CamNtech MotionWatch 8 User manual

MW8 & MotionWare User Guide: Issue 1.2.1 Page 1
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

MW8 & MotionWare User Guide: Issue 1.2.1 Page 2
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: [phone]
Fax: [phone]
Email: [e-mail]
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 (RxOnly) - 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
1Introduction 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
2Installing 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
3The 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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4Downloading Data.......................................................................................... 23
4.1 MotionWatch Download........................................................................... 23
4.2 Saving MotionWatch Data........................................................................ 23
4.3 Shutdown after Download........................................................................ 24
4.4 Join Files ................................................................................................. 24
5Preparing 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
6Sleep 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
7NPCRA 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
824 Hour Average Plot..................................................................................... 45
8.1Select Data for Analysis........................................................................... 45
Smoothing Period .................................................................................... 45
Daytime Period........................................................................................ 45
Activity Average....................................................................................... 45
Day/Night Average Ratio.......................................................................... 45
Fitted Cosine Peak................................................................................... 45
9Nap 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 UpdatesNew 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