processed by the on-board software of the MotionWatch to produce a quantitative measure of the activity during each epoch. This is a four stage process which is applied to the accelerometer data:
1. The channel perpendicular to the watch is separated and subjected to the bandwidth filtering specified above (3-11Hz).
2. The peak acceleration (either positive or negative) during each second is recorded.
3. This is compared to a minimum “not moving” threshold of approximately 0.1g. Values below this threshold are ignored to simplify the final activity graph.
4. The result from each second is summed over the epoch and scaled to produce a standard result in controlled jig testing. This value is then recorded as the MotionWatch count for the epoch.
This process is illustrated in the diagram below, showing the acceleration waveform over two epochs, each containing two seconds of data.
+35
+40
-25
-30
one second
First 2 second epoch
35 + 40 = 75
Second 2 second epoch
25 + 30 = 55
75 MW counts
55 MW counts
Sensitive in this
direction
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MW8 & MotionWare User Guide: Issue 1.2.1 Page 77
Tri-Axial Mode Data Processing
This is similar to above except all three axes are utilized to form counts based upon a peak vector magnitude.
1. The X, Y and Z axes are sampled with filtering at 3-11Hz.
2. The peak X2 + Y2 + Z2 value is found per second.
3. The square root of the sum of squares is calculated and added to the epoch sum.
4. This is compared to a minimum “not moving” threshold of approximately 0.1g. Values below this threshold are ignored to simplify the final activity graph.
5. The values are scaled to produce a ‘Tri-Axial count’ for the epoch.
The diagram below shows the X, Y, Z orientation relative to the watch casing:
MotionWatch XYZ axes: Tri-Axial mode
Z Axis
Y Axis
X Axis
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MW8 & MotionWare User Guide: Issue 1.2.1 Page 78
Appendix E – Utilities
E1 – CSV Import Utility
To allow import of data recorded with the Actiwatch Spectrum or Actiwatch 2, a CSV import utility is provided. Three steps are required to import the data:
1. Export the data in CSV format from the Actiware Software.
2. Load the CSV into the utility and perform the conversion.
3. Load the resulting AWD file into MotionWare.
Step 1 – Export the CSV
In the Actiware Software, select new analysis and then
click the Actogram button to show the graph of the required data.
Next set up the Actiware report generation (you should
only need to do this once).
From the tools menu, select ‘options’ and then click on
the export tab. Ensure that the ‘full header’ and ‘epoch- by-epoch list’ options are checked.
Now click the ‘data list’ tab and ensure that the ‘activity’
option is checked.
 Click OK to save and close the options window.  From the main file menu, select the ‘export…’ option –
ignore the reminder pop-up.
You can now choose the file name and location and
then save the export data as a csv file.
Step 2 – Convert the CSV Data
Run the CSV_Import utility from the MotionWare start
menu:
Click on the ‘Load CSV file’ button.
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MW8 & MotionWare User Guide: Issue 1.2.1 Page 79
Browse to locate the CSV file saved in step 1 and click
‘Open’
The user ID, Gender etc. from the exported CSV file
should be displayed.
Confirm that the recording details are correct in the
display.
If the details are not correct, the export may not be in
the correct format – please ensure the correct settings were applied in Actiware for CSV export.
Click ‘Save AWD’ to generate the output file.
Step 3 – Load the AWD File
Use the MotionWare software to browse for the AWD
file created in step 2. (Note you will need to change the ‘file type’ to .AWD to see the files):
Load the AWD file The data may now be analysed and re-saved as
required.
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MW8 & MotionWare User Guide: Issue 1.2.1 Page 80
Document Revision History
Issue From
Issue
To
Date
Description
Initiator
0.0
1.0
28/05/12
First draft Issue
HS
1.0
1.1
30/05/12
First Issue
HS
1.1
1.2
01/06/12
Added Utilities Tab information to section 8
HS
1.2
1.3
24/08/12
Added MotionWise view menu options + minor tweaks & additions
HS
1.3
1.4
10/10/12
Corrected MotionWatch counts mode
TE
1.4
1.5
07/01/13
Removed warning regarding use with pacemakers (section 10.5)
HS
1.5
1.0.12
06/03/13
Added 24 hour average graph, recent file management, csv import, moved safety info to front, moved rev history to back, changed issue no to match software.
HS
1.0.12
1.0.13
12/03/13
Added description of accelerometer processing, added details of auto-check for updates, added details of strap fitting.
TE/HS
1.013
1.0.13a
19/04/13
Changed FW update details
HS
1.0.13a
1.0.13b
30/05/13
Added details of ‘Longer periods’ menu and saved period functionality
HS
1.0.13b
1.0.14
22/06/13
Added battery gauge details.
HS
1.0.14
1.0.19
23/09/13
Added battery life update button details and details for minor revs.
HS
1.0.19
1.0.20
22/11/13
Updated software registration section
HS
1.0.20
1.0.20a
04/12/13
Added Australian Sponsor Details
HS
1.0.20a
1.0.20b
10/12/13
Updated indications for use to align with FDA submission
HS
1.0.20b
1.0.22
14/01/14
Updated screenshots and added instructions for new View options and Editing Data
TE
1.0.22
1.0.22a
31/01/14
Updated battery replacement procedure in section A5
HS
1.0.22a
1.0.27
24/04/14
Changed Battery Life, added section for nap analysis
HS
1.0.27
1.0.27a
25/06/14
Corrected battery gauge info, corrected sleep epoch r ecommendation
HS
1.0.27a
1.1.2
30/09/14
Added new reporting options and data compression details.
HS
1.1.2
1.1.5
22/10/14
Added Daytime Analysis section
TE
1.1.5
1.1.9
11/03/2015
Tweaked Day Analysis section, added updated screenshots and calibration i nfo
DW
1.1.9
1.1.15
28/05/15
Added Tri-mode, mounting locations + straps and misc. software revisions
HS
1.1.15
1.1.15a
07/07/15
Corrected email contact for E Van Someren in NPCRA section
HS
1.1.15a
1.1.20
17/11/15
Updated battery life info and battery fitted date to coincide with V1.1.20 SW
HS
1.1.20
1.1.21
13/01/16
Added ‘Definition of Result’ sub section which describes each day analysis
result in detail.
DW
1.1.21
1.1.25
29/06/16
Updated for V1.1.25 software and V03.20 firmware release
HS
1.1.25
1.1.25a
22/09/16
Added coin cell warning, updated accelerometer processing and CSV export sections.
HS
1.1.25a
1.1.25b
01/11/16
Added join files, daylight saving and restore data instructions
HS
1.1.25b
1.1.39
07/02/17
Updated descriptions of Zero/Non-zero data.
DW
1.1.39
1.2.1
30/03/17
Updated Day Analysis section, added CDM section
DW
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