CamNtech PRO-Diary Motion User manual

PRO-Diary User Guide 1.2.1 10/02/15 Page 1
The PRO-Diary Motion
User Guide
Document Reference: 30119
Version: 1.2.1
Date of current version: 10/02/2015
Author: Tom Evans
The PRO-Diary is a Class I Medical Device (EU)

PRO-Diary User Guide 1.2.1 10/02/15 Page 2
PRO-Diary Motion Regulatory Information
Medical Device Directive (European Union)
The PRO-Diary Motion 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 PRO-Diary is FDA cleared for prescription use only with FDA 510(k) number
K132764.
Manufacturer:
CamNtech Ltd
Upper Pendrill Court
Papworth Everard
Cambridgeshire
CB23 3UY, UK
Tel: [phone]
Fax: [phone]
Email: [e-mail]
Web: www.camntech.co.uk
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
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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IMPORTANT SAFETY INFORMATION
WARNINGS
Not Defibrillation proof.
Not indicated for use on areas of broken, damaged or irritated skin.
Devices removed from subjects must be considered to be contaminated –see SECTION12.
Safety Classification Information:
PRO-Diary Motion is INTERNALLY POWERED EQUIPMENT.
PRO-Diary Motion mode of operation is CONTINUOUS OPERATION.
PRO-Diary Motion is for PRESCRIPTION USE ONLY (RXonly) in the 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
IP42
The PRO-Diary is not suitable for immersion in water
(splash-proof –avoid contact with liquids if possible).
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 PRO-Diary is a TYPE B APPLIED PART.
(Internally Powered –no mains connection)
FOR FURTHER HANDLING & ENVIRONMENTAL INFORMATION PLEASE REFER TO SECTION 12

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Contents
IMPORTANT SAFETY INFORMATION ............................................................................................................3
WARNINGS...................................................................................................................................................3
Safety Classification Information:................................................................................................................3
Device and Packaging Symbols and Markings:..........................................................................................3
Contents...........................................................................................................................................................4
1Introduction to the PRO-Diary System....................................................................................................6
1.1 An Overview of the PRO-Diary System ...............................................................................................6
1.2 Intended Use.......................................................................................................................................7
1.3 Contraindications.................................................................................................................................7
1.4 Required Skills, Training & Knowledge of Intended Users...................................................................7
1.5 General Description of Use..................................................................................................................7
2Installing the PRO-Diary Software...........................................................................................................8
2.1 System Requirements.........................................................................................................................8
2.2 Software Installation Menu ..................................................................................................................8
2.3 Users upgrading from an earlier version of the Software .....................................................................9
2.4 Installing the USB Drivers....................................................................................................................9
2.5 Using the software for the first time ...................................................................................................10
3Charging the PRO-Diary Battery ...........................................................................................................11
3.1 Charging the Diary from the PC.........................................................................................................11
3.2 Charging the Diary using the Mains Power Supply............................................................................11
3.3 Charging Several Diaries from a USB Hub........................................................................................11
4Creating and Editing Questionnaires....................................................................................................12
4.1 Basic Concepts .................................................................................................................................12
4.2 Questions..........................................................................................................................................13
Multiple Choice.........................................................................................................................................13
Visual Analogue .......................................................................................................................................14
Enter a Number........................................................................................................................................14
Enter a Time.............................................................................................................................................15
Just a Message........................................................................................................................................15
List ...................................................................................................................................................16
Free Text..................................................................................................................................................16
Likert Scale ..............................................................................................................................................17
4.3 Questionnaires..................................................................................................................................17
4.4 Schedules .........................................................................................................................................17
Day Designation.......................................................................................................................................18
Time/Type of Entry...................................................................................................................................18
Motion Logging.........................................................................................................................................18
4.5 Locked and Unlocked Items ..............................................................................................................18
4.6 Creating a New Question Database ..................................................................................................19
4.7 Diary Menu Customisation.................................................................................................................19
4.8 Conditional Questionnaire Sequences...............................................................................................19
Quick Summary........................................................................................................................................19
Simple example (to omit some questions depending on a previous answer) ............................................20
Bigger example (to present a nested set of options).................................................................................21
Random Ordering Example......................................................................................................................24
5Setting up a Diary...................................................................................................................................25
5.1 User Name........................................................................................................................................25
5.2 Schedule...........................................................................................................................................25
5.3 Question Size....................................................................................................................................25

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5.4 Menu Customisation..........................................................................................................................25
5.5 Enable Keylock..................................................................................................................................26
5.6 Enable Demo Beeps..........................................................................................................................26
6Using the Diary.......................................................................................................................................27
6.1 Waking it up ......................................................................................................................................27
6.2 Using Menus and Answering Questions............................................................................................27
6.3 Answering a Scheduled Questionnaire..............................................................................................27
6.4 Requesting a Questionnaire..............................................................................................................27
6.5 Silent Mode .......................................................................................................................................28
6.6 Not Waterproof..................................................................................................................................28
6.7 Wearing & Strap options....................................................................................................................28
7Downloading Results.............................................................................................................................29
8Viewing Results......................................................................................................................................30
8.1 Filtering by Questionnaire..................................................................................................................30
8.2 Transposing the Results Table..........................................................................................................31
8.3 Filtering by Scheduled/Requested.....................................................................................................31
8.4 Exporting Motion Logging Data .........................................................................................................31
8.5 Other Exports/Data Analysis..............................................................................................................31
9Tutorial....................................................................................................................................................32
9.1 Create a Schedule.............................................................................................................................32
9.2 Waking Up.........................................................................................................................................34
9.3 Going to Bed .....................................................................................................................................37
9.4 Afternoon Tiredness..........................................................................................................................38
9.5 Using the Schedule...........................................................................................................................38
9.6 Downloading Results.........................................................................................................................39
9.7 Demonstrating a Timed Questionnaire..............................................................................................40
10 Frequently Asked Questions..............................................................................................................41
11 Additional Documents........................................................................................................................42
12 Safety and Handling Information.......................................................................................................43
12.1 De-contamination..............................................................................................................................43
12.2 Battery...............................................................................................................................................43
12.3 Water Ingress....................................................................................................................................43
12.4 Disposal ............................................................................................................................................43

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1 Introduction to the PRO-Diary System
1.1 An Overview of the PRO-Diary System
The PRO-Diary system consists of a wrist-worn electronic patient diary and
associated PC software which can record the user’s answers to questions during
daily living in a very flexible and easy to use way. The PRO-Diary incorporates a
tri-axial accelerometer to allow objective actigraphy data to be collected while the
device is worn. Actigraphy data may be saved and loaded into the CamNtech
MotionWare Software for off line analysis. The device is intended to monitor
limb or body movements during daily living and sleep. The PRO-Diary can be
used to assess activity in any instance where quantifiable analysis of physical
motion is desired.
The PRO-Diary has a built-in score pad that allows the wearer to subjectively
assign and enter responses to pre-programmed questions. The score pad can be
used as a substitute or in addition to the traditional written patient diary in
conjunction with activity monitoring.
The PRO-Diary system comprises of:
One or more PRO-Diary devices –to be worn or carried by the subject
PC software for designing questionnaires, setting-up, downloading,
viewing and exporting recorded answers
The PRO-Diary has a direct USB connection for setting up, downloading and
charging the battery. See Section 3 for details of battery charging and expected
life.
The PRO-Diary has a clear, high contrast OLED display and the character size
may be changed during configuration. The front panel keys are touch sensitive
and require no force to operate. There are three main controls: the function key
which has multiple functions, the select key which is generally used to choose a
selection and slider control which allows precise item selection by means of left
or right swiping movements.
‘Select’ Key
‘Function’ Key
Slider Control
OLED Display
USB Port

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1.2 Indications For Use
The PRO-Diary 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 PRO-Diary can be used to assess
activity in any instance where quantifiable analysis of physical motion is desired.
The PRO-Diary has a built-in score pad that allows the wearer to subjectively
assign and enter responses to pre-programmed questions. The score pad can be
used as a substitute or in addition to the traditional written patient diary in
conjunction with activity monitoring.
1.3 Contraindications
The PRO-Diary Motion 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.
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 PRO-Diary Motion provides patient diary functionality by means of PC
software based questionnaire configuration and upload to the device. The device
will automatically prompt the subject for input at pre-defined intervals or,
depending upon configuration, upon user request. The responses to the
questions are recorded to internal non-volatile memory and the date may then be
downloaded using the PC software. The resulting data may be exported for
further analysis in third party software packages.
The PRO-Diary Motion 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. Activity data recorded by the PRO-Diary may be analysed off-line
using the MotionWare Software Package.

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2 Installing the PRO-Diary Software
2.1 System Requirements
The PRO-Diary software is supplied on a CD-ROM containing all of the
components required to install the software package. The following are the
minimum requirements of a host PC for installing the PRO-Diary software:
Windows XP, Vista, Windows 7 or 8, 32 or 64bit operating systems.
IBM compatible 2GHz + processor speed recommended
500 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 Software Installation Menu
Place the CD-ROM into the drive; the software should start automatically and
display the following installation menu:
To install the software, click on ‘Install PRO-Diary PC Software’ and follow the
installation process. Note that the installation will differ for new users and existing
users as described in Section 2.3 below.
A message warning that ‘Publisher cannot be verified’ may be displayed – click
‘Run’ to accept. (this is a Windows security warning and is not a problem).
If the above menu is not automatically displayed, browse the CD and run the file
‘SplashMenu.exe’.
Note that the software requires the Microsoft .NET Framework 4 to operate –this
will be automatically installed if not present.

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2.3 Users upgrading from an earlier version of the Software
Upon following the procedure described in Section 2.2, users upgrading older
versions of software may be asked if they wish to repair or remove the existing
version of the software when the new software installation is run for the first time.
The option to remove should be selected and then the software installation run
for a second time to install the new version as described in Section 2.2.
A message warning that ‘Publisher cannot be verified’ may be displayed – click
‘Run’ to accept. (this is a Windows security warning and is not a problem).
2.4 Installing the USB Drivers
If the Installation menu is not already displayed, insert the supplied CD ROM into
the CD/DVD drive on the host PC then connect the PRO-Diary to a free USB
Port using the cable provided. The Installation menu should be automatically
displayed (as shown in Section 2.2).
Depending upon the operating system in use and the current driver status, the
computer may display a message saying ‘Found New Hardware’ and will then
load the drivers with no user intervention. If the drivers loaded automatically,
simply close the installation menu and the drivers should be ready to use.
If the drivers do not load automatically, you should select ‘Manually Install
CamNtech USB Drivers’ and carefully follow the on-screen instructions. If you
have any problems installing the drivers, please read the help document and
download the latest drivers from http://www.camntech.com/drivers.
During manual installation, a screen may appear that tells the user that the driver
is not digitally signed by Microsoft. Select ‘Continue Anyway’ (Please note that
this is NOT a problem and just means that the CamNtech version of the driver
software has not been assessed by Microsoft. In fact the actual drivers are
Microsoft approved). The drivers will be installed and the computer will then tell
the user that the new hardware is ready to use. If you change the USB port that
the reader is plugged into then the driver may be automatically re-installed by
Windows. This is an automatic process and the user need take no action.

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2.5 Using the software for the first time
Double clicking on the PRO-Diary icon on the desktop will start the software.
This will display the main menu as shown below. Each option is introduced in a
section of this guide.
EDIT QUESTIONNAIRES
Create or edit questions, questionnaires
and schedules.
See Section 4
SET-UP A DIARY
Apply the questionnaire to the PRO-Diary
with various use options.
See Section 5
DOWNLOAD RESULTS
Read the stored answers and activity data
from the PRO-Diary.
See Section 7
OPEN RESULTS VIEWER
View and export the answers and activity
data.
See Section 8