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

MW8 & MotionWare User Guide: Issue 1.2.1 Page 3
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

MW8 & MotionWare User Guide: Issue 1.2.1 Page 4
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

MW8 & MotionWare User Guide: Issue 1.2.1 Page 5
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

MW8 & MotionWare User Guide: Issue 1.2.1 Page 8
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

MW8 & MotionWare User Guide: Issue 1.2.1 Page 9
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

MW8 & MotionWare User Guide: Issue 1.2.1 Page 10
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